Good day, and thank you for standing by. Welcome to Moderna's Third Quarter 2026 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one again. Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead.
Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's Third Quarter 2026 financial results and business updates. 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 are Stéphane Bancel, our Chief Executive Officer, Stephen Hoge, our President, Jamey Mock, our Chief Financial Officer, and David Berman, our Chief Development Officer. Before we begin, please note that this call will include forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see slide two of the accompanying presentation 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.
With that, I will turn the call over to Stéphane.
Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start today with a review of third quarter. Jamey will then cover our financial results and outlook, followed by Stephen with our current business updates in infectious disease. David will then review our clinical progress in oncology and rare diseases, and I will come back quickly for a close on our key value drivers before Q&A. The Moderna team delivered a great third quarter, generating $1,300,000,000 in revenues, representing 29% growth year-over-year. Importantly, this strong commercial performance translated into $200 million in net income for the quarter. We also ended the quarter with a strong balance sheet, with $8 billion in cash and investments, reflecting a combination of solid operational and commercial execution, along with a highly successful convertible debt financing.
We continue to demonstrate financial discipline across the company, reducing cash cost by 10% compared to the third quarter of last year. Together, these strong results underscore our ability to deliver strong commercial performance while maintaining financial discipline and strengthening our financial position. During the quarter, we achieved several important milestones across our pipeline and our business. U.S. FDA approval of mFLUSIVA, making Moderna's fifth approved product and the first mRNA-based influenza vaccine to reach the market. In Canada, we secured approvals of both mFLUSIVA and mCOFLU yesterday, the local brand name for mCOMBRIAX, further expanding our respiratory portfolio internationally. In oncology, we are very proud to present positive phase III data for Intismeran autogene, our individualized cancer therapy being developed in partnership with Merck. The result demonstrated a significant clinical benefit, with a 42% reduction in the risk of recurrence or death in patients with resected melanoma.
An additional analysis suggesting an even greater benefit of 49% reduction in the risk of recurrence or death in patients who received at least one dose of intismeran as planned. Importantly, this marks the first combination immunotherapy regimen to demonstrate additional benefit over KEYTRUDA alone in the adjuvant melanoma setting, representing a significant milestone for melanoma patients and their families around the world. David will discuss these results in greater details. We also took an important step to further strengthen our financial position. During the quarter, we raised $3 billion through a 0% convertible note debt, securing long-term capital on highly attractive terms. After accounting for the purchase of capped calls designed to mitigate potential future dilution and fees, we raised approximately $2,600,000,000 in net proceeds.
This financing strengths our ability to invest in the growth of our oncology business, a key strategic priority for Moderna as we approach candidate important clinical milestone. In global health, our Ebola vaccine candidate, mRNA-1469, developed in collaboration with CEPI, was selected to advance into phase II/III following a recommendation from the WHO Technical Advisory Group. I am extremely proud of the performance delivered by the team in Q3. Strong sales growth, profitability, approval, and quick launch of flu in the U.S., intismeran positive phase III, and the convert debt financing. I am also very pleased and happy to welcome back Juan Andres to Moderna executive committee. Many of you will remember Juan for his previous time at Moderna, where he played a critical role in building and scaling our global manufacturing network during the pandemic. He also led the scale-out of individualized manufacturing for Intismeran autogene.
He knows our company, our technology, and our culture extremely well. As we enter this next phase of Moderna's growth with an expanded commercial portfolio and important opportunities ahead in oncology, having Juan back on the team will be invaluable. I am personally very excited to be working with him again, and I know the entire Moderna team is delighted to welcome him back. With that, I turn to Jamey.
Thanks, Stéphane, and hello, everyone. Today, I will begin with a review of our third quarter financial performance, followed by an update on our 2026 financial framework. Let me start with our commercial performance on slide eight. We delivered a strong third quarter, with revenue of $1.3 billion , bringing our year-to-date revenue to $1.8 billion . Our geographic mix for the quarter was approximately 60% U.S. and 40% international. Both the U.S. and international markets delivered stronger-than-expected revenue in 3Q, driven by a mix of increased demand, operational execution, and timing of shipments between the third and fourth quarters. As mentioned in prior calls, we forecasted two primary growth drivers in 2026. In creased mNEXSPIKE adoption and growth in our strategic partnerships in the U.K., Canada, and Australia.
In the U.S., while the vaccination season is still ongoing, we have seen increased uptake of mNEXSPIKE, and vaccination rates have been relatively stable versus the prior year. Internationally, our teams have executed well, particularly in the U.K. and Canada. Year-to-date international revenue of $900 million is already $200 million ahead of the full year we delivered in 2025. Based on the strong start to the season, combined with the visibility we have into the fourth quarter, we are increasing our full-year revenue framework to a range of 15%-25% growth, which exceeds our prior framework of up to 10% growth. We continue to expect an approximately even split between U.S. and international revenue for the full year. Now let me turn to our third-quarter financial performance on slide nine.
As I just mentioned, total revenue was $1.3 billion for the quarter, up 29% from last year, primarily driven by higher COVID sales. Cost of sales for the quarter was $318 million, representing 24% of total revenue for the quarter. This was a 54% increase in our cost of sales from Q3 last year, primarily driven by higher product sales volume and other manufacturing-related costs. We remain on track to drive significant gross margin improvements in 2026, excluding the $900 million litigation charge. R&D expenses for the quarter were $583 million, down 27% from last year, driven by completion and wind-down of studies in our infectious disease portfolio, as well as efficiency gains across the organization. SG&A expenses for the quarter were $282 million, a 5% increase year-over-year. We continue to maintain cost discipline across the organization while investing for growth.
Our income tax provision was immaterial in both periods. Net income for the quarter was $162 million, an improvement of $362 million compared to last year. Diluted earnings per share was $0.38, compared to a loss per share of $0.51 last year. We ended the quarter with cash and investments of $8 billion, up from $6.9 billion at the end of the second quarter. The increase was primarily driven by $2.6 billion of net proceeds from our convertible note issuance and capped call transaction, partially offset by a $950 million litigation settlement payment, as well as the seasonal impact to working capital. Now let's turn to our financial framework for 2026.
For total revenue, as I mentioned in my earlier remarks, we are improving our revenue outlook to a range of 15%-25% growth, which exceeds our prior framework of up to 10% growth. Cost of sales is unchanged at $1.7 billion , which includes $0.9 billion of expense related to the previously announced litigation settlement charge. We are lowering our R&D expense by $200 million to $2.7 billion due to further wind-down of studies and continued operational efficiencies. SG&A expenses are still expected to be approximately $1 billion, flat versus the prior year. Similar to last year, we expect higher SG&A expenses in the fourth quarter, primarily due to commercial-related activity. In aggregate, excluding the $0.9 billion litigation charge, we are expecting total GAAP operating expenses of $4.5 billion and $3.8 billion of cash costs, which excludes stock-based compensation, depreciation, and amortization.
Each reflect a $200 million improvement compared to our previous framework. We expect taxes to be negligible in 2026, and we are lowering our capital expenditure estimate to $200 million from our previous range of $200 million-$300 million. Cash and investments are now projected to be between $8.1 billion and $8.3 billion at the end of 2026. Excluding the $2.6 billion net proceeds from the convertible note and capped call transaction, our cash projection would be $5.5 billion-$5.7 billion, which is an improvement from our previous framework of $4.7 billion-$5.2 billion. The increase in our cash projection is due to our improved revenue outlook and reductions in both our cash cost and CapEx projections. Our cash cost framework does not assume any additional drawdown from our remaining $0.9 billion undrawn credit facility.
With that, I will now turn the call over to Stephen.
Thank you, Jamey, and good morning or good afternoon, everyone. I will now take you through our recent business updates. As a reminder, slide 12 outlines our multi-year revenue growth strategy, which continues to be anchored in two key drivers: geographic expansion and portfolio expansion through continued pipeline advancement. We are building a more diversified portfolio with new opportunities across respiratory vaccines, oncology, and rare diseases, while expanding our commercial footprint in markets around the world. We are making tangible progress against this strategy, with several important milestones achieved during the quarter. Starting with mFLUSIVA, we recently received FDA approval for adults aged 50- 64 and accelerated approval for adults aged 65 and older in the U.S. In Canada, we secured approvals for both mFLUSIVA and mCOFLU, the local brand name for mCOMBRIAX, for adults aged 60 and older.
For mNEXSPIKE, we saw approvals for the annual strain updates in the U.S., Canada, Japan, and Taiwan for the 2026-2027 vaccination season. For mRESVIA, we continue to make progress in the U.S. and international markets. We expanded our international presence with a five-year agreement signed with a local manufacturer in Mexico to support COVID-19 vaccine supply. Finally, in oncology, we presented positive phase III data for intismeran in adjuvant melanoma at the ESMO Presidential Symposium, as highlighted earlier. These milestones demonstrate continued execution against our strategy to drive revenue growth. Turning to our approved infectious disease portfolio, we continue to make progress across our five commercial products. Starting with our COVID vaccines, as I mentioned earlier, mNEXSPIKE received approval for the updated XFG strain for this coming vaccination season in the U.S., Canada, Japan, and Taiwan, with additional regulatory reviews and filings underway.
Spikevax has also received approval for the updated strain in these markets and also in the European Union. Deliveries of our updated COVID-19 vaccines are now underway globally. Turning to RSV, mRESVIA is approved in 44 countries. We also received published results from a phase III study evaluating revaccination with mRESVIA in adults aged 60 and older who had previously received a protein-based RSV vaccine. The study demonstrated robust immune responses, comparable to those seen following the initial vaccination with mRESVIA, with no new safety concerns identified, highlighting the potential for mRESVIA in revaccination. A link to the study can be found on this slide. For mFLUSIVA, our seasonal influenza vaccine, we have approvals in the U.S. and now Canada, with reviews ongoing in the European Union, Australia, and Taiwan.
In the U.S., the American Academy of Family Physicians has recommended mFLUSIVA for adults aged 65 and older as an enhanced influenza vaccine. Finally, for mCOMBRIAX, our combination influenza and COVID-19 vaccine, we now have approvals in Europe and Canada. The product remains under review in Japan, the U.K., Australia, and Switzerland, with a decision on filing in the U.S. subject to further discussion with the FDA. Turning to U.S. respiratory vaccination trends, overall demand remains strong, as I said before. Through late October, approximately 44.1 million flu, COVID-19, and RSV vaccinations have been administered in the retail and long-term care channels, a 3% increase over the comparable period last year. Flu vaccinations are trending slightly ahead of last year, and COVID-19 vaccinations are trending slightly behind, but momentum in October suggests vaccinations may end up flat year-over-year in the channel.
These trends demonstrate the healthy demand for seasonal respiratory vaccines in the United States. Turning to our late-stage infectious disease pipeline and our norovirus vaccine program, mRNA-1403. As a reminder, as previously disclosed, the phase III study did not meet the statistical criteria for early success at its interim analysis. Following a review of the program, we have decided not to enroll an additional cohort this coming winter season. Instead, we are engaging with health authorities to determine the next steps for the program, and we will provide further updates following those discussions. With that, I will now turn the call over to David to review our oncology and rare disease pipeline.
Thank you, Stephen. Hello, everyone. I will review the progress across our oncology and rare disease pipeline, starting with Intismeran autogene, our individualized cancer therapy, which is being developed in partnership with Merck. Last month, we presented the positive phase III INTerpath-001 melanoma results at the Presidential Symposium at ESMO. I will discuss these in greater detail shortly. A link to the ESMO presentation can be found at the bottom of this slide. Beyond melanoma, our intismeran development program continues to advance across multiple tumor types and stages of disease. In non-small cell lung cancer, the adjuvant phase III study is fully enrolled. Two additional phase III studies in non-small cell lung cancer continue to enroll patients.
One phase III is in patients who did not have a pathologic complete response following neoadjuvant therapy. The other phase III is in Stage 1 disease, evaluating intismeran both as a monotherapy and in combination with KEYTRUDA QLEX. Phase II studies in adjuvant renal cell carcinoma and muscle-invasive bladder cancer are fully enrolled. Both of these studies are randomized against KEYTRUDA and are event-driven studies. We continue to enroll phase II clinical studies in non-muscle invasive bladder cancer, metastatic melanoma, and metastatic squamous non-small cell lung cancer. Phase I studies in pancreatic and gastric cancer are fully enrolled. At ESMO, we presented a poster highlighting encouraging translational data from the phase I pancreatic cancer study. Despite the low tumor mutational burden typically seen in pancreatic cancer, we were able to generate neoantigen-specific T-cell responses in all 19 evaluable patients.
A link to the poster is at the bottom of the slide. Now let's review the phase III melanoma results. In the INTerpath-001 trial, the primary endpoint was relapse-free survival. Intismeran plus pembrolizumab demonstrated a significant 42% reduction in the risk of recurrence or death compared with pembrolizumab alone. The hazard ratio was 0.58 and P-value below 0.001. These remarkable results were observed at the first interim analysis of this large randomized phase III trial, enrolling more than 1,100 patients with resected Stage IIB through IV melanoma. At two years, recurrence-free survival was 82.2% in the combination arm, compared with 70% for pembrolizumab alone, representing a 12 percentage point absolute improvement. These results represent two important firsts. The first positive phase III trial for an individualized cancer vaccine, and the first positive phase III trial demonstrating benefit over anti-PD-1 therapy in adjuvant melanoma.
This is a summary of the phase II results at three different follow-ups. That study also tested intismeran plus pembrolizumab versus pembrolizumab monotherapy, and also had an RFS primary endpoint. What's particularly remarkable is the consistency between the phase II hazard ratio of 0.56 and the phase III hazard ratio of 0.58 at the primary analyses, where both had similar follow-up. In our phase II study, the RFS hazard ratio improved from 0.56 to 0.51 at three years, and that benefit was maintained through five years of follow-up. We are optimistic about the potential to see similar strengthening of the treatment benefit in phase III as the data matures. This optimism is further supported by sensitivity analyses from the phase III trial. In the phase III trial, we conducted pre-specified sensitivity analyses that provide additional insights into the treatment to benefit.
One of these analyses evaluated the modified intention-to-treat, or mITT population, which evaluates only patients who received the intended intismeran or placebo injection. Patients were randomized and received pembrolizumab, but either relapsed or withdrew prior to the first dose of intismeran or placebo as planned were excluded. In other words, while the ITT analysis shows the results of a phase III clinical trial, the mITT analysis, by limiting to patients actually treated with the blinded vaccine, shows the true treatment effect of intismeran. In this mITT analysis, we observed an even greater treatment benefit with a 49% reduction in the risk of recurrence or death, compared with the 42% reduction observed in the primary ITT. Notably, the hazard ratio of 0.51 is consistent with what we observed in phase II at the three and five-year follow-ups.
At two years, the recurrence-free survival was 84.2% with the combination, compared with 70.4% for pembrolizumab alone, representing nearly a 14 percentage point absolute improvement. Together, the ITT and mITT analyses reinforce the strength and consistency of the efficacy between phase III and phase II. The degree of benefit for the combination over pembrolizumab monotherapy, which itself is a great drug, is one reason that I am optimistic intismeran will work in other tumor types. The combination of intismeran plus pembrolizumab was generally well tolerated, with findings consistent with the known safety profiles of the individual therapies. Adding intismeran did not meaningfully increase pembrolizumab-associated adverse events of interest, which occurred in 36% of patients receiving the combination, compared to 35% of patients receiving pembrolizumab alone. Adverse events associated with intismeran were also consistent with its expected safety profile.
The most common adverse events in the combination arm were pyrexia, injection site pain, and fatigue. These events were generally low-grade, transient, and were managed with standard supportive care. These findings are encouraging, particularly in the context of the significant improvement in relapse-free survival demonstrated in the study. I'll now turn to our broader oncology portfolio. Outside of intismeran, we continue to advance a diversified portfolio of oncology programs across cancer antigen therapies, T-cell engagers, and cell therapy enhancement. Starting with mRNA-4359, a cancer antigen therapy, we have an ongoing phase II study in first-line metastatic melanoma, second-line or later metastatic melanoma, and first-line metastatic non-small cell lung cancer. Our mRNA-4194 program is progressing in a phase I/II study in Lynch syndrome, with phase I dose escalation ongoing. We also continue to advance mRNA-4106 and mRNA-4200, with phase I studies dosing patients currently.
Turning to our T-cell engager program, mRNA-2808 is in a phase I study in multiple myeloma. The initial clinical results have been selected for an oral presentation at the upcoming ASH Annual Meeting in December, and we look forward to presenting the data and advancing this program. Finally, in collaboration with Immatics, we continue dosing in the phase I study of our cell therapy enhancer, mRNA-4203, in combination with anzu-cel. Across these programs, we're evaluating several distinct therapeutic approaches and continue to generate clinical evidence to guide further development. Turning briefly to our rare disease pipeline, our registrational trial in propionic acidemia, or PA, is on track, and we look forward to the results later this year. For methylmalonic acidemia, or MMA, we've deferred the decision to initiate a pivotal trial until after the PA readout. With that, I'll hand the call back to Stéphane.
Thank you, David, Stephen, and Jamey. Looking ahead, we continue to see important value drivers across our commercial business, financial performance, and pipeline. We have raised our full-year 2026 revenue growth expectations to between 15% and 20% growth, exceeding our previous revenue growth expectation of up to 10%. We also continue to execute with financial discipline, lowering our adjusted cash cost target by another $200 million to approximately $3,800,000,000 for fiscal year 2026. And we have raised our year-end cash and investment outlook to between $8,100,000,000 and $8,300,000,000 . On the commercial side, we continue to pursue additional regulatory approvals to expand the global reach of our respiratory vaccine portfolio. Turning to our pipeline, 2026 has been a landmark year for oncology, highlighted by our positive phase III melanoma result for intismeran and the presentation of encouraging early pancreatic cancer data at ESMO.
Looking ahead, key milestones include our event-driven, p hase II renal cancer readout, the intismeran BLA submission, the presentation of mRNA-2808 at ASH, and a registration readout in propionic acidemia, or PA, our most advanced rare genetic disease program. Our priorities remain clear, grow our commercial business, maintain financial discipline, and advance our pipeline toward important clinical and regulatory milestones. I am very proud of what our team have accomplished this year and excited about the opportunities ahead for Moderna.
We look forward to hosting the investment community next week at our upcoming Analyst Day on November 12th. The event will be held in person at our intismeran manufacturing site in Marlborough, Massachusetts, where attendees will have also the opportunity to tour the site. A webcast of our presentation will be available for those joining remotely. I want to close by thanking our teams around the world for their dedication and execution.
This has been an important year for Moderna, and our progress reinforces what we can accomplish when we combine bold science with disciplined execution. Our platform is delivering. Five approved infectious disease vaccines around the world, positive phase III for intismeran, and a new modality with mRNA-2808 proof of concept in multiple myeloma T-cell engagers. Our mission remains at the heart of everything we do, to deliver the greatest possible impact to people through mRNA medicine. With that, we will be happy to take your questions.
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 remove 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 Salveen Richter with Goldman Sachs. Your line is open.
Thank you. Good morning. Two questions for me. One is, could you frame your confidence into the interim data in renal cell carcinoma, particularly as we think about the statistical plan with regard to number of events that needs to be hit around that interim? If you could also touch on the fact that there's been some questions in the contribution of the LNP to immunogenicity with regard to the melanoma trial, and maybe just help frame that for us as well. Thank you.
Hi, Salveen. Thank you very much for the question. In terms of the timing, it's event-driven for the RCC trial, so it could be end of this year or early next year. In terms of the confidence for that, why I'm confident, I would say probably a couple of reasons. First is that we know that RCC is an anti-PD-1-sensitive tumor. Anti-PD-1s work by T-cells, by reactivating T-cells. We work by generating novel T-cells. It's a T-cell-sensitive disease, and so that's confidence number one. Confidence number two derives from the fact that in our phase II trial, we saw efficacy in the melanoma population that was equivalent for high TMB and for low TMB patients. If you overlap the low TMB spectrum in the melanoma, it actually does overlap with RCC.
Finally, the treatment benefit that we saw in the primary analysis has ratio 0.58 versus pembrolizumab alone. That was the same treatment effect that pembrolizumab alone saw versus placebo in their KEYNOTE-054, and then we know KEYTRUDA went on to be positive in RCC as well. So those are the reasons why I have confidence or belief that we are likely potentially to have a positive result. I don't say anything more about the statistical analysis plan. In terms of the LNP immunogenicity question, this is a question that's been going on for a while. Just to orient everyone, it came up a few years ago when MD Anderson published a retrospective analysis. It wasn't a randomized trial, it was just observation, and they suggested that patients who got the mRNA LNP vaccine had better outcomes to immunotherapy.
That data from MD Anderson has subsequently been repeated and not been repeated by different groups. In fact, most recently, Memorial Sloan Kettering, which is the other large cancer center in the U.S., came out with their own analysis showing that actually there was no treatment effect by the addition of mRNA LNP. So, I don't think that answer is clear. I don't think the evidence is strong enough to claim it, and I don't think LNP can generate such an incredibly strong hazard ratio in the adjuvant setting.
Thank you. One moment for our next question. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.
Great. Thanks so much for taking the question. I was just wondering, I know you're not going to guide on price at this point for INT, but was just wondering if you could talk through some of the inputs that you and Merck are considering as you think about pricing that therapy. The second question I had is just on the phase II RCC study, if those data are positive, do you think that can support a registration in that setting? Thank you.
Yeah, thank you. Look, this is Stephen. I'll take the first part of it on price and then I think hand it over to David. On price, look, it's premature at this point. We're working on getting a submission done this year and obviously working towards approval. We will always look to price our products to represent the value they create in healthcare systems, and obviously we're thrilled by the data. But it is premature at this point to say anything more, and we'll work closely with Merck on that process.
Thanks, Stephen. Terence, in regard to your second question, look, it's a pretty large randomized, well-controlled phase II with 282 patients. But it is a phase II. So, at a base case, I would say it can be practice-informing, especially with compendium listing if it's positive. In an upside, if the results are very strong, I think we can consider taking it to FDA, but it will be data-dependent.
Thank you. One moment for our next question. Our next question comes from Ellie Merle with Barclays. Your line is open.
Hey, guys. Thanks so much for taking my question. On the back of the pancreatic data at ESMO, can you elaborate on how you're thinking about potential next development steps here? Would you study in combo with PD-1, with chemo, or both? Just a quick one on RCC. If the study is not successful on the first interim, is that something you'd disclose if it moves on to additional analyses? Thanks.
Ellie, with regard to the PDAC, look, the good news is that in this low TMB tumor, we were able to generate cassettes from the patients, and in all of the evaluable patients, we were able to see T-cell reacting to those neoantigens. I think that's a really good sign. We did it in combination with the standard of care, which is FOLFIRINOX. So, it informed us that it can safely be given with chemotherapy, which I think we probably assumed it could, and that we can still generate T-cell reactivity in the face of the addition of chemotherapy. I think for next steps, we're actively discussing that with Merck right now. I think it could be in the same regimen that we studied. It could be in combination with the RAS inhibitor.
I think we need to do a little more thinking about that because the standard of care is changing. In terms of the disclosure, I don't think we've decided yet how we're going to handle that.
Thank you. One moment for our next question. Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open.
Great. Thank you very much, and congrats on all the progress. My questions are just on the BLA for intismeran. What still has to happen, and are you working collaboratively with Merck on that? Are they driving the bus? Then just trying to get a sense for when we might get data from the lung cancer studies, and maybe you can kind of break out how those different studies might read out. Thanks so much.
Hey, Ed. It's Stephen. I'll take the first part of that and then hand it over to David to speak through the lung cancer work. We're working intensely with our partner, Merck. As we said earlier, as Stéphane mentioned a moment ago, we are working to make sure that submission of the BLA happens this year. You know, if everything goes well, as has been said before, we would hope to see approval next year. There are lots of steps, as you know, pulling those things together, including getting ready for pre-approval inspections and everything. I can assure you, working around the clock to make sure that not only the submission happens on time, but the review is facilitated with the FDA because o ur goal here ultimately is approval. But working very closely with Merck together on that as we speak. David?
Thanks, Stephen. The lung cancer adjuvant program is actually really comprehensive. We announced that we have just about completed, we have completed enrollment in the INTerpath-002, which is adjuvant after chemotherapy with no neoadjuvant therapy. In fact, this was the fastest enrolling, one of Merck's fastest enrolling trials, just to give you a sense of the excitement. We are still ongoing in enrollment in patients who had neoadjuvant pembro- chemo and did not have pathologic complete response. That is still enrolling, so it is too soon to know what is going to happen in terms of timing there. Then we have the really exciting high-risk Stage 1 lung cancer phase III, where for the first time, we are testing intismeran monotherapy in one of the arms, also still enrolling there. In terms of readouts and timings, I think it is a little too soon. We just finished to predict.
We just finished enrolling, and so now we need to start monitoring events, and then we will have a better idea about timing.
Thanks, David.
One moment for our next question. Our next question comes from Alec Stranahan with Bank of America. Your line is open.
Hey, guys. Thanks for taking our questions. Two from us, one on mRNA-2808 and one financial question. Looking forward to the data at ASH. I guess, what will the update add beyond the first 11 response-evaluable patients in terms of more patients, higher dose, durability? I guess, how does this program maybe reflect the broader oncology opportunity you see for the platform? Quickly on your 2026 growth guidance increase, how much of this came from timing, meaning deliveries moved into 2026, and does any of it, I guess, pull revenue forward from 2027? Thanks.
Alec, with regard to your program, thanks for highlighting mRNA-2808. It is actually one of the exciting early-stage programs we have. There have been obviously lots of T-cell engagers in myeloma. There have been some that are targeting two antigens. This, of course, is the first time ever that three antigens have been targeted, and that's why we're excited this is going to be an oral presentation. The data cut is later for the oral than it was the abstract, so you can expect more patients, longer follow-up, and evaluation of whether we can get a deeper response and activity in patients who had prior BCMA and GPRC5D. In terms of the broader implications, this is testing a hypothesis we have that one of the benefits of our platform is that we can multiplex.
We're multiplexing here against different tumor antigens in the form of three T-cell engagers, but it can also show that we can multiplex on the other side, going after different T-cell stimulation approaches as well. The fact that this works shows that we can multiplex, we can generate systemic proteins to treat cancer, and I think that's a very important proof of principle.
Thanks, David. Yeah. Alec, thanks for the question. We're encouraged that this is really broad-based growth this year. It is both U.S. and international. I just go back to some of my prepared remarks, which was, we came into the year with two key growth drivers, mNEXSPIKE, that is performing extremely well in the U.S. In addition to that, in the U.S., vaccination rates are stable, which Stephen walked through on his chart. Internationally, we came in thinking about the strategic partnerships, and those have all performed extremely well also. So when we look to 2027, I go back to what Stephen presented in terms of there are still four growth drivers out there. Flu is relatively immaterial right now for us in 2026, and we expect to grow next year. Europe opens up for us, Latin America partnerships. Hopefully, we will have INT approved.
So we are quite encouraged. So again, it was a broad-based growth in 2026, and the two primary growth drivers are going well for us.
Thank you.
One moment for our next question. Our next question comes from Myles Minter with William Blair. Your line is open.
Hi. Congrats on the quarter and all of the updates with the INTerpath-001. I actually had just a question on norovirus. I think at your last quarterly update, you indicated you were going to enroll another cohort. Now you are not, and you are going to the regulators. Just wondering what changed there and what you are hoping to get out of those regulatory discussions. Thanks very much.
Yeah, Myles, thank you for the question. At this point, I don't have much more to say than we already did. You're correct. We did not meet the criteria for early success, and we were going forward with a cohort initially. But as we reviewed the program, we think the most appropriate next step is not to go forward with that cohort, but instead consult with regulators. At this point, it's premature for me to guide any further on that. But once we've had those discussions with them about the potential next steps of the program, we'll be able to provide an update more broadly. For now, we'll have to have those conversations before I can offer anything more.
No worries. Thanks.
One moment for our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.
Hey, guys. Thanks so much for taking the questions, and congrats on the quarterly results. The melanoma INT results are clearly stellar. But regarding the next readout in RCC, some KOLs have brought up research suggesting that RCC immunogenicity may be driven in part by HIF-regulated endogenous retroviral elements. Can the current INT- antigen selection process identify and incorporate those types of non-canonical antigens, and how might that impact the probability of success?
Hi, Tyler. Thanks for the question. Yeah, it's an interesting hypothesis that has been put out there. I think it's a hypothesis and it's a question whether endogenous retrovirals play a role or not. What I do know is that our algorithm does include insertion deletions, indels, which are actually strongly demonstrated to be important in RCC, as well as neoantigens and single point neoantigens, that is. I'll also point you out to a publication recently from Dana-Farber where they did their own personalized cancer vaccine and were able to identify sufficient neoantigens without the addition of endogenous retroviral. So, the ERVs are interesting, they're speculative, and I think more research needs to be made before we include them.
Great. Thanks, David.
One moment for our next question. Our next question comes from Andrew Tsai with Jefferies. Your line is open.
Hi. Good morning. Thanks for the updates. As we think about the BLA submission for melanoma with INT, can you talk about whether you would need some kind of special FDA approval on the algorithm side on top of the drug side? Secondly, if the power of AI continues to improve rapidly, can you just maybe talk about why competitors, hypothetically speaking, can't catch up to you on the algorithm side? Why do you think you have a protective moat? Thank you.
Great. Thank you for that question. First of all, yes, obviously the algorithm for selection, in fact, the entire front-end process for designing an INT for an individual patient is a part of the drug. Effectively, there is software in it. That is a proprietary feature of our platform, our technology. It is not something that will be readily available. The important question maybe is the second part of yours, which is then how does that play forward? We are incredibly excited by what we have learned in our clinical trials. Bear in mind, the randomized data we have on immunogenicity from the phase II was in about 150 people, about 100 people who received INT . There has now been followed through five years, and at ASCO this year, we presented some of the updated data. At a recent ESMO event, we presented some of that.
We learned a tremendous amount from the 34 neoantigens that we put into those people in that study. What is remarkable is, with the melanoma study that has just read out, we have taken the number of patients up that we have that experience with by almost a factor of 10. If you look across the other nine studies that are up and running, we will go another factor of five again. We are starting to develop a tremendous amount of real experience with what sorts of neoantigens are generating T-cell clones. What are the features of that T-cell clonality that we think is really valuable for a neoantigen vaccine, an individualized neoantigen vaccine? We are constantly looking to bring that back into how we predict and design INT for individuals going forward. That data is a goldmine.
I think we presented this 5,000 neoantigens across the 100+ participants in that first study, the phase II. It has gone up by a factor of 10. We will be, with our partner, we are deeply going through that data and continuing to treat that proprietary information as one of the really special sauces as we continue to try and make INT more and more effective going forward in the, really, in the decades ahead. We think we are at the very beginning of a scientific revolution, and we are excited to be in the lead and to have that proprietary information.
Thank you.
One moment for our next question. Our next question comes from Michael Yee with UBS. Your line is open.
Hey, guys. Thanks. Good morning. Two questions. On INT, the clinical trial protocols are available for renal cell and bladder cancer, and we understand that they are an alpha spend, one-sided alpha of 0.10, very much like you nicely designed your phase II melanoma study, and very much the same assumptions. Do you stand by that protocol and can confirm that those assumptions are correct? The second question is, as it relates to filing in melanoma, is there a general timing guidance for that, just so we can think about the gating steps and other things that need to be done there in terms of the filing? Thank you.
Hi, Michael. We're not aware of the protocols that you cite, and I obviously can't comment on it, so I'm going to have to pass on that. In terms of the BLA, we're obviously working closely with Merck on that, and stay tuned for our next message on that.
Thank you. One moment for our next question. Our next question comes from Courtney Breen with Bernstein. Your line is open.
Hi, Moderna team. Thanks so much for taking the question. A couple for me. I did want to zoom back to the pancreatic cancer study, the phase I data that you presented at ESMO this year. Obviously, we saw the neoantigen generation, the T-cell expansion, et cetera, that you've spoken to. There was also a small swimmer plot of kind of performance for these patients and recurrence details for these patients. Can you just help us understand what you're taking from that efficacy data so far. We see it as relatively early compared to kind of what performance can be generated with FOLFIRINOX on its own. Just want to understand kind of what you're already able to take from those insights and the potential to move forward, or do you need more time to assess that data before you would move forward?
Just, the second question, just a really practical one on that revenue generation. Can you just talk a little bit about the ex-U.S. components here and how much of that is coming from kind of commitments, how much of that is coming from pure demand, and we're just trying to figure out how we kind of appropriately carry some of this forward. Thank you so much.
Courtney, thank you very much for this. David, thank you for the pancreatic question. It was very exciting data because we can generate T cells reactive to neoantigens that are present in the PDAC patients, which is something that actually was not necessarily given. In terms of the swimmer plot that you noticed, yes, I think I agree that it's probably too early, point one. Point two, this was a mix of patients. Some of them had neoadjuvant treatment, some of them didn't, and so it's really hard for us to discern an efficacy signal. I'm always careful about discerning efficacy signals in single-arm trial time-to-event analyses. I think the immunogenicity data is great, the safety is great, and we'll have to figure out the next step.
Question on international. I would say a significant portion is very durable. We've talked about these strategic partnerships, and it comprises over 50% of our revenue, for sure. I think what's also great about our international growth is, one, we're playing in a lot of other markets outside of these strategic partnerships that we have been for some time, and we are increasing share to some degree, as well as I think, as I mentioned earlier, the vaccination rates are improving in a lot of these markets as well. I think we are seeing a shift year-over-year globally that vaccination rates have become more stable. So we hope that that is pretty durable moving forward.
Thank you.
One moment for our next question. Our next question comes from Alexandria Hammond with Wolfe Research. Your line is open.
Hi, guys. Thanks for taking the question. On INT, what learnings have you guys been able to take in regard to the optimal number of neoantigens coded? Do you think 34 neoantigens is a sweet spot, or do you think essentially next-generation assets of your internal platform could encompass more? I guess, what kind of has the data demonstrated about how much of the breadth of these neoantigen payloads matters? Is more always better, or could a smaller number of really highly immunogenic neoantigens be more favorable? Thank you.
I love the science question, and I am happy to take it and expound on it. You are asking the exact question, which is, what makes an optimal neoantigen? How many you need? These are things that we are now looking into because we have a randomized phase III trial. You need the efficacy in order to decode, go back to how many neoantigens you actually need. In melanoma, which has several hundred neoantigens to choose from, we know that 34 neoantigens selected is enough. We can see that roughly one out of three of them generate a T-cell response, although that may be higher. Actually, we are learning that we may actually have more immunogenicity than we actually thought we did. I am not sure more is better because I am not sure, a hazard ratio of 0.58 or 0.51 in the mITT is pretty good.
Against KEYTRUDA, it is really, really good. Would more have been better? It is hard to imagine more would have been better, but I don't know. These are things we now need to decode with our phase III data.
Thank you. One moment for our next question. Our next question comes from Jess Fye with JP Morgan. Your line is open.
Hey, guys. Thanks for taking my question. Just following up on Alec's question there. You mentioned now you have this sort of treasure trove of phase III data. If I recall from the phase II with the translational work we saw at ASCO, there were like seven patients to work with, and it was maybe a little hard to draw conclusions based on the small sample size. Do you have the actual samples and data that you need to run that analysis to figure out those answers about sort of optimal number of neoantigens?
Jess, thanks. The seven patients that you talk about is correct. The N is equal to seven because in order to do very deep immunological monitoring, you have to withdraw a decent amount of blood, and not all patients are willing to do that. In this case, there were seven patients willing to do that. We do have more patients available from across the trial, so that is point number one. Secondly, we have developed really exciting novel ways to decode T-cell reactivity from just looking at the expression data, from the whole blood gene analysis, TCR beta. We have a way that we are beginning to learn to try to decode back neoantigen specificity. I mean, that is part of the holy grail. So, I am hopeful that we will be able to get insights from the phase III that we didn't have in the phase II.
I think that it remains to be seen how far we can go, but that is certainly the goal.
Thanks.
One moment for our next question. Our next question comes from Luca Issi with RBC. Your line's open.
Oh, great. Thanks so much for taking my question. Congrats on all the progress. Maybe, David, one more on RCC and the upcoming phase II. Could you just maybe talk about the stratification strategy there? It looks like you're stratifying patients by either clear cell versus papillary histology, as well as by high versus low disease risk. I guess what I'm trying to ask is, are there any specific subpopulations within RCC that are maybe more immunologically active that you're more optimistic that this approach can work, or do you think this can work kind of across the board? And then maybe related to it, are you tracking the blinded event rates for progressions and death, and are they on track with internal expectations or not? And then maybe separately, Steve, any update on the ongoing conversations with the FDA and the timelines for COVID plus flu in the U.S.?
Thanks so much.
Yeah. In terms of the tracking of the events, we don't comment on that. In terms of the subpopulations, I think we believe this can work in multiple subpopulations. I think that was one of the insights we made from the phase II and the phase III study, that pretty much all of the subsets we looked at have had a trend or a point estimate in favor of intismeran, including high stage versus low stage, high TMB versus low TMB. Some subtypes, papillary renal cell obviously is different than clear cell RCC, but that's why we're stratifying against that. As long as they have new antigens, we think that we can generate novel T-cell clones, and that can potentially have benefits. I don't think I would narrow it down to a population right now.
Thank you. Ladies—
Great. I'll—
Sorry.
—just on the question on the flu/COVID combo vaccine for the U.S., as we said before, we were waiting for the approval in August, that was just two months ago, and then the launch of the flu and COVID vaccines in the U.S., and that was our key to then start the process of engaging with the FDA. That will take some time. There's a lot going on right now across our whole portfolio. We will, in the next number of months, be able to sit down and understand better what the U.S. FDA expects in terms of submission of the mRNA-1083 program. Once we have that information, we'll obviously provide an update.
All right. Thanks so much, guys.
Ladies and gentlemen, this does conclude the Q&A portion of today's program. I'd like to turn the call back over to Stéphane for any further remarks.
Well, thank you, everybody, for joining us today. We really appreciate it. We're looking forward to seeing many of you in person next week for our annual Analyst Day, November 12. And we're very excited for you to tour and to discover the intismeran manufacturing site. Have a nice weekend.
Thank you, ladies and gentlemen. This does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.