Moderna Inc (MRNA) — Q1 2026 Earnings Call Transcript

Thank you, Kevin. Good morning, everyone, and thank you for joining us today to discuss Moderna's First Quarter 2026 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 Jamie Mock, our Chief Financial Officer. Please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the 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 performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I will turn the call over to Stéphane.

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a review of our first quarter, Jamie will then cover our financial results and outlook, followed by Stephen on commercial and clinical progress. I will close by discussing our value drivers before we take your questions. The Moderna team delivered a great quarter all around. In the first quarter, we grew year-over-year revenues significantly to $0.4 billion, driven primarily by execution of our long-term strategic partnership with the U.K. government. With a strong Q1, we are reiterating up to 10% growth in 2026. We reported a net loss of $0.5 billion, excluding the previously announced Arbutus litigation settlement or $1.3 billion on a GAAP basis. We ended the quarter with $7.5 billion in cash and investments, maintaining a strong balance sheet as a result of continued financial discipline. Our cost reduction efforts continued in the first quarter, building on actions taken in 2025 and resulting in a 26% year-over-year reduction in adjusted cash cost in the first quarter, excluding the litigation settlement. This performance keeps us on track with our full year objective of approximately $4.2 billion in adjusted cash costs. We also advanced our commercial portfolio and our pipeline. In our respiratory portfolio, we achieved an important milestone with the approval of mCOMBRIAX in the European Union. mCOMBRIAX was previously known as mRNA-1083, a flu plus COVID combination vaccine. This is the first flu plus COVID combination vaccine approved in the world, and this marks Moderna's fourth approved product. I am very proud of the team for bringing this innovation to patients. This is exactly what Moderna stands for. We also secured approval for mNEXSPIKE in the European Union. These two new approved products in Europe will be important growth drivers in the EU in 2027, and we anticipate the COVID market reopening for Moderna. In the U.S., our seasonal flu vaccine mRNA-1010 was assigned a PDUFA date of August 5. In oncology, for Intismeran, we initiated a new Phase III clinical trial in non-small cell lung cancer for patients with high-risk Stage 1 disease. It's our first Phase III clinical trial evaluating Intismeran in a monotherapy arm in patients with early-stage disease. I am very excited about this new clinical development because Stage 1 lung cancer is mainly treated with surgery alone today. Additionally, we look ahead to our upcoming ASCO oral presentation, where we'll report a 5-year update of our Intismeran in adjuvant melanoma. We were also pleased to recently present at AACR the new clinical data for mRNA-4359, which is currently in Phase II for patients with Stage IV metastatic disease in melanoma and lung cancer. Lastly, with support from BARDA, our pandemic flu program, mRNA-1018, has now initiated its Phase III study. I'm very pleased with the company's strong performance in Q1 and very thankful for our team that executed across the board. With that, I'll turn it over to Jamie.

Thanks, Stéphane, and hello, everyone. Today, I'll cover our first quarter financial results and then review our 2026 financial framework. Let me start with our commercial performance on Slide 7. For the first quarter, total revenue was $400 million, coming in above our guidance and represents a $300 million increase versus the prior year. Our geographic mix was approximately 80% from international markets and 20% from the United States. This strong international revenue performance was primarily driven from deliveries under our long-term strategic partnerships. For the second quarter, we are expecting revenue of between $50 million and $100 million, evenly split between U.S. and international markets, which would bring our first half revenue to approximately $440 million to $490 million. Our strong revenue performance year-to-date puts us on a solid path to achieve our full year revenue growth target of up to 10%, which we are reiterating today. Now I'll round out our full first quarter financial performance on Slide 8. As I just mentioned, revenue was $400 million in the quarter. Cost of sales for the quarter was $955 million. This includes $878 million related to our previously disclosed litigation settlement. Excluding this item, cost of sales was $77 million, a 14% year-over-year decline on a non-GAAP basis, driven by reduced unutilized capacity costs, losses on purchase commitments and inventory write-downs, partially offset by higher sales volume. Regarding the litigation settlement in March, we announced that we entered into a settlement agreement with Arbutus, resolving all litigation with them worldwide. Under the deal terms, we will make a lump sum payment of $950 million in the third quarter of 2026, of which $878 million was recognized in cost of sales during the first quarter of 2026, and the remaining $72 million is being amortized over the next three years. Under the agreement, Moderna will appeal to the Federal Circuit to argue its government contractor immunity defense, which limits its liability under federal statute Section 1498. If Moderna ultimately prevails on that issue, no further payments will be due. If, however, the Federal Circuit affirms liability under Section 1498, Moderna has agreed to make an additional payment of up to $1.3 billion. We have concluded that a loss related to this pending Section 1498 proceeding is not probable. And accordingly, no charge has been recorded. R&D expenses for the quarter were $649 million, a 24% decrease compared to last year, driven by lower clinical development and manufacturing costs as we wind down large Phase III respiratory programs, and our CMV Phase III study, partially offset by higher post-marketing commitments from our COVID products. SG&A expenses for the quarter were $173 million, an 18% decrease compared to last year, driven by lower spend across all functions, reflecting continued cost discipline while supporting the business. Our income tax provision was immaterial in both periods as we continue to maintain a global valuation allowance, which limits our ability to recognize tax benefits from losses. Net loss for the quarter was $1.3 billion or $3.40 per share compared to a net loss of $1 billion or $2.52 per share last year, primarily driven by the litigation settlement. Excluding this item, the net loss would have been $0.5 billion or $1.18 per share, down over 50% versus the prior year. We ended the first quarter with cash and investments of $7.5 billion compared to $8.1 billion at the end of 2025. The decrease was primarily driven by operating losses as we continue to invest in R&D and advance our pipeline. The litigation settlement did not impact cash in the first quarter as the $950 million payment is due in the third quarter of 2026. Now let's turn to our financial framework for 2026. As mentioned earlier, we expect total revenue to grow up to 10% in 2026, with a geographic mix of roughly 50% from the U.S. market, and 50% from international markets. Our 2026 revenue guidance factors in potential future declines in COVID vaccination rates, offset by increased penetration of mNEXSPIKE and revenue from our long-term strategic partnerships. As a reminder, this guidance assumes no revenue from our flu vaccine or mRNA-1010. Our cost of sales projection has increased from $0.9 billion to $1.8 billion, and now includes the $0.9 billion litigation settlement charge. Without the litigation charge, our cost of sales projection would have been unchanged versus our previous guidance and reflects our expectation of gross margin improvement from manufacturing efficiency gains and volume leverage. R&D expenses are still anticipated to be approximately $3 billion as we continue to invest in our pipeline while maintaining financial discipline. We now expect the timing of our R&D spend to be slightly weighted more to the second half of the year. SG&A expenses are still expected to be approximately $1 billion, flat versus the prior year. Similar to 2025, our commercial spend will be more heavily weighted to the second half of the year due to the seasonality of our commercial business. In aggregate, excluding the $0.9 billion litigation charge, we are expecting total GAAP operating expenses of $4.9 billion and cash costs of $4.2 billion, which excludes stock-based compensation, depreciation and amortization. Additionally, we do not see any material impacts from the ongoing conflict in the Middle East to our 2026 financial outlook, but we'll continue to monitor geopolitical developments. We expect taxes to be negligible in 2026. Capital expenditures are still projected to be between $0.2 billion and $0.3 billion, and we expect to end 2026 with between $4.5 billion to $5 billion of cash and investments. Our cash guidance does not assume any additional drawdown from our remaining $0.9 billion undrawn credit facility. Overall, we are encouraged by the strong start to the year and remain focused on executing in Q2 and beyond. With that, I will now turn the call over to Stephen, who will walk through the commercial outlook in more detail.

Thank you, Jamie, and good morning or good afternoon, everyone. Today, I'll review our commercial outlook as well as progress across our pipeline. Slide 11 outlines our multiyear revenue growth strategy, anchored in both geographic expansion and continued advancement of our product pipeline. In 2026, as Jamie mentioned, we expect a 10% revenue growth driven by our long-term strategic partnerships in the United Kingdom, Canada and Australia, and supported by the continued growth of mNEXSPIKE. Looking across the three-year horizon, we are building a diversified portfolio, adding a flu vaccine, a combination vaccine and a norovirus vaccine as well as late-stage assets in oncology and rare diseases, and all while expanding our global footprint into new markets. We made good progress against this strategy in the quarter. We delivered our first shipment under a strategic partnership in the United Kingdom. We secured key regulatory approvals in the European Union, including mNEXSPIKE for individuals 12 and older, and mCOMBRIAX for adults 50 and above, positioning us well in the large $1.8 billion annual European respiratory vaccines market. We expect both products to contribute to revenue growth starting in 2027 and in the U.S., our flu program continues to advance with a PDUFA date set for August 5, 2026. Stepping back, our execution in the quarter gives us confidence in our ability to deliver in the near term and to grow over the long term. Slide 12 highlights our approved products within the infectious disease portfolio. With the recent EU approval of mCOMBRIAX, we now have four approved products, a remarkable milestone for our commercial portfolio. Starting with our COVID vaccines, we plan to submit annual strain updates across all approved geographies shortly. More than 30 countries for Spikevax and in the United States, Canada and Australia and now the European Union for mNEXSPIKE. mNEXSPIKE also remains under review in Taiwan, Japan and Switzerland, with additional filings planned for the second half of 2026 to further expand global access to this important vaccine. Turning to RSV, mRESVIA is approved in the United States, European Union and Canada. Most recently, the European Commission also extended that approval to expanded indications to include adults age 18 and older, broadening the eligible population. For our flu plus COVID combination vaccine, mCOMBRIAX, we recently received approval in the European Union for adults 50 and older. The product is also under review in Canada and Australia, and we are awaiting further guidance from the FDA on the next steps for resuming filing in the United States. Finally, at ESCMID, we presented new data supporting heterologous vaccination with mRESVIA as well as results from a Japanese cohort from our Phase III mCOMBRIAX studies. Links to both presentations are included on this slide. Our late-stage infectious disease pipeline also continues to progress. Starting with flu, mRNA-1010 is under review in the United States, Europe, Canada and Australia, and the U.S. FDA PDUFA date is set for August 5. We recently presented revaccination data for mRNA-1010 at a medical meeting, with a link to the presentation included on this slide. And for our norovirus vaccine, our ongoing Phase III study is now fully enrolled in its second Northern Hemisphere season. Based on case accrual to date, we continue to expect data from this study in 2026. Turning to oncology, starting with Intismeran, our individualized cancer therapy developed in partnership with Merck. This trial program continues to expand with nine ongoing Phase II and Phase III studies. As Stéphane previously mentioned, we have initiated another Phase III study in non-small cell lung cancer, our third Phase III in lung cancer. This one is in high-risk Stage 1 disease, expanding us to the earliest stage of the disease. The trial includes an evaluation of Intismeran as a monotherapy. This is our second monotherapy study following our non-muscle invasive bladder cancer study announced previously and highlighting Intismeran's safety and tolerability profile as we move into earlier stage disease. Across the portfolio, we now have multiple late-stage studies fully enrolled, including Phase III adjuvant melanoma as well as Phase II studies in renal cell carcinoma and muscle invasive bladder cancer, all of which are accruing events towards their interim readouts. We continue to make progress towards completing enrollment in our other Phase III and Phase II trials, including in non-small cell lung cancer, bladder cancer and metastatic melanoma. This broad late-stage portfolio is supported by the strong clinical data including robust 5-year results from our Phase II adjuvant melanoma study, which will be presented at ASCO. Beyond late-stage programs, our Phase I studies in pancreatic and gastric cancers are also fully enrolled, and we look forward to providing updates on those trials later this year. Now outside of Intismeran, we continue to advance additional oncology programs. For mRNA-4359, our cancer antigen therapy, Phase II cohorts are enrolling across first-line metastatic melanoma and first-line metastatic non-small cell lung cancer. We recently presented new data in the first-line metastatic melanoma setting at AACR with a link to the presentation included on this slide. And finally, our early stage pipeline continues to progress, including our T cell engager, mRNA-2808, in a Phase I/II study, a cancer antigen therapy mRNA-4106 and cell therapy enhancer mRNA-4203 in Phase I studies in patients actively dosing. Now in rare diseases, our propionic acidemia or PA program is fully enrolled in its potentially registrational study. We continue to expect pivotal data from this study later in 2026. For our methylmalonic acidemia or MMA program, we have decided to defer the start of a registrational trial for that program until after we receive the pivotal readout from the PA program later this year. With that review, I will hand the rest of the call over to Stéphane.

Thank you, Stephen and Jamie. Looking ahead to 2026, we see multiple value drivers across our company in commercial, in new product approvals and in our early-stage pipeline. On the commercial side, we continue to expect up to 10% revenue growth and remain focused on delivering our adjusted cash cost target of approximately $4.2 billion. We'll continue to invest in AI with a number of cross-enterprise projects to reinvent work with AI. We will, of course, continue to drive increased personnel productivity across the company. We also expect potential approvals across the respiratory portfolio in additional geographies. We could, later this year, see our fifth product approved with mRNA-1010 for flu. From a pipeline perspective, oncology remains a key focus with upcoming data for Intismeran and mRNA-4359. We're also waiting for a Phase III readout for norovirus, subject to case accrual, and for our PA program, which should read out this year. The team remains focused on disciplined execution across these priorities. Over the coming months, we also look forward to engaging with the investment and medical communities at several upcoming events. This includes our investor event on June 1 at ASCO. But also, we would like to invite you in person to Cambridge or via webcast for our Science Day on June 25, where we'll provide a deeper look into our early stage pipeline, also how we're using AI and robotics to accelerate our ability to discover new technologies to expand the use of mRNA to new drug modalities. On November 12, we also will host our Annual Analyst Day, where we plan to focus on commercial priorities, product launches and expanding late-stage pipeline. In closing, I want to thank our teams around the world for the progress we've delivered this quarter. We have been executing consistently over the past 1.5 years, and I'm very excited about what is to come in 2026 and beyond. We are advancing our science, expanding our portfolio and continuing to translate mRNA into innovative medicines for patients. Each milestone achieved is important momentum and reconfirms our commitment to deliver meaningful impact to people through mRNA medicine. With this, operator, we'll be happy to take questions.

So you newly disclosed initiation of a Phase III study for Intismeran as monotherapy and in combination with KEYTRUDA subcutaneous for the treatment of high-risk Stage 1 non-small cell lung cancer. You spoke to it a little bit, but could you discuss your strategy to pursue this line and where it fits into the treatment landscape and why pursue a monotherapy here in addition to the combination?

Yes. Thank you for the question, Salveen. We and our partner, Merck, have been really excited by the clinical data that we've seen with Intismeran to date, including the Phase II. And it's important to highlight that the two pieces of that, one is obviously the efficacy signal we see, but the second is the remarkable safety profile associated with that efficacy — really no significant increase in serious or Grade 3 events when you get a combination IO-IO-like benefit. So the real question for us has been could we get that benefit-risk profile in a monotherapy context? Could Intismeran provide immune-oncology-like protection against a relapse or recurrence of disease with a profile that really looks like a vaccine? And the best opportunity for us to do that, we and Merck have decided, is across a couple of studies. Now the first I previously discussed was in bladder cancer, but we ultimately decided that in lung cancer, given the incredibly high burden of disease, the right approach there was to go into a Phase III potentially pivotal study. In that context, as Stéphane mentioned, as you referenced, standard of care more often than not is surgery and then watchful waiting. And so essentially, there is no other intervention. We're therefore looking at Intismeran as monotherapy as opposed to just surgery and watchful waiting for high-risk Stage 1 disease. Now we're also going to look at whether or not there's an incremental benefit of combining Intismeran with KEYTRUDA in that setting because obviously, the best way to address cancer is to have it never recur after Stage 1. Unfortunately, many of those Stage 1 patients will recur, and sometimes even recur as Stage IV or metastatic disease, and that is when we're fighting very late to try and control a quite progressed cancer. Our goal, simply put, is to intervene early, prevent the relapse or recurrence from ever happening and in so doing, try and achieve cures in the earliest stages of disease. Benefit-risk there needs to have a very good safety profile, and we really do think that the monotherapy safety profile of Intismeran will be strongly supportive if we can see in that Phase III study a strong efficacy signal. So we and Merck have been talking about this one for a while. Our strategy has been to focus on the adjuvant settings, but we have started some metastatic studies, and we have always wanted to move earlier, signaled that from the beginning because of that benefit/risk profile of Intismeran and we are really excited to see the potential now in Stage 1 disease in a Phase III lung cancer trial.

With a significant amount of international sales this quarter, I remember the U.K. order from last year got pushed into early '26. I'm just trying to think about those contracts and the right way to think about what more could come from the U.K. for the remainder of '26? Like is it possible this is a double order year? And maybe you could just elaborate on how that works?

Yes, sure, I'll take that. The delivery that happened in the first quarter is for their spring campaign. In the United Kingdom, there's a recommendation for both spring and fall boosters for the targeted population, those over the age of 75 or with significant risk factors. A second campaign is planned for the fall, in the third and fourth quarter of this year, and that would be an additional delivery later this year.

Great. Just wondering if you can be any more specific about the timing of the interim Phase III of the Intismeran adjuvant melanoma. I know you said 2026, but can you refine that at all at this point? And then maybe talk to the range of potential outcomes there? Are there only two outcomes, either the trial hits at the interim and continues as planned? Or is futility also a potential outcome on this interim?

Thank you for both questions. I will disappoint in the sense that we won't refine that guidance. We have said we are confident based on the event accrual that we will see an interim analysis conducted in 2026. That confidence should indicate where we think we are. On the question of the outcomes, there is not a built-in futility assessment. The interim analysis is either to declare early success or to continue to accrue events in the trial towards a subsequent interim analysis or final analysis, both of which could happen in the years ahead. The study is very well powered and has been balanced in terms of its accrual. So we have continued to accrue events in a way that we would expect, and therefore, we're optimistic about that interim analysis. But obviously, if we have not yet hit the critical hazard ratio to declare early success, we will have the benefit of continuing to look at more events afterwards. Futility is not a part of the current plan.

Great. Maybe, Jamie, on IP, can you just walk us through why the legal team deemed the additional $1.3 billion charge on Section 1498 is not probable. I guess the question is what gives you confidence that you will ultimately prevail there? And then maybe just kind of bigger picture, remind us the timeline of when the final ruling could come? And then maybe quickly, Stephen, what's the latest thinking on flu in the U.S. ahead of PDUFA? We obviously now have a new Acting Director. I wonder if you have had any interactions with her, and whether you think that having her is incrementally positive or incrementally negative for you? So any color there, much appreciated.

Yes. Thanks for the question, Luca. I may disappoint as well because we're not really going to comment too much on the merits of the trial. All I can say is our legal team and ourselves, we are confident, and therefore, we believe it improbable that we would lose and therefore, have not recorded anything. From a timeline perspective, it's always difficult to exactly read, but we think that it could be perhaps late 2027 maybe into 2028 is where we think that this might be resolved. But again, that's a moving target.

For the question on the FDA and particularly the flu 1010 program, we continue to progress well in that review in the normal back and forth with the review team and the folks in the Office of Vaccines towards our PDUFA date, which is currently at the mid-cycle. We would describe that as a pretty normal course, the kinds of exchanges we're having. We're encouraged by that and look forward to the August 5 PDUFA date. We'll work hard to answer any remaining questions the FDA has as they complete that review. As to the senior leadership, whether it's the new Acting Director or otherwise, we don't usually interact with them in these reviews at all. Really, this is the review staff, the folks in the Office of Vaccines, and that is the only place that we've been going back and forth. We don't expect any impact as a result of the new Acting Director. We do look forward to working with the leadership broadly across our portfolio. So the 1010 flu vaccine review continues somewhat independently, and we have a large portfolio of other products — Intismeran, norovirus, and our first rare disease program, the propionic acidemia program — all of which we hope have pivotal readouts this year. We are grateful for the partnership across FDA and CBER as we try to bring these medicines forward to patients.

Congrats on the quarter. For the Phase III Intismeran adjuvant melanoma top line data, can you remind us what it is powered for? And perhaps more importantly, can you give us your latest thoughts on what constitutes success from a clinical standpoint? What do you need to show in RFS on an absolute basis or as we think about relative benefit there?

Thank you. We haven't disclosed the powering assumptions for the interim analysis. Suffice it to say, the Phase II data had a really strong hazard ratio and very narrowly missed in a substantially smaller population, and so we think we are very well powered if we see a similar hazard ratio. That would be a huge success. But to your second part about the range of outcomes, obviously anything like the Phase II would be spectacular. Candidly, we think the opportunity for benefit could be anywhere between that Phase II result and a more modest but still meaningful effect. We would be pleased with outcomes that demonstrate a clinically meaningful improvement in relapse-free survival (RFS), and additional supportive signals in distant metastasis-free survival (DMFS) or overall survival (OS) would be highly encouraging. There is a range of outcomes that could be meaningful for patients and for commercialization. For now, we feel like we are well powered going into that interim analysis. If we do not declare early success, we will continue to accrue and look to subsequent analyses.

Curious what your expectations are for timing for data from RCC and muscle invasive bladder cancer. Can you elaborate on what good data would look like in these indications? And what the next steps would be in those indications if the data are positive?

Both of those randomized Phase II studies are fully enrolled, about 300 participants in each. We're excited to fill in the picture on the strength of Intismeran across different tumors. For RCC we are particularly interested to see if we can provide a meaningful clinical benefit; there's still headroom for improvement there. These are event-driven trials, and we want to protect registrational possibility for those trials, so we're blinded and accruing events towards the first interim analysis in both. If possible, we would want those studies to be registrational. Because that's an event-driven timeline, it's hard to precisely guide timing; results could come later this year or early next year depending on event accrual. If results are positive, next steps could include moving quickly toward pivotal Phase III studies or regulatory discussions depending on the strength of the data and discussions with regulators. Positive data would also inform how broadly Intismeran could be used across different tumor types.

We have two questions on Intismeran. First on the melanoma study: is it similarly designed as it relates to the interim? I recall that the Phase II strongly hit at the interim. Trying to understand if a similar type of standard interim was built in here such that if it doesn't stop at the interim, it would imply some sort of different hazard ratio for the first term versus the second term? Second, on the renal study: acknowledging RCC is a much slower progressing tumor if you look at the KEYTRUDA adjuvant studies, trying to understand how it would be possible that a potential interim would come this year, or is that a much differently designed study in terms of an interim?

We haven't given any statistical guidance on the Phase III interim analysis. We wouldn't be conducting the interim unless we thought there was a chance of success; we're not defining it as the exact hazard ratio from Phase II. There were population differences. If the interim isn't successful, there's still opportunity in later analyses, and we have reserved alpha for subsequent analyses. On RCC, events can happen more slowly, but there is still substantial headroom for improvement even beyond the KEYTRUDA combinations that have shown benefit. The RCC study has about 300 participants – roughly twice the size of our Phase IIb adjuvant melanoma study. We are not intending to power that as a registrational study by default, but it has registrational potential. The key unknown is timing: we'll hit an event trigger for a human analysis; the DSMB will review and advise whether to declare early success or remain blinded. If there's a strong signal, we would move quickly toward the next step, potentially a registrational pathway or a larger Phase III.

Just a couple more on Intismeran. I wanted to understand revenue recognition between you and your partner. Number one, can you help us understand the parameter here, and what this might look like to Moderna's realized contribution in the P&L, recognizing that it is a partnership? And then second, in the Stage 1 monotherapy and combination study, can you just again help us understand a little bit about Stage 1 prevalence of diagnosis relative to later stages? It would be helpful to understand how you think about this market and potential build if we can see opportunities for those patients. Any comments on what the bar looks like particularly compared to a watch-and-wait scenario?

Thanks, Courtney. On revenue recognition as it pertains to Intismeran, we don't have the product approved yet, and we're working with our auditors. It is not a traditional joint venture. To the best of our knowledge, the likely structure is that we would deliver the product to Merck, because they're the marketing authorization holder, and they would sell it on to the customer. That means the first part of the transaction would be recognition of our cost of goods sold plus some markup on the initial sale. Thereafter, whatever the profit split is, we would take our share — historically about 50%. So it ends up being somewhat greater than 50% of the profit share because it's predicated upon first shipping the product with some markup and then taking the margin on top of that. This will change over time as our cost of goods sold improves with automation and manufacturing efficiencies. So it will start at a higher level and come down over time. That's the general framework. Again, we hope to be in a position next year to start recognizing that revenue.

On Stage 1 lung cancer: lung cancer represents a unique opportunity because screening, including chest X-rays and CT screening programs, has been an important intervention for identifying earlier-stage disease. The majority of diagnoses still show up later at Stage 3 and Stage 4, but you're seeing an increase — north of 30% of diagnoses are now earlier stage, Stage 1 or Stage 2. That has grown over the last decade and could continue to grow through better screening. That creates a natural opportunity to try to intercept and intervene if you have a strong benefit-risk profile. If we can intervene early, we can dramatically reduce the number of late-stage diagnoses. We have the safety profile, and if we can demonstrate efficacy in Stage 1, there is a significant potential to change outcomes for patients.

I have two quick ones. First on Intismeran, as you grow the experience and data here, are there other I-O combination mechanisms that could also bear fruit, or is that better addressed with the rest of your oncology pipeline? And second on norovirus, as we get closer to data, do you have any updated view of what success looks like here, given the standard of care? My sense is a significant benefit is all you need, but want to get your perspective.

On alternative IO combinations, we are looking in the adjuvant setting and earlier in many of these Phase III studies. Generally, IO-IO combinations and the associated toxicity have not always been advantageous, so much of our focus is on the combination with the PD-1 agent KEYTRUDA because of our partnership with Merck. We are interested in subsequent studies exploring alternative IO combinations, and those efforts are being pursued elsewhere in our pipeline. For example, mRNA-4359 is exploring combinations such as CTLA-4 plus PD-1 in metastatic melanoma, and there we are looking at alternative regimens. You may see us explore other combinations in off-the-shelf contexts first, but that doesn't rule out future exploration with Intismeran. On norovirus, given there is currently no approved vaccine, and given the high societal and medical costs associated with severe norovirus infections — particularly among those over age 75 or with comorbidities — a vaccine that reduces that burden would be highly valuable. Statistical significance is the bar, and we would look for vaccine efficacy that is meaningful, ideally north of 50%. Given there is no standard of care, anything above that would be considered a success and would create value for health care systems and patients.

I also have one on Intismeran. How critical is it to demonstrate an overall survival benefit in INTERPATH-001? Given the challenges of showing OS in adjuvant melanoma, do you believe physicians would interpret the data set any differently absent a clear OS signal?

A couple of observations: RFS is a strong predictor in this context. In our Phase II study, we have released RFS, DMFS and OS trend data, and we look forward to presenting the five-year update at ASCO to provide physicians and health systems with further confidence in the relationship between RFS and overall outcomes. The Phase III will follow OS as well, and it will take time to accumulate OS events, but RFS is a meaningful endpoint here and tends to correlate with longer-term outcomes. We believe positive RFS in a well-powered Phase III would be compelling for physicians and payers even as OS data continue to mature.

Just looking at the Q2 revenues, could you give any color on the split? Or should we assume that the entirety is Spike vaccine? Also, Jamie, could you comment on phasing? It was a very strong number against our expectations, but I wanted to know if there was any pull-through of expected revenues from Q2, particularly with some of those governmental orders outside the U.S.?

Let me address the product split first. The majority of revenue is still COVID-related. We do not anticipate RSV being a significant growth driver in 2026; that will take time. For the second quarter, we laid out $50 million to $100 million, which should bring our first half to approximately $440 million to $490 million. To give context versus last year, last year we had $700 million of sales outside the United States, with $100 million in the first half and $600 million in the second half. With $400 million in the first half of this year outside the United States and modeling for declines in the U.S., that contextualizes how the year could shape up. In the second half last year we didn't have any U.K. revenue, so should there be a fall campaign in the U.K. this year, that could add incremental international revenue. We've guided up to 10% growth for the year and provided this phasing context to help you model the splits.

It's a bigger picture question. I'm curious what your latest thoughts are on business development and even considering technology or assets beyond mRNA. Does it make sense to add more assets to your pipeline? Or do you think you're right sized for now?

Thanks for the question. We've always focused on building the most impactful mRNA platform to enable families of medicines using the same technology components. We've done it with infectious vaccines, with Intismeran, and we're doing it in rare disease. At our Science Day on June 25 we'll share more on how we've been investing to expand into new modalities — you can already see that with a T cell engager and other assets. We continue to look at science across academia and companies, public or private. If we find the right opportunity to increase what we can do, we will execute on those priorities. We don't have a pipeline problem — we have an abundance of products. We've been disciplined on cost to get back to breakeven, but we have a lot of exciting science waiting to go into the clinic and we'll share more on June 25.

With the recent approval of the COVID-flu vaccine in the EU, can you walk us through your commercialization strategy? What does a successful launch look like a year from now and five years from now?

First, as is our pattern, we do not expect revenues in the year of approval for these vaccines. mCOMBRIAX or mRNA-1010 are not in our 2026 guidance. Looking forward to 2027 and 2028, the first step is securing market access — pricing and reimbursement — which is a national process across major markets in Europe. For example, France has initiated that process already, which is encouraging. Across Europe the respiratory vaccine market is roughly $1.8 billion to $2 billion annually. Flu is a big part of that, COVID is a large part, and RSV is also important. We see a very large opportunity for the combo COVID-flu vaccine. Patients appreciate a single shot; payers and health care systems appreciate lower administrative burden. Providers save time, and there are system-level savings that are part of our value proposition. Over the next 12 months we'll be building the economic value story and presenting real-world effectiveness data to help payers and health systems understand the benefits. We hope for a successful launch in 2027 in the first markets where we secure pricing and access, and broader uptake through 2028. We aim to capture a significant share of that respiratory market because we have a product that can save the health care system money and deliver better value for patients and providers. We'll continue to work on pricing, reimbursement, and access over the next year to enable a strong launch in 2027 and growth in 2028.

Well, thank you very much for joining us today. As you can see, we're excited about 2026, returning to sales growth and critical Phase III readouts for norovirus, Intismeran and propionic acidemia. We look forward to talking to many of you over the next few days and weeks. We're excited to host you on Monday, June 1 at ASCO, and on June 25 here in Cambridge for a Science Day. Have a nice day, and have a great weekend.