Q4 2025 Moderna Inc Earnings Call

February 13, 2026

Speaker #1: Good day, and thank you for standing by. Welcome to the Moderna fourth quarter 2025 conference call. At this time, all participants are on a listen-only mode.

Operator 1: Good day, and thank you for standing by. Welcome to Moderna's Fourth Quarter 2025 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one 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, Head of IR. Please go ahead.

Operator: Good day, and thank you for standing by. Welcome to Moderna's Fourth Quarter 2025 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one 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, Head of IR. Please go ahead.

Speaker #1: 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 one one on your telephone.

Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised today's conference is being recorded.

Speaker #1: I would now like to hand the conference over to your speaker today, Lavina Talukdar, Head of IR. Please go ahead.

Speaker #2: Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's fourth quarter 2025 financial results and business updates.

Lavina Talukdar: Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's Q4 2025 financial results and business update. You can access the press release issued this morning, as well as the slides that we'll be reviewing, by going to the Investors section of our website. On today's call are Stéphane Bancel, our Chief Executive Officer, Stephen Hoge, our President, and Jamey Mock, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Please see slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.

Speaker #2: 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 #2: On today's call are Stephane Bancel, our Chief Executive Officer; Stephen Hoge, our President; and James Mock, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Speaker #2: 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 #2: With that, I will turn the call over to Stéphane.

Lavina Talukdar: With that, I will turn the call over to Stéphane.

Speaker #1: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start with a quick review of 2025. Jamie will present our financial results and 2026 outlook.

Stéphane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start with a quick review of 2025. Jamey will present our financial results and 2026 outlook. Stephen will review our commercial outlook and clinical programs, and then I will come back and share our key value drivers as we look ahead before we take your questions. Let me start with a review of 2025. Our revenues were $1.9 billion, driven by sales of our COVID vaccine, Spikevax, and mNEXspike. We continue to make tremendous progress on cost in 2025. Operating expenses were down $2.2 billion, or 30% year-over-year. I would like to thank the entire Moderna team for this great accomplishment in 2025. I'm very proud of this.

Speaker #1: Stéphane will review our commercial outlook and clinical programs. And then I will come back and share our key value drivers as we look ahead, before we take your questions.

Speaker #1: Let me start with a review of '25. Our revenues were $1.9 billion, driven by sales of our COVID vaccine Spikevax and MX Spike. We continue to make tremendous progress on cost in 2025.

Speaker #1: Operating expenses were down $2.2 billion, or 30%, for the year. I would like to thank the entire Moderna team for this great accomplishment in 2025.

Speaker #1: I'm very proud of this. Net loss for the year was $2.8 billion, and we ended the year with $8.1 billion in cash and investments.

Stéphane Bancel: Net loss over year was $2.8 billion, and we ended the year with $8.1 billion in cash and investments. Before I start a review of 2025, I want to express our disappointment to the FDA refusal to file letter on our flu program, mRNA-1010. The current uncertainty in the US FDA regulatory environment creates real challenges for businesses, patients, and the broader innovation ecosystem. When expectations and review timelines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines. This delays patient access and increases overall healthcare costs. Sustained regulatory uncertainty threatens US leadership in innovative medicines. This can also result in transformative medicine developed by US companies becoming available to patients outside the US before reaching American patients. Turning now to the execution on commercial and pipeline.

Speaker #1: Before I start a review of 2025, I want to express our disappointment with the FDA, who refused to file a letter on our flu program, MRNA-1010.

Speaker #1: The current uncertainty in the U.S. FDA regulatory environment creates real challenges for businesses, patients, and the broader innovation ecosystem. When expectations and review timelines are at greater risk, companies can hesitate to invest.

Speaker #1: Slowing the development of breakthrough medicines delays patient access and increases overall healthcare costs. Sustained regulatory uncertainty threatens U.S. leadership in innovative medicines. This can also result in transformative medicine developed by U.S. companies becoming available to patients outside the U.S. before reaching American patients.

Speaker #1: Turning now to the execution on commercial and pipeline. On the commercial side, in 2025, we had three products on the market: Spikevax, MX Spike, and MRSVia.

Stéphane Bancel: On the commercial side, in 2025, we had 3 products on the market, Spikevax, mNEXspike, and mRESVIA. mNEXspike was approved in the US in 2025 and had an excellent launch, quickly became our leading product in the US. In the past 2 weeks, we announced 2 commercial agreements. First, an agreement with Recordati for the global commercialization of our propionic acidemia rare disease candidate, currently in a pivotal study. Recordati brings deep rare disease commercial expertise and an established global infrastructure with a propionic acidemia community. We also announced earlier this week a 5-year strategic agreement with the government of Mexico for respiratory vaccine supply. We currently have 2 products under regulatory review in multiple countries. Our seasonal flu vaccine is filed under the review in Europe, Canada, and Australia. Our flu plus COVID combination vaccine is filed and under review in Europe and Canada.

Speaker #1: MX Spike was approved in the US in 2025. It had an excellent launch and quickly became our leading product in the US. In the past two weeks, we announced two commercial agreements.

Speaker #1: First, an agreement with Recordati for the global commercialization of our propionic acidemia, a rare disease candidate, currently in a pivotal study. Recordati brings deep rare disease commercial expertise and an established global infrastructure with a propionic acidemia community.

Speaker #1: We also announced earlier this week a five-year strategic agreement with the government of Mexico for respiratory vaccine supply. We currently have two products under regulatory review in multiple countries.

Speaker #1: Our seasonal flu vaccine is filed and under review in Europe, Canada, and Australia. Our full-plus COVID combination vaccine is filed and under review in Europe and Canada.

Speaker #1: Additionally, we made strong programs across the pipeline. For INTIS Moran, our individual cancer therapy developed in partnership with Merck, we recently reported positive five-year Phase 2 data in adjuvant melanoma.

Stéphane Bancel: Additionally, we made strong progress across the pipeline. For INTismeran, our individual cancer therapy developed in partnership with Merck, we recently reported positive 5-year phase 2 data in adjuvant melanoma, demonstrating the durability of clinical benefit and reinforcing our confidence in the program's long-term potential. I am very happy to announce that we have completed enrollment in our phase 2 study in muscle-invasive bladder cancer. This marks fully staged studies in three different cancer types that are now fully enrolled: adjuvant melanoma, adjuvant renal cell carcinoma, and now muscle-invasive bladder cancer. We look forward to the readout from these studies. For cancer antigen therapy, mRNA-4359, we announced positive phase 1b data, and the program is now in phase 2. Our phase 3 norovirus program is now fully enrolled, so we could see phase 3 data in 2026.

Speaker #1: Demonstrating the durability of clinical benefit and reinforcing our confidence in the program's long-term potential, I am very happy to announce that we have completed enrollment in our Phase 2 study in muscle-invasive bladder cancer.

Speaker #1: This marks fully staged studies in three different cancer types that are now fully enrolled: adjuvant melanoma, adjuvant renal cell carcinoma, and now muscle-invasive bladder cancer.

Speaker #1: We look forward to the data we got from these studies. For cancer antigen therapy, mRNA-4059, we announced positive Phase 1b data, and the program is now in Phase 2.

Speaker #1: Our Phase 3 norovirus program is now fully enrolled, so we could see Phase 3 data in 2026. And our peer program is also fully enrolled in its registration study, and we could see data in 2026.

Stéphane Bancel: In our PA program, is also fully enrolled in this registration study, and we could see data in 2026. I am pleased to welcome to Moderna, our new Chief Development Officer and Executive Committee member, Dr. David Berman. He has contributed to the development of more than a dozen clinical-stage immunotherapies at BMS and AstraZeneca. His expertise will serve Moderna well as we continue to expand our oncology pipeline. David served most recently as Head of R&D of Immunocore. We very much look forward to David joining Moderna's team on March 2. I would like, of course, to take this opportunity to thank Jackie Miller for her many contributions in over the last five years of the company, especially her tremendous leadership during the pandemic. With this, I would like to take over to Jimmy.

Speaker #1: I'm pleased to welcome to Moderna our new Chief Development Officer and Executive Committee Member, Dr. David Berman. He has contributed to the development of more than a dozen clinical-stage immunotherapies at BMS and AstraZeneca.

Speaker #1: His expertise will serve Moderna well as we continue to expand our oncology pipeline. David served most recently as head of R&D at Immunocore. We very much look forward to David joining Moderna's team on March 2.

Speaker #1: I would like, of course, to take this opportunity to thank Jackie Miller for her many contributions in the last five years at the company, especially her tremendous leadership during the pandemic.

Speaker #1: With this, I would like to take over to Jamie.

Speaker #2: Thanks, Stephane. And hello, everyone. Today, I'll cover our fourth quarter and full year 2025 results, and then wrap up with our 2026 financial framework.

Jamey Mock: Thanks, Stéphane, and hello, everyone. Today, I'll cover our Q4 and full year 2025 results, and then wrap up with our 2026 financial framework. I'll begin with our 2025 revenue performance on slide 8. For the fourth quarter, total revenue was $700 million, coming in at the higher end of our recent guidance. Our revenue split in the quarter was $300 million in the US and $400 million from international markets. For the full year, total revenue was $1.9 billion, with the majority generated from COVID vaccine sales, along with approximately $100 million of other revenue. From a geographic perspective, US revenue totaled $1.2 billion, while international revenue was $700 million.

Speaker #2: I'll begin with our 2025 revenue performance on Friday. For the fourth quarter, total revenue was $700 million, coming in at the higher end of our recent guidance.

Speaker #2: Our revenue split in the quarter was $300 million in the US and $400 million from international markets. For the full year, total revenue was $1.9 billion.

Speaker #2: With the majority generated from COVID vaccine sales, along with approximately $100 million of other revenue. From a geographic perspective, U.S. revenue totaled $1.2 billion.

Speaker #2: International revenue was $700 million. In the US, while overall COVID market demand declined year-over-year, we had strong market share in the retail channel, supported by the successful launch of MX Spike.

Jamey Mock: In the US, while overall COVID market demand declined year-over-year, we had strong market share in the retail channel, supported by the successful launch of the Next Spike. In international markets, we landed at the higher end of our range, driven by operational performance and vaccination rates, which were above or in line with our expectations. Turning to slide 9, I'll review our fourth quarter results. As we discussed on the prior slide, revenue was $700 million. Compared to the fourth quarter of last year, operating expenses were down 31%, reflecting continued cost discipline and execution across the organization. I'll discuss these expense trends from a full year perspective on the next slide. Our net loss for the quarter was $800 million, compared to a net loss of $1.1 billion in the fourth quarter of 2024.

Speaker #2: In international markets, we landed at the higher end of our range, driven by operational performance and vaccination rates, which were above or in line with our expectations.

Speaker #2: Turning to slide nine, I'll review our fourth quarter results. As we discussed on the prior slide, revenue was $700 million. Compared to the fourth quarter of last year, operating expenses were down 31%, reflecting continued cost discipline and execution across the organization.

Speaker #2: I'll discuss these expense trends from a full-year perspective on the next slide. Our net loss for the quarter was $800 million, compared to a net loss of $1.1 billion in the fourth quarter of 2024.

Speaker #2: Loss per share was $2.11, compared to a loss per share of $2.91 last year. Now, turning to slide 10, I'll walk through our full year 2025 financial results.

Jamey Mock: Loss per share was $2.11, compared to a loss per share of $2.91 last year. Now, turning to slide 10, I'll walk through our full year 2025 financial results. As I mentioned earlier, total revenue was $1.9 billion. Cost of sales was $868 million, representing a 41% decrease compared to 2024, primarily driven by productivity and lower inventory write-downs, contract manufacturing, wind-down costs, and sales volumes. R&D expenses were $3.1 billion, representing a 31% decrease compared to 2024, driven by continued investment prioritization and efficiency gains in the execution of our clinical trials. These reductions were partially offset by increased investment in our norovirus vaccine and oncology programs. SG&A expenses were $1 billion, representing a 13% decrease compared to 2024.

Speaker #2: As I mentioned earlier, total revenue was $1.9 billion. Cost of sales was $868 million, representing a 41% decrease compared to 2024. This was primarily driven by productivity and lower inventory write-downs, contract manufacturing wind-down costs, and sales volumes.

Speaker #2: R&D expenses were $3.1 billion, representing a 31% decrease compared to 2024. This was driven by continued investment prioritization and efficiency gains in the execution of our clinical trials.

Speaker #2: These reductions were partially offset by increased investment in our norovirus vaccine and oncology programs. SG&A expenses were $1 billion, representing a 13% decrease compared to 2024.

Speaker #2: The decline was driven across all functions, and reflects our continued focus on operating efficiently while supporting the business in a disciplined manner. Our income tax provision for 2025 was immaterial.

Jamey Mock: The decline was driven across all functions and reflects our continued focus on operating efficiently while supporting the business in a disciplined manner. Our income tax provision for 2025 was immaterial. We continue to maintain a global valuation allowance against the majority of our deferred tax assets, which limits our ability to recognize tax benefits from losses. Net loss for the full year was $2.8 billion, compared to a net loss of $3.6 billion in 2024. Loss per share was $7.26, compared to a loss per share of $9.28 last year. We ended 2025 with cash and investments of $8.1 billion, compared to $9.5 billion at the end of 2024.

Speaker #2: We continue to maintain a global valuation allowance against the majority of our deferred tax assets, which limits our ability to recognize tax benefits from losses.

Speaker #2: Net loss for the full year was $2.8 billion, compared to a net loss of $3.6 billion in 2024. Loss per share was $7.26, compared to a loss per share of $9.28 last year.

Speaker #2: We ended 2025 with cash and investments of $8.1 billion, compared to $9.5 billion at the end of 2024. The year-over-year decrease was primarily driven by operating losses, as we continued to invest in R&D and advance our pipeline.

Jamey Mock: The year-over-year decrease was primarily driven by operating losses as we continued to invest in R&D and advance our pipeline, partially offset by the $600 million initial draw of our $1.5 billion credit facility. Excluding the credit facility draw, we would have ended the year with $7.6 billion of cash and investments, which was above our 3Q guidance of $6.5 to 7 billion, due to lower operating expenses, lower capital expenditures, and working capital improvements. Now, let's turn to our financial framework for 2026. We expect total revenue growth of up to 10% in 2026. This growth is expected to come primarily from international markets, and we estimate our geographic mix will be well-balanced between the US and markets outside the US in 2026.

Speaker #2: Partially offset by the $600 million initial draw of our $1.5 billion credit facility. Excluding the credit facility draw, we would have ended the year with $7.6 billion of cash and investments.

Speaker #2: Which was above our Q3 guidance of $6.5 to $7 billion, due to lower operating expenses, lower capital expenditures, and working capital improvements. Now let's turn to our financial framework for 2026.

Speaker #2: We expect total revenue growth of up to 10% in 2026. This growth is expected to come primarily from international markets, and we estimate our geographic mix will be well balanced between the US and markets outside the US in 2026.

Speaker #2: This is a shift from our 2025 revenue split of approximately 62% U.S. and 38% international. We will begin selling locally manufactured products in both the U.K. and Australia in 2026.

Jamey Mock: This is a shift from our 2025 revenue split of approximately 62% US and 38% international. We will begin selling locally manufactured products in both the UK and Australia in 2026, which is the largest driver of our international growth. Our 2026 revenue guidance factors in future potential declines in COVID vaccination rates, and also assumes no revenue from our flu vaccine or our flu-COVID combination vaccine. Similar to 2025, we expect 2026 revenue to be weighted to the second half of the year, with approximately 15% in the first half of our revenue and approximately 85% in the second half. Cost of sales is projected to be approximately $900 million. While this is flat year over year in absolute terms, we are expecting gross margin rate improvement from manufacturing efficiency gains and volume leverage.

Speaker #2: Which is the largest driver of our international growth. Our 2026 revenue guidance factors in future potential declines in COVID vaccination rates and also assumes no revenue from our flu vaccine.

Speaker #2: For our flu/COVID combination vaccine, similar to 2025, we expect 2026 revenue to be weighted to the second half of the year, with approximately 15% of our revenue in the first half.

Speaker #2: And approximately 85% in the second half. Cost of sales is projected to be approximately $900 million. While this is flat year over year in absolute terms.

Speaker #2: We are expecting gross margin rate improvement from manufacturing efficiency gains and volume leverage. R&D expenses are anticipated to be approximately $3 billion, as we continue to invest in our late-stage pipeline while maintaining financial discipline.

Jamey Mock: R&D expenses are anticipated to be approximately $3 billion as we continue to invest in our late-stage pipeline while maintaining financial discipline. It's a relatively small decline from the $3.1 billion we had in 2025 due to the continued execution of our late-stage trials in infectious disease. For modeling purposes, we expect our R&D spend to be relatively balanced in the first half versus the second half of 2026, similar to what we experienced in 2025. SG&A expenses are expected to be approximately $1 billion, flat versus the prior year. We remain focused on driving efficiency and cost savings across the organization, which we will use to fund new commercial investments to support both geographic expansion and future product launches.

Speaker #2: It's a relatively small decline from the $3.1 billion we had in 2025, due to the continued execution of our late-stage trials in infectious disease.

Speaker #2: For modeling purposes, we expect our R&D spend to be relatively balanced in the first half versus the second half of 2026, similar to what we experienced in 2025.

Speaker #2: SG&A expenses are expected to be approximately $1 billion, flat versus the prior year. We remain focused on driving efficiency and cost savings across the organization.

Speaker #2: Which we will use to fund new commercial investments to support both geographic expansion and future product launches. Similar to 2025, our commercial spend will be more heavily weighted to the second half of the year.

Jamey Mock: Similar to 2025, our commercial spend will be more heavily weighted to the second half of the year due to the seasonality of our commercial business. In aggregate, we are expecting total GAAP operating expenses of $4.9 billion and $4.2 billion of cash costs, which excludes stock-based compensation, depreciation, and amortization. We expect taxes to be negligible in 2026. Capital expenditures are projected to be between $200 and 300 million dollars. This guidance includes our previously announced investment in building our own fill-finish capacity in the United States at our existing site in Norwood, Massachusetts. We expect to end 2026 with $5.5 to 6 billion dollars of cash and investments. Our cash guidance does not assume any additional drawdown from our credit facility. In summary, 2025 was a key turning point in our financial story.

Speaker #2: Due to the seasonality of our commercial business, in aggregate, we are expecting total GAAP operating expenses of $4.9 billion, and $4.2 billion of cash costs.

Speaker #2: Which excludes stock-based compensation, depreciation, and amortization. We expect taxes to be negligible in 2026. Capital expenditures are projected to be between $200 million and $300 million.

Speaker #2: This guidance includes our previously announced investment. In building our own fill-finish capacity in the United States. At our existing site in Norwood, Massachusetts. We expect in 2026 with $5.5 to $6 billion of cash and investments.

Speaker #2: Our cash guidance does not assume any additional drawdown from our credit facility. In summary, 2025 was a key turning point in our financial story.

Speaker #2: We improved our commercial execution, exceeded our cost reduction plan by over $1 billion, and ended the year with over $2 billion more cash than our original 2025 guidance.

Jamey Mock: We improved our commercial execution, exceeded our cost reduction plan by over $1 billion, and ended the year with over $2 billion more cash than our original 2025 guidance, all while still advancing our pipeline. I want to thank the entire Moderna team for their efforts over this past year. We have strong momentum heading into 2026, with multiple levers for revenue growth and a strong commitment to drive additional cost reductions across the company. With that, I will now turn the call over to Stephen.

Speaker #2: All while still advancing our pipeline. I want to thank the entire Moderna team for their efforts over this past year. And we have strong momentum heading into 2026.

Speaker #2: With multiple levers for revenue growth, and a strong commitment to drive additional cost reductions across the company. With that, I will now turn the call over to Stephen.

Speaker #1: Thank you, Jamie. And good morning or good afternoon, everyone. Today I'll review our commercial outlook as well as pipeline. As Jamie mentioned earlier, we expect 2026 to mark a return to revenue growth for Moderna.

Stephen Hoge: Thank you, Jamey, and good morning or good afternoon, everyone. Today, I will review our commercial outlook as well as progress across our pipeline. As Jamey mentioned earlier, we expect 2026 to mark a return to revenue growth for Moderna. This year, we expect growth to be driven primarily by our strategic partnerships and the second year of launch for mNEXspike, which I will discuss in more detail in a moment. But first, looking forward to 2027, we see three additional growth drivers. We look forward to significant expansion of our addressable market with the opening of the $1.8 billion European respiratory vaccines market. As a reminder, we have been excluded from this region for several years due to a competitor pandemic contract, which expires in 2026.

Speaker #1: This year, we expect growth to be driven primarily by our strategic partnerships and the second year of launch for Mnexspike, which I will discuss in more detail in a moment.

Speaker #1: But first, looking forward to 2027, we see three additional growth drivers. We look forward to significant expansion of our addressable market, with the opening of the $1.8 billion European respiratory vaccines market.

Speaker #1: As a reminder, we have been excluded from this region for several years due to a competitor pandemic contract, which expires in 2026. We expect to launch Mnexspike, our standalone flu vaccine mRNA-1010, and our combination flu/COVID vaccine in the European region by the 2027 winter season.

Stephen Hoge: We expect to launch mNEXspike, our standalone flu vaccine, mRNA-1010, and our combination flu-COVID vaccine in Europe by 2027 winter season, adding to mRESVIA and Spikevax, which are already approved. This broad portfolio represents the opportunity to grow our share in the large European market, which will contribute to meaningful revenue growth from 2027 forward. Second, we expect growth from our new multi-year strategic agreements in Latin America and Asia Pacific. Third, with the acceptance of our flu filings in Europe, Canada, and Australia, we anticipate that our flu vaccine will begin to contribute to revenue internationally. In 2028, we expect continued new product-driven growth opportunities with both our combination flu, COVID, and norovirus vaccines, potentially being launched across many of our markets.

Speaker #1: Adding to Mresvia and Spikevax, which are already approved, this broad portfolio represents the opportunity to grow our share in the large European market. This will contribute to meaningful revenue growth from 2027 forward.

Speaker #1: Second, we expect growth from our new multi-year strategic agreements in Latin America and Asia Pacific. And third, with the acceptance of our flu filings in Europe, Canada, and Australia, we anticipate that our flu vaccine will begin to contribute to revenue internationally.

Speaker #1: In 2028, we expect continued new product-driven growth opportunities, with both our combination flu/COVID and Norovirus vaccines potentially being launched across many of our markets.

Speaker #1: Recent execution supports this growth strategy, with approvals for mRNA-1273.815 (Spikevax) in Canada and Australia, and the approval of our strain-updated Spikevax COVID vaccine in the UK.

Stephen Hoge: Recent execution supports this growth strategy with approvals for mNEXspike in Canada and Australia, and the approval of our strain-updated Spikevax COVID vaccine in the UK. We have already shown strong momentum against the 2027 growth drivers. We announced a multi-year strategic agreement with Mexico earlier this week and Taiwan last month, and we continue to make progress under our previously announced strategic agreement in Brazil. Finally, although not a major driver, we also signed a global commercialization collaboration in PA with Recordati as we prepare that potential launch in 2028. Let's take a look or a closer look at the key contributors to that growth in 2026, beginning with our strategic partnerships with the UK, Canada, and Australia. As a reminder, these are long-term agreements under which Moderna has built local manufacturing sites and committed to ongoing domestic research and development.

Speaker #1: We have already shown strong momentum against the 2027 growth drivers. We announced a multi-year strategic agreement with Mexico earlier this week, and Taiwan last month.

Speaker #1: And we continue to make progress under our previously announced strategic agreement in Brazil. Finally, although not a major driver, we also signed a global commercialization collaboration in PA with Recordati.

Speaker #1: As we prepare for that potential launch in 2028, the UK is the—let's take a closer look at the key contributors to that growth in 2026.

Speaker #1: Beginning with our strategic partnerships with the UK, Canada, and Australia. As a reminder, these are long-term agreements under which Moderna has built local manufacturing sites.

Speaker #1: And committed to ongoing domestic research and development. These partnerships are core to each country's national security and public health strategy, strengthening preparedness against current viruses.

Stephen Hoge: These partnerships are core to each country's national security and public health strategy, strengthening preparedness against current viruses and future pandemic threats. The UK is the largest of these markets, and we expect a $200 million UK COVID order to be fulfilled in the first half of 2026 for their spring booster campaign. We also expect to supply vaccines for the UK's fall vaccination campaign, initially this year for COVID, with the potential to expand to other respiratory vaccines such as flu, RSV, and our combination vaccine in the years ahead. In Canada, we were thrilled to deliver made in Canada COVID vaccines in 2025 and expect to see the full annualized impact of the agreement in 2026. And in Australia, we expect to deliver the full annualized benefit of our agreement in 2026 as well.

Speaker #1: And future pandemic threats. The UK is the largest of these markets, and we expect a $200 million UK COVID order to be fulfilled in the first half of 2026.

Speaker #1: For their spring booster campaign. We also expect to supply vaccines for the UK's fall vaccination campaign, initially this year for COVID, with the potential to expand to other respiratory vaccines, such as flu, RSV, and our combination vaccine in the years ahead.

Speaker #1: In Canada, we are thrilled to deliver made in we were thrilled to deliver made in Canada COVID vaccines in 2025. And expect to see the full annualized impact of the agreement in 2026.

Speaker #1: And in Australia, we expect to deliver the full annualized benefit of our agreement in 2026 as well. Moving to slide 15. Our second major expected growth driver in 2026 is our new COVID vaccine, mRNA-1283, branded as mRNA Spike.

Stephen Hoge: Moving to Slide 15. Our second major expected growth driver in 2026 is our new COVID vaccine, mNEXspike. mNEXspike had a very successful launch in 2025. This is especially notable because mNEXspike was approved mid-year in 2025 and was only available commercially in the United States. We are extremely pleased with the market share achieved in that first season, with mNEXspike capturing 24% of the total US retail market and 34% of the retail market among adults aged 65 and older. As a reminder, the retail market is the largest customer segment, representing approximately 3/4 of the US COVID market, and the majority of that volume is in seniors. Looking ahead to 2026, we expect to continue to drive the uptake of mNEXspike in the United States.

Speaker #1: Mnexspike had a very successful launch in 2025. This is especially notable because Mnexspike was approved mid-year in '25 and was only available commercially in the United States.

Speaker #1: We are extremely pleased with the market share achieved in that first season, with Mnexspike capturing 24% of the total U.S. retail market, and 34% of the retail market among adults age 65 and older.

Speaker #1: As a reminder, the retail market is the largest customer segment, representing approximately three-quarters of the US COVID market. And the majority of that volume is in seniors.

Speaker #1: Looking ahead to 2026, we expect to continue to drive the uptake of Mnexspike in the United States. And internationally, we look forward to approvals and launches in multiple countries this year and in the years to come.

Stephen Hoge: Internationally, we look forward to approvals and launches in multiple countries this year and the years to come. Moving to Slide 16, which outline-- This outlines the latest developments in our infectious disease portfolio. Starting with our approved products, the updated formulation of Spikevax is approved in countries around the world, and importantly, in 2025, we received the supplemental BLA approval in the US for high-risk children as young as 6 months. As mentioned earlier, mNEXspike was approved and launched in the US. It was approved in Canada in 2025 and recently approved in Australia as well. We are targeting further approvals in, of mNEXspike in Europe, Japan, and Taiwan this year. mRESVIA, our RSV vaccine, has been approved for adults aged 60 and older in 40 countries and approved for high-risk adults aged 18 to 59 in 31 of those 40 countries.

Speaker #1: Moving to slide 16, which outlines the latest developments in our infectious disease portfolio. Starting with our approved products, the updated formulation of Spikevax is approved in countries around the world.

Speaker #1: And importantly, in 2025, we received the supplemental BLA approval in the United States for high-risk children as young as six months. As mentioned earlier, Mnexspike was approved and launched in the US.

Speaker #1: It was approved in Canada in 2025, and recently approved in Australia as well. We are targeting further approvals of Mnexspike in Europe, Japan, and Taiwan this year.

Speaker #1: Mresvia, our RSV vaccine, has been approved for adults age 60 and older in 40 countries, and approved for high-risk adults age 18 to 59 in 31 of those 40 countries.

Speaker #1: In addition to those three approved vaccines, we've filed for two additional approvals. mRNA-1010, our flu vaccine, has been accepted for review in Europe, Canada, and Australia.

Stephen Hoge: In addition to those three approved vaccines, we've filed for two additional approvals. mRNA-1010, our flu vaccine, has been accepted for review in Europe, Canada, and Australia, with the first potential approvals coming late in 2026 or early 2027. We were disappointed with the FDA's refusal to file a letter for mRNA-1010 and have requested a Type A meeting to understand the path forward for the program in the United States. mRNA-1083, our flu plus COVID combination vaccine, is under review in Europe and Canada, with first potential approvals in 2026. And finally, our norovirus vaccine is in an ongoing phase III trial, which is fully enrolled in its second Northern Hemisphere season, and is accruing cases towards its interim analysis. Now, turning to our therapeutics pipeline.

Speaker #1: With the first potential approvals coming late in '26 or early '27, we were disappointed with the FDA's Refusal to File letter for mRNA-1010.

Speaker #1: And have requested a Type A meeting to understand the path forward for the program in the United States—mRNA-1083, our flu plus COVID combination vaccine.

Speaker #1: It is under review in Europe and Canada, with the first potential approvals expected in 2026. And finally, our norovirus vaccine is in an ongoing Phase 3 trial.

Speaker #1: Which is fully enrolled in its second Northern Hemisphere season. And is accruing cases towards its interim analysis. Now turning to our therapeutics pipeline. Intisprin, our individualized cancer therapy, developed in collaboration with Merck.

Stephen Hoge: INTismeran, our individualized cancer therapy, developed in collaboration with Merck, has a total of eight phase II or phase III studies ongoing. The most advanced of these is our phase III adjuvant melanoma study, as well as our phase II randomized adjuvant renal cell carcinoma study, both of which have been previously announced as fully enrolled. As Stéphane mentioned previously, we are very excited to announce that we have now fully enrolled our phase II randomized muscle-invasive bladder cancer study. Bladder cancer is the third cancer type now in a fully enrolled late-stage study. In addition to these three trials, we are looking forward to completing enrollment in our ongoing phase III studies in adjuvant non-small cell lung cancer. We also look forward to completing enrollment in our ongoing phase II trials in non-muscle invasive bladder cancer, first-line metastatic melanoma, and first-line metastatic squamous non-small cell lung cancer.

Speaker #1: We have a total of eight Phase 2 or Phase 3 studies ongoing. The most advanced of these is our Phase 3 adjuvant melanoma study, as well as our Phase 2 randomized adjuvant renal cell carcinoma study.

Speaker #1: Both of which have been previously announced as fully enrolled. As Stephane mentioned previously, we are very excited to announce that we have now fully enrolled our Phase 2 randomized muscle invasive bladder cancer study.

Speaker #1: Bladder cancer is the third cancer type now in a fully enrolled late-stage study. In addition to these three trials, we are looking forward to completing enrollment in our ongoing Phase 3 studies in adjuvant non-small cell lung cancer.

Speaker #1: We also look forward to completing enrollment in our ongoing Phase 2 trials in non-muscle invasive bladder cancer, first-line metastatic melanoma, and first-line metastatic squamous non-small cell lung cancer.

Speaker #1: Beyond these Phase 2 and Phase 3 studies, we are fully enrolled in our Phase 1 studies for adjuvant pancreatic cancer and perioperative gastric cancer.

Stephen Hoge: Beyond these phase II and phase III studies, we are fully enrolled in our phase I studies for adjuvant pancreatic cancer and perioperative gastric cancer, and we look forward to data from these studies in the year ahead. Aside from INTismeran, aside from our collaboration in INTismeran with Merck, we continue to make progress in additional oncology programs. In the phase II study of our cancer antigen therapy, mRNA-4359, cohorts are enrolling in first-line metastatic melanoma, second-line metastatic melanoma, and first-line metastatic non-small cell lung cancer. In mRNA-2808, our T-cell engager in multiple myeloma, we are dosing in our phase I/II study. We're also dosing in the phase I study of our cancer antigen therapy, mRNA-4106.

Speaker #1: And we look forward to data from these studies in the year ahead. Aside from Intisprin, aside from our collaboration in Intisprin with Merck, we continue to make progress in additional oncology programs.

Speaker #1: In the Phase 2 study of our cancer antigen therapy, mRNA-4359, cohorts are enrolling in first-line metastatic melanoma, second-line metastatic melanoma, and first-line metastatic non-small cell lung cancer.

Speaker #1: In mRNA-2808, our T-cell engager in multiple myeloma, we are dosing in our Phase 1/2 study. We are also dosing in the Phase 1 study of our cancer antigen therapy, mRNA-4106.

Speaker #1: And rounding out our early-stage oncology programs, our Phase 1 study is also dosing in our cell therapy-enhancing program, mRNA-4203, in collaboration with Immatics.

Stephen Hoge: Rounding out our early-stage oncology programs, our phase I study is also dosing in our cell therapy enhancing program, mRNA-4203, in collaboration with Immunocore.... In rare diseases, our propionic acidemia, or PA program, is fully enrolled in its registrational study, and in methylmalonic acidemia, or MMA, we expect our registrational study to start in 2026. With that, I'll hand the call back over to Stéphane.

Speaker #1: In rare diseases, our propionic acidemia, or PA, program is fully enrolled in its registrational study. And in methylmalonic acidemia, or MMA, we expect our registrational study to start in 2026.

Speaker #1: With that, I'll hand the call back over to Stephane.

Speaker #2: Thank you, Stephane and Jamie. Looking ahead, we see multiple commercial pipeline and financial value drivers that will move more than half forward in 2026.

Stéphane Bancel: Thank you, Stephen and Jamey. Looking ahead, we see multiple commercial pipeline and financial value drivers that will move Moderna forward in 2026. Commercially, we believe the market share gains from mNEXspike will continue in 2026 and beyond. We will also benefit from a full year contribution from our strategic partnership in the UK, Canada, and Australia. That will be an important growth driver for Moderna in 2026, and we expect up to 10% revenue growth in 2026. From a pipeline standpoint, we look forward to potential regulatory approval of mNEXspike in Europe, in Japan, and in Taiwan. We also expect potential approval of our combination flu plus COVID vaccine in Europe and Canada, where regulatory filings are under review. In the US, we plan to refile pending further guidance from the FDA.

Speaker #2: Commercially, we believe the market share gains from Mnexspike will continue to 2026 and beyond. We will also benefit from a full contribution from our strategic partnership in the UK, Canada, and Australia.

Speaker #2: That will be an important growth driver for more than half in 2026. And we expect up to 10% revenue growth in 2026. From a pipeline standpoint, we look forward to potential regulatory approval of Mnexspike in Europe, in Japan, and in Taiwan.

Speaker #2: We also expect potential approval of our combination flu plus COVID vaccine in Europe and Canada, where our regulatory filings are under review. In the U.S., we plan to refile pending further guidance from the FDA.

Speaker #2: For the seasonal flu vaccine, we look forward to an approval in Canada this year. This is going to be an important year for oncology patients and for Moderna.

Stéphane Bancel: For seasonal flu vaccine, we look forward to approval in Canada this year. This is going to be an important year for oncology patients and for Moderna. We also expect continued clinical momentum from our INT program, as Stephen just described. Last month, we reported positive 5-year phase II data in adjuvant melanoma. Potential clinical milestones for our INT program include phase III adjuvant melanoma data, phase II adjuvant renal cell carcinoma data, and phase I data in adjuvant pancreatic and perioperative gastric cancers, all of which have been fully enrolled for quite some time. We also look forward to a phase II readout for our cancer antigen therapy, mRNA-4359, a phase II readout for norovirus, and the pivotal data readout from our PA program. That will be a busy year.

Speaker #2: We also expect continued clinical momentum from our Intisprin program, as Stephane just described. Last month, we reported positive five-year Phase 2 data in adjuvant melanoma.

Speaker #2: Potential clinical milestones from the Intisprin program include Phase 3 adjuvant melanoma data, Phase 2 adjuvant renal cell carcinoma data, and Phase 1 data in adjuvant pancreatic and perioperative gastric cancers, all of which have been fully enrolled for quite some time.

Speaker #2: We also look forward to a Phase 2 readout from our cancer antigen therapy, mRNA-4359. A Phase 2 readout for norovirus. And a pivotal data readout from our PA program.

Speaker #2: That will be a busy year. From a financial standpoint, teams across the company continue to make progress on cost discipline and we expect cash costs to decline approximately to 4.2 billion dollars in the year.

Stéphane Bancel: From a financial standpoint, teams across the company continue to make progress on cost discipline, and we expect cash costs to decline approximately to $4.2 billion in the year. As part of our cost efficiency program, the adoption of AI tools has touched every part of our business, and we expect further productivity improvement in 2026. Moderna has strong momentum as we head into 2026. We are poised to deliver up to 10% revenue growth as we continue to reduce costs. We expect to see approval of infectious disease vaccines that will expand our commercial portfolio, and we foresee multiple potential clinical data catalysts to remember our late-stage oncology programs in rare disease and infectious disease. In closing, I want to recognize the entire Moderna team for their relentless drive.

Speaker #2: As part of our cost efficiency program, the adoption of AI tools has touched every part of our business. And we expect further productivity improvement in 2026.

Speaker #2: More than a strong momentum as we head into 2026. We are poised to deliver up to 10% revenue growth as we continue to reduce cost.

Speaker #2: We expect to see approvals of infectious disease vaccines that will expand our commercial portfolio. And we foresee multiple potential clinical data catalysts driven by our late-stage oncology programs.

Speaker #2: And rare disease and infectious disease. In closing, I want to recognize the entire Moderna team for their relentless drive. All our progress—clinical, commercial, operational—is dedicated to one mission: delivering the greatest possible impact to people through mRNA medicine.

Stéphane Bancel: All our progress, clinical, commercial, operational, is dedicated to one mission: delivering the greatest possible impact to people for mRNA medicine. With this, operator, we'll be happy to take questions.

Speaker #2: With this 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 and you wish to remove yourself from the queue, please press *11 again.

Operator 1: 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 Terence Flynn with Morgan Stanley. Your line is open.

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 Terence Flynn with Morgan Stanley. Your line is open.

Speaker #1: We'll pause for a moment while we compile our Q&A roster. Our first question comes from Terence Flynn with Morgan Stanley. Your line is open.

Speaker #3: Hi, thanks so much for taking the question. I had two parts. I guess the first one is just on the flu RTF—implications for the 2028 cash flow break-even guidance.

Terence Flynn: Hi, thanks so much for taking the question. I had two part. I guess the first one is just on the flu RTF, implications for the 2028 cash flow break-even guidance, and then timing of the Type A meeting, like, when you might get some visibility on next steps. And then the INT program in adjuvant melanoma, I know that's a very important program and catalyst for the company. And so can you refine at all the timing of that data, whether it's going to be first half or second half? Thank you so much.

Speaker #3: And then, timing of the Type A meeting—like when you might get some visibility on next steps. And then the INT program in adjuvant melanoma.

Speaker #3: I know that's a very important program and catalyst for the company. And so, can you refine at all the timing of that data, whether it's going to be first half or second half?

Speaker #3: Thank you so much.

Speaker #1: Sure. Maybe I'll take the questions on regulatory first and then Jamie hand it over to you on any break-even implications. So we're actually very pleased that the flu file is under review now in Europe, Canada, Australia.

Stephen Hoge: Sure. Maybe I'll take the questions on regulatory first, and then Jamey, hand it over to you on any break-even implications. So, we're actually very pleased that the flu file is under review now in Europe, Canada, Australia. We'll be filing in additional countries this year. And all of that is with an eye towards having that start to contribute, as I said a moment ago, in 2027, in the fall of 2027, to our growth. We also are pleased that the flu COVID combination product remains under review and making progress in Europe for this year. As relates to the US timing, it really- we need to engage with the FDA in the Type A meeting.

Speaker #1: We'll be filing in additional countries this year, and all of that is with an eye towards having that start to contribute, as I said a moment ago, in 2027.

Speaker #1: In the fall of 2027, to our growth. We also are pleased that the flu/COVID combination product remains under review and is making progress in Europe for this year.

Speaker #1: As it relates to the US timing, we really need to engage with the FDA and the Type A meeting. That's usually 30 days as a process.

Stephen Hoge: That's usually 30 days as a process, and understand from them what is going to be required to get that product moving forward in the US. We absolutely feel that American seniors should have access to the same innovations. We do think this year, in particular, where there's a potential for a mismatch in one of the strains, it's particularly important that technologies like Moderna, Moderna's mRNA platform, are used to advance new and potentially improved products. But at this point, until we have that Type A meeting, we won't really know how quickly we can get moving forward with a 1010 file in the US, as we've been doing outside the US. Jamie?

Speaker #1: And understand from them what is going to be required to get that product moving forward in the US. We absolutely feel that American seniors should have access to the same innovations. We do think this year in particular is important, where there's a potential for a mismatch in one of the strains.

Speaker #1: It's particularly important that technologies like Moderna's mRNA platform are used to advance new and potentially improved products. But at this point, until we have that Type A meeting, we won't really know how quickly we can get moving forward with a 10/10 file in the U.S.

Speaker #1: As we've been doing outside the U.S. Jamie?

Speaker #2: Yeah, so Terence, thanks for the question. I appreciate it, and I recognize that it's on investors' minds. As Stephane just said, though, this is a bit of a fresh and fluid situation.

Stéphane Bancel: Yeah. So Terence, thanks for the question. I appreciate it, and I recognize that it's on investors' minds. As Stephen just said, though, this is a bit of a fresh and fluid situation. And without understanding the resolution of what is next for our flu product, it's a little bit difficult to comment at this time. But here's what I would say: if you go back to the growth drivers we laid out at Analyst Day, as well as Stephen had in his prepared remarks, we have 10 large shots on goal.

Jamey Mock: Yeah. So Terence, thanks for the question. I appreciate it, and I recognize that it's on investors' minds. As Stephen just said, though, this is a bit of a fresh and fluid situation. And without understanding the resolution of what is next for our flu product, it's a little bit difficult to comment at this time. But here's what I would say: if you go back to the growth drivers we laid out at Analyst Day, as well as Stephen had in his prepared remarks, we have 10 large shots on goal.

Speaker #2: And without understanding the resolution of what is next for our flu product, it's a little bit difficult to comment at this time. But here's what I would say.

Speaker #2: If you go back to the growth drivers we laid out at Analyst Day, as well as Stephane had in his prepared remarks, we have 10 large shots on goal.

Jamey Mock: ... to increase revenue over the coming years, all with a wide range of potential outcomes. And Stephen mentioned some of the progress. We announced our long-term partnerships with Mexico and Taiwan. We're excited about, as I said, we're excited to deliver for the UK and Australia this year, which will be substantial revenue growth. mNEXspike had a great first year. We're excited about the second year both in the US and outside the United States. We're looking forward to Europe opening up. So it's really, there's still so many scenarios that could happen here, Terence, that it's a little bit too early to tell. On top of that, we have a ton of momentum on productivity and what we're doing from a cost perspective. So we're really excited about our financial profile.

Speaker #2: To increase revenue over the coming years, all with a wide range of potential outcomes. And Stephane mentioned some of the progress. We announced our long-term partnerships with Mexico and Taiwan.

Speaker #2: We're excited about, as I said, we're excited to deliver for the UK and Australia this year, which will be substantial revenue growth. NextSpike had a great first year.

Speaker #2: We're excited about the second year, both in the US and outside the United States. We're looking forward to Europe opening up. So, really, there are still so many scenarios that could happen here, Terence, that it's a little bit too early to tell.

Speaker #2: On top of that, we have a ton of momentum on productivity and what we're doing from a cost perspective. So we're really excited about our financial profile.

Speaker #2: We ended the year with over $8 billion in cash. We have a ton of momentum from a cost perspective, and we have a lot of opportunities for growth.

Jamey Mock: We ended the year with over $8 billion in cash. We have a ton of momentum from a cost perspective, and we have a lot of opportunities for growth. So at this point, without knowing resolution to what's going to happen on flu, I think it's a little too early to tell.

Speaker #2: So, at this point, without knowing the resolution to what's going to happen on flu, I think it's a little too early to tell.

Speaker #3: Awesome.

Stephen Hoge: On INT, the second question. We don't have obviously more specific guidance than we previously put out there. I'd highlight, as I said a moment ago, that there are five histologies now under review or under the different stages of clinical development. So INT for melanoma, the adjuvant melanoma study is one that we are confident will read out this year. It is an event-driven trial, and so it will depend upon the accrual of those events. We have RCC, so renal cell and bladder, now fully enrolled. And again, those are going to be event-driven and milestone-driven readouts, and so it's possible. And then the phase 1 data that we referenced before for our peri-adjuvant gastric and adjuvant pancreatic monotherapy cohort.

Speaker #1: And on INT, the second question. We don't have obviously more specific guidance than we previously put out there. I'd highlight, as I said a moment ago, that there are five histologies now under review.

Speaker #1: Or under different stages of clinical development. So, INT for melanoma—the adjuvant melanoma study—is one that we are confident will read out this year. It is an event-driven trial.

Speaker #1: And so it will depend upon the accrual of those events. We have RCC, so renal cell and bladder, now fully enrolled. And again, those are going to be event-driven and milestone-driven readouts.

Speaker #1: And so it's possible. And then the Phase 1 data that we referenced before for our peri-adjuvant gastric and adjuvant pancreatic monotherapy cohort. And so it's going to be a busy year for us over the next number of months.

Stephen Hoge: And so it's going to be a busy year for us, over the next number of months. But we don't have more specific guidance because some of the most important readouts are ultimately event-driven.

Speaker #1: But we don't have more specific guidance, because some of the most important readouts are ultimately event-driven.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Salvine Richter with Goldman Sachs. Your line is open.

Operator 2: Thank you. One moment for our next question. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open.

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

Speaker #4: Good morning. Thank you for taking our question. This is Elizabeth on for Salvine. We wanted to ask about the flu and COVID combination vaccine and, just given the RTF for 10/10, how should we think about this refiling?

Salveen Richter: Good morning. Thank you for taking our question. This is Elizabeth on for Salvine. We wanted to ask about the flu and COVID combination vaccine, and just given the RTF for ten ten, how should we think about this refiling, and is there any read-through from a regulatory standpoint in the US? And then maybe just remind us of the study data that went into the submission initially, and what the latest thinking is on what might needed to be added for refiling. And then a second question on INTismeran: wanted your thoughts on which of those five histologies you just mentioned have the highest probability of success, kind of based on the read-through from data generated to date. Thank you so much.

Speaker #4: And is there any read-through from a regulatory standpoint in the US? And then maybe just remind us of the study data that went into the submission initially.

Speaker #4: And what the latest thinking is on what might need to be added for refiling. And then a second question on Intismaran. Wanted your thoughts on which of those five histologies you just mentioned have the highest probability of success, kind of based on the read-through from data generated to date.

Speaker #4: Thank you so much.

Speaker #1: Thanks for both questions. So first, on the 10/83 file, again, I'll underscore that we are hoping for approval of the flu COVID combination product in Europe first in the this year.

Stephen Hoge: Thanks for both questions. Yeah, so first, on the 108 refile, again, I'll underscore that we're hoping for approval of the flu COVID combination product in Europe first, in this year, and so we'll move forward there. As it relates to the US, we were holding back on refiling the combo vaccine until we'd completed some portion of the review of the flu vaccine. With the refusal to start the review of the flu vaccine, I think that is now gated on, again, the feedback from the Type A meeting, which we haven't had, about what more would be necessary for us to refile for the mRNA-1010 program. And then we would be able to provide more clarity on the flu COVID program and refiling there.

Speaker #1: And so we'll move forward there. As relates to the US, we were holding back on refiling the combo vaccine until we'd completed some portion of the review of the flu vaccine.

Speaker #1: With the refusal to start the review of the flu vaccine, I think that is now gated on, again, the feedback from the Type A meeting—which we haven't had—about what more would be necessary for us to refile for the mRNA 10/10 program.

Speaker #1: And then we would be able to provide more clarity on the flu/COVID program and refiling there. Again, all of this in the US, because all of those files are moving forward internationally.

Stephen Hoge: Again, all of this in the US, because all of those files are moving forward internationally. You asked about the data that was in the file. We had a phase III study for the mRNA-1010 file, which we have previously presented the results on, and actually it's out for a peer review publication right now. But really excited by that phase III study, which is a randomized 41,000-person study that we had agreed with the FDA and agencies around the world with prior to initiation. In that study, as a reminder, we saw 27% superior relative vaccine efficacy compared to the standard dose control.

Speaker #1: You asked about the data that was in the file. We had a phase three study for the mRNA 10/10 file. Which we have previously presented the results on.

Speaker #1: And actually, it's out for a peer review publication right now. But really excited by that phase three study, which was a randomized 41,000-person study that we had agreed with the FDA and agencies around the world with prior to initiation.

Speaker #1: In that study, as a reminder, we saw 27% superior relative vaccine efficacy compared to the standard dose control. And just to give you a sense of where that stands relative to competitors, two of the licensed, preferentially recommended vaccines for those over the age of 65 had run essentially the same study design.

Stephen Hoge: And just to give you a sense of where that stands, relative to comparators, you know, the two of the licensed preferentially recommended vaccines for those over the age of 65, had run essentially the same study design, one of them even with exactly the same comparator, and those, if you look at the USPI for Fluzone, they had seen 24% relative vaccine efficacy for Flublok. If you look in there, you see USPI, you'll see 30% relative vaccine efficacy. So at 27%, we felt very good, that we were in line, in demonstrating superiority in exactly the same way that those standard of cares have, in the same population, those over the age of 65.

Speaker #1: One of them, even with exactly the same comparator. And those, if you look at the USPI for Fluzone, they had seen 24% relative vaccine efficacy for Flublok.

Speaker #1: If you look in there, you see USPI, you'll see 30% relative vaccine efficacy. So at 27%, we felt very good that we were in line in demonstrating superiority in exactly the same way that those standards of care have in the same population, those over the age of 65.

Stephen Hoge: We also ran a phase III study, an immunogenicity and safety study, comparing our vaccine candidate for flu against Fluzone High Dose. And in that case, we showed statistical superiority to Fluzone High Dose on immunogenicity. That study has been published in the Journal of Vaccine, and is available, I think, on our website for those who are interested. So, that package was in the initial file. We think it's a very comprehensive data set. We do think if, if we can get the review initiated, it will, it will support the use of the product.

Speaker #1: We also ran a phase three study an immunogenicity and safety study comparing our vaccine candidate for flu, against flu zone high dose. And in that case, we showed statistical superiority to flu zone high dose on immunogenicity.

Speaker #1: That study has been published in the Journal of Vaccine and is available, I think, on our website for those who are interested. So that package was in the initial file.

Speaker #1: We think it's a very comprehensive dataset. We do think if we can get the review initiated, it will support the use of the product.

Speaker #1: But we do need to understand first from FDA, in that Type A meeting, what they would need to initiate the review of the file that they previously had agreed to review.

Stephen Hoge: We do need to understand first from FDA in that Type A meeting what they would need to initiate the review of the file that they previously had agreed to review. Moving to Intismeran, I think it's obvious that you asked where we see the highest probability of success. It's hard to argue with the Phase IIb results that we have for adjuvant melanoma. As we announced last month, the five-year survival data continues to look really strong, approximately a 50% reduction in the rates of relapse or death from melanoma. Real stability in those curves through now five years.

Speaker #1: Moving to Intismaran, I think it's obvious that the U.S. is where we see the highest probability of success. It's hard to argue with the Phase 2b results that we have for adjuvant melanoma.

Speaker #1: As we announced last month, the five-year survival data continues to look really strong. There's approximately a 50% reduction in the rates of relapse or death from melanoma.

Speaker #1: Real stability in those curves through now five years. And if you ask me where do I think the read-through of that is, I think it's clearly—we hope—into the phase 3 adjuvant melanoma study that is testing in largely the same population, in exactly the same standard of care.

Stephen Hoge: If you ask me, where do I, you know, think the read-through of that is, I think it's clearly, we hope, into the phase III adjuvant melanoma study that is testing in largely the same population, exactly the same standard of care. You know, I think if it works, if we see that there, one of the reasons we and our partner, Merck, went in with renal cell and, and bladder, was we thought, muscle-invasive urothelial cell carcinoma, is we thought those would be places, where we might also see, relatively quick read-through.

Speaker #1: I think if it works, if we see that there, one of the reasons we and our partner Merck went in with renal cell and bladder was we thought muscle-invasive urothelial cell carcinoma is we thought those would be places where we might also see relatively quick read-through.

Stephen Hoge: And so I hope that, you know, that those also have positive readouts, but I think if you're asking where we think the probability of success is highest, it's clearly in the, it's in the phase III adjuvant melanoma.

Speaker #1: And so I hope that those also have positive readouts. But I think if you're asking where we think the probability of success is highest, it's clearly in the—it's in the Phase 3 adjuvant melanoma.

Operator 2: Thank you. One moment for our next question. Our next question comes from Eliana Merrill with Barclays. Your line is open.

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

Speaker #3: Thank you. One moment for our next question. Our next question comes from Eliana Merle with Barclays. Your line is open.

Speaker #5: Hey, guys. Thanks for taking the question. Can you elaborate a little bit on how you're thinking about the European COVID vaccination market and how you see the vaccination rate and pricing evolving there?

Eliana Merle: Hey, guys. Thanks for taking the question. Just can you elaborate a little bit on how you're thinking about the European COVID vaccination market and how you see the vaccination rate and pricing evolving there? And also how, outside of the US, you're thinking about the pathway for a potential flu COVID combination vaccine approval. And then also on that topic around flu, just in your filings for flu in Europe and Canada, has there been any discussion around potential strain selection in the future and potentially selecting the strains closer to the season start? Thanks.

Ellie Merle: Hey, guys. Thanks for taking the question. Just can you elaborate a little bit on how you're thinking about the European COVID vaccination market and how you see the vaccination rate and pricing evolving there? And also how, outside of the US, you're thinking about the pathway for a potential flu COVID combination vaccine approval. And then also on that topic around flu, just in your filings for flu in Europe and Canada, has there been any discussion around potential strain selection in the future and potentially selecting the strains closer to the season start? Thanks.

Speaker #5: And also how outside of the US, you're thinking about the pathway for potential flu COVID combination vaccine approval. And then also on that topic around flu, just in your filings for flu in Europe and Canada, has there been any discussion around potential strain selection in the future and potentially selecting the strains closer to the season start?

Speaker #5: Thanks.

Speaker #1: Yeah. Yeah. Thank you for all three. So first, I'll take the combination question. So oh, actually, the COVID question. So Mnexpike is moving forward with approvals internationally.

Stephen Hoge: Yeah, yeah. Thank you for all three. So, first I'll take the combination question, so, or actually the COVID question. So, mNEXspike is moving forward with approvals internationally, and we're really pleased with the profile of that product. As I'll remind you, we had demonstrated in that phase III study higher relative vaccine efficacy. In fact, you know, in a post-hoc analysis, very high, approximately 25% higher relative vaccine efficacy compared to Spikevax in older adults with comorbidities. And so, really do think it's got a strong profile as the European COVID market reopens. Now, as to pricing, you know, we haven't issued that yet, but we do believe that the current market is, as we've shared, approximately $700 million today.

Speaker #1: And we're really pleased with the profile of that product. As I'll remind you, we had demonstrated in that Phase 3 study higher relative vaccine efficacy—in fact, in the post hoc analysis, very high, approximately 25% higher relative vaccine efficacy compared to mRNA-1273 Spike.

Speaker #1: In older adults with comorbidities, and so I really do think it's got a strong profile as the European COVID market reopens. Now, as to pricing, we haven't issued that yet, but we do believe that the current market is, as we've shared, approximately $700 million today.

Stephen Hoge: And that doesn't account for wastage that exists in the market. There are many more doses that are being purchased under that pandemic contract that are not getting used. That estimate of approximately 700 million is just what we see as shots in arms. So we do believe that market will be larger than that, larger than even if we see nothing more than the approximately 20 million shots in arms that currently are happening. And we do hope to get a sizable share. We think mNEXspike will be a very competitive product profile in that market, and we're scaling up for that launch. As you know, Europe is not one market. It is a series of different markets, and some places will compete traditionally with sales and market activities.

Speaker #1: And that doesn't account for wastage that exists in the market. There are many doses that are being—more doses that are being purchased under that pandemic contract that are not getting used.

Speaker #1: That estimate of approximately 700 million is just what we see as shots in arms. So we do believe that market will be larger than that.

Speaker #1: Larger than even if we see nothing more than the approximately 20 million shots in arms that currently are happening. And we do hope to get a sizable share.

Speaker #1: We think Mnexpike will be a very competitive product profile in that market, and we're scaling up for that launch. As you know, Europe is not one market.

Speaker #1: It is a series of different markets. In some places, we'll compete traditionally with sales and market activities. Other markets are more tender-driven. And we're preparing for all of that activities really starting this year.

Stephen Hoge: Other markets are more tender-driven, and we're preparing for all of that, activities, really starting this year, but as we said, as a meaningful driver of growth in 2027 and beyond. On the combination product, we actually think that's the next step in that strategy. We're very pleased by the combo product's progress in its international reviews. As we've said, based on timing, we do expect a European review to move forward, and we are hoping for approval this year. Which gives us a chance to launch, you know, as early as this year, more likely in 2027. Again, it just depends on timing of these events because proximity to the season will make a launch very difficult.

Speaker #1: But as we said, as a meaningful driver of growth in 2027 and beyond. On the combination product, we actually think that's the next step in that strategy.

Speaker #1: We're very pleased by the combo products progress in its international reviews. As we've said, based on timing, we do expect a European review to move forward and we are hoping for approval this year.

Speaker #1: Which gives us a chance to launch as early as this year, more likely in 2027. Again, it just depends on timing of these events because proximity to the season will make a launch very difficult.

Stephen Hoge: But it is clearly a great opportunity for us to move beyond just COVID into a combination product, and an opportunity to both expand our share in the COVID space, but also grab share in the flu space. And we are proceeding with the filings elsewhere. I think we referenced in the PR Canada for that combination product as well, and hope to similarly bring forward that innovation, because we believe there's strong demand from health systems as well as patients for one shot, or one vaccine that does multiple things. Now, as relates to the flu, we have been having those conversations. So mRNA-1010, as we've proceeded outside of the US, there has been strong appetite for the question of better strain matching.

Speaker #1: But it is clearly a great opportunity for us to move beyond just COVID into a combination product and an opportunity to both expand our share in the COVID space but also grab share in the flu space.

Speaker #1: And we are proceeding with the filings elsewhere. I think we referenced in the PR Canada for that combination product as well, and hope to similarly bring forward that innovation because we believe there's strong demand from health systems as well as patients for one shot, or one vaccine, that does multiple things.

Speaker #1: Now, as it relates to the flu, we have been having those conversations. So, mRNA-1010, as we've proceeded outside of the U.S., there has been strong appetite for the question of better strain matching.

Stephen Hoge: And in fact, in some public comments, you've seen some European regulators, but also some from other, other markets, you know, vocally advocate for, later strain selection and more diverse strain, selections happening, in flu vaccines, because of the precedent we've shown with COVID vaccines. I'll remind you that we sometimes forget in the US, but, in this country, we've actually, the FDA has chosen different strains of COVID vaccine than the rest of the world in 2 out of the 4 past seasons. And the data has shown that that better matching for the market has lead, led to, slightly better efficacy. In fact, we ran a clinical trial once head-to-head back in the bivalent days, and showed, higher point estimates for efficacy. Which makes sense.

Speaker #1: And in fact, in some public comments, you've seen some European regulators, but also some from other markets, vocally advocate for later strain selection and more diverse strain selections happening in flu vaccines.

Speaker #1: Because of the precedent we've shown with COVID vaccines. I'll remind you that, and we sometimes forget in the US, but in this country, the FDA has actually chosen different strains of COVID vaccine than the rest of the world in two out of the four past seasons.

Speaker #1: And the data has shown that better matching for the market has led to slightly better efficacy. In fact, we ran a clinical trial once, head-to-head, back in the bivalent days and showed higher point estimates for efficacy.

Speaker #1: Which makes sense. Better matched vaccine, you would expect to be better at protecting people. And what we're hearing from the international flu community, including, as I said, in Europe, is quite strong support for that.

Stephen Hoge: A better-matched vaccine, you would expect to be better at protecting people. And what we're hearing from the international flu community, including, as I said, in Europe, is quite strong support for that. It's a real question today. I mean, just to make the point, there are a couple of different strains of influenza B circulating around the world right now. In the United States, it is a different strain than is circulating in the rest of the Northern Hemisphere, and there doesn't look like there would be great cross-protection. So it just highlights that the right answer for this fall could be very different from a composition perspective for Europe, North America, or other regions.

Speaker #1: It's a real question today. I mean, just to make the point, there are a couple of different strains of influenza B circulating around the world right now. In the United States, it is a different strain than is circulating in the rest of the Northern Hemisphere.

Speaker #1: And there doesn't look like there would be great cross-protection. And so it just highlights that the right answer for this fall could be very different from a composition perspective for Europe or North America or other regions, and that's where the technology that we have, that has allowed us to tailor and meet regional needs with COVID, we think can have an impact.

Stephen Hoge: That's where the technology that we have that has allowed us to tailor and meet regional needs with COVID, we think can have an impact. There are many other things we need to do to improve flu vaccines, but this is one we know we can do right now.

Speaker #1: There are many other things we need to do to improve flu vaccines, but this is one we know we can do right now.

Speaker #2: Thank you. One moment for our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Operator 2: Thank you. One moment for our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

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

Speaker #3: Hey, good morning. This is Greg on for Tyler from TD Cowen. Thanks for taking my question. So, some investors have been surprised by the higher-than-expected cash balance at year-end.

Tyler Van Buren: Hey, good morning. This is Greg on for Tyler from TD Cowen. Thanks for taking my question. So some investors have been surprised by the higher-than-expected cash balance at year-end. So can you explain why that occurred and what the additional levers to lower cash costs are moving forward? Thanks.

Gregory Solazzo: Hey, good morning. This is Greg on for Tyler from TD Cowen. Thanks for taking my question. So some investors have been surprised by the higher-than-expected cash balance at year-end. So can you explain why that occurred and what the additional levers to lower cash costs are moving forward? Thanks.

Speaker #3: So can you explain why that occurred and what the additional levers to lower cash costs are moving forward? Thanks.

Speaker #4: Yeah, sure, Greg. So maybe I'll just go back to our original guidance. So when we laid out our original guidance, we said $1.5 to $2.5 billion of revenue.

Jamey Mock: Yeah, sure, Greg. So I maybe I'll just go back to our original guidance. So when we laid out our original guidance, we said $1.5 to 2.5 billion of revenue, so $2 billion at the midpoint, and we said $5.5 billion of cash costs. So if you take those two together, it's a $3.5 billion-dollar usage from a starting point of $9.5 billion, which is why we guided $6 billion. Since then, revenue essentially came in online. We had $1.944 billion, let's call that pretty close. And cash cost came in at $4.3 billion, so we beat by $1.2 billion.

Speaker #4: So, $2 billion at the midpoint. And we said $5.5 billion of cash costs. So if you take those two together, it's a $3.5 billion usage.

Speaker #4: From a starting point of $9.5 billion, which is why we guided $6 billion. Since then, revenue essentially came in online. We had $1.944 billion—let's call that pretty close.

Speaker #4: And cash costs came in at $4.3 billion. So we beat by $1.2 billion. On top of that, we took $600 million of the initial draw from the loan.

Jamey Mock: On top of that, we took $600 million of the initial draw from the loan, so that's now $1.8 billion better. Our capital expenditures were $100 million less than we forecasted at the outset of the year, so that's $1.9 billion better. And then if you look at the working capital, I am really pleased, it doesn't get a lot of attention, with how the team has performed. Our receivables are at $180 million. Inventory was flat year over year at $270 million. Payables at $300 million. We have a net working capital balance of $150 million to which we run this company on. And that is really incredible performance from the team, and that drove the last $200 million.

Speaker #4: So that's now $1.8 billion better. Our capital expenditures were $100 million less than we forecasted at the outset of the year. So that's $1.9 billion better.

Speaker #4: And then if you look at the working capital, I am really pleased. It doesn't get a lot of attention, but I'm very happy with how the team has performed.

Speaker #4: Our receivables are at $180 million. Inventory was flat year over year at $270 million. Payables are at $300 million. We have a net working capital balance of $150 million, which we run this company on.

Speaker #4: And that is really incredible performance from the team. And that drove the last 200 million dollars. So I don't think it should be too much of a surprise that it's mostly cash costs.

Jamey Mock: So I don't think it should be too much of a surprise that it's mostly cash costs for $1.2 billion above our original guidance, the loan, a little bit less work, capital expenditures, and then terrific performance on working capital from the team.

Speaker #4: For $1.2 billion above our original guidance, the loan, a little bit less capital expenditures, and then terrific performance on working capital from the team.

Speaker #2: Thank you. One moment for our next question. Our next question comes from Michael Yee with UBS. Your line is open.

Operator 2: 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: Great, thanks. We had two questions as well. First, on the adjuvant Phase 3 melanoma study, can you remind us if that study has interims built in?

Mike Yee: Great, thanks. We had two questions as well. First, on the adjuvant, phase 3 melanoma study, can you remind us, that that study has interims built in, and then, of course, a final? And so, like other, design studies you've done, there's a certain number of cases accrue, you take a look at it, and then if it doesn't stop, you move to the next case, the next interim. Can you just describe a little bit how that works, and remind us that the phase 2, I think, did stop at an interim, if that, if I was correct there. And then on norovirus, I don't think anyone's asked on that, but, can you just remind us there, you, are enrolling or expect to complete enrollment, and then there's actually a readout, I think, planned this year.

Operator: Great, thanks. We had two questions as well. First, on the adjuvant, phase 3 melanoma study, can you remind us, that that study has interims built in, and then, of course, a final? And so, like other, design studies you've done, there's a certain number of cases accrue, you take a look at it, and then if it doesn't stop, you move to the next case, the next interim. Can you just describe a little bit how that works, and remind us that the phase 2, I think, did stop at an interim, if that, if I was correct there. And then on norovirus, I don't think anyone's asked on that, but, can you just remind us there, you, are enrolling or expect to complete enrollment, and then there's actually a readout, I think, planned this year.

Speaker #5: And then, of course, a final.

Speaker #1: And so , like other design studies you've done , there's a certain number of cases of crew . You take a look at it and then if it doesn't stop , you move to the next case and next interim .

Speaker #1: Can you just describe a little bit how that works ? And remind us the phase two , I think , did an interim if I was correct .

Speaker #1: There and then on norovirus , I don't think anyone's asked on that . But can you just remind us there you are enrolling or expect to complete enrollment .

Speaker #1: And then there's actually a readout . I think , planned this year . What is your confidence level there ? I know there's been a lot of disappointments previously , but I think your targeting in a different approach and using three different strains , which I think I assume you believe will capture the majority of coverage .

Mike Yee: What is your confidence level there? I know there's been a lot of disappointments previously, but I think you are targeting a different approach and using three different strains, which I think I assume you believe will capture the majority of coverage. Can you just remind us there and how you think about that result? Thank you.

Speaker #1: Can you just remind us there, and how you think about that result? Thank you.

Speaker #2: Yeah . Thanks Mike for both questions . So first on the Intx phase three for adjuvant melanoma , you're correct . It's the first analysis that we'll see this year will be an interim analysis .

Stephen Hoge: Yeah. Thanks, Mike, for both questions. So first on the INT phase 3 for adjuvant melanoma. You're correct, it's the first analysis that we'll see this year will be an interim analysis, looking at our primary endpoint, so relapse-free survival. We have a number of additional analyses, if that, you know, if you get there and, we don't have, the statistical power to declare early success then, then we would move forward to subsequent analyses, and ultimately, additional endpoints, including things like distant metastasis-free survival. What I'd remind you is, is the phase 2, hit, essentially, its statistical hypothesis at the interim, and then what we've been following since are the others.

Speaker #2: Looking at our primary endpoint . Or relapse free survival . We have a number of additional analyses if that . You know if you get there and we don't have the statistical power to declare early success , then then we would move forward to subsequent analyses and ultimately additional endpoints , including things like distant metastasis , free survival .

Speaker #2: What I'd remind you is the phase two , a hit Essentially is statistical hypothesis . At the interim . And then what we've been following since are the others .

Speaker #2: And we believe we've conservatively designed this study so that if those results are repeated , we would be well powered to see that in this first interim .

Stephen Hoge: We believe we've conservatively designed this study, so that if those results are repeated, we would be well-powered to see that in this first interim. But if for whatever reason, we're told to continue forward, there would be a subsequent analysis, and that again would be event-driven, but presumably would come, you know, the year after. As to the norovirus study, we are very excited to see those results potentially this year. Again, a case-driven trial. As you highlighted, there had been some previous efforts in norovirus. Ours are quite different.

Speaker #2: But if for whatever reason , we're told to continue forward , there would be a subsequent analysis and that again , would be event driven .

Speaker #2: But presumably would come , you know , the year after the as to the norovirus study , we we are very excited to see those results potentially this year .

Speaker #2: Again , a case driven trial as you as you highlighted , there had been some previous efforts in norovirus . Ours are quite different .

Speaker #2: So first , the composition of our vaccine as you highlighted , is a trivalent here . And we are looking at strain matched efficacy , which is important because it does allow us to make sure that we're looking at the performance of the vaccine , which is matched at , you know , strains that are in approximately in most years , two thirds to 70% of the circulating norovirus disease .

Stephen Hoge: So first, the composition of our vaccine, as you highlighted, is a trivalent here, and we are looking at strain-matched efficacy, which is important, because it does allow us to make sure that we're looking at the performance of the vaccine, which is matched at, you know, strains that are in, you know, approximately in most years, two-thirds to 70% of the circulating norovirus disease. And so that trivalent composition, and the VLPs that our technology make, we think, is a differentiator. But perhaps the more important one relative to the trial I think you were referencing is... We're looking in seropositive populations, not children.

Speaker #2: And so that trivalent composition and the the vlps that our technology make , we think is is a differentiator . But perhaps the more important one , relative to the trial , I think you were referencing is we're looking in in seropositive populations , not children .

Speaker #2: And so earlier studies that have struggled in norovirus have looked at in children in primary vaccination , you know , often a couple of doses as opposed to really where the burden of disease is , as you become an adult is in older adults , those particularly over the age of 65 , where you know , the threat of really profound dehydration can lead to hospitalization and complications of a whole number of medical comorbidities .

Stephen Hoge: Earlier studies that have struggled in norovirus have looked at in children, in primary vaccination, you know, often a couple of doses, as opposed to really where the burden of disease is, as you become an adult, is in older adults, those particularly over the age of 65, where, you know, the threat of really profound dehydration can lead to hospitalization and complications of a whole number of medical comorbidities. There's actually even bigger need in that population. In that case, it's more of a booster trial.

Speaker #2: And so there's a actually even bigger need in that population . And in that case , it's more of a booster trial . It's much more like , you know , it's a bit like primary vaccination for whatever it is .

Stephen Hoge: It's much more like, you know, it's a bit like primary vaccination for, you know, whatever it is, RSV or flu or COVID, being very, very different than boosting seropositive people so that they can protect, which is a lot more like what you see with our, our senior flu, COVID, and RSV vaccines, which have obviously been successful. Norovirus is a different one, but we're- we do believe that that difference in population will make a difference in terms of the ability of a vaccine to help protect them against this disease.

Speaker #2: RSV or flu or Covid being very , very different than boosting people so that they can protect , which is a lot more like what you see with our our senior flu , Covid and RSV vaccines , which have obviously been successful .

Speaker #2: Norovirus is a different one, but we do believe that that difference in population will make a difference in terms of the ability of a vaccine to help protect them against this disease.

Speaker #1: Thank you . And as a follow up , do you think that the guidance with FDA or the discussion or regulatory path for this would be very different ?

Michael Yee: Thank you. As a follow-up, do you think that the guidance with FDA or the discussion or regulatory path for this would be very different? Or, and put another way, much more obvious than perhaps what's going on in the flu?

Mike Yee: Thank you. As a follow-up, do you think that the guidance with FDA or the discussion or regulatory path for this would be very different? Or, and put another way, much more obvious than perhaps what's going on in the flu?

Speaker #1: Or put another way , much more obvious than perhaps what's going on in flu

Speaker #2: So look , Michael , I remind that we have we got three products approved last year in the US or , you know , some label expansions , RSV and a new Covid product and a pediatric Covid and and in those cases , you know , the guidance was different .

Stephen Hoge: Look, Michael, I'd remind that we have, we got three products approved last year in the US, or, you know, some label expansions, RSV, a new COVID product, and a pediatric COVID. In those cases, you know, the guidance was different. What we're experiencing with flu is, I think, we hope, flu specific. Our norovirus study, to your point, is a very large placebo-controlled study. The type A, the refusal to file letter that we have received from the FDA on flu really speaks to a change in their perspective on the comparator used. In the case of norovirus, there is no comparator to use, and so the comparator in that clinical trial is placebo.

Speaker #2: What we're experiencing with flu is I think we hope flu specific our norovirus study to your point , is a very large , placebo controlled study .

Speaker #2: And so the the type , the the refusal to file letter that we have received from the FDA on flu really speaks to a change in their perspective on on the comparator used .

Speaker #2: But in the case of norovirus , there is no comparator to use . And so the comparator in that clinical trial is placebo .

Speaker #2: If we're able to demonstrate efficacy over placebo, it's hard to argue that there's a problem with the comparator.

Stephen Hoge: If we're able to demonstrate efficacy over placebo, it's hard to argue that there's a problem with the comparator.

Speaker #1: Perfect . Thank you .

Michael Yee: Okay, thank you.

Mike Yee: Okay, thank you.

Speaker #3: One moment for our next question. Our next question comes from Luca ESI with RBC Capital Markets. Your line is open.

Operator 2: One moment for our next question. Our next question comes from Luca Issi with RBC Capital Markets. Your line is open.

Operator: One moment for our next question. Our next question comes from Luca Issi with RBC Capital Markets. Your line is open.

Speaker #4: Oh , great . Hi , team . This is Shelby on for Luca and thanks for taking the question . Maybe on int congrats on the recent five year data for melanoma .

Luca Issi: Oh, great. Hi, team. This is Shelby on for Luca, and thanks for taking the question. Maybe on INT, congrats on the recent five-year data for melanoma, and it's great to see the hazard ratio for RFS is remaining consistent with prior cuts. However, what about OS? I remember at ASCO in 2024, you showed some pretty compelling data with the initial separation of the curves, but the press release this time was silent on OS. How should we read that? Does that mean the OS curves are no longer separated, or are you just keeping the details or maybe an upcoming medical meeting? Any color there, much appreciated. Thanks.

Shelby Ward: Oh, great. Hi, team. This is Shelby on for Luca, and thanks for taking the question. Maybe on INT, congrats on the recent five-year data for melanoma, and it's great to see the hazard ratio for RFS is remaining consistent with prior cuts. However, what about OS? I remember at ASCO in 2024, you showed some pretty compelling data with the initial separation of the curves, but the press release this time was silent on OS. How should we read that? Does that mean the OS curves are no longer separated, or are you just keeping the details or maybe an upcoming medical meeting? Any color there, much appreciated. Thanks.

Speaker #4: And it's great to see the hazard ratio for PFS is remaining consistent with prior cuts. However, what about OS? I remember at ASCO in 2024 you showed some pretty compelling data with the initial separation of the curves.

Speaker #4: But the press release this time was silent on OS . How should we read that . Does that mean the OS curves are no longer separated , or are you just keeping the details ?

Speaker #4: Or maybe an upcoming medical meeting ? Any color there ? Much appreciated . Thanks

Speaker #2: Yeah , let me say it this way . We look forward to sharing the OS curves at an upcoming medical meeting . We , you know , where you see relapse free survival holding obviously included in relapse free survival is survival .

Stephen Hoge: Yeah, let me say it this way: We look forward to sharing the OS curves at an upcoming medical meeting. We, you know, where you see relapse-free survival holding, obviously included in relapse-free survival is survival. And so, we obviously didn't put that out, because we wanna make sure that we're able to bring that forward to the community in a place where they can see all of that data. But all data from this five-year interim analysis will be presented at an upcoming medical meeting. Until then, I really shouldn't say more.

Speaker #2: And so we we obviously didn't put that out because we want to make sure that we're able to bring that forward to the community in a place where they can see all of that data .

Speaker #2: But all data from the five year interim analysis will be presented at an upcoming medical meeting . Until then , I really shouldn't say more

Speaker #3: Thank you one moment for our next question Our next question comes from Courtney Breen with with Bernstein . Your line is open

Operator 2: Thank you. One moment for our next question. Our next question comes from Courtney Breen with Bernstein. Your line is open.

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

Speaker #5: Hi all. Thanks so much for taking our question today. Just a couple, and building off the conversation around the data that you got for the flu.

Courtney Breen: Hi, all. Thanks so much for taking our question today. Just a couple and building off the RTF that you got for the flu ten/ten. We've managed to find kind of an immunogenicity substudy, I think, of that phase III efficacy study, which suggested, and it was a very small population of that study, suggested there was a 50/50 ratio between those under and over 65. Can you just remind us or share with us what percentage of patients in that efficacy study were 65 or older? And then additionally, as we think about kind of INT and the path to approval, have you had any feedback in the design of that clinical trial that perhaps provided some recommendations that weren't followed?

Speaker #5: 1010 . We've managed to find kind of a immunogenicity substudy , I think of that phase three efficacy study , which suggested and it was it was a very small population of that study suggested there was a 50 over 50 ratio between those under and over 65 .

Speaker #5: Can you just remind us or share with us what percentage of patients in that efficacy study were 65 or older ? And then additionally , as we think about kind of int and the path to approval and kind of have you had any feedback in the design of that clinical trial that perhaps provided some recommendations that weren't followed ?

Courtney Breen: Additionally, kind of, will it be you or Merck taking that file forward, and kind of, can we assume that CBER will be the FDA group that will assess that particular file? Thank you so much.

Speaker #5: Additionally , kind of will it be you or Merck taking that file forward ? And kind of can we assume that Ciba will be the the FDA group that will assess that particular file ?

Speaker #5: Thank you so much .

Speaker #2: Yeah , thank you for the questions . So first , on the phase three trial design for our flu vaccine , you're correct in your memories , right .

Stephen Hoge: Yeah, thank you for the questions. So, first on the phase III trial design for our flu vaccine, you're correct, and your memory's right. More than 50% of the population in the study, but it was stratified that at least 50% would be over the age of 65. We also had a very large population of, you know, north of 10% that was above the age of 75. And as we have presented at medical meetings and will be available in the upcoming publication, we've seen really strong, superior efficacy across all of those populations. In fact, it's remarkably consistent.

Speaker #2: More than 50% of the population in the study . But it was stratified that at least 50% would be over the age of 65 .

Speaker #2: We also had a very large population , you know , north of 10% . That was above the age of 75 . And as we have presented at medical meetings , and we'll be available in the upcoming population publication , we've seen really strong superior efficacy across all of those populations .

Speaker #2: In fact , it's remarkably consistent . And as you add frailty or other risk factors to age or as you look to severe outcomes such as hospitalization , you'll see those point estimates for superiority go even higher .

Stephen Hoge: As you add frailty or other risk factors to age, or as you look to severe outcomes such as hospitalization, you'll see those point estimates for superiority go even higher, and in many cases, become even more statistically significant. So we feel very good about that 41,000-person study, which as you just described, or as I just said, has more than 20,000 people over the age of 65 in it. I did describe a separate Phase 3 study, just to avoid confusion, the P303 study, Part C, that has 3,000 people in it, and that was the study that was head-to-head against Fluzone High Dose that showed superior immunogenicity. But the efficacy study, I think, was the one that you were asking about.

Speaker #2: And in many cases become even more statistically significant . So we feel very good about that . 41,000 person study , which , as you just described , or as I just said , has more than 20,000 people over the age of 65 .

Speaker #2: In it I did describe a separate phase three study just to avoid confusion . The P303 study , part C that has 3000 people in it , and that was the study that was head to head against Fluzone High-dose that showed superior immunogenicity .

Speaker #2: But the efficacy study , I think , was the one that you were asking about . Now , as relates to int , int is we're moving forward in a very novel field .

Stephen Hoge: Now, as it relates to INT, INT is, we're moving forward, in a very novel field, and so we've had, robust, and I would say, highly productive engagement, with the FDA and truly global regulators, around the what will be a first of its kind, individualized neoantigen treatment. Those dialogues are detailed and, you know, I think, you know, broadly, we are very aligned, both ourselves and Merck, with those regulators. It is with Weber at FDA, but obviously, other offices are involved, because it is, as an oncology therapy, of high import, it gets a lot of attention.

Speaker #2: And so we've had robust and I would say highly productive engagement with the FDA . And truly global regulators around the around the what will be a first of its kind individual neoantigen treatment .

Speaker #2: Those dialogues are detailed . And , you know , I think broadly , we are very aligned both ourselves and Merck with those regulators .

Speaker #2: It is with CBER at FDA, but obviously other offices are involved because it is as an oncology therapy of import. It gets a lot of attention.

Stephen Hoge: I would just say, generally, we're working closely with regulators to make sure that we're doing everything they want so that they can conduct rapid reviews of the file. Merck is our partner in this. Merck is the sponsor for the Phase 3 study. So they, we and they participate in those discussions and back and forth, and we each have different responsibilities in our 50/50 joint venture partnership. But the BLA submission, if it goes forward, will be from Merck.

Speaker #2: And I would just say generally we are we're working closely with regulators to make sure that we're doing everything they want so that they can conduct rapid reviews of the file .

Speaker #2: Merck is our partner in this . Merck is the sponsor for the phase three study . So they we and they participate in the in those discussions and back and forth .

Speaker #2: And we each have different responsibilities in our 5050 joint venture partnership . But the Bla submission , if it goes forward will be from Merck

Speaker #3: Thank you . One moment for our next question Our next question comes from Alex Renehan with Bank of America . Your line is open .

Operator 2: Thank you. One moment for our next question. Our next question comes from Alex Renahan with Bank of America. Your line is open.

Operator: Thank you. One moment for our next question. Our next question comes from Alex Renahan with Bank of America. Your line is open.

Speaker #6: Hey guys , this is Matthew on for Alec . Appreciate you taking our questions . Maybe for RCC . Can you walk us through what makes you confident the phase two could be registrational ?

[Analyst] (Bank of America): Hey, guys, this is Matthew on for Alex. Appreciate you taking our questions. Maybe for RCC, can you walk us through what makes you confident that Phase 2 could be registrational, and what hazard ratio or benefit you think would be compelling? And then if you do need to run a Phase 3, curious whether you think KEYTRUDA would be the appropriate comparator arm or whether KEYTRUDA balzutamab combo would be preferred pending the Lightspark-22 data. Thanks.

[Analyst] (Bank of America Corporation): Hey, guys, this is Matthew on for Alex. Appreciate you taking our questions. Maybe for RCC, can you walk us through what makes you confident that Phase 2 could be registrational, and what hazard ratio or benefit you think would be compelling? And then if you do need to run a Phase 3, curious whether you think KEYTRUDA would be the appropriate comparator arm or whether KEYTRUDA balzutamab combo would be preferred pending the Lightspark-22 data. Thanks.

Speaker #6: And what hazard ratio or benefit do you think would be compelling? And then, if you do need to run a Phase 3, I'm curious whether you think Keytruda would be the appropriate comparator arm, or whether a Keytruda-belzutifan combo would be preferred, pending the LIGHTSPARK-022 data?

Speaker #6: Thanks .

Speaker #2: Yeah , that's a great question . You know , one of the exciting things in oncology is it's a fast moving space . And in individual histologies , sometimes the standard of care will evolve and you're highlighting value for .

Stephen Hoge: Yeah, that's a great question. You know, one of the exciting things in oncology is it's a fast-moving space, and in individual histologies, sometimes the standard of care will evolve, and you're highlighting balzu for RCC. Look, first I'd say the phase 2 study is blinded, it's powered, and if we see a, you know, really significant or profound benefit, you know, we haven't guided on what that hazard ratio would be, but let's assume it's something that would look really dramatic and highly statistically significant. Then it is structured so that it could be a registrational study. But, you know, it wasn't initially intended and powered as that.

Speaker #2: Look , first , I'd say the phase two study is blinded . It's powered . And if we see a really significant or profound benefit , you know , we haven't gotten on what that hazard ratio would be .

Speaker #2: But let's assume it's something that would look really dramatic and highly statistically significant. Then it is structured so that it could be a registrational study.

Speaker #2: But, you know, it wasn't initially intended or empowered as that. It's not a phase three study because our primary goal here was we wanted to confirm the hypothesis that it works well across a range of tumors.

Stephen Hoge: It's not a phase 3 study, because our primary goal here was we wanted to confirm the hypothesis that INT works well across a range of tumors, and in particular places that we thought there was an opportunity to improve upon pembro as a standard of care. And since we started and enrolled that study, there's obviously been the good news of the balzu results. Again, that's with our partner, Merck. And so, if we see a equally great response here for INT, we'll have a conversation with Merck about what we do with INT. It may mean going forward, it may mean adding it to those, because there's always a desire to improve outcomes in cancer. It'll entirely depend upon what the data actually says.

Speaker #2: And in particular, places that we thought there was an opportunity to improve upon Pembro as a standard of care, since we started and enrolled that study, there's obviously been the good news of the results.

Speaker #2: Again, that's with our partner Merck. And so if we see equally great response here for INT, we'll have a conversation with Merck about what we do with INT.

Speaker #2: It may mean going forward, it may mean adding it to those, because there's always a desire to improve outcomes in cancer.

Speaker #2: It'll entirely depend upon what the data actually says. And so, at this point, we're just excited to look forward to it.

Stephen Hoge: At this point, we're just excited to look forward to it. But once we have it, the thing that, you know, I think we will be most focused on is, does this confirm the opportunity for INT to work across a range of different cancers and other histologies?

Speaker #2: But once we have it , the thing that I think we will be most focused on is , does this confirm the opportunity for INT to work across a range of different cancers and other histologies

Speaker #3: Thank you one moment for our next question Our next question comes from Cory Kasimov with Evercore . Your line is open

Operator 2: Thank you. One moment for our next question. Our next question comes from Corey Kasimov with Evercore. Your line is open.

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

Speaker #7: Hi . This is Adi on for Cory . We had a question on the adjuvant melanoma as well . Could you share how do you anticipate use across the broader PD1 , Pd-l1 class or primarily only with pembrolizumab separately , as Subcu Pembro and and other options become more prevalent ?

Umer Raffat: Hi, this is Addie on for Corey. We had a question on the adjuvant melanoma, as well. Could you share how do you anticipate use across the broader PD-1, PD-L1 class, or primarily only with pembrolizumab? Separately, as subQ pembro and other options become more prevalent, do you see any impact on regimen selection, logistics, or ultimately uptake, for INT?

Adi Jayaraman: Hi, this is Addie on for Corey. We had a question on the adjuvant melanoma, as well. Could you share how do you anticipate use across the broader PD-1, PD-L1 class, or primarily only with pembrolizumab? Separately, as subQ pembro and other options become more prevalent, do you see any impact on regimen selection, logistics, or ultimately uptake, for INT?

Speaker #7: Do you see any impact on regimen selection, logistics, or ultimately uptake for mAb?

Stephen Hoge: Thank you for both questions. So, first, I think we will be pursuing a label. Obviously, it's on top of a standard of care in the trial, which is pembro. But we believe that that label could broadly apply to other PD-1, PD-L1s that are approved in the same indication for adjuvant melanoma. Obviously, that'll depend upon discussions with regulators, but I think that would follow the precedent of other approaches. And it's in our mutual interest with Merck. We want to see INT be used for as many patients as possible, regardless of the choice of the PD-1 or PD-L1 backbone. As relates to subQ, you know, I think it... That's really a within the PD-1 class question.

Speaker #2: Thank you for both questions . So so first , I think we will be pursuing a label . Obviously it's on top of a standard of care in the trial , which is pembro .

Speaker #2: But we believe that that label could broadly apply to other PD1 , Pd-l1 that are approved in the same indication for adjuvant melanoma .

Speaker #2: Obviously , that will depend upon discussions with regulators , but I think that would follow the precedent of other approaches . And it's in our mutual interest with with Merck , we want to see int be used for as many patients as possible , regardless of the choice of the PD one or Pd-l1 backbone .

Speaker #2: The as As relates to Subcu , you know , I think that's really within the PD one class question . And so how do those antibodies , you know , get subbed out for each other going forward ?

Stephen Hoge: And so how do those antibodies, you know, get subbed out for each other going forward? It really wouldn't relate in our mind to INT, which would be a category of one. And the benefit that INT provides, we believe would apply equally well, although we'll have to see what regulators want to see to see this. But we think the community would agree that would likely to apply equally well, whether you're doing a subcutaneous or IV use of a PD-1 antibody. But that's really a question about what they're doing in terms of class share there, 'cause INT will be in a category unto itself.

Speaker #2: It really wouldn't relate in our mind to INT, which would be a category of one. And the benefit that INT provides.

Speaker #2: We believe it would apply equally well, although we'll have to see what regulators want to see to see this. But we think the community would agree that it would likely apply equally well.

Speaker #2: Whether you're doing a subcutaneous or IV use of PD one antibody . But that's really a question about what they're doing in terms of class share there , because INT will be in a category unto itself .

Speaker #7: Thank you

Stéphane Bancel: Thank you.

Adi Jayaraman: Thank you.

Speaker #3: Ladies and gentlemen, that concludes the Q&A portion of today's presentation. I'd like to turn the call back to Stephane for any further remarks.

Operator 1: Ladies and gentlemen, this concludes the Q&A portion of today's presentation. I'd like to turn the call back to Stéphane for any further remarks.

Operator: Ladies and gentlemen, this concludes the Q&A portion of today's presentation. I'd like to turn the call back to Stéphane for any further remarks.

Speaker #8: Well , thank you very much , everybody for joining . We look forward to speaking to many of you in the coming hours , days and weeks .

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

Speaker #8: Have a great day. Thank you.

Operator 1: Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day. Good day, and thank you for standing by. Welcome to Moderna Fourth Quarter 2025 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one 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, Head of IR. Please go ahead.

Operator: Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day. Good day, and thank you for standing by. Welcome to Moderna Fourth Quarter 2025 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one 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, Head of IR. Please go ahead.

Speaker #3: Good day . And thank you for standing by . Welcome to Moderna . Fourth quarter 2025 conference call . At this time , all participants are in a listen only mode .

Speaker #3: 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 one one on your telephone .

Speaker #3: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised, today's conference is being recorded.

Speaker #3: I would now like to hand the conference over to your speaker today , Lavina Talukdar , head of IR . Please go ahead .

Speaker #9: Thank you . Kevin . Good morning , everyone , and thank you for joining us on today's call to discuss Moderna's fourth quarter 2020 financial results and business update .

Speaker #9: You can access the press release issued this morning, as well as the slides that we will be reviewing, by going to the Investors section of our website on today's call.

Speaker #9: Our Stephane Bancel , our chief Executive Officer , Stephen Hoge , our president , and James Mock , our Chief Financial Officer Before we begin , please note that this conference call will include forward looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 .

Speaker #9: Please see slide two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward looking statements .

Speaker #9: With that, I will turn the call over to Stephane.

Lavina Talukdar: With that, I will turn the call over to Stéphane.

Speaker #8: Thank you . Lavina . Good morning or good afternoon everyone . Thank you for joining us . I will start with a quick review of 2025 .

Stéphane Bancel: Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start with a quick review of 2025. Jamey will present our financial results and 2026 outlook. Stephen will review our commercial outlook and clinical programs, and then I will come back and share our key value drivers as we look ahead before we take your questions. Let me start with a review of 2025. Our revenues were $1.9 billion, driven by sales of our COVID vaccines, Spikevax and mNEXspike. We continued to make tremendous progress on cost in 2025. Operating expenses were down $2.2 billion, or 30% over year. I would like to thank the entire Moderna team for this great accomplishment in 2025. I'm very proud of this.

Speaker #8: Jimmy will present our financial results and 26 outlook . Steven will review our commercial outlook and clinical programs and then I will come back and share our key value drivers as we look ahead .

Speaker #8: Before we take your questions, let me start with a review of '25. Our revenues were $1.9 billion, driven by sales of our COVID vaccines.

Speaker #8: Spikevax and spike We continue to make tremendous progress on cost in 2025 , operating expenses were down $2.2 billion , or 30% , for the year .

Speaker #8: I would like to thank the entire Moderna team for this great accomplishment in 2025 . I'm very proud of this net loss for the year was 2.8 billion , and we ended the year with 8.1 billion in cash and investments Before I start a review of 2025 , I want to express our disappointment with the FDA refusal to file letter on our flu program .

Speaker #8: mRNA 1010 . The current uncertainty in the US , FDA regulatory environment creates real challenges for businesses , patients , and the broader innovation ecosystem .

Speaker #8: When expectations and review timelines are unpredictable Companies face greater risk and can hesitate to invest , slowing the development of breakthrough medicines These delays patient access and increases overall healthcare costs Sustained regulatory uncertainty threatens US leadership in innovative medicines This can also result in transformative medicines developed by US companies becoming available to patients outside the US before reaching American patients Turning now to the execution on commercial and pipeline on the commercial side , in 2025 , we had three products on the market Spikevax and Spike and Mitzvah was approved in the US in 2025 and has an excellent launch , quickly became our leading product in the US in the past two weeks .

Stéphane Bancel: On the commercial side, in 2025, we had three products on the market, Spikevax, mNEXspike, and mRESVIA. mNEXspike was approved in the US in 2025. It had an excellent launch, quickly became our leading product in the US. In the past two weeks, we announced two commercial agreements. First, an agreement with Recordati for the global commercialization of our propionic acidemia rare disease candidate, currently in a pivotal study. Recordati brings deep rare disease commercial expertise and an established global infrastructure with a propionic acidemia community.... We also announced earlier this week a five-year strategic agreement with the government of Mexico for respiratory vaccine supply. We currently have two products under regulatory review in multiple countries. Our seasonal flu vaccine is filed for review in Europe, Canada, and Australia. Our flu plus COVID combination vaccine is filed and under review in Europe and Canada.

Speaker #8: We announced two commercial agreements . First , an agreement with Recordati for the Global commercialization of our proprionic acidemia rare disease candidate currently in the pivotal study , Recordati brings deep rare disease , commercial expertise and an established global infrastructure with propionic acidemia community .

Speaker #8: We also announced earlier this week a five-year strategic agreement with the Government of Mexico for respiratory vaccine supply. We currently have two products under regulatory review in multiple countries.

Speaker #8: Our seasonal flu vaccine is filed under review in Europe, Canada, and Australia. Our COVID combination vaccine is filed and under review in Europe and Canada. Additionally, we made strong progress across the pipeline for antihistamine for individuals, and cancer therapy developed in partnership with Merck.

Stéphane Bancel: Additionally, we made strong progress across the pipeline. For INTismeran, our individual cancer therapy developed in partnership with Merck, we recently reported positive 5-year phase 2 data in adjuvant melanoma, demonstrating the durability of clinical benefit and reinforcing our confidence in the program's long-term potential. I am very happy to announce that we have completed enrollment in our phase 2 study in muscle invasive bladder cancer. This marks 3 late-stage studies in 3 different cancer types that are now fully enrolled: adjuvant melanoma, adjuvant renal cell carcinoma, and now muscle invasive bladder cancer. We look forward to the data readout from these studies. For cancer antigen therapy, mRNA-4359, we announced positive phase 1b data, and the program is now in phase 2. Our phase 3 norovirus program is now fully enrolled, so we could see phase 3 data in 2026.

Speaker #8: We recently reported positive five year phase two data in adjuvant melanoma , demonstrating the durability of clinical benefit and reinforcing our confidence in the program's long term potential .

Speaker #8: I am very happy to announce that we have completed enrollment in our phase two study in muscle invasive bladder cancer . This marks three late stage studies in three different cancer types that are now fully enrolled .

Speaker #8: Adjuvant melanoma , adjuvant renal cell carcinoma and muscle evasive bladder cancer . We look forward to the data results from these studies for cancer antigen therapy , mRNA 1459 we announced positive phase one B data and the program is now in phase two or phase three .

Speaker #8: The norovirus program is now fully enrolled, so we could see Phase 3 data in 2026. In our peer program, it is fully enrolled in this registration study, and we could see data in 2026.

Stéphane Bancel: Our PA program is also fully enrolled in this registration study, and we could see data in 2026. I'm pleased to welcome to Moderna our new Chief Development Officer and Executive Committee member, Dr. David Berman. He has contributed to the development of more than a dozen clinical-stage immunotherapies at BMS and AstraZeneca. His expertise will serve Moderna well as we continue to expand our oncology pipeline. David served most recently as head of R&D of Immunocore. We very much look forward to David joining Moderna's team on 2 March. I would like, of course, to take this opportunity to thank Jackie Miller for her many contributions over the last 5 years of the company, especially her tremendous leadership during the pandemic. With this, I would like to hand over to Jamey.

Speaker #8: I'm thrilled to welcome to Moderna , our new Chief Development officer and executive committee member , Doctor David Berman . He has contributed to the development of more than a dozen clinical stage immunotherapies at BMS and AstraZeneca His expertise will serve more than how , as we continue to expand our oncology pipeline .

Speaker #8: David served most recently as head of R&D of Immunocore We very much look forward to David joining the team on March 2nd . I would like , of course , to take this opportunity to thank Jackie Miller for many contributions in over the last five years at the company , especially a tremendous leadership during the pandemic With this , I would like to take over to Jimmy .

Speaker #10: Thanks, Stephane, and hello everyone. Today I'll cover our fourth quarter and full year 2025 results, and then wrap up with our 2026 Financial Framework. I'll begin with our 2025 revenue performance on slide eight.

Jamey Mock: Thanks, Stéphane, and hello, everyone. Today, I'll cover our Q4 and full-year 2025 results, and then wrap up with our 2026 financial framework. I'll begin with our 2025 revenue performance on slide 8. For the fourth quarter, total revenue was $700 million, coming in at the higher end of our recent guidance. Our revenue split in the quarter was $300 million in the US and $400 million from international markets. For the full year, total revenue was $1.9 billion, with the majority generated from COVID vaccine sales, along with approximately $100 million of other revenue. From a geographic perspective, US revenue totaled $1.2 billion, while international revenue was $700 million.

Speaker #10: For the fourth quarter , total revenue was $700 million , coming in at the higher end of our recent guidance . Our revenue split in the quarter was $300 million in the US and $400 million from international markets For the full year , total revenue was $1.9 billion , with the majority generated from Covid vaccine sales , along with approximately $100 million of other revenue from a geographic perspective .

Speaker #10: US revenue totaled $1.2 billion , while international revenue was $700 million . In the US . While overall Covid market demand declined year over year , we had strong market share in the retail channel , supported by the successful launch of Nextbike in international markets .

Jamey Mock: In the US, while overall COVID market demand declined year-over-year, we had strong market share in the retail channel, supported by the successful launch of the mNEXspike. In international markets, we landed at the higher end of our range, driven by operational performance and vaccination rates, which were above or in line with our expectations. Turning to slide 9, I'll review our Q4 results. As we discussed on the prior slide, revenue was $700 million. Compared to the Q4 of last year, operating expenses were down 31%, reflecting continued cost discipline and execution across the organization. I'll discuss these expense trends from a full year perspective on the next slide. Our net loss for the quarter was $800 million, compared to a net loss of $1.1 billion in the Q4 of 2024.

Speaker #10: We landed at the higher end of our range, driven by operational performance and vaccination rates, which were above or in line with our expectations. Turning to slide nine.

Speaker #10: I'll review our fourth quarter results As we discussed on the prior slide , revenue was $700 million compared fourth quarter of last year .

Speaker #10: Operating expenses were down 31% , reflecting continued cost discipline and execution across the organization I'll discuss these expense trends from a full year perspective on the next slide Our net loss for the quarter was $800 million , compared to a net loss of $1.1 billion in the fourth quarter of 2020 .

Speaker #10: For loss per share was $2.11, compared to a loss per share of $2.91 last year. Now, turning to slide ten.

Jamey Mock: Loss per share was $2.11, compared to a loss per share of $2.91 last year. Now, turning to slide 10, I'll walk through our full-year financial results. As I mentioned earlier, total revenue was $1.9 billion. Cost of sales was $868 million, representing a 41% decrease compared to 2024, primarily driven by productivity and lower inventory write-downs, contract manufacturing, wind-down costs, and sales volumes. R&D expenses were $3.1 billion, representing a 31% decrease compared to 2024, driven by continued investment prioritization and efficiency gains in the execution of our clinical trials. These reductions were partially offset by increased investment in our norovirus vaccine and oncology programs. SG&A expenses were $1 billion, representing a 13% decrease compared to 2024.

Speaker #10: I'll walk through our full year 2025 financial results . As I mentioned earlier , total revenue was $1.9 billion . Cost of sales was $868 million , representing a 41% decrease compared to 2020 .

Speaker #10: For primarily driven by productivity and lower inventory write downs , contract manufacturing wind down costs and sales volumes . R&D expenses were $3.1 billion , representing a 31% decrease compared to 2020 .

Speaker #10: For driven by continued investment prioritization and efficiency gains in the execution of our clinical trials . These reductions were partially offset by increased investment in our norovirus vaccine and oncology programs And expenses were $1 billion , representing a 13% decrease compared to 2020 .

Speaker #10: The decline was driven across all functions and reflects our continued focus on operating efficiently while supporting the business in a disciplined manner. Our income tax provision for 2025 was immaterial.

Speaker #10: We continue to maintain a global valuation allowance against the majority of our deferred tax assets, which limits our ability to recognize tax benefits from losses. Net loss for the full year was $2.8 billion, compared to a net loss of $3.6 billion in 2020.

Speaker #10: Our loss per share was $7.26, compared to a loss per share of $9.28 last year. We ended 2025 with cash and investments of $8.1 billion, compared to $9.5 billion at the end of 2020.

Speaker #10: For the year over year decrease was primarily driven by operating losses . As we continued to invest in R&D and advance our pipeline , partially offset by the $600 million initial draw of our $1.5 billion credit facility Excluding the credit facility draw , we would have ended the year with $7.6 billion of cash and investments , which was above our three Q guidance of 6.5 to $7 billion due to lower operating expenses , lower capital expenditures and working capital improvements .

Jamey Mock: The year-over-year decrease was primarily driven by operating losses as we continued to invest in R&D and advance our pipeline, partially offset by the $600 million initial draw of our $1.5 billion credit facility. Excluding the credit facility draw, we would have ended the year with $7.6 billion of cash and investments, which was above our 3Q guidance of $6.5 to 7 billion, due to lower operating expenses, lower capital expenditures, and working capital improvements. Now let's turn to our financial framework for 2026. We expect total revenue growth of up to 10% in 2026. This growth is expected to come primarily from international markets, and we estimate our geographic mix will be well balanced between the US and markets outside the US in 2026.

Speaker #10: Now , let's turn to our financial framework for 2026 . We expect total revenue growth of up to 10% in 2026 . This growth is expected to come primarily from international markets , and we estimate our geographic mix will be well balanced between the US and markets outside the US in 2026 .

Speaker #10: This is a shift from our 2025 revenue split of approximately 62% US and 38% international . We will begin selling locally manufactured products in both the UK and Australia in 2026 , which is the largest driver of our international growth Our 2026 revenue guidance factors in future potential declines in Covid vaccination rates and also assumes no revenue from our flu vaccine or our flu Covid combination vaccine Similar to 2025 , we expect 2026 revenue to be weighted to the second half of the year , with approximately 15% of our revenue in the first half and approximately 85% in the second half .

Jamey Mock: This is a shift from our 2025 revenue split of approximately 62% US and 38% international. We will begin selling locally manufactured products in both the UK and Australia in 2026, which is the largest driver of our international growth. Our 2026 revenue guidance factors in future potential declines in COVID vaccination rates and also assumes no revenue from our flu vaccine or our flu COVID combination vaccine. Similar to 2025, we expect 2026 revenue to be weighted to the second half of the year, with approximately 15% of our revenue in the first half and approximately 85% in the second half. Cost of sales is projected to be approximately $900 million. While this is flat year over year in absolute terms, we are expecting gross margin rate improvement from manufacturing efficiency gains and volume leverage.

Speaker #10: Cost of sales is projected to be approximately $900 million. While this is flat year over year in absolute terms, we are expecting gross margin rate improvement from manufacturing efficiency gains and volume leverage. R&D expenses are anticipated to be approximately $3 billion.

Speaker #10: As we continue to invest in our late stage pipeline while maintaining financial discipline It's a relatively small decline from the $3.1 billion we had in 2025 due to the continued execution of our late stage trials in infectious disease for modeling purposes , we expect our R&D spend to be relatively balanced in the first half versus the second half of 2026 , similar to what we experienced in 2025 .

Speaker #10: SG&A expenses are expected to be approximately $1 billion flat versus the prior year We remain focused on driving efficiency and cost savings across the organization , which we will use to fund new commercial investments to support both geographic expansion and future product launches Similar to 2025 , our commercial spend will be more heavily weighted to the second half of the year due to the seasonality of our commercial business .

Jamey Mock: Similar to 2025, our commercial spend will be more heavily weighted to the second half of the year due to the seasonality of our commercial business. In aggregate, we are expecting total GAAP operating expenses of $4.9 billion and $4.2 billion of cash costs, which excludes stock-based compensation, depreciation, and amortization. We expect taxes to be negligible in 2026. Capital expenditures are projected to be between $200 and 300 million. This guidance includes our previously announced investment in building our own fill-finish capacity in the United States at our existing site in Norwood, Massachusetts. We expect to end 2026 with $5.5 to 6 billion of cash and investments. Our cash guidance does not assume any additional drawdown from our credit facility. In summary, 2025 was a key turning point in our financial story.

Speaker #10: In aggregate , we are expecting total GAAP operating expenses of $4.9 billion and $4.2 billion of cash costs , which excludes stock based compensation , depreciation and amortization .

Speaker #10: We expect taxes to be negligible in 2026 . Capital expenditures are projected to be between 200 and $300 million . This guidance includes our previously announced investment in building our own filth .

Speaker #10: Capacity in the United States . At our existing site in Norwood , Massachusetts We expect to end 2026 with 5.5 to $6 billion of cash and investments Our cash guidance does not assume any additional drawdown from our credit facility .

Speaker #10: In summary , 2025 was a key turning point in our financial story . We improved our commercial execution , exceeded our cost reduction plan by over $1 billion , and ended the year with over $2 billion more cash than our original 2025 guidance .

Speaker #10: All while still advancing our pipeline I want to thank the entire Moderna team for their efforts over this past year , and we have strong momentum heading into 2026 with multiple levers for revenue growth and a strong commitment to drive additional cost reductions across the company With that , I will now turn the call over to Steven .

Speaker #2: Thank you , Jamie , and good morning or good afternoon , everyone Today I will review our commercial outlook as well as progress across our pipeline .

Stephen Hoge: Thank you, Jamie, and good morning or good afternoon, everyone. Today, I'll review our commercial outlook as well as progress across our pipeline. As Jamie mentioned earlier, we expect 2026 to mark a return to revenue growth for Moderna. This year, we expect growth to be driven primarily by our strategic partnerships and the second year of launch for mNEXspike, which I will discuss in more detail in a moment. But first, looking forward to 2027, we see three additional growth drivers. We look forward to significant expansion of our addressable market with the opening of the $1.8 billion European respiratory vaccines market. As a reminder, we have been excluded from this region for several years due to a competitor pandemic contract, which expires in 2026.

Speaker #2: As Jamie mentioned earlier , we expect 2026 to mark a return to revenue growth for Moderna . This year , we expect growth to be driven primarily by our strategic partnerships and the second year of launch for Nextbike , which I will discuss in more detail in a moment .

Speaker #2: But first, looking forward to 2027, we see three additional growth drivers. We look forward to significant expansion of our addressable market with the opening of the $1.8 billion.

Speaker #2: European respiratory vaccines market. As a reminder, we have been excluded from this region for several years due to a competitor pandemic contract, which expires in 2026.

Speaker #2: We expect to launch Nextbike , our standalone flu vaccine . mRNA 1010 , and our combination flu Covid vaccine in the European region by 2027 , winter season Adding to M Rizvia and Spikevax , which are already approved .

Stephen Hoge: We expect to launch mNEXspike, our standalone flu vaccine, mRNA-1010, and our combination flu COVID vaccine in the European region by 2027 winter season, adding to mRESVIA and Spikevax, which are already approved. This broad portfolio represents the opportunity to grow our share in the large European market, which will contribute to meaningful revenue growth from 2027 forward. Second, we expect growth from our new multiyear strategic agreements in Latin America and Asia Pacific. And third, with the acceptance of our flu filings in Europe, Canada, and Australia, we anticipate that our flu vaccine will begin to contribute to revenue internationally. In 2028, we expect continued new product-driven growth opportunities with both our combination flu, COVID, and norovirus vaccines, potentially being launched across many of our markets.

Speaker #2: This broad portfolio represents the opportunity to grow our share in the large European market, which will contribute to meaningful revenue growth from 2027 forward. Second, we expect growth from our new multiyear strategic agreements in Latin America and Asia Pacific.

Speaker #2: And third, with the acceptance of our flu filings in Europe, Canada, and Australia, we anticipate that our flu vaccine will begin to contribute to revenue internationally in 2028.

Speaker #2: We expect continued new product driven growth opportunities , with both our combination flu , Covid and neurovascular norovirus vaccines potentially being launched across many of our markets Recent execution supports this growth strategy , with approvals for Nextbike in Canada and Australia and the approval of our strain .

Stephen Hoge: Recent execution supports this growth strategy with approvals for mNEXspike in Canada and Australia, and the approval of our strain-updated Spikevax COVID vaccine in the UK. We have already shown strong momentum against the 2027 growth drivers. We announced a multi-year strategic agreement with Mexico earlier this week and Taiwan last month. We continue to make progress under our previously announced strategic agreement in Brazil. Finally, although not a major driver, we also signed a global commercialization collaboration in PA with Recordati as we prepare that potential launch in 2028. The UK is the. Let's take a look, a closer look at the key contributors to that growth in 2026, beginning with our strategic partnerships with the UK, Canada, and Australia.

Speaker #2: Updated Spikevax Covid vaccine in the UK . We have already shown strong momentum against the 2027 growth drivers . We announced a multi-year strategic agreement with Mexico earlier this week and Taiwan last month , and we continue to make progress under our previously announced strategic agreement in Brazil Finally , although not a major driver , we also signed a global commercialization collaboration in PA with Recordati .

Speaker #2: As we prepare for that potential launch in 2028, the UK is the—let's take a closer look at the key contributors to that growth in 2026.

Speaker #2: Beginning with our strategic partnerships with the UK , Canada and Australia . As a reminder , these are long term agreements under which Moderna has built local manufacturing sites and committed to ongoing domestic research and development .

Stephen Hoge: As a reminder, these are long-term agreements under which Moderna has built local manufacturing sites and committed to ongoing domestic research and development. These partnerships are core to each country's national security and public health strategy, strengthening preparedness against current viruses and future pandemic threats. The UK is the largest of these markets, and we expect a $200 million UK COVID order to be fulfilled in the first half of 2026 for their spring booster campaign. We also expect to supply vaccines for the UK's fall vaccination campaign, initially this year for COVID, with the potential to expand to other respiratory vaccines such as flu, RSV, and our combination vaccine in the years ahead.

Speaker #2: These partnerships are core to each country's national security and public health strategy , strengthening preparedness against current viruses and pandemic threats . The UK is the largest of these markets , and we expect a $200 million UK Covid order to be fulfilled in the first half of 2026 .

Speaker #2: For their spring booster campaign , we also expect to supply vaccines for the UK's fall vaccination campaign initially this year for Covid , with the potential to expand to other respiratory vaccines such as flu , RSV and our combination vaccine in the years ahead .

Speaker #2: In Canada, we are thrilled to deliver made—and we were thrilled to deliver Made in Canada, COVID vaccines in 2025, and expect to see the full annualized impact of the agreement in 2026.

Stephen Hoge: In Canada, we were thrilled to deliver made in Canada COVID vaccines in 2025 and expect to see the full annualized impact of the agreement in 2026. In Australia, we expect to deliver the full annualized benefit of our agreement in 2026 as well. Moving to slide 15. Our second major expected growth driver in 2026 is our new COVID vaccine, mNEXspike. mNEXspike had a very successful launch in 2025. This is especially notable because mNEXspike was approved mid-year in 2025 and was only available commercially in the US. We are extremely pleased with the market share achieved in that first season, with mNEXspike capturing 24% of the total US retail market and 34% of the retail market among adults aged 65 and older.

Speaker #2: And in Australia, we expect to deliver the full annualized benefit of our agreement in 2026 as well. Moving to slide 15, our second major expected growth driver in 2026 is our new Covid vaccine.

Speaker #2: And Next Spike IM Nextbike had a very successful launch in 2025. This is especially notable because Nextbike was approved mid-year in 2025 and was only available commercially in the United States.

Speaker #2: We are extremely pleased with the market share achieved in that first season, with the next bike capturing 24% of the total US retail market and 34% of the retail market.

Speaker #2: Among adults aged 65 and older . As a reminder , the retail market is the largest customer segment , representing approximately three quarters of the US Covid market and the majority of that volume is in seniors Looking ahead to 2026 , we expect to continue to drive the uptake of Nextbike in the United States and internationally .

Stephen Hoge: As a reminder, the retail market is the largest customer segment, representing approximately three-quarters of the US COVID market, and the majority of that volume is in seniors. Looking ahead to 2026, we expect to continue to drive the uptake of mNEXspike in the United States. Internationally, we look forward to approvals and launches in multiple countries this year and the years to come. Moving to slide 16, this outlines the latest developments in our infectious disease portfolio. Starting with our approved products, the updated formulation of Spikevax is approved in countries around the world, and importantly, in 2025, we received the supplemental BLA approval in the United States for high-risk children as young as six months. As mentioned earlier, mNEXspike was approved and launched in the US. It was approved in Canada in 2025 and recently approved in Australia as well.

Speaker #2: We look forward to approvals and launches in multiple countries this year and in the years to come. Moving to slide 16, which outlines this, and outlines the latest developments in our infectious disease portfolio. Starting with our approved products, the updated formulation of Spikevax is approved in countries around the world.

Speaker #2: And importantly, in 2025, we received the supplemental BLA approval in the United States for high-risk children as young as six months.

Speaker #2: As mentioned earlier , Nextbike was approved and launched in the US . It was approved in Canada in 2025 and recently approved in Australia as well We are targeting further approvals in of Europe , Japan and Taiwan this year .

Stephen Hoge: We're targeting further approvals in of mNEXspike in Europe, Japan, and Taiwan this year. mRESVIA, our RSV vaccine, has been approved for adults aged 60 and older in 40 countries and approved for high-risk adults aged 18 to 59 in 31 of those 40 countries. In addition to those three approved vaccines, we've filed for two additional approvals. mRNA-1010, our flu vaccine, has been accepted for review in Europe, Canada, and Australia, with the first potential approvals coming late in 2026 or early 2027. We were disappointed with the FDA's refusal to file a letter for mRNA-1010 and have requested a Type A meeting to understand the path forward for the program in the United States. mRNA-1083, our flu plus COVID combination vaccine, is under review in Europe and Canada, with first potential approvals in 2026.

Speaker #2: Amnesia, our RSV vaccine has been approved for adults aged 60 and older in 40 countries, and approved for high-risk adults aged 18 to 59.

Speaker #2: In 31 of those , 40 countries , in addition to those three approved vaccines , we filed for two additional approvals mRNA 1010 , our flu vaccine has been accepted for review in Europe , Canada and Australia , with the first potential approvals coming late in 2016 or early 27 .

Speaker #2: We were disappointed with the FDA's refusal to file letter for MRI . 1010 and have requested a type A meeting to understand the path forward for the program in the United States mRNA 1083 , our flu Covid combination vaccine is under review in Europe and Canada , with first potential approvals in 2026 .

Speaker #2: And finally , our norovirus vaccine is in an ongoing phase three trial , which is fully enrolled in its second northern hemisphere season and is accruing cases towards its interim analysis Now , turning to our therapeutics pipeline in Temporin , our individualized cancer therapy , developed in collaboration with Merck , has a total of eight phase two or phase three studies ongoing .

Stephen Hoge: Finally, our norovirus vaccine is in an ongoing Phase 3 trial, which is fully enrolled in its second Northern Hemisphere season, and is accruing cases towards its interim analysis. Now turning to our therapeutics pipeline. Intismeran, our individualized cancer therapy, developed in collaboration with Merck, has a total of eight Phase II or Phase III studies ongoing. The most advanced of these is our Phase III adjuvant melanoma study, as well as our Phase II randomized adjuvant renal cell carcinoma study, both of which have been previously announced as fully enrolled. As Stéphane mentioned previously, we are very excited to announce that we have now fully enrolled our Phase II randomized muscle-invasive bladder cancer study. Bladder cancer is the third cancer type now in a fully enrolled late-stage study.

Speaker #2: The most advanced of these are our phase 3 adjuvant melanoma study, as well as our phase 2 randomized adjuvant renal cell carcinoma study.

Speaker #2: Both of which have been previously announced as fully enrolled. As Stephane mentioned previously, we are very excited to announce that we have now fully enrolled our Phase 2 randomized muscle invasive bladder cancer study.

Speaker #2: Bladder cancer is the third cancer type now in a fully enrolled late-stage study. In addition to these three trials, we are looking forward to completing enrollment in our ongoing phase 3 studies in adjuvant non-small cell lung cancer.

Stephen Hoge: In addition to these three trials, we are looking forward to completing enrollment in our ongoing phase III studies in adjuvant non-small cell lung cancer. We also look forward to completing enrollment in our ongoing phase II trials in non-muscle invasive bladder cancer, first-line metastatic melanoma, and first-line metastatic squamous non-small cell lung cancer. Beyond these phase II and phase III studies, we are fully enrolled in our phase I studies for adjuvant pancreatic cancer and perioperative gastric cancer, and we look forward to data from these studies in the year ahead. Aside from INTismeran, aside from our collaboration in INTismeran with Merck, we continue to make progress in additional oncology programs. In the phase II study of our cancer antigen therapy, mRNA-4359, cohorts are enrolling in first-line metastatic melanoma, second-line metastatic melanoma, and first-line metastatic non-small cell lung cancer.

Speaker #2: We also look forward to completing enrollment in our ongoing phase two trials in Non-muscle invasive bladder cancer . First line metastatic melanoma and first line metastatic squamous non-small cell lung cancer Beyond these , phase two and phase three studies , we are fully enrolled in our phase one studies for adjuvant pancreatic cancer and perioperative gastric cancer , and we look forward to data from these studies in the year ahead Aside from anti-submarine , aside from our collaboration and anti-submarine with Merck , we continue to make progress in additional oncology programs .

Speaker #2: In the phase two study of our cancer antigen therapy , mRNA 4359 . Cohorts are enrolling in first line metastatic melanoma , second line metastatic melanoma , and first line metastatic non-small cell lung cancer in mRNA 2808 .

Stephen Hoge: In mRNA-2808, our T-cell engager in multiple myeloma, we are dosing in our phase I/II study. We're also dosing in the phase I study of our cancer antigen therapy, mRNA-4106. And rounding out our early-stage oncology programs, our phase I study is also dosing in our cell therapy enhancing program, mRNA-4203, in collaboration with Immunocore. In rare diseases, our propionic acidemia, or PA program, is fully enrolled in its registrational study, and in methylmalonic acidemia, or MMA, we expect our registrational study to start in 2026. With that, I'll hand the call back over to Stéphane.

Speaker #2: Our T-cell engager in multiple myeloma , we are dosing in our phase one two study . We are also dosing in the phase one study of our cancer antigen therapy mRNA 406 and rounding out our early stage oncology programs .

Speaker #2: Our phase one study is also dosing in our cell therapy enhancing program . mRNA 4203 . In collaboration with Immatics . In rare diseases , our propionic acidemia , or PA program is fully enrolled in its Registrational study and in methylmalonic acidemia or MMA .

Speaker #2: We expect our Registrational study to start in 2026 . With that , I'll hand the call back over to Stefan .

Speaker #8: Thank you . Steven and Jamie Looking ahead , we see multiple commercial pipeline and financial value drivers that will move Moderna forward in 2026 .

Speaker #8: Commercially, we believe the market share gains from the MGH spike will continue to increase and beyond. We will also benefit from a full-year contribution from our strategic partnership in the UK, Canada, and Australia.

Speaker #8: That will be an important growth driver for Moderna in 2026. And we expect up to 10% revenue growth in '26. From a pipeline standpoint, we look forward to potential regulatory approval of Spike in Europe, in Japan, and in Taiwan.

Speaker #8: We also expect potential approval of our combination flu-COVID vaccine in Europe and Canada. While regulatory filings are under review in the U.S., we plan to refile pending further guidance from the FDA for our seasonal flu vaccine.

Stéphane Bancel: For seasonal flu vaccine, we look forward to the approval in Canada this year. This is going to be an important year for oncology patients and for Moderna. We also expect continued clinical momentum from our INTismeran program, as Stephen just described. Last month, we reported positive five-year Phase II data in adjuvant melanoma. Potential clinical milestones from INTismeran program include: Phase III adjuvant melanoma data, Phase II adjuvant renal cell carcinoma data, and Phase I data in adjuvant pancreatic and perioperative gastric cancers, all of which have been fully enrolled for quite some time. We also look forward to Phase II readouts from our cancer antigen therapy, mRNA-4359, Phase II readouts for norovirus, and the pivotal data readouts from our PA program. That will be a busy year.

Speaker #8: We look forward to the approval in Canada this year . This is going to be an important year for oncology patients and for Moderna .

Speaker #8: We also expect continued clinical momentum from our one program . As Stephen just described last month , we reported positive five year phase two data in adjuvant melanoma .

Speaker #8: Potential clinical milestones from the intestinal program include Phase 3 adjuvant melanoma data, Phase 2 adjuvant renal cell carcinoma data, and Phase 1 data in adjuvant pancreatic and perioperative gastric cancers.

Speaker #8: All of which have been fully enrolled for quite some time . We also look forward to a phase two readout from our cancer antigen therapy , mRNA 4359 , a phase three results for norovirus and the pivotal data readout from our PA program .

Speaker #8: That will be a busy year from the standpoint. Teams across the company continue to make progress on cost discipline, and we expect cash costs to decline approximately to $4.2 billion in the year.

Stéphane Bancel: From a financial standpoint, teams across the company continue to make progress on cost discipline, and we expect cash costs to decline approximately to $4.2 billion in the year. As part of our cost efficiency program, the adoption of AI tools has touched every part of our business, and we expect further productivity improvement in 2026. Moderna has strong momentum as we head into 2026. We are poised to deliver up to 10% revenue growth as we continue to reduce costs. We expect to see approval of the infectious disease vaccine that will expand our commercial portfolio, and we foresee multiple potential clinical data catalysts to drive our late-stage oncology programs in rare disease and infectious disease. In closing, I want to recognize the entire Moderna team for their relentless drive.

Speaker #8: As part of our cost efficiency program . The adoption of AI tools has touched every part of our business , and we expect further productivity improvements in 2026 .

Speaker #8: More than a strong momentum as we head into 2026 . We are poised to deliver up to 10% revenue growth as continue to reduce costs .

Speaker #8: We expect to see approvals of infectious disease vaccines that will expand our commercial portfolio , and we foresee multiple potential clinical data catalysts driven by late stage oncology programs .

Speaker #8: And rare disease and infectious disease . In closing , I want to recognize the entire Moderna team for their relentless drive . Our progress .

Stéphane Bancel: All our progress, clinical, commercial, operational, is dedicated to one mission, delivering the greatest possible impact to people through mRNA medicine. With this, operator, we'll be happy to take questions.

Speaker #8: Clinical, commercial, and operational is dedicated to one mission: delivering the greatest possible impact to people through mRNA medicine. With this operator, we'll be happy to take questions.

Speaker #3: Thank you . Ladies and gentlemen , if you have a question or a comment at this time , please press star one . One on your telephone .

Operator 1: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered and you wish to move 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 Terence Flynn with Morgan Stanley. Your line is open.

Operator: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered and you wish to move 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 Terence Flynn with Morgan Stanley. Your line is open.

Speaker #3: If your question has been answered , you wish to move yourself from the queue . Please press star one one again . We will pause for a moment while we compile our Q&A roster Our first question comes from Terence Flynn with Morgan Stanley .

Speaker #3: Your line is open

Speaker #11: Hi . Thanks so much for taking the question . I had two part , I guess the first one is just on the flu .

Speaker #11: AATF implications for the 2028 cash flow break-even guidance, and then timing of the Type A meeting—like when you might get some visibility on next steps.

Speaker #11: And then the INT program in adjuvant melanoma . I know that's a very important program . And catalyst for the company . And so can you refine it all the timing of that data , whether it's going to be first half or second half .

Speaker #11: Thank you so much

Speaker #2: Sure maybe I'll take the questions on regulatory first . And then Jamie , hand it over to you on any break . Even implications .

Stephen Hoge: Sure. Maybe I'll take the questions on regulatory first, and then Jamey, hand it over to you on any break-even implications. So, we're actually very pleased that the flu file is under review now in Europe, Canada, Australia. We'll be filing in additional countries this year. And all of that is with an eye towards having that start to contribute, as I said a moment ago, in 2027, in the fall of 2027, to our growth. We also are pleased that the flu-COVID combination product remains under review and making progress in Europe for this year.

Speaker #2: So we we're actually very pleased that the flu file is under review now in Europe , Canada , Australia . We'll be filing an additional countries this year and all of that is with an eye towards having that start to contribute .

Speaker #2: As I said a moment ago , in 2027 , in the fall of 2027 , to our growth . We also are pleased that the flu , Covid combination product remains under review and making progress in Europe for this year , as relates to the US timing , it really we need to engage with the FDA and the type A meeting that's usually 30 days as a process and understand from them what is going to be required to get that product moving forward .

Stephen Hoge: As relates to the US timing, it really, we need to engage with the FDA and the Type A meeting. That's usually 30 days as a process, and understand from them what is going to be required to get that product moving forward in the US. We absolutely feel that American seniors should have access to the same innovations. We do think this year, in particular, where there's a potential for a mismatch in one of the strains, it's particularly important that technologies like Moderna, Moderna's mRNA platform, are used to advance new and potentially improved products. But at this point, until we have that Type A meeting, we won't really know how quickly we can get moving forward with a ten ten file in the US, as we've been doing outside the US. Jamey?

Speaker #2: In the US , we absolutely feel that American seniors should have access to the same innovations . We do think this year in particular , where there's a potential for a mismatch in one of the strains , it's particularly important that technologies like Moderna , Moderna's mRNA platform , are used to advance new and potentially improved products .

Speaker #2: But at this point , until we have that type A meeting , we won't really know how quickly we can get moving forward with the 1010 file in the US , as we've been doing outside the US .

Speaker #2: Jamie . Yeah .

Speaker #10: So thanks for the question . I appreciate it , and I recognize that it's on investors minds . Steven just said though , this is a bit of a fresh and fluid situation and without understanding the resolution of what is next for flu product , it's a little bit difficult to comment at this time .

Speaker #10: But here's what I would say . If you go back to the growth drivers we laid out at Analyst Day , as well as Steven had in his prepared remarks , we have ten large shots on goal to increase revenue over the coming years , all with a wide range of potential outcomes and Steven's mentioned some of the progress .

Speaker #10: We announced long term partnerships with Mexico and Taiwan . We're excited about . As I said , we're excited to deliver for the UK and Australia this year , which will be substantial revenue growth next .

Stéphane Bancel: As I said, we're excited to deliver for the UK and Australia this year, which will be substantial revenue growth. mNEXspike had a great first year. We're excited about the second year, both in the US and outside the United States. We're looking forward to Europe opening up. So it's really, there's still so many scenarios that could happen here, Terence, that it's a little bit too early to tell. On top of that, we have a ton of momentum on productivity and what we're doing from a cost perspective. So we're really excited about our financial profile. We ended the year with over $8 billion in cash. We have a ton of momentum-

Speaker #10: Bike had a great first year . We're excited about the second year both in the US and outside the United States . We're looking forward to Europe opening up , so it's really there's still so many scenarios that could happen here .

Speaker #10: Terence , that it's a little bit too early to tell . On top of that , we have a ton of momentum on productivity and what we're doing from a cost perspective .

Q4 2025 Moderna Inc Earnings Call

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