Q4 2023 Moderna Inc Earnings Call

February 22, 2024

Operator: Good day, and thank you for standing by. Welcome to the Moderna Fourth Quarter 2023 Conference Call. [Operator Instructions] Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today. Lavina Talukdar, please go ahead.

Operator: Good day, and thank you for standing by. Welcome to the Moderna Fourth Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question, you'll need to press *11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press *11 again. Please be advised, today's conference is being recorded.

Good day, and thank you for standing by walking through the mud during the fourth quarter of 2023 conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during the session I need to press star one on your telephone you will then hear an automated message advising your hand is raised to withdraw your question. Please press star.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised.

Operator: To withdraw your question, please press star 11 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today. Lavina Talukdar, please go ahead.

I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead.

Wouldn't want again, please be advised today's conference is being recorded I would now like to hand, the comps don't really speak today living in it to Luke Dr. Please go ahead.

Lavina Talukdar: Thank you, Kevin. Good morning, everyone. And thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2023 financial results and business updates. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stphane Bancel, our Chief Executive Officer; Steven Hoge, our president; and Jamey Mock, our chief financial officer.

Lavina Talukdar: Thank you, Kevin. Good morning, everyone. And thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2023 financial results and business updates. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stéphane Bancel, our Chief Executive Officer; Stephen Hoge, our President; and Jamey Mock, our Chief Financial Officer.

Luke: Thank you Kevin Good morning, everyone and thank you for joining us on today's call to discuss Mcdonalds fourth quarter and full year 2023 financial results and business update.

Speaker Change: You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investors section of our website.

Speaker Change: On today's call are Stefan Bansal, our chief commercial.

On today's call are Stphane Bancel, our Chief Executive Officer; Steven Hoge, our president; and Jamey Mock, our chief financial officer.

Speaker Change: Executive Officer.

Jamey Mock: Stephen Hoge, our president and Jamey mock our Chief Financial Officer.

Lavina Talukdar: Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I'll turn it over to Sepak. Thank you, Lavina. Good morning or good afternoon, everyone.

Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.

Jamey Mock: Before we begin please note that this conference call will include forward looking statements made pursuant to the Safe Harbor provisions of the private Securities Litigation Reform Act of $19 95.

Stphane Bancel: Please see slide two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward looking statements with that I'll turn it over to Stephane. Thank.

With that, I'll turn it over to Stephane. Thank you, Lavina. Good morning or good afternoon, everyone.

With that, I'll turn it over to Stéphane.

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of 2023. Jamey will then present our financial results. Stephen will then review our late-stage clinical programs, and I will close by sharing our 2024 priorities. Let me start with our mission. Moderna's commitment to deliver the greatest possible impact to people. Who am I?

Stéphane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of 2023. Jamey will then present our financial results. Stephen will then review our late-stage clinical programs, and I will close by sharing our 2024 priorities.

Stephane: Thank you lavina good morning, well good luck.

Stephane: Afternoon, everyone.

Stphane Bancel: Thank you for joining us today. I will start with a review of 2023. Jamey will then present our financial results, civil review, and review of late-stage clinical programs, and I will close by sharing our 2024 priorities. Let me start with our mission. Moderna's commitment to deliver the greatest possible impact to people. Who am I?

Stephane: Thank you for joining us today.

Stephane: We started with a review of 2023.

Stephane: Jimmy we've been pleased that our financial results.

Stephane: Stephen will then review our late stage clinical programs and then we can close by sharing ultimately default priorities.

Stephane: Then just talking about me Sean.

Let me start with our mission. Moderna's commitment to deliver the greatest possible impact to people through mRNA medicines. In 2023, every member of the Moderna team helped to advance our mission, which is a driving force that motivates our team every single day. We impacted more than 100 million people around the world. And we advance our development pipeline across all of our franchises, including infectious disease, oncology, and rare disease. 2023 was a difficult year as we transitioned from a pandemic to a seasonal endemic market. We reported sales of $6.1 billion for 2023, which was at the low end of our financial framework. These cells exclude the recognition of $600 million of deferred revenue from GAVI in the U.S. However, the vaccination rate was down year over year.

Stephane: <unk> commitment to deliver greater placebo impact to people.

Stephane: Melanie medicine.

Stphane Bancel: In 2023, every member of the Moderna team helped to advance publisher, which is a driving force that motivates our team every season. We impacted more than 100 million people around the world. And we advance our development pipeline across all of our franchises, including infectious disease, oncology, and rare disease. 2023 was a difficult year as we transitioned from a pandemic to a seasonal endemic market. We reported sales of $6.1 billion for 2023, which was at the low end of our financial framework. These cells exclude the recognition of $600 million of deferred revenue from GAVI in the U.S. However, the vaccination rate was down year over year.

Stephane: In 2020 free every member over more than that.

Stephane: Help to advance publisher.

Stephane: Which is a driving force that motivates our team every single day.

Stephane: We impacted moving 100 million people around the world and with backlog development pipeline across all of our franchisees liquidity picture. This is oncology and revenues.

Stephane: Yes.

Stephane: 2023 was a difficult year as we transition from a pandemic with seasonal endemic market.

2023 was a difficult year as we transitioned from a pandemic to a seasonal endemic market. We reported sales of $6.1 billion for 2023, which was at the low-end of our financial framework range. These sales exclude the recognition of $600 million of deferred revenue from Gavi. In the U.S., the vaccination rate was down year-over-year.

We reported sales of $6 1 billion of 2023.

Stephane: It was at the low end of our financial framework clash.

Stephane: These exclude the recognition of $600 million of deferred revenue from Gary.

Stephane: In the U S. The vaccination rates was down year over year.

Stphane Bancel: We are pleased that our U.S. commercial team drove an increase in our retail market share from 37% to 48%. Outside of the U.S., we were not able to compete in the EU market in the second half of 2023 due to a competitor contract, and our performance led to a low market share in Japan. We did have a strong performance in Israel, Switzerland, and Taiwan.

Stephane: We were pleased that the U S. Commercial team drove an increase in our retail market share from <unk>, 37% to 48%.

Stephane: Outside of the U S. We were not able to compete in the EU market in the second half of 2023 due to a competitive contract and.

Stephane: And the performance led to a low market share in Japan.

Stephane: We did have a strong performance in Israel, and Switzerland in Taiwan.

We did have a strong performance in Israel, Switzerland, and Taiwan.

We took several important actions in 2023 that will set our commercial COVID business up for success. We resized our manufacturing footprint, which has been established to support capacity at pandemic levels. We exited contract manufacturing relationships and reduced inventory levels. These initiatives will improve cash flow from our COVID business moving forward.

Stephane: We took several important actions in 2020 free that we've set our commercial corporate business <unk>.

Stephane: Yes.

Stephane: We resized the manufacturing footprint, which has been established to support capacity as pandemic levels.

Stephane: Exhibited contract manufacturing relationships and reduced inventory levels.

Stphane Bancel: These initiatives will improve cash flow from our COVID business moving forward. We have also flattened the commercial structure. All regions report directly to me now for more targeted self-execution and also better integration with the global business. We focus our R&D spending and our SG&A expenditures towards near-term growth and higher return on investment projects. While cellular challenges in 2023, our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with the Respiratory Vax.

These initiatives will improve cash flow from our COVID business moving forward.

Stephane: These initiatives will improve cash flow from our Covid business moving forward.

We also flattened the commercial structure. All regions report directly to me now for more targeted self-execution and also better integration with the global teams. We focus our R&D spending and our SG&A expenditures towards near-term growth and higher return on investment projects. While cellular challenges in 2023, our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with the Respiratory Vax.

Stephane: We've also flattened the commercial structure.

Stephane: All the regions, we pulled therapy to me now.

Stephane: Targeted solid execution and.

Stephane: <unk> better integration with global teams.

Stephane: We focus our R&D spending.

Stephane: SG&A expenditures towards near term growth and higher return on investment projects.

While sales were challenging in 2023, our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with the respiratory vaccine.

We're excited about challenging in 2023, our development team had a great year with excellent progress across many of our late stage pipeline programs.

Stephane: In 2023 with vessel pipeline and up nine late stage programs.

Let's start with respiratory vaccine for RSV, we filed for approvals around the World We reported positive data from our flu <unk> study.

Stphane Bancel: For RSV, we filed for approvals around the world. We reported positive data from a flu P303 study. And we are fully enrolled in the Phase III studies for our next-gen COVID, mRNA-1283, and the flu-plus-COVID combination vaccine, mRNA-1083. In our latent franchise, we are very excited that our Phase III CMV trial is now fully enroll. In our individualized neoantigen therapy program, or INT, where we partner with Merck, Phase III studies in adjuvant melanoma and non-small cell lung cancer are enrolled. We purchased and are currently building out a manufacturing site in Marlborough, Massachusetts to enable commercialization of our R&D program. Already, these therapy programs continue to progress well. We are in dose selection for the registrational study of a propionic acidemia program. In MMA, we are pleased to see improvements in biomarkers and clinical outcomes.

For RSV, we filed for approvals around the world. We reported positive data from a flu P303 study. And we are fully enrolled in the Phase III studies for our next-gen COVID, mRNA-1283, and the flu-plus-COVID combination vaccine, mRNA-1083. In our latent franchise, we are very excited that our Phase III CMV trial is now fully enroll. In our individualized neoantigen therapy program, or INT, where we partner with Merck, Phase III studies in adjuvant melanoma and non-small cell lung cancer are enrolling. We purchased and are currently building out a manufacturing site in Marlborough, Massachusetts to enable commercialization of our INT program. Already, these therapy programs continue to progress well.

Stephane: And we have fully enrolled in the phase III studies for our next income reason amounted 12, 80 fruit and fruit preps copied combination vaccine <unk> 10 in Q3.

Stephane: In our later franchise, we are very excited Thats all phase III <unk> trial is now fully enrolled.

Stephane: Individualized new Angiogenic therapy program.

Stephane: IMT, where we partner with mill Phase III studies in adjuvant melanoma, and non small cell lung cancer are enrolling.

Stephane: We purchased <unk>.

Stephane: Actually building out our manufacturing site in Marlborough, Massachusetts to enable commercialization of our R&D program.

Stephane: While rather disruptive programs continue to progress.

We are in dose selection for the registrational study of a propionic acidemia program. In MMA, we are pleased to see improvements in biomarkers and clinical outcomes. In research, we made 6 external investments, including 1 acquisition, which we expect will increase the strategic reach and also the breadth of our mRNA platform. Now turning to our 2023 financial summary, we reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to resizing of manufacturing, and a tax valuation allowance. We are pleased to end the year with cash and cash investments of 13.3 billion dollars. Let me talk to Jamey for more color on the final. Thanks, Japan, and hello, everyone.

Stephane: When growth in extra stress.

Stephane: Stretching those study of appropriately serving our program.

Stphane Bancel: In MMA, we are pleased to see improvements in biomarkers and synchro rates. In research, we made six external investments, including one acquisition, which we expect will increase the strategic reach and loss of breadth of our mRNA platform. Now turning to our 2023 financial summary, we reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to resizing of manufacturing, and a tax valuation allowance. We are pleased to end the year with cash and cash investments of 13.3 billion dollars. Let me talk to Jamey for more color on the final. Thanks, Japan, and hello, everyone.

In MMA, we are pleased to see improvements in biomarkers and synchro

Stephane: In MMA, we are pleased to see improved Matthew biomarker and clinical outcomes.

rates. In research, we made six external investments, including one acquisition, which we expect will increase the strategic reach and loss of breadth of our mRNA platform. Now turning to our 2023 financial summary, we reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to resizing of manufacturing, and a tax valuation allowance. We are pleased to end the year with cash and cash investments of 13.3 billion dollars. Let me talk to Jamey for more color on the final. Thanks, Japan, and hello, everyone.

Stephane: In research, we made six X amount of investments, including one acquisition, which we expect will increase this strategic rich and the rest of our breath, although I'm on your platform.

Now turning to our 2023 financial summary. We reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to resizing of manufacturing, and the tax valuation allowance. We are pleased to end the year with cash and cash investments of $13.3 billion dollars. Let me talk to Jamey for more color on the financials. Thanks, Japan, and hello, everyone.

Stephane: Now turning to our 2023 financial summary, we reported GAAP revenue of $6 8 billion.

Stephane: A net loss of $4 7 billion, primarily driven by mostly non cash charges of <unk> 7 billion related to risk I think our manufacturing and the tax valuation allowance.

Stephane: We're pleased to end the year with cash and cash investment of $30 3 billion.

Let me turn to Jamey for more color on the financials.

Stephane: Let me talk to Jamie for more color on our financials.

Thanks, Stéphane. and hello, everyone. Today, I will review our financial performance for both the fourth quarter and the full year of 2023. I'll also provide our financial framework for 2024. Let me start with a review of our commercial performance this year. In the first half of 2023, we reported product sales of $2.1 billion with the majority of sales from advanced purchase agreements signed for delivery in 2022 that were deferred into 2023. We do not expect these sales to repeat in 2024. In the second half of 2023, we recorded $4 billion in sales from seasonal endemic demand and an additional $600 million from deferred revenue related to Gavi. Sales in the fourth quarter were $2.8 billion, with $0.8 billion in sales in the U.S., and $0.6 billion in Europe and $1.4 billion in the rest of the world, including deferred revenue from Gavi.

Jamey Mock: Thanks, Stéphane. and hello, everyone. Today, I will review our financial performance for both the fourth quarter and the full year of 2023. I'll also provide our financial framework for 2024. Let me start with a review of our commercial performance this year. In the first half of 2023, we reported product sales of $2.1 billion with the majority of sales from advanced purchase agreements signed for delivery in 2022 that were deferred into 2023. We do not expect these sales to repeat in 2024.

Jamie: Thanks, Stefan and Hello, everyone.

Jamey Mock: Today I will review our financial performance for both the fourth quarter and the full year of 2020. I'll also provide our financial framework for 2024. Let me start with a review of our commercial performance this year. In the first half of 2023, we reported product sales of $2.1 billion. With the majority of sales from advanced purchase agreements signed for delivery in 2022 that were deferred into 2023, we do not expect these sales to repeat in 2024. In the second half of 2023, we recorded $4 billion in sales from seasonal endemic demand and an additional $600 million from deferred revenue related to Gavi. Sales in the fourth quarter were $2.8 billion, with $0.8 billion in sales in the U.S., and $0.6 billion in Europe and $1.4 billion in the rest of the world, including deferred revenue from Gavi.

Jamie: Today, I will review our financial performance for both the fourth quarter and the full year of 2023.

Jamie: Also provide our financial framework for 2024.

Jamie: Let me start with a review of our commercial performance this year.

Jamie: In the first half of 2023, we reported product sales of $2 1 billion.

Jamie: With the majority of sales from advanced purchase agreement signed for delivery in 2022 that were deferred into 2023, we.

Jamie: We do not expect these sales to repeat in 2024.

In the second half of 2023, we recorded $4 billion in sales from seasonal endemic demand, and an additional $600 million from deferred revenue related to GAVI. Sales in the fourth quarter were $2.8 billion, with $0.8 billion in sales in the U.S., and $0.6 billion in Europe and $1.4 billion in the rest of the world, including the deferred revenue from Gavi. For the full year 2023, product sales were $6.7 billion, comprised of $1.7 billion in sales in the U.S., $1.4 billion in Europe, and $3.6 billion in the rest of the world, again, including deferred revenue from Gavi.

Jamie: In the second half of 2023, we recorded $4 billion in sales from seasonal endemic demand and an additional $600 million from deferred revenue related to <unk>.

Jamie: Sales in the fourth quarter were $2 8 billion.

Jamie: With zero point $8 billion in sales in the U S and <unk> $6 billion in Europe, and $1 4 billion and the rest of the world, including the deferred revenue from <unk> for.

Jamey Mock: For the full year 2023, product sales were $6.7 billion, comprised of $1.7 billion in sales in the U.S., $1.4 billion in Europe, and $3.6 billion in the rest of the world, again, including deferred revenue from GAVI. Moving to side 10. As mentioned, net product sales were $2.8 billion this quarter, a 43% decrease from last year. This was largely attributable to the anticipated reduction in sales volume, which was partially offset by a higher average selling price. This decrease is indicative of the evolving market dynamics as we navigate the transition of the COVID-19 vaccine market towards a more predictable seasonal pattern like traditional flu vaccine. The cost of sales was $929 million, down from 39% of net product sales in the previous year to 33% this year.

For the full year 2023, product sales were $6.7 billion, comprised of $1.7 billion in sales in the U.S., $1.4 billion in Europe, and $3.6 billion in the rest of the world, again, including deferred revenue from GAVI.

Jamie: For the full year 2023 product sales were $6 7 billion comprised.

Jamie: Comprised of $1 $7 billion in sales in the U S $1 4 billion in Europe, and $3 6 billion and the rest of the world again, including deferred revenue from guidance.

Moving to side 10. As mentioned, net product sales were $2.8 billion this quarter, a 43% decrease from last year. This was largely attributable to the anticipated reduction in sales volume, which was partially offset by a higher average selling price. This decrease is indicative of the evolving market dynamics as we navigate the transition of the COVID-19 vaccine market towards a more predictable seasonal pattern like traditional flu vaccine. The cost of sales was $929 million, down from 39% of net product sales in the previous year to 33% this year.

Jamie: Moving to slide 10 as mentioned net product sales were $2 8 billion. This quarter of 43% decrease from last year. This was largely attributable to the anticipated reduction in sales volume, which was partially offset by a higher average selling price.

Jamie: This decrease is indicative of the evolving market dynamics as we navigate the transition of the COVID-19 vaccine market towards a more predictable seasonal pattern like traditional flu vaccines.

Cost of sales was $929 million, down from 39% of net product sales in the previous year to 33% this year. This is a demonstration of our strategic efforts in Q3 to resize our manufacturing footprint, which, as expected, led to additional charges in Q4 of $169 million, primarily related to the wind-down of certain contract manufacturing operations. Additionally, cost of sales also includes an inventory write-down of $322 million, reflecting revised demand forecasts. R&D expenses increased by 16% to $1.4 billion.

Jamie: Cost of sales was $929 million down from 39% of net product sales in the previous year to 33% this year.

Jamie: This is a demonstration of our strategic efforts in Q3 to resize, our manufacturing footprint, which as expected led to additional charges in Q4 of $169 million, primarily related to the wind down of certain contract manufacturing operations.

Jamie: Additionally cost of sales also includes an inventory write down of $322 million, reflecting revised demand forecasts.

Jamie: R&D expenses increased by 16% to $1 4 billion.

R&D expenses increased by 16% to $1.4 billion. This uptick reflects our commitment to advancing our late-stage clinical development program, particularly with our RSV vaccine, CMV vaccine, combination vaccine against flu, and COVID-19, as well as our INT program. The increase also included an upfront payment of $120 million associated with the strategic research and development collaboration with Immatics. SG&A expenses were $470 million, up 25% year-over-year.

Jamie: This uptick reflects our commitment to advancing our late stage clinical development programs.

Jamie: Particularly with our RSV vaccine CMV vaccine combination vaccine against flu and COVID-19, as well as our <unk> program.

Jamie: The increase also included an upfront payment of $120 million associated with the strategic research and development collaboration with <unk>.

Jamie: SG&A expenses were $470 million up 25% year over year.

SG&A expenses were $470 million, up 25% year-over-year. The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U.S. market. Income tax with a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 U.S. tax return. Net income for the quarter was $217 million compared to $1.5 billion in the fourth quarter last year. Diluted earnings per share was $0.55 compared to $3.61 in 2022. We closed the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter.

Jamie: The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U S market.

Jamie: Income tax was a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 U S tax return.

Jamie: Net income for the quarter was $217 million compared to $1 5 billion in the fourth quarter last year.

Jamey Mock: Diluted earnings per share was $0.55 compared to $3.61 in 2022. We closed the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter. Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to Gavi. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework.

Diluted earnings per share was $0.55 compared to $3.61 in 2022. We closed the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter.

Jamie: Diluted earnings per share was <unk> 55, compared to $3 61 in 2022.

Jamie: We closed the quarter with a strong cash position of $13 3 billion.

Jamie: Which is slightly higher than the $12 $8 billion, we had at the end of the prior quarter.

Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to GAVI. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework.

Jamie: Now, let's turn to our annual performance on page 11.

Jamie: Net product sales for the full year 2023 were $6 7 billion.

Jamie: A decrease of 64% from the previous year.

Jamie: Mainly due to lower sales volume of our COVID-19 vaccine.

Jamie: As mentioned earlier. This includes the recognition of <unk> 6 billion from the deferred revenue related to Gavin.

Jamie: Excluding this item our sales of $6 $1 billion, we're still in line with the framework, we provided for the full year.

Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operations, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework. Research and development spend was $4.8 billion, and SG&A was $1.5 billion, both in line with our expectations. Our income tax provision was $772 million for the full year 2023.

Cost of sales for the full year represented 70% of net product sales a substantial increase from 29% of product sales in 2022.

Jamie: This shift is largely attributable to our strategic efforts to optimize our manufacturing operations, resulting in charges of $1 6 billion.

Jamie: And other manufacturing and distribution costs over reduced sales volume.

Jamie: Overall cost of sales came in at $4 7 billion.

Jamie: Slightly below the 5 billion, we provided in our latest framework.

Research and development spend was $4.8 billion, and SG&A was $1.5 billion, both in line with our expectations. Our income tax provision was $772 million for the full year 2023.

Jamie: Research and development spend was $4 $8 billion and SG&A was $1 $5 billion, both in line with our expectations.

Jamie: Our income tax provision was $772 million for the full year 2023.

Jamie: During our Q3 earnings call, we discussed the requirement under GAAP to establish a valuation allowance against deferred tax assets when the current year and cumulative income projection for the next three years is in a loss position.

During our Q3 earnings call, we discussed the requirement under GAAP to establish a valuation allowance against deferred tax assets when the current year and cumulative income projection for the next 3 years is in a lost position. It's important to note that future income from products not yet approved by regulators are excluded from these income projections, which restricts us to just our COVID vaccine, and it does not include expected future launches. This valuation allowance does not impact future cash flows, future cash returns or the company's ability to utilize deferred tax assets in future periods. The net loss for the year was $4.7 billion, compared to a net income of $8.4 billion last year.

During our Q3 earnings call, we discussed the requirement under GAAP to establish a valuation allowance against deferred tax assets when the current year and cumulative income projection for the next three years is in a lost position. It's important to note that future income from products not yet approved by regulators are excluded from these income projections, which restricts us to just our COVID vaccine, and it does not include expected future launches. This valuation allowance does not impact future cash flows, future cash returns or the company's ability to utilize deferred tax assets in future periods.

Jamie: It is important to note that future income from products not yet approved by regulators are excluded from these income projections.

Jamie: Which restricts us to just our Covid vaccine and it does not include expected future launches.

This valuation allowance does not impact cash flows future tax returns or the company's ability to utilize deferred tax assets in future periods.

Net loss for the year was $4 7 million compared to net income of $8 4 billion last year the.

Net loss for the year was $4.7 billion, compared to net income of $8.4 billion last year. The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023. Diluted loss per share was $12.33 compared to diluted earnings per share of $20.12 in 2022. So now let's move to slide 12. We wanted to provide you additional perspective on our full year financial results. By presenting them alongside a summarized version that excludes the impact of the Gavi Deferred Revenue Recognition, our resizing charges, and the tax valuation. Our total gap net loss for the full year was $4.7 billion.

Jamie: The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023.

Jamie: Diluted loss per share was $12 33 compared to diluted earnings per share of $20 12 in 2022.

Speaker Change: So now let's move to slide 12, we wanted to provide you additional perspective on our full year financial results.

Speaker Change: By presenting them alongside a summarized version that excludes the impact of the <unk> deferred revenue recognition on a re sizing charges and the tax valuation allowance.

So now let's move to slide 12. We wanted to provide you additional perspective on our full year financial results by presenting them alongside a summarized version that excludes the impact of the GAVI deferred revenue recognition, or resizing charges, and the tax valuation allowance. Our total GAAP net loss for the full year was $4.7 billion. However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion.

Speaker Change: Our total GAAP net loss for the full year was $4 7 billion. However, when excluding these primarily noncash items. The net loss was reduced to $1 6 billion.

Speaker Change: Now, let's turn to our 2024 financial framework on Slide 13, which is mostly in line with what I shared on our Q3 call.

Speaker Change: We expect net sales for 2024 or approximately $4 billion.

However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion.

Speaker Change: Which we think will be a low point as we expect to return to growth in 2025.

Now let's turn to our 2024 financial framework on slide 13, which is mostly in line with what I shared on our Q3 call. We expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025. Sales in the first half of the year are expected to be approximately $100 million, reflecting the strong seasonality of respiratory vaccines. We expect a cost of sales of approximately 35% of product sales, in line with our cost of sales framework, which we introduced in our Q3 earnings call last year. For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2022. We also expect taxes to be negligible in 2024.

Speaker Change: Sales in the first half of the year are expected to be approximately $100 million rift.

Speaker Change: Reflecting the strong seasonality of respiratory vaccines.

Speaker Change: We expect cost of sales of approximately 35% of product sales in line with our cost of sales framework, which we introduced in our Q3 earnings call last year.

Speaker Change: For R&D, we expect full year expenses to be approximately $4 5 billion.

Speaker Change: Down from $4 8 billion in 2023 and for SG&A, We expect full year expenses to be approximately $1 3 billion.

Speaker Change: Down from $1 5 billion in 2023.

Speaker Change: We also expect taxes to be negligible in 2024.

Speaker Change: And our Q3 earnings call I provided our Mcdonough operating principles, which largely centered around a very disciplined approach to capital allocation.

For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2022. We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principals, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mostly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to see revenue of approximately $9 billion in 2024. I will now turn the call over to... Thank you, Jamey. Good morning or good afternoon, everyone.

Speaker Change: Our number one priority has been and will continue to be reinvesting in the business.

Speaker Change: In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately zero point $9 billion as we mostly complete the construction of our facilities across the globe.

Jamey Mock: In our Q3 earnings call, I provided our Moderna operating principals, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mostly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to see revenue of approximately $9 billion in 2024. I will now turn the call over to... Thank you, Jamey. Good morning or good afternoon, everyone.

Speaker Change: Our teams are laser focused on operational improvements for both expense management and working capital.

In our Q3 earnings call, I provided our Moderna operating principles, which largely centered around a very disciplined approach to capital allocation. Our #1 priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mostly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to... Thank you, Jamey. Good morning or good afternoon, everyone.

Speaker Change: As a result, we expect to end 2024 with approximately $9 billion in cash I will now turn the call over to Steven.

Steven: Thank you Jamie good morning, or good afternoon, everyone.

Steven: Today I'll do a quick review of our clinical highlights from our late stage programs in 2023, and then look ahead to anticipated milestones in 2024.

Steven: While we have over 40 programs in development, but ill focus on our late stage pipeline, which consists of nine programs across four franchises.

Steven: Made significant progress in 2023.

Steven: Four of these programs are in our respiratory vaccine franchise, we hope to launch all of these potential products by the end of 2025.

Steven: These further enrollment.

Steven: The other five late stage programs are spread across late in vaccines oncology therapeutics and rare disease Therapeutics, we hope to begin launching these beginning in 2026 and I'll discuss our progress in these areas as well.

cash. I will now turn the call over to... Thank you, Jamey. Good morning or good afternoon, everyone.

cash.

I will now turn the call over to Stephen. Thank you, Jamey. Good morning or good afternoon, everyone.

I will now turn the call over to Stephen.

Thank you, Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they'll focus on our late-stage pipeline, which consists of nine programs across four franchises, all of which made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdar, The other five late stage programs are spread across late infection.

Stephen Hoge: Thank you, Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2024. While we have over 40 programs in development, they'll focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our respiratory vaccine franchise. We hope to launch all of these potential products by the end of 2025. I'll discuss this further in a moment.

Steven: In infectious disease vaccines.

Steven: Many important clinical milestones.

Steven: <unk>.

Steven: Within our respiratory vaccine franchise, we felt for RSV vaccine approvals in many countries around the world.

While we have over 40 programs in development, they'll focus on our late-stage pipeline, which consists of 9 programs across 4 franchises, all made significant progress in 2023. 4 of these programs are in our respiratory vaccine franchise. We hope to launch all of these potential products by the end of 2025. I'll discuss this further in a moment. The other five late stage programs are spread across late infection.

Steven: We recently.

Steven: Presented follow up data from our phase III study at the RSV VW meeting then I'll recap in a moment.

Steven: Our mrna 10, 10 flu program, our phase III <unk> III study met its primary safety endpoint and hit all eight co primary immunogenicity endpoints against all strains of influenza.

Steven: We're also excited that we fully enrolled the phase III Immunogenicity and safety study of our Nextgen Covid vaccine.

Steven: And the phase III Immunogenicity safety and safety study of our flu and Covid combination vaccine.

The other 5 late-stage programs are spread across latent vaccines, oncology therapeutics and rare disease therapeutics. We hope to begin launching these in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones in 2023. Within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase III study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza.

The other five late-stage programs are spread across latent vaccines, oncology therapeutics and rare disease therapeutics. We hope to begin launching these in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones in 2023. Within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase III study at the RSVVW meeting that I'll recap in a moment.

Steven: In our Layton and other vaccine franchise, we're proud of the great progress our team made to complete enrollment in the phase III study of our CMV vaccine in 2023 that study is now accruing cases towards its first interim analysis of efficacy.

Stephen Hoge: We hope to begin launching these in 2026, and I'll discuss our progress in these areas as well. For infectious disease vaccines, we've achieved many important clinical milestones. Within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza.

Steven: On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023.

Steven: The study met its primary and key secondary endpoints, leading the DSM be to recommend unblinded.

Steven: Vaccine efficacy was 83, 7% against RSV with two or more symptoms at the lower respiratory tract disease at a median follow up of three seven months with a wide range of two weeks to 12 months of total follow up.

In our mRNA-1010 flu program, our Phase III P303 study met its primary safety endpoints and hit all 8 co-primary Immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase II Immunogenicity and Safety study of our next-gen COVID vaccine and the Phase II Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the Phase III study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND.

In our mRNA-1010 flu program, our Phase III P303 study met its primary safety endpoints and hit all eight co-primary Immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase II Immunogenicity and Safety study of our next-gen COVID vaccine and the Phase II Immunogenicity and Safety study of our Flu and COVID combination vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the Phase III study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy.

Steven: The primary analysis showed also showed 82, 4% and 68, 4% vaccine efficacy against three or more symptoms and acute respiratory distress respectively.

Stephen Hoge: We're also excited that we fully enrolled the phase three immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND.

Steven: These data were recently published in the New England Journal of Medicine in December of last year.

Steven: We've continued to follow the participants in the trial and pronounced follow up data at the Rspb RSV VW conference earlier this month.

Steven: And additional analysis showed sustained vaccine efficacy against RSV with <unk> of 63, 3% against RSV lower respiratory tract disease with two or more symptoms through a median follow up of $8 six months and a maximum follow up 17 seven months.

On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend unblinded. Vaccine efficacy was 83.7% against RSV with 2 or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of 2 weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against 3 or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7.

Steven: The vaccine efficacy was 74, 6% against RSV lower respiratory tract disease associated with shortness of breath, which has been shown to be a key driver of seeking a higher level of medical care and the associated burdens cost.

Slide 19 summarizes the overall timing of enrollment primary efficacy analysis and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial.

Steven: Our trial enrolled steadily over 13 months between November 2021, and December 2022.

Steven: As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021, and 2022 and the much more significant RSV season of 2022 and 2023.

We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV lower respiratory tract disease, with 2 or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7 months. The vaccine efficacy was 74.6% against RSV lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial enrolled steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021 and 2022 and the much more significant RSV season of 2022 and 2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding.

Steven: Due to enrollment throughout the year. The median follow up of the primary analysis was three seven months, but as I noted the maximum follow up was 12 months.

The primary analysis made its success criteria leading to steady unwinding.

Steven: We continue the Preplanned additional analysis on April 30 of 2023.

Steven: That means at that analysis. The median follow up was eight 6%.

Steven: Maximum follow up of $17 seven months or put another way approximately 17000 persistence. We're between nine and 18 months of study follow up at the time of the analysis with many completing their second RSV season on the study.

Steven: Per protocol, we are continuing to follow cases through one year, but it is evident from the epidemiology very few cases would be expected in the six months. After the April 30th cutoff date from the last analysis.

Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial enrolled steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021 and 2022 and the much more significant RSV season of 2022 and 2023. Due to enrollment throughout the year, the median follow-up of the primary analysis was 3.7 months. But as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria leading the study Unblinding.

Steven: In summary, we are pleased the data show sustained efficacy through two seasons, including the large RSV season of 2022, 2023, and we look forward to providing further updates from this ongoing study.

Steven: We also achieved clinical milestones across our therapeutic franchises in 2023.

Steven: In oncology, our individualized Neo engine therapy developed in partnership with Merck began phase III clinical studies in both adjuvant melanoma and non small cell lung cancer.

Both phase III trials are now actively enrolling.

Steven: Our primary analysis from the Phase II study was recently published in the lancet, giving greater detail on the two year follow up data that we had released in 2022.

Steven: Now in December of 2023, we shared top line follow up data from that same phase II study in adjuvant melanoma patients confirming the durability of the initially reported responses.

Stephen Hoge: We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6 months, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants were between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSV season on the study. Per protocol, we are continuing to follow cases through 1 year, but it is evident from the epidemiology, very few cases would be expected in the 6 months after the April 30th cutoff date from the last analysis. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling.

We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6 months, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants were between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSV season on the study. Per protocol, we are continuing to follow cases through one year, but it is evident from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last analysis.

Steven: At a median follow up of now three years, the recurrence free survival in distant metastasis free survival remained extremely favorable with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death of 62% both results were highly statistically.

Steven: Significantly in three years.

Steven: And in PAA in M&A, our most advanced rare disease therapeutic programs, we continued to see positive clinical data in our phase one two studies, including improvements in Biomarkers and clinical outcomes such as metabolic decompensation.

Steven: Turning to slide 21.

Speaker Change: While we're proud of the progress in 2023, we have much more head in 2024, let me take you through some of the late stage milestones, we anticipate for this year.

In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023. And we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. In oncology, our individualized neoantigen therapy developed in partnership with Merck, began Phase III clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase III trials are now actively enrolling.

Speaker Change: Start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine beginning in the first half of 2024 with commercial launches shortly thereafter.

Speaker Change: With our flu vaccine we are in discussions with regulators about potential submissions for approvals and we expect to begin filing this year.

Speaker Change: Phase III data from our Nextgen Covid vaccine is expected in the first half of 2024, which will inform the next steps and we expect phase III data for our flu and Covid combination vaccine this year.

Speaker Change: In Layton vaccines, we're looking forward to potential efficacy data from our CMV phase III study.

Stephen Hoge: Our primary analysis from the Phase II study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same Phase II study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distal metastasis or death by 62%. Both results were highly statistically significant at three years.

Speaker Change: In oncology, we expect continued progress enrolling our two phase III studies.

Speaker Change: For adjuvant melanoma, and non small cell lung cancer. We also expect to expand into additional tumor types. This year.

Speaker Change: And finally in rare diseases, we expect to move into Registrational studies for both PAA and MMA in 2024.

Speaker Change: It'll be a very busy year, and we look forward to sharing progress with you as the year progresses with that I'll turn the call over to Stephane.

Stephane: Thank you Stephen and Jamie.

Stephane: For mobile now and the patients we serve.

Stephane: 2024 is all about execution.

Stephane: <unk> commercial.

Stephane: Execution of our late stage pipeline.

Stephane: And execution with financial discipline.

Stephane: So I think we've commercial.

Stephane: Our COVID-19 vaccine.

Stephane: We will continue to work with health authorities to increase vaccination rates and improved public health by reducing the substantial burden of disease from Covid in this upcoming 2020 for 2025 season.

Both results were highly statistically significant at three years

And in PA and MMA, our most advanced rare disease therapeutic programs, we continue to see positive clinical data in our Phase I/II studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensations. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approvals for our RSV vaccine beginning in the first half of 2024, with commercial launches shortly thereafter.

Stephane: While I am pleased with the U S market share outcome of our current season I believe we can and must do better on vaccination rates.

Now returning to slide 21, while we're proud of the progress in 2023. We have much more ahead in 2024. Let me take you through some of the late-stage milestones we anticipate for this year. I'll start with our respiratory franchise, where we are targeting the first approvals for our RSV vaccine beginning in the first half of 2024, with commercial launches shortly thereafter.

Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approvals for our RSV vaccine beginning in the first half of 2024, with commercial launches shortly thereafter.

Stephane: Our team actively working on it already.

Stephane: A few weeks ago, the <unk> published a new ammonia COVID-19 vaccine tender.

Stephane: Up to 36 million doses per year for up to four years.

Stephane: Our team is actively working to respond to this number.

Stephane: We are prioritizing our commercial focus on specific markets around the world to deliver where it matters. The most.

With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase III data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase III data for our flu and COVID combination vaccine this year. In latent vaccines, we are looking forward to potential efficacy data from our CMV Phase III study. In Oncology, we expect continued progress enrolling our two Phase III studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types this year.

Stephane: Moving to our RSV vaccine candidate.

Stephane: We are very excited about launching our RSV vaccine this year.

Stephen Hoge: Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps, and we expect phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell

Stephane: We will also have a second product.

Stephane: While our monarch platform is delivering.

Stephane: The FDA <unk> date is may 12.

Stephane: You'd be outcome is positive we anticipate that it will include <unk> 45 on the agenda in late June.

Stephane: In Europe, we expect Germany to launch in 2024.

Stephane: So expect us to launch this year, what other markets will actually launch in 2025.

Stephane: In many markets around the world, we need to secure regulatory approval before we can participate in candles.

Stephen Hoge: We also expect to expand into additional tumor types. And finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie.

We also expect to expand into additional tumor types.

Stephane: Communicated last year, given expected approval by the U S, Germany, and Australia, we anticipate losses in this market is probably around five.

And finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stéphane.

Stephane: The Aussie market is estimated to be $10 billion opportunity consisting of roughly 6 billion in all the other <unk>.

Stephane: In the pediatric and methanol setting.

With that, I'll turn the call over to Stéphane.

Stephane: In 2023, the first tier IV vaccine launches consumer awareness of RSV.

Stphane Bancel: Thank you, Stephen and Jamey. For Moderna and the patients we serve, 2024 is all about execution: execution in commercial, execution of all late-stage pipelines, and execution with financial discipline. Starting with commercial. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is actively working on it already.

Stéphane Bancel: Thank you, Stephen and Jamey. For Moderna and the patients we serve, 2024 is all about execution: execution in commercial, execution of all late-stage pipelines, and execution with financial discipline.

Stephane: <unk> is the vaccine was strong.

Stephane: For 2023, others argue vaccine market was around $2 5 billion.

Stephane: This is quite impressive given you wrote their first tier RSV vaccine who are variable.

Stephane: Even the variable for a full year and the products we offer in many countries.

Starting with commercial. First, our COVID vaccine. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is actively working on it already. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this tender. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most.

Stephane: We have 2020, the vaccination right as a small percentage of the total addressable market. We are quite excited to launch a product into this large and growing market.

Speaker Change: Let me now turn to RSV vaccine profile.

Speaker Change: We believe we have the best profile to serve patients and completing the allergy market.

Speaker Change: <unk> safety.

Speaker Change: Ease of use.

Speaker Change: Our clinical data show strong vaccine efficacy.

Speaker Change: Well established safety and Tolerability profile that Leverages the same amount of technology that has been delivered.

Stphane Bancel: A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most.

Speaker Change: 1 billion Covid vaccine.

Speaker Change: Additionally, Additionally, we have not seen any case of your priority to grow Mark UBS phase III trial.

Speaker Change: We expect to be the only company to offer an RSV vaccine in ready to use quickly to reach a PFS.

Speaker Change: Our one step administration comprehensive well.

Speaker Change: Relative to competitive products and requirements for proprietary steps by pharmacists and clinicians.

Stphane Bancel: Moving to RSV vaccine candidates, we are very excited about launching the RSV vaccine this year. That will be the launch of our second product our mRNA platform is delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024. We also expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders.

Moving to RSV vaccine candidates, we are very excited about launching the RSV vaccine this year. That will be the launch of our second product our mRNA platform is delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024. We also expect Australia to launch this year, while other markets will likely launch in 2025.

Speaker Change: As you know one of our competitor product required nine step of progression for each consumer <unk> Andy.

Speaker Change: And the other competitors' products required post type of propulsion.

Speaker Change: We've got 90% of U S D vaccine given to date in the pharmacy setting.

Speaker Change: Presentation of the ease of use.

Speaker Change: I'm saving.

Speaker Change: And the potential to reduce medical errors.

Speaker Change: Given the that work stoppage in retail pharmacy channel, we anticipate our PFS presentation would be welcomed by pharmacist in a very busy respiratory vaccine season, where pharmacies nib. In addition to very good golf out. So let me spell flu vaccine COVID-19 vaccine and RSV vaccine.

In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the U.S., Germany and Australia will anticipate launching early in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal set. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine were strong. The 2023 adult R&D vaccine market was around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RIV vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay.

Speaker Change: Two that we talked about how much progress we made in the late stage pipeline in 2023.

Stphane Bancel: As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal set. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine were strong. The 2023 adult R&D vaccine market was around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RIV vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay.

Speaker Change: This year, we look forward to continued execution and reporting microphone in each of these programs.

The RSV market is estimated to be a $10 billion opportunity, consisting roughly of $6 billion to $8 billion in older adults and $2 billion to $4 billion in the pediatric and maternal set. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine were strong. The 2023 adult RSV vaccine market was around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 RSV vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Let me now turn to our RSV vaccine profile. We believe we have the best profile to serve patients and compete in the RSV market, efficacy, safety and ease of use.

Speaker Change: If you look at this slide it is going to be a very busy and very exciting year with multiple phase III readouts like with Kobe Nextgen also throughput COVID-19 phase III data and potentially CMV phase III data.

Speaker Change: Well first of all we're going to be fighting products like through which will be our first product.

Speaker Change: And of course approvals in many countries around the world for RSV.

Speaker Change: Finally, we are all committed to exercising financial discipline across the business.

Speaker Change: While we have resized, our manufacturing footprint in 2023, we will continue to find ongoing cost improvement in manufacturing.

Speaker Change: We will reduce operating expenses in R&D and SG&A and protest programming R&D, we've been near term commercial potential in areas of unmet medical need.

Speaker Change: Overall, our capex will be up mostly modestly in 2024 compared to 2000 and quantified and.

Let me now turn to our RSV vaccine profile. We believe we have the best profile to serve patients and compete in the RSV market, efficacy, safety and ease of use. Our clinical data shows strong vaccine efficacy. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré Syndrome or GBS in our Phase III trial. We expect to be the only company to offer an RSV vaccine in ready-to-use pre-filled syringes, or PFS. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require 4 steps of preparation. With over 90% of U.S. RSV vaccines given to date in the pharmacy setting, PFS presentations offer ease of use time saving, and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcome by pharmacists in a very busy respiratory vaccine season where pharmacists need in addition to their regular tasks to administer the flu vaccine, COVID vaccine, and RSV vaccine.

Speaker Change: And were mostly complete construction of several important class.

Speaker Change: Marlborough, Massachusetts for IMT, and Canada, UK and Australia.

Speaker Change: In 2025, we expect capex to be down significantly.

Speaker Change: We're also targeting working capital improvement and importantly, as you know we are adopting AI across the business, which we expect to save time increased productivity and reps capability. In addition to cost savings.

Speaker Change: Use of AI is increasing by the week and use cases, I think we will see how our teams are embracing this new tool across the business.

We expect to be the only company to offer an RSV vaccine in ready-to-use pre-filled syringes, or PFS. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product requires nine steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation.

Speaker Change: In summary, 2024 is an important year of execution across our company.

Speaker Change: One is we set the stage for the next several years.

Speaker Change: I am very excited our company's position.

Speaker Change: I believe 2024 will be a year, where many of our model now go from thinking of us as a COVID-19 vaccine company.

Stphane Bancel: As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSU vaccine, and the other competitors' products require four steps of preparation. We have over 90% of USRG vaccines given to date in a pharmacy setting. PFS presentations offer ease of use.

Speaker Change: So we're seeing more than that as the name on a platform company with several products and.

Speaker Change: And more progress on the way for 2025 and beyond.

With over 90% of U.S. RSV vaccines given to date in the pharmacy setting, PFS presentations offer ease of use, time saving, and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcome by pharmacists in a very busy respiratory vaccine season where pharmacists need in addition to their regular tasks to administer the flu vaccine, COVID vaccine, and RSV vaccine.

Speaker Change: Over the next few year, our ability to deliver on Misha will increase significantly and be very meaningful for us.

Stphane Bancel: I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made in the Let's Touch pipeline for 2025. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts, like the COVID next gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be finding products like flu. This will be our third product file and, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business.

I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine.

Speaker Change: Operator, we'd be now happy to take questions.

Speaker Change: Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered wishing with yourself from the queue. Please press star one again and to accommodate everyone. In the queue. We ask that you limit yourself to one question, we will pause for a moment, while we compile our Q&A roster.

Today we talked about how much progress we made in the late stage pipeline in 2023. This year, we look forward to continued execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple Phase III readouts, like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be finding products like flu. This will be our third product file and, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business.

Today we talked about how much progress we made in the late stage pipeline in 2023. This year, we look forward to continued execution and reporting milestones in each of these programs.

Speaker Change: Our first question comes from Michael Yee with Jefferies. Your line is open.

Michael Yee: Hey, guys good morning, and thanks for the question.

Michael Yee: Focusing on RSV I know you've made a number of nice comments about comparing the data.

If you look at this slide, it is going to be a very busy and very exciting year with multiple Phase III readouts, like the COVID next-gen, also flu plus COVID Phase III data, and potentially CMV Phase III data. But we're also going to be finding products like flu, which will be our third product file and, of course, approvals in many countries around the world for RSV. Finally, we are all committed to exercising financial discipline across the business.

Michael Yee: Maybe you could talk to two or three points one is.

Michael Yee: Perhaps how it will work in the commercial market in the U S. With contracting is that contracting season or do you have to have contracts and how does that work between the two different other competitors.

Michael Yee: Secondly, how would that work at the pharmacy level when either patients or doctors are making the selection given the fact that the Pfizer and GSK both had similar sales, but different profiles, maybe talk to those two different things and how you expect that to play out for this year. Thank you.

Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing. We will reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical needs. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We are also targeting working capital improvement.

Speaker Change: Great. Thank you Mike.

Speaker Change: So in terms of contracting obviously, we cannot start constructing now because our product is not approved but our medical team has been quite engaged across the board at.

Speaker Change: At Medical conference is talking to healthcare professionals and sharing the great data that was published in December as you know from our phase III in the New England Medicine. So we have active discussions base quite high exact math about the possibility again EBIT product for us to be approved to get the prefilled syringe product.

Overall, our CAPEX will be up mostly--modestly in 2024 compared to 2023, and we'll mostly complete construction of several important plants in Marlborough, Massachusetts for INT and Canada, the U.K. and Australia In 2025, we expect CAPEX to be down significantly. We are also targeting working capital improvement.

Speaker Change: As we discussed in my remarks.

Speaker Change: As you know labor stoppages, our big issue in pharmacy for any of those that have gone through a pharmacy in the fall.

Speaker Change: You could see <unk> <unk> cell therapy, two hectic and so the leadership of our big retail pharmacies.

We are also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and decrease scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years?

We are also targeting working capital improvement.

are also targeting working capital improvement.

And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and drive scalability in addition to cost savings. Our use of AI is increasing by the week. And new use cases are exciting to see how teams are embracing this new tool across the business. In summary, 2024 is an important year of execution across our company, one that we set the stage for the next several years.

Speaker Change: We engage to think about coffee at verso, OFC and helps us simplify the work for us to reduce medical errors, which is why those medical discussion thats driving so far do you mean significant hope that the products will be meaningful to us for all customers.

Stphane Bancel: And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and decrease scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years?

Speaker Change: Thank you. Our next question comes from Gena Wang with Barclays. Your line is open.

In summary, 2024 is an important year of execution across our company, one that we set the stage for the next several years. I am very excited by how our company is positioned. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to seeing Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for our teams. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again.

Gena Wang: Thank you.

Gena Wang: I have two very quick questions first one is regarding the RSV vaccine.

Gena Wang: Portion of Dougherty.

Stphane Bancel: I am very excited. I have been waiting for this for a long time. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again.

Gena Wang: 85% to 36000 participants that completed two seasons and regarding February 29 meeting.

Gena Wang: Additional data will be presented and very quickly on 2024 guidance now we have a better understanding of both cogan RSV market size for 2023, and 2024 season, what could be the upside or downside for you our 2020 for revenue guidance for Damien.

With that, Operator, we'll be now happy to take questions. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again.

With that, Operator, we'll be now happy to take questions.

Great: Great. Thanks, Gino I'll take the first part of that.

Operator: Thank you, ladies and gentlemen, if you have a question or a comment at this time, please press *11 on your telephone. If your question has been answered and you wish to remove yourself from the queue, please press *11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We'll pause for a moment while we compile our Q+A roster. Our first question comes from Michael Yee with Jeffries. Your line is open.

Damien: So I actually cant I don't know off the top of my head the proportion because there are both some in.

Damien: Southern and northern Hemisphere participants that were rolled in the study and so counting the two RSV seasons will depend upon upon that it is.

Damien: Visible proportion.

Operator: And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A roster. Our first question comes from Michael Yee on Jeffries. Your line is open. Hey, guys.

Damien: Because as I said the maximum follow up at the additional analysis about 18 months medium was nine months and so by definition about half as you just said about 17000 participants here between the <unk> and we did enroll pretty continuously over 13 months not exactly evenly but pretty close to it so.

Operator: Our first question comes from Michael Yee with Jefferies. Your line is open.

Michael Yee: Hi, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is it contracting season, or do you have to have contracts? And how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both have similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out for this year? Thank you.

Damien: I don't want to give you an accurate number but I would suspect it is a pretty sizeable proportion because of that steady pretty consistent enrollment over the course of 13 months its not exactly.

Damien: <unk>, but but it trended that direction.

Damien: As far as additional data for the CIP meeting, we will obviously continue to provide updates for many additional analysis. We're doing on durability. We obviously had the immunogenicity data as well as data across different sub populations.

Damien: And if we're fortunate enough to have the opportunity to present at the CIP. We will of course listened to their community on anything they would like to see as well on the performance of $13 45, as a vaccine and the performance of the vaccines in general in terms of durability.

Stphane Bancel: Thank you. Great, thank you Michael, Stphane. So, in terms of contracting, obviously, we cannot start contracting now because the product is not approved, but our medical team has been quite engaged across the board at medical conferences, talking to healthcare professionals, and sharing the great data that was published in December, as you know, for Phase 3 in the New England Journal of Medicine. So, we have active discussions, and there is quite high excitement about the possibility, again, if a product was to be approved, to get As we discussed in my remarks, as you know, labor shortages are a big issue in pharmacy. For any of us that have gone to a pharmacy in the fall, you could see it was very busy, sometimes a bit too hectic, and so the leadership of a big retail pharmacy is very engaged to think about COVID versus RRSE and how to simplify the workflow, how to reduce medical errors, which is why those medical discussions that we've had Thank you. Our next question comes from Gena Wang, and the Barclayser Line is open. Thank you. I have two very quick questions.

Thank you. Great, thank you Michael, Stphane. So, in terms of contracting, obviously, we cannot start contracting now because the product is not approved, but our medical team has been quite engaged across the board at medical conferences, talking to healthcare professionals, and sharing the great data that was published in December, as you know, for Phase 3 in the New England Journal of Medicine. So, we have active discussions,

Thank you.

Stéphane Bancel: Great, thank you Michael. I'm Stéphane. So in terms of contracting, obviously, we cannot start contracting now because our product is not approved, but our medical team has been quite engaged across the board at medical conferences, talking to healthcare professionals, and sharing the great data that was published in December, as you know, for our Phase III in the New England Journal of Medicine. So we have active discussions.

Damien: Guidance.

Damien: Decision, making around repeat dosing or boosting on some scheduled and the public health.

Speaker Change: Thanks, Steven and Jean on the upside than downside on the sales for this year I think on the upside obviously the COVID-19 in Europe as I just mentioned.

There is quite high excitement about the possibility, again, if a product was to be approved, to get a prefilled syringe product. As we discussed in my remarks, as you know, labor shortages are a big issue in pharmacy. For any of us that have gone through a pharmacy in the fall, you could see it was very busy, sometime a bit too hectic. And so the leadership of a big retail pharmacy is very engaged to think about COVID versus RSV and how to simplify the workflow, how to reduce medical errors, which is why those medical discussions that we're having so far give me a significant hope that our products will be meaningful tools for our customers. Thank you. Our next question comes from Gena Wang, and the Barclayser Line is open. Thank you. I have two very quick questions.

Speaker Change: We don't participate in the market last fall.

Speaker Change: The new tender is an opportunity for us to participate quite a number of doctors hospitals public video I've actually complained that the malaria vaccine given their higher efficacy reported for reduction of hospitalization was not available, especially for the elderly for immunocompromised people stuffs and interesting.

Speaker Change: Site of both vaccination rates in the U S. As we reported the vaccination rates in the current ending season was lower than last year as I said in my remarks, we need to do better to protect more people.

Speaker Change: <unk> actively already working.

Thank you. Our next question comes from Gena Wang from Barclays. Your line is open. Thank you. I have two very quick questions.

Operator: Thank you. Our next question comes from Gena Wang from Barclays. Your line is open.

Speaker Change: Most of them out there too.

Speaker Change: To address the VCR and increase vaccination rates and you have upside could be if the bulk of a market growth as well as I'll share how quickly can we get share from the current two solutions are anymore on the downside of course, the vaccination rates could be a downside.

Thank you. I have 2 very quick questions. The first one is regarding the RSV vaccine. What portion of 35,000 to 36,000 participants that completed 2 seasons? And regarding February 29 ACIP meeting, what additional data you will be presenting? And very quickly on 2024 guidance. Now we have a better understanding of both COVID and RSV market size for 2023 and 2024 seasons. What could be the upside or downside for your 2024 revenue guidance of $4 billion? Great, thanks, Gina. I'll take the first part of that. So I actually can't, I don't know off the top of my head the proportion because there are both Southern and Northern Hemisphere participants that were enrolled in the study, and so counting the two RSV seasons will depend on that.

Gena Wang: Thank you. I have two very quick questions. The first one is regarding the RSV vaccine. What portion of 35,000 to 36,000 participants that completed two seasons? And regarding February 29 ACIP meeting, what additional data you will be presenting? And very quickly on 2024 guidance. Now we have a better understanding of both COVID and RSV market size for 2023 and 2024 seasons. What could be the upside or downside for your 2024 revenue guidance of a $4 billion?

Speaker Change: And do you have a window of course timing of always being given.

Speaker Change: When we rollout the regulators all over your approval of products and then the public capital commendations lacks CDC have a different <unk> in the different countries that took off.

Speaker Change: <unk> delayed launches of course impacting sales.

Speaker Change: Thank you.

Speaker Change: Thank you. Our next question comes from Ellie Merle with UBS. Your line is open.

Stephen Hoge: Great, thanks, Gina. I'll take the first part of that. So I actually can't--I don't know, off the top of my head, the proportion because there are both Southern and Northern Hemisphere participants that were enrolled in the study. And so counting the two RSV seasons will depend upon that.

Speaker Change: Okay.

Ellie Merle: Hey, guys. Thanks, so much for taking the question just turning to the CMV phase III can you talk a little bit about what you would view as clinically meaningful or commercially relevant on vaccine efficacy.

Ellie Merle: If successful also how are you thinking about your <unk> negative breast in Seattle.

Ellie Merle: Okay.

Speaker Change: For sure. So thank you for the question so in CMV.

Stephen Hoge: It is a sizable proportion because, as I said, the maximum follow-up at the additional analysis is about 18 months. Median was 9 months. And so, by definition, about half, as you just said, about 17,000 participants were between it. And we did enroll pretty continuously over 13 months, not exactly evenly, but pretty close to it. So I don't want to give you an inaccurate number, but I would suspect it is a pretty sizable proportion because of that steady, pretty consistent enrollment over the course of 13 months. It's not exactly equal, but it trended that direction.

Speaker Change: Obviously, there is currently no vaccine that can prevent infection against CMV.

Speaker Change: And as it is a source of devastating.

Speaker Change: Birth defects.

Speaker Change: Anything that provides a statistically significant reduction in the rate of infection, and therefore vertical transmission would be.

Speaker Change: Would be we think terrific now the minimum bar that we are powering a study would support is a vaccine up to approximately 50% as we pared.

Speaker Change: As shared previously anything above that would obviously beat our expectations and be incredibly exciting for the field.

As far as additional data for the ACIP meeting, we will obviously continue to provide updates from any additional analysis we're doing on durability. We obviously have Immunogenicity data as well as data across different subpopulations. And if we're fortunate enough to have the opportunity to present at the ACIP, we will, of course, listen to the committee on anything they would like to see as well on the performance of mRNA-1345 as a vaccine and the performance of vaccines in general in terms of durability as it guides decision making around repeat dosing or boosting on some schedule in the public health.

Speaker Change: We are in the phase III study enrolling both seropositive and zero negative participants and part of the reason for that is that there's currently no broadly use diagnostic and so we want to demonstrate.

Speaker Change: Benefit our safety in both populations.

Speaker Change: Because we do believe that the most likely use of the vaccine could be that it's given regardless of cero status to both you and I guess I'm sort of positives and there are potential benefits for zero positives that could include control of shedding or viremia or other long term cycle of CMV, but we would have to approve those and again those are not something we're exploring split.

Speaker Change: In the current phase III study.

Stéphane Bancel: Thanks, Stephen. And Gena, it's Stéphane. On the upside and downside on the sales for this year, I think on the upside, obviously, the COVID in Europe, as I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, for immunocompromised people. So that's an interesting upside.

Speaker Change: As a practical matter from a labeling perspective, and a launch perspective, our goal is to try and launch the product for both seropositive Encierro negatives no diagnostic would be needed and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission two to newborn babies.

Speaker Change: Thank you. Our next question comes from <unk> Singh with Oppenheimer. Your line is open.

Hartaj Singh: Great. Thank you.

Hartaj Singh: Kate is that.

Hartaj Singh: Enrollment for CMV this year and maybe have a readout can you just walk us through the steps.

Hartaj Singh: How that would look like and maybe just give us some ideas.

Speaker Change: Tuscola assumptions. Thank you.

Stphane Bancel: Of course, the vaccination rate in the U.S., as we reported, the vaccination rate in the current ending season was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is actively already working in a cross-functional matter to address the VCR and increase the vaccination rates. And the other upside could be the RSV both the market growth, as well as our share, how quickly can we get share from the current two solutions available.

Kate: Yes of course, thanks, sorry to ask so we're currently fully enrolled and we are accruing cases in that study and I think as we've said before we've actually made substantial progress.

Speaker Change: And the number of cases it is a case driven endpoint and we will need to see approximately 80 cases before we will do the first interim analysis for efficacy.

Kate: That.

Kate: That 81 cases to be specific.

Kate: That interim analysis strategy will look a lot like our other vaccine efficacy studies.

Kate: SMB will we'll evaluate that data and if we meet the statistical threshold, which is Earl for early efficacy, meaning we're doing better than our minimum of 49, 5% vaccine efficacy then they will at that moment tell us to unwind and share the results and of course, we will share them broadly with the world.

On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC over different ITAGs in different countries, that could, of course, delay launches and, of course, impacting sales. Thank you.

Kate: If for whatever reason, we don't quite have the statistical power in that first interim analysis efficacy. The study is powered to continue on and continue to accrue cases.

Operator: Thank you. Our next question comes from Ellie Merle with UBS. Your line is open.

Kate: Towards the final analysis of efficacy.

Kate: Given the rate of.

Ellie Merle: Hi, guys. Thanks so much for taking the question. Just turning to CMV Phase III, can you talk a little bit about what you would view as clinically meaningful or commercially relevant on vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? Thanks.

Kate: The final analysis at 112 cases.

Kate: Now given the rate of a case of crew that we are currently seeing in the study we do expect that we will have more than enough cases this year.

Kate: We are therefore, we're pretty confident that we're going to be seeing a readout.

Kate: From the interim analysis, possibly even a final analysis for efficacy in 2024, but again since its case and event driven we just have to bide our time.

Stephen Hoge: For sure. So thank you for the question. So in CMV, you know, obviously, there's currently no vaccine that can prevent an infection against CMV. And as it is a source of devastating birth defects, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are powering in our study would support is a vaccine efficacy of approximately 50%, as we've shared previously, anything above that would obviously exceed our expectations and be incredibly exciting for the field.

Kate: And ultimately.

Kate: We will depend upon the DSM V to tell us whether or not we've met that statistical threshold.

Kate: Okay.

Kate: Thank you. Our next question comes from Luca <unk> with RBC capital. Your line is open.

Luca: Great. Thanks, so much for taking my question, maybe Steve maybe.

Luca: Can you remind us what's your latest thinking in terms of potential for accelerated approval there for melanoma and then maybe on the additional tumor types did you guys and Merck are thinking about it can you just maybe talk about what are the tumor types, you're contemplating and wetter does tumor types are going to be in the adjuvant settings or in the metastatic setting and then maybe on <unk>.

Stephen Hoge: We are in the Phase III study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic. And so we want to demonstrate benefit or safety in both populations because we do believe that the most likely use of the vaccine could be that it's given regardless of sero status to both seronegatives and seropositives. And there are potential benefits for seropositives that could include control of shedding or viremia or other long-term sequelae of CMV, but we would have to prove those. And again, those are not something we're exploring explicitly in the current Phase III study. So as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it could be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborn babies. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open.

We are in the Phase III study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic. And so we want to demonstrate benefit or safety in both populations because we do believe that the most likely use of the vaccine could be that it's given regardless of sero status to both seronegatives and seropositives. And there are potential benefits for seropositives that could include control of shedding or viremia or other long-term sequelae of CMV, but we would have to prove those. And again, those are not something we're exploring explicitly in the current Phase III study. So as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it could be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborn babies.

Luca: <unk> quickly can you just maybe expand on durability in the context of your competitor.

Speaker Change: Is there a scenario where each recommenced the GSK vaccine for every other year for some of your vaccine for every year any color there much appreciate it. Thanks so much.

Speaker Change: Quite a few questions there I'll try and get them I apologize if I, if I forget any one.

So first on the question of IMT and accelerated approval in the adjuvant melanoma setting.

Speaker Change: So as we've said before we continue to be really excited by the data and are excited to start looking to talk to regulators about it there have been three things that we've tried to say that had to be true for us to believe it is appropriate to even ask about accelerated approval. The first was we had to see durability and clearly the data that we just saw from dish.

And again, those are not something we're exploring explicitly in the current Phase III study. So as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it could be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborn babies.

Speaker Change: Remember just two months ago shows that durability and really clear statistically significant result.

Speaker Change: Where the.

Operator: Thank you. Our next question comes from Hartaj Singh with Oppenheimer. Your line is open.

Speaker Change: Comparator arm the control arm looks really just like the labeled data and so we're incredibly encouraged by that durability that was criteria one but the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase III study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence.

Hartaj Singh: Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps of how that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you.

Speaker Change: To allow that confirmatory data to come in so that three years or four years from now that further readout would confirm anything that would happen and accelerated approval context, and then the third and perhaps.

Stephen Hoge: Yes, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis for efficacy. That-- 81 cases to be specific. That interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data. And if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they will, at that moment tell us to unblind and share the results. And of course, we will share them broadly with the world. If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112.

Speaker Change: Now increasingly important criteria was that we had to establish the commercial manufacturing facility and so as we've announced we've been building a facility in Marlborough, Massachusetts.

Speaker Change: There'll be a purpose built personalized individualized new agent therapy.

Speaker Change: Facility.

Speaker Change: That is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval.

Speaker Change: That facility is coming online, we look forward to hosting many of you and others.

Speaker Change: In tours as we bring it online, but without that facility there isn't really a product here to talk about and so all three of them are essential we're making progress on all three and I think the most exciting thing is what you were just alluding to which is the durability of the benefit we've been seeing really causes us to lean into completing.

If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112 cases.

Speaker Change: Working hard to complete the enrollment of that confirmatory study criteria, two and finish the build out of that Marlborough facility, which is the third criteria.

Speaker Change: Now in the point of other indications that we're going after.

Speaker Change: <unk>.

Speaker Change: We will I will.

Speaker Change: Deferred work and by our partners Merck on the specifics we will do it together at the right time opening up additional phase III Confirmatory studies, we do expect to open multiple this year.

Stephen Hoge: Now, given the rate of a case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are, therefore, pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold.

Those include some additional adjuvant indications. They also include some potential metastatic indications and we are looking at monotherapy indications.

Speaker Change: There can be either in places where.

Speaker Change: Where PD ones Keytruda may not be indicated or even earlier lines of therapy and so all of those are under consideration.

Stephen Hoge: And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Uluka Issi with RBC Capital. Your line is open.

And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold.

Operator: Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open.

Speaker Change: And as soon as we start those studies up and begin enrolling of course, we'll make announcements about them with our partner Merck.

Stephen Hoge: Great. Thanks so much for taking my question. Maybe, Stephen, on INT, maybe you could remind us what's your latest thinking in terms of potential for accelerated approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about it, could you just maybe talk about what the tumor types that you're contemplating and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated.

Great. Thanks so much for taking my question. Maybe, Stephen, on INT, maybe you could remind us what's your latest thinking in terms of potential for accelerated approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about it, could you just maybe talk about what the tumor types that you're contemplating and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings?

Luca Issi: Great. Thanks so much for taking my question. Maybe, Stephen, on INT, maybe you could remind us what's your latest thinking in terms of potential for accelerated approval there for melanoma?

Speaker Change: Now lastly on the question of RSV.

Speaker Change: We continue to be really enthusiastic about the data of our that our product CASM and I think the the durability now shown through these two the second large season is quite encouraging.

And then maybe on the additional tumor types that you guys and Merck are thinking about it, could you just maybe talk about what the tumor types that you're contemplating and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings?

Speaker Change: We'll be sharing that data with the CIP well first we have to.

Speaker Change: Get through the regulatory process and approval in.

Speaker Change: In this country and Stefan mentioned that our <unk> date in May.

Speaker Change: And if we have the opportunity will be sharing the data.

And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? Any color there, much appreciated. Thanks so much.

Speaker Change: With the ACI.

Speaker Change: Which includes in our case booster data on Immunogenicity from from ongoing work that has actually already previously been presented publicly.

Speaker Change: At meetings and so just like our competitors.

Stephen Hoge: Thanks so much. There are quite a few questions. I'll try and answer them.

Thanks so much.

Quite a few questions there. I'll try and get them all. I apologize if I forget any one. So, first, on the question of INT and accelerated approval in the adjuvant melanoma setting. So, as we've said before, we continue to be really excited by the data, and are excited to start looking to talk to regulators about it. There have been 3 things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first was we had to see durability.

Stephen Hoge: Quite a few questions there. I'll try and get them all. I apologize if I forget any one. So, first, on the question of INT and accelerated approval in the adjuvant melanoma setting. So, as we've said before, we continue to be really excited by the data, and are excited to start looking to talk to regulators about it.

Speaker Change: We have shared data of what a second dose looks like in terms of boosting neutralizing antibody titers back up both at one year and we're also going to be looking at two years.

Stephen Hoge: I apologize if I forget anyone. So, first, on the question of INT and accelerated approval in the adjuvant setting. So, as we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability.

Speaker Change: And all of the data ourselves as well as that booster similar booster data from from the competitor products will likely be.

Speaker Change: Brought together to inform the ACI piece recommendation of how they think.

There have been 3 things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first was we had to see durability. And clearly, the data that we just saw from December, just 2 months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so, we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important.

There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first was we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so, we're incredibly encouraged by that durability. That was criteria one.

Speaker Change: RSV vaccines should be re administered.

Speaker Change: When when a booster might be necessary.

Speaker Change: It really falls to the committee to make that termination not US. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine at this point given the immunogenicity data and booster data that has been shared across all three products, which is remarkably consistent as.

Speaker Change: As well as the consistent picture in terms of efficacy, including some waning efficacy for all products in the second year.

But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory Phase III study for an accelerated approval in this space, we do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that 3 or 4 years from now, that further readout would confirm anything that would happen in accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility.

But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory Phase III study for an accelerated approval in this space, we do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in accelerated approval context.

Speaker Change: We would suspect that they will we'll continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination at least from my perspective, I certainly think the science would support that.

Stephen Hoge: The second is that we have to substantially enroll the confirmatory phase three study. For an accelerated approval in this space, we do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility.

Salveen Richter: Thank you. Our next question comes from Celgene <unk> Richter with Goldman Sachs. Your line is open hey.

And then the third and perhaps, now increasingly important criteria was that we had to establish the commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized, neoantigen therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others in tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so, all three of them are essential.

Stephen Hoge: And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized, neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or, you know, in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so, all three of them are essential.

And so, all 3 of them are essential. We're making progress on all 3. And I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing-- working hard to complete the enrollment in that confirmatory study criteria 2 and finish the build-out of that Marlborough facility, which is the third criteria. Now, on the point of other indications that we're going after, we will--I will defer to our partners, Merck, on the specifics. We will do it together at the right time, opening up additional Phase III and confirmatory studies. We do expect to open multiple this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, KEYTRUDA, may not be indicated or even earlier lines of therapy.

And so, all three of them are essential. We're making progress on all three. And I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing-- working hard to complete the enrollment in that confirmatory study criteria 2 and finish the build-out of that Marlborough facility, which is the third criteria.

Salveen Richter: As we've shown you know I Ain't T programs.

Salveen Richter: <unk> says walk very well some of the vaccination taking your video from Madonna. So what do you expect to have good directly to you have a time, but again, we have to wait until the data to make such a determination. Thank you.

Now, on the point of other indications that we're going after, we will--I will defer to our partners, Merck, on the specifics. We will do it together at the right time, opening up additional Phase III and confirmatory studies. We do expect to open multiple this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, KEYTRUDA, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling, of course, we'll make announcements about them with our partner, Merck.

Salveen Richter: Our next question comes from just Meacham with the Bank of America. Your line is open.

Meacham: Hello. This is <unk>. Thank you for taking my question.

Meacham: Okay, Great <unk> excuse me <unk> protection.

Meacham: B when do you think you can have a light <unk> mmm, how important could this be for competitive dynamics. Thank you.

Speaker Change: Good morning.

Speaker Change: So.

Speaker Change: Sorry about that the small technical snafu, so and I'm back I believe I caught the end of the question, which is how when do we think will have a correlate of protection that can inform dynamics, both between products and and boosting.

And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner.

Speaker Change: If that's correct the the we and all the other manufacturers had been sharing publicly there or work on a quota protection. We do believe that we've identified a.

Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through these-- through the second large season is quite encouraging. We'll be sharing that data with the ACIP. Well, first, we have to get through the regulatory process and approval in this country. And Stéphane mentioned our PDUFA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings.

Speaker Change: A strong candidate in neutralizing antibodies not surprisingly from our clinical study, we've been sharing that data with regulators and we've been sharing the preliminary analysis with public health officials, including advisory groups and I tags like the CIP.

Stephen Hoge: We'll be sharing that data with the ACIP. But first, we have to get through the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us.

We'll be sharing that data with the ACIP. But first, we have to get through the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings.

Speaker Change: We will be publishing that data and ultimately submitting that to our regulatory submissions as a call. It uhm through this the balance of this year and if we and I think the other competitors are successful in establishing neutralizing antibodies against RSV correlate of protection. Narcy, then it really will probably be the primary way that public health officials make determinations.

And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And those--all of the data ourselves, as well as that booster-- similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation of how they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us.

Speaker Change: [noise] about re vaccination and boosting.

Speaker Change: And ultimately how we maintain durable protection against RRSP for pirates populations like older adults uhm from a competitive dynamic perspective once once each product has established their correlate they're correlate will relate to them, but we do think there's probably going to be more commonality than not in the corner was separate.

Speaker Change: Section, which makes sense because at the end of the day, we're still talking about the same virus and vaccination against it for.

Stephen Hoge: Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. At this point, given the immunogenicity data and booster data that has been shared across all three products, which is remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that.

Speaker Change: For all three products.

Speaker Change: [noise]. Thank you. Our next question comes from <unk> Morgan Stanley. Your line is open.

Morgan Stanley: Great. Thanks for taking my question I was just wondering if you could provide an update on your discussions with the F. D. A for 10 10 years seasonal flu vaccine and what skating to filing here. Thank you.

Morgan Stanley: Uhm. Thanks. So we we are speaking to the F. D. A M regulators around the world about what would be what day would like to see from a submission perspective or are in first generation or influenza program mrna 10, 10 programs you referenced I don't have any specific nowadays right now we're.

Operator: Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open.

Morgan Stanley: Those conversations as we speak I I really don't want to get ahead of them you know the kinds of things, we're talking about or what's the total.

Hi, good morning, and thank you for taking our questions. This is Elizabeth on for Salveen. 2 questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question.

Elizabeth Webster: Hi, good morning, and thank you for taking our questions. This is Elizabeth on for Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population?

Morgan Stanley: Submission data package, what's the <unk> the duration of follow up and some of these studies and what additional studies or data might be supportive to the application uhm. Those conversations are ongoing uhm, we will provide updates as and when we have them, but I have nothing further to add right now.

And then for the Phase III CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women/adolescent population? Thank you. Hello, so I'll take the question.

Speaker Change: Thank you. Our next question comes from justify with J P. Morgan Your line is open.

Speaker Change: Hey, guys. Good morning, and thanks for taking my question.

Yes. So I'll take the question. So on RSV pediatrics, we have not started the study yet. We are, of course, considering taking this into a Phase III. It is in the clinic with Phase I/II. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't yet have data yet on durability. Again, like we've done for other programs, when we share the data, we share all the data, including durability, because it's very important. As you know, the benefit of young women is that they have a very strong immune system.

Stéphane Bancel: Yes. So I'll take the question. So on RSV pediatrics, we have not started the study yet. We are, of course, considering taking this into a Phase III. It is in the clinic with Phase I/II. We are waiting for the data to be able to move at the right time into the pediatric setting.

Speaker Change: Mm.

Speaker Change: For.

Stphane Bancel: So on RSV-PageRatrix, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1 and 2. We are waiting for the data to be able to move it at the right time into the pediatric setting. In terms of CMV, we don't yet have data yet on durability. Again, like we've done for other programs, when we share the data, we share all the data, including durability, because it's very important. As you know, the benefit of young women is that they have a very strong immune system.

Speaker Change: <unk> can.

justify: Can you talk about what's driving your confidence to go into metastatic setting.

justify: How's enrollment is going in.

justify: Eight three melanoma trial, and I know you touched on manufacturing being important here.

justify: What's the status of that manufacturing Scaleup work and when does that facility can be ready to go live.

In terms of CMV, we don't yet have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data, including durability, because it's very important. As you know, the benefit of young women is they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna. So we really expect to have good durability over time. But again, we have to wait for the data to make such a determination. Thank you.

Speaker Change: Great question adult so I'll take the first part of that so uhm. So first of all metastatic yeah. So we have not formally decided or announce that we're going into a minutes like indication. We we do have data from our phase one.

As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you.

Speaker Change: Study our initial phase one study in metastatic patients, including non small cell lung cancer.

Speaker Change: But we have not yet made a determination that we're going into the metastatic indication and I think you know.

Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham.

Operator: Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open.

Speaker Change: Behind your question is a view that I would agree with which is to the extent that I N. T is gonna provide a really substantial benefit we think it is probably an earlier lines of therapy. So not just adjuvant, but perhaps even stayed one disease or in stage two disease, depending on the indication because.

Hi, this is Alex Hammond on for Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlative of protection. So for RSV, when do you think we could have a light-- line of sight into this type of metric? And how important could this be for a competitive dynamics? Thank you. Good morning, Stphane. Ayato.

Alexandria Hammond: Hi, this is Alex Hammond on for Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlative of protection. So for RSV, when do you think we could have a light-- line of sight into this type of metric? And how important could this be for a competitive dynamics? Thank you.

Speaker Change: Cause the safety and Tolerability profile is is we think incredibly favourable and the benefits. We're seeing are pretty remarkable from the noon perspective.

Stéphane Bancel: Good morning. It's Stéphane, so...

Stephen Hoge: Sorry-- small technical stuff. So I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlate of protection that can inform dynamics, both between products and boosting? If that's correct. The-- we and all the other manufacturers have been sharing publicly their-- our work on a correlate of protection. We do believe that we've identified a strong candidate in neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITAGs like the ACIP. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three.

Stephen Hoge: Sorry-- small technical snafu. So I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlate of protection that can inform dynamics, both between products and boosting? If that's correct.

Speaker Change: That said there is still a really high on that need and administer attic space and you know even immunotherapies like the P. D ones like Keytruda provided substantial benefit there and so at the right time, we may well choose to studying the metastatic indication, but as I said metastatic indications in settings, but as I said, we have not yet formally decided to do that today.

The-- we and all the other manufacturers have been sharing publicly their-- our work on a correlate of protection. We do believe that we've identified a strong candidate in neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITAGs like the ACIP.

Speaker Change: And we're really focused on adjuvant and earlier and mono therapy principally.

Speaker Change:

Speaker Change: On the question on the manufacturing process and enrollment we have substantially scaled up our ability to enroll patients in those phase three studies I can assure you that with our partner Mark we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the.

We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate through this--the balance of this year. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection in RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and boosting, and ultimately how we maintain durable protection against RSV for high-risk populations like older adults. From a competitive dynamics perspective, once each product has established their correlate, their correlate will relate to them. But we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense, because at the end of the day, we're still talking about the same virus and vaccination against it for all 3 products.

Speaker Change: <unk> demand from those clinical research sites.

Speaker Change: Four I N T manufacturing.

Speaker Change: We haven't specifically put out numbers, but uhm suffice to say, where we are rapidly enrolling in those studies and we would expect to make substantial progress this year and even perhaps getting close to completing enrollment and at least one of those studies. If it continues to direct fee. So we're excited about the progress we've made in ski.

From a competitive dynamics perspective, once each product has established their correlate, their correlate will relate to them. But we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense, because at the end of the day, we're still talking about the same virus and vaccination against it for all three products.

Speaker Change: Mailing up the manufacturing for clinical supply we're excited about the progress we're making right now in enrolling patients in the demand and we're seeing from clinical sites and we do believe that we've solved a lot of the for clinical research for clinical development and manufacturing uhm requirements.

Operator: Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Speaker Change: The question, then becomes commercial and that's where he alluded to a few minutes ago. The Marlboro site would really become the purpose built commercial site, which needs to not only be able to deliver high quality product at high volumes, but also do it at like at a.

Stephen Hoge: Great. Thanks for taking the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine? And what's gating to filing here? Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them.

Terence Flynn: Great. Thanks for taking the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine? And what's gating to filing here? Thank you.

Thanks. So we are speaking to the FDA and regulators around the world about what would be-- what they would like to see from a submission perspective for our first-generation of our influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them.

Stephen Hoge: Thanks. So we are speaking to the FDA and regulators around the world about what would be-- what they would like to see from a submission perspective for our first-generation of our influenza program, our mRNA 1010 program, as you referenced.

Speaker Change: Valuable price and course point and all of that work is ongoing we've made great progress in building that site. Our goal is to establish that site for at least clinical supply. This year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use and ultimately it depends upon.

I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. The kinds of things we're talking about are, what's the total submission data package? What's the duration of follow-up in some of these studie? And what additional studies or data might be supportive to the application? Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now.

Stephen Hoge: The kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc.

The kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now.

Speaker Change: One discussions with by designers as well.

Kevin: Kevin will take our last question. Okay. Our last question comes from urban Wang with Guggenheim Securities. Your line is open.

Gena Wang: Great. Thank God two from me first one RSV now there are some additional studies expand the initial population can you comment on one let me ask you got it from the days threes, and 50, plus and the Iris <unk> and when you could potentially supplemental filing if everything's positive.

Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc.

Operator: Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open.

Jessica Fye: Hi, guys, good morning. Thanks for taking my question. For INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase III melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility going to be ready to go live?

Stephen Hoge: INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the phase three melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live?

Gena Wang: And then you know I know you commented on Australia.

Gena Wang: So just you know as you were thinking about or as you you know you've talked about Australia as a proxy for Covid tails and 2020 at three now can you comment on how to interpret all Australia would be will be sure. Our three launch and as we look for trends and cut it vaccination rates. Thanks.

Stephen Hoge: What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all.

What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live?

Stephen Hoge: Great questions all. So, I'll take the first part of that. So, first on metastatic. So we have not formally decided or announced that we're going into a metastatic indication. We do have data from our Phase I study, our initial Phase I study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into the metastatic indication.

Speaker Change: Alright, I'll quickly take the first part of that and then hand, it over to Stefan for a second.

Stphane Bancel: So the.

Stphane Bancel: Additional data 150, plus we have an obviously in the emerging data and co administration data, we'll be sharing that at the appropriate time and with public health officials and others that could be as soon as the idea to spend on when the data comes in as well as the 18th plus high risk populations in your.

Stephen Hoge: And I think, behind your question is a view that I would agree with, which is to the extent that INT is going to provide a really substantial benefit, we think it is probably in earlier lines of therapy. So not just adjuvant, but perhaps even Stage 1 disease or Stage 2 disease, depending on the indication, because the safety and tolerability profile is, we think, incredibly favorable, and the benefits we're seeing are pretty remarkable from an immune perspective. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there.

And I think, behind your question is a view that I would agree with, which is to the extent that INT is going to provide a really substantial benefit, we think it is probably in earlier lines of therapy. So not just adjuvant, but perhaps even Stage 1 disease or Stage 2 disease, depending on the indication, because the safety and tolerability profile is, we think, incredibly favorable, and the benefits we're seeing are pretty remarkable from an immune perspective.

Stphane Bancel: Your question about getting isn't a label Uhm, it's important to note that public health officials can recommend use even beyond the label Uhm and may choose to do that but our responsibility to get it in the label and we will need to complete the initial b L. A before we then we could submit the S. P. L a to get that data and the label and so obviously it would follow shortly.

Stphane Bancel: The after our our our hopefully successful uhm preval come in May.

That said, there is still a really high unmet need in the metastatic space. And, even immunotherapies like the PD-1s, like KEYTRUDA, provide a substantial benefit there. And so at the right time, we may, well, choose to study the metastatic indication, but as I said-- or metastatic indications and settings. But as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the question on the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those Phase III studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second Phase III study and be talking about the third, if we didn't have confidence in our ability to rapidly meet the demand for--the substantial demand from clinical research sites for INT manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues to go well.

Stphane Bancel: <unk> yeah. So if you think <unk> I mean, I'll see if I said, you've got a strong performance on Kobe done Australia, we've even had people to go on that.

Stphane Bancel: Being a a pandemic as you recall, we have announced a long tenure.

Stphane Bancel: <unk> I was trying to go on that and.

Stphane Bancel: <unk> <unk> <unk> <unk> that she doesn't seem quite successfully.

Stphane Bancel: And we are actually just Christians were broken it fills around Australia for I V approval.

Stphane Bancel: The point that will make you that Australia is you know is quite different market commercially to the U S. <unk>, mostly driven by the government. So we are compelled 40, I'm also a european market than to the U S market.

Stphane Bancel: I don't think we can enjoy a need for this you've only got these coalition I need to know what happened in Australia caught me to always be to what will happen in the U S.

We haven't specifically put out numbers, but suffice to say, we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps getting close to completing enrollment in at least 1 of those studies if it continues the trajectory.

Stphane Bancel: And the 424, we felt 25.

Stphane Bancel: So much for the questions today and thank you for taking the time to be with US we look forward to talking and seeing menu of you in the coming days and weeks I Hope that you would have on March 27th in your vaccine Daniel calendar, we saw that presentation at nine a M east some time so.

Speaker Change: Have a great day and thank you for joining.

Speaker Change: Ladies and gentlemen does conclude today's presentation. You may now disconnect and have a wonderful day.

Speaker Change: Mmm Mmm.

Speaker Change: [music].

Stephen Hoge: And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year. But we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me.

And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year. But we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well.

Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me.

Lavina Talukdar: Kevin, we'll take our last question.

Okay. Our last question comes from Evan Wang with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me.

Operator: Okay. Our last question comes from Evan Wang with Guggenheim Securities. Your line is open.

Great. Thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from the Phase IIIs and 50-plus and the high-risk younger adults and when you could potentially supplement the filing if everything is positive? And then, you know, I know you commented on Australia.

Evan Wang: Great. Thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from the Phase IIIs and 50-plus and the high-risk younger adults and when you could potentially supplement the filing if everything is positive?

Stephen Hoge: First on RSV, you know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher risk younger adults and when you could potentially supplement the filing if everything's positive? And then, you know, I know you commented on Australia.

And then, you know, I know you commented on Australia. So just, as you were thinking about--or as you've talked about Australia as a proxy for COVID sales in 2023. Now, can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks.

Stephen Hoge: So just, you know, as you were thinking about, or as you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that.

So just, you know, as you were thinking about, or as you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates?

Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that.

Thanks.

Great. I'll quickly take the first part of that, and then hand it over to Stéphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that.

Stephen Hoge: Great. I'll quickly take the first part of that, and then hand it over to Stéphane for the second.

So the Additional data on 50-plus we have, obviously immunebridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that.

In your question about getting those in the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label. And we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. And so, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May.

Stephen Hoge: But our responsibility would be to get it in the label. And we will need to complete the initial BLA before we could submit the SBLA to get that data in the label. And so, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things.

But our responsibility would be to get it in the label. And we will need to complete the initial BLA before we could submit the SBLA to get that data in the label. And so, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May.

Stéphane Bancel: Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government since the beginning of the pandemic, as you recall, we have announced a long-term 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is advancing quite successfully. And we are in active discussions with regulators around Australia for RSV approval.

Stphane Bancel: First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially to the US. It's really mostly driven by the government, so I will compare Australia more to a European market than to the US market.

First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval.

Speaker Change: [music].

The point I will make is that Australia, as you know, is a quite different market commercially to the U.S. It's really mostly driven by the government, so I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, it's what will happen in the U.S. in the fall '24, winter '25.

Stphane Bancel: I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the US in the fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking and seeing many of you in the coming days and weeks. I hope that you all have March 27th, annual vaccine day, in your calendar. We'll start the presentation at 9am Eastern time. So have a great day, and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the US in the fall 24, winter 25. So

Thank you so much for the questions today. Thank you for taking the time to be with us. We look forward to talking and seeing many of you in the coming days and weeks. I hope that you all have on March 27th, Annual Vaccine Day in your calendar. We will start the presentation at 9:00 a.m. Eastern time. So have a great day, and thank you for joining. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Operator: Ladies and gentlemen, this does concludes today's presentation. You may now disconnect, and have a wonderful day. This is a demonstration of our strategic efforts in Q3 to resize our manufacturing footprint, which, as expected, led to additional charges in Q4 of $169 million primarily related to the wind-down of certain contract manufacturing operations. Additionally, cost of sales also includes an inventory write-down of $322 million, reflecting revised demand forecasts. R&D expenses increased by 16% to $1.4 billion. This uptick reflects our commitment to advancing our late-stage clinical development program, particularly with our RSV vaccine, CMV vaccine, combination vaccine against flu, and COVID-19, as well as our INT program. The increase also included an upfront payment of $120 million associated with the Strategic Research and Development Collaboration with EMATICS. SG&A expenses were $470 million, up 25% year-over-year. The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U.S. market. Income tax with a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 US tax return. Net income for the quarter was $217 million, compared to $1.5 billion in the fourth quarter last year. Diluted earnings per share were $0.55 compared to $3.61 in 2022. We close the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter. Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to Gavi. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework. Research and development spend was $4.8 billion, and SG&A was $1.5 billion, both in line with our expectations. Our income tax provision was $772 million for the full year 2023. During our Q3 earnings call, we discussed the requirement under GAAP to establish a valuation allowance against deferred tax assets when the current year and cumulative income projection for the next three years is in a lost position. It's important to note that future income from products not yet approved by regulators is excluded from these income projections, which restricts us to just our COVID vaccine and does not include expected future launches. This valuation allowance does not impact cash flows, future tax returns, or the company's ability to utilize deferred tax assets in future periods. The net loss for the year was $4.7 billion compared to net income of $8.4 billion last year. The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023. Diluted loss per share was $12.33 compared to diluted earnings per share of $20.12 in 2020. So now let's move to slide 12. We wanted to provide you additional perspective on our full year financial results. By presenting them alongside a summarized version that excludes the impact of the GAVI Deferred Revenue Recognition, our resizing charges, and the Tax Valuation, our total gap net loss for the full year was $4.7 billion. However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion. Now let's turn to our 2024 financial framework on slide 13, which is mostly in line with what I shared on our Q3 call. We expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025. Sales in the first half of the year are expected to be approximately 100 million dollars, reflecting the strong seasonality of respiratory vaccines. We expect a cost of sales of approximately 35% of product sales, in line with our cost of sales framework, which we introduced in our Q3 earnings call last year. For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principal, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mainly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they all focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdarc The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Operator: Ladies and gentlemen, this does concludes today's presentation. You may now disconnect, and have a wonderful day.

Operator: ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Boutique, Talukdar, Andrea Tan, Jamey Mock, Stphane Bancel, Lorence Kim, Ted Tenthoff, Edward Tenthoff, Jamey Mock, Stphane Bancel, Lorence Kim, Andrea Tan, Jamey Mock, Stphane Bancel, Lorence Kim, Andrea Tan, Jamey Mock, Stphane Bancel, Lorence Kim, Ted Tenthoff, ?? ?? ?? ?? ?? ?? ?? ?? ?? Good day and thank you for standing by. Welcome to the Moderna Fourth Quarter 2023 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead. Thank you, Kevin. Good morning, everyone. And thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2023 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stphane Bancel, our Chief Executive Officer; Stephen Hoge, our president, and Jamey Mock, our chief financial officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I'll turn it over to Sepak. Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of 2023. Jamey will then present our financial results, civil review, and review of late-stage clinical programs, and I will close by sharing our 2024 priorities. Let me start with our mission: Moderna's commitment to deliver the greatest possible impact to people. Good morning. In 2023, every member of the Moderna team helped to advance Publishers, which is a driving force that motivates our team every single day. We reached more than 100 million people around the world. And we have a vast development pipeline across all of our franchises, including infectious disease, oncology, and rare disease. 2023 was a difficult year as we transitioned from a pandemic to a seasonal endemic market. We reported sales of $6.1 billion for 2023, which was at the low end of our financial framework. These cells exclude the recognition of $600 million of deferred revenue from GAVI in the U.S. However, the vaccination rate was down year over year. We are pleased that our U.S. commercial team drove an increase in our retail market share from 37% to 48%. Outside of the US, we were not able to compete in the EU market in the second half of 2023 due to a competitor contract, and our performance led to a low market share in Japan. We did have a strong performance in Israel, Switzerland, and Taiwan. We took several important actions in 2023 that will set our commercial COVID business up for success. We resized our manufacturing footprint, which has been established to support capacity at the pandemic level. We exited contract manufacturing relationships and reduced inventory levels. These initiatives will improve cash flow from our COVID business moving forward. We have also flattened the commercial structure. All regions report directly to me now for more targeted self-execution and also better integration with the global business. We focus on R&D spending and on SG&A expenditures towards near-term growth and higher return on investment projects. While cellular challenges in 2023, our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with the Respiratory Vax. For RSV, we fight for approval around the world. We recently reported positive data from a flu P3R3 study. And we are fully enrolled in the Phase 3 studies for next-gen COVID, mRNA-1283, and the flu plus COVID combination vaccine, mRNA-1085. In our latest franchise, we are very excited that our Phase 3 CMV trial is now fully underway. In our Individualized Neuroantigen Therapy Program, or INT, we partner with Merck, and phase 3 studies in adjuvant melanoma and non-small cell lung cancer are enrolling. We purchased and are currently building out a manufacturing site in Marlborough, Massachusetts to enable commercialization of our R&D program. Already these therapeutic programs continue to progress well; we were in those selections for the re-selectional study of our proprionic acidemia program. In MMA, we are pleased to see improvements in biomarkers and clinical outcomes. In research, we made six external investments, including one acquisition, which we expect will increase the strategic reach and loss of breadth of our mRNA platform. Now turning to our 2023 financial summary, we reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to the resizing of manufacturing, and a tax valuation allowance. We are pleased to end the year with cash and cash investments of 13.3 billion dollars. Let me talk to Jamey for more color on the final. Thanks, Stphane, and hello everyone. Today I will review our financial performance for both the fourth quarter and the full year of 2023. I'll also provide our financial framework for 2024. But let me start with a review of our commercial performance this year. In the first half of 2023, we reported product sales of $2.1 billion, with the majority of sales from advanced purchase agreements signed for delivery in 2022 that were deferred into 2023. We do not expect these sales to repeat in 2024. In the second half of 2023, we recorded $4 billion in sales from seasonal endemic demand, and an additional $600 million from deferred revenue related to Gavi. Sales in the fourth quarter were $2.8 billion, with $0.8 billion in sales in the U.S., $0.6 billion in Europe, and $1.4 billion in the rest of the world, including deferred revenue from Gavi. For the full year 2023, product sales were $6.7 billion, comprised of $1.7 billion in sales in the US, $1.4 billion in Europe, and $3.6 billion in the rest of the world, again including deferred revenue from government. Moving to slide 10. As mentioned, net product sales were $2.8 billion this quarter, a 43% decrease from last year. This was largely attributable to the anticipated reduction in sales volume, which was partially offset by a higher average selling price. This decrease is indicative of the evolving market dynamics as we navigate the transition of the COVID-19 vaccine market towards a more predictable seasonal pattern like traditional flu vaccine. The cost of sales was $929 million, down from 39% of net product sales in the previous year to 33% this year.

This is a demonstration of our strategic efforts in Q3 to resize our manufacturing footprint, which, as expected, led to additional charges in Q4 of $169 million primarily related to the wind-down of certain contract manufacturing operations. Additionally, cost of sales also includes an inventory write-down of $322 million, reflecting revised demand forecasts. R&D expenses increased by 16% to $1.4 billion. This uptick reflects our commitment to advancing our late-stage clinical development program, particularly with our RSV vaccine, CMV vaccine, combination vaccine against flu, and COVID-19, as well as our INT program. The increase also included an upfront payment of $120 million associated with the Strategic Research and Development Collaboration with EMATICS. SG&A expenses were $470 million, up 25% year-over-year. The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U.S. market. Income tax with a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 US tax return. Net income for the quarter was $217 million, compared to $1.5 billion in the fourth quarter last year. Diluted earnings per share were $0.55 compared to $3.61 in 2022. We close the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter. Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to Gavi. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework. Research and development spend was $4.8 billion, and SG&A was $1.5 billion, both in line with our expectations. Our income tax provision was $772 million for the full year 2023. During our Q3 earnings call, we discussed the requirement under GAAP to establish a valuation allowance against deferred tax assets when the current year and cumulative income projection for the next three years is in a lost position. It's important to note that future income from products not yet approved by regulators is excluded from these income projections, which restricts us to just our COVID vaccine and does not include expected future launches. This valuation allowance does not impact cash flows, future tax returns, or the company's ability to utilize deferred tax assets in future periods. The net loss for the year was $4.7 billion compared to net income of $8.4 billion last year. The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023. Diluted loss per share was $12.33 compared to diluted earnings per share of $20.12 in 2020. So now let's move to slide 12. We wanted to provide you additional perspective on our full year financial results. By presenting them alongside a summarized version that excludes the impact of the GAVI Deferred Revenue Recognition, our resizing charges, and the Tax Valuation, our total gap net loss for the full year was $4.7 billion. However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion. Now let's turn to our 2024 financial framework on slide 13, which is mostly in line with what I shared on our Q3 call. We expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025. Sales in the first half of the year are expected to be approximately 100 million dollars, reflecting the strong seasonality of respiratory vaccines. We expect a cost of sales of approximately 35% of product sales, in line with our cost of sales framework, which we introduced in our Q3 earnings call last year. For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principal, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mainly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they all focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdarc The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead. Thank you, Kevin. Good morning, everyone. And thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2023 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stphane Bancel, our Chief Executive Officer; Stephen Hoge, our president, and Jamey Mock, our chief financial officer.

Lavina Talukdar: To withdraw your question, please press star 11 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead. Thank you, Kevin. Good morning, everyone. And thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2023 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stphane Bancel, our Chief Executive Officer; Stephen Hoge, our president, and Jamey Mock, our chief financial officer.

Lavina Talukdar: And thank you for joining us on today's call to discuss Moderna's fourth quarter and full year 2023 financial results and business update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stphane Bancel, our Chief Executive Officer; Stephen Hoge, our president, and Jamey Mock, our chief financial officer.

Lavina Talukdar: Thank you for joining us today. I will start with a review of 2023. Jamey will then present our financial results, civil review, and review of late-stage clinical programs, and I will close by sharing our 2024 priorities. Let me start with our mission: Moderna's commitment to deliver the greatest possible impact to people. Good morning.

Stphane Bancel: In 2023, every member of the Moderna team helped to advance Publishers, which is a driving force that motivates our team every single day. We reached more than 100 million people around the world. And we have a vast development pipeline across all of our franchises, including infectious disease, oncology, and rare disease. 2023 was a difficult year as we transitioned from a pandemic to a seasonal endemic market. We reported sales of $6.1 billion for 2023, which was at the low end of our financial framework. These cells exclude the recognition of $600 million of deferred revenue from GAVI in the U.S. However, the vaccination rate was down year over year.

Stphane Bancel: We are pleased that our U.S. commercial team drove an increase in our retail market share from 37% to 48%. Outside of the US, we were not able to compete in the EU market in the second half of 2023 due to a competitor contract, and our performance led to a low market share in Japan. We did have a strong performance in Israel, Switzerland, and Taiwan. We took several important actions in 2023 that will set our commercial COVID business up for success. We resized our manufacturing footprint, which has been established to support capacity at the pandemic level. We exited contract manufacturing relationships and reduced inventory levels. These initiatives will improve cash flow from our COVID business moving forward. We have also flattened the commercial structure. All regions report directly to me now for more targeted self-execution and also better integration with the global business. We focus on R&D spending and on SG&A expenditures towards near-term growth and higher return on investment projects. While cellular challenges in 2023, our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with the Respiratory Vax.

Speaker Change: [music].

Stphane Bancel: We did have a strong performance in Israel, Switzerland, and Taiwan. We took several important actions in 2023 that will set our commercial COVID business up for success. We resized our manufacturing footprint, which has been established to support capacity at the pandemic level. We exited contract manufacturing relationships and reduced inventory levels. These initiatives will improve cash flow from our COVID business moving forward. We have also flattened the commercial structure. All regions report directly to me now for more targeted self-execution and also better integration with the global business. We focus on R&D spending and on SG&A expenditures towards near-term growth and higher return on investment projects. While cellular challenges in 2023, our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with the Respiratory Vax.

Stphane Bancel: These initiatives will improve cash flow from our COVID business moving forward. We have also flattened the commercial structure. All regions report directly to me now for more targeted self-execution and also better integration with the global business. We focus on R&D spending and on SG&A expenditures towards near-term growth and higher return on investment projects. While cellular challenges in 2023, our development team had a great year, with excellent progress across many of our late-stage pipeline programs. In 2023, we advanced our pipeline and now have nine late-stage programs. Let's start with the Respiratory Vax.

Speaker Change: Good day and thank you for standing by if you walked through the mid during the fourth quarter 2023 conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during the session will need to press star one on your telephone you will then hear an automated message advising your hand is raised to withdraw your question. Please press star wouldn't want again.

Speaker Change: Please be advised today's conference is being recorded I would now like to turn the conference over to speaker today living in it to Luke Dar. Please go ahead.

Lavina Talukdar: Thank you Kevin Good morning, everyone and thank you for joining us on today's call to discuss Mcdonalds fourth quarter and full year 2023 financial results and business update.

Stphane Bancel: For RSV, we fight for approval around the world. We recently reported positive data from a flu P3R3 study. And we are fully enrolled in the Phase 3 studies for next-gen COVID, mRNA-1283, and the flu plus COVID combination vaccine, mRNA-1085. In our latest franchise, we are very excited that our Phase 3 CMV trial is now fully underway. In our Individualized Neuroantigen Therapy Program, or INT, we partner with Merck, and phase 3 studies in adjuvant melanoma and non-small cell lung cancer are enrolling. We purchased and are currently building out a manufacturing site in Marlborough, Massachusetts to enable commercialization of our R&D program. Already these therapeutic programs continue to progress well; we were in those selections for the re-selectional study of our proprionic acidemia program. In MMA, we are pleased to see improvements in biomarkers and clinical outcomes. In research, we made six external investments, including one acquisition, which we expect will increase the strategic reach and loss of breadth of our mRNA platform. Now turning to our 2023 financial summary, we reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to the resizing of manufacturing, and a tax valuation allowance. We are pleased to end the year with cash and cash investments of 13.3 billion dollars. Let me talk to Jamey for more color on the final.

Speaker Change: You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investors section of our website.

Speaker Change: On today's call are Stefan bond, so our chief commercial Executive Officer.

Speaker Change: Stephen Hoge, our president and Jamey mock our Chief Financial Officer.

Speaker Change: Before we begin please note that this conference call will include forward looking statements made pursuant to the Safe Harbor provisions of the private Securities Litigation Reform Act of $19 95.

Stphane Bancel: Already these therapeutic programs continue to progress well; we were in those selections for the re-selectional study of our proprionic acidemia program. In MMA, we are pleased to see improvements in biomarkers and clinical outcomes. In research, we made six external investments, including one acquisition, which we expect will increase the strategic reach and loss of breadth of our mRNA platform. Now turning to our 2023 financial summary, we reported GAAP revenue of $6.8 billion, a net loss of $4.7 billion, primarily driven by mostly non-cash charges of $3.7 billion related to the resizing of manufacturing, and a tax valuation allowance. We are pleased to end the year with cash and cash investments of 13.3 billion dollars. Let me talk to Jamey for more color on the final.

Stephane: Good morning, or good afternoon, everyone.

Stephane: You for joining us today.

Stephane: I will start with a review of 2020 free Jimmy.

Stephane: Jamie will then present our financial results.

Stephane: We will then review our late stage clinical programs and then we can close by sharing our 2024 priorities.

Stephane: Let me just talk about Michelle.

Stephane: <unk> commitment to deliver the greatest possible impact to people.

Stephane: Melanie medicine.

Stephane: In 2020 free every member over more than that.

Stephane: To advance Felicia.

Stephane: Which is a driving force that motivates us every single day.

Stephane: We impacted more than 100 million people around the world and with backlog development pipeline across all of our franchisees liquidity picture. This is oncology and revenues.

Jamey Mock: Thanks, Stphane, and hello everyone. Today I will review our financial performance for both the fourth quarter and the full year of 2023. I'll also provide our financial framework for 2024. But let me start with a review of our commercial performance this year. In the first half of 2023, we reported product sales of $2.1 billion, with the majority of sales from advanced purchase agreements signed for delivery in 2022 that were deferred into 2023. We do not expect these sales to repeat in 2024. In the second half of 2023, we recorded $4 billion in sales from seasonal endemic demand, and an additional $600 million from deferred revenue related to Gavi. Sales in the fourth quarter were $2.8 billion, with $0.8 billion in sales in the U.S., $0.6 billion in Europe, and $1.4 billion in the rest of the world, including deferred revenue from Gavi. For the full year 2023, product sales were $6.7 billion, comprised of $1.7 billion in sales in the US, $1.4 billion in Europe, and $3.6 billion in the rest of the world, again including deferred revenue from government. Moving to slide 10. As mentioned, net product sales were $2.8 billion this quarter, a 43% decrease from last year. This was largely attributable to the anticipated reduction in sales volume, which was partially offset by a higher average selling price. This decrease is indicative of the evolving market dynamics as we navigate the transition of the COVID-19 vaccine market towards a more predictable seasonal pattern like traditional flu vaccine. The cost of sales was $929 million, down from 39% of net product sales in the previous year to 33% this year.

Stephane: 2023 was a difficult year as we transition from a pandemic with seasonal endemic market.

Stephane: We reported sales of $6 1 billion.

Stephane: 23.

Stephane: It was at the low end of our financial framework clash.

Stephane: This excludes the recognition of $600 million of deferred revenue from Gary.

Stephane: In the U S. The vaccination rates was down year over year.

Stephane: We were pleased that the U S. Commercial team drove an increase in our retail market share from 37% to 48%.

Stephane: Outside of the U S. We were not able to compete in the EU market in the second half of 2023 due to a competitor contracts.

Stephane: And then performance led to a low market share in Japan.

Stephane: We did have a strong performance in Israel, and Switzerland, and Taiwan.

Stephane: We took several important actions in 2020 that we've set our commercial corporate business up for success.

Jamey Mock: For the full year 2023, product sales were $6.7 billion, comprised of $1.7 billion in sales in the US, $1.4 billion in Europe, and $3.6 billion in the rest of the world, again including deferred revenue from government. Moving to slide 10. As mentioned, net product sales were $2.8 billion this quarter, a 43% decrease from last year. This was largely attributable to the anticipated reduction in sales volume, which was partially offset by a higher average selling price. This decrease is indicative of the evolving market dynamics as we navigate the transition of the COVID-19 vaccine market towards a more predictable seasonal pattern like traditional flu vaccine. The cost of sales was $929 million, down from 39% of net product sales in the previous year to 33% this year.

Stephane: We recycle manufacturing footprint, which has been established to support capacity at pandemic levels.

Stephane: We exited contract manufacturing relationships and reduced inventory levels.

Stephane: These initiatives will improve cash flow from our core it business moving forward.

Stephane: We've also flattened the commercial structure.

Stephane: All regions were pulled therapy to me now.

Stephane: Targeted solid execution.

Stephane: And also a better integration with global teams.

Stephane: We focused our R&D spending.

Stephane: SG&A expenditures, so while near term growth and higher return on investment projects.

Stephane: We're excited about challenging in 2023, our development team had a great year with excellent progress across many of our late stage pipeline programs.

Stephane: In 2023, we advanced our pipeline and up nine late stage programs.

Jamey Mock: This is a demonstration of our strategic efforts in Q3 to resize our manufacturing footprint, which, as expected, led to additional charges in Q4 of $169 million primarily related to the wind-down of certain contract manufacturing operations. Additionally, cost of sales also includes an inventory write-down of $322 million, reflecting revised demand forecasts. R&D expenses increased by 16% to $1.4 billion. This uptick reflects our commitment to advancing our late-stage clinical development program, particularly with our RSV vaccine, CMV vaccine, combination vaccine against flu, and COVID-19, as well as our INT program. The increase also included an upfront payment of $120 million associated with the Strategic Research and Development Collaboration with EMATICS. SG&A expenses were $470 million, up 25% year-over-year. The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U.S. market. Income tax with a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 US tax return. Net income for the quarter was $217 million, compared to $1.5 billion in the fourth quarter last year. Diluted earnings per share were $0.55 compared to $3.61 in 2022. We close the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter. Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to Gavi. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework. Research and development spend was $4.8 billion, and SG&A was $1.5 billion, both in line with our expectations. Our income tax provision was $772 million for the full year 2023. During our Q3 earnings call, we discussed the requirement under GAAP to establish a valuation allowance against deferred tax assets when the current year and cumulative income projection for the next three years is in a lost position. It's important to note that future income from products not yet approved by regulators is excluded from these income projections, which restricts us to just our COVID vaccine and does not include expected future launches. This valuation allowance does not impact cash flows, future tax returns, or the company's ability to utilize deferred tax assets in future periods. The net loss for the year was $4.7 billion compared to net income of $8.4 billion last year. The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023. Diluted loss per share was $12.33 compared to diluted earnings per share of $20.12 in 2020. So now let's move to slide 12. We wanted to provide you additional perspective on our full year financial results. By presenting them alongside a summarized version that excludes the impact of the GAVI Deferred Revenue Recognition, our resizing charges, and the Tax Valuation, our total gap net loss for the full year was $4.7 billion. However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion. Now let's turn to our 2024 financial framework on slide 13, which is mostly in line with what I shared on our Q3 call. We expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025. Sales in the first half of the year are expected to be approximately 100 million dollars, reflecting the strong seasonality of respiratory vaccines. We expect a cost of sales of approximately 35% of product sales, in line with our cost of sales framework, which we introduced in our Q3 earnings call last year. For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principal, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mainly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they all focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdarc The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: This helps with respiratory vaccine for RSV, we filed for approvals around the World We reported positive data from our flu <unk> study.

Stephane: And we have fully enrolled in the phase III studies for our next inquiries amounted 12, 80 fruit and fruit preps Covid combination vaccine <unk> 10 in Q3.

Stephane: In our later franchise, we are very excited by the phase III CMV trial is now fully enrolled.

Stephane: In our individualized new anti Gen therapy program, our IMT, where we partner with mill Phase III studies in adjuvant melanoma, and non small cell lung cancer are enrolling.

Jamey Mock: This uptick reflects our commitment to advancing our late-stage clinical development program, particularly with our RSV vaccine, CMV vaccine, combination vaccine against flu, and COVID-19, as well as our INT program. The increase also included an upfront payment of $120 million associated with the Strategic Research and Development Collaboration with EMATICS. SG&A expenses were $470 million, up 25% year-over-year. The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U.S. market. Income tax with a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 US tax return. Net income for the quarter was $217 million, compared to $1.5 billion in the fourth quarter last year. Diluted earnings per share were $0.55 compared to $3.61 in 2022. We close the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter. Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to Gavi. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework.

Stephane: We picture and are currently building out our manufacturing site in Marlborough, Massachusetts to enable commercialization of our R&D program.

Stephane: Already this property programs continue to progress work when growth in extra although recession those study of appropriate in each asset in our program.

Stephane: In MMA, we are pleased to see improvement in biomarker and clinical outcomes.

Stephane: In research, we made six X amount of investments, including one acquisition, which we expect will increase this strategic rich and most of our breath, although I'm on the platform.

Jamey Mock: The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U.S. market. Income tax with a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 US tax return. Net income for the quarter was $217 million, compared to $1.5 billion in the fourth quarter last year. Diluted earnings per share were $0.55 compared to $3.61 in 2022. We close the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter. Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to Gavi. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework.

Stephane: Now turning to our 2023 financial summary, we reported GAAP revenue of $6 8 billion.

Stephane: Net loss of $4 7 billion, primarily driven by mostly noncash charges of $3 7 billion related to resizing of manufacturing and the tax valuation allowance.

Stephane: We are pleased to end the year with cash and cash investment of $30 3 billion.

Jamey Mock: Diluted earnings per share were $0.55 compared to $3.61 in 2022. We close the quarter with a strong cash position of $13.3 billion, which is slightly higher than the $12.8 billion we had at the end of the prior quarter. Now, let's turn to our annual performance on page 11. Net product sales for the full year 2023 were $6.7 billion, a decrease of 64% from the previous year, mainly due to lower sales volume of our COVID-19 vaccine. As mentioned earlier, this includes the recognition of $0.6 billion from deferred revenue related to Gavi. Excluding this item, our sales of $6.1 billion were still in line with the framework we provided for the full year. Cost of sales for the full year represented 70% of net product sales, a substantial increase from 29% of product sales in 2022. This shift is largely attributable to our strategic efforts to optimize our manufacturing operation, resulting in charges of $1.6 billion and other manufacturing and distribution costs over reduced sales volume. Overall, the cost of sales came in at $4.7 billion, slightly below the $5 billion we provided in our latest framework.

Stephane: Let me talk to Jamie for more color on the financials.

Jamie: Thanks, Stefan and Hello, everyone today, I will review our financial performance for both the fourth quarter and the full year of 2023.

Jamie: I will also provide our financial framework for 2024.

Jamie: Let me start with a review of our commercial performance this year.

Jamie: In the first half of 2023, we reported product sales of $2 1 billion.

Jamie: With the majority of sales from advanced purchase agreement signed for delivery in 2022.

Jamie: That were deferred into 2023.

Jamie: We do not expect these sales to repeat in 2024.

Jamie: In the second half of 2023, we recorded $4 billion in sales from seasonal endemic demands.

Jamie: And an additional $600 million from deferred revenue related to Gabby.

Jamie: Sales in the fourth quarter were $2 8 billion.

Jamie: With zero point $8 billion in sales in the U S and <unk> $6 billion in Europe, and $1 4 billion and the rest of the world, including the deferred revenue from Gavin.

Jamie: For the full year 2023 product sales were $6 $7 billion comprised.

Jamie: Comprised of $1 $7 billion in sales in the U S $1 $4 billion in Europe, and $3 6 billion and the rest of the world again, including deferred revenue from government.

Jamey Mock: Research and development spend was $4.8 billion, and SG&A was $1.5 billion, both in line with our expectations. Our income tax provision was $772 million for the full year 2023. During our Q3 earnings call, we discussed the requirement under GAAP to establish a valuation allowance against deferred tax assets when the current year and cumulative income projection for the next three years is in a lost position. It's important to note that future income from products not yet approved by regulators is excluded from these income projections, which restricts us to just our COVID vaccine and does not include expected future launches. This valuation allowance does not impact cash flows, future tax returns, or the company's ability to utilize deferred tax assets in future periods. The net loss for the year was $4.7 billion compared to net income of $8.4 billion last year. The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023. Diluted loss per share was $12.33 compared to diluted earnings per share of $20.12 in 2020. So now let's move to slide 12. We wanted to provide you additional perspective on our full year financial results. By presenting them alongside a summarized version that excludes the impact of the GAVI Deferred Revenue Recognition, our resizing charges, and the Tax Valuation, our total gap net loss for the full year was $4.7 billion. However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion. Now let's turn to our 2024 financial framework on slide 13, which is mostly in line with what I shared on our Q3 call. We expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025. Sales in the first half of the year are expected to be approximately 100 million dollars, reflecting the strong seasonality of respiratory vaccines. We expect a cost of sales of approximately 35% of product sales, in line with our cost of sales framework, which we introduced in our Q3 earnings call last year. For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principal, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mainly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they all focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdarc The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Jamie: Cost of sales was $929 million down from 39% of net product sales in the previous year to 33% this year.

Jamie: Additionally cost of sales also includes an inventory write down of $322 million, reflecting revised demand forecasts.

Jamie: R&D expenses increased by 16% to $1 4 billion.

Jamie: This uptick reflects our commitment to advancing our late stage clinical development programs.

Jamie: Particularly with our RSV vaccine CMV vaccine combination vaccine against flu and COVID-19, as well as our <unk> program.

Jamie: The increase also included an upfront payment of $120 million associated with the strategic research and development collaboration with <unk>.

Jamey Mock: The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023. Diluted loss per share was $12.33 compared to diluted earnings per share of $20.12 in 2020. So now let's move to slide 12. We wanted to provide you additional perspective on our full year financial results. By presenting them alongside a summarized version that excludes the impact of the GAVI Deferred Revenue Recognition, our resizing charges, and the Tax Valuation, our total gap net loss for the full year was $4.7 billion. However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion. Now let's turn to our 2024 financial framework on slide 13, which is mostly in line with what I shared on our Q3 call. We expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025. Sales in the first half of the year are expected to be approximately 100 million dollars, reflecting the strong seasonality of respiratory vaccines. We expect a cost of sales of approximately 35% of product sales, in line with our cost of sales framework, which we introduced in our Q3 earnings call last year. For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principal, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mainly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they all focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdarc The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Jamie: SG&A expenses were $470 million up 25% year over year.

Jamie: The increase in spending was primarily due to the expansion of our commercial operations, particularly in the U S market.

Jamie: Income tax was a benefit of $147 million for the fourth quarter of 2023, largely attributable to the tax benefits as part of finalizing our 2022 U S tax return.

Jamie: Net income for the quarter was $217 million compared to $1 5 billion in the fourth quarter last year.

Jamie: Diluted earnings per share was <unk> 55, compared to $3 61 in 2022 weeks.

Jamey Mock: However, when excluding these primarily non-cash items, the net loss is reduced to $1.6 billion. Now let's turn to our 2024 financial framework on slide 13, which is mostly in line with what I shared on our Q3 call. We expect net sales for 2024 of approximately $4 billion, which we think will be a low point as we expect to return to growth in 2025. Sales in the first half of the year are expected to be approximately 100 million dollars, reflecting the strong seasonality of respiratory vaccines. We expect a cost of sales of approximately 35% of product sales, in line with our cost of sales framework, which we introduced in our Q3 earnings call last year. For R&D, we expect full-year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. And for SG&A, we expect full-year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principal, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mainly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to Jamey. Good morning or good afternoon, everyone. Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they all focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdarc The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Jamie: We closed the quarter with a strong cash position of $13 3 billion.

Jamie: Which is slightly higher than the $12 8 billion, we had at the end of the prior quarter.

Jamie: Now, let's turn to our annual performance on page 11.

Jamie: Net product sales for the full year 2023 were $6 7 billion.

Jamie: A decrease of 64% from the previous year.

Jamie: Mainly due to lower sales volume of our COVID-19 vaccine.

Jamie: As mentioned earlier. This includes the recognition of <unk> 6 billion from the deferred revenue related to <unk>.

Jamie: Excluding this item our sales of $6 $1 billion, we're still in line with the framework, we provided for the full year.

Jamie: Cost of sales for the full year represented 70% of net product sales a substantial increase from 29% of product sales in 2022.

Jamie: This shift is largely attributable to our strategic efforts to optimize our manufacturing operations, resulting in charges of $1 6 billion and other manufacturing and distribution costs over reduced sales volume.

Jamie: Overall cost of sales came in at $4 7 billion.

Jamie: Slightly below the 5 billion, we provided in our latest framework.

Jamey Mock: We also expect taxes to be negligible in 2024. In our Q3 earnings call, I provided our Moderna operating principal, which largely centered around a very disciplined approach to capital allocation. Our number one priority has been and will continue to be reinvesting in the business. In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately $0.9 billion, as we mainly complete the construction of our facilities across the globe. Our teams are laser focused on operational improvements for both expense management and working capital. As a result, we expect to end 2024 with approximately $9 billion in cash. I will now turn the call over to Jamey. Good morning or good afternoon, everyone.

Jamie: Research and development spend was $4 8 billion and SG&A was $1 $5 billion, both in line with our expectations.

Jamie: Our income tax provision was $772 million for the full year 2023.

Jamie: It's important to note that future income from products not yet approved by regulators are excluded from these income projections.

Jamie: Which restricts us to just our Covid vaccine and it does not include expected future launches.

Jamie: This valuation allowance does not impact cash flows future tax returns or the company's ability to utilize deferred tax assets in future periods.

Jamie: Net loss for the year was $4 7 million compared to net income of $8 4 billion last year.

Stephen Hoge: Today, I'll do a quick review of our clinical highlights from our late-stage programs in 2023, and then look ahead to anticipated milestones in 2021. While we have over 40 programs in development, they all focus on our late-stage pipeline, which consists of nine programs across four franchises, all made significant progress in 2023. Four of these programs are in our Respiratory Vaccine franchise. We hope to launch all of these potential products by the end of 2020. Talukdarc The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Jamie: The decrease in profit was primarily due to lower product sales and higher R&D expenses in 2023.

Jamie: Diluted loss per share was $12 33, compared to diluted earnings per share of <unk> $20 12 and 2022.

Speaker Change: So now let's move to slide 12, we wanted to provide you additional perspective on our full year financial results.

Speaker Change: By presenting them alongside a summarized version that excludes the impact of the <unk> deferred revenue recognition on a resizing charges and the tax valuation allowance.

Speaker Change: Our total GAAP net loss for the full year was $4 7 billion. However, when excluding these primarily noncash items. The net loss was reduced to $1 6 billion.

Stephen Hoge: The other five late stage programs are spread across late infection. We hope to begin launching these beginning in 2026, and I'll discuss our progress in these areas as well. In infectious disease vaccines, we've achieved many important clinical milestones. For example, within our respiratory vaccine franchise, we filed for RSV vaccine approvals in many countries around the world. We recently presented follow-up data from our Phase 3 study at the RSVVW meeting that I'll recap in a moment. In our mRNA 1010 flu program, our phase 3 P303 study met its primary safety endpoints and hit all eight co-primary immunogenicity endpoints against all strains of influenza. We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Speaker Change: Now, let's turn to our 2024 financial framework on Slide 13, which is mostly in line with what I shared on our Q3 call.

Speaker Change: We expect net sales for 2024 of approximately $4 billion.

Speaker Change: Which we think will be a low point as we expect to return to growth in 2025.

Speaker Change: Sales in the first half of the year are expected to be approximately $100 million rich.

Speaker Change: Reflecting the strong seasonality of respiratory vaccines.

Speaker Change: We expect cost of sales of approximately 35% of product sales in line with our cost of sales framework, which we introduced in our Q3 earnings call last year.

Speaker Change: For R&D, we expect full year expenses to be approximately $4 5 billion.

Stephen Hoge: We're also excited that we fully enrolled the Phase 3 immunogenicity and safety study of our next-gen COVID vaccine and the Phase 3 Immunogenicity and Safety Study of our Flu and COVID Combination Vaccine. In our latent and other vaccines franchise, we're proud of the great progress our team made to complete enrollment in the phase three study of our CMV vaccine in 2023. That study is now accruing cases towards its first interim analysis of efficacy. On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023. The study met its primary and key secondary endpoints, leading the DSMB to recommend UNBLIND. Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Speaker Change: Down from $4 8 billion in 2023 and for SG&A, We expect full year expenses to be approximately $1 3 billion.

Speaker Change: Down from $1 5 billion in 2023.

Speaker Change: We also expect taxes to be negligible in 2024.

Speaker Change: And our Q3 earnings call I provided our Medina operating principles, which largely centered around a very disciplined approach to capital allocation.

Speaker Change: Our number one priority has been and will continue to be reinvesting in the business.

Speaker Change: In addition to the investment into our pipeline, we expect capital expenditures in 2024 to be approximately zero point $9 billion.

Speaker Change: As we mostly complete the construction of our facilities across the globe.

Speaker Change: Our teams are laser focused on operational improvements for both expense management and working capital as a result, we expect to end 2024 with approximately $9 billion in cash I will now turn the call over to Steven.

Stephen Hoge: Vaccine efficacy was 83.7% against RSC with two or more symptoms of lower respiratory tract disease at a median follow-up of 3.7 months with a wide range of two weeks to 12 months of total follow-up. The primary analysis also showed 82.4% and 68.4% vaccine efficacy against three or more symptoms and acute respiratory distress, respectively. These data were recently published in the New England Journal of Medicine in December of last year. We've continued to follow the participants in the trial and announced follow-up data at the RSVVW conference earlier this month. And an additional analysis showed sustained vaccine efficacy against RSV, with VE of 63.3% against RSV, lower respiratory tract disease, with two or more symptoms, through a median follow-up of 8.6 months and a maximum follow-up of 17.7. The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: Thank you Jamie good morning, or good afternoon, everyone.

Steven: Today I'll do a quick review of our clinical highlights from our late stage programs in 2023, and then look ahead to anticipated milestones in 2024.

Steven: While we have over 40 programs in development <unk> focus on our late stage pipeline, which consists of nine programs across four franchises.

Steven: Made significant progress in 2023.

Steven: Four of these programs are in our respiratory vaccine franchise, we hope to launch all of these potential products by the end of 2025.

Steven: These further enrollment.

Steven: In infectious disease.

Steven: We've achieved many important clinical milestones.

Steven: <unk>.

Steven: Within our respiratory vaccine franchise, we felt for RSV vaccine approvals in many countries around the world.

Stephen Hoge: The vaccine efficacy was 74.6% against RSV, lower respiratory tract disease, associated with shortness of breath, which has been shown to be a key driver of seeking higher levels of medical care and the associated burdens and costs. Slide 19 summarizes the overall timing of enrollment, primary efficacy analysis, and subsequent analysis overlaid against the epidemiology of RSV over the two seasons that have now contributed to the efficacy in the trial. Our trial unfolded steadily over 13 months between November 2021 and December 2022. As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021-2022 and the much more significant RSV season of 2022-2023. Due to enrollment throughout the year, the median follow-up for the primary analysis was 3.7 months, but as I noted, the maximum follow-up was 12 months. The primary analysis met its success criteria, leading to a study on blinding. We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: We recently.

Steven: Presented follow up data from our phase III study at the RSV VW meeting, but I'll recap in a moment.

Steven: In our mrna 10, 10 flu program, our phase III <unk> III study met its primary safety endpoint and hit all eight co primary immunogenicity endpoints against all strains of influenza.

Steven: We're also excited that we fully enrolled the phase III Immunogenicity and safety study of our Nextgen Covid vaccine.

Steven: And the phase III Immunogenicity safety and safety study of our flu and Covid combination vaccine.

Steven: On slide 17, I want to briefly review the primary analysis for our RSV vaccine, which was first shared in January of 2023.

Steven: The study met its primary and key secondary endpoints, leading the DSM be to recommend unblinded.

Stephen Hoge: We continue to pre-plan additional analysis on April 30th, 2023. At that analysis, the median follow-up was 8.6%, with a maximum follow-up of 17.7 months, or put another way, approximately 17,000 participants with between 9 and 18 months of study follow-up at the time of the analysis, with many completing their second RSD season on the study. Per protocol, we are continuing to follow cases through one year, but from the epidemiology, very few cases would be expected in the six months after the April 30th cutoff date from the last. In summary, we are pleased that the data shows sustained efficacy through two seasons, including the large RSV season of 2022-2023, and we look forward to providing further updates from this ongoing study. We also achieved clinical milestones across our therapeutics franchises in 2023. For example, in oncology, our individualized neoangine therapy, developed in partnership with Merck, began phase three clinical studies in both adjuvant melanoma and non-small cell lung cancer. Both Phase 3 trials are now actively enrolling. Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: Vaccine efficacy was 83, 7% against RSV with two or more symptoms as the lower respiratory tract disease at a median follow up of three seven months with a wide range of two weeks to 12 months of total follow up.

Steven: The primary analysis showed also showed 82, 4% and 68, 4% vaccine efficacy against three or more symptoms and acute respiratory distress respectively.

Steven: These data were recently published in the New England Journal of Medicine in December of last year.

Steven: We've continued to follow the participants in the trial and pronounced follow up data at the Rspb RSV VW conference earlier this month.

Steven: Slide 19 summarizes the overall timing of enrollment primary efficacy analysis and subsequent analysis overlaid against the epidemiology of RSC over the two seasons that have now contributed to the efficacy in the trial.

Stephen Hoge: Our primary analysis from the Phase 2 study was recently published in The Lancet, giving greater detail on the two-year follow-up data that we had released in 2022. Now, in December of 2023, we shared top-line follow-up data from that same phase 2 study in adjuvant melanoma patients, confirming the durability of the initially reported responses. At a median follow-up of now three years, the recurrence-free survival and distant metastasis-free survival remained extremely favorable, with a reduction of the risk of recurrence or death by 49% and a reduction of the risk of distant metastasis or death by 62%. Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: Our trial enrolled steadily over 13 months between November 2021, and December 2022.

Steven: As a result, the primary efficacy analysis included cases from both the smaller RSV season of 2021, and 2022 and the much more significant RSV season of 2022 and 2023.

Steven: Due to enrollment throughout the year. The median follow up of the primary analysis was three seven months, but as I noted the maximum.

Steven: Was 12 months.

Steven: The primary analysis made its success criteria leading to steady unwinding.

Stephen Hoge: Both results were highly statistically significant at three years and in PA and MMA, our most advanced rare disease therapy. We continued to see positive clinical data in our Phase 1-2 studies, including improvements in biomarkers and clinical outcomes, such as metabolic decompensation. Returning to slide 21, Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: We continue the Preplanned additional analysis on April 30 of 2023.

Steven: That means at that analysis. The median follow up was $8 six with a maximum follow up of $17 seven months or put another way approximately 70000 persistence. We're between nine and 18 months of study follow up at the time of the analysis with many completing their second RSV season on the study.

Stephen Hoge: Well, we're proud of the progress in 2023. We have much more ahead of us in 2024. Let me take you through some of the late stage milestones we anticipate. I'll start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine in the first half of 2024, with commercial launches shortly thereafter. With our flu vaccine, we're in discussions with regulators about potential submissions for approvals, and we expect to begin filing this year. Phase 3 data from our next-gen COVID vaccine is expected in the first half of 2024, which will inform the next steps. And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: We also achieved clinical milestones across our therapeutic franchises in 2023.

Steven: In oncology, our individualized Neo engine therapy developed in partnership with Merck began phase III clinical studies in both adjuvant melanoma and non small cell lung cancer.

Stephen Hoge: And we expect Phase 3 data for our flu and COVID combination vaccine in latent vaccines. We are looking forward to potential efficacy data from our CMV phase 3, in Oncology. We expect continued progress in rolling out our two phase three studies in INT for adjuvant melanoma and non-small cell lung cancer. We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: Both phase III trials are now actively enrolling.

Steven: Our primary analysis from the Phase II study was recently published in the lancet, giving greater detail on the two year follow up data that we had released in 2022.

Steven: Now in December of 2023, we shared top line follow up data from that same phase II study in adjuvant melanoma patients confirming the durability of the initially reported responses.

Stephen Hoge: We also expect to expand into additional tumor types, and finally, in rare diseases, we expect to move into registrational studies for both PA and MMA in 2024. It'll be a very busy year, and we look forward to sharing progress with you as the year progresses. With that, I'll turn the call over to Stephanie. Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stphane Bancel: Thank you, Stephen and Jamey. For Moderna, and the patients we serve, 2024 is all about exams. Execution in commercial, execution of all late-stage pipelines, and execution with finance. Setting of commercial. Fiat Occo-vita. We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: <unk> in three years.

Steven: And in PAA in MMA, our most advanced rare disease therapeutic programs, we continued to see positive clinical data in our phase one two studies, including improvements in Biomarkers and clinical outcomes such as metabolic decompensation.

Stphane Bancel: We will continue to work with health authorities to increase vaccination rates and improve public health by reducing the substantial burden of disease from COVID in this upcoming 2024-2025 season. While I am pleased with the U.S. market share outcome of the current season, I believe we can and must do better on vaccination rates. Our team is already actively working on it. A few weeks ago, the EU published a new mRNA COVID vaccine tender, up to 36 million doses per year for up to four years. Our team is actively working to respond to this standard. We are prioritizing our commercial focus on specific markets around the world to deliver where it matters the most. Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: Turning to slide 21.

Speaker Change: While we're proud of the progress in 2023, we have much more head in 2024, let me take you through some of the late stage milestones, we anticipate for this year.

Steven: Start with our respiratory franchise, where we are targeting the first approval for our RSV vaccine beginning in the first half of 2024 with commercial launches shortly thereafter.

Steven: With our flu vaccine we are in discussions with regulators about potential submissions for approvals and we expect to begin filing this year.

Steven: <unk> phase III data from our Nextgen Covid vaccine is expected in the first half of 2024, which will inform the next steps and we expect phase III data for our flu and Covid combination vaccine this year.

Stphane Bancel: Moving to our RSV vaccine candidates, we are very excited about launching the IG vaccine this year. That will be the launch of our second product, for Emane Platform in Delivering. The FDA PDUFA date is May 12th. If the outcome is positive, we anticipate that ACIP will include mRNA-1345 on the agenda in late June. In Europe, we expect Germany to launch in 2024, and we expect Australia to launch this year, while other markets will likely launch in 2025. In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: In late and vaccines, we are looking forward to potential efficacy data from our CMV phase III study.

Steven: In oncology, we expect continued progress enrolling our two phase III studies.

Steven: For adjuvant melanoma, and non small cell lung cancer. We also expect to expand into additional tumor types. This year.

Steven: And finally in rare diseases, we expect to move into Registrational studies for both PAA and MMA in 2024.

Stphane Bancel: In many markets around the world, we need to secure regulatory approval before we can participate in tenders. As communicated last year, given expected approval outside the US, Germany and Australia will anticipate launching R&D in this market in 2025. The R&D market is estimated to be a $10 billion opportunity, consisting roughly of 6 to 8 billion in older adults and 2 to 4 billion in the pediatric and maternal sector. In 2023, the first-year RSV vaccine launches, consumer awareness of RSV, and demand for the RSV vaccine was strong. The 2023 adult R&D vaccine market is around $2.5 billion. This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Steven: It'll be a very busy year, and we look forward to sharing progress with you as the year progresses with that I'll turn the call over to Stephane.

Stephane: Thank you Stephen and Jamie.

Stephane: For mobile now and the patients we sell 2024 is all about execution.

Stephane: It is a trend in commercial.

Stephane: <unk> of our late stage pipeline.

Stephane: And execution with financial discipline.

Stephane: Starting with commercial.

Stephane: Our COVID-19 vaccine.

Stephane: While I am pleased with the U S market share outcome of our current season I believe we can and must do better on recognition rates.

Stphane Bancel: This is quite impressive; even if it was the first year that the vaccines were available, they were not even available for a full year, and the products were not approved in many countries. With the 2023 R&D vaccination rate as a small percentage of the total addressable market, we are quite excited to launch our product into this large and growing market. Lavina, turn to our RID Vaccine profile. We believe we have the best profile to serve patients and compete in the R&D market. Efficacy. Sexy and he's okay. For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: Our team actively working on it already.

Stephane: A few weeks ago, the EU published a new ammonia COVID-19 vaccine tender.

Stephane: Up to $36 million per year for up to four years.

Stephane: Our team is actively working to respond to December.

Stephane: We are prioritizing our commercial focus on specific markets around the world to deliver where it matters. The most.

Stephane: Moving to our RSV vaccine candidate.

Stephane: We are very excited about launching our RSV vaccine DCF.

Stphane Bancel: For clinical data, it's actually a strong vaccine. We have a well-established safety and tolerability profile that leverages the same mRNA technology that has been delivered in over 1 billion COVID vaccines. Additionally, we have not seen any cases of Guillain-Barré syndrome or GBS in our phase 3 trials. We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: We will launch our second product.

Stephane: While our monarch platform is delivering.

Stephane: The FDA <unk> date is may 12.

Stephane: You'd be outcome is positive we anticipate that <unk> will include <unk> 45 on the agenda in late June.

Stephane: In Europe, we expect Germany to launched in 2024.

Stphane Bancel: We expect to be the only company to offer an RZ vaccine in ready-to-use pre-filled syringes. Our one-step administration compares well relative to competitive products and requires multiple preparation steps by pharmacists and clinicians. As you know, whenever a company sells a product, it requires 9 steps of preparation for each consumer needing an RSV vaccine, and the other competitors' products require four steps of preparation. With over 90% of USRG vaccines given to date in a pharmacy setting, PFS presentations offer ease of use. I'm saving money and the potential to reduce medical errors. Given the labor shortage in retail pharmacy channels, we anticipate our PFS presentation will be welcomed by pharmacists in a very busy respiratory vaccine season where pharmacists need, in addition to their regular tasks, to administer the flu vaccine, COVID vaccine, and HIV vaccine. Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: So expect us to launch this year, what other markets will actually launch in 2025.

Stephane: In many markets around the world, we need to secure regulatory approval before we can participate in tandem.

Stephane: Communicated last year, given the expected approval of IV, Europe, Germany, and Australia, we anticipate losses in this market is probably around five.

Stephane: The Aussie market is estimated to be $10 billion opportunity consisting of roughly 6 billion in older adults and two to 4 billion in the pediatric and muscle milk setting.

Stephane: In 2023, the first year RSV vaccine launches consumer awareness and demand for is the vaccine was strong.

Stephane: For 2023, other RSV vaccine market was around $2 5 billion.

Stephane: This is quite impressive given you wrote their first RSV vaccine to a variable there without even the variable for a full year and the products will have to approve in many countries.

Stphane Bancel: Today we talked about how much progress we made on the Let's Stage Pipeline in 2021. This year, we look forward to continuing the execution and reporting milestones in each of these programs. If you look at this slide, it is going to be a very busy and very exciting year with multiple phase three readouts like the COVID next-gen, also flu plus COVID phase three data, and potentially CMV phase three data. But we're also going to be fighting products like flu. And, of course, approvals in many countries around the world for RISC-V. Finally, we are all committed to exercising financial discipline across the business. While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: We have 2023, RSV vaccination right as a small percentage of the total addressable market. We are quite excited to launch a product into this large and growing market.

Stephane: Now onto our RSV vaccine profile.

Stephane: We believe we have the best profile to serve patients and completing the allergy market efficacy safety and ease of use.

Stephane: Clinical data show strong vaccine efficacy.

Stephane: We have a well established safety and Tolerability profile that leverages. The same amount of technology that has been delivered over 1 billion Covid vaccine.

Stephane: Additionally, Additionally, we have not seen any case of guillain Barre syndrome at UBS phase III trial.

Stphane Bancel: While we have resized our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing, which reduced operating expenses in R&D and SG&A and prioritized programming R&D with near-term commercial potential in areas of unmet medical need. Overall, our capex will be up modestly in 2024 compared to 2023 and will mostly complete the construction of several important plants in Marlborough, Massachusetts for iron, and Canada, the UK In 2025, we expect CAPEX to be down significantly. We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: We expect to be the only company to offer an RSV vaccine in ready to use prefilled syringe or PFS.

Stephane: One step administration comprehensive well.

Stephane: Relative to competitive products and requirement for progression steps by pharmacists and clinicians.

Stephane: As you know one of our competitor product required nine step of progression for each consumer <unk>.

Stephane: And the other competitors' products required post type of propulsion.

Stephane: We have about 90% of U S. Aussie vaccine <unk> date in the pharmacy setting PFS presentation of ease of use.

Speaker Change: I'm saving.

Stephane: And the protocol to reduce medical errors.

Stphane Bancel: We're also targeting working capital improvement. And importantly, as you know, we are adopting AI across the business, which we expect to save time, increase productivity, and reduce scalability in addition to cost savings. Our use of AI is increasing by the week, and new use cases are exciting to see how teams are embracing this new tool across the company. In summary, 2024 is an important year of execution across our company. Why don't we set the stage for the next several years? I am very excited. I have company for this. I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: Given the that work stoppage in retail pharmacy channel, we anticipate our PFS presentation will be welcomed by pharmacies in a very busy respiratory vaccine season, where pharmacies nib. In addition to very good opt out so let me spell flu vaccine COVID-19 vaccine and RSV vaccine.

Stephane: Two that we talked about how much progress we made in the late stage pipeline in 2023.

Stephane: This year, we look forward to continued execution and reporting milestones in each of these programs.

Stephane: If you look at this slide it is going to be a very busy and very exciting year with multiple phase III readouts like recovery Nextgen also throughput COVID-19 phase III data and potentially CMV phase III data.

Stphane Bancel: I believe 2024 will be a year where many observers of Moderna go from thinking of us as a COVID-19 vaccine company to think of Moderna as an mRNA platform company with several products approved and more approvals on the way for 2025 and beyond. Over the next few years, our ability to deliver on our mission will increase significantly and be very meaningful for us. With that, Operator, we'll be happy to take questions now. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered and you wish to move yourself from the queue, please press star 11 again. And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: Well first of all we're going to be products like fruit, which will be our first product.

Stephane: And of course approvals in many countries around the world for IV.

Stephane: Finally, we are all committed to exercising financial discipline across the business.

Stephane: While we have resized, our manufacturing footprint in 2023, we will continue to find ongoing cost improvements in manufacturing.

Stephane: We will reduce operating expenses in R&D and SG&A and protest programming R&D, we've been near term commercial potential in areas of unmet medical need.

Stephane: Overall, our capex will be up modestly modestly in 2024 compared to 2023.

Operator: And to accommodate everyone in the queue, we ask that you limit yourself to one question. We will pause for a moment while we compile our Q&A list. Our first question comes from Michael Yee, with Jeffries. Your line is open. Hey, guys, good morning, and thanks for the question. Focusing on RSV, I know you made a number of nice comments about comparing the data. Maybe you could talk about two or three points. One is perhaps how it will work in the commercial market in the U.S. with contracting. Is that contracting season, or do you have to have contracts, and how does that work between the two different other competitors? And secondly, how would that work at the pharmacy level when either patients or doctors are making the selection, given the fact that Pfizer and GSK both had similar sales but different profiles? Maybe talk about those two different things and how you expect that to play out this year.

Stephane: And we must be complete construction of several important class in Marlborough, Massachusetts for IMT, and Canada, UK and Australia.

Stephane: In 2025, we expect capex to be down significantly.

Stephane: What's the targeted working capital improvement and importantly, as you know we are adopting AI across the business, which we expect to save time increased productivity and reps capability. In addition to cost savings.

Stephane: AI is increasing by the week and use cases are exciting to see how our teams are embracing this new tool across the business.

Stephane: In summary, 2024 is an important year of execution across our company.

Stephane: One is we set the stage for the next several years.

Stephane: I am very excited by our company's position.

Stephane: I believe 2024 will be a year, where many of cellular model now go from thinking of us as a COVID-19 vaccine company. So.

Stephane: So we're seeing model now has an M&A platform company with several products.

Stephane: And more approvals on the way for 2025 and beyond.

Over the next few year, our ability to deliver on our mission will increase significantly and be very meaningful for us.

Stphane Bancel: Thank you. Great, thank you Michael, Stphane. So in terms of contracting, obviously, we cannot start contracting now because the product is not approved, but our medical team has been quite engaged across the board at medical conferences, talking to healthcare professionals, and sharing the great data that was published in December, as you know, for phase three in the New England Journal of Medicine. So we have active discussions, and there is quite a high excitement about the possibility, again, if a product was to be approved, to get As we discussed in my remarks, as you know, labor shortages are a big issue in pharmacy. For any of us that have gone to a pharmacy in the fall, you could see it was very busy, sometimes a bit too hectic. And so the leadership of the big retail pharmacy is very engaged in thinking about COVID-19 and how to simplify the workflow, how to reduce medical errors, which is why those medical discussions that we've had so far give me significant hope that our products will be meaningful tools for our customers. Thank you. Our next question comes from Gena Wang with Barclays. Your line is open. Thank you. I have two very quick questions. The first one is regarding the RSV vaccine. What portion of 35,000 to 36,000 participants that completed two seasons and regarding the February 29 ASEP meeting, what additional data will you be presenting? And very quickly on 2024 guidance. Now we have a better understanding of both COVID and RSV market size for 2023 and 2024 seasons. What could be the upside or downside for your 2024 revenue guidance? Great, thanks, Gina. I'll take the first part of that. So I actually can't, I don't know off the top of my head the proportion because there are both Southern and Northern Hemisphere participants that were enrolled in the study, and so counting the two RSV seasons will depend on that. It is a sizable proportion because, as I said, the maximum follow-up at the additional analysis is about 18 months, and the medium was nine months, and so by definition, about half, as you just said, about 17,000 participants are between them. And we did enrol pretty continuously over 13 months, not exactly evenly, but pretty close to it. I don't want to give you an inaccurate number, but I would suspect it is a pretty sizable proportion because of that steady, pretty consistent enrollment over the course of 13 months. It's not exactly equal, but it trended that way. As far as additional data for the ACIP meeting, we will obviously continue to provide updates from any additional analysis we're doing on durability. We obviously have immunogenicity data as well as data across different subpopulations. And if we're fortunate enough to have the opportunity to present at the ACIP, we will, of course, listen to the committee on anything they would like to see as well as the performance of mRNA-1345 as a vaccine and the performance of vaccines in general in terms of durability as it guides decision-making around repeat dosing or boosting on some schedule and the public. Thanks, Stephen. And Gena and Stphane, on the upside and downside of sales for this year, I think on the upside, obviously, COVID in Europe. As I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, and public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, in immunocompromised people. That's an interesting upside. Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Operator, we'd be now happy to take questions.

Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered and wish him with yourself from the queue. Please press star one again and to accommodate everyone. In the queue. We ask that you limit yourself to one question, we will pause for a moment, while we compile our Q&A roster.

Our first question comes from Michael Yee with Jefferies. Your line is open.

Hey, guys good morning, and thanks for the question.

Focusing on RSV I know you've made a number of nice comments about comparing the data.

Stphane Bancel: And so the leadership of the big retail pharmacy is very engaged in thinking about COVID-19 and how to simplify the workflow, how to reduce medical errors, which is why those medical discussions that we've had so far give me significant hope that our products will be meaningful tools for our customers. Thank you. Our next question comes from Gena Wang with Barclays. Your line is open. Thank you. I have two very quick questions. The first one is regarding the RSV vaccine. What portion of 35,000 to 36,000 participants that completed two seasons and regarding the February 29 ASEP meeting, what additional data will you be presenting? And very quickly on 2024 guidance. Now we have a better understanding of both COVID and RSV market size for 2023 and 2024 seasons. What could be the upside or downside for your 2024 revenue guidance? Great, thanks, Gina. I'll take the first part of that. So I actually can't, I don't know off the top of my head the proportion because there are both Southern and Northern Hemisphere participants that were enrolled in the study, and so counting the two RSV seasons will depend on that. It is a sizable proportion because, as I said, the maximum follow-up at the additional analysis is about 18 months, and the medium was nine months, and so by definition, about half, as you just said, about 17,000 participants are between them. And we did enrol pretty continuously over 13 months, not exactly evenly, but pretty close to it. I don't want to give you an inaccurate number, but I would suspect it is a pretty sizable proportion because of that steady, pretty consistent enrollment over the course of 13 months. It's not exactly equal, but it trended that way. As far as additional data for the ACIP meeting, we will obviously continue to provide updates from any additional analysis we're doing on durability. We obviously have immunogenicity data as well as data across different subpopulations. And if we're fortunate enough to have the opportunity to present at the ACIP, we will, of course, listen to the committee on anything they would like to see as well as the performance of mRNA-1345 as a vaccine and the performance of vaccines in general in terms of durability as it guides decision-making around repeat dosing or boosting on some schedule and the public. Thanks, Stephen. And Gena and Stphane, on the upside and downside of sales for this year, I think on the upside, obviously, COVID in Europe. As I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, and public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, in immunocompromised people. That's an interesting upside. Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Maybe you could talk to two or three points one is.

Perhaps how it will work in the commercial market in the U S. With contracting is that contracting season or do you have to have contracts and how does that work between the two different other competitors.

Secondly, how would that work at the pharmacy level when either patients or doctors are making the selection given the fact that the Pfizer and GSK both had similar sales, but different profiles, maybe talk to those two different things and how you expect that to play out for this year. Thank you.

Stephen Hoge: The first one is regarding the RSV vaccine. What portion of 35,000 to 36,000 participants that completed two seasons and regarding the February 29 ASEP meeting, what additional data will you be presenting? And very quickly on 2024 guidance. Now we have a better understanding of both COVID and RSV market size for 2023 and 2024 seasons. What could be the upside or downside for your 2024 revenue guidance? Great, thanks, Gina. I'll take the first part of that. So I actually can't, I don't know off the top of my head the proportion because there are both Southern and Northern Hemisphere participants that were enrolled in the study, and so counting the two RSV seasons will depend on that. It is a sizable proportion because, as I said, the maximum follow-up at the additional analysis is about 18 months, and the medium was nine months, and so by definition, about half, as you just said, about 17,000 participants are between them. And we did enrol pretty continuously over 13 months, not exactly evenly, but pretty close to it. I don't want to give you an inaccurate number, but I would suspect it is a pretty sizable proportion because of that steady, pretty consistent enrollment over the course of 13 months. It's not exactly equal, but it trended that way. As far as additional data for the ACIP meeting, we will obviously continue to provide updates from any additional analysis we're doing on durability. We obviously have immunogenicity data as well as data across different subpopulations. And if we're fortunate enough to have the opportunity to present at the ACIP, we will, of course, listen to the committee on anything they would like to see as well as the performance of mRNA-1345 as a vaccine and the performance of vaccines in general in terms of durability as it guides decision-making around repeat dosing or boosting on some schedule and the public. Thanks, Stephen. And Gena and Stphane, on the upside and downside of sales for this year, I think on the upside, obviously, COVID in Europe. As I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, and public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, in immunocompromised people. That's an interesting upside. Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Speaker Change: Great. Thank you <unk>.

Speaker Change: So in terms of contracting obviously, we cannot start constructing now because our product is not approved but our medical team has been quite engaged across the board at.

Stephen Hoge: Now we have a better understanding of both COVID and RSV market size for 2023 and 2024 seasons. What could be the upside or downside for your 2024 revenue guidance? Great, thanks, Gina. I'll take the first part of that. So I actually can't, I don't know off the top of my head the proportion because there are both Southern and Northern Hemisphere participants that were enrolled in the study, and so counting the two RSV seasons will depend on that. It is a sizable proportion because, as I said, the maximum follow-up at the additional analysis is about 18 months, and the medium was nine months, and so by definition, about half, as you just said, about 17,000 participants are between them. And we did enrol pretty continuously over 13 months, not exactly evenly, but pretty close to it. I don't want to give you an inaccurate number, but I would suspect it is a pretty sizable proportion because of that steady, pretty consistent enrollment over the course of 13 months. It's not exactly equal, but it trended that way. As far as additional data for the ACIP meeting, we will obviously continue to provide updates from any additional analysis we're doing on durability. We obviously have immunogenicity data as well as data across different subpopulations. And if we're fortunate enough to have the opportunity to present at the ACIP, we will, of course, listen to the committee on anything they would like to see as well as the performance of mRNA-1345 as a vaccine and the performance of vaccines in general in terms of durability as it guides decision-making around repeat dosing or boosting on some schedule and the public. Thanks, Stephen. And Gena and Stphane, on the upside and downside of sales for this year, I think on the upside, obviously, COVID in Europe. As I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, and public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, in immunocompromised people. That's an interesting upside. Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

At Medical conference is talking to healthcare professionals and sharing the great data that was published in December as you know from our phase III in the New England Medicine. So we have active discussions base quite high excitement about the possibility again EBIT product for us to be approved to get the prefilled syringe product.

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Stephen Hoge: It is a sizable proportion because, as I said, the maximum follow-up at the additional analysis is about 18 months, and the medium was nine months, and so by definition, about half, as you just said, about 17,000 participants are between them. And we did enrol pretty continuously over 13 months, not exactly evenly, but pretty close to it. I don't want to give you an inaccurate number, but I would suspect it is a pretty sizable proportion because of that steady, pretty consistent enrollment over the course of 13 months. It's not exactly equal, but it trended that way. As far as additional data for the ACIP meeting, we will obviously continue to provide updates from any additional analysis we're doing on durability. We obviously have immunogenicity data as well as data across different subpopulations. And if we're fortunate enough to have the opportunity to present at the ACIP, we will, of course, listen to the committee on anything they would like to see as well as the performance of mRNA-1345 as a vaccine and the performance of vaccines in general in terms of durability as it guides decision-making around repeat dosing or boosting on some schedule and the public. Thanks, Stephen. And Gena and Stphane, on the upside and downside of sales for this year, I think on the upside, obviously, COVID in Europe. As I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, and public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, in immunocompromised people. That's an interesting upside. Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

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Thank you. Our next question comes from Gena Wang with Barclays. Your line is open.

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Stephen Hoge: As far as additional data for the ACIP meeting, we will obviously continue to provide updates from any additional analysis we're doing on durability. We obviously have immunogenicity data as well as data across different subpopulations. And if we're fortunate enough to have the opportunity to present at the ACIP, we will, of course, listen to the committee on anything they would like to see as well as the performance of mRNA-1345 as a vaccine and the performance of vaccines in general in terms of durability as it guides decision-making around repeat dosing or boosting on some schedule and the public. Thanks, Stephen. And Gena and Stphane, on the upside and downside of sales for this year, I think on the upside, obviously, COVID in Europe. As I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, and public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, in immunocompromised people. That's an interesting upside. Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Additional data will be presented and very quickly on 2024 guidance now we have a better understanding of both kogan RSV market size for 2023, and 2024 season, what could be the upside or downside for you our 2020 for revenue guidance for Damien.

Great. Thanks, Gino I'll take the first part of that.

So I actually cant I don't know off the top of my head the proportion because there are both some.

Southern and northern Hemisphere participants that were rolled in the study and so accounting that to RSV seasons will depend upon upon that it is a sizeable proportion.

Stephen Hoge: And Gena and Stphane, on the upside and downside of sales for this year, I think on the upside, obviously, COVID in Europe. As I just mentioned, we couldn't participate in the market last fall. The new tender is an opportunity for us to participate. Quite a number of doctors, hospitals, and public health leaders have actually complained that the Moderna vaccine, given the higher efficacy reported for reduction of hospitalization, was not available, especially for the elderly, in immunocompromised people. That's an interesting upside. Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Because as I said the maximum follow up at the additional analysis about 18 months medium was nine months and so by definition about half as you just said about 17000 participants so between that and we did enroll pretty continuously over 13 months not exactly evenly but pretty close to it so.

I don't want to give you an inaccurate number but I would suspect it is a pretty sizeable proportion because of that steady pretty consistent enrollment over the course of 13 months its not exactly.

Stphane Bancel: Of course, the vaccination rate in the US, as we reported, was lower than last year. As I said in my remarks, we need to do better to protect more people. And our team is already actively working in a cross-functional way to address the VCR and increase the vaccination rate. And the other upside could be market growth, as well as our share. How quickly can we get share from the current two solutions available? On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

But but it trended that direction.

As far as additional data for the CIP meeting, we will obviously continue to provide updates for many additional analysis. We're doing on durability. We obviously had the immunogenicity data as well as data across different sub populations.

If we're fortunate enough to have the opportunity to present at the CIP, we will of course listened to that can we.

Any on anything they would like to see as well on the performance of <unk> 45, as a vaccine and the performance of the vaccines in general in terms of durability.

Stphane Bancel: On the downside, of course, the vaccination rate could be a downside. And the other one is, of course, the timing of the RSV launch, given we rely on regulators for the approval of products and then public health recommendations, like CDC, over different NITAGs in different countries, that could, of course, delay launches and, of course, impact sales. Thank you. Thank you. Our next question comes from Ellie Murrell with UBS. Your line is open. Hey guys, Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Guidance.

Decision, making around repeat dosing or boosting on some scheduled and the public health.

Thanks, Steven and <unk> on the upside than downside on the sales for this year I think on the upside obviously.

In Europe as I just mentioned.

The debate in the market last fall.

The new tender is an opportunity for us to participate quite a number of doctors hospitals public video I've actually complained that the model that vaccine given their higher efficacy reported for reduction of hospitalization was not available, especially for the elderly for immunocompromised people. So that's an interesting up.

Stephen Hoge: Thanks so much for taking the question. Just turning to CMV phase 3, can you talk a little bit about what you would view as clinically meaningful or commercially relevant for vaccine efficacy? And if successful, also, how are you thinking about use in seronegative versus seropositive patients? For sure. So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Side of both vaccination rates in the U S. As we reported the vaccination rates in the current <unk> season was lower than last year as I said in my remarks, we need to do better to protect more people.

Stephen Hoge: So thank you for the question. For CMV, you know, obviously, there's currently no vaccine that can prevent infection against CMV. And as it is a source of devastating birth defects, you know, anything that provides a statistically significant reduction in the rate of infection and therefore vertical transmission would be, we think, terrific. Now, the minimum bar that we are aiming at in our study would support a vaccine efficacy of approximately 50 percent, as we've shared previously. Anything above that would obviously exceed our expectations and be incredibly exciting for the field. We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

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Function of them out there.

To.

Address the VCR and increase vaccination rates and you have upside could be the <unk> the bulk of a market growth as well as I'll share how quickly can we get share from the current two solutions available on the downside of course, the vaccination rates could be a downside.

And do you have a window of course timing of always being given.

When we rollout the regulators all over your approval of products and then there could be kept recommendations like CDC have a different <unk> in the different countries that could of course delayed launches of course impacting sales.

Thank you.

Stephen Hoge: We are in the Phase 3 study enrolling both seropositive and seronegative participants, and part of the reason for that is that there is currently no broadly used diagnostic, and so we want to demonstrate benefit or safety in both populations. Because we do believe that the most likely use of the vaccine could be that it's given regardless of serostatus to both seronegatives and seropositives, and there are potential benefits for seropositives that could include control So, as a practical matter, from a labeling perspective and a launch perspective, our goal is to try and launch the product for both seropositives and seronegatives so that no diagnostic would be needed, and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission to newborns. Thank you. Our next question comes from Hartaj Singh on Oppenheimer. Your line is open. Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Thank you. Our next question comes from Ellie Merle with UBS. Your line is open.

Okay.

Hey, guys. Thanks, so much for taking the question just churn.

Turning to the CMV phase III can you talk a little bit about what you would view as clinically meaningful or commercially relevant on vaccine efficacy and if successful also how are you thinking about your zero negative versus positive patient.

For sure. So thank you for the question so in CMV.

Obviously, there is currently no vaccine that can prevent infection against CMV.

And as it is a source of devastating.

The effects.

Anything that provides a statistically significant reduction in the rate of infection, and therefore vertical transmission would be.

We think terrific now the minimum bar that we are powering a study would support is a vaccine up to approximately 50% as we pared.

She had previously anything above that would obviously beat our expectations and the incredibly exciting for the field.

We are in the phase III study enrolling both <unk> positive and zero negative participants and part of the reason for that is that there's currently no broadly used diagnostic and so we want to demonstrate.

Benefit our safety in both populations.

Stephen Hoge: Great, thank you. You indicated that you're going to complete enrollment for CMV this year and maybe have a readout. Can you just walk us through the steps or what that would look like, and maybe just give us some ideas on powering statistical assumptions? Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Because we do believe that the most likely use of the vaccine could be that it is <unk>.

Given regardless of cero status to both here and I guess Im zero positives and there are potential benefits for zero positives that could include control of shedding or viremia or other long term sequel in CMV, but we would have to approve those and again those are not something we're exploring so explicitly in the current phase III study.

Stephen Hoge: Thank you. Yeah, of course. Thanks, Hartaj. So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Stephen Hoge: So we're currently fully enrolled, and we're accruing cases in that study. I think, as we've shared before, we've actually made substantial progress in the number of cases. It is a case-driven endpoint, and we'll need to see approximately 80 cases before we do the first interim analysis. That, 81 cases to be specific; that interim analysis strategy will look a lot like our other vaccine efficacy studies. DSMB will evaluate that data, and if we meet the statistical threshold, which is for early efficacy, meaning we're doing better than our minimum of 49.5% vaccine efficacy, then they If, for whatever reason, we don't quite have the statistical power in that first interim analysis of efficacy, the study has power to continue on and continue to recruit cases towards a final analysis of efficacy. Now, given the rate of the final analysis at 112. Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

As a practical matter from a labeling perspective, and a launch perspective, our goal is to try and launch the product for both seropositive Encierro negatives no diagnostic will be needed and it can be broadly used across populations to try and prevent the devastating effects of CMV on vertical transmission two to newborn babies.

Thank you. Our next question comes from <unk> Singh with Oppenheimer. Your line is open.

Great. Thank you.

Kate is that Youre going to.

Enrollment for CMV this year and maybe have a readout can you just walk us through the steps of how that would look like.

And maybe just give us some ideas.

Tuscola assumptions. Thank you.

Yeah. Thanks, Scott. So we're currently fully enrolled and we are accruing cases in that study and I think as we've said before we've actually made substantial progress.

The number of cases, it is a case driven endpoint and we will need to see approximately 80 cases before we'll do the first interim analysis for efficacy.

<unk>.

That 81 cases to be specific.

That interim analysis strategy will look a lot like our other vaccine efficacy studies.

<unk>, we will we will evaluate that data and if we meet the statistical threshold, which is Earl for early efficacy, meaning we're doing better than our minimum of 49, 5% vaccine efficacy then they will at that moment tell us to unwind and share the results and of course, we will share them broadly with the world.

Stephen Hoge: Now, given the rate of case accrual that we're currently seeing in the study, we do expect that we will have more than enough cases this year. We are therefore pretty confident that we are going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024. But again, since it's case and event driven, we just have to bide our time. And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

If for whatever reason, we don't quite have the statistical power in that first interim analysis efficacy. The study is powered to continue on and continue to accrue cases.

Stephen Hoge: And ultimately, we will depend upon the DSMB to tell us whether or not we've met that statistical threshold. Thank you. Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

The final analysis of efficacy.

Given the rate of.

The final analysis at 112 cases.

Now given the rate of a piece of crew that we are currently seeing in the study we do expect that that we will have more than enough cases.

Stephen Hoge: Oh, great. Thanks so much for taking the time to answer my question. Maybe, Stephen and INT, maybe you could remind us what your latest thinking is in terms of potential for accelerator approval there for melanoma? And then maybe on the additional tumor types that you guys and Merck are thinking about, can you just maybe talk about what the tumor types that you're contemplating are and whether those tumor types are going to be in the adjuvant settings or in the metastatic settings? And then maybe on RSV quickly, can you just maybe expand on durability in the context of your competitor? Is there a scenario where ACIP recommends the GSK vaccine for every other year versus your vaccine for every year? And Nicole there. It is much appreciated. Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

This year we are.

We are therefore, we're pretty confident that we're going to be seeing a readout.

From the interim analysis, possibly even the final analysis for efficacy in 2024, but again since its case and event driven we just have to bide our time.

And ultimately.

We will depend upon the DSM V to tell us whether or not we've met that statistical threshold.

Thank you. Our next question comes from Luca <unk> with RBC capital. Your line is open.

Great. Thanks, so much for taking my question maybe Steve.

Maybe can you remind us what's your latest thinking in terms of potential for accelerated approval. There for melanoma and then maybe on the additional tumor types did you guys and Merck are thinking about it can you just maybe talk about what are the genotype youre contemplating and wetter does tumor types are going to be in the adjuvant settings or into the metastatic setting and then maybe.

Stephen Hoge: Thanks so much. Quite a few questions there. I'll try and answer them all. I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Stephen Hoge: I apologize if I forget anyone. So first, on the question of INT and accelerated approval in the adjuvant melanoma setting. As we've said before, you know, we continue to be really excited by the data and are excited to start looking to talk to regulators about it. There have been three things that we've tried to say that had to be true for us to believe it was appropriate to even ask about accelerated approval. The first consideration was that we had to see durability. And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

<unk> quickly can you just maybe expand on durability in the context of your competitor.

Is there a scenario where Asia recommenced the GSK vaccine for F Street.

Here are some of your vaccine for every year any color there much appreciate it thanks so much.

Quite a few questions there I'll try and get them I apologize if I, if I forget any one.

So first on the question of IMT and accelerated approval in the adjuvant melanoma setting.

Stephen Hoge: And clearly, the data that we just saw from December, just two months ago, shows that durability and really a clear statistically significant result where the comparator arm, the control arm, looks really just like the labeled data. And so we're incredibly encouraged by that durability. That was criteria one. But the second and third are still there and really important. The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

So as we've said before we continue to be really excited by the data and are excited to start looking to talk to regulators about it.

There have been three things that we've tried to say that had to be true for us to believe it is appropriate to even ask you about accelerated approval. The first was we had to see durability and clearly the data that we just saw from December just two months ago shows that durability and really clear statistically significant result.

Stephen Hoge: The second is that we have to substantially enroll the confirmatory phase three study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence to allow that confirmatory data to come in so that three or four years from now, that further readout would confirm anything that would happen in an accelerated approval context. And then the third and perhaps, you know, now increasingly important criteria was that we had to establish a commercial manufacturing facility. And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Where the.

Comparator arm the control arm looks really just like the labeled data and so we're incredibly encouraged by that durability that was criteria one but the second and third are still there and really important. The second is that we have to substantially enrolled the confirmatory phase III study for an accelerated approval in this space. We do believe we have to show we've really already done the diligence.

To allow that confirmatory data to come in so that three years or four years from now that further readout would confirm anything that would happen and accelerated approval context, and then the third and perhaps.

Now increasingly important criteria was that we had to establish the commercial manufacturing facility and so as we've announced we've been building a facility in Marlborough, Massachusetts.

Stephen Hoge: And so, as we've announced, we've been building a facility in Marlborough, Massachusetts. It will be a purpose-built, personalized, individualized neoengine therapy facility that is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval. That facility is coming online. We look forward to hosting many of you and others for tours as we bring it online. But without that facility, there isn't really a product here to talk about. And so all three of them are essential. We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

It'll be a purpose built personalized individualized new agent therapy.

Facility.

That is ultimately what will be licensed to create this product for the world, whether it's in an accelerated context or in the future with full approval.

That facility is coming online, we look forward to hosting many of you and others.

In tours as we bring it online, but without that facility there isn't really a product here to talk about and so all three of them are essential we're making progress on all three and I think the most exciting thing is what you were just alluding to which is the durability of the benefit we've been seeing really causes us to lean into completing.

Stephen Hoge: We're making progress on all three, and I think the most exciting thing is what you were just alluding to, which is the durability of the benefit we've been seeing really causes us to now lean into completing, working hard to complete the enrollment in that confirmatory study criterion too and finish the build out of that Marlborough facility, which is the third criterion. Now on the point of other indications that we're going after, I will defer to our partners on the specifics. We will do it together at the right time, opening up additional phase three and confirmatory studies. We do expect to open multiple locations this year. Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Working hard to complete the enrollment of that confirmatory study criteria, two and finish the build out of that Marlborough facility, which is the third criteria.

Now in the point of other indications that we're going after.

<unk>.

We will I will.

Deferred work and by our partners Merck on the specifics we will do it together at the right time opening up additional phase III Confirmatory studies, we do expect to open multiple this year.

Stephen Hoge: Those include some additional adjuvant indications. They also include some potential metastatic indications, and we are looking at monotherapy indications. And that can be either in places where PD-1s, Keytruda, may not be indicated or even earlier lines of therapy. And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Those include some additional adjuvant indications. They also include some potential metastatic indications and we are looking at monotherapy indications and then there can be either in places where.

Where PD ones Keytruda may not be indicated or even earlier lines of therapy and so all of those are under consideration.

Stephen Hoge: And so all of those are under consideration. And as soon as we start those studies up and begin enrolling patients, of course, we'll make announcements about them with our partner. Now, lastly, on the question of RSV, we continue to be really enthusiastic about the data that our product has. And I think the durability now shown through this second large season is quite encouraging. We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

And as soon as we start those studies up and begin enrolling of course, we'll make announcements about them with our partner Merck.

Now lastly on the question of RSV.

We continue to be really enthusiastic about the data of our that our product CASM and I think the.

The durability now shown through these two the second large season is quite encouraging.

Stephen Hoge: We'll be sharing that data with the ACIP. But first, we have to get to the regulatory process and approval in this country. And Stphane mentioned our PDUPA date in May. And if we have the opportunity, we'll be sharing the data with the ACIP, which includes, in our case, booster data on immunogenicity from ongoing work that has actually already previously been presented publicly at meetings. And so, just like our competitors, we have shared data of what a second dose looks like in terms of boosting, and neutralizing antibody titers back up, both at one year, and we're also going to be looking at two years. And all of the data from ourselves, as well as that similar booster data from the competitor products, will likely be brought together to inform the ACIP's recommendation. How they think RSC vaccines should be re-administered, when a booster might be necessary. It really falls to the committee to make that determination, not us. Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

I'll be sharing that data with the CIP well first we have to.

Get through the regulatory process and approval.

In this country and Stefan mentioned, our <unk> date in May.

And if we have the opportunity will be sharing the data.

With the ACI.

Which includes in our case booster data on Immunogenicity.

From.

From ongoing work that has actually already previously been presented publicly.

At meetings and so just like our competitors.

We have shared data of what a second dose looks like in terms of boosting neutralizing antibody titers back up both at one year and we're also going to be looking at two years.

And then all of the data ourselves as well as that booster similar booster data from from the competitor products will likely be.

Together to inform the ACI piece recommendation of how they think.

RSV vaccines should be re administer.

When when a booster might be necessary.

It really falls to the committee to make that determination not us.

Stephen Hoge: Your question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine. You know, at this point, given the immunogenicity data and booster data that have been shared across all three products, which are remarkably consistent, as well as the consistent picture in terms of efficacy, including some waning efficacy for all products in a second year, we would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination. At least from my perspective, I certainly think the science would support that. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Question was about whether we expect there to be any difference or distinction in terms of how they treat the vaccine at this point given the immunogenicity data and booster data that has been shared across all three products, which is remarkably consistent as.

As well as the consistent picture in terms of efficacy, including some waning efficacy for all products in the second year.

We would suspect that they will we'll continue to view the products as more similar than not and therefore continue with consistent recommendations, but it's really up to the committee to make that determination at least from my perspective, I certainly think the science would support that.

Stephen Hoge: Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Hey, good morning, and thank you for taking our questions. This is Elizabeth on behalf of Salveen. Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Thank you. Our next question comes from Celgene Richter with Goldman Sachs. Your line is open.

Good morning, and thank you for taking our questions. This is Elizabeth <unk> for Zalviso.

Stephen Hoge: Two questions from us. First, can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population? And then for the phase three CMV vaccine, can you walk us through what you've seen on durability to date and how you're thinking about the durability of that vaccine, particularly as it relates to the potential commercial opportunity in a younger adult women slash adolescents population? Thank you. Hello, so I'll take the question. Based on our z-page metrics, we have not started the study yet. We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Two questions from US first can you just remind us of where you stand with evaluating the RSV vaccine in the pediatric population and then for the phase III CMV vaccine can you walk us through what you've seen on durability to date and how youre thinking about the durability of that vaccine, particularly as it relates to.

The potential commercial opportunity in a younger adult women slash adolescent population. Thank you.

So I'll take the question.

So obviously pediatrics.

Just started the study yes, we off course.

Stphane Bancel: We are, of course, considering taking this into phase 3. It is in the clinic with phase 1-2. We are waiting for the data to be able to move at the right time into the pediatric setting. In terms of CMV, we don't have data yet on durability. Again, like we've done for other programs, when we share the data, we share the data including durability because it's very important. As you know, the benefit of young women is that they have a very strong immune system. As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Considering.

Taking these into a phase III is in the clinic with phase one two.

We're waiting for the data to be able to.

I mean to the pediatric setting.

CMV, we'd also have data on durability again like we've done for all of our programs when we share the data that we've shown data, including durability because it's.

Paul as you know the benefits of young women is you have a very strong gaming system.

Stphane Bancel: As we've shown in our INT programs, our T-cells work very well in terms of the vaccination technology of Moderna, so we really expect to have good durability over time, but again, we have to wait for the data to make such a determination. Thank you. Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open. Hi, this is Alex Hanmanoff on behalf of Geoff Meacham. Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

As we've shown in the IMT programs.

Our T cells.

<unk> work very well and some of them are our commission technical review of Madonna. So we expect to have good directly to you over time, but again, we have to wait for the data to make such a determination.

No.

Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is open.

Hi, This is Alexandra <unk> on for Geoff Meacham. Thank you for taking our question.

Stephen Hoge: Thank you for taking our question. So a great way to equalize vaccine efficacy results is to use a correlation of protection. So for RSV, when do you think we could have a light line of sight into this type of metric? And how important could this be for a competitive, Thank you. Good morning, Stphane. Ayato. I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Great way to equalize vaccine efficacy results into the correlated protection.

When do you think you can have a light line of sight into this type of metric on how important could this be for competitive dynamics. Thank you.

Good morning.

So.

Sorry about that.

Small technical Snafu, so I'm back I believe I caught the end of the question, which is how when do we think we'll have a correlated protection that can inform dynamics both between products and boosting.

Stephen Hoge: I'm back. I believe I caught the end of the question, which is, when do we think we'll have a correlative protection that can inform dynamics, both between products and boost them? If that's correct, we and all the other manufacturers have been sharing publicly our work on correlative protection. We do believe that we've identified a strong candidate for neutralizing antibodies, not surprisingly, from our clinical study. We've been sharing that data with regulators, and we've been sharing the preliminary analysis with public health officials, including advisory groups and ITACs like the CITC. We will be publishing that data and ultimately submitting that to our regulatory submission as a correlate of protection against RSV. And if we, and I think the other competitors, are successful in establishing neutralizing antibodies against RSV as a correlate of protection against RSV, then it really will probably be the primary way that public health officials make determinations about revaccination and booster vaccination and ultimately how we maintain durable protection against RSV for high-risk populations like older adults From a competitive dynamics perspective, once each product has established its correlate, their correlate will relate to them, but we do think there's probably going to be more commonality than not in the correlates of protection, which makes sense because, at the end of the day, we're still talking about the same virus and vaccination against it for all three. Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

If that's correct.

The.

We and all the other manufacturers have been sharing publicly they're our work on our core water protection, we do believe that we've identified.

<unk> candidate in neutralizing antibodies not surprisingly from our clinical study, we've been sharing that data with regulators and we've been sharing the preliminary analysis.

Public health officials, including advisory groups <unk> like the CIP.

We will be publishing that data and ultimately submitting that to our regulatory submissions.

As a correlate through this the balance of this year.

And if we and I think the other competitors are successful in establishing neutralizing antibodies against RSV correlate of protection North sea than it really will probably be the primary way that public health officials make determinations about re vaccinations and boosting.

And ultimately how we maintain durable protection against RSV for high risk populations like older adults.

From a competitive dynamic perspective once once each product has established there correlate.

<unk> will relate to them, but we do think there is probably going to be more commonality than not in the correlates of protection, which makes sense because at the end of the day, we're still talking about the same virus and vaccination against it for <unk>.

Stephen Hoge: Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open. Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

All three products.

Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Stephen Hoge: Great. Thanks for taking the time to answer the question. I was just wondering if you could provide an update on your discussions with the FDA for 1010, your seasonal flu vaccine, and what's preventing you from filing here. Thank you. Thanks. So we are speaking to the FDA and regulators around the world about what they would like to see from a submission perspective for our first-generation or influenza program, our mRNA 1010 program, as you referenced. I don't have any specific updates right now. We're in those conversations as we speak. I really don't want to get ahead of them. You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Great. Thanks for taking the question I was just wondering if you could provide an update on your discussions with FDA for 10, 10 year seasonal flu vaccine and what's gating to filing here. Thank you.

Okay.

So we.

We are speaking to the FDA and regulators around the world about what would be.

What they would like to see from a submission perspective for our first generation of our influenza program mrna 10, 10 programs you referenced I don't have any specific updates right now we're in those conversations as we speak I really don't want to get ahead of them.

Stephen Hoge: You know, the kinds of things we're talking about are what the total submission data package is, what the duration of follow-up in some of these studies is, and what additional studies or data might be supportive of the application. Those conversations are ongoing. We will provide updates as and when we have them, but I have nothing further to add right now. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good morning; thanks for taking my question. Talukdarc. INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

The kinds of things, we're talking about or whats the total.

Submission data package, what's the duration of follow up in some of these studies and what additional studies or data.

Be supportive to the application those conversations are ongoing we will provide updates as and when we have them, but I have nothing further to add right now.

Thank you. Our next question comes from Jessica Fye with Jpmorgan. Your line is open.

Hey, guys. Good morning, Thanks for taking my question.

Yeah.

Four.

Stephen Hoge: INT, can you talk about what's driving your confidence to go into metastatic settings? How's enrollment going in the Phase 3 melanoma trial? And I know you touched on manufacturing being important here. What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Can you talk about what's driving your confidence to go into metastatic setting.

How is enrollment going in the phase III melanoma trial.

And I know you touched on manufacturing being important here.

Stephen Hoge: What's the status of that manufacturing scale-up work? And when is that facility gonna be ready to go live? Great questions, all. So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

The status of that manufacturing scale up work and when is that facility going to be ready to go live.

Great question Bill.

Stephen Hoge: So, I'll take the first part of that. So, first of all, metastatic. We have not formally decided or announced that we're going into a metastatic indication. We do have data from our phase one study, our initial phase one study in metastatic patients, including non-small cell lung cancer. But we have not yet made a determination that we're going into a metastatic indication. And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

I'll take the first part of that.

So so first of all metastatic.

We have not formally decided or announce that we're going into a <unk> indication, we do have data from our phase one.

Study our initial phase one study in metastatic patients, including non small cell lung cancer.

But we have not yet made a determination that we're going into the metastatic indication and I think.

Stephen Hoge: And I think, you know, behind your question is a view that I would agree with, which is that to the extent that INT is going to provide a really, you know, substantial benefit, we think it is probably in earlier lines of therapy. You know, so not just as an adjuvant, but perhaps even stage one disease or stage two disease, depending on the indication, because the safety and tolerability profile is, you know, is, we think, incredibly favorable. And the benefits we're seeing are pretty remarkable from the new. That said, there is still a really high unmet need in the metastatic space. And, you know, even immunotherapies like the PD-1s, like Keytruda, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Behind your question is.

You then I would agree with which is to the extent that <unk> is going to provide a really.

Substantial benefit we think it is probably in earlier lines of therapy.

So not just adjuvant, but perhaps even stage, one disease or stage II disease, depending on the indication.

Cause the safety and Tolerability profile is as we think incredibly favorable and the benefits, we're seeing a pretty remarkable from an immune perspective.

That said there is still a really high unmet need and the metastatic space and.

Even immunotherapies like the PD ones like Keytruda provide a substantial benefit there.

Stephen Hoge: And so at the right time, we may well choose to study the metastatic indication, but as I said, or metastatic indications and settings, but as I said, we have not yet formally decided to do that today. And we're really focused on adjuvant and earlier, and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those phase three studies. I can assure you that, with our partner, Merck, we wouldn't have opened a second phase three study and be talking about the third if we didn't have confidence in our ability to rapidly meet the demand for the substantial demand from clinical research for INT Manufacturing. We haven't specifically put out numbers, but suffice to say we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps get close to completing enrollment in at least one of those studies if it continues. So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

And so at the right time, we may well choose to study in the metastatic indication, but as I said.

Metastatic indications and settings, but as I said, we have not yet formally decided to do that today.

And we're really focused on adjuvant and earlier in monotherapy principally.

On the question on the manufacturing process and enrollment we have substantially scaled up our ability to enroll patients in those phase III studies.

I can assure you that with our partner Merck, we wouldn't have opened a second phase III study and be talking about the third.

We didn't have confidence in our ability to rapidly meet the demand for the substantial demand from those clinical research sites for.

<unk> manufacturing.

We haven't specifically put out numbers, but suffice to say we are we are rapidly enrolling in those studies and we would expect to make substantial progress this year and even perhaps getting close to completing enrollment in at least one of those studies. If if it continues trajectory. So we're excited about the progress we've made in scale.

Stephen Hoge: So, we're excited about the progress we've made in scaling up the manufacturing for clinical supply. We're excited about the progress we're making right now in enrolling patients and the demand that we're seeing from clinical. And we do believe that we've solved a lot of the problems for clinical research and clinical development that manufacturing requires. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only deliver high-quality products at high volumes but also do it at a valuable price and cost point. And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Going up the manufacturing for clinical supply we're excited about the progress, we're making right now and enrolling patients in the demand that we're seeing from clinical sites.

And we do believe that we've sold a lot of the for clinical research for clinical development the manufacturing requirements.

Requirements.

The question, then becomes commercial and that's where he alluded to few minutes ago. The Marlboro site would really become the purpose built commercial site, which needs to not only be able to deliver high quality product at.

At high volumes, but also do it at a.

Valuable price.

And cost point and all of that work is ongoing we've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year.

Stephen Hoge: And all of that work is ongoing. We've made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven't provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well. Kevin, we'll take our last question. Okay. Our last question comes from Evan Nguyen with Guggenheim Securities. Your line is open. Great, thanks, guys. Two from me. First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

But we haven't provided further guidance on when we will have that fully operational.

For potential commercial use and ultimately it depends upon discussions with regulators as well.

Kevin we'll take our last question.

Our last question comes from Evan Wang with Guggenheim Securities. Your line is open.

Great. Thanks, guys. Two for me first one on RSV no. There are some additional studies to expand the initial population can.

Stephen Hoge: First on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from phase three and 50 plus in the higher-risk younger adults and when you could potentially supplement a filing if everything's positive? And then, you know, I know you commented on Australia. So just, you know, as you were thinking about, or as you, you know, you've talked about Australia as a proxy for COVID cases in 2023, now can you comment on how interpretable Australia will be for your RSV launch and as we look for trends in COVID vaccination rates? Thanks. Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Can you comment on when we May see data from the phase III and 50, plus and the high risk are adults and when you could potentially supplemental filing if everything is positive.

And then I know you commented on Australia.

So just.

As you were thinking about or as you've talked about Australia as a proxy for <unk> and 'twenty 'twenty. Three now can you comment on how to interpret all of Australia. It would be it will be fair RSV launch and as we look for trends and cut it vaccination rates.

Stephen Hoge: Great, I'll quickly take the first part of that and then hand it over to Stphane for the second. So the Additional data on 50-plus, we obviously have immune bridging data and co-administration data. We'll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP, it just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those on the label, it's important to note that public health officials can recommend use even beyond the label and may choose to do that. But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

<unk>.

Great I'll quickly take the first part of that and then hand, it over to Stephane for a second.

So the.

Additional data for 150, plus we haven't obviously immune bridging data and co administration data, we'll be sharing that at the appropriate time.

With public health officials and others that could be as soon as the S&P. It just depend on when the data comes in as well as the 18 plus.

High risk populations.

In your question about getting it in the label it's important to note that public health officials can recommend us even.

Even beyond the label and May choose to do that but our responsibility to get it in the label.

Stephen Hoge: But our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. So, obviously, it would follow shortly after our hopefully successful PDUFA outcome in May. Thanks, Stephen. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

And we will need to complete the initial BLA before we then we could submit the BLA to get that data in the label and so obviously it would follow shortly after.

Our hopefully successful proof outcome in may.

Thanks, Steven and Australia. So a few things first our team has delivered a strong performance from Kobe them, Australia, we've been helping the government seems to being able to pandemic as you recall, we have announced a long 10 year partnership with the Australian government and we are currently building a plant.

Stephen Hoge: And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We've been helping the government. Since the beginning of the pandemic, as you recall, we have announced a long-term, 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is progressing quite successfully. And we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know, is a quite different market commercially from the U.S. It's really mostly driven by the government. So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

In Melbourne that he doesn't think quite successfully.

And we are in active discussions with regulators around Australia for <unk> approval.

The point that will make you that Australia as you know.

Different markets commercially.

To the U S.

Mostly driven by the government.

Stphane Bancel: So I will compare Australia more to a European market than to the U.S. market. I don't think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in fall 24, winter 25. So much for the questions today. Thank you for taking the time to be with us. We look forward to talking with and seeing many of you in the coming days and weeks. I hope that you all have March 27th, an annual vaccine day, on your calendar. We'll start the presentation at 9am eastern time. So, have a great day and thank you for joining us. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Compared with probably a multiyear European markets than the U S market.

I don't think we can draw any positive or negative correlation at all what happened in Australia coffee the IV to what will happen in the U S.

424, we've got 25.

Okay.

Much for the questions today and thank you for taking the time to be with us.

So talking and seeing many of you in the coming days and weeks I Hope that you would have on March 27.

And your vaccine Daniel Canada, where we saw the presentation at nine a M. Eastern time, so I have a great day and thank you for joining.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

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