We're gonna get going here with our next company presenter at the Bank of America Annual Health Care Conference. We got Viatris, and joining with us is CFO, Doretta Mistras, and Philippe Martin, the Chief R&D Officer. So thank you both for joining us. My name is Jason Gerberry. I cover mid-cap biotech and specialty pharma. And, so yeah, let's jump into it. I think a big part of the Viatris story, I think, of late has been solidification of the base business, some divestitures, and then, you know, strategic pivoting to more long-dated, durable kind of growth, specialty brands at a high level.
Maybe we can start with the base business in terms of, you know, where the company is at with its key regions and, where you're seeing the most momentum, where you've got a little bit of work to do. Perhaps markets like Japan, where I know you guys have flagged, you know, looking to do some things to offset some of the kind of pressures in that segment. Then maybe we'll start there and then go into other deeper questions.
Yeah, great. First, Jason, thanks for having us. We're incredibly excited to be here. And we're on the back of reporting earnings last week. And I would say in summary, we feel good about where we are, both from a continued execution perspective, as well as kind of the business continuing to deliver as we expect. In terms of our key strategic priorities, you mentioned a few of them in terms of continuing to focus on closing our divestitures, repaying down our debt, continuing to deliver capital to shareholders, driving growth in the base business, and continuing to invest to drive that growth.
So, specifically, as we think about the base business, it's a stable and steady portfolio, really, given our well-diversified global platform, and we expect total revenue to grow operationally approximately 2% for the year. That's really driven as we think about the various components in North America. It's because of our brands in YUPELRI and Tyrvaya, its existing complex generics like WIXELA, and its strong contribution from new products like BREYNA and lisdexamfetamine, as well as expected new product contributions from our complex pipeline-
... which we expect to come over the next couple of years. Then moving to Europe, this is a business that grows—we expect to grow 3%, and it's really driven by our kind of broad portfolio across brands, across generics in key markets like Italy and France, as well as new product introductions like generic Aubagio. In emerging markets, this is a mid to high single-digit growing market, again, driven by strength in our brands, whether it's Lipitor, Elidel, XALATAN brands, and our generic portfolio. And we continue to feel good about our business in China. Continued focus on execution there, focus on the retail and self-pay market, and the opportunity to bring new products into the market over the next couple of years.
So as you look at our kind of portfolio, the diversification of it, we feel good about the portfolio that we have and the opportunities ahead of us.
So that's a helpful characterization of top line. As we think about these different units and how the company is sort of structured and leverages the cost structure that you have, are there certain geographical segments that are probably meaningfully better margin contributors and more important to the bottom line at the moment, versus others that might be more strategic and offer top-line diversification, but are maybe less consequential to the bottom line? I mean, most investors tend to think the U.S. market drives most of these companies', you know, operating profits, but curious if how you'd frame that.
I think one of the uniqueness of our portfolio is that it is broad and diverse. I mean, the U.S. market currently for us is kind of less than 20% of our revenue.
And so we do benefit from having this, this global platform. As we think about growth, U.S. will continue to be a kind of key driver for us as we look to contribute. We have a strong base there that we can leverage, and as we've talked about, we're looking for branded, durable, high-margin assets that we think we can be successful in continuing to add to that portfolio. But there's opportunities to leverage that beyond that, right?
Yeah.
There's opportunities to add regional, country-specific, assets that leverage our global infrastructure. And so it's really about kind of balancing those various components, and kind of finding opportunities to drive growth.
And so maybe if we just kinda go through some of the segments, start with China. I mean, how do you feel about the geopolitical landscape, VBP exposure, and then the appetite to, you know, as you look to acquire more innovation in the portfolio, the ability to get properly kind of a good return on investment in that market? I mean, so how are you feeling about that, as an end market that you'd wanna maybe increase exposure to or just sort of maintain kind of where you're at?
Yeah. So China, actually, about 95% of our business in China has already gone through ... VBP. And so given our focus on the retail channel, on the self-pay channel, we're focused on continued execution as well as bringing in new products. And we have the opportunity not only to bring additional products into the market and leverage our existing infrastructure, but we also have the ability, for example, with selatogrel and cenerimod, two assets that we recently bought into our pipeline. Those are both global opportunities, especially in selatogrel. And given our cardio franchise globally, there's real opportunities, not only with what we are doing globally in terms of our expansion, but also on region-specific opportunities to continue to invest in. As it continues...
You mentioned it, kind of it does continue to be a very complex dynamic-g iven the breadth, and we continue to kind of manage that evolving policy dynamic.
Okay. And how—I'm just trying to get my head around, you know, the retail model, right? And so you—Lipitor, NORVASC, these sort of products where you're leveraging an established brand equity that's been built over years, and those seem to be disproportionate drivers of growth through this retail channel. Will more innovative products move through retail, or will have to go through, like, more of the traditional hospital model in the early infancy of the product life cycle? I guess I'm trying to understand that distinction, if there's a distinction at all to be had.
Yeah, it's, I mean, it's evolving, and we still kind of have infrastructure both in the hospital, but there's also opportunities much broader than that.
Just given the kind of feet that we have on the ground, the relationships that we have. And so there's real opportunity to kind of broaden our kind of our presence there, our and kind of really create a portfolio approach. But it's not just. The benefit we have is it's not just China, it's the other regions and kind of how that all plays together.
Okay. And then maybe in terms of North America, how that's been evolving, it sounds like you're getting good momentum on the brand side. To whatever extent to the U.S. generics, which maybe was a problem child five or seven years ago as an end market, that natural erosion is more than outpaced by what you're seeing kind of collectively on your brand growth. Is that sort of what drives the operating assumption on growth there?
Yeah, it's a couple of factors. One, it's we continue to evolve our portfolio towards more branded products like YUPELRI and our eye care franchise, Tyrvaya, Ryzumvi. But then there's also the kind of our existing complex generics products like WIXELA, our additional product opportunities. And so, kind of at the same time, we're also trying to manage our kind of base legacy brand portfolio that we have. But on the brand side, there's really the opportunity to continue to evolve that portfolio. And then on the generic side, it's the combination of existing products, new products, our pipeline that we expect to contribute, kind of over the next several years. And then the totality of that, to your point, we expect to more than offset the base business erosion.
Okay. Now, there's a lot of moving parts with divestitures, with scaling up a brand business and investing in that, and then potentially even overlay with future BD. So how do you think about the legacy margin structure of the business, and do you want to sort of accomplish all these future goals while maintaining that margin structure? You know, maybe if you can just sort of outline kind of how you're thinking about the margin structure within that broader context.
Yeah, and I think it's an evolving story, but we feel really good about our base, the ability to generate kind of the 2% top line growth that we've talked about in the immediate term. We realize that it is going to take some investment in order to continue to migrate our portfolio towards these kind of higher more durable, higher margin-
... branded portfolio. But, underpinning all of this is our stable free cash flow generation, right? And that allows us the ability, not only to invest in growth, but also to deploy that capital to shareholders, whether it's via share repurchases or dividend, and really also drive EPS growth over the longer term. And so, as you think about the branded portfolio coming in, driving some margin, driving some of that higher, higher margin, coupled with kind of capital allocation-
Yeah
... you have the opportunity to really deliver on the EPS side.
Okay. Maybe I'll pull Philippe into the conversation here. So maybe thinking about BD and therapeutic areas of focus, I know that at one point, there were sort of the three core areas: GI, ophtho, and derm. It's been broadened out, right? So should investors think more about the focus being more opportunistic and TA agnostic, ultimately, and with a focus on just good drugs and, you know, drugs that can be differentiated in large markets? Just kind of curious if you can give us a little bit of a snippet or sense of what's going on behind the scenes in terms of the asset scans.
Yeah, I mean, I think we haven't changed our strategy. We're still looking at the three areas we said we were going to look at, but dermatology, eye care, and GI. There's a lot of good drugs there that we're looking at, and may bring in at some point, but we're not stopping there, right? We have a lot of inbound interest that we're seeing a lot of assets, and when the assets make sense, and that where we can leverage our existing structure globally to commercialize those drugs, then that might make sense for us to go forward. Again, it's more important. It's often more difficult to get a good drug than to commercialize it, at least from an R&D standpoint.
And so I think that's really where we're looking at, is trying to get the best drugs that we can possibly develop and or commercialize.
Mm-hmm. In terms of-
There's a level of opportunist, opportunism. We got to be a little opportunistic when it comes down to, to BD.
Yeah. And I think, maybe some of the legacy and shareholder base was less accustomed to the company taking on clinical risk, right? And so when we think about the Idorsia deal, when we think about future BD, how much appetite for clinical risk is there? Is, at a minimum, the company wants to see maybe a phase II proof of concept data set in place to feel comfortable versus, you know, maybe earlier stage deals and building out more platforms, for example.
Yeah. I mean, risk is top of mind, right? Clinical regulatory risk. When we look at these assets, we screen them. So typically, the assets we're going to be looking for are either phase III assets, either about to start phase III or already in phase III, such as Idorsia, where the asset is considered de-risked to some extent, strong proof of concept, and so, you know, and good regulatory interactions that lead you to believe that there's the probability of getting the drug approved is very high. So we're looking at these assets that have where the level of risk is lower. We're not going to go in phase I, II assets that don't have a clear proof of concept.
Mm-hmm. And I imagine you're somewhat opportunistic about the geographical availability of these assets. Oftentimes, assets are encumbered and I imagine you want assets that give you worldwide rights, given the infrastructure and the ability to kind of maximize value for those.
Yeah, I mean, generally speaking, we're looking for global rights where we can leverage Viatris's current structure. Sometimes it happens, like with cenerimod, where one of the region is already taken, such as Japan, that's fine. If the asset still makes sense for us globally, for the rest of the markets, then we'll certainly go forward with it.
Yeah. And the only thing I would, I would add to that is we, we are looking for global opportunities. A fill-the-hole scenario that fits, fits in that camp. But we also have this global infrastructure, and there's a lot of companies out there, especially in biopharma, that may have a great line of sight in terms of how to commercialize a drug in the U.S., but may lack, whether it's resources, expertise outside of the U.S. And so we have the opportunity to leverage that, our global footprint, potentially kind of partner with some of these assets to not only potentially derive growth within the U.S., but globally as well. And so there's kind of we have a lot of options in terms of how we think about things, given the global diversification that we have.
Okay. And just coming back to the point on therapeutic area and just construction of a more of a branded, longer tail durable business, I get the sense that, like, the cost of the sales infrastructure is not rate limiting so much, right? So, you know, when you think about building out a solid vertical, is it more about internal know-how and expertise to scale that and to get more brands, and maybe that gives you more leverage with payers versus, you know, just... It used to be in the old days, get more bang for your buck in terms of infrastructure and multiple products in the bag. But that seems like the areas you're targeting, you could probably target, and say, the U.S. with 150 reps.
Yeah, I mean, Doretta, you comment if you can add, but I think we're looking for specialty type products, right? Where the sales force is generally relatively small, targeted, so you don't need to build a humongous sales force, right? It is pretty constrained and relatively easy to do. Again, getting the right drug is probably more important in long- term than the commercial considerations.
Yeah, I would echo that. The first and foremost, you need a kind of drug that we think is going to be successful, and we are the right people to commercialize that asset, whether it's in the U.S., opportunities to leverage our global capabilities. And then how do you kind of leverage that in a targeted way and have the ability to build kind of real franchises around that asset? But it really revolves around the asset.
Okay. And as we think about the interplay with share buybacks and other capital allocation commitments, so to speak, is it fair to say that, "Hey, we have certain guardrails regarding cap deployment for divvy and for buybacks, and that's just set. And so it's not like we're constantly, every year, gonna be looking at sort of the best return on investment from BD decision-making versus deal buybacks. I guess it matters, like, I wonder if investors should be thinking about that, the deployment for buybacks flexing up and down in future years?
I mean, there, there's a number of factors that play into how we think about specific BD opportunity. But I can say every BD opportunity we look at, we compare it against what a share buyback would look like. But part of kind of the benefit of our strong free cash flow generation is that we do have the flexibility to be able to do both, and we expect to continue to return capital to shareholders, but also invest in the business to be able to drive future growth. In the first quarter, we returned $393 million via both share buyback and dividends. But we believe kind of a balanced capital allocation strategy is important to drive both near-term and longer-term shareholder return.
Okay. Maybe Philippe, if we could talk about selatogrel? You know, very unique and novel clinical trial for prevention of acute MI. Can you just talk about... You had an update on your 1Q about just enrollment assumptions, and there might be some, it sounds like you need to kind of monitor how these tweaks to the enrollment protocol might affect enrollment. But currently, you're talking about maybe having data in the second half of 2026. But, I don't know if you can kind of elaborate a little bit more on some of those changes and when you might expect to have a better handle on the enrollment dynamics.
Yeah. So, what we're doing since since we started the collaboration with Idorsia, is we are adding a significant number of sites to both the cenerimod and the selatogrel studies. We're basically doubling the number of sites, and we're doing that by going into regions where Viatris has a presence, has a know-how that Idorsia may not have had, right? And that allows us to increase the speed of enrollment. Enrollment so far, I got to say, is doing well. It's going according to plan, but we want to speed that up.
And that's one of the way to do that is to add additional sites. The other way, which we are doing also, is to reengage investigators, having more face-to-face interactions with sites and investigators, and so we've initiated that aspect as well. So we think that early next year, we'll get a good grasp on whether we've seen a different inflection point in terms of enrollment for both assets. But so far it's going well, I got to say, but we want to speed that up if we can.
Okay. And maybe just talk about the current standard of care, right? A patient has a heart attack, they get to the ER, presumably, they get IV cangrelor. Is that... You're looking to kinda speed up the window, right, to get this antiplatelet on board in a faster manner. And so if you could just maybe talk about how you believe that selatogrel may represent a step change in care.
Yeah. So I think there's a current gap in the treatment of MI. That gap is between the time the patient has the MI and the time the patient gets to the hospital and can get a drug like cangrelor, for instance. That's when selatogrel changes everything, right? The patient has a pen that they carry with them, and if they feel a symptom similar to what an MI would look like, they self-inject and then have to take themselves to the hospital. But they have time to do that because the drug stops the MI from progressing, stop the damages to the heart that can happen when the MI is happening.
The other aspect that is particularly important from an efficacy standpoint is that the thrombus that is formed during the MI process is formed of platelet at the beginning of the process, but then within an hour to two hours post the formation, it now turns into more of a fibrin type that doesn't respond to P2Y12 as well as it would at the beginning of the treatment. So ensuring that patients get treated early is critical to the success. There's a lot of data supporting this out there. So the concept is to basically change the way MI is being treated by having patients self-inject at the right time to save muscle, basically.
Yeah. And the way that the endpoint is tabulated, you know, what if you just lessen the severity of the heart attack, but the patients could they still be deemed a heart attack, and thus the differentiation may be more on whether the patient ultimately has death versus a nonfatal event?
So it's an endpoint that we've developed in discussion with FDA, with KOL, and was the purpose of the SPA, so it's well accepted by the regulators, but at this point. It's been used in other studies recently that just started. I think that you got to remember what the endpoint is about, right? The endpoint is death within seven days, and then various sorts of severe what you would could characterize as severe MI.
And then there's a category that is none of the above, which is basically mild MI or just chest pain, right? And so the ability of the drug to... And it's ranked by severity. So the ability of the drug to reduce the severity is one aspect of the endpoint versus placebo, right? And that will have an impact on how many severe events are on placebo versus how many severe events are on treatment... but it's all about, it's also reducing the number of death. It's also reducing the number of severe MIs. So it's a combination of all that. At the end of the day-
It's a hierarchical analysis.
That's right. It's a composite endpoint, hierarchical, hierarchical analysis. At the end of the day, what the way the study is powered is really to try to show a 20% risk reduction between treatment versus placebo for all these adverse events, right? And, you know, it's been documented that with P2Y12 that are not given at the right time, and not given to the right patient necessarily, that 20% is conservative. So we feel good about the assumptions we have for the study, and we think that that's an endpoint that is definitely achievable for the drug.
I know a big component and a lot of questions that you guys get is: Are the patients going to inject properly, right? I know you're monitoring this on a blinded basis. If you can just talk a little bit about how that impacts the hierarchical analysis, if at all. So in the end, it's just about events, irrespective of whether they injected properly or not, and then you'll just tabulate that data as a separate analysis to just show to regulators and clinicians that people actually did know to properly inject.
Yeah. So, you know, we are monitoring the data, obviously, on a blinded basis, very, very closely. But we also have an unblinded safety committee that monitors that data, and then a team of independent assessors that are adjudicating all the MIs, as well as the bleeding events, right? So we are looking at this very, very closely. What we are paying particular attention to is are the patients injecting for the right reasons? Are the patients injecting soon after the symptom of MI, right? And are they taking themselves to the hospital afterwards? Are they getting medical support? What we've said is that that's what we've observed. We've observed patients are injecting for the right reasons.
Symptoms of chest pain is what we're asking them to look for. And they're doing it within 30 minutes of the symptoms showing up, and they're then all taking themselves to the hospital for proper care and also for proper diagnostic of which kind of MI are they getting. So we've seen that. Now, we do expect that a number of patients will not inject for the right reasons. We have assumptions around that as part of the study, and that's okay, right? As long as the drug doesn't lead to severe bleeding, which is... We've said, so far, we haven't seen any signals of it. We have over 6,000 patients randomized at this point.
The phase II data did not show any severe bleeding as well. Then we have a DMC that met seven times since the beginning of the study and really has not changed anything to the study. It is asking us to continue unchanged. So we feel good about both the efficacy and the benefit-risk profile that we're seeing today from the drug.
The key thing in that assessment, on a blinded basis, is just the patient's characterization of the symptom-
Yeah.
right? To ensure that-
Chest pain, we wanna make sure they go ahead and inject themselves. If it turns out it was not an MI, that's okay. That's good data to have for us to show that the drug is safe, and can be used in that setting. But it's for those that have an MI, making sure that they inject at the right time. They have time, but the sooner they do it, the better it is, right, for the drug.
Mm-hmm. How are you thinking—This is a very paradigm-shifting type of therapeutic that you're looking to develop. Just in terms of actually getting patients to walk around with a device on them at all times, right, to get the buy-in for the clinician community, are we putting the cart before the horse a little bit here? Do we just need to wait and see how solid the data is, and then you think it'll be a lot easier to drive that paradigm shift?
I mean, that paradigm is coming from the community, right? That they've asked us to do that, and they've asked Idorsia at the time to do that study. They saw the opportunity. That's the way they think the treatment of MI should be progressing, going forward. So we're not reinventing anything here. It's just they are seizing an opportunity that they're seeing with this drug, based on the PK of the drug, that's fast-acting, short duration. That's the perfect drug for an injector pen that can be carried around. I mean, we have experience with pens in general. We know how to manage it. So I think if there's one company that's the right one to do that, that would be Viatris, right?
You're also dealing with a patient population that has already been through one MI. And so the kind of desire for them to prevent future MIs is significant as well.
All right. Well, we are up against our time, but thank you both for joining us at the conference.
Thank you very much.
Thank you.