Moderna, Inc. (MRNA) Earnings Call Transcript & Summary
November 13, 2024
Earnings Call Speaker Segments
Eliana Merle
analystGood 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 from Moderna is Jamey Mock, Chief Financial Officer. Jamey, thank you so much for joining us.
Eliana Merle
analystMaybe 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?
James Mock
executiveWell, first off, thanks for having us, Ellie. It's great to be here, and thanks to UBS as well. 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 is 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 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 everything -- it will be more noise than actual change. So -- 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 what we believe.
Eliana Merle
analystThat's reassuring. Maybe turning to the quarter and how to think about COVID for this year. Yes, 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 1 of the most challenging vaccines to model.
James Mock
executiveIt has, for sure. And even we've struggled with it over time. So 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 what's -- 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 2 markets as well. But if you look at through December 31 last year, there were 28 million Americans that got vaccinated with COVID. So we're almost already there and we still have 2 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 very -- we've been saying, "Hey, we believe this is a durable and 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 to $3.5 billion, and I'll go through some of the variables that we laid out there. And 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. As you just said, we broke it down between the U.S. and then OUS. And there's probably 3 variables inside the United States and 2 variables outside the United States as it pertains to 2024's guidance, then we can talk about 2025 and beyond. So as it pertains to the United States, there were really 3 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 is down 10% and our market share is at 40%, and we'll talk about RSV, that will 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. And we can talk about the RSV market, I'm sure we'll get into it, but that is changing and evolving over time. So 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 of the United States, there's really only a couple of variables left. Most of the revenue we forecasted for the fourth quarter is contracted and confirmed already, and it's already November 13. So we're a good bit through the quarter already. There's really 2 variables. One is specific revenue recognition items in a couple of markets that will either fall inside the year 2024 or inside the year 2025, but it won't be lost revenue. And 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 will have 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.
Eliana Merle
analystGreat. And 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?
James Mock
executiveIt's a great question. So particularly in the United States, that is really comes down to having the full portfolio. Well, there's a couple of 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 1 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 or 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 will 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 do know -- we won't have flu at that point. We won't have combinations. So it will be better, but not the full portfolio by that time. But then to the 40% market share, I think you can see over time. 1 of the good pieces about respiratory, 1 of the good pieces of news about respiratory, it's a huge market. The flu market is a $7 billion market, COVID is an $8 billion-plus market. We believe RSV will be a large market. We hope our 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. And our job is to get 25%, 33% share and you got a pretty sizable respiratory business there, and that's kind of our overall goal moving forward.
Eliana Merle
analystAnd thinking long term, I mean, I guess, we'll see in terms of market share in 2025 ahead of the combo launch. But thinking 2026 and beyond, if you are the only COVID Flu combination vaccine, now I mean volume is a separate question. But 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?
James Mock
executiveSo big picture in terms of the amount of people that get flu or flu vaccination that is -- there's about 150 million Americans that get a flu vaccination. And I mentioned 28 million through the end of December for COVID. But really, if you look at total COVID, it's probably like a 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 of 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 1 shot. And so therefore, you can maybe take some of the flu market as well. So we have 2 growth factors 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 know we've learned a lot as we've tried to forecast COVID and our overall revenue projection. 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.
Eliana Merle
analystWell, I guess my question is, if someone is going to get a COVID vaccine, why wouldn't they get the combo? Like, I mean, could you see a spike in -- and I guess we can debate whether it's like the volumes for COVID vaccines will be 10 million or 40 million in 2026, but...
James Mock
executiveYes. 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 some portion, 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 will disprove that, I think that will be fine. I think reactogenicity will be one. And as we look at what we've been -- 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 1 shot, that's kind of our philosophy. So I agree. I think a lot of people will move to the combination vaccine.
Eliana Merle
analystCan you walk us through the reactogenicity profile in a little bit more detail?
James Mock
executiveYes, it wasn't all that different from an adverse events perspective versus the individual vaccines. So when -- and we published some of this data, but it's still relatively similar to getting a COVID shot. I think it's maybe slightly more, but not by much at all. So not 1 that we believe would dissuade somebody from getting the combination vaccine.
Eliana Merle
analystTurning 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?
James Mock
executiveSo 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 to $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 in sales this year. We reported $10 million in sales in the third quarter. And so the low end assumes we still get no growth. So take out a lot of -- 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, and we'll see what happens. On the low end, on the COVID side, we had said, okay, 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 same. 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 grow 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 of advanced purchase agreements that are converting into long-term contracts in certain countries. And I know a lot of people have asked 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 will offset it. But our assumption is, at least in the markets that we have, we have larger advanced 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 in the market size inside the United States.
Eliana Merle
analystWhat volumes do you assume in terms of the U.S. COVID vaccine market in '25 in your guidance?
James Mock
executiveOn the low end, we had assumed -- we're 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, okay, 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 any specific estimate around what that would be in terms of COVID volumes, but we definitely took down the low end to account for those 3 factors, not any specifics around it, but we said, hey, the U.S. market is going to be down on the low end.
Eliana Merle
analystGot 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. Like maybe just thinking in the near term, how would you handle that from a spend perspective?
James Mock
executiveI mean the short answer is, if our revenue line doesn't get to where it needs to be, but over the coming years and then also in 2028, which we said we'd breakeven at $6 billion, we will have to adjust. 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 to $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 billion. And maybe even it gets down to something less than that. We then have to grow $3 billion to $4 billion with all the new products we're bringing to market. So as we bring our flu vaccine to market, the combination of 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 nonrespiratory portfolio. But as I said, I mean, it's a -- we believe, $20 billion marketplace. And why wouldn't we deserve $20 billion to $25 billion to maybe $33 billion 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 is 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 not -- people don't really recognize it or see is, I mean, we are really breaking out into nonrespiratory products. So Norovirus, although it's sold in retail, nonrespiratory virus, CMV, which I knows, something we'll probably talk about today, we're really excited about that coming to market. INT, 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 4 or 5 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.
Eliana Merle
analystMakes sense. And just in terms of thinking about the scenarios for ACIP recommendations around the combination vaccine, I mean being mindful of 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 the COVID vaccine alone? And I guess, what are the scenarios for that in 2026?
James Mock
executiveProbably somebody is 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 will 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 will take some education to the marketplace. So that will 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.
Eliana Merle
analystYes. That will be interesting to play out. But kind of going back to this sort of down volume scenario in '25, and I'm sorry to ask about the negative scenarios, but these are getting a lot of questions around sort of the ability to fund yourself through breakeven. How much flexibility do you have on spend? I mean you mentioned that like if COVID volumes or respiratory volumes were significantly down that you do have visibility. 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?
James Mock
executiveI 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 of choice. You're not committed to anything. Development, there is a handful of programs that we are committed to and we'll 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 there's a -- we have a 40-plus 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 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 the [ sketch '22 ]. So we're going to have to face into -- we don't need to be spending that much in terms of selling and marketing expense. But that's -- 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 then 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.
Eliana Merle
analystYes. No, I think it's important and something that I think is maybe not fully appreciated is the flexibility to like around spend and breakeven. Maybe turning to the pipeline in the next and say, like 1 to 3 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?
James Mock
executiveYes. I mean, we couldn't be more excited for CMV, both because its CMV and how important that is to mothers in particular, the way we are going at it right now. But also it unlock -- helps unlock and it's the first data point in terms of the 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 effects. 1 in 200 babies in the United States are infected with CMV through congenital transmission as well as 1 in 5 of those, it's very severe. This is blindness, deafness, 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 to $5 billion opportunity, which was the heart of your question in terms of what we think the financials could be. And it will come down to a lot of different things, and this will take time. I mean, we're going to educate the market, but it will come down to the durability of the product, the efficacy -- obviously, the efficacy of the product. The sero status 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, yes, 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. And so 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 about the actual disease and its impact and what it unlocks for the future potential pipeline that we have at Moderna.
Eliana Merle
analystWhat are your assumptions around the $2 billion side versus around the $5 billion side range?
James Mock
executiveYes. I mean when we gave that guidance, it was -- you look at something like GARDASIL, which is also 3 administrations and there's compliance. And so here's what I would say. So we're studying it in 16, age 16 to 40. The women of child-bearing age is really the 25 to 35 time period. Duration will matter based and we're going to hopefully age deescalate. When we come out with the data, we will have Phase II immunogenicity durability, which is a real efficacy, but for 4 years almost. So -- and when we come out with efficacy, by the time it's actually launched, it will be maybe 2 to 3 years of data. So I think you 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, certain patient population, maybe more in the 25 to 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.
Eliana Merle
analystAnd from a commercialization perspective, what kind of sales force would you need?
James Mock
executiveDefinitely 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. And I mean, just to put this into perspective, CMV is 3x the prevalence of Down's syndrome. And I think a lot of people know about Down's syndrome. So we're going to have to educate the market, that's probably the bigger part of the spend. But the sales force will definitely have to invest in, but I think it's more of the education part that's going to be more costly.
Eliana Merle
analystUnderstood. 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 like ACOG recommendations in terms of having that broader uptake?
James Mock
executiveYes. So at a minimum, we believe the 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% plus is really going to be seen well in the marketplace. From a broad label -- I think I 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 gate, but it might take a little time to get the full breadth of that entire patient population. Yes, we're excited for that. All in 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 -- we 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 #1, 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. And so that's -- but at least seronegative is the primary endpoint here.
Eliana Merle
analystGot 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?
James Mock
executiveYes. So in terms of -- maybe I'll adjust 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 food -- anybody in the food industry. And so that what we call lifestyle is a big portion. It's maybe 1/4 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 will be really valuable. And there's no other vaccine in the marketplace. So it will be us that's bringing it to that channel.
Eliana Merle
analystYes, absolutely. It's an interesting readout next year. When it comes to maybe your capital base, given the investor question around time to breakeven, you did the Blackstone deal around flu. Maybe just like 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?
James Mock
executiveYes. I mean, we always look at it. There's really only a handful of remaining sizable Phase IIIs that we're going under -- 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, there's -- flu is already funded. COVID's basically done. RSVs got a little bit of a 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 different -- 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 it's not -- I know it's on people's minds, is the next 2 to 4 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 thing that would change our capital outlook from a cash perspective are CMV, Norovirus, and we look at that all the time. And back to your original -- 1 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.
Eliana Merle
analystAnd lastly, another pipeline program that we haven't talked about is your rare disease franchise, and how you're like thinking about that opportunity?
James Mock
executiveYes. We're, I mean, very excited. So PA and MMA is what we prioritized. And so we want to see how it goes as we try to -- we enter pivotal studies right now or have entered kind of all 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 in understanding how much do we want to invest in a commercial force? Do we want to invest in the commercial force? Do we want to get help? So we said that those 2 programs would be also on the market by 2028. And 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. But we are certainly excited for the patients that are going to receive that therapy.
Eliana Merle
analystAnd then a little further out, but oncology, which maybe 2026, we could get Phase III data. Maybe just, yes, how you're thinking about that opportunity and what we could learn from that, that would inform maybe further investments and other indications...
James Mock
executiveThat's a great one. So I mean, we continue to expand that portfolio. So I think we have 6 Phase II or Phase III trials, and Stephane has 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, it'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 pass forward if that's, let's call it, September 2024, that could be September 2025 or early part of 2026 till somebody sees a Phase III trial with -- from INT that has very material data that is -- that we're excited about. So that's probably the next data point. But in the meantime, both Merck and Moderna has 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.
Eliana Merle
analystGreat. Well, thank you so much. I think we're out of time, but thank you for joining us and sharing all the insights.
James Mock
executiveThank you, Ellie. It's been great.
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