Q2 2026 Moderna Inc Earnings Call

July 31, 2026

Operator: Good day, and thank you for standing by. Welcome to the Moderna Q2 2026 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star 1 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.

Operator: Good day, and thank you for standing by. Welcome to the Moderna Q2 2026 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one 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.

Speaker #1: John, you will meet us.

Speaker #2: Good day. Thank you for standing by. Welcome to the Moderna Second Quarter 2026 Conference Call. At this time, all participants are in listen-only mode.

Speaker #2: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 11 on your telephone.

Speaker #2: You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised, today's conference is being recorded.

Speaker #2: I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead.

Speaker #3: Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's second quarter 2026 financial results and business update.

Lavina Talukdar: Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's Q2 2026 financial results and business update. You can access the press release issued this morning, as well as the slides that we will be reviewing by going to the investor section of our website. On today's call are Stéphane Bancel, our Chief Executive Officer, Stephen Hoge, our President, James Mock, our Chief Financial Officer, and David Berman, our Chief Development Officer.

Speaker #3: You can access the press release issued this morning, as well as the slides that we will be reviewing, by going to the investor section of our website.

Speaker #3: On today's call, our Stephane Bancel, our chief executive officer, Stephen Hoge, our president, Jamie Mock, our chief financial officer, and David Berman, our chief development officer.

Speaker #3: 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.

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 two of the accompanying presentation in our SEC filing for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I will now turn the call over to Stéphane.

Speaker #3: 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.

Speaker #3: With that, I will now turn the call over to Stephane.

Speaker #1: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. After my review of the second quarter, Jamie will present our financial results and outlook, followed by Stephane, who will present business updates.

Stéphane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. After my review of the Q2, James will present our financial results and outlook, followed by Stephen with recent business updates. David will review our clinical progress in oncology and rare diseases, and I will close by discussing our key value drivers. As you know, the Q2 is always light for seasonal vaccines. We generated revenue of $0.1 billion, which exceeded the top of our range. Our focus on financial discipline continued. We reduced cash costs by 10% in Q2 compared to the Q2 of 2025. We reported a net loss of $0.8 billion. We ended the quarter with $6.9 billion in cash and investments, maintaining a strong balance sheet while continuing to invest in our pipeline.

Speaker #1: Then David will review our clinical progress in oncology and rare diseases. And then I will close by discussing our key value drivers. As you know, the second quarter is always light for seasonal vaccines.

Speaker #1: We generated revenue of $100 million, which exceeded the top of our range. Our focus on financial discipline continued. We reduced cash cost by 10% in Q2, compared to the second quarter of 2025.

Speaker #1: We reported a net loss of $0.8 billion. We ended the quarter with $6.9 billion in cash and investments, maintaining a strong balance sheet while continuing to invest in our pipeline.

Speaker #1: Overall, I am pleased with our continued execution across the business. The team has done a great job to get us ready for the 2026-2027 vaccination season, and our pipeline is progressing well.

Stéphane Bancel: Overall, I am pleased with our continued execution across the business. This team has done a great job to get us ready for the 2026, 2027 vaccination season, and our pipeline is progressing well. During the quarter, we delivered several important updates across our pipeline. In our respiratory portfolio, our seasonal flu vaccine, mRNA-1010, received a positive recommendation from the US VRBPAC. This represents another important milestone ahead of our 5 August PDUFA date and brings us one step closer to potentially making our flu vaccine available to patients. For norovirus vaccine, mRNA-1403, following an interim analysis, we are preparing to enroll an additional cohort in its phase III trial. In oncology, we are very pleased to present the five-year phase II update of intismeran autogene in combination with KEYTRUDA in adjuvant melanoma at ASCO 2026, highlighting the continued durability of a clinical benefit observed of this program.

Speaker #1: During the quarter, we delivered several important updates across our pipeline. In our respiratory portfolio, our seasonal flu vaccine, mRNA-1010, received a positive recommendation from the US VRBPAC.

Speaker #1: This represents another important milestone ahead of our August 5th PDUFA date and brings us one step closer to potentially making our flu vaccine available to patients.

Speaker #1: For another virus vaccine, mRNA-1403, following an interim analysis, we are preparing to enroll an additional cohort in its Phase 3 trial. In oncology, we are very pleased to present the 5-year Phase 2 update of Intismar and AutoGene in combination with Ketudra in adjuvant melanoma at ASCO 2026.

Speaker #1: Highlighting the continued durability of a clinical benefit observed of this program. We also presented important translation data that provides additional confidence in the mechanism of action of our individualized neoantigen therapy.

Stéphane Bancel: We also presented important translation data that provides additional confidence in the mechanism of action of our individualized neoantigen therapy. Finally, we're excited to announce that dosing has begun in two cancer antigen therapy programs, the phase I/II study of mRNA-4194 in Lynch syndrome, and the phase I study of mRNA-4200 in solid tumors. Beyond our pipeline, we also had several notable corporate achievements during the quarter. We were pleased to expand our partnership with CEPI to explore the development of an Ebola vaccine, reinforcing our longstanding commitment to global health security and pandemic preparedness. We were also honored to be named the world's most impactful company by "Time" magazine, recognizing our pioneering work in mRNA science. This recognition reflects both the global impact we made during the pandemic and our continued effort to advance a broad pipeline of innovative medicine and extend access to mRNA technology worldwide.

Stéphane Bancel: We also presented important translation data that provides additional confidence in the mechanism of action of our individualized neoantigen therapy. Finally, we're excited to announce that dosing has begun in two cancer antigen therapy programs, the phase I/II study of mRNA-4194 in Lynch syndrome, and the phase I study of mRNA-4200 in solid tumors. Beyond our pipeline, we also had several notable corporate achievements during the quarter. We were pleased to expand our partnership with CEPI to explore the development of an Ebola vaccine, reinforcing our longstanding commitment to global health security and pandemic preparedness. We were also honored to be named the world's most impactful company by "TIME" magazine, recognizing our pioneering work in mRNA science. This recognition reflects both the global impact we made during the pandemic and our continued effort to advance a broad pipeline of innovative medicine and extend access to mRNA technology worldwide.

Speaker #1: And finally, we're excited to announce that dosing has begun in two cancer antigen therapy programs—the Phase 1/2 study of mRNA-4194 in Lynch syndrome, and the Phase 1 study of mRNA-4200 in solid tumors.

Speaker #1: Beyond our pipeline, we also had several notable corporate achievements during the quarter. We are pleased to expand our partnership with CEPI to explore the development of an Ebola vaccine, reinforcing our longstanding commitment to global health security and pandemic preparedness.

Speaker #1: We were also honored to be named the world's most impactful company by Time Magazine, recognizing our pioneering work in mRNA science. This recognition reflects both the global impact we made during the pandemic and our continued efforts to advance a broad pipeline of innovative medicines, and expand access to mRNA technology worldwide.

Speaker #1: Turning now to our leadership team, I'd like to highlight two important appointments to announce this quarter. As we continue to strengthen Moderna for the next phase of growth, I am very pleased to welcome Elster Bank as our new Chief Commercial Officer.

Stéphane Bancel: Turning now to our leadership team. I'd like to highlight two important appointments we announced this quarter. As we continue to strengthen Moderna for the next phase of growth, I am very pleased to welcome Ester Banque as our new chief commercial officer. Ester joins us with more than 30 years of commercial leadership experience and an outstanding track record of leading high-performing organizations across the healthcare industry. More recently, she led US operation at Zoetis, and before that, held several commercial leadership roles at BMS and Novartis, where she helped bring important medicines to patients around the world. Ester now leads our global commercial organization as we prepare for multiple launches and continue expanding into new markets. We're delighted to have Ester join Moderna and have been enjoying working closely with her. I'm also pleased to welcome Michael McDonnell to Moderna's board of directors.

Speaker #1: Elster will join us with more than 30 years of commercial leadership experience and an outstanding track record of leading high-performing organizations across the healthcare industry.

Speaker #1: More recently, she led U.S. operations at Zoetis, and before that, held several commercial leadership roles at BMS and Novartis, where she helped bring important medicines to patients around the world.

Speaker #1: Elster now leads our global commercial organization as we prepare for multiple launches and continue expanding into new markets. We are delighted to have Elster join Moderna and have been enjoying working closely with her.

Speaker #1: I am also pleased to welcome Michael McDonald to Moderna's Board of Directors. Michael is familiar to many of you, as most recently he served as Executive Vice President and Chief Financial Officer of Biogen.

Stéphane Bancel: Michael is familiar to many of you, as most recently, he served as executive vice president and chief financial officer of Biogen. Michael brings more than two decades of public company CFO experience and deep expertise across finance, capital markets, investor relations, and corporate governance. His experience across the life science and technology sectors will be a valuable addition to our board as we continue to execute our strategy and create long-term value. We are delighted to welcome Michael to Moderna's board. With that, I will now talk to Jamey.

Speaker #1: Michael brings more than two decades of public company CFO experience, and deep expertise across finance, capital markets, investor relations, and corporate governance. His experience across the life science and technology sectors will be a valuable addition to our board as we continue to execute our strategy and create long-term value.

Speaker #1: We are delighted to welcome Michael to Moderna's board. With that, I will now turn it over to Jamie.

Speaker #2: Thanks, Stephane, and hello, everyone. Today, I'll start with our second quarter financial results and then review our updated financial framework for 2026. Let me start with our commercial performance.

James Mock: Thanks, Stéphane, and hello, everyone. Today, I'll start with our Q2 financial results and then review our updated financial framework for 2026. Let me start with our commercial performance. For Q2, total revenue was $145 million, above the guidance range we provided on the Q1 call. Our geographic mix for the quarter was 60% US and 40% international. For H1, total revenue was $0.5 billion, with 31% from the US and 69% from international markets. Our long-term strategic partnerships drove the strong international contribution during H1. Overall, we are pleased with our H1 performance and are reiterating our expectation for revenue growth of up to 10% in 2026. We continue to expect a roughly 50/50 split between US and international revenue for the full year, and we expect Q3 revenue will represent approximately 55% of our H2 revenue.

Speaker #2: For the second quarter, total revenue was $145 million, above the guidance range we provided on the first quarter call. Our geographic mix for the quarter was 60% U.S. and 40% international.

Speaker #2: For the first half of the year, total revenue was $0.5 billion, with 31% from the US and 69% from international markets. Our long-term strategic partnerships drove the strong international contribution during the first half.

Speaker #2: Overall, we are pleased with our first-half performance and are reiterating our expectation for revenue growth of up to 10% in 2026. We continue to expect a roughly 50/50 split between U.S. and international revenue for the full year, and we expect third-quarter revenue will represent approximately 55% of our second-half revenue.

Speaker #2: Now let me turn to our second quarter financial performance on slide 10. As I just mentioned, revenue was $145 million in the quarter, up 2% from the prior year.

James Mock: Now let me turn to our Q2 financial performance on slide 10. As I just mentioned, revenue was $145 million in the quarter, up 2% from the prior year. Cost of sales for the quarter was $93 million, a 22% decrease compared to the prior year, primarily driven by lower unutilized manufacturing capacity costs as we continue to improve our manufacturing efficiency. R&D expenses for the quarter were $651 million, a 7% decrease compared to last year. The decline was driven by lower clinical development costs following the wind-down of several late-stage programs. SG&A expenses for the quarter were $216 million, down 6% from last year, reflecting continued cost discipline across the organization. Our income tax provision was immaterial in both periods, as we continue to maintain a global valuation allowance, which limits our ability to recognize tax benefits from losses.

Speaker #2: Cost of sales for the quarter was $93 million, a 22% decrease compared to the prior year, primarily driven by lower unutilized manufacturing capacity costs as we continue to improve our manufacturing efficiency.

Speaker #2: R&D expenses for the quarter were $651 million, a 7% decrease compared to last year. The decline was driven by lower clinical development costs, following the wind-down of several late-stage programs.

Speaker #2: SG&A expenses for the quarter were $216 million. Down 6% from last year. Reflecting continued cost discipline across the organization. Our income tax provision was immaterial in both periods, as we continue to maintain a global valuation allowance, which limits our ability to recognize tax benefits from losses.

Speaker #2: Net loss for the quarter was $782 million, improving by $43 million, or 5%, compared to last year. Loss per share was $1.97 for the quarter, compared to $2.13 last year.

James Mock: Net loss for the quarter was $782 million, improving by $43 million, or 5%, compared to last year. Loss per share was $1.97 for the quarter, compared to $2.13 last year. We ended the quarter with cash and investments of $6.9 billion, compared to $7.5 billion at the end of Q1. The decrease primarily reflected cash used to fund operations as we continued to invest in R&D and advance our pipeline. In July, we paid $950 million related to the litigation settlement announced earlier this year, which will be reflected in our Q3 cash balance. Now let's turn to our financial framework for 2026.

Speaker #2: We ended the quarter with cash and investments of $6.9 billion, compared to $7.5 billion at the end of the first quarter. The decrease primarily reflected cash used to fund operations as we continued to invest in R&D and advance our pipeline.

Speaker #2: In July, we paid $950 million related to the litigation settlement announced earlier this year, which will be reflected in our third quarter cash balance.

Speaker #2: Now, let's turn to our financial framework for 2026. We still expect total revenue to grow up to 10% in 2026, with the geographic mix and quarterly phasing I previously mentioned.

James Mock: We still expect total revenue to grow up to 10% in 2026, with the geographic mix and quarterly phasing I previously mentioned. Our 2026 revenue guidance factors in potential future declines in COVID vaccination rates and continues to assume no revenue from mFlusiva and mCOMBRIAX. We are lowering our cost of sales projection by $0.1 billion to $1.7 billion, reflecting additional manufacturing efficiency gains. The $1.7 billion estimate includes $0.9 billion of expense related to the previously announced litigation settlement charge. We are also lowering our R&D expense estimate by $0.1 billion to $2.9 billion due to operational efficiencies. SG&A expenses are still expected to be approximately $1 billion flat versus the prior year. Similar to 2025, our commercial spend will be more heavily weighted to H2 due to the seasonality of our business.

Speaker #2: Our 2026 revenue guidance factors in potential future declines in COVID vaccination rates, and continues to assume no revenue from mPlusiva and mCambriaX. We are lowering our cost of sales projection by $0.1 billion, to $1.7 billion, reflecting additional manufacturing efficiency gains.

Speaker #2: The $1.7 billion estimate includes $0.9 billion of expense related to the previously announced litigation settlement charge. We are also lowering our R&D expense estimate by $0.1 billion.

Speaker #2: To $2.9 billion, due to operational efficiencies. SG&A expenses are still expected to be approximately $1 billion, flat versus the prior year. Similar to 2025, our commercial spend will be more heavily weighted to the second half of the year, due to the seasonality of our business.

Speaker #2: In aggregate, excluding the $0.9 billion litigation charge, we are expecting total gap operating expenses of $4.7 billion, and $4 billion of cash costs, which excludes stock-based compensation, depreciation, and amortization.

James Mock: In aggregate, excluding the $0.9 billion litigation charge, we are expecting total GAAP operating expenses of $4.7 billion and $4 billion of cash costs, which excludes stock-based compensation, depreciation, and amortization. Each reflect a $0.2 billion improvement compared to our previous guidance. We expect taxes to be negligible in 2026. Capital expenditures are still projected to be between $0.2 and $0.3 billion. Cash and investments are now projected to be between $4.7 and $5.2 billion at the end of 2026, which reflect the improvement in our cash cost guidance. As a reminder, our cash guidance does not assume any additional drawdown from our remaining $0.9 billion undrawn credit facility. With that, I will now turn the call over to Stephen.

Speaker #2: Each reflects a 0.2 billion improvement compared to our previous guidance. We expect taxes to be negligible in 2026. Capital expenditures are still projected to be between $0.2 and $0.3 billion, cash and investments are now projected to be between $4.7 and $5.2 billion at the end of 2026, which reflect the improvement in our cash cost guidance.

Speaker #2: As a reminder, our cash guidance does not assume any additional drawdown from our remaining $0.9 billion undrawn credit facility. With that, I will now turn the call over to Stephane.

Speaker #1: Thank you, Jamie. And good morning or good afternoon, everyone. Today, I'll take you through our recent business updates. Slide 13 outlines our multi-year revenue growth strategy, anchored in geographic expansion and portfolio expansion from the continued advancement of our product pipeline.

Stephen Hoge: Thank you, Jamie, and good morning or good afternoon, everyone. Today, I will take you through our recent business updates. Slide 13 outlines our multi-year revenue growth strategy, anchored in geographic expansion and portfolio expansion from the continued advancement of our product pipeline. For 2026, we continue to expect revenue growth of up to 10%, driven by our long-term strategic partnerships in the United Kingdom, Canada, and Australia, and supported by the continued growth of mNEXSPIKE. Looking across the three-year horizon, we are building toward a broader and more diversified portfolio, including flu, our combination flu and COVID vaccine, and norovirus, as well as late-stage programs in oncology and rare disease, while continuing to expand our global commercial footprint. We are making tangible progress against this strategy, mNEXSPIKE is now approved in Japan and Taiwan.

Speaker #1: For 2026, we continue to expect revenue growth of up to 10%, driven by our long-term strategic partnerships in the United Kingdom, Canada, and Australia, and supported by the continued growth of Mnexspike.

Speaker #1: Looking across the three-year horizon, we are building toward a broader and more diversified portfolio, including flu, our combination flu and COVID vaccine, and norovirus.

Speaker #1: As well as late-stage programs in oncology and rare disease, while continuing to expand our global commercial footprint. We're making tangible progress against this strategy.

Speaker #1: Mnexspike is now approved in Japan and Taiwan. Our flu program received a unanimous recommendation from the VRBPAC FDA advisory committee, and we signed a joint procurement contract with the European Commission for up to 24 million doses of mRESVIA across six countries.

Stephen Hoge: Our flu program received a unanimous recommendation from the VRBPAC FDA advisory committee. We signed a joint procurement contract with the European Commission for up to 24 million doses of mRESVIA across six countries. We also received approval for mRESVIA in Mexico and a label expansion for the product in Australia. In Latin America, we advanced our strategic partnership in Brazil by signing an agreement with a local manufacturer to support our multi-year COVID vaccine supply agreement with the government. Finally, as our commercial portfolio expands, emerging real-world evidence strengthens the support for our respiratory portfolio. Slide 14 highlights our approved infectious disease portfolio and several recent updates across the products. Starting with COVID, health authorities in the United States and Europe have selected the XFG strain for the 2026-2027 season, and we are updating both SPIKEVAX and mNEXSPIKE to target this strain for the upcoming vaccination season.

Speaker #1: We also received approval for mrezvia in Mexico, and a label expansion for the product in Australia. In Latin America, we advanced our strategic partnership in Brazil by signing an agreement with a local manufacturer to support our multi-year COVID vaccine supply agreement with the government.

Speaker #1: Finally, as our commercial portfolio expands, emerging real-world evidence strengthens that support for our respiratory portfolio. Slide 14 highlights our approved infectious disease portfolio and several recent updates across the products.

Speaker #1: Starting with COVID, health authorities in the United States and Europe have selected the XFG strain for the 2026-2027 season, and we are updating both SpikeVax and mRNA-1283, also known as mNexSpike, to target this strain for the upcoming vaccination season.

Speaker #1: For Spikevax, we also recently published a real-world evidence study—a link to the study is included on this slide. mRNA-1283 Spike is now approved in the United States, Europe, Canada, Australia, and, as mentioned earlier, now in Japan and Taiwan.

Stephen Hoge: For SPIKEVAX, we also recently published a real-world evidence study. A link to the study is included on this slide. mNEXSPIKE is now approved in the United States, Europe, Canada, Australia, and as mentioned earlier, now in Japan and Taiwan. Additional filings are planned for H2 2026. We also published a real-world evidence study evaluating the adjusted vaccine effectiveness against COVID-related hospitalization during the most recent 2025-2026 season, which I will discuss in more detail shortly. Turning to mRESVIA, which is approved in 44 countries, most recently, it was approved in Mexico for all adults aged 60 and older, as well as high-risk adults aged 18 to 59. We also received a label expansion in Australia to include high-risk adults aged 18 to 59. In addition, a real-world evidence study evaluating vaccine effectiveness against hospitalization and associated with RSV-related acute respiratory illness was published for mRESVIA.

Speaker #1: Additional filings are planned for the second half of 2026. We also published a real-world evidence study evaluating the adjusted vaccine effectiveness against COVID-related hospitalization during the most recent 2025-2026 season.

Speaker #1: Which I will discuss in more detail shortly. Turning to MRESVIA, which is approved in 44 countries. Most recently, it was approved in Mexico for all adults aged 60 and older, as well as high-risk adults aged 18 to 59.

Speaker #1: We also received a label expansion in Australia to include high-risk adults aged 18 to 59. In addition, a real-world evidence study evaluating vaccine effectiveness against hospitalization and associated with RSV-related acute respiratory illness was published for mrezvia.

Speaker #1: Finally, mRNA-1010 is now approved in the European Union and is under review in Canada, Australia, and most recently, Japan. In the United States, we are awaiting approval of our standalone flu vaccine before seeking further guidance from the FDA on next steps for refiling the combo here.

Stephen Hoge: Finally, mCOMBRIAX is now approved in the European Union and is under review in Canada, Australia, and most recently, Japan. In the United States, we are awaiting approval of our stand-alone flu vaccine before seeking further guidance from the FDA on next steps for refiling the combo here. Slide 15 highlights the emerging real-world evidence supporting mNEXSPIKE's clinical profile. As a reminder, during its first season on the market in 2025-2026, mNEXSPIKE captured approximately 24% of the total US retail COVID vaccine market. Uptake was particularly strong among older adults, with mNEXSPIKE accounting for approximately 34% of the retail market among individuals aged 65 and older. This market uptake was supported in part by the phase III head-to-head data of mNEXSPIKE versus SPIKEVAX.

Speaker #1: Slide 15 highlights the emerging real-world evidence supporting Mnexspike's clinical profile. As a reminder, during its first season on the market in 2025–2026, Mnexspike captured approximately 24% of the total U.S. retail COVID vaccine market.

Speaker #1: Uptake was particularly strong among older adults, with Mnexspike accounting for approximately 34% of the retail market among individuals aged 65 and older. This market uptake was supported in part by the Phase III head-to-head data of Mnexspike versus Spikevax.

Speaker #1: The subsequent real-world analysis evaluated adjusted vaccine effectiveness against hospitalization with documented COVID-19 during the 2025-2026 season. Among adults aged 65 and older, vaccine effectiveness was approximately 59% for Mnexspike, compared with a matched unvaccinated cohort.

Stephen Hoge: The subsequent real-world analysis evaluated adjusted vaccine effectiveness against hospitalization with documented COVID-19 during the 2025-2026 season. Among adults aged 65 and older, vaccine effectiveness was approximately 59% for mNEXSPIKE compared with a matched unvaccinated cohort. Among adults aged 75 and older, it was approximately 67%. These estimates were numerically higher than those observed for a competitor vaccine in separately matched analysis. While this real-world study was not designed as a head-to-head comparison, the numerical differences are encouraging, particularly when considered alongside the vaccine efficacy observed for mNEXSPIKE versus SPIKEVAX in the phase III head-to-head trial. Taken together, the strong initial market uptake and the emerging real-world evidence highlight mNEXSPIKE's potential, particularly among older adults.

Speaker #1: Among adults aged 75 and older, it was approximately 67%. These estimates were numerically higher than those observed for a competitor vaccine in a separately matched analysis.

Speaker #1: While this real-world study was not designed as a head-to-head comparison, the numerical differences are encouraging, particularly when considered alongside the vaccine efficacy observed for mRNA-1283 versus SpikeVax in the Phase III head-to-head trial.

Speaker #1: Taken together, the strong initial market uptake and the emerging real-world evidence highlight Mnexspike's potential, particularly among older adults. Turning now to our late-stage infectious disease pipeline, and starting with flu, we are grateful for the unanimous VervePak recommendation for mRNA-1010 and look forward to the potential for approval with the PDUFA date of August 5th in the United States.

Stephen Hoge: Turning now to our late-stage infectious disease pipeline, and starting with flu, we are grateful for the unanimous VRBPAC recommendation for mRNA-1010 and look forward to the potential for approval with the PDUFA date of 5 August in the United States. mRNA-1010 is also under review in the European Union, Canada, and Australia. The efficacy and safety results from our phase III study were recently published in The New England Journal of Medicine. A link to the publication is included at the bottom of the slide. For our norovirus vaccine, mRNA-1403, the phase III study did not meet the statistical criteria for early success at its interim analysis. The study remains blinded as we now prepare to enroll an additional fourth cohort. With that, I will now turn the call over to David, who will provide a more detailed update on our oncology and rare disease pipelines.

Speaker #1: mRNA-1010 is also under review in the European Union, Canada, and Australia. The efficacy and safety results from our Phase III study were recently published in the New England Journal of Medicine.

Speaker #1: A link to the publication is included at the bottom of the slide. For our norovirus vaccine, mRNA-1403, the Phase 3 study did not meet the statistical criteria for early success at its interim analysis.

Speaker #1: The study remains blinded as we now prepare to enroll an additional, fourth cohort. With that, I will now turn the call over to David, who will provide a more detailed update on our oncology and rare disease pipelines.

Speaker #2: Thanks. Thank you, Stephen. Before I begin the review of our oncology and rare disease pipeline, I want to take a moment to say how excited I am to be here.

David Berman: Thank you, Stephen. Before I begin the review of our oncology and rare disease pipeline, I want to take a moment to say how excited I am to be here. Before joining Moderna, I followed the company's oncology portfolio, and intismeran in particular, very closely. The strength and potential of the pipeline were an important part of what attracted me to the Chief Development Officer role. Since joining the company and spending time with the teams, I have become even more impressed by the quality of the science, the depth of the programs, and the opportunities ahead of us. With that, let me take you through the progress we are making across our oncology and rare disease pipeline. Starting with intismeran, our individualized cancer therapy developed in partnership with Merck, the program continues to advance across a broad portfolio of nine phase II and phase III studies.

Speaker #2: Before joining Moderna, I followed the company's oncology portfolio—and Tismaran, in particular—very closely. The strength and potential of the pipeline were an important part of what attracted me to the Chief Development Officer role.

Speaker #2: Since joining the company and spending time with the teams, I have become even more impressed by the quality of the science, the depth of the programs, and the opportunities ahead of us.

Speaker #2: With that, let me take you through the progress we are making across our oncology and rare disease pipeline. Starting within Tisotumab, our individualized cancer therapy developed in partnership with Merck, the program continues to advance across a broad portfolio of nine Phase II and Phase III studies.

Speaker #2: In adjuvant melanoma, the Phase III study is fully enrolled, and we look forward to the interim analysis in 2026. At ASCO, we presented the five-year update from the Phase II study of Tisagen in combination with Keytruda in the adjuvant melanoma setting, as well as translational data demonstrating the induction of de novo neoantigen-specific T cells following treatment.

David Berman: In adjuvant melanoma, the phase III study is fully enrolled, and we look forward to the interim analysis in 2026. At ASCO, we presented the five-year update from the phase II study of intizomeran in combination with KEYTRUDA in the adjuvant melanoma setting, as well as translational data demonstrating the induction of de novo neoantigen-specific T-cells following treatment. A link to our ASCO investor event presentation is on the bottom of this slide. Our phase III development program also includes studies in adjuvant non-small cell lung cancer, including a phase III study in patients without a pathologic complete response following neoadjuvant therapy, as well as the recently initiated stage 1 study evaluating intizomeran both as monotherapy and in combination with KEYTRUDA QLEX. Across the phase II portfolio, the adjuvant renal cell carcinoma and muscle-invasive bladder cancer studies are fully enrolled and continue to accrue events.

Speaker #2: A link to our ASCO investor event presentation is at the bottom of this slide. Our Phase III development program also includes studies in adjuvant non-small cell lung cancer, including a Phase III study in patients without a pathologic complete response following neoadjuvant therapy, as well as the recently initiated Stage I study evaluating IntisMiran both as monotherapy and in combination with Keytruda/CTX.

Speaker #2: Across the Phase II portfolio, the adjuvant renal cell carcinoma and are fully enrolled and continue to accrue events. We are often asked when we expect these studies to read out.

David Berman: We are often asked when we expect these studies to read out. Because both studies are event-driven, it is difficult to predict the timing with precision. The renal cell carcinoma study has been fully enrolled since Q2 2025, so it is possible that the threshold for the analysis could be reached this year. However, it is also possible that this occurs next year. It depends on the pace of event accrual. The muscle-invasive bladder cancer study completed enrollment earlier this year, and we currently expect the readout to be more likely in 2027, again, subject to the timing of event accrual. Non-muscle invasive bladder cancer study continues to enroll. As a reminder, this trial is evaluating both intizomeran with BCG in combination as well as intizomeran monotherapy.

Speaker #2: Because both studies are event-driven, it is difficult to predict the timing with precision. The renal cell carcinoma study has been fully enrolled since the second quarter of 2025, so it is possible that the threshold for the analysis could be reached this year.

Speaker #2: However, it is also possible that this occurs next year. It depends on the pace of event accrual. The muscle invasive bladder cancer study completed enrollment earlier this year, and we currently expect the readout to be more likely in 2027.

Speaker #2: Again, subject to the timing of event accrual. Non-muscle invasive bladder cancer study continues to enroll. As a reminder, this trial is evaluating both in Tismaran with BCG in combination, as well as in Tismaran monotherapy.

Speaker #2: Beyond the late-stage portfolio, our Phase I studies in adjuvant pancreatic cancer, and perioperative gastric cancer, are also fully enrolled. And we look forward to sharing data from these programs as they mature.

David Berman: Beyond the late-stage portfolio, our phase I studies in adjuvant pancreatic cancer and perioperative gastric cancer are also fully enrolled, and we look forward to sharing data from these programs as they mature. Taken together, the breadth and continued execution across the intizomeran program reflect our commitment to evaluating this therapy across multiple tumor types and stages of disease. Outside of intizomeran, we continue to advance a broad portfolio of oncology programs across cancer antigen therapies, T-cell engagers, and cell therapy enhancement. mRNA-4359 is in a phase II program in first-line metastatic melanoma and second-line or later metastatic melanoma. It is also being evaluated in first-line metastatic non-small cell lung cancer. We are also advancing two additional cancer antigen therapies, mRNA-4106 and mRNA-4200, in a phase I study in patients with advanced solid tumors.

Speaker #2: Taken together, the breadth and continued execution across the Intisiman program reflect our commitment to evaluating this therapy across multiple tumor types and stages of disease.

Speaker #2: Outside of in Tismaran, we continue to advance a broad portfolio of oncology programs across cancer antigen therapies, T cell engagers, and cell therapy enhancement.

Speaker #2: mRNA-4359 is in a Phase II program in first-line metastatic melanoma and second-line or later metastatic melanoma. It is also being evaluated in first-line metastatic non-small cell lung cancer.

Speaker #2: We are also advancing two additional cancer antigen therapies, mRNA-4106 and mRNA-4200, in a Phase I study in patients with advanced solid tumors. I am pleased to report that dosing has now begun with mRNA-4200, alongside the ongoing evaluation of mRNA-4106.

David Berman: I am pleased to report that dosing has now begun with mRNA-4200 alongside the ongoing evaluation of mRNA-4106. In addition, mRNA-4194 has entered clinical development with dosing now underway in a phase I/II study in individuals with Lynch syndrome. This program is designed to evaluate the potential of our technology in an earlier cancer interception setting. Our T-cell engager, mRNA-2808, also continues to advance in a phase I/II study in multiple myeloma, with patients actively dosing. Finally, in collaboration with Immatics, dosing continues in the phase I study of mRNA-4203 in combination with the anzu-cel therapy. These programs demonstrate the breadth of our oncology pipeline and the continued progress we are making across several distinct therapeutic approaches. Moving now to slide 20. In rare diseases, our propionic acidemia, or PA program, is fully enrolled in its registrational study, and we expect data from the study in 2026.

Speaker #2: In addition, mRNA-4194 has entered clinical development, with dosing now underway in a Phase I/II study in individuals with Lynch syndrome. This program is designed to evaluate the potential of our technology in an earlier cancer interception setting.

Speaker #2: Our T cell engager, mRNA-2808, also continues to advance in a Phase I/II study in multiple myeloma, with patients actively dosing. Finally, in collaboration with Immatics, dosing continues in the Phase I study of mRNA-4203 in combination with the Anzu cell therapy.

Speaker #2: These programs demonstrate the breadth of our oncology pipeline and the continued progress we are making across several distinct therapeutic approaches. Moving now to slide 20—in rare diseases, our propionic acidemia, or PA, program is fully enrolled in its registrational study, and we expect data from the study in 2026.

David Berman: These programs demonstrate the breadth of our oncology pipeline and the continued progress we are making across several distinct therapeutic approaches. Moving now to slide 20. In rare diseases, our propionic acidemia, or PA program, is fully enrolled in its registrational study, and we expect data from the study in 2026. For our methylmalonic acidemia, or MMA program, as mentioned last quarter, we have deferred our decision on a pivotal trial until the PA readout. With this review, I will now hand it over to Stéphane.

Speaker #2: For our methylmalonic acidemia, or MMA, program, as mentioned last quarter, we have deferred our decision on a pivotal trial until the PA readout. With this review, I will now hand it over to Stephane.

David Berman: For our methylmalonic acidemia, or MMA program, as mentioned last quarter, we have deferred our decision on a pivotal trial until the PA readout. With this review, I will now hand it over to Stéphane.

Speaker #3: Thank you, David, Stephane, and Jamie. Looking at the second half of the year, on the commercial and financial side, we remain on track for up to 10% revenue growth this year.

Stéphane Bancel: Thank you, David, Stephen, and Jamie. Looking at H2 of the year, on the commercial and financial side, we remain on track for up to 10% revenue growth this year, and also remain committed to improving our operational efficiency and achieving our new lower cash cost guidance of approximately $4 billion. We also expect to build on last year's success, mNEXSPIKE launch, and to continue expanding across recovered patients around the world. We look forward to approvals for mCOMBRIAX in Canada and Japan. Following the positive recommendation from the US VRBPAC, we now look forward to the 5 August PDUFA date and potential approval of our seasonal flu vaccine in the US. We also anticipate approval for flu in Canada and Europe. From a pipeline perspective, oncology remains a key focus with important milestones ahead for intizomeran in multiple tumor types.

Speaker #3: And also, we remain committed to improving our operational efficiency and achieving our new, lowered cash cost guidance of approximately $4 billion. We also expect to build on last year's success, MRM's next pike launch, and to continue expanding across the COVID patient base around the world.

Speaker #3: We look forward to approvals for mRNA vaccines in Canada and Japan. Following the positive recommendation from the U.S. via PAC, we now look forward to the August 5 PDUFA date and the potential approval of our seasonal flu vaccine in the U.S.

Speaker #3: We also anticipate approval for flu in Canada and Europe. From a pipeline perspective, oncology remains a key focus with important milestones ahead for intisamran in multiple tumor types.

Speaker #3: As David said, regarding our research and study in PA, we expect data this year. We have a busy second half of the year ahead of us.

Stéphane Bancel: As David said, our registrational study in PA, we expect data this year. We have a busy H2 of the year ahead of us. Success will come from disciplined execution across our key priorities, and I'm confident in our team's ability to deliver. We will be happy to host you in Cambridge or online for Analyst Day on 12 November. Finally, I would like to thank our employees around the world for their continued commitment to our mission and for everything they have accomplished this quarter. With that, operator, we'll be happy to take questions.

Speaker #3: Success will come from disciplined execution across our key priorities, and I'm confident in our team's ability to deliver. We will be happy to host you in Cambridge or online for our Analyst Day on November 12.

Speaker #3: Finally, I would like to thank our employees around the world for their continued commitment to our mission and for everything they have accomplished this quarter.

Speaker #3: With that, operator, we'll be happy to take questions.

Speaker #1: Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press *11 on your telephone. If your question has been answered, or you wish to remove yourself from the queue, please press *11 again.

Operator: Thank you. Ladies and gentlemen, if you have a question or comment at this time, please press star one one on your telephone. If your question has been answered and you wish to remove yourself from the queue, please press star one one 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 #1: We'll pause for a moment while we compile our Q&A roster. Our first question comes from Salvian Richter with Goldman Sachs. Your line is open.

Speaker #4: Good morning. Thanks for taking my question. I have two questions. The first is, in the case that the Phase 3 Intisiran melanoma study passes the first interim and progresses to a second and/or final analysis, how should we interpret that in the context of powering and event accrual?

Salveen Richter: Good morning. Thanks for taking my question. Two questions from me. One is, in the case that the phase III intizomeran melanoma study passes the first interim and progresses to a second and/or final analysis, how should we interpret that in the context of powering an event accrual, and how detailed will your disclosure be? The second question for me is, if the trial is indeed positive here, how do we think about read-through to other tumor types like lung in the context of tumor mutational burden, but also the fact that you're talking about different neoantigens that play the key role there as you think about the cassette? Thank you.

Speaker #4: And how detailed will your disclosure be? And the second question from me is, if the trial is indeed positive here, how do we think about read-through to other tumor types, like lung, in the context of tumor mutational burden, but also the fact that you're talking about different neoantigens that play the key role there, as you think about the cassette?

Speaker #4: Thank you.

Speaker #2: Thank you very much, a lot of questions in there. I think with regard to the Phase III to your first question, if the Phase III INT study in melanoma continues, it continues.

David Berman: Thank you very much. A lot of questions in there. I think with regard to your first question, if the phase III INT study in melanoma continues, it continues. We haven't disclosed the statistical powering or the thresholds for early interim efficacy. I think I won't really address any more about that. With regard to the press release, I think it's too early. Let's see what the data is, we'll figure out what exactly the wording will be in the press release. I think with your other question, if intizomeran is positive, what's the read-through? I think it's a very important question, one I've given a lot of thought to. I think there are several important things we need to see here. One is, what is the degree of efficacy that we see? Number two, are we confident that the mechanism that we see can be validated?

Speaker #2: We haven't disclosed the statistical powering or the thresholds for early interim efficacy. So I think I won't really address any more about that. With regard to the press release, I think it's too early.

Speaker #2: Let's see what the data is, and then we'll figure out what exactly the wording will be in the press release. I think with your other question, if in Tismaran is positive, what's the read-through?

Speaker #2: I think it's a very important question, one I've given a lot of thought to. I think there are several important things we need to see here.

Speaker #2: First, what is the degree of efficacy that we see? Second, are we confident that the mechanism we observe can be validated?

Speaker #2: And I think with regard to that, the answer that the data that we've shown at ASCO confirms that we do give when we give the neoantigen vaccine, we do see neoantigen-specific T cells and we know those T cells can kill the tumor.

David Berman: I think with regard to that, the data that we've shown at ASCO confirms that when we give the neoantigen vaccine, we do see neoantigen-specific T cells, and we know those T cells can kill the tumor. I think that we have moved to other tumors where checkpoints do work, and we know that this mechanism that I just talked about is the mechanism by which other checkpoints do work, since checkpoints work in lung cancer and bladder, I think that gives us increased reason to believe in bladder. I think the big question comes out in tumors where checkpoints don't work, and that's pancreatic cancer and to a lesser degree, gastric. That's why we're conducting phase II trials and phase II expanded trials in those other tumors.

David Berman: I think with regard to that, the data that we've shown at ASCO confirms that when we give the neoantigen vaccine, we do see neoantigen-specific T-cells, and we know those T cells can kill the tumor. I think that we have moved to other tumors where checkpoints do work, and we know that this mechanism that I just talked about is the mechanism by which other checkpoints do work, since checkpoints work in lung cancer and bladder, I think that gives us increased reason to believe in bladder. I think the big question comes out in tumors where checkpoints don't work, and that's pancreatic cancer and to a lesser degree, gastric. That's why we're conducting phase II trials and phase II expanded trials in those other tumors.

Speaker #2: So, I think that we have moved to other tumors where checkpoints do work, and we know that this mechanism that I just talked about is the mechanism by which other checkpoints do work.

Speaker #2: And so, since checkpoints work in lung cancer and bladder, I think that gives us increased reason to believe in bladder. I think the big question comes up in tumors where checkpoints don't work, and that's pancreatic cancer and, to a lesser degree, gastric.

Speaker #2: So that's why we're conducting Phase II trials and Phase I expanded trials in those other tumors.

Speaker #1: And Salvian, maybe on your first question, just to fill in a little bit—as David said, we haven't disclosed the statistical analysis plan. But suffice it to say, it's an interim analysis.

Stéphane Bancel: Salveen, maybe on your first question, just to fill in a little bit, as David said, we haven't disclosed the statistical analysis plan. But suffice it to say, it's an interim analysis, and there are still subsequent planned analyses. Ourselves with our partner, Merck, designed the overall study to evaluate the full commercial profile of the product. We do think that there's a commercially valuable product that could emerge maybe only in the final analysis, but that wouldn't meet the criteria for early efficacy at the interim. Obviously, we'll move forward with the study accruing events to characterize that, but we do still see there is an opportunity there.

Speaker #1: And there are still subsequent planned analyses. And ourselves, with our partner Merck, designed the overall study to evaluate the full commercial profile of the product.

Speaker #1: And so we do think that there's a commercially valuable product that could emerge maybe only in the final analysis, but that wouldn't meet the criteria for early efficacy at the interim.

Stephen Hoge: that could emerge maybe only in the final analysis, but that wouldn't meet the criteria for early efficacy at the interim. Obviously, we'll move forward with the study accruing events to characterize that, but we do still see there is an opportunity there.

Speaker #1: And obviously, we'll move forward with the study, accruing events to characterize that. But we do still see there is an opportunity there.

Speaker #4: Thank you.

Salveen Richter: Thank you.

Speaker #1: One moment for our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Operator: One moment before our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Speaker #5: Hey guys, good morning. Thanks for all the updates. Another one on the Phase III melanoma INT readout— forgive me, but I have to ask for more granularity on timing.

Tyler Van Buren: Hey, guys. Good morning. Thanks for all the updates. Another one on the phase III melanoma IMT readout. Forgive me, I have to ask for more granularity on timing. How close are you to achieving all the events required for the first analysis? What percentage of events for the first analysis have been observed, and what's your level of confidence that we'll get the data readout this year?

Speaker #5: How close are you to achieving all the events required for the first analysis? What percentage of events for the first analysis have been observed?

Speaker #5: And what's your level of confidence that we'll get the data readout this year?

Speaker #2: Tyler, hi, good to hear from you. So, we're not going to disclose any more details around the specific timing, aside from that it's the second half, in terms of powering.

David Berman: Tyler, hi. Good to hear from you. We're not going to disclose any more details around the specific timing, aside from that it's the H2 in terms of powering. I think in terms of confidence, the fact that we had this very strong randomized phase II data that had consistent efficacy in all the subsets was very promising to me. The fact, as I mentioned, that the translational data confirms the mechanism of action, I don't think that there's anything else that can be done ahead of a randomized phase III. That's what we're conducting.

Speaker #2: I think, in terms of confidence, the fact that we had this very strong randomized Phase II data that had consistent efficacy in all the subsets was very promising to me.

Speaker #2: And the fact, as I mentioned, that the translational data confirms the mechanism of action—I don't think that there's anything else that can be done ahead of a randomized Phase III.

Speaker #2: And so that's what we're conducting.

Speaker #5: Got it. And if it succeeds in Phase III, do you expect standard review, or is a priority review possible? And can you remind us what your capacity to treat patients would be upon approval?

Tyler Van Buren: Got it. If it succeeds in the phase III, do you expect standard review, or is a priority review possible? Can you remind us what your capacity to treat patients would be on approval?

Speaker #2: Yeah, so priority review will always be subject to the data. But we certainly hope that, if we're successful, it will be under consideration.

Stephen Hoge: Priority review will always be subject to the data, but we certainly hope, certainly if we're successful, that it will be under consideration. An accelerated review process is possible. As David said, we are highly confident we'll get that data in the H2 of this year, or at least that interim analysis will be conducted. If that is positive, again, we don't have the data yet, we would obviously make the case for an accelerated review. We think it'd be supported by any profile that looked like the phase II. Now, as to commercial capabilities, we have been establishing the manufacturing in Massachusetts in a dedicated facility that will be able to support launch. We believe that facility can support our commercial profiles that ourselves and our partner, Merck, have articulated for several years to come.

Speaker #2: And then an accelerated review process is possible. As David said, we are highly confident we'll get that data in the second half of this year, or at least that interim analysis will be conducted.

Speaker #2: And if that is positive—again, we don't have the data yet—then we would obviously make the case for an accelerated review, and we think it would be supported by any profile that looked like the Phase II.

Speaker #2: Now, as to commercial capabilities, we have been establishing manufacturing in Massachusetts in a dedicated facility that will be able to support launch. We believe that facility can support our commercial profiles, as articulated by ourselves and our partner, Merck, for several years to come.

Stephen Hoge: We believe that facility can support our commercial profiles that ourselves and our partner, Merck, have articulated for several years to come. We hope we have to build more in the future if there's more demand, if all goes well. We do believe we can satisfy the initial indication out of that facility and that we'd be ready to go next year if all went perfectly to plan.

Speaker #2: We hope we have to build more in the future if there's more demand. If all goes well. But we do believe we can satisfy the initial indication out of that facility and that we'd be ready to go next year if all went perfectly to plan.

Stephen Hoge: We hope we have to build more in the future if there's more demand, if all goes well. We do believe we can satisfy the initial indication out of that facility and that we'd be ready to go next year if all went perfectly to plan.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Ellie Merle with Barclays. Your line is open.

Operator: Thank you. One moment for our next question. Our next question comes from Ellie Merrill with Barclays. Your line is open.

Speaker #6: Hey guys, thanks for taking the question. Just two for me—one on flu and then one on INT. Just in terms of flu, I guess I'm curious if you’ve had any discussions with the FDA regarding strain selection for 2027. Specifically, if there’s a mismatch in the selected strains at the beginning of the year with the circulating strains later in the year, would you be able to update your strains?

Ellie Merrill: Hey, guys. Thanks for taking my question. Just two for me, one on flu, then one on INT. Just in terms of flu, I guess curious if you've had any discussions with the FDA regarding strain selection for 2027, specifically if there's a mismatch in the selected strains in the beginning of the year with the circulating strains later in the year, would you be able to update your strains, whereas the other flu vaccines wouldn't be able to? Basically, just curious if this came up at all in the discussions and how you're thinking about this as a potential possibility in 2027. Just a second question, INT, interesting analysis on the immunogenicity that you presented at ASCO.

Ellie Merle: Hey, guys. Thanks for taking my question. Just two for me, one on flu, then one on INT. Just in terms of flu, I guess curious if you've had any discussions with the FDA regarding strain selection for 2027, specifically if there's a mismatch in the selected strains in the beginning of the year with the circulating strains later in the year, would you be able to update your strains, whereas the other flu vaccines wouldn't be able to? Basically, just curious if this came up at all in the discussions and how you're thinking about this as a potential possibility in 2027. Just a second question, INT, interesting analysis on the immunogenicity that you presented at ASCO.

Speaker #6: Or is it that the other flu vaccines wouldn’t be able to? Basically, I’m just curious if this came up at all in the discussions, and how you’re thinking about this as a potential possibility.

Speaker #6: In 2027. And then just a second question. Interesting analysis on the immunogenicity that you presented at ASCO. Curious if there were any learnings in terms of how you think about the algorithm for the selection of the neoantigen, since there seemed to be variability between patients in terms of the number of neoantigens that patients had immune responses for.

Ellie Merrill: Curious if there was any learnings in terms of how you think about the algorithm for the selection of the neoantigens, since there seems to be variability between patients in terms of the number of neoantigens that patients had immune responses for. Curious how you're thinking about that and potential ways that you could theoretically optimize the selection of the neoantigens. Thanks.

Ellie Merle: Curious if there was any learnings in terms of how you think about the algorithm for the selection of the neoantigens, since there seems to be variability between patients in terms of the number of neoantigens that patients had immune responses for. Curious how you're thinking about that and potential ways that you could theoretically optimize the selection of the neoantigens. Thanks.

Speaker #6: So curious how you're thinking about that and potential ways that you could theoretically optimize the selection of the neoantigen? Thanks.

Speaker #2: Thank you for both questions. So I'll take the flu one, and obviously have David take INT. So, first, in terms of discussions with the US FDA, the answer is yes, those have happened.

Stephen Hoge: Thank you for both questions. I'll take the flu one, obviously have David take INT. First, in terms of discussions with US FDA, the answer is yes, those have happened. In fact, they even happened at the advisory committee. There was active discussion both between the agency, the committee members, as well as the company on how we would address a potential mismatch or a late strain selection. Our demonstrated capability in the COVID context is less than 2 months, strain selections have happened as late as early July in the history of COVID, we've been able to make a full vaccination season work with millions of doses. That was discussed at the VRBPAC, obviously had been part of the basis for pursuing accelerated approval in our discussions with the agency.

Speaker #2: In fact, they even happened at the advisory committee and so there was active discussion both between the agency, the committee members, as well as the company on how we would address potential mismatch or a late strain selection.

Speaker #2: Our demonstrated capability in the COVID context, less than two months, and so strain selections have happened as late as early July in the history of COVID.

Speaker #2: And we've been able to make a fall vaccination season work with millions of doses. And that was discussed at the Verve pack. And obviously had been part of the basis for pursuing accelerator approval in our discussions with the agency.

Speaker #2: Now, the process by which that would happen would ultimately fall to public health to articulate. And so FDA, CDC, WHO, others would need to accommodate a late strain selection if they wanted to.

Stephen Hoge: The process by which that would happen would ultimately fall to public health to articulate. FDA, CDC, WHO, others would need to accommodate a late strain selection if they wanted to. Those discussions I would describe as in their early stage. The first step is to get the product approved so that there's a potential to address such a situation. The second step is to work closely with public health to define how we would do that and under what circumstances they would want us to do that.

Speaker #2: And those discussions, I would describe as in their early stages. The first step is to get the product approved, so there's a potential to address such a situation.

Speaker #2: And then the second step was to work closely with public health to define how we would do that and under what circumstances they would want us to do that.

Speaker #3: Ellie, with regard to your second question, it's a very interesting question. So, we see that about 29% of our neoantigens that go into our cassettes in general are immunogenic.

David Berman: Ellie, with regard to your second question, it's a very interesting question. We see that about 29% of our neoantigens that go into our cassettes in general are immunogenic. The data that we showed is that for the patients that we showed, there were between one to 18 neoantigens that were reactive in each patient. The good news is you only need one neoantigen-reactive T-cell in order for there to be activity. Of course, in theory at least, the more the better. In terms of what we're doing to improve. We do have an ongoing program to try and improve this algorithm. In fact, we're using artificial intelligence to try to develop the next algorithm. I think the key thing will be when we get an efficacy readout linking our algorithm to efficacy. I think that will be the next important step here.

Speaker #3: And the data that we showed is that, for the patients that we showed, there were between 1 to 18 neoantigens that were reactive in each patient.

Speaker #3: So the good news is you only need one neoantigen reactive T-cell in order for there to be activity. Of course, the more the in theory, at least the more the better.

Speaker #3: In terms of what we're doing to improve, we do have an ongoing program to try and improve this algorithm. In fact, we're using artificial intelligence to try to develop the next algorithm. I think the key thing will be when we get an efficacy readout linking our algorithm to efficacy.

Speaker #3: I think that will be the next important step here.

Speaker #6: Great. Thanks.

Ellie Merrill: Great. Thanks.

Ellie Merle: Great. Thanks.

Speaker #1: One moment for our next question. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

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

Speaker #5: Great, thanks for taking the questions. Maybe just on your flu vaccine—I was wondering if you could provide any update in terms of your thoughts on potential pricing, either some of the inputs or how you think about analogs there.

Terence Flynn: Great. Thanks for taking the questions. Maybe just on your flu vaccine, I was wondering if you could provide any update in terms of your thoughts on potential pricing, either some of the inputs or how you're thinking about analogs there. On the norovirus interim, just any insight in terms of what that means for potential effect size. Thank you very much.

Speaker #5: And then on the norovirus interim, just any insight in terms of what that means for potential effect size? Thank you very much.

Speaker #2: Great, thank you for both questions. So, first on flu pricing—look, it's a little premature. Those conversations are ongoing, but it's all subject to us getting the product approved, obviously.

Stephen Hoge: Great. Thank you for both questions. First on flu pricing, look, it's a little premature. Those conversations are ongoing, but it's all subject to us getting the product approved, obviously. When we think about the positioning of that product, at least on our own with the data, we feel confident about that profile given the relative vaccine efficacy demonstrated in the phase III trial. It's been published in the New England Journal, relative standard dose, that it really is in the enhanced category from our perspective. Importantly, offers some features, for instance, the lack of egg adaptation, that are even more specialized than some of the available therapies. We will be assessing from a health economic perspective, the potential value of those, and in discussions with payers and other bodies, making sure that we characterize those potential benefits as we think about pricing in the future.

Speaker #2: When we think about the positioning of that product, at least on our own with the data, we feel confident about that profile given the relative vaccine efficacy demonstrated in the Phase 3 trial.

Speaker #2: It's been published in the New England Journal, relative to standard dose, that it really is in the enhanced category from our perspective. And importantly, it offers some features, for instance, the lack of egg adaptation, that are even more specialized than some of the available therapies.

Speaker #2: And so, we will be assessing, from a health economic perspective, the potential value of those, and in discussions with payers and other bodies, making sure that we characterize those potential benefits as we think about pricing in the future.

Speaker #2: But again, the first step is let's get the product approved, which we're working on right now. As it relates to norovirus, there will not be much more I can say than what we have right now because the study is still blinded and continuing.

Stephen Hoge: Again, first step is let's get the product approved, which we're working on right now. As relates to norovirus, there will not be much more I can say than what we have right now because the study is blinded and continuing. We have not previously disclosed the statistical analysis plan associated with it, so it'd be inappropriate to do that now. Suffice it to say, what we are doing is we know we will need additional cases from a further cohort to strengthen that statistical analysis, and we're working hard on preparing to stand up that part of the study now.

Speaker #2: We have not previously disclosed these statistical analysis plans associated with it, so it would be inappropriate to do that now. Suffice it to say, what we are doing is we know we will need additional cases from a further cohort to strengthen that statistical analysis.

Speaker #2: And we're working hard on preparing to stand up that part of the study now.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Corey Kazmov with Evercore ISI. Your line is open.

Operator: Thank you. One moment for our next question. Our next question comes from Cory Kasimov of Evercore ISI. Your line is open.

Cory Kasimov: Hey, good morning, guys. Thanks for taking the question. Wanted to also ask on intizomeran, but on the RCC front. Can you speak to the immunogenicity data that you have, and it gives you confidence that intizomeran works as well in low TMB RCC as what you've seen so far in melanoma and non-small cell lung cancer? Thank you.

Speaker #4: Hey, good morning, guys. Thanks for taking the question. I wanted to also ask on Intismaran, but on the RCC front. Can you speak to the immunodensity data that you have, that kind of gives you confidence that Intismaran works as well in low TMB RCC as what you’ve seen so far in melanoma and non-small cell lung cancer?

Speaker #4: Thank you.

Speaker #3: So that trial is still ongoing, so we don't actually have that data yet. But we will be showing some data later this year on other tumors that are hard to treat.

David Berman: That trial is still ongoing, so we don't actually have that data yet. We will be showing some data later this year on other tumors that are hard to treat. I think the fact that we can demonstrate immunogenicity in, for example, pancreatic cancer, I think leads us to believe that we can identify neoantigens and create a neoantigen vaccine for RCC as well. I think we have confidence in that.

Speaker #3: And I think the fact that we can demonstrate immunogenicity in, for example, pancreatic cancer, I think leads us to believe that we can identify neoantigens and create a neoantigen vaccine for RCC as well.

Speaker #3: I think we have confidence in that.

Speaker #2: And I think the one thing I'd add is, at least in the context of our Phase 2 melanoma study, which is now through five years, we had previously published or presented that TMB did not correlate with a difference.

Stephen Hoge: I think the one thing I'd add is, at least in the context of our phase II melanoma study, which is now through five years, we had previously published or presented that TMB did not correlate with a difference. In fact, low TMB adjuvant melanoma patients had a consistent hazard ratio as those with high. It gives us some reason to believe that that will translate. To be fair, that is in the melanoma context. As David said, we're still waiting for data in other histologies.

Speaker #2: In fact, low TMB adjuvant melanoma patients had a consistent hazard ratio as those with high TMB. So it gives us some reason to believe that that will translate.

Speaker #2: But to be fair, that is in the melanoma context. And as David said, we're still waiting for data in other histologies.

Speaker #4: Yeah, and I guess, just to be clear, I was wondering kind of where the confidence came from, recognizing we're waiting on that data later this year or next.

Cory Kasimov: Yeah. I guess to be clear, I was wondering kind of where the confidence came from recognizing we're waiting on that data later this year or next.

Speaker #2: Yeah, and I think it comes from the lack of a role of TMB-high versus -low in driving the effect size that we saw in the Phase 2, and in the totality of data we have around that.

Stephen Hoge: Yeah. I think it comes from the lack of a role of TMB high versus low in driving the effect size that we saw in the phase II, and the totality of data we have around that.

Speaker #4: Got it. Thank you.

Cory Kasimov: Got it. Thank you.

Speaker #1: One moment for our next question. Our next question comes from Andrew Sy. Would Jeff reach? Your line is open.

Operator: One moment for our next question. Our next question comes from Andrew Sy with Jefferies. Your line is open.

Operator: One moment for our next question. Our next question comes from Andrew Tsai with Jefferies. Your line is open.

Speaker #5: Hey, good morning. Thanks for taking my question. So, just thinking about your "Horizon 2" wave of assets coming—first, for the IDO compound, it sounds like that could have pivotal data in 2027, since you mentioned it as a revenue contributor in 2028.

Andrew Sy: Hey, good morning. Thanks for taking my question. Just thinking about your, quote unquote, "Horizon 2 wave of assets coming." First, for the IDO compound, sounds like that could have pivotal data in 2027, since you mentioned it as a revenue contributor in 2028. Can you talk about what the approvable bar in first-line and second-line melanoma is? Then you also have a T-cell engager program that you announced at the Science Day, that I believe could have data at year-end. I'd be curious to know in a seemingly refractory population, what would a positive data look like in myeloma, and is there a strategy for you to go upstream? Thank you.

Andrew Tsai: Hey, good morning. Thanks for taking my question. Just thinking about your, quote unquote, "Horizon 2 wave of assets coming." First, for the IDO compound, sounds like that could have pivotal data in 2027, since you mentioned it as a revenue contributor in 2028. Can you talk about what the approvable bar in first-line and second-line melanoma is? Then you also have a T-cell engager program that you announced at the Science Day, that I believe could have data at year-end. I'd be curious to know in a seemingly refractory population, what would a positive data look like in myeloma, and is there a strategy for you to go upstream? Thank you.

Speaker #5: So, can you talk about what the approval bar is in first-line and second-line melanoma? And then, you also have a T-cell engager program that you announced at the Science Day.

Speaker #5: I believe it could have data year-end. And so, I'd be curious to know, in a seemingly refractory population, what would positive data look like in myeloma? And is there a strategy for you to go upstream?

Speaker #5: Thank you.

Speaker #3: Thank you, Andrew. So, horizon two—I'm glad you picked up on that. 4359, which is the IDO/PD-L1, is a very interesting program. There was proof of confidence from a randomized study from another company, which was very interesting.

David Berman: Thank you, Andrew. Horizon 2, I'm glad you picked up on that. 4359, which is the IDO PD-L1, is a very interesting program. There was proof of confidence from a randomized study from another company, which was very interesting. For us, we saw very intriguing data, which we showed last year, and we had a follow-up first-line data set earlier this year. What we're doing now in the ongoing phase II expansion is to confirm that signal. Is the signal that we saw real, and is there a path forward based on that signal? I don't want to get ahead of whether it's pivotal or not. I think let's first confirm the signal and identify what is the best opportunity in melanoma. Is it to go first line or is it to go second line plus?

Speaker #3: For us, we saw very intriguing data, which we showed last year, and we had a follow-up first-line data set earlier this year. What we're doing now in the ongoing Phase 2 expansion is to confirm that signal.

Speaker #3: Is the signal that we saw real? And is there a path forward based on that signal? I think I don't want to get ahead of whether it's pivotal or not.

Speaker #3: I think, let's first confirm the signal and identify what is the best opportunity in melanoma. Is it to go first line, or is it to go second line plus?

David Berman: I think as we all know, in terms of your question about what is the bar for approval in second line for single-arm trials, it's a moving target as we see. I think suffice it to say that you have to show sufficiently high response rates that have sufficient durability, and I think no one really exactly knows what that definition of sufficiently high is. In terms of first line, we do have an ongoing combination with nivo/ipi. We showed data earlier with pembro plus 4359, which was very intriguing. We have to remember also that in single-arm trials, especially in the first-line setting, the combination of two active agents may sometimes be hard to disentangle what the activity is through. We're looking for can you safely combine them in first line? Do we see some signal of increased activity?

Speaker #3: I think, as we all know, the bar — in terms of your question about what is the bar for approval in second line for single-arm trials — you know, it's a moving target as we see. I think, suffice it to say, that you have to show sufficiently high response rates that have sufficient durability.

Speaker #3: And I think no one really exactly knows what that definition of 'sufficiently high' is. In terms of first-line, we do have an ongoing combination with NIVO IPI.

Speaker #3: We showed data earlier with Pembro plus 4359, which was very intriguing. But we have to remember also that in single-arm trials, especially in the first-line setting, the combination of two active agents may sometimes make it hard to disentangle what the activity is coming from.

Speaker #3: So we're looking for: can you safely combine them in first line? Do we see some signal of increased activity? And in second line, in the PD-1 relapsed/refractory setting, we're looking: do we see sufficiently increased signal of activity above what we would expect to see?

David Berman: In second line in the PD-1 relapse refractory, we're looking do we see sufficiently increased signal of activity above what we would expect to see? In particular, in patients who progressed on prior PD-1s, are we seeing durable responses? More to come on that next year. With regard to 2808, which is the T-cell engager program, this is something that's very interesting. Multiple myeloma obviously has a number of T-cell engagers and we recently heard this week from J&J very exciting news about the first combination of two targets. That's the first time ever two T-cell engagers have been combined. For us, the reason we're excited is we have the first three T-cell engagers in a single product ever being studied. As you mentioned, we're studying this in relapsed refractory myeloma in patients who've progressed on multiple CAR-Ts, on multiple T-cell engagers.

Speaker #3: And in particular, in patients who progressed on prior PD-1s, are we seeing durable responses? So, more to come on that next year. With regard to 2808, which is the T-cell engager program, this is something that's very interesting.

Speaker #3: So multiple myeloma obviously has a number of T-cell engagers, and we recently heard this week from J&J, very exciting news about the first combination of two targets as the first time ever two T-cell engagers have been combined.

Speaker #3: And so for us, the reason we're excited is we have the first three T-cell engagers in a single product ever being studied. And as you mentioned, we're studying this in relapsed/refractory myeloma in patients who have progressed on multiple CAR-Ts and multiple T-cell engagers—essentially patients who have no other options available.

David Berman: Essentially, patients who have no other options available. We're going to be looking, first of all, can we produce three T-cell engagers? Number one. Is it safe and well-tolerated? Number two. Is there evidence of complete responses and partial responses and how durable they are? That's, I think, what we're looking for. I'm quite intrigued and excited about both of these programs.

Speaker #3: And so we're going to be looking, first of all, can we produce three T-cell engagers? Number one, is it safe and well tolerated? Number two, is there evidence of complete responses and partial responses, and how durable they are?

Speaker #3: That's, I think, what we're looking for. But I'm quite intrigued and excited about both of these programs.

Speaker #5: Thank you.

Andrew Sy: Thank you.

Andrew Tsai: Thank you.

Speaker #1: One moment for our next question. Our next question comes from Courtney Breen with Bernstein. Your line is open.

Operator: One moment for our next question. Our next question comes from Courtney Breen with Bernstein. Your line is open.

Speaker #6: Thank you so much for taking the question this morning. Just a couple of others—one to push a little bit further on norovirus and the update there.

Courtney Breen: Thank you so much for taking the question this morning. Just a couple of others. One, to push a little bit further on norovirus and the update there. Obviously, the question I think many of us are asking is this enrollment, is this an efficacy or is this an events situation? Perhaps if you can help us understand kind of the overall event rate relative to expectations and what might be driving that. The second question is a little different. You obviously just announced a new chief commercial officer into the company. You've obviously got kind of a broadening business, particularly as we look at the pipeline and the number of readouts over the next couple of years. Can you just help us understand what are the top priorities for the chief commercial officer over the next six months?

Speaker #6: Obviously, the question that I think many of us are asking is: is this enrollment, is this efficacy, or is this an events situation?

Speaker #6: And so perhaps you can help us understand the overall event rate relative to expectations, and what might be driving that. Then, the second question is a little different.

Speaker #6: You're obviously just announced a new chief commercial officer into the company. And you've obviously got kind of a broadening business, particularly as we look at the pipeline.

Courtney Breen: You've obviously got kind of a broadening business, particularly as we look at the pipeline and the number of readouts over the next couple of years. Can you just help us understand what are the top priorities for the chief commercial officer over the next six months? What might be the changes or the evolution required longer term in the commercial structure to support this evolving business?

Speaker #6: And the number of readouts over the next couple of years—can you just help us understand what are the top priorities for the Chief Commercial Officer over the next six months?

Speaker #6: And what might be the changes or the evolution required longer-term within the commercial structure to support this evolving business?

Courtney Breen: What might be the changes or the evolution required longer term in the commercial structure to support this evolving business?

David Berman: Right. Thank you. I'll take the first question and obviously turn it over to Stéphane to handle the second. First on the question of noro, again, limited in what I can say because the trial remains blinded. It suffice to say we are going forward with another season this year. We have been able to enroll the trial, which I think was your question, the cohorts. The epidemiology of the primary endpoint cases has been a little bit slower coming. As we had previously discussed, some of that in the first season for that trial was the result of a unique outbreak of a different set of strains of norovirus that were not contributing to that primary endpoint. Cases came a little bit slower in that season. For that reason, we were a little bit slower to achieve the interim analysis than we intended.

Speaker #3: Great, thank you. I'll take the first question and obviously turn it over to Stephane to handle the second. The first one, the question of noro—again, limited in what I can say because the trial remains blinded.

Speaker #3: But it suffice to say we have we are going forward with another season this year. We have been able to enroll the trial, which I think was your question, in a cohort.

Speaker #3: But the epidemiology of the primary endpoint cases has been a little bit slower coming. As we had previously discussed, some of that in the first season for that trial was the result of a unique outbreak of a different set of strains of norovirus that were not contributing to that primary endpoint.

Speaker #3: And so, cases have come a little bit slower in that season, and for that reason, we were a little bit slower to achieve the interim analysis than we intended.

Speaker #3: We ultimately did, though, power the study for a final analysis—a full number of cases. And really, what we're doing now is we've kind of gone through that second season, been able to conduct the interim analysis, and we're preparing for that third, which will be the third winter this year.

David Berman: We ultimately did, though, power the study for a final analysis, a full number of cases. Really what we're doing now is we've kind of gone through that second season, been able to conduct the interim analysis, is we're preparing for that third, which will be the third winter this year. This has happened with other vaccines in the past. If you think about flu vaccines, they often have to do multiple season studies to accrue sufficient cases. It did ultimately happen to us here, or at least appears to have happened to us here. For that reason, we're getting ready to stand up that new case accrual. It's unique in that we have to enroll new patients to get new cases because it's a seasonal vaccine, a seasonal infection, and ultimately we will go one more season, we expect this winter for norovirus mRNA-1403.

Speaker #3: This has happened with other vaccines in the past. If you think about flu vaccines, they often have to do multiple season studies, to accrue sufficient cases, and that did ultimately happen to us here, or at least appears to have happened to us here.

Speaker #3: And so, for that reason, we're getting ready to stand up that new case accrual. It's unique in that we have to enroll new patients to get new cases.

Speaker #3: Because it's a seasonal vaccine, a seasonal infection. And ultimately, we'll go one more season we expect this winter for norovirus 1403.

Speaker #4: Thank you, Stephan.

Operator: Thank you, Stephen.

Stephen Hoge: Thank you, Stéphane.

Speaker #3: Thank you, Stephane. Good morning, Courtney. So, in terms of context, as we talked about in the press release when we announced the position of Esther, basically, if you look at the business, as you know, we have three products on the market today.

Stéphane Bancel: Thank you, Stephen. Morning, Courtney. In term of context, as we talked about in the press release when we announced the position of Ester. Basically, if you look at the business, as you know, we have three products on the market today. We have since the spring, a fourth product approved in Comirix, the mCOMBRIAX, which we are preparing the launch for 2027. Potentially a fifth product approved in H2, which of course flu, as we talked about before. As you can see, what is just in front of us is a very large growing ID pipeline of products. The other piece as well as you know is Europe. As you know, we have not been able to participate in the European market because of an exclusive partnership that the EU set up during the pandemic.

Speaker #3: We have seen the spring of fourth product approved and combo reacts. The flu-COVID combo, which we are preparing to launch for 2027. Potentially a fifth product approved in the second half, which, of course, is flu, as we talked about before.

Speaker #3: So, as you can see, just what is in front of us, there's a very, very large growing ID pipeline of product. And the other piece, also, as you know, is Europe.

Speaker #3: As you know, we have not been able to participate in the European market because of an exclusive partnership that the U.S. set up during the pandemic.

Speaker #3: But this partnership expires, as we've said before, in 2026. So we really see Europe as a very important growth driver for us. And as you know, in Europe, the markets are all very, very different.

Stéphane Bancel: This partnership expires, as we said before, in 2026. We really see Europe as a very important growth driver for us. As you know, in Europe, the markets are all very different. There's a lot of complexity there. Of course, there is INT. As we said, we expect the phase III data potentially in the second half of the year, given all the trends. As you can imagine, Moderna and our Merck colleague have been very active. Stephen talked about manufacturing a minute ago, but we have been very active on the commercial side of the house in terms of medical affairs, marketing, commercial. That's another piece where Ester is also going to be helping and leading, working hand in hand with Merck.

Speaker #3: So, there's a lot of complexity there. And then, of course, there is INT. As we said, we expect the phase 3 data potentially in the second half of the year, given the trend.

Speaker #3: And so as you can imagine, Moderna and/or Merck colleague have been very active Stephen talked about manufacturing a minute ago. But they have been very active on the commercial side of the house in terms of medical affairs, marketing, commercial.

Speaker #3: And so that's another piece where Esther is also going to be helping and leading, working hand in hand with Merck. And of course, there's also rare disease with PA—as you know, we've said PA because it's a time-driven Phase 3.

Stéphane Bancel: Of course, there's also rare disease with PA, as you know, we've said PA because it's a time-driven phase III. We should have data this year. Of course, it's partnered with Recordati, but we're going to be, of course, working with a partner to ensure a great launch. If you look at the next few years, as Stephen had the good slide earlier in the presentation, looking at the geographic expansion, including also in Asia and Latin America, the product expansion. There's a lot to do. As we are gearing for the growth stage of a company coming ahead of us, we feel that this role was important. Also the new role for Stephen, who is really overseeing ID, INT, and rare from a kind of general management to make sure that all the functions are integrated together.

Speaker #3: We should have data this year. Of course, it's partnered with Ricarda T, but we're going to be, of course, working with a partner to ensure a great launch.

Speaker #3: So if you look at the next few years, Stephen had a good slide earlier in the presentation looking at the geographic expansion, including also in Asia and Latin America.

Speaker #3: The product expansion. So there's a lot to do. And so as we are gearing for the growth stage of a company coming ahead of us, we thought that this role was important.

Speaker #3: And also the new role for Stephen, who is really overseeing ID, INT, and rare from a kind of general management standpoint to make sure that all the functions are integrated together.

Speaker #3: So, it's just us getting ready for the next stage of growth of a company that's exciting.

Stéphane Bancel: It's just us getting ready for the next stage of growth of the company. That's exciting.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Michael Yee with UBS. Your line is open.

Operator: Thank you. One moment for our next question. Our next question comes from Michael Yee with UBS. Your line is open.

Speaker #5: Thanks. We have two questions. First is on INT for David or Stephen. At the interim analysis, while you're not going to disclose the powering, if you go back to your Phase 2b—it was statistically significant, but you were using a one-sided alpha of 0.1.

Michael Yee: Thanks. We have 2 questions. First is on INT for David or Stephen. At the end of analysis, while you're not going to disclose the powering, if you go back to your phase II-B, it was statistically significant, but you were using a one-sided alpha of 0.1. That's a much different hurdle rate than, say, traditional interims that you might be using here. To what extent that people have too high of expectations for the interim versus the final, where you could have a non-proportional hazard ratio, where the effect size gets better over time due to the way the drug works? That's question number 1, is the thought around the effect size getting better over time and a non-proportional hazard ratio. The second question is on the COVID flu combo in Europe.

Speaker #5: And so that's a much different hurdle rate than, say, traditional interims that you might be using here. So to what extent do people have too high of expectations for the interim versus the final, where you could have a non-proportional hazard ratio—where the effect size gets better over time due to the way the drug works?

Speaker #5: So that's question number one: the thought around the effect size getting better over time, and a non-proportional hazard ratio. The second question is on the COVID-flu combo in Europe.

Michael Yee: The second question is on the COVID flu combo in Europe. Can you just remind us at what point you engage in conversations to do contracting for that? Because I guess you could have actually revenues for that in 2027, and when we get visibility on that. Thank you.

Speaker #5: Can you just remind us at what point you engage in conversations to contracting for that? Because I guess you could actually have revenues for that in 2027.

Michael Yee: Can you just remind us at what point you engage in conversations to do contracting for that? Because I guess you could have actually revenues for that in 2027, and when we get visibility on that. Thank you.

Speaker #5: And when we get visibility on that, thank you.

Speaker #3: Hey, Michael. I'll take the first question. So we are not going to disclose anything on the statistical analysis plan, but I do think there is maybe two key points to highlight.

David Berman: Hey, Michael. I'll take the first question. We're not going to disclose anything on the statistical analysis plan, but I do think there is maybe 2 key points to highlight. The first is, if you remember back to the phase II study, of course, updated ASCO, there was, as you said, somewhat of a non-proportional hazard with about 12 months for really strong separation to occur. The good news in the phase III study, which was designed with Merck, who has a lot of expertise in melanoma, is that it requires also a minimum of 18 months follow-up. Every patient has been followed way beyond where there was before or after the separation occurred. I think that with regard to that gives us increased confidence. Stephen, the 2nd question?

Speaker #3: The first is, if you remember back to the phase 2 study—of course, updated at ASCO—there was, as you said, somewhat of a non-proportional hazard.

Speaker #3: With about 12 months for really strong separation to occur, the good news in the Phase 3 study, which was designed with Merck, who has a lot of expertise in melanoma, is that it requires also a minimum of 18 months follow-up.

Speaker #3: And so every patient has been followed way beyond where they where there was before after the separation occurred. So I think that with regard to that, that gives us increased confidence.

Speaker #3: Stephen, your second question?

Speaker #2: Yeah. On the question of combo in Europe and negotiations—so with approval, we can start the pricing negotiations with many governments, where that is a separate process.

Stephen Hoge: Yeah. On the question of combo in Europe and negotiations, with approval, we can start the pricing negotiations with many governments where that is a separate process. In most cases, we have then submitted those HTA documents, those health technology assessments, or the supporting pricing negotiations are underway. In some cases, you need a recommending body, sort of analogous to CDC recommending body recommendations before you engage in that process. In all those cases, we've been supporting those. Some of that has been happening publicly, you'll see recommending bodies in countries like Germany, where STIKO or others have begun to contemplate the combo vaccine. As I said, in other countries, we've begun the pricing negotiations. There are first instances of pricing being issued in a couple of countries, and we'll continue that process through this year.

Speaker #2: And so in most cases, we have then submitted those HTA documents as health technology assessments or the supporting pricing negotiations are underway. In some cases, you need recommending bodies, sort of analogous to CDC, recommending body recommendations before you engage in that process.

Speaker #2: And in all those cases, we've been supporting those. Some of that has been happening publicly. And so you'll see recommending bodies in countries like Germany, which or others have begun to contemplate the combo vaccine.

Speaker #2: And then, as I said, in other countries, we're we've begun that pricing negotiations. There are first instances of pricing being issued in a couple of countries.

Speaker #2: And we'll continue that process through this year. Once that's there, we will have achieved market access. And then we begin the process of engaging in tenders, or in countries that are not tender countries in Europe, in commercialization and straightforward commercialization.

Stéphane Bancel: Once that's there, we will have achieved market access, then we begin the process of engaging in tenders or in countries that are not tender countries in Europe, in commercialization, in straightforward commercialization. About half of those markets will be more tender-related. Some of those tenders will deal with 2027. Some of those tenders will deal with 2028 because the timing of their flu or COVID tenders may be a year forward. We'll provide more clarity on that as we get into that year. We would expect some contribution from traditional commercialization markets as well as tender markets beginning in 2027, but the full effect really probably not felt until 2028, and maybe a little bit beyond, depending upon what individual countries require from real-world effectiveness data or other things post-approval to support market access. We're excited to be approved.

Speaker #2: About half of those markets will be more tender-related. Some of those tenders will deal with 2027. Some of those tenders will deal with 2028, because the timing of their flu or COVID tenders may be a year forward.

Speaker #2: And we'll provide more clarity on that as we get into that year. So, we would expect some contribution from traditional commercialization markets as well as tender markets beginning in 2027.

Stéphane Bancel: We would expect some contribution from traditional commercialization markets as well as tender markets beginning in 2027, but the full effect really probably not felt until 2028, and maybe a little bit beyond, depending upon what individual countries require from real-world effectiveness data or other things post-approval to support market access. We're excited to be approved. We have a lot of work to do in Europe to drive that growth. We think that there's real enthusiasm for the product. Obviously, we have it ourselves. We're working hard to start impacting as early as 2027, but really build the business over the couple of years thereafter.

Speaker #2: But the full effect really probably not felt until 2028. And maybe a little bit beyond, depending upon what individual countries require from real-world effectiveness data or other things post-approval to support market access.

Speaker #2: So we're excited to be approved. We have a lot of work to do in Europe. To drive that growth, we think there's real enthusiasm for the product.

Stéphane Bancel: We have a lot of work to do in Europe to drive that growth. We think that there's real enthusiasm for the product. Obviously, we have it ourselves. We're working hard to start impacting as early as 2027, but really build the business over the couple of years thereafter.

Speaker #2: Obviously, we have it ourselves. And we're working hard to start impacting as early as 2027. But really build the business over the couple of years thereafter.

Michael Yee: Thank you, guys.

Speaker #5: Thank you, guys.

Speaker #1: Our next question comes from Jeff Meacham with Citigroup. Your line is open. Meacham with Citigroup. Your line is open.

Operator: Our next question comes from Geoff Meacham with Citigroup. Your line is open. Meacham with Citigroup, your line is open.

Speaker #4: Great. Hey, guys. A couple of quick ones. I guess for Jamie—the 10% revenue growth guidance for the balance of the year—maybe just give us a reminder of the puts and takes of that when it comes to different geographies.

Geoff Meacham: Great. Hey, guys. Thanks for the question. I just have a couple of quick ones. I guess for Jamey, the 10% revenue growth guidance for the balance of the year, maybe just give us a reminder of the puts and takes of that when it comes to different geographies. Are there still more contracts or more sources of potential new pockets of demand? On the rare disease portfolio, you guys have completed enrollment in mRNA-3927. Just wanted to get a sense for what determines the timing, maybe the regulatory usability of the readout. I wasn't sure what you guys are looking for from an effect size or from a clinical meaningful standpoint. Thank you.

Speaker #4: Are there still more contracts or more sources of potential new pockets of demand? And then on the rare disease portfolio, you guys have completed enrollment in 3927.

Speaker #4: I just wanted to get a sense for what determines the timing, maybe the regulatory usability, of the readout. I wasn't sure what you guys are looking for in terms of effect size, or from a clinically meaningful standpoint.

Speaker #4: Thank you.

Speaker #3: Yeah, thanks, Jeff. For the question, I'll take the first one, on revenue. So we're sitting pretty good after the first half of the year in terms of half a billion dollars in revenue—roughly 70% international, 30% in the US. And your question is getting at where's the upside, where are the variables for the second half.

James Mock: Yeah. Thanks, Geoff, for the question. I'll take the first one on revenue. We're sitting pretty good after the H1 in terms of a half a billion dollars in revenue, roughly 70% international, 30% in the US. Your question is getting at where's the upside, where's the variables to the H2. I just want to start by saying, if you look at our H1, we are up almost $300 million versus the prior year. If we are flat in the H2, that would actually be above 10% growth for the year. Now what are the variables to the H2? If you look at what we said is we're basically 50/50 for the entire year, US versus international. Obviously having a higher percentage in the H1 international, that means we have a higher percentage in the US.

Speaker #3: So I just want to start by saying, if you look at our first half, we are up almost $300 million versus the prior year.

Speaker #3: So if we are flat in the second half, that would actually be above 10% growth for the year. So now, what are the variables for the second half?

Speaker #3: If you look at what we said, we're basically 50/50 for the entire year, US versus international. So, obviously, having a higher percentage in the first half international means we have a higher percentage in the US in the second half.

Speaker #3: And that's really where the biggest variable is. So, across the globe, we've basically contracted; we have to execute. There are some countries that have minor vaccination rates—some shipments could happen this year, or some could go into the first quarter of the following year.

James Mock: That's really where the biggest variable is. Across the globe, we've basically contracted, we have to execute. There are some countries that have minor vaccination rate. Some shipments could happen in the year or some could go into the Q1 of the following year, but I would call that relatively small. I think the biggest variable comes down to the US. We've provided for, as I mentioned in my prepared remarks, that we have provided for a vaccination rate decline, particularly in the US. The biggest upside swing is if it is not as big a decline as we've projected, then we should have upside in the US. If it's worse than we've projected, then obviously there would be downsides to that.

Speaker #3: But I would call that relatively small. I think the biggest variable comes down to the US. And we've provided for, as I mentioned in my prepared remarks, that we have provided for vaccination rate decline, particularly in the US.

Speaker #3: And so, the biggest upside swing is if it is not as big a decline as we've projected, then we should have upside in the US.

Speaker #3: If it's worse than we've projected, then obviously there would be downside to that. And so if you just kind of think about the second half in terms of broad pictures—and I kind of said this on the last call—in the second half, international, last year, we had no UK volume and not some of the strategic partnerships volume.

James Mock: If you just think about the H2 in terms of broad pictures, and I said this on the last call, is in the H2 international, last year we had no UK volume and not some of the strategic partnerships volume. This year we will supply some of the strategic partnerships that we have, it's quite material. That's basically the upside that is offsetting the provision that we put in to the US in terms of vaccination rate decline. For the most part, we're really confident. We've got a substantial growth through the H1 here. If we are flat to last year with international growing and offsetting the US decline, then we should be above our 10% guidance. The biggest variable at this point is just what is the size of the US market.

Speaker #3: This year, we will supply some of the strategic partnerships that we have, and it's quite material. That's basically the upside that is offsetting the provision that we put in to the US in terms of the vaccination rate decline.

Speaker #3: So for the most part, we're really confident we've got substantial growth through the first half here. If we are flat to last year, with international growing and offsetting the US decline, then we should be above our 10% guidance.

Speaker #3: And the biggest variable at this point is just what is the size of the U.S. market.

Speaker #1: Thank you. With regard to the question on PA, at this time, around 20 patients were enrolled, and the primary endpoint, which is metabolic decompensation events on treatment relative to pre-treatment—so each patient serves as their own control—is based on a 12-month follow-up.

David Berman: Thank you. With regard to the question on PA, it's around 20 patients were enrolled, the primary endpoint, which is metabolic decompensation events on treatment relative to pre-treatment, so each patient serves as their own control, is based on a 12-month follow-up. That should happen sometime in Q4. Just as a reminder, in our prior releases, we showed about a 60% to 80% efficacy with our therapy. That's why we have confidence or hope for this trial.

Speaker #1: And so that should happen sometime in the fourth quarter. And just as a reminder, in our prior releases, we showed about a 60% to 80% efficacy.

Speaker #1: With our therapy. And so that's why we have confidence or hope for this trial.

Speaker #4: Hey, great. Thanks, guys.

Geoff Meacham: Great. Thanks, guys.

Speaker #1: One moment for our next question. Our next question comes from Miles Minter with William Blair. Your line is open.

Operator: One moment for our next question. Our next question comes from Myles Minter with William Blair. Your line is open.

Speaker #5: Oh, hi. Thanks, everyone. Congrats on the quota. My question is just one of clarification. I think Dr. Colino at ASCO mentioned in Interpat 001 that approximately two-thirds of patients would have micrometastatic disease.

Myles Minter: Hey, thanks, everyone. Congrats on the quarter. My question is just one on clarification. I think Dr. Kalino at ASCO mentioned in INTerpath-001 that approximately two-thirds of patients would have micrometastatic disease. It's a little bit confusing to me as to whether that was just restricted in the Stage 3 patients or that was the overall trial. Just wondering whether you can confirm or adjust his comments that are said on record. Secondly, just the potential impact of going from a third micrometastatic in the Stage 1-2 study to two-thirds in INTerpath-001 and any sort of impact that we could see there. Thanks very much.

Speaker #5: It's a little bit confusing to me as to whether that was just restricted to the stage three patients or if that was the overall trial.

Speaker #5: So, just wondering whether you can confirm or adjust his comments that are on the record. And then secondly, regarding the potential impact of going from a third micrometastatic in the Phase 1/2 study to two-thirds in INTERPAT-001, and any sort of impact that we could see there.

Speaker #5: Thanks very much.

Speaker #3: So, I don't recall exactly what he was referring to in that statement. But for the trial, we haven't released the baseline demographics yet.

David Berman: I don't recall exactly what he was referring to in that statement, but we haven't released the baseline demographics of the trial, essentially to say that it's Stage 2B to fully resected Stage 4. In terms of why we believe we can go to that broad eligibility based on the phase II data, it's because when you look at the subsets from an efficacy standpoint, they were all consistent. Secondly, we know that the earlier you go, i.e., Stage 3A and then Stage 2B and 2C, the immune system should be healthier, the tumor burden should be even lower, the ability to induce a T-cell response and to have those T-cells kill, whether it's micrometastatic or still even before it's micrometastatic, should still be there. I think that's what I would say. I don't remember exactly the point about two-thirds micrometastatic.

Speaker #3: So essentially, to say that it's stage 2B to fully resected stage 4. And in terms of why we believe we can go to that broad eligibility based on the phase 2 data, it's because when you look at the subsets from an efficacy standpoint, they were all consistent.

Speaker #3: And secondly, we know that the earlier you go, i.e., stage three A and then stage two B and two C, the immune system should be healthier.

Speaker #3: The tumor burden should be even lower. And so, the ability to induce a T-cell response and to have those T-cells kill—whether it's micrometastatic or even before it's micrometastatic—should still be there.

Speaker #3: So I think that's what I would say. I don't remember exactly the point about two-thirds micrometastatic.

Speaker #5: No worries. Appreciate the response. Thanks.

Myles Minter: No worries. Appreciate the response. Thanks.

Speaker #1: One moment for our next question. The last question comes from Jessica 5, JP Morgan. Your line is open.

Operator: One moment for our next question. The last question comes from Jessica Fye of JPMorgan. Your line is open.

Speaker #6: Hey, guys. Good morning. Thanks for taking my question. I just wanted to confirm two things on INT. First, if the interim in the phase 3 adjuvant melanoma trial passes without stopping for efficacy, how will the Street learn about that?

Jessica Fye [Managing Director and Equity Research Analyst: Hey, guys. Good morning. Thanks for taking my question. Just wanted to confirm two things on INT. First, if the interim in the phase III adjuvant melanoma trial passes without stopping for efficacy, how will the Street learn about that? I guess, is the study simply continuing a material event that we would hear about right away, or would we just hear about that maybe later in normal course updates? Then the second one on INT is the translational poster at ASCO had a relatively small number of patients relative to the number who were in the phase II. I'm curious if you know what the data looked like in the broader study population. Thank you.

Jessica Fye: Hey, guys. Good morning. Thanks for taking my question. Just wanted to confirm two things on INT. First, if the interim in the phase III adjuvant melanoma trial passes without stopping for efficacy, how will the Street learn about that? I guess, is the study simply continuing a material event that we would hear about right away, or would we just hear about that maybe later in normal course updates? Then the second one on INT is the translational poster at ASCO had a relatively small number of patients relative to the number who were in the phase II. I'm curious if you know what the data looked like in the broader study population. Thank you.

Speaker #6: I guess, is the study simply continuing, or is it a material event that we would hear about right away, or would we just hear about that maybe later in normal course updates?

Speaker #6: And then the second one on INT: the translational poster at ASCO had a relatively small number of patients compared to the number who were in the Phase 2.

Speaker #6: I'm curious if you know what the data looked like in the broader study population. Thank you.

Speaker #3: So, we will be issuing a press release on that data, Jess, for the interim. And with regard to the second question, the reason that the data set on the translational was only seven patients is because that in-depth T-cell antigenicity required leukapheresis, which is a little bit more burdensome to the patients than just collecting a tube of blood.

David Berman: We will be issuing a press release on that data, Jess, for the interim. With regard to the second question, the reason that the dataset on the translational was only seven patients is because that in-depth T-cell antigenicity required leukapheresis, which is a little bit more burdensome to the patients than just collecting a tube of blood, the patients have to consent to that. We do hope to expand that because we do think that that degree of biomarker analysis is important for understanding the mechanism of the drug. Actually, we're also looking at ways, and we're exploring ways to try and disentangle T-cell immunogenicity without having to do leukapheresis. That's still exploratory, but more to come on that. That's the reason why there were only seven patients.

Speaker #3: And so the patients have to consent to that. We do hope to expand that, because we think that level of biomarker analysis is important for understanding the mechanism of the drug.

Speaker #3: And actually, we're also looking at ways, and we're exploring ways, to try and disentangle T-cell immunogenicity without having to do leukapheresis. So that's still exploratory, but more to come on that.

Speaker #3: That's the reason why there were only seven patients.

Jessica Fye [Managing Director and Equity Research Analyst: Thank you.

Jessica Fye: Thank you.

Speaker #6: Thank you.

Speaker #1: This concludes our Q&A session. I will now turn the call back to Stephane for any closing remarks.

Operator: This concludes our Q&A session. I'd like to turn the call back to Stéphane for any remarks.

Speaker #3: Thank you very much, everybody, for joining. We look forward to speaking to many of you in the coming days and weeks. And have a great day and weekend.

Stéphane Bancel: Thank you very much, everybody, for joining. We look forward to speaking to many of you in the coming days and weeks, have a great day and weekend. Bye.

Speaker #3: Bye.

Operator: Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.

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