Viatris Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 8, 2025
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Operator

Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Bill Cyblowski, Head of Capital Markets. Please go ahead.

Bill Szablewski
Bill Szablewski
Head of Capital Market at Viatris

Good morning, everyone. Welcome to our Q1 twenty twenty five earnings call. With us today is our CEO, Scott Smith CFO, Doretta Mistras Chief R and D Officer, Philippe Martin and Chief Commercial Officer, Karine Lagasse. During today's call, we will be making forward looking statements on a number of matters, including our financial guidance for 2025 and various strategic initiatives. These statements are subject to risks and uncertainties.

Bill Szablewski
Bill Szablewski
Head of Capital Market at Viatris

We will 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 2025 actual reported results, we will be making certain comparisons to 2024 actual or reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 2024 from the 2024 period. We may refer to those as changes on an operational basis When comparing our 2025 actual or reported results to our expectations, we're making comparisons to our 2025 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Scott Smith
Scott Smith
Director & CEO at Viatris

Good morning, everyone. 2025 is off to a good start as we continue to focus on executing on our strategic priorities. Highlights include Q1 operational performance in line with expectations, significant pipeline progress, including three positive Phase three data readouts returned approximately $450,000,000 in capital to shareholders with approximately $300,000,000 of that through share repurchases continued remediation of our indoor facility and on track to request reinspection midyear, significant progress on our enterprise wide strategic review working to set the organization up for future growth. In Q1, we delivered $3,300,000,000 in total revenues, down 2% on a divestiture adjusted operational basis, driven primarily by the impact of indoor. We were particularly pleased with our strong execution and growth in Europe and China this quarter.

Scott Smith
Scott Smith
Director & CEO at Viatris

So far this year, we've made tremendous progress in advancing our pipeline and Philippe will provide additional detail shortly. This morning, we announced positive data for Phase three studies of our novel fast acting meloxicam in moderate to severe acute pain. This is a significant advancement for Viatris in an area of high unmet medical need. We believe there's a tremendous demand for more non opioid treatment options for patients in moderate severe acute pain. We look very much forward to progressing this treatment for registrational filings in 2025.

Scott Smith
Scott Smith
Director & CEO at Viatris

Additionally, in the quarter, we received positive data for Zulane Low, a transdermal patch that is being developed to offer women a low dose estrogen combination birth control option. We plan to submit our NDA in the second half of this year. Earlier this quarter, we received positive results from the Phase three open label long term extension study for Effexor required for approval in Japan where we filed an sNDA for Effexor for the treatment of generalized anxiety disorder, an indication for which no other treatment option is currently available or approved in Japan. To date, we've received three of the six Phase three data readouts that we are expecting this year. Importantly, all other studies remain on track to readout later this year.

Scott Smith
Scott Smith
Director & CEO at Viatris

In addition, we continue to make great progress on selatogrel, cenerimod and sotagliflozin and these innovative assets remain on track for important data readouts beginning in 2026. As previously discussed, in Q1, we entered into agreement with our partners from Idorsia that allows us even greater control over the selatogrel and sunerimod development programs and expands our geographic ownership of sunerimod. From a capital allocation perspective, during this period of significant market and policy unpredictability, we have prioritized returning capital to shareholders. To date, we have returned approximately $450,000,000 in capital to shareholders with approximately $300,000,000 of that from share repurchases and $143,000,000 from dividends. We are reaffirming our commitment to prioritize return of capital to shareholders in 2025.

Scott Smith
Scott Smith
Director & CEO at Viatris

We continue to make progress on our remediation at our indoor facility and have engaged third party subject matter experts to assist in this task. As stated in February, we expect to submit a request for reinspection midyear. We have also kicked off our enterprise wide strategic review and are taking the opportunity to look at our business holistically. We will do this while ensuring we continue to protect and grow the base business and further develop our innovative capabilities. This is an opportunity for us to look at streamlining costs globally to reflect our smaller and more simplified post divestiture footprint and ensure we are ready for the next stage of sustainable revenue and earnings growth.

Scott Smith
Scott Smith
Director & CEO at Viatris

Considering our performance in the first quarter, we are reaffirming our outlook for the year. Turning to the current discussions around tariffs, at Beatrice, we take seriously our mission to empower people worldwide to live healthier at every stage of life. In fact, we are very proud that we serve approximately 1,000,000,000 patients worldwide each year. While tariffs on pharmaceuticals, if enacted, could have a negative financial impact on the organization, we are also concerned about the potential for additional supply shortages and disruptions that could have a significant impact on the ability for Americans and indeed patients around the globe to access the medicines they need. We currently commercialize our products in 165 countries and have 36 manufacturing, R and D and packaging sites around the globe.

Scott Smith
Scott Smith
Director & CEO at Viatris

Eight of these facilities are in The United States. We have deep expertise in managing a global supply network and we are continually taking steps to be nimble and responsive to any opportunities or challenges that lie ahead. While our global and diverse supply chain is optimized to support patients where they live, as a U. S. Company, we have been in the past and continue to be today firmly committed to manufacturing in The United States.

Scott Smith
Scott Smith
Director & CEO at Viatris

Last year, we manufactured approximately 8,500,000,000 doses in The U. S. And more than 50 of our U. S. Revenue is currently sourced from The U.

Scott Smith
Scott Smith
Director & CEO at Viatris

S. Manufacturing site. We look forward to understanding more about the specifics around the executive order issued earlier this week as we continue to explore ways to optimize the flexibility of our global network, including the potential to increase our manufacturing capacity in The U. S. We remain focused on ensuring we have the right footprint in the right places, so we can continue to serve our patients worldwide, while also maintaining a profitable and sustainable business.

Scott Smith
Scott Smith
Director & CEO at Viatris

I'm now very excited to talk about the most recent addition to our executive leadership team. Hemanth Verges joined us in April as Chief Strategy Officer. He brings deep experience across the biotech and pharmaceutical industries and in every area of our portfolio generics, complex generics, brands and innovative products. He also holds a PhD in medical biophysics giving him a unique perspective into the healthcare industry. I look forward to working with Hemith, the rest of our leadership team and in fact all of our colleagues globally as we continue to work to drive our base business, execute on our pipeline, return capital to shareholders and position ourselves for growth in 2026 and beyond.

Scott Smith
Scott Smith
Director & CEO at Viatris

Now, let me turn it over to Philippe to discuss the exciting developments in our pipeline in more detail. Philippe?

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Thank you, Scott. We have strong momentum advancing our Phase three programs, which is one of our key priorities this year. We previously mentioned that we would have six Phase three readouts in 2025. We've already had the first three readouts and I'm pleased to report that all three are positive. These programs are now moving to the regulatory submission preparation phase.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Let's begin with the Phase three readout of our investigational MR107A02 program for the treatment of moderate to severe acute pain that we announced earlier today. The development of safe and effective alternative treatments to opioids is an important public health need. The improvement in pain we observed from our fast acting meloxicam compared to placebo was statistically significant and clinically meaningful, building on an established mechanism of action and well characterized safety profile. All primary and secondary endpoints were met in both Phase three studies. These results were consistent across multiple post surgical models of moderate to severe acute pain.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

We believe that when approved, this oral non opioid analgesic option for the treatment of moderate to severe acute pain will get us closer to addressing this important public health need. In addition to placebo, these trials included an opioid arm, tramadol fifty milligram given every six hours to confirm the sensitivity of the pain model. Importantly, and in contrast to recently approved agents, our fast acting meloxicam demonstrated superior pain control versus the opioid arm in both surgical models, further strengthening its value as a potential non opioid option for acute moderate to severe pain. For context, this regimen of tramadol equals forty oral morphine equivalents, which is twofold higher than hydrocodone twenty milligram. Additionally, our fast acting meloxicam demonstrated a significant reduction in opioid usage across both studies.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

This was demonstrated by a significant reduction in opioid use versus placebo and a significantly higher number of opioid free patients on fast acting meloxicam than placebo. Our fast acting meloxicam were generally well tolerated. In both studies, incidence of TAEs was comparable to placebo in a post surgical setting. Few severe TAEs and SAEs were reported with a rate consistent with placebo. No TAEs leading to death were reported.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

These two pivotal studies ultimately position our fast acting meloxicam for potential first line treatment for moderate to severe acute pain. The company is targeting to submit a new drug application to the FDA by the end of the year based on the positive data from these two Phase three studies and the supportive positive Phase two dose ranging finding data in dental pain. We also anticipate that the full dataset from both Phase three studies will be presented during the Pain Week Medical Conference in September in Las Vegas. Next, let me provide more details about the positive results from our investigational Zulane Loh Phase three readout that we have also announced today. There are three important conclusions from the study.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

One, it confirmed the effectiveness of Zulane Loh weekly patch for birth control in women of childbearing potential. Two, it demonstrated a favorable safety and tolerability profile with most TAEs reported as mild to moderate and no new safety concerns identified. And three, it demonstrated potential best in class patch performance with very few patches completely detaching over the seven day wearing period and less than one percent of trial subjects reporting severe local application site reactions. Overall, we are pleased with the results and believe Zulane Law also has the potential to address an important unmet need for women seeking a reversible birth control option with a lower dose of estrogen. We also designed our patch with certain texture and sizing properties that we believe could be appealing to women who are seeking another weekly birth control patch option.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Viatris has a long history and strong track record of developing and manufacturing dermal patches at our R and D and manufacturing facilities in Vermont. We are looking forward to progressing this product toward regulatory submission, which we anticipate will be in the second half of this year. We also anticipate that the result from this Phase three study will be presented at the next American College of Obstetrician and Gynecologists Conference. Our remaining Phase three readouts anticipated this year relate to our ophthalmology programs. We remain on track to receive three key Phase three registrational readouts in the first half of the year.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

These include pimecrolimus for blepharitis, phantolamine ophthalmic solution for presbyopia and for visual loss in low light condition associated with keratorefractive surgery. As for other advancements in our pipeline, our regulatory team is hard at work advancing key submissions. We recently filed application to the Japanese health authorities for approval of Effexor for the treatment of adults with generalized anxiety disorder. There is no other treatment option currently approved for this indication in Japan. Our positive results from our previously announced Phase three efficacy and safety studies laid the foundations for our applications.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

We are also pleased that these results have been accepted as a poster presentation at the Japanese Society of Neurology and Psychiatry Conference. In addition, we are focused on preparing our submissions for sotagliflozin in a number of ex U. S. Markets. Our filings in UAE and Saudi Arabia have been submitted and we expect to submit our filing in Canada soon.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Moving to selatogrel and cenerimod, enrollment for both programs remains on schedule. We recently presented data at PANLAR that covered the multifaceted immunomodulatory properties of cenerimod. Also, we are pleased to share the acceptance of our abstracts covering data from the additional analysis of the Phase two CARE study providing information related to fatigue and quality of life at Lupus twenty twenty five and maintenance of response at EULAAR twenty twenty five. We look forward to continuing to engage with the rheumatology and lupus scientific and patient communities at several congresses throughout the year. For selatogrel, we had very productive discussions at the recent American College of Cardiology Congress and continue to see strong interest in the trial within the cardiology community.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Lastly, regarding our best business portfolio, we are on track with the approvals required for us to deliver $450,000,000 to $550,000,000 of new product revenue this year, including our anticipated approval for iron sucrose, octreotide and liraglutide. Overall, it's a strong start to the year. Our R and D strategy is driven by deep in house development capabilities and expertise and we are very pleased with our steady disciplined progress to date. I will now turn the call to Loretta.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Thank you, Philippe, and good morning, everyone. I am glad you could join us. Today, I will walk you through the key drivers and takeaways for the quarter, the progress we're making against our capital allocation plan and our outlook for the remainder of the year. Our first quarter results were in line with our expectations and reflect our well diversified global business. Total revenues for the quarter were $3,250,000,000 down 2% versus the prior year.

Doretta Mistras
Doretta Mistras
CFO at Viatris

The impact from indoor in the first quarter was approximately $140,000,000 which was in line with our expectations. Excluding this impact, operational revenue would have increased 2% versus the prior year. As Scott mentioned, the remediation effort at Indoor is progressing as planned. Our revenues benefited from growth in our brands of 3%. This was primarily driven by the expansion of our cardiovascular portfolio in emerging markets and growth in Greater China and developed markets.

Doretta Mistras
Doretta Mistras
CFO at Viatris

In developed markets, overall net sales were impacted by declines in our generics business, partially offset by growth in brands. From a regional perspective, we continue to see consistent and durable growth from our European business growing approximately 1% this quarter. The brand portfolio grew 2% led by Creon, Brufen and our thrombosis portfolio. Generics performance was flat year over year despite the indoor impact and continues to benefit from key markets such as France. Our North American business decreased 8% versus the prior year, primarily as a result of the indoor impact and competition on select generic products, which was expected.

Doretta Mistras
Doretta Mistras
CFO at Viatris

This was partially offset by new product revenues and continued growth in Brenna. In Emerging Markets, net sales decreased approximately 5% versus the prior year, primarily driven by the indoor impact and customer buying patterns affecting the ARV generics business. Partially offsetting this performance was growth in brands across the cardiovascular portfolio in certain Latin American countries and continued strength in the MENA and Eurasia regions. In our Jan segment, net sales decreased approximately 6%. Results were primarily driven by expected government price regulations in Japan and Australia and a change in reimbursement impacting off patent brands in Japan.

Doretta Mistras
Doretta Mistras
CFO at Viatris

This was partially offset by volume increases in the generics portfolio. Lastly, we see continued positive momentum in Greater China. Net sales grew 4%, which was as a result of our diversified model across e commerce, retail and private hospitals. This led to growth across the portfolio, particularly brands that are sensitive to proactive patient choice. And looking at the P and L, adjusted gross margin of approximately 56% in the quarter was in line with expectations.

Doretta Mistras
Doretta Mistras
CFO at Viatris

As anticipated, margins declined versus the prior year due to price regulations in JANS, the impact of indoor and the increase in certain product supply costs. Operating expenses were roughly flat versus prior year. Cost savings initiatives benefiting SG and A were offset by investments in R and D to advance our innovative pipeline. Finally, the company had a triggering event for goodwill impairment testing in the first quarter due to a decline in our share price and the increased uncertainty and volatility in the geopolitical and economic environments in which we operate. As a result, for U.

Doretta Mistras
Doretta Mistras
CFO at Viatris

S. GAAP purposes, we recorded a non cash goodwill impairment charge of $2,900,000,000 driven by an increase in discount rate assumptions reflecting the increased business risk. Despite this, we remain confident in our base business outlook and in our ability to deliver on our expectations for the year. Turning to free cash flow. For the quarter, it was $493,000,000 and would have been $535,000,000 excluding transaction costs and taxes from the divestitures.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Moving to capital allocation. We continue to prioritize capital return. And since the beginning of the year, we have repurchased over $300,000,000 worth of shares. Including our Q1 dividend payment, we are pleased to have already returned more than $450,000,000 of capital to our shareholders. Now a few comments on our outlook and phasing for the rest of the year.

Doretta Mistras
Doretta Mistras
CFO at Viatris

Based on the performance in the first quarter and trends we are seeing across the business, we are reaffirming our outlook for the year. Within our guidance, the drivers of total revenue include no change to the base business outlook, including the estimated financial impact from Indoor and continued confidence in meeting our new product revenue range of $450,000,000 to $550,000,000 While foreign exchange has been volatile, we've seen spot rates move favorably over the past month. And if current rates hold for the remainder of the year, this could offset the 2% to 3% headwind we had previously incorporated in our full year revenue guidance. Due to finalizing an agreement to expand our commercial rights for cenerimod, adjusted EBITDA and adjusted EPS guidance reflects a $10,000,000 impact from IP R and D. Adjusted EPS also reflects the benefit from share repurchases executed to date.

Doretta Mistras
Doretta Mistras
CFO at Viatris

It's important to note that our guidance does not account for any potential impact related to industry tariffs. With regards to anticipated phasing for the rest of the year, total revenues are still expected to be higher in the second half at approximately 52% of our full year outlook. This reflects the estimated impact of indoor, normal product seasonality and back weighted launches of new products. Adjusted EBITDA and adjusted EPS are still expected to be higher in the second half. And as a reminder, free cash flow is expected to be lowest in Q2 due to timing of semi annual interest payments and working capital requirements.

Doretta Mistras
Doretta Mistras
CFO at Viatris

In conclusion, I want to take the opportunity to reiterate our confidence in the fundamentals of our business and the progress we continue to make executing against our strategic priorities. Our well diversified global business and our strong cash flow enables us to continue delivering on returning capital to our shareholders. We believe we are well positioned to meet our expectations for the remainder of this year. And with that, I'll hand it back to the operator to begin the Q and A.

Operator

Ladies and gentlemen, we will now begin the question and answer session. Our first question today comes from Chris Shutt from JPMorgan. Please go ahead with your question.

Chris Schott
Chris Schott
Managing Director at JP Morgan

Great. Thanks so much. Just two questions for me. Maybe first on the meloxicam opportunity. Can you just help us frame out how you're thinking about the peak sales opportunity and kind of the ramp once approved for this drug and how much of your existing infrastructure can you leverage to launch the product?

Chris Schott
Chris Schott
Managing Director at JP Morgan

And then my second question was just on tariffs. Scott, I appreciate some of the comments in the opening remarks. But for the 50% of your sales in The U. S. That aren't manufactured domestically, how should we think about the company's ability to mitigate the impact there?

Chris Schott
Chris Schott
Managing Director at JP Morgan

Maybe specifically, is there opportunity to take price to offset some of this? And is there capacity within The U. S. Manufacturing network to shift things to U. S.

Chris Schott
Chris Schott
Managing Director at JP Morgan

If needed? Thanks so much.

Scott Smith
Scott Smith
Director & CEO at Viatris

Good morning, Chris and thank you for the question. Let me answer the tariff question first and then I'll kick it over to Corinne and to potentially Philippe to talk a little bit about meloxicam. So yes, so more than 50% of our U. S. Revenues come from U.

Scott Smith
Scott Smith
Director & CEO at Viatris

S. Based manufacturing. We have eight manufacturing R and D packaging sites here. We already produce 8,500,000,000 doses here annually. The countries we import from into The U.

Scott Smith
Scott Smith
Director & CEO at Viatris

S. Where we don't manufacture in The U. S. Are Ireland, The UK and India. And obviously, we don't know where tariffs are going to land, but we've been involved in a lot of mitigation strategies both short term and long term thinking about what it is that we can do.

Scott Smith
Scott Smith
Director & CEO at Viatris

So we're focused on, of course, increasing production within The U. S. Network that we have already. We're looking at adjusting our inventory levels for The U. S.

Scott Smith
Scott Smith
Director & CEO at Viatris

Market. And longer term, we're looking at things like transfers, leveraging third parties here are in The U. S. Investment potentially in a larger U. S.

Scott Smith
Scott Smith
Director & CEO at Viatris

Network and manufacturing facility. So, can control, we can only what we can control. I don't know where the tariffs are going to land, but we're looking at a wide variety of mitigation strategies to be able to handle any whatever comes at us from the tariffs. And I will say though that, if there are significant tariffs enacted in the pharma sector, it's likely to have a financial impact on the company. I think the degree to which I can't say, but we're doing everything we can to mitigate that.

Scott Smith
Scott Smith
Director & CEO at Viatris

But from my perspective, just as important as that or maybe more important is this idea of patient access. And I think the discussions that we're having with the administration and with Congress are around the ability of the generic industry, particularly to be able to continue to provide access to patients for all medications. So we're trying to get our messages across. But in the meantime, we're very, very involved, I would say in a daily basis talking about mitigation strategies to minimize any impact that may come both financially for patients. So I'll kick it over to Karim.

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

Yes. So good morning, Chris. Before I give you a bit of some color on how we see the positioning of fast acting meloxicam, I just would like to ask first Philippe to comment a bit on the data.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Yes. So thank you. I think the profile that we've seen, we're very happy with from both Phase three studies. Results were very consistent across the two studies. We made all primary and key secondary endpoints.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

And importantly, we are able show superior profile versus our opioid competitor, which as I said in my remarks is highly potent competitor, which has been shown to be highly efficacious in these two models of hernia and vignettectomy in clinical trials. And it's about twofold more important than oziconone at twenty milligram. So we feel very strongly about our data versus this opioid comparator. On top of it, we were able to demonstrate significantly lower opioid usage than placebo in this study, which will be extremely important going forward. The safety profile was also well tolerated in incidence of TAs were comparable to placebo, fewer TAs and SAEs were reported with a rate consistent with placebo as well.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

So overall, the benefit risk profile emerging from this Phase three study positions this drug very well for first line treatment.

Chris Schott
Chris Schott
Managing Director at JP Morgan

Great.

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

So Chris, obviously, are very pleased with the data. Just to give you an idea of how we look at the potential of these assets, it is potentially a large addressable market. There are about over seventy million acute pain cases annually in The United States. More than eighty million patients take pain medication for acute pain on a yearly basis. And we still see an overreliance on opioids despite addiction risk.

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

So the market demand for safer alternatives, non sedating alternatives, strong efficacy products with an established safety profile and we believe that the novel fat pack in meloxicam can fit what the market is asking for. So potentially this asset could fit seamlessly both into the inpatient and outpatient care pathways. It will be a good treatment alternative for acute care management and has a very competitive profile. And we're in the process of refining our forecast, so I cannot disclose any data at this point, but we'll make sure that we'll keep you abreast on our progress here.

Scott Smith
Scott Smith
Director & CEO at Viatris

Just one final comment from me, Chris. And that is, I've been involved directly in a number of pain launches over my many years. And when I take a look at this data and it's really fresh and new data for us, it's very, very compelling. I think we have a really nice opportunity to have a major position in the acute pain market going forward here.

Operator

Our next question comes from Ash Verma from UBS. Please go ahead with your question.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Yes, thanks for taking our questions. Maybe just on the share repurchases, I see you've done $300,000,000 already and aiming for 500,000,000 to $650,000,000 Is there more appetite here to go up substantially on the repo given where the stock is? And then secondly, on MR-one hundred seven, can you help us understand like how fast acting is this? Like for example, how quickly does this get SATSIG benefit in terms of hours, let's say, the primary endpoint on the Slide 15? And then can you get a fast acting claim on the label versus let's say Mobic?

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Thanks.

Scott Smith
Scott Smith
Director & CEO at Viatris

So good morning, Ash, and thanks for the question. And I'll take the first one on capital allocation. Philippe can talk a little bit more about the meloxicam and the data. We've already, as you noted, repurchased more than $300,000,000 to this point in time. We're going to we're firmly committed to our goal of 500,000,000 to $650,000,000 Given the environment and the volatility in the macro environment, we want to and tariff uncertainty and things, don't we want to keep a little bit of strategic flexibility in terms of our capital allocation.

Scott Smith
Scott Smith
Director & CEO at Viatris

It's potential potentially we may lean in even more and do more than $650,000,000 but we're going to sort of let the year play out given the uncertainty and see where we are. But given where the share price is, this is a year where we've talked about really leaning into the share repurchases as an important part of our capital allocation plan.

Doretta Mistras
Doretta Mistras
CFO at Viatris

And importantly, I would also say nothing has changed in terms of our expectations of the ability to generate free cash flow for the year and have about $1,700,000,000 of deployable cash flow. And so to Scott's point, we do have the strategic flexibility as we move forward to the year. We have multiple levers that we can push and play with.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Okay. Thank you, Ash. On the question about our fast acting minoxicam in terms of time of response, we measured it in the phase in both Phase three studies. We looked at medium time to meaningful pain relief and medium time to perceptible pain relief. And we saw a fast acting meloxicam to put this data in context against others and you have that data in the slide that we've already.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

But to put that data in context, we also did a post hoc analysis where we looked at two points or more reduction in NPRF from baseline, which has been demonstrated with others and we were very fast with ninety five minutes versus a placebo of three thirty eight minutes. So we feel that the fast acting properties of our fast acting meloxicam have been demonstrated in Phase three twice in both studies. As to whether we are able to get a claim, think I don't want to speculate on what FDA may or may not do, but we'll certainly have the conversation with the agency.

Operator

Our next question comes from David Amsellem from Piper Sandler. Please go ahead with your question.

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

Hey, thanks. So a couple for me. On indoor, can you talk about '26 and the potential for impact to spill over into '26?

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

How should we think about that? Also, there is another facility in India, and I apologize if I missed any commentary on this. But can you talk about, your inspection at the other facility in India that happened last year and where things stand on that? And then switching gears regarding strategic priorities and biz dev M and A, can you talk to your appetite for taking on assets that are in mid to late stage development along the lines of cineremot and selatogrel. How are you thinking about development stage assets versus your appetite for commercial stage brand assets?

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

Thank you.

Scott Smith
Scott Smith
Director & CEO at Viatris

So, thank you. Good morning, David. Yes, so the remediation in indoor is coming along fine. We are at progress as expected. We expect to submit a request for reinspection midyear.

Scott Smith
Scott Smith
Director & CEO at Viatris

We can only control what we can control. Can't control the timing of that inspection. So we're making sure that we also qualify other plans in the network outside of indoor to be able to supply The U. S. Network.

Scott Smith
Scott Smith
Director & CEO at Viatris

I think we'll see significant rebound in indoor related products as we move into 2026. Some like lenalidomide sort of go away as we get into '26, but we should see some restoration of our products from indoor in '26 and we don't think it will have a significant impact on our overall financials. In terms of NASHIC, the same status has been that inspection happened approximately a year ago. We got a four eighty three. We have not heard from the FDA relative to the classification of that inspection.

Scott Smith
Scott Smith
Director & CEO at Viatris

And we have importantly completed all committed actions that we agreed to with the FDA on that plan. So we're waiting to see. We've also qualified other facilities in the network as well in case there is any action in NASH. We're to hear back from the FDA on that. And again, we've completed all committed actions at this point

Doretta Mistras
Doretta Mistras
CFO at Viatris

And just to add some color and contextualize on the potential indoor impact, we've talked about approximately $500,000,000 revenue impact from indoor. As Scott mentioned, about 40% of that is melanomide related and so we don't anticipate that to come back. But about $100,000,000 of that is due to penalties and short term supply disruptions, which we don't anticipate occurring in 2026 and the remainder to Scott's point we're in the process of either moving and is subject to the reinspection and initiation of indoor.

Scott Smith
Scott Smith
Director & CEO at Viatris

Thank you. And your second question was relative to our BD priorities. And I believe you said mid to late stage development assets. And first of all, I'd like to say that we could not be more excited to have Sonarima and SlideRail in the portfolio in the pipeline. The development of them is going very well.

Scott Smith
Scott Smith
Director & CEO at Viatris

We've been able to accelerate the development and the timing of those assets. We've taken more control over the development programs. We've expanded the geography for Sonerima. We're very, very excited about those assets. However, our business development focus right now is for in market or very near to market assets.

Scott Smith
Scott Smith
Director & CEO at Viatris

We want to be able to build short term revenue and EBITDA. So we're looking at assets that are closest rather than mid stage development either very, very late stage that are close to launch or in market is what our focus is right now.

Operator

Our next question comes from Jason Gerberry from Bank of America. Please go ahead with your question.

Pavan Patel
Pavan Patel
Analyst at Bank of America

Hey guys, this is Bhavan Patel on for Jason Gerberry. First question is that the first quarter showed brand resilience, the generic weakness. So maybe if you can elaborate on the volume versus price drivers for key brands like Lipitor in developed markets in Greater China? And then for generics, beyond the quantified indoor impact, what drove the decline there? And how sustainable is the overall 2% underlying core business growth ex divestitures, ex indoor that you saw this quarter?

Pavan Patel
Pavan Patel
Analyst at Bank of America

And then my second question is that the guidance assumes a significant second half ramp in revenue, EBITDA and earnings per share. So maybe if you can provide some more color on the expected timing and contribution cadence within the second half from the key launches, including iron, sucrose, octreotide, LAR, glucagon, which may or may not be needed to hit the four fifty to five fifty new product revenue target? Thank you.

Scott Smith
Scott Smith
Director & CEO at Viatris

So thank you very much for the question. Doretta, do you want to take that to your questions?

Doretta Mistras
Doretta Mistras
CFO at Viatris

Yes. So let's start with the brand resilience. And to your point, we feel good about the momentum that we've seen on the brand side. I would say it was really driven in a couple of pieces. Number one in China, we continue to see good momentum and uptake in our brand portfolio there.

Doretta Mistras
Doretta Mistras
CFO at Viatris

We reported 4% growth this quarter. The other area is in Europe. We saw great growth in our portfolio there with Creon, Brufen, as well as our thrombosis portfolio. And so overall, to your point, we are seeing good momentum in brands. On the generic portfolio, that part of our portfolio has been the most impacted by indoor.

Doretta Mistras
Doretta Mistras
CFO at Viatris

If you ex the impact of indoor, I would say expectations and the performance of our generics portfolio is actually performing in line with what we expect. With respect to guidance in the second half, as we mentioned, we do expect our performance to be second half weighted about 52% of our revenue we expect to hit in second half. There is a couple of pieces to that. Number one, the indoor impact is expected to be more acute in the first half versus the second half. The second piece of that is just the ramp of new product launches.

Doretta Mistras
Doretta Mistras
CFO at Viatris

I'll have Philippe talk a little bit about how we think about that, but we do expect new product launches to be slightly more second half weighted and we do have normal product seasonality that occurs in the second half, especially as it relates to some of our portfolio in Europe and that's what's letting us to some of the trends that we're seeing between the first half and the second half.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Yes. And you mentioned a number of key launches. I just want to remind you that glucagon has been launched already. Iron sucrose, egiraglutide and octreotide are all scheduled for the second half of this year and so that's we are on schedule with these three assets to get them approved in this in the second half.

Operator

Our next question comes from Umer Raffat from Evercore. Please go ahead with your question.

Umer Raffat
Senior Managing Director at Evercore ISI

Hi guys. Thanks for taking my questions. I have a few here if I may. First, if you could just remind us about your manufacturing network for your U. S.

Umer Raffat
Senior Managing Director at Evercore ISI

Business, the India facilities versus Morgantown and what percentage is made in U. S? On meloxicam, I had a couple of questions, if I may. First, your trials are obviously in acute setting and surgery setting, where traditionally meloxicam takes a few hours to kick in. So congrats to you on the data.

Umer Raffat
Senior Managing Director at Evercore ISI

My question to you is surgeons have historically hesitated doing NSAIDs in for bleeding reasons in surgery setting. And to what extent do you see your product's usage in acute setting versus in chronic settings like arthritis where meloxicam has been used? Secondly, how do you think about potential risks with the Cmax because it definitely goes higher than the traditional meloxicam? And if there's any potential bleeding risks? And finally, do you anticipate this being a hospital drug or not?

Umer Raffat
Senior Managing Director at Evercore ISI

Thank you.

Scott Smith
Scott Smith
Director & CEO at Viatris

Thank you, Umer for the questions and nice to hear from you. The first one was relative to some facts around our U. S. Manufacturing network. We have 26 facilities in network globally.

Scott Smith
Scott Smith
Director & CEO at Viatris

We have eight facilities manufacturing, packaging, R and D in The U. S. We manufacture approximately greater than 50% of our total revenues come from The U. S. The rest comes from combination of Ireland, The UK and India.

Scott Smith
Scott Smith
Director & CEO at Viatris

So that's a little bit of just a fact pattern of what our manufacturing footprint looks like. And obviously, given tariffs, we're looking at a number of short and long term remediations of tariffs come and where they come from. So we're doing a lot of significant planning. We talked about it on a daily basis on things that we can do to remediate, but we including taking a look at expanding our current U. S.

Scott Smith
Scott Smith
Director & CEO at Viatris

Network, which again produces greater than 50% of our revenues.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

Yes. And I will cover the three questions I believe on meloxicam. First of all so first about the surgery setting. We studied in three clinical trials, one Phase two in post surgery dental pain, bigneidectomy and uranyuraphy post surgery. And we've seen no increased risk of bleeding as part of these three studies in our clinical studies.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

As a matter of fact, the safety profile was very much consistent with placebo. So we saw no increased risk in this post surgery population. In terms of Cmax, you're correct the Cmax is higher. However, as I just said it did not lead to in an acute setting lead to additional or any additional risk of bleeding. Have not seen any of it in the Phase two and the Phase three program.

Philippe Martin
Philippe Martin
Chief R&D Officer at Viatris

So to the last question about hospital drug, I'll give that to Corinne to answer.

Corinne Le Goff
Corinne Le Goff
Chief Commercial Officer at Viatris

Yes. So we believe that this Plastic Heme Oxicam, if I think could be used already in the hospital as it was done in the clinical trial setting, but also of course for outpatient usage. And we're also looking at not only utilization of the product post surgery, but also in any episode of acute care and that could be dental acute pain or other type of acute pain as we have also demonstrated very positive data in Phase two model in dental pain.

Operator

And ladies and gentlemen, with that, we'll conclude today's question and answer session. I'd like to turn the floor back over to Scott Smith, CEO for any closing remarks.

Scott Smith
Scott Smith
Director & CEO at Viatris

Thank you very much, Stuart. In closing, we've had a really good start to the year. We've got operational performance in line with our expectations, significant pipeline progress, continued capital return to our shareholders, we remain very optimistic about the future of Beatrice. Our growing pipeline, capital discipline, operational excellence and significant global scope give us confidence in our ability to navigate through periods of volatility and uncertainty that our industry has been experienced for much of the year. Thank you all very much for your attention this morning.

Operator

Ladies and gentlemen, the conference has now concluded. We do thank you for attending today's presentation. You may now disconnect your lines.

Executives
    • Bill Szablewski
      Bill Szablewski
      Head of Capital Market
    • Scott Smith
      Scott Smith
      Director & CEO
    • Philippe Martin
      Philippe Martin
      Chief R&D Officer
    • Doretta Mistras
      Doretta Mistras
      CFO
    • Corinne Le Goff
      Corinne Le Goff
      Chief Commercial Officer
Analysts
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Key Takeaways

  • Q1 total revenues were $3.3 billion, down 2% on a divestiture-adjusted operational basis primarily due to the indoor facility impact, while Europe, China and the brand portfolio delivered durable growth.
  • The R&D pipeline made significant progress with three positive Phase III readouts—fast-acting meloxicam for acute pain, the Zulane Loh birth-control patch and Effexor for GAD in Japan—supporting planned 2025 NDA submissions and future data readouts for selatogrel, cenerimod and sotagliflozin.
  • During Q1 the company returned approximately $450 million of capital to shareholders—$300 million via buybacks and $143 million in dividends—and reaffirmed its commitment to prioritize capital return in 2025.
  • Remediation at the indoor manufacturing site remains on track, with a reinspection request expected midyear, while the enterprise is optimizing its global supply network to mitigate potential pharmaceutical tariffs and exploring U.S. capacity expansion.
  • An enterprise-wide strategic review has been launched to streamline costs, simplify the post-divestiture footprint and position the organization for sustainable revenue and earnings growth.
AI Generated. May Contain Errors.
Earnings Conference Call
Viatris Q1 2025
00:00 / 00:00

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