Q1 2024 Moderna Inc Earnings Call

Operator: - thank you for standing by. Welcome to the Moderna’s First Quarter 2024 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 need to press Star 11 on your telephone, you'll then hear an automated message advising 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.

Good day, and thank you for standing by and welcome to <unk>.

First quarter 2024 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 you need to press star one on your telephone you all didn't he.

Speaker Change: You're an automated message device and you're paying this race to withdraw your question. Please press star. One again. 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 lift our please go ahead.

Operator: Please be advised that this conference is being recorded. Thank you, Kevin. Good morning, everyone.

Please be advised that this conference is being recorded.

Lavina A. Talukdar: Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's first quarter 2024 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. 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. I'll now turn the call over to Stéphane.

Operator: And thank you for joining us on today's call to discuss Moderna's third quarter 2024 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; Stephen Hoge, our President, and Jamey Mock, our Chief Financial Officer. Before we begin, please note this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Security 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. I will now turn the call over to Stephan.

Thank you Kevin Good morning, everyone and thank you for joining us on today's call to discuss <unk> first quarter 2024 financial results and business update.

You can access the press release issued this morning as well as the slides that will be reviewed by the.

The only for the investors section of our website.

On today's call are <unk>, Chief Executive Officer, Stephen Hoge, our President and Jamie Miller, our Chief Financial Officer.

Operator: Before we begin, please note this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Security 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. I will now turn the call over to Stephan. Thanks for letting us do this. Good morning or good afternoon, everyone.

Before we begin, please note this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Security 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. I will now turn the call over to Stephan.

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 I will now turn the call over to Stephane. Thanks. Good luck. Good morning, good afternoon, everyone.

Stéphane Bancel: Thank you, Lavina. Good morning, or good afternoon, everyone. Thank you for joining us today. I will start with a review of a business, Jamey will then present our financial results. Stephen will review our late-stage clinical programs and I will close by sharing our 2024 commercial priorities and major upcoming milestones. Our COVID vaccine has already impacted hundreds of millions of people. I'm excited by the progress we've made with our pipeline that has the potential to impact many more people. During the first quarter, we presented substantial clinical progress during our vaccine date with exciting data on EBV, VZV, and norovirus. In addition, along with our partner Merck, we expanded studies for individualized neoantigen therapy, INT, into three new indications. In addition to our ongoing Phase III studies in adjuvant melanoma and adjuvant non-small cell lung cancer, a Phase II free study has started in neoadjuvant and adjuvant cutaneous squamous cell carcinoma, another form of skin cancer. Phase II clinical trials have started in adjuvant bladder and adjuvant kidney cancer. Together, our vaccines and therapeutic portfolio have a potential to impact hundreds of millions of people each year.

Stphane Bancel: Thank you for joining us today. I will start with a review of a group of examples, then we will present our final results. Stephen will review our latest clinical programs, and I will close by sharing our 2024 commercial priorities and major upcoming milestones. A COVID-19 vaccine has already impacted hundreds of millions of people. I'm excited by the progress we've made with our pipeline that has the potential to impact many more people. During the first quarter, we presented substantial clinical progress during our vaccine days with exciting data on the BV, BGV, and norovirus. In addition, along with our partners, we have funded studies for individualized neoantigen therapy, i.e., into three new indicators, in addition to ongoing phase 3 studies in aggrevant melanoma and aggrevant non-small cell lung cancer. The Phase II pre-study has started in neoadjuvant adjuvants glutamines for squamous cell carcinoma, another form of skin cancer. These two clinical trials are hosted in Adjuvant Laboratory and Adjuvant Kidney Center. Together, our vaccines and therapeutic portfolio has the potential to impact hundreds of millions of people each year.

Yes.

Thank you for joining us for their our staff will go with you.

Okay.

Clinical programs and I will close by sharing our 2024 commercial priorities and major upcoming milestones.

Of course vaccine has already impacted hundreds of millions of people.

Im excited about the progress we've made with our pipeline.

Thanks, Ron can impact many more people.

Stphane Bancel: During the first quarter, we presented substantial clinical progress during our vaccine days with exciting data on the BV, BGV, and norovirus. In addition, along with our partners, we have funded studies for individualized neoantigen therapy, i.e., into three new indicators, in addition to ongoing phase 3 studies in aggrevant melanoma and aggrevant non-small cell lung cancer. The Phase II pre-study has started in neoadjuvant adjuvants glutamines for squamous cell carcinoma, another form of skin cancer. These two clinical trials are hosted in Adjuvant Laboratory and Adjuvant Kidney Center. Together, our vaccines and therapeutic portfolio has the potential to impact hundreds of millions of people each year.

During the first quarter, we presented substantial clinical progress Bringle vaccine David.

The data on the BV.

Speaker Change: And all of ours.

Yes, Sean.

One of our partner Mayo, we expanded studies four in giving you that neogen therapy IMT intra.

<unk> three new indications.

Speaker Change: In addition to our ongoing phase III studies.

Grand Nomura and non.

Non small cell lung cancer.

Stphane Bancel: The Phase II pre-study has started in neoadjuvant adjuvants glutamines for squamous cell carcinoma, another form of skin cancer. These two clinical trials are hosted in Adjuvant Laboratory and Adjuvant Kidney Center. Together, our vaccines and therapeutic portfolio has the potential to impact hundreds of millions of people each year. I am pleased with our Q1 results. Since the beginning of the year, we have now entered into a 40% business agreement and collaboration. We entered into a non-exclusive, IP, out-licensing agreement with a leading pharmaceutical company in Japan.

The Phase II pre-study has started in neoadjuvant adjuvants glutamines for squamous cell carcinoma, another form of skin cancer. These two clinical trials are hosted in Adjuvant Laboratory and Adjuvant Kidney Center. Together, our vaccines and therapeutic portfolio has the potential to impact hundreds of millions of people each year.

Phase two three study stop.

Speaker Change: Got it in New York.

Okay got you.

This.

Mark.

Speaker Change: Recall of skin cancer.

Speaker Change: Phase two clinical trials in <unk>.

Have you been plateau.

Acura kidney cancer.

Together or vaccine.

Our property portfolio.

I heard from you.

Okay, yes people each year.

Stéphane Bancel: I am pleased with our Q1 performance. Since the beginning of the year, we announced four important business agreements and collaboration. We entered into a non-exclusive IP out-licensing agreement with a leading pharmaceutical company in Japan. The agreement includes a lump sum payment and low double-digit royalties to Moderna on net sales of COVID-19 products marketed in Japan by this company. It is nice to see a company recognizing our IP and asking us for a license. Second, we recently announced a contract to provide 12.5 million doses of COVID-19 vaccine to the Ministry of Health in Brazil. I am very pleased with this partnership as it is the very first time that Moderna works with the Brazilian government and we look forward to providing these doses to protect people in Brazil as they go into their winter season. We announced a project financing program for up to $750 million in funding with Blackstone to further develop our flu program. We also made public our collaboration with OpenAI to use AI as a transformative tool to increase speed and efficiency, and ultimately, to improve patient outcomes across our business. Finally, we agreed to Metagenomi to terminate our gene editing collaboration. All rights granted under the collaboration will be returned to Metagenomi. It is a good proof point of Moderna's continuing to prioritize our assessment for best opportunities to drive returns.

I am pleased with our Q1 performance.

Speaker Change: Since the beginning over here, we announced four important PSA agreement and collaboration.

We have built into a non exclusive IP.

Speaker Change: I can think of agreement with a leading pharmaceutical company in Japan.

Stphane Bancel: The agreement includes a lot of prompt payments, and... Low-carbohydrate yeast was added to Moderna at the expense of a COVID-19 product marketed in Japan by this company. It is nice to see a company recognizing R&D and obstacles for life. Thank you. We recently announced a contract to provide more than 5 million doses of COVID-19 vaccine to the Ministry of Health in Brazil. I am very pleased with this partnership as it is the very first time that Moderna works with the Brazilian government, and we look forward to providing these services to protect people in Brazil as they go into their winter season. We announce the project financing program of $715 million in funding for the Blackstone Technology Growth Offer Program. We also make public our collaboration with OpenAI to use AI as a transformative tool to increase speed and efficiency and ultimately improve patient outcomes across our patients. Finally, we are pleased to present the nominee to terminate our Gene and Team collaboration. All right, granted, a lot of collaboration will be recent in the digital age. It is a good proof point of Moderna's continuity and our priority to prioritize our investment for the best opportunity for great results.

The agreement includes.

Pamer.

Low double digit royalties on.

Okay great.

Products marketed in Japan by this company.

It is nice to see a company you broke up on that single IP and also congrats Paul.

Second.

Stphane Bancel: We recently announced a contract to provide more than 5 million doses of COVID-19 vaccine to the Ministry of Health in Brazil. I am very pleased with this partnership as it is the very first time that Moderna works with the Brazilian government, and we look forward to providing these services to protect people in Brazil as they go into their winter season. We announce the project financing program of $715 million in funding for the Blackstone Technology Growth Offer Program. We also make public our collaboration with OpenAI to use AI as a transformative tool to increase speed and efficiency and ultimately improve patient outcomes across our patients. Finally, we are pleased to present the nominee to terminate our Gene and Team collaboration. All right, granted, a lot of collaboration will be recent in the digital age. It is a good proof point of Moderna's continuity and our priority to prioritize our investment for the best opportunity for great results.

We recently announced a contract to provide support.

Speaker Change: <unk> 5 million.

Speaker Change: COVID-19 vaccine.

Thank you.

Hey, Brian.

I am very pleased with this partnership is the very first time.

<unk> works with you Brian you can go on that and we look forward to providing diesel is to protect reporting point of view as we go into there we still see them.

Speaker Change: We announced the project financing program for $750 million in Fannie with Blackstone.

Barbara.

Stphane Bancel: We also make public our collaboration with OpenAI to use AI as a transformative tool to increase speed and efficiency and ultimately improve patient outcomes across our patients. Finally, we are pleased to present the nominee to terminate our Gene and Team collaboration. All right, granted, a lot of collaboration will be recent in the digital age. It is a good proof point of Moderna's continuity and our priority to prioritize our investment for the best opportunity for great results. You don't need to be one-fifth an angel's wizard.

We also make public our collaboration with OpenAI to use AI as a transformative tool to increase speed and efficiency and ultimately improve patient outcomes across our patients. Finally, we are pleased to present the nominee to terminate our Gene and Team collaboration. All right, granted, a lot of collaboration will be recent in the digital age. It is a good proof point of Moderna's continuity and our priority to prioritize our investment for the best opportunity for great results.

We also make public our collaboration with Oprah.

As a transformative quarter for <unk>.

Great Steve.

And this came at me to improve patient outcomes across our business.

Speaker Change: Finally, we appointed Mr. Amit will terminate.

Alright.

The collaboration will be returned from concession homey.

Is there a good profile open without Inc.

And to prioritize.

Our best opportunities to drive results.

Stéphane Bancel: Turning to Q1 financial results. In revenues, we were ahead of our plans at $167 million, reflecting the highly seasonal nature of our respiratory vaccine business. The net loss was $1.2 billion. We ended the quarter with $12.2 billion of cash and investments. We communicated during the November call our focus on financial discipline. I am pleased with what the team has achieved. Our operating expenses, cost of manufacturing expenses, plus cost of R&D expenses, plus cost of SG&A expenses were down almost $800 million in Q1 2024 versus Q1 2023. Jamey will elaborate on this in his section. With that, I will now turn to Jamey.

Speaker Change: Turning to Q1 financial results.

Stphane Bancel: In overview, we were ahead of our plans at 167 million, which I think is a highly seasonal nature of our respiratory market business. The net bill is 1.2 billion dollars. We ended the quarter with $12.2 billion of cash in investment. We communicated during the November call about a prison financial dispute. I am pleased with what the team has achieved. We were all particularly excited. Cost of manufacturing expenses, first, cost of army expenses, first, cost of DNA expenses went down almost $800 million in Q1 2024 versus Q1 2023. Jamey will have a voice on this in his lecture. With that, I will now stop the program.

<unk> revenues were a heck of a planned 167 million.

The highly seasonal nature of our respiratory vaccine business.

Does that point to begin Dora.

Speaker Change: We ended the quarter 12 point to bring out of cash and investments.

Stphane Bancel: I am pleased with what the team has achieved. We were all particularly excited. Cost of manufacturing expenses, first, cost of army expenses, first, cost of DNA expenses went down almost $800 million in Q1 2024 versus Q1 2023. Jamey will have a voice on this in his lecture. With that, I will now stop the program. Click the button and below everyone.

I am pleased with what the team has achieved. We were all particularly excited. Cost of manufacturing expenses, first, cost of army expenses, first, cost of DNA expenses went down almost $800 million in Q1 2024 versus Q1 2023. Jamey will have a voice on this in his lecture. With that, I will now stop the program.

I am pleased with what the team have achieved with our operating.

Speaker Change: Operating expense David.

Speaker Change: Cost of manufacturing expensive cost.

Cost of R&D expenses correct.

SG&A expenses were down.

Almost $800 million Euro in Q1, 2024 basis point Brian.

Speaker Change: Jimmy we are alright.

Speaker Change: With that I will now also for Jamie.

Jamey Mock: Thanks, Stéphane, and hello, everyone. Today I will walk you through our financial performance for the first quarter and provide commentary on our 2024 financial framework. Let me start with our commercial performance on Slide 8. Net product sales for Q1 were $167 million, down 91% year-over-year, mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside the United States. This decline aligns with the anticipated transition of the COVID-19 vaccine market towards a seasonal pattern. Whereas in the first quarter of 2023 we primarily delivered doses that were deferred from 2022. Q1 was driven by sales in the U.S. and the rest of the world, largely Latin American markets. For Q2, we expect about $100 million in sales for a total of approximately $300 million in the first half of 2024. Q2 will include a portion of our recently announced contract with Brazil.

Thanks, Dave and Hello, everyone.

Jamey Mock: Today I will walk you through our financial performance for the first quarter and provide commentary on our 2024 financial framework. Let me start with our commercial performance on slide 8. Net product sales for Q1 were $167 million, down 91% year-over-year. This decline is mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside the United States. This decline aligns with the anticipated transition of the COVID-19 vaccine market towards a seasonal pattern. Whereas, in the first quarter of 2023, we primarily delivered doses that were deferred from 2022. Q1 was driven by sales in the U.S. and the rest of the world, largely Latin American markets. For Q2, we expect about $100 million in sales for a total of approximately $300 million in the first half of 2024. Q2 will include a portion of our recently announced contract with Brazil.

Today, I will walk you through our financial performance for the first quarter and provide commentary on our 2024 financial framework.

Let me start with our commercial performance on slide eight.

Net product sales for Q1 were $167 million.

Jamie: Down 91% year over year, mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside the United States.

Jamey Mock: This decline is mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside the United States. This decline aligns with the anticipated transition of the COVID-19 vaccine market towards a seasonal pattern. Whereas, in the first quarter of 2023, we primarily delivered doses that were deferred from 2022. Q1 was driven by sales in the U.S. and the rest of the world, largely Latin American markets. For Q2, we expect about $100 million in sales for a total of approximately $300 million in the first half of 2024. Q2 will include a portion of our recently announced contract with Brazil.

This decline in line with the anticipated transition of the COVID-19 vaccine market towards a seasonal pattern.

Whereas in the first quarter of 2023, we primarily delivered doses that were deferred from 2022.

Q1 was driven by sales in the U S and the rest of the world largely Latin American markets.

Jamey Mock: For Q2, we expect about $100 million in sales for a total of approximately $300 million in the first half of 2024. Q2 will include a portion of our recently announced contract with Brazil. Moving to side nines.

For Q2, we expect about $100 million in sales for a total of approximately $300 million in the first half of 2024. Q2 will include a portion of our recently announced contract with Brazil.

For Q2, we expect about $100 million in sales for a total of approximately $300 million in the first half of 2020 for.

Q2 will include a portion of our recently announced contract with Brazil.

Jamey Mock: Moving to Slide 9, net product sales were $167 million as I just explained. For the first quarter of 2024 our cost of sales was $96 million, which included third-party royalties of $8 million, inventory write-downs of $30 million, and $27 million related to unutilized manufacturing capacity and wind-down costs. This resulted in our cost of sales representing 58% of net product sales up from 43% in the same quarter last year. The increase in cost of sales percentage was primarily due to the lowest level of sales in the quarter. We continue to expect the full year cost of sales to be approximately 35% of product sales. However, due to the strong seasonality of our business, we expect a higher percentage in the first half.

Jamey Mock: Net product sales were $150,000,000, as I just explained. For the first quarter of 2024, our proxy sales were $96 million, which included third-party royalties of $8 million, inventory write-downs of $30 million, and $27 million related to unutilized manufacturing capacity and wind-up costs. This resulted in our cost of sales representing 58% of net product sales, up from 43% in the same quarter last year. The increase in cost of sales percentage was primarily due to the lowest level of sales in the quarter. We continue to expect the full year cost of sales to be approximately 35% of product sales, however, due to the strong seasonality of our business, we expect a higher percentage in the first half.

Moving to slide nine net product sales were $167 million as I just explained.

For the first quarter of 2020 for our cost of sales with $96 million, which.

<unk> third party royalties of $8 million.

Tori write downs at $30 million and $27 million related to Unutilized manufacturing capacity and wind up costs.

This resulted in our cost of sales representing 58% of net product sales up from 43% from the same quarter last year.

The increase in cost of sales percentage was primarily due to the lowest level of sales in the quarter.

Jamey Mock: We continue to expect the full year cost of sales to be approximately 35% of product sales, however, due to the strong seasonality of our business, we expect a higher percentage in the first half. Moving to our R&D efforts, Q1 R&D expenses were $1.1 billion, reflecting a decrease of 6% year-over-year. This production was primarily due to the absence of up-front collaboration teams being made this quarter. The upfront payments made in the first quarter of 2023 were related to our strategic collaborations with Generation Bio and LifeVeterans. With a Q1 spend of $1.1 billion, we are tracking towards a full year expected spend of approximately $4.5 billion. Q1 FD&A expenses were $274 million, marking a 10% decrease year-over-year.

We continue to expect the full year cost of sales to be approximately 35% of product sales, however, due to the strong seasonality of our business, we expect a higher percentage in the first half.

We continue to expect a full year cost of sales to be approximately 35% of product sales. However, due to the strong seasonality of our business, we expect a higher percentage in the first half.

Moving to our R&D efforts Q1, R&D expenses were $1 1 billion.

Jamey Mock: Moving to our R&D efforts, Q1 R&D expenses were $1.1 billion, reflecting a decrease of 6% year-over-year. This reduction was primarily due to the absence of upfront collaboration payments being made this quarter. The upfront payments made in the first quarter of 2023 were related to our strategic collaborations with Generation Bio and Life Edit. With the Q1 spend of $1.1 billion, we are tracking towards the full year expected spend of approximately $4.5 billion. Q1 SG&A expenses were $274 million, marking a 10% decrease year-over-year. Importantly, this decrease was driven by all functions in SG&A, and it is a result of our strong focus on cost discipline and strategic investments driving productivity. I will provide additional color on the next page.

Reflecting a decrease of 6% year over year.

This reduction was primarily due to the absence of upfront collaboration payments being made this quarter.

The upfront payments made in the first quarter of 2023 were related to our strategic collaborations with generation bio and thanks Eddie.

With Q1 spend of $1 1 billion, we are tracking towards the full year expected spend of approximately $4 5 billion.

Q1, SG&A expenses were $274 million, marking a 10% decrease year over year.

Jamey Mock: Importantly, this decrease was driven by all functions of SG&A, and it is a result of our strong focus on cost discipline and strategic investments driving productivity. I will provide an additional folder on the next page. We reported an income tax expense of $10 million for the first quarter of 2024, compared to an income tax benefit of $384 million for the same period last year. The shift is primarily due to the continued application of the evaluation allowance on the majority of our deferred tax assets, which we first established in the first quarter of 2023. The net loss for the period was $1.2 billion compared to a net income of $79 million last year.

Importantly, this decrease was driven by all functions of SG&A, and it is a result of our strong focus on cost discipline and strategic investments driving productivity. I will provide an additional folder on the next page.

Importantly, this decrease was driven by all function of SG&A and it is the result of our strong focus on cost discipline and strategic investments driving productivity.

I will provide additional color on the next page.

Jamey Mock: We reported an income tax expense of $10 million for the first quarter of 2024, compared to an income tax benefit of $384 million in the same period last year. The shift is primarily due to the continued application of evaluation allowance on the majority of our deferred tax assets, which we first established in the third quarter of 2023. Net loss for the period was $1.2 billion compared to net income of $79 million last year. Diluted loss per share was $3.07 compared to diluted earnings per share of $0.19 in 2023. We ended the first quarter with cash and investments totaling $12.2 billion, down from $13.3 billion at year-end 2023, largely attributable to research and development expenses and operating activities.

We reported an income tax expense of $10 million for the first quarter of 2024 compared to an income tax benefit of $384 million in the same period last year.

The shift is primarily due to the continued application of evaluation allowance on the majority of our deferred tax assets, which we first established in the third quarter of 2023.

Net loss for the period was $1 2 billion.

<unk> to net income of $79 million last year.

Jamey Mock: Diluted loss per share was $3.07 compared to diluted earnings per share of $0.19 in 2023. We ended the first quarter with cash flow investments totaling $12.2 billion, down from $13.3 billion at year-end 2023. Largely attributable to research and development expenses and operating activities. Moving to slide 10, I want to take a moment to elaborate on the efficiencies we are now seeing across the company. As a platform company, we have the opportunity to build a unique operating, And over the last few years, we have invested perfectly in people, processes, and technologies to build foundational capabilities that will allow us to scale efficiently.

Diluted loss per share was $3.07 compared to diluted earnings per share of $0.19 in 2023. We ended the first quarter with cash flow investments totaling $12.2 billion, down from $13.3 billion at year-end 2023. Largely attributable to research and development expenses and operating activities.

Diluted loss per share was $3 seven compared to diluted earnings per share of <unk> 19 in 2023.

We ended the first quarter with cash and investments totaling $12 2 billion.

Down from $13 3 billion at year end 2023, largely attributable to research and development expenses and operating activities.

Jamey Mock: Moving to Slide 10, I want to take a moment to elaborate on the efficiencies we are now seeing across the company. As a platform company, we have the opportunity to build a unique operating model. And over the last few years, we have invested purposely into people, processes, and technologies to build foundational capabilities that will allow us to scale efficiently. First, we ended 2023 with nearly 6,000 employees, up from 1,300 at the end of 2020. Every function scaled capabilities to enable the increasing product launches we expect over the coming years. Additionally, as you know, Moderna has always led with a digital-first mindset. Over the past three years, we have nearly doubled our built-for-purpose software applications to digitally enable our teams. As an example, we recently went live with a newly implemented rebuilt ERP system. SAP 4 HANA is our new digital backbone for all our operational activities. We've used SAP in the past, however, it was built for a research and development-focused company. And now we have implemented an entirely revised version supporting our end-to-end business processes more effectively and efficiently.

Moving to slide 10, I wanted to take a moment to elaborate on the efficiencies. We are now seeing across the company.

As a platform company, we have the opportunity to build a unique operating model.

And over the last few years, we have invested purposely into people processes and technologies to build foundational capabilities that will allow us to scale efficiently.

Jamey Mock: First, we entered 2023 with nearly 6,000 employees. Up from 1,300 at the end of 2020, every function, scale, and capability is going to enable the increasing number of product launches we expect over the coming year. Additionally, as you know, Moderna has always had a physical-first mindset. Over the past three years, we have nearly doubled our built-for-perfect software application to digitally enable our. As an example, we recently went live with a newly implemented rebuilt ERP. Safety Corps at Honolulu is our new digital backbone for all our operational activities. We have used SAP in the past, but it was built for a research and development focused company. And now we have implemented an entirely revised version, supporting our end-to-end business processes more effectively and efficiently.

First we ended 2023 with nearly 6000 employees.

From 13 <unk> hundred at the end of 2020 every function scale capabilities to enable the increasing product launches, we expect over the coming years.

Additionally, as you know Madonna has always led with a digital first mindset.

For the past three years, we have nearly doubled our built for purpose software applications to digitally enable our teams.

As an example, we recently went live with the newly implemented rebuilt ERP system SAP.

<unk> is our new digital backbone for all our operational activities.

We have used FTP in the past. However, it was built for a research and development focused company and now we have implemented an entirely revised version supporting our end to end business processes more effectively and efficiently.

Jamey Mock: And now we have implemented an entirely revised version, supporting our end-to-end business processes more effectively and efficiently. Another example is our rapid adoption of artificial intelligence. Over the past year, we've built over 750 GPCs. For example, in the legal space, we have contracts in Canyon GPP, streamlining the task of reviewing and summarizing contracts across the business.

And now we have implemented an entirely revised version, supporting our end-to-end business processes more effectively and efficiently.

Jamey Mock: Another example is our rapid adoption of artificial intelligence. Over the past year, we've built over 750 GPTs. One example in the legal space, our Contract Companion GPT streamlines the task of reviewing and summarizing contracts across the business, with the GPTs providing step-by-step guidance to craft a tailored, insightful summary. This enables any function to extract critical insights from contracts whenever needed, minimizing bottlenecks, and freeing up Moderna's legal department to focus on work of higher strategic value, thus enhancing operational efficiency and decision-making.

Another example is a rapid adoption of artificial intelligence over the past year, we've built over 750 gpt's.

One example, in the legal space our contract companion GPT streamlines, the task of reviewing and summarizing contracts across the business with.

Jamey Mock: With the GPP providing step-by-step guidance to practice tailored and cycled health, this enables any function to extract critical insights from contracts whenever needed, minimizing bottlenecks, and freeing up Moderna's legal department to focus on work of higher strategic value. Substance Handling Operational Efficiency and Decision-Making

With the GPT, providing step by step guidance for profit tailored insightful summary.

This enables any function to extract critical insights from contracts whenever needed minimizing bottlenecks and freeing up the legal department to focus on work of higher strategic value.

Thus enhancing operational efficiency and decision making.

Jamey Mock: Another example in G&A is a purchase-to-pay GPT for all questions around our procurement and payment processes. Instead of our employees having to find and read policies and procedures, they can easily query the GPT. It also saves time for our procurement and payables teams from answering numerous questions. AI has already changed our way in a short period. In general, we see the area developing at an incredible speed that allows for an unprecedented impact on productivity in many areas. We have rolled out a comprehensive training program and are committed to driving this technology breakthrough. As a result of these strategic investments in the people, processes, and technology, we were able to significantly reduce purchased services and our use of external consultants, which contributed heavily to the 10% year-over-year reduction in SG&A spend. We are also seeing similar benefits in R&D and manufacturing. In general, we now have a solid foundation with our operating model. As we continue to grow our commercial activities, we will need to further invest, however, we will be able to do that more efficiently.

Another example in G&A is a purchase to pay GPT for all questions around our procurement and payment processes.

Instead of our employees have been defined and re policies and procedures. They can easily query the GPT.

Also save time for our procurement and payables teams from answering numerous questions.

Jamie: AI has already changed our way.

Sure.

And gentlemen, PV areas, helping incredible speed.

As for an unprecedented impact on productivity.

Jamey Mock: We have rolled out a comprehensive training program and are committed to driving this technology breakthrough. As a result of these strategic investments into people, processes, and technology, we were able to significantly reduce purchase derivatives and our use of external consulting, which contributed heavily to the 10% year-over-year reduction in SDNA spread. We are also seeing similar benefits in R&D and manufacturing. In general, we now have a solid foundation with our operations. As we continue to grow our commercial activity... We will need to further invest, but we will be able to do that more efficiently.

We have pulled out the comprehensive training program and are committed to driving this technology breakthroughs.

As a result of these strategic investments into people processes and technology, we were able to significantly reduce purchased services and our use of external consultants, which contributed heavily to the 10% year over year reduction in SG&A expense.

We are also seeing similar benefits in R&D and manufacturer.

In general we now have a solid foundation with our operating model.

As we continue to grow our commercial activities, we will need to further invest however, however, we will be able to do that more efficiently.

Jamey Mock: Now let's turn to the 2024 financial framework on Slide 11, which is in line with what I shared on our last earnings call in February. We continue to 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 now expected to be approximately $0.3 billion. We continue to expect cost of sales of approximately 35% of product sales for the full year. For R&D, we continue to expect full year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023, rest we continue to expect full year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. And we expect taxes to be negligible in 2024 and capital expenditures in 2024 to be approximately $0.9 billion. Finally, we expect to end 2024 with approximately $9 billion in cash after touching a low point of approximately $8 billion at the end of Q3 due to the seasonality of collections.

Now, let's turn to the 2024 financial framework on slide 11.

Which is in line with what I shared on our last earnings call in February.

We continue to expect net sales for 2020 for 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 now expected to be approximately zero point $3 billion.

Jamey Mock: We continue to expect cost of sales to be approximately 35% of product sales for the full year. For R&D, we continue to expect full year expenses to be approximately $4.5 billion, down from $4.8 billion in 2023. For SG&A, we continue to expect full year expenses to be approximately $1.3 billion, down from $1.5 billion in 2023. And we expect taxes to be negligible in 2024, and capital expenditures in 2024 to be approximately $0.9 billion. Finally, we expect N2024 to have approximately $9 billion in cash, after touching a low point of approximately $8 billion at the end of Q3 due to the seasonality of the collection.

We continue to expect cost of sales of approximately 35% of product sales for the full year for R&D. We continue to expect full year expenses to be approximately $4 5 billion.

Down from $4 8 billion in 2023.

SG&A, we continue to expect full year expenses to be approximately $1 3 billion down.

Down from $1 5 billion in 2023.

Jamey Mock: And we expect taxes to be negligible in 2024, and capital expenditures in 2024 to be approximately $0.9 billion. Finally, we expect N2024 to have approximately $9 billion in cash, after touching a low point of approximately $8 billion at the end of Q3 due to the seasonality of the collection. Finally, let me also touch on our recently announced project, Enhancing Theatres with Blackstone, which we are excited about. In March, we entered into a development and commercialization funding agreement, which commits Flaxmans to providing us with up to $750 million of funding for our flu program.

And we expect taxes to be negligible in 2024, and capital expenditures in 2024 to be approximately $0.9 billion. Finally, we expect N2024 to have approximately $9 billion in cash, after touching a low point of approximately $8 billion at the end of Q3 due to the seasonality of the collection.

And we expect taxes to be negligible in 2024 and capital expenditures.

<unk> 2024 to be approximately 0.9 billion.

Finally, we expect to end 2024 with approximately $9 billion in cash after touching a low point of approximately $8 billion at the end of Q3 due to the seasonality of collections.

Jamey Mock: Finally, let me also touch on our recently announced project financing deal with Blackstone, which we are excited about. In March, we entered into a development and commercialization funding arrangement, which commits Blackstone to providing us with up to $750 million of funding for our flu program so that we can strengthen the product label and fulfill our remaining regulatory applications. Subject to the regulatory approval in the United States, which depends on data from the funded activities, Blackstone will be entitled to receive up to $750 million in sales in milestone payments. These milestone payments are contingent upon achieving specified cumulative net sales targets for our future influenza and combination vaccines. Additionally, Blackstone will earn royalties on applicable net sales at a low single digit percentage rate. This funding will offset R&D expenses and is factored into our R&D framework for the year of approximately $4.5 billion. Overall, we are excited that this deal enables us to accelerate the advancement for our pipeline. And with that, I will now hand the call over to Steve.

Finally, let me also touch on our recently announced project financing deal with Blackstone, which we are excited about.

In March we entered into a development and commercialization funding arrangement, which commenced blackstone to providing us with up to $750 million of funding for our flu program. So that we can strengthen the product label and fulfill our remaining regulatory applications.

Jamey Mock: So that we can strengthen the product label and fulfill our remaining regulatory applications. Subject to regulatory approval in the United States, which depends on data from the funded activities, Class 1 will be entitled to receive up to $730 million in sales milestones. These milestone payments are contingent upon achieving specified cumulative net sale targets for our future influenza and combination vaccines. Additionally, Blackstone will earn royalties on applicable net sales at a low single-digit percentage rate. The funding will offset our R&D expenses and is factored into our R&D framework for the year of approximately $4.5 billion. Overall, we are excited that this deal enables us to accelerate the advancements of our pipeline. With that, I will now hang up.

Subject to regulatory approval in the United States, which depends on data from the funded activities Blackstone will be entitled to receive up to $750 million in sales milestone payments.

These milestone payments are contingent upon achieving specified cumulative net sales targets for our future influenza and combination vaccines.

Additionally, Blackstone will earn royalties on applicable net sales at a low single digit percentage rate.

Stephen Hoge: The funding will offset our R&D expenses and is factored into our R&D framework for the year of approximately $4.5 billion. Overall, we are excited that this deal enables us to accelerate the advancements of our pipeline. With that, I will now hang up. Thank you. Today I'll review updates from our clinical programs that were shared during our Release Infectees Day, as well as new developments in our therapeutic portfolio. Starting with respiratory vaccines, we shared updates to many of our respiratory programs at Vaccine Day in March. Our RF feedback in Canada is undergoing regulatory review in multiple countries, and pending approval, we expect to launch the product in the United States following the June ACIP meeting and recommendations this year.

The funding will offset our R&D expenses and is factored into our R&D framework for the year of approximately $4.5 billion. Overall, we are excited that this deal enables us to accelerate the advancements of our pipeline. With that, I will now hang up.

Jamie: This funding will offset our R&D expenses and is factored into our R&D framework for the year of approximately $4 5 billion.

Overall, we are excited that this deal enables us to accelerate the advancement of our pipeline and with that I will now hand, the call over to Steve.

Stephen Hoge: Thank you Jamey. Today I will review updates from our clinical programs that were shared during our recent Vaccines Day, as well as new developments in our therapeutics portfolio. Starting with respiratory vaccines, we shared updates to many of our respiratory programs at Vaccines Day in March. Our RSV vaccine candidate is undergoing regulatory review in multiple countries, and pending approval we expect to launch the product in the United States following the June ACIP Meeting and Recommendations this year. At Vaccines Day, we shared updates from core administration studies of RSV confirming the ability to administer our vaccine and other vaccines given during the respiratory season. With our flu program we have recently presented data from our Phase III P303 study at ESCMID, and continue discussions with regulators globally toward the goal of filing this year. For our next generation COVID vaccine and mRNA-1283, we've presented positive Phase III safety and immunogenicity data and are engaging with regulators on the path to approval for that product. Our combination Flu and COVID vaccine mRNA-1083 is in Phase III, and we look forward to sharing those clinical data in the current quarter.

Thanks, Jamie.

Steve: Today I'll review updates from our clinical programs that were shared during our recent vaccine.

As well as new developments in our therapeutics portfolio.

Starting with respiratory vaccines, we shared updates to many of our respiratory programs at vaccines day in March.

<unk> RSV vaccine candidate is undergoing regulatory review in multiple countries and pending approval, we expect to launch the product in the United States. Following the June <unk> meeting and recommendations this year.

Stephen Hoge: At Vaccines Day, we share an update from Co-Administration Studies, ORC, confirming the ability to administer our vaccine and other vaccines given during the respiratory tract infection. With our flu program, we recently presented data from our phase 3 T303 study at and continue discussions of the curriculum globally toward the goal of filing this year's. For our next generation COVID vaccine, mRNA12A3, we've presented positive phase three safety and immuno Our combination flu and COVID vaccine, MRA1083, is in Phase 3, and we look forward to sharing those clinical data with the firm. Turning now to our leaders and other backgrounds.

At Vaccines Day, we share an update from Co-Administration Studies, ORC, confirming the ability to administer our vaccine and other vaccines given during the respiratory tract infection. With our flu program, we recently presented data from our phase 3 T303 study at and continue discussions of the curriculum globally toward the goal of filing this year's. For our next generation COVID vaccine, mRNA12A3, we've presented positive phase three safety and immuno Our combination flu and COVID vaccine, MRA1083, is in Phase 3, and we look forward to sharing those clinical data with the firm.

Steve: Our vaccines day, we shared updates from co administration studies of RSV confirming.

The ability to administer our vaccine and other vaccines, giving during the respiratory season.

With our flu program, we recently presented data from our phase III <unk> III study and estimate and continued discussions with regulators globally towards the goal of filing this year.

For our next generation Covid vaccine mrna 12, 33, we presented positive phase III safety and Immunogenicity data and are engaging with regulators on the path to approval for that product.

Our combination with a COVID-19 vaccine mrna Kennedy three is in phase III and we look forward to sharing those clinical data in the current quarter.

Stephen Hoge: Turning now to our latent and other vaccines. I shared at Vaccines Day, we've had - we've made significant progress in this portfolio. Our CMV vaccine, mRNA-1647, has fully enrolled its Phase III trial, and we have the potential for an interim analysis of efficacy this year. We announced positive Phase I immunogenicity and safety data from our EBV vaccine candidate, mRNA-1189, and we are now advancing towards pivotal trials with that program. A second therapeutic EBV candidate, mRNA-1195, is in a separate ongoing Phase I study. mRNA-1468, our vaccine against varicella zoster virus showed strong immunogenicity, including strong T cell responses, and we are preparing to move that program forward towards a pivotal Phase III study as well. And our HSV vaccine against herpes simplex, mRNA-1608 is now fully enrolled in its Phase I-II study, and we look forward to sharing clinical data updates when that's available. Now, rounding out this portfolio, we presented the positive clinical data from our norovirus vaccine candidate mRNA-1403, and shared that we are advancing that program towards its pivotal Phase III trial.

Turning now to our maintenance and other vaccines.

Stephen Hoge: I share the vaccine say we've made significant progress in this portfolio. A CMV vaccine mRNA 1647 has fully enrolled in your Phase III trial, and we have the potential for an improvement analysis of efficacy this year. We announced positive phase 1 immunogenicity and safety data from our EGV vaccine candidates, mRNA 1189. And we are now advancing towards critical trials of that program. A second therapeutic CBD candidate, mRNA-1195, is in a separate, ongoing state. mRNA-1468 power vaccine against varrocellulose thruster virus shows strong immunogenicity, including strong T cell responses, and we are preparing to move that program forward towards a pivotal phase 3 study as well. And our HFV vaccine against herpes simplex, mRNA-1608, is now fully enrolled in its Phase 1-2 study, and we look forward to sharing clinical data updates when that's available. Now rounding out this portfolio, we presented the positive clinical data from our norovirus vaccine candidate, mRNA-1403, and shared that we are advancing that program towards its typical Phase III product.

As shared in vaccines day, we've had we've made significant progress in this portfolio.

Our CMV vaccine mrna 16, 47 has fully enrolled its phase III trial, and we have the potential for an interim analysis of efficacy this year.

We announced positive phase, one immunogenicity and safety data from our EBV vaccine candidate mrna 11 89.

Stephen Hoge: And we are now advancing towards critical trials of that program. A second therapeutic CBD candidate, mRNA-1195, is in a separate, ongoing state. mRNA-1468 power vaccine against varrocellulose thruster virus shows strong immunogenicity, including strong T cell responses, and we are preparing to move that program forward towards a pivotal phase 3 study as well. And our HFV vaccine against herpes simplex, mRNA-1608, is now fully enrolled in its Phase 1-2 study, and we look forward to sharing clinical data updates when that's available. Now rounding out this portfolio, we presented the positive clinical data from our norovirus vaccine candidate, mRNA-1403, and shared that we are advancing that program towards its typical Phase III product.

And we are now advancing towards pivotal trials for that program.

Steve: Second therapeutic CBD candidate mrna $11 95 is in a separate ongoing phase one second.

Mrna $14 68, our vaccine against Varicella zoster virus showed strong immunogenicity, including strong T cell responses and we are preparing to move that program more towards a pivotal phase III study as well.

And our HSV vaccine against herpes simplex simplex mrna <unk> is now fully enrolled its phase one two study and we look forward to sharing clinical data updates when that's available.

Stephen Hoge: Now rounding out this portfolio, we presented the positive clinical data from our norovirus vaccine candidate, mRNA-1403, and shared that we are advancing that program towards its typical Phase III product. Cranial Oncology Therapy We are happy to report that our ongoing phase 3 studies are going well. We were excited to announce three new INT trials, including a randomized phase 2-3 study in neoadjuvanted adjuvanted zeutinous squamous cell carcinoma and a randomized phase 2 trial in adjuvant high-risk macroinvasive bladder cancer.

Now rounding out this portfolio, we presented the positive clinical data from our norovirus vaccine candidate, mRNA-1403, and shared that we are advancing that program towards its typical Phase III product.

Now rounding out this portfolio, we presented positive clinical data from our norovirus vaccine candidate mrna 14 are three and share that we are advancing that program towards that pivotal phase III trial.

Stephen Hoge: Turning now to Oncology Therapeutics. We are happy to report our ongoing Phase III studies are enrolling well. We were excited to announce three new INT trials, including a randomized Phase II-III study in neoadjuvant and adjuvant cutaneous squamous cell carcinoma, a randomized Phase II trial in adjuvant high risk muscle invasive bladder cancer, and lastly, a randomized Phase II trial in an adjuvant renal cell carcinoma. Now, recently at AACR, we presented Phase I data from our INT program in advanced unresectable HPV negative head and neck cancer in the metastatic setting. At AACR we also presented Phase I translational data from another oncology therapeutic program, mRNA-2752 in various tumor types. Links to both of these presentations are provided on the slide. Now, as a final note, at ASCO we will be hosting another Moderna oncology event on the evening of June 3rd and we look forward to seeing you there or having you join us virtually. With that I'll turn it back over to Stéphane.

Steve: Turning now to oncology Therapeutics, we are happy to report our ongoing phase III studies are enrolling well.

We were excited to announce three new IMT trials, including a randomized phase III study and neo adjuvant and adjuvant cutaneous squamous cell carcinoma.

Steve: A randomized phase II trial in adjuvant high risk muscle invasive bladder cancer.

Stephen Hoge: And lastly, a randomized phase 2 trial in an adjuvant renal cell carcinoma. Now recently at AACR, we presented phase one data from our IMHE program in advanced unreflectable HPV negative head and neck cancer in the metabolic setting. At ACR, we also presented Phase 1 translational data from another oncology therapeutic program, MRA 2752, in various tumor types. Links to both of these presentations are provided in the slides. Now, as a final note, at ASCO, we'll be hosting another Moderna Oncology event on the evening of June 3rd, and we look forward to seeing you there or having you join us virtually. With that, I'll turn it back over to Svante.

And lastly, a randomized phase II trial in an adjuvant renal cell carcinoma.

Steve: Now recently at ACR, we presented phase one data from our IMT program in advanced Unresectable, Unresectable, HPV negative head and neck cancer in the metastatic setting.

At ACR, we also presented phase one translational data from another oncology therapeutic program mrna 2752 in various tumor types.

Steve: Links to both of these presentations are provided on the slide.

As a final note that Africa will be hosting another Madonna oncology event on the evening of June 3rd and we look forward to seeing you. There are having you join us virtually.

With that I'll turn it back over to Scott.

Stéphane Bancel: Thank you Stephen and Jamey. Slide 18 is an overview of our COVID-19 strategy for 2024, which is focused on the needs of each region. In the U.S. our focus is working with public health officials, healthcare providers, and pharmacies to increase vaccination coverage rates. In Europe we are actively participating in the 2024 tender process. The tender allows for up to $36 million per year for up to four years. And in the rest of the world we have reoriented our commercial teams to prioritize markets for greater commercial focus and impact. As mentioned earlier, the Brazil contract is an example of how this is working.

Thank you, Steve and thanks, Jamie.

Slide 18, even overview of our COVID-19 strategy, while trying to April we'll just focus on the needs of each region.

Steve: In the U S. Our focus is working with property cat property shows has kept providers and pharmacies to increase effectiveness.

Corporate story.

In Europe, we are actively participating in the 2020 for tender process.

<unk> allows for up to $56 million per year.

Up to four years.

And in the rest of the World, we have reoriented, our commercial teams to prioritize market.

Greater commercial focus any park I've.

As mentioned earlier, the Brazil contract is an example of how this is working.

Stéphane Bancel: In the Fall of 2023, U.S. COVID vaccination rates lagged behind flu vaccination rates. U.S. COVID vaccination rates were 11%, with flu vaccination rates at four times that. And yet COVID continues to show a higher burden of disease. U.S. hospitalizations for COVID between October 2023 and last week were 424,000 people which is markedly higher than hospitalization from either flu or RSV infection. Actually, COVID hospitalizations were around the same level as hospitalizations of flu plus RSV combined. In addition, long COVID coughs continues to be a serious risk. Too many healthy young adults in their 20s, their 30s, their 40s are losing lung capacity and/or mental capacity due to long COVID. The data shows that COVID-19 vaccine reduces the risk of long COVID by 70%.

For 2023 U S COVID-19 vaccination rates lack behind through vaccination rates and.

Steve: At risk are we back to historical rates were 11.

You develop a stat, we prove our commission rate at four times that.

And yet.

<unk> continues to show a higher burden of disease.

Europe.

Corporate is between October 2023.

And last week, we have 424000 people.

Steve: Which is markedly higher than expectation from either flu or RSV infection.

Akshay <unk> were around the same level of expectations of flow.

These combined.

Stphane Bancel: In addition, Long Covid continues to be a serious problem. Too many healthy young adults in their 20s, their 30s, their 40s are losing their capacity and or lack of capacity due to long careers. The data shows that COVID-19 vaccine reduces the risk of long Covid-19. We believe in K-trend, and awareness will be very important. We are working on informing criminals about the need for an annual COVID vaccine. Geoff Black

In addition, Long Covid continues to be a serious problem. Too many healthy young adults in their 20s, their 30s, their 40s are losing their capacity and or lack of capacity due to long careers. The data shows that COVID-19 vaccine reduces the risk of long Covid-19.

Yes, Hi, Shang long corvid continues to be of service risk too.

Too many healthy yogurts in the 20th crafted puppies.

Steve: Should we think about capacity and domestic capacity neutral long corvid.

The data shows that COVID-19 vaccine.

Coming off a weak by 70%.

Stéphane Bancel: We believe education and awareness will be very important. We are working on educating consumers about the need for an annual COVID vaccine just like flu. Too many people are getting hurt when we have safe and effective vaccines available. Our job will not stop until these hospitalization numbers come down significantly. As you know, strength detection will help authorities receive approval and launch of COVID vaccine. Health authorities, including the W.H.O. and EMA in Europe, have recently selected JN 1 strain for the 2024-2025 formula. The FDA will host the VRBPAC Meeting on May 16th to select a strain for the U.S. market.

Steve: We believe education and awareness will be very important.

We are working on educating consumers about the need for on your Covid vaccine.

<unk>.

Stphane Bancel: Too many people are getting hurt when we have safe and effective vaccines available. Our job will not stop until this number comes down significantly. As you know, the strength election ahead of COVID-19, received the approval and launch of COVID-19. As before, it is including the WSO and EMA Bureau, have recently selected the GM.1 strain for the 2024-2025 formula. The FDA will hold the VF-5 meeting on May 16 to select a strain for the U.S. market. Moderna has already manufactured GNY drug substance to support a potential overthrow.

Too many people are getting hurt when we have safe and effective vaccines available. Our job will not stop until this number comes down significantly. As you know, the strength election ahead of COVID-19, received the approval and launch of COVID-19. As before, it is including the WSO and EMA Bureau, have recently selected the GM.1 strain for the 2024-2025 formula. The FDA will hold the VF-5 meeting on May 16 to select a strain for the U.S. market.

Too many people are getting higher when we have a safe and effective vaccine as a vertical.

Our job, we did not stock activities aspiration umbrella come down significantly.

Steve: As you know strengthened action.

We received the approval and launch of Kobe vaccine.

Before we begin.

Steve: Reading, the debit Rachel and MAA in Europe.

Recently selected the Jan one strength for the 'twenty to 'twenty four clarified formula.

The FDA with us via proxy meeting on May 16 to select the strength of our U S market.

Stéphane Bancel: Moderna has already manufactured JN1 drug substance to support the potential August launch. We have also prepared for backups in case the FDA does not select JN1. In 2023 COVID vaccines were available five weeks later with flu vaccine. In the recent channel alone, more than 3 million flu vaccines were administered before the updated COVID vaccines were available. As we look into the Fall 2024 season, we see the potential to align the timing of flu and COVID vaccine approvals. We are encouraged by an earlier VRBPAC for this year's COVID front selection versus last year. And we're working with the FDA and regulators to offer timely COVID approval. We expect higher vaccination updates if COVID vaccines are available sooner.

Steve: Most of that has already manufacturer Jan one drug <unk>.

To support the perpetual August launch.

Stphane Bancel: We have a group prepared for back-up in the 10th year here, but not the next year in this one. In 2023, COVID vaccines were available five weeks later than flu vaccines. In the recent China lockdown, more than 3 million flu vaccines were administered before the updated COVID vaccines were available. As we look into the fall 2024 season, We see the potential to align the planning of flu and COVID vaccine approvals, were encouraged by the earlier Vietnam meeting for this year's COVID-19 transaction just this last year, and we're working really hard here, and we're really thankful for the funding for this program. We expect higher vaccination uptakes if COVID vaccines are available.

We are also prepared for backups in case, the FDA does not elect Jan one.

In 2020 free Covid vaccines, where available five weeks later flu vaccine.

In the retail channel at all moving Premier Pro vaccines, where AG sales would be updated COVID-19 vaccines where available.

As we look into the fall 2024 season.

Stphane Bancel: We see the potential to align the planning of flu and COVID vaccine approvals, were encouraged by the earlier Vietnam meeting for this year's COVID-19 transaction just this last year, and we're working really hard here, and we're really thankful for the funding for this program. We expect higher vaccination uptakes if COVID vaccines are available. Joining me now to be any secret tip-off of what second subscriber you like to see, or how else you like to see them. If you expect it to last, it will last.

We see the potential to align the planning of flu and COVID vaccine approvals, were encouraged by the earlier Vietnam meeting for this year's COVID-19 transaction just this last year, and we're working really hard here, and we're really thankful for the funding for this program. We expect higher vaccination uptakes if COVID vaccines are available.

We see the product go to align with time, you go through and going back to the progress.

We are encouraged by earlier, we approximate inc. For ECS Kobe transit vis vis last year.

And we're working with year on year, and we get a feel for timely Kobe Airport.

We expect higher fractionation update.

Stéphane Bancel: Turning now to the anticipated launch of a second respiratory vaccine, or RSV vaccine, which is expected to launch into a large market. In its first year, the older adult RSV market was $2.5 billion in sales, and analysts expect the older adult market to grow between $6 billion and $8 billion per year. With marketing applications filed in markets globally, we anticipate seeing approval beginning in the first half of 2024. In the U.S. we are targeting a launch after the June ACIP meeting. We're very excited to bring a product with a strong differentiated profile to market. Our vaccines has shown stronger efficacy and safety data in clinical trials. And will be the only product available in a pre-filter range of PFS presentation.

Covid vaccine available elsewhere.

Steve: Turning now can be anticipated loss of signal infrastructure or your vaccine for RSV vaccine, which is expected to launch into a large market.

Stphane Bancel: In its first year, the order adults will be demarcated. [inaudible] Analysts expect the older adults market to grow between 6 and 8 billion dollars per year. We are maximizing application time in the market globally. We are anticipating approval beginning in the first half of 2024 in the U.S., who are targeting Iran after the June 8th meeting. We're very excited to bring the product to the strong differentiated profile of the market, and we will be the only product available in a 3x3 range of DSS presentations.

In its first year the order.

Steve: The market.

$2 5 billion underlying sales.

And now that you expect the order.

Market will grow between six and 8 billion per year.

Sure.

We are marketing application filed in markets globally, we are celebrating approval beginning in the first half of 2024.

In the U S with Ivy I think after the June ACR meeting.

We're very excited to bring a product from a strong differentiated profile per market.

<unk> strong efficacy.

Safety data in clinical trials.

And would we be R&D productivity in a prefilled syringe or PFS presentation.

Stéphane Bancel: Let me now double-click on what we believe are the benefits of PFS. We recently published a time-and-motion study that shows faster preparation time for PFS relative to vaccines that require constitution. Recall that both RSV competitors' vaccines on the market require multiple steps to prepare their vaccines for administration. One vaccine requires four steps and the other nine steps to prepare. Our PFS presentation is ready to use vaccine straight out of the box. The study found that PFS presentation to be three to four times more efficient as measured by preparation time. Details from the study can be found through the link on the slide. We believe our PFS presentation for RSV vaccine has the potential to ease the personal burden on pharmacies during the fall respiratory season. Big pharmacies chains but also independent pharmacies were looking forward to launch.

Let me now double click on what we believe our Vascepa PFS.

We recently published a time and motion study that should foster a quick question.

Our PFS relative productive that require constitution.

Recall that both Aussie corporate default vaccines on the market require multiple steps to prepare for the vaccine.

Stphane Bancel: One vaccine requires all steps, and we have around 90 steps to prepare. Our PSN presentation is ready for those of you lacking stress at work. The study found that the effect of rotation could be 3 to 4 times more efficient as measured by preparation.

Steve: This ratio.

I'm not getting request process and the overall next steps to prepare.

PFS program. Thanks, Sean is a rep is ready to use the strength of our books.

The study found that PFS program, Thanks, Sean to be three to four times more efficient as rigs go back to your question.

Stphane Bancel: The teleconference will begin in five minutes, four minutes on the fly. We believe our best presentation for HIV vaccines has the potential to ease the personal burden of pharmacies during the fall respiratory season. The party chain serves independent parties, and we are looking for what we want. Let me close with a major upcoming pipeline milestone and why we're excited about the comic book prospects of the year.

The teleconference will begin in five minutes, four minutes on the fly. We believe our best presentation for HIV vaccines has the potential to ease the personal burden of pharmacies during the fall respiratory season. The party chain serves independent parties, and we are looking for what we want.

Details from the study can be found link on the site.

We believe our PFS progression for RSV vaccine.

Potential to ease the personal umbrella pharmacies.

Paul refractory Steven <unk>.

<unk> market share for independent.

Independent pharmacies, and we're looking forward to launch.

Stéphane Bancel: Let me close with major upcoming pipeline milestones. While we are excited about our commercial prospects for the year, we are even more excited about the upcoming pipeline milestones and the effect they will have on our commercial outlook for the next several years serving patients. In respiratory vaccines, we are eagerly awaiting the approval of RSV and ACIP. We are also waiting for data for RSV in the age group 18 and above. We are in discussion with regulators on our flu program, and intend to file in 2024. With our next-gen COVID vaccine, mRNA-1283, we are pleased with positive Phase 3 immunogenicity data and are engaging with regulators.

Let me close with major upcoming pipeline milestones.

While we're excited about the commercial prospects over here.

Stphane Bancel: We're even more excited about the upcoming Pipeline milestone and the effect that it will have on our commercial art group for the next several years, starting this year. In Westbrook, in Westbrook, we're back. We are eagerly awaiting the approval of ISEE and the ACIP recommendation. We are also waiting for data for RG in the age group 18 and above. We are in discussion with regulators on those two programs and intend to apply them in 2023. We've all mentioned COVID-19, and on Equiracy 3, we are cleaning repository phase 3 emergency data and are engaging regulators, or Flux of COVID-19 Combo should get its face reneged as well.

We're even more excited about the upcoming Pipeline milestone and the effect that it will have on our commercial art group for the next several years, starting this year. In Westbrook, in Westbrook, we're back. We are eagerly awaiting the approval of ISEE and the ACIP recommendation. We are also waiting for data for RG in the age group 18 and above. We are in discussion with regulators on those two programs and intend to apply them in 2023. We've all mentioned COVID-19, and on Equiracy 3, we are cleaning repository phase 3 emergency data and are engaging regulators,

In rhetoric in the respiratory vaccine.

We're eagerly awaiting the approval of our NDA keep recommendation.

We are also waiting for data for RSV in the age group 18 and above.

We are in discussion with regulators on our food program and intend to finance about that point Paul.

We've run Nextgen Covid vaccine.

<unk> hundred 83, we are pleased with the positive phase III, Immunogenicity, Paypal and engaging with regulators.

Stéphane Bancel: Our flu plus COVID vaccine combo should get its Phase III data soon. In latent, with CMV fully enrolled and occurring cases, we look forward to potential for Phase III data efficacy data in 2024. In INT program, we are looking forward to completion of our enrollment for Phase III adjuvant melanoma study. In addition, we are keen to discuss the possibility of accelerated approval with regulators brd on Phase II study data. As we shared before, there are three things we view as necessary before we could consider pursuing accelerated approval for INT.

Our fruit plus COVID-19 vaccine combo to get these phase III data.

Stphane Bancel: In Latent, with CMU fully enrolled and accurate changes, we look forward to potential for phase 3 data efficacy data in 2020. In our IT program, we're looking forward to completion of enrollment for Phase III Adjuvant Management Studies. In addition, we are keen to discuss the possibility of accessing the program with regulators based on state-of-the-art data. As we shared before, there are three things we could do as necessary before we could consider pursuing successful approval for hiring.

In later with CMV, if we enroll and that Green cases, we're looking forward to a potential phase III data efficacy data in 2024.

IMT program, we're looking forward to completion of enrollment for phase III adjuvant melanoma study.

In addition, we are keen to discuss the possibility of accelerated approval.

We've recruited based on phase II study data.

I've shared before we acquire things we view as necessary before we could consider kristen that approval for IMT.

Stéphane Bancel: First, durability data from our Phase II study, which we announced in December last year. Second, a substantially enrolled Phase III adjuvant melanoma study. And third, manufacturing readiness at our Marlboro site. And last but not least, our REVD portfolio, we look forward to initiating pivotal study for PNMMA. This milestone will represent continued progress toward our mission to deliver the greatest possible impact to people through mRNA medicine. And as Moderna, we are dedicated to achieving them all. Every data continues to confirm the power of our platform and its breadth in the service of patients. Two important save-the-dates for your calendars. We will discuss oncology program in Chicago on June 1st and our Annual R&D day will be held in New York the morning of September 12th. Thank you for listening and we look forward to taking your questions. Operator?

First directly to data from our phase II study.

Which we announced in December last year.

Second as to.

Thanks, Jeremy and road Phase III adjuvant melanoma study.

Phil manufacturing readiness at our micro site.

And less personal fleet, our revenue portfolio, we look forward to initiating pivotal study for PMA.

This milestone we represents progress towards our mission to deliver greatest placebo impact to people who are monumental Ting mobile.

Steve: We are dedicated to achieving therefore.

Everyday hypotenuse of roughly of the power of our platform and breadth in the service operations.

So important for your calendars, we'll discuss all coffee program in Chicago Auto Unfurl.

Stphane Bancel: And our annual R&D day will be held in New York on the morning of September 12th. Thank you for listening, and we look forward to reading your questions. Au revoir et à!

And on your R&D day will be in New York The morning of September five.

Thank you Polly Sydney and workforce, taking your question operator.

Operator: 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 remove yourself from the queue, please press Star 11 again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Salveen Richter with Goldman Sachs. Your line is open.

Thank you ladies and gentlemen, if you have a question or comment at this time. Please press star one on your telephone. If your question has been answered it yourself in queue. Please press star one again, we will pause for a moment, while we compile the Q&A roster.

Operator: We'll pause for a moment while we compile our Q&A. Our first question comes from Salveen Richter with Goldman Sachs. Good morning, thanks for taking my question. Firstly, could you discuss your strategy for pursuing contracts for the RFC vaccine given two approved vaccines out of a head start timing-wise, and help us understand if you've communicated with large retail pharmacies about how significant the PFS formulation is to them? And then, secondly, with regard to moving into the three new indications for the INT program, maybe help us understand signals or specific data points that support that. Thank you. Good morning.

We'll pause for a moment while we compile our Q&A. Our first question comes from Salveen Richter with Goldman Sachs.

Steve: Our first question comes from <unk> Richter with Goldman Sachs. Your line is open.

Richter: Hi, good morning, Thanks for taking my question.

Salveen Richter: Good morning, thanks for taking my question. Firstly, could you discuss your strategy for pursuing contracts for the RFC vaccine given two approved vaccines out of a head start timing-wise, and help us understand if you've communicated with large retail pharmacies about how significant the PFS formulation is to them? And then, secondly, with regard to moving into the three new indications for the INT program, maybe help us understand signals or specific data points that support that. Thank you. Good morning.

Salveen Richter: Good morning. Thanks for taking my questions. Firstly, could you discuss your strategy for pursuing contracts for the RSV vaccine, given two approved vaccines that have a head start timing-wise and help us understand, if you've communicated with large retail pharmacies, how significant the PFS formulation is to them? And then secondly, with regard to moving into the three new indications for the INT program, maybe help us understand signals or specific data points that support that? Thank you.

Firstly could you discuss your strategy for pursuing contracts for the RSV vaccine.

Given Q approved vaccines that have a head start timing wise and help us understand if you've communicated with large retail pharmacy, how significant the PFS formulation is to them.

Richter: And then secondly, with regard to moving into the three new indications for the IMT programs, maybe help us understand signals or specific data points that support that thank you.

Stéphane Bancel: Good morning. On the RSV contract, so as you know we're not allowed to contract until the product is approved by the regulator. But what we are doing, because we can do that, is our medical team actively engage with retail pharmacies, but also IDN hospital networks, in terms of making sure the data on the efficacy profile of a product, on safety, and of course on the PFS and the benefits of PFS in terms of productivity. Those discussions are ongoing literally on a daily basis, including with leadership of those pharmacies. And the next step, of course, is to wait for the FDA approval. Stephen?

Stphane Bancel: On the IG contract, so as you know, we're not allowed to sign contracts until the product is approved by the regulators. But what we are doing, because we can do that, is our medical team is actively engaged with telecom activities, but also IG and hospital networks, in terms of making sure the data on the efficacy profile of a product, on safety, and, of course, the PFS and the benefits of PFS in terms of productivity. Those discussions are ongoing pretty much on a daily basis, including with the leadership of those pharmacies. And the next step, of course, is to wait for FDA approval. Yeah, sure.

On the IG contract, so as you know, we're not allowed to sign contracts until the product is approved by the regulators. But what we are doing, because we can do that, is our medical team is actively engaged with telecom activities, but also IG and hospital networks, in terms of making sure the data on the efficacy profile of a product, on safety, and, of course, the PFS and the benefits of PFS in terms of productivity. Those discussions are ongoing pretty much on a daily basis, including with the leadership of those pharmacies. And the next step, of course, is to wait for FDA approval.

Good morning.

The IC contracts. So as you know we're not allowed to contract until the product is approved by the <unk>.

We are doing because we can do that is our medical team actively engaged with retail pharmacies, but also IGN hospital networks in terms of making sure the data.

Richter: On the efficacy profile of a product sale.

Safety and of course in the PFS and the affinity for PFS in terms of productivity.

Question ongoing literally on a daily basis.

Our <unk> with leadership of those pharmacies.

And the next step of course is to wait.

Richter: <unk> Steve.

Stephen Hoge: Yeah, sure. So, thanks for the question. So, on the three additional INT indications, I think the short version of it is they are all adjuvant settings, similar to our melanoma Phase II results is encouraging where our KEYTRUDA has a known benefit, and where we still believe that there's an opportunity to improve upon that by driving a specific T cell response with INT. And so, as you know, in Phase I we looked across a range of different indications. That was more in the metastatic setting. But as we announced, since we first saw that positive Phase II results from melanoma, we have been aggressively pursuing adjuvant indications where IO is approved, and where we see an opportunity in all three of these fits squarely in that space.

Stephen Hoge: So thanks for the question. So on the three additional INT indications, I think the short version of it is that they are all agile settings, similar to our melanoma phase two results, which are so encouraging, where our t-trug has a known method, and where we still believe that there's an opportunity to improve upon that by driving a specific T cell response with INT. And so, as you know, in phase one, we looked across a range of different indications, but that was more in the metastatic setting. But as we announced, as we first saw positive phase two results from melanoma, we have been aggressively pursuing adjuvant indications where IO is approved, and we're going to see an opportunity in all three of these fifth-square arena spaces.

Yeah sure. So thanks for the question so on the three additional IMT indications.

I think the short version of it is they are all adjuvant settings.

Similar to our melanoma phase.

Phase II results have been so encouraging.

Where our Keytruda has a known benefit and where we still believe that there is an opportunity to improve on that by driving specific T cell response with IMT.

And so as you know in phase one we looked across a range of different indications that was more of that static setting, but as we announced since we first saw that positive phase II results from melanoma.

Stephen Hoge: But as we announced, as we first saw positive phase two results from melanoma, we have been aggressively pursuing adjuvant indications where IO is approved, and we're going to see an opportunity in all three of these fifth-square arena spaces. Our next question comes from Michael Yee with Geoffrey's Alliance. Hey guys, thanks.

But as we announced, as we first saw positive phase two results from melanoma, we have been aggressively pursuing adjuvant indications where IO is approved, and we're going to see an opportunity in all three of these fifth-square arena spaces.

Richter: We have been aggressively pursuing adjuvant indications where IL assets.

Richter: And where do we see an opportunity in all three of these fits squarely in that space.

Our next question comes from Michael Yee with Geoffrey's Alliance. Hey guys, thanks.

Operator: Thank you. Our next question comes from Michael Yee with Jefferies. Your line is open.

Speaker Change: Thank you Sir.

Speaker Change: Question comes from Michael Yee with Jefferies. Your line is open.

Michael Yee: Hey, guys. Thanks. Two questions as well. On RSV, I guess the competitor GSK as well this week was commenting about how they are expecting you to be in the mix and contracting is ongoing. I know you have some RSV in your guidance. I think the math implies maybe hundreds of millions of dollars. Can you just perhaps comment on how you adjusted or probability adjusted or thought about how much is there in your guidance and your confidence on that for this year? And then secondly, on INT as well, I know you have some data at ASCO. I know you have breakthrough therapy and prime designation. How important is the Phase III enrollment progress, the confirmatory study, I feel like that's always an important discussion with FDA, so how important is that progress before you can really engage with FDA? Thank you.

Jamey Mock: Two questions as well on RSV. I guess the competitor, GSK, this week was commenting about how they're expecting you to be in the mix when contracting is ongoing. I know you have some RSV in your guidance. I think the math implies maybe hundreds of millions of dollars. Can you just perhaps comment on how you adjusted or probability adjusted or thought about how much there is in your guidance, your confidence in that for the future? And then secondly, on INC as well; we often date at ASCO. I know you have breakthrough therapy and prime designation. How important is the phase three enrollment progress? The confirmatory study, I feel like that's always an important discussion with FDA. So how important is that progress before you can really engage with FDA? Thank you.

Michael Yee: Hey, guys. Thanks.

Michael Yee: Two questions as well on RSV.

Michael Yee: I guess the competitor GSK as well this week was commenting about how they're expecting you to be in the mix and contracting is ongoing I know you have some RSV in your guidance.

Michael Yee: I think the math implies maybe one hundreds of millions of dollars can you just perhaps comment on how you adjusted your probability adjusted or thought about how much is there in your guidance and your confidence on that.

Michael Yee: This year and then secondly on IFC as well.

Stephen Hoge: I know you have breakthrough therapy and prime designation. How important is the phase three enrollment progress? The confirmatory study, I feel like that's always an important discussion with FDA. So how important is that progress before you can really engage with FDA? Thank you. Okay, maybe I'll take the first one.

I know you have breakthrough therapy and prime designation. How important is the phase three enrollment progress? The confirmatory study, I feel like that's always an important discussion with FDA. So how important is that progress before you can really engage with FDA? Thank you.

Michael Yee: Awesome data at scale I know you have breakthrough therapy and prime designation.

Michael Yee: How important is the phase III enrollment progress the confirmatory study I feel like that's always an important discussion with FDA, Joe Hello point is that progress before you can really engage with FDA. Thank you.

Jamey Mock: Yeah. Maybe I'll take the first one. Thanks, Mike, for the question. So, as you may know, we haven't guided any specific guidance or number for RSV. In the past, we did break down the 4 billion into three different segments around the U.S. market, the APAs we locked into the year with, and then another category of other COVID sales that didn't have any APAs across the rest of the world. So, a good example is Brazil that we just signed, as well as RSV. So, no specific guidance for RSV from a financial perspective.

Jamey Mock: Thanks, Mike, for the question. So, as you may know, we haven't given any specific guidance or number for RSC. In the past, we did break down the $4 billion into three different segments around the US market, all of the APAs we walked into the year with, and then another category of other COVID sales that didn't have any APAs across the rest of the world. A good example is Brazil, which we just signed, as well as RSC. So no specific guidance for RSC from a financial perspective.

Joe: Yes, maybe I'll take the first one and thanks, Mike for the question. So as you May know, we haven't guided any specific guidance or numbers for RSV in the past, we did break down the $4 billion into three different segments around the U S market.

Speaker Change: As we walked into the year with and then another category. Other COVID-19 sales that didn't have any apis across the rest of the world. A. Good example is Brazil, we just signed as well as RSV. So no specific guidance for RSV from a financial perspective.

Stephen Hoge: So no specific guidance for RSC from a financial perspective. And on the question about IT, I think you nailed it. It's a really important topic, in particular right now, as we think about accelerated approval, that we demonstrate diligence and substantially enroll the confirmatory studies. So really, all you're waiting for is for that study to mature. We think it's really important.

So no specific guidance for RSC from a financial perspective.

Speaker Change: Another question about <unk> I think you nailed it is clearly an important topic.

Stephen Hoge: And on the question of INT, I think you nailed it. It's a really important topic. In particular right now, as we think about accelerated approval, that we demonstrate the diligence and substantially enroll the confirmatory study. So, really all you're waiting for is for that study to mature, could be several years. We think it's really important. To be fair, we have not consulted with the agency on that yet. As we've said, we're waiting until we've crossed our own threshold and also at this point until we've established the manufacturing facility or outlined site to them. But we do feel that, as we've said, substantial enrollment demonstrating that essentially all you're waiting for is the readout on that confirmatory study is our obligation before we even want to go full of that question. We are making great progress this year, and we're optimistic that both that and the facility will be available in short order. And then, of course, we'll want to start engaging with our data, including the FDA on the question of accelerated approval.  Got it. Thank you very much.

Stephen Hoge: And on the question of INT, I think you nailed it. It's a really important topic. In particular right now, as we think about accelerated approval, that we demonstrate the diligence and substantially enroll the confirmatory study. So, really all you're waiting for is for that study to mature, could be several years. We think it's really important. To be fair, we have not consulted with the agency on that yet. As we've said, we're waiting until we've crossed our own threshold and also at this point until we've established the manufacturing facility or outlined site to them. But we do feel that, as we've said, substantial enrollment demonstrating that essentially all you're waiting for is the readout on that confirmatory study is our obligation before we even want to go full of that question. We are making great progress this year, and we're optimistic that both that and the facility will be available in short order. And then, of course, we'll want to start engaging with our data, including the FDA on the question of accelerated approval.

Speaker Change: In particular right now.

Speaker Change: As we think about et cetera approval that we demonstrate the diligence and substantially enroll a confirmatory study so really all year waiting for this for that study to mature could be several years.

Stephen Hoge: To be fair, we have not consulted with the agency on that yet. As we've said, we're waiting until we've crossed our own threshold and, also at this point, until we've established the manufacturing facility that lines up with that. But we do feel that, as we've said, substantial enrollment demonstrating that essentially all you're waiting for is the readout on that confirmatory study is our obligation before we even want to go forward with that. Thank you for that question. We are making great progress this year, and we're optimistic that both that and the facility will be available in short order. And then, of course, we'll want to start engaging with our guests, including the FDA, on the question of the charter.

Speaker Change: We think it's really important to be fair, we have not consulted with the agency on that yet as we've said we're waiting until we cross our threshold and also at this point until we have established the manufacturing facility in that line of sight to that.

Speaker Change: But we do feel that.

Speaker Change: As we've said substantial enrollment demonstrating that essentially all youre waiting for is the readout on that confirmatory study is our obligation before we even more to go for.

Jamey Mock: We are making great progress this year, and we're optimistic that both that and the facility will be available in short order. And then, of course, we'll want to start engaging with our guests, including the FDA, on the question of the charter. Our next question comes from Terrence Flynn, Morgan Stanley. Your line is open. Great. Thanks for taking the question. Maybe two parts from me.

We are making great progress this year, and we're optimistic that both that and the facility will be available in short order. And then, of course, we'll want to start engaging with our guests, including the FDA, on the question of the charter.

Speaker Change: We are making great progress this year and we're optimistic that both that and the facility.

Speaker Change: I'll be available in short order and then of course, we want to start engaging with our guests, including the FDA on the question of accelerated approval.

Michael Yee: Got it. Thank you very much.

Our next question comes from Terrence Flynn, Morgan Stanley. Your line is open. Great. Thanks for taking the question. Maybe two parts from me.

Our next question comes from Terrence Flynn, Morgan Stanley. Your line is open. Great. Thanks for taking the question.

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

Speaker Change: Yes.

Speaker Change: Got it thank you very much.

Speaker Change: Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Terence Flynn: Great. Thanks for taking the question. Maybe two parts for me. Just on the RSV vaccine, can you provide your latest perspective on what the most likely ACIP recommendation will be, will you get a parity recommendation to the competitors or do you think there's a potential for a differential recommendation here? And then just wondering, any update on your ongoing conversations regarding filing your seasonal flu vaccine, I know you mentioned in your prepared remarks, but just any more insight in terms of what the guiding steps are here? Thank you.

Maybe two parts from me. Just on the RSV vaccine, can you provide your latest perspective on what the most likely ACIP recommendation will be? Will you get a parity recommendation with the competitors? Do you think there's a potential for a differential recommendation here? And then, just wondering, any update on your ongoing conversations regarding the administration of your seasonal flu vaccine? I know you mentioned this in your prepared remarks, but just any more insight in terms of what the gating steps are here. Thank you.

Stephen Hoge: Just on the RSV vaccine, can you provide your latest perspective on what the most likely ACIP recommendation will be? Will you get a parity recommendation with the competitors? Do you think there's a potential for a differential recommendation here? And then, just wondering, any update on your ongoing conversations regarding the administration of your seasonal flu vaccine? I know you mentioned this in your prepared remarks, but just any more insight in terms of what the gating steps are here. Thank you.

Terence Flynn: Great. Thanks for taking the question maybe.

Terence Flynn: Two part for me just on the RSV vaccine can you provide your latest perspective on what the most likely a sip recommendation will be will you get a parity recommendation to the competitors or do you think there is a potential for a differential recommendation here and then just wondering any update on your <unk>.

Terence Flynn: Ongoing conversations regarding filing your seasonal flu vaccine I know you mentioned in your prepared remarks, but just any more insight in terms of what the gating steps are here. Thank you.

Stephen Hoge: Thank you. Thank you for both questions. So first on RSV, I'll caveat by saying we have to complete the approval process with FDA, and then, at the end of the day, the recommendation really falls to ACIP and the committee members that defer to them. Our expectation, our hope, is that when they review the data package that we already have, as well as additional data that we expect to be able to share at the ACIP meeting on durability through the second season and on continuity across other populations We certainly think the data supports that. But again, I'll defer to the committee members on that.

Thank you.

Stephen Hoge: Thanks for both questions. So, first on RSV, caveat by saying we have to complete the approval process with FDA. And then at the end of the day, the recommendation really falls to ACIP and the committee members that defer to them. Our expectation, our hope, is that when they review the data package that we already have, as well as additional data that we expect to be able to share at the ACIP meeting on durability through a second season and on immunogenicity across other populations, we expect a parity recommendation. We certainly think the data supports that. But again, I'll defer to the committee members on the ultimate decision. On the question of flu, we are actively engaged right now with regulators on the process for submission of the flu vaccine. As I mentioned a moment ago, we are also closing in on clinical data from our combination flu COVID vaccine, mRNA-1083 and that obviously has an important role in our engagement with regulators generally on flu versus flu COVID combinations. And so, those discussions are ongoing. I won't provide any other update on it, except to say, as we said today, and we continue to say we expect to file the flu product this year. But it will be dependent upon a number of considerations, possibly also including the COVID data that we expect soon.

Speaker Change: Thanks for both questions.

Speaker Change: So first on RSV caveat by saying, we have to complete the approval process with FDA and then at the end of the day the recommendation Ali fault to raise the IP and the committee members I'd defer to them.

Speaker Change: Our expectation our hope is that when they review the data package that we already have as well as additional data that we expect to be able to share at the <unk> meeting.

Speaker Change: On durability through a second season.

Speaker Change: Generically across other populations.

Speaker Change: We expect a parity recommendation, we certainly think the data supports that but again I'll defer to the committee members on the ultimate decision.

Stephen Hoge: On the question of flu, we are actively engaged right now with regulators on the process for submission of the flu vaccine. As I mentioned a moment ago, we are also closing in on clinical data from our combined flu COVID vaccine, mRNA10A3, and that obviously has an important role in our engagement with regulators generally on flu versus flu COVID combinations. So those discussions are ongoing. I won't provide any other update on it except to say, as we've said today, and we will continue to say, we expect to file the flu product this year, but it will be dependent upon a number of considerations, possibly also including the flu COVID data that we have. Thank you. Our next question comes from Ellie Merle with UBS. Your line is open. Thanks for taking the time to answer the question.

On the question of flu, we are actively engaged right now with regulators on the process for submission of the flu vaccine. As I mentioned a moment ago, we are also closing in on clinical data from our combined flu COVID vaccine, mRNA10A3, and that obviously has an important role in our engagement with regulators generally on flu versus flu COVID combinations. So those discussions are ongoing. I won't provide any other update on it except to say, as we've said today, and we will continue to say, we expect to file the flu product this year, but it will be dependent upon a number of considerations, possibly also including the flu COVID data that we have.

Speaker Change: On the question of flu.

Speaker Change: We are actively engaged right now on the.

Speaker Change: With regulators on the process for submission of the flu vaccine.

Speaker Change: As I mentioned a moment ago. We are also closing in on clinical data from our combination fluid COVID-19 vaccine mrna Kenny III.

Speaker Change: And that obviously has an important role in our engagement with regulators generally on on flu virtuous loop codebase and combinations and so those discussions are ongoing I won't provide any other update on it except to say as we've said today and we would continue to say we expect to file.

Speaker Change: Fluid product this year.

Speaker Change: It'll be dependent upon a number of considerations plus we also included US interpret data that we expect to Susan.

Thank you. Our next question comes from Ellie Merle with UBS. Your line is open. Thanks for taking the time to answer the question.

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

Ellie Merle: Hey, guys. Thanks for taking the question. On CMV, how are you thinking about the need or benefits of potentially boosting, both from a clinical, as well as a commercial perspective and if you would study this? And then second, just on CMV, if you don't meet the interim analysis there, would you disclose that? Thanks.

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

Stephen Hoge: Um, on CMV, how are you thinking about the need or benefits of potentially boosting it both from a clinical as well as a commercial perspective as you study this? And then, second, just on CMV, if you don't meet the analysis there, would you disclose that? Great, thank you.

Ellie Merle: Hey, guys. Thanks for taking the question.

Ellie Merle: <unk>.

Ellie Merle: How are you thinking about the need or benefits of potentially boosting.

Ellie Merle: Welcome to clinical as well as the commercial post market.

Ellie Merle: Study that.

Ellie Merle: And then second just on CMV, if you don't meet the interim.

Ellie Merle: That analysis or would you disclose that.

Jamey Mock: So, first on the question of boosting. So, so far, what we have, we actually don't have the efficacy readout yet; that's the phase three studies ongoing. But we do expect to have quite substantial durability data on immunogenicity, and if that's possible, the efficacy data will give us a signal of what the correlation of progression could be. And so, we don't right now have any evidence that they're not good, durable, multi-year, possibly a long five-year to continue to track immunogenicity protection. It's possible that they will stand out for 10 years, and then some boosting is necessary. It's also possible that we decide that a booster might be necessary for a term of now, say, five years or 10 years. We just don't know at this time. And so, at present, the data we do have on the durability of immunogenicity looks quite strong. Great. Thanks. 

Stephen Hoge: So, first on the question of boosting. So, so far, what we have, we actually don't have the efficacy readout yet; that's the phase three studies ongoing. But we do expect to have quite substantial durability data on immunogenicity, and if that's possible, the efficacy data will give us a signal of what the correlation of progression could be. And so, we don't right now have any evidence that they're not good, durable, multi-year, possibly a long five-year to continue to track immunogenicity protection. It's possible that they will stand out for 10 years, and then some boosting is necessary. It's also possible that we decide that a booster might be necessary for a term of now, say, five years or 10 years. We just don't know at this time. And so, at present, the data we do have on the durability of immunogenicity looks quite strong.

Ellie Merle: So first on the question of boosting.

Ellie Merle: So far what we have we obviously don't have the efficacy readout the phase III study is ongoing but.

Ellie Merle: But we do expect to have quite substantial durability data on immunogenicity and its quite possible. The efficacy data will give us a signal of what the quality of production could be and so we don't right now have any evidence that theyre not good durable multi year, possibly as long as five years with continued attractive engineer city.

Ellie Merle: Protection as possible that will extend out to 10 years.

Stephen Hoge: It's possible that they will stand out for 10 years, and then some boosting is necessary. It's also possible that we decide that a booster might be necessary for a term of now, say, five years or 10 years. We just don't know at this time. And so, at present, the data we do have on the durability of immunogenicity looks quite strong. And so, we do think our three dose series will likely be protective for a very long period of time, all subject to the efficacy data that you just referenced.

It's possible that they will stand out for 10 years, and then some boosting is necessary. It's also possible that we decide that a booster might be necessary for a term of now, say, five years or 10 years. We just don't know at this time. And so, at present, the data we do have on the durability of immunogenicity looks quite strong.

Ellie Merle: And then some boosting and necessary. It is also possible that we decided that a booster might be necessary shorter term analysis five years or 10 years.

Ellie Merle: We just don't know at this time.

Ellie Merle: So at present the data we do have on the durability of Immunogenicity it looks quite strong and so we do think that three dose series will likely be protective for a very long period of time.

Ellie Merle: Great. Thanks.

Jamey Mock: And so, we do think a three-dose series will likely be productive for a very long period of time, all subject to the efficacy data that you just referenced. So, on the interim analysis for efficacy, as we've said before, we're making great progress in that study in recurring cases and we do expect to be able to provide an update on or conduct at least an initial interim efficacy analysis this year. Because of the rate of case accrual and also because the protocol calls for us to cross a median of one year follow-up, the timing may be such that by the time we get to that first interim analysis, we also have enough cases for a final analysis or that a final analysis is imminent. Let's say it's a very short period of time away. And so, because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don't think we can commit one way or the other, whether we're going to be updating. It will really depend upon the data we see and then how quickly we expect to get that final analysis. At the end of the day, if we have news to share both on the interim and the final, we, of course, will. But I don't think we can commit at this stage because we haven't seen the data yet. Great, thanks.

Jamey Mock: And so, we do think a three-dose series will likely be productive for a very long period of time, all subject to the efficacy data that you just referenced. So, on the interim analysis for efficacy, as we've said before, we're making great progress in that study in recurring cases and we do expect to be able to provide an update on or conduct at least an initial interim efficacy analysis this year. Because of the rate of case accrual and also because the protocol calls for us to cross a median of one year follow-up, the timing may be such that by the time we get to that first interim analysis, we also have enough cases for a final analysis or that a final analysis is imminent. Let's say it's a very short period of time away. And so, because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don't think we can commit one way or the other, whether we're going to be updating. It will really depend upon the data we see and then how quickly we expect to get that final analysis. At the end of the day, if we have news to share both on the interim and the final, we, of course, will. But I don't think we can commit at this stage because we haven't seen the data yet.  Great, thanks.

Stephen Hoge: And so, we do think a three-dose series will likely be productive for a very long period of time, all subject to the efficacy data that you just referenced. So, on the interim analysis for efficacy, as we've said before, we're making great progress in that study in recurring cases and we do expect to be able to provide an update on or conduct at least an initial interim efficacy analysis this year. Because of the rate of case accrual and also because the protocol calls for us to cross a median of one year follow-up, the timing may be such that by the time we get to that first interim analysis, we also have enough cases for a final analysis or that a final analysis is imminent. Let's say it's a very short period of time away. And so, because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don't think we can commit one way or the other, whether we're going to be updating. It will really depend upon the data we see and then how quickly we expect to get that final analysis. At the end of the day, if we have news to share both on the interim and the final, we, of course, will. But I don't think we can commit at this stage because we haven't seen the data yet.

Ellie Merle: All subject to the efficacy data that you just referenced so on the interim analysis for efficacy.

Stephen Hoge: So, on the interim analysis for efficacy, as we've said before, we're making great progress in that study in improving cases, and we do expect to be able to provide enough data or conduct at least an initial interim efficacy analysis this year. Because of the rate of case approval, and also because the protocol calls for us to cross a median of one-year follow-up, the timing may be such that by the time we get to that first interim analysis, we also have enough cases for a final analysis or that a final analysis is imminent, let's say, a short period of time away. And so, because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don't think we can commit one way or the other whether we're going to be updating. It will really depend upon the data we see and then how quickly we expect to get that final analysis. At the end of the day, if we have news to share, both on the interim and the final, we will, of course, but I don't think we can commit at this stage because we haven't seen the data yet.

Ellie Merle: As we've said before we're making great progress in that study and occurring cases, and we do expect to be able to provide an update on our conducted at least an initial.

Ellie Merle: Interim efficacy analysis this year because of the rate of <unk> growth and also because the protocol calls for us to cross a median of one year follow up.

Ellie Merle: The timing may be such that by the time, we get to that first interim analysis. We are also have enough cases for a final analysis for the final analysis is imminent.

Stephen Hoge: And so, because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don't think we can commit one way or the other whether we're going to be updating. It will really depend upon the data we see and then how quickly we expect to get that final analysis. At the end of the day, if we have news to share, both on the interim and the final, we will, of course, but I don't think we can commit at this stage because we haven't seen the data yet. Our next question comes from Hartaj Singh with Oppenheimer. Your line is open.

And so, because of that uncertainty, until we see that data and understand how close we are to that final analysis, I don't think we can commit one way or the other whether we're going to be updating. It will really depend upon the data we see and then how quickly we expect to get that final analysis. At the end of the day, if we have news to share, both on the interim and the final, we will, of course, but I don't think we can commit at this stage because we haven't seen the data yet.

Ellie Merle: Let's say, it's a very short period of time.

Ellie Merle: So because of that uncertainty until we see that data and understand how close we are to that final analysis I don't think we can commit one way or the other but we're going to be updating it will really depend upon the data we see and then how quickly we expect to get that final analysis.

Ellie Merle: At the end of the day, if we have news to share.

Ellie Merle: On the interim and the final we of course will.

Ellie Merle: But I don't think we can commit at this stage is we haven't seen the data yet.

Speaker Change: Great. Thanks.

Ellie Merle: Great, thanks.

Ellie Merle: Great, thanks.

Speaker Change: Our next question comes from Hartz Hutch thing with Oppenheimer. Your line is open.

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

Hartaj Singh: Great. Thank you for the question. I just have a question on, you're developing a refrigerator stable vaccine and flu vaccine, I believe. And I'd just like to kind of understand how you think about that, when could that get approved, and then will the combo vaccines also be refrigerator stable? Thank you.

Hartaj Singh: Great. Thank you for the question I just had a question on <unk>.

Hartaj Singh: You're developing a refrigerated stable vaccine.

Hartaj Singh: And flu vaccine I believe and I just wanted to kind of understand how you think about that when you could that get approved when the combo vaccine also be refrigerators. Thank you Paul.

Stephen Hoge: Great. Thank you, Hartaj. So - [technical issues].

Operator: Ladies and gentlemen, please stand by. Your conference will resume momentarily. Once again, ladies and gentlemen, please stay on the line. And, pardon me, can you hear me now? Could you try speaking again, your line was muted.

Paul: Great. Thank you.

Hartaj Singh: Okay.

Operator: Ladies and gentlemen, please stand by. Your conference will resume momentarily. Once again, ladies and gentlemen, please stay on the line. And pardon me, can you hear me now? Could you try speaking again? Your line was muted. Yeah, I'm here. Can you hear me? Yeah, we can hear you now. Your volume got muted, but you can go ahead and continue. Great. Sorry for that brief interruption.

Ladies and gentlemen, please stand by. Your conference will resume momentarily. Once again, ladies and gentlemen, please stay on the line. And pardon me, can you hear me now? Could you try speaking again? Your line was muted.

Hartaj Singh: Please stay on the lines.

Yeah, I'm here. Can you hear me? Yeah, we can hear you now. Your volume got muted, but you can go ahead and continue. Great. Sorry for that brief interruption.

Stephen Hoge: Yeah. I'm here. Can you hear me?

Yeah, we can hear you now. Your volume got muted, but you can go ahead and continue. Great. Sorry for that brief interruption.

Operator: Yeah. We can hear you now. Your line got muted, but you can go ahead and continue.

Speaker Change: And part of that can you hear me now could you try speaking again your line was muted.

Speaker Change: Yes, I'm here can you hear me, yes, we can hear you announced your alarm we've gotten good at but you can go ahead and continue.

Stephen Hoge: Great. Sorry for that brief interruption. So, Hartaj thank you for the question. Just to quickly restate what I was saying. All of our respiratory protocol portfolio, RSV, flu, COVID, and the flu COVID combo are being developed toward refrigerator stable PFS. And so our mRNA-1083 program, the flu COVID program, as well as the flu program are intended to be refrigerator stable, prefilled syringes. As Stephane mentioned a moment ago, we really view that as the ideal presentation now, whole presentation for healthcare providers really around the world to facilitate their delivery of the vaccine to patients.

Stephen Hoge: So, Hartaj, thank you for the question. Just to quickly restate what I was saying, all of our respiratory portfolio, RSV, flu, COVID, and the flu-COVID combo, are being developed for refrigerator-stable PFS. And so our mRNA-1083 program, the flu-COVID program, as well as the flu program, are intended to be refrigerator-stable, pre-filled syringes. As Stephane mentioned a moment ago, we really view that as the ideal presentation, the optimal presentation for healthcare providers around the world to facilitate their delivery of the vaccine to patients.

Speaker Change: Greg sorry for that brief interruption, so hard to us. Thank you for the question.

Greg: Just a quickly.

Greg: Restate, what I'm, saying.

Greg: All of our respiratory portfolio portfolio, RSV flu COVID-19 and the fluid Covid combo are being developed towards refrigerator stable PFS from so our mrna tenants three program the fluid Coker program as well as the crew program are intended to be a refrigerator stable pre filled syringes as defined mentioned a moment ago.

Greg: We really view that as the ideal presentation. The alcohol presentation for for health care providers really around the world.

Greg: Facilitate their delivery of the vaccine to patients.

Greg: Okay.

Hartaj Singh: Great. Thank you. Thanks for the question, Stephen.

Speaker Change: Great. Thank you thanks for the question.

Speaker Change: Thank you.

Speaker Change: Demand for our next question.

Operator: Our next question comes from Gena Wang with Barclays. Your line is open. Thank you for taking my questions. I have two.

Operator: One moment for our next question. Our next question comes from Gena Wang with Barclays. Your line is open.

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

Gena Wang: Thank you for taking my questions. I have two. One is regarding COVID. So for the EU, you say up to 36 million doses every year in EU. What could be the scenario, you can get 36 million doses in EU and also the price in Brazil and the EU, should we use pandemic price of $25 to $30 per doses as the benchmark? Quickly on key accelerator approval pass based on today's comments and the prior discussion, our impression as you could achieve all the three key components by the end of this year, is Merck is also fully on board to submit for the accelerator approval in melanoma?

Gena Wang: Thank you for taking my questions guys Q1 is regarding COVID-19.

Stphane Bancel: One is regarding COVID. So for the EU, you set up to 36 million doses every year. In the EU, what could be the scenario where you can get 36 million doses in the EU? And also the price in Brazil and the EU. Should we use a pandemic price of $25 to $30 per dose as a benchmark? Quickly on IMT, an accelerated approval path. Based on today's comments and the prior discussion, our impression is you could achieve all.

Speaker Change: So.

Stphane Bancel: Should we use a pandemic price of $25 to $30 per dose as a benchmark? Quickly on IMT, an accelerated approval path. Based on today's comments and the prior discussion, our impression is you could achieve all. Thank you, Gena. It's Stphane.

Should we use a pandemic price of $25 to $30 per dose as a benchmark? Quickly on IMT, an accelerated approval path. Based on today's comments and the prior discussion, our impression is you could achieve all.

Gena Wang: Should we use pandemic price of 25 to $30 per doses at the benchmark crack.

Gena Wang: Quickly on key accelerated approval.

Gena Wang: Based on today's comments enterprise discussion our impression is you could achieve all the three key components by the end of this year is Merck is also.

Speaker Change: Oh boy.

Stéphane Bancel: Thank you, Gena, it's Stephane, I will take the COVID question and then Stephen will talk about INT. So, the tender is up to $36 million. It will depend on the number of countries that apply to the tender for the EU. So, this we will know at the end of the process. And as you know it is a tender process so there's no dialogue which is enshrined all the files and all the data and that's really ongoing, but we are obviously very active on it. And on price for obvious competitive reasons, we're not going to share price in the markets because probably it doesn't know the price right away. Stephen, INT?

Speaker Change: You submit for accelerated approval in melanoma.

Stphane Bancel: I'll take the COVID question and then Stephen will talk about IEC. So the tender is up to 36 million dollars. We depend on a number of countries that apply for the tender for the EU. So this is what we know at the end of the process, and that's the end of the process. So there's no dialogue; we just enter in all the files and all the data. And that's really ongoing; the team is obviously very active in it. And on price, for obvious competitive reasons, we're not going to share the price in any market, because the company doesn't know the price, by the way.

Speaker Change: Thank you Gena, it's Stefan I will take the Covid question Steven.

Speaker Change: IMT.

Speaker Change: The tender is up to 56 million those views.

Stefan: It depends on in both countries that's applied to Nintendo.

Stefan: The EU. So this will know at the end of a process and those who makes a tender process. So there is no dialogue, we're just and trained.

Stefan: Your files in order to date.

Stefan: What are your ongoing TWC very active life.

Stephen Hoge: And that's really ongoing; the team is obviously very active in it. And on price, for obvious competitive reasons, we're not going to share the price in any market, because the company doesn't know the price, by the way. Yeah, so we haven't specifically gotten to when we expect to complete, obviously, the second and third parts of our three-part criteria. That being manufacturing readiness, which as you can imagine, work is going on around the clock, as well as enrollment, which we've made great progress on.

And that's really ongoing; the team is obviously very active in it. And on price, for obvious competitive reasons, we're not going to share the price in any market, because the company doesn't know the price, by the way.

Stefan: On price for obvious competitive reasons, we're not going to shop pricing in the market.

Stefan: Because the company you're talking about price right away.

Speaker Change: Thank you.

Speaker Change: Yeah. So.

Stefan: We haven't specifically.

Stephen Hoge: Yeah. So, we haven't specifically got into when we expect to complete, obviously, the second and third parts of our three-part criteria, that being manufacturing readiness. As you can imagine work is going on around the clock, as well as the enrollment where we've made great progress, but you have to sustain that progress. On your question of where's Merck on this, I think you'll have to direct it to them. Our view is that if we're able to get to the point where until your approval is appropriate, and regulators are supportive of that, we can't imagine why ourselves and Merck wouldn't want to make the product available to help people suffering from cancer right now. But the contingencies there are obviously we have to do our work and our diligence this year. And then ultimately, we have to speak to regulators, and they get to decide whether that pathway is available to us. And so, I think for both ourselves and our partner, Merck will want to defer to regulators ultimately on that choice. Thank you.

Stephen Hoge: Yeah. So, we haven't specifically got into when we expect to complete, obviously, the second and third parts of our three-part criteria, that being manufacturing readiness. As you can imagine work is going on around the clock, as well as the enrollment where we've made great progress, but you have to sustain that progress. On your question of where's Merck on this, I think you'll have to direct it to them. Our view is that if we're able to get to the point where until your approval is appropriate, and regulators are supportive of that, we can't imagine why ourselves and Merck wouldn't want to make the product available to help people suffering from cancer right now. But the contingencies there are obviously we have to do our work and our diligence this year. And then ultimately, we have to speak to regulators, and they get to decide whether that pathway is available to us. And so, I think for both ourselves and our partner, Merck will want to defer to regulators ultimately on that choice.

Stefan: You guided to when we expect to complete obviously, the second and third parts of our three part criteria.

Stefan: That being the manufacturing readiness as you can imagine work is going on around the clock as well as the enrollment we've made great progress.

Stefan: To sustain that.

Stephen Hoge: On your question of where Merck is on this, I think you'll have to direct it to them. Our view, you know, is that if we're able to get to the point where supplier approval is appropriate and regulators are supportive of that, we can't imagine why ourselves and Merck wouldn't want to make a product available to help people suffering from cancer right now. But they, you know, the contingencies there are obviously, we have to do our work and our diligence this year. And then ultimately, we have to speak to regulators, and they get to decide whether that pathway is available to us. And so I think for both ourselves and our partner, Merck, we're one of the first companies on that.

Speaker Change: On your question.

Speaker Change: Whereas mark on this I think you'll have to direct it to them.

Speaker Change: Our view.

Speaker Change: Is that if we're able to get to the point where in salary approval as appropriate and regulators are supportive of that we can't imagine why ourselves landmark wouldn't want to make the product available to help people suffering from cancer right now.

Speaker Change: But the contingencies there obviously, we have to do our work and our <unk> this year.

Stephen Hoge: And then ultimately, we have to speak to regulators, and they get to decide whether that pathway is available to us. And so I think for both ourselves and our partner, Merck, we're one of the first companies on that. Our next question comes from Luca Issi with RBC Capital. Alright, thanks so much for taking our questions. Maybe a very quick one on RFP.

And then ultimately, we have to speak to regulators, and they get to decide whether that pathway is available to us. And so I think for both ourselves and our partner, Merck, we're one of the first companies on that.

Speaker Change: And then ultimately we have to speak to regulators and they get to the site whether that Apple is available to us and so I think for both ourselves and our partner Merck will wanted to FERC regulators ultimately on that choice.

Gena Wang: Thank you.

Our next question comes from Luca Issi with RBC Capital. Alright, thanks so much for taking our questions. Maybe a very quick one on RFP.

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

Speaker Change: Thank you.

Luca Issi: Great. Thanks so much for taking my questions. Maybe a very quick one on RSV. I think the last press release actually cited May 12th as the PDUFA date. While today, you're simply saying the initial regulatory approvals is in the first half of 2024. So, is there anything to read to it, can you just confirm that the PDUFA date is still May 12th, which is actually the end of next week? And then, maybe second on IP, can you just comment on the recent decision by Judge Goldberg to rule in favor of Arbutus or you're looking on a particle, our understanding, this can have pretty material impact on both prior and future sales of COVID, so again, any thoughts there, much appreciated? And then, super quickly on INT. Stephen, what's holding you back on starting the randomized trial intended at cancer into metastatic studies, I thought the data at ACL was pretty impressive so, any thoughts there, much appreciated? Thanks so much.

Speaker Change: Our next question comes from Luca <unk> with RBC capital Your line is open.

Stephen Hoge: I think the last press release actually cited May 12th as the producer date, while today it's simply saying that initial register approval is in the first half of 24, so is there anything to read, is there anything to confirm that the producer date is still May 12th, which is actually the end of next week? And then maybe a comment on intellectual property, can you comment on the recent decision by Judge Goldberg to rule in favor of Arbutus, or you're looking at a partial, our understanding this can have a pretty material impact on both prior and future sales of COVID, so again, any thoughts there? And then, super quickly, on IMT, Steve, what's holding you back from starting a randomized trial in head and neck cancer, even in a static setting? I thought the data that you threw out was pretty impressive, so any thoughts there? Much appreciated. Thanks so much.

Luca: Oh, great. Thanks, so much for taking my question, maybe a quick very quick one on RSV I seek your last press release actually decided needs well.

Luca: Once a day you sustain this initial Brexit approvals in the first half of 2004. So is there anything to read through it can you just confirm just produced.

Luca: The data still May 12, which is actually the end of next week and then maybe second on IP can you just comment on the recent decision by judge Goldberg to rule, obviously, the CFO of our view of this sorted youre looking at a particle.

Stephen Hoge: And then, super quickly, on IMT, Steve, what's holding you back from starting a randomized trial in head and neck cancer, even in a static setting? I thought the data that you threw out was pretty impressive, so any thoughts there? Much appreciated. Thanks so much.

Luca: I understand and just can has a pretty material impact on both prior and future sales of Covid. So again any thoughts there much appreciated and then super quickly on IMT Steve.

Luca: Maybe you back and starting a randomize trial intended to cancer metastatic study I saw David ACI was pretty impressive so any thoughts there much appreciate it thanks so much.

Stephen Hoge: Great. Thank you for the questions. I'll take this first from the third very quickly. So, on the question of RSV, we continue working toward the same PDUFA date, and there's no change to that. As you know, there's a lot of work and around the clock work by ourselves, obviously, and folks at the agency. And so we're hopeful that, that happens as planned, but if it takes a little bit longer, at the end of the day, what really matters is the - meeting, but there's been no change to report. So, don't read anything into that. As far as the INT question, on head and neck, I appreciate the question because we are also obviously enthusiastic about that data. However, our partner, Merck and ourselves, we have not yet decided where that fits in the priority of other indications, pathologies, and opportunities we're pursuing. As you've already seen in the past year, we've stood up a very large number of study. And we're just trying to pace ourselves. And so, it will take us a little bit of time with our partner, Merck to determine what the next steps are in head and neck. And at this point, we do not have an update on it.

Speaker Change: Great Perfect question I'll take this from a third very quickly.

Speaker Change: So on the question of RSV.

Speaker Change: Continue working towards the same paducah date.

Speaker Change: And there has not changed that as you know.

Speaker Change: Rob Mcleod worked by ourselves, obviously and folks at the agency.

Speaker Change: And so we're we're we're hopeful that that happens at plan, but if it takes a little bit longer at the end of the day, what really matters.

Stephen Hoge: So on the question of RFC, we continue working towards the same fiduciary, and there's not been any change to that. As you know, there's a lot of work and a lot of work by ourselves, obviously, and folks at the agency. And so we're, you know, we're hopeful that that happens as planned. But if it takes a little bit longer, at the end of the day, what really matters is the June NCIP meeting. But There's been no change to report. So don't read anything into that. As far as the INC is concerned, I appreciate the question because we are also obviously enthusiastic about that data. However, our partners and ourselves have not yet decided where that sits in the priority of other indications, technologies, and opportunities we're pursuing. As you've already seen in the past year, we've set up a very large number of studies, and we're just trying to pace ourselves. It'll take us a little bit of time with our partner, Merck, to determine what the next steps are ahead of us. At this point, we do not have an answer.

Speaker Change: June exactly beating but theres been no change to report.

Speaker Change: Read anything into that.

Speaker Change: As far as the IMT.

Stephen Hoge: So don't read anything into that. As far as the INC is concerned, I appreciate the question because we are also obviously enthusiastic about that data. However, our partners and ourselves have not yet decided where that sits in the priority of other indications, technologies, and opportunities we're pursuing. As you've already seen in the past year, we've set up a very large number of studies, and we're just trying to pace ourselves. It'll take us a little bit of time with our partner, Merck, to determine what the next steps are ahead of us. At this point, we do not have an answer.

Speaker Change: <unk>.

Speaker Change: Question.

Speaker Change: On head and neck I appreciate the question because.

Speaker Change: We are also obviously enthusiastic about the data however, our partner Merck and ourselves we have not yet decided where that fits in the priority of other indications technologies and opportunities we're pursuing as you've already seen in the past year, we stood up a very large number of studies.

Speaker Change: And we're just trying to pace ourselves and so.

Speaker Change: It will take us a little bit of time.

Speaker Change: With our partner Merck to determine what the next steps arm had mechanisms pardon me do not have an update on.

Stephen Hoge: At this point, we do not have an answer. Thank you. I'll take the questions. I mean, as you know, COVID-19 vaccine technology, including our lipid nephropotical delivery system, is a result of independent research and development. We have a strong belief that all technology does nothing on the patterns associated with how we do it.

At this point, we do not have an answer.

Speaker Change: Thank you and I think the key questions I mean, as you know our COVID-19 vaccine technology, including our lipid nanoparticle delivery system.

Stéphane Bancel: Thank you. I'll take the IP questions. I mean as you know, our COVID-19 vaccine technology, including our lipid nanoparticle delivery system is the result of independent research and development. We have a strong belief that our technology does not impact on the patent asserted by Arbutus. We are confident in our position, and we look forward to presenting our case and trial next year.

Speaker Change: In the fund that research and development we.

Speaker Change: We have a strong belief that they'll technology does not infringe.

Speaker Change: On the patent Thats operated by operators.

Stphane Bancel: We are confident in our position, and we look forward to presenting our case at trial next. Thank you. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Hey guys, good morning. Thanks for taking my questions. I have a few here.

We are confident in our position, and we look forward to presenting our case at trial next.

Speaker Change: We're confident in our position and we look forward to productive okay.

Thank you. Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Hey guys, good morning. Thanks for taking my questions. I have a few here.

Luca Issi: Thank you.

Thank you. Our next question comes from Jessica Fye with J.P. Morgan. Hey guys, good morning. Thanks for taking my questions. I have a few here.

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

Speaker Change: Next year.

Speaker Change: Thank you.

Jessica Fye: Hey, guys. Good morning. Thanks for taking my questions. I had a few here. So for INT, I know you mentioned you can't comment on when you expect to complete the manufacturing scale up. But can you provide a status update on where you stand with that today and the number of patients you can support right now, as well as where you want to take that capacity once you get to the end of this three-phase scale-up process, even if you don't put a timeline on when you'll get there? Next one is coming back to flu, can you just refine a little bit when the 1083 immunogenicity data will be available and maybe elaborate on how the combo data play a role in the regulatory tox on 1010, I thought you previously said these products could stand on their own and that you might not need 1010 approved to get 1083 approval, so now wondering kind of why 1083 might factor in for 1010? And then lastly, on CMV, can you remind me how the risk of CMV and pregnancy compares in seropositive versus seronegative individuals, I'm thinking from a commercial standpoint, how you weigh the strategy of pursuing vaccinating everyone versus just seronegative people? Thanks.

Speaker Change: Gentlemen.

Operator: So for ING, I know you mentioned you can't comment on when you expect to come up with the manufacturing scale-up, but can you provide a status update on where you stand with that today and the number of stations you can support right now, as well as where you want to take that capacity once you get to the end of this three-phase scale-up process, even if you don't have a timeline on when you'll get there? Next one is coming back to the flu. Can you just refine a little bit when the 1083 immunogenicity data will be available, and maybe elaborate on how the combo data play a role in the regulatory task for 1010? I thought you previously said these products could stand on their own, and that you might not need 1010 approved to get 1083 approval, so now I'm wondering kind of why 1083 might factor in for 1010. And then lastly, on CMD... Can you remind me how the risk of CMV in pregnancy compares in seropositive versus seronegative individuals? I'm thinking from a commercial standpoint, how you weigh the strategy of pursuing vaccinating everyone versus just seronegative people. Thanks.

Speaker Change: Hey, guys. Good morning, Thanks for taking my questions I had a few here so.

Speaker Change: Our IMT and you mentioned you can't comment on when you expect the manufacturing scale up but can you provide a status update on where you stand with that today and the number of patients right now as well as where you want to take that capacity. Once you get to the end of this three phase scale up process, even if you don't put a timeline on.

Operator: Can you just refine a little bit when the 1083 immunogenicity data will be available, and maybe elaborate on how the combo data play a role in the regulatory task for 1010? I thought you previously said these products could stand on their own, and that you might not need 1010 approved to get 1083 approval, so now I'm wondering kind of why 1083 might factor in for 1010. And then lastly, on CMD... Can you remind me how the risk of CMV in pregnancy compares in seropositive versus seronegative individuals? I'm thinking from a commercial standpoint, how you weigh the strategy of pursuing vaccinating everyone versus just seronegative people. Thanks.

Speaker Change: On when Youll get their next one is.

Speaker Change: <unk> previously said these products could stand on their own.

Speaker Change: And that you might not need 10, 10 approved to get <unk> approval.

Speaker Change: Now I'm wondering kind of why it <unk> factor in for Tien Tsin.

Stephen Hoge: And then lastly, on CMD... Can you remind me how the risk of CMV in pregnancy compares in seropositive versus seronegative individuals? I'm thinking from a commercial standpoint, how you weigh the strategy of pursuing vaccinating everyone versus just seronegative people. Thanks. Great, thank you for the question. I'll stop with the R&D question on manufacturing and I'll see you at the next event. So, we have not provided some capacitive numbers of the factory in Marlborough, because of course, as you can assume, we know the size of our melanoma market, and we know how strong those data are, we want to be benefiting from the phase 2 data, so we size the plant accordingly, as you can imagine, but also, we are building the plant for scale, because as you know, Stephen and his team and his other colleagues are running a lot of studies, so this is not a plant for melanoma, it's a plant for INT, again, for melanoma from a factory standpoint, we don't care which cancer it is in terms of organ, because we use genetic information to design an individual product for every human being, so basically, we bought a plant last year, that was a big building, finished, seven times to market, obviously, we don't have to get the timing in and build the building, and so the team since then, that is now more than a year ago, has been working actively to get the plant ready, and the plant will be in modules inside the building, so basically, we'll go around to the first module of manufacturing capacity, and then, And one day, maybe we do an opening of a facility that could be for Norwood, you will see that there's a lot of empty space left behind, which allows for very quick ramp-up, because the HVAC system, all the utility systems have been set up for the entire plant, and so then you just have modules as you go.

And then lastly, on CMD... Can you remind me how the risk of CMV in pregnancy compares in seropositive versus seronegative individuals? I'm thinking from a commercial standpoint, how you weigh the strategy of pursuing vaccinating everyone versus just seronegative people. Thanks.

Speaker Change: And then lastly on CMV can.

Speaker Change: Can you remind me how the risk of CMV and pregnancy correct errors in the zero positive versus zero negative individuals.

Stéphane Bancel: Great, thank you for the question. I'll stop with the R&D question on manufacturing and I'll see you at the next event. So, we have not provided some capacitive numbers of the factory in Marlborough, because of course, as you can assume, we know the size of our melanoma market, and we know how strong those data are, we want to be benefiting from the phase 2 data, so we size the plant accordingly, as you can imagine, but also, we are building the plant for scale, because as you know, Stephen and his team and his other colleagues are running a lot of studies, so this is not a plant for melanoma, it's a plant for INT, again, for melanoma from a factory standpoint, we don't care which cancer it is in terms of organ, because we use genetic information to design an individual product for every human being, so basically, we bought a plant last year, that was a big building, finished, seven times to market, obviously, we don't have to get the timing in and build the building, and so the team since then, that is now more than a year ago, has been working actively to get the plant ready, and the plant will be in modules inside the building, so basically, we'll go around to the first module of manufacturing capacity, and then, And one day, maybe we do an opening of a facility that could be for Norwood, you will see that there's a lot of empty space left behind, which allows for very quick ramp-up, because the HVAC system, all the utility systems have been set up for the entire plant, and so then you just have modules as you go.

Stéphane Bancel: Great. Thank you for the questions. I'll start with the INT question on manufacturing, then Stephen can add. So, we have not provided some capacity numbers of the factory in Marlboro. But of course, as you can assume, we know the size of the melanoma market. And we know our stronger data. We have plenty of people benefiting from the Phase II data. So we've sized the plant accordingly, as you can imagine. But also, we are building the plant of care because, as you know, Stephen and his team and his colleagues are running a lot of studies. So, this is not a platform in melanoma. Again, from a manufacturing standpoint, we don't care which cancer is in terms of organ because we use genetic information to design an individual product for every human being. So basically, we bought a plant last year that was kind of a big building finished, saves us time to market.

Speaker Change: From a commercial standpoint, how you weigh the strategy of pursuing vaccinating, everyone versus just zero negative people.

Speaker Change: Yes.

Speaker Change: Thank you for the questions, possibly be IMT question on manufacturing.

Speaker Change: We have not provided.

Speaker Change: Number.

Speaker Change: III Marlboro, but of course as you kind of assume we have the size of Manhattan.

Speaker Change: Yes.

Speaker Change: And we know a stronger base.

Speaker Change: Two people are benefiting faced.

Speaker Change: Faced with Paypal, So we've signed with Blackhawk I'll give you guys a Kenyan margin. So we are building the platform because as you know Steven and his team and our colleagues are running a lot of studies. So this is another point from an abnormality surplus for IMT.

Stéphane Bancel: Obviously, we don't have to get the permitting and build the building. And so the team since then, that is now more than a year ago, has been working actively to get the plant ready. And the plant we will reviewing in modules inside the building. So basically, we're going to launch with the first module of manufacturing capacity. And then - and one day maybe we do an opening of a facility like we did for Norwood. You will see that there's another empty space left behind, which has also a very quick ramp-up because the HVAC system and all the utility has been set up for the entire plant. And so then you just add modules as you go. So, we'll be able to scale very quickly as we get more indication available. But again, we're aware of the melanoma number of cases. And so, the plant will be sized so we make sure we can provide products to patients. Stephen?

Speaker Change: Again from a manufacturing standpoint, we don't count, which cancer easing some of auger because we use genetic information to design a product for every human being so basically we bought a plant that was kind of.

Speaker Change: Building finished.

Speaker Change: Time to market obviously.

Speaker Change: Given the comments you made <unk>, Inc, and <unk> since then.

Speaker Change: The yogurt has been working actively to get them ready and then perhaps it will be in module type of buildings, which Keith.

Speaker Change: We're going to Nordstrom refresh module manufacturing capacity and then.

Stephen Hoge: So we'll have the ability to scale very quickly as we get more indications available. But again, we are aware of the melanoma number of cases, and so the plant will be sized, so we make sure we can correct [inaudible] Thank you for the clarifying question on the flu.

So we'll have the ability to scale very quickly as we get more indications available. But again, we are aware of the melanoma number of cases, and so the plant will be sized, so we make sure we can correct [inaudible]

Speaker Change: In one day.

Speaker Change: We do.

Speaker Change: You will see that empty space left behind which had also a very quick ramp up because of the HVAC systemic Puerto Rican CVC stair might be similar Fob plant and so maybe you can just add modules as we grow so we would have the ability to scale very quickly as we get more indication.

Speaker Change: But again, we're up in Manhattan.

Stephen Hoge: Thank you for the clarifying question on flu. So, let me just start by saying that independently, we are looking to submit both the flu program and the flu COVID combo program. So, that's 1010 and 1083. Obviously, we need to see the 1083 data, and we'll announce that when we have it. The question on the timing of that data, it's imminent. And so, in the coming quarter, we expect to be able to share that update. The point about interdependency, I suppose, is just more about sequencing of those submissions and in some places and some regulatory geographies, obviously, you can't stack them on the same day, if you will. There's a logical sequence and what we will want to assess once we see the 1083 data is our regulatory strategy as well as our preparation and delivery of data for the submissions to determine which one will go first or second.

Speaker Change: Number of cases, and so perhaps would be size. So we make sure we can provide products for patient Steven great.

Stphane Bancel: So let me just start by saying that independently, we are looking to submit both the flu program and the flu-COVID combo program, so that's N10 and N10A3. Obviously, we need to see the N10A3 data, and we'll announce that when we have it. The question on the timing of that data is imminent, and so in the coming quarter, we expect to be able to share that update. But at this point, we're trying hard to make sure that we can do both products across all of our major markets if the data is positive this year.

So let me just start by saying that independently, we are looking to submit both the flu program and the flu-COVID combo program, so that's N10 and N10A3. Obviously, we need to see the N10A3 data, and we'll announce that when we have it. The question on the timing of that data is imminent, and so in the coming quarter, we expect to be able to share that update.

Speaker Change: Great. Thank you for the clarifying question on flu. So let me just start by saying that independently we are looking to sell.

Speaker Change: Both flu program and the fluid Covid combo program. So that's <unk> three.

Speaker Change: <unk>.

Speaker Change: Obviously, when you see the <unk> III data and we'll announce that when we have it.

Speaker Change: The question on the timing of that data.

Speaker Change: <unk>.

Speaker Change: Imminent and so in the coming.

Speaker Change: <unk>, we expect to be able to share that update.

Speaker Change: Point about inter dependency I suppose it's just more about sequencing of those submissions and then some places and some regulatory geography, obviously.

Speaker Change: You can see.

Speaker Change: On the same day. Thank you.

Speaker Change: Logical sequence in what we would want to assess once we see the <unk> data is our regulatory strategy as well as our preparation and delivery of data for the submissions to determine which one will go first for a second.

Stephen Hoge: But at this point, we're trying hard to make sure that we can do both products across all of our major markets, if the data is filed this year. And so, we'll go more on that as we move forward. But for now, we are proceeding without independent sorry for the confusion in your model. On the question of CMV and seropositivity. So, it's a really important point. Thank you for raising it. But while the majority - well, the risk of vertical transmission of CMV to pregnancy to the fetus is highest in seronegative. It does happen in seropositives as well. So, congenital CMV is a disease that's seen in - particularly in reactivation or sometimes reinfection, even in the seropositive context. And so, we do believe that there's a potential for benefit for a vaccine even in the seropositive population. We are evaluating the study right now in seronegative because the rate of that transmission and obviously, the potential to prevent against infection is more enriched and therefore the study primarily are focused on seronegatives. But we are looking.

Stephen Hoge: But at this point, we're trying hard to make sure that we can do both products across all of our major markets, if the data is filed this year. And so, we'll go more on that as we move forward. But for now, we are proceeding without independent sorry for the confusion in your model. On the question of CMV and seropositivity. So, it's a really important point. Thank you for raising it. But while the majority - well, the risk of vertical transmission of CMV to pregnancy to the fetus is highest in seronegative. It does happen in seropositives as well. So, congenital CMV is a disease that's seen in - particularly in reactivation or sometimes reinfection, even in the seropositive context. And so, we do believe that there's a potential for benefit for a vaccine even in the seropositive population. We are evaluating the study right now in seronegative because the rate of that transmission and obviously, the potential to prevent against infection is more enriched and therefore the study primarily are focused on seronegatives.

Speaker Change: But at this point, we are trying hard to make sure that we can do bulk products across all of our major markets. If the data is positive this year.

Stphane Bancel: And so more on that as we move forward. But for now, we are proceeding independently. On the question of CMV and seropositivity, so it's a really important point. Thank you for raising it. But while the majority, while the risk of vertical transmission of CMV to pregnancy, to the fetus, is highest in seronegatives, it does happen in seropositives as well. So congenital CMV is a disease that's seen particularly in reactivation or sometimes reinfection, even in the seropositive context. And so we do believe that there's a potential for benefit for a vaccine, even in the seropositive population. We are evaluating the study right now in seronegatives because the rate of that transmission and, obviously, the potential to prevent against infection is more enriched, and therefore, the study's primary aims are focused on seronegatives. But we are looking,

Speaker Change: And so.

Speaker Change: More on that as we move forward, but for now we are proceeding with independent bank, sorry about that confusion.

Stephen Hoge: So congenital CMV is a disease that's seen particularly in reactivation or sometimes reinfection, even in the seropositive context. And so we do believe that there's a potential for benefit for a vaccine, even in the seropositive population. We are evaluating the study right now in seronegatives because the rate of that transmission and, obviously, the potential to prevent against infection is more enriched, and therefore, the study's primary aims are focused on seronegatives. But we are looking,

Speaker Change: On the question of CMV and zero positivity so.

Speaker Change: Really important point, thank you for raising it.

Speaker Change: While the majority while the risk of vertical transmission of CMV too.

Speaker Change: Pregnancy to the fetus.

Speaker Change: Yes zero negative it does happen in seropositive as well so congenital CMV is a disease that seeing it.

Speaker Change: And particularly in <unk> reactivation of our sometimes reinfection, even in the seropositive context, and so we do believe there is a potential for benefit for a vaccine even in the <unk> positive population.

Speaker Change: We are evaluating a study right now in seronegative, because the rate of of that transmission and then obviously the potential to prevent against infections with more enriched and therefore starting site.

Speaker Change: Primary Ed are focused on the pseudo negatives, but we are looking we have studied the vaccine from a safety perspective into robotics and we are looking at things like sharing.

Stephen Hoge: But we are looking. We have studied the vaccine from a safety perspective in seropositives. And we are looking at things like shank, if you draw a little bit of an analogy to correlate to the EBV data that we've already put out there in a different virus, but we've been able to show that we can really control the rate of setting even in seropositive is the simpolovirus. And so, we have some reasons for optimism and believe that when we pull together the totality of the data, there will both be the obvious potential benefit, which is that there is still vertical transmission in seropositives and some - potentially some data on the rate of - that would be supportive to that. Ultimately, though, we're studying all the way down to 16 year olds. And our goal will be a label that 16 plus, with the goal going into a population that is not as highly seropositive as it is later in life and therefore, we see a very large opportunity, and primary infection in CMV with the vaccine and potential positive for [inaudible].

Stephen Hoge: But we are looking, we have studied the vaccine from a safety perspective in seropositive people, and we are looking at things like shang. And if you draw a little bit of an analogy to, or correlate to the EDV data that we've already put out there in a different virus, what we've been able to show is that we can really control the rate of setting even in seropositive people. We have some reasons for optimism that when we pull together the totality of the data, there will be the obvious potential benefit, which is that there is still vertical transmission in the seropositive, and potentially some data on the rate of shedding that would be supportive of that.

But we are looking,

we have studied the vaccine from a safety perspective in seropositive people, and we are looking at things like shang. And if you draw a little bit of an analogy to, or correlate to the EDV data that we've already put out there in a different virus, what we've been able to show is that we can really control the rate of setting even in seropositive people. We have some reasons for optimism that when we pull together the totality of the data, there will be the obvious potential benefit, which is that there is still vertical transmission in the seropositive, and potentially some data on the rate of shedding that would be supportive of that. Ultimately, though, we're studying all the way down to 16-year-olds, and our goal will be a label of the 16th mark, with the goal of going into a population that is not as highly seropositive as it is with their life, and therefore, we see a very large opportunity to find primary infection with a vaccine and potential. [inaudible]

Speaker Change: And so we have some reasons for optimism.

Speaker Change: When we pull together the totality of the data they will both be the obvious potential benefit which is that there is still vertical transmission zero pathway and some potentially some data on that rates would be supportive of that.

Stephen Hoge: Ultimately, though, we're studying all the way down to 16-year-olds, and our goal will be a label of the 16th mark, with the goal of going into a population that is not as highly seropositive as it is with their life, and therefore, we see a very large opportunity to find primary infection with a vaccine and potential. [inaudible] Our next question comes from Geoff Meacham with VFA. Hi, this is Allison and Geoffrey Meacham.

Ultimately, though, we're studying all the way down to 16-year-olds, and our goal will be a label of the 16th mark, with the goal of going into a population that is not as highly seropositive as it is with their life, and therefore, we see a very large opportunity to find primary infection with a vaccine and potential. [inaudible]

Speaker Change: Ultimately, though we're studying all the way down to 16 year olds.

Speaker Change: And our goal will be a label that 16, plus with the goal going into a population that is not.

Speaker Change: As high as <unk> zero positive as it is later in life and therefore, we see a very large opportunity.

Speaker Change: For our properties in such a site.

Speaker Change: Okay.

Speaker Change: Our next question comes from Geoff Meacham, Geoff Meacham with Bofa. Your line is open.

Our next question comes from Geoff Meacham with VFA. Hi, this is Allison and Geoffrey Meacham.

Operator: Our next question comes from Geoff Meacham with BofA. Your line is open.

Alex Hammond: Hi, this is Alex Hammond on for Geoff Meacham. Thanks for taking our questions. So, on your zoster vaccine candidate, when should we receive updates on your pivotal strategy and is there any color you can provide today in terms of your current thinking on the Phase III design? And then our second question is on the PA and MMA programs that are advancing into pivotal trials, can you provide any thoughts on the nature of editorial and the comments on safety? Thank you.

Speaker Change: Hi, This is Alex <unk> on for Geoff Meacham. Thanks for taking our question. So on your just your vaccine candidate once you receive updates on your pivotal strategy and is there any color you can provide today in terms of your current thinking on the phase III design.

Operator: Thanks for taking our question. So, I'm your booster vaccine candidate. When should we receive updates on your pivotal strategy, and is there any color you can provide today in terms of your current thinking on the safe redesign? And then our second question is about the PA and MMA programs that are advancing into pivotal trials. Can you provide any help on the NACER editorial and the comments on safety? Thank you. Yeah, um, could you talk about what the first part of the question was on which program?

Speaker Change: Second question is on the Ta and MMA programs that are advancing into pivotal trials.

Speaker Change: Can you provide any thoughts on the nature editorial and the comments on thank you.

Speaker Change: Yes could you just clarify the first part of the question was on which program the booster.

Speaker Change: The eastern Michigan.

Stephen Hoge: [inaudible] So on the VVD program, we have, we're actually very excited by the Phase 1 data, which we've compared against the licensed product, and we saw really strong T cell responses in the. We're in the process right now of trying to find a pivotal strategy that will include obviously dose selection, the number of doses in that study, and then how we're going to conduct that study. We do not have an update as yet on what that will look like.

Stephen Hoge: Yes. Could you describe about the first part of the question was on which program? The booster? The zoster, the shingles.

Stephen Hoge: Yes. Could you describe about the first part of the question was on which program? The booster?

Alex Hammond: The zoster, the shingles.

Stephen Hoge: Shingle booster, thank you. So, on the VZV program, we have - we're obviously very excited by the Phase I data which was compared against a licensed product, and we saw really strong T cell response in immunogenicity. And generally, we've been seeing that across our programs. But in that one, it was very encouraging. We're in the process right now of trying to find the pivotal strategy that will include, obviously, dose selection, the number of doses in that study and then how we're going to expect that study. We do not have an update today on what that will look like in addition to our own thoughts on it, we obviously want to consult with regulators before we finalize that. But we are moving toward a pivotal study in VZV. We do not have any more update yet.

Speaker Change: How seamless.

Speaker Change: Yes.

Speaker Change: So.

Speaker Change: On the PCV program.

Speaker Change: We.

Speaker Change: We have we're obviously very excited by the phase one data.

Speaker Change: Which was compared against a licensed product and we saw really strong T cell responses.

Speaker Change: Generally <unk> been seeing.

Speaker Change: That across our programs, but in that one it was very encouraging we are in the process right now of trying to find the pivotal strategy that will include obviously dose selection.

Speaker Change: Number of doses in that study and how we can expect that we do not have an update on.

Speaker Change: What that will look like in.

Stephen Hoge: In addition to our own thoughts on it, we'll obviously want to consult with regulators before we finalize plan number four, but we are moving forward with a pivotal study in BDD. As relates to M&A and TA, the clinical data that we have continues to show compelling benefits with profile, good safety profile, and in fact, in the TA studies, we have many folks who have been in those studies on drugs for well over a year, and over 30 years, I think, for the last update on overall patient testing experience.

In addition to our own thoughts on it, we'll obviously want to consult with regulators before we finalize plan number four, but we are moving forward with a pivotal study in BDD.

Speaker Change: In addition to our own thoughts on it will obviously want to consult with regulators before we finalize our final, but we are moving forward towards a pivotal study.

Speaker Change: In PCB we.

Speaker Change: We do not have a timing on that update yet.

Stephen Hoge: As it relates to MMA and PA, the clinical data that we have continues to show a compelling benefit risk profile, good safety profile. In fact, in the PA studies, we have many folks who've been in those study on drug for well over a year. And over 30 years, I think, from our last update in overall patient dosing experience. So, we are starting to get a very clear perspective on the safety profile. The editorial question, I don't have a view on editorials or opinions based on the preclinical data. I think we stand behind the clinical data that we have and are quite encouraged by that profile, and we'll continue to watch it closely in our ongoing Phase I studies, but we do not have any specific or new concerns based on the clinical data today.

Speaker Change: As it relates to MMA MPA the clinical data that we have continues to show.

Speaker Change: Compelling benefit risk profile good safety profile.

Speaker Change: In fact in the PK studies, we have many folks.

Speaker Change: <unk> been in those in the study on drug for well over a year.

Speaker Change: And over 30 years, I think pro last update in overall patient overall patient dosing experience.

Stephen Hoge: So we are starting to get a very clear perspective on the safety profile. The editorial question: I don't have a view on editorials or opinions based on the pre-clinical data. I think we stand behind the clinical data that we have and are quite encouraged by that profile and will continue to watch it closely in our ongoing phase one studies, but we do not have any specific or new concerns based on the clinical data that I have. Our next question comes from Evan Wang with Guggenheim Security. Your line is open, one question. Two from me.

So we are starting to get a very clear perspective on the safety profile. The editorial question: I don't have a view on editorials or opinions based on the pre-clinical data. I think we stand behind the clinical data that we have and are quite encouraged by that profile and will continue to watch it closely in our ongoing phase one studies, but we do not have any specific or new concerns based on the clinical data that I have.

So we are starting to get a very clear perspective on the safety profile. The editorial question: I don't have a view on editorials or opinions based on the pre-clinical data. I think we stand behind the clinical data that we have and are quite encouraged by that profile and will continue to watch it closely in our ongoing phase one studies, but we do not have any specific or new concerns based on the clinical data that

Speaker Change: So we are starting to get very clear perspective on the safety profile.

Speaker Change: The editorial question I don't have a view on editorials are opinions based.

Speaker Change: Based on preclinical data I think we stand behind the clinical data that we have and are quite encouraged by that profile and we will continue to watch it closely and our ongoing phase one studies, but but we do not have any specific or new concerns based on the clinical data.

Alex Hammond: Thanks.

Speaker Change: Thanks.

Our next question comes from Evan Wang with Guggenheim Security. Your line is open, one question. Two from me.

Operator: Our next question comes from Evan Wang with Guggenheim Securities. Your line is open. One moment.

Speaker Change: Our next question comes from Evan Wang with Guggenheim Securities. Your line is open from one moment.

Evan Wang: Great. Two from me. First, on the combo 1083 program, so data, it sounds like this quarter, I believe enrollment was completed a few months ago. So, I guess how comprehensive will the top line update be in terms of follow-up? And then with submission, is longer-term vault needed there and are there parallels from 1010 that we can take in terms of regulatory filing speed for 1083 or is that more impacted by the decision for buying one or the other first? And then second, on RSV, it's kind of early ahead of approval, but with some international markets, it seems that's more nascent in terms of establishing some reimbursement there. So, I guess how are you thinking about positioning internationally? Thanks.

Stephen Hoge: First, on the Combo 1083 program, the data sounds like this quarter. I believe your enrollment was completed a few months ago. So I guess how comprehensive will the top line update be in terms of follow-up? And then, with submission, is a longer-term default needed there? And are there parallels from 1010 that we can take in terms of regulatory buying speed for 1083, or is that more like a decision about buying one or the other first? And then second on RTV, you know, it's kind of early ahead of approval, but with some international markets, seems that's more amazing in terms of establishing some reimbursement there. So I guess, how are you thinking about positioning internationally? Thanks.

Evan Wang: Question two from me first on the combo <unk> III program.

Evan Wang: Like this quarter I believe enrollment was completed a few months ago. So I guess, how comprehensive with a top line update would be in terms of follow up.

Evan Wang: And then with submission as longer term follow up needed there and are there parallels from 10, Tim that we can take in terms of regulatory filing speed for Canadian <unk> or is that more impacted by this decision for buying one or the other first then.

Stephen Hoge: And then second on RTV, you know, it's kind of early ahead of approval, but with some international markets, seems that's more amazing in terms of establishing some reimbursement there. So I guess, how are you thinking about positioning internationally? Thanks. Great, thank you. So for the 10A3 data, yes, on this quarter, and I would say we enrolled the majority of the 10A3 studies we know last fall, and the 1010 second generation study, so we talked about the P303 study, the first part of that enrolled over last summer, just a few months before the combo study, and the second part of it, the Part B and C, as you know, looking at head-to-head against blue zone HC, that actually enrolled the same time as the 10A3 study, so last fall, and so they've been actually kind of tracking right on top of each other.

And then second on RTV, you know, it's kind of early ahead of approval, but with some international markets, seems that's more amazing in terms of establishing some reimbursement there. So I guess, how are you thinking about positioning internationally? Thanks.

Evan Wang: And then second on RSV kind.

Evan Wang: Kind of early ahead of approval, but with some international market. It seems thats more than made sense in terms of establishing some reimbursement barrier. So I guess, how are you thinking about positioning internationally. Thanks.

Stephen Hoge: Great. Thank you. So, for the 1083 data, yes, on this quarter, and I would say that we're - we enrolled the majority of the 1083 studies you know last fall. And the 1010 second-generation study. So, we talked about the P303 study. The first part of that enrolled over last summer, just a few months before the combo study. And the second part of it, there was a part B and C, as you know, looking head-to-head against Fluzone HD, that actually enrolled the same time as the 1083 study last fall. And so, they've been actually kind of tracking right on top of each other. I think we're going to wait to see the data before we can provide growth guidance on timing. But obviously, we're - we've been working toward that flu COVID combination product for a while, and we will want to make sure that we get that filed, if it is positive as fast as possible. I wouldn't draw too many, because of the difference in the structures of the study between the P303 study, which has a part A and the B and a C, and the 1083 study, which was done very quickly. I wouldn't too many correlations between - reading out and the timing for submission on either one. Stephane, do you want to take the RSV question?

Evan Wang: Great. Thank you so for the <unk> III data yet on this quarter.

Evan Wang: I would say that we're we enrolled the majority.

Evan Wang: We already have <unk> III study as you know last fall.

Evan Wang: And the 10 10 second generation study so we've talked about the <unk> III study. The first part of that enrolled over last summer just a few months before the combo study and the second part of it. It was a part B and C. As you know looking at head to head against Fluzone HD that actually enrolled the same timing of the tank.

Stephen Hoge: I think we're going to wait to see the data before we can go ahead and go on timing, but obviously, we've been working towards that flu-COVID combination product for a while, and we will want to make sure that we get that found, if the data is positive, as fast as possible. I wouldn't draw too many conclusions because of the difference in the structure of the study between the 10A3 study, which had Part A, Part B, and Part C, and the 10A3 study, which was done very quickly in the fall. I wouldn't draw too many correlations between the data being out and the timing for submission on your line. Chalmers. So, you think that the RFP will be the most important in the future? Yes, I think so. Can you give me a snapshot of the RFP?

Evan Wang: So last fall and so they've been actually kind of tracking right on top of each other.

Speaker Change: I I think we're going to wait to see the data before we can go guidance on timing, but obviously, we are we've been working towards that Luc COVID-19 combination product for a while and and we will want to make sure that we get that filed.

Speaker Change: If the data are positive as fast as possible I wouldn't draw too many because the difference in the structures. The study between the <unk> III study, which had a part a and a b and C and the phase III study, which was done very quickly I wouldn't draw too many correlation between.

Speaker Change: Reading out and the timing for submission.

Speaker Change: Audio demand.

Stephen Hoge: So, you think that the RFP will be the most important in the future? Yes, I think so. Can you give me a snapshot of the RFP? Sure. So, the international markets are obviously very important; the U.S. is very important, but the U.S. is also super important. As we showed before, we have seen all the major geographies already, you know, of course, EU, UK, Canada, Australia, you know, some countries in Asia, some countries in the Middle East.

So, you think that the RFP will be the most important in the future? Yes, I think so. Can you give me a snapshot of the RFP?

Speaker Change: You will take the RSV question sure. So reinfection of Opex, obviously, where you bought them the UFC starting point would be with and touch on also to bring product as we've shut in are we funding all of our major artery properties already.

Stéphane Bancel: Sure. So, the internal markets, obviously, very important, the U.S. is very important, the U.S. - international also super important. As we shared before, we found in all the major geographies already. Of course, EU, U.K., Canada, Australia, some countries in Asia, some countries in the Middle East. RSV is well known by public health leaders like it is in the U.S. So, I think that there's a very strong desire, again, to protect the elderly with what we are doing here in terms of flu COVID RSV, that's becoming very kind of a standard that probably [inaudible] across at least the developed world. But even in developing countries, there's more and more interest as you see aging population everywhere. So, it's not only the U.S. approval that we expect coming soon as we have several geographies that would start being approved.

Speaker Change: Across EU UK kind of that was probably somewhat.

Speaker Change: Recent Asia at some point.

Stephen Hoge: You know, RFP is well known by public health leaders, like it is in the U.S., so I think that there is a very strong desire, again, to protect the elderly, like what we are doing here, you know, in some of, you know, through COVID-19. That's becoming a very kind of a stand-off as public health leaders are advancing it across, I think it's the developed world, but even So, if somebody in the U.S. approves it, as we expect from its food, we have several geographies that should start being approved. Thank you. Our next question comes from Simon Baker with Redburn Atlantic. Your line is open. Thank you for taking my questions. Two quick ones, if I may.

You know, RFP is well known by public health leaders, like it is in the U.S., so I think that there is a very strong desire, again, to protect the elderly, like what we are doing here, you know, in some of, you know, through COVID-19. That's becoming a very kind of a stand-off as public health leaders are advancing it across, I think it's the developed world, but even So, if somebody in the U.S. approves it, as we expect from its food, we have several geographies that should start being approved.

Speaker Change: RSV is well known by probably carefully selected <unk> in the U S. So I think that is a very strong desire to protect the value of that.

Speaker Change: I mean come on.

Speaker Change: Kavita Aussie, becoming what are you kind of.

Speaker Change: He built has been built.

Speaker Change: Yes, the developed world, but even in European countries with more and more interest as you see aging population everywhere.

Speaker Change: No.

Speaker Change: On a U S approval, we expect to know coming.

Speaker Change: Coming soon as we have several.

Thank you. Our next question comes from Simon Baker with Redburn Atlantic. Your line is open. Thank you for taking my questions. Two quick ones, if I may.

Operator: Thank you. Our next question comes from Simon Baker with Redburn Atlantic. Your line is open.

Speaker Change: From Scott being approved.

Speaker Change: Thank you. Our next question comes from Simon Baker with Redburn Atlantic Your line is open.

Simon Baker: Thank you for taking my questions. Two quick ones, if I may. Just in terms of the timing on the CMV interim data. You said this quarter, it could be as early as the end of 2024. That sounds slightly later than you had previously said. I just wondered if that's me over-interpreting the semantics or whether there is a slight delay there? And then the second question is on the HSV vaccine. Previous quarters, we talked about the EBV vaccine and the potential utility in multiple sclerosis. I was just wondering what your thoughts were about HSV and it's the hypothesis that implicates its role in Alzheimer's disease? Thanks so much.

Operator: Just in terms of the timing of the CMV interim data, you said this quarter it could be as early as the end of 2024. That sounds slightly later than you'd previously said. I just wondered if that's me over-interpreting the semantics or whether there is a slight delay there. And then the second question is on the HFV vaccine. In previous courses, we talked about the EBV vaccine and its potential utility in multiple sclerosis. I just wondered what your thoughts were about HFV and the hypothesis that implicates its role in Alzheimer's disease. Thanks very much.

Simon P. Baker: Taking my questions two quick ones if I may.

Simon P. Baker: Just in terms of the timing on.

Simon P. Baker: See in the CMV interim data.

Simon P. Baker: You said this quarter it could be as early as the end of 'twenty four.

Simon P. Baker: Slightly later than you'd previously said I just wanted to touch me.

Simon P. Baker: I would point to approaching the semantics of whether there is.

Simon P. Baker: A slight delay there.

Simon P. Baker: And then the second question is on the HSV vaccine.

Stephen Hoge: And then the second question is on the HFV vaccine. In previous courses, we talked about the EBV vaccine and its potential utility in multiple sclerosis. I just wondered what your thoughts were about HFV and the hypothesis that implicates its role in Alzheimer's disease. Thanks very much.

Simon P. Baker: Previous quarters, we talked about the EBV vaccine and the potential utility.

Simon P. Baker: Multiple sclerosis, so I just wonder what your thoughts were about HSV Amit.

Amit: The hypothesis that implicates slow.

Speaker Change: Sorry, Mr. Xie, thanks very much.

Stephen Hoge: Thank you for both questions. So, first on the clarification. There's no change to our expectations on when the CMV readout will happen. I think we previously tried to be careful in saying that we expect it to happen this year. And so obviously, by the end of this year, it is meant to say the same thing, but there's no change in our expectations at this point. On the HSV Alzheimer's hypothesis, it's a very interesting - there's a lot of neuro-inflammatory questions that go with the Herpes Simplex virus infection across a range of different mutations, Alzheimer's one of them. At this point, the studies that we expect to move forward with HSV will be for seropositive to improve outcomes. So, shedding-based for instance, or lesion-based.

Amit: Thank you for both questions. So so first on the clarification there.

Speaker Change: No change to our expectations on when the CMV readout will happen.

Speaker Change: I think we previously.

Speaker Change: Tried to.

Speaker Change: Be careful in saying that we expect it to happen this year and so obviously by the end of this year is meant to say the same thing, but there is no change in our expectation at this point.

Speaker Change: On the HSV Alzheimer's.

Speaker Change: Alzheimer's hypothesis, it's a very interesting.

Speaker Change: Yes, there's a lot of neuro inflammatory questions that go with herpes simplex.

Speaker Change: <unk> and infection.

Speaker Change: Across a range of different mutations Alzheimers one of them at this point.

Stephen Hoge: At this point, the studies that we expect to move forward with HSD will be for seropositive to improve outcomes, so shedding days, for instance, or lesion days, and then eventually, we will want to consider whether we want to go with prevention of infection, which is a different standard of difference indication that might be more relevant for then how you think about some of the neuro-inflammatory or long-term support.

At this point, the studies that we expect to move forward with HSD will be for seropositive to improve outcomes, so shedding days, for instance, or lesion days,

Speaker Change: Studies that we expect to move forward with the HSV will be.

Speaker Change: <unk> zero positives to improve outcomes.

Stephen Hoge: And then eventually, we will want to consider whether we want to go at prevention of infection, which is obviously a different standard of different indication. That might be more relevant for them, how you think about some of the neuro-inflammatory or long-term supply. I think you asked my opinion on it, I think it's incredibly interesting and exciting. I do think it's early for us to start drawing connection from a vaccine perspective, in terms of our potential impact for it. I hope over time, there is an opportunity to intervene and things like that. Obviously, in the EBV vaccine with multiple sclerosis, that science has firmed up to the point where there's reasonably high conviction that there's a potential for benefit there. We have to go prove that. But at this point, it's still earlier days, I think, with HSV and Alzheimer's.

Speaker Change: Shedding days for instance, or lesion days.

Speaker Change: And then eventually we will want to consider whether we want to go at prevention of infection, which is obviously at a different standard a different indication.

Speaker Change: It might be more relevant for them, how you think about.

Stephen Hoge: I think you asked my opinion on the science. I think it's incredibly interesting and exciting. I do think it's early for us to start drawing conclusions from a vaccine perspective in terms of our potential impact on it. You know, I hope over time there is an opportunity to intervene in things like that. Obviously, in the EBD vaccine with multiple sclerosis, the science has firmed up to the point where there's reasonably high conviction that there's a potential for benefit there. We have to approve that. But at this point, it's still early days, I think, with HSD and all.

Speaker Change: Some of the neuro inflammatory or long term. So Bob I think you asked my opinion on the side I think it's incredibly interesting and exciting I do think it's early for us to start drawing connection from a vaccine perspective in terms of our potential impact for it.

Speaker Change: I hope over time, there is an opportunity to intervene and things like that obviously, an EBV vaccine with multiple sclerosis that science has firmed up to the point, where there is reasonably high conviction that there is a potential for benefit there we have to go prove that.

Stephen Hoge: We have to approve that. But at this point, it's still early days, I think, with HSD and all. Thanks so much. Our next question comes from Edward Tenthoff of Piper Stanley, Eliana's office. [inaudible] Great. Thank you very much for taking the question and congratulations on everything. Actually, most of my questions have been answered, but I wanted to ask with respect to the cancer efforts. You know, are you able to break out what the actual R&D cost is for that? Program, and that's still a cost and profit share with Mark. And how many indications do you guys ultimately plan on pursuing? Thank you so much. Oh, maybe I'll take the first one then.

We have to approve that. But at this point, it's still early days, I think, with HSD and all.

Speaker Change: But at this point, it's still earlier days I think with HSV in Alzheimer's.

Speaker Change: Great. Thanks, so much.

Speaker Change: Our next question comes from Edward <unk> with Piper Sandler Your line is open.

Thanks so much. Our next question comes from Edward Tenthoff of Piper Stanley, Eliana's office. [inaudible] Great. Thank you very much for taking the question and congratulations on everything. Actually, most of my questions have been answered, but I wanted to ask with respect to the cancer efforts. You know, are you able to break out what the actual R&D cost is for that? Program, and that's still a cost and profit share with Mark. And how many indications do you guys ultimately plan on pursuing? Thank you so much. Oh, maybe I'll take the first one then.

Simon Baker: Ok. Thanks so much.

Our next question comes from Edward Tenthoff of Piper Stanley, Eliana's office. [inaudible] Great. Thank you very much for taking the question and congratulations on everything. Actually, most of my questions have been answered, but I wanted to ask with respect to the cancer efforts. You know, are you able to break out what the actual R&D cost is for that? Program, and that's still a cost and profit share with Mark. And how many indications do you guys ultimately plan on pursuing? Thank you so much. Oh, maybe I'll take the first one then.

Operator: Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open.

Speaker Change: Alright.

[inaudible] Great. Thank you very much for taking the question and congratulations on everything. Actually, most of my questions have been answered, but I wanted to ask with respect to the cancer efforts. You know, are you able to break out what the actual R&D cost is for that? Program, and that's still a cost and profit share with Mark. And how many indications do you guys ultimately plan on pursuing? Thank you so much. Oh, maybe I'll take the first one then.

Edward Tenthoff: Great. Thank you very much for taking the questions. And congrats on everything. Actually, most of my questions have been answered. But I wanted to ask with respect to the cancer efforts, are you able to break out what the actual R&D cost is for that program and that's still a cause some profit share with Merck? And how many indications do you guys ultimately plan on pursuing? Thank you so much.

Edward: Great. Thank you very much for taking the question and congrats on everything.

Edward: Actually most of my questions have been answered.

Edward: But I wanted to ask with respect to the.

Edward: Cancer efforts.

Speaker Change: Are you able to break out what the actual R&D cost is for that.

Speaker Change: Program and that's still a.

Speaker Change: Cause some province here with Mark.

Speaker Change: And how how many indications do you guys ultimately plan on pursuing thank you so much.

Stephen Hoge: Maybe I'll take the first one, Ed. So, we obviously know what we're spending, but at this point, we are not prepared to disclose. So, maybe someday, but not at this time.

Speaker Change: Okay.

Stephen Hoge: So, uh, no, we all already know what we're spending at this point, uh, that we are prepared to throw away. So, maybe someday, but not today. As I said, on the expense indication, look, it's a great decision. Our partnership with Merck has been really strong. We've been building this out. We do like to review those strategically and then bring them forward once we've started them. And I don't want to get ahead of that because of our private strategic competition with Merck.

So, uh, no, we all already know what we're spending at this point, uh, that we are prepared to throw away. So, maybe someday, but not today.

Speaker Change: Yes.

Speaker Change: Maybe I'll take the first one is that so.

Edward: No. We are we obviously know what we're spending.

Edward: Yes.

Speaker Change: Good point.

Edward: Yes.

Edward: <unk> is prepared to do so.

Edward: Maybe someday, but not at this point.

Jamey Mock: [inaudible] - Yes. On the expansion indication, look, it is a joint decision, our partnership with Merck has been really strong. We've been building this out. We do like to review those strategically and then bring them forward once we've started them. And so, I don't want to get ahead of that because those are our private strategic competition with Merck. But we are not done yet. We will keep adding in the years ahead.

Edward: Understood and then.

Edward: Yes, yes, yes on the expansion indications look at the joint decision and our partnership with Merck has been really strong we have been building. This out we do like to review those strategically and then bringing them forward. Once we once we've started them and so I don't want to get ahead of that.

Edward: Because those are our private strategic competition of the market, but we are not done yet we will keep adding in the years ahead.

Edward: Very exciting liquidity seeing in Chicago.

Stephen Hoge: But we are not done yet. We will keep adding in the years to come. Ladies and gentlemen, that concludes the Q&A portion of today's conference. I'd like to turn it back over to Stephane for any closing remarks. Well, thank you everybody for joining me today and for all the great questions. We look forward to seeing you at our events at ASCO. Have a great day. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Edward Tenthoff: Very exciting. Look forward to seeing you in Chicago.

Ladies and gentlemen, that concludes the Q&A portion of today's conference. I'd like to turn it back over to Stephane for any closing remarks. Well, thank you everybody for joining me today and for all the great questions. We look forward to seeing you at our events at ASCO. Have a great day. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Operator: Ladies and gentlemen, this does conclude the Q&A portion of today's conference. I'd like to turn the call back over to Stephane for any closing remarks.

Edward: We would like to do good luck, ladies and gentlemen. This does conclude the Q&A portion of today's conference I'd like to turn the call back over to Stefan for any closing remarks.

Stéphane Bancel: Well, thank you everybody for joining me today and for all the great questions. We look forward to seeing you at our events at ASCO. Have a great day. Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

Stéphane Bancel: Well, thank you, everybody, for joining in today for a great session. We look forward to seeing you at the latest ASCO. Have a great day.

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

Stefan: Thank you everybody for tuning into the AFR great great job.

Edward: Follow up to <unk>.

Speaker Change: Gentlemen. This concludes today's presentation you may now disconnect and have a wonderful day.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Great.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Thank you.