Viatris Inc. (VTRS) Q2 2026 Earnings Report, Transcript and Summary

Good morning, everyone, and welcome to the Viatris Q2 2026 Earnings Call. [Operator Instructions] 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. Sir, please go ahead.

Good morning, everyone. Welcome to our Q2 2026 earnings call. With us today is CEO, Scott Smith; Interim CFO, Paul Campbell; Chief R&D Officer, Philippe Martin; and Chief Commercial Officer, Corinne Le Goff. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2026 and various strategic initiatives. These statements are subject to 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 most directly comparable GAAP measures. When discussing 2026 actual or reported results, we will be making certain comparisons to 2025 actual or reported results on an operational basis, which excludes the impact of foreign currency rates. When comparing our 2026 actual or reported results to our expectations, we are making comparisons to our 2026 financial guidance. With that, I'll hand the call over to our CEO, Scott Smith.

Good morning, everyone. We're off to an exceptional start in 2026. We delivered another strong quarter that reinforces our confidence in the strategy we outlined earlier this year. In the second quarter, we delivered $3.8 billion in total revenues, representing 3.5% operational revenue growth year-over-year, adjusted EBITDA of $1.2 billion and adjusted EPS of $0.69 per share. These results exceeded our expectations and reflect the strong momentum across our businesses and continued improvement in operating leverage. Just as importantly, these results give us confidence to raise our outlook for the remainder of the year. Let me briefly highlight some of the progress we've made across our businesses. Commercial execution was excellent across our global portfolio during the quarter, led once again by Greater China, where the commercial investments in our portfolio of established brands are generating meaningful growth. In North America, execution across our complex generics and transdermal products also drove solid growth. Our pipeline is progressing as expected. As we announced last week, we received U.S. regulatory approval for Gwyn Lo and expect to launch the product later this year. At the same time, launch preparations continue for fast-acting meloxicam as it progresses through FDA review. We're confident in the differentiated clinical profiles of both medicines and also in our commercial readiness. In Japan, we recently reported Phase III results for Nefecon, while pitolisant continues to progress through the final stages of regulatory review, underscoring the momentum we're building across our pipeline in the strategically important market. Beyond these opportunities, our Phase III programs for selatogrel and cenerimod remain on track with important readouts expected in 2027, which, if successful, we believe will represent meaningful long-term blockbuster growth opportunities. Taken together, these milestones provide a robust set of near-term catalysts with the potential to accelerate our long-term growth profile. As we prepare for our next phase of growth, we're prioritizing our capital, talent and resources toward the opportunities we believe offer the greatest long-term growth potential. As part of that effort, we agreed to sell the global rights to Tyrvaya, reflecting a strategic shift away from eye care as a therapeutic area of focus. Turning to our enterprise-wide strategic review. We're delivering the savings we committed to earlier this year while reinvesting a portion of those savings to support future growth. We're beginning to see those actions translate into the real operating leverage we expected. That's creating a stronger Viatris with greater flexibility to invest in growth and create long-term value. Turning to capital allocation. We continue to take a balanced and opportunistic approach, supported by strong cash generation and the additional financial flexibility created through the monetization of our Biocon equity stake. We're executing across all our capital allocation priorities. We continue to return significant capital to shareholders through our dividend and more recently through our continued share repurchases, together totaling approximately $550 million to date. At the same time, we're maintaining flexibility to pursue disciplined business development opportunities that we believe can play a significant role in accelerating our long-term growth. As we think about our performance so far this year and the outlook for the rest of the year, we're raising the midpoint of our 2026 financial guidance ranges across all key financial metrics. Our updated outlook incorporates all the business dynamics we expect in the second half, including certain intermittent manufacturing disruptions at our Nashik facility following the Q1 fire and the FDA's May 2026 inspection. We are communicating with the FDA, working closely with external experts and have initiated a comprehensive remediation plan to address the inspection observations. In summary, I'm very pleased with our execution through the first half of the year and the momentum we're carrying into the second half. We're entering a catalyst-rich period with multiple upcoming launches, important Phase III milestones and the financial flexibility to pursue disciplined, accretive business development. Together, we believe these opportunities position Viatris to accelerate long-term growth and create meaningful value for shareholders. With that, I'll turn it over to Philippe.

Thank you, Scott. We have delivered a strong first half of the year in R&D as we continue to execute with discipline against our strategy. Starting with our value-added medicines, we were pleased to receive FDA approval for Gwyn Lo last week ahead of its PDUFA date. Gwyn Lo is a new discreet once-weekly transdermal hormonal contraceptive patch that offers women a noninvasive reversible option with a low dose of estrogen. Importantly, the approved label reflects the strength of our clinical program, including demonstrated efficacy in women with a BMI of 25 to less than 30 kilogram per square meter with no BMI-based limitation of use for this population. We are also working on addressing the unmet need for women with a BMI at or above 30 through our next contraceptive transdermal system, a progestin-only patch currently in development. This program has completed Phase III enrollment, and we expect top line results in the first half of 2027. As patients continue to seek convenient and noninvasive treatment options, we believe our deep expertise in developing and manufacturing transdermal drug delivery systems position us well to advance additional opportunities across this platform. Regarding fast-acting meloxicam, we continue to have positive engagement with FDA as the NDA review progresses and as we approach the mid-cycle point of the review. We continue to believe that the investigational profile of fast-acting meloxicam, including its rapid absorption, clinically meaningful pain relief and reductions in opioid use positions the product as a meaningful addition to the evolving acute pain treatment landscape, pending final labeling negotiations ahead of an anticipated FDA approval. Regarding our pipeline in Japan, we recently announced positive top line Phase III results evaluating the efficacy and safety of Nefecon in Japanese adults with primary IgA nephropathy, a designated intractable disease in Japan. If approved, Nefecon has the potential to provide a meaningful disease-modifying treatment option for these patients. We are targeting submission of a new drug application in Japan by the end of 2026. In addition, our applications for pitolisant for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy remain on track and have reached the final stages of review. We anticipate regulatory decisions for both indications in the second half of this year. Turning to our innovative global Phase III programs. For cenerimod, we continue to expect results from both Phase III SLE studies, OPUS-1 and 2 in the first half of 2027. So far, most patients have elected to continue treatment in the open-label extension study with a study treatment duration extending up to 5 years. Selatogrel, we remain on track to reach full enrollment in our SOS-AMI Phase III study around year-end and are maintaining an enrollment rate of approximately 1,200 patients per month. We continue to expect a data readout in the first half of 2027. And finally, turning to our generic pipeline. We continue to execute well across our pipeline and remain on track to achieve more than 100 new product approvals this year with 70 approvals already secured in the first half. The key area of focus remains our complex generics, including complex injectables, where we have established a meaningful expertise. Over the past 2 years, we have secured approval in the U.S. for 11 complex injectables, including octreotide and recently, we're the first approved for all 3 strengths for both iron sucrose and ferric carboxymaltose injection. Overall, the substantial progress we've made in the first half of the year reflects both the disciplined execution of our teams and the breadth of capabilities we've built. With multiple regulatory, clinical and scientific milestones ahead, we remain confident in our ability to execute our R&D strategy, advance meaningful medicines for patients and continue strengthening our scientific leadership. With that, I'll turn it over to Paul.

Thank you, Philippe, and good morning, everyone. I'm pleased to report that we delivered another strong quarter, reflecting the durability of our global portfolio and disciplined execution of our strategy. This morning, I'll highlight the drivers of the strong second quarter performance, the progress we've made delivering on our capital allocation priorities and details supporting our financial guidance ranges for the year. Beginning with our second quarter results. Total revenues were $3.8 billion, representing operational growth of approximately 3.5% year-over-year. This performance was driven primarily by continued growth in our cardiovascular portfolio in Greater China and strong performance across our generics product category in developed markets, led primarily by our complex generics and transdermal products in North America. The commercial highlights for the quarter across each of our segments is as follows: in developed markets, net sales increased by 2% versus the prior year, exceeding our expectations. For North America, net sales grew 1%, driven by increased demand across our diverse generics portfolio, including estradiol patches as well as continued strength from Breyna. New product revenues also benefited from continued momentum across our more durable, higher-margin complex injectable portfolio, including octreotide and iron sucrose. Within our branded product category, solid growth from Yupelri was more than offset by anticipated competitive pressure within our established brands portfolio. In Europe, net sales increased 2% versus prior year, primarily driven by strength in the generics portfolio across key countries, including France and Italy as well as contributions from new product revenues. The brands portfolio declined slightly year-over-year as continued solid growth from Creon and Brufen was offset by anticipated competitive pressure on Dymista. Turning to emerging markets. Net sales declined 2% versus the prior year, coming in below our expectations. The decline was primarily driven by continued supply constraints affecting our lower-margin ARV generics portfolio. Net sales in our brand product category increased 6% year-over-year, supported by stable growth across established brands. Within JANZ, net sales were essentially flat versus the prior year, exceeding our expectations. This result reflects uptake from the launch of Effexor for generalized anxiety disorder and broad volume growth in generics, offset by the anticipated impact from government-driven price regulations in Japan and increased competition for certain brands in Australia. Lastly, we delivered another exceptional quarter in Greater China with net sales increasing 16% year-over-year, once again ahead of our expectations. We continue to benefit from favorable market fundamentals in China, including an aging population and demand for our cardiovascular products. In addition, our strategic investments in selling and marketing capabilities, including our e-commerce and retail platforms have positioned us to capitalize on the strength of our well-recognized brands. As a result, we saw growth across all channels during the quarter, including e-commerce, where sales increased 36% versus the prior year. Now turning to the remainder of the P&L. Adjusted gross margin was 57.5% for the quarter, representing nearly 1% improvement versus the prior year. The increase was driven primarily by the strong performance in Greater China and the favorable product mix in our North American generics portfolio, as mentioned earlier. Operating expenses declined as a percentage of total revenues compared with the prior year, partially reflecting continued SG&A discipline and realization of the expected savings from our enterprise-wide strategic review. R&D investment progressed in line with our expectations, driven primarily by the ongoing Phase III programs for selatogrel and cenerimod. For free cash flow, we generated $329 million of cash during the quarter, inclusive of transaction and restructuring-related costs and taxes. Excluding these items, free cash flow would have been $449 million. The year-over-year improvement was primarily driven by stronger operating performance and favorable working capital dynamics. Turning to capital allocation. Through early August, we have deployed approximately $1.4 billion of capital, consistent with our balanced capital allocation strategy, including the return of approximately $550 million of capital to shareholders through dividends and approximately $270 million of share repurchases. Additionally, we continue to strengthen our balance sheet by repaying approximately $900 million of debt that matured in June while refinancing the remaining balance. As a result, we ended the quarter with a gross leverage ratio of approximately 2.9x, below the midpoint of our long-term target range of 2.8 to 3.2x. For the remainder of the year, we expect to have approximately $1.6 billion in deployable capital. This includes approximately $380 million of pretax proceeds from the sale of our equity stake in Biocon. Now a few comments on our updated financial guidance and phasing for the remainder of the year. Based primarily on our strong first half performance and our continued confidence in the momentum of our businesses, we are raising our 2026 financial guidance for all key metrics. The midpoint of each of our revised guidance ranges represents expected operational growth of approximately 2% for total revenues, 5% for adjusted EBITDA and 7% for adjusted EPS versus the prior year. To provide further visibility into the segments, our updated full year guidance for total revenues reflects the following expectations compared to the prior year: low double-digit growth in Greater China, developed markets roughly flat with North America declining slightly, low single-digit growth in emerging markets and low single-digit decline in JANZ. In addition, this takes into account the following expected second half dynamics. Moderation in Greater China growth due to the implementation of a procurement policy change expected to negatively impact volumes in our hospital channel; additional competitive pressure in developed markets, including Breyna and Wixela in North America; and additional expected supply disruptions, primarily resulting from our Nashik facility and primarily impacting our low-margin oral solid dose generics in emerging markets and certain generic products in Europe. We currently anticipate the impact of supply disruptions to be between $100 million and $150 million to total revenues in the second half of 2026. Lastly, as Scott mentioned, we reached an agreement to divest our global product rights for Tyrvaya. The transaction is expected to close in the second half of 2026, subject to customary closing conditions. The anticipated impact of this transaction has been fully considered in our updated 2026 financial guidance. Turning to phasing for the remainder of the year. Total revenues are expected to be weighted to the second half at approximately 51% of our full year outlook. Adjusted EBITDA and adjusted EPS are now expected to be slightly lower in the second half and free cash flow is still expected to be more heavily weighted to the second half. In closing, we are pleased with our performance through the first half of the year, reflecting strong execution against our strategy. As we look ahead, we believe our diversified portfolio, strong commercial execution and financial flexibility positions us well to deliver sustainable revenue and earnings growth. With that, I'll hand it back to the operator to begin the Q&A.

[Operator Instructions] Our first question today comes from Ash Verma from UBS.

Congrats on the progress. Maybe just on China. So great to see solid operational growth here that you've seen in the first 2 quarters. I know you've noted e-commerce has been a big source of growth. Just help us understand what percentage of your revenue right now is coming from e-commerce, retail or the government channel, where I know you mentioned some headwinds on the procurement in the hospital channel. So if you can just give us a little bit of a breakdown, that will be helpful. And then secondly, just to help us understand the guidance. So at the midpoint of 2026 guide, you're raising revenue by $50 million, but EBITDA by $100 million. Is this because you're expecting some very high-margin products to launch? Or is there a chance that your reiterated OpEx guides come towards the lower end?

Good morning, Ash, and thank you for the questions. Let me make some comments. I'll kick it over to Paul for some more detail. Relative to China, a really strong quarter for China. Our commercial team, I believe, is doing an outstanding job. I think we've got great leadership there. We've made the right investments in China and are participating very, very well in health care in China. There's a real focus right now in China on health care, quality of life. There's a sizable aging middle class, et cetera, which really allows us to participate strongly in China. We're very, very pleased with the progress there. And we continue to see what I believe is real and strong demand for the iconic brands that we have in China, which is really nice to see. Relative to the guidance, very pleased based on the strength of the first half and the strength that we see throughout the rest of the year, being able to raise guidance on all our key financial metrics. And I think we're in really good shape as we sit here in August in '26 and are moving towards the second half '26 and '27 and feel very, very good about the strength of the business. Now I'll kick it over to Paul to comment specifically on China and also the guidance.

Yes. Thanks, Ash. So as far as China goes, I think it's important to note that we have seen growth across all channels in the market, not just the retail platform or e-commerce. However, e-commerce is about 10% -- between 10% and 15% of the overall business, which is specifically why I know you didn't ask, but in the second half of the year, we expect some decline in the hospital channel growth as a result of the implementation of the policy. But we do expect -- I think in first quarter, we said it was too early. We do expect the growth overall to continue similar to the trajectory we saw in the first half. It's just going to be muted because of the policy issue. As far as the guidance goes, so we ran ahead of expectations for the first half, both revenue and EBITDA. Adjusted EBITDA was approximately twice the growth or the increase in expectation over revenue, right? And a lot of that is because of the cost containment measures. We are on track and even ahead of schedule in certain instances. However, in the back half of the year, we do see the challenges on the additional competition that we have in the North America products, which are high margin and the China business, which is high margin, kind of muting that. But if you also think about the revenue challenges from Nashik that we've talked about, the back half of the year, they're lower-margin generic products that are impacted. So the revenue component of the guidance, we had to mute a little bit because of that, whereas EBITDA ran pretty strong in the first half of the year. And even with the challenges in the second half of the year, we expect that, that will, for the full year, exceed the midpoint to where we put it compared to revenue.

Paul hit on, I think, an issue that I think it's good for us to expand on a little bit, and that's the enterprise-wide strategic review, which we've engaged in taking a look at the company, making sure we got the resources in the right place. And we're executing that. We're delivering on that. And from that, we're seeing real EBITDA leverage here for the second quarter in a row. So we're very pleased with the outcome of that particular enterprise-wide strategic review.

Our next question comes from Umer Raffat from Evercore.

I just wanted to ask a 3-part question on selatogrel, if I may. First, at what point in the patient's journey post an event are they initiating an oral antiplatelet? I understand in the trial, if you're on an active arm, you'll be on selatogrel perhaps right away. But at what point once you're in the hospital after the index event, are you initiating an oral antiplatelet number one, which sort of leads me to my second part, which is what -- I know what the half-life is, but what's the off time where no more platelet inhibition is in place? And I ask because if I go by your EC50, which is, I think, 14 nanomolar, it looks like the 16 mg dose doesn't get to that EC50 until 8 to 10 hours post the dosing. And then finally, for patients that do end up needing a more intensive procedure like a CABG, I guess, how is that being handled in the trial in terms of how they're taking on the blood thinner or the timing post initial selatogrel administration?

Before we get to that to answer the technicalities of your question, first of all, thank you for the question. We're really excited about selatogrel. We expect the readout when we get into the first half of '27 on this. We've enrolled a lot of patients. Philippe can give you some context on that. And I think we've been very, very pleased with the execution and enrollment and progress of this particular trial. We see -- if positive, we see real blockbuster opportunities for selatogrel here and a major expansion. I say the same thing for cenerimod. There's a lot of attention on selatogrel, which is great, very unique product, but we're also really excited about the progress execution and the potential of cenerimod as well. So I really appreciate the question. Love talking about new interesting products that can help drive our revenue future. And let me kick it over to Philippe to give you some context.

Thanks, Scott, and thank you, Umer, for the question. So patients that are on the study, the vast majority are on dual antiplatelet therapy to begin with. So they're already on an oral clopidogrel for the most part is what we expect to see. So that -- while selatogrel is added on top of that. Now for those that are not necessarily on it, they could be post treatment within 24 hours or so, the effect of selatogrel is no longer present. And therefore, treatment with an oral P2Y12 could be initiated at that point in time should it be required. With regards to the offset, as I said, I think we know that within 6 to 7 hours, we get to peak platelet inhibition, 80% platelet inhibition after 15 minutes -- more than 80% after 15 minutes is what we've seen in Phase II. The offset is, as I said, within 24 hours, selatogrel is no longer present. Now in terms of the CABG, I think CABG can be initiated at any point should it be required, should it be deemed required the current guidelines. There is no need to wait if it is deemed urgent. But that being said, again, within post 8 hours, CABG -- post 8-hour post selatogrel injection, CABG can be initiated safely. Again, it is not a requirement to wait.

Our next question comes from Matt Dellatorre from Goldman Sachs.

Congrats on the progress. Maybe a couple on the branded pipeline, starting with fast-acting meloxicam or FAM. Could you comment on any recent interactions with the FDA regarding the label being opioid sparing? And then just remind us how this asset is factored into your longer-term guidance targets and the degree to which success could represent upside to those, either the base or bull case? And then on selatogrel, could you just remind us what magnitude of benefit you believe we need to see? I think you've disclosed in the past that the study is powered for a 20% benefit. So I guess what's the minimum benefit that could drive meaningful uptake? And then when we see the data, will there be any subtleties that we need to keep in mind given it is a composite endpoint, for instance, it doesn't matter which of the components is driving the benefit? It seems like they're all fairly serious, but I just wanted to confirm.

Thanks, Matt. First of all, on meloxicam fast-acting, we think it's going to be a significant contributor to our pipeline, to our revenue to the U.S. business between now and 2030. And so I'm not getting into specific numbers at this point in time. We don't have a label yet, and there are some other things that we really need to look at. We see it being a very significant contributor in the U.S. to high-margin branded portfolio in the United States. Philippe can talk a little bit about the label and the progression of discussions with the FDA in selatogrel. And then maybe we can loop back to Corinne to talk a little bit about the potential she sees in selatogrel.

Yes. Thank you. So with regards to meloxicam first and the progress of the review currently ongoing with FDA. We are reaching mid-cycle. Things are progressing as planned, FDA is very engaged. We are answering all the queries that they have and expect to get approval towards the end of the year at the time of PDUFA. In terms of the labeling negotiations, there's been -- I mean, there's interaction on the clinical data with the agency. Labeling negotiations won't start until October, November time frame. So this is when really we will start talking about the exact language around opioid sparing. As I previously mentioned, this was heavily discussed with the agency during Phase II and during the -- putting the protocol together for Phase III. And we've followed every recommendation that the agency had for us in order to be able to get this language included in the label section. Where in the label section and exactly what language, I can't tell you as of today, but we should get a better idea around the October, November time frame.

And we see a lot of excitement about this product. We are getting very positive feedback from KOLs. Definitely, the results of the Phase III program and notably on the opioid-sparing effect is seen as a real positive. So in terms of potential that we see for fast-acting meloxicam, FAM, as you call it, the potential is large. You know that pain is -- and acute pain is a broad market with about 80 million patients suffering from acute pain every year. And unfortunately, half of those patients already are dependent on opioids for pain relief. So we see that this product has the right profile. It is generating a lot of interest, and we can imagine that with a market exclusivity that could potentially go beyond 3 years as we are finding more patents, we could reach up to $500 million in peak sales with this asset, and that will contribute meaningfully to our long-term guidance.

And then on your question on selatogrel. So the actual benefit that the study is sized for is approximately a 20% risk reduction. We have discussed this obviously heavily with our KOLs and investigators. The minimal bar is much lower than that in the mind of the investigators and KOL. I think if we were to be able to show risk closer to 10% to 15%, that would be very much acceptable and the lowest bar commercially to get this drug to patients. So again, the study is overpowered for that 20% risk reduction. And that's really the minimum bar we're seeking at this point in time. In terms of the endpoint itself, as you know, it is -- the endpoint is ranked according to the outcome and according to their clinical importance. What we expect to see is that selatogrel is blunting acute MI from happening if injected at the right time. And we also expect to see that selatogrel will reduce the severity of the MI that these patients are expecting, making them a lot more manageable for the patient with a lot less sequelae over time, which leads to patients being in the hospital a lot less, a lot -- for a much shorter amount of time as well. So adds a lot of benefits to the patient and to the payers overall.

And these post-MI patients are very, very expensive for the health care system. They're very difficult to manage over time. And so being able to improve any particular outcome for a patient has not only tremendous benefits for that patient, but also on the health care system overall. So that's why part of the excitement that we feel about selatogrel being a unique drug in the space.

Our next question comes from Glen Santangelo from Barclays.

Scott, I just had a couple of follow-up questions. I wanted to talk about this China dynamic. It seems like you're describing a situation that maybe has some durability in those commercial efforts beyond just 2026 because it seems like it's that market that gave you the ability to sort of raise guidance despite the fire-related disruptions you're sort of calling out in the back half of the year. And so I know it's a little bit too early to comment on '27, but I was kind of curious if you could comment on the durability of the strength there. And then should these fire-related disruptions be contained to just 2026? And then my follow-up was on meloxicam. It seems like meloxicam and the presbyopia solution are the 2 meaningful approvals you have left this year. At your Analyst Day, you sort of highlighted that value-added medicines pipeline. Would add about 1% to the growth algorithm. And in the previous question, you just sort of highlighted that you think it can be a meaningful contributor. And I'm just kind of curious, when I think about that value-added pipeline, are you still thinking about it as a 1% contributor to the growth algorithm? Or do you have maybe greater expectations at this point?

Thank you very much for the question. So yes, we're really pleased with the performance in China. There seems to be some good durability. We had good performance last year. We see good performance this year. I think we see some of the investments that we've made in China in terms of the channels that we're going to reaching to the patients, trying to restructure our business there, trying to make sure that we're overinvesting in some of the demand for some of these iconic brands. There seems to be good durability there. The only thing you worry about in China is there's policy changes at times and sometimes you see them coming and sometimes not. Sometimes they're inconsistently applied across provinces and things. We try and obviously work with the government in China to deliver the best health care we can. But China seems to me to be a good engine for us moving forward. And I think it's not only China that allowed us to sort of beat and raise and to have a good outlook for this particular year. There was some good strength in a number of other businesses as well. We see good strength in the value-added medicines that we're bringing in the United States and other places. So we're very pleased with the business overall. You raised Nashik. And just to put that in perspective for you, we currently operate 26 manufacturing facilities around the world. We have inspections and observations and things all the time. Specific to Nashik, as I said in my prepared remarks, we're communicating with the FDA. We're working closely with the external experts and initiated comprehensive remediation plan to address all the issues or any issues that we see there. And we had a fire, as you said, in Q1 and some inspection observations in May. We expect the remediations, as Paul was pointing out, to have some impact on second half revenues, but it's fully baked into our guidance. And as a reminder, we raised guidance for the year for all key financial metrics. We see this being sort of intermittent as we remediate the fire and some of the things from the observations and the inspection, and we don't expect this to be long-term affecting the business now.

Yes. Maybe if I could just add one thing, too, from an expectation perspective. We do see the impact being larger in Q3 and moderating a bit in Q4. So I think as Scott intimated, we expect this supply disruption to be shorter term in nature. And hopefully, by exiting the end of the year into the beginning of next year, we will have been gotten ourselves past it. That's our expectation.

And, Nashik, just to characterize, it is a lot of smaller products. It's mainly emerging markets, JANZ. There's no one product there that's more than $20 million in revenue. So it's a lot of little pieces. And again, as we remediate and get things online, we expect to see relatively short-term intermittent effects of that. But the strength of the business allows us to get through that and again, be in a position to raise our guidance across all financial metrics. I think you had a question around meloxicam as well.

Yes. And maybe I can address this again, Glen. Just to say that, again, we remain very optimistic about meloxicam. We're expecting PDUFA date at the end of the year. So of course, we'll wait for the label to be available to finalize our pricing strategy and value proposition. But everything we are seeing so far and the feedback that we get from the market is very positive. So we believe that there is room for another asset that is fast-acting that will have a meaningful role in acute pain and really expand the utilization of NSAID that with fast-acting meloxicam having a very well-characterized tolerability and safety profile. So we're looking forward to launching this product. It will be a branded asset. We will deploy a specialty sales force and I'm looking forward to talking about our launch at the next call.

And I think one of the reasons we're so excited is not only the strength of the data relative to the competitive set out there, but also the real market need. And I think Corinne hit on that earlier, the need for non-opioid solutions for patients with acute pain is really, really large, particularly in the U.S. And so we're excited about the profile. We're excited about the product, but we're also excited that it's going to fill a really significant need in the U.S.

Our next question comes from Chris Schott from JPMorgan.

This is Ethan on for Chris. Just starting off, what are your latest thoughts on the M&A environment? Are you still seeing a good amount of assets in the marketplace? Or has that changed at all over the past couple of months? And then secondly, just thoughts on the latest headlines for potential U.S. generic tariffs and maybe how you're thinking about the potential impact to Viatris specifically?

I think the M&A environment is obviously pretty active right now. It's a good environment. There's a lot of things going on. Certainly, there's a lot of assets still out there. Certainly, I still get a lot of inbound. I talk about getting inbound virtually every day, sometimes multiple times a day. And so we're looking hard at business development, adding things in market accretive things to the portfolio. We're going to be disciplined though. We're going to try and find the right assets, the ones that we can be good owners of at the right price to bring them in. So we're looking at a lot of things. We're excited about our ability to use our capital not only to pay back to shareholders, dividends and share buybacks, but also really build a portfolio of assets. And again, we're sort of focused on in-market accretive assets right now. And there's a lot of things out there that we're looking at for sure. The second part was tariffs. Yes, I mean, it's difficult for me to comment. We're still gathering information. The administration has not released any official policy details at all here. Just it's important to note that I think we're in a pretty good position regardless of how this goes, if it goes relative to tariffs. We currently have 8 manufacturing, R&D and distribution sites in the United States. Over half our U.S. revenues are from products that are manifested in the U.S. We're planning as we move forward to manufacture higher-margin products like complex generics, transdermal products, value-added products and such in the United States. And we'll always work to partner with the administration as we understand the details of what they're trying to do here from a policy perspective and work with them to help better health care for Americans.

Our next question comes from Dennis Ding from Jefferies.

I have two pipeline questions. So one on lupus and one on selatogrel. So for cenerimod, I appreciate that the Phase III is enriching for high IFN-1 and we've seen with other lupus programs like iberdomide and Saphnelo that SRI-4 is consistently higher in this population versus low interferon-1. But when I look at your Phase II, this relationship breaks apart. It seems like the 4-milligram dose was a clear outlier on both SRI-4 and also SLEDAI. So what is it about the prior data that really gives you confidence going into that readout outside of this high interferon-1 relationship? And then question number two, on selatogrel. I believe the CVOT was initially 14,000 patients, but then you upsized the trial by almost 50% to 25,000. So I want to understand what went into that decision to add 11,000 patients? And what are you seeing on blinded event rates? Is it tracking with what you initially planned? Or are they lower than expected?

Thank you for the question. So with regard to cenerimod and the interferon-1 signature, in Phase II, we saw that the 4-milligram dose, which was the highest dose tested was the dose that was clinically -- show a clinically meaningful improvement and a nominally statistically significant p-value. That was in the total population. And then in that 4-milligram arm dose, we had approximately 50%, actually 45% of patients that were interferon-1 high. The interferon-1 high patients responded better than the interferon-1 low with a delta versus placebo of about 24%, which is one of the highest delta reported for this population. So -- and we also saw, which is what is so much expected that the interferon-1 high patients were the patients that were the most active in terms of their disease. And this is the kind of patients we are actively enrolling in Phase III. We are ensuring that we're targeting patients with higher disease activity and higher interferon-1 high expression. Our goal was to get to approximately 70% of patients that were interferon-1 high in Phase III, and we have exceeded that goal in both studies. So that's the data from our Phase II and then we have also, just to finish on this, implemented a number of things in Phase III that were different than Phase II, obviously, that we believe will lead to better outcomes. First of all, the primary endpoint is at one year and not at six months, which will lead to, we believe, continued and better strength of the data as we've seen continued improvement in patients exposed to one year to cenerimod. And then another important part I would mention is the fact that -- because the endpoint is at one year, we're able to implement steroid sparing -- mandatory steroid sparing for patients that will lead to further differentiation versus placebo. So that's our strategy. We feel good about the data that we've generated so far, and we are actively cleaning that data so that we can report our top line results in 2027 -- early 2027. And then there's another question on...

Selatogrel powering.

The patient enrollment...

14 was the...

Yes, yes. So yes, the protocol always contemplated enrolling up to 21,000 patients. That's the -- that's where we were. It was anywhere between 14,000 to 21,000. We have -- we are seeing an event rate that is what we expected. That being said, what we're trying to do is to enroll patients all the way to the end. By that, I mean, all the way to the time point where we get all the needed events that we need. We are not going to stop and wait for the events to happen. We will continue to enroll through that. And we may need a little bit more than 21,000 patients that remains to be determined. But we will continue to enroll through that. What's important is that we believe we'll get the events we need by the end of the year so that we can -- early next year so that we can get data in the first half of 2027.

Our next question comes from Jason Gerberry from Bank of America.

Just 2 for me. Just wanted to follow up on the China policy question because I didn't quite understand. So it sounds like despite the policy change, you're still bullish on the market overall. Perhaps there might be a little bit of fluidity with the situation with the comment about the variability at the province levels. But I guess I'm just wondering, as I look at the back half of the year, sort of an implied low single-digit growth. Is that sort of what we should think about first half the carryover into next year? Does that create tough comps for 2027 is ultimately what I'm trying to get at? And then on selatogrel, just curious, once you complete enrollment towards the end of the year, for the primary endpoint, I think you only need to assess the patient for like 2 to 7 days to determine the impact on mortality or the other measures. And so could you just remind me the different lag factors that go into once you complete enrollment to actually the time to which you can generate top line data?

So just on China first. Again, we're very, very pleased with the business. It's running very strong. We think it's going to -- obviously, we're going to have strong results in '26, and we believe '27 and beyond as well. There's good momentum there. It's a very important part of our company going forward. Good growth. In terms of policy, it's not finalized at this point in time. There's discussions with the government around different policy executions. So we're being a little bit careful to try and understand that policy. We will be in a position, I think, in November to really talk about the policy, what it looks like with any changes, if we think it's going to impact our business or not, what that's going to look like. And so it's just an active discussion right now with the government. We're not exactly sure how that policy is going to be executed. And again, policy in China tends to get executed in a kind of a spotty way and different execution in different provinces and things. So we're taking a look at it. We're in active discussions. We think it could have some effect in the second half of the year. And we'll have a much better view on the policy execution when we get to November.

Yes. And let me just add, we've built all of that into the forecast, right? So I would say, from my perspective, we are hopeful we'll continue to see momentum and grow beyond '26. But as of right now, we don't see the 16%, 17% continued growth, right? And so we do expect growth, but it will moderate back down. That's our current expectation based on everything we know.

Right. And nothing to add to this, just to say that -- and you mentioned it, the implementation of this new policy, which is a new product revenue that concerns only public hospitals will be done at the provincial level, right? So there are 31 provinces in China. And some of our products that have high volume utilization might be impacted, but we will know more as those 31 provinces adopt this policy. And definitely, by the end of the year, we'll have a much better picture of the impact. But again, we are confident, as Paul said, that we're going to grow through this policy implementation.

And then regarding your question on selatogrel. So yes, you are correct that the primary endpoint is that 7 days for death and within 2 days of injections for the other types of MI. That being said, the secondary endpoint are 30 days. So we need to get that data at 30 days. And then remember, this is a very sizable study with 45 countries involved and close to 900 sites. So we need to make sure that we gather all that data and clean all that data, which is why we're talking about the first half data. We take some time to clean all that and bring that back, right? So...

It's a very large study, right, large global study. So it takes some time to clean and prepare the data properly.

Our next question comes from David Amsellem from Piper Sandler.

So 2 for me. First on cenerimod. My understanding is that background Benlysta is allowed in the trial. So I was wondering about the thought process there? And is it stratified or the patients stratified for background Benlysta? So that's number one. And then switching gears to complex generics. I wanted to ask about the hormonal patch business with the acceleration following the removal of the box warnings. I wanted to get your thoughts on how long you think that could be a relatively limited competition market for you and how big of a growth driver for generics in developed markets, namely the U.S., that could be in '27?

So on your question about belimumab, yes, belimumab is considered standard of care and therefore, is included in the medications that can be given in combination with cenerimod as part of this trial. That being said, we don't expect a significant number of patients that will be on belimumab as part of the study. We expect it to be closer to 5% of the patients. So this will have limited potential impact on the data. Second, the randomization ensures balance and mitigation bias. It is the effect that you could see with belimumab and you feel in both placebo and the treatment arm. And then it's important to generate this data just from a pure safety and clinical value to show that the efficacy of cenerimod is seen on top of belimumab or Benlysta and that it is safe to co-administer these 2 drugs. So that's part of the reason why we also included it in the clinical trial. And then should we see an effect, I mean, we have sensitivity analysis that we would be looking at. Remember, we have 2 identical studies. This allows us to pull data across both studies to determine whether an effect that we would see is real or not. So that gives us more robustness behind that data. But overall, I would say that we do not expect this to affect the study in any way.

And so regarding your question on estradiol patch, we have seen over the last year -- over the past year, a strong increase in demand for estradiol patch for hormone replacement therapy. And you're right that the first reason for this is the market expansion, which is due to the FDA removing a black box warning at the end of last year. And we believe that this market expansion is here to stay. Now there is a secondary factor, a bit less important, but worth mentioning as well, which is the increased use of GLP-1s that has an impact on the utilization of patches because it's been demonstrated that they are -- there is a contraindication with the use of not only oral contraceptive but HRT products as well. So we benefit from those 2 factors. Now it's -- we are -- we have a leading position in the manufacturing of patches. We have our facility, which is based out of Vermont that produces high-tech next-generation transdermal systems. And we continue to increase capacity there. We continue to drive efficiencies. So we will continue to be a major leader in this market as we see the expansion forward.

Yes. And just to finalize the thought around estradiol, we do see it as an opportunity. Again, less about additional competition from my perspective. It is that demand has blown up. We're currently, as a data point, being able to fulfill about 70% of orders. So just as the demand is there, we're trying to ramp up production to meet that demand. And I think there's opportunity there. And as Corinne said, we are looking at our own plant. We're looking externally to see what's available to meet that demand in the future.

And certainly, this is a place that we're willing to invest to go forward to meet what we see as sort of unprecedented increases in demand for the reasons that Corinne was saying. So I think a real nice area of opportunity for us and one that we're going to invest in and likely to be a good driver of our revenues at least through now to 2030.

And our next question comes from -- is a follow-up question from Umer Raffat from Evercore.

I wanted to touch up on something I meant to ask early on as well. I think kind of came up on a question a few moments ago as well. So Philippe, I think you mentioned the original sample size was 14,000 to 21,000. And I think clinical trials has it, having gone from 14,000 to 25,000, even though in practice, what's happened is it's gone from 14,000 to 21,000 to 25,000 to 35,000. Could you just speak to that, if that was informed more by powering or more by sort of you're just letting it continue to enroll, so you just keep getting the events faster?

That's exactly what the latter, right, which is that we are letting it enroll -- this is a sizable study. We spent quite a bit of time and energy and money, quite frankly, in this study. So we want to leverage it as best we can. Getting that data will be important for positioning of the drug. And therefore, we believe it is important to let it run as close to the time point where we're going to lock the data, so -- which will mean that we'll have more events that we need eventually, right? But for the timing of the primary endpoint that allows us to get there faster than if we were to stop now and wait for the events to occur, right? So that's that strategy that you see in play. These numbers that we put on ClinicalTrials.gov are to give us flexibility in how many patients we want to enroll. I don't want to have to change it 15 times. So we change it once, give a window, and then we'll end up somewhere there.

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

Thank you very much. And let me close with just 3 thoughts here. First, our second quarter performance and indeed sort of the strong first half results reinforce that the strategy we outlined earlier in the year is working. Second, we're entering an important time period for our company. Over the coming quarters, we expect multiple regulatory milestones, important product launches and continued progress across our pipeline. Finally, we're building a stronger company. We're improving the quality of our earnings, strengthening our operating model, sharpening our portfolio and investing behind the opportunities we believe will drive sustainable long-term growth. We're excited about the opportunities ahead, confident in our ability to execute and believe Viatris is well positioned to deliver sustainable long-term value to shareholders. Thank you very much for your attention this morning.

And with that, we'll be concluding today's conference call and presentation. We thank you for joining. You may now disconnect your lines.