All right. I guess it's quiet, we'll probably get going then. Thanks for joining the session with Moderna, Inc., thanks for attending the Bank of America 2026 Global Healthcare Conference. My name's Alec Stranahan. I'm a senior biotech analyst at Bank of America covering Moderna, I'm pleased to be joined by Lavina Talukdar, Head of Investor Relations. Lavina, thanks for being here.
Thank you so much for having me. That was the best pronunciation of my last name.
I've been practicing but just for this. Maybe just to start, you know, you've got four approved products. You've guided to revenue growth for 2026. You've already beaten your own reduction targets ahead of schedule. I guess is 2028 still the breakeven target, and is this now maybe conservative? I guess what are the key variables that could accelerate or delay this?
Yeah, great question. Thank you for asking it. We did guide to up to 10% growth in 2026. There are two contributors to that growth that, you know, I would focus you guys on. There's increased growth of mRESVIA,
Which was approved last year and participated in the fall 2025, 2026 season, as well as our strategic partnerships in the U.K., Canada, and Australia, where we have very good visibility to the growth coming from those three markets owing to the fact that we've built facilities there, and those facilities have been online since 2025, so the full year effect of those contracts or those strategic partnerships come into play in 2026. We've also, as you just highlighted, beaten our costs guidance that we gave for 2025.
The beginning of the year, we guided to taking $1 billion out of our infrastructure costs within Moderna. We came in at taking out $2 billion in cash costs. Already ahead of the game, 1Q, we are on track to meet our cash cost guidance of $4.3 billion for the remainder, all of 2026. What we can control, we've been really controlling.
There are factors that aren't necessarily fully under our control that will contribute to growth in 2027 and 2028 to ultimately get us to that breakeven. Those include approvals. I mean, we do have a flu PDUFA date coming up later this year, which I'm sure we're gonna talk about. The data there looks great.
We're working very well with the FDA, there are approvals that will also play into that growth, reaching that growth, as well as continued cost containment. For 2027, we've guided to $3.5 billion-$3.9 billion in cash costs, another reduction in 2027. Those are the things we'll control and make sure that we do get to that breakeven in 2028.
Okay. I believe intismeran is not contemplated in the breakeven. That would be an additive?
Intismeran, we're expecting to hopefully see data from the phase III study. There are approval timelines that go into effect as well, as you know. We do think there's a possibility we'll see the approval there in 2027, but the first year of launch won't be a meaningful contributor in 27 to get us to the 28 breakeven. But there hopefully will be some sales from intismeran as well.
Okay. Maybe circling back on flu that you mentioned. You've got your PDUFA date later this summer. It got an RTF, and then that was pulled back. Makary is resigning. Not saying that there's a direct line to be drawn there, but it did create, I guess, some uncertainty around the U.S. revenue bill here. I guess what are your expectations around, you know, when this could become available in the U.S., and, you know, how do you sort of see this playing out in terms of approval sequentially, thinking about a combo in the U.S. as well?
You're right. There was some uncertainty with a change in administration. every year, any time there is a change in administration and changes at regulatory bodies, one should expect some uncertainty. I think 2025, when we entered 2025, there was a tremendous amount of uncertainty that we had to deal with, and yet we got through 2025 pretty well.
We have three products that were approved, and we came in at the higher end of our guidance that we gave on the third quarter earnings call. I would characterize that as Moderna really having a strong collaboration with reviewers and scientists at the FDA, including, you know, those that are higher up as well. To see some more of that continue in 2026 is something that we will try and stay ahead of.
Going back to that very strong relationship with, you know, FDA, the career FDA folks that are there, I think is testament to us navigating through some of this uncertainty. Coming back to flu, as you mentioned, we do have an August fifth PDUFA date. We're on track to hopefully see what that result is in terms of a thumbs up or a thumbs down on the approval.
The data speaks for itself. We showed 27% better vaccine efficacy versus the standard of care there. We're hopeful that August fifth is when we'll see that PDUFA date go positively for us. That will be another data point that suggests that our relationship with the regulator is pretty strong.
Okay. I guess how have your interactions with the agency evolved over the past year? I guess, are there any near-term PDUFA timelines or review interactions that, you know, are being affected in practice?
As I just mentioned, it's been a pretty collaborative two-way street with the FDA. Other than to say that we have that PDUFA date on August 5th, there isn't much more to say on that. I think the collaboration is something, you know, that I just talked about, is one that, you know, we're pretty proud of.
Okay. In terms of, I guess, sentiment, and this is gonna be a hantavirus question.
Moderna's technology has always been, or has had the capabilities to be kind of first mover for any emerging pandemic. I feel like that's just being reiterated with hantavirus. Obviously, you had something in the works, I think, since 2024, I believe. Maybe you can just speak about that program and sort of what we're seeing, understanding that it's still sort of a evolving situation.
Yeah. You're right. We do have an early program. It's preclinical, that's in collaboration with the U.S. Army Medical Research, as well as through our mRNA Access Program, we've allowed for access to our technology to major institutions around the world. In the case of hantavirus, it's with Korea University. They have an innovation center. Hantavirus is one of those viruses that, you know, the WHO ranks as high potential for becoming an epidemic pandemic.
The whole realm of pandemic preparedness is what mRNA Access is also trying to accomplish through that program. This early stage program that we have, I think could be something that gives us a leg up should hantavirus turn into something a little bit more serious than what we're all reading about in the headlines.
I mean, we see a lot of things in the headlines about hantavirus. Is this another COVID? I mean, it's a fundamentally different virus in terms of the R0 and spreadability and how it's transmitted. I guess, how are you thinking about this as being a potential, you know, public disaster like COVID was, or is it maybe something that's a little bit more isolated?
That's a great question. I think we're still learning a lot about hantavirus. There is some speculation that there is human-to-human transmission once somebody does have or is infected with hantavirus. It is particularly from rodents, is my understanding, 'cause they're the carriers of the virus. Once you have exposure to you know, their excrement, it could be something that you have to worry about. We have heard, you know, from recent headlines that there is a possibility of human-to-human transmission.
All of those things, I think, are gonna be what regulators and health agencies around the world monitor. We'll continue to monitor that as well. The key point you brought up, which is being ready for something like this, is what where the world is today.
Owing to what happened with COVID, having a technology like mRNA, technology, as well as an early program in development, again, preclinical, that gives the world a leg up on potentially avoiding something like a major pandemic.
Yeah. Yeah.
Than COVID.
Well put. I want to circle back sort of on the European combo approval. That was a recent positive update for the company. You know, the European market does have a, the potential to be a large growth driver with the pandemic era contracts expiring. I guess, you know, with mRESVIA and Comirnaty approved in the EU, how are you sort of seeing the European market evolving in terms of your up to 10% revenue guidance this year? When does the combo kind of add to that top line growth?
Yeah. Great question again. For 2026, we do not have Comirnaty contributing to, or even NIPs from the EU contributing to the 2026 top line. You shouldn't expect any contribution from the EU for 2026 growth at up to 10%. You did mention the competitor contract that lapses later this year, it will make 2027 an open opportunity for us, it's a fairly large respiratory vaccines market in the EU. Based off of demand, we believe the COVID market is $700 million in sales for the EU, $1 billion for flu.
Roughly $100 million or so for mRESVIA. We'll be entering 2027, as you just mentioned, mRESVIA is approved in the EU and C omirnaty, the first approval in the world for a combination flu plus COVID vaccine, is also approved in the EU. We have mRESVIA approved. The flu standalone program is actually being reviewed by the EU regulators. We may be in a position to have that product approved as well, and that would be our fifth product that's approved globally.
It gives us two things. One, the competitor contract lapses, so the market opens up for us, then we'll have a full portfolio to offer the EU territories. We're looking forward to competing in that market. As of the end of 2025, sales from the EU was less than $100 million.
Even if you assumed a fairly modest penetration or market share in the EU, you would see still meaningful growth coming from the EU once 2027 hits and we're competing in that respiratory market.
Okay. Great. Appreciate the color on the timing piece. I guess when we think about the launch preparedness in flu, this feels like kind of bread and butter for you guys, it's kind of an established market, right? Whereas mRESVIA was like you're building that out. COVID was like the pandemic funneling into a established market. Flu feels kind of like the first established market launch. How should we sort of think about the trajectory there and how does this get positioned versus say, you know, some of the approved flu vaccines?
Yeah. You're right, flu is a competitive market. We feel we're entering that market with a very strong profile in our vaccine. I'll remind everyone, we showed roughly a 27% relative vaccine efficacy relative to standard flu vaccines that are on the market. That already positions us pretty well for that enhanced market, for that highly vulnerable population, older adults, and people who have medical issues that might want a little bit better coverage in their flu vaccines.
We'll be entering that market, which wouldn't include the standard flu vaccines, and so a little bit more limited in terms of who's competing there. Given the profile of this vaccine, plus having it be part of a portfolio of vaccines that we'll be selling to our customers, I think will position us well for that market.
It's a fairly large market, the flu vaccine market. It's $6 billion worldwide with the U.S. making up, you know, roughly half of that. We look forward to the launch. You're right, it's competitive, so we'll see what we can do there.
Okay. Okay, great. I do wanna shift gears and ask about oncology now. We're all eagerly awaiting the intismeran adjuvant melanoma update. The five-year data's look pretty compelling, roughly a 50% reduction in relapse or death. I think this is kind of the context for the ASCO presentation later this month. For the phase III interim expected later this year, I guess, what is the sort of statistical framework? What are the hazard ratios that give you early success versus, you know, continued blinding?
Yeah. Our partners, Merck and Moderna, have not discussed the statistical plan for the trial, so unfortunately, I'm not gonna be able to say anything about that. We do think on timing, it's gonna be in 2026, and that's been the guidance all along. We look forward. We're just as anticipatory and anxious about that data and wanna see that data as all of our investors are as well.
Okay. I think the phase IIb show, showed a median RFS of like 19.4 months, if I'm remembering correctly. Would that be kind of a win?
The phase II.
Yeah
was an absolute home run. That would definitely be a win. Is it the hurdle you need to have in a product that could be successful on the market at the end of the day? Probably not. I would like say if you looked in the sea of other oncology products that are approved, you'd often find hazard ratios of 0.8 as products that are approved, and that's oftentimes in relation or with a control arm of placebo, so not an active comparator.
Which a hazard ratio of 0.8 means there's a 20% reduction in an event or death happening. In the case of our phase III, at the end of the day, if we, you know, had a 0.8 hazard ratio, would it still be a meaningful clinical impact for patients?
We believe so because it's on top of a very good active comparator in KEYTRUDA. That would still be a meaningful result for patients.
Okay. That, that's helpful. I guess, in a few weeks at ASCO, you'll have, like I said, five-year data, I believe. Anything specifically that you think, you know, bodes well or sort of informs what we should be looking at from the phase III?
We've already released the top line data of RFS, and we said the hazard ratio was sustained at the five-year mark as well, you know, a 49% reduction in having a recurrence or dying if you get the combination of intismeran and KEYTRUDA. That already kinda tells you. You know, when I get that question, Alec, I often think to myself, other than the durability now out to five years, continuing to see that hazard ratio, which we all know and is gonna be presented at ASCO as well, can you glean any more from that phase II?
I feel like the phase II result in and of itself at three years and the top line at five years kinda tells you a lot of why we're, and our partners Merck, are excited about potentially having that phase III readout. Is there anything more you'll learn? I know that outside of the Kaplan-Meier curves, and this has already been released with the abstracts, there will be some translational data, so this is speaking to the mechanism. We've announced is fully enrolled and has been now fully enrolled since the Q2 of 2025. It is one, as you mentioned, where KEYTRUDA also works.
A lot of the development programs that are under this broad development program within intismeran is to really exploit that synergy, if you will, with INT plus KEYTRUDA, because we do believe there's that synergism in terms of how the two act together or, you know, behave together. KEYTRUDA has shown positive results in RCC as well. It felt low risk to go after that type of a tumor because KEYTRUDA has shown a benefit already.
If this is true synergism with intismeran, then we would expect to see that follow through in RCC. All the other cancers that we're developing this intismeran program in. Despite being less tumor mutation, having less tumor mutational burden, we do think that's one that could be interesting.
It's a phase II randomized study, as you pointed out, an N that is nearly twice the N of the phase II in adjuvant melanoma. In terms of whether or not it serves as a registrational study depends on the strength of the data and also conversations we have with regulators. We're looking forward to that data readout as well at some point in the future.
Okay. on your 1Q call, you disclosed that your partner Merck recently launched a new study in Stage I lung cancer. That's basically the very earliest population in combination with KEYTRUDA. I guess, does this, in your view, kind of signal confidence from Merck in the program or continued confidence? Obviously, they've been confident in it.
Yes.
You know, how should we be thinking about this new study start in the context of all the other studies you have ongoing?
Definitely continued confidence because it already was a very broad development program. As you know, this is our third non-small cell lung cancer study that we've started. I think it does speak to how committed Merck is to this intismeran program. It is a 50/50 joint venture with Moderna, they're splitting the costs and resources, all of that, evenly with us.
The other thing I'd say from, you know, personally, I'm actually super excited about this study because it gives intismeran two opportunities to win. What do I mean by that? This is a 3-arm study where you've got in 1 arm intismeran plus KEYTRUDA, in 1 arm intismeran monotherapy, and then the final arm, the control arm, of placebo.
In Stage 1 non-small cell lung cancer, the standard of care is watchful waiting. After you've resected the cancer, you're just waiting for a recurrence. Hopefully, it doesn't happen, but if it does happen. You've got now 2 active arms with intismeran in it, so two opportunities to win in that study.
I'm super excited to have the ability through this study to offer patients active and proven through at least the phase II studies that we've conducted in adjuvant melanoma to show meaningful clinical benefit with intismeran plus KEYTRUDA. as well as intismeran by itself. It also speaks to another thing that, you know, both Merck and ourselves have been pointing out, which is the safety profile of intismeran and the combination of the two, intismeran and KEYTRUDA.
There isn't any overlapping toxicity that you see oftentimes with other IO-IO combinations. You just don't see that with intismeran plus KEYTRUDA. That offers us this ability to move earlier into the earliest stages of disease in the case of non-small cell lung cancer in the Stage I setting. The risk-benefit there is something also that I think is another reason why Merck and ourselves felt very comfortable moving as early as we did.
Okay. That's helpful. I want to ask about mRNA-4359. This is your 100% owned cancer antigen therapy going after IDO and PD-L1. The IDO component of that we haven't seen for a little while. It shows some pretty encouraging, I guess, initial activity at AACR earlier this year. I guess, maybe you could walk us through sort of the emerging profile for that therapy. I guess what sort of efficacy signal would be sufficient to move this into pivotal study?
Yeah, great question. You're right. This is wholly owned by Moderna off-the-shelf antigen therapy, cancer antigen therapy, and we are targeting epitopes of both PD-L1 protein as well as epitopes of IDO1. The mechanism that we're using, I know when I speak to investors about IDO, they recall the small molecule approach, back, several years ago that did not actually have a successful readout. Here, we are teaching your T cells to look for epitopes of IDO1 as well as PD-L1. We've learned a lot from INT and how we can teach your T cells to look for neoantigens in the case of INT. Here, it's epitopes of those two proteins.
The data we've seen so far, and we've now turned over the cards from the phase I study at ESMO last year, we showed some pretty compelling early, still early data, in highly refractory patients, so people who have had multiple rounds of therapy, some three lines plus. Most recently at AACR, which is what you asked about, in the phase II portion of that study in frontline melanoma patients, we've seen the ORR now of 83%. 11 out of the 12 patients, or 10 out of the 12 patients have now had a meaningful response rate. Again, very encouraging, but this is still, you know, a handful of patients of data.
I think if David Berman, who just joined, us here at Moderna, were here, he'd say he'd want to see a little bit more quantum of data in a few more you know, many more patients, to actually then move this forward. We're running the phase II, so let's see if this data consistently holds up as we've been finding with this program, then it will be ripe to move into the later stages.
Okay. Great. Maybe in the last minute that we have, I want to ask, in terms of the burn vis-a-vis investing today in the Moderna of the future, do you feel like you've rounded a corner on that kind of seesaw of trimming expenses to a point where now you feel confident in, you know, building out the pipeline further, doing external BD or additional partnerships? I guess, where are we in that continuum leading up to 2028? I guess, what are the investments that you're comfortable making today to build Moderna for the future?
Yeah, what a great question, and I'm gonna probably take a, more than a minute to even answer it. The key thing to note that on that kind of rounding out on the cost side, many of the phase III that we ran up until, you know, the last one that we'll be doing in the infectious disease arena is the norovirus vaccine study that also has a readout in 2026, by the way.
Once those phase III are done, that cost is largely behind you because the maintenance cost for infectious disease vaccines is probably 10%, maybe 15% of sales, and so a lot more manageable. That large cost that you needed to make in order to get the product on the market is behind you. In oncology, the cost of a late-stage development program pales in comparison to infectious disease vaccines, phase III studies costs, and that's largely driven by the N, the number of people you have to have in your studies.
In infectious diseases is tens of thousands of patients. A phase III in INT is 1,000 patients. Even though the cost per patient might be a little bit higher, the number of the N in those phase III studies are so much lower that you can handle the cost.
If the future for us is now going into cancer as a big therapeutic area and other therapeutic areas that don't require large clinical studies like infectious diseases do, and now we've have this commercial portfolio that's coming to market, all of the R&D costs associated with that is behind us. We still can now invest without the quantum of investing being as large as it should be for infectious diseases and have a plethora of opportunity from oncology and other therapeutic areas going forward.
Okay. Very good. Well, with that, I know we're over time, so really want to thank you, Lavina, for the great conversation. Thanks everyone for attending.
Thank you.