Viatris - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 delivered revenue of $3.58B and adjusted EPS of $0.62, both above expectations; excluding the Indore FDA import alert impact (~$160M), divestiture-adjusted operational revenue grew ~3% YoY.
• Management reiterated full-year 2025 guidance and expects to be in the top half of ranges for total revenues and adjusted EPS; capital returns YTD exceed $630M, including $350M in buybacks.
• Regional mix was resilient: Greater China +9% YoY, Europe steady, while North America declined amid Indore and Wixela competition; adjusted gross margin of 56.6% reflected mix and lower penalty impacts vs Q1.
• Pipeline momentum continued (positive Phase 3 MR‑141/142; meloxicam NDA targeted by year-end), with MR‑139 in blepharitis failing its primary endpoint; remediation at Indore is “nearly complete,” meeting requested with FDA for reinspection timing.
• Near-term stock drivers: revenue/EPS beat vs consensus, reiterated guidance with “top-half” bias, China strength, capital returns, and clarity on Indore reinspection path.

What Went Well and What Went Wrong

• What Went Well

  • “We delivered a strong second quarter… and continued to make meaningful progress against our key 2025 strategic priorities,” including execution and late-stage pipeline momentum.
  • Adjusted gross margin 56.6% and revenue strength in Europe and Greater China; excluding Indore, divestiture-adjusted operational revenue grew ~3% YoY.
  • Capital returns: >$630M YTD with $350M buybacks; management expects to be in the top half for revenue and adjusted EPS in 2025.

• What Went Wrong

  • Indore impact weighed on generics and North America; Q2 Indore revenue headwind ~$160M.
  • MR‑139 (blepharitis) Phase 3 did not meet primary endpoint; program under review.
  • Adjusted EBITDA and adjusted EPS declined YoY due to Indore; free cash flow was impacted by transaction-related costs and the semiannual interest timing.

Transcript

Speaker 7

Good day, everyone, and welcome to the Viatris second quarter 2025 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please say to a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one on your touch-tone phones. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I would like to turn the floor over to Bill Szablewski, Head of Investor Relations. Sir, please go ahead.

Speaker 2

Good morning, everyone. Welcome to our Q2 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 risk 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 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 are making comparisons to our 2025 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Speaker 0

Good morning, everyone. We delivered strong second quarter performance as a stage sharply focused on our key 2025 strategic priorities, which are driving strong commercial execution across our global business of generics and established brands, advancing our late-stage pipeline to drive future innovation, continuing to look at strategic accretive in-market business development opportunities to drive near and mid-term growth, progressing our enterprise-wide strategic review to position Viatris for sustainable growth in 2026 and beyond, and returning capital to shareholders through dividends and share buybacks. Let me begin with a few highlights from our second quarter performance. We achieved 3% divestiture-adjusted operational revenue growth, excluding the impacts from indoor, driven primarily by strength in Europe and the Greater China region. These results reflect the strength of our execution and the resilience of our diversified global business. We have also made significant pipeline progress.

Five of our six anticipated phase three readouts have shown positive results. Most recently, this includes positive data from two ophthalmology programs targeting dim light disturbances and presbyopia, both of which address high unmet medical needs. With these readouts and our commercial assets, our eye care division remains well positioned to become a more meaningful contributor to Viatris over the next few years. Earlier this year, we shared positive results for Effexor for generalized anxiety disorder in Japan, XULANE LO for contraception, and our fast-acting formulation of meloxicam in acute pain. These achievements reinforced the strength of our pipeline and laid the foundation for our future. Of particular note, the two phase three studies for our meloxicam candidate demonstrated meaningful improvement in pain and reduced opioid use relative to placebo, a well-characterized and well-tolerated safety profile, and superior pain control versus an opioid arm in post-hoc analyses.

We expect to file by year-end and intend to commercialize this as a branded product, tapping into an $80 billion U.S. acute pain market. For Selatogrel and Cenerimod, enrollment for the phase three global programs for both assets is progressing well, with first data readouts expected in 2026. We continue to view both of these as potentially transformational blockbuster treatments for patients in their respective therapeutic areas. For Sotalgloflozin, we received our first approval in the UAE earlier this year, and filings are progressing well in other key countries around the world. As our pipeline advances, we remain committed to returning meaningful capital to shareholders. So far this year, we have returned more than $630 million, including $350 million in share repurchases. We continue to balance our focus on shareholder returns with strategic accretive in-market business development investments that could fuel future growth.

We are also making strong progress on our enterprise-wide strategic review, evaluating all aspects of our business to ensure we're building a company that is both competitive today and prepared for the future. We plan to share an update of our progress during our Q3 earnings call in November. Turning to operational priorities, we remain focused on remediation efforts at our indoor facility, which are now nearly complete. Before the end of this month, we'll be asking the FDA for a meeting to discuss the progress of our remediation efforts and the potential timing for reinspection of the facility. At our Nashik facility, while FDA classification is still pending, all committed actions have been completed for some time. Encouragingly, we recently received FDA approval for Derinovir tablets and antiretroviral medicine made at our Nashik facility. Finally, I'd like to touch on recent policy developments, including proposed U.S.

tariffs, which could impact the broader pharmaceutical landscape. Viatris serves approximately 1 billion patients worldwide each year. Our global supply chain is built to support patients where they live. Of the 37 manufacturing, distribution, R&D, and packaging sites within our global network, eight are located in the United States, which should position us well to navigate the impact of any future changes to trade policy. While we're monitoring tariff developments closely in order to assess potential impact on our business, based on the available information, we do not anticipate any material effect on our 2025 financial picture. We will continue to assess the impact of any potential tariffs on patient access and company financials and will provide updates accordingly.

We also continue to advocate strongly for thoughtful policy making that protects access to medications, especially generics, which account for 90% of prescriptions filled in the United States and just 1% of the total healthcare spend. Currently, more than half of our U.S. revenue is sourced domestically, and we are currently exploring ways to further leverage and expand our network. With that said, based on the current pricing dynamics in the generics industry, we believe that moving additional manufacturing of non-complex generics to the United States would be very difficult in the short term and not likely sustainable in the long term. However, our move towards more complex, innovative, higher margin products does bring potential opportunity to further expand our domestic footprint. We are committed to evaluating all possible options.

Ultimately, our goal is to ensure the right infrastructure is in place to serve patients in the United States and around the globe and maintain a sustainable business model. In closing, we have great momentum going into the second half of the year. Given the strength of the results, we are reiterating our 2025 financial guidance ranges across all key metrics and currently expect to be in the top half of the range on revenue and adjusted EPS. We remain confident in the long-term trajectory of Viatris. The strength of our business, our maturing late-stage pipeline, discipline capital allocation, and strategic flexibility position us well for sustainable growth in 2026 and beyond. Now, I'd like to turn it over to Philippe for more details on the pipeline.

Speaker 3

Thank you, Scott. We are proud of the significant progress our R&D team has made in advancing our pipeline of generics and late-stage novel and innovative assets. Starting with our phase three programs, where five of our six anticipated phase three readouts have shown positive results. We'll be presenting detailed results from our fast-acting meloxicam pivotal studies at the upcoming Pain Week Medical Congress in September. Five abstracts were accepted covering efficacy, safety, and reduction in opioid use in two different surgery models, as well as pharmacokinetics data. Overall, we remain highly enthusiastic about the potential of this asset as an acute pain non-opioid treatment option with a benefit-risk profile that offers potential advantages over available treatment options and may lead to a significant reduction in opioid use.

We are awaiting FDA's response on the potential for an early submission and accelerated approval path given the strength of the data and the unmet public health need. We continue to target the submission of a new drug application by the end of this year. Turning to XULANE LO, we remain on track to submit the NDA in the coming weeks and anticipate approval mid-next year. Our second contraceptive patch in development, a norelgestromin-only weekly patch, is more than halfway through phase three enrollment with data expected by early 2027. Now shifting to our ophthalmology programs, we are pleased with the positive results we recently shared from the second pivotal phase three trial of MR-141 in presbyopia. The results reinforced our confidence in MR-141 and its benefit-risk profile as a potential non-invasive option to support the millions of patients impacted by this condition.

We expect that this data will be presented at the American Society of Cataract and Refractive Surgery annual meeting in April 2026. We are targeting our application to the FDA in the second half of 2025. In June, we also announced positive top-line results from our pivotal phase three trial evaluating MR-142 in treating visual disturbances in low-light conditions following keratorefractive surgery. The study demonstrated significant functional improvement in these patients in their ability to drive and function under low-light conditions. Importantly, there are currently no FDA-approved options, and the FDA has granted fast-track designation, further emphasizing the unmet need. This data will be presented at the American Academy of Optometry in October 2025. We recently started our second pivotal study and expect to have results in the first half of 2026.

The last of the ophthalmology results that we recently announced was our phase three study of MR-139 for blepharitis. The study did not meet its primary endpoint of complete resolution of debris at week six. A nominally significant change from baseline in debris at week six was observed, suggesting that this mechanism of action remains relevant for the treatment of blepharitis. MR-139 was generally safe and well tolerated. Additional work is ongoing to determine the appropriate next step for this program. Moving to Selatogrel and Cenerimod, we are pleased with our recruitment efforts for these two programs. For Selatogrel, we have reached an enrollment rate of approximately 600 patients per month and anticipate we will reach approximately 1,000 patients per month by the end of the year and reach full enrollment in 2026.

Turning to Cenerimod in SLE, enrollment is nearing completion, and we have started notifying sites and investigators accordingly. We anticipate the first phase three readout near the end of 2026, followed shortly thereafter by the second readout. In an effort to explore additional value this asset can bring to patients, we have received positive feedback from FDA and EMA on our proposed phase three registration study in lupus nephritis and anticipate having our first patient enrolled by the end of the year. We are also making great progress with a reminder of our late-stage pipeline. Regarding Sotagliflozin, we recently received our first approval in the UAE within a very short turnaround time. We have filed in Saudi Arabia and are expecting to file in Canada, Australia, New Zealand, Mexico, and Southeast Asian countries before the end of the year.

As we mentioned in our last call, the JNDA for Effexor is under review by the Japanese Health Authority and is progressing well. We anticipate approval in the first half of 2026. In addition, we've had two recent approvals in China for BRAINA and UPELRI, demonstrating our capabilities in that market. Finally, within our generic pipeline, all products scheduled for approval in Q2 were approved, except for iron sucrose. We believe our application is substantially through its scientific review and expect approval in the near future. The majority of our anticipated generics approvals are weighted toward the back half of the year. They remain largely on track, including for octreotide. Overall, we are pleased with the strong momentum we have across our pipeline and remain focused on delivering meaningful innovation for patients that address areas of significant unmet medical need. I will now turn the call to Doretta Mistras.

Speaker 6

Thank you, Philippe, and good morning, everyone. We had another strong quarter, and the underlying fundamentals of our base business of generics and established brands remain strong. Today, I'll walk you through the key highlights, the progress we've made against our capital allocation plan, and our confidence in the outlook for the remainder of the year. Our second quarter results came in ahead of our expectations, reflecting our well-diversified global business. Total revenues for the quarter were $3.58 billion, which were down approximately 2% versus the prior year. Excluding the indoor impact of approximately $160 million, our operational revenue growth versus the prior year would have been approximately 3%. Now, let me walk you through the commercial highlights for the quarter across our segment, which includes the indoor impact. In developed markets, we saw continued strength in brands, which helped to partially offset the indoor impact.

From a regional perspective, we continue to see consistent and durable growth from our European business, which grew approximately 2% this quarter, in line with our expectations. In Europe, the brands portfolio grew approximately 3%, led by EpiPen, Creon, and Brufen, in addition to positive contributions from key markets, including Italy. Generics performance in Europe was flat year over year, despite the indoor impact, and continues to benefit from the new product revenues in key markets such as France. As anticipated, our North American business decreased 11% versus the prior year, primarily as a result of the indoor impact and competition on Wixela and other products. This was partially offset by continued growth in UPELRI and BRAINA, as well as contributions from new product revenues. In emerging markets, net sales exceeded expectations and increased approximately 1% versus the prior year.

This was primarily driven by continued strength in Turkey and our emerging Asia region, as well as stabilization in the Korean market. This performance helped to more than absorb the indoor impact affecting our ARV generics business. In Japan, net sales decreased approximately 11%. Results were primarily driven by expected government price regulations and a change in reimbursement policy impacting off-patent brands in Japan and competition in Australia. This was partially offset by slight volume increases in our generics portfolio in Japan. Lastly, we continue to see positive momentum in Greater China. Net sales exceeded expectations and grew 9%, driven by continued growth across our portfolio due to proactive patient choice. Net sales also benefited from the timing of customer purchasing patterns in the quarter, which we expect to moderate in the second half.

Moving to the remainder of the P&L, adjusted gross margin of 56.6% in the quarter was in line with our expectations. As anticipated, margins were impacted versus the prior year due to the indoor impact, as well as price regulations in Japan. Operating expenses were down versus the prior year as a result of the planned cost-saving initiative, which primarily benefited SG&A. Turning to free cash flow, we generated $167 million of cash in the quarter. Excluding the impact of transaction-related costs, we would have generated $241 million during the quarter. This was in line with our expectations and reflects the timing of semiannual interest payments and working capital requirements in the quarter. Moving to capital allocation, we have repurchased shares totaling $350 million year to date. Including dividends paid, we have returned more than $630 million of capital this year to our shareholders.

With this continued progress, we remain on track to deliver on our commitment of capital return this year. Now, a few comments on our outlook and phasing for the rest of the year. Based on the strong operational performance year to date and continued visibility of the anticipated indoor impact, we are reaffirming all guidance ranges. Within total revenues, we expect to be in the top half of the guidance range as a result of positive operational momentum and the year-to-date benefit from foreign exchange. We also expect adjusted EPS to be in the top half of the guidance range, primarily driven by share repurchases.

Some of the pushes and pulls in this outlook include our continued expectation of divestiture-adjusted growth, excluding the indoor impact of approximately 2%, continued growth in Europe, Greater China, and emerging markets regions, and delays in the anticipated timing of approvals and launches of certain generic products, which could negatively impact our new product revenues this year. Lastly, we continue to monitor foreign exchange. If current rates were to hold for the remainder of the year, it could result in an additional 1% to 2% tailwind on total revenues. This could also result in adjusted EBITDA being in the top half of our guidance range. As a reminder, any potential foreign exchange tailwind benefiting total revenues would incorporate certain hedging program costs, which could reduce the benefit to adjusted EBITDA. It is important to note that our guidance does not account for any potential impact related to industry tariffs.

However, as Scott mentioned, we continue to assess the potential for future impact, but based on available information, we do not anticipate any material impact on our 2025 financial results. The following are a few points about anticipated phasing for the rest of the year. Total revenues are still expected to be slightly higher in the second half at approximately 51%. This reflects phasing of indoor, normal product seasonality, and low to mid-single-digit growth in Greater China. Adjusted EBITDA and adjusted EPS are still expected to be higher in the second half. This incorporates the timing of spend and investments we are making to support our pipeline and upcoming launches. Last, free cash flow is also expected to be higher in the second half and is expected to benefit from the timing of networking capital and disciplined inventory management. As you heard, our results for the quarter reflect strong performance.

We remain encouraged by the underlying fundamentals of our global business growth and the success of our recent pipeline readouts. With these positive trends, we are building strong momentum for the rest of the year. With that, I'll hand it back to the operator to begin the Q&A.

Speaker 7

Ladies and gentlemen, at this time, we'll begin the question and answer session. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the keys to ensure the best sound quality. Once again, that is star and then one to join the question queue. We'll pause momentarily to assemble the roster. Our first question today comes from Matt Dellator from Goldman Sachs. Please go ahead with your question.

Hey, guys. Good morning, and thanks for the question and congrats on the progress. Maybe just on capital allocation in the context of the current split between buybacks and BD, you know how much of a priority is growth at this point and what level of growth are you now aiming for if you think about full year 2026 and beyond? In particular, what would make you more aggressive on the BD front? Thank you.

Speaker 0

Thank you very much, Matt. You know I'm not going to talk specifically about 2026 and a number for growth. Relative to capital allocation, our plan has not changed, staying the same. We're evenly, over a period of time, over the next three to five years, we expect to both give back through dividends and share buybacks. Also, and I think very importantly, we also need to build a portfolio of growth assets, use our capital to do business development. What we're really looking for here in terms of business development is strategic assets that are accretive and in-market growing assets to build a growth portfolio. We're very focused on doing both, delivering capital right back to shareholders and also finding ways to build a growth pipeline. I will say business development is just part of that growth pipeline going forward.

We're focused on strategic accretive in-market assets to bring into the portfolio. We also have, as we look at 2026 and beyond, a lot of excitement around the launches that we have. Positive data readouts that we had in 2025 lead to launches, for example, Effexor GAD in Japan, XULANE LO, which is a contraceptive product in the United States, fast-acting meloxicam, a couple of eye care readouts and launches in presbyopia and dim light, and also launching sotagliflozin in some key ex-U.S. markets. We've got a lot of launches in 2026. We've got some nice inflection points in terms of data readouts in 2026 as well. Nefcon Japan, progestin-only patch, and really importantly, cenerimod and selatogrel. We feel good about the growth prospects. The base of the business is very solid.

We've got a number of launches going into 2026, and we've got capital to deploy to build a portfolio of growth assets.

Speaker 4

What we'd also add is we've talked about the base business growth. We continue to see visibility generally to generate low single digits from a revenue perspective for the base business. This year, for example, we're on track to deliver on that 2% operational growth ex-indoor. The incremental investments and opportunities that Scott is mentioning would be competitive to that baseline rate.

Speaker 0

Absolutely. We are looking for, you know, not just growth in one year. We are looking to put a program together to have sustainable long-term revenue and EBITDA growth over time.

Speaker 7

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

Good morning, guys. This is JP in lieu of Umer. Congrats on a strong quarter, and thanks for taking our questions. Going back to tariffs, you mentioned you have flexibility for next year. How are you thinking on the proportion of the risk India versus EU? It looks like we're going to have two different kind of tariffs for each region.

Speaker 0

Thank you for the question, Aizus. You know, it's not clear to us at this point in time whether tariffs will be placed on pharmaceuticals. If they are, will they be placed on generic products? At this point, there are no tariffs, and we're monitoring the situation very, very, very carefully. About half our products in the United States, from a revenue perspective, are manufactured in the United States. We do have some exposure in Europe and India. I would say India is about 10% of our revenue. Significant volume in terms of product. It tends to be low-margin OSD-type products coming out of India, but it's 10%. As the situation evolves, as we get more clarity on how tariffs may affect the overall industry, the generic industry, et cetera, we model all kinds of things. Until we have clarity on that, it's very difficult to think of an impact.

I think both Doretta and I in our prepared remarks mentioned that, regardless of tariffs, how it evolves during the course of this year, we put mitigations in place. We do not see any material financial impact in 2025. We'll know more about 2026 and beyond once we get some specifics.

Speaker 7

Our next question comes from David Amsellem from Piper Sandler. Please go ahead with your questions. David, is it possible that your phone is on mute? All right. We'll move on to Ashwani Verma from UBS. Please go ahead with your questions.

Speaker 4

Hey, good morning. Thanks for taking our question. I wanted to ask about the China business. It seems particularly strong this quarter. I know you called out some purchasing patterns. What's the growth excluding that? More broadly, there's been a lot of biopharma dealmaking activity in the region increasingly. How much of that is a focus for you for your BD efforts? The second thing, on the enterprise-wide strategic review, I'm still waiting to hear a little bit of clarity in terms of what is the scope of activities that you want to showcase and what's the timeline for that? Is there any potential cost optimization that can be a part of that exercise or should we not expect that? Thanks.

Speaker 0

Let me maybe address that part first and then we'll go into China. The enterprise-wide strategic review, we're well engaged in it. We're actively looking at every part of the business. I think the reason we're doing this now is I think it's a good time. We've done four divestitures. The company is a product of a merger of two different companies. We're evolving our business model to sort of move up the value chain, get involved in more complex and innovative products. Now is a good time to really take a look at things. Do we have the right people in the right places to be effective? This is about making sure the company is as effective and efficient as possible, delivering the business today and delivering the business in the future.

I believe there will be significant cost savings that come out of it as well, which will benefit the company. I don't want to get ahead of myself. We're not through that full process yet. In Q3, we have an expectation, my goal, to be able to provide significant granularity relative to that program by the time we get to the Q3 call.

Speaker 4

Ash, let me address your China question. In Q2, China grew 9% operational growth. That's really the result of our diversified commercial model, which is across e-commerce, retail, and private hospitals. We also benefited in the quarter from the timing of customer buying patterns. That's what Doretta Mistras mentioned in her prepared remarks. For the rest of the year, we expect the growth to moderate more to the low to our middle-digit growth. What we're seeing is the consistent demand for our iconic brands that have very strong brand equity, and notably the brands that offer patients really the trust that they need. The brands that are sensitive to proactive patient demands. The outlook is positive for China for the rest of the year. As a reminder, about 95% of all our brands went through the BBP process already. That gives us some certainty on the outlook in the region.

Speaker 0

A couple of comments on the China business for me. Overall, the market has progressed very well, both in the base side and the innovative side in China. I was very, very proud of the team we have there and how well they're executing. We see some really good momentum in our China business, which we're very pleased about. Relative to your BD comment, there's a lot of companies out there from a sort of biotech, small pharma perspective. There are lots of discussions going on. China seems to be very active in that so far, not only products in China for China, but China for the rest of the world. There are lots of discussions, lots of interesting things happening in the China bio world for sure.

Speaker 7

Our next question comes from David Amsellem from Piper Sandler. David, please go ahead with your questions.

Thanks, and sorry about that, and thanks for accommodating me. A couple for me. Number one, and sorry if I missed this, can you just talk about contribution from new products in developed markets this year, if you can quantify that? Is that tracking to your stated expectation? Secondly, looking beyond indoor, can you just talk about inspections at the other facilities that you've called out in the past? I think there was Nashik as well. I just wanted any color there to the extent there was anything new to add. Lastly, on Meloxicam, can you just talk about the commercial infrastructure you're going to be putting in place here? Is this going to be an office-based product, a hospital product, or both? There's some promotion intensity here. How are you thinking about overall level of investment, given that you've got a filing coming up for that product? Thank you.

Speaker 4

Yeah, please, Doretta, why don't you take the first question?

Speaker 6

I want to start on the new product revenue. I would just say generally, to your point, David, on any given year, our expectation is to generate about $450 million to $550 million of new product revenue. I don't want to get into makeshifts between developed markets, emerging markets. We really view it as a portfolio in terms of the total revenue. This year, and you heard in our commentary, we did assume that new product revenue would be back half weighted just based on our estimated approval and launch timing of certain generics. Ultimately, that will be an impact of any potential delays of timing of approvals, such as, for example, iron sucrose and others could negatively impact our new product revenues. Overall, I would just say we've taken all of these pushes and pulls into account with respect to our guidance commentary and our total revenue range.

We're going to continue to monitor things as we move through the back half of the year.

Speaker 0

I'll send it over to Corinne to talk about the fast-acting meloxicam commercial strategy.

Speaker 4

Hi, David. As you know, we are very bullish about fast-acting meloxicam. This is the moderate to severe acute pain market. It's large. It's an $80 billion opportunity in the U.S. We are in the midst of our launch planning, and it's progressing very nicely. We are currently focusing on doing market research for positioning. We are doing our pricing and payer research. It's a bit too early for us at the moment to give you more details on how we're going to go about launching this product, although we have some ideas. What I can tell you is that it's going to be a large opportunity for Viatris going forward. We are very much looking forward to our filing this asset before the end of the year and launching this product potentially next year.

Speaker 0

Thank you, Corinne. Yeah, we see that as a very significant opportunity for us going forward. There'll be the right time and place to go through full commercial strategy structures. Do we do partnerships? Do we not? Exactly how do we approach the market and those sorts of things? We've got some work to do to get ready for that. We just got the data again in May, and we've been doing a lot of work, very hard work, head down, figuring out what our strategies are. There'll be the right time when we can sort of unveil all of that to you in a good way. We think this is going to be a very significant part of our portfolio going forward. In terms of the operations update, we are approximately 80% or so remediated in our indoor facility.

We've got a good line of sight on completing all the remaining items. In the next couple of days, we're going to ask the FDA for a meeting to discuss not only how the remediation has been going, but also talk about timing for reinspection of that facility. We'll have more clarity on the timelines of reinspection and things once we do have that meeting, which will happen this month. The request will go in this month for that meeting. In terms of Nashik, I think it was an encouraging sign that the FDA approved the product that is manufactured in Nashik. Having said that, the FDA classification is still pending. We've completed all the actions some time ago. Getting that approval of the product manufactured in Nashik, I think, is a positive sign there. We're making a lot of progress on the operations front.

Speaker 7

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

Hey, guys. This is Nassal and Patel on for Jason. A couple of questions from us. First, on the pipeline for MR-141. How do you see this drug positioned relative to other newer eye drop therapies for the improvement of near vision? Do you expect a similar label indication? What's the strategy to build this market where AbbVie was unable to with EUV? My second question is with regards to gross margins. We saw a sequential improvement from 1Q 56% to 2Q 58%. Maybe if you could provide some more color on the key drivers of this improvement. Is it from the mix shift from new product launches, or are cost savings initiatives and supply chain efficiencies starting to materialize earlier than expected? Thank you.

Speaker 0

For the eye care question, I'm going to ask Philippe and Corinne to address that first.

Speaker 3

Thank you. Yeah. Let me start and then ask Corinne to add. As you know, MR-141 offers a different mechanism of action than the approved myotic products, including the recently approved one. We believe that this will lead to important differences in safety profile between these assets. The myotic effect on the ciliary body leads to significant risk, blurry vision, headaches, and risk of retinal detachment or tear. We do not expect that kind of labeling for MR-141 based on the mechanism of action and the data that we generated in phase three. Importantly, you will remember that this asset was designed to reduce the pupil size to no less than 2 millimeters, which if you go below 2 millimeters, which is the case with the myotic assets, that will lead to reduced vision in a dim light setting. Also a significant difference between these two assets.

We will present our data in a medical meeting very soon in April of 2026 and anticipate that we will be able to file by the second half of 2025. I can turn it to Corinne now.

Speaker 4

To your question about how this market is going to evolve, you know it's a very large addressable market in the U.S. We have about 128 million patients who suffer from presbyopia. We really believe that this market is opening up to therapeutics. We now have two approved agents in this market. As Philippe mentioned, we believe that our asset, phentolamine, can play a very important role in addressing the unmet needs in this market and its very unique patient population. It's a different mechanism of action. We expect a very different efficacy and safety profile than the assets that are currently approved. We think it's a great opportunity as we build and continue to build our eye care business.

As you know, we have already an eye care division with capabilities in the U.S., and we're looking forward to having phentolamine contribute to the revenues of the eye care business going forward.

Speaker 0

I just want to make a comment on the eye care business in general. We've had some significant management changes who changed the footprint and the approach a little bit. I think we have now in place a world-class team of people who have developed and marketed and sold blockbuster products, innovative products that really understand the marketplace very, very well. There is some real world-class talent in that group. I think as I take a look at it, the world-class group, the people that we have in place, the changes that we've made, two positive readouts recently for presbyopia and dim light. I look for the eye care division to become a significant contributor, a much more significant contributor than it is today to our overall business. We're putting the efforts in there, and hopefully, we'll see some good return.

I expect more positive contribution from the eye care division as we move forward. I turn it over to Doretta to answer the gross margin question.

Speaker 6

Great. With respect to gross margins, gross margins came in for the quarter in line with our expectations. The primary driver of the step-up versus Q1 was a couple of fold. One, we did see a slightly less mix shift impact from indoor specifically as it relates to some of the penalties. We also saw some improved product and segment that impacted the quarter. Generally, it was in line with our expectations. As we look in the second half, I would also say that from a second-half perspective, gross margins we expect to be consistent from a phasing perspective as what we saw in the first half.

Speaker 7

Ladies and gentlemen, with that, we'll be concluding today's question and answer session. I'd like to turn the call back over to Scott Smith for closing remarks.

Speaker 0

Thank you very much, and thank you to everybody on the call. 2025 is shaping up to be an important year for Viatris. We are executing with purpose and precision, driving our business, advancing a high potential pipeline, and returning meaningful value to shareholders. At the same time, we're planning for long-term success. I'd like to add my sincere thank you to the more than 30,000 Viatris employees around the world for delivering an exceptional quarter in a challenging global environment. Thank you, everybody.

Speaker 7

Ladies and gentlemen, that does conclude today's conference call and presentation. We thank you for joining. You may now disconnect your line.