Moderna, Inc. — Call Transcript 2026

All right. Okay. Good afternoon, everyone. Tyler Van Buren here, Senior Biotech Analyst at TD Cowen. Thank you very much for joining TD Cowen's 46th Annual Healthcare Conference. For this next session, it's a privilege to be hosting a fireside chat with Moderna management. From Moderna, it's my pleasure to introduce Jamey Mock, Chief Financial Officer of Moderna. Jamey, it's so great to have you here. Thank you for joining me. Thanks for having us, Tyler. We'll start at a high level before we get into some of the more detailed programs or specific programs. For the full year 2025, product revenue came in at the high end of the guidance, which I think surprised some, given the COVID normalization concerns and macro factors throughout the year and volatility on that front. Maybe you could just talk about what drove the resilience of the COVID franchise and the great result you guys ended the year with. Sure. Well, thanks, everybody, for your interest in Moderna. Yeah, I would say obviously a lot of things going on from a macro perspective. That said, I think the team executed extremely well, number one, and I also think it tells you that there's still plenty of people that wanna get vaccinated. In the U.S., for example, there were over 30 million Americans that got vaccinated against COVID last year. If I break down and kinda go through the numbers, we had guided $1.6 billion-$2 billion of revenue, and we came in at $1.9 billion. If you double-click on that, we had said the U.S. would be about $1 billion-$1.3 billion, and two things happened there. Vaccination rates were on the better end of what we thought they would be. MNEXSPIKE, which is our latest COVID vaccine, performed very well. We did well from a share perspective, particularly in retail. Outside the United States, there wasn't a lot of volatility left. We just had to execute. There was a little bit around vaccinations, but we hit the high end of that guide. We had guided $600 million-$700 million, we hit $700 million outside the United States and $1.2 billion inside the United States, and we're really pleased with the execution. That's a little bit about how we hit the high end. Great. mNEXSPIKE, which you mentioned, 24% of the U.S. retail channel, impressive early uptake for that product. Is that the penetration that we should expect moving forward, or ultimately, what share of your COVID franchise do you expect mNEXSPIKE to take? Thank you for saying that. We were really encouraged by what we saw. I think the product was approved in mid-June. For six months of the year, having a product that was just approved going into the season, we thought it performed extremely well. I think it really just comes down to the product profile. It has superior efficacy versus Spikevax, particularly in older adults, which is really who we're targeting, is high risk in older adults. I think that's where the large majority of vaccinations are targeting. It's 13.5% better from an efficacy perspective versus Spikevax. That got in the marketplace and performed extremely well. Looking forward, that is one of the growth drivers we're hoping for in 2026 as well and beyond, and that we do hope that it takes up a larger share of our of the market overall and of our proportion of that market as well. For 2026, another recent surprise was the up to 10% growth guidance. I guess that means anywhere from 1% to 10% over the course of the year. How should we think about the potential outcomes within that range, swing factors? What gives you confidence that you can potentially hit that up 10%? Yeah. I guess it's 0.1% up to 10%, you know, but yeah. Fair, fair, decimals. I think the other important thing that we've said about that, and I'll come back to that, but I think it's telling when we break down and as I talk about what is gonna drive growth, is we also said that the geographic distribution was roughly 50/50 inside the United States and outside the United States. I'll speak to each geography and talk about the upside to your point or the range of outcomes. In the United States, I just mentioned in 2025, we had $1.2 billion in sales. If you take a 50% midpoint of our guidance, that's about $2 billion. That would imply $1 billion in the United States and $1 billion outside the United States at the midpoint of up to 10%. That means that we are expecting or planning for, not expecting, we're planning for the United States, that could potentially drop from $1.2 billion to roughly $1 billion. That's based on vaccination rates and/or market share or competitive forces, whatever it might be, but that is our planning assumption in this guidance. Now, what could be the upside to that? mNEXSPIKE could continue to perform well and take a larger share, or vaccination rates might not be down as much. If it's another $1.2 billion overall, that would be on the higher end. If it's down to the $1 billion, that would be towards the midpoint, or lower end. Then outside the United States, I said we had $700 million of revenue in 2025, and again, that's gonna go to $1 billion. That's really based upon we've been talking about these large strategic partnerships we have primarily in three geographies, in the United Kingdom, in Canada, and in Australia. Those we started to execute against in 2025, particularly in Canada, but many of them, particularly the UK and Australia, we had very nominal revenue. As those annualize, and they can continue to grow over time, and we can get into that, we're getting a big uptick. That is why international revenue mix is growing. You'll see it in the first half. We mentioned back in 2025 that some revenue that we thought might land in 2025 slipped out to the first half of 2026 for about $200 million. We expect that you'll start seeing the fruits of that in the first half of this year. Great. Moderna has stated that its path to cash flow break even in 2028 is dependent on flu outcomes, where we've seen some volatility lately and cost discipline. You have levers to adjust across 2027, 2028. Can you outline what sits under your control bucket versus what's external? Yeah. well, maybe I'll start with cost because that is in our control. We had guided, if I just look at 2027, we haven't guided 2028. We guided 2027 to a midpoint of $3.7 billion. That means by 2028, we either have to be at $3.7 billion from a revenue perspective, which I'll talk about in a second, or we're going to have to take down costs a little bit or have a mixture of both growth and cost. This breakeven story is both a growth and a cost reduction story. Just to kind of talk a little bit more about cost because I think the bigger story is really the revenue side. Cost, we have great line of sight to this $3.7 billion. There are some trials ongoing in the year 2026, specifically in our infectious disease with norovirus as that completes, and some other things going on with COVID. Those will roll off, and we have terrific visibility to the $3.7 billion. After that, it's really a bunch of capital investment choices that we've made and have made over the last three years. We've always had the high level strategy of investing behind the business, but monitoring the revenue line, and 2026, 2027, and 2028 are no different than that. Cost very much in our control. I think the bigger story is, and we tried to lay this out at Analyst Day, is we have, you know, 10 shots on goal of what we call growth drivers that are all several hundred million dollars. There's no revenue item that is perfectly under our control. Even the solidified contracts with the three geographies I just talked about, I mean, we have obviously greater control and it's more on our execution, but, you know, at the end of the day, it's still two parties for any kind of revenue. We've got that. It's really a mix of international expansion as well as new products. International expansion, we've got the contracts I've mentioned. We've announced additional partnerships in Mexico and Taiwan recently. Europe will open up in 2027, and that's a rather sizable market, not just for COVID, but for all infectious disease. We plan to grow there. Then on the new product side, we'll talk about flu, I'm sure. We've got flu and plus COVID from a combination perspective, both inside the United States and outside the United States. We've got norovirus, that's kinda the, I'll call it, infectious disease or vaccines portfolio. On top of that, I'm sure we'll get into it, but hopefully our INT product reads out well and is approved. PA reads out well, mRNA-4359. We have a lot of shots on goal. Getting back to answer your question, cost is in our control. We have good line of sight to it to bring it down to at least 3.7. Revenue, we've got a lot of shots on goal to get that up to some level like that. Great. Maybe related to the cash flow break even plan, and thematically, you all have been clear about reallocating capital towards area with better risk-adjusted returns. Before we get into respiratory franchise and vaccines, just, you know, talking about potentially oncology, autoimmune, rare disease, and of course, partnered vaccines. Can you elaborate on these recent comments? Also if that means that you might explore other modalities outside of mRNA as well. Yeah. You know, I don't read into those comments as much. Let me just step back for a second. Over the last five or six years, we've probably invested 80% of our research and development into infectious disease, and we've been very conscious about doing that, and we knew we wanted the full portfolio. When we have the full portfolio, we think that brings a lot of value to our customers. What is the full portfolio? That is 2 COVID vaccines, that is RSV, that is flu, hopefully, that is flu plus COVID, and that is norovirus, which can also sell through the retail channel. Those investments will largely be done, and that's not to say that there can't be more, and we will continue to invest in more, but after investing all that capital, we've got to make that business a profitable, growing, sustainable business, and that's really been the strategy, and I think you'll see that over the next coming years as each of those products grow and as I talk through the international expansion as well. That said, we've always been trying to diversify into oncology. We've always said mRNA is not gonna be a one therapeutic area company. It's gonna be many different modalities and therapeutic areas. We're excited about what we have in oncology, INT, which we'll talk about, I'm sure, which we think can break through on cancer vaccines broadly. Should INT do well, it's kind of the bellwether for cancer vaccines, and we have numerous ones behind them. Then we've got other modalities, in vivo, CAR T therapy, T-cell engagers, and then there's rare disease as well and, you know, an entire pipeline in our research and preclinical behind that as well. I think it's just the time that we are kinda completing some very heavy investments. We have to make that business grow and be profitable, and it's the time to diversify the company as well. My final general question is actually gonna be on AI. Yeah. I think this is the first time I ever asked about AI at our conference, you know, I can't include a line item in my model on AI yet. Can you just talk a little bit about that, what we might be underappreciating, and when might the fruits of that labor become more obvious? Yeah. It's a great question. It is a total game changer. We are obviously in inning 1, and we believe that we are very far ahead at Moderna across all areas, which I'll get into. There is so much productivity, not just from a cost perspective, but from a working capital perspective in terms of materials management, from a scheduling perspective for patients, which really affects our INT business. There is enormous amount of returns, and we've been very broad across all functions and very methodical about it. I just walked out of a two-hour review with our entire digital team walking through exactly what we've got going on. AI is one thing, but it has to be backed by a terrific set of software and data, and we believe we have that. There's back office productivity, there's front office productivity. I think we've actually started to realize some of those benefits in 2025. If you remember, we entered 2025 believing we would be $5.5 billion of cash costs and ended at $4.3 billion. Not all of that is AI, and probably a small portion of it, but it's still yielding benefits. It is difficult to model. I can totally understand that. I think you will see the productivity through what is our operating cost and what are those metrics? What does it look like from a margin perspective? What is our working capital? Our working capital last year ended at $150 million, so it's very capital efficient. You'll see that over time as we grow that the cost of the infrastructure of our company does not have to grow nearly as much, and which is why we're still confident in our overall break even and our ability to impact costs in the coming years. That's great. We'll get to the specific programs, starting with mRNA-1010 and flu. An unusual regulatory sequence with the RTF and then the BLA acceptance a few days later, to say the least. Maybe you could walk us through that briefly and also touch on the post-marketing confirmatory study in adult 65+, and how you plan to fund that. What happened was certainly unexpected. To be specific about it, the refusal to review our application was related to the control arm, and whether it was at the right standard. That was surprising to us because we had had years of dialogue with the FDA. When we reflected on that, we said, "We've gotta dig in and understand a little bit more," and we requested a Type A meeting and through that Type A meeting, worked through it with the FDA and came to a good spot. What is that spot? That spot allows us to be fully approved from ages 50 to 64, and then 65 plus requires will be an accelerated approval should this all be approved. What is required is a post-marketing commitment, which I'll talk about which was one of your questions. I mean, the PDUFA date we got is August 5th or 2nd, which is now five months away, which is terrific. That is probably faster than we've originally anticipated, frankly. We're excited about the opportunity. It is in the near future. We're working well with the FDA on it, that's what I'll say about that overall. In terms of the post-marketing commitment, this is a pragmatic real world evidence study that will take place over several years, it is much more cost efficient than what one might think is a typical, you know, phase II or even phase III trial. It doesn't affect our break even or our cost estimate at all. We always knew that we would need some real world evidence over time, and had already positioned and planned for this. We're excited about what's to come. Remind us briefly, in the 50+ age group, what % of the flu market that is in terms of vaccines roughly. Is it similar to COVID? I think COVID makes up a larger majority- Yeah ... Of 50+. I think 150 million patient or people vaccinated in the United States. I think it's probably not the same split. I don't know if you have it off the top of your... I do. I think it's a little bit less than that. Okay. COVID has, I think 55% 65+, 65, 70% 50+. It's not at that level. Okay. It's more split 50/50. Got it. All right. It's 5x the market. Yep. Then, for ex-U.S. regulatory reviews, can you elaborate on that? Has your experience been a little different there than the U.S.? I'll just say that they've all been approved for review in Europe and Canada and Australia. Great. The flu COVID combo, just remind us the timelines there for ex U.S., how meaningful that is for the opportunity ex U.S. over the next few years, maybe you could touch on your U.S. plans for the flu COVID combo. Yeah. So on Friday, actually, we announced that we received a positive CHMP opinion on our flu plus COVID combo, which is exciting. And so therefore, we believe that it could be approved in Europe in the coming months. Um, so that's terrific and would be the first combination vaccine in that market, uh, as it pertains to infectious disease. Uh, and we've also filed-- Well, if you think about the US, uh, the US, we are still waiting now that we have a discussion on flu. We need to understand what is required on flu first. So I think that'll take a few months, uh, and be further along into what the FDA is seeing on flu. But I'll remind investors that none of this is planned as revenue in twenty twenty-six. Not any standalone flu revenue, not any co-combination revenue. We really are not expecting this to be a 2026 revenue driver whatsoever. We think it's a substantial growth Both of them are a substantial growth driver, come 2027. The combination, particularly in Europe, as Europe opens up, it happens to coincide with Europe opening up. What do I mean by opening up? We've been basically locked out of Europe for the last few years because a competitor has a contract there which ends by the start of 2027. We'll be able to compete ideally, with both a combination product, with a flu product, and with a COVID product, and RSV, obviously. We're excited about what that means to 2027, particularly in Europe. We're excited for flu in the US in 2027. It remains to be seen what it means for the combination vaccine, which we had planned really to be a 2028 revenue driver. None of our plans have COVID in the U.S. or the combination in the U.S. in 2027 or 2026. Understood. RSV quickly. You know, should we start to get a little bit more excited about that with a potential flu approval, or do you think you need further maturation of your portfolio to, you know, in terms of contracting for RSV? Should we keep expectations low? Yeah. We, we intentionally tried to keep expectations low. Okay. There will be growth, but it is nominal growth. It's coming off a low base and growth is helpful, but it is not to the tune of the 10 growth drivers that I've been speaking about. I think what's really required there is clarity around what is the revaccination schedule. In the first year, I think there were 12 million Americans that got vaccinated. This is back in 2023, and that's down to, I think, 2 million or less last year. we were 3rd to market, so therefore, you kinda need another revaccination period for it to warrant-Us kind of breaking in, that comes at a time ideally in the next few years here, where we will have a fulsome portfolio and think we will be able to compete very well. In 2026, actually, in the next few years, we're not counting it as a growth driver. Should there be a revaccination year that is in this time period, that would be upside to what we are planning for. Great. Norovirus, you're now guiding the two-season interim data in 2026, which was earlier than prior expectations. Have you provided any granularity on that timing, and what would a successful interim readout look like with that program? Yeah. We're basically, what we've said is that we are enrolling a second Northern Hemisphere cohort, there will be a readout in 2026. We haven't really adjusted the timing all that much. We're excited about it. I mean, just stepping back for norovirus, I think it's getting more and more press nowadays, actually. You know, it is a significant unmet need out there and does impact many lives, again, particularly older adults. I think what most people, most FDA or most agencies look for is at least a 50% vaccine efficacy. Based upon the data that we saw from our immunogenicity studies, both in phase I and phase II, we're encouraged, and we're whole optimistic that it will be a terrific vaccine and read out well. It actually enters a pretty large market. The market for occupational health and healthcare workers and lifestyle travelers, we think it could be rather substantial. I think we put this one also as a 2028 revenue driver, just to be clear. We're hopeful that it is a terrific interim readout this year. Right now, we're planning on a 2028 launch. That really does pair well. We believe it'll be going to the retail channel where many vaccines are sold. Going back to this whole portfolio approach, that's why 2028 is such a difficult year to call from a revenue perspective. That's why we've only guided through 2027. We know that we can get to 2028 with a lot of these growth drivers and the ability to take down cost. We're excited about it. Great. Transitioning to oncology with intismeran, INT, and several other programs now. Possible pivotal readout for adjuvant melanoma in 2026. If this hits, could, you know, transform the entire company. You made a recent hire in terms of on the R&D front, head of R&D, David Berman, who has tremendous background, who I'm a big fan of. I guess the timing of this readout is, it's very, you know, it's impossible. It's event-based, right? You can't give perfect granularity. What do you think is the probability that it comes in 2026 versus 2027, you know, and slips into 2027? Can you give us anything on that front? Yeah. I mean, all I'll say is everything. I'll just echo everything you said. I can't give a probability. It's obviously enough that we said it could come in 2026. Therefore, we don't control that, obviously, because it is event-driven. Obviously, the last thing maybe the other thing I'd say is just to remind investors, the adjuvant melanoma trial was fully enrolled in September of 2024. What we're looking at is the shape of the curves on the phase two versus this phase three, which was fully enrolled in September of 2024. If you look at that, if it performs similarly, then you should see some kind of readout in 2026. I can't assign a probability to that. I would just say that we've obviously said that it could read out in 2026, which must mean that there is some additional confidence in that. Yep. if it performs similarly to phase two, it's gonna be a huge success, clearly. The data were really impressive. maybe you could just talk... have you guys said anything on powering or kinda what's the minimum bar in RFS or DMFS that you guys need to meet in the phase three to be successful? Can you give us your latest thoughts on the size of that market? Yeah. Let me back up and talk phase II, and then I'll answer your question on phase III and then the market as well. The phase II, just to replay the results, at year three, RFS, so no recurrence or death, was 49%. Really obviously a remarkable impact on patients. DMFS was at 62%, I believe, at year three. I guess it was January? January, we just came out with it. It's a lot going on. In January, we came out with our five-year data on phase II, and that basically replicated. We only came out with RFS data, but it was exactly 49% again. Remarkable durability through five years on the phase II, which we're encouraged by. If we saw close to that on the phase III, we'd be thrilled. I think more importantly, patients would be thrilled. As a reminder, it was one of the fastest phase III trials ever enrolled, you know. I think there's a lot of it. We know there's a lot of excitement about it. We're excited about it. If we see something even remotely similar to what we saw in the phase II, I think many stakeholders will be quite pleased. As for the market size, there's, you know, I think 100,000 patients that have melanoma in the United States. I'm just talking United States here, in the United States. When you whittle it down to what phase are they in, you know, have they been resected, you know, it's down to, I don't know if we've given out specifics, but it's in the lower thousands, you know, let's call it 10,000-20,000, that is the market opportunity. Then you have to apply a price to it. We think it brings substantial value, to patients. It's a pretty significant opportunity for us. you know, even 1,000 patients, which we just enrolled in, you know, 14 months or whatever it was, you know, in our first year would be phenomenal. Five-year OS data from phase II expected later this year, I believe. Yeah. Is there anything you could say about that? What level of benefit would be meaningful or what we should expect? Yeah. What we saw in the phase III was early. It was promising, but early from an overall survival perspective. We're excited to release what the phase II data will be through five years at a upcoming conference, both for DMFS and for overall survival. We were encouraged by what we saw, three years in. Great. Beyond melanoma, let's see, lung, RCC, bladder, others, when can you lay out the timelines for readouts in those potential indications? Which ones could come sooner than later? Could we get some of those this year? Yeah, great question. I think first it speaks to just how excited both Merck and Moderna are to invest behind this. We now have three Phase III trials, and I think five Phase IIs or, you know, two Phase Is. We've got a lot going on. To speak to what you just asked, I would follow when these trials are fully enrolled. We had previously announced the renal cell carcinoma was fully enrolled sometime in the second half of last year. I forget the exact date. At our recent earnings call, we said muscle invasive bladder cancer was fully enrolled. That starts ticking to when are the events and when can we have a readout, similar to what I just spoke about from a melanoma perspective. That's what I would track. Same thing with on small cell lung cancer. We are still enrolling, once it enrolls, then the events start ticking. There's clearly a lot of investment behind this. They are enrolling rather rapidly. We now have three fully enrolled, I would track enrollment is the best thing I would tell investors. Great. In the last couple of minutes, maybe we'll touch on rare disease. You know, you made the decision to out-license the PA program to Recordati. Maybe you could touch on that decision as well as also the decision to keep MMA in-house and the status of that program and the future of the rare disease portfolio. I mean, we're thrilled to have Recordati as a partner. They already sell into PA with a different type of therapeutic. They already have that commercial infrastructure to really rapidly identify patients that have propionic acidemia. This was a capital allocation decision. We think that's the most efficient way to have an impact for PA patients and obviously impact as many as we can, as quickly as we can. It's also, we don't have to invest in advance. We can wait to see the data. We already have a commercial partner, and there are many numerous rare diseases behind that. Before going and investing ahead of a hopefully a positive outcome, then we can do this with somebody that already can do it, accelerate that program, and then hopefully MMA and many numerous ones behind them, we can make that choice whether we're gonna create our own commercial infrastructure. You'll have a data point. You have a data point on is this, you know, performing well? First of all, did it read out well? Is it commercially performing well? we really, you know, we're excited for patients, but it was also a capital allocation decision, and I think a prudent one to not advance our investment before you actually have, you know, a readout on this. Great. Maybe related to rare disease, you mentioned a continued focus on nucleic acid technologies. Outside of mRNA, that would include RNAi potentially or DNA. Could we see something like a new program on that front anytime soon, or is that a very long-term statement? What's the- Yeah. Latest there? Yeah. Nucleic acids includes that. I think that's a long-term statement. I know we have a lot on our plate to execute and a lot of opportunity, which we are enormously excited about, including in the very near term, next three years. We have enough with mRNA technology to keep us busy for the coming years, and we're excited about it. Fair enough. In closing, maybe I'll ask you, Jamey, what aspect of the Moderna story do you believe is most underappreciated by investors right now? That's a good question. Well, the first one I'll just put in a plug, and I'll answer it in two ways. One is the people. I think the people at Moderna are incredible. I think they are extraordinarily accomplished and have an enormous expertise. I think they are passionate, and I think they are resilient, particularly in a time over the last two years that has been challenging for many different reasons. I'll put that plug in for people. I think in terms of the business we're building, I think it is both durable and diversified. I don't think investors, and part of this is us trying to guide investors as well, that we have, you know, a pretty durable COVID franchise, perhaps more so than others might think. I think we look at some of the contracts that we have, particularly outside the United States, that should provide a solid buffer for us for years to come. From a diversified perspective, I won't reiterate everything I just said, which is all these shots on goals and the fact that we think we can grow internationally. You combine that with a pretty strong balance sheet that we just ended the year with, both the cash on hand plus the liquidity we have through the loan that we have at our disposal. I think it's a really exciting story that, you know, we can invest behind and be excited about, and we are. I'm not sure that's always appreciated. Wonderful. Jamey, thank you so much for your time. Thank you. Thanks for having me. Thanks, everyone, for joining.

Speaker 3: All right. Okay. Good afternoon, everyone. Tyler Van Buren here, Senior Biotech Analyst at TD Cowen. Thank you very much for joining TD Cowen's 46th Annual Healthcare Conference. For this next session, it's a privilege to be hosting a fireside chat with Moderna management. From Moderna, it's my pleasure to introduce Jamey Mock, Chief Financial Officer of Moderna. Jamey, it's so great to have you here. Thank you for joining me. All right. all right Okay. okay Good afternoon, everyone. good afternoon everyone Tyler Van Buren here, Senior Biotech Analyst at TD Cowen. tyler van buren here senior biotech analyst at td cowen Thank you very much for joining TD Cowen's 46th Annual Healthcare Conference. thank you very much for joining td cowen's 46th annual healthcare conference For this next session, it's a privilege to be hosting a fireside chat with Moderna management. for this next session it's a privilege to be hosting a fireside chat with moderna management From Moderna, it's my pleasure to introduce Jamey Mock, Chief Financial Officer of Moderna. from moderna it's my pleasure to introduce jamey mock chief financial officer of moderna Jamey, it's so great to have you here. jamey it's so great to have you here Thank you for joining me. thank you for joining me

Speaker 2: Thanks for having us, Tyler. Thanks for having us, Tyler. thanks for having us tyler

Speaker 3: We'll start at a high level before we get into some of the more detailed programs or specific programs. For the full year 2025, product revenue came in at the high end of the guidance, which I think surprised some, given the COVID normalization concerns and macro factors throughout the year and volatility on that front. Maybe you could just talk about what drove the resilience of the COVID franchise and the great result you guys ended the year with. We'll start at a high level before we get into some of the more detailed programs or specific programs. we'll start at a high level before we get into some of the more detailed programs or specific programs For the full year 2025, product revenue came in at the high end of the guidance, which I think surprised some, given the COVID normalization concerns and macro factors throughout the year and volatility on that front. for the full year 2025 product revenue came in at the high end of the guidance which i think surprised some given the covid normalization concerns and macro factors throughout the year and volatility on that front Maybe you could just talk about what drove the resilience of the COVID franchise and the great result you guys ended the year with. maybe you could just talk about what drove the resilience of the covid franchise and the great result you guys ended the year with

Speaker 2: Sure. Well, thanks, everybody, for your interest in Moderna. Yeah, I would say obviously a lot of things going on from a macro perspective. That said, I think the team executed extremely well, number one, and I also think it tells you that there's still plenty of people that wanna get vaccinated. In the U.S., for example, there were over 30 million Americans that got vaccinated against COVID last year. If I break down and kinda go through the numbers, we had guided $1.6 billion-$2 billion of revenue, and we came in at $1.9 billion. If you double-click on that, we had said the U.S. would be about $1 billion-$1.3 billion, and two things happened there. Vaccination rates were on the better end of what we thought they would be. Sure. sure Well, thanks, everybody, for your interest in Moderna. well thanks everybody for your interest in moderna Yeah, I would say obviously a lot of things going on from a macro perspective. yeah i would say obviously a lot of things going on from a macro perspective That said, I think the team executed extremely well, number one, and I also think it tells you that there's still plenty of people that wanna get vaccinated. that said i think the team executed extremely well number one and i also think it tells you that there's still plenty of people that wanna get vaccinated In the U.S., for example, there were over 30 million Americans that got vaccinated against COVID last year. in the u.s for example there were over 30 million americans that got vaccinated against covid last year If I break down and kinda go through the numbers, we had guided $1.6 billion-$2 billion of revenue, and we came in at $1.9 billion. if i break down and kinda go through the numbers we had guided $1.6 billion-$2 billion of revenue and we came in at $1.9 billion If you double-click on that, we had said the U.S. would be about $1 billion-$1.3 billion, and two things happened there. if you double-click on that we had said the u.s would be about $1 billion-$1.3 billion and two things happened there Vaccination rates were on the better end of what we thought they would be. vaccination rates were on the better end of what we thought they would be MNEXSPIKE, which is our latest COVID vaccine, performed very well. We did well from a share perspective, particularly in retail. Outside the United States, there wasn't a lot of volatility left. We just had to execute. There was a little bit around vaccinations, but we hit the high end of that guide. We had guided $600 million-$700 million, we hit $700 million outside the United States and $1.2 billion inside the United States, and we're really pleased with the execution. That's a little bit about how we hit the high end. MNEXSPIKE, which is our latest COVID vaccine, performed very well. mnexspike which is our latest covid vaccine performed very well We did well from a share perspective, particularly in retail. we did well from a share perspective particularly in retail Outside the United States, there wasn't a lot of volatility left. outside the united states there wasn't a lot of volatility left We just had to execute. we just had to execute There was a little bit around vaccinations, but we hit the high end of that guide. there was a little bit around vaccinations but we hit the high end of that guide We had guided $600 million-$700 million, we hit $700 million outside the United States and $1.2 billion inside the United States, and we're really pleased with the execution. we had guided $600 million-$700 million we hit $700 million outside the united states and $1.2 billion inside the united states and we're really pleased with the execution That's a little bit about how we hit the high end. that's a little bit about how we hit the high end

Speaker 3: Great. mNEXSPIKE, which you mentioned, 24% of the U.S. retail channel, impressive early uptake for that product. Is that the penetration that we should expect moving forward, or ultimately, what share of your COVID franchise do you expect mNEXSPIKE to take? Great. mNEXSPIKE, which you mentioned, 24% of the U.S. retail channel, impressive early uptake for that product. great mnexspike which you mentioned 24% of the u.s retail channel impressive early uptake for that product Is that the penetration that we should expect moving forward, or ultimately, what share of your COVID franchise do you expect mNEXSPIKE to take? is that the penetration that we should expect moving forward or ultimately what share of your covid franchise do you expect mnexspike to take

Speaker 2: Thank you for saying that. We were really encouraged by what we saw. I think the product was approved in mid-June. For six months of the year, having a product that was just approved going into the season, we thought it performed extremely well. I think it really just comes down to the product profile. It has superior efficacy versus Spikevax, particularly in older adults, which is really who we're targeting, is high risk in older adults. I think that's where the large majority of vaccinations are targeting. It's 13.5% better from an efficacy perspective versus Spikevax. That got in the marketplace and performed extremely well. Thank you for saying that. thank you for saying that We were really encouraged by what we saw. we were really encouraged by what we saw I think the product was approved in mid-June. i think the product was approved in mid-june For six months of the year, having a product that was just approved going into the season, we thought it performed extremely well. for six months of the year having a product that was just approved going into the season we thought it performed extremely well I think it really just comes down to the product profile. i think it really just comes down to the product profile It has superior efficacy versus Spikevax, particularly in older adults, which is really who we're targeting, is high risk in older adults. it has superior efficacy versus spikevax particularly in older adults which is really who we're targeting is high risk in older adults I think that's where the large majority of vaccinations are targeting. i think that's where the large majority of vaccinations are targeting It's 13.5% better from an efficacy perspective versus Spikevax. it's 13.5% better from an efficacy perspective versus spikevax That got in the marketplace and performed extremely well. that got in the marketplace and performed extremely well Looking forward, that is one of the growth drivers we're hoping for in 2026 as well and beyond, and that we do hope that it takes up a larger share of our of the market overall and of our proportion of that market as well. Looking forward, that is one of the growth drivers we're hoping for in 2026 as well and beyond, and that we do hope that it takes up a larger share of our of the market overall and of our proportion of that market as well. looking forward that is one of the growth drivers we're hoping for in 2026 as well and beyond and that we do hope that it takes up a larger share of our of the market overall and of our proportion of that market as well

Speaker 3: For 2026, another recent surprise was the up to 10% growth guidance. I guess that means anywhere from 1% to 10% over the course of the year. How should we think about the potential outcomes within that range, swing factors? What gives you confidence that you can potentially hit that up 10%? For 2026, another recent surprise was the up to 10% growth guidance. for 2026 another recent surprise was the up to 10% growth guidance I guess that means anywhere from 1% to 10% over the course of the year. i guess that means anywhere from 1% to 10% over the course of the year How should we think about the potential outcomes within that range, swing factors? how should we think about the potential outcomes within that range swing factors What gives you confidence that you can potentially hit that up 10%? what gives you confidence that you can potentially hit that up 10%

Speaker 2: Yeah. I guess it's 0.1% up to 10%, you know, but yeah. Yeah. yeah I guess it's 0.1% up to 10%, you know, but yeah. i guess it's 0.1% up to 10% you know but yeah

Speaker 3: Fair, fair, decimals. Fair, fair, decimals. fair fair decimals

Speaker 2: I think the other important thing that we've said about that, and I'll come back to that, but I think it's telling when we break down and as I talk about what is gonna drive growth, is we also said that the geographic distribution was roughly 50/50 inside the United States and outside the United States. I'll speak to each geography and talk about the upside to your point or the range of outcomes. In the United States, I just mentioned in 2025, we had $1.2 billion in sales. If you take a 50% midpoint of our guidance, that's about $2 billion. That would imply $1 billion in the United States and $1 billion outside the United States at the midpoint of up to 10%. I think the other important thing that we've said about that, and I'll come back to that, but I think it's telling when we break down and as I talk about what is gonna drive growth, is we also said that the geographic distribution was roughly 50/50 inside the United States and outside the United States. i think the other important thing that we've said about that and i'll come back to that but i think it's telling when we break down and as i talk about what is gonna drive growth is we also said that the geographic distribution was roughly 50/50 inside the united states and outside the united states I'll speak to each geography and talk about the upside to your point or the range of outcomes. i'll speak to each geography and talk about the upside to your point or the range of outcomes In the United States, I just mentioned in 2025, we had $1.2 billion in sales. in the united states i just mentioned in 2025 we had $1.2 billion in sales If you take a 50% midpoint of our guidance, that's about $2 billion. if you take a 50% midpoint of our guidance that's about $2 billion That would imply $1 billion in the United States and $1 billion outside the United States at the midpoint of up to 10%. that would imply $1 billion in the united states and $1 billion outside the united states at the midpoint of up to 10% That means that we are expecting or planning for, not expecting, we're planning for the United States, that could potentially drop from $1.2 billion to roughly $1 billion. That's based on vaccination rates and/or market share or competitive forces, whatever it might be, but that is our planning assumption in this guidance. Now, what could be the upside to that? mNEXSPIKE could continue to perform well and take a larger share, or vaccination rates might not be down as much. If it's another $1.2 billion overall, that would be on the higher end. If it's down to the $1 billion, that would be towards the midpoint, or lower end. Then outside the United States, I said we had $700 million of revenue in 2025, and again, that's gonna go to $1 billion. That means that we are expecting or planning for, not expecting, we're planning for the United States, that could potentially drop from $1.2 billion to roughly $1 billion. that means that we are expecting or planning for not expecting we're planning for the united states that could potentially drop from $1.2 billion to roughly $1 billion That's based on vaccination rates and/or market share or competitive forces, whatever it might be, but that is our planning assumption in this guidance. that's based on vaccination rates and/or market share or competitive forces whatever it might be but that is our planning assumption in this guidance Now, what could be the upside to that? mNEXSPIKE could continue to perform well and take a larger share, or vaccination rates might not be down as much. now what could be the upside to that mnexspike could continue to perform well and take a larger share or vaccination rates might not be down as much If it's another $1.2 billion overall, that would be on the higher end. if it's another $1.2 billion overall that would be on the higher end If it's down to the $1 billion, that would be towards the midpoint, or lower end. if it's down to the $1 billion that would be towards the midpoint or lower end Then outside the United States, I said we had $700 million of revenue in 2025, and again, that's gonna go to $1 billion. then outside the united states i said we had $700 million of revenue in 2025 and again that's gonna go to $1 billion That's really based upon we've been talking about these large strategic partnerships we have primarily in three geographies, in the United Kingdom, in Canada, and in Australia. Those we started to execute against in 2025, particularly in Canada, but many of them, particularly the UK and Australia, we had very nominal revenue. As those annualize, and they can continue to grow over time, and we can get into that, we're getting a big uptick. That is why international revenue mix is growing. You'll see it in the first half. We mentioned back in 2025 that some revenue that we thought might land in 2025 slipped out to the first half of 2026 for about $200 million. That's really based upon we've been talking about these large strategic partnerships we have primarily in three geographies, in the United Kingdom, in Canada, and in Australia. that's really based upon we've been talking about these large strategic partnerships we have primarily in three geographies in the united kingdom in canada and in australia Those we started to execute against in 2025, particularly in Canada, but many of them, particularly the UK and Australia, we had very nominal revenue. those we started to execute against in 2025 particularly in canada but many of them particularly the uk and australia we had very nominal revenue As those annualize, and they can continue to grow over time, and we can get into that, we're getting a big uptick. as those annualize and they can continue to grow over time and we can get into that we're getting a big uptick That is why international revenue mix is growing. that is why international revenue mix is growing You'll see it in the first half. you'll see it in the first half We mentioned back in 2025 that some revenue that we thought might land in 2025 slipped out to the first half of 2026 for about $200 million. we mentioned back in 2025 that some revenue that we thought might land in 2025 slipped out to the first half of 2026 for about $200 million We expect that you'll start seeing the fruits of that in the first half of this year. We expect that you'll start seeing the fruits of that in the first half of this year. we expect that you'll start seeing the fruits of that in the first half of this year

Speaker 3: Great. Moderna has stated that its path to cash flow break even in 2028 is dependent on flu outcomes, where we've seen some volatility lately and cost discipline. You have levers to adjust across 2027, 2028. Can you outline what sits under your control bucket versus what's external? Great. great Moderna has stated that its path to cash flow break even in 2028 is dependent on flu outcomes, where we've seen some volatility lately and cost discipline. moderna has stated that its path to cash flow break even in 2028 is dependent on flu outcomes where we've seen some volatility lately and cost discipline You have levers to adjust across 2027, 2028. you have levers to adjust across 2027 2028 Can you outline what sits under your control bucket versus what's external? can you outline what sits under your control bucket versus what's external

Speaker 2: Yeah. well, maybe I'll start with cost because that is in our control. We had guided, if I just look at 2027, we haven't guided 2028. We guided 2027 to a midpoint of $3.7 billion. That means by 2028, we either have to be at $3.7 billion from a revenue perspective, which I'll talk about in a second, or we're going to have to take down costs a little bit or have a mixture of both growth and cost. This breakeven story is both a growth and a cost reduction story. Just to kind of talk a little bit more about cost because I think the bigger story is really the revenue side. Cost, we have great line of sight to this $3.7 billion. Yeah. well, maybe I'll start with cost because that is in our control. yeah well maybe i'll start with cost because that is in our control We had guided, if I just look at 2027, we haven't guided 2028. we had guided if i just look at 2027 we haven't guided 2028 We guided 2027 to a midpoint of $3.7 billion. we guided 2027 to a midpoint of $3.7 billion That means by 2028, we either have to be at $3.7 billion from a revenue perspective, which I'll talk about in a second, or we're going to have to take down costs a little bit or have a mixture of both growth and cost. that means by 2028 we either have to be at $3.7 billion from a revenue perspective which i'll talk about in a second or we're going to have to take down costs a little bit or have a mixture of both growth and cost This breakeven story is both a growth and a cost reduction story. this breakeven story is both a growth and a cost reduction story Just to kind of talk a little bit more about cost because I think the bigger story is really the revenue side. just to kind of talk a little bit more about cost because i think the bigger story is really the revenue side Cost, we have great line of sight to this $3.7 billion. cost we have great line of sight to this $3.7 billion There are some trials ongoing in the year 2026, specifically in our infectious disease with norovirus as that completes, and some other things going on with COVID. Those will roll off, and we have terrific visibility to the $3.7 billion. After that, it's really a bunch of capital investment choices that we've made and have made over the last three years. We've always had the high level strategy of investing behind the business, but monitoring the revenue line, and 2026, 2027, and 2028 are no different than that. Cost very much in our control. I think the bigger story is, and we tried to lay this out at Analyst Day, is we have, you know, 10 shots on goal of what we call growth drivers that are all several hundred million dollars. There are some trials ongoing in the year 2026, specifically in our infectious disease with norovirus as that completes, and some other things going on with COVID. there are some trials ongoing in the year 2026 specifically in our infectious disease with norovirus as that completes and some other things going on with covid Those will roll off, and we have terrific visibility to the $3.7 billion. those will roll off and we have terrific visibility to the $3.7 billion After that, it's really a bunch of capital investment choices that we've made and have made over the last three years. after that it's really a bunch of capital investment choices that we've made and have made over the last three years We've always had the high level strategy of investing behind the business, but monitoring the revenue line, and 2026, 2027, and 2028 are no different than that. we've always had the high level strategy of investing behind the business but monitoring the revenue line and 2026 2027 and 2028 are no different than that Cost very much in our control. cost very much in our control I think the bigger story is, and we tried to lay this out at Analyst Day, is we have, you know, 10 shots on goal of what we call growth drivers that are all several hundred million dollars. i think the bigger story is and we tried to lay this out at analyst day is we have you know 10 shots on goal of what we call growth drivers that are all several hundred million dollars There's no revenue item that is perfectly under our control. Even the solidified contracts with the three geographies I just talked about, I mean, we have obviously greater control and it's more on our execution, but, you know, at the end of the day, it's still two parties for any kind of revenue. We've got that. It's really a mix of international expansion as well as new products. International expansion, we've got the contracts I've mentioned. We've announced additional partnerships in Mexico and Taiwan recently. Europe will open up in 2027, and that's a rather sizable market, not just for COVID, but for all infectious disease. We plan to grow there. Then on the new product side, we'll talk about flu, I'm sure. There's no revenue item that is perfectly under our control. there's no revenue item that is perfectly under our control Even the solidified contracts with the three geographies I just talked about, I mean, we have obviously greater control and it's more on our execution, but, you know, at the end of the day, it's still two parties for any kind of revenue. even the solidified contracts with the three geographies i just talked about i mean we have obviously greater control and it's more on our execution but you know at the end of the day it's still two parties for any kind of revenue We've got that. we've got that It's really a mix of international expansion as well as new products. it's really a mix of international expansion as well as new products International expansion, we've got the contracts I've mentioned. international expansion we've got the contracts i've mentioned We've announced additional partnerships in Mexico and Taiwan recently. we've announced additional partnerships in mexico and taiwan recently Europe will open up in 2027, and that's a rather sizable market, not just for COVID, but for all infectious disease. europe will open up in 2027 and that's a rather sizable market not just for covid but for all infectious disease We plan to grow there. we plan to grow there Then on the new product side, we'll talk about flu, I'm sure. then on the new product side we'll talk about flu i'm sure We've got flu and plus COVID from a combination perspective, both inside the United States and outside the United States. We've got norovirus, that's kinda the, I'll call it, infectious disease or vaccines portfolio. On top of that, I'm sure we'll get into it, but hopefully our INT product reads out well and is approved. PA reads out well, mRNA-4359. We have a lot of shots on goal. Getting back to answer your question, cost is in our control. We have good line of sight to it to bring it down to at least 3.7. Revenue, we've got a lot of shots on goal to get that up to some level like that. We've got flu and plus COVID from a combination perspective, both inside the United States and outside the United States. we've got flu and plus covid from a combination perspective both inside the united states and outside the united states We've got norovirus, that's kinda the, I'll call it, infectious disease or vaccines portfolio. we've got norovirus that's kinda the i'll call it infectious disease or vaccines portfolio On top of that, I'm sure we'll get into it, but hopefully our INT product reads out well and is approved. on top of that i'm sure we'll get into it but hopefully our int product reads out well and is approved PA reads out well, mRNA-4359. pa reads out well mrna-4359 We have a lot of shots on goal. we have a lot of shots on goal Getting back to answer your question, cost is in our control. getting back to answer your question cost is in our control We have good line of sight to it to bring it down to at least 3.7. we have good line of sight to it to bring it down to at least 3.7 Revenue, we've got a lot of shots on goal to get that up to some level like that. revenue we've got a lot of shots on goal to get that up to some level like that

Speaker 3: Great. Maybe related to the cash flow break even plan, and thematically, you all have been clear about reallocating capital towards area with better risk-adjusted returns. Before we get into respiratory franchise and vaccines, just, you know, talking about potentially oncology, autoimmune, rare disease, and of course, partnered vaccines. Can you elaborate on these recent comments? Also if that means that you might explore other modalities outside of mRNA as well. Great. great Maybe related to the cash flow break even plan, and thematically, you all have been clear about reallocating capital towards area with better risk-adjusted returns. maybe related to the cash flow break even plan and thematically you all have been clear about reallocating capital towards area with better risk-adjusted returns Before we get into respiratory franchise and vaccines, just, you know, talking about potentially oncology, autoimmune, rare disease, and of course, partnered vaccines. before we get into respiratory franchise and vaccines just you know talking about potentially oncology autoimmune rare disease and of course partnered vaccines Can you elaborate on these recent comments? can you elaborate on these recent comments Also if that means that you might explore other modalities outside of mRNA as well. also if that means that you might explore other modalities outside of mrna as well

Speaker 2: Yeah. You know, I don't read into those comments as much. Let me just step back for a second. Over the last five or six years, we've probably invested 80% of our research and development into infectious disease, and we've been very conscious about doing that, and we knew we wanted the full portfolio. When we have the full portfolio, we think that brings a lot of value to our customers. What is the full portfolio? That is 2 COVID vaccines, that is RSV, that is flu, hopefully, that is flu plus COVID, and that is norovirus, which can also sell through the retail channel. Yeah. yeah You know, I don't read into those comments as much. you know i don't read into those comments as much Let me just step back for a second. let me just step back for a second Over the last five or six years, we've probably invested 80% of our research and development into infectious disease, and we've been very conscious about doing that, and we knew we wanted the full portfolio. over the last five or six years we've probably invested 80% of our research and development into infectious disease and we've been very conscious about doing that and we knew we wanted the full portfolio When we have the full portfolio, we think that brings a lot of value to our customers. when we have the full portfolio we think that brings a lot of value to our customers What is the full portfolio? what is the full portfolio That is 2 COVID vaccines, that is RSV, that is flu, hopefully, that is flu plus COVID, and that is norovirus, which can also sell through the retail channel. that is 2 covid vaccines that is rsv that is flu hopefully that is flu plus covid and that is norovirus which can also sell through the retail channel Those investments will largely be done, and that's not to say that there can't be more, and we will continue to invest in more, but after investing all that capital, we've got to make that business a profitable, growing, sustainable business, and that's really been the strategy, and I think you'll see that over the next coming years as each of those products grow and as I talk through the international expansion as well. That said, we've always been trying to diversify into oncology. We've always said mRNA is not gonna be a one therapeutic area company. It's gonna be many different modalities and therapeutic areas. We're excited about what we have in oncology, INT, which we'll talk about, I'm sure, which we think can break through on cancer vaccines broadly. Those investments will largely be done, and that's not to say that there can't be more, and we will continue to invest in more, but after investing all that capital, we've got to make that business a profitable, growing, sustainable business, and that's really been the strategy, and I think you'll see that over the next coming years as each of those products grow and as I talk through the international expansion as well. those investments will largely be done and that's not to say that there can't be more and we will continue to invest in more but after investing all that capital we've got to make that business a profitable growing sustainable business and that's really been the strategy and i think you'll see that over the next coming years as each of those products grow and as i talk through the international expansion as well That said, we've always been trying to diversify into oncology. that said we've always been trying to diversify into oncology We've always said mRNA is not gonna be a one therapeutic area company. we've always said mrna is not gonna be a one therapeutic area company It's gonna be many different modalities and therapeutic areas. it's gonna be many different modalities and therapeutic areas We're excited about what we have in oncology, INT, which we'll talk about, I'm sure, which we think can break through on cancer vaccines broadly. we're excited about what we have in oncology int which we'll talk about i'm sure which we think can break through on cancer vaccines broadly Should INT do well, it's kind of the bellwether for cancer vaccines, and we have numerous ones behind them. Then we've got other modalities, in vivo, CAR T therapy, T-cell engagers, and then there's rare disease as well and, you know, an entire pipeline in our research and preclinical behind that as well. I think it's just the time that we are kinda completing some very heavy investments. We have to make that business grow and be profitable, and it's the time to diversify the company as well. Should INT do well, it's kind of the bellwether for cancer vaccines, and we have numerous ones behind them. should int do well it's kind of the bellwether for cancer vaccines and we have numerous ones behind them Then we've got other modalities, in vivo, CAR T therapy, T-cell engagers, and then there's rare disease as well and, you know, an entire pipeline in our research and preclinical behind that as well. then we've got other modalities in vivo car t therapy t-cell engagers and then there's rare disease as well and you know an entire pipeline in our research and preclinical behind that as well I think it's just the time that we are kinda completing some very heavy investments. i think it's just the time that we are kinda completing some very heavy investments We have to make that business grow and be profitable, and it's the time to diversify the company as well. we have to make that business grow and be profitable and it's the time to diversify the company as well

Speaker 3: My final general question is actually gonna be on AI. My final general question is actually gonna be on AI. my final general question is actually gonna be on ai

Speaker 2: Yeah. Yeah. yeah

Speaker 3: I think this is the first time I ever asked about AI at our conference, you know, I can't include a line item in my model on AI yet. Can you just talk a little bit about that, what we might be underappreciating, and when might the fruits of that labor become more obvious? I think this is the first time I ever asked about AI at our conference, you know, I can't include a line item in my model on AI yet. i think this is the first time i ever asked about ai at our conference you know i can't include a line item in my model on ai yet Can you just talk a little bit about that, what we might be underappreciating, and when might the fruits of that labor become more obvious? can you just talk a little bit about that what we might be underappreciating and when might the fruits of that labor become more obvious

Speaker 2: Yeah. It's a great question. It is a total game changer. We are obviously in inning 1, and we believe that we are very far ahead at Moderna across all areas, which I'll get into. There is so much productivity, not just from a cost perspective, but from a working capital perspective in terms of materials management, from a scheduling perspective for patients, which really affects our INT business. There is enormous amount of returns, and we've been very broad across all functions and very methodical about it. I just walked out of a two-hour review with our entire digital team walking through exactly what we've got going on. AI is one thing, but it has to be backed by a terrific set of software and data, and we believe we have that. Yeah. yeah It's a great question. it's a great question It is a total game changer. it is a total game changer We are obviously in inning 1, and we believe that we are very far ahead at Moderna across all areas, which I'll get into. we are obviously in inning 1 and we believe that we are very far ahead at moderna across all areas which i'll get into There is so much productivity, not just from a cost perspective, but from a working capital perspective in terms of materials management, from a scheduling perspective for patients, which really affects our INT business. there is so much productivity not just from a cost perspective but from a working capital perspective in terms of materials management from a scheduling perspective for patients which really affects our int business There is enormous amount of returns, and we've been very broad across all functions and very methodical about it. there is enormous amount of returns and we've been very broad across all functions and very methodical about it I just walked out of a two-hour review with our entire digital team walking through exactly what we've got going on. i just walked out of a two-hour review with our entire digital team walking through exactly what we've got going on AI is one thing, but it has to be backed by a terrific set of software and data, and we believe we have that. ai is one thing but it has to be backed by a terrific set of software and data and we believe we have that There's back office productivity, there's front office productivity. I think we've actually started to realize some of those benefits in 2025. If you remember, we entered 2025 believing we would be $5.5 billion of cash costs and ended at $4.3 billion. Not all of that is AI, and probably a small portion of it, but it's still yielding benefits. It is difficult to model. I can totally understand that. I think you will see the productivity through what is our operating cost and what are those metrics? What does it look like from a margin perspective? What is our working capital? Our working capital last year ended at $150 million, so it's very capital efficient. There's back office productivity, there's front office productivity. there's back office productivity there's front office productivity I think we've actually started to realize some of those benefits in 2025. i think we've actually started to realize some of those benefits in 2025 If you remember, we entered 2025 believing we would be $5.5 billion of cash costs and ended at $4.3 billion. if you remember we entered 2025 believing we would be $5.5 billion of cash costs and ended at $4.3 billion Not all of that is AI, and probably a small portion of it, but it's still yielding benefits. not all of that is ai and probably a small portion of it but it's still yielding benefits It is difficult to model. it is difficult to model I can totally understand that. i can totally understand that I think you will see the productivity through what is our operating cost and what are those metrics? i think you will see the productivity through what is our operating cost and what are those metrics What does it look like from a margin perspective? what does it look like from a margin perspective What is our working capital? what is our working capital Our working capital last year ended at $150 million, so it's very capital efficient. our working capital last year ended at $150 million so it's very capital efficient You'll see that over time as we grow that the cost of the infrastructure of our company does not have to grow nearly as much, and which is why we're still confident in our overall break even and our ability to impact costs in the coming years. You'll see that over time as we grow that the cost of the infrastructure of our company does not have to grow nearly as much, and which is why we're still confident in our overall break even and our ability to impact costs in the coming years. you'll see that over time as we grow that the cost of the infrastructure of our company does not have to grow nearly as much and which is why we're still confident in our overall break even and our ability to impact costs in the coming years

Speaker 3: That's great. We'll get to the specific programs, starting with mRNA-1010 and flu. An unusual regulatory sequence with the RTF and then the BLA acceptance a few days later, to say the least. Maybe you could walk us through that briefly and also touch on the post-marketing confirmatory study in adult 65+, and how you plan to fund that. That's great. that's great We'll get to the specific programs, starting with mRNA-1010 and flu. we'll get to the specific programs starting with mrna-1010 and flu An unusual regulatory sequence with the RTF and then the BLA acceptance a few days later, to say the least. an unusual regulatory sequence with the rtf and then the bla acceptance a few days later to say the least Maybe you could walk us through that briefly and also touch on the post-marketing confirmatory study in adult 65+, and how you plan to fund that. maybe you could walk us through that briefly and also touch on the post-marketing confirmatory study in adult 65+ and how you plan to fund that

Speaker 2: What happened was certainly unexpected. To be specific about it, the refusal to review our application was related to the control arm, and whether it was at the right standard. That was surprising to us because we had had years of dialogue with the FDA. When we reflected on that, we said, "We've gotta dig in and understand a little bit more," and we requested a Type A meeting and through that Type A meeting, worked through it with the FDA and came to a good spot. What is that spot? That spot allows us to be fully approved from ages 50 to 64, and then 65 plus requires will be an accelerated approval should this all be approved. What happened was certainly unexpected. what happened was certainly unexpected To be specific about it, the refusal to review our application was related to the control arm, and whether it was at the right standard. to be specific about it the refusal to review our application was related to the control arm and whether it was at the right standard That was surprising to us because we had had years of dialogue with the FDA. that was surprising to us because we had had years of dialogue with the fda When we reflected on that, we said, "We've gotta dig in and understand a little bit more," and we requested a Type A meeting and through that Type A meeting, worked through it with the FDA and came to a good spot. when we reflected on that we said "we've gotta dig in and understand a little bit more," and we requested a type a meeting and through that type a meeting worked through it with the fda and came to a good spot What is that spot? what is that spot That spot allows us to be fully approved from ages 50 to 64, and then 65 plus requires will be an accelerated approval should this all be approved. that spot allows us to be fully approved from ages 50 to 64 and then 65 plus requires will be an accelerated approval should this all be approved What is required is a post-marketing commitment, which I'll talk about which was one of your questions. I mean, the PDUFA date we got is August 5th or 2nd, which is now five months away, which is terrific. That is probably faster than we've originally anticipated, frankly. We're excited about the opportunity. It is in the near future. We're working well with the FDA on it, that's what I'll say about that overall. In terms of the post-marketing commitment, this is a pragmatic real world evidence study that will take place over several years, it is much more cost efficient than what one might think is a typical, you know, phase II or even phase III trial. It doesn't affect our break even or our cost estimate at all. What is required is a post-marketing commitment, which I'll talk about which was one of your questions. what is required is a post-marketing commitment which i'll talk about which was one of your questions I mean, the PDUFA date we got is August 5th or 2nd, which is now five months away, which is terrific. i mean the pdufa date we got is august 5th or 2nd which is now five months away which is terrific That is probably faster than we've originally anticipated, frankly. that is probably faster than we've originally anticipated frankly We're excited about the opportunity. we're excited about the opportunity It is in the near future. it is in the near future We're working well with the FDA on it, that's what I'll say about that overall. we're working well with the fda on it that's what i'll say about that overall In terms of the post-marketing commitment, this is a pragmatic real world evidence study that will take place over several years, it is much more cost efficient than what one might think is a typical, you know, phase II or even phase III trial. in terms of the post-marketing commitment this is a pragmatic real world evidence study that will take place over several years it is much more cost efficient than what one might think is a typical you know phase ii or even phase iii trial It doesn't affect our break even or our cost estimate at all. it doesn't affect our break even or our cost estimate at all We always knew that we would need some real world evidence over time, and had already positioned and planned for this. We're excited about what's to come. We always knew that we would need some real world evidence over time, and had already positioned and planned for this. we always knew that we would need some real world evidence over time and had already positioned and planned for this We're excited about what's to come. we're excited about what's to come

Speaker 3: Remind us briefly, in the 50+ age group, what % of the flu market that is in terms of vaccines roughly. Remind us briefly, in the 50+ age group, what % of the flu market that is in terms of vaccines roughly. remind us briefly in the 50+ age group what % of the flu market that is in terms of vaccines roughly Is it similar to COVID? Is it similar to COVID? is it similar to covid

Speaker 2: I think COVID makes up a larger majority- I think COVID makes up a larger majority- i think covid makes up a larger majority-

Speaker 3: Yeah Yeah yeah

Speaker 2: ... Of 50+. I think 150 million patient or people vaccinated in the United States. I think it's probably not the same split. I don't know if you have it off the top of your... ... Of 50+. of 50+ I think 150 million patient or people vaccinated in the United States. i think 150 million patient or people vaccinated in the united states I think it's probably not the same split. i think it's probably not the same split I don't know if you have it off the top of your... i don't know if you have it off the top of your

Speaker 1: I do. I do. i do

Speaker 2: I think it's a little bit less than that. I think it's a little bit less than that. i think it's a little bit less than that

Speaker 3: Okay. Okay. okay

Speaker 2: COVID has, I think 55% 65+, 65, 70% 50+. It's not at that level. COVID has, I think 55% 65+, 65, 70% 50+. covid has i think 55% 65+ 65 70% 50+ It's not at that level. it's not at that level

Speaker 3: Okay. Okay. okay

Speaker 2: It's more split 50/50. It's more split 50/50. it's more split 50/50

Speaker 3: Got it. All right. Got it. got it All right. all right

Speaker 2: It's 5x the market. It's 5x the market. it's 5x the market

Speaker 3: Yep. Then, for ex-U.S. regulatory reviews, can you elaborate on that? Has your experience been a little different there than the U.S.? Yep. yep Then, for ex-U.S. regulatory reviews, can you elaborate on that? then for ex-u.s regulatory reviews can you elaborate on that Has your experience been a little different there than the U.S.? has your experience been a little different there than the u.s

Speaker 2: I'll just say that they've all been approved for review in Europe and Canada and Australia. I'll just say that they've all been approved for review in Europe and Canada and Australia. i'll just say that they've all been approved for review in europe and canada and australia

Speaker 3: Great. The flu COVID combo, just remind us the timelines there for ex U.S., how meaningful that is for the opportunity ex U.S. over the next few years, maybe you could touch on your U.S. plans for the flu COVID combo. Great. great The flu COVID combo, just remind us the timelines there for ex U.S., how meaningful that is for the opportunity ex U.S. over the next few years, maybe you could touch on your U.S. plans for the flu COVID combo. the flu covid combo just remind us the timelines there for ex u.s how meaningful that is for the opportunity ex u.s over the next few years maybe you could touch on your u.s plans for the flu covid combo

Speaker 2: Yeah. So on Friday, actually, we announced that we received a positive CHMP opinion on our flu plus COVID combo, which is exciting. And so therefore, we believe that it could be approved in Europe in the coming months. Um, so that's terrific and would be the first combination vaccine in that market, uh, as it pertains to infectious disease. Uh, and we've also filed-- Well, if you think about the US, uh, the US, we are still waiting now that we have a discussion on flu. We need to understand what is required on flu first. So I think that'll take a few months, uh, and be further along into what the FDA is seeing on flu. But I'll remind investors that none of this is planned as revenue in twenty twenty-six. Not any standalone flu revenue, not any co-combination revenue. Yeah. yeah So on Friday, actually, we announced that we received a positive CHMP opinion on our flu plus COVID combo, which is exciting. so on friday actually we announced that we received a positive chmp opinion on our flu plus covid combo which is exciting And so therefore, we believe that it could be approved in Europe in the coming months. and so therefore we believe that it could be approved in europe in the coming months Um, so that's terrific and would be the first combination vaccine in that market, uh, as it pertains to infectious disease. um so that's terrific and would be the first combination vaccine in that market uh as it pertains to infectious disease Uh, and we've also filed-- Well, if you think about the US, uh, the US, we are still waiting now that we have a discussion on flu. uh and we've also filed-- well if you think about the us uh the us we are still waiting now that we have a discussion on flu We need to understand what is required on flu first. we need to understand what is required on flu first So I think that'll take a few months, uh, and be further along into what the FDA is seeing on flu. so i think that'll take a few months uh and be further along into what the fda is seeing on flu But I'll remind investors that none of this is planned as revenue in twenty twenty-six. but i'll remind investors that none of this is planned as revenue in twenty twenty-six Not any standalone flu revenue, not any co-combination revenue. not any standalone flu revenue not any co-combination revenue We really are not expecting this to be a 2026 revenue driver whatsoever. We think it's a substantial growth Both of them are a substantial growth driver, come 2027. The combination, particularly in Europe, as Europe opens up, it happens to coincide with Europe opening up. What do I mean by opening up? We've been basically locked out of Europe for the last few years because a competitor has a contract there which ends by the start of 2027. We'll be able to compete ideally, with both a combination product, with a flu product, and with a COVID product, and RSV, obviously. We're excited about what that means to 2027, particularly in Europe. We're excited for flu in the US in 2027. We really are not expecting this to be a 2026 revenue driver whatsoever. we really are not expecting this to be a 2026 revenue driver whatsoever We think it's a substantial growth Both of them are a substantial growth driver, come 2027. we think it's a substantial growth both of them are a substantial growth driver come 2027 The combination, particularly in Europe, as Europe opens up, it happens to coincide with Europe opening up. the combination particularly in europe as europe opens up it happens to coincide with europe opening up What do I mean by opening up? what do i mean by opening up We've been basically locked out of Europe for the last few years because a competitor has a contract there which ends by the start of 2027. we've been basically locked out of europe for the last few years because a competitor has a contract there which ends by the start of 2027 We'll be able to compete ideally, with both a combination product, with a flu product, and with a COVID product, and RSV, obviously. we'll be able to compete ideally with both a combination product with a flu product and with a covid product and rsv obviously We're excited about what that means to 2027, particularly in Europe. we're excited about what that means to 2027 particularly in europe We're excited for flu in the US in 2027. we're excited for flu in the us in 2027 It remains to be seen what it means for the combination vaccine, which we had planned really to be a 2028 revenue driver. None of our plans have COVID in the U.S. or the combination in the U.S. in 2027 or 2026. It remains to be seen what it means for the combination vaccine, which we had planned really to be a 2028 revenue driver. it remains to be seen what it means for the combination vaccine which we had planned really to be a 2028 revenue driver None of our plans have COVID in the U.S. or the combination in the U.S. in 2027 or 2026. none of our plans have covid in the u.s or the combination in the u.s in 2027 or 2026

Speaker 3: Understood. RSV quickly. You know, should we start to get a little bit more excited about that with a potential flu approval, or do you think you need further maturation of your portfolio to, you know, in terms of contracting for RSV? Should we keep expectations low? Understood. understood RSV quickly. rsv quickly You know, should we start to get a little bit more excited about that with a potential flu approval, or do you think you need further maturation of your portfolio to, you know, in terms of contracting for RSV? you know should we start to get a little bit more excited about that with a potential flu approval or do you think you need further maturation of your portfolio to you know in terms of contracting for rsv Should we keep expectations low? should we keep expectations low

Speaker 2: Yeah. We, we intentionally tried to keep expectations low. Yeah. yeah We, we intentionally tried to keep expectations low. we we intentionally tried to keep expectations low

Speaker 3: Okay. Okay. okay

Speaker 2: There will be growth, but it is nominal growth. It's coming off a low base and growth is helpful, but it is not to the tune of the 10 growth drivers that I've been speaking about. I think what's really required there is clarity around what is the revaccination schedule. In the first year, I think there were 12 million Americans that got vaccinated. This is back in 2023, and that's down to, I think, 2 million or less last year. we were 3rd to market, so therefore, you kinda need another revaccination period for it to warrant-Us kind of breaking in, that comes at a time ideally in the next few years here, where we will have a fulsome portfolio and think we will be able to compete very well. There will be growth, but it is nominal growth. there will be growth but it is nominal growth It's coming off a low base and growth is helpful, but it is not to the tune of the 10 growth drivers that I've been speaking about. it's coming off a low base and growth is helpful but it is not to the tune of the 10 growth drivers that i've been speaking about I think what's really required there is clarity around what is the revaccination schedule. i think what's really required there is clarity around what is the revaccination schedule In the first year, I think there were 12 million Americans that got vaccinated. in the first year i think there were 12 million americans that got vaccinated This is back in 2023, and that's down to, I think, 2 million or less last year. we were 3rd to market, so therefore, you kinda need another revaccination period for it to warrant-Us kind of breaking in, that comes at a time ideally in the next few years here, where we will have a fulsome portfolio and think we will be able to compete very well. this is back in 2023 and that's down to i think 2 million or less last year we were 3rd to market so therefore you kinda need another revaccination period for it to warrant-us kind of breaking in that comes at a time ideally in the next few years here where we will have a fulsome portfolio and think we will be able to compete very well In 2026, actually, in the next few years, we're not counting it as a growth driver. Should there be a revaccination year that is in this time period, that would be upside to what we are planning for. In 2026, actually, in the next few years, we're not counting it as a growth driver. in 2026 actually in the next few years we're not counting it as a growth driver Should there be a revaccination year that is in this time period, that would be upside to what we are planning for. should there be a revaccination year that is in this time period that would be upside to what we are planning for

Speaker 3: Great. Norovirus, you're now guiding the two-season interim data in 2026, which was earlier than prior expectations. Have you provided any granularity on that timing, and what would a successful interim readout look like with that program? Great. great Norovirus, you're now guiding the two-season interim data in 2026, which was earlier than prior expectations. norovirus you're now guiding the two-season interim data in 2026 which was earlier than prior expectations Have you provided any granularity on that timing, and what would a successful interim readout look like with that program? have you provided any granularity on that timing and what would a successful interim readout look like with that program

Speaker 2: Yeah. We're basically, what we've said is that we are enrolling a second Northern Hemisphere cohort, there will be a readout in 2026. We haven't really adjusted the timing all that much. We're excited about it. I mean, just stepping back for norovirus, I think it's getting more and more press nowadays, actually. You know, it is a significant unmet need out there and does impact many lives, again, particularly older adults. I think what most people, most FDA or most agencies look for is at least a 50% vaccine efficacy. Based upon the data that we saw from our immunogenicity studies, both in phase I and phase II, we're encouraged, and we're whole optimistic that it will be a terrific vaccine and read out well. Yeah. yeah We're basically, what we've said is that we are enrolling a second Northern Hemisphere cohort, there will be a readout in 2026. we're basically what we've said is that we are enrolling a second northern hemisphere cohort there will be a readout in 2026 We haven't really adjusted the timing all that much. we haven't really adjusted the timing all that much We're excited about it. we're excited about it I mean, just stepping back for norovirus, I think it's getting more and more press nowadays, actually. i mean just stepping back for norovirus i think it's getting more and more press nowadays actually You know, it is a significant unmet need out there and does impact many lives, again, particularly older adults. you know it is a significant unmet need out there and does impact many lives again particularly older adults I think what most people, most FDA or most agencies look for is at least a 50% vaccine efficacy. i think what most people most fda or most agencies look for is at least a 50% vaccine efficacy Based upon the data that we saw from our immunogenicity studies, both in phase I and phase II, we're encouraged, and we're whole optimistic that it will be a terrific vaccine and read out well. based upon the data that we saw from our immunogenicity studies both in phase i and phase ii we're encouraged and we're whole optimistic that it will be a terrific vaccine and read out well It actually enters a pretty large market. The market for occupational health and healthcare workers and lifestyle travelers, we think it could be rather substantial. I think we put this one also as a 2028 revenue driver, just to be clear. We're hopeful that it is a terrific interim readout this year. Right now, we're planning on a 2028 launch. That really does pair well. We believe it'll be going to the retail channel where many vaccines are sold. Going back to this whole portfolio approach, that's why 2028 is such a difficult year to call from a revenue perspective. It actually enters a pretty large market. it actually enters a pretty large market The market for occupational health and healthcare workers and lifestyle travelers, we think it could be rather substantial. the market for occupational health and healthcare workers and lifestyle travelers we think it could be rather substantial I think we put this one also as a 2028 revenue driver, just to be clear. i think we put this one also as a 2028 revenue driver just to be clear We're hopeful that it is a terrific interim readout this year. we're hopeful that it is a terrific interim readout this year Right now, we're planning on a 2028 launch. right now we're planning on a 2028 launch That really does pair well. that really does pair well We believe it'll be going to the retail channel where many vaccines are sold. we believe it'll be going to the retail channel where many vaccines are sold Going back to this whole portfolio approach, that's why 2028 is such a difficult year to call from a revenue perspective. going back to this whole portfolio approach that's why 2028 is such a difficult year to call from a revenue perspective That's why we've only guided through 2027. We know that we can get to 2028 with a lot of these growth drivers and the ability to take down cost. We're excited about it. That's why we've only guided through 2027. that's why we've only guided through 2027 We know that we can get to 2028 with a lot of these growth drivers and the ability to take down cost. we know that we can get to 2028 with a lot of these growth drivers and the ability to take down cost We're excited about it. we're excited about it

Speaker 3: Great. Transitioning to oncology with intismeran, INT, and several other programs now. Possible pivotal readout for adjuvant melanoma in 2026. If this hits, could, you know, transform the entire company. You made a recent hire in terms of on the R&D front, head of R&D, David Berman, who has tremendous background, who I'm a big fan of. I guess the timing of this readout is, it's very, you know, it's impossible. It's event-based, right? You can't give perfect granularity. What do you think is the probability that it comes in 2026 versus 2027, you know, and slips into 2027? Can you give us anything on that front? Great. great Transitioning to oncology with intismeran, INT, and several other programs now. transitioning to oncology with intismeran int and several other programs now Possible pivotal readout for adjuvant melanoma in 2026. possible pivotal readout for adjuvant melanoma in 2026 If this hits, could, you know, transform the entire company. if this hits could you know transform the entire company You made a recent hire in terms of on the R&D front, head of R&D, David Berman, who has tremendous background, who I'm a big fan of. you made a recent hire in terms of on the r&d front head of r&d david berman who has tremendous background who i'm a big fan of I guess the timing of this readout is, it's very, you know, it's impossible. i guess the timing of this readout is it's very you know it's impossible It's event-based, right? it's event-based right You can't give perfect granularity. you can't give perfect granularity What do you think is the probability that it comes in 2026 versus 2027, you know, and slips into 2027? what do you think is the probability that it comes in 2026 versus 2027 you know and slips into 2027 Can you give us anything on that front? can you give us anything on that front

Speaker 2: Yeah. I mean, all I'll say is everything. I'll just echo everything you said. I can't give a probability. It's obviously enough that we said it could come in 2026. Therefore, we don't control that, obviously, because it is event-driven. Obviously, the last thing maybe the other thing I'd say is just to remind investors, the adjuvant melanoma trial was fully enrolled in September of 2024. What we're looking at is the shape of the curves on the phase two versus this phase three, which was fully enrolled in September of 2024. If you look at that, if it performs similarly, then you should see some kind of readout in 2026. I can't assign a probability to that. Yeah. yeah I mean, all I'll say is everything. i mean all i'll say is everything I'll just echo everything you said. i'll just echo everything you said I can't give a probability. i can't give a probability It's obviously enough that we said it could come in 2026. it's obviously enough that we said it could come in 2026 Therefore, we don't control that, obviously, because it is event-driven. therefore we don't control that obviously because it is event-driven Obviously, the last thing maybe the other thing I'd say is just to remind investors, the adjuvant melanoma trial was fully enrolled in September of 2024. obviously the last thing maybe the other thing i'd say is just to remind investors the adjuvant melanoma trial was fully enrolled in september of 2024 What we're looking at is the shape of the curves on the phase two versus this phase three, which was fully enrolled in September of 2024. what we're looking at is the shape of the curves on the phase two versus this phase three which was fully enrolled in september of 2024 If you look at that, if it performs similarly, then you should see some kind of readout in 2026. if you look at that if it performs similarly then you should see some kind of readout in 2026 I can't assign a probability to that. i can't assign a probability to that I would just say that we've obviously said that it could read out in 2026, which must mean that there is some additional confidence in that. I would just say that we've obviously said that it could read out in 2026, which must mean that there is some additional confidence in that. i would just say that we've obviously said that it could read out in 2026 which must mean that there is some additional confidence in that

Speaker 3: Yep. if it performs similarly to phase two, it's gonna be a huge success, clearly. The data were really impressive. maybe you could just talk... have you guys said anything on powering or kinda what's the minimum bar in RFS or DMFS that you guys need to meet in the phase three to be successful? Can you give us your latest thoughts on the size of that market? Yep. if it performs similarly to phase two, it's gonna be a huge success, clearly. yep if it performs similarly to phase two it's gonna be a huge success clearly The data were really impressive. maybe you could just talk... have you guys said anything on powering or kinda what's the minimum bar in RFS or DMFS that you guys need to meet in the phase three to be successful? the data were really impressive maybe you could just talk have you guys said anything on powering or kinda what's the minimum bar in rfs or dmfs that you guys need to meet in the phase three to be successful Can you give us your latest thoughts on the size of that market? can you give us your latest thoughts on the size of that market

Speaker 2: Yeah. Let me back up and talk phase II, and then I'll answer your question on phase III and then the market as well. The phase II, just to replay the results, at year three, RFS, so no recurrence or death, was 49%. Really obviously a remarkable impact on patients. DMFS was at 62%, I believe, at year three. I guess it was January? January, we just came out with it. It's a lot going on. In January, we came out with our five-year data on phase II, and that basically replicated. We only came out with RFS data, but it was exactly 49% again. Remarkable durability through five years on the phase II, which we're encouraged by. If we saw close to that on the phase III, we'd be thrilled. Yeah. yeah Let me back up and talk phase II, and then I'll answer your question on phase III and then the market as well. let me back up and talk phase ii and then i'll answer your question on phase iii and then the market as well The phase II, just to replay the results, at year three, RFS, so no recurrence or death, was 49%. the phase ii just to replay the results at year three rfs so no recurrence or death was 49% Really obviously a remarkable impact on patients. really obviously a remarkable impact on patients DMFS was at 62%, I believe, at year three. dmfs was at 62% i believe at year three I guess it was January? i guess it was january January, we just came out with it. january we just came out with it It's a lot going on. it's a lot going on In January, we came out with our five-year data on phase II, and that basically replicated. in january we came out with our five-year data on phase ii and that basically replicated We only came out with RFS data, but it was exactly 49% again. we only came out with rfs data but it was exactly 49% again Remarkable durability through five years on the phase II, which we're encouraged by. remarkable durability through five years on the phase ii which we're encouraged by If we saw close to that on the phase III, we'd be thrilled. if we saw close to that on the phase iii we'd be thrilled I think more importantly, patients would be thrilled. As a reminder, it was one of the fastest phase III trials ever enrolled, you know. I think there's a lot of it. We know there's a lot of excitement about it. We're excited about it. If we see something even remotely similar to what we saw in the phase II, I think many stakeholders will be quite pleased. As for the market size, there's, you know, I think 100,000 patients that have melanoma in the United States. I'm just talking United States here, in the United States. I think more importantly, patients would be thrilled. i think more importantly patients would be thrilled As a reminder, it was one of the fastest phase III trials ever enrolled, you know. as a reminder it was one of the fastest phase iii trials ever enrolled you know I think there's a lot of it. i think there's a lot of it We know there's a lot of excitement about it. we know there's a lot of excitement about it We're excited about it. we're excited about it If we see something even remotely similar to what we saw in the phase II, I think many stakeholders will be quite pleased. if we see something even remotely similar to what we saw in the phase ii i think many stakeholders will be quite pleased As for the market size, there's, you know, I think 100,000 patients that have melanoma in the United States. as for the market size there's you know i think 100,000 patients that have melanoma in the united states I'm just talking United States here, in the United States. i'm just talking united states here in the united states When you whittle it down to what phase are they in, you know, have they been resected, you know, it's down to, I don't know if we've given out specifics, but it's in the lower thousands, you know, let's call it 10,000-20,000, that is the market opportunity. Then you have to apply a price to it. We think it brings substantial value, to patients. It's a pretty significant opportunity for us. you know, even 1,000 patients, which we just enrolled in, you know, 14 months or whatever it was, you know, in our first year would be phenomenal. When you whittle it down to what phase are they in, you know, have they been resected, you know, it's down to, I don't know if we've given out specifics, but it's in the lower thousands, you know, let's call it 10,000-20,000, that is the market opportunity. when you whittle it down to what phase are they in you know have they been resected you know it's down to i don't know if we've given out specifics but it's in the lower thousands you know let's call it 10,000-20,000 that is the market opportunity Then you have to apply a price to it. then you have to apply a price to it We think it brings substantial value, to patients. we think it brings substantial value to patients It's a pretty significant opportunity for us. you know, even 1,000 patients, which we just enrolled in, you know, 14 months or whatever it was, you know, in our first year would be phenomenal. it's a pretty significant opportunity for us you know even 1,000 patients which we just enrolled in you know 14 months or whatever it was you know in our first year would be phenomenal

Speaker 3: Five-year OS data from phase II expected later this year, I believe. Five-year OS data from phase II expected later this year, I believe. five-year os data from phase ii expected later this year i believe

Speaker 2: Yeah. Yeah. yeah

Speaker 3: Is there anything you could say about that? What level of benefit would be meaningful or what we should expect? Is there anything you could say about that? is there anything you could say about that What level of benefit would be meaningful or what we should expect? what level of benefit would be meaningful or what we should expect

Speaker 2: Yeah. What we saw in the phase III was early. It was promising, but early from an overall survival perspective. We're excited to release what the phase II data will be through five years at a upcoming conference, both for DMFS and for overall survival. We were encouraged by what we saw, three years in. Yeah. yeah What we saw in the phase III was early. what we saw in the phase iii was early It was promising, but early from an overall survival perspective. it was promising but early from an overall survival perspective We're excited to release what the phase II data will be through five years at a upcoming conference, both for DMFS and for overall survival. we're excited to release what the phase ii data will be through five years at a upcoming conference both for dmfs and for overall survival We were encouraged by what we saw, three years in. we were encouraged by what we saw three years in

Speaker 3: Great. Beyond melanoma, let's see, lung, RCC, bladder, others, when can you lay out the timelines for readouts in those potential indications? Which ones could come sooner than later? Could we get some of those this year? Great. great Beyond melanoma, let's see, lung, RCC, bladder, others, when can you lay out the timelines for readouts in those potential indications? beyond melanoma let's see lung rcc bladder others when can you lay out the timelines for readouts in those potential indications Which ones could come sooner than later? which ones could come sooner than later Could we get some of those this year? could we get some of those this year

Speaker 2: Yeah, great question. I think first it speaks to just how excited both Merck and Moderna are to invest behind this. We now have three Phase III trials, and I think five Phase IIs or, you know, two Phase Is. We've got a lot going on. To speak to what you just asked, I would follow when these trials are fully enrolled. We had previously announced the renal cell carcinoma was fully enrolled sometime in the second half of last year. I forget the exact date. At our recent earnings call, we said muscle invasive bladder cancer was fully enrolled. That starts ticking to when are the events and when can we have a readout, similar to what I just spoke about from a melanoma perspective. That's what I would track. Yeah, great question. yeah great question I think first it speaks to just how excited both Merck and Moderna are to invest behind this. i think first it speaks to just how excited both merck and moderna are to invest behind this We now have three Phase III trials, and I think five Phase IIs or, you know, two Phase Is. we now have three phase iii trials and i think five phase iis or you know two phase is We've got a lot going on. we've got a lot going on To speak to what you just asked, I would follow when these trials are fully enrolled. to speak to what you just asked i would follow when these trials are fully enrolled We had previously announced the renal cell carcinoma was fully enrolled sometime in the second half of last year. we had previously announced the renal cell carcinoma was fully enrolled sometime in the second half of last year I forget the exact date. i forget the exact date At our recent earnings call, we said muscle invasive bladder cancer was fully enrolled. at our recent earnings call we said muscle invasive bladder cancer was fully enrolled That starts ticking to when are the events and when can we have a readout, similar to what I just spoke about from a melanoma perspective. that starts ticking to when are the events and when can we have a readout similar to what i just spoke about from a melanoma perspective That's what I would track. that's what i would track Same thing with on small cell lung cancer. We are still enrolling, once it enrolls, then the events start ticking. There's clearly a lot of investment behind this. They are enrolling rather rapidly. We now have three fully enrolled, I would track enrollment is the best thing I would tell investors. Same thing with on small cell lung cancer. same thing with on small cell lung cancer We are still enrolling, once it enrolls, then the events start ticking. we are still enrolling once it enrolls then the events start ticking There's clearly a lot of investment behind this. there's clearly a lot of investment behind this They are enrolling rather rapidly. they are enrolling rather rapidly We now have three fully enrolled, I would track enrollment is the best thing I would tell investors. we now have three fully enrolled i would track enrollment is the best thing i would tell investors

Speaker 3: Great. In the last couple of minutes, maybe we'll touch on rare disease. You know, you made the decision to out-license the PA program to Recordati. Maybe you could touch on that decision as well as also the decision to keep MMA in-house and the status of that program and the future of the rare disease portfolio. Great. great In the last couple of minutes, maybe we'll touch on rare disease. in the last couple of minutes maybe we'll touch on rare disease You know, you made the decision to out-license the PA program to Recordati. you know you made the decision to out-license the pa program to recordati Maybe you could touch on that decision as well as also the decision to keep MMA in-house and the status of that program and the future of the rare disease portfolio. maybe you could touch on that decision as well as also the decision to keep mma in-house and the status of that program and the future of the rare disease portfolio

Speaker 2: I mean, we're thrilled to have Recordati as a partner. They already sell into PA with a different type of therapeutic. They already have that commercial infrastructure to really rapidly identify patients that have propionic acidemia. This was a capital allocation decision. We think that's the most efficient way to have an impact for PA patients and obviously impact as many as we can, as quickly as we can. It's also, we don't have to invest in advance. We can wait to see the data. We already have a commercial partner, and there are many numerous rare diseases behind that. I mean, we're thrilled to have Recordati as a partner. i mean we're thrilled to have recordati as a partner They already sell into PA with a different type of therapeutic. they already sell into pa with a different type of therapeutic They already have that commercial infrastructure to really rapidly identify patients that have propionic acidemia. they already have that commercial infrastructure to really rapidly identify patients that have propionic acidemia This was a capital allocation decision. this was a capital allocation decision We think that's the most efficient way to have an impact for PA patients and obviously impact as many as we can, as quickly as we can. we think that's the most efficient way to have an impact for pa patients and obviously impact as many as we can as quickly as we can It's also, we don't have to invest in advance. it's also we don't have to invest in advance We can wait to see the data. we can wait to see the data We already have a commercial partner, and there are many numerous rare diseases behind that. we already have a commercial partner and there are many numerous rare diseases behind that Before going and investing ahead of a hopefully a positive outcome, then we can do this with somebody that already can do it, accelerate that program, and then hopefully MMA and many numerous ones behind them, we can make that choice whether we're gonna create our own commercial infrastructure. You'll have a data point. You have a data point on is this, you know, performing well? First of all, did it read out well? Is it commercially performing well? we really, you know, we're excited for patients, but it was also a capital allocation decision, and I think a prudent one to not advance our investment before you actually have, you know, a readout on this. Before going and investing ahead of a hopefully a positive outcome, then we can do this with somebody that already can do it, accelerate that program, and then hopefully MMA and many numerous ones behind them, we can make that choice whether we're gonna create our own commercial infrastructure. before going and investing ahead of a hopefully a positive outcome then we can do this with somebody that already can do it accelerate that program and then hopefully mma and many numerous ones behind them we can make that choice whether we're gonna create our own commercial infrastructure You'll have a data point. you'll have a data point You have a data point on is this, you know, performing well? you have a data point on is this you know performing well First of all, did it read out well? first of all did it read out well Is it commercially performing well? we really, you know, we're excited for patients, but it was also a capital allocation decision, and I think a prudent one to not advance our investment before you actually have, you know, a readout on this. is it commercially performing well we really you know we're excited for patients but it was also a capital allocation decision and i think a prudent one to not advance our investment before you actually have you know a readout on this

Speaker 3: Great. Maybe related to rare disease, you mentioned a continued focus on nucleic acid technologies. Outside of mRNA, that would include RNAi potentially or DNA. Could we see something like a new program on that front anytime soon, or is that a very long-term statement? What's the- Great. great Maybe related to rare disease, you mentioned a continued focus on nucleic acid technologies. maybe related to rare disease you mentioned a continued focus on nucleic acid technologies Outside of mRNA, that would include RNAi potentially or DNA. outside of mrna that would include rnai potentially or dna Could we see something like a new program on that front anytime soon, or is that a very long-term statement? could we see something like a new program on that front anytime soon or is that a very long-term statement What's the- what's the-

Speaker 2: Yeah. Yeah. yeah

Speaker 3: Latest there? Latest there? latest there

Speaker 2: Yeah. Nucleic acids includes that. I think that's a long-term statement. I know we have a lot on our plate to execute and a lot of opportunity, which we are enormously excited about, including in the very near term, next three years. We have enough with mRNA technology to keep us busy for the coming years, and we're excited about it. Yeah. yeah Nucleic acids includes that. nucleic acids includes that I think that's a long-term statement. i think that's a long-term statement I know we have a lot on our plate to execute and a lot of opportunity, which we are enormously excited about, including in the very near term, next three years. i know we have a lot on our plate to execute and a lot of opportunity which we are enormously excited about including in the very near term next three years We have enough with mRNA technology to keep us busy for the coming years, and we're excited about it. we have enough with mrna technology to keep us busy for the coming years and we're excited about it

Speaker 3: Fair enough. In closing, maybe I'll ask you, Jamey, what aspect of the Moderna story do you believe is most underappreciated by investors right now? Fair enough. fair enough In closing, maybe I'll ask you, Jamey, what aspect of the Moderna story do you believe is most underappreciated by investors right now? in closing maybe i'll ask you jamey what aspect of the moderna story do you believe is most underappreciated by investors right now

Speaker 2: That's a good question. Well, the first one I'll just put in a plug, and I'll answer it in two ways. One is the people. I think the people at Moderna are incredible. I think they are extraordinarily accomplished and have an enormous expertise. I think they are passionate, and I think they are resilient, particularly in a time over the last two years that has been challenging for many different reasons. I'll put that plug in for people. I think in terms of the business we're building, I think it is both durable and diversified. I don't think investors, and part of this is us trying to guide investors as well, that we have, you know, a pretty durable COVID franchise, perhaps more so than others might think. That's a good question. that's a good question Well, the first one I'll just put in a plug, and I'll answer it in two ways. well the first one i'll just put in a plug and i'll answer it in two ways One is the people. one is the people I think the people at Moderna are incredible. i think the people at moderna are incredible I think they are extraordinarily accomplished and have an enormous expertise. i think they are extraordinarily accomplished and have an enormous expertise I think they are passionate, and I think they are resilient, particularly in a time over the last two years that has been challenging for many different reasons. i think they are passionate and i think they are resilient particularly in a time over the last two years that has been challenging for many different reasons I'll put that plug in for people. i'll put that plug in for people I think in terms of the business we're building, I think it is both durable and diversified. i think in terms of the business we're building i think it is both durable and diversified I don't think investors, and part of this is us trying to guide investors as well, that we have, you know, a pretty durable COVID franchise, perhaps more so than others might think. i don't think investors and part of this is us trying to guide investors as well that we have you know a pretty durable covid franchise perhaps more so than others might think I think we look at some of the contracts that we have, particularly outside the United States, that should provide a solid buffer for us for years to come. From a diversified perspective, I won't reiterate everything I just said, which is all these shots on goals and the fact that we think we can grow internationally. You combine that with a pretty strong balance sheet that we just ended the year with, both the cash on hand plus the liquidity we have through the loan that we have at our disposal. I think it's a really exciting story that, you know, we can invest behind and be excited about, and we are. I'm not sure that's always appreciated. I think we look at some of the contracts that we have, particularly outside the United States, that should provide a solid buffer for us for years to come. i think we look at some of the contracts that we have particularly outside the united states that should provide a solid buffer for us for years to come From a diversified perspective, I won't reiterate everything I just said, which is all these shots on goals and the fact that we think we can grow internationally. from a diversified perspective i won't reiterate everything i just said which is all these shots on goals and the fact that we think we can grow internationally You combine that with a pretty strong balance sheet that we just ended the year with, both the cash on hand plus the liquidity we have through the loan that we have at our disposal. you combine that with a pretty strong balance sheet that we just ended the year with both the cash on hand plus the liquidity we have through the loan that we have at our disposal I think it's a really exciting story that, you know, we can invest behind and be excited about, and we are. i think it's a really exciting story that you know we can invest behind and be excited about and we are I'm not sure that's always appreciated. i'm not sure that's always appreciated

Speaker 3: Wonderful. Jamey, thank you so much for your time. Wonderful. wonderful Jamey, thank you so much for your time. jamey thank you so much for your time

Speaker 2: Thank you. Thanks for having me. Thank you. thank you Thanks for having me. thanks for having me

Speaker 3: Thanks, everyone, for joining. Thanks, everyone, for joining. thanks everyone for joining