Q2 2024 Moderna Inc Earnings Call

August 1, 2024

Speaker Change: Good day and thank you for standing by. Welcome to the Moderna Second Quarter 2024 conference call. At this time, all participants are in 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 will then hear an automated message advising your hand is raised.

Speaker Change: 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.

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

Speaker Change: I will now turn the call over to Stephane.

Stephane: Thanks for that.

Stephane: Good morning, or good afternoon, everyone.

Stephane: Thank you for joining us today.

Stephane: We have Calvin will review of our business.

Stephane: Jimmy will present, our financial results for the quarter.

Jimmy: Thank you for basic financial framework.

Speaker Change: So we then review our clinical progress or we weren't close by sharing our commercial progress and the outlook for major upcoming milestones.

Stéphane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of our business. Jamey will present our financial results for the quarter and thank you for our based financial framework. There will then review our clinical progress. I will then close by sharing our commercial progress and our outlook for major upcoming milestones. In the second quarter of 2024, our respiratory franchise has shown remarkable progress and is poised to positively impact millions of lives globally each year. This is why we started Moderna to impact patients, and that is why the Moderna team is so focused on execution because of that profound impact on so many lives. Our mRNA-1273 vaccine, SPIKEVAX, continues to play a critical role in combating COVID. Based on CDC data for the season just ending, October ’23 to June ’24, COVID continues to result in higher hospitalization than other respiratory viruses. We are pleased that the RSV vaccine, which brand name is mRESVIA, of second respiratory product has launched in the U.S. and has now shipped to U.S. customers. It is poised to impact public health in the U.S. this year and soon in many other countries for many years to come. and tackle multiple respiratory illnesses effectively.

Jimmy: In the second quarter of 2020 for our respiratory franchise has been remarkable progress and is poised to positively impact millions of lives globally each year.

Speaker Change: Why are we starting.

Speaker Change: We in fact patient and that is why the model.

Speaker Change: So focus on execution because of that pro forma impact on so many lives.

Speaker Change: It's what I said.

Speaker Change: Thank you for your vaccine spiked about.

Speaker Change: Continues to play a critical role in combating Kobe.

Speaker Change: Based on CDC data, obviously is understanding October 'twenty three to June 'twenty fall Covid continues to result in higher optimization than all of our respiratory viruses.

Speaker Change: We are pleased that the Aussie vaccine with Brian.

Speaker Change: Our second respiratory product is launched in the U S and Thats now shipped to U S customers.

Speaker Change: It is poised to impact company category in the U S. This year and soon in many of our countries for many years.

Speaker Change: Our flu vaccine candidates.

Speaker Change: Tim.

Tim: Demonstrate positive phase III results meeting all evening, guys as key endpoints in adults 18 and older.

Speaker Change: While food Briscoe with combo vaccine candidate and $10 83.

Speaker Change: Positive results in phase III.

Speaker Change: Growing our ability to innovate.

Speaker Change: In fact over 50 quota respiratory illnesses effectivity.

Speaker Change: These achievements highlight the strength of volume on the platform and upcoming Tobias appropriately.

Speaker Change: We are now part of our buyback themes with positive phase III data Covid, RSV flu, Nextgen, Kobe, and monitory pretty free and helped us grow at Campbell.

Speaker Change: We are very excited about these achievements in a very few football teams.

Speaker Change: We believe our technology is a perpetual to significantly reduce the burden of these risk bressler MSB globally.

Speaker Change: And saved millions of us considerations around the world.

Speaker Change: And both impacting millions of families.

Speaker Change: Moving to business highlights for Q2.

Speaker Change: We manufacture the 'twenty four 'twenty five Steven Covid vaccine targeting both the <unk> and Jan one strength of a virus.

Speaker Change: We are ready to meet the demand over 'twenty four 'twenty five respiratory season.

Speaker Change: In addition, we are providing the U S. We're pleased yes, we received the positive opinion from Europe, where we've got three agency.

Speaker Change: Can we see HMP.

Speaker Change: We are waiting for regulatory approvals in additional countries around the world.

Speaker Change: For pandemic flu, we recently announced a partnership in the U S. We bother to address xscribe implement that virus and future property sales.

Speaker Change: The agreement rather than Madonna 176 million in funding to accelerate the development of mrna based pandemic flu vaccine.

Stéphane Bancel: Our flu vaccine candidate, mRNA-1010, has demonstrated positive Phase III results, meeting all immunogenicity end points in adults 18 and older. Our flu + COVID combo vaccine candidate, mRNA-1083, has also shown positive results in Phase III, underscoring our ability to innovate and tackle multiple respiratory illnesses effectively. These achievements highlight the strength of our mRNA platform and our commitment to public health. We have now five out of five vaccines with positive Phase III data: COVID, RSV, flu, next-gen COVID, mRNA-1083 and our cold + COVID combo. We are very excited about these achievements and are very thankful for our teams. We believe our technology has the potential to significantly reduce the burden of these respiratory illnesses globally and save millions of hospitalizations around the world and thus impacting millions of families.

Stéphane Bancel: Moving to business highlights for Q2, we manufactured the ’24-’25 season COVID vaccine targeting both the KP2 and GA1 strains of the virus. We are ready to meet the demand for the ’24-’25 respiratory season. In addition to RSV approval in the U.S, we are pleased that mRESVIA received a positive opinion from Europe’s regulatory agency, EMA CHMP. We are waiting for regulatory approvals in additional countries around the world. For pandemic flu, we recently announced a partnership in the U.S. with BARDA to address H5 influenza virus and future public health threats. The agreement awarded Moderna $176 million in funding to accelerate the development of mRNA-based pandemic flu vaccines. Lastly, our Japanese partnership with Mitsubishi Tanabe Pharma Corporation is an important collaboration. With this joint agreement, we will co-promote Moderna respiratory vaccines in Japan, extending our reach and impact in the Japanese market. In Q2, our revenues were up $241 million, which currently reflect the highly seasonal nature of our respiratory vaccine business. The net loss was $1.3 billion. We ended the quarter with $10.8 billion [inaudible] strong cash and investment position. This progress [inaudible] allows us to continue investing in our key programs and initiatives. Additionally, we continue to make considerable progress in reducing our operating expenses. Compared to Q2 2023, we have decreased our operating expenses by more than $600 million in Q2 2024. This reduction highlights our commitment to operational efficiency and financial discipline. Before I hand over to Jamey, I want to touch on the announcement we made last week. We are very pleased and proud to welcome David Rubinstein, the co-founder and co-chairman of Carlyle Group to the Moderna board, starting next week. David has decades of experience investing and growing businesses across a number of industries. He is also one of the most respected voices globally on matters related to international affairs and public policy. We are very excited to have him join us to help build Moderna to reach to the next level.

Speaker Change: Lastly, our Japanese partnership.

Speaker Change: Mitsubishi Tanabe Pharma Corporation is an Epo collaboration.

Speaker Change: With this Jonathan agreement, we will co promote to prevent that risk, but that's where we are active in Japan.

Speaker Change: Pending all reach and impact in the Japanese market.

Speaker Change: In Q2, our revenues were $241 million, which continue to reflect the highly seasonal nature of our scrubber your vaccine business.

Speaker Change: The net loss was $1 3 billion.

We ended the quarter with $10 8 billion.

Speaker Change: <unk> met any of the strong cash and investment position.

Speaker Change: This robust financial foundation allows us to continue investing in key programs.

Steve: Sure Steve.

Steve: Additionally, we continue to make considerable progress.

Steve: Did you see gold processing expenses.

Stéphane Bancel: This progress [inaudible] allows us to continue investing in our key programs and initiatives. Additionally, we continue to make considerable progress in reducing our operating expenses. Compared to Q2 2023, we have decreased our operating expenses by more than $600 million in Q2 2024. This reduction highlights our commitment to operational efficiency and financial discipline. Before I hand over to Jamey, I want to touch on the announcement we made last week. We are very pleased and proud to welcome David Rubinstein, the co-founder and co-chairman of Carlyle Group to the Moderna board, starting next week. David has decades of experience investing and growing businesses across a number of industries. He is also one of the most respected voices globally on matters related to international affairs and public policy. We are very excited to have him join us to help build Moderna to reach to the next level.

Speaker Change: Compared to Q2 2020 for you we have decreased our operating expenses by more than $600 million in Q2 2024.

Steve: This reduction highlights our commitment to operational efficiency and financial discipline.

Steve: Before I hand over to Jamie I want to touch on the announcement, we made last week.

David Rubinstein: We're very pleased and proud to welcome David Rubinstein, the cofounder and co chairman of the Carlyle group.

Jamie: Bob something next week.

Jamie: David has decades of experience investing.

Jamie: And growing business needs across a number of industries.

Jamie: So one of the most particularly in Voorhees globally on matters related to interest on our payout and public policy.

Stéphane Bancel: With David joining the board, Stephen Berenson is stepping down from the board, and I would like to personally thank him for his many contributions during his tenure, including through the pandemic. We also announced that Bob Langer has informed the board of his intention to retire from the board. As one of our co-founders, Bob has made incredible contributions to Moderna and we would not the company we are today without his vision and insights. I am personally very grateful to Bob for his coaching and mentoring, especially during the early years of Moderna, where his start-up experience was so valuable to me. With that, let me turn to Jamey.

Speaker Change: We are very excited to have joined us to help us beautiful data rich to the next level.

Speaker Change: With David during the ball, Steven Berns, certainly stepping down from the board and I would like to personally thank him for his many contributions during his tenure including for pandemic.

Speaker Change: We also announced that Bob Langer as informed the ball I'll begin to retire from the ball.

Speaker Change: As well of course, what has made incredible contributions to Modena and would not be the company. We are today, we brought his vision and insights.

Speaker Change: I am personally very grateful to Bob for his coaching.

Speaker Change: Coaching and mentoring, especially during the early years of Marianna, We're a startup experience was so valuable to me.

Speaker Change: Let me start with Jamie.

Jamie: Thanks, Stefan and Hello, everyone. Today, I will walk you through our financial performance for the second quarter and also update you on our financial outlook for the remainder of 2024.

Speaker Change: Let me start with our commercial performance on slide nine.

Speaker Change: Net product sales for Q2 were $184 million down 37% year over year.

James M. Mock: Thanks Stéphane, and hello everyone. Today I will walk you through our financial performance for the second quarter and also update you on our financial outlook for the remainder of 2024. Let me start with our commercial performance on Slide 9. Net product sales for Q2 were $184 million, down 37% year-over-year, mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside of the United States compared to the second quarter of 2023, when we fulfilled orders from prior year contracts. Q2 sales were above our guidance of approximately $100 million, primarily due to stronger than expected sales in the United States. We recognized sales from a number of other countries, including a small portion of the Brazil contract we announced last quarter. Year-to-date sales were $351 million, down 83% year-over-year, largely driven by the same Q2 year-over-year trends I just mentioned a moment ago.

Speaker Change: Mainly driven by lower sales volumes of our COVID-19 vaccine in regions outside of the United States <unk>.

Speaker Change: Compared to the second quarter of 2023, when we fulfill the orders from prior year contracts.

Speaker Change: Q2 sales were above our guidance of approximately $100 million.

Speaker Change: Primarily due to stronger than expected sales in the United States.

Speaker Change: We recognize sales from a number of other countries, including a small portion of the Brazil contracts, we announced last quarter.

Speaker Change: Year to date sales were $351 million down 83% year over year, largely driven by the same Q2 year over year trends I, just mentioned a moment ago.

James M. Mock: Moving to Slide 10, as I just explained, net product sales were $184 million. In Q2, we recognized $30 million of licensing revenue which is included in the other revenue line of $57 million. This revenue comes from a non-exclusive intellectual property out-licensing agreement with a leading pharmaceutical company in Japan announced in our Q1 earnings call. The deal includes an upfront payment and low double-digit royalties on net sales of their COVID-19 product in Japan. For the second quarter of 2024, our cost of sales was $115 million, which included $10 million of third party royalties, $55 million related to unutilized manufacturing capacity and wind down costs, and $14 million of inventory write-downs. This resulted in our cost of sales representing 62% of net product sales. As a result of our initiative to resize our manufacturing cost structure, cost of sales was down 84% from Q2 last year when cost of sales was 249%. R&D expenses were $1.2 billion in Q2, reflecting a slight increase of $73 million or 6% year-over-year. We purchased a priority review voucher during the second quarter which is included in our Q2 results. With first half R&D spending at $2.3 billion, we are tracking towards a full year expected spend of approximately $4.5 billion.

Speaker Change: Moving to slide 10, as I, just explained that product sales were $184 million.

Speaker Change: In Q2, we recognized $30 million of licensing revenue, which is included in the other revenue line of $57 million.

Speaker Change: This revenue comes from a non exclusive intellectual property licensing agreement with a leading pharmaceutical company in Japan announced in our Q1 earnings call.

Speaker Change: The deal includes an upfront payment and low double digit royalties on net sales of their COVID-19 product in Japan.

Speaker Change: For the second quarter of 2020 for our cost of sales was $115 million, which included $10 million of third party royalties.

Speaker Change: $55 million related to Unutilized manufacturing capacity, and wind down costs and $14 million of inventory write downs.

This resulted in our cost of sales representing 62% of net product sales.

Speaker Change: As a result of our initiatives to resize, our manufacturing cost structure cost of sales was down 84% from Q2 last year when cost of sales was 249%.

Speaker Change: R&D expenses were $1 2 billion in Q2, reflecting a slight increase of $73 million or 6% year over year.

Speaker Change: We purchased a priority review voucher during the second quarter, which is included in our Q2 results.

Speaker Change: With first half R&D spending of $2 3 billion, we are tracking towards our full year expected spend of approximately $4 5 billion.

Speaker Change: SG&A expenses for Q2 or $268 million, reflecting a 19% decrease year over year.

James M. Mock: SG&A expenses for Q2 were $268 million, reflecting a 19% decrease year-over-year. This reduction is a result of our continued strong focus on cost discipline and strategic investments driving productivity, on which I will provide additional detail in the upcoming slide. We reported zero income tax expense for the second quarter of 2024 compared to an income tax benefit of $369 million in the same period last year. This shift is primarily due to the continued application of a valuation allowance on a majority of our deferred tax assets, which we first established in the third quarter of 2023. Our net loss for the period was $1.3 billion, an improvement from the net loss of $1.4 billion recorded last year. Loss per share was $3.33 compared to a loss of $3.62 in the second quarter of 2023. We ended Q2 with cash and investments totaling $10.8 billion, down from $12.2 billion at the end of Q1, primarily due to ongoing research and development expenses and operating activities. Moving to Slide 11 and similar to Q1, I want to provide additional detail on the cost reductions we are driving across the company. You can see in our Q2 results that we had a 19% year-over-year reduction in SG&A spend due to efficiency gains. One of the main drivers for the year-over-year reduction in SG&A is from our commercial and medical affairs group. Over the past year, we have built our internal capabilities, which has allowed us to drive cost efficiencies by reducing our use of external consultants and other purchased services.

Speaker Change: This reduction is a result of our continued strong focus on cost discipline and strategic investments driving productivity on which I will provide additional detail in the upcoming slides.

Speaker Change: We reported zero income tax expense for the second quarter of 2024 compared to an income tax benefit of $369 million in the same period last year.

Speaker Change: The shifted 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.

Speaker Change: Our net loss for the period was $1 3 billion and.

Speaker Change: An improvement from the net loss of $1 4 billion recorded last year.

Speaker Change: Loss per share was $3 33, compared to a loss of $3 62 in the second quarter of 2023.

Speaker Change: We ended Q2 with cash and investments totaling $10 8 billion.

Speaker Change: From $12 2 billion at the end of Q1.

Speaker Change: Primarily due to ongoing research and development expenses and operating activities.

Speaker Change: Moving to slide 11, and similar to Q1 I want to provide additional detail on the cost reductions we are driving across the company.

James M. Mock: You can see in our Q2 results that we had a 19% year-over-year reduction in SG&A spend due to efficiency gains. One of the main drivers for the year-over-year reduction in SG&A is from our commercial and medical affairs group. Over the past year, we have built our internal capabilities, which has allowed us to drive cost efficiencies by reducing our use of external consultants and other purchased services. We’ve also been more focused and targeted on how we invest in these areas to drive the strongest possible return on investment. As the endemic market has been more seasonal, we have shifted more of our commercial spend to the second half of the year. Additionally, our procurement team has successfully driven company-wide cost reductions in the first half of 2024. Their primary focus has been on reducing third party supplier rates, and we have seen strong progress in contract rates for raw materials, components, clinical, travel, and consulting services. We continue to see strong adoption in artificial intelligence by our employees, which will allow us to scale the business in an efficient manner with a digital-first mindset. For example, in the second quarter our HR team launched benefits and equity GPTs. These AI-driven assistants are designed to handle frequently asked questions previously directed to the HR operations team and allow us to scale efficiently.

Speaker Change: You can see in our Q2 results that we had a 19% year over year reduction in SG&A spend due to efficiency gains.

Speaker Change: One of the main drivers for the year over year reduction in SG&A from our commercial and medical Affairs group.

Speaker Change: Over the past year, we have built our internal capabilities, which has allowed us to drive cost efficiencies by reducing our use of external consultants and other purchased services.

Jamey Mock: We've also been more focused on and targeted in how we invest in this area to drive the strongest possible return on investment. And as the endemic market has been more seasonal, we have shifted more of our commercial spending to the second half, which will allow us to scale the business in an efficient manner with a digital first mindset and allow us to scale efficiently. Overall, we have built a solid foundation and made purposeful investments in people, processes, and technology. We've highlighted some of the significant drivers of the 2Q cestianaceae.

We've also been more focused on and targeted in how we invest in this area to drive the strongest possible return on investment. And as the endemic market has been more seasonal, we have shifted more of our commercial spending to the second half, which will allow us to scale the business in an efficient manner with a digital first mindset and allow us to scale efficiently.

Speaker Change: We've also been more focused and targeted on how we invest in this area to drive the strongest possible return on investment.

Speaker Change: And at the endemic market has been more seasonal we have shifted more of our commercial spend for the second half of the year.

Speaker Change: Additionally, our procurement team has successfully driven companywide cost reductions in the first half of 2024.

Speaker Change: Their primary focus has been on reducing third party supply of rates and we are seeing strong progress in contract rates for raw materials components clinical travel and consulting services.

Speaker Change: We continue to see strong adoption in artificial intelligence by our employees.

James M. Mock: Overall, we have built a solid foundation and made purposeful investments in people, processes and technology. We’ve highlighted some of the significant drivers of the Q2 SG&A savings, but we are also seeing additional efficiency savings in R&D and manufacturing. I’m very pleased with the cost savings results in the first half of the year and want to thank our Moderna teams. Now let’s turn to our 2024 financial framework on Slide 12. We are revising our expectation for 2024 net product sales to a range of $3.0 billion to $3.5 billion. There are three primary drivers for the updated outlook. First, we are now expecting very low sales in 2024 from EU member states, based on recent feedback and discussions with country health officials. Second, in the U.S. we are seeing increased competitive pressures for our respiratory vaccines. While this has led to a slower RSV ramp than previously anticipated, we continue to believe and mRESVIA’s long term potential. Third, in the rest of the world we have provided for the potential risk of revenue deferrals from 2024 into 2025. We remain committed in our attempt to mitigate these risks, but believe it’s appropriate to adjust our guidance at this time. Finally, this revenue framework assumes a U.S. COVID vaccination rate similar to last season.

Speaker Change: Which will allow us to scale the business in an efficient manner with a digital first mindset.

Speaker Change: For example, in the second quarter, our HR team launched benefits and equity Gpt's. These.

Speaker Change: These AI driven assistance are designed to handle a frequently asked questions previously directed to the HR operations team and allow us to scale efficiently.

Overall, we have built a solid foundation and made purposeful investments in people, processes, and technology. We've highlighted some of the significant drivers of the 2Q cestianaceae.

Speaker Change: Overall, we have built a solid foundation and made purposeful investments in people processes and technology.

Speaker Change: Highlighting some of the significant drivers of the <unk> SG&A savings, but we are also seeing additional efficiency savings in R&D and manufacturing.

Jamey Mock: But we are also seeing additional efficiency savings in R&D and manufacturing. I'm very pleased with the cost-savings results in the first half of the year and want to thank our Moderna team. We are revising our expectations for 2024 net product sales to a range of $3.0 to $3.5 billion. Based on recent feedback and discussions with country health, while this has led to a slower RSD ramp than previously anticipated, we continue to believe in MRESVIA's long-term potential.

Mcdonough: I am very pleased with the cost savings results in the first half of the year and want to thank our Mcdonough teams.

Speaker Change: Now, let's turn to our 2024 financial framework on slide 12.

Speaker Change: Our revising our expectations for 2024 net product sales to a range of 3.0 to $3 5 billion.

Speaker Change: There are three primary drivers for the updated outlook.

Speaker Change: First we are now expecting very low sales in 2024 from EU member States based on recent feedback from discussions with health country Health officials.

Speaker Change: Second in the U S. We are seeing increased competitive pressures for our respiratory vaccines.

Speaker Change: While this has led to a slower RSP ramp than previously anticipated. We continue to believe <unk> long term potential.

Jamey Mock: Third, in the rest of the world, we have provided for the potential risk of revenue deferrals from 2024 into 2025. We remain committed in our attempt to mitigate these risks, but believe it's appropriate to adjust our guidance at this time. Finally, this revenue framework assumes a US COVID vaccination rate similar to last. Our second half sales mix will be dependent on the timing of regulatory approvals across the world and the number of days available in the third quarter to show.

Third, in the rest of the world, we have provided for the potential risk of revenue deferrals from 2024 into 2025. We remain committed in our attempt to mitigate these risks, but believe it's appropriate to adjust our guidance at this time. Finally, this revenue framework assumes a US COVID vaccination rate similar to last.

Speaker Change: Third in the rest of the World we have provided for the potential risk of revenue deferrals from 2024 and to 2025.

Speaker Change: We remain committed in our attempt to mitigate these risks, but believe it is appropriate to adjust our guidance at this time.

Speaker Change: Finally, this revenue framework assumes a U S COVID-19 vaccination rate similar to last season.

Speaker Change: Our second half sales mix will be dependent on timing of regulatory approvals across the world and the number of days available to us in the third quarter to ship.

James M. Mock: Our second half sales mix will be dependent on timing of regulatory approvals across the world and the number of days available in the third quarter to ship. We currently expect a remaining sales lift of 40% to 50% in Q3, with the balance in Q4. We expect cost of sales as a percentage of product sales for the full year to be in the range of 40% to 50%, based upon our updated sales range. 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. Note that we expect SG&A to be higher in the second half versus the first half, primarily due to increased commercial activity, but still expect the second half to be down on a year-over-year basis. We continue to expect taxes to be negligible in 2024 and capital expenditures to be approximately $0.9 billion. Finally, we continue to expect that we will end 2024 with approximately $9 billion in cash. We have made strong progress in improving our working capital management, which is offsetting the change in our product sales outlook. With that, I will now hand the call over to Stephen.

Speaker Change: We currently expect a remaining sales split of 40% to 50% in Q3 with the balance in Q4.

Jamey Mock: We expect cost of sales as a percentage of product sales for the full year to be in the range of 40 to 50% based upon our updated sales. We continue to expect taxes to be negligible in 2024 and capital expenditures to be approximately $0.9 billion. Finally, we continue to expect that we will end 2024 with approximately $9 billion in cash. With that, I will now end the call. Thank you, Jamey.

We expect cost of sales as a percentage of product sales for the full year to be in the range of 40 to 50% based upon our updated sales. We continue to expect taxes to be negligible in 2024 and capital expenditures to be approximately $0.9 billion. Finally, we continue to expect that we will end 2024 with approximately $9 billion in cash. With that, I will now end the call.

Speaker Change: Today, I'll review updates from our clinical programs and three of the four development areas in our portfolio.

Speaker Change: In the second quarter, we made we had important updates in respiratory vaccines oncology and rare diseases.

Stephen Hoge: Thank you Jamey. Today I’ll review updates from our clinical programs in three of the four development areas in our portfolio. In the second quarter, we had important updates in respiratory vaccines, oncology and rare diseases. Starting with respiratory vaccines, we are very pleased by the approval and ATIP recommendation for our RSV vaccine, mRESVIA, in the U.S. for all unvaccinated adults 75 years and older and in unvaccinated adults 60 to 74 years of age who are at increased risk from RSV. This recommendation was the same as for the other two previously approved RSV vaccines. We also recently received a positive CHMP opinion from the European Medicine Agency for mRESVIA, and as Stéphane mentioned earlier, we are working towards approvals in additional countries. Turning to flu, we are in discussions with multiple regulatory authorities and intend to file in 2024. For our next-generation COVID vaccine, mRNA-1283, we announced positive Phase III efficacy results demonstrating non-inferior efficacy against COVID-19 compared to SPIKEVAX in all trial participants 12 years of age and older. Efficacy was higher than SPIKEVAX in adults 18 years and older. We are excited by the data and are sharing the results with regulators and intend to file for approval beginning in 2024.

Speaker Change: Starting with respiratory vaccines, we are very pleased by the approval in ACI P recommendation for our RSV vaccine <unk>.

Stephane Bancel: We are very pleased by the approval and ACIP recommendation for our RSV vaccine, Emrysia. Turning to flu, we are in discussions with multiple regulatory authorities and intend to file for it in 2024.

Speaker Change: In the U S for all Unvaccinated adult 75 years and older and an unmatched vaccinated adults 60 to 74 years of age or an increased rent from RSV. This recommendation was the same as for the other two previously approved RSV vaccines.

Stefan: We also recently received a positive <unk> opinion from the European Medicines agency for them rescue yet and as Stefan mentioned earlier, we are working towards approvals in additional countries.

Speaker Change: Turning to flu, we're in discussions with multiple regulatory authorities and intend to file in 2024.

Stefan: For our next generation Covid vaccine mrna 12, 33, we announced positive phase III efficacy results demonstrating non inferior efficacy against COVID-19 compare despite effects in all trial participants 12 years of age and older.

Stephen Hoge: Rounding out the news in respiratory vaccines development, in the quarter we shared positive results from our Phase III trial with our combination flu and COVID vaccine. The trial met its primary immunogenicity end points with the combination vaccine eliciting higher immune responses against flu and SARS-CoV-2 than the licensed flu and licensed COVID vaccines given separately in adults 50 years of age and older in the trial. In the subset of participants 65 years of age and older, our combination vaccine also elicited higher immune responses than an enhanced flu vaccine that is recommended in the 65 and older age group in many countries, including the United States. These results are exciting, and we have begun sharing them with regulators and planning for the next steps. Turning now to oncology, in the quarter we share an update on our mRNA-4157 program, also known as INT, which elicits anti-tumor T-cell responses by targeting a patient’s unique tumor mutations, or neoantigens. INT is in multiple large randomized trials, including two Phase III trials, one in adjuvant melanoma and the other in adjuvant non-small cell lung cancer; one Phase II/III trial in adjuvant cutaneous squamous cell carcinoma, and two randomized Phase II studies, one in adjuvant kidney cancer and the other in bladder cancer. We and our partner, Merck expect to start additional studies in new tumor types.

Stephane Bancel: Turning now to oncology, in the quarter, we shared an update on our mRNA-4157 program, also known as INT, which elicits anti-tumor T-cell responses by targeting a patient's unique tumor mutations or neoantibodies. We and our partner Merck expect to start additional studies in new tumor types.

Stephen Hoge: INT is in multiple large randomized trials, including two Phase III trials, one in adjuvant melanoma and the other in adjuvant non-small cell lung cancer; one Phase II/III trial in adjuvant cutaneous squamous cell carcinoma, and two randomized Phase II studies, one in adjuvant kidney cancer and the other in bladder cancer. We and our partner, Merck expect to start additional studies in new tumor types. The development program was launched on the back of impressive randomized Phase II trial results in adjuvant melanoma. We recently shared the three-year follow-up data from that trial at ASCO this past June, and in the next few slides, I will quickly summarize the highlights from that presentation. The primary clinical end point for the Phase II adjuvant melanoma study is recurrence-free survival, or RFS. As presented at ASCO, there is a sustained improvement in RFS with the combination of INT plus KEYTRUDA, versus KEYTRUDA alone through three years of follow-up. 74.8% of patients receiving the combination treatment of INT plus KEYTRUDA were alive and tumor-free at three years, which was 19 percentage points higher than KEYTRUDA alone, and resulted in an impressive hazard ratio of 0.51.

Stephane Bancel: The development program has launched on the back of, was launched on the back of impressive randomized phase two trial results in adjuvant melanoma. We recently shared the three-year follow-up data from that trial at ASCO this past June. And on the next few slides, I will quickly summarize the highlights from that presentation. The primary clinical endpoint for the Phase 2 adjuvant melanoma study is Recurrence Free Survival or RFS. 74.8% of patients receiving the combination treatment of INT plus Keytruda were alive and tumor-free at three years, which was 19 percentage points higher than Keytruda alone. 89.3% of patients in the combined INT plus Keytruda treatment group were alive and without metastases or distant spread of their tumor at 3 years of follow-up versus 68.7% of patients in a Keytruda monotherapy group.

The development program has launched on the back of, was launched on the back of impressive randomized phase two trial results in adjuvant melanoma. We recently shared the three-year follow-up data from that trial at ASCO this past June. And on the next few slides, I will quickly summarize the highlights from that presentation. The primary clinical endpoint for the Phase 2 adjuvant melanoma study is Recurrence Free Survival or RFS. 74.8% of patients receiving

Speaker Change: The development program has launched on the back was launched on the back of impressive randomized phase two trial results in adjuvant melanoma. We recently shared the three year follow up data from that trial at <unk>. This past June and in the next few slides I will quickly summarize the highlights from that presentation.

Stefan: The primary clinical endpoint for the phase III adjuvant melanoma study is recurrence free survival or RFS.

Speaker Change: As presented at Ash, there was a sustained improvement in RFS with a combination of I N T plus keytruda versus Keytruda alone through three years of follow up.

Speaker Change: 74, 8% of patients receiving the combination treatment of <unk>, plus keytruda were alive and tumor free at three years, which was 19 percentage points higher than.

Speaker Change: Then keytruda alone and.

Speaker Change: And resulted in an impressive hazard ratio of 0.51.

Stephen Hoge: The combination of INT plus KEYTRUDA also showed sustained improvement in distant metastasis-free survival at three years. 89.3% of patients in combination INT plus KEYTRUDA treatment group were alive and without metastases or distant spread of their tumor at three years of follow-up versus 68.7% of patients in the KEYTRUDA monotherapy group. This is an equally impressive and remarkable hazard ratio of 0.38. Lastly, we were pleased to share data showing an early favorable trend in overall survival at three years of follow-up. Finally on the safety side, INT continues to demonstrate a remarkable profile for a novel cancer therapy. Immune-related adverse events were not higher in the combination INT plus KEYTRUDA arm despite the benefits than in the KEYTRUDA monotherapy arm. This highlights the impressive emerging benefit-risk profile for our INT program.

Speaker Change: The combination of <unk> plus Keytruda also showed sustained improvement in distant metastasis free survival at three years.

Stephane Bancel: Now, on the safety side, INT continues to demonstrate a remarkable profile for a novel cancer. (Inaudible) This highlights the impressive emerging benefit-risk profile for our INT program. Moving now to rare diseases, I'm happy to share that our MMA candidate, mRNA 3705, was selected for the FDA STAR program. M&A is a rare disease in which patients cannot properly break down proteins from the food they take. As a result, toxins build up in the bloodstream and cause recurrent episodes of life-threatening metabolic decompensation.

Now, on the safety side, INT continues to demonstrate a remarkable profile for a novel cancer. (Inaudible) This highlights the impressive emerging benefit-risk profile for our INT program.

Stephen Hoge: Moving now to rare diseases, I’m happy to share that our MMA candidate, mRNA-3705, was selected for the FDA START program. MMA is a rare disease in which patients cannot properly break down proteins from the food they digest; as a result, toxins build up in the bloodstream and cause recurrent episodes of life-threatening metabolic decompensation. The FDA START program is a program designed to accelerate development of new and promising therapies in rare diseases where there is a high unmet need. Our MMA candidate, mRNA-3705 is being evaluated in patients in a Phase I/II study with encouraging early results that we’ve previously shared, and we look forward to working with the FDA to accelerate the development of this promising potential medicine. With that, I’ll now turn it back to Stéphane.

Stephane Bancel: The FDA STAR Program is a program designed to accelerate the development of new and promising therapies in rare diseases where there is a high unmet need. With that, I'll now turn it back to Stphane. Thank you, Stephen and Jamey. The start of the COVID season is only a few weeks away. Contracting for the season is almost completed. In the US, we have seen increased competitive pressure during the contracting season compared to last year.

The FDA STAR Program is a program designed to accelerate the development of new and promising therapies in rare diseases where there is a high unmet need. With that, I'll now turn it back to Stphane.

Stéphane Bancel: Thank you Stephen and Jamey. Let’s start with COVID. With the start of the COVID season only a few weeks away, contracting for the season is almost completed as we speak. In the U.S., we have seen increased competitive pressure during the contracting season compared to last year, and we have not finalized most of the contracts. We are working closely with public health officials, healthcare providers, pharmacies [inaudible] with these stakeholders are critical in driving widespread vaccination adoption. In the EU, we are in advanced discussions on the tender framework to provide market access; however, based on recent feedback from several large governments, we are now expecting very low sales to EU member states in 2024. Some large countries will not buy SPIKEVAX for the ’24-’25 season. In the rest of the world, we have multiple signed contracts in place, some of which could be deferred into 2025. Contracting discussions are ongoing with some additional countries, but we do not expect this will have a significant impact on our updated sales framework.

Speaker Change: As shared during the contracting season.

Speaker Change: Two last year.

Stephane Bancel: And we have not finalized most of the contracts. We're in advanced discussions on the standard framework to provide market access. In the rest of the world, we have multiple signed contracts in place, some of which could be deferred into 2025.

Speaker Change: And we have not finalized most of the contracts.

Speaker Change: We're working closely with public health officials has kept provided us.

Speaker Change: Pharmacies to grab acts nationally.

Speaker Change: Our collaborative efforts with key stakeholders are critical in driving widespread recognition adoption.

Speaker Change: In the EU.

Speaker Change: We're in advanced discussions on the tender framework to provide market access.

However, based on recent feedback from several large governments.

Speaker Change: We are now expecting variable sales to EU member state in 2024.

Speaker Change: Some large countries will note that <unk> for 2025 season.

Speaker Change: In the rest of the world, we have multiple signed contracts in place.

Speaker Change: Could be deferral into 2025.

Stephane Bancel: Contracting discussions are ongoing with some additional countries, but we do not expect this to have a significant impact on our updated sales framework. Moving now to the launch preparation for the 24-25 season, our organization is fully prepared for the upcoming season.

Contracting discussions are ongoing with some additional countries, but we do not expect this to have a significant impact on our updated sales framework.

Speaker Change: Contracting discussions ongoing with some additional countries, but we do not expect this to have a significantly better.

David Rubinstein: David sales framework.

Stéphane Bancel: Moving now to launch preparation for the ’24-’25 season, our organization is fully prepared for the upcoming season thanks to the substantial efforts made by the Moderna teams to ensure the global availability of COVID vaccines. In North America, we are ready to supply SPIKEVAX targeting the KP2 strain, as asked by the FDA, demonstrating our ability to quickly pivot and manufacture SPIKEVAX for selected strains. In the rest of the world, we are supplying vaccine targeting the GA1 strain as requested by health authorities in those regions. Let me now take you through details on the U.S. COVID market. We’ll be ready to supply millions of SPIKEVAX doses to all segments of the U.S. market upon regulatory approval. Our goal is to ensure that SPIKEVAX is available to all customers--large retail pharmacies, independent pharmacies, healthcare professionals, [inaudible] hospital network and public health entities at the same time, facilitating early and widespread vaccination. [inaudible] the world healthcare system to be ready to vaccinate is a key priority for us this season. To this end, we have implemented a real-time order tracking system which is available to all of our customers and provides detailed information on every order, including [inaudible] timing, package size, and temperature status. Our supply chain is using AI tools to estimate the optimal order of distribution to locations within the U.S. market. These preparations highlight our commitment to ensuring the broad availability of SPIKEVAX and meeting market demand.

Stéphane Bancel: Moving now to launch preparation for the ’24-’25 season, our organization is fully prepared for the upcoming season thanks to the substantial efforts made by the Moderna teams to ensure the global availability of COVID vaccines. In North America, we are ready to supply SPIKEVAX targeting the KP2 strain, as asked by the FDA, demonstrating our ability to quickly pivot and manufacture SPIKEVAX for selected strains. In the rest of the world, we are supplying vaccine targeting the GA1 strain as requested by health authorities in those regions. Let me now take you through details on the U.S. COVID market. We’ll be ready to supply millions of SPIKEVAX doses to all segments of the U.S. market upon regulatory approval. Our goal is to ensure that SPIKEVAX is available to all customers--large retail pharmacies, independent pharmacies, healthcare professionals, IDN and hospital networks, and public health entities at the same time, facilitating early and widespread vaccination. [inaudible] the world healthcare system to be ready to vaccinate is a key priority for us this season.

David Rubinstein: Moving now to the launch preparation for 'twenty four 'twenty five season.

Stephane Bancel: Thanks to a substantial effort made by the Moderna team to ensure the global availability of COVID-19 vaccines. In North America, we are ready to supply SPAC VACs targeting KP2 strains, as asked by the FDA, demonstrating our ability to quickly pivot and manufacture SPAC VACs for selected strains. Amina Afeyan contributed to a marketing effort.

Thanks to a substantial effort made by the Moderna team to ensure the global availability of COVID-19 vaccines. In North America, we are ready to supply SPAC VACs targeting KP2 strains, as asked by the FDA, demonstrating our ability to quickly pivot and manufacture SPAC VACs for selected strains.

Stéphane Bancel: To this end, we have implemented a real-time order tracking system which is available to all of our customers and provides detailed information on every order, including [inaudible] timing, package size, and temperature status. Our supply chain is using AI tools to estimate the optimal order of distribution to locations within the U.S. market. These preparations highlight our commitment to ensuring the broad availability of SPIKEVAX and meeting market demand. Let me now turn to our marketing efforts. We believe education and awareness campaigns will be important drivers to increase vaccination rates. We have started these efforts early. Ahead of the season, we have launched a back-to-basics campaign. This initiative is designed to raise awareness about how the SARS-CoV-2 virus works and why it is critical to get a new booster each year, like for flu. The virus mutates over time and we need to have a new tool to teach your immune system the new mutation to reduce infection, reduce hospitalization, and reduce deaths. Additionally, we are working with public health authorities to educate the public on the impact of long COVID, highlighting how vaccines can help reduce risk for young and middle age adults. Soon, we will start our in-season outreach to high risk groups. By collaborating with major retail pharmacies, we aim to effectively market our products during the season. This targeted approach ensures that our efforts are focused on those who are the most vulnerable, maximizing the benefits of vaccination for those groups. By leveraging media channels, we aim to reach a broader audience and emphasize the critical need for vaccination to mitigate [inaudible] outcomes.

Stéphane Bancel: To this end, we have implemented a real-time order tracking system which is available to all of our customers and provides detailed information on every order, including arrival timing, package size, and temperature status. Our supply chain is using AI tools to estimate the optimal order of distribution to locations within the U.S. market. These preparations highlight our commitment to ensuring the broad availability of SPIKEVAX and meeting market demand. Let me now turn to our marketing efforts. We believe education and awareness campaigns will be important drivers to increase vaccination rates. We have started these efforts early. Ahead of the season, we have launched a back-to-basics campaign. This initiative is designed to raise awareness about how the SARS-CoV-2 virus works and why it is critical to get a new booster each year, like for flu. The virus mutates over time and we need to have a new tool to teach your immune system the new mutation to reduce infection, reduce hospitalization, and reduce deaths. Additionally, we are working with public health authorities to educate the public on the impact of long COVID, highlighting how vaccines can help reduce risk for young and middle age adults. Soon, we will start our in-season outreach to high risk groups.

Amina Afeyan contributed to a marketing effort. We believe education and awareness campaigns will be important drivers to increase vaccination rates. At the end of the season, we launched a Back to Basics campaign. This initiative is designed to raise awareness about how the SARS-CoV-2 virus works and why it is critical to get a new roster each year like Forflow because the virus can spread over time. By collaborating with major retail pharmacies, we aim to effectively market our products during the season. This targeted approach ensures that our efforts are focused on those who are the most vulnerable, maximizing the benefits of vaccination for those groups. By leveraging media channels, we aim to reach a broader audience and emphasize the critical need for vaccination to mitigate severe outbreaks. We are very excited about the launch of our second product, Ambrosia. Specifically, ACIP University recommended a single dose of the RRD vaccine for all unvaccinated adults age 75 and above, while CPSO recommended a single dose for unvaccinated adults between the age of 60 and 74. We are at an increased risk. In RSV, our focus is to direct our efforts to the segments where the vast majority of vaccinations occur. In the US, we're targeting the pharmacy segment, which includes both large retail chains as well as independent pharmacies. We will begin shipping products to pharmacy in July, and as Jamey mentioned earlier, we are seeing a highly competitive environment. Additionally, larger competitor contracts were negotiated prior to approval and launch, resulting in lower 2024 shares than we would have liked, offering them the ability to use their time much more efficiently during the busy fall vaccination season and also to reduce potential medical errors. For respiratory vaccines, we expect COVID approval, and we'll be ready to ship in the U.S. and the rest of the world in the August-September timeframe. Dinarazi respectively, face-free data for high-risk individuals 18 years of age and above.

Stephane Bancel: We believe education and awareness campaigns will be important drivers to increase vaccination rates. At the end of the season, we launched a Back to Basics campaign. This initiative is designed to raise awareness about how the SARS-CoV-2 virus works and why it is critical to get a new roster each year like Forflow because the virus can spread over time. By collaborating with major retail pharmacies, we aim to effectively market our products during the season. This targeted approach ensures that our efforts are focused on those who are the most vulnerable, maximizing the benefits of vaccination for those groups. By leveraging media channels, we aim to reach a broader audience and emphasize the critical need for vaccination to mitigate severe outbreaks. We are very excited about the launch of our second product, Ambrosia. Specifically, ACIP University recommended a single dose of the RRD vaccine for all unvaccinated adults age 75 and above, while CPSO recommended a single dose for unvaccinated adults between the age of 60 and 74. We are at an increased risk. In RSV, our focus is to direct our efforts to the segments where the vast majority of vaccinations occur. In the US, we're targeting the pharmacy segment, which includes both large retail chains as well as independent pharmacies. We will begin shipping products to pharmacy in July, and as Jamey mentioned earlier, we are seeing a highly competitive environment. Additionally, larger competitor contracts were negotiated prior to approval and launch, resulting in lower 2024 shares than we would have liked, offering them the ability to use their time much more efficiently during the busy fall vaccination season and also to reduce potential medical errors. For respiratory vaccines, we expect COVID approval, and we'll be ready to ship in the U.S. and the rest of the world in the August-September timeframe. Dinarazi respectively, face-free data for high-risk individuals 18 years of age and above.

David Rubinstein: And reduce deaths.

David Rubinstein: Additionally, we are working with public health authorities to educate the public on the impact of loan Covid highlights.

David Rubinstein: Our vaccine to help reduce the risk for.

David Rubinstein: For Europe, and Middle <unk> Adams.

David Rubinstein: Soon we will start our season outreach to high risk groups.

Stephane Bancel: By collaborating with major retail pharmacies, we aim to effectively market our products during the season. This targeted approach ensures that our efforts are focused on those who are the most vulnerable, maximizing the benefits of vaccination for those groups. By leveraging media channels, we aim to reach a broader audience and emphasize the critical need for vaccination to mitigate severe outbreaks. We are very excited about the launch of our second product, Ambrosia. Specifically, ACIP University recommended a single dose of the RRD vaccine for all unvaccinated adults age 75 and above, while CPSO recommended a single dose for unvaccinated adults between the age of 60 and 74. We are at an increased risk. In RSV, our focus is to direct our efforts to the segments where the vast majority of vaccinations occur. In the US, we're targeting the pharmacy segment, which includes both large retail chains as well as independent pharmacies. We will begin shipping products to pharmacy in July, and as Jamey mentioned earlier, we are seeing a highly competitive environment. Additionally, larger competitor contracts were negotiated prior to approval and launch, resulting in lower 2024 shares than we would have liked, offering them the ability to use their time much more efficiently during the busy fall vaccination season and also to reduce potential medical errors. For respiratory vaccines, we expect COVID approval, and we'll be ready to ship in the U.S. and the rest of the world in the August-September timeframe. Dinarazi respectively, face-free data for high-risk individuals 18 years of age and above.

David Rubinstein: By collaborating with major retail pharmacies, we end to effectively market our products during the season.

David Rubinstein: This targeted approach ensures that our efforts are focused on those where the most of them have narrower maximizing the benefits of explanation for those groups.

David Rubinstein: By leveraging major channels, we aim to reach a broader audience and emphasize the critical need for vaccination to mitigate CV outcomes.

David Rubinstein: Let me now turn to <unk> launch.

Stéphane Bancel: By collaborating with major retail pharmacies, we aim to effectively market our products during the season. This targeted approach ensures that our efforts are focused on those who are the most vulnerable, maximizing the benefits of vaccination for those groups. By leveraging media channels, we aim to reach a broader audience and emphasize the critical need for vaccination to mitigate [inaudible] outcomes. Let me now turn to our RSV launch. We are very excited about the launch of our second product, mRESVIA. Following approval, [inaudible] vaccine recommendation on par with competitor vaccines. Specifically, ACIP [inaudible] recommended a single dose of RSV vaccine for all unvaccinated adults age 75 and above. ACIP also recommended a single dose for unvaccinated adults between the age of 60 and 74 who are at increased risk. Based on these recommendations, approximately 40 million people in the U.S. are eligible for vaccination. The RSV market size beyond the ’24-’25 season will depend on re-vaccination recommendations which are anticipated to be discussed by ACIP in future meetings.

Speaker Change: We are very excited about the launch of our second product <unk>.

Speaker Change: Following the approval the ACP and go vaccine a recommendation on par with competitor vaccines.

Speaker Change: Specifically.

Stephane Bancel: We are at an increased risk. In RSV, our focus is to direct our efforts to the segments where the vast majority of vaccinations occur. In the US, we're targeting the pharmacy segment, which includes both large retail chains as well as independent pharmacies. We will begin shipping products to pharmacy in July, and as Jamey mentioned earlier, we are seeing a highly competitive environment. Additionally, larger competitor contracts were negotiated prior to approval and launch, resulting in lower 2024 shares than we would have liked, offering them the ability to use their time much more efficiently during the busy fall vaccination season and also to reduce potential medical errors. For respiratory vaccines, we expect COVID approval, and we'll be ready to ship in the U.S. and the rest of the world in the August-September timeframe. Dinarazi respectively, face-free data for high-risk individuals 18 years of age and above.

Stéphane Bancel: In RSV, our focus is to direct our efforts to the segments where the vast majority of vaccinations occur. In the U.S., we’re targeting the pharmacy segment, which includes both large retail chains as well as independent pharmacies. Together, the total pharmacy segment accounted last year for around 95% of RSV vaccine administration. We began shipping product in pharmacy in July, and as Jamey mentioned earlier, we are seeing a highly competitive environment. Additionally, larger competitor contracts will negotiate prior to approval and launch, resulting in lower 2024 share than we would have liked.--Long term, we continue to believe our [inaudible] will resonate well with customers, offering them the ability to use their time, maximize efficiency during the busy fall vaccination season, and also reduce potential medical errors. We look forward to some major upcoming milestones in the near term. In respiratory vaccine, we expect a COVID approval and will be ready to ship in the U.S. and rest of the world in the August-September time frame. In RSV, we expect to release Phase III data for high risk individuals 18 years of age and above. We are in discussions with regulators also on our flu program and intend to file in 2024. We also expect to present immunogenicity data in older adults for our flu vaccine, Fluzone HD.

Stephane Bancel: We will begin shipping products to pharmacy in July, and as Jamey mentioned earlier, we are seeing a highly competitive environment. Additionally, larger competitor contracts were negotiated prior to approval and launch, resulting in lower 2024 shares than we would have liked, offering them the ability to use their time much more efficiently during the busy fall vaccination season and also to reduce potential medical errors. For respiratory vaccines, we expect COVID approval, and we'll be ready to ship in the U.S. and the rest of the world in the August-September timeframe. Dinarazi respectively, face-free data for high-risk individuals 18 years of age and above.

Stephane Bancel: We are in discussion with regulators on a flu vaccine program, and it's 10 to 5 in 2024. We also expect to present immunogenicity data in older adults for the flu vaccine versus flu zones. For our next-gen COVID vaccine, mRNA-1283, we're engaging regulators and incentivizing 2024. And as Stephen just talked about, we're very excited about the RIT program. We're looking forward to the completion of enrollment in Phase 3 in adjuvant melanoma, which is, of course, a major milestone.

We are in discussion with regulators on a flu vaccine program, and it's 10 to 5 in 2024. We also expect to present immunogenicity data in older adults for the flu vaccine versus flu zones.

Stéphane Bancel: For our next-gen COVID vaccine, mRNA-1283, we are engaging with regulators and intend to file in 2024. In our combination flu-COVID vaccine, mRNA-1083, we are engaging regulators and hope to be able to give an update soon. [inaudible] fully enrolled and [inaudible] we look forward to potentially Phase III vaccine efficacy readout in 2024. As Stephen just talked about, we are very excited about the INT program and we are looking forward to the completion of enrollment of our Phase III in adjuvant melanoma, which is of course a major milestone. We are keen to discuss with regulators the possibility of accelerated approval based on the Phase II study data. As we shared before, they are treating the review as necessary before we could consider pursuing accelerated approval for INT: first, durability of data, which we believe that as Stephen presented, we are there; second, a substantially enrolled Phase III adjuvant melanoma study, and third, manufacturing readiness at our Marlborough site. Lastly, in our rare disease portfolio, we look forward to initiating a pivotal study for [inaudible].

Speaker Change: I, we've shared before there are three things, we view as necessary before we could consider pursuing accelerated approval for R&D.

Speaker Change: Durability of data, which we believe that's a Stephen presented we are there.

Stephane Bancel: Second, a substantially enrolled phase 3 adjuvant melanoma study, and third, manufacturing readiness at our Marlborough site. Our first question comes from Salveen Richter with Goldman Sachs. Your line is open. Good morning. Thanks for taking my question. There are a couple for me here.

Stéphane Bancel: We are eager to achieve these milestones and to continue to progress towards our mission to deliver the greatest possible impact to people [inaudible]. We expect these near term events combined with further advancement in our pipeline will confirm the power of our platform and its potential to serve patients for years to come. An important save the date for your calendar, our annual R&D day will be the morning of September 12 in New York City. Of course, a webcast will also be available. Thank you for listening to the call, and we would like now with the team to take your questions. Operator?

Speaker Change: Second is substantially enrolled phase III adjuvant melanoma study and film manufacturing readiness at our Marlboro site.

Speaker Change: Lastly, R&D portfolio, we look forward to initiating pivotal study for PNM again.

Speaker Change: We're eager to achieve these milestones and to continue to progress towards our mission to deliver great explicitly when you talk to people for a mountain of medicine.

Speaker Change: We expect these near term events combined with further advancement in our pipeline, we are comfortable power of our platform and its potential to serve patients four years ago.

Our first question comes from Salveen Richter with Goldman Sachs. Your line is open. Good morning. Thanks for taking my question. There are a couple for me here.

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.

Speaker Change: Unimportant save the date for your calendar our annual R&D day will be the morning of September 12 in New York City.

Speaker Change: Of course, a webcast will also be available.

Speaker Change: Thank you for listening to the call and we will act now with the team to take your questions operator.

Salveen Richter: Good morning. Thanks for taking my question. A couple from me here. Can you help us understand the factors contributing to maintenance of the year-end cash balance guidance following the lowered product revenue guidance range? Then with regard to competitive pressures noted regarding contracts for COVID into second half, can you be more specific on the factors here, whether it’s contracting logistics or the clinical profile competitive dynamics, or what that might be? Third, how much visibility do you have on second half demand for the RSV vaccine based on contracting to date? Thank you.

Speaker Change: Ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered you were seeing with yourself from the queue. Please press star one again, we will pause for a moment, while we compile our Q&A roster.

Jamey Mock: Can you help us understand the factors contributing to maintenance of the year-end cash balance guidance following the lowered product revenue guidance range? And then, with regard to competitive pressures noted regarding contracts for COVID into the second half, can you be more specific on the factors here, whether it's contracting logistics or the clinical profile, competitive dynamics, or what that might be? And third, how much visibility do you have on second half demand for the RSV vaccine based on contracting to date? Thank you. Yeah, so hi Salveen.

Can you help us understand the factors contributing to maintenance of the year-end cash balance guidance following the lowered product revenue guidance range? And then, with regard to competitive pressures noted regarding contracts for COVID into the second half, can you be more specific on the factors here, whether it's contracting logistics or the clinical profile, competitive dynamics, or what that might be? And third, how much visibility do you have on second half demand for the RSV vaccine based on contracting to date?

James M. Mock: Hi Salveen, I’ll take the first question regarding the year-end cash balance. I would say there’s a few factors in there. Number one, on the deferrals of revenue, some of which we have already collected the cash and ultimately we will collect the remaining balance that might push into 2025, but some of that is already a prepayment. Number two, as I mentioned in my prepared remarks, we have been working on working capital. We’ve got a whole team focused on it, and the teams are doing a great job from accounts payable, inventory balances, receivables and our collections progress. You can see our receivables balance on the balance sheet is relatively small at this point, so the team’s done a great job, which helps offset it. Then third, just coming into the year, we had a little bit of cushion to the $9 billion, so overall we remain confident in the $9 billion and are pleased with that kind of ending balance heading into 2025.

Jamey Mock: I'll take the first question regarding the year-end cash balance. So I would say there are a few factors in there. Number one, on deferrals of revenue, some of which we have already collected cash, and ultimately, we will collect the remaining balance that might push into 2025, but some of that is already a prepayment. Number two, as I mentioned in my prepared remarks, we have been working on working capital. We've got a whole team focused on it, and the teams are doing a great job with accounts payable, inventory balances, receivables, and our collections progress. You can see that our receivables balance on the balance sheet is relatively small at this point. So the team's doing a great job, which helps offset it. And then third, just coming into the year, we had a little bit of a cushion against the nine billion dollars. So overall, we remain confident in the nine billion dollars and are pleased with that kind of ending balance heading into 2025.

Jamey Mock: So the team's doing a great job, which helps offset it. And then third, just coming into the year, we had a little bit of a cushion against the nine billion dollars. So overall, we remain confident in the nine billion dollars and are pleased with that kind of ending balance heading into 2025. [inaudible] So it's really an ability if you want to also be much more aggressive on activity, whether it's supply chain, whether it's pricing, whether it's co-marketing funding, and all those activities. So it's really a mix at the customer-to-customer level.

So the team's doing a great job, which helps offset it. And then third, just coming into the year, we had a little bit of a cushion against the nine billion dollars. So overall, we remain confident in the nine billion dollars and are pleased with that kind of ending balance heading into 2025.

Stéphane Bancel: And Salveen, I’ll take the two or the question--it’s Stéphane. On the competitive pressure, I think on both products, COVID and RSV, we are seeing similar things, which is [inaudible] from larger competitors with a portfolio of products, an ability, if you want, to also be much more aggressive on activities, whether it’s supply chain, whether it’s pricing, whether it’s co-marketing funding and dollars activity, so it’s really a mix at the customer level. We’ve just seen much more intensity and pressure on COVID versus last year, and on RSV, as you know, we’re entering a market where there’s two large established players, one with very large market share where of course [inaudible], the other one who, as indicated, they want to gain market share because they are not pleased with their market share last year, and so we have been working really actively on that. In terms of visibility for RSV, we have some contracts that have already been signed and that we are actively supplying customers now that the product has shipped. We have some contracts that are being finalized with ability in season to demonstrate to the customer the value of PFS and to be able to move that into season, so we are working through all of those things. We’ll provide updates as the season goes, but we know this is very important for patients, it’s very important for the company, so we’re all hands on deck on COVID and RSV.

Jamey Mock: We've just seen much more intense pressure on COVID versus last year. And on ISV, as you know, we're entering a market where there are two large established players, one with a very large market share, which we, of course, are trying to defend. The other one, who has indicated they want to gain market share because they were not pleased with their market share last year. And so we have been working really actively on that. In terms of visibility, for RSV, we have some contracts that have already been signed and that we are actively supplying customers now that the product has shipped. There are some contracts that are being finalized with the ability in season to demonstrate to the customer the value of PFS and to be able to move that into season. So we're working through all those things. We provide updates as the season goes, but we know this is very important for patients. It's very important for the company. So we're all hands on deck on COVID and our team.

Jamey Mock: In terms of visibility, for RSV, we have some contracts that have already been signed and that we are actively supplying customers now that the product has shipped. There are some contracts that are being finalized with the ability in season to demonstrate to the customer the value of PFS and to be able to move that into season. So we're working through all those things. We provide updates as the season goes, but we know this is very important for patients. It's very important for the company. So we're all hands on deck on COVID and our team.

Stéphane Bancel: We have some contracts that are being finalized with ability in season to demonstrate to the customer the value of PFS and to be able to move that into season, so we are working through all of those things. We’ll provide updates as the season goes, but we know this is very important for patients, it’s very important for the company, so we’re all hands on deck on COVID and RSV.

Jamey Mock: So we're working through all those things. We provide updates as the season goes, but we know this is very important for patients. It's very important for the company. So we're all hands on deck on COVID and our team. Thank you. Our next question comes from Terrence Flynn with Morgan Stanley. Your line is open.

So we're working through all those things. We provide updates as the season goes, but we know this is very important for patients. It's very important for the company. So we're all hands on deck on COVID and our team.

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

Terence C. Flynn: Great, thanks for taking the questions. Maybe two for me as well. Was just wondering on the guidance cut, if you can quantify how much was from COVID versus RSV, and then on the seasonal flu and the seasonal flu plus COVID combo, I might be parsing words here, but on seasonal flu, I notice the press release said intend to file in 2024, the combo said engaging with regulators on next steps, so maybe you could just help us think through the gating factors for each of those and the difference in language there. Thank you.

Stephane Bancel: Thank you. Great. And for the question on the language, good pick.

Thank you.

Speaker Change: So the 10 three flu Covid program is the most recent phase III results are really quite fresh and we've just begun the process of engaging with regulators, meaning sharing that data and discussing with them what their expectations would be on submission.

James M. Mock: Yes, thanks Terence. I’ll take the first one related to guidance and what’s the split between COVID and RSV. What I would say is if you look at the three drivers, all of them are, first, similar in size. Then if I break them down, the deferrals are all related to COVID, the EU is all related to COVID, and then that last category of competitiveness in RSV vaccine--or in respiratory vaccines, there’s a split between COVID and RSV, so that should give you some understanding of the general split between COVID and RSV. Great. And for the question on the language, good pick.

Speaker Change: For the other programs that you referenced obviously, we had more time had some of those discussions and we're obviously preparing for submissions as we said in our prepared remarks.

Stephen Hoge: Great, and for the question on the language, good pick-up. The 1083 flu COVID program is the most recent Phase III results, really quite fresh, and we have just begun the process of engaging with regulators, meaning sharing that data and discussing with them what their expectations would be on submission. For the other programs that you referenced, obviously we’ve had more time, had some of those discussions, and we’re obviously preparing for submissions, as we said in our prepared remarks.

Stephane Bancel: So the 10A3 Flu COVID program is the most recent phase three results, really quite fresh. And we've just begun the process of engaging with regulators, meaning sharing that data and discussing with them what their expectations would be for submission. For the other programs that you referenced, obviously, we've had more time, had some of those discussions, and we're obviously preparing for submissions, as we said in our Thank you. Our next question comes from Michael Yee with Jeffries. Your line is open.

So the 10A3 Flu COVID program is the most recent phase three results, really quite fresh. And we've just begun the process of engaging with regulators, meaning sharing that data and discussing with them what their expectations would be for submission. For the other programs that you referenced, obviously, we've had more time, had some of those discussions, and we're obviously preparing for submissions, as we said in our

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

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

Michael Yee: Thank you guys. Two questions from us. Looking forward on guidance, you obviously have revenue guidance this year, you have opex guidance which we see is around $6 billion of R&D and SG&A, and as you project out to the following years, you have already given cash flow guidance, so if things are generally staying along the same trajectory, I would think that cash guidance would be lower. Can you speak to the math there, and perhaps Jamey, who has said you could flex opex, is that of heightened importance and heighted priority more aggressively as you think about where things stand today in the change of guidance and talk to that, given cash guidance is a big concern for investors? The second question is going back to RSV--I appreciate the comments you just said, that was super helpful in breaking it down. Is that to say that the RSV projections you have are going to be perhaps in half, and is that due to lower share and lower price, and speak to that? Thank you.

Michael Yee: Thank you guys two questions from us.

Speaker Change: Looking forward.

Speaker Change: On guidance.

Speaker Change: You obviously have revenue guidance. This year, you have opex guidance, which we see is around 6 billion of R&D and SG&A and as you project out to the following year you have already given cash flow guidance.

Speaker Change: So if things are generally staying along the same trajectory.

Speaker Change: I would think that cash guidance would be lower can.

Jamey Mock: Is that of heightened importance and heightened priority more aggressively as you think about where things stand today and the change in guidance? And talk about that, given cash guidance is a concern for investors. The second question is going back to RSV. I appreciate the comments you just said that were super helpful in breaking it down. Is that to say that the RSV projections you have are going to be perhaps in half? And is that due to lower share and lower price? And speak to that. Thank you.

Jamey Mock: And speak to that. Thank you. Yeah, thanks, Mike.

And speak to that. Thank you.

James M. Mock: Yes, thanks Mike. We are still--as I mentioned, we’re still expecting $9 billion in cash next year and don’t currently have any different change in our outlook for the $6 billion to $7 billion that we said we’d end 2025 with, and let me break that down. First, this year we went from the start of the year, $13 billion to $9 billion, so a $4 billion loss in cash. That included many prepayments coming into the year that will no longer repeat, so we’re not actually getting the cash from operations and that won’t be a drag year-over-year. Second, we plan to return to growth in 2025 and, as I mentioned earlier, some of that will also be buoyed by the fact that we have some deferrals heading into 2025, but more so we’ll have an entire year and operating experience on RSV, we hope to bring new products to market, and so we’re still expecting to return to growth. But yes, I mean, we continue to look at opex and understand what we want to do there, and we are always laser focused on our cash balance, and at this time we don’t think the $6 billion to $7 billion will change. Okay, and then on RSV, breaking it down, just a little more specifics on the impact of market share contracting and price, and how to think about that?

Michael Yee: Okay, and then on RSV, breaking it down, just a little more specifics on the impact of market share contracting and price, and how to think about that?

Jamey Mock: So we are still, as I mentioned, we're still expecting $9 billion in cash next year and don't currently have any different change in our outlook for the $6 to $7 billion that we said we'd end 2025 with. Let me break that down. That included many prepayments coming into the year that will no longer repeat, so we're not actually getting the cash from operations, and that won't be a drag year over year. Our next question comes from Eliana Merle with UBS. Your line is open. Hi, this is Elliot Bosco from UBS on behalf of Ellie Merle.

James M. Mock: Yes, it’s a bit of both. We’re not breaking it down, nor have we given guidance on RSV, but I would say this year is not turning out as we expected, and I answered Terence’s questions in terms of how much is really split between COVID and RSV, so you can kind of get an understanding there. But again, we were third to market this year, some of the contracts were already negotiated, we only are participating in the second half, but I think our hope is that we get access across many of the retail chains, they start to get comfortable with us with the second product so that when we head into 2025, we can get a more fair market share on RSV. Perfect. Thank you.

Michael Yee: Perfect. Thank you.

Our next question comes from Eliana Merle with UBS. Your line is open. Hi, this is Elliot Bosco from UBS on behalf of Ellie Merle.

Operator: Our next question comes from Eliana Merle with UBS. Your line is open.

Eliana Merle: Hi, this is Elliott Bosco from UBS on for Eli Merle. Two from us. Can you elaborate on the latest timing you expect for the Phase III CMV study, based on how event rates are tracking, and brd on just the necessary 12 months of median safety follow-up, from a purely protocol perspective, what is the earliest we could potentially get the interim? Then second on international COVID revenues in future years, what do you see as the likelihood of potential deferral again in 2025?

Stephane Bancel: Two from us, can you elaborate on the latest timing you expect for the phase three CMV study based on how event rates are tracking? And based on just the necessary 12 months of median safety follow-up, from a purely protocol perspective, what is the earliest we could potentially get the interim? And then second, on international COVID revenues and future years, what do you see as the likelihood of potential deferral again in 2025? Thank you for the question. I'll answer first.

Two from us, can you elaborate on the latest timing you expect for the phase three CMV study based on how event rates are tracking? And based on just the necessary 12 months of median safety follow-up, from a purely protocol perspective, what is the earliest we could potentially get the interim? And then second, on international COVID revenues and future years, what do you see as the likelihood of potential deferral again in 2025?

Stephen Hoge: Great, thanks for the questions. I’ll take it first. First, we have enough data on case numbers for CMV. We may have an update at R&D day, I’m not sure, but we don’t have any change to our prior guidance, which is we do think that the interim analysis of efficacy could happen this year, and that would account for also median safety follow-up from a timing perspective, and so at this point, no new update, but we continue to stand behind the belief that the interim analysis for efficacy on the CMV program could happen this year.

Stephane Bancel: So first, we have an update on case numbers for CMV. We may have an update on R&D, I'm not sure, but we don't have any change to our prior guidance, which is that we do think that the interim analysis of efficacy could happen this year. And that would also account for median safety follow-up from a timing perspective. And so at this point, there is no new update, but we continue to stand by the belief that the interim analysis for the CMV program could happen this year. Yeah, on the deferrals. Could they happen in 2025? The answer is yes, they can always happen.

So first, we have an update on case numbers for CMV. We may have an update on R&D, I'm not sure, but we don't have any change to our prior guidance, which is that we do think that the interim analysis of efficacy could happen this year. And that would also account for median safety follow-up from a timing perspective. And so at this point, there is no new update, but we continue to stand by the belief that the interim analysis for the CMV program could happen this year.

James M. Mock: Yes, and Elliott, on the deferrals, could they happen in 2025, the answer is yes, they can always happen. That said, some of this will push into next year, so, and if some of those push into the following year, those two would offset, but we’re not expecting that at that point. The only thing I’d say is we will come to market with our resilience contracts in the U.K., Australia and Canada, that provides us additional growth in those areas as well as potentially participating in additional public tenders as well, so there’s a little bit of risk but I think we can mitigate it with the deferrals from this year, as well as additional resilience contracts.

Stephane Bancel: That said, some of this will push into next year, and if some of those push into the following year, those two would offset, but we're not expecting that at this time. The other thing I'd say is we will go to market with our resilience contracts in the UK, Australia, and Canada, that provides us with additional growth in those areas, as well as potentially participating in additional public tenders as well. Thank you. The next question comes from Gena Wang with Barclays. Your line is open.

That said, some of this will push into next year, and if some of those push into the following year, those two would offset, but we're not expecting that at this time. The other thing I'd say is we will go to market with our resilience contracts in the UK, Australia, and Canada, that provides us with additional growth in those areas, as well as potentially participating in additional public tenders as well.

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

Gena Wang: Thank you. I just have one question regarding the guidance for this year, particularly regarding the COVID revenue in the U.S. It seems contracting is mostly down, and you already also expect similar vaccination rates versus last year, and we know there is mainly only two players, so what could lead to the lower COVID revenue this year from prior $2 billion guidance?

Jamey Mock: So what could lead to the lower COVID revenue this year from prior to billion guidance? Yeah, thanks, Gina. So we define competitiveness both in terms of share and in price. So we're relatively pleased with our market share; there's potentially some price pressure in there. But generally speaking, we think that the US will perform pretty well compared to last year. But we are seeing a bit of a competitive, more competitive market this year after a year where in the US, we had nearly 50% or approximately 50% market share. So, we're seeing the pressure but are still confident in the overall performance of the US business. Thank you.

So what could lead to the lower COVID revenue this year from prior to billion guidance?

Yeah, thanks, Gina. So we define competitiveness both in terms of share and in price. So we're relatively pleased with our market share; there's potentially some price pressure in there. But generally speaking, we think that the US will perform pretty well compared to last year. But we are seeing a bit of a competitive, more competitive market this year after a year where in the US, we had nearly 50% or approximately 50% market share. So, we're seeing the pressure but are still confident in the overall performance of the US business. Thank you.

Stephen Hoge: Yes, thanks Gena. We define competitiveness both in terms of share and in price, so we’re relatively pleased with our market share, there’s potentially some price pressure in there. But generally speaking, we think that the U.S. will perform pretty well compared to last year, but we are seeing a bit of a competitive--a more competitive market this year after a year where in the U.S., we had nearly or approximately 50% market share, so. We’re seeing the pressure but still confident in the overall performance of the U.S. business.

Gena Wang: Thank you.

Stephane Bancel: Our next question comes from Luca Issi with RBC Capital. Your line is open. Oh, great. Thanks so much for taking my question. Maybe Stephen, a quick question on the recent ACIP meeting. It feels to me that the debate before that ACIP meeting was whether RSV was going to be either an annual vaccine or an every other year vaccine. However, ACIP clearly chose neither of them and simply said this was one and done. So two questions. Were you surprised by that decision?

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

Luca Issi: Oh, great. Thanks so much for taking my questions. Maybe Stephen, quick question on the recent ACIP meeting, it feels to me that the debate before that ACIP meeting was whether RSV was going to be either an annual vaccine or an every-other-year vaccine. However, ACIP clearly chose neither of them and simply said, this is one and done, so two questions. Were you surprised by that decision, and two, how should we think about the market potential for RSV long term, in light of the fact this is maybe a one and done vaccine versus obviously COVID and flu are annual vaccines? Any color there would be much appreciated, and then maybe quickly walk us through what’s the latest thinking on the opportunity for bird flu. Thanks so much.

Stephane Bancel: And two, how should we think about the market potential for RSV long term in light of the fact this is maybe one and done vaccine versus obviously COVID and flu or annual vaccines. Any call there, much appreciated. And then maybe quickly walk us through what's the latest thinking on the opportunity for bird flu. Thanks so much.

Stephen Hoge: Great, thank you for both questions. Obviously first and foremost, our focus at the ACIP meeting was we were quite pleased with the parity recommendation, and I think we were all pleased with the clear recommendation for those over the age of 75 and those with higher risk from RSV, that they really should get vaccinated. As its only a year old is the market, the most important thing we can do is cover the large number of people who are now recommended, the 40 million-plus who are not vaccinated, and that’s quite a large increase in the number of folks who we hope to cover soon. Now, on the question--the specific question of revaccination, I think it’s also important to say that we are--you know, the ACIP is really just looking at one year of real-world data, and all three of the vaccines, but including mRESVIA, show significant second season protection, although it does decrease, and so there is the decline from season one into season two from a clinical trial perspective, but there’s still protection there in that year two. While you’re only one year into that public experience--public health experience, I think ACIP took a prudent choice and said there’s still a benefit, and maybe the focus should be on increasing vaccination coverage rates for those who are current unprotected because there clearly is some benefit, even still at that second year.

Stephane Bancel: And that's quite a large increase in the number of folks who we hope to cover soon. Now, on the question of your specific question of revaccination, I think it's also important to say that we are, you know, the ACIP is really just looking at one year of real world data. And all 3 of the vaccines, but including MRSA, show significant second season protection, although it does decrease. And so there is a decline from season 1 into season 2 from a clinical trial perspective. But there's still protection there in that year too. And so while you're only 1 year into that public experience, public health experience, I think ACIP took a prudent choice and said there's still a benefit. And maybe the focus should be on increasing vaccination coverage rates for those who are currently unprotected because there clearly is some benefit even in that 2nd year.

Speaker Change: Covered the large number of people who are now recommended 40 million plus who are not vaccinated and that's a quite large increase in the number of folks who we hope to cover soon now on the question to your specific question.

Speaker Change: Hum re vaccination I think it's also important to say that we are you know the CIP is really just looking at one year of real world data and all three of the vaccines, but including in Brisbane shows significant second season protection, Although it does decrease and so there was a decline from <unk>.

Stephane Bancel: And so while you're only 1 year into that public experience, public health experience, I think ACIP took a prudent choice and said there's still a benefit. And maybe the focus should be on increasing vaccination coverage rates for those who are currently unprotected because there clearly is some benefit even in that 2nd year. I think if you fast forward a year, and this would be my perception, but if you fast forward a year, if you look at the rates of waning for the other 2 vaccines and ours, there's clearly a decline from year 1 to 2 and from year 2 to 3.

And so while you're only 1 year into that public experience, public health experience, I think ACIP took a prudent choice and said there's still a benefit. And maybe the focus should be on increasing vaccination coverage rates for those who are currently unprotected because there clearly is some benefit even in that 2nd year.

Stephen Hoge: While you’re only one year into that public experience--public health experience, I think ACIP took a prudent choice and said there’s still a benefit, and maybe the focus should be on increasing vaccination coverage rates for those who are current unprotected because there clearly is some benefit, even still at that second year. I think if you fast forward a year--and this would be my perception--but if you fast forward a year, if you look at the rates of waning for the other two vaccines than ours, there is clearly a decline from year one to two, and from year two to three. The pace of that decline suggests that by year three, there really won’t be much protection for those people who have received vaccines in the first year. I think that’s when you probably need to start asking the question of, do we continue to leave those people unprotected or boost them again? Now, from a scientific perspective, you asked my view, you will be infected with RSV almost 20 times in your life, you will repeatedly get ill. In fact, many people who are at risk of severe complications over the age of 75 or otherwise with medical co-morbidities, they’ve seen RSV before. It’s the waning protection from that infection that ultimately is the reason why you need a vaccine, and because you get infected multiple times by that virus over life, even if you’ve seen it before, you probably will benefit from a booster in future.

I think if you fast forward a year, and this would be my perception, but if you fast forward a year, if you look at the rates of waning for the other 2 vaccines and ours, there's clearly a decline from year 1 to 2 and from year 2 to 3. And the pace of that decline suggests that by year 3, there won't be much protection for those people who had received vaccines in the 1st year. I think that's when you probably need to start asking the question, do we continue to leave those people unprotected or boost them again? Now, from a scientific perspective, if you ask my view, you will be infected with RSV dozens, almost 20 times in your life. You will repeatedly get ill. In fact, many people who are at risk of severe complications over the age of 75 or otherwise with medical comorbidities have seen RSV before. It's the waning protection from that infection that ultimately is the reason why you need a vaccine. And because you get infected multiple times by that virus over your life, even if you've seen it before, you probably will benefit from a booster shot in the future.

Stephane Bancel: And the pace of that decline suggests that by year 3, there won't be much protection for those people who had received vaccines in the 1st year. I think that's when you probably need to start asking the question, do we continue to leave those people unprotected or boost them again? Now, from a scientific perspective, if you ask my view, you will be infected with RSV dozens, almost 20 times in your life. You will repeatedly get ill. In fact, many people who are at risk of severe complications over the age of 75 or otherwise with medical comorbidities have seen RSV before. It's the waning protection from that infection that ultimately is the reason why you need a vaccine. And because you get infected multiple times by that virus over your life, even if you've seen it before, you probably will benefit from a booster shot in the future.

Stephane Bancel: In fact, many people who are at risk of severe complications over the age of 75 or otherwise with medical comorbidities have seen RSV before. It's the waning protection from that infection that ultimately is the reason why you need a vaccine. And because you get infected multiple times by that virus over your life, even if you've seen it before, you probably will benefit from a booster shot in the future. And so we continue to believe that as the public health story evolves, that recommending bodies and CDC and ACIP will look at the waning efficacy, the potential to boost people again and hopefully provide additional public benefit, and that eventually there will be recommendations for revaccination But it is not our choice alone.

In fact, many people who are at risk of severe complications over the age of 75 or otherwise with medical comorbidities have seen RSV before. It's the waning protection from that infection that ultimately is the reason why you need a vaccine. And because you get infected multiple times by that virus over your life, even if you've seen it before, you probably will benefit from a booster shot in the future.

Stephen Hoge: In fact, many people who are at risk of severe complications over the age of 75 or otherwise with medical co-morbidities, they’ve seen RSV before. It’s the waning protection from that infection that ultimately is the reason why you need a vaccine, and because you get infected multiple times by that virus over life, even if you’ve seen it before, you probably will benefit from a booster in future. And so we continue to believe that as the public health story evolves, that recommending bodies and CDC and ACIP will look at the waning efficacy, the potential to boost people again and hopefully provide additional public benefit, and that eventually there will be recommendations for revaccination for those who are at highest risk of RSV, but it is not our choice. We are providing that data to obviously the regulators but principally to groups like CDC, and then they will determine the right moment, if ever, to recommend that revaccination in the United States. As it relates to bird flu, we continue to follow that very closely. It’s drifted a little bit out of the news more recently--I think that’s a good thing, but the most important news for us has been in the quarter, we executed an agreement with BARDA to advance into Phase III with our pandemic bird flu vaccine, which we’ll provide updates on as we move forward in the months and the year ahead. But we will be sure to be partnering with public health entities across the world, including the United States government specifically. We’re grateful for working with BARDA again in the event that bird flu does emerge as a pandemic or epidemic threatening this country.

And so we continue to believe that as the public health story evolves, that recommending bodies and CDC and ACIP will look at the waning efficacy, the potential to boost people again and hopefully provide additional public benefit, and that eventually there will be recommendations for revaccination But it is not our choice alone. We are providing that data to, obviously, the regulators, but principally to groups like CDC now, and then they will determine the right moment, if ever, to recommend that revaccination in the United States. As it relates to BERCVU, you know, we continue to follow that very closely. It has definitely drifted a little bit out of the news more recently. I think that's a good thing. But the most important news for us has been that in the quarter, we actually had an agreement with BARDA to advance into phase three with our pandemic BERCVU vaccine, which we'll provide updates on as we move forward in the months and year ahead. But we will be sure to be partnering with public health entities across the world, including the United States government, which is specifically grateful for working with BARDA again, in the event that BERCVU does emerge as a pandemic or epidemic threat in this country.

Stephane Bancel: We are providing that data to, obviously, the regulators, but principally to groups like CDC now, and then they will determine the right moment, if ever, to recommend that revaccination in the United States. As it relates to BERCVU, you know, we continue to follow that very closely. It has definitely drifted a little bit out of the news more recently. I think that's a good thing. But the most important news for us has been that in the quarter, we actually had an agreement with BARDA to advance into phase three with our pandemic BERCVU vaccine, which we'll provide updates on as we move forward in the months and year ahead. But we will be sure to be partnering with public health entities across the world, including the United States government, which is specifically grateful for working with BARDA again, in the event that BERCVU does emerge as a pandemic or epidemic threat in this country.

Stephen Hoge: It’s drifted a little bit out of the news more recently--I think that’s a good thing, but the most important news for us has been in the quarter, we executed an agreement with BARDA to advance into Phase III with our pandemic bird flu vaccine, which we’ll provide updates on as we move forward in the months and the year ahead. But we will be sure to be partnering with public health entities across the world, including the United States government specifically. We’re grateful for working with BARDA again in the event that bird flu does emerge as a pandemic or epidemic threatening this country. Thanks so much.

Stephane Bancel: I think that's a good thing. But the most important news for us has been that in the quarter, we actually had an agreement with BARDA to advance into phase three with our pandemic BERCVU vaccine, which we'll provide updates on as we move forward in the months and year ahead. But we will be sure to be partnering with public health entities across the world, including the United States government, which is specifically grateful for working with BARDA again, in the event that BERCVU does emerge as a pandemic or epidemic threat in this country. Our next question comes from Alexandria Hammond with B of A. Your line is open.

I think that's a good thing. But the most important news for us has been that in the quarter, we actually had an agreement with BARDA to advance into phase three with our pandemic BERCVU vaccine, which we'll provide updates on as we move forward in the months and year ahead. But we will be sure to be partnering with public health entities across the world, including the United States government, which is specifically grateful for working with BARDA again, in the event that BERCVU does emerge as a pandemic or epidemic threat in this country.

Luca Issi: Thanks so much.

Operator: Our next question comes from Alexandria Hammond with BofA. Your line is open.

Alexandria Hammond: Hi, thanks for taking my question. Ahead of results for VX-522 in collaboration with Vertex for CF, if results provide positive proof of concept for the ability of mRNA and liquid nanoparticles to be aerosolized and cross the mucus barrier in the lung, can you walk us through additional indications you may be interested in, and should we expect you to develop these indications in partnership with Vertex? Thank you.

Stephen Hoge: Thanks for the question. We have--as you highlight, there is a large number of pulmonary diseases for which respiratory delivery could be quite impactful. We have not provided any updates on the preclinical programs that we’ve moved into development, and so I would describe those activities right now as still research and discovery phase, and not something for competitive reasons and for scientific reasons that we’ll talk about. They’re in the earlier stages. As it relates to whether we would partner with Vertex on it, we would of course always welcome partnering with Vertex given their expertise, but the partnership we have right now, the deal we have with them is limited to the cystic fibrosis program at this point.

Stephane Bancel: And so I would describe those activities right now as still in the research and discovery phase and therefore not something for competitive reasons and for scientific reasons that we'll talk about. They're in the earlier stages. As relates to whether we would partner with Virtex on it, we would, of course, always be welcome to partner with Virtex, given their expertise. But the partnership we have right now, the deal we have with them is limited to the Cystic Fibrosis Program at this time. Great, thank you. Most of my questions have been answered. I appreciate all the detail.

And so I would describe those activities right now as still in the research and discovery phase and therefore not something for competitive reasons and for scientific reasons that we'll talk about. They're in the earlier stages. As relates to whether we would partner with Virtex on it, we would, of course, always be welcome to partner with Virtex, given their expertise. But the partnership we have right now, the deal we have with them is limited to the Cystic Fibrosis Program at this time.

Operator: Thank you. Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open. Great, thank you. Most of my questions have been answered. I appreciate all the detail.

Operator: Thank you. Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open. Great, thank you. Most of my questions have been answered, but I appreciate all the detail. I wanted to ask a little bit about the orphan disease program, and maybe you can provide a little bit of color on what the regulatory path might look like in MMA and PA. Thank you.

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

Edward Tenthoff: Great, thank you. Most of my questions have been answered, but I appreciate all the detail. I wanted to ask a little bit about the orphan disease program, and maybe you can provide a little bit of color on what the regulatory path might look like in MMA and PA. Thank you.

Operator: Great, thank you. Most of my questions have been answered. I appreciate all the detail.

Stephane Bancel: I wanted to ask a little bit about the Orphan Disease Program, so maybe you can provide a little bit of color on what the regulatory path might look like in MMA and PA. Thank you.

Stephen Hoge: Thanks Ted. They are somewhat different, and they are in early stages of those regulatory conversations, so we just received the FDA START designation, but if you look at the data that we shared last R&D day, and we’ll obviously provide updates on this going forward, one of the clearer pictures that emerged was that in MMA, we are seeing good movement of a biomarker of methylmalonic acid that’s pathognomonic for the disease, and so you can imagine of the challenges very quickly when you have a good biomarker is how do you validate that biomarker and show that moving that biomarker is reasonably likely to predict benefit, and that’s a scientific question we will work on and ultimately engage with regulators, including FDA, as a key step for moving forward. We are evaluating in the clinical trial folks movement in their biomarker from baseline, so it’s a clear study to run. In the case of proprionic acidemia, there is not as clear a biomarker in the field because of the structure of that particular part of the metabolic pathway. And so, there we’ve been following events, and as you know, we’ve previously shared in a single-arm study the pre and post treatment rates of metabolic decompensations. We have seen a favorable trend in that--we’re actually quite excited by that. That takes a little more time than a biomarker, but we obviously have been working on that a little bit longer, and so we’ll be engaging with regulators on that single arm approach and understanding the difference between internal controls or other controls to evaluate that.

Stephane Bancel: And that's a scientific question we will work on and ultimately engage with regulators, including FDA, on as a key step for moving forward. We are evaluating the clinical trial folks and their movement in their biomarker from baseline. So it's a clear study to run. In the case of propionic acidemia, there is not as clear a biomarker in the field because of the structure of that particular part of the metabolic pathway. And so there, we've been following events. And as you know, we previously shared in a single-arm study the pre- and post-treatment rates of metabolic decompensations. We have seen a favorable trend in that. We're actually quite excited by that. That takes a little more time than a biomarker, but we obviously have been working on that a little bit longer. And so we'll be engaging with regulators on that single-arm approach and understanding the difference between internal controls or other control groups to evaluate that.

Stephen Hoge: And so, there we’ve been following events, and as you know, we’ve previously shared in a single-arm study the pre and post treatment rates of metabolic decompensations. We have seen a favorable trend in that--we’re actually quite excited by that. That takes a little more time than a biomarker, but we obviously have been working on that a little bit longer, and so we’ll be engaging with regulators on that single arm approach and understanding the difference between internal controls or other controls to evaluate that. In any event, you may end up with a randomized study, you may be able to use a single arm study, and in the case of MMA, you may be able to use a biomarker, so those are the kinds of conversations we’re having, but as I said, they’re early days. The FDA discussion on MMA just started, and so we’ll provide updates as we have more clarity on those timelines. Great, thanks. Looking forward to the R&D day.

Stephane Bancel: And so there, we've been following events. And as you know, we previously shared in a single-arm study the pre- and post-treatment rates of metabolic decompensations. We have seen a favorable trend in that. We're actually quite excited by that. That takes a little more time than a biomarker, but we obviously have been working on that a little bit longer. And so we'll be engaging with regulators on that single-arm approach and understanding the difference between internal controls or other control groups to evaluate that.

Speaker Change: We've been following events and as you know we previously shared in a single arm study the pre and post treatment rates of metabolic decompensation, we have seen them a favorable trend in that we're actually quite excited by that that takes a little more time than a biomarker, but we obviously have been working on that a little bit longer and so it will be engaging with regular.

Stephane Bancel: And so we'll be engaging with regulators on that single-arm approach and understanding the difference between internal controls or other control groups to evaluate that. In any event, you may end up with a randomized study. You may be able to use a single-arm study. And in the case of mRNA, you may be able to use a biomarker.

And so we'll be engaging with regulators on that single-arm approach and understanding the difference between internal controls or other control groups to evaluate that.

Speaker Change: There's on that single arm approach and understanding the difference between our internal controls or other controls group to evaluate that.

In any event, you may end up with a randomized study. You may be able to use a single-arm study. And in the case of mRNA, you may be able to use a biomarker. So those are the kinds of conversations that we're having. But, as I said, they're early days. The FDA-START discussion on MMA just started, and so we'll provide updates as we have more clarity. I'm looking forward to R&D day.

Speaker Change: In any event.

Speaker Change: You may end up with a randomized study you may be able to use a single arm study and in the case of there may you may be able to use a biomarker. So those are the kinds of conversations that we're having but as I said there early days the FDA start discussion on M&A just started and so we'll provide updates as we have more clarity on this time.

Stephane Bancel: So those are the kinds of conversations that we're having. But, as I said, they're early days. The FDA-START discussion on MMA just started, and so we'll provide updates as we have more clarity. I'm looking forward to R&D day.

Stephane Bancel: I'm looking forward to R&D day. Our next question comes from Jessica Fye with J.P. Morgan. Your line is open.

I'm looking forward to R&D day.

Edward Tenthoff: Great, thanks. Looking forward to the R&D day.

Speaker Change: Great. Thanks, looking forward to the R&D day.

Operator: Our next question comes from Jessica Fye with JP Morgan. Your line is open.

Jessica Fye: For RSV, I'm curious about your take on Pfizer's comment that customers want to carry an RSV. I saw it on the near-term milestone slide, but to clarify, what's your latest projection on when you expect to complete enrollment in the Phase III adjuvant melanoma trial? This is the latest you can share on manufacturing progress for that product. Are there any updates to share on how that's going? Yeah, but that's the maternal side.

Jessica Fye: Hey guys, good morning. Thanks for taking my questions. For RSV, I’m curious your take on Pfizer’s comment that customers want to carry an RSV vaccine that could address both maternal and the older adult population. Then for INT, I saw it on the near term milestone slide, but to clarify, what’s your latest projection on when you expect to complete enrolment of the Phase III adjuvant melanoma trial, and what’s the latest you can share on manufacturing progress for that product? Are there any updates to share on how that’s going? Thank you.

Stephen Hoge: [inaudible]--Sure, I’ll take that. Obviously the majority of the recommended population in this country continues to be the older adults. I wouldn’t comment on Pfizer’s competitive positioning on our quarterly call except to say that in the retail channel overwhelmingly and in many physicians’ offices overwhelmingly, the focus is on protecting older Americans. What’s happening with the younger population, maternal population is obviously smaller in terms of an overall market opportunity. We do recognize the need to try and provide the broadest potential label and, as we’ve previously updated, we are pleased that we’ve conducted our Phase III study in 18 to 59-year-old high risk populations, and we intend to file that this year with a goal of expanding that label for those who are at high risk for medical reasons and may benefit from an RSV vaccine, even if they are younger. I would say we agree that a broad label is valuable, but I think it’s important to cover as many people as possible, and that’s what we’re excited by moving forward with our 18 to 59-year-old filing.

Stephane Bancel: Yeah, I'll try to get that both. So, obviously, the majority of the recommended population in this country continues to be older adults. You know, I wouldn't comment on Pfizer's competitive positioning on their quarterly call except to say that, you know, in the retail channel, overwhelmingly, and in many physician offices, overwhelmingly, the focus is on protecting older Americans. What's happening with a younger population, the maternal population, is obviously smaller in terms of an overall market opportunity. We do recognize the need to try and provide the broadest potential label, and as we've previously updated, we are pleased that we've conducted our phase three study in 18 to 59-year-old high-risk populations, and we intend to follow that this year with the goal of expanding that label for those who are at high risk for medical reasons and may benefit from an RSC vaccine, even if they're younger. And so I would say we agree that a broad label is valuable, but I think it's important to cover as many people as possible, and that's why we're excited by moving forward with our 18 to 59-year-old filing.

Stephane Bancel: We do recognize the need to try and provide the broadest potential label, and as we've previously updated, we are pleased that we've conducted our phase three study in 18 to 59-year-old high-risk populations, and we intend to follow that this year with the goal of expanding that label for those who are at high risk for medical reasons and may benefit from an RSC vaccine, even if they're younger. And so I would say we agree that a broad label is valuable, but I think it's important to cover as many people as possible, and that's why we're excited by moving forward with our 18 to 59-year-old filing. On the question of INT, we have not, with our partner, updated you yet on where we are in enrollment.

We do recognize the need to try and provide the broadest potential label, and as we've previously updated, we are pleased that we've conducted our phase three study in 18 to 59-year-old high-risk populations, and we intend to follow that this year with the goal of expanding that label for those who are at high risk for medical reasons and may benefit from an RSC vaccine, even if they're younger. And so I would say we agree that a broad label is valuable, but I think it's important to cover as many people as possible, and that's why we're excited by moving forward with our 18 to 59-year-old filing.

Speaker Change: High risk populations, and we intend to file that this year with the goal of expanding that label for those who are at high risk for medical reasons and may benefit from an RSV vaccine, even if they're younger and so I would say we agree that a broad label is valuable, but I think it's important to cover as many people as possible and that's why we're excited by it.

Speaker Change: Going forward with our 18 to 59 year old filings.

Speaker Change: On the question of I N T.

Stephen Hoge: On the question of INT, we have not with our partner, updated yet on where we are in enrolment. Obviously as we had said at ASCO, and there was quite some coverage of risk, we are pleased, very pleased with the pace of enrolment, and we do expect that to conclude quickly, but we have not yet provided any updates and we’ll obviously do so at the appropriate time with our partner, Merck. As it relates to manufacturing, we actually have made great progress there, establishing our Marlborough facility, as well as demonstrating through the clinical trial our ability to manufacture at high volume, frankly commercially relevant volumes, and so we’re--we feel like we’re in a good place in terms of the manufacturing trajectory. It’s still a few months of work to go this year to get to where we want to be, but we’re starting to feel quite optimistic that the manufacturing will be online as and when we hope. Thank you.

Speaker Change: Where.

Speaker Change: We have not with our partner updated yet on where we are in enrollment obviously as we had said at Astro and there was quite some coverage of it's it's been brisk. We are pleased very pleased with the pace of enrollment.

Stephane Bancel: Obviously, as we said at ASCO, and there was quite some coverage of, it's been brisk. We are pleased, very pleased with the pace of enrollment, and we do expect that to conclude quickly, but we have not yet provided any updates, and we'll obviously do so at the appropriate time with our partner, Merck. Now, as it relates to manufacturing, we actually have made great progress there in establishing our mobile facility, as well as demonstrating through the clinical trial our ability to manufacture at high volumes, which is, frankly, commercially relevant. And so we feel like we're in a good place in terms of the manufacturing trajectory. It's still a few months of work to go this year to get to where we want to be, but we're starting to feel quite optimistic that the manufacturing will be online as and when we,

Speaker Change: And we.

Speaker Change: We do expect that to <unk> to conclude.

Stephane Bancel: And so we feel like we're in a good place in terms of the manufacturing trajectory. It's still a few months of work to go this year to get to where we want to be, but we're starting to feel quite optimistic that the manufacturing will be online as and when we, Hey guys, thanks for taking the questions. A few from me.

And so we feel like we're in a good place in terms of the manufacturing trajectory. It's still a few months of work to go this year to get to where we want to be, but we're starting to feel quite optimistic that the manufacturing will be online as and when we,

Stephen Hoge: Thank you. Our next question comes from Evan Wang with Guggenheim Securities. Your line is open.

Jessica Fye: Thank you.

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

Evan Wang: Hey guys, thanks for taking the questions. A few from me. Just first, just given the comments on the higher competitive environment, how are you thinking longer term about the outlook for RSV and COVID versus some of the [inaudible] you made earlier in the year and historically, just given some of the pricing and market share dynamics there? Second, with COVID and the EU tender, what’s your level of confidence in the EU being a meaningful contributor in 2025, and what changes between now and then? You know, does having the combo or potentially having a combo add to competitiveness there? Lastly, I saw that you guys purchased a PRV, is that for use on the combo or the standalone flu, and are you comfortable in getting ahead of the potential June recommendation next year? Thanks.

Stephane Bancel: Just first, given all the comments on the higher competitive environment, how are you thinking longer term about the outlook for RSV and COVID versus some of the efforts you've made earlier in the year and historically, just given some of the pricing and market share dynamics there? Second, with COVID in the EU tender, what's your level of confidence in the EU being a meaningful contributor in 2095? And what changes between now and then? Does, you know, having the combo or potentially having a combo add to competitiveness there? And lastly, I saw that you guys purchased a PRV. Is that for use on a combo or the standalone flu? And are you comfortable in getting ahead of a potential June recommendation next year?

Stephane Bancel: And are you comfortable in getting ahead of a potential June recommendation next year? Thanks, Stphane. So in the high competitive environment for COVID and ISV, what we believe is for ISV, our customers are going to experience the PFS product. And that's going to have the ability to really have kind of a full season to be able to train and get the products for the channel. That will help a lot.

And are you comfortable in getting ahead of a potential June recommendation next year?

Stéphane Bancel: Thanks, this is Stéphane. On the high competitive environment on COVID and RSV, what we believe is on RSV, our customers are going to experience the PFS product, and that’s going to be ability to really have full season, to be able to try and get the products to a channel that will have lots, so we anticipate in ’25 to have better share than in ’24 for the U.S. We’re going to be launching probably outside U.S. markets in ’25, that’s of course we’ll not have sales in ’24, so that’s all going to be important for growth. In COVID, we believe the portfolio in terms of next-gen COVID and then flu plus COVID, it’s going to be an important driver to kind of reset the expectation moving forward and the market dynamics. In terms of the EU, the current contract between Pfizer and the EU ends in 2026, so we think 2025 and 2026 are still going to be low. Some countries have actually used a lot of our vaccine and so we could see some countries in ’25 and more in ’26 needing COVID vaccine and then wanting to diversify their supply base, [inaudible] vaccine as well, given its performance. So as you mentioned the combo, it’s something that we have been discussing quite a lot with governments in Europe. They see the value of a combo given its strong performance, as we’ve shared, to be an important tool for public health in terms of compliance.

Stephane Bancel: So we anticipate a better share than in 2024 for the US. So we're going to be launching all the outside US markets in 2025. But, of course, we don't have sales in 2024. So that's also going to be important for growth. For COVID, we believe the portfolio in terms of next-gen COVID and then 2 plus COVID is going to be an important driver to kind of reset the expectations moving forward and the market dynamics. In terms of the EU, the current contract between Pfizer and the EU ends in 2026. So we think 2025 and 2026 are still going to be low. Some countries have actually used a lot of our vaccines. And so we could see some countries in 2025 and more in 2026 needing the COVID vaccine and then wanting to diversify their supply base with our vaccine as well, given its performance. So as you mentioned, the combo is something that we'll be discussing quite a lot with governments in Europe. They see the value of a combo, given its strong performance, as we've shared, as an important tool for public health in terms of compliance.

Speaker Change: 2012 for the U S. So we're gonna be launching all the outside U S markets in 25 of course, we know that sales in 2012, so that's all going to be important for growth in COVID-19.

Speaker Change: Believes the portfolio in terms of Nexsan Covid event Kupres Caribbean. He said the beautiful and it brought them to drive us to kind of reset the expectation moving forward in the market dynamics.

Stephane Bancel: So that's also going to be important for growth. For COVID, we believe the portfolio in terms of next-gen COVID and then 2 plus COVID is going to be an important driver to kind of reset the expectations moving forward and the market dynamics. In terms of the EU, the current contract between Pfizer and the EU ends in 2026. So we think 2025 and 2026 are still going to be low. Some countries have actually used a lot of our vaccines. And so we could see some countries in 2025 and more in 2026 needing the COVID vaccine and then wanting to diversify their supply base with our vaccine as well, given its performance. So as you mentioned, the combo is something that we'll be discussing quite a lot with governments in Europe. They see the value of a combo, given its strong performance, as we've shared, as an important tool for public health in terms of compliance.

Speaker Change: In terms of the EU.

Speaker Change: The current contract between Pfizer and the EU and in 2026, So we think 2025 and 'twenty only six oxycodone below some countries.

Stéphane Bancel: Some countries have actually used a lot of our vaccine and so we could see some countries in ’25 and more in ’26 needing COVID vaccine and then wanting to diversify their supply base, [inaudible] vaccine as well, given its performance. So as you mentioned the combo, it’s something that we have been discussing quite a lot with governments in Europe. They see the value of a combo given its strong performance, as we’ve shared, to be an important tool for public health in terms of compliance. In a world where governments are worried about people getting their flu shot, and their COVID shot, and their RSV shot, that’s just a lot of shots and nobody likes needles, nobody likes to go to the doctor or to the pharmacist, and so the combo is something that customers are really valuing, so that could be another opportunity in countries when this product is available to go back into growing Europe. The key priority for us in Europe now for 2025 is really launching RSV and growing the business on RSV until we see the flu mono or flu plus COVID launch.

Speaker Change: I've actually used a lot of our vaccine.

Stephane Bancel: And so we could see some countries in 2025 and more in 2026 needing the COVID vaccine and then wanting to diversify their supply base with our vaccine as well, given its performance. So as you mentioned, the combo is something that we'll be discussing quite a lot with governments in Europe. They see the value of a combo, given its strong performance, as we've shared, as an important tool for public health in terms of compliance.

Speaker Change: And so we could see some countries in 'twenty, five and 926 needing COVID-19 vaccine and then walking to the ratify their supply base.

Stéphane Bancel: You know, in a world where governments are worried about people getting their flu shots and their COVID shots and their RSV shots, they're just a lot of shots, and nobody likes needles, or anybody likes to go to the doctor or to the pharmacist. And so the combo is something that our customers are really valuing. And so that could be another opportunity in countries when this product is available to go back into growing Europe. The key priority for us in Europe now for 2025 is really launching RSV and growing the business around RSV until we see the flu mono or the flu plus COVID launch.

Stephane Bancel: And so the combo is something that our customers are really valuing. And so that could be another opportunity in countries when this product is available to go back into growing Europe. The key priority for us in Europe now for 2025 is really launching RSV and growing the business around RSV until we see the flu mono or the flu plus COVID launch. Thank you. Our next question comes from Tyler Van Beurden with TD Securities. Your line is open.

And so the combo is something that our customers are really valuing. And so that could be another opportunity in countries when this product is available to go back into growing Europe. The key priority for us in Europe now for 2025 is really launching RSV and growing the business around RSV until we see the flu mono or the flu plus COVID launch.

Operator: Thank you. Our next question comes from Tyler Van Buren with TD Securities. Your line is open.

Tyler Van Buren: Hi there, this is Greg on behalf of Tyler from TD Securities. I am more interested in your thoughts on the magnitude of the RSV market. [inaudible] small in relation to last year during earnings, so do you agree? And what is your latest thinking on the overall sizes of the RSV market in elderly patients versus the prior that you built you’re your expectations?

Stephane Bancel: And what is your latest thinking on the overall size of the RRSP market in elderly patients versus the prior, [inaudible] So you broke up a little bit during your question. I think we caught the tail end of your question, which is what is the size of the RSV market relative to, you know, what we thought previously? The current organization is what it is, but as Stephen said, we believe it will potentially evolve over time.

And what is your latest thinking on the overall size of the RRSP market in elderly patients versus the prior, [inaudible]

So you broke up a little bit during your question. I think we caught the tail end of your question, which is what is the size of the RSV market relative to, you know, what we thought previously? The current organization is what it is, but as Stephen said, we believe it will potentially evolve over time.

Lavina A. Talukdar: You broke up a little bit during your question. I think we caught the tail end of your question, which is what is the size of the RSV market, relative to what we thought previously?

Speaker Change: Smaller relative to last earnings.

Speaker Change: Earnings though.

Speaker Change: Just didn't know if you agree with that what is your latest thinking on the overall side versus the prior $6 billion to $8 billion as a limitation.

Speaker Change: Yes, So let me try to take a stab at it.

Speaker Change: Sandy.

Speaker Change: In the long run we.

Speaker Change: We believe that.

Speaker Change: Real world evidence data gathered by probably carefully barrels.

Speaker Change: They will most probably be a boost inc.

Tyler Van Buren: Yes, thank you. Just to reiterate quickly, I believe that GSK discussed the RSV market being smaller this year relative to last year [inaudible] earnings. Just didn’t know if you agree with that and what was your latest thinking on the overall size versus the prior $6 billion to $8 billion [inaudible]. The current organization is what it is, but as Stephen said, we believe it will potentially evolve over time.

Speaker Change: They were trying to look at my vision is what it is.

Speaker Change: But as Steven said, we believe between potentially evolve over time.

Steven: This year I think what is interesting is.

Stéphane Bancel: Yes, so let me try to take a stab at it. As Stephen stated, in the long term we believe that as real-world evidence data is gathered by public health leaders, that they will most probably be in for boosting. The current recommendation is what it is, but as Stephen said, we believe it will potentially evolve over time. For this year, I think what is interesting is on paper, it seems that it could be a smaller market. The thing that’s going to be interesting to see how it plays out in terms of market size and number of doses in arms is the guidelines are much more clear than last year, and as you know, sometimes in vaccinations, you get a better reaction from the doctors and pharmacists and consumers with clear guidelines versus not as clear guidelines with larger population potential. Because of those two factors, it’s going to be interesting to see how the season plays out.

Stephane Bancel: And as you know, sometimes with vaccinations, you get a better reaction from doctors and pharmacists and consumers with clear guidelines versus not as clear guidelines with a larger population potential. So because of those two factors, it's going to be interesting to see how the season plays out. Our next question. Oh, sorry about that.

And as you know, sometimes with vaccinations, you get a better reaction from doctors and pharmacists and consumers with clear guidelines versus not as clear guidelines with a larger population potential. So because of those two factors, it's going to be interesting to see how the season plays out.

Operator: [inaudible] Our next question--oh, sorry about that.

Stephen Hoge: I would just comment on the current year market size as well. I think we talked about what we believe the patient population is, which is still sizeable, and we believe that the market will still be overall sizeable this year and similar to last year, if not a little bit more. I think there are other factors at play with those comments, you know, there was a lot of inventory that was--or a lot of sales that happened in the prior year, that customers may be sitting on some of that inventory, so from a revenue perspective that might be different, but from a vaccination rate perspective, we believe that it will still be similar, if not a little bit bigger this year.

Stephane Bancel: Similar, if not a little bit bigger this year. Hi, good morning. This is Addy on for Corey.

Operator: Our next question comes from Cory Kasimov with Evercore. Your line is open.

Cory Kasimov: Hi, good morning. This is Adi on for Cory. I have a question on has the recent summer COVID surge caused any concern for fall vaccinations as the infected population is usually recommended not to get vaccinated for six months post infection, and is the base case for the U.S. COVID revenue similar vaccination as last year, which I think per CDC tracking was 22.5 overall population and 14% for 65 and above?

Stephane Bancel: I have a question about whether the recent summer COVID surge caused any concern for fall vaccination, as the infected population is usually recommended not to get vaccinated for six months post infection? And as the base case for the US COVID revenue is similar vaccination as last year, which I think for CDC tracking was 22.5 overall population and 40% for 65 and above. Yeah, I'll take it.

I have a question about whether the recent summer COVID surge caused any concern for fall vaccination, as the infected population is usually recommended not to get vaccinated for six months post infection? And as the base case for the US COVID revenue is similar vaccination as last year, which I think for CDC tracking was 22.5 overall population and 40% for 65 and above.

Steven: So one for fall vaccination as the infected population is usually recommended not to get vaccinated for six months.

Speaker Change: Post infection and it's the best guess for the U S. Corporate revenue is similar vaccination as last year, which I think for C. D. C tracking was $22 five overall population at 40% plus 65 and above.

Stephen Hoge: Yes, I’ll take it. First, the question on the summer wave and the epidemiology, we’ve seen this multiple years in a row now, and so in some ways, there is a move in certain geographies towards a little bit of a summer wave. It just highlights the fact that this virus is incredibly effectively at spreading, incredibly effective in creating disease even for folks many years after vaccination and other protection, and why we need to protect people for the winter season, because whatever we see in the summer, you see a dramatically higher wave in the November through February time horizon, and so that’s really where we’re trying to protect people for. But in terms of does the summer wave impact, the small summer wave impact the view of the fall wave, it really doesn’t change year-over-year that perspective, and that’s why we’re confident vaccination coverage rates will still be there, and as Jamey said, we see them the same--we hope to do better, but we see them minimally as similar to last year in the United States.

Stephane Bancel: So first, the question on the summer wave and the epidemiology, you know, we've seen this multiple years in a row now. And so, in some ways, there is a move in certain geographies towards a little bit of a summer wave. It just highlights the fact that this virus is incredibly effective at spreading, incredibly effective at creating disease, even for folks many years after, you know, vaccination and other protection, and why we need to protect people during the winter season. Because whatever we see in the summer, you see a dramatically higher wave in the November through February time horizon. And so that's really where we're trying to protect people for. But in terms of the summer wave impact, the small summer wave impact, the view of the fall wave, you know, it really doesn't change year over year. That perspective. And that's why we're confident vaccination coverage rates will still be there. And as Jamie said, we see them the same, we hope to do better, but we see them minimally as similar to last year.

Speaker Change: Yeah, I'll take I'll take it first.

Speaker Change: First the question on the summer wave and the epidemiology, we've seen this multiple years in a row now and so in some ways.

Speaker Change: Yes, there is.

Stephane Bancel: Because whatever we see in the summer, you see a dramatically higher wave in the November through February time horizon. And so that's really where we're trying to protect people for. But in terms of the summer wave impact, the small summer wave impact, the view of the fall wave, you know, it really doesn't change year over year. That perspective. And that's why we're confident vaccination coverage rates will still be there. And as Jamie said, we see them the same, we hope to do better, but we see them minimally as similar to last year.

Stephane Bancel: And that's why we're confident vaccination coverage rates will still be there. And as Jamie said, we see them the same, we hope to do better, but we see them minimally as similar to last year. Thank you, ladies and gentlemen. This concludes the Q&A portion of today's call. I'd like to turn it back to Stphane Bancel for any closing remarks. Well, thank you everybody for joining us, and we look forward to speaking to many of you in the coming days and weeks and, if not, seeing you for R&E Day on September 12th.

And that's why we're confident vaccination coverage rates will still be there. And as Jamie said, we see them the same, we hope to do better, but we see them minimally as similar to last year.

Thank you, ladies and gentlemen. This concludes the Q&A portion of today's call. I'd like to turn it back to Stphane Bancel for any closing remarks. Well, thank you everybody for joining us, and we look forward to speaking to many of you in the coming days and weeks and, if not, seeing you for R&E Day on September 12th.

Operator: Thank you. Ladies and gentlemen, this does conclude the Q&A portion of today’s call. I’d like to turn it back to Stéphane Bancel for any closing remarks.

Stéphane Bancel: Well, thank you everybody for joining us, and we look forward to speaking to many of you in the coming days and weeks, and if not, seeing you for R&D day on September 12th. Have a great day, bye.

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

Speaker Change: [music].

Speaker Change: Yeah.

Speaker Change: [music].

Q2 2024 Moderna Inc Earnings Call

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