Okay. Good afternoon, everyone. Thank you for joining us at the UBS Healthcare Conference. I'm Ellie Merle. I'm one of the biotech analysts here at UBS. Very happy to have Moderna here with us today for a fireside chat. Joining us for Moderna is Jamey Mock, Chief Financial Officer. Jamey, thank you so much for joining us. Maybe to kick it off, you had a strong third quarter, but we've seen the recent stock move. Maybe what are some of the implications of the recent election and potential political headwinds or potential noise that you're at least hearing from a headline perspective?
Yeah, well, first off, thanks for having us, Ellie. It's great to be here and thanks to UBS as well. Yeah, so we'll get into the quarter, which we thought was a good one, but yes, there seems to be some amount of political overhang. When we look at it, I think it's more noise right now than actually a long-term effect. I think if you listen to what's been said, nobody's saying that they're going to take away vaccines.
I think a lot of people want the actual data and the science to be shared, and we stand behind our science, and we stand behind our data, so we've always led with a science-first mentality. We believe in our products. We have to take all the right precautions around that, so I'm hopeful when the truth comes out around that, that it'll be more noise than actual change. And in the past, we've worked with the Trump administration in the past during COVID. And so we've worked with several different administrations of both sides, both political parties. So hopefully, it will just be a short-term noise and not really a long-term impact. That's not what we believe.
That's reassuring. Maybe turning to the quarter and how to think about COVID for this year. Yeah, how should we think about the breakdown between U.S., ex-U.S., and what you've seen so far in terms of volumes? I think COVID has probably been one of the most challenging vaccines to model.
It has, for sure, and even we've struggled with it over time, though I do think that the major takeaway through the season right now is that I think we're really starting to see stability, so I'll get into the numbers in a second, but if you just look at the amount of people that have actually been vaccinated through the end of October, it's already at 20 million, over 20 million Americans, in retail, that is, so we'll get into which is the largest part of vaccination in terms of markets, but we'll get into the other two markets as well, but if you look at through December 31 last year, there were 28 million, so 28 million Americans that got vaccinated with COVID, so we're almost already there, and we still have two months to go.
So I think while it has been difficult to predict over time, we're starting to see some stability. And so that's why we've been saying, hey, we believe this is a durable, in sizable market. And I think that's the major takeaway we see thus far. As for the quarter, I'll get into the revenue. But we held our revenue guidance of $3 billion-$3.5 billion. And I'll go through some of the variables that we laid out there. I think we also are really proud of the productivity that we're seeing within the company. So in all categories, we saw our cost of sales come down in terms of the range as a percent of sales came down for the year. We took R&D down versus our prior guidance. And then SG&A is going to be down 20%. And it was down 36% in the third quarter.
So really happy there. And we also said we'd end the year with $9 billion in cash. And that's with the purchase of our Norwood facility for $400 million, which will happen by the end of December. And so all that productivity we're seeing affords us the ability to actually purchase Norwood and still have $9 billion in cash. But back to the revenue guidance. So as you just said, we broke it down between the U.S. and then OUS. And there's probably three variables inside the United States and two variables outside the United States as it pertains to 2024's guidance. And then we can talk about 2025 and beyond. So as it pertains to the United States, there were really three things. One is the market size, which I just talked about in terms of we've already seen 20 million vaccinations.
We track it on a COVID to flu ratio, and I won't get into all the details, but we kind of see the market being flat to maybe down 10%, but we're already 70% there from where we were last year, and there's still a healthy part of the season to go. Second is market share, so we've been seeing in retail as well, 40% market share, and so we've assumed at the low end of our guidance that that will continue, and so if the market's down 10% and our market share is at 40%, and we'll talk about RSV, that'll be the low end. The high end would actually be a flat vaccination market, and our market share upticks a little bit, which we're hopeful for, but at this point, we're just being conservative at this point, and then RSV, we're not assuming much uptick as well.
We can talk about the RSV market. I'm sure we'll get into it. That is changing and evolving over time. We're not assuming any uptick. If there is any uptick, that would also provide the high end of our guidance. In terms of outside the United States, there's really only a couple variables left. Most of the revenue we forecasted for the fourth quarter is contracted and confirmed already. It's already November 13. We're a good bit through the quarter already. There's really two variables. One is specific revenue recognition items in a couple markets that will either fall inside the year 2024 or inside the year 2025. It won't be lost revenue. Then the second is our performance in some markets, markets like Japan, markets like Switzerland. I don't think it's a major driver in the low end of our range.
But if it comes in higher than our expectation, then it'll add a little bit. So that's kind of what we said. But all told, we're really proud of the productivity. We're really proud of where we are from a cash perspective. We're maintaining our guidance. And I think we feel even much more comfortable with the variables that remain to at least get to the low end and hopefully better than that.
Great. In terms of COVID market share, and we'll talk about volumes going forward as well. But just starting with market share, what are the factors here that you think are driving this?
That's a great question. So particularly in the United States, that really comes down to having the full portfolio. Well, there's a couple factors. One is the timing of when our products were launched. So for instance, in 2024, we weren't approved with RSV until the end of May. And so that prohibited us from actually getting into the contracting period. So that's one big factor. But as I just think bigger picture and look forward, our goal is to build the best respiratory portfolio out there.
So we already believe we have the best COVID product. Having all the full indications of RSV is important, getting into the flu market, and then ultimately coming with a combination vaccine. And then there are other vaccines that we'll bring to market, like norovirus, that will really be sold through the retail channel as well.
And so when you really have the full portfolio, I think we will be in a much stronger position. So we're heading into 2025 in a better position because we have RSV as well as COVID. But we won't have flu at that point. We won't have combination. So it'll be better, but not the full portfolio by that time. But then to the 40% market share, I think you can see over time, one of the good pieces about respiratory, one of the good pieces of news about respiratory is it's a huge market.
The flu market's a $7 billion market. COVID's an $8 billion plus market. We believe RSV will be a large market. We hope combination vaccines increase all of that. It's not respiratory. But norovirus, we believe, will be a sizable market. So when you add all that up, it's a $20 billion plus market. Our job is to get 25%, 33% share. You've got a pretty sizable respiratory business there. That's kind of our overall goal moving forward.
Thinking long term, I mean, I guess we'll see in terms of market share in 2025 ahead of the combo launch. Thinking 2026 and beyond, if you are the only COVID-flu combination vaccine, now, I mean, volumes is a separate question. Just in terms of the people that are getting their COVID vaccine, what is sort of your market research suggest in terms of how having a combo could impact market share if you're the only combination vaccine?
Yeah, so big picture in terms of the amount of people that get flu, so a flu vaccination, that is, there's about 150 million Americans that get a flu vaccination, and I mentioned the 28 million through the end of December for COVID. But really, if you look at total COVID, it's probably like 45 million Americans that get COVID. So I think our hope is that really, by getting into the flu market, people will just naturally uptick a little bit of the COVID vaccine as well, and so that increases the compliance and increases the overall size of the COVID market.
But even absent that, if we just people that are getting COVID vaccinations, I think some people just want one shot, and so therefore, you can maybe take some of the flu market as well. So we have two growth vectors there. Either we are capturing some portion of the flu market, or we're actually increasing the overall size of the COVID market. And as for our projections, I mean, I think we've learned a lot as we've tried to forecast COVID and our overall revenue projections.
So I think we've been very realistic about what is the impact to the year 2026. Should it be approved and ready for 2026? And then what does that grow over time? We're not expecting to come out and just all of a sudden take the flu market over or increase COVID vaccination compliance. But I think we are banking on some small growth in each individual year.
I guess my question is, if someone's going to get a COVID vaccine, why wouldn't they get the combo? I mean, could you see a spike in and I guess we can debate whether the volumes for COVID vaccines will be 10 million or 40 million in 2026.
That's a great point. Yeah, great point. So we've studied more of this detail in retail than IDNs and the U.S. government. But if you look at the retail, the people that got a vaccination in retail, probably 80% of them actually got a COVID plus flu shot. There are still some portion that only got a COVID shot. And there's obviously some portion that only got a flu shot. And so that 80%, you would think, why wouldn't I just get a combination vaccine?
And I think some people might worry about efficacy, which I think we'll disprove that. I think that'll be fine. I think reactogenicity will be one. And as we look at what we've seen in some of the early results from our combination studies, there's really not that big of a difference. So if there's not a big difference from a reactogenicity perspective, you get the same efficacy, why not get it in one shot? That's kind of our philosophy. So I agree. I think a lot of people will move to the combination vaccine.
Can you walk us through the reactogenicity profile in a little bit more detail?
Yeah. It wasn't all that different from an adverse event perspective versus the individual vaccines. And we published some of this data. But it's still relatively similar to getting a COVID shot. I think it's maybe a slightly more, but not by much at all. So not one that we believe would dissuade somebody from getting the combination vaccine.
Turning maybe to the volumes component. So we'll see the performance for COVID this year. How do we think about how that translates into 2025?
Yeah. So, 2025, so we gave some preliminary guidance at our R&D Day. And we said that our 2025 sales would be in the range of $2.5 billion-$3.5 billion. So we'll see where the market plays out. And we'll come out with our formal guidance at the end of next year. But I'll just kind of articulate what does all that mean. So on the low end of that range, we basically assume, let's break out COVID versus RSV. RSV, we will have very minimal share and sales this year. We reported $10 million in sales in the third quarter. And so the low end assumed we still get no growth. So take out a lot, really have immaterial revenue from RSV. That's the low end. On the high end, obviously, we want to take some share. And it's still a relatively sizable market. So we hope to grow.
We'll see what happens. On the low end, on the COVID side, we had said, OK, we're going to provide for a handful of things. One is what if the market size comes down, which still could happen this year. So it remains to be seen. We'll see what happens this year. What happens if our market share comes down versus in 2023, we were nearly 50% market share. And this year, we're about 40%. So that's already kind of happened inside the year 2024. And we're hopeful that it won't go down. If not, we actually want it to go higher. So the U.S. will be relatively flattish is our assumption, or maybe even down on the low end. And then outside the United States, we had a couple advance purchase agreements that are converting into long-term contracts in certain countries.
And I know a lot of people have asked a lot of questions about trying to be very specific about this. But let's just say that it's enough to drive revenue down in COVID. So we expect revenue in COVID to be down next year outside the United States in these markets. Now, if we win in other markets, that'll offset it. But our assumption is, at least in the markets that we have, we have larger advance purchase agreements in the year 2024 that will come down in 2025 and then grow from there substantially as we roll out new products. And there are minimum purchase commitments in these countries. So we are expecting COVID to be down next year outside the United States. And then we'll see what happens with our share and the market size inside the United States.
What volumes do you assume in terms of the U.S. COVID vaccine market in 2025 in your guidance?
Yeah. On the low end, we had assumed basically what we had when we gave that guidance in September, we were talking we only had the baseline of last of 2023, and we said, OK, well, by next year, we're going to provide for either some amount of reduction, so 10%-ish down in terms of market size, or market share reduction. Those were the primary or some price, and so we had put, we didn't give it a specific estimate around what that would be in terms of COVID volumes. But we definitely took down the low end to account for those three factors, not any specifics around it, but we said, hey, the U.S. market's going to be down on the low end.
Got it. And a scenario that investors ask about often, and I'm sure you get asked all the time, is in the scenario where volumes go down significantly. And look, I mean, I think it's a positive sign that volumes so far this year are relatively flat. But I think it's an aspect of human behavior that we'll have to see play out in the years to come. But if COVID vaccine volumes go down significantly, and of course, you have what I think is a very exciting pipeline longer term. But in the near term, you do have a lot of expenses associated with the respiratory portfolio. Maybe just thinking in the near term, how would you handle that from a spend perspective?
Yeah. I mean, the short answer is, if our revenue line doesn't get to where it needs to be over the coming years and also in 2028, which we said we'd break even at $6 billion, we will have to adjust. Full stop. So we will have to take down R&D, which is 2/3 of our overall spending. Cost of sales, you can only do so much. You can only get as efficient as you can get. I mean, you can restructure some of your footprint from a drug product perspective in terms of where we fill. And so we can try to get more efficient there. And then SG&A we'll have to take down as well. So that's the short answer. I think you already alluded to it.
I mean, we're optimistic that even if COVID is relatively low or shrinking to some degree, which let's just take the low end of our range this year. We said $3 billion-$3.5 billion in RSV is like nothing on the low end. So that's a $3 billion COVID number. And let's say it goes down to $2.5. And maybe even it gets down to something less than that. We then have to grow $3 billion-$4 billion with all the new products we're bringing to market.
So as we bring our flu vaccine to market, as the combination vaccine, the broader indications around RSVs, our next-gen COVID vaccine, all those provide an opportunity. And I'll get to the rest of the non-respiratory portfolio. But as I said, I mean, it's a we believe $20 billion marketplace. And why wouldn't we deserve 20- 25 to maybe 33% of that?
So I don't really have a hard time believing that, in general, that this could actually be even if it was a $15 billion marketplace, because we think COVID's going to come down. If we get 20%, that's $3 billion. If we get 33%, that's $5 billion. So I believe respiratory alone is going to be substantial, even if COVID comes down to some degree, particularly when we have the full portfolio over time. Then you get into what we're really excited about.
And I think that is, people don't really recognize yet or see, is, I mean, we are really breaking out into non-respiratory products. So norovirus, although it's sold in retail, non-respiratory virus, CMV, which I know is something we'll probably talk about today. We're really excited about that coming to market. INT, our rare, a couple of our rare disease programs as well.
So non-respiratory revenue is going to be material by the year 2028. And we hope sooner. But certainly by 2028 is not going to, when you take all four or five of those products, it's not going to be insignificant. And then ideally, I think the respiratory business is still going to be a pretty sizable TAM. And I think with the full portfolio, we deserve a pretty fair share of that. And I think it could be a pretty sizable business.
Makes sense. And just in terms of thinking about the scenarios for ACIP recommendations around a combination vaccine, I mean, being mindful that if, say, outside of the potential contribution from flu volumes, but if everyone that was going to get a COVID vaccine then gets the combo, so from market share, and then you also have presumably a higher price. But how could ACIP recommendations vary in terms of the recommendation for a combo versus just a COVID vaccine alone? And I guess what are the scenarios for that in 2026?
Yeah. Probably somebody's better to answer it than me. But I would find it hard to believe that ACIP would say you should get the combination vaccine. We're still a believer that there will be individual vaccine choices, that there'll be a flu. You can get a flu vaccine. You can get a COVID vaccine. Or you can get the combination.
So I don't think it'll be a recommendation that you should get the combination vaccine at that point. That's just my own belief. But that said, I think so that'll take some education to the marketplace. So that'll take us informing everybody, hey, it's just as effective. It's the same tolerability. And I think if people understand that and know that, I think the convenience of it will make a lot of sense to people.
Yeah. That'll be interesting to play out. But kind of going back to this sort of down volume scenario in 2025, and I'm sorry to ask about the negative scenarios. But we're getting a lot of questions around sort of the ability to fund yourself through break even. How much flexibility do you have on spend? I mean, you mentioned that if COVID volumes or respiratory volumes were significantly down, that you do have this ability. But how should we think about how much flexibility there is? Even in a significantly down scenario, can the respiratory portfolio remain profitable on its own?
I believe it can, yes, so I still think there's a lot of flexibility, and maybe let's go category by category, so R&D research is all a choice. You're not committed to anything. Development, there is a handful of programs that we are committed to and will have to see through and want to see through, because that's the 10 products that we're trying to bring to market, but then we have a 40+ drug pipeline that we're going to have to really reconsider should our revenue line not be where it needs to be.
In addition to that, we spend a lot of time trying to advance the technology of mRNA, and we call that in our technical development in our CMC world, and so perhaps that does. We're just going to need to delay some of that, so that could be stability that affords longer refrigeration life. That could be the way it's manufactured to have better yields. That could be reducing the cost of the product. We invest a lot there to really advance mRNA technology, and it's discretionary.
To some degree, sometimes you have to actually get certifications, but I mean, a lot of that is discretionary right now, so there is still a substantial portion of R&D that is very much discretionary. We believe it's the right thing to invest in right now, but should our revenue line not be there, we'll have to pare back, then SG&A, I mean, a large portion of that is S, so if we're not getting the revenue line that we need, it's kind of this catch-22, so we're either going to have to face into we don't need to be spending that much in terms of selling and marketing expense.
But then you're going to have to really have the realization that it's not working. And really, the market doesn't matter what you do. So that's what we toggle between. And we evaluate all the time. But there's a substantial amount that we would have to reevaluate to say if the revenue line in respiratory continues to drop and the efforts aren't useful, then you can take a fair amount out.
And then again, on the cost of goods sold line, we're looking for every dollar of efficiency all the time. I think the biggest fixed area is the commitments we make for getting our product filled into prefilled syringe or vial or whatever. And we're going to have to resize that if we think it's a different volume landscape moving forward. So maybe that's a long-winded way with a bunch of examples. But I still think there's a fair amount of flexibility.
Yeah. No, I think it's important, and something that I think is maybe not fully appreciated is the flexibility around spend and break even. Maybe turning to the pipeline, since in the next, I'd say, like one to three years, we probably have a lot of major readouts. Starting with CMV, maybe just from the financial perspective, how do you think about the opportunity size?
Yeah. I mean, we couldn't be more excited for CMV, both because it's CMV and how important that is to mothers in particular, the way we are going at it right now. But also, it helps unlock since the first data point in terms of a Phase III trial in terms of our entire latent portfolio, which we are, for the most part, delaying right now, and we'll talk about norovirus, I'm sure, which is also in that category.
But for CMV, for those that don't know, it's the most infectious cause of birth defects. One in 200 babies in the United States are infected with CMV through congenital transmission, as well as one in 5 of those, it's very severe. This is blindness, deafness, and encephalopathy. So quite severe. And there is no vaccine on the market. There's no prevention on the market.
So we are really excited to bring something forward. We think it could be a $2 billion-$5 billion opportunity, which was the harder question in terms of what we think the financials could be. And it'll come down to a lot of different things. And this will take time. I mean, we're going to have to educate the market. But it'll come down to the durability of the product, obviously the efficacy of the product, the serostatus of the product in terms of whether a mother is seropositive or seronegative. There's implications to the workflow as it pertains to somebody getting a vaccination.
But overall, yeah, the Phase III trial, we believe we will have data. It's imminent, let's say, at this point. We thought we would trigger the Phase III trial interim analysis by the end of this year. Whether we have a readout either inside the year or the early part of next year, we're excited by that for many reasons, everything I just said in terms of the actual disease and its impact and what it unlocks for the future potential pipeline that we have at Moderna.
What are your assumptions around the $2 billion side versus around the $5 billion side of that range?
Yeah. I mean, when we gave that guidance, it was you look at something like Gardasil, which is also three administrations. And there's compliance. And so here's what I would say. So we're studying it in age 16- 40. The women of childbearing age is really the 25- 35 time period. Duration will matter based on, and we're going to hopefully age de-escalate. When we come out with the data, we will have Phase II immunogenicity durability, which isn't really efficacy, but for four years almost.
And when we come out with efficacy, by the time it's actually launched, it'll be maybe two to three years of data. So I think you've got to be more and more durable and prove that durability to get into the younger population. And we want to serve that entire patient population from 16 all the way through 40. But on the low end, you probably start with maybe OB-GYNs, a certain patient population, maybe more in the 25-35 range. And then as you really open up the envelope to the entire patient population, then you can get to the higher end as well.
From a commercialization perspective, what kind of sales force would you need?
Definitely going to need some amount of sales force, because it is a different call point. It is not the retail sector. So it's probably at a minimum OB-GYNs, maybe primary care physicians, and then ideally pediatrics. But if we're getting into pediatrics, then you really have the entire patient population I was just talking about. So I don't think it's, ironically, I worked at my prior company, had a reproductive health business, and had a sales force around it. So I don't think it's a huge sales force if it's just OB-GYN in that area. But there's certainly, and I think the more material investment is around education. So not a lot of people talk about it right now, because there's nothing to prevent it. And so we're going to have to educate people.
I mean, just to put this into perspective, CMV is three times the prevalence of Down syndrome. And I think a lot of people know about Down syndrome. So we're going to have to educate the market. That's probably the bigger part of the spend. But the sales force we'll definitely have to invest in. But I think it's more the education part that's going to be more costly.
Understood. And so say the data reads out in the near term, how are you thinking about the implications of the efficacy in terms of a potential label, whether it would be broad across seronegative and seropositive, and what you would need to see from ACOG recommendations in terms of having that broader uptake?
Yeah. So at a minimum, we believe efficacy of 50% will be useful in the marketplace. Of course, we want it to be much higher. And we are shooting for that. But I think something that comes out that's at least 50% efficacy is useful. And of course, something that's maybe 70+% is really going to be seen well in the marketplace. From a broad label, I think I already addressed the patient population perspective in terms of what's the durability at that time. And therefore, which patient population should you target out of the gates? And ACIP's recommendation will be very meaningful. And the broader, the better out of the gates. But it might take a little time to get the full breadth of that entire patient population. But yeah, we're excited for that.
Great.
Oh, and seropositive, seronegative, sorry. So as you know, I think we've got about 7,000 patients on trial. And I think maybe 800 are in the seropositive category. Because we really don't want to say, hey, if it's only for seronegative versus seropositive, we want to just prevent. Yes, of course, we want to prevent primary infection, which is seronegative from a mother to a newborn. And that is because the mother has no built-up immunity inside.
And so therefore, it's probably much easier to transmit. So seronegative is number one. And that's why it's 90% of the entire population we're studying. But certainly, it's a lot easier to not have to diagnose and do some kind of test to say, are you seropositive or seronegative when we actually get to that recommendation and label. So we're hopeful that it also does a great job in seropositive women as well. That's but at least seronegative is the primary endpoint here.
I got it. Makes sense. And in terms of norovirus, which you quickly moved into Phase III, and we could potentially be getting the Phase III data next year, how are you thinking about the size of that opportunity? And it's historically been a more challenging indication for vaccines. What drives your confidence to make this investment?
Yeah. So in terms of maybe I'll just address the size of it first. I mean, it is a really big target population. And so there's obviously older adults. And it's got a significant health burden. So older adults, call it 80 million. We said 155 million patients in the United States that we would target. About half of that is older adults. But then there's people with comorbidities and health risk. And then there's lifestyle. So it could be a parent, a parent that knows that their kids bring this home from school or whatever. It could be health care professionals. It could be anybody in the food industry. And so what we call lifestyle is a big portion. It's maybe a quarter of that entire population that we're talking about. So a really big market with a pretty significant health burden.
In terms of why we're confident, we've been looking at the data and looking at it over time and understanding how our immunogenicity works and how we're targeting it, and so we're optimistic that norovirus will be successful for us, and so we'll see, so we dosed our first patient not too long ago. And we said that maybe this could come to market by 2026, which would mean we would need to have something by the end of next year from a readout perspective or early 2026, so we're optimistic to bring it to market. And again, I think selling into the retail channel, since it's such a large portion of our revenue and customer base right now, I think it'll be really valuable, and there's no other vaccine on the marketplace, so it'll be us that's bringing it to that channel.
Yeah, absolutely. It's an interesting readout next year. When it comes to maybe your capital base and given the investor question around time to break even, you did the Blackstone deal around flu. Maybe just thinking strategically, what are some of the other potential options at your disposal and how you're thinking about this? And is this something you're actively looking at?
Yeah. I mean, we always look at it. There's really only a handful of remaining sizable Phase IIIs that we have going on right now. And so I'll get to the stuff that we've delayed in a second. But in terms of what it means for funding our R&D line over the next few years in terms of what we've already said from a guidance perspective, flu's already funded. COVID's basically done. RSV's got a little bit of trail off, but that's far along the way.
And so CMV, norovirus would be opportunities. And those might be ones that we evaluate from a funding perspective. But then there's so that would actually make a difference that would make a noticeable difference in terms of what we projected already from a cash balance perspective and what we projected already from an R&D perspective.
What wouldn't is whether we want to accelerate something that VZV, HSV, you name it, that we have consciously delayed right now. So there wouldn't be a cash impact to that, except for accelerating the program, bringing it to market sooner, which would ultimately improve our cash generation once it comes to market.
But I know what's on people's minds is the next two to four years. And so advancing those programs with somebody that project finance it doesn't really change our financial outlook from a capital perspective. The only things that would change our capital outlook from a cash perspective are CMV, noro. And we look at that all the time. And back to your original, one of your prior questions, maybe that's something we do if our revenue line isn't there. So I already talked about everything else we could do. And then project financing would be another one.
And lastly, another pipeline program that we haven't talked about is your rare disease franchise and how you're thinking about that opportunity.
Yeah. I mean, very excited. So PA and MMA is what we've prioritized. And so we want to see how it goes as we try to enter pivotal studies right now or have entered pivotal studies and bring those to market as soon as possible. And that program also takes a lot of education. So in terms of cash flow generation and what that means, I think starting smaller makes sense and understanding how much do we want to invest in a commercial footprint?
Do we want to invest in a commercial footprint? Do we want to get help? So we said that those two programs would be also on the market by 2028. We've kind of slowed down some of the rest of the programs until we actually understand the commercial model we want, how is it selling, as well as there's going to be some investment there that's required to educate the market to bring those products to market. We are certainly excited for the patients that are going to receive that therapy.
Then a little further out, but oncology, which maybe 2026 we could get Phase III data, maybe just, yeah, how you're thinking about that opportunity and what we could learn from that that would inform maybe further investments and other indications as well.
That's a great one. So I mean, we continue to expand that portfolio. So I think we have six Phase II or Phase III trials. And Stephen already said this. In addition to Merck and that partnership, we continue to look at more and more to continue to invest behind it because we are clearly liking what we're seeing. In terms of the first, well, the next data, because we already think we've shown some good data, but the Phase III adjuvant melanoma data, we finished enrolling, I think we said not too long ago. Let's call it a few months ago. And if you look at the Phase II, we saw the separation in the curves in terms of the impact that it's having, really starting in month 12. And really by month 18, it was quite apparent.
So if you fast forward, if that's, let's call it September of 2024, that could be September of 2025 or early part of 2026 till somebody sees a Phase III trial from INT that has very material data that we're excited about. So that's probably the next data point. But in the meantime, both Merck and Moderna have enough confidence to continue and invest behind, which is why we announced yet another Phase III trial not too long ago, maybe a few weeks ago. And so we will continue to invest behind it because everything we're seeing right now, knock on wood, has been good.
Great. Well, thank you so much. I think we're at time. But thank you for joining us and sharing all the insights.
Thank you, Ellie. It's been great.