Moderna Inc (MRNA) — Q2 2025 Earnings Call Transcript

Thank you, Kevin. Good morning, and good afternoon, everyone. Thank you for joining today's call to discuss Moderna's Second Quarter 2025 Financial Results and Business Update. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stéphane Bancel, Chief Executive Officer; Stephen Hoge, our President; and James Mock, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please see Slide 2 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. With that, I'll now turn it over to Stéphane.

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us today. I will start with a quick review of Q2. Jamey will present our financial results and outlook. Stephen will review our clinical programs, and then I will come back and share our key priorities and catalysts before we take your questions. Let me start with a review of our financials. In the second quarter, our revenues of $2.1 billion and a loss of $0.8 billion were in line with our expectations, and they reflect the highly seasonal nature of our respiratory vaccine business. We ended the quarter with $7.5 billion in cash and investments. We remain highly focused on financial discipline. I'm very pleased to announce that continued cost reduction efforts across the company in the second quarter of 2025 led to a 35% reduction of cost of sales and the SG&A combined compared to the second quarter of 2024. As you know, we are very focused on cash costs, and I'm happy to report that on a cash cost basis, we reduced operating expenses by $581 million in Q2 2025 versus Q2 2024, which is a 40% reduction year-over-year. During the quarter, we made solid progress across our 3 strategic priorities: Priority 1, driving use of our commercial products. We made strong progress in securing 3 approvals from the U.S. FDA. On May 31, we were very pleased to announce the FDA approval of mNEXSPIKE, our next-generation COVID vaccine that has shown even higher efficacy than our prior Spikevax vaccine. In mid-June, we received FDA approval of our mRESVIA vaccine for high-risk individuals aged 18 to 59. As a reminder, we are also approved for adults 60 and older in the U.S. and in 38 other countries. And in July, the FDA granted full approval of our Spikevax COVID vaccine for high-risk children aged 6 months through 11 years. This vaccine has previously been used under EUA. These approvals support our broader goal of driving use of our commercial products and driving the company back into sales growth. On our second priority, advancing our pipeline to drive sales growth. We are very happy to announce positive and strong Phase III efficacy data for flu, which we believe will advance both our flu program and our flu plus COVID combination program. Stephen will discuss these results shortly. And our third priority, executing with financial discipline. The second quarter of 2025 marked the fourth consecutive quarter we have reduced combined R&D and SG&A expenses by double digits year-over-year. Additionally, in the second quarter, we expanded our cost reduction plan well beyond what we announced in the first quarter. We estimate that these measures will take an additional $400 million out of the 2025 cost structure we previously laid out. This cost reduction includes a very difficult decision that we announced yesterday to reduce headcount by around 10% to better align Moderna's cost structure and capabilities with current business conditions while also sustaining investments in our mRNA pipeline. This decision was obviously not made lightly. It impacts people who have dedicated themselves to our mission, teammates and friends who have built Moderna. I want to express on behalf of the entire executive committee, our deepest thanks to all of those affected for what they have contributed to the company. These colleagues will always be part of the Moderna story. Finally, before I hand it to Jamey, you may have seen that in the last couple of hours, the U.K. Court of Appeal issued its decision. The court has decided to uphold the high court's finding that Moderna's EP'949 patent is valid and infringed by Pfizer and BioNTech. Moderna will continue to pursue and enforce its patent rights globally to protect its innovative mRNA technology. Jamey?

Thanks, Stéphane, and hello, everyone. Today, I'll discuss our second quarter financial results, our updated outlook for full-year 2025, and our strategy to meet our operating cost targets for 2027. Let's start with the second quarter financial results. Net product sales reached $114 million, primarily due to COVID vaccine sales. The U.S. represented about 80% of sales this quarter, with the rest coming from international markets. Although product sales fell 38% compared to the second quarter of 2024, they slightly exceeded our expectations because of a stronger-than-anticipated U.S. spring booster season. We also generated $28 million in other revenue, bringing the total revenue for the quarter to $142 million. The decline in other revenue compared to last year was mainly from a $30 million upfront licensing payment recognized in the same quarter last year. The cost of sales for this quarter was $119 million, relatively unchanged from $115 million last year. This amounted to 105% of net product sales this quarter, up from 62% the previous year, mainly due to lower volume. Research and development expenses were $700 million in the second quarter, reflecting a 43% decrease from last year. This decrease was mainly due to the winding down of our respiratory trials and reduced clinical manufacturing costs. We also experienced reductions in preclinical and external service costs, which are part of our ongoing portfolio prioritization and productivity efforts. Last year's results included an expense for a priority review voucher. Selling, general, and administrative expenses were $230 million for the quarter, down 14% year-over-year, reflecting widespread cost reductions in external services, personnel, and commercial activities as we streamline operations and manage expenses carefully. Our income tax provision for the quarter was minimal, consistent with the previous year. We maintain a global valuation allowance against most of our deferred tax assets, limiting our ability to recognize tax benefits for the quarter. The net loss for the quarter was $825 million, improving by $454 million from a $1.3 billion loss in the second quarter of 2024. Loss per share was $2.13, an improvement from a loss of $3.33 in 2024. We ended Q2 with cash and investments totaling $7.5 billion, down from $8.4 billion at the end of Q1, due mainly to the operating loss this quarter. Moving to our 2025 financial framework, we are updating our projected revenue range for 2025 to $1.5 billion to $2.2 billion, reflecting a $300 million reduction at the high end due to a timing shift of U.K. COVID shipments from the latter half of 2025 to the first quarter of 2026. This timing shift is based on the government's use of their fiscal year minimum product purchase for the spring campaign in 2026. Importantly, this shift does not affect the total value of our long-term contract with the U.K. government. Our updated revenue range also reflects uncertainties regarding vaccination rates, the competitive market scenario, the size of the RSV market, and the licensure and product approval timelines in Australia and Canada. Geographically, we are forecasting U.S. product sales of $1.0 billion to $1.5 billion, international product sales of $0.4 billion to $0.6 billion, and other revenues of about $100 million, mostly from international sources. For U.S. product sales, the high end assumes performance consistent with last year, adjusting for a $200 million prior period return reserve reversal. The low end takes into account potential impacts from lower vaccination rates and market competition. For international product sales, the low end comes primarily from secured contracts, while the high end includes projected revenue from active tenders. This range considers the shipment timing shift from the U.K. The other revenues of $100 million include $50 million already recognized in the first half of the year, with an expectation of a similar amount in the second half. Most of this revenue relates to our new manufacturing sites, as well as some grant, collaboration, licensing, and royalty revenue. The distribution of our revenue between Q3 and Q4 will depend on the timing of regulatory approvals and the shipping days available in the third quarter. We expect a revenue split of 40% to 50% in Q3, with the remainder in Q4. Our cost of sales estimate of $1.2 billion remains unchanged, reflecting year-over-year efficiency improvements in manufacturing, offset by rising costs linked to new international manufacturing sites. Newly introduced tariffs are not anticipated to materially impact our cost of sales as we keep an eye on global tariff changes. We are reducing our R&D expense forecast from $4.1 billion to a range of $3.6 billion to $3.8 billion due to winding down Phase III trials and ongoing portfolio prioritization and productivity efforts. We anticipate an increase in R&D costs in the second half of the year, influenced by vaccine spending seasonality and studies supporting regulatory approvals. SG&A expenses are still expected to be $1.1 billion, with a rise anticipated in the latter half of the year primarily due to commercial activities and severance charges from the announced workforce reduction. We expect taxes to be minimal in 2025. We have reduced our capital expenditures forecast from $400 million to $300 million owing to continued prioritization and efficiency gains. We still anticipate ending 2025 with around $6 billion in cash and investments. As previously mentioned, we are planning to reduce annual GAAP operating expenses by more than $6 billion, from $11 billion in 2023 to $5 billion or below in 2027. On a cash cost basis, excluding stock-based compensation, depreciation, and amortization, we are lowering annual operating expenses from $8.9 billion in 2023 to our midpoint target of $4.2 billion in 2027, a reduction of over 50%. Our revised 2025 GAAP operating expense range is now set at $5.9 billion to $6.1 billion, reflecting a $400 million reduction from our previous guidance. This updated guidance keeps us on track to realize the initial $5 billion of our overall $6 billion reduction in annual GAAP expenses within two years. Our updated 2025 guidance includes $0.9 billion in noncash expenses, with cash costs now projected at approximately $5.1 billion. The strong progress in cost reductions has been a broad company-wide initiative, and while we continue to seek additional cuts, the primary future reductions will derive from R&D, which makes up over 60% of our cost structure. On the next slide, I will detail our strategy to achieve our 2027 operating expense targets. The midpoints of our ranges target a $1.1 billion reduction in GAAP costs and a $900 million reduction in cash costs by 2027. Key drivers include reducing R&D expenses through completing large Phase III trials and continued manufacturing efficiencies. We've made significant strides in optimizing our COVID vaccine manufacturing footprint and expect further savings via process enhancements. Additionally, we aim to generate procurement savings, with ongoing renegotiations expected to yield benefits. Lastly, our workforce restructuring, affecting about 10% of employees, will further lower our workforce. While these decisions are difficult, they are essential for aligning our capabilities with our long-term cost structure. In summary, the team has made remarkable strides toward our $5 billion cash cost reduction plan. By the close of 2025, we will have removed nearly $4 billion in costs, with an actionable plan to eliminate another $1 billion in the next two years, reinforcing our commitment to break even on a cash cost basis by 2028 and adjusting expenditures as needed. I will now hand the call over to Stephen.

Thank you, Jamey, and good morning or good afternoon, everyone. Today, I'll review progress across our pipeline. Slide 12 is a review of our prioritized pipeline. As Stéphane stated earlier, we have announced significant updates for many of these programs, including the recent approval for mNEXSPIKE, an expanded label for mRESVIA and approval of our pediatric Spikevax COVID vaccine, which was previously available in the United States under an emergency use authorization. In the quarter, we also reported strong vaccine efficacy results from our Phase III seasonal flu trial, and we continue to make progress in the rest of the prioritized portfolio, where we are targeting a total of 8 additional potential filings through 2028. Moving to Slide 13, which outlines the latest developments of our late-stage respiratory portfolio. I'll start with our COVID vaccine, Spikevax and mNEXSPIKE. As mentioned earlier, we are very pleased with the FDA's approval of the mNEXSPIKE, our next-generation COVID vaccine, which has shown strong relative vaccine efficacy compared to Spikevax in its Phase III trial, including in the 65 and older age subgroup and in those with risk factors for severe COVID-19. mNEXSPIKE was approved in the U.S. for individuals 65 and older and for people, 12 to 64 with at least 1 risk factor. An extensive analysis of the Phase III clinical data for mNEXSPIKE was published last month in The Lancet and the link to the publication can be found on this slide. We submitted the annual updates for our COVID-19 vaccines for the currently recommended LP.8.1 strain in the quarter and expect mNEXSPIKE and Spikevax will be available this fall in the United States. Speaking of Spikevax, the vaccine was recently approved by the FDA for high-risk children ages 6 months to 11 years. Spikevax had previously been available to this age group in the U.S. only under an emergency use authorization. Earlier this week, Spikevax also received EMA approval for the current season update LP.8.1 strain update for the coming season. For RSV, our mRESVIA vaccine was approved by the FDA on June 12 for individuals ages 18 to 59 with at least 1 risk factor. The CDC subsequently adopted the ACIP recommendation for the 50- to 59-year-old age cohort in this group, which means that recommendations for our vaccine are now consistent with competitors. For our seasonal flu vaccine, we announced positive results from our Phase III efficacy study. We are very pleased with the results, which I'll talk through on the next slide. We expect these flu results will also support our discussions with regulators about our flu plus COVID combination vaccine, and we have begun consultations with regulators on the submission requirements for both vaccines. On Slide 14, I will discuss the very encouraging P304 flu vaccine efficacy data released during the quarter. In this 40,000-person study conducted across 11 countries, our seasonal flu vaccine, mRNA-1010, demonstrated relative vaccine efficacy that was 26.6% higher than the licensed standard dose comparator in adults aged 50 and above. Safety and tolerability of mRNA-1010 were consistent with previously reported Phase III results, and the majority of solicited adverse reactions were mild. Importantly, strong relative vaccine efficacy was observed for all 3 influenza strains contained in the vaccine, including H1N1, H3N2, and the B/Victoria strain. Likewise, the relative vaccine efficacy was consistently strong across age groups, risk factors, and previous vaccination status. In the important 65 and older demographic, relative vaccine efficacy was a strong 27.4%. We look forward to presenting these data at an upcoming medical conference, and we are preparing to file for FDA approval for this vaccine. Now turning to our non-respiratory vaccine and rare disease portfolios. In our Phase III CMV efficacy study for mRNA-1647, we have now accrued sufficient primary endpoint cases for the final analysis. The analysis has not yet been conducted, and the company remains fully blinded at this time. We've submitted an amendment to the analysis plan to add important powered secondary endpoints that we hope will increase the scientific value of the results. Once the updated analysis plan is formalized, we will proceed with the analysis of primary and secondary endpoints, which we expect to complete in the fall. Our Phase III norovirus study is now accruing cases in its first season; as with other studies, the interim analysis of efficacy is dependent on case accrual. And depending upon the rate of case accrual, the study has been designed so that it may proceed to a second season of enrollment if necessary. In rare diseases, our propionic acidemia or PA program is currently in a registrational study, and we believe we are on track for a potential 2027 approval. For methylmalonic acidemia, or MMA, we plan to initiate the registrational trial this year. We continue to advance our oncology portfolio, with significant progress across our individualized neoantigen therapy, known as intismeran, mRNA-4359 previously called Checkpoint, and our early-stage oncology pipeline. In collaboration with Merck, we have several late-stage studies underway for intismeran. As a reminder, the Phase III trial in adjuvant melanoma is fully enrolled and accruing cases towards its interim analysis. Our Phase II adjuvant renal cell carcinoma trial is fully enrolled as well. And as we have disclosed previously, we have 2 Phase III studies in non-small cell lung cancer, one Phase II study in high-risk muscle-invasive bladder cancer, and one Phase II study in high-risk non-muscle invasive bladder cancer. We have also expanded our intismeran program into a Phase II study in first-line metastatic melanoma. This could be the first of many studies using intismeran and KEYTRUDA together in metastatic indications. Following on from intismeran, mRNA-4359 is now in a Phase II study in first-line metastatic melanoma and first-line metastatic non-small cell lung cancer, and we are currently enrolling patients in the lung cancer portion of that study. We are pleased that the data from the Phase Ib study of mRNA-4359 plus KEYTRUDA in checkpoint inhibitor refractory PD-L1 positive patients was accepted as a mini oral presentation at ESMO. We look forward to presenting these findings at the meeting in October. In early-stage oncology, we are also dosing patients in our Phase I tumor-targeted antigen therapy, mRNA-4106. The INDs for our cell therapy enhancing engine therapy, mRNA-4203, and our T cell engager, mRNA-2808, are also now both open. We are pleased by our growing oncology pipeline and the continued strong momentum of the large intismeran clinical trial program in partnership with Merck. With that, I'll hand over to Stéphane.

Thank you, Stephen and Jamey. As you know, we have 3 priorities: Part 1 drive sales of approved products. Priority 2, focus on our late-stage pipeline where we can drive product growth for approvals, and priority 3, delivering on our cost efficiency across the company. Our first priorities will drive use of mNEXSPIKE, Spikevax, and mRESVIA vaccines. We entered the third quarter of 2025 with 3 approved products in the U.S., and we are seeing a growing number of approvals in countries worldwide. For priority 2, we are focused on delivering up to 10 products approval, which we believe will drive sales growth for the company. Together, these 10 anticipated products target an addressable market that is over $30 billion. In Q2, we secured U.S. approvals for mNEXSPIKE and mRESVIA for high-risk people, and we had exciting data in flu, enabling flu and flu COVID combo. On the cost side of the house, we've demonstrated our commitment to cost discipline for reduction achieved in last year in 2024 and also in 2025 to date. We remain confident in our ability to further streamline our operational structure for the remaining of '25 to 2027. Jamey just took you through our plans to cut an additional $400 million of our 2025 cost structure, and we are not done. We have many new projects in the works to reduce cost further. These cost reduction activities we have in place gives us even greater confidence in our plan to reduce our cash cost to $4.2 billion in 2027. These actions are very important to help us achieve our cash breakeven targets in 2028. As we make these cost improvements, we are seeing continued use of AI across Moderna. We rolled out GPT Enterprise in 2024 and established widespread GPT literacy across the entire organization. Today, 100% of our knowledge workers are active daily users of ChatGPT. As you can see on Slide 22, GPT users have grown very fast at the company. And in 2025, we enhanced AI tools to allow for deep research capabilities allowing for the creation of comprehensive reports without compromised quality of output. An example of a deep research application is the creation of target product profiles. This AI-based activity greatly reduces the amount of time it takes our product planners to create marketing strategies. We're excited about how AI has already improved our business. And given the doubling of AI capabilities every 6 to 7 months, we are working hard to continue to reinvent our company across each business process, department, and team. We're excited about the coming months and quarters as we have a lot of important catalysts. First, of course, the potential approvals of seasonal flu and the flu plus COVID combo programs based on the data Stephen shared with you. We're also eager to get the CMV Phase III efficacy data later this year. Norovirus Phase III readout is, of course, subject to case accruals. In oncology, we look forward to the readout of our ongoing intismeran Phase II 5-year durability data in adjuvant melanoma. And of course, we look forward to a Phase III adjuvant melanoma trial readout for Intismeran. Stephen said, in oncology, we are looking forward to sharing the checkpoint Phase Ib data at ESMO in Berlin in October. And at a later date, we look forward to sharing the Phase II data of this program. PA is already in the registration study and MMA will be very soon. I'm pleased with the progress we have made on all 3 of our priorities over the course of the first 6 months of the year. We now have 3 products approved by the U.S. FDA. We are highly encouraged about the progress in the pipeline and very pleased by flu. And on financial discipline, we have accelerated our plan for cost efficiency and expect to deliver an additional $400 million of cost savings this year. I want to thank the team for all the great work that was done this quarter. We are very focused on executing those priorities going forward. This work allows us to focus on our mission to deliver the greatest possible impact to people for mRNA medicine. With this, operator, we'll be happy to take questions.

I was wondering if you could put the changes to CMV in context for us and just help us understand the rationale behind the addition of the secondary endpoints and then secondly, as we look to the individualized neoantigen therapy, and I know we're going to data at ESMO. Could you help us understand the cadence of data reads over maybe the next 12 months or so as we look to some of the other programs to mature?

Thank you, Salveen. So first on CMV secondary endpoints. Obviously, we're pleased to now have sufficient primary endpoint cases, which, as you know, were based on primary prevention of infection in immunogenicity endpoints, so antibodies against antigens not the vaccine. But there's a lot of other data that will help inform the potential value of a CMV vaccine, including looking at things like the presence of the virus in bodily fluids and/or other markers or measures of infection that could be quite relevant for the use of the CMV vaccine across a wider range of populations, including even in the congenital CMV space. Given that this is now the final analysis and as we've accrued a large number of cases and a lot of data, including against some of those secondary potential endpoints, we want to make sure that we reflected those in the final analysis plan as we hope that we will see a positive primary endpoint and also get the benefit of some of those secondary powered endpoints in the totality of data that would come out of the study. I'll just remind you again that the best approach for doing this is while we are completely blinded. So the company does not know the results on the primary or any of the secondary. We are just making sure to protect the integrity of the study that we update the statistical analysis plan and receive approvals for it prior to initiating that analysis with an unblinded team at which point we would then become unblinded the results after the DSMB. And so this is just making sure we're protecting the integrity of the study. And we think it's a prudent decision to take a little bit of time here to update all those documents prior to conducting the analysis. Really looking forward to that result in the fall. As it relates to the cadence of results on intismeran, we're fully enrolled in the Phase III, as we noted, for the confirmatory study in melanoma we are accruing events. We continue to hope that we will be able to have a successful interim analysis for efficacy on that study on the timelines we previously mentioned. We have a number of other studies that are randomized. Actually, all of the Phase III and Phase II studies are randomized controlled studies. And several of those could read out similarly in the near term, including the studies in bladder cancer, particularly those that are largely enrolled as well as renal cell carcinoma. So those are event driven. And so as is always the case for event-driven studies, it's hard for us to predict exactly when we'll have sufficient data to conduct those interim analyses. But I do believe that in the coming year or 2, there will be a consistent cadence of results from these randomized studies that will come out. Hopefully first with a successful Phase III adjuvant melanoma study, but really soon thereafter with some of these Phase IIs and then moving into the lung cancer space.

Can you discuss how we should think about pricing for the COVID vaccine in the U.S. this year? And what your expectations are for the net price? Or I guess, how pricing this year would compare versus last year? And any takeaways from your contracting discussions so far?

Thanks, Ellie. Yes. So what I'd say is in the U.S., we've given a range of $1 billion to $1.5 billion. And as I mentioned in my prepared remarks, we put in variability for competitive pressures, which gets into contracting and pricing, to your point, to your question as well as vaccination rates. First on vaccination rates, if you look at the first half, as I mentioned, when we look at the spring booster, it was down roughly 10% or 11%. So that makes us feel good. It's a smaller sample size. But as we go into the second half, it's the only barometer we have heading into the second half. As it pertains to pricing and contracting. Contracting is basically complete now. So we will look to the second half and pricing is also completed there. We're also looking at mNEXSPIKE in there as well. I would say just right now, all those factors are within the range, and we have confidence within that range. So I don't really want to be specific on pricing or our share at this point, but it's factored into our range, and we feel confident in it.

Appreciate the opportunity for 2 questions. One is on CMV. I just wanted to follow up for Stephen. And maybe just talk to expectations about what you guys think is a positive readout, both on VE, but also what is a good readout on the secondary endpoint that would help payers or patients or clinicians think about the value of CMV given this novel type of vaccine for patients? And then second, obviously, there has been various changes within FDA and CBER and within the ACIP, I just wanted to understand if you think that the dialogue remains very positive? And how are you expect things going forward?

Great. Thank you, Michael, for both. So first, on the CMV results, we powered the study, and as we've said, we believe the product will have an impact if the vaccine efficacy in the primary endpoint is better than 49.1%. That was a lower bound acceptability threshold for the primary analysis against preventive infection. That's because you might say, well, 49% or 50% is that a substantial benefit. If you think of all of the burden of disease associated with CMV over a lifetime, a 50% reduction in that would be a pretty profound benefit, we believe, on public health and for individuals. There is complexity in terms of the individual indications because prevention of infection is one thing, but there's going to be a need to demonstrate value. Some of that will be demonstrated post-approval with some of the real-world evidence generation studies that always happen around vaccines. But we wanted to maximize the value we get of secondary endpoints in this study because we have such a rich study of information. And those include looking at things that you might think of as the persistence of virus in the blood or in the urine, the shedding, and whether or not you were able to control that latent infection. I'll remind you that in their EBV vaccine Phase I study, which we shared previously a year ago, we were able to show quite strong impacts on the rates of virus, the presence of the virus over time in patients that were EBV-positive who received our EBV vaccine, a different program, but shows the level of control that we were excited to see in that program. If we saw something similar here in CMV, we think that would speak to the potential benefit about the risk of congenital transmission from, let's say, a pregnant mother who's becoming infected to her unborn child, as well as other potential benefits related to the chronic health issues that can come from CMV. Obviously, for those, we don't have a prespecified hypothesis in the primary endpoint but we would love to see efficacy as good or better than what we're seeing in the primary of 49%. So 49% feels good for us, that's where we designed the study, and we are looking forward to it. Obviously, we hope to do better than that. But we will ultimately look to the totality of the data to understand the value of the product and given the burden of CMV in health systems and for individuals. We're quite hopeful that we'll be able to demonstrate that value quite quickly, including out of this Phase III study with the new secondary endpoints. As it relates to the CBER changes and some of the ACIP changes, I'll just say that we continue to work closely with our review teams across all of our products. We are very grateful for the 3 approvals that happened in the last quarter. I will note that they happened on time, and that was through the obviously, the incredibly diligent work of the folks at FDA to conduct those reviews in a rigorous way, and we continue to feel that those productive dialogues are going on now even on our existing files for the seasonal update. We will always make sure that we provide prompt and fully transparent answers to the agency and work closely with them so that they can conduct that work and we're incredibly grateful for that, as well as CDC and ACIP, where we get questions that they need information on so that they can guide public health, we'll make sure that we provide that information, and we look forward to working with both CDC, ACIP, and FDA and CBER to continue to advance our pipeline and our mission.

This is Greg on for Tyler. Do you have any early indications of what demand for COVID vaccines might look like this upcoming fall and winter season based on interactions with customers? Or will we need to wait to see early uptake at the end of this month or early next month?

Yes. Look, I think first, let's separate outside the U.S. versus inside the U.S. part of that question; I think that that's probably more focused on the U.S. But outside the U.S., many of our government customers are purchasing through advanced purchase agreements. And so those indications are pretty firm. You can see that in our even how we're guiding forward. And so some of those are under advanced purchase agreements. Others are under tenders that have been completed and published in those countries, and that feels quite stable. In the U.S., with customers, what I'd say is we saw a quite solid spring booster campaign. If you look from March 1 forward, the actual volumes in the spring booster campaign in the U.S. were only slightly down from last year. And if you actually look at the 65-plus population, which is the core population, we think, going forward, given the new labels and framework for recommendation, it was actually down only 1% or 2% from March 1 to the end of the quarter, June 30, which I think speaks to the realization that those at high risk of severe COVID-19 continue to be compliant with public health recommendations and want to protect themselves even in the spring campaign. That has been the same experience, therefore, of our customers in the retail channel and elsewhere where they have seen that evidence in the last 4 months. And as we look to the fall, we obviously have some uncertainty, both about what the ultimate ACIP recommendation will be, as well as some of the other market uncertainties that exist. But we all want to be prepared to deliver a season that could be in line with prior seasons if the trends continue from the spring till now. So we're going to remain cautiously optimistic. Certainly, our customers are preparing to make sure they have vaccines available if their customers and patients show up, and the early signs are encouraging, but we need to be careful going into the fall. We think we really won't know until the end of the third quarter, until the end of September. As is always the case, for our seasonal business, which is we'll really get a clear picture in the first 6 weeks of the season as we launch.

This is Charlie on for Geoffrey. 2 real quick questions. You mentioned additional cost-cutting areas that you could target. You noted that R&D is a primary driver of costs right now. How might you balance the need to bring later-stage infectious products to market and also the need to shift away from seasonality factors that current products have? And then second, on CMV, did these secondary endpoints, the decision to add them come on the back of interactions or discussions from FDA? Some color on that would be really helpful.

Thanks, Charlie. So I think the first question was on how are we balancing our late-stage pipeline. I mean we still think we are investing quite a bit in our late-stage pipeline. So $3.6 billion to $3.8 billion is still significant, particularly, we are very conscious of where we are from a revenue standpoint. And we've made this decision and really stood by it for the last 2 years. We laid this out in 2023 that we were going to invest in our late-stage pipeline, we continue to do that. We are actively adjusting as we go, and we will continue to adjust as we go. And that's why we're taking our cash costs from $9 billion down to $4 billion. But at the end of the day, you also mentioned seasonality. We think we are building a diversified portfolio that is not just seasonal. We do want to complete the respiratory portfolio that will be stronger when we have all the products together and give us more ability to compete. But then when you look at CMV, our oncology pipeline, and our rare disease pipeline, those aren't as seasonal. And so we believe that we are balancing both the need to complete the respiratory portfolio, invest in our late-stage pipeline, and invest in diversification in the company. And we've been doing that for the last 2 years, and we'll continue to do it, but we have had to adjust it down. So we did have greater ambitions, but we will continue to adjust and have adjusted, and I think that's what we're seeing.

And maybe just to add to Jamey's point, we've also said that we will not invest in Phase III studies for new latent vaccines. So as you know, EBV, HSV, and vaccines but we also say that we might be looking for partners, other project financing or pharma partners. And the rare disease, of course, small in terms of dollars. We also said we're going to focus on PA and MMA for now. We'll advance more programs later, but now we need to be financially disciplined. And in oncology, as you know, for intismeran, Merck is paying 50% of the cost, which is why, as Jamey explained, we have discussed this mechanical effect that is based on the strategy we decided to pursue to make sure that we drive back the company to profitability in 2028.

On the CMV question, we remain blinded to the primary and secondary results of the study. The interim analysis from earlier this year focused only on the primary endpoint, as per the study design. Since we did not meet the criteria for early success in that interim analysis, we will proceed to the final analysis, which will provide much more information. The primary endpoint will remain unchanged, and we will continue testing against it. If that is successful, there is an opportunity to pass down the alpha to the powered secondary endpoints, as well as a final chance to assess whether we are gathering all necessary information from the blinded analysis before the unbinding event. Internally, at Moderna, we have successfully collected data throughout the study on a range of potential endpoints and aim to elevate some of those into the secondary endpoint analysis. To do this while blinded, we need to update the statistical analysis plan, which we have consulted with regulators about. We are focused on ensuring this is conducted to the highest gold standard and integrity prior to the analysis, maximizing the benefits of the additional information in the study. We remain blinded and are diligently ensuring this update is accurate, and we look forward to proceeding with that analysis. We initiated this consultation with regulators ourselves. Lastly, I want to emphasize that we still expect this to be completed in 2025. We have the data ready; it’s just a matter of ensuring everything is in order before conducting that analysis this fall.

A couple of pieces that I wanted to just touch on. First, with the INT, it looks like you've added the first-line melanoma in there. How do you think about kind of patients being treated over the course of their disease? You're already kind of hitting them in the early stages of the adjuvant space and now popping up with a new first-line trial for the metastatic space. Could you imagine a world where patients might get kind of an INT twice in the course of their disease state if they were to progress? Or will this be a more narrow patient population in the first line, those that perhaps haven't had it in an earlier stage? The second question that I did want to ask was just in terms of the kind of employee headcount cost-cutting that you have just announced. Can you just add some more context and apologies if I've missed this on kind of where you are focused with kind of removing some of that headcount, are there any places that you're adding to kind of enhance efficiencies? And so just talking about kind of what the ins and outs might look like to get to that new employee headcount.

Thank you. I'll address the INT question first. As you noted, we are focusing on first-line metastatic melanoma. We anticipate a future where melanoma patients receive INTs early in the adjuvant setting. Currently, we are not yet approved for use in that area, and there is still a significant need in frontline metastatic treatment. Your question was about the possibility of us being used in both settings in the future. I believe that is a possibility. It's important to remember that treatment is personalized, based on a biopsy of the tumor when it occurs. It's conceivable that a patient could experience lasting benefits in the adjuvant setting and later face a metastatic event, during which the neoantigens in their tumor may have evolved. Consequently, the INT for frontline treatment would be tailored to reflect the changes in their individual cancer. This scenario envisions a future where patients could receive different versions of their personalized neoantigens therapy throughout their cancer treatment. While this is speculative and may be a long way off, it is certainly possible.

And I'll take the second question on employees, Courtney. If you look at it, basically, there's a few buckets, clearly the manufacturing driven by productivity, whether it's technology productivity or processes or other things we are doing. In R&D, as we talked about a lot and again, this is part of our strategy. We are not investing in new Phase III studies in respiratory. So as those phase out, of course, there are some capacities that we need to kind of resize as you can imagine, and we're not starting new ones. We're not starting later on Phase III. And then G&A is a lot of productivity across the board. So we'll, of course, continue to hire, I think if you check, I think a week ago, there's still around 150 positions on Moderna's website right now. We are hiring as we need to grow the business, to prepare the launches. So of course, this is very important.

This is Adi filling in for Cory. I wanted to inquire further about the decision to initiate the first-line metastatic melanoma trial for intismeran. What insights does this provide regarding what you are discovering about the product, its optimal use, and your increasing confidence in the program?

Thank you for the question. We are closely monitoring the randomized Phase IIb results from our adjuvant melanoma study. Based on repeated updates, we remain enthusiastic about this study, which supports our optimism about the overall program. Our most significant investments with our partner, Merck, have been in the adjuvant settings. This approach makes sense as the tumor burden is lower, giving the immune system a better chance to achieve a strong response. We believe adjuvant settings are critical. Additionally, we've initiated some smaller monotherapy studies that focus on even earlier interventions. We are excited about the potential of the program from both the adjuvant and earlier stages. However, we are also diligently evaluating opportunities for late-stage intervention, especially in metastatic cases, where we have seen the most applicability for metastatic melanoma. This exploration has been supported by advancements in our manufacturing capabilities. It’s important to note that patients at this advanced stage tend to progress quickly, so we must ensure we can deliver a product reliably within six weeks or sooner, allowing them to begin treatment promptly after enrolling in the study. We believe it's practical to establish our capabilities in the adjuvant and early spaces while also investigating late-stage possibilities. Throughout our clinical portfolio with intismeran, involving over a thousand treated patients, we have identified opportunities for efficient late-stage treatment with a swift turnaround. Nevertheless, we remain committed to the adjuvant space, which is where we see the most promise, while also exploring earlier than adjuvant and potentially frontline options in our newly announced studies.

Got it. And then just a follow-up. Can you discuss any regulatory interactions you have had on the path ahead for Check Point AIM-T? I see on Slide 12, that is now expected to be filed for approval by 2028?

Thank you for that question. So 4359, we have been engaging with regulators. Those are early stage. I won't get into the specifics of them, I'll remind you, we're just now moving into Phase II. And so these are really Phase I stage conversations, which would make it premature to go too much into specifics. That said, we are investing behind the program. And as we announced at the last quarter, we're investing as though this could become one of our submissions over the next 3 years, as you identified sort of by 2028, that really is a statement about our prioritization of the program and our conviction given the very early stage data and not necessarily a statement about anything we've done either out of Phase II and subsequent discussions with regulators about approval timeline. So it's our prioritization of the program that brings that forward. But we believe it is possible.

Well, great. Maybe one, Stéphane, bigger picture, can you maybe just talk about business development here? We've obviously seen a lot of assets being in-license from China, including obviously one of your competitors that actually licensed the assets and even flipped it to pharma for some means of profits. Given your long-term ambition to become a key player in oncology, are you actively spending time in China? And if so, are you just looking at strengthening your mRNA capabilities? Or are you open to other modalities? And then maybe second, Stephen, can you just talk about the COVID plus flu how should we think about the sequence of the filing here with the FDA? Is it fair for us to think that you first need to get approved for flu monotherapy and then you can file the combo or can you possibly do both concurrently? I guess any color there, much appreciated so we can think about timelines.

So on the first question, as we've said before, we have such a productive platform in mRNA that we have an abundance of assets. Actually, what we are doing, as you heard on the cost structure, we are deciding not to take forward to Phase III asset that we believe deeply in, take EBV, for example, because we ought to be financially disciplined. But we've said we believe this vaccine is really important for patients. As you know, we have 2 programs in EBV. There is a prophylactic program to prevent mononucleosis and potentially long-term sequelae of MS, and there's a potential therapeutic program for people that are already sick. And we believe those programs have to move forward, which is why, as we've said on previous calls, we are actively talking to potential pharmaceutical partners and potential product financing partners for several of those assets that we cannot prosecute forward alone because they are great assets, but we need to be financially disciplined at the same time. We've always thought that partnering is a great way to access assets that are non-mRNA technology. I mean, a good example, of course, is our important strategic partnership with Merck with KEYTRUDA. We could have decided to develop our own PD-1; everybody doesn't think this was the right thing to do. But partnering with Merck in terms of having an approved product and the right capabilities was. So we're always going to look at the biology. That's what has always driven us to try to find the best way to help patients and to create the best asset. And if we need a partnership, we will do so.

And thanks for the question on the COVID flu combo. So look, I'll first say, concurrent is certainly possible. You're asking whether it's theoretically possible. I think we think it is. But as a practical matter, there will probably be some sequencing. And as a practical matter in the case of the U.S. FDA, it's likely that the flu vaccine will be sequenced first for all of the reasons that are obvious. It's a chance to review that efficacy data from that flu vaccine feels very important for ungating the flu COVID combination. Now the one caveat I'd put on that is there are markets where we continue to proceed with our flu COVID vaccine application, including in Europe, where we believe we're going to be able to amend that file to include the flu efficacy data. And so the answer is ultimately dependent on the different regulators in different markets. It is possible that we could proceed in parallel, but for pragmatic reasons, we may proceed in sequence. And so that doesn't mean that we're delaying for 1 to be approved before we submit, but we are allowing substantially through to proceed before proceeding with the flu COVID, again, market to market, different answers.

I have 2, maybe just follow flu combo comments here or discussion here. So any latest thoughts regarding flu combo submission requirement? This is specifically regarding the FDA. And then second, regarding the CMV, how do you decide the statistical hierarchy for the secondary endpoint? And also given the study basically already completed, is it fair to say in 2 months, we will see the data?

Thank you, Gena, for your specific questions. Regarding the flu COVID, we are starting consultations with the FDA and will wait a week for their guidance on requirements. From previous reviews, it was clear we need to submit the flu efficacy results and confirm the correlational protection from our study. We will verify that this is necessary and understand any additional information the FDA may want to see in the application. After these consultations, we will have more clarity, but I don't have it at this moment. Regarding CMV and the statistical hierarchy, we haven't disclosed what the powered secondary endpoint will be yet or some other details we are considering. We will provide that information once we begin unblinding the study. We plan to use hierarchical testing, passing the alpha down to the secondary endpoint while ensuring we characterize all additional secondary endpoints that may help illustrate the vaccine's performance across various immunologic and virologic measures. As for when we will see the data, we have completed the study and are being diligent and thorough in our processes. We haven’t finished the analysis yet and are completely blinded to the results. It will take some time to gather all the necessary approvals for updating the statistical analysis plan and then initiate the analysis. There will also be a period for an unblinded statistical team to carry out the appropriate analysis and review with the DSMB. We anticipate that this will occur this fall. However, I cannot say whether we expect it to happen in the next two months, as I am unsure how long it will take to secure those approvals and complete the analyses. We are confident it will happen soon.

Well, thank you, everybody, for joining us today. We really appreciate it. We look forward to speaking to you in the next days or weeks. Have a nice day and a good weekend. Thanks.