Good morning, everyone, and welcome to the Viatris Q1 2025 Earnings Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask a question. Please also note, today's event is being recorded. At this time, I'd like to turn the floor over to Bill Szablewski, Head of Capital Markets. Please go ahead.

Good morning, everyone. Welcome to our Q1 2025 earnings call. With us today is our CEO Scott Smith; CFO, Doretta Mistras; Chief R&D Officer, Philippe Martin; and Chief Commercial Officer, Corinne Le Goff. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2025 and various strategic initiatives. These statements are subject to risks and uncertainties. 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 or 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 proportion of 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 are making comparisons to our 2025 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Good morning, everyone. 2025 is off to a good start as we continue to focus on executing our strategic priorities. Highlights include: Q1 operational performance in line with expectations; significant pipeline progress, including three positive Phase 3 data readouts; returned approximately $450 million in capital to shareholders with approximately $300 million of that through share repurchases; continued remediation of our Indore facility; and on track to request re-inspection mid-year; significant progress on our enterprise wide strategic review, working to set the organization up for future growth. In Q1, we delivered $3.3 billion in total revenues, down 2% on a divestiture adjusted operational basis, driven primarily by the impact of Indore. We were particularly pleased with our strong execution and growth in Europe and China this quarter. So far this year, we've made tremendous progress in advancing our pipeline, and Philippe will provide additional details shortly. This morning, we announced positive data for Phase 3 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 forward to progressing this treatment for registrational filings in 2025. Additionally, in the quarter, we received positive data for XULANE LO, 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 3 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 3 data readouts that we are expecting this year. Importantly, all other studies remain on track to read out later this year. 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 Cenerimod development programs and expands our geographic ownership of Cenerimod. 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 million in capital to shareholders with approximately $300 million of that from share repurchases and $143 million from dividends. We are reaffirming our commitment to prioritize return of capital to shareholders in 2025. We continue to make progress on our remediation at our Indore 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 re-inspection mid-year. 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. Considering our performance in the first quarter, we are reaffirming our outlook for the year. Turning to the current discussions around tariffs at Viatris, 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 billion 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&D, and packaging sites around the globe. 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. Last year, we manufactured approximately 8.5 billion doses in the U.S., and more than 50% of our U.S. revenue is currently sourced from a U.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 US. 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. I am now very excited to talk about the most recent addition to our executive leadership team. Hemanth Varghese 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 Hemanth, the rest of our leadership team, and 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. Now, let me turn it over to Philippe to discuss the exciting developments in our pipeline in more detail. Philippe?

Thank you, Scott. We have strong momentum advancing our Phase 3 programs, which is one of our key priorities this year. We previously mentioned that we would have six Phase 3 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. Let's begin with the Phase 3 readout of our investigational MR-107A-02 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 3 studies. These results were consistent across multiple post-surgical models of moderate to severe acute pain. 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 50 milligrams 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 40 year-old morphine equivalents, which is two-fold higher than hydrocodone 20 milligrams. Additionally, our fast-acting meloxicam demonstrated a significant reduction in opioid usage across both studies. 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 was generally well tolerated. In both studies, the incidence of treatment emergent adverse events was comparable to placebo in a post-surgical setting. Few severe treatment emergent adverse events and serious adverse events were reported with a rate consistent with placebo. No treatment emergent adverse events leading to death were reported. These two pivotal studies optimally 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 3 studies and the supportive positive Phase 2 dose-ranging finding data in dental pain. We also anticipate that the full data set from both Phase 3 studies will be presented during the PAINWeek Medical Conference in September in Las Vegas. Next, let me provide more details about the positive results from our investigational XULANE LO Phase 3 readout that we have also announced today. There are three important conclusions from the study. One, it confirmed the effectiveness of XULANE LO weekly patch for birth control in women of childbearing potential. Two, it demonstrated a favorable safety and tolerability profile with most treatment emergent adverse events 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 1% of trial subjects reporting severe local application site reactions. Overall, we are pleased with the results, and believe XULANE LO 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. Viatris has a long history and strong track record of developing and manufacturing dermal patches at our R&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 results from this Phase 3 study will be presented at the next American College of Obstetricians and Gynecologists Conference. Our remaining Phase 3 readouts anticipated this year relate to our ophthalmology programs. We remain on track to receive three key Phase 3 registrational readouts in the first half of the year. These include Pimecrolimus for blepharitis, Phentolamine ophthalmic solution for presbyopia, and for visual loss in low-light conditions associated with keratorefractive surgery. As for other advancements in our pipeline, our regulatory team is hard at work advancing key submissions. We recently filed applications 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 3 efficacy and safety studies laid the foundations for our applications. 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 findings in UAE and Saudi Arabia have been submitted, and we expect to submit our findings in Canada soon. 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 analyses of the Phase 2 care study, providing information related to fatigue and quality of life at LUPUS 2025 and maintenance of response at EULAR 2025. 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. Lastly, regarding our best business portfolio, we are on track with the approvals required for us to deliver $450 million to $550 million 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&D strategy is driven by our deep in-house development capabilities and expertise. And we are very pleased with our steady disciplined progress today. I will now turn the call to Doretta.

Thank you, Philippe, and good morning, everyone. I'm 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 $3.25 billion, down 2% versus the prior year. The impact from Indore in the first quarter was approximately $140 million, 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 Indore 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. 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 Indore 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 Indore impact and competition on select generic products which was expected. This was partially offset by new product revenues and continued growth in Breyna. In emerging markets, net sales decreased approximately 5% versus the prior year, primarily driven by the Indore 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 strengths in the MENA and Eurasia regions. In our JANZ 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. 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. In looking at the P&L, adjusted gross margin of approximately 56% in the quarter was in line with expectations. As anticipated, margins declined versus the prior year due to price regulations and JANZ, the impact of Indore, and the increase in certain product supply costs. Operating expenses were roughly flat versus prior year. Cost savings initiatives benefiting SG&A were offset by investments in R&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.S. GAAP purposes, we recorded a non-cash goodwill impairment charge of $2.9 billion, 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 million and would have been $535 million excluding transaction costs and taxes from the divestitures. Moving to capital allocation, we continue to prioritize capital return and since the beginning of the year, we have repurchased over $300 million worth of shares. Including our Q1 dividend payment, we are pleased to have already returned more than $450 million of capital to our shareholders. Now, a few comments on our outlook and phasing for the rest of the year. 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 Indore, and continued confidence in meeting our new product revenue range of $450 million to $550 million. While foreign exchange has been volatile, we've seen spot rates move favorably over the past month. 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 million impact from IPR&D. Adjusted EPS also reflects the benefit from share repurchases executed to date. It's important to note that our guidance does not account for any potential impact related to industry tariffs. With regard 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 Indore, 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. 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&A.

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

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? 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? Maybe specifically, is there opportunity to take price tops off some of this, and is there capacity within the U.S. manufacturing network to shift things to the U.S. if needed? Thanks so much.

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 potentially Philippe to talk a little bit about meloxicam. So yes, more than 50% of our U.S. revenues come from U.S.-based manufacturing. We have eight manufacturing R&D packaging sites here. We already produce 8.5 billion doses here annually. The countries we import from into the U.S. where we don't manufacture are Ireland, the UK, and India. 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 we can do. So we're focused on increasing production within the U.S. network that we have already. We're looking at adjusting our inventory levels for the U.S. market. In the longer term, we're looking at things like transfers, leveraging third parties here in the U.S., and potentially investing in a larger U.S. network of manufacturing facilities. We can only control 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. If there are significant tariffs enacted in the pharma sector, it likely will have a financial impact on the company. I can't say to what degree, but we're doing everything we can to mitigate that. Just as importantly, we are also concerned about patient access and the discussions we are having with the administration and with Congress. We're talking about mitigating any financial impacts while ensuring patient access. So I'll kick it over to Corinne.

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 would like to ask Philippe to comment a bit on the data.

Yes. So thank you. I think the profile that we've seen, we're very happy with from both Phase 3 studies. The results were consistent across two studies. We met all primary and key secondary endpoints. Importantly, we were also able to show a superior profile versus our opioid comparator, which is a highly potent comparator shown to be highly efficacious in these two trials of hernia and bunionectomy. It is about two-fold more potent than hydrocodone 20 milligrams. We feel very strongly about our data versus this opioid comparator. On top of it, we could also demonstrate significantly lower opioid usage than placebo, which could be extremely important going forward. The safety profile was also well tolerated. The incidence of treatment emergent adverse events was comparable to placebo. Fewer treatment emergent adverse events and serious adverse events were reported with a rate consistent with placebo. Overall, the benefit-risk profile emerging from these Phase 3 studies positions very well for first-line treatment.

So, Chris, obviously we are very pleased with the data. Just to give you an idea of how we look at the potential of this asset, there is potentially a large addressable market. There are over 70 million acute pain cases annually in the United States. More than 80 million patients take pain medication for acute pain yearly, and there remains an over-reliance on opioids despite addiction risks. So there is demand for safer alternatives, non-addictive alternatives, and strong efficacy products with an established safety profile. We believe the novel fast-acting meloxicam can fit what the market is asking for, potentially fitting seamlessly into both inpatient and outpatient care pathways. It will serve as a good treatment alternative for acute care management and has a competitive profile. We are currently refining our forecasts, so I cannot disclose any data points at this moment, but I assure you we'll keep you informed of our progress here.

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

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

Thanks for taking your questions. Maybe just on the share repurchases. I see you've done $300 million already and aiming for $500 million to $650 million. Is there more appetite here to go up substantially on the repurchase given where the stock is? Then secondly, on MR-107, can you help us understand how fast-acting this is? For example, how quickly does this get static benefit in terms of hours, let's say, on the primary endpoint on Slide 15? And can you get a fast-acting claim on the label versus traditional meloxicam?

So, good morning, Ash. Thank you for the question. I'll take the first one on capital allocation. Philippe can talk a little bit more about the meloxicam data. We've already, as you noted, repurchased more than $300 million to this point. We are firmly committed to our goal of $500 million to $650 million. Given the environment and the volatility, we want to keep a bit of strategic flexibility in terms of capital allocation. Potentially, we may lean in more and do more than $650 million, considering where the share price is. This is the year where we’ve talked about leaning into share repurchases as an important part of our capital allocation plan.

Importantly, I would also say nothing has changed in terms of our expectations of the ability to generate free cash flow for the year, maintaining about $1.7 billion of deployable cash flow. So, as Scott said, we do have the strategic flexibility as we move through the year with multiple levers to adjust.

Okay. Thank you, Ash. On the question about our fast-acting meloxicam, in terms of time of response, we measured median time to meaningful pain relief and median time to perceptible pain relief in both Phase 3 studies. For context, we also did a post-hoc analysis where we looked at a two-point or more reduction in NPR from baseline, which has been demonstrated with others. We found our fast-acting meloxicam showed responsiveness with results of 95 minutes versus a placebo of 338 minutes. We feel the fast-acting properties of meloxicam have been demonstrated in both Phase 3 studies. Regarding whether we can achieve a claim, I don’t want to speculate on what the FDA may do, but we are certainly having discussions with the agency.

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

Hey, thanks. So, a couple for me. On Indore, can you talk about 2026 and the potential for impact to spill over into 2026? How should we think about that? Also, there's 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 BizDev M&A, can you talk to your appetite for taking on assets that are in mid to late stage development along the lines of Cenerimod and Selatogrel? How are you thinking about development stage assets versus your appetite for commercial stage brand assets? Thank you.

Thank you. Good morning, David. Yes, the remediation in Indore is progressing as expected. We expect to submit a request for re-inspection mid-year. We can only control what we can control. We can't control the timing of that inspection. We should see significant rebound in Indore-related products as we move into 2026. Some, like lenalidomide, sort of go away as we get into 2026, but we should see some restoration of our products from Indore in 2026, and we don't think it will have a significant impact on our overall financials. As for Nashik, we got a 483 from last year's inspection. We haven't heard from the FDA on the classification of that inspection. We’ve completed all committed actions agreed with the FDA. We’re also qualifying other facilities to supply the U.S. network just in case. We're waiting to hear back from the FDA. We've completed all committed actions at this point.

And just to add some color to the potential Indore impact, we’ve talked about approximately $500 million revenue impact from Indore. As Scott mentioned, about 40% of that is lenalidomide-related. We don’t anticipate that coming back, but about $100 million is due to penalties and short-term supply disruptions we don't expect to continue in 2026. The remainder is subject to the re-inspection and remediation of Indore.

Thank you. Your second question related to our business development priorities, specifically regarding mid to late-stage development assets. We’re very excited about Cenerimod and Selatogrel in our portfolio. The development of these assets is going very well, and we're able to accelerate their timelines while taking greater control over their development programs. Our focus, however, is currently on in-market or very near-to-market assets. We want to build short-term revenue and EBITDA, so we're focusing on assets that are closest to market or already launched.

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

Hey, guys. This is Bhavin 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 Indore impact, what drove the decline there and how sustainable is the overall 2% underlying core business growth, ex-divestitures, ex-Indore that you saw this quarter? 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, which may or may not be needed to hit the $450 million to $550 million new product revenue target. Thank you.

Yes, so let’s start with the brand resilience. To your point, we feel good about the momentum on the brand side, which was driven by a couple of factors. In China, we continue to see good momentum and uptake in our brand portfolio, reporting 4% growth this quarter. The other area is in Europe, seeing great growth through Creon, Brufen, and our Thrombosis portfolio. We are seeing good momentum in brands. On the generic portfolio, that has been the most impacted by Indore. Excluding the impact, we believe the expectations for performance are in line with what we expect. About 52% of revenue is expected to be in the second half; this reflects the impact of Indore, normal product seasonality, and back-weighted launches of new products.

Yes, and just to remind you about key launches, glucagon has been launched already. Iron Sucrose, Liraglutide, and Octreotide are all scheduled for the second half of this year, and we're on schedule with these three assets to get them approved in the second half.

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

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. business, the India facilities versus Morgantown and what percentage is made in the U.S.? On meloxicam, I had a couple of questions if I may. First, your trials are obviously in acute settings, in surgery settings, where traditionally meloxicam takes a few hours to kick in. So congrats to you on the data. My question is, surgeons have historically hesitated to use NSAIDs for bleeding reasons in surgery settings, and to what extent do you see your product’s usage in acute settings versus 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 are any potential bleeding risks. And finally, do you anticipate this being a hospital drug or not? Thank you.

Thank you, Umar, for the questions, and it’s nice to hear from you. The first one relative to our U.S. manufacturing network: we have 26 facilities in our network globally. We have eight facilities for manufacturing, packaging, and R&D in the U.S. We manufacture over 50% of our total revenue here. The rest comes from a combination of Ireland, the UK, and India. We’re looking at several remediations if tariffs come into play. Regarding our fast-acting meloxicam, I believe Philippe can take that question.

Yes, so first about the surgery setting. We studied in three clinical trials — post-surgery dental pain and laparoscopic surgery. We’ve seen no increased risk of bleeding as part of these three studies. The safety profile was consistent with placebo, so we saw no increased risk in this post-surgery population. In terms of CMAX, you are correct that it is higher, but as I said, it did not lead to any increased bleeding risk. We have not seen that in either the Phase 2 or Phase 3 programs. Regarding whether it will be a hospital drug, I’ll pass it over to Corinne.

Yes, we believe that this fast-acting meloxicam can definitely be used in hospital settings from our clinical trial experiences, as well as for outpatient usage. We are also looking at its utilization not only in post-surgery but also in any episode of acute care, such as dental pain or other types of acute pain where we have demonstrated positive data.

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.

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, and continued capital returns to our shareholders. We remain very optimistic about the future of Viatris. 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 the industry has experienced for much of the year. Thank you all very much for your attention this morning.

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