Side of our business, particularly North America. North America being up 3%, driven by the generics portfolio. Kudos to Philippe and the team for continuing to get our complex portfolio approved and also launched. Last year, we launched two complex injectables, which is helping drive that growth. We're seeing continued strong trends with our generic Symbicort in the market. North America positioned in a very favorable manner. Overall, I think when you look at this business, you know, we're on a trend line right now of 2 %+ operational growth. You mentioned the enterprise-wide strategic review. We're beginning to implement that cost savings program this year. We're expected to deliver $120 million of net savings, so that's certainly helping with the operating leverage we're seeing in the business.
Overall, I think the business is in a really good spot as we look out to the rest of the year.
Okay. You know, I guess for some of us who followed you guys for 10-plus years, the company's gone through a lot of permutations between Mylan, the Upjohn, you know, deals and divestitures. When we look ahead to the $11 billion of capital return that you talked about, maybe half of which could be used for BD, is that a firm number or are there some, you know, variables that could enable you to push greater on the BD toggle for the business, depending upon the accretion profile of the target and/or other facets of the target asset that's out there?
Coming off of our investor event earlier this year, one of the, I would say, key areas of where we can create value as a company is certainly capital allocation. It really all starts with the strength and durability of the free cash flow of the company. I think that's been a hallmark of Viatris for some time. When you look at the cash that we have on the balance sheet exiting Q1, free cash flow generation of over $2 billion, and thinking about the growth profile of the business, we expect free cash flow to accelerate between now and 2030. That sets us up from a strategic flexibility point of view, where we have a lot of optionality.
When we look at the balance of capital allocation, it's gonna be a balanced approach. First and foremost, we're gonna continue to return capital to shareholders. Our commitment to the dividend will be a part of that. We'll continue to look at share repurchases in an opportunistic fashion. Last year, we leaned in a little bit more into share repo. The remainder, really 50%, thinking about how we can use that capital to accelerate the underlying growth of our business. Thinking about BD in terms of really two priorities. one is, how do we continue to strengthen our regional segments? Where can we find assets that we can plug into that existing infrastructure? Also a strategic priority for us is to expand our innovative business in the U.S..
As we think about the continuum of BD, it's not necessarily a sizing perspective. It's where can we find assets where we can be, they have a good strategic fit, we can build a cornerstone franchise around, and really we can be big, good owners of those assets. I don't wanna kind of anchor us to a size, as you think about how we're dimensionalizing it over the next three years-four years, we've talked about bringing in [$1 billion-$1.5 billion] of revenue from BD and about a half a billion of adjusted EBIT. Really, the goal is to take BD and use it to accelerate the underlying growth of the company.
Mm-hmm. Then maybe talk about the cadence of the launches that you have coming up, how that can accelerate that growth, which I think you said was 2%, 2.5% now. As you layer in those launches, some of which, like meloxicam, are a little chunkier and bigger than some of the other ones that you've outlined on the come, like pitolisant, I imagine. Just any framing that you can in terms of the cadence of launches and how that gets you to that 3%-4% growth target by 2030.
Yeah, sure. You know, the company, as you look at kind of our evolution, from being predominantly a generics and established brands company, we set a strategy out to really expand our value-added medicines and also our innovative bucket. When you look at what those can do for the company, this year we have a number of upcoming launches. One of our prioritized markets is Japan. That's where strategically we've looked to strengthen that market with more branded innovative medicines. Recently we launched our Effexor for generalized anxiety disorder. It's early days, but we're seeing some promising signs for that launch. Upcoming this year, we'll be launching pitolisant in Japan.
When you think about the sleep and wake category, it's a very underdiagnosed, undertreated market in Japan. We see a lot of opportunity there. Next year, we also expect to launch our Nefecon product. Those launches, when you look at our Japan segment, really have the potential to return Japan to growth by 2028. As you think about opportunities for our North America business, you mentioned . First one with our XULANE LO or low dose weekly estrogen patch. We have a PDUFA for the end of July. That is the first of two products when we think about the contraceptive patch portfolio that Philippe and his team are developing. Collectively, we think that portfolio could generate at peak sales over $300 million between those two products.
The big one that we're really excited about in the portfolio is our fast-acting meloxicam. This is an opportunity to market where you've got a very sizable broad market in acute pain, and we have a non-opioid option with a really attractive profile. We think that that product over its lifespan could be up to $500 million. Collectively, when you look at the base trend line, you add in the new launches, it's the collective basket that we believe accelerates the growth to that 3%-4% top-line expectation between now and the next few years.
Okay. Maybe shifting gears to the meloxicam opportunity. You know, as we think about the importance of label, labeling and product labeling, how important is getting that opioid kind of sparing attribute in the product labeling, and test what resonates with healthcare providers in terms of addressing unmet need? If maybe you can speak to, I guess, some of the important label product label outcomes that are on the come.
Yeah. You know, I think, as you know, we are very proud of the data we've generated, in particular, the profile that emerged from the phase III program, rapid onset, strong efficacy, in line, if not better than opioid. When we look at the way we set up the data, and we had a lot of back and forth with the agency during phase II when we designed the study, the phase III studies. Our first two secondary endpoints are two endpoints that look at opioid sparing, reducing the number of doses and the number of patients that are opioid-free. Highly statistically significant, clinically meaningful results for these two endpoints.
We feel good about our opportunity to include that data as part of the label. Where exactly in the label it's going to be, whether it's gonna be in the indication section or in the clinical section of the label, it doesn't matter, as long as this data is in the label. In terms of importance going back to your question, I think it's good to have it. It would simplify things for us, but the data is out there, right?
I think when we went to a number of congresses, medical congresses this year, the onset and the opioid sparing data is what really resonated with doctors, and this ability that they can now go ahead and reduce the opioid use, which they've been trying to do for many years now. They have an option that they are very comfortable with. They know the mechanism of action. They have a good understanding of the safety profile. We expect the uptick to be pretty significant pretty early.
Okay. I'll preface my next question just by, I imagine a lot of investors are going to benchmark your launch to Vertex's JOURNAVX.
I think part of the answer is what you define as success, $500 million peak, is probably not what Vertex investors would define as success for JOURNAVX. With that said, what have you learned from their launch, how you're approaching the market maybe differently? I know you focused a lot of folks, investors on the outpatient opportunity where you think access could be more favorable. Just kind of curious what you've learned from the Vertex JOURNAVX launch and why you're optimistic about how the rollout of meloxicam will play.
Yeah. I think what I'll start, and then maybe I can give it to [Bill]. I think what we are seeing is that I'll come at an angle from a data angle. I think our data is really resonating with prescribers. I would say that the JOURNAVX data less so. I think that creates a need. Now, what, as you point out, what is important for us, because we have a shorter exclusivity window than a typical new molecule, we have to go after uptick much more than they do. They have more time to build.
Yeah.
We gotta build faster. I think that's the strategy that the commercial team is putting in place, going after ability to go after a postsurgical patient, out of the hospital, patients and then start narrow with a specialty sales force and then expand to a broader group of patients potentially with a partner, if that makes sense for us at that point. I think that strategy is different because of that, shorter exclusivity that you see with us versus the typical molecule.
You said 2026 is unlikely material contribution from meloxicam. Is 2027 a material contribution, from that product that should investors expect?
Yes. I think 2026 is we anticipate to get approval toward the end of the year. Therefore, you would see, start seeing a meaningful contribution toward 2027.
Okay. You mentioned IP and the IP runway. pretty much all the CNS companies that I cover, you know, there's serendipitous discovery of older molecules, right? There's build-out of IP to protect that when the clinical trial is run. We did an analysis, I think, for like a bunch of companies that had older repurposed molecules. They ended up getting 16-year product life cycles with a lot of the IP generation that followed. You guys have alluded to working on other IP. Could you open the curtain a little bit and talk a little bit about that dynamic and what you guys are doing?
Well, I can only tell you so much, but I think the what you are I mean, Viatris is usually on the other side, right, of the equation.
Yeah.
We know what needs to be done for us to maximize our exclusivity. That's what we are working on. We have a number of patents we filed that we believe will extend our exclusivity around a number of things like formulation, like other method of use type of thing. We also have the opportunity to extend with pediatric exclusivity and other things that we're also looking at sort of with the FDA currently, right? That's the strategy. I think you heard Scott say that we anticipate this that we'll be able to go well into the thirties with this asset, and that's our expectation.
Okay. Maybe shifting gears to selatogrel. I think this is the largest commercial opportunity that you guys have explicitly flagged in your pipeline. With data sometime, I believe in perhaps 2027.
I know that a lot of people focus on the uniqueness of the trial, right? Trying to understand the different risk factors in conducting a trial like that. Can you rank order when you did the deal, what you saw as like the key risks in running this sort of novel trial approach, be it patient who's on a control arm getting maybe faster access to IV cangrelor or false injections? I know there's a lot of discussions around these different points. How did you guys look at risk with this asset?
The phase III clinical trial, SOS-AMI, that we are currently running is a pretty simple study, right? Patients have to have a qualifying MI. Once they do, they are randomized to either selatogrel or placebo. They are trained to recognize the symptom of an MI. Remember, they just had one, so they kind of know what to look for. We still train them again. They're trained to use the autoinjector. They go home and wait for an event to happen. Event meaning is an injection.
Right? We keep track with the patient, with phone calls on a regular basis. Very easy study to conduct. The challenge comes with the size of the study, and I think we've kept on updating you guys that we are 1,300 patients a month currently, and we anticipate we'll have all the patients we need by the end of the year. Where I think, to your very question, the key assumptions that needs to occur for this study to be positive is that patient needs to self-inject early. By early, we mean within the first hour of symptoms onset. Because that's the concept of early platelet inhibition leads to better outcome for the MI. This has been proven.
It's been shown, the earlier you treat, the better, the better the outcome. What we're seeing in the study, and I think we've kept on updating, folks about this, is that we're seeing patients are self-injecting in less than 30 minutes from, symptom onset. That part of the equation, which was critical, is going well. It's happening. Patients are self-injecting for the right reason and self-injecting in the right timeframe. The other part that was also an equation that I wasn't sure was going to necessarily play out was, patients self-inject, do they think they're cured and not take themselves to the hospital to get a proper diagnosis, which is important for the purpose of the primary endpoint.
What we're seeing is that patients are taking themselves to the hospital post-injection, they typically get there within two hours, right? Which is more than enough for selatogrel. Selatogrel will continue to work for approximately eight hours. Patients have enough time. Not too much time, because we need also those platelets to go back to normal should they need surgery and so on. We're seeing patients self-injecting for the right reason, in the right timeframe, and then going to the hospital for diagnosis.
Can you talk about this is effectively narrowing the treatment gap, right? Like, if you can get medication on board faster, 'cause there's proven data that if you get IV cangrelor, you can reduce some of these more negative downstream outcomes that are part of your primary endpoint. If you can tie that to, if you narrow the treatment gap, I'm lowering the mortality rate by x or other components within the endpoint. Can you just talk a little bit about the endpoint design and just how narrowing the treatment gap, what your understanding is, what that'll reduce those rates by and
IV cangrelor is, you mentioned a couple of times, is not used for what we're doing. It's used for peri-PCI, so patients that already know they're gonna have a PCI. And they're typically only reserved for patients that are at very high risk, right? Placebo patients will not be getting IV cangrelor. And neither will selatogrel patients. Remember, selatogrel is first, right? selatogrel will be given by the patients, then the patient goes to the hospital. If they need P-PCI, then, them can be given IV cangrelor should they need that. Our in-vitro data shows that when you combine selatogrel and IV cangrelor, you still see a synergistic effect. You still see an increase in inhibition of platelet aggregation. They can be given together.
You still see a benefit. I will assume that, in practice, you will get selatogrel first, and then either continue to get selatogrel or switch to IV cangrelor should you need that for the purpose of a surgery, right? I think that will not interfere with the primary endpoint. The primary endpoint is a hierarchical composite endpoint. It ranks the severity of the MI, starting with the most severe, which is death down to less severe types of acute MIs. It's ranking that and what we expect to see shift from severity of the MI from less severe on the placebo arm. Well, might just give it on the placebo arm, and just help with my hands.
That's what the outcome of the study will be, is a risk reduction for more severe MI on selatogrel versus placebo. We estimate that reduction to be around 20%. That's how we sized the study. We're obviously powered for a lot less, but the risk reduction we anticipate to see will be around 20%.
Just to clarify on the hierarchy, what are the tests for primary endpoint versus are there components of the hierarchy that are secondary analyses or secondary endpoint?
We're not looking at your standard event rate, right? Or rate. It's a win ratio. You are for each patient on selatogrel, you're comparing in against each patient on placebo. Each time you win, we anticipate that selatogrel will win 1.25 x more than placebo. That's your 20% risk reduction. It's a win ratio that we're using as a method to analyze the primary endpoint.
Okay. If successful with that sort of treatment effect size, I know you guys have experience historically with rescue treatment markets with EpiPen. Can you talk a little bit about how you see the market opportunity, challenges and opportunities that went into the company kind of target of a $1 billion-plus in revenue for that?
Yeah, me starting.
Sure.
Yeah. I, you know, we've mentioned previously all the epidemiology data that we have that lead to a certainly a case that is above that $1 billion. It's a [$1 billion+] opportunity, right? I think you see about 24 million patients have already have an MI and that exclude China, where the numbers are not necessarily clear. They're, I think, way understated. Significant opportunity in terms of epidemiology. What is I think the most important is that we will be the first treatment to be able to prevent MI from leading to significant sequelae, right?
We're looking at a reduction of the severity of the MI, which will lead patients to have less sequelae on their muscle, on their heart, and will then spend less time in the hospital. That will help the overall healthcare system. These are patients that are probably the most expensive patients for the healthcare system. What we've also seen is that just carrying the pen itself makes the quality of life of the patients a lot better. Just knowing that they have this rescue medication help them from a quality of life. We're seeing a significant opportunity for this asset to change the treatment paradigm in acute MI.
We'll start with patients that already had an MI, and then over time, should the safety profile continue to hold, we'll be able to expand into more patients that are at risk of getting an MI. Never had one before, but are more at risk of it, further expanding the opportunity.
[Ken], I think maybe just one point quick to your point on the potential product profile. You mentioned it being a global opportunity for us. We have the global infrastructure to commercialize a product like this. We'd have to certainly make investments in the U.S.. I think the other piece too is, given it's a pen and you can envision a model similar to other rescue medications, there's also gonna be a refill component to this market, right? Based on the product life, right, you can imagine, you know, a patient that's had rescue medications for a number of years, right? That refill piece, when you kind of do the math across the epidemiology, you think about a refill assumption. You don't have to really stretch to believe that this could be over a billion-dollar opportunity for the company.
Is there a low-hanging fruit embedded in there? What I mean by that is, like, I imagine that the patient who's had an MI within the last year is going to be more motivated to keep that on in their pocket on the ready, right? Versus somebody that may be five years removed or high risk, where perhaps, you know, keeping a pen at your, at your side all the time will be kind of difficult, I imagine. Just trying to think through how you think about that as a market segmentation factor.
I think patients will have multiple pens to begin with, right? Not just one. It's important also that their caregiver, typically their family members, have access to a pen as well, should they not be able to self-inject. I think you have that component also that is important. Look at the EpiPen, right? I have three kids. They all have to have an EpiPen. They've never used it. Every year I will renew the prescription, and it's been years, right? Just because you know that if you need it, you have the opportunity to get the pen.
Okay. We got about three and a half minutes, maybe some quick hitters here. cenerimod.
Yeah.
Can you talk about your trial enrichment strategy with high interferon, are you pre-specifying that as, like, a subgroup and then looking at all-comer as well in that trial and how that may differentiate the SLE space is very competitive. I'm wondering how your trial design at least compares to some of the other approaches out there in phase III.
Yeah. In phase II, we had patients within a high type I interferon signature had a much better response than patients with low signature. We enriched the phase III trial. We set a bar at 70%. Trials are fully enrolled, now we know that we are above that 70% threshold. If you compare, for instance, Saphnelo at 83%, I believe on average of patients with high type I interferon signature. Regardless of that, they got a broad label. That's our assumption that we will go for a broad label. That said, we have two large studies that are identical. We can pool those studies together and target that type I interferon signature should we wanna do that, should we see a much better response rate.
I think the base assumption is that we'll have a label similar to Saphnelo broad label.
Okay. By our count, I think there's five or six competitor programs in phase III. How do you foresee your products stacking up competitively versus them? It's obviously a difficult question to answer before you see all the data.
Yeah.
how it's turned. Based on the support of phase II data, how comfortable are you in a competitive profile?
Our type I interferon signature result is probably one of the best efficacy data. Our safety profile is typically more favorable than what you see with this other product because we're not an immunosuppressant. We're more of an immunomodulator. The S1P have had a history of being more on the safe side than those more aggressive treatment. That said, I think, you know, SLE, we have now a much better understanding of what SLE is and the pathogenesis of the disease. We know it's an heterogeneous disease with multiple pathway involved. cenerimod is the only drug that targets all these pathways. The other drug that you see in phase II go after one specific pathway. At the end of the day, it's an heterogeneous disease.
There will be room for multimodal administration. I believe that this is how drugs will continue to be used in this disease because of the heterogeneicity of the disease. Therefore, having other assets coming in is not necessarily detrimental to cenerimod. Cenerimod has the opportunity to be the first treatment prior to biologic treatment based on the benefit risk that we've observed in phase II.
Lastly, [Phil], we've gotten through the whole conversation without talking about generics. Generics has been a key part of the business historically. How should investors think about the strategic value of generics to the company longer term? If some of the branded pipeline pivot is ultimately successful, do you still see the business is it priority to remain a hybrid business that leverages the cash flows from generics with select targeted investment with the shifting focus to brands?
Yeah, I think it's a good question. It's certainly one where, you know, the company really has a dual category approach. You think about the value of generics, access to medicines. You think about what we've done to move the portfolio up the value chain into more complex products. We've laid out a bunch of those at the investor event, not only injectables, but other technologies. It's also as we start to pivot into the 2030s, thinking about what role we can play in the GLP-1 space. I think, you know, when you look at generics always having a role, but think about it as a selective role in terms of where we can win. I think you've seen that now with our complex strategy on the generic side, but also in other areas of the world.
Particularly Europe, we have a very healthy generics business. Sometimes it doesn't probably get the attention it deserves, but I think you should continue to think about us from a branded and a generics perspective going forward.
All right, great. Thank you, gentlemen.
Thank you.
Thank you.
Appreciate the question. Thank you.
Thank you.
Vancouver Healthcare Facilities and Management Bank of America. Thanks so much for joining us. This is, you know, gonna be exciting conference, and we starting now this session with Encompass Health. They are the largest operator of inpatient rehab facilities. Today with us we have Doug Coltharp, the CFO, and Zavi Hosaki, who's the VP of finance, but also Mark is here from IR. Just in case you have any follow-up questions, he's right there. Thank you so much for being here today with us. We appreciate it. I guess maybe we'll go right into Q&A, by the way.
I want to start with volumes, 'cause really this is like an exciting part of the story for this company growing much faster than a lot of different provider types. You know, you guys targeting 6%-8% long-term discharge growth. Obviously, this quarter, you know, had some puts and takes, maybe just refresh people where we stand, you know, as we think about Q1 and also how you're thinking about the volume growth for this year.
Yeah, absolutely. Excuse me. Thank you for hosting us, and thank you again for hosting the tour of our hospital yesterday, which was very well attended. In the way of further introduction, many of you may have not met Zavi before. Zavi joined us about 2.5 years ago as the Senior Vice President of Finance and Strategy. His last stop before joining us was at Stericycle, but he's had some great experience, relevant experience beforehand, and he is becoming an increasing participant in our investor relations functions as well, so glad to have him here today. As Joanna mentioned, back at our investor day in the fall of 2023, we laid out a five-year discharge growth CAGR. I say discharge growth because that is our primary measure of patient volumes in this industry.
That objective was to have a five-year CAGR of 6%-8%. We attempted to be clear in our communications at that time, but apparently have fallen short that that 6%-8% was indeed meant to be a five-year CAGR and not a series of quarterly targets that would be 6%-8% or a series of annual targets. If you wind the clock forward to the end of 2025, we would be three years into that five-year CAGR, and we were fortunate that we had operated at the high end of that range with a 7.6% CAGR. We've said all along that there would be fluctuations, particularly from quarter to quarter, depending on things like the constitution of the calendar and what day of the quarter it ends on.
Yes, that makes a difference because our discharge patterns based on the day of the week are a little different. As well as things like the comp that you're up against from the prior period, and when you have new capacity rolling in, because we've been adding a lot of new capacity to our business, both in the form of opening up new hospitals and then adding beds to existing hospitals. The last two quarters, our discharge growth has slowed from those levels a little bit, but it was readily explainable. In particular, when we look at the first quarter, our discharge growth was 4.3%, and that was impacted by a number of factors.
First, something that's a little bit anomalous in the business is between the second half of last year and February of this year, we closed four units that we were operating that were actually housed within joint venture acute care hospital partners. All of those were situations where we were operating Excuse me, three of them were that, and one of them was the lone SNF unit, skilled nursing facility unit that we that we operated. With regard to the three unit closures, those were leased space within the hospital. They operated as remote locations, they were tied to the same Medicare provider number as a freestanding hospital that we operated in that market. We operated those units at all of which ran at essentially breakeven EBITDA as an accommodation to that acute care hospital partner. They were not strategic to us.
They were not financially contributing. In each 1 of those cases, it was just coincidental that it happened within a one-year period of time. The host hospital wanted to take that space back for other purposes. We were glad to turn that back over to them. The aggregate impact of that plus we closed our one skilled nursing facility. We had skilled nursing facility housed within one of our freestanding IRFs in Lexington, Kentucky. That was a facility that we acquired in 2014. Based on our relationship with the University of Kentucky, we agreed to continue to operate that skilled nursing facility, even though that too was not strategic for us for a period of time. They agreed that it was no longer necessary for us to do that, so we closed that as well.
All of those together constituted about 85 basis points of a discharge growth headwind, but no impact to EBITDA. The second thing that we commented on, and I'm gonna ask Zavi to elaborate, is we got a high-class problem, which is because of that rapid discharge growth that we experienced over the three years, ending in 2025, our hospitals, even as we were adding capacity, filled up more quickly than we had anticipated. We had about 35% of our hospitals in the first quarter that ran at an average occupancy rate of 95%. We've got some planning.