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<p>Viatris ranks No. 19 on the 2025 World’s 25 Best Workplaces list.

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CTW 2021-05-Viatris

Viatris, the global drug maker that resulted from the recent merger of Mylan and Pfizer’s Upjohn unit, has transformed the treatment of HIV around world in the past five years. Working through public-private partnerships with organizations like Unitaid, the WHO-affiliated global health agency, and the Bill and Melinda Gates Foundation, the company introduced the first low-cost antiretroviral with dolutegravir, the recommended first-line treatment for HIV, expanding that drug’s access to the 35 million people living with the virus in low- and middle-income countries. Priced at just $75 per year, the product was game-changing, says Unitaid’s Robert Matiru, who notes that the same is true of the version—strawberry-flavored tablets that dissolve in liquid—that Viatris recently launched for children (adult drugs are not formulated for young patients, and their bitter taste makes them hard for kids to take). The children’s version also lowers the cost of treatment by 75%, to $120 per year. Moreover, Matiru marvels at the “record-pace” speed and professionalism with which Viatris, now the world’s largest provider of antiretrovirals, has developed these low-cost, state-of-the-art medicines for populations who previously had no way to get them.

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This year’s Fortune 500 marks the 67th running of the list.

Freshly formed in 2020 in the merger of Mylan and Upjohn, the health care company owns the major medicine brands Epi-Pen, Viagra, and Lipitor.

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Viatris is a global pharmaceutical company with over 250 medicines on the World Health Organization’s List of Essential Medicines, which treat a range of conditions including cardiovascular, immunological, cancer, infectious diseases, and diabetes. Viatris products include generics and branded drugs such as Xanax, Lyrica, and Viagra. Viatris supplies medicines to 1 billion people around the world each year. The company also has a number of partnerships, including with the European Innovation Partnership on Active and Healthy Ageing, to improve prevention and treatment of noncommunicable diseases. The company was born from the merger of Mylan and Upjohn in 2020.

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Viatris (VTRS): Company Profile, Stock Price, News, Rankings

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Viatris

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Good morning. Welcome to the Viatris first quarter 2026 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Bill Szablewski, Head of Capital Markets. Please go ahead.

Good morning, everyone. Welcome to our Q1 2026 earnings call. With us today is our CEO, Scott Smith, Interim CFO, Paul Campbell, Chief R&D Officer, Philippe Martin, and Chief Commercial Officer, Corinne Le Goff. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2026 and various strategic initiatives. These statements are subject to risk and uncertainties. We'll also be referring to certain actual and projected Non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those Non-GAAP measures to the most directly comparable GAAP measures. When discussing 2026 actual or reported results, we'll be making certain comparisons to 2025 actual or reported results on an operational basis, which excludes the impact of foreign currency rates.

When comparing our 2026 actual or reported results to our expectations, we are making comparisons to our 2026 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Good morning, everyone. We're pleased to report another strong quarter. We're off to an exceptional start to the year. Before I get into the results, we recently presented our plan for long-term sustainable growth driven by three strategic imperatives: driving our base business, fueling our innovative portfolio, and modernizing for sustainable growth. What you're seeing in our results is proof that that strategy is working. In the first quarter, we delivered total revenues of $3.5 billion, up 3% from a year ago. Adjusted EBITDA of $1 billion and adjusted EPS of $0.59 per share. Our overall performance reinforces the growth trajectory of our business. Based on what we're seeing, we're confident in our outlook for the remainder of the year. Let me briefly touch on what's driving that confidence. First, on the commercial side, execution remains strong.

Notably, Greater China was a significant contributor this quarter. We're seeing strong execution and our commercial investments are leading to accelerated growth. In Japan, momentum is building following the launch of Effexor for generalized anxiety disorder. We're expecting to see a return to growth with the Effexor launch and several more launches expected in the coming years in this strategically important market. Second, on the pipeline, we're continuing to make progress. We've already achieved regulatory approval for one of our six product candidates we're anticipating this year, Effexor for GAD in Japan. We remain on track for the remaining five regulatory decisions in the second half of the year, including our weekly contraceptive patch, Xulane, and our fast-acting meloxicam. We're excited about these upcoming U.S. launches, which we believe will be important for patients and also accelerate our growth.

We have a highly experienced and talented leadership team in place with a strong track record of successful launch execution. We're confident we have the right people and capabilities to deliver. Our phase III programs for selatogrel and cenerimod remain on track and represent important potential longer-term growth drivers. That said, our near-term focus is squarely on execution, securing approvals, launching products effectively, and building momentum. Third, capital allocation. We continue to take a disciplined approach. We intend to deploy our capital in a balanced way, returning capital to shareholders through dividends and share repurchases, investing in the business to support sustainable growth. Business development is an important component of our strategy. We're focused on opportunities that are in-market, accretive, and aligned with our capabilities to strengthen the durability of our growth profile. Finally, on the organization.

We're making progress on the opportunities identified through our enterprise-wide strategic review to optimize our cost structure, improve resource allocation, and drive operational efficiency. We are on track to deliver those savings while also reinvesting in the business to support future growth. In summary, it's a great start to the year. There's strong momentum in the business, and we are well-positioned for sustained revenue and earnings growth. Before I turn it over to Philippe, I wanna thank Doretta Mistras for her significant contribution as CFO over the past two years. Her leadership has played an important role in helping prepare the company to enter a period of sustainable future growth. With Doretta's transition, I'm pleased to have Paul Campbell step into the role of interim Chief Financial Officer.

Paul brings deep experience, a thorough understanding of our business, and a long tenure with the company, making him ideally positioned to ensure continuity and maintain operational discipline. With that, I'll turn it over to Philippe to go through some pipeline updates.

Thank you, Scott. We've had a strong start of the year, continuing to advance our value-added and innovative portfolio while executing on our generic pipeline. Let me begin with fast-acting meloxicam for the treatment of moderate-to-severe acute pain. Our NDA has been accepted for review by FDA. We remain confident that we will receive their regulatory decision by year-end, pending confirmation from FDA on a PDUFA goal date. We continue to believe that the strength of our data supports inclusion of opioid sparing language in our label, acknowledging that this will be subject to review and discussion with FDA. Regarding Xulane, our low-dose estrogen transdermal contraceptive patch, we remain on track against the expected PDUFA goal date of July 30th, 2026, and continue to see strong engagement at key medical congresses.

Most recently at ACOG, the American College of Obstetricians and Gynecologists annual meeting, we presented six abstracts, including positive results from our previously announced phase III study, as well as new data on adhesion performance under both normal and extreme conditions, pharmacokinetics, and cycle control. Within our eye care portfolio, the phentolamine ophthalmic solution phase III data for the treatment of presbyopia has been presented at multiple congresses, and our sNDA remains on track against an assigned PDUFA goal date of October 17th, 2026. I will now highlight key milestones in Japan. In March, as anticipated, we received approval for Effexor in adults with generalized anxiety disorder. Pitolisant, with regulatory reviews progressing well, we expect PMDA regulatory decisions for two indications in the second half of this year. For excessive daytime sleepiness associated with obstructive sleep apnea and associated with narcolepsy type 1 and 2.

Lastly, we continue to progress our phase III study of Nefecon for the treatment of IgA nephropathy in Japan and remain on track for a top-line readout in the first half of this year. These milestones underscore the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address significant unmet needs. Turning to CREON in Europe, which is considered the standard of care for pancreatic exocrine insufficiency treatment due to different underlying conditions and is another value-added medicine in our pipeline. We conducted a phase III study in non-cystic fibrosis patients to determine whether dose escalation to double or triple the currently approved dose allows for the achievement of better symptom control and nutritional status.

The interim analysis showed that approximately 76% of patients were not adequately treated with the maximum approved dose of CREON for this indication and benefited from a further dose increase. The study medication was well tolerated at these higher doses. Based on this data, together with an increased body of real-world evidence and in consultation with German health authority, we intend to file a type two variation in Europe before the end of the year and anticipate an approved label update in the first half of 2027. This will be followed by additional submissions outside of Europe, where applicable. Together with significantly expanded manufacturing capacity, we expect this will position CREON for sustainable growth and bridge an important unmet medical need for patients. Regarding Inpefa, we continue to progress our regulatory applications and anticipate additional regulatory decision in key markets this year.

Turning to our innovative global phase III program, selatogrel and cenerimod. For selatogrel, we continue to maintain an enrollment rate of approximately 1,200 patients per month in our SOS-AMI phase III study, keeping us on track to potentially reach full enrollment by the end of 2026. For cenerimod, our phase III studies in the SAD, OPUS-1 and OPUS-2, are fully enrolled, and we expect results for both studies in the first half of 2027. Importantly, regarding our generic portfolio, we continue to drive excellence in execution and are making significant progress in meeting our submissions and approval goals for the year. In particular, with regard to our complex generics pipeline, we remain on track for FDA regulatory decisions this year on our iron ferric carboxymaltose injection and rotigotine patch.

Additionally, we have already secured approval of our generic to ABILIFY MAINTENA, which is on track to launch in the U.S. before the end of the year. Our continued pipeline momentum reinforces our confidence for the rest of the year and beyond, driven by disciplined execution across our innovative, value-added, and generic programs, and a clear focus on advancing meaningful medicines for patients. With that, I'll turn it over to Paul.

Thank you, Philippe. Good morning, everyone. Let me begin by briefly introducing myself. I have served as the company's Chief Accounting Officer and Corporate Controller for nearly 10 years. I've been with the company, including Legacy Mylan, for more than 23 years. With that perspective, I can honestly say that I've never been more excited about the future of the company, and I'm very happy to be with you this morning. Regarding our results, I am pleased to report that we're off to a strong start this year, reflecting the strength of our global portfolio and continued execution of our strategy to enable us to deliver sustainable revenue and adjusted earnings growth. This morning, I'll cover the drivers of our strong first quarter performance and how this performance provides us with confidence in delivering our outlook for the remainder of the year. Beginning with our first quarter results.

Total revenues were $3.5 billion, representing operational growth of 3% year-over-year. This performance was driven primarily by accelerated growth in our cardiovascular portfolio in Greater China and strong generics performance in North America. Now let me walk you through the segment performance. In Developed Markets, net sales increased by 1% versus the prior year, which was roughly in line with our expectations. North America grew 3%, driven by increased demand for estradiol, continued strong performance from Breyna and new product revenue contributions from complex generic launches. In Europe, net sales declined approximately 1% versus the prior year, mainly due to softer market conditions in select countries, anticipated competitive pressure on Dymista and certain supply constraints.

That said, the underlying fundamentals in Europe remain strong, driven by the performance of key brands such as CREON, contributions from new product revenues and solid growth in Italy. Turning to emerging markets, net sales were flat year-over-year, which was below our expectations. Performance was supported by continued strength in our established brands across certain key markets. This was offset by supply constraints in our lower margin ARV portfolio. Within JANZ, net sales decreased approximately 2% versus the prior year, coming in above our expectations. The decline was driven by anticipated increased competition in Australia and the impact of government price regulations in Japan. This was partially offset by solid performance from key brands including Creon and Amitiza. Lastly, we delivered a very strong quarter in Greater China, with growth accelerating ahead of expectations at 18% year-over-year.

The main drivers of this performance were favorable market fundamentals, including an aging population and increasing demand for cardiovascular products. The cumulative impact of our strategic selling and marketing investments and growth across all channels, and more specifically, our continued focus on growing demand through e-commerce platforms, where sales more than doubled compared to the prior year. Moving to the remainder of the P&L, adjusted gross margin was 56% in the quarter, flat versus the prior year. Margins were slightly better than expected, driven by favorable product mix. Operating expenses were also favorable versus the prior year, reflecting our disciplined cost management, cost savings from the implementation of our enterprise-wide strategic review and from the phasing of spend. In addition, we continue to generate strong and durable free cash flow.

During the quarter, we generated $348 million of cash inclusive of transaction and restructuring related costs and taxes. Excluding these items, free cash flow would have been about $459 million. Turning to capital allocation, we continue to expect more than $2.5 billion of cash available for deployment during 2026, providing meaningful flexibility to execute against all of our stated capital allocation priorities. During the quarter, we returned $140 million of capital to shareholders through our dividend. Based on our strong first quarter performance and favorable trends, we are reaffirming our guidance ranges. As we think about our outlook for total revenues, we now expect stronger growth in Greater China in the range of mid to high single digits and delayed competition for Amitiza in Japan.

These tailwinds are expected to be partially offset by certain temporary supply constraints related to lower margin generics and additional competitive pressure across generics in developed markets. Lastly, a comment about foreign currency exchange rates. If current rates were to hold for the remainder of the year, we would expect an incremental 1% tailwind on total revenues and adjusted EBITDA. Turning to phasing for the remainder of the year, total revenues, adjusted EBITDA and adjusted EPS are still expected to be weighted to the second half at approximately 52% of our full year outlook. This reflects normal product seasonality and the timing of new product launches and takes into account the expected ramp up in operating expenses through the year.

Free cash flow is also expected to be higher in the second half, reflecting the timing of working capital and benefiting from a step down in one-time operating cash costs. In closing, we are highly confident in the strength and durability of our business. The first quarter demonstrates continued strong execution against our strategy to deliver sustainable revenue and adjusted earnings growth while generating substantial free cash flow for a balanced capital allocation framework. Because of the strong momentum of the first quarter results, we believe we are well positioned to meet or potentially exceed our expectations for the remainder of the year. With that said, I'll hand it back to the operator to begin Q&A.

We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Glen Santangelo with Barclays. Please go ahead.

Yeah, good morning. Thanks for taking my question. Hey, hey, Scott. You know, congrats on finally getting to the point where the quarters are sort of clean year-over-year, and it's a lot easier to interpret. You know, when you look at these results, it looks like you got very strong incremental contribution from both brands and generics. Then on the geography side, you know, from China in particular. In your prepared remarks, you suggested it was strong execution and commercial efforts.

You know, the growth rate doubled in that geography, I'm trying to get a better sense of the stability of, or I shouldn't say stability, the durability of that strength and the momentum that you've seen in trying to reconcile that, you know, with maintaining the guidance, given that Q1 is already sort of running ahead of, I guess, your overall expectation for the year. I just had a follow-up for Philippe.

Yeah, relative to maintaining guidance, I guess I'll take it a little bit backwards. Right. It's early. We're really pleased with the quarter. Clean quarter, as you say. Strong quarter. We're pleased that it's just early, and, you know, we'll continue to monitor, and when we get to Q2, we'll update you at that point in time. Feel very good about it. Yeah, it was a clean quarter driven a lot by revenue in China and North America. You ask about China. I've been involved with business in China since the late nineties. I actually ran China operations for a prior company, and so I'm close to that market.

It's the strongest China market over the last 12 month, 18 months that I've ever seen, both on the innovative side and on the total side. China's very, very strong. We're very, very pleased with our performance there. But it's not just the market, right? We also have a very strong team in China. We've made a lot of investments in China, particularly on the e-commerce side, and we're starting to see those pay off now. We're very, very pleased with the China performance.

Yeah. On your question about the durability, I mean, you heard from my remarks, we've increased our expectation from the beginning of the year of low single digits to now mid to high single digit growth in China. However, you know, there's always the policy risk that's very dynamic and unpredictable and, you know, as Scott said, it's too early in the year for us to really, you know, be that bullish on it, but we'll monitor through Q2, and we'll let you know.

Maybe I can add, in terms of the outlook for China. We are very confident that we will see no policy change this year. One thing we have done, Scott just mentioned it, is that we have consistently invested in our commercial platforms and, switching the positioning the business from, hospitals that are more susceptible to policy changes to retail and e-commerce. E-commerce this year, in this first quarter, we've seen a doubling of our sales in this channel. Great success on all these spaces.

Okay. Well, thanks for all the details. Maybe if I could just ask a quick follow-up to Philippe. Philippe, thanks for all the detail on all the pipeline stuff. What I was hoping to try to do is maybe just sort of boil it down a little bit for investors in terms of what you think the biggest opportunities are here over the next 12 months. I think you said you expect to get a decision on the estrogen patch by the end of July and on fast-acting meloxicam sometime in 4Q. Then I think as we look to 2027, you know, we have cenerimod, the readouts coming in the first half of the year and selatogrel maybe behind that in late 2027.

Are those sort of the four biggest opportunities that you see, or is there something else you'd add to that mix? I'll stop there. Thanks.

Thanks for the question. You know, as you point out, importantly in the U.S., we have meloxicam and Winlow this year. I think these are two key important launch for us, supported by very strong clinical data. The review process for these two assets with the agency, with the FDA, is going as planned. We have good confidence that we'll get the approval by the time of the PDUFA date for Winlow and later in the second half for meloxicam. We're still waiting for FDA to give us that PDUFA date, which should be coming very, very soon. Japan remains very important for us. As you heard from Scott, we have a number of readouts and approvals in Japan this year.

Particularly pitolisant is our next approval in the second half of the year, early second half. That will be followed also by important data for Nefecon in IgA nephropathy. Japan is, we're getting the approvals we need and we have a strong team there that has experience in launching these types of assets. Then finally, to your point, selatogrel, cenerimod, everything is on schedule. Everything is behaving like we had planned. Everything is working according to plan. We'll get data very, very late this year, early next year for cenerimod, and followed by selatogrel in the first half of the year is what we anticipate.

I just wanted before we go to the next question, just to wrap it up here on meloxicam and Winlow. Very, very pleased with the data, as Philippe pointed out. I also feel great about the commercial teams we're putting in place to commercialize both those assets. Strong teams, a lot of experience in the launching blockbuster products in the U.S. I think they're gonna execute really, really well on these products. We're very focused on making sure that we execute those first couple of launches. Of course, the opportunity to have readouts on selatogrel, cenerimod, et cetera, is gonna be very strong for us.

The next question is from Umer Raffat with Evercore. Please go ahead.

Hi, guys. Thanks for taking my question. I have two, if I may. First, if you could just expand on the free cash flow, year-over-year and what some of the drivers are. Secondly, and perhaps more importantly, I just wanted to expand on the selatogrel trial in the cardiovascular setting. Specifically, I feel like there hasn't been an appropriate amount of discussion on the endpoint. The way I understand it, and Philippe, I would love for you to correct me. The way I understand it is, it's not a composite endpoint. Instead, it's one of six things that could happen on an ordinal scale, and per patient, the worst thing is taken forward.

I guess, my question is: If someone has a STEMI versus a death, how Is there like a score that's assigned to those two different events? Also, I would imagine because there's 5 different things that could contribute into this primary endpoint, and there's probably a score assigned to each one of them, what happens if you have more NSTEMIs and less deaths than you were anticipating in your sample size? Would you need to do a sample size re-estimation? When will that happen? Thank you.

Thank you, Umer. Thank you for your questions. First, you know, I'll have Paul talk a little bit about to give some detail around the cash flow, and then Philippe can get into the selatogrel endpoints and study design and beyond.

Sure. As far as the change year-over-year in Q1, I think it's important to point out that even though it's down, it exceeded our expectations, what we thought was gonna happen for the quarter. Essentially, the drivers are timing and networking capital, which is both the timing and then we had business growth this year. In last year's comparative period, we had a decline. Our one-time cost did increase year-over-year. Those are the main drivers.

Okay. Regarding selatogrel. Maybe we need to spend some time together to go over the actual design and the primary endpoint. It is an endpoint that we design in collaboration with the FDA and with our KOLs. It's a ranking endpoint where we're ranking the severity of the AMI. It can go from a scale of death all the way to an acute MI without a significant impact. In the middle, you have, as you pointed out, STEMI, non-STEMI as severity of the acute MI. The way it's calculated, it is the worst outcome for the patient that is taking into account.

If your patient has two events, as death and a STEMI, for instance, then the death will be the adjudication that will be taken into account for the calculation of the endpoint. What we're intending to see is a relative risk reduction of about 20%. That's how the study is powered, and that's what we anticipate to see as part of the assumption to designing the study. You know, I think the It's relatively straightforward from that standpoint. Adjudication is happening by a blinded, by an unblinded committee that looks at the severity of the outcome and determine which one is for us to take into account.

The outcome we anticipate to see is that patients. You will see a reduction. If the study works as advertised, you will see a reduction of severity in the selatogrel arm versus the placebo arm, right. There will be less patient with death, less patient with severe acute MI versus placebo. That risk reduction, if you will be characterized that way. A lot more to go. We can go into a lot more details about this endpoint, but I think that should answer your question at this point.

Yeah. Before the next question and on a much less granular level, you know, I, you know, I'm really pleased with the execution from a clinical development perspective for selatogrel and for cenerimod. We've accelerated the enrollment of obviously both of those fully enrolled now with cenerimod. Right now, we are enrolling approximately 1,200 patients a month in the selatogrel study, which is, you know, a pretty strong number. We're very pleased with how those are progressing. We're looking forward to turning over those cards and seeing those results and see what we get. Very pleased with the clinical development execution thus far.

The next question is from Matthew Dellatorre with Goldman Sachs. Please go ahead.

Great. Good morning, guys, and congrats on the strong quarter. Maybe coming back to fast-acting meloxicam again, just briefly. Could you comment on whether priority review is still a possibility there? Anything further you could share regarding the expected label. I know you said in the prepared remarks you do expect opioid sparing to be on the label to some degree. Just anything kind of further you could share would be helpful. Maybe with regard to the cost savings, could you comment on progress with regard to achieving I think you put out an estimate of 30% of that $400 million in net savings this year.

you know, I realize there's some offsets this year in terms of mix shift and LOEs that you don't expect that to flow through to margins. you know, perhaps walk us through what the base case and the upside case looks like in 2027 and 2028 with respect to EBITDA margins. Thanks a lot.

Thanks, Matt. Good morning. Let me just overall say we'll address the second question first around the enterprise-wide strategic review. You know, I'll kick it over to Paul for some, you know, discussion around margins. We are completely on track at this point in time to deliver the savings that we outlined before. You can really see the effect of that as we're starting to get some significant EBITDA leverage, you know, with 3% growth and 10% EBITDA growth in the quarter. We are on track to deliver the savings this year and also for 2027 and 2028. Paul, around the margins.

I think it's important, as Scott said, part of our beat in the quarter was related to OpEx. OpEx comes, you know, lower OpEx comes from our disciplined cost management. Obviously, there's a little bit of phasing in there. The cost savings program, as you pointed out, I think it's about $120 million. If you do the math on what we expected for this year, we're on track to deliver that for this year. We do expect that operating leverage to continue, you know, as the savings flow in not only the rest of this year but into the next few years also.

Philippe, around meloxicam, regulatory and.

We anticipate that the agency or we are expecting that the agency will be giving us the PDUFA date and timing of review within the next couple of weeks. We should get much more visibility on that timing, and we will let you know. In terms of the label, there is clearly based on the data, our expectation is that the opioid-sparing language will be included as part of the label. Where it is exactly in the label will be a matter of review and discussion with the agency. But our expectation is that the data that supports opioid sparing will be included as part of the label. They were our key secondary endpoint.

They were discussed and designed in collaboration with the agency. We have, we believe that they will be included in the label.

Matt, this is Corinne. You know, as it comes to the commercial opportunity for fast-acting meloxicam, having the opioid-sparing in the indication section is helpful but not essential, I would say, right? It will be in the label as Philippe said. The opportunity is driven by the total clinical profile of this product. We have demonstrated that fast-acting meloxicam can deliver very fast, rapid, meaningful pain relief. It's a non-opioid option, and it's really what will make a difference in the moderate to severe acute pain market.

It's a great point, Corinne, that, you know, overall the data is very, very strong. The opioid sparing is an important part of the data, but it's just part of the overall data, which again, really looks, very strong and we're very hopeful, about, and anxious, in a good way about getting to the launch and getting it out there. We think it's gonna be a very important product for us, in, you know, in 2027 and beyond.

The next question is from Leszek Sulewski with Truist Securities. Please go ahead.

Good morning. Thank you for taking my questions, and congrats on the progress. Appreciate you providing the new product contribution figure of $71 million. Could you comment on that, how much of that was tied to product sales versus one-time channel stocking? Is this a figure you intend to provide moving forward? On the BD front, appears the market is a lot more active now. Has the bar for BD changed given the strong start to the year and the $2.5 billion cash available? Lastly, how should we think about the CFO transition? Should investors expect any change in capital allocation or disclosure or the cost-saving side? Thank you.

Maybe we'll just take it from the bottom and go forward. First of all, on the CFO question, we should expect no changes to capital allocation or financial policy, with no expectations at all. You know, since it's been brought up, you know, the first thing, besides the fact there will be no changes, I would like to thank Doretta for being, you know, a great partner to me. She's leaving to pursue another opportunity on the West Coast, and her leadership played an important role in helping prepare the company to enter a period of sustainable growth. Having said that, I'm thrilled to have Paul sitting here beside me. I've got tremendous confidence in him as the interim CFO.

He's got a long tenure and tremendous understanding of our business, and we're very, very lucky to have him. I feel very good about the CFO transition and how that's going. From a BD perspective, there seems to be a lot of activity going on right now. BD priorities have not changed. We're looking for in-market accretive assets that can help, you know, fuel our growth as we go into the future. There's lots of things out there, I think, that are sort of in our sweet spot, right? That may be a little bit too small for the big pharma world, but the right size for us. You know, we wanna, you know, embedded in the BD question is capital allocation. We wanna remain balanced, right?

We're gonna continue to return to shareholders through dividends and share repurchases, but we're also gonna be aggressive in business development and we want to be able to, over the next period of time, continue with the internal efforts on the pipeline, build a portfolio of growth assets to help fuel our future sustainable growth. So, you know, we're excited about having the cash available to enter into business development and support the strong base business and the pipeline that we're developing.

Okay. Yeah, on the new product revenue. I think that's a figure that we generally give out each quarter, so that, you know, we can all track against it. The $71 million included the launches of iron sucrose and octreotide for us, and it was actually in line with our expectations. We've always said or we said in February that we expected a ramp over the course of the year in the new product revenue, it's definitely more heavily weighted to the second half. As far as the question on channel inventories, you know, our channel inventories are very normal and standard. There's no significant impact or increase in those inventories that drove any of the results for the first quarter.

I think you also said in your question, you know, are we gonna continue to give the figures for new product revenues? Yes, we are. However, we're probably gonna have to evolve that over time as we're evolving the portfolio. You know, that works really well for the generic and complex generic pipeline. As we start getting into more value-added products, 505(b)(2)s and others, and particularly innovative portfolio, you know, new product revenue is not just year 1 or 12 months, right? Those are new products for, you know, 1, 2, 3, sometimes 4 years that you're developing them. We're gonna have to think a little bit about how we characterize our success in introducing new molecules into the portfolio.

The next question is from Jason Gerberry with Bank of America. Please go ahead.

Hi, this is Melanie on for Jason. Thanks for taking our question. On fast-acting meloxicam, can you discuss your specialty sales force strategy? You know, what % of the market do you think you'll be able to access given your HCP and outpatient focus?

Good. Thank you for the question. Corinne.

Yes, thank you, Melanie. For the launch of fast-acting meloxicam, we've done a lot of work to really identify the key targets for us. We have a specialty approach, meaning that we are going to go after the patients that are treated in the outpatient setting, but really post-operative pain as a start. In terms of sizing of our skill force, we are thinking of building a skill force about 150 to 200 reps. You know, potentially going beyond this through partnerships as we develop this product further and target, you know, more non-operative pain at this point, dentistry and other type of pain. This we would do in partnership very likely.

The next question is from David Amsellem with Piper Sandler. Please go ahead.

Thanks. At a high level, Scott, I want to get a better sense of what Viatris is aspiring to be regarding the innovative business in the U.S. You've got an immunology program, you've got a cardiovascular program. You've talked about pain. There's a number of different therapeutic verticals that potentially you're going to have your hands in commercially. Can you help us better understand how you're thinking about leveraging those verticals? I realize that's a high-class problem to the extent that cenerimod and/or selatogrel work. I think it would be helpful to illuminate us on how you're thinking about that. Then secondly, I know you talked about accretive M&A, commercial stage M&A.

Can you also talk about the extent to which you want to take on additional R&D risk via in-licensings? The kinds where you have relatively small upfront payments, and you're not really doing anything to your capital structure, but you're bolstering the pipeline. Is that something that's going to be a priority in parallel to your priorities related to commercial stage M&A? Thanks.

Thank you. Thank you, David. I wouldn't say a priority. I think, you know, over a five-year period, we will likely put some things into the pipeline that are early clinical, but right now we're focused on in-market accretive assets that we can be good owners of. That's our focus. Again, over the next five years, there may be some things that come into the pipeline, but it's not the same priority as focusing on things which are, in market, accretive, and can help drive our revenue and EBIT in the short term.

The U.S., yeah, therapeutic indications. Again, you know, we're a little less focused on therapeutic indications than we are about, you know, can or can we be good owners of these assets? Do we have the right people? Do they fit the portfolios going forward? You know, even though there may be a couple of differences, as you said, a high-class problem of, you know, of phase III programs being successful and us launching in the U.S., you know, we're gonna have a specialty focus. These are not huge from a spend perspective. We're not going into primary care. We're not gonna have thousands of sales reps out of there. We feel we can build strong therapeutically focused sales forces that are able to deliver good results.

The way that I look at it is if you had a positive, for example, result with cenerimod and we're launching cenerimod, that's a cornerstone product in that therapeutic area. We launched that successfully, and we can continue to add products there. We don't wanna be in everything, right? We're trying to find good assets that can be cornerstone products, and then we'll build on those from a therapeutic perspective as we move forward.

David, if I can comment also on how we build infrastructure in the U.S., I think it's very important to understand, I mentioned it for, that I think with oxyget, that we have a very targeted specialty-driven approach. The sales force will never be beyond 200 people. It's really what we are looking at doing. I can give the example of Women's Health as well, where we have a portfolio of products that we're gonna launch with XULANE LO first, but then we have other products that we launch in a couple of years. Again, a sales force that will be maybe 70 people, you know, at the most. That's how we are going to look at launching those products. Beyond this, as I said, it will be in partnerships.

The next question is from Chris Schott with JP Morgan. Please go ahead.

Hi, this is Ethan on for Chris Schott. Thanks for taking our questions today. Congrats on the great quarter. Just starting off, maybe with generic semaglutide beginning to enter in some specific markets, just wondering if there's any learnings that you've been taking away thus far and more broadly, how you're thinking about that generic GLP-1 opportunity, including potential sizing and timing of any contribution to Viatris. My second question is just on the ARV business, how are you thinking about the go-forward impact of the supply constraints that you highlighted this quarter? Thank you.

Philippe talked a little bit about our GLP-1 strategy, which is going to be important to our future. It's a driver more in the 2030 and beyond timeframe than it is short term. Very important to our long-term strategy, the GLP-1 strategy. Philippe?

You know, we intend to be a significant player in the GLP-1 space. We are developing every GLP-1s that are currently approved. This is, as you know, a market that is very dynamic, we gotta be ready for whatever changes may be coming and leverage that. I think we are particularly focusing on the U.S. because this is a region where we believe we have the opportunity to differentiate versus other potential generic players, in particular around our ability to come up with the right auto-injector to be substituted, for instance.

We have developed a significant strategy for GLP-1s and we'll be supplying a significant part of that market with an hyper focus on the U.S. going forward. That does not mean we're not gonna launch in other regions, but we'll do that selectively based on the dynamics of a specific region.

It's a complicated area, right? There's a number of molecules out there. There's a number of indications. There's different dosage forms. There's different applications. It's very complicated out there. You know, we wanna be thoughtful on where we go. We wanna make the right kind of investments. I think as a company, given our device expertise and other things, I think we are uniquely qualified to participate in this marketplace in the future.

Yep. As far as the ARV business, you know, from a supply disruption perspective, you know, it's important to note that we've, you know, we've mitigated by moving production to, you know, additional sources if we can. The team's working very hard to, you know, alleviate those constraints, and I think we're getting, you know, making significant progress there. We're gonna hopefully ramp up supply, you know, sooner rather than later. I think it's also very important to point out that in our updated forecast, we've included all the risk that we currently see. It's all baked into the numbers that give us confidence that we're gonna deliver for the rest of the year. As I said in my remarks, there might be some upside to those numbers.

The next question is from Ashwani Verma with UBS. Please go ahead.

Hey, thanks for taking our question. Sorry, circling through a few calls here. Congrats on the revenue growth, particularly strong. I know at the investor day, you had outlined the long-term goal of growing 4% organic, and here you're doing pretty well at 3% in 1Q. Just trying to get a sense of how soon can we get there at the 4% run rate. Is that something that's feasible, let's say, later this year or 2027? Is that more of a subject of some of the branded pipeline kicking in and that would enable that growth? Thanks.

Yeah, the 4% number is where we expect to get by 2030. You know, along the way, starting off this quarter with 3% growth, I think is a strong start to that. We feel very confident in our ability to deliver those long-term targets that we put out there. Again, the strength of this kind of first quarter, it's early, right, relative to long-term targets. You know, we feel very, very good about where those targets sit and about our performance and our ability to hit those targets. Again, you know, we will have in this period, you know, significant cash to be able to supplement what we're doing. We've got very large number of clinical readouts coming, We've got a lot of launches right now.

We expect to see that growth rate ramp up as we go into 2027, 2028, 2029.

This concludes our question-and-answer session. I would like to turn the conference back over to Scott Smith, CEO, for any closing remarks.

Thank you very much, and thank you all for participating in the call this morning. Obviously, I'm really excited about the exceptionally strong performance this quarter and the momentum that we're seeing in our business. We delivered 3% revenue growth and 10% adjusted EBITDA growth this quarter. We are expecting multiple near-term pipeline catalysts and product launches, and we have significant financial flexibility to execute our capital allocation plan and accelerate shareholder value. As we move through 2026, our focus remains on disciplined execution and continuing to build a more durable, higher quality growth profile. Thank you very much for your time today.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Viatris (VTRS) Q1 2026 Earnings Call Transcript

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