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DATE

Thursday, May 7, 2026 at 8:30 a.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Scott Smith
  • President, Research & Development — Philippe Martin
  • Interim Chief Financial Officer — Paul Campbell
  • Chief Commercial Officer — Corinne Le Goff

TAKEAWAYS

  • Total Revenues -- $3.5 billion, reflecting 3% growth attributed primarily to cardiovascular strength in Greater China and strong North America generics performance.
  • Adjusted EBITDA -- $1 billion, representing 10% growth; margin leverage driven by disciplined cost management and favorable product mix.
  • Adjusted EPS -- $0.59 per share, with management characterizing this as consistent with expectations and supportive of company outlook.
  • Free Cash Flow -- $459 million excluding transaction, restructuring costs, and taxes; reported cash generation was $348 million including these items.
  • Greater China Revenue Growth -- 18% year over year from aging population demand, cardiovascular portfolio strength, and e-commerce channels, with sales through e-commerce more than doubling.
  • Developed Markets Segment -- Net sales increased 1% overall; North America up 3% from estradiol demand and new complex generic launches, Europe down 1% due to supply constraints and competitive pressure on Dymista offset by strong Creon and Italy results.
  • Emerging Markets Segment -- Net sales were flat, falling below management expectations, with ARV portfolio supply constraints explicitly cited as the main drag.
  • JANZ Segment -- Net sales decreased 2%, which management noted was better than expected, with Australia competition and Japanese price regulation offset by Creon and Amitiza.
  • Adjusted Gross Margin -- 56%, unchanged from the prior year, with slight upside due to favorable sales mix.
  • Operating Expenses -- Lower year over year, reflecting savings from an ongoing enterprise-wide cost review and disciplined spending.
  • Capital Return -- $140 million returned to shareholders via dividend payments during the quarter.
  • Cash Deployment Expectation -- Management guidance of more than $2.5 billion available for 2026 provides flexibility for capital return, internal investment, and business development prioritization.
  • Guidance Update -- Management reaffirmed full-year guidance, now assuming "mid- to high-single-digit" Greater China growth and slower anticipated competition for Amitiza in Japan, partially offset by continued supply constraints in low-margin generics and generic competition in developed markets.
  • Currency Tailwind -- Anticipated 1% upside to total revenue and adjusted EBITDA should current foreign exchange rates persist.
  • H2 Financial Weighting -- Management expects approximately 52% of full-year revenue, adjusted EBITDA, and adjusted EPS will occur in the second half due to product seasonality and timing of launches.
  • Pipeline Progress -- NDA for fast-acting meloxicam accepted by FDA, with regulatory review, and XULANE LO on track for a July 30, 2026 PDUFA date; additional U.S. approvals expected in the second half.
  • Japan Product Approvals -- EFFEXOR for GAD approved, PMDA reviews for pitolisant expected in the second half for two sleep disorders, and top-line Nefecon data for IgA nephropathy expected in the first half of the year.
  • Creon in Europe -- Phase III interim data showed 76% of patients benefitted from dosage escalation, supporting a regulatory label update filing before year-end with approval anticipated in the first half of 2027.
  • Generic Portfolio Execution -- U.S. approval for generic Abilify Maintena secured, with launch planned before year-end; FDA decisions pending for iron ferric carboxymaltose injection and rotigotine patch; $71 million new product revenue contribution highlighted.
  • Global Phase III Programs -- Selatogrel enrollment rate at 1,200 patients/month targeting full enrollment by year-end 2026; cenerimod SLE studies fully enrolled with results expected in first half of 2027.
  • Cost Savings Program -- $120 million of the targeted $400 million in annual net savings on track to be delivered this year, with full program expected to drive ongoing margin expansion into 2027 and 2028.
  • CFO Transition -- Paul Campbell named Interim Chief Financial Officer, with management stating, "we should expect no changes to capital allocation or financial policy."
  • Business Development Strategy -- Focus remains on in-market, accretive opportunities sized appropriately for Viatris, with management emphasizing continued capital discipline and pipeline portfolio growth.
  • GLP-1 Pipeline -- Full portfolio development underway with focus on device-enabled, substitutable products for U.S. market entry post-2030 and global launches considered selectively by region.

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RISKS

  • Management cited "policy risk" in China as "very dynamic and unpredictable," although leadership expressed confidence that there will be "no policy change this year."
  • Supply constraints in the ARV portfolio were reported as the primary factor holding back emerging markets' net sales growth, with efforts ongoing to alleviate the disruption.
  • Competitive pressure and market softness in select European countries, particularly around Dymista and generic products, presented as a drag on segment performance.
  • JANZ segment results negatively impacted by "anticipated increased competition in Australia" and Japanese "government price regulations," only partially offset by brand performance.

SUMMARY

Management delivered 3% operational revenue growth and 10% adjusted EBITDA growth, crediting commercial strength in Greater China and disciplined execution on cost savings initiatives. Multiple near-term pipeline milestones—particularly the expected U.S. launches of fast-acting meloxicam and XULANE LO, Japan regulatory approvals, and pending FDA decisions for complex generics—were signaled as key catalysts for 2026 and future growth trajectories. The CFO transition to Paul Campbell was positioned as seamless, with no expected changes to capital allocation strategy. In-market business development, an expanding GLP-1 pipeline, and a meaningful cash deployment capability support a focus on both immediate operational execution and longer-term portfolio transformation.

  • Selatogrel's pivotal cardiovascular Phase III is designed with "a ranking endpoint," using "the worst outcome for the patient" as the adjudication metric, with the trial powered for a targeted 20% relative risk reduction.
  • Creon European Phase III interim data revealed 76% of non-cystic fibrosis patients "were not adequately treated with the maximum approved dose," supporting a regulatory filing aimed at label expansion and broader market reach in 2027.
  • North America segment's 3% growth was driven by "increased demand for estradiol, continued strong performance from Breyna and new product revenue contributions from complex generic launches."
  • Free cash flow was negatively impacted year over year by "timing and net working capital" and higher one-time costs, though the result beat internal expectations.
  • Management expects over 52% of annual revenue and profitability to be realized in the second half due to product launches and typical seasonality, shaping investor expectations for future quarters.

INDUSTRY GLOSSARY

  • PDUFA: Prescription Drug User Fee Act date; the target deadline for FDA action on new drug applications.
  • sNDA: Supplemental New Drug Application; a request to the FDA to approve a change to an already approved product.
  • PMDA: Pharmaceuticals and Medical Devices Agency, the Japanese regulatory authority.
  • ARV: Antiretroviral; drugs used to manage HIV infection, referenced in context of portfolio supply constraints.
  • JANZ: Japan, Australia, New Zealand; Viatris reporting segment aggregating these regions.
  • LOE: Loss of exclusivity; the expiration of market exclusivity for a branded drug, which can impact sales and margins.
  • MI: Myocardial infarction; referenced in the context of the selatogrel cardiovascular trial endpoints.
  • STEMI/NSTEMI: Specific types of myocardial infarction; used to categorize severity in clinical trial endpoints.
  • IgA nephropathy: A kidney disease treated with Nefecon, under Phase III investigation in Japan segment discussion.
  • 505(b)(2): An FDA regulatory pathway allowing approval of new drug applications relying in part on data not developed by the applicant.

Full Conference Call Transcript

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 3 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.

And 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 1 of our 6 product candidates we're anticipating this year, EFFEXOR for GAD in Japan. We remain on track for the remaining 5 regulatory decisions in the second half of the year, including our weekly contraceptive patch XULANE LO and our fast-acting meloxicam. We are 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 and 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 and 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. And 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 want to thank Doretta Mistras for her significant contribution as CFO over the past 2 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.

Philippe Martin: 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 the 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 LO ], our low-dose estrogen transdermal contraceptive patch.

We remain on track against the expected PDUFA goal date of July 30, 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 6 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 17, 2026. I will now highlight key milestones in Japan.

In March, as anticipated, we received approval for EFFEXOR in adults with generalized anxiety disorder. For pitolisant, with regulatory reviews progressing well, we expect PMDA regulatory decisions for 2 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 2 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 decisions 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 SLE OPUS-1 and 2 are fully enrolled, and we expect results for both studies in the first half of 2027. And 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.

Paul Campbell: Thank you, Philippe, and 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 remains 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, but 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 onetime 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 our 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.

Operator: [Operator Instructions] The first question comes from Glen Santangelo with Barclays.

Glen Santangelo: Scott, 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. When you look at these results, it looks like you've got very strong incremental contribution from both brands and generics and then on the geography side, from China in particular. And in your prepared remarks, you suggested it was strong execution and commercial efforts. But the growth rate doubled in that geography.

And so 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 and trying to reconcile that with maintaining the guidance given that 1Q is already sort of running ahead of, I guess, your overall expectation for the year? And then I just had a follow-up for Philippe.

Scott Smith: Yes, relative to maintaining guidance, so I guess I'll take it a little bit backwards, right? It's early. We're really, really pleased with the quarter, clean quarter, as you say, strong quarter. We're pleased that it's just early, and we'll continue to monitor and when we get to Q2, we'll update you at that point in time. But I feel very, very good about it. Yes, it was a clean quarter, driven a lot by revenue in China and North America. You asked about China. I've been involved with business in China since the late '90s. 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, 18 months that I've ever seen, both on the innovative side and on the total side. So China is very, very strong, and we're very, very pleased with our performance there. So -- 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. So we're very, very pleased with the China performance.

Paul Campbell: Yes. Maybe I'll just add -- sorry, Glen.

Glen Santangelo: No, go ahead.

Paul Campbell: Yes, on your question about the durability, I mean, we -- you've 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, there's always the policy risk that's very dynamic and unpredictable. And as Scott said, it's too early in the year for us to really be that bullish on it, but we'll monitor through Q2, and we'll let you know.

Corinne Le Goff: And 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, and Scott just mentioned it, is that we have consistently invested in our commercial platforms. And switching the -- transitioning the business from hospitals that are most susceptible to policy changes to retail and e-commerce. And e-commerce this year, in this first quarter we've seen a doubling of our sales in this channel. So good success from our perspective.

Glen Santangelo: Okay. Maybe if I could just ask a quick follow-up to Philippe. Philippe, thanks for all the detail on all the pipeline stuff. But 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. And 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. And then I think as we look to 27, we have cenerimod, the readouts coming in the first half of the year and selatogrel maybe behind that in late '27.

Are those sort of the 4 biggest opportunities that you see? Or is there something else you'd add to that mix? And I'll stop there.

Philippe Martin: Thanks for the question. So as you point out, importantly, in the U.S., we have meloxicam and [ XULANE LO ] this year. I think these are 2 key important launch for us, supported by very strong clinical data. The review process for these 2 assets with the agency, with the FDA is going as planned. And so we have good confidence that we'll get the approval by the time of the PDUFA for [ XULANE LO and later in the second half for meloxicam, we're still waiting for FDA to give us that PDUFA date. It 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 and that will be followed also by important data for Nefecon in IgA nephropathy. So Japan is -- we're getting the approvals we need, and we'll -- we have a strong team there that has experience in launching these types of assets. And then finally, to your point, selatogrel, cenerimod, everything is on schedule. Everything is behaving like we have planned.

So everything is working according to plan and 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.

Scott Smith: I just want to -- before we go to the next question, just to wrap it up here on meloxicam and [ XULANE LO ]. Very, very pleased with the data, as Philippe pointed out. But 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 launching blockbuster products in the U.S., and I think they're going to execute really, really well on these products. So we're very focused on making sure that we execute those couple of launches. And then, of course, the opportunity to have readouts on selatogrel, cenerimod, et cetera, is going to be very, very strong for us.

Operator: The next question is from Umer Raffat with Evercore.

Umer Raffat: I have 2, if I may. First, if you could just expand on the free cash flow year-over-year and what some of the drivers are. But secondly, and perhaps more importantly, I just wanted to expand on the selatogrel trial in the cardiovascular setting. And specifically, I feel like there hasn't been an appropriate amount of discussion on the endpoint. So 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 1 of 6 things that could happen on an ordinal scale. And per patient, the worst thing is taken forward.

So I guess my question is, if someone has a STEMI versus a death, how -- is there like a score that's assigned to those 2 different events? But 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 reestimation and when will that happen?

Scott Smith: Thank you, Umer. Thank you for your questions. First, 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, the study design and beyond.

Paul Campbell: Sure. So 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 going to happen for the quarter. But essentially, the drivers are timing and net working capital, which is both the timing and then we had business growth this year and last year's comparative period, we had a decline. And then our onetime cost did increase year-over-year. Those are the main drivers.

Philippe Martin: Okay. So regarding selatogrel. So maybe we need to spend some time together to go over the actual design and the primary endpoint. But it is an endpoint that we designed in collaboration with the FDA and with our KOL. So we -- it's a ranking endpoint where we have -- where we're ranking the severity of the MI and it can go from a scale of death all the way to an acute MI without a significant impact. And 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.

So if you're -- a patient has 2 events, as death and 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. So I think it's relatively straightforward from that standpoint. Adjudication is happening by 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? So there will be less patient with death, less patient with severe acute MI versus placebo. That's -- that risk reduction, if you will, that will be characterized that way. So a lot more to go -- we can go into a lot more detail about this endpoint, but I think that should answer your question at this point.

Scott Smith: Yes. And before the next question and on a much less granular level, I'm really pleased with the execution from a clinical development perspective for selatogrel and for cenerimod, but we've accelerated the enrollment of obviously, both of those fully enrolled now with cenerimod, and right now, we are enrolling approximately 1,200 patients a month in the selatogrel study, which is a pretty strong number. So 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, but very, very pleased with the clinical development execution thus far.

Operator: The next question is from Matt Dellatorre with Goldman Sachs.

Matthew Dellatorre: Congrats on the strong quarter. Maybe coming back to fast-acting meloxicam just briefly, could you comment on whether priority review is still a possibility there? And then 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, but just anything kind of further you could share would be helpful. And then maybe with regard to the cost savings, could you comment on progress with regard to achieving -- I think you've put out an estimate of 30% of that $400 million in net savings this year.

And then 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. But perhaps walk us through what the base case and the upside case looks like in '27 and '28 with respect to EBITDA margins.

Scott Smith: Thanks, Matt. So let me just overall say we'll address the second question first around the enterprise-wide strategic review and I'll kick it over to Paul for some discussion around margins, but we are completely on track at this point in time to deliver the savings that we outlined before. So you can really see the effect of that as we're starting to get some significant EBITDA leverage with 3% growth and 10% EBITDA growth in the quarter. We are on track to deliver the savings this year and also for '27 and '28. Paul, around the margins?

Paul Campbell: Yes. So I think it's important, as Scott said, part of our beat in the quarter was related to OpEx. And OpEx comes -- lower OpEx comes from our disciplined cost management. And then, obviously, there's a little bit of phasing in there. And then 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. And we do expect that operating leverage to continue as the savings flow in, not only the rest of this year but into the next few years also.

Scott Smith: Philippe, around meloxicam regulatory and label?

Philippe Martin: So we anticipate that the agency -- we're expecting that the agency will be giving us the PDUFA date and timing of review within the next couple of weeks. So 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 endpoints.

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

Corinne Le Goff: And Matt, this is Corinne. And as it comes to the commercial opportunity for fast-acting meloxicam, having no opioid sparing in the indication section, it's helpful but not essential, I would say. It will be in the label, as Philippe said. And the opportunity is driven by the total clinical profile of this product. And we have demonstrated that fast-acting meloxicam can deliver very fast, rapid, meaningful pain relief. It's a non-opioid option, and that's really what will make a difference in the moderate-to-severe acute pain market.

Scott Smith: No, that's a great point, Corinne, that 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, 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 going to be a very important product for us in '27 and beyond.

Operator: The next question is from Les Sulewski with Truist Securities.

Leszek Sulewski: Congrats on the progress. I 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 onetime channel stocking? And is this a figure you intend to provide moving forward? And then on the BD front, it appears the market has been -- 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? And then lastly, how should we think about the CFO transition? Should investors expect any change in capital allocation or disclosure or on the cost savings side?

Scott Smith: Maybe we'll just take it from the bottom and go forward. So first of all, on the CFO question, we should expect no changes to capital allocation or financial policy with no expectations at all. And since it's been brought up, the first thing besides the fact there will be no changes, I'd like to thank Doretta for being 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, a tremendous understanding of our business, and we're very, very lucky to have him. So I feel very good about the CFO transition and how that's going. From a BD perspective, yes, it's a little -- 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 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.

And so we want to -- embedded in the BD question is capital allocation. We want to remain balanced, right? We're going to continue to return to shareholders through dividends and share repurchases, but we're also going to 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 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.

Paul Campbell: Okay. Yes. On the new product revenue, so I think that's a figure that we generally give out each quarter so that 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 at -- in February that we expected a ramp over the course of the year in the new product revenue. So it's definitely more heavily weighted to the second half. And then as far as the question on channel inventories, 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.

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

Operator: The next question is from Jason Gerberry with Bank of America.

Unknown Analyst: This is Melanie on for Jason. On fast-acting meloxicam, can you discuss your specialty sales force strategy? And what percent of the market are you -- do you think you'll be able to access given your HCP and outpatient focus?

Scott Smith: Thank you for the question. Corinne?

Corinne Le Goff: Yes. Thank you, Melanie. So for the launch of fast-acting meloxicam, we've done a lot of work to really identify the key target 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 postoperative pain as a start. And in terms of sizing of our sales force, we are thinking of building a sales force of about 150 to 200 reps. And potentially going beyond this through partnerships as we develop this product further and target more nonoperative pain at this point, dentistry and other type of pain. And this we would do in partnership very likely.

Operator: The next question is from David Amsellem with Piper Sandler.

David Amsellem: So 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 United States. You've got an immunology program. You've got a cardiovascular program. You've talked about pain. So there's a number of different therapeutic verticals that potentially you're going to have your hands in commercially. So can you help us better understand how you're thinking about leveraging those verticals? And I realize that's a high-class problem to the extent that cenerimod and/or selatogrel work. But I think it would be helpful to illuminate us on how are you thinking about that? And then secondly, I know you talked about accretive M&A, commercial stage M&A.

But can you also talk about the extent to which you want to take on additional R&D risk via in-licensing, 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?

Scott Smith: Thank you, David. I wouldn't say a priority. I think over a 5-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. And so that's our focus. Again, over the next 5 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 EBITDA in the short term.

Philippe Martin: Therapeutic indication.

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

And 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 continue to add products there. We don't want to be in everything, right? And 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.

Corinne Le Goff: And David, if I can comment also on how we build infrastructure in the U.S., I think it's very important to understand, and I mentioned it for fast-acting meloxicam that we have a very targeted specialty-driven approach, so the sales force will never be beyond 200 people. It's really what we are looking at doing. And I can give the example of women's health as well where we have a portfolio of products that go to launch with [ XULANE LO ] first, but then we have other products that will launch in a couple of years.

Again, a sales force that will be maybe 70 people at the most and that's how we're going to look at launching those products. Beyond this, as I said, it will be in partnerships.

Operator: The next question is from Chris Schott with JPMorgan.

Ethan Brown: This is Ethan on for Chris Schott. 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. And then 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?

Scott Smith: So Philippe, talk 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 time frame than in the short term. But very important to our long-term strategy, the GLP-1 strategy. Philippe?

Philippe Martin: Yes. So we are -- 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. And so we got to be ready for whatever changes may be coming and leverage that. I think we are particularly focusing on the U.S. because this is an area -- 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.

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

Scott Smith: 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. And so it's very, very complicated out there, but we want to be thoughtful on where we go. We want to make the right kind of investments. And 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.

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

We'll see how the rest of the year goes.

Operator: The next question is from Ash Verma with UBS.

Ashwani Verma: Circling through a few calls here. And 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? Or is that more of a subject of some of the branded pipeline kicking in, and that would enable that growth?

Scott Smith: Yes. The 4% number is where we expect to get by 2030. And 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. And again, the strength of this kind of first quarter, it's early, right? relative to long-term targets, but we feel very, very good about where those targets sit and about our performance and our ability to hit those targets. And again, we will have, in this period, significant cash to be able to supplement what we're doing.

We've got a very large number of clinical readouts coming, and we've got a lot of launches right now. So we expect to see that growth ramp up as we go into '27, '28, '29.

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

Scott Smith: 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.

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