Moderna, Inc. (MRNA) Earnings Call Transcript & Summary

Good afternoon, everyone. I'm Cory Kasimov, one of the senior biotech analysts here at Evercore ISI. It's my pleasure to host our next session with Moderna. And as you can see, we have Lavina Talukdar, the Senior Vice President and Head of Investor Relations. Lavina, always great to see you. Thanks for being with us here today in Miami.

So to get started, why don't I just hand it over to you for kind of a brief review of Moderna's kind of year as you've transitioned into a 2-product company?

Sure. Great. Thank you for having us, Cory. This is a great location. Happy to be here outside of freezing weather up in the Northeast. So thank you again for everyone who's here and listening on the webcast. So this year marked a pivotal year for us where we do now have 2 products on the market. Obviously, many of us know us from our COVID vaccine. But we were also fortunate to have our RSV vaccine approved this year as well, so now we're a 2-product mRNA company. The only company with 2 products that are mRNA-based and on the market. More exciting for the future of the year is the positive Phase III data readouts we've had mostly in that respiratory vaccine space this year as well. Three of which, we are going to file for approval in 2025 by the end of this year, and those include our next-gen COVID vaccine, our RSV vaccine in the 18- to 59-year-old population, as well as our combination flu-plus-COVID vaccine. So filing for approval by the end of this year and looking for approvals in 2025. At our most recent R&D Day, we actually highlighted beyond those 3 programs that are very late stage, other programs that we expect to have filed and approved and contributing to revenue over the next few years between '25 and '28. And those 10 priority programs, I'm sure we're going to get into. But they run the gamut of latent and other vaccines, vaccines for latent and other viruses, as well as oncology and rare diseases. So it's an exciting time for Moderna on the look forward.

Okay. Perfect. So yes, you mentioned the R&D Day in September, a very thorough overview with the priorities and the prioritized programs. One of those priorities, obviously, Spikevax, the COVID vaccine. I guess, what are you learning about the kind of continued evolution of the COVID market now for, I guess, 4 years post pandemic? And how are current trends sort of informing your views of what the future holds when we get to what we anticipate would be a more steady state?

Yes, that's a great question. So you're right. It's 4 years post the pandemic, but really 2 years of a commercial U.S. market. And in the last several years, a few years now, what we're learning is that when people are given a choice, and it's no longer -- it's not a mandated vaccine, but you have a choice to go get your COVID vaccine, anywhere between 40 million and 60 million over that 3-year time horizon are the number of folks that went in and elected to go get a COVID vaccine. This year, in particular, we're seeing very similar trends to what we saw last year. Right now, we still have another 5 weeks to go in this season. But if you look at the curves and the number of doses that have been given last year in that retail segment, because that's where we have the most visibility, to comparing it to this year, the number of doses are really just right on top of each other. A delta of like 100,000 is where we're at, and we still do have another 5 weeks to go. So what we're learning is that COVID is here to stay, and it's a durable and sizable market. So when you think about our revenue from COVID this year, we've projected $3 billion to $3.5 billion, with obviously the vast majority coming from COVID, competitors are looking at $5 billion in revenue from COVID vaccine sales. It's turning out to be a sizable $8 billion market. Year in and year out, we will have to execute and get market share in that large $8 billion market. But that's something that we think our strategy that's in place now and our commercial strategy for the future will really give us an opportunity to prove ourselves there.

Okay. And we follow those vaccination trends very closely and agree. It seems like we're at that steady state, at least gives us more confidence about the future, at least in the U.S. where that gets published. How do you -- how is it different rest of world? And how much more difficult is it to kind of capture share outside of the U.S. for Moderna?

Right. So there are differences in the rest of world areas. So in the U.S., it truly is a commercial market. Whereas the rest of world, we're still contracting with government officials, health ministers and agencies there. And what we're seeing in ex-U.S. markets is that there is some level of lower vaccinations than what we saw during the pandemic, and that's obvious. But we're seeing pretty good uptake in different markets that are committed to vaccinations. And the other thing that's specific to Moderna for ex-U.S. markets is that three of the markets that make up our ex-U.S. revenue will be transitioning next year from advanced purchase agreements or APAs that we've talked about in the past for ex-U.S. markets into multiyear contracts, based on the fact that we've now built facilities in those 3 countries, which include Canada, U.K. and Australia. And as those facilities are being licensed, that transition from APA to multiyear contract will be taking place. So the visibility we have into 2025 as these facilities get licensed is the timing of licensure is really going to dictate revenue from those 3 regions. And those 3 countries make up a good majority of the revenue in the international markets for us. Outside of those 3, in the EU, as you know, we are not a player there because our competitor has a multiyear contract that goes through 2026. So we don't anticipate having share there until really that 2027 time period. And other markets will continue to be APA markets, where we'll be going in and looking forward to signing contracts for the 2025 and beyond years.

Do these contracts just come down to price at this point with various governments?

So price, obviously, is going to be a big factor, but reliability on supply is also something that we hear. We are -- have built up and continue to build up relationships with these health agencies around the world. And so aside from the 3 countries that I spoke to, price does often come up as a big thing, but like supplying and being a good partner is also very important.

Something I've never thought of before but curious if you know. How do flu vaccination rates compare outside of the U.S. within the U.S.? And does that give you any sort of insight into where COVID vaccination rates may go in the future?

Yes, good question. So flu vaccination rates in the U.S. are pretty high. There are 150 million flu vaccinations that are given every year for the last 5 to 10 years in the U.S. That compares to an overall global number of 500 million to 600 million doses, but obviously spread out through the world. The U.S. is one of the larger vaccination countries there is, which is why it's a sizable market for all companies. But I don't have any more detail.

Okay. No, that's helpful. So back in the U.S., one particular tailwind that seems to have gone, I guess, somewhat surprisingly unnoticed is ACIP's recent recommendation for revaccination against COVID for some segments of the population. Any thoughts you have on how this might impact kind of the U.S. market going forward?

Yes, that's a great question. So just this past October, ACIP recommended a spring vaccination, if you will, for older adult populations and immunocompromised populations. So those are the folks that are most at risk. And so that sets up for a 2-vaccination schedule in a year, if you will, for those populations, one in the spring. And I think what they're doing is following what we're seeing, now 2 years in, of summer or late summer surge. So to really protect those vulnerable populations, the recommendation is to get a spring vaccination as well as one in the fall when we're all congregating inside, and that's when transmission rates are the highest. What that means for the market overall is that there likely will be more because the recommendation came earlier than it did last -- this earlier this year, for instance. Could be that there will be more vaccinations throughout the tail end and into that spring season in that first half as a result of that recommendation. But it is still early days, so we're watching to see how that turns out.

Right. And I would guess, as you guys think about guidance next year, do you -- you'd stay conservative in terms of thinking through the impact of that, at least first year in?

Sure. So that's right. We would stay pretty conservative just because it would be like the first year in, maybe the second year, depending on how you're counting it in terms of what that uptake rate looks like. We did give a framework on how we're thinking about 2025. We gave that framework in September of this year. So it was before we even had a view on this season as well as some of the things that we just talked about. On timing, we'll gain a lot more visibility as we go through the first part of that year. So that's when we'll have more information on the actual guide for 2025.

Okay. All right. So let's talk about the second product now, mRESVIA for RSV. Obviously, initial sales have been below what was expected coming in for the entire category. This is not just an mRESVIA issue. What do you make of the headwinds? And how difficult might this be to overcome without revised guidelines?

Yes. So there are, I guess, Moderna-specific issues in the mRESVIA number, obviously, but also more of a market question in there as well. And so on the mRESVIA front, we unfortunately were shut out of the contracting season by virtue of our approval coming at the end of May and then the June ACIP taking place in the middle of June, for instance. And so we didn't really have a seat at the table for the major contracts that were being finalized and signed. So we missed that opportunity in 2024. We learned from that. And so many of our approvals for the additional vaccines are now approvals, but we're looking for contribution to revenue in the year following approval as a result of that experience with mRESVIA. When it comes to the market, the ACIP did hold a meeting in June that kind of spelled out what they are recommending as for RSV vaccinations. And it's for all comers who are 75 and above, those with high-risk factors who are 60 to 74 years old and immunocompromised. So there isn't a revaccination schedule that's been talked to yet. That could be a big driver of really understanding this market. In the meantime, the number of individuals who are eligible for an RSV vaccine, even with a lifetime recommendation because that's kind of the stop gap until we have a revaccination schedule, is still pretty sizable. This year, we're going into this season with 50 million Americans who are eligible, off of those ACIP guidelines for next year. However, many got the vaccine this year. You would subtract that from that 50 million eligible population. It will still be a sizable opportunity in the U.S. And then for next year, we're expecting to have approvals in ex-U.S. countries, where we hope to make some inroads and gain market share for mRESVIA as well.

Okay. So to go back to the contracting, were you surprised that the contracting was done prior to the approval in the ACIP meeting? Because earlier on in the year, the company had a lot of confidence in the outlook for mRESVIA. That didn't pan out because of how contracting played out.

We -- I would say we were surprised because the feedback we were getting, not in contracting discussions because you can't have those until you have the approval, but through our medical affairs conversations with customers, was that they were looking forward to having another product potentially as an offering, especially given our prefilled syringe that we were very excited about as well. So when contracting was pretty much sealed as well as inventory being sold into the channel, it took us by surprise, which is why, unfortunately, we didn't have the sales we expected to have with RSV.

Okay. And then I'm very curious kind of what your market research is telling you and whether this is coming from your field force or -- in how this RSV market might evolve. What are the KOLs telling you? Do you have any insight into what ACIP is thinking with regard to some of the longer-term data that's coming out from -- be coming from Moderna, also be coming from your competitors, in terms of what an eventual revaccination schedule might look like?

Yes. So we could also -- instead of just reading the tea leaves, if you actually listen to some of those ACIP deliberations, it's very clear that they really want to understand what that revaccination schedule should look like. And there are some data sets that they might be waiting for. A few of those are how effective are these vaccines as you're going through multiple seasons. So far, ACIP views all 3 vaccines on par with each other in terms of the VE in multiple seasons. What they may be looking for is really understanding a correlate of protection. And there, you're going to look for antibody level data. That equates to some level of vaccine efficacy. And then it's a question for them on what level of vaccine efficacy that correlates with that antibody level that they're most comfortable with going into a season and having that level of vaccine efficacy. So as that data is available from ourselves and from competitors, I think that's going to influence their decision on revaccination. The other thing that they look at through the real-world experience data is really the risk benefit. And so there has been some level of GBS that has been seen with the competitor vaccines. We have not seen that with mRESVIA, our RSV vaccine, nor have we seen that with our COVID vaccine. And it's the same technology. So that risk-benefit profile will also, in some populations, define maybe how they're thinking about revaccination. So I think it's really just stay tuned. ACIP meets 3 times a year, February, June and October. So there'll be multiple opportunities to really understand what they're looking for before they make that recommendation.

Okay. And what's the plan for Moderna to update the longer-term data from your clinical trials?

So just at the recent ACIP meeting, we shared 3-season data. And we showed it on our primary endpoint, which is 2 symptoms of RSV. But we also shared some data that, while none of these studies were done head-to-head, looks closer to a more severe endpoint, which is the shortness of breath endpoint. And when you stack our vaccine up against the competitor vaccines, particularly the GSK one, the overall 3-year data, 2-year data and 1-year data look very similar to each other when you're looking at a more severe endpoint in 2 symptoms plus shortness of breath. And so going back to probably one of the reasons why ACIP felt good about parity recommendation.

Okay. And then lastly, on the subject, can you explain the decision to use one of your prior -- or to use a priority review voucher for the approval of mRESVIA in the 18- to 59-year-old high-risk segment? How meaningful of an opportunity is that for the product?

So it's really a positioning opportunity, right? The broader indication that you can have for your vaccine, the better positioned you are during contracting season. So we are using a priority review voucher. For this particular program, it's an sBLA. So using a priority review voucher for sBLA shaves off 4 months of the review time, so it's a 6-month review time, which could get us to the June ACIP for deliberation on the 18- to 59-year-old population. And so that was the rationale for using it there. For new BLAs, it's an 8-month review time, and we are using another PRV for our next-gen COVID vaccine.

Okay. Does it imply -- I mean, just correct me if I'm wrong. If the going rate for PRV is in that $100 million to $150 million range, by using that on this application, that you have confidence that getting this approval sooner and the contracting you would get, you would more than make up for that in what you would do in sales in 2025?

It'd be great to like have a 1:1 relationship like that, but it really is kind of over time and making sure that we are positioned well with that RSV broader indications.

Okay. And then I guess, to stay on this PRV subject, but different product. Curious as to why you decided not to use that for the COVID-flu combination, the mRNA-1083.

Yes, great question. So you're right. We announced that we will not use a PRV there and save it for a different product in our pipeline, mainly because with the combo flu-plus-COVID, it is a new BLA, not an sBLA, so it's an 8-month review time. And you would -- unless you're signed, sealed and kind of filing as early as October, you're really using that PRV for naught. As well as the contracting season for flu being a little bit earlier than for COVID, it's unclear to us. Does it go for the -- does contracting happen on the COVID schedule or the flu schedule? So it was just better not to use the PRV for that program and save it for the multiple other programs we have in development.

Okay. That makes sense. So let's assume down the road, people have a choice between a COVID-flu combination vaccine and then, of course, each of the vaccines on their own, the COVID one and the flu one. How do you anticipate this market might shake out in terms of who chooses to get what?

Yes, that's a great question. We do have some data in that commercial market setting over a couple of years now. And what we've seen is that when you're at a CVS or Walgreens, the number of people who go in, signed up for just a flu vaccine or just a COVID vaccine, if offered to get either the flu or the COVID at that same setting or within a short period of time, now we have data that suggests 25% to 50% of people will elect to get both. And so that gives us some starting point to try and figure out what the penetration of a combo would be. And that's real-world evidence type data, if you will.

Okay. And is this people who -- do you anticipate this is collecting more individuals who are on the fence about whether they would get a COVID shot or a COVID boost? And they're going in to get a flu shot, so like just the idea of, all right, since I can get it both in one shot, that's -- is that like the primary target market for this?

It would be a good target market for it, not necessarily the primary target market for it. But it really is trying to bring up the compliance rate with COVID because there's 150 million people who get flu vaccines in the U.S. But roughly only 50 million, let's call it, over the season, in COVID. And so what the combination offers is compliance for both, and you're really trying to use the flu to piggyback off of flu to bring up COVID vaccination rates. So we'll see how that launch goes, but some of the data that we have, the 25% to 50% that elect to do both when offered, is a good starting point to kind of think through that.

And then when you think about Moderna getting into the flu business, how confident are you that the reactogenicity is something that would be acceptable to individuals getting the flu shot? I mean because people have been used to getting a flu shot for a very long time, and it's no big deal. And the adverse event rates, they're low, right? The grade 3-plus are low, but they're not nothing. And so like what does your market research tell you about the uptake that, that would have relative to what's out in the market today from the Sanofis of the world?

Yes. Good question. So the first combo product that we will get approved is in that older adult population. And typically, in the older adult population, you don't see the reacto as strong as some of the 18-year-old population, for instance. That could be due to like the immune response that they're having, for instance. And so, so far, it hasn't been a detriment in the market research that we've done in that segment of the population. We are working on an 18- to 64-year-old population program, and that might be at a lower dose because the dose is related to your reactogenicity profile. That's still in development and for future -- bringing it to market in the future. So our market research on the combination, from the data that we've shown thus far, the 2 combined isn't a 1 plus 1 equals 2 on the reactogenicity. It's more like a 1 plus 1 equals 1.2. And in that older adult population, market research says that it's going to be well tolerated.

Okay. And then last question on the flu front. I remember going back to the days when you were still private and we were meeting, and the big competitive advantage or one of the big competitive advantages for mRNA technology is the efficiency of manufacturing and the speed of manufacturing. And so this notion that you could wait until longer in the season to get a better prediction of what these flu strains would be that would be circulating make the product -- make a more accurate product for that particular season. That doesn't seem to get talked about anymore. Is there something that -- is that still on the horizon or a possibility that could emerge in time?

Yes, that is. And so let me walk you through the thinking on that and some of the evidence we have that we don't need as much lead time. So in the COVID setting, for instance, for the last 3 years now, the selection of the variant has happened roughly 2 months before the season starts and before supply needs to be ready. And we've delivered for the last 3 years on that selection. It shouldn't be any different for flu. So we can produce a flu vaccine very close to the season 2 months out, just like in the COVID case. Traditional flu vaccines do require 6 to 9 months of lead time in order to make enough quantities of vaccines to be on the market. And so the reason why maybe it doesn't get talked about is the first stop would be for us to get an mRNA flu vaccine on the market. Once we're on the market, there are years where there is a large mismatch in what's in the flu vaccine, the traditional flu vaccines, versus what's circulating during flu season. We could, if we're on the market already, work with regulators to have, in those years of large mismatches, a vaccine that's ready 2 months prior to the season and then look to see if that makes a big difference. We think it should because you're closer to the circulating virus. But that real-world evidence data could actually then highlight that advantage on mRNA vaccines that you're talking about.

Right. Okay. Yes, I think it would be incredible if something could pan out in the future. All right. So I want to talk a little bit about CMV. This is obviously somewhat imminent Phase III readout here. Can you kind of discuss the program and elaborate how the interim look works here in this case?

Sure. So what we've said about the program is that we anticipate that the first interim analysis, which is triggered at 81 events or cases that happen in the study, should occur by the end of this year. Once it occurs, it's no longer Moderna that's looking at the analysis. It's the DSMB that will do the analysis. That analysis takes some time. And given that it's towards year-end, there's no guarantee that the DSMB is going to drop everything and get the results out to us by December 31. So it could fall into the early part of next year is one point on that CMV first interim analysis. And then the second point is they will let us know if we've hit on that interim analysis or not. And because the process of the analysis takes some time and we're continuing to accrue cases, in the meantime, it could be that if they tell us that we didn't hit at the interim, we only need a few more cases, several more cases, to get to the final analysis, which is 112 events, that we may just wait to give the market or the Street the full analysis data at the final analysis. And so still yet to be determined in terms of how we're going to communicate that, but those are the 2 points on the CMV data readout.

And you guys have talked and published the graphs on how it looks in terms of the overall efficacy for the study to hit at various time points. How important is that ultimate efficacy when you think about the market opportunity for CMV? Do you think there's sufficient -- I guess, it's a multipart question. Do you think there's also sufficient awareness about this virus and maybe the role ACIP can ultimately play here?

Yes, good question. So we do think there is going to be education on our part for this market. Like you said, not many people are aware of CMV, although certain physician communities are highly aware of CMV. OB/GYNs, for instance, very highly aware of CMV. But the public isn't like they are for flu, for instance. So there is going to be an education piece to the launch here. The way to think about the vaccine efficacy at that very first interim, the minimum we have to hit is about 58% vaccine efficacy to be stopped at that first interim. And at the final, it's 49%, about 50%, let's call it. And so some people have asked us, is that enough to get a vaccine on the market? And so there are examples in the past. ZOSTAVAX is one of those examples for shingles that was approved on a roughly 50% vaccine efficacy. It was the only product on the market. Until many years later, Shingrix came on to the market. And so there's that example. So we think 50% is the bar, roughly 49%, 50% is the bar for us to deem the study as a positive study. And then we'll go to the regulators and ACIP. In terms of uptake, there's always this perception, right, that higher numbers are better. And so could the uptake in the education efforts be smoother if it is higher than 50%, at the 60%, 70%, we're aiming for much higher? Yes, that seems reasonable to us. But nonetheless, at any level of vaccine efficacy, we think there's education that needs to get done in this marketplace.

Okay. And I mean there's -- there are analogs you look in the past, where vaccines that are now very large struggled initially until ACIP issued guidelines and their kind of broad treatment recommendations for them. Would you expect that to be the same for CMV?

Yes. That's a great question. So we do talk about CMV and using GARDASIL as a proxy because there are many similarities here. GARDASIL, when it was first approved, it was to prevent HPV infection that would ultimately prevent cervical cancer, so you're vaccinating now for the real benefit down the road. With CMV, we are vaccinating women of child-bearing age in the first indication to prevent birth defects because CMV is one of the -- it's the leading cause of infectious birth defects in women carrying a child. And so there is that kind of latent or later positive effect that we're looking for. And so with GARDASIL, where you saw kind of a slower ramp at first, it was approved for HPV prevention, which kind of came with a stigma around being sexually active in like young populations. But when it was understood that there was this benefit of preventing cancer, cervical cancer, that's when it really kind of took off. So maybe early in the trajectory of CMV, you can think of it as smaller in terms of market potential. But over time, it can get much larger with education and understanding in that first population of women of child-bearing age. But there is a part 2 to the CMV, which is that we are now in the midst of an adolescent study in a Phase I/II identifying a dose to take forward there. And that $2 billion to $5 billion opportunity that we talk about, the high end really contemplates getting into universal vaccination for adolescents because CMV is one of those viruses like rubella, in a similar issue with rubella with birth defects, where humans are the only species that's infected by CMV. So it's not zoonotic where it can go from species to species. So there is this potential with universal vaccination to get very close, if not eradicating CMV, as an issue for the human population. We did that with rubella in the world. I mean, there are some pockets where if you're not getting your MMR vaccine, you can see rubella outbreaks. And because of eradicating rubella for the most part in developing and developed nations, we don't see deafness as a birth defect. And in fact, if you look, many of the schools for the deaf have kind of come down ever since MMR has been universally recommended. So ultimately, we do want to get into that pediatric population life cycle management through this and get into the 9 to 15 year olds, which is where we're studying the vaccine right now in a Phase I/II.

Got it. Okay. So another potential first of its kind vaccine you're working on is the norovirus vaccination. Can you go into again a market research here in terms of the unmet need in the target population you would have for this particular program?

Sure. So we are in a Phase III study. That started already this year. It is a 2-season study, so -- but if we get enough cases in this season, there's a likelihood that it could read out in mid-2025. So where are we targeting that study and the population, the eligible populations? So norovirus is a lot like the flu virus but for your gut, and so the virus itself has many different genotypes. Could ultimately need boosters in the future as well as updates to the virus -- to the vaccine itself. And so the target populations we're going after are older adult populations because they're very vulnerable to norovirus because of a weakened immune system. But also, occupational risk folks, those that are working in hospitals or in the health care industry as well as lifestyle risk factors like cruise goers, for instance. Many of them actually know about norovirus because it could ruin your vacation plans if there's an outbreak. And so adding all of those populations together, we estimate it's about 155 million people who would be eligible for this vaccine, and we are studying that group in the Phase III study. So again, ACIP will be pretty much involved once we get approval, knock on wood, hopefully, if the study looks good, to then be the recommending body for norovirus vaccines.

And is the study looking at -- you get vaccinated for this, you see the efficacy of the vaccination. Longer term, following up to about -- you mentioned boosting and things like that, how are you going to evaluate that?

So there is a potential for boosting down the road, especially given if you do see the different genotypes become more prevalent in different years. And so that's still yet to be determined, but there is this cadence of getting infected and reinfected over a few years even in the epidemiology of norovirus.

Okay. All right. Another completely different subject now, another very important program for the company is the INT cancer vaccine. Can you kind of, I guess, just start to provide kind of the status of the various trials that are ongoing here?

Sure. So it is a full development program with our partner, Merck. And we are in a Phase III study against adjuvant melanoma. This is where we shared Phase II data head-to-head against the standard of care in adjuvant melanoma, which is KEYTRUDA. And we were testing INT plus KEYTRUDA versus KEYTRUDA alone. That's a similar population that we're going after in a Phase III study with the same setup there, which has now met its target enrollment as of September of this year. If you look at the Phase II data readout, this curve, survival curve start to separate at 12 months, and then really separate in our stat sig or statistically significant at 18 months. So now that we are at target enrollment, is it fair to think that readout in the Phase III could happen anytime between September '25 and the first half of 2026? I think it's pretty reasonable. And so that's the Phase III in adjuvant melanoma. We have 2 adjuvant non-small cell lung cancer studies ongoing right now. The first one started in adjuvant -- sorry, non-small cell lung cancer, and that was October of 2023 when that started. Very recently, less than a month ago, we announced a periadjuvant, if you will, study where you're getting in the neoadjuvant setting KEYTRUDA plus chemo, followed by adjuvant INT plus KEYTRUDA versus KEYTRUDA alone or with placebo. And that study is really asking the question, for those folks who do not respond to neoadjuvant therapy, and it's about 50% of folks right now, can we still help them in the adjuvant setting with an INT plus KEYTRUDA program? And so that study, again, just started enrolling and is up and running. So that's another Phase III. We have a Phase II/III in cutaneous squamous cell carcinoma that's ongoing as well as 2 Phase IIs, one in bladder cancer adjuvant as well as adjuvant kidney cancer. And those 2 are set up to -- and powered to potentially become pivotal studies, should those programs actually look good if the data looks good there.

Okay. And you obviously decided not to pursue accelerated approval after some feedback from the FDA. Certainly doesn't seem to have dampened the company's enthusiasm for this program at all. At the end of the day, how much time would that have shaved off anyway, if you're looking at the outcome of this Phase III trial over potentially the next 12 to 18 months?

Yes. So at R&D Day, we gave you kind of a schedule of when we think these approvals might come through. And for adjuvant melanoma, we said 2027 for an approval. So it would have shaved off, if we were successful with an accelerated approval, probably a year or 1.5 years from that approval time from 1.5 years to 2 years. And so it's unfortunate that we didn't get that. We thought we should absolutely give it a try, and so we did.

Okay. So in the last few minutes we have here, I'm going to shift back to some bigger picture questions. And one I want to would just love your take on is what's going on with the stock in terms of where it's trading at current levels. What do you feel like investors are missing right now? And what can the company do to change the narrative?

Sure. That's all good questions. So there's the overarching everything that's going on with the incoming administration that I think is affecting all biopharma companies. And we've worked with both administrations. We've worked with the Trump administration in the past during the pandemic and very successfully worked with them. So we're just going to continue to make sure that we're bringing what we can control, innovative medicines to market. And so I think that's one factor on what's going on with the stock. The other, I think, hopefully starts to get a little bit cleared up, which is there was this narrative that COVID was going to just disappear as a market. And so what we're seeing this year, with still 5 weeks to go in the season, is that COVID is here to stay. And it's a sizable and durable market. So $8 billion market. Again, we'll see what our share looks like each year, year in and year out. Our strategy is to have the largest portfolio of vaccines that we can offer because that should give us a competitive advantage in positioning all of our vaccines, both on price as well as market share. And so we look forward to executing on that strategy. I think what the market is missing is that they're very overly concerned about cash burn and not giving us credit for like what that investment, we like to think about it as investment, may bring to the top line. So we've laid out for everyone, there's 10 products that are potentially coming to market between next year through 2028. If you consider COVID a stable market, and this year, we're going to do $3 billion to $3.5 billion in revenue, give us a haircut and say it's a $2 billion revenue -- recurring revenue stream for us. Then you're looking at an incremental $4 billion in revenue to the top line by 2028. A lot of these programs have been de-risked because we have Phase III data, so it's now just getting the regulatory approval. Many of them are in large opportunities that are multibillion dollar TAMs. So if you're lazy, let's say, you can take that $4 billion incremental revenue, divide it by the 10 programs, and you're looking for an incremental $400 million in revenue from each of those programs, which doesn't seem like a very tall order. I mean, there's work to be done for sure. But there are many of those programs, and products will be with limited or no competition. And in cancer, for instance, if it looks good for adjuvant melanoma with INT, we're against the standard of care. So we're looking forward to what that looks like. I think a lot of investors are more climbing that wall of worry about cash burn and not thinking of it as investment that could lead to better returns because revenue is coming in.

No, it makes total sense. Okay. So in our last minute we have, there's obviously a lot going on with the company right now. As we look ahead to 2025, starting with CMV data likely early on in the year, what do you see is the other potential really true value-inflecting milestones for Moderna next year?

Yes. Great question. So you'll have on the data side, the CMV data. You could potentially have the data from the norovirus, should the first season be enough in terms of the number of cases. You -- we would be in a position to have stand-alone flu vaccine efficacy data. And that's -- again, it's a 2-season study, but if we have enough cases in this first season. There's a potential late in the year because of that window of when events could accrue to the adjuvant melanoma study. And then just the approvals, right, that we're filing for approval on, as we're getting regulatory decisions on those approvals, that can serve as potential catalysts that de-risk the future of the company.

Perfect. A lot to look forward to. Thank you very much, Lavina, for being here.

Thank you for having us.