Moderna Q2 2026 Earnings Call Transcript

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Provided by Quartr
July 31, 2026

Key Takeaways

  • Positive Sentiment: 2026 revenue and cost outlook improved: Moderna reiterated revenue growth of up to 10% and lowered its full-year cost-of-sales and R&D forecasts by $100 million each, while reducing expected cash costs by $200 million to approximately $4 billion.
  • Positive Sentiment: Flu vaccine advances toward potential approval: mRNA-1010 received a unanimous positive recommendation from the FDA advisory committee, with a U.S. PDUFA decision expected August 5 and regulatory reviews ongoing in Europe, Canada, and Australia.
  • Positive Sentiment: mNEXSPIKE showed strong initial commercial traction: The COVID vaccine captured approximately 24% of the U.S. retail market in its first season and about 34% among adults aged 65 and older, supported by encouraging real-world effectiveness data against hospitalization.
  • Negative Sentiment: Norovirus vaccine development faces a delay: mRNA-1403 did not meet statistical criteria for early success at its interim analysis, requiring enrollment of an additional cohort and another seasonal period to collect sufficient cases; the trial remains blinded.
  • Positive Sentiment: Pipeline milestones remain active: Moderna expects an interim analysis for the fully enrolled phase III intismeran melanoma study in the second half of 2026 and data from its registrational propionic acidemia study in the fourth quarter, while expanding oncology programs into Lynch syndrome and solid tumors.
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Earnings Conference Call
Moderna Q2 2026
00:00 / 00:00

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Operator

Welcome to the Moderna second 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 one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lavina Talukdar. Please go ahead.

Lavina Talukdar
Lavina Talukdar
SVP and Head of Investor Relations at Moderna

Thank you, Kevin. Good morning, everyone, and thank you for joining us on today's call to discuss Moderna's second quarter 2026 financial results and business update. 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 conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see Slide 2 of the accompanying presentation in 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.

Lavina Talukdar
Lavina Talukdar
SVP and Head of Investor Relations at Moderna

With that, I will now turn the call over to Stéphane.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Jamey Mock
Jamey Mock
CFO at Moderna

Thanks, Stéphane, Hello everyone. Today, I'll start with our second quarter financial results and then review our updated financial framework for 2026. Let me start with our commercial performance. For the second quarter, total revenue was $145 million, above the guidance range we provided on the first quarter call. Our geographic mix for the quarter was 60% U.S. and 40% international. For the first half of the year, total revenue was $0.5 billion, with 31% from the U.S. and 69% from international markets. Our long-term strategic partnerships drove the strong international contribution during the first half. Overall, we are pleased with our first half performance and are reiterating our expectation for revenue growth of up to 10% in 2026.

Jamey Mock
Jamey Mock
CFO at Moderna

We continue to expect a roughly 50/50 split between U.S. and international revenue for the full year, and we expect third quarter revenue will represent approximately 55% of our second half revenue. Now let me turn to our second quarter financial performance on Slide 10. As I just mentioned, revenue was $145 million in the quarter, up 2% from the prior year. Cost of sales for the quarter was $93 million, a 22% decrease compared to the prior year, primarily driven by lower unutilized manufacturing capacity costs as we continue to improve our manufacturing efficiency. R&D expenses for the quarter were $651 million, a 7% decrease compared to last year. The decline was driven by lower clinical development costs following the wind down of several late-stage programs. SG&A expenses for the quarter were $216 million, down 6% from last year, reflecting continued cost discipline across the organization.

Jamey Mock
Jamey Mock
CFO at Moderna

Our income tax provision was immaterial in both periods as we continue to maintain a global valuation allowance, which limits our ability to recognize tax benefits from losses. Net loss for the quarter was $782 million, improving by $43 million or 5% compared to last year. Loss per share was $1.97 for the quarter compared to $2.13 last year. We ended the quarter with cash and investments of $6.9 billion compared to $7.5 billion at the end of the first quarter. The decrease primarily reflected cash used to fund operations as we continued to invest in R&D and advance our pipeline. In July, we paid $950 million related to the litigation settlement announced earlier this year, which will be reflected in our third quarter cash balance. Now let's turn to our financial framework for 2026.

Jamey Mock
Jamey Mock
CFO at Moderna

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

Jamey Mock
Jamey Mock
CFO at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

Finally, mCOMBRIAX is now approved in the European Union and is under review in Canada, Australia, and most recently, Japan. In the U.S., we are awaiting approval of our standalone flu vaccine before seeking further guidance from the FDA on next steps for refiling the combo here. Slide 15 highlights the emerging real-world evidence supporting mNEXSPIKE's clinical profile. As a reminder, during its first season on the market in 2025-2026, mNEXSPIKE captured approximately 24% of the total U.S. retail COVID vaccine market. Uptake was particularly strong among older adults, with mNEXSPIKE accounting for approximately 34% of the retail market among individuals aged 65 and older. This market uptake was supported in part by the phase III head-to-head data of mNEXSPIKE versus SPIKEVAX. The subsequent real-world analysis evaluated adjusted vaccine effectiveness against hospitalization with documented COVID-19 during the 2025-2026 season.

Stephen Hoge
Stephen Hoge
President at Moderna

Among adults aged 65 and older, vaccine effectiveness was approximately 59% for mNEXSPIKE compared with a matched unvaccinated cohort. Among adults aged 75 and older, it was approximately 67%. These estimates were numerically higher than those observed for a competitor vaccine in separately matched analysis. While this real-world study was not designed as a head-to-head comparison, the numerical differences are encouraging, particularly when considered alongside the vaccine efficacy observed for mNEXSPIKE versus SPIKEVAX in the phase III head-to-head trial. Taken together, the strong initial market uptake and the emerging real-world evidence highlight mNEXSPIKE's potential, particularly among older adults. Turning now to our late-stage infectious disease pipeline, and starting with flu, we are grateful for the unanimous VRBPAC recommendation for mRNA-1010 and look forward to the potential for approval with the PDUFA date of August 5th in the U.S.

Stephen Hoge
Stephen Hoge
President at Moderna

mRNA-1010 is also under review in the European Union, Canada, and Australia. The efficacy and safety results from our phase III study were recently published in The New England Journal of Medicine. A link to the publication is included at the bottom of the slide. For our norovirus vaccine, mRNA-1403, the phase III study did not meet the statistical criteria for early success at its interim analysis. The study remains blinded as we now prepare to enroll an additional fourth cohort. With that, I will now turn the call over to David, who will provide a more detailed update on our oncology and rare disease pipelines.

David Berman
David Berman
Chief Development Officer at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

I'm pleased to report that dosing has now begun with mRNA-4200 alongside the ongoing evaluation of mRNA-4106. mRNA-4194 has entered clinical development, with dosing now underway in a phase I-II study in individuals with Lynch syndrome. This program is designed to evaluate the potential of our technology in an earlier cancer interception setting. Our T-cell engager, mRNA-2808, also continues to advance in a phase I-II study in multiple myeloma, with patients actively dosing. Finally, in collaboration with Immatics, dosing continues in the phase I study of mRNA-4203 in combination with the anzu-cel cell therapy. These programs demonstrate the breadth of our oncology pipeline and the continued progress we are making across several distinct therapeutic approaches. Moving now to Slide 20.

David Berman
David Berman
Chief Development Officer at Moderna

In rare diseases, our propionic acidemia, or PA program, is fully enrolled in its registrational study, and we expect data from the study in 2026. For our methylmalonic acidemia, or MMA program, as mentioned last quarter, we have deferred our decision on a pivotal trial until the PA readout. With this review, I will now hand it over to Stéphane.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Operator

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

Salveen Richter
Salveen Richter
Analyst at Goldman Sachs

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

David Berman
David Berman
Chief Development Officer at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

Number 2, are we confident that the mechanism that we see can be validated? I think with regard to that, the data that we've shown at ASCO confirms that when we give the neoantigen vaccine, we do see neoantigen-specific T cells, and we know those T cells can kill the tumor. I think that we have moved to other tumors where checkpoints do work, and we know that this mechanism that I just talked about is the mechanism by which other checkpoints do work. Since checkpoints work in lung cancer and bladder, I think that gives us increased reason to believe in bladder. I think the big question comes out in tumors where checkpoints don't work, and that's pancreatic cancer and to a lesser degree, gastric. That's why we're conducting phase II trials and phase I expanded trials in those other tumors.

Stephen Hoge
Stephen Hoge
President at Moderna

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

Salveen Richter
Salveen Richter
Analyst at Goldman Sachs

Thank you.

Operator

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

Tyler Van Buren
Tyler Van Buren
Analyst at TD Cowen

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

David Berman
David Berman
Chief Development Officer at Moderna

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

Tyler Van Buren
Tyler Van Buren
Analyst at TD Cowen

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Operator

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

Ellie Merle
Ellie Merle
Analyst at Barclays

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

Ellie Merle
Ellie Merle
Analyst at Barclays

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

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

Ellie Merle
Ellie Merle
Analyst at Barclays

Great. Thanks.

Operator

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

Terence Flynn
Terence Flynn
Analyst at Morgan Stanley

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Operator

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

Cory Kasimov
Cory Kasimov
Analyst at Evercore ISI

Hey, good morning, guys. Thanks for taking the question. Wanted to also ask on intismeran, but on the RCC front. Can you speak to the immunogenicity data that you have, and it gives you confidence that intismeran works as well in low TMB RCC as what you've seen so far in melanoma and Non-Small Cell Lung Cancer? Thank you.

David Berman
David Berman
Chief Development Officer at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Cory Kasimov
Cory Kasimov
Analyst at Evercore ISI

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Cory Kasimov
Cory Kasimov
Analyst at Evercore ISI

Got it. Thank you.

Operator

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

Andrew Tsai
Andrew Tsai
Analyst at Jefferies

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

David Berman
David Berman
Chief Development Officer at Moderna

Thank you, Andrew. Horizon 2, I'm glad you picked up on that. 4359, which is the IDO PD-1, is a very interesting program. There was proof of confidence from a randomized study from another company, which was very interesting. For us, we saw very intriguing data, which we showed last year, and we had a follow-up first line data set earlier this year. What we're doing now in the ongoing phase II expansion is to confirm that signal. Is the signal that we saw real, and is there a path forward based on that signal? I think I don't want to get ahead of whether it's pivotal or not. I think let's first confirm the signal, and identify what is the best opportunity in melanoma. Is it to go first line or is it to go second line plus?

David Berman
David Berman
Chief Development Officer at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

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

David Berman
David Berman
Chief Development Officer at Moderna

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

Andrew Tsai
Andrew Tsai
Analyst at Jefferies

Thank you.

Operator

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

Courtney Breen
Courtney Breen
Analyst at Bernstein

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

Courtney Breen
Courtney Breen
Analyst at Bernstein

Can you just help us understand what are the top priorities for the Chief Commercial Officer over the next six months, and what might be the changes or the evolution required longer term in the commercial structure to support this evolving business?

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Thank you, Stephen. Morning, Courtney. In term of context, as we talked about in the press release when we announced the position of Ester. If you look at the business, as you know, we have three products on the market today. We have, since the spring, a fourth product approved in mCOMBRIAX, the Flu COVID combo, which we are preparing the launch for 2027. Potentially a fifth product approved in H2, which of course flu, as we talked about before. As you can see, what is just in front of us is a very large growing ID pipeline of product. The other piece also as you know is Europe. As you know, we have not been able to participate in the European market because of an exclusive partnership that the EU set up during the pandemic. This partnership expires, as we've said before, in 2026.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

We already see Europe as a very important growth driver for us. As you know in Europe, the markets are all very different. There's a lot of complexity there. Of course, there is INT. As we said, we expect the phase III data potentially in the second half of the year, given on the trend. As you can imagine, Moderna and our Merck colleague have been very active. Stephen talked about manufacturing a minute ago, but they have been very active on the commercial side of the house in term of medical affairs, marketing, commercial. That's another piece where Ester is also going to be helping and leading, working hand in hand with Merck. Of course, there's also rare disease with PA, as you know. We've said PA because it's a time-driven phase III.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

We should have a data this year. Of course, its partners will recall our team, but we're going to be, of course, working with a partner to ensure a great launch. If you look at the next few years, as Stephen had the good slide earlier in the presentation, looking at the geographic expansion, including also in Asia and Latin America, the product expansion. There's a lot to do. As we are gearing for the growth stage of a company coming ahead of us, we feel that this role was important. Also the new role for Stephen, who is really overseeing ID, INT, and rare from a kind of general management to make sure that all the functions are integrated together. It's just us getting ready for the next stage of growth for company. That's exciting.

Operator

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

Michael Yee
Michael Yee
Analyst at UBS

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

Michael Yee
Michael Yee
Analyst at UBS

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

David Berman
David Berman
Chief Development Officer at Moderna

Hey, Michael. We're not going to disclose anything on the statistical analysis plan, but I do think there is maybe two key points to highlight. The first is if you remember back to the phase II study, of course updated ASCO

David Berman
David Berman
Chief Development Officer at Moderna

There was, as you said, somewhat of a non-proportional hazard with about 12 months for really strong separation to occur. The good news in the phase III study, which was designed with Merck, who has a lot of expertise in melanoma, is that it requires also a minimum of 18 months follow-up. Every patient has been followed way beyond where there was before or after the separation occurred. I think that with regard to that gives us increased confidence. Stephen, the second question?

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Stephen Hoge
Stephen Hoge
President at Moderna

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

Michael Yee
Michael Yee
Analyst at UBS

Thank you, guys.

Operator

Our next question comes from Geoff Meacham with Citigroup. Your line is open.

Geoff Meacham
Geoff Meacham
Analyst at Citigroup

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

Jamey Mock
Jamey Mock
CFO at Moderna

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

Jamey Mock
Jamey Mock
CFO at Moderna

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

Jamey Mock
Jamey Mock
CFO at Moderna

If you just think about the second half in terms of broad pictures, and I kind of said this on the last call, is in the second half international, last year we had no U.K. volume and not some of the strategic partnerships volume. This year, we will supply some of the strategic partnerships that we have, and it's quite material. That's basically the upside that is offsetting the provision that we put into the U.S. in terms of vaccination rate decline. For the most part, we're really confident we've got a substantial growth through the first half here. If we are flat to last year with international growing and offsetting the U.S. decline, then we should be above our 10% guidance.

Jamey Mock
Jamey Mock
CFO at Moderna

The biggest variable at this point is just what is the size of the U.S. market.

David Berman
David Berman
Chief Development Officer at Moderna

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

Geoff Meacham
Geoff Meacham
Analyst at Citigroup

Great. Thanks, guys.

Operator

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

Myles Minter
Myles Minter
Analyst at William Blair

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

David Berman
David Berman
Chief Development Officer at Moderna

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

Myles Minter
Myles Minter
Analyst at William Blair

No worries. Appreciate the response. Thanks.

Operator

One moment for our next question. The last question comes from Jessica Fye of J.P. Morgan. Your line is open.

Jessica Fye
Jessica Fye
Analyst at J.P. Morgan

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

David Berman
David Berman
Chief Development Officer at Moderna

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

Jessica Fye
Jessica Fye
Analyst at J.P. Morgan

Thank you.

Operator

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

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

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

Operator

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

Executives
    • Lavina Talukdar
      Lavina Talukdar
      SVP and Head of Investor Relations
    • Stéphane Bancel
      Stéphane Bancel
      CEO
    • Jamey Mock
      Jamey Mock
      CFO
    • Stephen Hoge
      Stephen Hoge
      President
    • David Berman
      David Berman
      Chief Development Officer
Analysts
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