Moderna (MRNA) Q3 2026 Earnings Call Transcript

In Canada, we secured approvals of both mFLUSIVA, and mCOMBRIAX yesterday. The local brand name for mCOMBRIAX. Further expanding our respiratory portfolio internationally. In oncology, we are very proud to present positive phase 3 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 of death in patients who received at least 1 dose of Intismeran as planned.

Importantly, this marked the 1st combination immunotherapy regimen to demonstrate additional benefit of 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 detail. We also took an important step to further strengthen our financial position. During the quarter, we raised $3 billion for a 0% convertible note. Securing long term capital on highly attractive terms, After accounting for the purchase of cap calls, these to mitigate potential future dilution and access and fees, we raised approximately $2.6 billion in net proceeds.

This financing strengthens our ability to invest in the growth of oncology business, key strategic priority for Moderna as we approach important clinical milestones. In global health, our Ebola vaccine candidate mRNA-1.47 thousand developed in collaboration with SAPI was selected to advance into Phase 2/3 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., intismiran positive Phase 3, and the convert that financing. 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. I know the entire Moderna team is delighted to welcome him back. With that, I will turn to James.

James Mock: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 8. 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 2 primary growth drivers in 2026.

Increased MNEXT spike 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 MNEXT spike 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% to 25% growth, which exceeds our prior framework of up to 10% growth. We continue to expect an approximately even split between US and international revenue for the full year. Now let me turn to our third quarter financial performance on Slide 9. 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 proceedss, 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% to 25% growth which exceeds our prior framework of up to 10% growth. Cost of sales is unchanged at $1.7 billion, which includes $900 million 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 $900 million 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 to $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 proceedss from the convertible note and cap call transaction, our cash projection would be $5.5 billion to $5.7 billion which is an improvement from our previous framework of $4.7 billion to $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 $900 million undrawn credit facility. With that, I will now turn the call over to Steven.

Stephen Hoge:Thank you, James, and good morning or good afternoon, everyone. I will now take you through our recent business updates. As a reminder, Slide 12 outlines our multiyear revenue growth strategy. Which continues to be anchored in 2 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 to 64 and accelerated approval for adults aged 65 and older in the U.S.

In Canada, we secured approvals for both mFLUSIVA and mCOMBRIAX, the local brand name for mCOMBRIAX. For adults aged 60 and older. For mNEXSPIKE, we saw approvals For The Annual Strain Updates In The United States, Canada, Japan, and Taiwan for the 2027 vaccination season. And for mRESVIA, we continue to make progress in the U.S. and international markets. Expanded our international presence with a 5-year agreement signed with a local manufacturer in Mexico to support COVID-19 vaccine supply. And finally, in oncology, we presented positive phase 3 data for Intismeran in 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 5 commercial products. Starting with our COVID vaccine, as I mentioned earlier, mNEXSPIKE received approval for the updated XBB strain for this coming vaccination season. In The United States, 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 3 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 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 United States and now Canada. With reviews ongoing in the European Union, Australia, and Taiwan. In The US, the American Academy of Family Physicians, has recommended mFLUSIVA for adults aged 65 and older as an enhanced influenza vaccine. And finally, for mCOMBRIAX, our combination influenza/COVID-19 vaccine, we now have approvals in Europe and Canada.

The product remains under review in Japan, the United Kingdom, Australia, and Switzerland with a decision on filing in United States subject to further discussion with the FDA. Turning to US respiratory vaccination trends. Overall demand remains strong, as we 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, 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-1.4 thousand. As a reminder, as previously disclosed, the phase 3 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.

David Berman:Thank you, Steven. Hello, everyone. Will review the progress across our oncology and rare disease pipeline, starting with intismaran auto gene, our individualized cancer therapy, which is being developed in partnership with Merck. Last month, we presented the positive phase 3 INTerpath-001 melanoma results at the Presidential Symposium at ESMO. And I will discuss these in greater detail shortly. A link to the ESMO presentation can be found at the bottom of the 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 3 study is fully enrolled. 2 additional phase 3 studies in non small cell lung cancer continued to enroll patients.

1 Phase 3 is in patients who did not have a pathologic complete response, following neoadjuvant therapy And the other Phase 3 is in stage I disease evaluating Intismeran both as a monotherapy and in combination with KEYTRUDA. Phase 2 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 2 clinical studies in non muscle invasive bladder cancer, metastatic melanoma, and metastatic squamous cell and squamous non-small cell lung cancer. Phase 1 studies in pancreatic and gastric cancer are fully enrolled.

At ESMO, we presented a poster highlighting encouraging translational data from the phase 1 pancreatic cancer study. Despite the low tumor mutational burden, typically seen in pancreatic cancer, we were able to generate neoantigen 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 3 melanoma results. In the INTerpath-001 trial, the primary endpoint was relapse-free survival. Entismaran 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 3 trial, enrolling more than 1.1 thousand patients with resected stage IIB through IV melanoma. At 2 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 2 important firsts. The 1st positive Phase 3 trial for an individualized cancer vaccine and the first positive Phase 3 trial demonstrating benefit over anti PD-1 therapy in adjuvant melanoma. This is a summary of the phase 2 results at 3 different follow-ups.

That study also tested intismaran plus pembrolizumab versus pembrolizumab monotherapy and also had an RFS primary endpoint. what is particularly remarkable is the consistency between the phase 2 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 2 study, the RFS hazard ratio improved. From 0.56 to 0.51 at 3 years, and that benefit was maintained through 5 years of follow-up. We are optimistic about the potential to see similar strengthening of the treatment benefit in phase 3 as the data matures. This optimism is further supported by sensitivity analyses from the phase 3 trial.

In the phase 3 trial, we conducted pre specified sensitivity analyses that provide additional insights into the treatment benefit. 1 of these analyses evaluated the modified intent to treat or MITT, population. Which evaluates only patients who received the intended entismaran or placebo injection. Patients were randomized and received pembrolizumab but either relapsed or withdrew prior to the first dose of intismiran or placebo as planned were excluded. In other words, while the ITT analysis shows the results of a phase 3 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 a 42% reduction observed in the primary ITT. Notably, the hazard ratio of 0.51 is consistent with what we observed in phase 2 at the 3 and 5 year follow ups. At 2 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 3 and phase 2.

The degree of benefit for the combination over pembrolizumab monotherapy, which itself is a great drug, is 1 reason that I am optimistic Intismeran will work in other tumor types. The combination of entismaran plus pembrolizumab was generally well tolerated. With findings consistent with the known safety profiles of the individual therapies. Adding entismaran did not meaningfully increase pembrolizumab associated adverse events of interest, which occurred in 36 percent of patients receiving the combination compared to 35 percent of patients receiving pembrolizumab alone. And adverse events associated with entismaran 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 will 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-4.16 thousand a cancer antigen therapy, we have an ongoing phase 2 study in first line metastatic melanoma, second line or later metastatic melanoma, and first line metastatic non small cell lung cancer. Our mRNA-4.19 thousand program is progressing in a phase 2 study in Lynch syndrome.

With phase 1 dose escalation ongoing. We also continue to advance mRNA-4.11 thousand and mRNA-4.2 thousand. With phase 1 studies dosing patients currently. Turning to our T cell engager program. mRNA-2.81 thousand is in a Phase 1-- Is in a phase 1 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 continued dosing in the phase 1 study of our cell therapy enhancer, mRNA-4.2 thousand in combination with Anzu cell.

Across these programs, we are 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. We look forward to the results later this year. For methylmalonic acidemia, or MMA, we have deferred the decision to initiate a pivotal trial until after the PA readout. With that, I will hand the call back to Stéphane.

Stéphane Bancel:Thank you, David, Steven, and James. 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 25% growth. Exceeding our previous revenue growth expectation of up to 10%. Also continue to execute with financial discipline lowering our adjusted cash cost target by another $200 million to approximately $3.8 billion for fiscal year 2026. And we have raised our year end cash and investment outlook to between $8.1 billion and $8.3 billion. 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 3 melanoma result for intismaran, and the presentation of encouraging early pancreatic cancer data at ESMO. Looking ahead, key milestones include our events driven phase 2 renal cancer readout, the intismaran BLA submission, the presentation of mRNA-2.81 thousand at ASH, and a registrational 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, regulatory milestones. I am very proud of what our teams have accomplished this year, and excited about the opportunities ahead for Moderna.

We look forward to hosting the investment community next week at the upcoming Analyst Day on November 12th. The event will be held in person at our Intismarin manufacturing site in Marlboro, 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 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 both science with disciplined execution. Our platform is delivering. 5 approved infectious disease vaccines around the world Positive Phase 3 for intismiran.

And the new modality with mRNA-2.81 thousand 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 medicines. With that, we will be happy to take your questions.

Operator:You. If your question has been answered and you wish to remove yourself from the queue, please press *11 again. Our first question comes from Salveen Richter with Goldman Sachs. Your line is open.

Salveen Richter:Thank you. Good morning. 2 questions for me. 1 is, could you frame your confidence in the interim data in renal cell carcinoma, particularly as we think about the statistical plan with regard to number of events that need to be hit around that interim? And then if you could also touch on the fact that there is been some question on 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.

David Berman:Hi, Salveen. Thank you very much for the question. In terms of the timing, it is event driven for the RCC trial. So it could be end of this year or early next year. In terms of the confidence of that, why I am 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. And so it is a T cell, sensitive disease, and so that is confidence number 1. Confidence number 2 derives from the fact that in our phase 2 trial, we saw efficacy the melanoma population at both.

That was equivalent for high TMB and for low TMB patients And if you overlap the low TMB spectrum, in the melanoma, it actually does overlap with RCC. And then finally, the treatment benefits that we saw in the primary analysis, a hazard ratio 0.58. Versus pembrolizumab alone. That was the same treatment effect that pembrolizumab alone saw versus placebo. 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 believe that we are likely potentially to have a positive result. I do not say anything more about the statistical analysis plan.

In terms of the LNP immunogenicity question, this is a question that is been going on for a while. Just to orient everyone, it came up a few years ago. When MD Anderson published a retrospective analysis And it was not a randomized trial. It was just observation. And they suggested that patients who got the mRNA LNP vaccine had better outcomes to immunotherapy. That has. That data from MD Anderson has subsequently been repeated and not been repeated by different groups. And 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 do not think that this. That answer is clear. I do not think the evidence is strong enough to claim it, and I do not think LNP can generate such an incredibly strong hazard ratio in the adjuvant setting. Thank you.

Operator:1 moment for our next question. Our next question comes from Terence Flynn with Mortgage Stanley. Your line is open.

Terence Flynn:Great. Thanks so much for taking the question. I was just wondering, I know you are 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 the therapy? And then the second question I had is just on the phase 2 RCC study. If those data are positive, do you think that can support a registration in that setting? Thank you.

Stephen Hoge:Yeah. Thank you. Look, I-- this is Stephen. I will take the first part of it on price, and then can hand it over to David. The on price, look, it is premature at this point. We are 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 health care systems. And, obviously, we are thrilled by the data. But it is premature at this point to say anything more. And we will work closely with Merck on that process. Steve.

David Berman:Thanks, Steven. Terence, in regard to your second question, look. it is it is a it is a pretty large randomized well controlled Phase 2 with 282 patients. But it is a phase 2. So at a base case, I would say it can be practice informing, especially with compendium listing if it is 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.

Operator:1 moment for our next question. Our next question comes from Eliana Merle with Barclays. Your line is open.

Eliana Merle:Hey, guys. Thanks so much for taking my question. On the back of the pancreatic data at ESMO, can you elaborate on how you are thinking about potential next development steps here? Would you study in combo with PD-1, with chemo, or both? And then just a quick 1 on RCC. If the study is not successful on the first interim, is that something you disclose if it moves on to additional analyses? Thanks.

David Berman:Ellie, so 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 these neoantigens. I think that is a really good sign. And 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 are 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. And in terms of the disclosure, I do not think we have decided yet how we are going to handle that. Thank you.

Operator:1 moment for our next question. Our next question comes from Edward Tennoff with Piper Sandler. Your line is open.

Analyst:Great. Thank you very much, and congrats on all the progress. My questions are just on the BLA for Intismeran. What has to happen, and are you working collaboratively with Merck on that? Are they driving the bus? And then just trying to get a sense for when we might get data from the lung cancer studies maybe you can kind of break out sort of how those different studies might read out. Thanks so much.

Stephen Hoge:Hey, Ted. I will. it is Steven. I will take the first part of that and then hand it over to David to speak through the lung cancer work. So we are working intensely with our partner Merck. As we said earlier, as Stéphane mentioned a moment ago, we are working to make sure that submission with the BLA happens. This year. And, 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 preapproval inspections and everything.

And 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 our goal here ultimately is approval. But working very closely with Merck together on that as we speak. David?

David Berman:Thanks, David. 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-- 1 of the fastest enrolling trials, just to give you a sense of the excitement. We are still ongoing enrollment in patients who had neo adjuvant 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.

And then we have the really exciting high risk stage 1 lung cancer phase 3 where for the first time, we are testing intismaran monotherapy in 1 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. it is just finished enrolling, and so now we need to start monitoring events and then we will have a better idea about timing. Thanks, Steven.

Operator:1 moment for our next question. Our next question comes from Alexandria Hammond with Bank of America. Your line is open. Hey, guys. Thanks for taking our question. 2 from us, 1 on 2.81 thousand and 1 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? And how does this program maybe reflect the broader oncology opportunity you see for the platform? And 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.

Alexandria, with regard to your question, thanks for highlighting 2.81 thousand.

David Berman:It is actually 1 of the exciting early stage programs we have You know, there have been obviously lots of T cell engagers in myeloma. Have been some that are targeting 2 antigens. This, of course, is the first time ever that 3 antigens have been targeted, and that is why we are excited this is going be an oral presentation. The data cut is later for the oral than it was for 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 1 of the benefits of our platform is that we can multiplex. And, so we are multiplexing against different tumor antigens. The form of 3 T cell engagers, but it can also show that we can multiplex on the other side. You know, going after different T cell stimulation approaches as well. So the fact that this works shows that, we can multiplex. We can generate systemic proteins to treat cancer, and I think that is a very important proof of principle. Thanks, David.

James Mock:Yeah. And Alex, thanks for the question. So we are encouraged that this is really broad based growth this year. It is both US and international. And I just go back to some of my prepared remarks, which was we came into the year with 2 key growth drivers, MNEXT Spike, that is performing extremely well in the U.S. But in addition to that, in The US, vaccination rates are stable, which Steven 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 is Steven presented in terms of there are still 4 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 2 primary growth drivers are going well for us. Thank you.

Operator:1 moment for our next question. Our next question comes from Myles Minter with William Blair. Your line is open.

Myles Minter:Congrats on the quarter and all of the updates for INTerpath-001. I actually had just a question on I think at your last quarterly update, you indicated you were gonna enroll another cohort Now you are not, and you are going to the regulators. Just wondering, you know, what changed there and what you are hoping to get out of those regulatory discussions. Thanks very much.

Stephen Hoge:Yeah, Myles. Thank you for the question. At this point, I do not have much more to say than we already did. You are correct. We did not meet the criteria for early success. And we were going forward with a cohort initially. But as we review the program, we think the most appropriate next step is not to go forward with that cohort, but instead consult with regulators. And at this point, it is premature for me to guide any further on that. But once we have had those discussions, with them about the potential next steps of the program, be able to provide an update more broadly.

So for now, we will have to have those conversations before I can offer anything more. No worries. Thanks.

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

Tyler Van Buren:Hey, guys. Thanks so much for taking the questions and congrats on the quarterly results. So 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-like elements. So can the current INT antigen selection process identify and incorporate those types of noncanonical antigens and how might that impact the probability of success?

David Berman:Hi, Tyler. Thanks for the question. Yeah. it is an interesting hypothesis. That has been put out there. I think it is hypothesis, and it is 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. And then I will also point you 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 are speculative, and I think more research needs to be made before we include them. Great. Thanks, David.

Operator:1 moment for our next question. Our next question comes from Andrew Tsai with Jefferies. Your line is open.

Analyst: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. And secondly, if the power of AI continues to improve rapidly, can you just maybe talk about why competitors hypothetically speaking, cannot catch up to you on the algorithm side? Why do you think you have a protective moat? Thank you.

Stephen Hoge:Great. Thank you for that question. So 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. And 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 1 that you. The second part of your which is then how does that place forward? And, you know, we are we are incredibly excited by what we have learned in our clinical trial.

Bear in mind, you know, the randomized data we have on immunogenicity from the phase 2 was in about 150 people, about 100 people who received INT. it is now been followed through 5 years. And at ASCO this year, we presented some of the updated data. At our 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, you know, with the melanoma study that is just read out, we have taken the number of patients up that we have that experience with by almost a factor of 10.

And if you look across the other 9 studies that are up and running, we will go another factor of 5 again. So we are starting to develop a tremendous amount of real experience with what sorts of neoant 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 individual neoantigen vaccine, and we are constantly looking. To bring that back into how we predict and design INTs for individuals going forward. That data is a gold mine. You know? We had.

I think we presented these 5 thousand neoantigens across the 100-plus participants in that first study, the phase 2, it is gone up by a factor of 10. And we will be with our partner Merck deeply going through that data. And continuing to treat that proprietary information as 1 of the really special sauces as we continue to try and make INTs more and more effective, going forward in the, you know, really in the decades ahead. So 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.

Operator:1 moment for our next question. Our next question comes from Michael Yee with UBS. Your line is open.

Michael Yee:Hey, guys. Thanks. Good morning. 2 questions. On INT, the clinical trial protocols are available for renal cell and bladder cancer, and we understand that they have alpha spend, 1-sided alpha of 0.10, very much like you nicely designed your phase 2 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 what the gating steps and all the things that need to be done? There in terms of the filing. Thank you.

David Berman:Hi, Michael. We are not aware of the protocols that you cite, you know, obviously cannot comment on it, so I am gonna have to pass on that. In terms of the BLA, we are obviously working closely with Merck on that, and, stay tuned for our next message on that. Thank you.

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

Courtney Breen: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 1 data that you presented at ESMO this year. Obviously, we saw the neoantigen generation, the T cell expansion, etcetera, that you have 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 are 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 are 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? And then just the second question, just a really practical 1 on the on the 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 are just trying to figure out how we kind of appropriately carry some of this forward. Thank you so much.

David Berman: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 PDAC patients, which is something that actually was not really a given. In terms of the swimmer plot that you noticed, yes, I think I agree that it is probably too early, point number 1. And point number 2, this was a mix of patients. Some of them had neoadjuvant treatment. Some of them did not. And so it is really hard for us to discern an efficacy signal. I am always careful about discerning efficacy signals in single arm trial to time-to-event analyses.

Think the immunogenicity is great. The safety is great, and we will have to figure out the next step.

James Mock:Question on international So I would say a significant portion is very durable. We have talked about these strategic partnerships, and it comprises over 50% of our revenue for sure and then. But I think what is also great about our international growth is 1, we are 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. So I think we are seeing a shift year over year globally that vaccination rates have become more stable.

So we hope that is pretty durable moving forward. Thank you.

Operator:1 moment for our next question. Our next question comes from Alexandria Hammond with Wolfe Research. Your line is open.

Alexandria Hammond:Hey, guys. Thanks for taking the question. So on INT, what learnings have you guys been able take in regard to the optimal number of new antigens coded? Is 34 the sweet spot? Or do you think essentially next generation assets, or of your internal kind of platform could encompass more. I guess, what kind of data demonstrated about how much of the breadth of these neoantigens and payload matters? Is more always better, or could a smaller number of really highly immunogenic mutations be more favorable? Thank you.

David Berman:I love the science question, and I am happy to take it and expound on it. You are asking the exact question, right, 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 3 trial. And you need the efficacy in order to decode, go back to how many neoantigens you actually need. So in melanoma has several hundred neoantigens to choose from, we know that 34 selected is enough. We can see that roughly 1 out of 3 of them generate a T cell response, although that may be higher.

We are actually learning that we may actually have more immunogenicity than we actually thought we did. So I am not sure more is better because I. I am not sure. You know, it has a ratio of 0.58 or point 1, and the MITT is pretty good. Against Keytruda, it is really, really good. So with more being better, it is hard to imagine more would have been better, but I do not know. These are things we now need to decode. With our phase 3 data. Thank you.

Operator:1 moment for our next question. Our next question comes from Jessica Fye with JPMorgan. Your line is open.

Jessica Fye:Hey guys, Thanks for taking my question. Just following up on Alexandria's question there. You mentioned now you have the sort of treasure trove of Phase III data. Trove If I recall from the Phase 2 with the translational work we saw at ASCO, there were like 7 patients to work with, and it was like maybe a little hard to draw conclusions based on a small sample size. You have the actual, like, samples and data that you need to run that analysis to figure out those answers about sort of optimal number of neoantigens?

David Berman:Jessica, thanks. So the 7 patients that you talked about is correct, n is equal to 7, 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. And in this case, there were 7 patients willing to do that. We do have, more patients, available from across the trial. So that is point number 1. And 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 3 that we did not have in the phase 2. I think that it remains to be seen how far we can go, but that is certainly the goal. Thanks.

Operator:1 moment for our next question. Our next question comes from Luca Issi with RBC. Your line is open.

Luca Issi:Oh, great. Thanks so much for taking my question. Congrats on all the progress. Maybe, David, 1 more on RCC and the upcoming Phase 2. Just maybe talk about the stratification strategy there. It looks like you are stratifying patients by either clear cell versus papillary histology. As well as by high versus low disease risk. Guess what I am trying to ask is are there any specific subpopulations within RCC that are maybe more immunologically active that you are more optimistic that this approach can work, or do you think that this can work I do not know, across the board?

And then maybe related to it, are you tracking the blinded event rate and are they on track with internal expectations or not? And then maybe separately, Steve, any update on the ongoing conversations with the FDA on the time line for COVID plus flu in the U.S.? Thanks so much.

David Berman:Yeah. In terms of the tracking of the events, we do not comment on that. In terms of the what subpopulations I think we believe this can work in multiple subpopulations. I think that was 1 of the insights we made from the Phase 2 and the Phase 3 study that pretty much all of the subsets we looked at have had a trend or a point estimate in favor of mFLUSIVA, 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 is why we are stratifying against that.

But as long as they have new antigens, we think that we can generate novel T-cell clones and that can potentially have benefits. So I do not think I would narrow down to a population right now. Thank you.

Stephen Hoge:And then I will take-- sorry. Just on the question on the flu COVID combo vaccine for The US. We. You know, as we as we said before, we are waiting for the approval in August. That was just 2 months ago. And then the launch of the flu and COVID vaccines in The US And that was our key to then start the process of engaging with the FDA. That will take some time there is a lot going on right now. Across our whole portfolio. And so we will, in the next number of months, be able to sit down and understand better what the, US FDA expects in terms of submission of the mRNA-1.08 thousand program.

And once we have that information, we will, obviously provide an update. Alright. Thanks so much, guys.

Operator:Ladies and gentlemen, this does conclude the Q&A portion of today's program. I would like to turn the call back over to Stéphane for any further remarks.

Stéphane Bancel:Well, thank you everybody for joining us today. We really appreciate it. We are looking forward to seeing many of you in person next week for our annual Analyst Day, November 12th. We are very excited for you to tour and to discover the intismaran manufacturing. Site. Have a nice weekend.

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

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Moderna (MRNA) Q3 2026 Earnings Call Transcript was originally published by The Motley Fool