Next presenting company, Moderna. My name is Ted Tenthoff. I'm a senior biotech analyst at Piper Sandler. Before I begin, I am required to point out certain disclosures regarding the relationship between Piper and Moderna that are listed at the back of the room and also at the registration desk. As you know, Moderna is a leading developer of messenger RNA vaccines and medicines. Moderna shares have been under pressure over the last couple of years after really helping us through the COVID pandemic, in part as a result of decreasing immunization rates. I got my mRNA vaccine. I think anyone who gets a flu shot should get a COVID vaccine as well, as long as they're recommended by their doctor. Now, under the FDA and RFK Jr., it really feels like they've declared war on mRNA vaccines.
We recently had the setback with the CMVictory . It has been a tough slog here. You guys just recently had an R&D day and really pointed to all of the new vaccines and medicines that are coming. I think it is a really exciting time. Jamey, you always do such a great job going through sort of the financial underpinnings of what Stéphane and Stephen and everyone are working on and how you are going to get there. I am pleased to introduce Jamey Mock, CFO. Jamey, I am sorry to put you in the hot seat, but I have just gotten an overwhelming number of questions, as I am sure you guys have as well. What is really behind the FDA's claims that COVID vaccine caused these 10 children's deaths? There is offsetting news, too, from experts that are refuting these claims.
I guess, firstly, what's really behind this sort of onslaught on mRNA? Then we can kind of get into what you guys know about sort of the findings.
Yeah. First off, thanks for having me, Ted. It's good to see you. And thank you for getting your COVID vaccine. It's always helpful and I think important. Look, I don't know what's behind it, to be honest. We haven't seen any data. We haven't seen the analysis. Here's what I can say. We take safety very seriously at Moderna, as you would expect. We have rigorous monitoring across ourselves, across the FDA, across over 90 countries across the globe. I've been looking at it. There are multiple overlapping safety systems that look for any new data point, any evolving safety consideration. Remember, we've delivered over a billion doses over the last few years. All those safety monitoring systems haven't really given us anything new or anything undisclosed at this point. That's really all we can say. We haven't seen the data.
We haven't seen the analysis. It is inappropriate for me to comment on something that we haven't really discussed today.
Yeah. I think I've seen some have said that 10 out of 96 were related to the vaccine. At the same time, I think over 800 children in their teens or below died from COVID in that time frame. I think it's really we're going to have to weigh both sides of this for the two. I'll just pause there. Are there any questions about that from anyone? Again, I think the answer pretty much is we're going to see what becomes of this and what additional data comes. Jamie, I mentioned this in the beginning. You always do such a great job setting the framework for the company's commercial and financial performance. Let's start with COVID. Vaccine rates are down, kind of high 20%, maybe 30% from last year.
You're really now selling both Spikevax and mNEXSPIKE , which I think is a great product, like a fifth a dose, lower side effects, higher potency. What's the current outlook for COVID vaccine revenues for the remainder of this year and beyond?
Yeah. Thanks for the question. Yeah, we really think this is a turning point financially for our company. COVID will be the lion's share of our revenue until flu comes online and hopefully norovirus and our combination vaccine, which we'll get into. Let me just start with 2025. We guided $1.6-$2 billion. That was $1-$1.3 billion in the U.S. and $600-$700 million outside the U.S. Let me start with the U.S. The only thing, all the contracting's done. I mean, we're 80% through the season at this point. The only remaining variable is vaccination rates, as you mentioned. At the time of our guidance, we provided for vaccination rates that could be down 20%.
That would be on the low end of a billion dollars or on the high end of $1.3 billion or down 40%, which would be on the low end of a billion dollars within the United States. I think through last week, we're down 27% or 28%, as you said. We feel very confident in our guide for the United States, as well as outside the United States. The only remaining items are delivery timing. A little bit could push into the first quarter, or maybe it happens this year. There are only a few markets that are actually vaccination rate driven. Many are just contracted demands, but there are a few. There are a little bit of variables there. For 2025, it's predominantly 99% COVID related. I'm sure we'll talk about RSV in a moment as well.
When we look out to the next three years, I'd really encourage everybody to look at our analyst day webcast, which we really laid out, as you mentioned, what are the growth drivers for the next three years, which we see 10 of them. I won't get into all of them. I think the punchline there is it's still largely COVID until flu and norovirus come along. It's largely outside the U.S. It starts with a few contracts we have with three countries across the globe, in the U.K., in Australia, and in Canada, where these are long-term contracts that we believe we're fulfilling on right now in the case of all three of them. The majority of the revenue, the full year revenue, will be in 2026 versus 2025. That's significant growth for us, particularly in those three areas.
You mentioned mNEXSPIKE , which we're quite encouraged by. I think it's got 55% of our overall market share out of our and Spikevax being the 45%. We didn't even know coming into this year whether it would be approved. It got approved in early June. We had to double produce this year for both mNEXSPIKE and Spikevax. We're really encouraged that because of the product profile and the higher efficacy on mNEXSPIKE , it's doing extremely well, particularly in older adults. We're really excited to go into 2026 knowing that we have this product approved and knowing that it's had terrific uptake already in a year that it was only approved in June, which I think provides another growth driver for 2026. We said we'd grow up to 10%.
That's part of this whole story is that I think moving forward, starting in 2026, we believe we will start growing. In 2027, Europe opens up for us. We believe that we'll win in other regions around the world. In 2028, we have norovirus coming on. We have the combination vaccine, which could come in 2027 as well. We're quite excited for the growth rate of the company. That's really just in the seasonal vaccine business. If we are able to have terrific data in INT, if we're able to have terrific data in our 4359 product, which I'm sure we'll talk about, or in PA, that is upside to our overall revenue here. We're really excited about the future here.
Yeah. I agree. I think at the R&D day, I kept feeling that you guys are turning the corner. It is what really came through. We will go into a couple of these vaccines individually. For seasonal flu, I believe you guys are preparing to complete regulatory filings by January.
By January.
Could they be approved this year? How do you really envision kind of penetrating into the traditional seasonal flu market?
Yeah, we're excited about it. Yes, we will complete our filings for the U.S., Europe, Australia, Canada by January, as you mentioned. If the filing's done in January, it's really not a 2026 product. This is really a 2027 market that we are shooting for. We love the product profile. It really starts with the efficacy of the product and how it compares to standard dose. We believe that'll play well in older adults, which often have enhanced dose or high dose flu, and that's where they compete. If you look at the relative vaccine efficacy of our product versus that we showed in the phase III trial versus standard dose, it's 26.6% better than standard dose. We really do think we'll compete in that market well.
That, I think, speaks to our entire strategy here, which is we really need the breadth of products. I'm sure we'll get into the other ones. In the seasonal vaccine business, you have more purchasing power. If you have COVID, if you have two products in COVID, mNEXSPIKE and Spikevax, and you have RSV, and you have flu, perhaps a combination vaccine and norovirus, we think that that bundling effect is really helpful when we go to market with all of our customers.
I really think the combo product is a game changer. It combines 1010 with mRNA Spikevax. Excuse me. Right?
That's right.
mNEXSPIKE ? Yep. It's really the top of the two products. When do you think this could gain relationship? I know it's under review in Europe, which is promising and could start to help open up that market again. What's sort of the FDA waiting on to try to understand?
Yeah. Yeah, as you mentioned, it's already under review in Europe. That is a 2026 outcome. In Canada, we have refiled. For the U.S., they wanted to see our flu package and our flu filing first before they can give us guidance on what to do with our combination vaccine. I think, actually, we might see a combination product that is actually approved internationally before the U.S., particularly if Europe goes well. Maybe that's a 2026 product, or maybe it's a 2027 product, but it is relatively imminent, as well as Canada. In terms of the growth profile, I think there are two drivers. One is everywhere where we sell a COVID vaccine, if somebody also wants a flu vaccine, they get two in one. We already have the COVID revenue, but you add that flu revenue as well.
If you look at what we've studied the last two seasons, people that go into a doctor's office or retail or pharmacy to get a shot, in two seasons ago, I think it was roughly 30% on the same day got flu and COVID vaccines. Last season, it was almost 50%. People know they want COVID and flu on the same day. If we have a combination vaccine, perhaps we can capture some of that flu revenue as well. I think the second driver is anybody that's getting a flu vaccine, if it is one shot, perhaps it will increase the COVID market. We're not banking on that, but that is something that a combination vaccine, the ease of it, and the fact that you're double protected, perhaps that'll grow the actual COVID market for us as well.
We've got a third driver. I'm allergic to the adjuvant in the flu vaccine, so I can't get flu. But I will be able to get 110.
Oh, terrific.
I'm keeping.
Yeah, there you go.
When it comes to my seasonal vaccine preparedness.
Terrific.
You guys also gained approval for RSV vaccine, mRESVIA. This was last year, then had some label expansion this year. It's gotten off to a slow start. You have competition here from Pfizer and GSK, who had a solid year-end start. How do you sort of see this market evolving and mRESVIA's share within it or spot within it?
No doubt it's a slow start for us. I think that there's a couple of reasons for that. One is in 2023, when RSV launched, that was the highest year. You've seen a contraction in the market since then, every year since then. The second is we were a year behind. We came out with our 60-plus indication, 60-year-old plus indication in 2024. We were third to market. This year, as you mentioned, we got 18 years old to 59 broadened label. You've seen that market contract. That's number one. I think what we think will happen is we really need clear public guidance around when do people need to be revaccinated.
When those health guidelines are out there, and they could be in hopefully in the next year or two, that will really increase the market again because you'll go back to the original shots, and that'll have a higher market. There are a couple of other Moderna-specific items. One is our competitors have some inventory in the channel, so they kind of need to work through that, as well as we have to get reimbursement across all of the countries that we want to compete in. Our mRESVIA is approved in 40-plus countries, so we're in the process of doing that. I think when the revaccination guidance comes out, we'll be well prepared. We'll have a more fulsome portfolio at that time to be able to compete. That's what we're kind of hoping for.
The last thing I'd say is if you look at those 10 growth drivers that we laid out, RSV actually wasn't one of them. Now, Stephen mentioned it is part of the contracts in the U.K., Canada, and Australia, and we will have some growth. If there is a substantial increase in RSV growth, I would add that actually as an 11th driver to our growth plan.
Dave at the R&D day showed some really compelling data about how the vaccination rates do tail off year two and year three. The science is there to support revaccination. I think it'll be interesting to see sort of as that comes in. I'm going to bring in norovirus real quick. This is mRNA-1403. Tell us about this condition first and this vaccine. I think it's gotten a little bit more press recently.
Yeah.
It's not one of those that everybody necessarily knows where it is. You guys are running a phase III trial. I think it may be the only phase III norovirus trial, if I'm not mistaken. Really not the competitive issues that you had in COVID or flu or RSV. Tell us a little bit about this vaccine and disease and maybe when we could get data.
Yeah. It is one of the leading causes for gastroenteritis out there. I think in the U.S., we had this at our analyst day presentation. There might be 20 million incident rate per year for norovirus in the U.S. and maybe 700 million globally. When you get it, it spreads quickly, and it's not very good. It can be really tough from getting that disease. Yes, you're right. There is no vaccine. It is an unmet need that we're excited about. We are in a phase III trial. We announced recently that we did not accrue enough cases. We are starting another cohort in the fall right now, and it will stretch into the spring of 2026. We are optimistic that we'll have an interim analysis next year that will indicate what does our efficacy look like.
In terms of the other thing around the product profile, we think it can serve in the U.S. 150 million plus patients or individuals. Those are people that are at high risk from an occupation standpoint. That can be, think of healthcare workers, think of school teachers. Obviously, it still serves the older adults. That's where it's most acute, and actually, it can lead to death and hospitalizations. Think of lifestyle, like travel. A lot of people tend to joke that it's often caught on cruises. That's kind of the patient population. We think it's a material market. I think the last thing, kind of building on my prior point, we think it's going to be administered through retail.
Yet it's another one of our products that we think we can bring to the retail channel, and hopefully by 2028, if all goes well. As I mentioned, we'll have five or six products by that time that should really allow us to compete very well.
Yep. Great. I'm going to transition to oncology. We just wrote a big 190-something page report on RNA medicines and really talking about RNA medicines being the next major therapeutic class. If anybody's interested, reach out. We really highlighted a lot of different technologies, including antisense oligonucleotides, RNA interference, and of course, mRNA medicines. One of the real things that came out of this was the potential for RNA medicines to move into oncology. You guys are really leading the charge here. You mentioned the individualized neoantigen therapy, which is the partnered product with Merck. You guys are going to report phase III melanoma data this year. Maybe you can kind of tell us a little bit about this product, about the Merck collaboration, and really what this could mean for Moderna.
Yeah. First, it's a 50-50 partnership with Merck. All sales, all investments, all manufacturing facilities, research and development. We jointly go in and decide on which trials we're going to do and what's the development plan. We feel like we're partnered with a terrific oncology player and with a terrific product. In terms of the product, it is a combination with Keytruda, the Merck end of this. Typically, it tries to train the immune system to target the right cancer cells. It is individualized. We take somebody's blood, and we look for 34 proteins in the blood and try to identify and create a vaccine that is specific to it so that we can target the right cancer cells. That's a little bit about the product. In terms of the data, we've been tracking our phase II trial, which was 150 patients and 23.
It reduced the risk of death or recurrence by 49%. It reduced the risk of distant metastases by 62%. It was terrific three-year data, which is what's encouraged us. I'll get into the pipeline and why we continue to invest behind it with Merck. That phase II trial is now coming up on five years. That was two years ago. We should be getting that data soon. We are excited to see what that says at the five-year mark. You can really start to see the separation of the curves. The phase III trial, we started and completed enrollment in September of 2024. If you track what happened in phase II versus this latest, first our phase III, which is over 1,000 patients, we're optimistic that we're going to see something from a data readout in 2026.
We're excited to see what that has. As I mentioned, that has given us and Merck confidence to invest in seven other trials, all phase II or phase III in non-small cell lung cancer. Our renal cell trial is fully enrolled. We might see data on that in 2026, which we're excited about as well. I think there's lots to come here.
Yeah. That is a phase II in RCC that we could get data on this year. Definitely, I think one of the biggest drivers, obviously, for Moderna, but really for the field in general. You guys also sort of dropped a new program, not as new, but really starting to get data on it, which is your PD-L1 IDO cancer therapy, where you're really kind of using those antigens to target cancer cells. Tell us a little bit about this and sort of what the status is.
Yeah. I think one of the other, if there's two takeaways for our story, is I think we're really turning around the seasonal vaccines business. I think the next three years are quite exciting. I think the second story, as we lead hopefully to break even by 2028. The second story is we're investing a lot more in oncology, which is what you've mentioned. I think it starts with what we're seeing in cancer vaccines. So INT, which is individualized, is different than 4359, which is more off the shelf. It attacks both cancer cells and immunosuppressive cells. We only had a small phase I trial on this, but it was quite encouraging. I think it was a 67% response rate, again, a very small end. It's given us the confidence.
I think in general, as we see INT hopefully unlocks cancer vaccines, we think that we have a handful, but 4359 is the leading one. That is priority number one in oncology for us. We are in many other areas. The second one is around T-cell engagers. We've dosed our first patient in multiple myeloma. Your report also talked about in vivo cell therapy as well, which is very different than ex vivo from a manufacturing and a disruption perspective. We are quite encouraged by what we have going on in oncology.
I always have envisioned that being able to produce a protein endogenously makes a lot of sense for enzyme replacement. There are a lot of different orphan diseases where children basically require lifelong therapies. You guys have been active both with propionic acidemia and also methylmalonic acidemia. Maybe just in the minute or so, you can tell because I think we could get phase or registrational data from the PA program.
Yeah. We're excited. Yes. It's fully enrolled. PA, propionic acidemia, is fully enrolled. We believe that we could have a readout in 2026 or 2027. What we said at analyst day is we think it could be on the market by 2028. That is relatively imminent for us. We're quite excited by everything we've seen thus far. MMA is not too far behind that. It's hopefully going to enroll next year on a registrational study. You can think of it as a year or two behind from what might come to market at the right time.
Jamey, you always do a great job. You guys ended the third quarter with $6.6 billion. You recently entered into a credit facility with Ares and reiterated guidance to break even in 2028. Why take down this debt now? How are you guys focusing investment to get to break even?
Yeah. That's a great question. We are super confident in our base plan, which I laid out. We think we'll end absent the loan 2027 before we break even in the following year with $3-$4 billion in cash. There's always uncertainties and opportunities. This is a five-year loan. A lot can happen in five years, both on the upside and on the downside. We just thought it was the right time. If we were actually in a position of weakness, that's not the right time to borrow. In terms of the cost of this, it's actually quite low cost. It's non-dilutive. It's very flexible. We can pay it back anytime we want to. The uncalled portion is like a 1% interest rate. We're going to take the cash that we get out of the gates, put it into the bank.
That really nets down the low cost of it. A lot of people have asked, why take $600 million upfront? We really can't get a revolving credit facility when you are losing money. Nobody really can. You have to do a loan. The counterparty, Ares, who is terrific to work for, also needs to make a return. Their return, which traditionally on the marketplace is actually 50% funded upfront, they worked with us to only do 40%, $600 million on $1.5 billion. I know that was kind of lost out there in terms of all the investors asking, why are you drawing it now? When you look at it, we didn't think a convertible made sense at our stock price. We weren't going to issue equity at our stock price. You can't get a revolving credit facility when you're losing money.
This was the next best alternative. I think it is low cost. I think it positions us well over the next few years to be highly flexible.
Great. Excellent. It is going to be a really exciting 12 and 24 months. I always appreciate you guys coming down, all the support.
Thank you.
It's been a long road.
It has, but it is.
It's been a roller coaster ride.
That's right.
We are starting to go back up.
That's right. Thank you so much.
It's been great to see you.
Really appreciate it. Great to see you.
Thanks everybody.