Moderna, Inc. ($MRNA)

And today, they're a great privilege to have Moderna as part of our 2026 Global Healthcare Conference. Representing the company, we have Lavina Talukdar as Head of Investor Relationship here. Lavina, thanks so much for joining us. How are you doing today?

Great. Thank you so much for having us.

That's awesome. Yes. We have a long list of questions here. But maybe before we go into the individual programs, let's start big picture. Can you maybe talk about what progress has Moderna made over the last few months? And maybe most importantly, what's ahead here for Moderna?

Sure. Great question. So I'll start with like the foundations that have been laid in 2025. So we entered that year with a little bit of uncertainty given the change in administration and the transition that was taking place. However, we try to control what we can control and costs came out of the infrastructure pretty significantly. We set a goal to take out $1 billion in cash costs, and we took out $2 billion. And we also ended the year at the high end of our revenue guidance of $1.9 billion in sales, which I think, again, makes a really good foundation or establishes what we did in the first quarter of this year, also continuing on cost containment and beating sales expectations, mainly driven by where we see growth drivers this year, the ex U.S. strategic partnerships as well as next bike later in the fall to be continuing to drive growth for us.

Got you. Got you. Super helpful. Maybe given this is obviously been some headlines around Hntairus, -- we continue to see those headlines kind of daily. However, it looks like the risk to the general public remains relatively low. What has Moderna disclosed around what kind of effort you guys are doing around Hantavirus?

So we do have preclinical programs that we're working on with the U.S. Army Medical Research as well as a program that we've had with the Korean Institute of Innovation at Korea University. But again, it's preclinical data, preclinical efforts that are going on there. But as you said, we're watching Hantavirus. It doesn't seem to be posing too much of a risk at this point in time. But the good news is with mRNA technology, should there be an issue, we can spring into action pretty quickly.

Yes. That's helpful. Let's pivot to INT. You're going to obviously have some data at ASCO. Maybe just walk us through -- this is the Phase II data, melanoma. I think you're going to have the 5-year data. I think we already have seen the hazard ratio for progression-free survival. However, I'm assuming you're going to present some data for OS. -- what should be the expectations for OS into ASCO? Again, I think you presented data a couple of years ago. There was only 9 events at that time. I'm assuming we have more events now. But do we have enough events to have a meaningful OS Kaplan-Meier curve here? Or how should we think about that?

So you're right, we will be presenting data at ASCO, and it is the 5-year follow-up data to the Phase II study where we're testing incisiran plus KEYTRUDA versus KEYTRUDA alone. And the big news is really that the recurrence-free survival hazard ratio has remained the same. So we're really seeing a durable effect there. And -- good question on OS. I do want to talk about the significance of recurrence-free survival as well as OS. And so with recurrence-free survival, it is a higher bar than OS is in terms of you're asking 2 questions with recurrence-free survival, you're asking, did the cancer come back? And is the patient alive. And so that bar is a little bit more stringent and higher, which is why recurrence-free survival is the gold standard. And as you just mentioned, the fact that it held at a hazard ratio of 0.51 is very impressive. On OS, we are following OS as well. It still may be immature data. However, we will potentially have a full data set at ASCO, which will include OS as well as DMS.

Got you. Got you. That's helpful. Maybe just a quick follow-up on recurrence-free survival, which to your point is obviously the primary endpoint in the Phase III trial, right? So are you going to show us the p-value, both one-sided and 2-sided? I think in the press release, you have showed the p-value of one-sided. Is there -- are we going to share both at ASCO or still TBD?

I think you'll see the p-value and the one-sided versus 2-sided is literally, you can just multiply it by 2.

Okay. Okay. That's helpful. Maybe let's talk about the Phase III interim for melanoma. The company is obviously not committing to whether data is going to come this year or next year. It's possible this year, obviously it depends on the number of events and how those events will accumulate. Just maybe walk us through what's your latest thinking there? And how are you spending the alpha between the Phase III versus the Phase II? So in a scenario where the trial failed the interim look at Phase III, does that mean that the data is worse than the Phase II? Or are you spending the alpha differently so we can't compare one to the other? Any thoughts there?

So we -- you are correct that this study is event-driven. And we do expect that 2026 is a pretty good estimate of when we will see that data set. However, we haven't commented at all on any of the statistics. So I'm afraid I can't answer any of the questions around the statistics.

Got you. But the 2 scenario at this point is that either the trial continues to the next interim or it hits on efficacy. Is that the way to think about it?

There was an interim analysis, yes, the SMB will be looking at the results of that analysis, and it can either go on to the next analysis or we can stop the study for efficacy.

Is there a look for futility as well? Or is it just for efficacy?

The Phase II study was very strong, as we just talked about. And so there isn't a futility analysis.

Got you. Got you. That's helpful. We've seen this move in oncology over and over again with some time the standard of care evolves when you're kind of mid-trial, if you will. And obviously, the NADENA trial suggests that maybe PD-1 and CTLA-4 should be used in the neoadjuvant settings instead of the adjuvant settings of your trial is in the adjuvant setting. So is there a scenario where by the time you read out your trial, maybe the standard of care has moved and everybody has moved to the neoadjuvant setting and your trial is less relevant? Or is that maybe not the right way to think about it?

So my understanding is that the NADENA study was an investigator-run study and the results were impressive. It may take some time for it to actually become more of a standard of care. In any case, having an armamentarium of medicines and products that physicians can prescribe for their patients is important. And the other thing that I'd like to point out around the combination so far with imisiran and KEYTRUDA is the remarkable safety profile there. We don't see any overlapping safety, which makes it a pretty powerful offering should this be a positive Phase III trial and make it to market.

Got it. Got it. That's actually helpful. Moderna commented on price should that drug ultimately become a reality? We're all obviously rooting for patients here. How should we think about pricing in the context of where IO is today, in the context of where CAR-T is today? Like any big picture thoughts on that side?

So it's a little premature to talk about price. We'd like to see the data first. And so unfortunately, we won't have any comments on price. But as you pointed out, there are IO-IO programs and products on the market that can give you somewhat of a proxy of what pricing may look like, but it will also be data dependent as well.

Okay. That makes sense. You also have 2 additional Phase II trials that are fully enrolled for INT, obviously, both renal cell carcinoma as well as bladder. Maybe just talk talk about timing of when those data sets could come out. Again, my understanding is that the melanoma Phase III trial enrolled -- finished enrollment before the renal cell carcinoma trial. And I think if I look at the Kaplan-Meier curve for the PD-1 monotherapy, it looks like events are accumulating faster in melanoma than RCC. So would it be fair for us to assume that no matter what, the melanoma trial will come before RCC?

A couple of points for you. You're right that the melanoma study was fully enrolled in September of 2024. So there has been more time with that study being fully enrolled and events accruing. -- the RCC trial was fully enrolled as of the second quarter of 2025. So less time with that study being fully enrolled. And if you were to compare the Kaplan-Meier curves of IO programs or checkpoint inhibitors by themselves, you would probably see that melanoma patients recur quicker than RCC. So when we say that 2026, we feel pretty good about the melanoma readout despite it still being event-driven. There is a possibility maybe RCC could read out, but it is event-driven, but we haven't committed to a readout in 2026 at all.

Got you. Got you. That's helpful. We also have seen some interesting data published in Nature Biotech, where essentially patients that received -- that were on PD-1 and actually received COVID actually had better responses than patients that did not receive COVID. So in your Phase III for melanoma, are you stratifying in any capacity, the number of patients that are going to receive COVID on both arms? Should we -- or is there a scenario where maybe you have more patients that receive COVID in one arm versus the other and that imbalance can kind of skew the statistics, if you will? How should we think about that?

So we -- I don't believe we are stratifying for COVID vaccination. What I can say is that we are very keen on seeing the mechanism of action really shine through in incismiran with inisiran to KEYTRUDA. And there is some data that's been presented on the neoantigen selection at AACR earlier this year. We hope to have additional data on the neoantigens in our Inismiran product, where we're seeing an effect of the selected neoantigens and recurrence. And so very much in line with the mechanism of action that we expect to see. Whereas with the COVID vaccine, it's really hard to pinpoint what exactly is happening there. That study that was published, I believe, in nature, also could have many confounding issues there in terms of the type of patients that would get COVID vaccines are likely to be more healthier. So a lot to be kind of still seerited out from that study. But we will have our data, the Phase III data, hopefully, at some point in the future that should give us a good answer on the mechanism of action that's happening with inismiranus KEYTRUDA.

Got you. Got you. That's very helpful. What about the metastatic settings? I mean, so far, obviously, the data that we've seen is primarily in the adjuvant setting. We have seen some data in the metastatic settings from basket studies from back in the days, ASCO, I think maybe 18 or something. Just however, I believe that you and Merck have yet to commit to run a registrational trial in the metastatic settings. What's holding you back? Is there anything in the biology that makes you believe that this is much more likely to work in the adjuvant settings versus the metastatic settings?

So we do have a study, a Phase II study that's running in metastatic frontline melanoma as well as metastatic squamous cell carcinoma of the lung, so non-small cell lung cancer squamous. And those studies have just recently been up and running. And so we are eager to see what the data there looks like. But you're right, the vast majority of the program with partner Merck has been really focused on the earlier settings in the adjuvant setting as well as potentially going even earlier as we just announced our non-small cell lung cancer study in Stage 1 patients. So yet to be determined if it is something the mechanism of action is really the driver of that selection. We want to see the data, both in the metastatic setting as well as the adjuvant setting before we rule out any area where incismirab plus KEYTRUDA doesn't show a benefit.

Got you. Got you. That's helpful. I think in non-small cell lung cancer, which is obviously the largest potential commercial opportunity in the metastatic settings, I think the only trial that you have started is actually in the squamous histology, not in the non-squamous histology.

In the metastatic setting.

Metastatic setting, the squamous histology, non-squamous. Can you just maybe talk about why that's the case? Is that because squamous is more driven by smoking? And so patients have higher tumor mutational burden. And so this mechanism of action is more likely to respond in that histology or what?

I'm sure there's multiple reasons why we selected going into the squamous cell setting. I'll just remind you that there is a joint steering committee with both the Merck scientists and the Moderna scientists when we agree and move forward in the development and in the different areas of development. So there are probably multiple reasons why they decided to go with squamous in the metastatic setting.

Got you. Got you. That's helpful. Maybe pivoting to flu, never a boring day with the FDA these days, right? Maybe at a high level, is the fact that Makari and Prasad are no longer at the FDA, a good thing or a bad thing for Moderna? Speaker 4 I would just...

Really think about how Moderna has worked with the FDA and the review staff, the scientific career scientists that are there all throughout 2025 and remind folks that the relationship that we've built with the FDA based on the science and the products that we take through is a really strong one. And that's really evidenced in 3 different programs that were approved by the FDA last year. And that includes our new COVID vaccine, an expansion of the RSV label for high-risk individuals 18 to 59 years old. as well as the pediatric vaccine that was approved a full approval on the pediatric vaccine. And we are the only ones that have a COVID pediatric vaccine in the setting of 6 months to 5 years old. And so I think that shows that strong relationship rooted in the science, and we expect that to continue given that it's really started and is with the review staff and the career scientists that are at the FDA.

Sure. That's helpful. I think PDUFA date for flu is the upcoming, right, August 5, if I recall it correctly. What's the latest thinking there? Have you had any back and forth with the FDA? Are you already in label discussions? Like how should we think about that?

So that review is ongoing. And you're right, August 5 is our PDUFA date. We typically don't talk about back and forth with FDA, but we are looking forward to a decision on that date.

Got you. Got you. That's helpful. How should we think about the commercial opportunity for flu? Obviously, it's an established market. There's a lot of players out there. Probably the most intuitive competitor here will be Fluzone HD from Sanofi, which is obviously doing pretty well commercially. Like just walk us through how should we think about the ramp of the flu vaccine from here in the United States? And are there any lessons learned from RSV? Obviously, the launch of RSV hasn't been maybe what some of us were hoping for. So what are some of the key lessons learned from RSV that you're hoping to apply here for flu? And how should we think about the trajectory of this market going forward?

Sure. So the flu market versus the RSV market, there are some marked differences there. Flu is a very established market with players competitive. But RSV was a relatively new market when we entered that market. And it also had a number of recommendations that actually didn't happen for that RSV market. So I would characterize RSV as a competitive market. And so we entered a very competitive market where the market wasn't established as well as the lack of having a revaccination schedule that really impacted the market. Whereas with flu, again, a very established market, we'll be entering that market with a strong product profile should we get approved. And I'll just remind you that the head-to-head study that we did with standard flu vaccine showed a 27% relative vaccine efficacy. And so we think we're entering that market with a very strong profile despite the fact that it's a competitive market. We would like to position it as one for that enhanced market that Sanofi is in as well, as you mentioned, for the older adult population.

Got it. Helpful. What about the combo? Obviously, you filed in Europe, and hopefully, there will be a combination of flu and COVID available in Europe soon. However, what's the latest thinking on filing in the U.S.? It's my understanding that for a period of time, you guys were hoping to file them together versus now the FDA has come back and says like, hey, we want to first approve flu before we consider the combo. Where do we stand in the conversations with the regulators to get the combo over the finish line here?

All right. So a couple of corrections there in your question. We are approved in Europe with MCombriX. That approval came through pretty recently in this past quarter. So we're looking forward to starting discussions with NITAX and getting it ready for the fall of 2027. In the U.S., we first filed for the combination last year, and we were asked to withdraw that filing so that we can add in the flu filing. And now that the flu filing is on track, we're still awaiting guidance from the FDA for the next steps on the combination in the U.S.

Okay. Okay. That's helpful. Maybe COVID and the guide for the year. Again, you're still guiding for potential revenues up to 10% for the year. Obviously, your competitor, Pfizer, has a little bit of a different outlook. They're actually guiding, I think, their COVID franchise more broadly. This is both the vaccine as well as their therapeutics approach, I think, down 23%. So like what's kind of the best way to rationalize that dichotomy? And maybe just talk us through what are your expectations for vaccination rate in the U.S. I know you guys have guided that vaccination rate is expected to further decline. However, there's got to be some other dynamics that are more than offsetting that vaccination rate coming down. You already mentioned ex U.S. But yes, how should we think about the outlook for COVID for the rest of the year?

Sure. So you're right, we guided to up to 10% growth for 2026. And that growth is going to be driven by our strategic partnerships that are outside of the U.S. in the U.K., Canada and Australia as well as growth of MNeXpike, our new COVID vaccine, which also showed a better relative vaccine efficacy, so higher vaccine efficacy by 13% versus SpikeVax. Those 2 drivers are what will be contributing to that growth. And so while I can speak to our growth coming predominantly from the ex-U.S. strategic partnerships as well as continued growth of MNeXBike, it's hard for me to say what Pfizer was thinking about their own guidance. The visibility we have with those strategic partnerships is pretty strong. And so most of our growth is coming from that -- the international markets. In the U.S., as you pointed out, our guide of up to 10% growth, if you took the midpoint of that and said 5% off of the $1.94 billion of sales last year, you get to roughly $2 billion. And we said that ex U.S. versus U.S. would be a 50-50 split. which would then mean that our U.S. outlook would look for a 20% decline. And there could be multiple factors that go into why we see that U.S. declining. One of them is vaccination rates, anticipating another potential decline in the number of people getting vaccinations, but it could also be additional competition, for instance. We wanted to be -- take that into account just in case, but still we see growth. And so if we are flat on vaccination rates or flat to the U.S. versus last year, then we would see growth closer to the high end of that up to 10%.

Got you. Got you. That's helpful. Maybe related to it, -- how should we think about the long-term floor for COVID? Obviously, numbers have come down. And however, there is now some stability, especially ex U.S., to your point. However, again, the timing of the ex U.S. orders and whatnot can be lumpy, and it's kind of hard to fully model that. So what do you think is the floor here? Is it fair for us to think that maybe $1 billion to $1.5 billion floor going forward is the right number here? Or would you guide us against that?

So COVID specifically, last year was, again, on access was a pretty tough year with the transition in leadership at HHS, for instance. And so last year could serve as a pretty good proxy in terms of what we're looking for on the go forward, particularly since -- those folks who wanted to get their COVID vaccine showed up and got their COVID vaccine. But as you know, we'll just have to kind of go through the years to see if, in fact, last year's rate of vaccination is somewhere in the floor. But again, these strategic partnerships that we have that do give us visibility into international markets does provide a good sense and visibility on what the COVID and vaccines market will look like, which just gives us confidence in our projections going forward.

Got it. Super helpful. Last question. I know we're already out of time here. But -- what's the latest on the IP dispute with Roivant and Genevant. Obviously, you settled for a big chunk of money upfront. However, you're still in the hook for $1.3 billion potentially. You're obviously appealing that decision. Maybe just remind us what are the time lines? And I think in your press release, you mentioned that you believe that, that $1.3 billion additional payment is not probable. Why did the legal team concluded that, that $1.3 billion was not probable?

Yes. So a couple of points there. On the appealing, this is actually -- it's going to the court. We do not believe it is probable, and there isn't much more than I can say other than it is not probable in the eyes of our legal team, which is why there isn't a reservation or any kind of reserve on the cash.

Got you. Lavina, I have a lot more questions, but no more time. So I appreciate you joining us here at RBC. Thanks, everyone, for joining, and we'll talk soon. Thanks again.

Thank you.