Viatris Stock

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.

business, particularly North America, North America being up 3%, driven by the portfolio. Kudos to the team for continuing to get our complex portfolio approved and also launched. Last year, we launched two complex injectables, which is helping drive that growth.

But also, we're seeing continued strong trends with our generic Symbicort in the market. So North America positioned in a very favorable manner. And so overall, I think when you look at this business, we're on a trend line right now of 2-plus percent operational growth. You mentioned the enterprise-wide strategic review. We're beginning to implement that cost savings program this year.

We expect to deliver $120 million of net savings. So that's certainly helping with the operating leverage we're seeing in the business. So overall, I think the business is in a really good spot as we look out to the rest of the year.

I guess for some of us who followed you guys for 10-plus years, the company has gone through a lot of permutations between Mylan, the Upjohn deal, some divestitures. When we look ahead to the $11 billion of capital return that you talked about, maybe half of which could be used for BD. Is that a firm number?

Are there some variables that could enable you to push greater on the BD toggle for the business, depending upon the accretion profile of the target and/or other facets of a target asset that's out there.

Yes. So coming off of our investor event earlier this year, one of the, I would say, key areas of where we can create value as a company is certainly capital allocation but it really all starts with the strength and durability of the free cash flow of the company. I think that's been a hallmark of Viatris for some time.

And so when you look at the cash that we have on the balance sheet exiting Q1 free cash flow generation of over $2 billion and thinking about the growth profile of the business, we expect free cash flow to accelerate between now and 2030. So that sets us up from a strategic flexibility point of view, where we have a lot of optionality. When we look at the balance of capital allocation, it's going to be that. It's going to be a balanced approach. First and foremost, we're going to continue to return capital to shareholders, our commitment to the dividend will be a part of that. We'll continue to look at share repurchases in an opportunistic fashion.

Last year, we leaned in a little bit more to share repo. And then so the remainder really 50% thinking about how we can use that capital to accelerate the underlying growth of our business. And so thinking about BD in terms of really two priorities. One is how do we continue to strengthen or regional segments, where can we find assets that we can plug into that existing infrastructure, but also a strategic priority for us is to expand our innovative business in the U.S. So as we think about the continuum of BD, it's not necessarily a sizing perspective.

It's where can we find assets where we can be -- they have a good strategic fit we can build a cornerstone franchise around and really we can be good owners of those assets. So I don't want to kind of anchor us to a size, but as you think about how we're dimensionalizing it over the next 3 to 4 years, we've talked about bringing in $1 billion to $1.5 billion of revenue from BD and about $0.5 billion of adjusted EBITDA. But really, the goal is to take BD and use it to accelerate the underlying growth of the company.

And then maybe talk about the cadence of the launches that you have coming up, how that can accelerate that growth, which I think you said was 2%, 2.5% now. But like as you layer in those launches, some of which, like meloxicam rare a little chunkier and bigger than some of the other ones that you've outlined on the come like the [ Tolasite ] I imagine. So just any framing that you can in terms of the cadence of launches and how that gets you to that 3% to 4% growth target by 2030?

Yes. Sure. So the company, as you look at, kind of, our evolution, from being predominantly a generics and an established brands company. We set a strategy out to really expand our value-added medicines and also our innovative bucket. And so when you look at what those can do for the company, this year, we have a number of upcoming launches. One of our prioritized markets is Japan. That's where strategically we've looked to strengthen that market with more branded innovative medicines.

Recently, we launched our Effexor for Generalized Anxiety Disorder. It's early days, but we're seeing some promising signs for that launch upcoming this year, we'll be launching Pitolisant in Japan. When you think about the Sleep and Wake category, it's a very underdiagnosed, undertreated market in Japan. So we see a lot of opportunity there. And then next year, we also expect to launch our Nefecon product. So those launches when you look at our Japan segment, really have the potential to return Japan growth by 2028.

And then as you think about opportunities for our North America business, you mentioned two, first one with our [ Gwinlow ] dose weekly estrogen patch. We have a PDUFA for the end of July. That is the first of two products when we think about the contraceptive patch portfolio that Philippe and his team are developing. Collectively, we think that portfolio could generate peak sales over $300 million between those two products. And then the big one that we're really excited about in the portfolio is our fast-acting meloxicam. This is an opportunity in a market where you've got a very sizable broad market in acute pain.

And we have a non-opioid option with a really attractive profile. So we think that, that product over its lifespan could be up to 500 million. So collectively, when you look at the base trend line, you add in the new launches, it's the collective basket that we believe accelerates the growth to that 3% to 4% top line expectation between now and the next few years.

Okay. And maybe shifting gears to the meloxicam opportunity. And as we think about the importance of labeling and product labeling, how important is getting that opioid, kind of, sparing attribute in the product labeling when you do your market research and test what resonates with health care providers in terms of addressing unmet need. If maybe you can speak to, I guess, some of the important label -- product label outcomes that are on the [ come ]?

Yes. So I think, as you know, we are very proud of the data we've generated, in particular, the profile that emerged from the Phase III program, rapid onset strong efficacy in line, if not better, than opioid and then that capacity to spare opioid use, right? And when we look at the way we've set up the data and we have a lot of back and forth with the agency during Phase II when we designed the study -- the Phase III studies.

There -- our first two secondary endpoints are two endpoints that look at opioid sparing, reducing the number of doses and the number of patients that are opioid free. So highly statistically significant and clinically meaningful results for these two endpoints. So we feel good about our opportunity to include that data as part of the label. Where exactly in the label is going to be, whether it's going to be in the indication section or in the clinical section of the label, it doesn't matter as long as this data is in the label.

Now in terms of importance to -- going back to your question, I think it's good to have it. It would simplify things for us, but the data is out there, right? I think when we went through a number of congresses, medical congresses this year. The onset and the opioid-sparing data is what really resonated with doctors and this ability that they can now go ahead and reduce the opioid use, which they've been trying to do for many years now. So they have an option that they are very comfortable with. They know the mechanism of action. They have a good understanding of the safety profile. So we expect the uptake to be pretty significant, pretty early.

Okay. So I'll preface my next question just by -- I imagine a lot of investors are going to benchmark your launch to Vertex' JOURNAVX. And I think part of the answer is what you define as success 500 million peak is probably not what Vertex' investors would define as success for JOURNAVX. So with that said, what do you learn from their launch? How you're approaching the market maybe differently? I know you focused a lot of folks, investors on the outpatient opportunity where you think access could be more favorable? So just kind of curious what you've learned from the Vertex JOURNAVX launch and why you're optimistic about how the rollout of meloxicam will play?

Yes. So I think what -- I'll start and then maybe I can give it to Bill. I think what we are seeing is that -- that I'll comment an angle from a data angle. I think our data is really resonating with prescribers. I would say that the JOURNAVX data less so. And so I think that creates a need. Now what -- as you point out, what is important for us, because we have a shorter exclusivity window than a typical new molecule, we have to go after uptake much more than they do.

They have more time to build. We got to build faster. And I think that's the strategy that the commercial team is putting in place going after ability to go after a post-surgical patient out of the hospital. Patients and then start narrow with the specialty sales force and then expand to a broader group of patients potentially with partner if that makes sense for us at that point. But I think that strategy is different because of that shorter exclusivity that you see with us versus the typical molecule.

And you said '26 is unlikely material contribution from meloxicam is '27 a material contribution from that product that should investors expect?

Yes. I think '26 is we would -- we anticipate to get approval towards the end of the year. And therefore, you would see -- start seeing a meaningful contribution towards 2027.

Okay. You mentioned IP and the IP runway. Pretty much all the CNS companies that I cover, there's serendipitous discovery of older molecules, right? And so then there's a build-out of IP to protect that when the clinical trial was run, and we did an analysis. I think for a bunch of companies that had old or repurposed molecules, they ended up getting 16-year product life cycles with a lot of the IP generation that followed. And you guys have alluded to working on other IP. So could you open the curtain a little bit? Can you talk a little bit about that dynamic and what you guys are doing?

Well, I can only tell you so much. But I think the -- what you are -- I mean Viatris is usually on the other side, right, of the equation. So we know what needs to be done for us to maximize our exclusivity. And that's what we are working on. We have a number of patents. We filed that we believe will extend our exclusivity around a number of things like formulation like other method of use type of thing.

And we also have the opportunity to extend with pediatric exclusivity and other things that we're also looking at with the FDA currently, right? So that's the strategy. I think -- you've heard Scott say that we anticipate this. That we'll be able to go well into the 30s with this asset, and that's our expectations, right?

Okay. Maybe shifting gears to selatogrel. I think this is the largest commercial opportunity that you guys have explicitly flagged in your pipeline. So with data sometime, I believe, in first half '27. So I know that a lot of people focus on the uniqueness of the trial, right, and trying to understand the different risk factors in conducting a trial like that.

Can you rank order when you did the deal, what you saw is like the key risks in running this sort of novel trial approach? Be it patient who's on control arm, getting maybe faster access to IV Cangrelor or false injections. I know there's a lot of discussions around these different points. So how did you guys look at risk with this asset?

The Phase III clinical trial, SOS MI, that we are currently running is a pretty simple study, right? Patients have to have a qualifying MI. Once they do, they are randomized to either selatogrel or placebo. And they are trained to recognize the symptom of an MI. I remember, they just had one. So they kind of know what to look for, but we still train them again. And they're trying to use the auto-injector. And then they go home and wait for an event to happen, event meaning is an injection, right?

So that's -- and then we keep track with the patient. Will be a phone calls on a regular basis. So very easy study to conduct. Now the challenge comes with the size of the study. And I think we've kept on updating you guys that we are enrolling over -- we have 1,300 patients a month currently, and we anticipate we'll have all the patients we need by the end of the year.

Now where I think to your very question, where with the assumption -- the key assumptions that needs to occur for this study to be positive is that patient needs to self-inject early. By early, we mean within the first hour, right? Of symptoms onset, because that's the concept of early platelet inhibition leads to better outcome for the MI. This has been proven, this has been shown. The earlier you treat, the better the outcome.

So what we're seeing in the study, and I think we've kept on updating folks about this is that we're seeing patients are self-injecting in less than 30 minutes from symptom onset. So that part of the equation was critical is going well. It's happening. Patients are self-injecting, self-injecting for the right reason and self-injecting in the right time frame.

The other part that was also an equation that I wasn't sure was going to necessarily play out was patients self-inject, do they think they are cured and not take themselves to the hospital to get a proper diagnosis, which is important for the purpose of the primary endpoint. And what we're seeing is that patients are taking themselves to the hospital post injection, and they typically get there within 2 hours, which is more than enough for selatogrel. Selatogrel will continue to work for approximately 8 hours. So patients have enough time, not too much time because we need also those platelets to go back to normal, should they need surgery and so on. But we are seeing patient self-injecting, self-injecting for the right reason, in the right time frame and then going to the hospital for diagnosis.

Can you talk about, this is effectively narrowing the treatment gap, right? Like so if you can get medication on board faster because there's proven data that if you get IV Cangrelor, you can reduce some of these more negative downstream outcomes that are part of your primary endpoints. So if you can tie that to, if you narrow the treatment gap, I'm lowering the mortality rate by X or other components within the endpoint? And can you just talk a little bit about the endpoint design and just how narrowing the treatment gap, what your understanding is what that will reduce those rates by in?

IV Cangrelor is you mentioned a couple of times, is not used for what we are doing. It's used for PRECTI, so patients that already know they're going to have PCI. And typically only reserve for patients that are at very high risk, right? So placebo patients will not be getting IV cangrelor, neither will selatogrel patients. Remember, selatogrel is first, right? So however, will be given by the patients, then the patient goes to the hospital if they need PCI, then can be given IV Cangrelor should they need that. Our data shows that when you combine -- in vitro data shows that when you combine selatogrel and IV Cangrelor, you still see a synergistic effect.

You still see an increase in inhibition of platelet aggregation. So they can be given together, you still see a benefit. Now I would assume that in practice, if you will get either -- you will get selatogrel first and then either continue to get selatogral or switch to IV Cangrelor should you need that for the purpose of surgery, right? But I think that will not interfere with the primary endpoint. The primary endpoint is the Hierarchical Composite Endpoint. So it ranks the severity of the MI starting with the most severe, which is death down to less severe types of acute MIs.

So it's ranking that and what we expect to see shift from severity of the MI from less severe on the placebo arm, I need to stop in my hands. So that's what the outcome of the study will be the risk reduction for more severe MI on selatogrel versus placebo. We estimate that reduction to be around 20%. That's how we've sized the study. And we're obviously powered for a lot less. But the risk reduction we anticipate to see will be around 20%.

Just to clarify on the hierarchy, which what are the tests for primary endpoint versus are there components of the hierarchy that are secondary analysis or secondary endpoint?

So it's not a -- we're not looking at your standard event rate, right, or rate? It's a win ratio. So you are for each patient on selatogrel, you're comparing it against each patient on placebo. And each time you win, we anticipate that selatogrel will win 1.25x more than placebo, that's your 20% risk reduction. So it's a win ratio that we're using as a method to analyze the primary endpoint.

Okay. And if successful with that sort of treatment effect size, I know you guys have experienced historically with rescue treatment markets with EpiPen. Can you talk a little bit about how you see the market opportunity, challenges and opportunities that went into the company kind of target of $1 billion plus in revenue for that?

Yes. Let me start. Yes. So we've mentioned previously, all the epidemiology data that we have that lead to certainly the case that is above that $1 billion. So it's a $1 billion-plus opportunity, right? So I think you see about 24 million patients have already have in MI, and that excludes China, where the numbers are not necessarily clear. They are, I think, way understated. So significant opportunity for -- in terms of epidemiology, but what is I think the most important is that you are -- we will be the first treatment to be able to prevent MI from leading to significant [ siphily ], right?

We're looking at a reduction of the severity of the MI, which will lead patients to have less equally on their muscle, on their heart and will then spend less time in the hospital and that will help the overall health care system. These are patients that are probably the most expensive patients for the health care system. What we've also seen is that just carrying the pen itself makes the quality of life of the patients a lot better. Just knowing that they have this rescue medication help them from a quality of life. So we're seeing a significant opportunity for this asset to change the treatment paradigm in acute MI.

We'll start with patients that already had an MI and then over time, should the safety profile continue to hold, we'll be able to expand into more patients that are at risk of getting I never had one before, but are more at risk of it, further expanding the opportunity.

And I think maybe just one point, Philippe, to your point on the potential product profile and you mentioned it being a global opportunity for us, where we have the global infrastructure to commercialize a product like this, we'd have to certainly make investments in the U.S. But I think the other piece too is, given it's a pen, you can envision a model similar to other rescue medications. There's also going to be a refill component to this market, right? So based on the product life, right, you can imagine a patient that's had rescue medications for a number of years, right? So that refill piece, when you kind of do the math across the epidemiology, you think about a refill assumption, you'll have to really stretch to believe that this could be over a $1 billion opportunity for the company.

Is there a low-hanging fruit embedded in there? And what I mean by that is like I imagine the patient who's had an MI within the last year, is going to be more motivated to keep that in their pocket at the ready, right? Versus somebody that maybe 5 years removed or high risk, where perhaps keeping a pen at your side all the time will be kind of difficult, I imagine. And so I'm just trying to think through how you think about that as a market segmentation factor?

I think you'll have -- patients will have multiple pens to begin with, right, not just one, it's important also that the caregiver, typically their family members have access to a pen as well, should they not be able to self-inject. So I think you have that component also that is important. But look, look at the EpiPen, right? I have three kids. They all have to have an EpiPen. they've never used it. But every year, we'll renew the prescription, and it's been years, right? Just because you know that if you need it, you have the upturn to get the pen.

Okay. So we've got about 3.5 minutes, maybe some quick hitters here. So cenerimod. There's -- can you talk about your trial enrichment strategy with how interferon? And are you prespecifying that as like a subgroup and then looking at all comer as well in that trial and how that may differentiate the SLE space is very competitive. So I'm wondering how your trial design, at least compares to some of the other approaches out there in Phase III?

Yes. So in Phase II, we had patients with high interferon signature, had a much better response than patients with low signature. So we enriched the Phase III trial. We set a bar at 70%. Trials are fully enrolled. So now we know that we are above that 70% threshold. If you compare, for instance, [ Safnelo ] at 83%, I believe, on average of patients with high interferon signature. Regardless of that, they got a broad label. That's our assumption that we will go for a broad label. That said, we have two large studies that are identical. We can pull those studies together.

And target that interferon went high expression should we want to do that? Should we see a much, much better response rate. But I think the the base assumption is that we'll have a label similar to Safnelo broadly.

Okay. And by our count, I think there's 5 or 6 competitor programs in Phase III. How do you foresee your product stacking up competitively versus landscape. Obviously, a difficult question to answer before you see all the data cards turned. But based on the support of Phase II data, how comfortable are you in a competitive profile?

So I mean our interferon high signature results is probably one of the best efficacy data. Our safety profile is typically more favorable than what you see with this other product because we're not an immunosuppressant or an immunomodulator and the S1Ps have had a history of being more on the safe side than those more aggressive treatment.

That said, I think SLE, we have now a much better understanding of what SLE is and the pathogenesis of the disease. And we know it's a heterogeneous disease with multiple pathways involved. Cenerimod the only drug that targets all these pathways. The other drug that you see in Phase II go after one specific pathway.

At the end of the day, it's a heterogeneous disease, there will be room for multimodal administration. I believe that this is how drugs will continue to be used in this disease because of the heterogenicity of the disease. And therefore, having other assets coming in is not necessarily detrimental to scenario. Cenerimod has the opportunity to be the first treatment prior to biologic treatment based on the benefit risk that we've observed in Phase I.

And lastly, Bill, we've gotten through the whole conversation without talking about generics. Generics has been a key part of the business historically. So how should investors think about the strategic value of generics to the company longer term. If some of the branded pipeline pivot is ultimately successful. Do you still see the business? Is it a priority to remain a hybrid business that leverages the cash flows from generics with select targeted investment with shifting focus to brands?

Yes, I think it's a good question. It's certainly one where the company really has a dual category approach. If you think about the value of generics access to medicines -- you think about what we've done to move the portfolio up the value chain into more complex products. We laid out a bunch of those at the investor event, not only injectables, but other technologies. It's also as we start to pivot into the 2030s thinking about what role we can play in the GLP-1 space. So I think when you look at generics always having a role, but think about it as a selective role in terms of where we can win.

And I think you've seen that now with our complex strategy on the generic side, but also in other areas of the world, particularly Europe, we have a very healthy generics business. Sometimes, it doesn't probably get the attention it deserves. But I think you should continue to think about us from a branded and a generics perspective going forward.

All right. Great. Thank you, gentlemen.

Thank you. Appreciate question.

Thank you.

Good morning, and welcome to the Viatris First Quarter 2026 Earnings Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Bill Szablewski, Head of Capital Markets. Please go ahead.

Good morning, everyone. Welcome to our Q1 2026 earnings call. With us today is our 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'll 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 2026 actual or reported results, we will be making certain comparisons to 2025 actual 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 pleased to report another strong quarter. We're off to an exceptional start to the year. Before I get into the results, we recently presented our plan for long-term sustainable growth, driven by 3 strategic imperatives: driving our base business, fueling our innovative portfolio, and modernizing for sustainable growth. What you're seeing in our results is proof that, that strategy is working.

In the first quarter, we delivered total revenues of $3.5 billion, up 3% from a year ago, adjusted EBITDA of $1 billion and adjusted EPS of $0.59 per share. Our overall performance reinforces the growth trajectory of our business. And based on what we're seeing, we're confident in our outlook for the remainder of the year.

Let me briefly touch on what's driving that confidence. First, on the commercial side, execution remains strong. Notably, Greater China was a significant contributor this quarter. We're seeing strong execution and our commercial investments are leading to accelerated growth. In Japan, momentum is building following the launch of EFFEXOR for generalized anxiety disorder.

We're expecting to see a return to growth with the EFFEXOR launch and several more launches expected in the coming years in this strategically important market. Second, on the pipeline, we're continuing to make progress. We've already achieved regulatory approval for 1 of our 6 product candidates we're anticipating this year, EFFEXOR for GAD in Japan. We remain on track for the remaining 5 regulatory decisions in the second half of the year, including our weekly contraceptive patch XULANE LO and our fast-acting meloxicam. We are excited about these upcoming U.S. launches, which we believe will be important for patients and also accelerate our growth.

We have a highly experienced and talented leadership team in place with a strong track record of successful launch execution and we're confident we have the right people and capabilities to deliver. Our Phase III programs for selatogrel and cenerimod remain on track and represent important potential longer-term growth drivers. That said, our near-term focus is squarely on execution, securing approvals, launching products effectively and building momentum.

Third, capital allocation. We continue to take a disciplined approach. We intend to deploy our capital in a balanced way, returning capital to shareholders through dividends and share repurchases and investing in the business to support sustainable growth. Business development is an important component of our strategy. We're focused on opportunities that are in-market, accretive and aligned with our capabilities to strengthen the durability of our growth profile.

And finally, on the organization. We're making progress on the opportunities identified through our enterprise-wide strategic review to optimize our cost structure, improve resource allocation and drive operational efficiency. We are on track to deliver those savings while also reinvesting in the business to support future growth. In summary, it's a great start to the year. There's strong momentum in the business, and we are well positioned for sustained revenue and earnings growth.

Before I turn it over to Philippe, I want to thank Doretta Mistras for her significant contribution as CFO over the past 2 years. Her leadership has played an important role in helping prepare the company to enter a period of sustainable future growth. With Doretta's transition, I'm pleased to have Paul Campbell step into the role of Interim Chief Financial Officer. Paul brings deep experience, a thorough understanding of our business and a long tenure with the company, making him ideally positioned to ensure continuity and maintain operational discipline.

With that, I'll turn it over to Philippe to go through some pipeline updates.

Thank you, Scott. We've had a strong start of the year, continuing to advance our value-added and innovative portfolio while executing on our generic pipeline. Let me begin with fast-acting meloxicam for the treatment of moderate-to-severe acute pain. Our NDA has been accepted for review by FDA. We remain confident that we will receive the regulatory decision by year-end, pending confirmation from FDA on a PDUFA goal date.

We continue to believe that the strength of our data supports inclusion of opioid-sparing language in our label, acknowledging that this will be subject to review and discussion with FDA. Regarding [ XULANE LO ], our low-dose estrogen transdermal contraceptive patch. We remain on track against the expected PDUFA goal date of July 30, 2026, and continue to see strong engagement at key medical congresses. Most recently, at ACOG, the American College of Obstetricians and Gynecologists Annual Meeting, we presented 6 abstracts, including positive results from our previously announced Phase III study as well as new data on adhesion performance under both normal and extreme conditions, pharmacokinetics and cycle control.

Within our eye care portfolio, the phentolamine ophthalmic solution Phase III data for the treatment of presbyopia has been presented at multiple congresses and our sNDA remains on track against an assigned PDUFA goal date of October 17, 2026. I will now highlight key milestones in Japan. In March, as anticipated, we received approval for EFFEXOR in adults with generalized anxiety disorder. For pitolisant, with regulatory reviews progressing well, we expect PMDA regulatory decisions for 2 indications in the second half of this year for excessive daytime sleepiness associated with obstructive sleep apnea and associated with narcolepsy type 1 and 2.

Lastly, we continue to progress our Phase III study of Nefecon for the treatment of IgA nephropathy in Japan and remain on track for a top line readout in the first half of this year. These milestones underscore the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address significant unmet needs. Turning to Creon in Europe, which is considered the standard of care for pancreatic exocrine insufficiency treatment due to different underlying conditions and is another value-added medicine in our pipeline. We conducted a Phase III study in non-cystic fibrosis patients to determine whether dose escalation to double or triple the currently approved dose allows for the achievement of better symptom control and nutritional status.

The interim analysis showed that approximately 76% of patients were not adequately treated with the maximum approved dose of Creon for this indication and benefited from a further dose increase. The study medication was well tolerated at these higher doses. Based on this data, together with an increased body of real-world evidence and in consultation with German Health Authority, we intend to file a type 2 variation in Europe before the end of the year and anticipate an approved label update in the first half of 2027. This will be followed by additional submissions outside of Europe where applicable.

Together with significantly expanded manufacturing capacity, we expect this will position Creon for sustainable growth and bridge an important unmet medical need for patients. Regarding INPEFA, we continue to progress our regulatory applications and anticipate additional regulatory decisions in key markets this year.

Turning to our innovative global Phase III program, selatogrel and cenerimod. For selatogrel, we continue to maintain an enrollment rate of approximately 1,200 patients per month in our SOS-AMI Phase III study, keeping us on track to potentially reach full enrollment by the end of 2026. For cenerimod, our Phase III studies in the SLE OPUS-1 and 2 are fully enrolled, and we expect results for both studies in the first half of 2027. And importantly, regarding our generic portfolio, we continue to drive excellence in execution and are making significant progress in meeting our submissions and approval goals for the year. In particular, with regard to our complex generics pipeline, we remain on track for FDA regulatory decisions this year on our iron ferric carboxymaltose injection and rotigotine patch.

Additionally, we have already secured approval of our generic to Abilify Maintena, which is on track to launch in the U.S. before the end of the year. Our continued pipeline momentum reinforces our confidence for the rest of the year and beyond, driven by disciplined execution across our innovative value-added and generic programs and a clear focus on advancing meaningful medicines for patients. With that, I'll turn it over to Paul.

Thank you, Philippe, and good morning, everyone. Let me begin by briefly introducing myself. I have served as the company's Chief Accounting Officer and Corporate Controller for nearly 10 years. I've been with the company, including legacy Mylan for more than 23 years. With that perspective, I can honestly say that I've never been more excited about the future of the company, and I'm very happy to be with you this morning.

Regarding our results, I am pleased to report that we're off to a strong start this year, reflecting the strength of our global portfolio and continued execution of our strategy to enable us to deliver sustainable revenue and adjusted earnings growth. This morning, I'll cover the drivers of our strong first quarter performance and how this performance provides us with confidence in delivering our outlook for the remainder of the year.

Beginning with our first quarter results. Total revenues were $3.5 billion, representing operational growth of 3% year-over-year. This performance was driven primarily by accelerated growth in our cardiovascular portfolio in Greater China and strong generics performance in North America. Now let me walk you through the segment performance.

In developed markets, net sales increased by 1% versus the prior year, which was roughly in line with our expectations. North America grew 3%, driven by increased demand for estradiol, continued strong performance from Breyna and new product revenue contributions from complex generic launches.

In Europe, net sales declined approximately 1% versus the prior year, mainly due to softer market conditions in select countries, anticipated competitive pressure on Dymista and certain supply constraints. That said, the underlying fundamentals in Europe remains strong, driven by the performance of key brands such as Creon, contributions from new product revenues and solid growth in Italy.

Turning to emerging markets. Net sales were flat year-over-year, which was below our expectations. Performance was supported by continued strength in our established brands across certain key markets. This was offset by supply constraints in our lower margin ARV portfolio.

Within JANZ, net sales decreased approximately 2% versus the prior year, but coming in above our expectations. The decline was driven by anticipated increased competition in Australia and the impact of government price regulations in Japan. This was partially offset by solid performance from key brands, including Creon and Amitiza.

Lastly, we delivered a very strong quarter in Greater China with growth accelerating ahead of expectations at 18% year-over-year. The main drivers of this performance were favorable market fundamentals, including an aging population and increasing demand for cardiovascular products, the cumulative impact of our strategic selling and marketing investments and growth across all channels and more specifically, our continued focus on growing demand through e-commerce platforms, where sales more than doubled compared to the prior year.

Moving to the remainder of the P&L. Adjusted gross margin was 56% in the quarter, flat versus the prior year. Margins were slightly better than expected driven by favorable product mix. Operating expenses were also favorable versus the prior year, reflecting our disciplined cost management, cost savings from the implementation of our enterprise-wide strategic review and from the phasing of spend.

In addition, we continue to generate strong and durable free cash flow. During the quarter, we generated $348 million of cash, inclusive of transaction and restructuring-related costs and taxes. Excluding these items, free cash flow would have been about $459 million.

Turning to capital allocation. We continue to expect more than $2.5 billion of cash available for deployment during 2026, providing meaningful flexibility to execute against all of our stated capital allocation priorities. During the quarter, we returned $140 million of capital to shareholders through our dividend.

Based on our strong first quarter performance and favorable trends, we are reaffirming our guidance ranges. As we think about our outlook for total revenues, we now expect stronger growth in Greater China in the range of mid- to high-single digits, and delayed competition for Amitiza in Japan. These tailwinds are expected to be partially offset by certain temporary supply constraints related to lower-margin generics and additional competitive pressure across generics in developed markets.

Lastly, a comment about foreign currency exchange rates. If current rates were to hold for the remainder of the year, we would expect an incremental 1% tailwind on total revenues and adjusted EBITDA. Turning to phasing for the remainder of the year. Total revenues, adjusted EBITDA and adjusted EPS are still expected to be weighted to the second half at approximately 52% of our full year outlook. This reflects normal product seasonality and the timing of new product launches and takes into account the expected ramp-up in operating expenses through the year.

Free cash flow is also expected to be higher in the second half, reflecting the timing of working capital and benefiting from a step-down in onetime operating cash costs. In closing, we are highly confident in the strength and durability of our business. The first quarter demonstrates continued strong execution against our strategy to deliver sustainable revenue and adjusted earnings growth while generating substantial free cash flow for our balanced capital allocation framework.

Because of the strong momentum of the first quarter results, we believe we are well positioned to meet or potentially exceed our expectations for the remainder of the year.

With that said, I'll hand it back to the operator to begin Q&A.

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

Scott, congrats on finally getting to the point where the quarters are sort of clean year-over-year and it's a lot easier to interpret. When you look at these results, it looks like you've got very strong incremental contribution from both brands and generics and then on the geography side, from China in particular.

And in your prepared remarks, you suggested it was strong execution and commercial efforts. But the growth rate doubled in that geography. And so I'm trying to get a better sense of the stability of -- or I shouldn't say stability, the durability of that strength and the momentum that you've seen and trying to reconcile that with maintaining the guidance given that 1Q is already sort of running ahead of, I guess, your overall expectation for the year? And then I just had a follow-up for Philippe.

Yes, relative to maintaining guidance, so I guess I'll take it a little bit backwards, right? It's early. We're really, really pleased with the quarter, clean quarter, as you say, strong quarter. We're pleased that it's just early, and we'll continue to monitor and when we get to Q2, we'll update you at that point in time. But I feel very, very good about it.

Yes, it was a clean quarter, driven a lot by revenue in China and North America. You asked about China. I've been involved with business in China since the late '90s. I actually ran China operations for a prior company, and so I'm close to that market. It's the strongest China market over the last 12, 18 months that I've ever seen, both on the innovative side and on the total side. So China is very, very strong, and we're very, very pleased with our performance there. So -- but it's not just the market, right? We also have a very strong team in China. We've made a lot of investments in China, particularly on the e-commerce side, and we're starting to see those pay off now. So we're very, very pleased with the China performance.

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

No, go ahead.

Yes, on your question about the durability, I mean, we -- you've heard from my remarks, we've increased our expectation from the beginning of the year of low-single digits to now mid- to high-single-digit growth in China. However, there's always the policy risk that's very dynamic and unpredictable. And as Scott said, it's too early in the year for us to really be that bullish on it, but we'll monitor through Q2, and we'll let you know.

And maybe I can add in terms of the outlook for China, we are very confident that we will see no policy change this year. One thing we have done, and Scott just mentioned it, is that we have consistently invested in our commercial platforms. And switching the -- transitioning the business from hospitals that are most susceptible to policy changes to retail and e-commerce. And e-commerce this year, in this first quarter we've seen a doubling of our sales in this channel. So good success from our perspective.

Okay. Maybe if I could just ask a quick follow-up to Philippe. Philippe, thanks for all the detail on all the pipeline stuff. But what I was hoping to try to do is maybe just sort of boil it down a little bit for investors in terms of what you think the biggest opportunities are here over the next 12 months. And I think you said you expect to get a decision on the estrogen patch by the end of July and on fast-acting meloxicam sometime in 4Q.

And then I think as we look to 27, we have cenerimod, the readouts coming in the first half of the year and selatogrel maybe behind that in late '27. Are those sort of the 4 biggest opportunities that you see? Or is there something else you'd add to that mix? And I'll stop there.

Thanks for the question. So as you point out, importantly, in the U.S., we have meloxicam and [ XULANE LO ] this year. I think these are 2 key important launch for us, supported by very strong clinical data. The review process for these 2 assets with the agency, with the FDA is going as planned. And so we have good confidence that we'll get the approval by the time of the PDUFA for [ XULANE LO and later in the second half for meloxicam, we're still waiting for FDA to give us that PDUFA date. It should be coming very, very soon. Japan remains very important for us. As you heard from Scott, we have a number of readouts and approvals in Japan this year, particularly pitolisant is our next approval in the second half of the year, early second half and that will be followed also by important data for Nefecon in IgA nephropathy.

So Japan is -- we're getting the approvals we need, and we'll -- we have a strong team there that has experience in launching these types of assets.

And then finally, to your point, selatogrel, cenerimod, everything is on schedule. Everything is behaving like we have planned. So everything is working according to plan and we'll get data very, very late this year, early next year for cenerimod and followed by selatogrel in the first half of the year is what we anticipate.

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

The next question is from Umer Raffat with Evercore.

I have 2, if I may. First, if you could just expand on the free cash flow year-over-year and what some of the drivers are. But secondly, and perhaps more importantly, I just wanted to expand on the selatogrel trial in the cardiovascular setting. And specifically, I feel like there hasn't been an appropriate amount of discussion on the endpoint.

So the way I understand it, and Philippe, I would love for you to correct me. The way I understand it is it's not a composite endpoint. Instead, it's 1 of 6 things that could happen on an ordinal scale. And per patient, the worst thing is taken forward. So I guess my question is, if someone has a STEMI versus a death, how -- is there like a score that's assigned to those 2 different events? But also, I would imagine because there's 5 different things that could contribute into this primary endpoint, and there's probably a score assigned to each one of them, what happens if you have more NSTEMIs and less deaths than you were anticipating in your sample size, would you need to do a sample size reestimation and when will that happen?

Thank you, Umer. Thank you for your questions. First, I'll have Paul talk a little bit about -- to give some detail around the cash flow and then Philippe can get into the selatogrel endpoints, the study design and beyond.

Sure. So as far as the change year-over-year in Q1, I think it's important to point out that even though it's down, it exceeded our expectations, what we thought was going to happen for the quarter. But essentially, the drivers are timing and net working capital, which is both the timing and then we had business growth this year and last year's comparative period, we had a decline. And then our onetime cost did increase year-over-year. Those are the main drivers.

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

The way it's calculated, it is the worst outcome for the patient that is taking into account. So if you're -- a patient has 2 events, as death and STEMI, for instance, then the death will be the adjudication that will be taken into account for the calculation of the endpoint. What we're intending to see is a relative risk reduction of about 20%. That's how the study is powered, and that's what we anticipate to see as part of the assumption to designing the study.

So I think it's relatively straightforward from that standpoint. Adjudication is happening by blinded -- by an unblinded committee that looks at the severity of the outcome and determine which one is for us to take into account. The outcome we anticipate to see is that patients -- you will see a reduction -- if the study works as advertised, you will see a reduction of severity in the selatogrel arm versus the placebo arm, right? So there will be less patient with death, less patient with severe acute MI versus placebo. That's -- that risk reduction, if you will, that will be characterized that way. So a lot more to go -- we can go into a lot more detail about this endpoint, but I think that should answer your question at this point.

Yes. And before the next question and on a much less granular level, I'm really pleased with the execution from a clinical development perspective for selatogrel and for cenerimod, but we've accelerated the enrollment of obviously, both of those fully enrolled now with cenerimod, and right now, we are enrolling approximately 1,200 patients a month in the selatogrel study, which is a pretty strong number. So we're very pleased with how those are progressing. We're looking forward to turning over those cards and seeing those results and see what we get, but very, very pleased with the clinical development execution thus far.

The next question is from Matt Dellatorre with Goldman Sachs.

Congrats on the strong quarter. Maybe coming back to fast-acting meloxicam just briefly, could you comment on whether priority review is still a possibility there? And then anything further you could share regarding the expected label? I know you said in the prepared remarks, you do expect opioid sparing to be on the label to some degree, but just anything kind of further you could share would be helpful.

And then maybe with regard to the cost savings, could you comment on progress with regard to achieving -- I think you've put out an estimate of 30% of that $400 million in net savings this year. And then I realize there's some offsets this year in terms of mix shift and LOEs that you don't expect that to flow through to margins. But perhaps walk us through what the base case and the upside case looks like in '27 and '28 with respect to EBITDA margins.

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

Yes. So I think it's important, as Scott said, part of our beat in the quarter was related to OpEx. And OpEx comes -- lower OpEx comes from our disciplined cost management. And then, obviously, there's a little bit of phasing in there. And then the cost savings program, as you pointed out, I think it's about $120 million. If you do the math on what we expected for this year, we're on track to deliver that for this year. And we do expect that operating leverage to continue as the savings flow in, not only the rest of this year but into the next few years also.

Philippe, around meloxicam regulatory and label?

So we anticipate that the agency -- we're expecting that the agency will be giving us the PDUFA date and timing of review within the next couple of weeks. So we should get much more visibility on that timing, and we will let you know. In terms of the label, there is clearly based on the data our expectation is that the opioid-sparing language will be included as part of the label, where it is exactly in the label will be a matter of review and discussion with the agency.

But our expectation is that the data that supports opioid sparing will be included as part of the label, they were our key secondary endpoints. They were discussed and designed in collaboration with the agency. So we have -- we believe that they will be included in the label.

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

No, that's a great point, Corinne, that overall, the data is very, very strong. The opioid sparing is an important part of the data, but it's just part of the overall data, which, again, really looks very, very strong, and we're very hopeful about -- and anxious in a good way about getting to the launch and getting it out there. We think it's going to be a very important product for us in '27 and beyond.

The next question is from Les Sulewski with Truist Securities.

Congrats on the progress. I appreciate you providing the new product contribution figure of $71 million. Could you comment on that? How much of that was tied to product sales versus onetime channel stocking? And is this a figure you intend to provide moving forward? And then on the BD front, it appears the market has been -- is a lot more active now. Has the bar for BD changed, given the strong start to the year and the $2.5 billion cash available? And then lastly, how should we think about the CFO transition? Should investors expect any change in capital allocation or disclosure or on the cost savings side?

Maybe we'll just take it from the bottom and go forward. So first of all, on the CFO question, we should expect no changes to capital allocation or financial policy with no expectations at all. And since it's been brought up, the first thing besides the fact there will be no changes, I'd like to thank Doretta for being a great partner to me. She's leaving to pursue another opportunity on the West Coast and her leadership played an important role in helping prepare the company to enter a period of sustainable growth.

Having said that, I'm thrilled to have Paul sitting here beside me, I've got tremendous confidence in him as the interim CFO. He's got a long tenure, a tremendous understanding of our business, and we're very, very lucky to have him. So I feel very good about the CFO transition and how that's going.

From a BD perspective, yes, it's a little -- there seems to be a lot of activity going on right now. BD priorities have not changed. We're looking for in-market accretive assets that can help fuel our growth as we go into the future. There's lots of things out there, I think, that are sort of in our sweet spot, right, that may be a little bit too small for the big pharma world, but the right size for us.

And so we want to -- embedded in the BD question is capital allocation. We want to remain balanced, right? We're going to continue to return to shareholders through dividends and share repurchases, but we're also going to be aggressive in business development and we want to be able to, over the next period of time, continue with the internal efforts on the pipeline, build a portfolio of growth assets to help fuel our future sustainable growth.

So we're excited about having the cash available to enter into business development and support the strong base business and the pipeline that we're developing.

Okay. Yes. On the new product revenue, so I think that's a figure that we generally give out each quarter so that we can all track against it. The $71 million included the launches of iron sucrose and octreotide for us, and it was actually in line with our expectations. We've always said or we said at -- in February that we expected a ramp over the course of the year in the new product revenue. So it's definitely more heavily weighted to the second half.

And then as far as the question on channel inventories, our channel inventories are very normal and standard. There's no significant impact or increase in those inventories that drove any of the results for the first quarter.

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

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

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

Thank you for the question. Corinne?

Yes. Thank you, Melanie. So for the launch of fast-acting meloxicam, we've done a lot of work to really identify the key target for us. We have a specialty approach, meaning that we are going to go after the patients that are treated in the outpatient setting, but really postoperative pain as a start. And in terms of sizing of our sales force, we are thinking of building a sales force of about 150 to 200 reps.

And potentially going beyond this through partnerships as we develop this product further and target more nonoperative pain at this point, dentistry and other type of pain. And this we would do in partnership very likely.

The next question is from David Amsellem with Piper Sandler.

So at a high level, Scott, I want to get a better sense of what Viatris is aspiring to be regarding the innovative business in the United States. You've got an immunology program. You've got a cardiovascular program. You've talked about pain. So there's a number of different therapeutic verticals that potentially you're going to have your hands in commercially.

So can you help us better understand how you're thinking about leveraging those verticals? And I realize that's a high-class problem to the extent that cenerimod and/or selatogrel work. But I think it would be helpful to illuminate us on how are you thinking about that?

And then secondly, I know you talked about accretive M&A, commercial stage M&A. But can you also talk about the extent to which you want to take on additional R&D risk via in-licensing, the kinds where you have relatively small upfront payments, and you're not really doing anything to your capital structure, but you're bolstering the pipeline. Is that something that's going to be a priority in parallel to your priorities related to commercial stage M&A?

Thank you, David. I wouldn't say a priority. I think over a 5-year period, we will likely put some things into the pipeline that are early clinical. But right now, we're focused on in-market accretive assets that we can be good owners of. And so that's our focus. Again, over the next 5 years, there may be some things that come into the pipeline, but it's not the same priority as focusing on things which are in-market accretive and can help drive our revenue and EBITDA in the short term.

Therapeutic indication.

On the U.S., yes, therapeutic indications. Again, we're a little less focused on therapeutic indications than we are about can we be good owners of these assets? Do we have the right people? Do they fit the portfolios going forward. Even though there may be a couple of different, as you said, a high-class problem, of Phase III programs being successful and also launching in the U.S., we're going to have a specialty focus. These are not huge from a spend perspective.

We're not going into primary care. We're not going to have thousands of sales reps out there. We feel we can build strong therapeutically focused sales forces that are able to deliver good results. And the way that I look at it is if you had a positive, for example, result with cenerimod and we're launching cenerimod, that's a cornerstone product in that therapeutic area.

We launched that successfully, and we continue to add products there. We don't want to be in everything, right? And we're trying to find good assets that can be cornerstone products, and then we'll build on those from a therapeutic perspective as we move forward.

And David, if I can comment also on how we build infrastructure in the U.S., I think it's very important to understand, and I mentioned it for fast-acting meloxicam that we have a very targeted specialty-driven approach, so the sales force will never be beyond 200 people. It's really what we are looking at doing.

And I can give the example of women's health as well where we have a portfolio of products that go to launch with [ XULANE LO ] first, but then we have other products that will launch in a couple of years. Again, a sales force that will be maybe 70 people at the most and that's how we're going to look at launching those products. Beyond this, as I said, it will be in partnerships.

The next question is from Chris Schott with JPMorgan.

This is Ethan on for Chris Schott. Congrats on the great quarter. Just starting off maybe with generic semaglutide beginning to enter in some specific markets. Just wondering if there's any learnings that you've been taking away thus far and more broadly, how you're thinking about that generic GLP-1 opportunity, including potential sizing and timing of any contribution to Viatris.

And then my second question is just on the ARV business. How are you thinking about the go-forward impact of the supply constraints that you highlighted this quarter?

So Philippe, talk a little bit about our GLP-1 strategy, which is going to be important to our future. It's a driver more in the 2030 and beyond time frame than in the short term. But very important to our long-term strategy, the GLP-1 strategy. Philippe?

Yes. So we are -- we intend to be a significant player in the GLP-1 space. We are developing every GLP-1s that are currently approved. This is, as you know, a market that is very dynamic. And so we got to be ready for whatever changes may be coming and leverage that.

I think we are particularly focusing on the U.S. because this is an area -- this is a region where we believe we have the opportunity to differentiate versus other potential generic players, in particular, around our ability to come up with the right auto-injector to be substituted for instance.

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

It's a complicated area, right? There's a number of molecules out there. There's a number of indications, there's different dosage forms. There's different applications. And so it's very, very complicated out there, but we want to be thoughtful on where we go. We want to make the right kind of investments. And I think as a company, given our device expertise and other things, I think we are uniquely qualified to participate in this marketplace in the future.

Yes. As far as the ARV business, from a supply disruption perspective, it's important to note that we've mitigated by moving production to additional sources if we can. The team is working very hard to alleviate those constraints. And I think we're getting -- making significant progress there.

We're going to hopefully ramp up supply sooner rather than later. But I think it's also very important to point out that in our updated forecast, we've included all the risks that we currently see. So it's all baked into the numbers that give us confidence that we're going to deliver for the rest of the year.

And as I said in my remarks, it might be some upside to those numbers. We'll see how the rest of the year goes.

The next question is from Ash Verma with UBS.

Circling through a few calls here. And congrats on the revenue growth, particularly strong. I know at the Investor Day, you had outlined the long-term goal of growing 4% organic. And here, you're doing pretty well at 3% in 1Q, just trying to get a sense of how soon can we get there at the 4% run rate. Is that something that's feasible, let's say, later this year or 2027? Or is that more of a subject of some of the branded pipeline kicking in, and that would enable that growth?

Yes. The 4% number is where we expect to get by 2030. And along the way, starting off this quarter with 3% growth, I think, is a strong start to that. We feel very confident in our ability to deliver those long-term targets that we put out there. And again, the strength of this kind of first quarter, it's early, right? relative to long-term targets, but we feel very, very good about where those targets sit and about our performance and our ability to hit those targets.

And again, we will have, in this period, significant cash to be able to supplement what we're doing. We've got a very large number of clinical readouts coming, and we've got a lot of launches right now. So we expect to see that growth ramp up as we go into '27, '28, '29.

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

Thank you very much, and thank you all for participating in the call this morning. Obviously, I'm really excited about the exceptionally strong performance this quarter and the momentum that we're seeing in our business. We delivered 3% revenue growth and 10% adjusted EBITDA growth this quarter.

We are expecting multiple near-term pipeline catalysts and product launches and we have significant financial flexibility to execute our capital allocation plan and accelerate shareholder value. As we move through 2026, our focus remains on disciplined execution and continuing to build a more durable, higher-quality growth profile. Thank you very much for your time today.

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

Ladies and gentlemen, please welcome Head of Capital Markets Viatris, Bill Szablewski.

Good morning, everyone, and welcome to our Viatris Investor event. I'm Bill Szablewski, Head of Capital Markets and Investor Relations. It's great to see everyone here in a full room today. Before we begin, a few comments on our forward-looking and disclaimer.

During today's discussion, we will be making forward-looking statements on a number of matters, including our strategic initiatives and priorities, pipeline, products and long-term financial targets. These statements are subject to risks and uncertainties that could cause future results to differ materially from today's presentation.

Please refer to today's presentation and our SEC filings for more information. And with that, I'm pleased to introduce our leadership team. Starting with our CEO, Scott Smith; our Chief R&D Officer, Philippe Martin; our Chief Commercial Officer, Corinne Le Goff; our Chief Strategy Officer, Hemanth Varghese; and our Chief Financial Officer, Doretta Mistras. And with that, now I'd like to hand over today's presentation to Scott.

Thank you, Bill. Thank you very much, and thank you all for being here today. We're very excited about getting going here, talking about what's been accomplished to date, where we sit today and where we're going, particularly over the next 3 to 5 years.

We're very, very excited about the position the company is in and where we're going. You're going to see a lot of me today getting up and down, introducing speakers, talking about the business. But before we get into the bulk of the presentation, I just want to show a couple of quick slides to set the table for the presentation. So as many of you who followed the story know, we've done a lot of work over the last 5 years to get the company in the position it is today.

We've merged 2 companies, divested 4 major businesses, stabilized and returned the base business to growth, which is very, very important for our growth story going forward, strengthened the balance sheet, returned capital to shareholders, invested in innovation, refreshed the leadership team and the Board. And again, we'll talk about that a little bit later as well and completed an enterprise-wide strategic review.

These were purposeful actions that collectively have positioned us for the next phase. As we enter into '26 and beyond, we're more focused, more efficient, more future-ready organization. If we take a look at where we sit today, we're a strong, diversified global health care company.

We actually have 3 businesses that we run. We've got a global generics powerhouse business that we run. We've got an established brands business that has some of the most iconic brands in the world, Lipitors, Norvasc, CELEBREX, Xanax, Viagra, just to name a few. And we've got a growing innovative medicines business.

As we mentioned in February, we expect to generate approximately $14.7 billion in revenue this year, $4.3 billion in adjusted EBITDA and $2.40 a share in EPS and generate approximately $2.2 billion in free cash flow. We operate in 165 countries.

We have approximately 1,300 unique products -- we reach roughly 1 billion patients annually with our medication, which is a pretty remarkable statistic and makes us the most far-reaching company in the health care world in terms of the number of patients that we touch on an annual basis.

It gives us a tremendous platform to be able to positively affect the outcome of human health care. So something we're very, very proud of. And we also have 27 manufacturing and packaging distribution sites all around the world. These are our '26 and beyond strategic initiatives, drive the base business, fuel our innovative portfolio and modernize for sustainable growth.

We're driving our base business, disciplined execution, evolving the portfolio towards durable, higher-margin generic products, 505(b)(2)s and others, and we've done, I think, a pretty good job over the last couple of years of bringing those forward. We want to fuel the innovative portfolio, both the pipeline internally and looking for things externally, innovative assets, in market accretive assets that we can bring and really drive our growth. And we'll talk a lot about that as we go forward.

And we also want to modernize the company for sustainable growth. We want to simplify our structure, enhance our resource allocation and strengthen our capabilities. So these are the critical strategic initiatives that you're going to hear a lot about as we go through the presentation. Just a little bit on capital allocation, and it's going to be a focus of Doretta's presentation as we go forward here.

So I won't steal her thunder too much, but I just want you to know that between now and 2030, we're going to generate at least $11 billion in cash and deploy it. We're going to be balanced as we have been in the past between returning capital to shareholders and doing business development, which is a little bit of a new angle for us. We've done a little bit of business development, but having that capital to deploy to build a portfolio of growth assets to go alongside what is a strengthening and growing base business gives us the ability to feel very confident about the targets that we're talking about in the future.

And those targets are, as we take a look at 2030, we expect to see 5% to 6% total revenue growth, 7% to 8% adjusted EBITDA growth, 9% to 10% adjusted EPS growth. And I think very importantly, more than $3 billion a year in annual free cash flow by the time we get to 2030. Important to note, these long-term targets consist of base business targets, combined with other potential additional drivers, including cenerimod, selatogrel and the addition of accretive business development. But I can't emphasize enough how important that solid base business, which we've now turned to growth is for what our future prospects look like. What we do with cenerimod, selatogrel business development builds off that solid base that we've managed to create over the last couple of years.

Doretta is going to talk through much more explicitly the financial drivers behind these targets, and you'll get a good understanding of how we go from base business, other drivers to the long-term combined targets that we have for 2023. So that will be an important focus of her presentation. Here's sort of the lineup for today. We're going to talk about R&D capabilities in the pipeline first. which is very, very important. We made a lot of pipeline progress over the last little while, and we expect to continue to do so over the next few years.

Our commercial capabilities and building blocks for growth. And I think our commercial organization, we take a look at the assets that the company has, I think our commercial organization, the strength of that, the breadth of that geographically is really one of the strengths of the company. So that's going to be -- and Corinne is going to talk about that and how we not only continue to support the base, but also pivot to innovative products as well.

Hemanth is going to talk a little bit about our portfolio strategy and business development and where we're going and how we see accomplishing our business development goals. And then Doretta is going to wrap up before we get to Q&A with -- taking a look at the financial framework, capital allocation strategy, how do we get to our long-term targets and how do we really accelerate shareholder value.

So those are the 4 major portions of the presentation today. The first one is, as I say, on pipeline, and [ Philippe ] my turn is going to come up. Just to give you -- for those of you who don't know Philippe, he was the Chief R&D Officer. He is the Chief R&D Officer of Viatris.

A bad time to break that news, right? He's a highly, highly experienced R&D leader with over 25 years of experience. He's worked prior -- he was prior Chief of R&D at BioAtla. He had many leadership positions at Celgene. He's developed -- either been involved with or been [ signilarly ] responsible for the development of some very significant molecules in the world today, REMICADE, Cimzia, Otezla, Zeposia, just to name a few.

So Philippe has been the engine behind the research and development of a number of blockbuster drugs, and we hope he continues to do that the same. His job is to continue to focus on the pipeline, again, the base pipeline, continuing to drive there, but also starting to bring in more and more innovative products into that pipeline. So without further ado, Philippe?

Thank you, Scott.

All right. Good morning, everyone. It's a real pleasure to have the opportunity to go over Viatris R&D capabilities and pipeline. So first, let me start by saying that in R&D, we look at our portfolio in 3 distinct areas. First, our generic medicines, which is composed of our core and complex generics and for which we have a strong R&D foundation with our Mylan heritage.

Our value-added medicine is the second area that includes established brands and 505(b)(2)s for which we also have a strong R&D foundation with our Upjohn heritage. And then last is our innovative portfolio of medicine, which is emerging. And the recent acquisition of assets like selatogrel, cenerimod or pitolisant in Japan and their respective development teams have reinforced our expertise in the area of innovative development.

Now as Scott mentioned, the portfolio is evolving, and it's evolving more toward a more complex and differentiated assets. And in order to achieve that, our R&D team is using a broad range of capabilities, technologies and expertise. We also have a broad geographic presence, which is allowing us to tap into the best talent around the world and leverage their local knowledge to get our medicine approved around the world.

Now if we turn to our innovative capabilities specifically over -- as I said, over the last couple of years, we've added significant talent to our innovative platform through the Idorsia and Aculys acquisition. Together, they bring proven experience in developing and bringing innovative medicines to market.

Now importantly, these talents covered the -- all phases of development from IND to approval and life cycle management. So when you combine this existing -- we combine this talent with our existing CMC and medical affairs expertise that gives us all the tool we need, all the tool necessary to successfully develop innovative assets.

Now in addition to our talented colleagues, we've built significant expertise in the area of device technologies. And it's important because it's a cornerstone to the development of assets like respiratory medicine, like generic injectables, for instance, our GLP-1s or our transdermal patches like Xulane and Xulane low dose.

This deep knowledge also applies to our innovative portfolio. It's an important success factor for some of our innovative assets like selatogrel and its auto-injector. We have a long successful track record of developing and manufacturing this complex medicine and are building on this experience to develop our next wave of 505(b)(2) and complex injectables.

Now if we look at our complex injectable. So in addition to the device expertise, which is critical for complex injectables, we also have a deep expertise and proven track record in -- across a broad range of delivery and modified release technologies. But importantly, we've spent quite a bit of time and energy in developing our in-house analytical capabilities.

And that's important because for assets like complex generics, but like GLP-1s, oligonucleotides, a complex molecule, having these capabilities is critical in order to show API sameness. So we had many successes, including very recently in this area, and some of these successes are highlighted on this slide.

Now in addition to complex injectable, that I just mentioned, we have 3 additional key areas that will power our future growth in complex generics. And for these 3 areas, we are building on our proven capabilities in complex injectables and complex respiratory generics.

For GLP-1 specifically, we are covering the full spectrum of injectable and oral medicines. And we believe we're uniquely positioned for success with our integrated device -- drug device development and peptide formulation expertise.

The same applies to our oligonucleotides, where we'll leverage the same capabilities, but in this case, in particular, our strong identical chemistry team to meet the challenges of API sameness. Respiratory, we have a fully integrated development team here as well, and we have a very strong track record, and we'll be leveraging this talent and the team to develop our next-generation respiratory medicines.

Now turning to our medical affairs team. Having a strong patient-centered medical affairs team focused on our innovative and value-added portfolio of medicine is critical to our success and to our ability to launch innovative assets successfully. Through the Upjohn merger, we were able to retain a medical affairs team that is -- that has a strong track record in developing and launching iconic brands like Lipitor and Lyrica, brands that shape clinical practice.

So if we turn to the pipeline and our portfolio of value-added medicines, we have used the capabilities and technologies that I just mentioned to further leverage our existing portfolio of established brands. We've implemented a rigorous life cycle management to maximize the opportunity for each medicine.

And this year, we have multiple important milestones, including 4 anticipated regulatory decision, starting with Effexor in GAD in Generalized Anxiety Disorder in Japan in the first half of this year. But next, I will focus on our near-term U.S. opportunities, meloxicam and our transdermal patches. So for meloxicam, as you know, we are very proud of the strong data that we generated and believe that it's -- the clinical profile that we've seen is highly competitive.

We were able to demonstrate that fast-acting meloxicam has a pharmacokinetic profile and speed of onset that is far superior than Mobic. We were also able to demonstrate strong and sustained analgesic efficacy with a profile superior to placebo. And importantly, to the profile superior to its opioid comparator Tramadol in 2 different pain models.

And lastly, we were able to demonstrate that significant opioid-sparing effect for fast-acting meloxicam. And clearly, we intend to have that included as part of our product label. So we submitted our NDA earlier this year and anticipate we will get a regulatory decision in the second half of 2026.

Now switching to our portfolio of transdermal contraceptives. We are leveraging our experience with Xulane and our estrogen patches. We are developing weekly small, thin discrete patches that have the -- that have best-in-class adhesion. These patches are designed for today's patients' need and in particular, for patients seeking reduced or no estrogen exposure, which limit the potential for serious safety risks associated with prolonged exposure.

For our low-dose estrogen patch, FDA regulatory decision is anticipated in the second half of 2026, and this will be followed by our progestin-only patch for which Phase III enrollment is currently finishing. Now let me turn to our innovative portfolio. So we are focusing on assets that have a potential to have a differentiated profile and make a meaningful difference to patients.

We have multiple important milestones this year, including anticipated regulatory decision for Pitolisant in 2 different indications in Japan, sotagliflozin in Canada and Australia and data readout for Nefecon in IgA nephropathy in Japan.

So next, I will focus on our 2 most innovative assets, selatogrel and cenerimod.

So let me start with selatogrel. selatogrel is a P2Y12 inhibitor that is being investigated for patients self-administered emergency treatment of recurrent AMI. So in the treatment of acute MI, early intervention is key. Data, including recent data has shown that early platelet inhibition is key in driving better and long-term outcomes for patients.

Mechanistically, this is supported by the fact that the thrombus that is formed at the inception of the acute MI is platelet-rich, but within hours, will transition to fibrin-rich thrombus that is much less responsive to antiplatelet treatment.

There's currently no emergency treatment available for early intervention. Other commercially available P2Y12 inhibitors are either too slow to act from a PK/PD standpoint with a duration of effect that is too long and significantly in risk -- increases the risk of severe bleeding in case of emergency surgery or they cannot be self-administered due to their route of administration.

So selatogrel was developed specifically for the emergency treatment of acute MI. The profile demonstrated in Phase II is ideal for emergency treatment. We saw a robust and rapid effect that is of short duration, but that is long enough to give patients ample time to get to the hospital for proper diagnosis and treatment. That effect, importantly, was obtained on top of background chronic platelet therapy, either aspirin or aspirin in combination with P2Y12 inhibitors, typically Clopidogrel.

We did not observe any major bleeding events as part of the study, and that despite the fact that this patient were -- most of the patients were on background dual antiplatelet therapy. We believe that this is explained mechanistically by the high selectivity observed with selatogrel, which leads to no off-target effects interfering with hemostasis.

So this ideal profile led to the initiation of a large global registration study called SOSMI. I'm going to go over the design as briefly as I can. This is a simple design, though, that was developed in collaboration with KOLs and FDA under SPA.

Selatogrel was also granted Fast Track designation by the agency. So to be eligible, patients need to have a qualified AMI. The patient and the caregiver, including family members, are then trained to use the auto-injector and trained to recognize the symptom of acute MI, typically chest pain.

They are then randomized to placebo or selatogrel 1:1 and then followed until they have an event. An event is defined as an injection of either selatogrel or placebo. This is an event-driven study. The primary endpoint is death from any cause within 7 days or nonfatal AMI within 2 days after study treatment self-administration.

The outcomes are ranked based on severity from the most severe to the least severe outcome, and we are targeting a risk reduction of 20% as was observed in other antiplatelet studies that were studied on top of standard of care. That said, none of these studies were able to achieve platelet inhibition nearly as early as we think we'll be able to achieve with selatogrel.

Remember, time is muscle. So early intervention is key. So the primary endpoint is -- the primary safety endpoint is the occurrence of type 3 or 5 treatment-emergent bleeding event according to the BARC definition within 2 days of study treatment administration.

So what have we observed so far as part of this study? So this study is progressing as planned. Patients are self-injecting early. They are generally injecting for the right reasons and are following up with the proper diagnosis at the hospital. So far, we've not observed any signal -- safety signal, in particular, with regard to severe bleeding. An independent and unblinded safety committee has met 13 times and at this point, has recommended to continue the trial unchanged.

SOSMI is a large global study. We believe we'll hit the number of patients we need by year-end and anticipate a readout around the first half of 2027. Now let me turn to cenerimod. Cenerimod is an oral S1P1 receptor modulator that is being investigated for the treatment of SLE patients and lupus nephritis patients.

So SLE is a disease that affects many patients worldwide. This is an heterogeneous disease that affects female, a lot more than male and can range from mild to severe depending on which organ of the body are affected. Limited treatment option exists. They're ranging from old immunosuppressant, often combined with oral corticosteroids to more recent biologics.

Overall, the need for higher efficacy and better safety remains, in particular, with regards to the risk of serious infection, which can be very severe with these immunosuppressants and biologics. Due to the heterogeneous nature of the disease, a multimodal approach is expected to remain the standard of care for SLE treatment. So in summary, there is an unmet need -- a high unmet need that remains in the treatment of SLE, particularly for innovative oral therapy with a new MOA and a differentiated benefit risk profile when given on top of current standard of care and prior to biologic treatment.

Now cenerimod is an oral small molecule, an S1P1 receptor modulator, which as opposed to other treatment under development or approved treatment has been shown to act on the 3 pillars of SLE pathogenesis. S1P1 has a long track record. I should know I developed one that has a strong track record of efficacy and safety and as a disease-modifying therapy. And that we've seen that in 2 other T cells and B cell-driven autoimmune diseases like MS and ulcerative colitis.

Now we've generated robust data for cenerimod in SLE patients that demonstrates a highly competitive and importantly, very consistent profile across 3 Phase II studies at the chosen dose of 4 milligram. Let me focus on the largest data set, which is our Phase IIb CARE study that has shown a robust and consistent profile across all endpoints with the 4-milligram dose, which was the highest dose tested and the dose that has the most optimal benefit risk profile.

Regarding the primary endpoint, modified SLEDAI-2K at 6 months, we saw a clinically meaningful and nominally statistically significant effect with the 4-milligram dose. The secondary endpoint, which was SRI-4 response at 6 months was consistent with what we saw in the modified SLEDAI-2K. Now what was particularly important and impressive is that we saw an increased response in treatment effect in the preplanned analysis investigating patients with interferon-1 high signature.

Regarding the safety profile, we observed an optimized S1P profile. Particular importance, cenerimod was not associated with any increased risk of SAEs or infection and opportunistic infection. And that -- this infection remain a major concern for physician and SLE patients. So based on this robust profile and consistent profile, we initiated a large confirmatory pivotal program called OPUS, consists of 2 identical studies. They are multicenter, double-blind, placebo-controlled studies.

In each study, approximately 420 moderate to severe SLE patients receiving concurrent SLE background therapy will be randomized 1:1 to either cenerimod or placebo for 12 months. The primary endpoint is SRI-4 at month 12 compared to baseline, and patients will be stratified in 3 different stratas, including one with interferon-1 high, low. Importantly, we have a fourth oral corticosteroid tapering, which will be required from month 5 to month 8 in all subjects that have a baseline oral corticosteroid dose equal to or higher than 10 milligram at randomization.

So we've designed this confirmatory study and this pivotal program, taking into account the learnings from our Phase II study, learnings from recent Phase III studies and feedback from various health authorities, including FDA and EMA. This program was designed to maximize cenerimod treatment effect versus placebo.

So both studies are identical, as I mentioned, and well powered, which means that they can be pooled together to see a higher difference. Based on the data from our 2 Phase II studies, we've modified some of the inclusion criteria. And in particular, we are enriching the population for patients that are interferon-1 high.

We have a target of 70% and these studies are now enrolled, and we are above that 70%. And we also need to have patients that are more active than what we saw in the Phase II study. And so we've included a BILAG 1a and/or 2b entry criteria. Nothing is new here. This entry criteria have generally been used in Phase III studies across the board.

The primary endpoint is also now at 1 year. The data I was showing before was at 6 months for the Phase II study and 1 year is what is expected for a pivotal study in SLE. But importantly, that will allow our 4-milligram dose to reach full effect by 1 year. And also that duration allows for oral corticosteroid, which I mentioned is important and typically leads to an increased treatment effect versus placebo. Patients that are not able to taper off are considered nonresponder.

So as I said, fully -- the studies are now fully enrolled with an interferon-1 high percentage exceeding 70%. We anticipate results for both study in -- by the first half of 2027. We've also initiated an additional Phase III study in lupus nephritis that is currently actively enrolling.

And the S1P1 MOA is well suited for multiple expansion opportunities beyond SLE and lupus nephritis. So in summary, we've built a resilient R&D engine and are building on Viatris' strong foundation to drive next-generation innovation. Our pipeline has evolved and will continue to evolve over the next few years, but we have a significant number of near- and long-term catalysts across the pipeline from complex generics to value-added medicine and innovative medicines. I thank you for your attention. I think I was able to cover that in the time allowed it. So I will now turn it over to -- back to Scott. Thank you.

Thank you. And we're going to leave Philippe's last slide on here just for a second that something I'd like to address. First of all, I mean, we have a very strong R&D engine, both on the innovative side and on the generic side, importantly, been very productive, a lot of focus on the value-add medicines, 505(b)(2)s, et cetera.

We anticipate 95 approvals this year around the world. And it's important to know that I think a couple of those are on the innovative side with INPEFA and Pitolisant. We've got some of the value adds, particularly in the U.S., well, Effexor GAD in Japan. We've got Quinlo. We've got fast-acting Loxam. We've got the presbyopia, but that would leave 90 of them on the generic side.

And so we don't take our eye off that, right? Even though it's just a note here, there's too many to list, but it's of the 95 approvals that we're expecting during the course of the year, 90 of them on 89, 90 in the generic side, 4 or 5 on the value-add side and a couple on the innovative side. And we'll continue to evolve that portfolio. We'll never fully move away from the generics, but we will try and continue to evolve that portfolio towards higher margin, stickier revenue type of complex generics and 505(b)(2)s over time.

So I think we've made a lot of progress over the last couple of years on the pipeline. We're starting to really bring some new value-added innovative things to the marketplace along with the base business, and we're going to continue to do that. And Philippe talked about cenerimod and selatogrel. There's a lot of interest that we get in that. We're very, very excited about the potential of those products.

If approved, we believe they're global blockbuster drugs, which can have a tremendous impact on the company overall. But in '26, we remain laser-focused on the execution of the near-term launches that we're talking about, right? We're not -- we need to make sure that we launch the [indiscernible], the meloxicam, the presbyopias, others as maximally as we can. We'll get to the launch of cenerimod and selatogrel and we'll hopefully see some data later this year or early next year, but we remain tremendously focused on the launches that we have in hand in '26.

So thank you very much, Philippe. Now I'm going to ask Corinne to come on -- to come up, please, to the stage for us. She's the Chief Commercial Officer. She's been with us, and I was surprised when I read this that it's 2 years that Corinne has been with us. She came -- joined in April '24. She's a very accomplished biotech and pharmaceutical executive, more than 25 years of experience leading and building highly successful commercial teams. Her prior work experience includes Moderna as the Chief Commercial Officer, Amgen, Roche, Merck, Sanofi and Pfizer says here, but that was really pharmacy where we work together 25 years ago. So Corinne...

I was hoping you wouldn't -- said years, but...

Good morning, everyone. Today, I want to do 3 things. I will talk about the strength and the durability of our base business of generics and established brands. I will reinforce the key building blocks of growth of our current business and demonstrate the power and the discipline of our commercial organization. And I will show you how we plan to accelerate revenue growth and enhance capabilities through the launch of value-added and innovative medicines.

So Viatris benefits from a very strong commercial platform from which we expect to continue to grow. We have a broad commercial footprint and scale that reaches patients across more than 165 countries around the world, and we have a physical presence with commercial presence in 70 countries with a comprehensive set of capabilities.

But we also have demonstrated deep commercial leadership and expertise over many years and across more than 10 therapeutic areas. You can see here that we have a large sales force, approximately 8,500 people that drive product adoption and customer engagement around the globe. And we benefit from a broad, very diversified portfolio. And this unique combination of those foundational strengths is really key to secure resilience and long-term competitive advantage.

Now we expect over the next 5 years that we expect to see growth in all geographic regions. What I want to do here is to review the specific growth drivers for each region. I'll start with Europe. In Europe, our promoted brands continue to drive growth, and we also recognized as a generics leader, notably in key countries like France and Italy, and that's because of the breadth of our generics portfolio offering.

Now in North America, we have very successfully gained leadership in complex generics. We have some examples here with Wixela and Breyna. And those complex generics, as you know, drive more sustainable growth. And we continue to expand our portfolio of promoted brands.

Now in emerging markets and in Greater China, the majority of our revenues come from established brands. Now in these markets, we leverage the trust and loyalty for these iconic brands that are embedded in physician prescribing habits and in patients' preferences.

In Gens, while we continue to see and to experience government-mandated price decreases on generics and LOA brands, we anticipate that we will return to growth in Japan, notably with new innovative brand launches, and I'm going to come back to this in a few slides.

So our generics and established brands portfolio is powerful. It's a powerful cash generating engine, and it's very healthy. But let me dive deeper in how we're going to continue to perform and succeed in global generics. This is not a static business. Viatris is a high-performing, constantly renewing platform. Every year, we aim to replenish the portfolio with new products revenue that more than offset natural erosion.

Now IQVIA and our own internal projections indicate that between 2025 and 2030, the pharmaceutical industry faces a $175 billion patent cliff. And I'm talking only about non-biologics with several high-revenue non-biologic products that are losing exclusivity in developed markets. Viatris plans to develop generics for the highest value molecules focusing around about 70% of the LOE value.

Now as we replenish the portfolio at the same time, we actively optimize the portfolio with regular pruning to maintain a stable gross margin profile. And most importantly, we continue to shift the portfolio towards complex generics that drive more durable revenues and other oral small molecules. And we anticipate in the U.S. an increase of 35% in the number of complex generic launches in the coming years.

So in developed markets, we expect to deliver mid-single-digit net sales growth for generics through 2030. And frankly, our continued performance is anchored on our expertise on our very highly competitive positioning, but also on the strength and on the quality of the relationships that we have with our customers that expect from us that we provide quality and continuity of supply.

For the established brands, the established brands also require active management to maintain demand and even to drive growth. And the commercial approach here is tailored to each local market and leverages the deep market insights of the local dynamics, and we have very strong local expertise. So these brands being established require relatively low promotional intensity models, but they do require continuous education of prescribers on brand track record as well as engagement with those brand loyal patients through self-pay channels.

On this chart here, we see that we are very good owners of these brands and that we continue to demonstrate that we can deliver growth. And this example here is an example of the performance that comes from China, where we were able to successfully re-trend brands that went through VBP, while in comparison, other multinational companies could not do that.

Now this is one example. This is one country, but we see similar patterns of resilience and growth in other countries as well. So thanks to this very targeted commercial investments, thanks to the disciplined commercial execution, the Established Brands portfolio is expected to deliver low single-digit growth through 2030.

So I have reviewed the strength of the base business. Let me now discuss how the commercial organization is charting a credible and again, disciplined path to successful launch of our pipeline of value-added and innovative medicines. As I mentioned earlier, Viatris already has a broad commercial infrastructure and a lot of the fundamentals are in place. We have a lot of expertise on the team, including new talent that have joined Viatris recently with recent experience of launching blockbuster innovative products.

And we are building on our existing strengths and retooling and investing in areas, where we have opportunities to compete more effectively. And that's notably broadening capabilities in areas like market access, health economics, outcome research and also bringing more sophisticated commercial analytics and insights. And obviously, we're also taking a digital-first approach as we aim to simplify and automate our workflows.

We have a robust pipeline of 12 key anticipated launches across major geographies and notably, as you can see here, in the U.S. and in Japan. And of course, we expect cenerimod and selatogrel to be global launches with blockbuster potential. So what I'm going to do in the next few slides, I will explain the commercial strategies for key anticipated launches, highlighting positioning, revenue potential and execution road map.

But before I do that, I want to spend a minute on Japan. Today, our portfolio of generics and LOE brands is the target for intense government cost control policies and has been declining year-over-year. Now Japan is the third largest pharmaceutical market in the world and remains a very high reward environment for innovation. It is, therefore, a strategic market for Viatris.

And we decided to invest in building a more innovative portfolio. You remember, we acquired last year, Aculys with 2 assets in CNS, Spydia and Pitolisant. We are anticipating the approval of Effexor for Generalized Anxiety Disorders soon. And as you can imagine, our launch readiness is well underway. And we are planning to launch Nefecon in IgA nephropathy next year.

Altogether, we believe that this portfolio of new products will help us chart a path to return to growth with potential combined sales up to $300 million by 2030. Let me turn to the U.S. Fast-acting meloxicam has been designed as a new non-opioid option for moderate to severe acute pain.

And both physicians and patients confirmed that this is exactly what they want. They want a product that can offer fast pain relief and opioid reduction.

So let's look at the size of the opportunity. Pain is a heterogeneous indication, and the market is very broad, but we plan to focus on acute pain episodes that affect about 80 million patients each year in the U.S. And that's a number that goes about 2% to 3% every year. Now half of these patients are still treated with an opioid to get the relief that they need. So for us, the opportunity concentrates where opioid reliance is the highest and concentrates with medical specialties that manage high volume of acute pain cases. So we intend -- as we go about this launch, we intend to optimize the launch for speed, and we will have a very laser targeted approach. We will prioritize fast and broad value-based access. We will build a specialty field force that will target the high-volume specialties and postoperative pain, mainly. And we'll focus on the outpatient setting where we see the need for fast-acting oral pain medicines.

Now, should we expand beyond these targets? We plan to do so in partnership to broaden access to nonsurgical pain and a larger patient population in emerging medicine, in dentistry or with PCPs or NPs. We believe the potential peak net sales for Fast-Acting Meloxicam is up to $500 million and is driven by a patent exclusivity beyond 3 years and an expansion beyond the initial post-surgery market.

Another growth opportunity for the U.S. market is the expected launch of our novel Low-Dose Estrogen contraceptive patch, and we expect to launch this patch in the second half of this year. It will be the lowest estrogen dose patch available. Now the contraceptive market is a large market. More than 50 million women in the U.S. are on contraceptives. What's interesting is that among those users of combination birth control have used already a low-dose estrogen pill that generally have fewer side effects. Now the patch market in itself is still a niche market, but it is growing at 5% a year, and it is very promotionally sensitive. So it's an opportunity for us as we launch a branded product to drive market share.

To make our Low-Dose Estrogen weekly patch an option of choice for young women, we will focus on creating rapid access. We plan to target patient communities that respond well to digital marketing, and we will build a specialty sales force detailing OB/GYN targeting in priority current patch prescribers. We believe that our Low-Dose Estrogen weekly patch has a peak net sales potential of $180 million or higher. We also have another patch in development. It is a progestin-only patch that offers estrogen-free contraceptive option and could be important to expand the market for women, notably with BMI above 30. And we believe that peak net sales of our women's health portfolio with those 2 patches in the U.S. could be potentially more than $400 million in total.

A bit about Cenerimod, we are, as Philippe mentioned and as Scott mentioned, very excited about this opportunity, first oral therapy targeting simultaneously multiple pathways in SLE. Lupus is a disease that affects more than 5 million way around the world, mostly women, but it is rarely diagnosed because it affects many tissues, many organ systems and causes a variety of symptoms. So each year, 400,000 patients are diagnosed globally. But among those that are diagnosed, 60% of those patients already have moderate-to-severe lupus. And today, about half of the patients need more advanced therapy. So our objective is to position Cenerimod as the backbone of SLE therapies before biologics.

We will focus our commercial efforts on driving awareness of the burden of disease and on establishing the potential benefits of a multipronged immunomodulation approach in SLE. We're also investing in generating pharmacoeconomic evidence to support a clear payer value proposition to ensure broad access in a competitive space. An important point that we're going to work with the patient community. We're going to work with patient advocacy groups to build a patient design support program and facilitate patient onboarding. We believe that the Cenerimod global peak net sales potential is over $1 billion and could be more if utilized in lupus nephritis and other potential indications.

And finally, Selatogrel. Selatogrel has the potential to be the first patient administered treatment for heart attacks at symptom onset. So it's a completely new paradigm in the treatment of AMI. Now the addressable population here for Selatogrel is large. Globally, there are more than 20 people who already had an AMI recently. And the global incidence of AMI is about 3 million people per year, 800,000 in the U.S. only. Now 20% of the people who survive will have another AMI and sometimes a year, a couple of years later, maybe 5 years later and this despite being treated on maintenance therapy.

We anticipate first targeting these patients who can recognize the symptoms of AMI because they already had one. Once you had one, you know what it feels like. We are focusing on preparing for this paradigm change to position Selatogrel as an acute rescue therapy. And I want to emphasize here that Viatris has deep cardiovascular expertise around the world and a lot of experience with self-administered acute rescue medications. And we know from this experience that physician education, patient education is for symptom onset and recognition of the symptoms will be essential. We will also focus on establishing a value framework that will be linked to the reduction of the severity of the heart attack and subsequent complications, including death, to support value-based access. And we believe the global peak net sales potential is over $1 billion and potentially more with potential subsequent life cycle indications.

So to conclude the commercial section, I want to leave you with three messages. First, Viatris benefits from a resilient, diversified generics and established brands foundation that we believe is positioned for durable and profitable growth. Two, Viatris has a unique competitive advantage with a disciplined and experienced commercial organization with global scale for efficient execution. And Viatris is transforming and building on a strong base to accelerate growth with 12 value-added and innovative medicine launches anticipated over the next 4 years. And the commercial organization is primed to deliver.

Thank you very much. Scott?

Thank you. So I think Corinne made a great case outlining the commercial case behind some of the value-added medicines and Selatogrel, Cenerimod. I get a lot of questions, why were those 2 assets, Selatogrel, Cenerimod? Why you were so interested in them? And a couple of reasons why I think they could be really outstanding assets, much more than we project even here. And that is the S1P mechanism, very well understood. I've been involved in the development and commercialization of one as has Philippe. They've shown -- there's approvals for S1Ps in neurology and multiple sclerosis and IBD and other places. So depending on what the safety profile looks like when we get that database. If the safety database is appropriate, we could expand the indications to many other indications.

This could be a -- and it's got a long IP runway. By the time we get to the end of that, we could be in 5, 6, 7 different potential indications. It plays in rheumatology, dermatology, neurology, GI. So it's a very well understood, broadly applicable immunomodulatory mechanism of action that really gives a tremendous potential. Focus on getting the first indication first, looking at that -- making sure that it's positive, looking at that safety database. But after that, there could be a lot of opportunities to take that molecule in different places.

In terms of Selatogrel, I don't think there's any company in the world positioned better for acute rescue medicine, as Corinne said than us, first-in-kind acute MI. It's something that is near to me, two family members. My wife side have both died of acute MI in the first instance, a tremendous amount of risk to the other members of her family because of the genetic profile of those people. But one acute MI incident every 40 seconds in the United States with very little in terms of acute treatment. So this could be a real not only advance in medical care but could be a tremendous blockbuster drug as well when you think about the applicability of the label expansion opportunities going into maybe high-risk patients as opposed to just those who have already had an MI.

There's lots of places we can take it, again, depending on if the first study positive, what's the safety database look like, et cetera. So we're very, very excited about those opportunities. And again, we're very excited about all the things we have in hand to execute in the short term and getting the data on Selatogrel, Cenerimod. So thank you, Corinne, for outlining that case.

The next member who's going to come up is the newest member of the team and the only member of the team that we cannot properly pronounce his name. So we just call them H. So I'm going to ask H to come up. When we were looking for somebody to come take the strategy BD role, we were looking for somebody that had a broad number of skills, have played in different markets. Again, we have 3 businesses: generics, established products and innovative. The generics has a value-added component to it. And we were lucky to come across Hemanth, who has experience in all of those areas. And very few people have that kind of breadth of experience. I think he's done over 50 deals in his experience in different companies. He's also got some sort of commercial experience being a President and Chief Operating Officer of Venus Concept, an aesthetics company. And so a very broad range of experiences, very deep knowledge in the BD space, done a number of deals and is really going to be critical in helping us build the portfolio as we go forward. So H? Thank you.

Thanks, everybody. Really excited to be here today. As Scott said, just coming up on a year now in a couple of weeks of being with the company, incredible time to be a part of it given this critical time in our evolution. I'm going to try to talk a little bit about our portfolio strategy. As Scott mentioned, where we are today, where we're looking to evolve, why we have a right to win in the areas that we're planning on growing? And then to add some color on how our global business development function is intended to help be a key driver to that growth over time.

The strategy part of this is actually pretty simple. We spent a lot of time with Scott, the ELT and the Board over the last year, really aligning on that, and Scott said it right upfront, drive the base business, invest in the innovative portfolio, modernize for growth. You're going to hear that over and over again because everything we talk about is really building towards that.

And what I really want to add color to is where BD adds to what we already have ongoing within the base business. So building on what you heard already from Scott and Philippe and Corinne, I'm going to start with the current business and the platform we have as a foundation for where we plan to grow.

So as been said already, Viatris is uniquely positioned as a global health care company, able to deliver value across the entire spectrum of medicines. But more importantly, as Corinne highlighted in her section, a key differentiator for us is not only having global reach, but our deep regional market expertise, right? We have commercial, regulatory, medical professionals around the world who understand their markets and allow us to tailor unique strategies for assets in market that allow us to take advantage of unique opportunities at a local level.

That allows us to capitalize on regional opportunities, both for our internal programs as well when we think externally as a partner of choice for companies interested in working with us. As Philippe covered as well, well-established R&D capabilities that span across generics, value-added medicines, innovative medicines. The company has invested heavily in technologies, respiratory, patches, sterile injectables over several years and has built a strong pipeline of high-impact programs. But that platform is also equally meaningful to other parties who are interested in development partnerships that don't have our size, scale and depth.

Combine that with, as Scott mentioned at the beginning, an infrastructure that supports a global supply and distribution network that supports 1 billion patients a year and a well-established capability to build value from intellectual property. I think that's understated sometimes how valuable that is because that's not only important in terms of the durability of our products and our programs, but it also helps us as we look to invest in innovative programs as we go forward.

So take that all together, we've got a demonstrated ability to leverage all these capabilities at a global scale, but with deep regional market knowledge to create value across the entire product life cycle, provides a strong platform for sustainable growth. So I'll reiterate again, drive the base business, invest in the innovative portfolio and modernize for sustainable growth.

When we think then as to having that platform and how we can best leverage it to grow, where do we have capabilities -- unique capabilities to be able to not only grow but be the right owner of assets and areas where we have a right to win. I think it's useful, as Scott mentioned at the beginning, to think about the portfolio across 3 broad product categories: generics, established brands and innovative brands, as each has unique characteristics, market dynamics and drivers for growth.

Viatris has a strong track record of unlocking value across each by applying differentiated capabilities at scale. For example, as a generics leader, we've delivered consistent performance, bringing essential medicines as well as novel complex generics to the market while rapidly capturing value on launch through strong channel access and institutional and retail channels as well as leveraging our global platform to give us the broadest reach possible.

In established brands, Corinne highlighted, we have a global portfolio of iconic brands, well-established prescribing habits. But where we've been able to add value is that strong market knowledge that allows us to tailor strategies and stabilize and grow these brands on a region-by-region basis, something I can truly say we are probably one of the best at based on what we've seen out there. It positions us as a preferred partner for other pharmaceutical companies that are managing or underleveraged mature assets or have upcoming loss of exclusivity and they either don't have the resources or the focus to apply to those brands, that is something we're not only very good at, but have repeatedly been able to show performance with.

Then when we look towards our innovative brands, we've had demonstrated success to date with value-enhancing clinical and commercial partnerships. On the clinical side, leveraging our clinical development capabilities for late-stage programs, provide a level of depth, not only in core innovative markets, but imagine wanting to expand that around the world, the level of complexity market by market, country by country to be able to take a product and turn it into a global product, just the clinical regulatory component of that is very complex and something Viatris has a history of being able to do. And then when those products get approved, the ability then to launch at scale.

Do it really well in your local market, but then also be able to expand that across other markets. That makes us a natural partner for many small innovative or biotech companies with limited commercial scale, but a strong pipeline. So this combination of capabilities, credibility and global scale, together with a highly agile operating philosophy allows us to consistently enhance value across the entire core product portfolio.

So if we look forward then for the next 5 years, we've talked about the platform. We've talked about why we have a right to win in the areas that we're focusing. Let's talk about where we're planning on going. We're going to take a very disciplined approach to how we evolve this portfolio over time. I think we've given a long-term objective, drive the base, invest in innovative and modernize for sustainable growth. But how we go about doing that is really important.

And you've heard a lot from Corinne and Philippe and Scott as to what we're doing organically within the business with our existing pipelines. I'm going to add a little bit more as to how we're looking to augment that with business and corporate development. So if you think about our generics portfolio, global scale, very strong diversified portfolio with a rich pipeline. Our focus is maintaining the base, growing profitably over time while continuing to strengthen our position in higher margin, more durable complex generics. And that will be done both based on our internal program, but through partnership and targeted investment in BD.

In established brands, we're going to continue to find creative ways to extend the value and durability of our iconic brands while expanding new relationships with global brand partners and leveraging our regional capabilities and infrastructure through distribution and licensing partnerships with complementary products that allow us to enhance growth and profitability.

And then the innovative brands where we probably have the most potential to contribute to our long-term growth aspirations. The plan is to expand the portfolio with in-market branded products and durable businesses that we can scale profitably over time. Here, you can imagine the U.S. is going to be a core market for us. Our focus will be on high-growth specialty therapeutic areas that have long-term growth potential and where Viatris' unique strengths and capabilities position us as a natural owner.

So with that, let's think about how we're going to go about it, and this is a question that gets asked a lot. So if we're going to think about how we achieve those long-term goals, a critical driver of the strategy is how we approach business and corporate development. And I want to say business development in this company, and I'm very happy to say this, is not an add-on to our operating business. It is completely ingrained in what we do. And hopefully, I'll describe a little bit of that here. And so it's not me and my team out there chasing deals, throwing them over a wall to an organization that has to find a way to digest them. We have commercial leaders. We have R&D leaders around the world actively working to drive BD deals at any point in time over and above their base job. And that, for me, is an ideal position to be able to come into.

So the easy way to think about this is in two areas of focus. First, we're going to have opportunities that directly complement our regional capabilities and therapeutic area strengths. Think of this region by region, these could span generics, established products or innovative products depending on the region, but with an emphasis on delivering more high-margin, durable growth products to the region. We're deliberately flexible in terms of how we approach these. These could be licensing deals, strategic partnerships or even small-scale M&A. Individually, they might not be large transactions, but they're generally immediately accretive to revenue and EBITDA, support regional growth and offer clear operational leverage and synergies to take advantage of.

This type of BD has been a long core strength of Viatris and continues to be foundational to our base business. And that's what I meant by Viatris has been doing this for a long time, and they continue to do this. When Scott says, drive the base business, this is something we know how to do well and we'll continue to do.

Second, if we want to think about evolving the global platform, enhancing the company's long-term growth profile, expanding the innovative brands portfolio is a key priority. To grow in this segment, we're prioritizing in-market products and businesses that generate near-term cash flow that are anchored in high-margin branded medicines and not reliant on long-dated pipeline risk.

This often results in small to midsized M&A that offers not only products to add to the portfolio, but potentially also necessary infrastructure and new capabilities to grow the organization. While these are more material transactions, our primary focus would be in the United States, but also in other important innovative markets such as Japan and China, where we have a very strong branded presence that we can leverage.

In terms of scope, we're targeting specialist-driven TAs. As Corinne had mentioned, we are already present in a number of specialist TAs. It could be one of those or it could be another area where we see a lot of opportunity where there's sufficient market depth to support follow-on BD opportunities. And this is an important factor as well because what we're talking about here is building a platform and not asset selection. So we're not out there just chasing assets so that we can build a broad portfolio or a diversified portfolio of innovative assets. The intent is to build a business with infrastructure that we can leverage and get synergies with follow-on transactions and get to critical mass and a sizable enough business that can contribute to the overall growth profile of the company. And that's a scale that we'll build over time.

As Doretta will mention shortly, we will maintain a very high bar for financial discipline and capital allocation. And our approach to business development strategy is no exception to that. Any deal we look at, whether a regional-based business development deal or a large M&A transaction, clear expectations on both strategic fit as well as financial returns. Taken together, our goal over the next 5 years is to deliver an incremental $1 billion to $1.5 billion in incremental revenue and $500 million in EBITDA to help evolve the company's core portfolio and deliver long-term durable growth for the future.

With that, I'll turn it back over to Scott.

Thank you, H. So on this slide at the top is sort of the goal, the business development goal that we have that's embedded in our projection and our targets up to 2030 of $1 billion to $1.5 billion in revenue and $500 million for adjusted EBITDA from business development. I think highly, highly doable with the capital that we have to deploy. And so very excited to be able to do that.

If you take a look at the regional partnering part of this, I think we did 59 regional partnering deals last year, and we'll continue to do them. We're going to accelerate that opportunity. The strong foundation that we have from a commercial perspective that allows us to do those deals. And so we're going to continue that. We did one sort of innovative deal last year, and that was the Aculys transaction in Japan. Japan, a very important geography for us for a lot of reasons, bringing in important innovative growth assets there was a priority for us, and we did that. Now we want to be able to supplement what we do in the U.S. and others with this business development.

But the targets -- where we go with the way the targets were built, I think this business development component of those targets, given the amount of things that are out there, the capital that we have to deploy and the strength of the organization globally, highly, highly doable. So very excited about that.

So the next up, we're going to pivot to the financial part of the presentation. Doretta is going to come up. She is obviously our Chief Financial Officer, as many of you know her, a very accomplished financial executive with deep health care experience. Two decades of leadership advisory and capital markets expertise. Over the course of her career, she's advised transactions over $0.25 trillion. I see from the sheet here, which is pretty remarkable, $240 billion. And prior to joining Viatris, she was the Managing Director of Citi and also Goldman Sachs before that. So without further ado, thank you, Doretta.

Thank you for that introduction, Scott. Good morning, and welcome again to everyone that's here in the room and for those that are listening in. I am Doretta Mistras, the CFO of Viatris.

As I've been listening to the presentations this morning, it's really struck me how much work this leadership team and this company have done over the past few years to navigate through challenges and also execute on our business plan. This includes delivering on 11 consecutive quarters of year-over-year operational revenue growth, excluding adjustments. Today, we have a clear and focused strategy. And this morning, my goal is to outline the financial framework that supports this strategy.

Before I begin, it's worth briefly reflecting on the progress that we've made to position Viatris for this next phase. We started with a clear purpose and a real opportunity, bringing together two large but complementary companies to create a global organization with significant scale and a strong financial profile.

From the beginning, we've been focused on several priorities: Simplifying the organization and capturing efficiencies, stabilizing our base business while evolving our portfolio with a clear emphasis on moving up the value chain and launching value-added products and deploying our cash thoughtfully to strengthen the balance sheet through significant debt paydown while also continuing to return capital to shareholders. Together, these actions have fundamentally reshaped Viatris. Today, we have a company with a strong balance sheet and a solid foundation for long-term performance.

As we look ahead, we believe Viatris is entering into the next phase of its evolution, one where the work of the past several years begins to translate into sustained revenue and earnings growth. The financial framework I'll walk through today is really about how we intend to translate that progress into long-term shareholder value. We think about this framework in four clear and connected areas. First, sustainable revenue growth. We expect to drive this through continued execution in our base business, supported by our value-added launches. Over time, we expect this to be complemented by our innovative pipeline assets such as Selatogrel and Cenerimod.

Second, accelerating earnings growth through operating leverage. This is supported by the benefits of our enterprise-wide strategic review, disciplined reinvestment into higher-margin opportunities and an improving mix as our portfolio continues to evolve. Third, durable cash flow generation. This is a core strength of our business today and a critical enabler of our strategy going forward. And fourth, disciplined capital allocation. We expect to deploy our cash to return capital to shareholders while also maintaining the flexibility to pursue accretive business development, as Hemanth discussed earlier.

These four pillars are not theoretical. They are already embedded in how we operate our business today. Together, they define the next chapter of Viatris. One where we translate our strategy into financial performance and where financial performance is translated into shareholder value. So let me start with revenue by walking through our long-term targets and the assumptions that underpin them.

Before we get into the specific revenue drivers, it may be helpful just to take a step back and briefly explain how we think about our targets overall. We think about these in two parts. First, our base case long-term target. This reflects the growth we expect from our diversified base business, supported by our value-added product launches. And then our combined long-term target. This includes additional potential drivers that could further accelerate that growth over time.

So let's start with our base case from a revenue perspective. We expect this growth to be driven by three main drivers: Number one, continued performance from our established brands and generics portfolio in certain markets, which include Greater China, Europe and emerging markets; second, a consistent cadence of new product revenue with a deliberate shift towards more complex generics to help offset just the inherent erosion in certain markets; and the execution of our higher-margin value-added new launches, including products such as fast-acting Meloxicam and our low-dose weekly estrogen patch, which are currently awaiting regulatory approval.

Based on these drivers, we are very confident in our ability to generate 3% to 4% revenue growth through 2030. Beyond that, the combined target includes the potential contributions that we believe can further accelerate that growth by 2 percentage points. These include potential contributions from Selatogrel and Cenerimod, which we believe could become meaningful revenue growth drivers for us by 2030 and beyond and disciplined capital deployment through potential business development targeting accretive in-market assets. Together, this creates a durable and scalable growth profile, anchored by a strong base business, differentiated value-added launches and additional upside from our innovative pipeline and disciplined business development.

Now let me turn to how our base case revenue growth will be distributed through our regions. Corinne talked a little bit about it at a high level, but I want to take a bit of a double-click and give some additional color. As you can see on this slide, we expect growth across every region through 2030. And this is just another proof point of the durability and diversity of our business.

Let me start with North America. We have a strong and resilient base anchored in core and complex generics and supplemented by select brands. Expected launches, including our fast-acting Meloxicam and our low-dose weekly estrogen patch demonstrate our shift towards more complex and higher-margin offerings as well as a higher concentration of brands. Europe remains a scale market for us. We benefit from strong local capabilities, deep regulatory expertise and leadership positions across both brands and generics. With a strong base business, solid marketing positions and a steady cadence of anticipated new launches, we view Europe as a steady mid-single-digit growth contributor.

Emerging markets continues to be a consistent and reliable growth engine. Growth is expected to be driven by steady volume increases across our key brands and priority markets, supported by favorable demographics and expanding access to health care. JANZ is a region where we are investing meaningfully in Japanese assets, capabilities and infrastructure. As you heard from Corinne, beginning this year, we expect to launch multiple innovative and value-added launches, which we expect will gradually reshape the portfolio and improve the growth trajectory over time. While the business remains in transition today, we see a clear path to positive inflection beginning in 2028.

And finally, Greater China. Here, we expect continued growth driven by a significant unmet medical need as well as a rapidly evolving health care market, particularly in the cardiovascular space. Our differentiated multichannel go-to-market model, which includes retail, hospitals and e-commerce, allows us to reach patients broadly and scale efficiently as the market continues to evolve. As demonstrated, our portfolio reflects a global business, balanced across geographies with limited product concentration, improving mix and multiple drivers for growth. This regional view also gives us confidence in our base case revenue outlook of 3% to 4% through 2030.

Now let me turn to our long-term earnings growth, where we expect adjusted EBITDA to grow faster than revenue. Similar to our revenue framework, we think about this in two components: Our base case target of 4% to 5% and then additional potential drivers that could accelerate that growth over time. Starting with the base case shown on the left-hand side of this waterfall, there are several factors that support our growth target. First, incremental revenue growth expected from the base business flowing to EBITDA at stable gross margins. Also, additionally from that, potential upcoming launches of our higher-margin value-added assets that are expected to further improve that portfolio mix.

Second, continued discipline on our expense base, including the expected cost savings from our enterprise-wide strategic review, which should create additional operating leverage. Looking beyond the base case, our combined targets include additional drivers that could accelerate growth. These include capital expected to be deployed towards business development as well as potential contributions from Selatogrel and Cenerimod. While these pipeline assets could provide meaningful value for us over the longer term, we do expect limited adjusted EBITDA contribution just given launch investment. Collectively, these opportunities have the potential to add up to 300 basis points to our adjusted EBITDA growth profile over time.

As you saw on the previous slide, the net cost savings we expect from our enterprise-wide strategic review are a key driver of our operating leverage. We expect to deliver approximately $400 million of net cost savings evenly split between COGS and SG&A. Importantly, we expect SG&A to decline as a percentage of revenue as these savings are realized. In terms of timing, we expect to deliver approximately 60% of the savings by year 2 and the remaining 40% in 2028. To enable us to deliver on these commitments, we have established a transformation office responsible for ensuring strong accountability and oversight.

As you can see on this slide, we expect another key element of our framework is the strength of our ability to generate free cash. Over the past several years, we have maintained a stable cash conversion cycle, which has translated our earnings into meaningful free cash flow. We expect this trend to continue through 2030, continue to be supported by stable cash conversion, continued improvements in working capital, inventory optimization and disciplined capital expenditures.

Generating significant and durable cash flow is a critical enabler of our long-term strategy, which includes balanced capital deployment. Based on our base case targets and including our current liquidity, we expect to have more than $11 billion of capital available for deployment through 2030. That provides us with significant financial firepower and flexibility. We expect our capital allocation approach to remain balanced between continuing to return capital to shareholders while also having the flexibility to pursue disciplined business development that further strengthens our growth profile.

More specifically, we expect to maintain our dividend as a core component of capital return, which we believe represents a competitive differentiator versus our peers and to continue to execute share repurchases with a focus on accelerating shareholder value. For business development, we expect this to continue to remain an important lever for incremental shareholder value. Our focus will be on accretive assets that can strengthen the durability of our growth profile as well as regional opportunities where we can leverage our existing capabilities, infrastructure and scale to drive attractive returns.

Underlying this disciplined strategy is a strong balance sheet. Since the formation of Viatris, we have made a clear commitment to deleveraging and the results of our efforts can be seen on the following slide. As I mentioned earlier, we have delivered more than $10 billion in debt reduction since 2021. And today, we operate with an investment-grade financial profile. Looking ahead, we will continue to actively manage our balance sheet and intend to operate within our gross leverage target ratio of 2.8 to 3.2x. We believe this approach strikes the right balance between maintaining balance sheet strength while preserving the strategic flexibility to continue to invest and create shareholder value.

And with that, let me turn to my last slide. As we've talked about, the targets on the left reflect our base case, which includes meaningful growth across revenue, earnings and free cash flow through 2030. I would also just take a moment to note that our EPS base case target includes the benefits from future expected share repurchases.

Importantly, we also see opportunities to further accelerate our growth profile over time, including the contributions from our pipeline like Selatogrel and Cenerimod as well as selective disciplined business development. Today, Viatris stands with a stronger foundation with durable cash flow and meaningful levers to drive additional growth. As you heard from our leadership team this morning, we have laid out a credible, focused and achievable plan, one that positions us to deliver sustainable growth and value creation for patients and shareholders.

So with that, thank you, and I'll turn it back over to Scott.

Thank you, Doretta, and thank you to all the presenters for the presentations today. Let me just go -- talk a little bit about the investment case based on everything that you've heard. And then we're going to go a couple of more slides, and then we're going to have a short break and go to Q&A.

But the case that we've been laying out, which I think Doretta just said, credible, focused and achievable, which I think is exactly the right words for the business plan that we're putting together. And core to the investment thesis in the company is this idea that there is a credible path to sustainable top line and bottom line growth between now and 2030. That's the core of what we're doing.

How do we get there? Strong global platform, as we've talked about before. A growing base business, right, no longer declining or melting ice cube, but a growing base business that we're shifting and evolving to be -- to include more durable, higher-margin generics, value-added medicines and established brands. So a change or an evolution in a positive way for that segment of the business. Impactful near-term launches, and we've been through them here. I think there's something like 12 launches in the near term that we think can have impact on the company. We're focused on making sure those go well and launching those.

High-value innovative pipeline, including blockbusters selatogrel and cenerimod. And I would say, based on our investment case between now and 2030, those aren't even a key component of it. I think as Doretta showed, 1% revenue growth from selatogrel and cenerimod and 0% from an EBIT perspective in 2030. Where those 2 molecules are positive, have a tremendous impact on the organization is actually 2030 and beyond, where they show very, very significant growth. So we're excited about that. Those are great assets. We're looking forward to the data, but those really impact the company in the later part of this 2030 period and certainly in 2030 and beyond.

We've done a lot of work, and Andrew has been leading the transformation office and our efforts around our -- what we call enterprise-wide strategic review, which is really looking at the cost structure that we've got, enhancing resource allocation, taking a look at our skill sets, not only to save money, but also to reinvest. A majority of that will drop to the bottom line, but it also provides us an opportunity to reinvest in value-added medicines, higher-margin medicines, innovative medicines as we move forward.

And finally, the cash generation gives us financial flexibility. $11-plus billion between now and 2030 gives us that kind of strong free cash flow and balance sheet strength, and we can prioritize capital return, continue with the dividend, we can buy back as needed. But we can also build a portfolio of growth assets to supplement the strong base business that we have.

So that in a few sentences is really what the investment case is. And again, the core to that is that path to sustainable, visible, longer-term top and bottom line growth.

So you heard from the top level of the leadership team here today, but there is a broader leadership team that didn't present today here, including Paul; Andrew, who's Head of the Transformation Office; Matt, who's just joined us a couple of months ago as Chief Legal Officer; Peter, who is not here, but our Chief Supply Officer; and Lara, who's here. So I'd say this leadership team is a mix of people who have legacy people who have been here for a long time, new people with new skill sets, fresh approaches to things. So I'm very, very pleased with the people that we've been able to attract to this leadership team. They will all be here during the lunch, except for Peter, and it's a chance to mingle, talk, ask questions, get to know the leadership team. So they'll all be there once we conclude the formal part of the presentation and get to lunch.

Also, we've done significant Board refreshment. I think 6 new Independent Directors added since 2020 -- 2022, sorry. We've added just in the last few months, both Frank D'Amelio and David Simmons, both significant experience in the pharma industry to come join the team. We have joining us today our Independent Chair, Melina Higgins. She came and she'll be coming to lunch as well. So if you have thoughts or questions or comments for her, she'll be here for that. But we've significantly refreshed and enhanced the Board and very pleased where we are from a management and Board perspective.

So again, thank you very much for your attention. Hopefully, we made a great strong case in terms of why to invest in the company. We're very, very proud of what's been accomplished. But I think we're more than being proud of what's been accomplished over the last couple of years. We're very excited about what the next few years has in store, our ability to really transform the company into a strong growing company over the next -- between now and 2030 and build off that. So we're very, very excited about the position we're in and what the next few years hold. So thank you very much for your attention.

I believe we're going to have a 5-minute break and set up some chairs and things. I think there's refreshments outside, and then there'll be a Q&A period for 20, 25 minutes after that. So thank you very much. Cheers.

[Break]

Okay. Thanks, everyone, for rejoining us. And Scott and team, appreciate the fantastic presentation. We'll commence our Q&A session. So we're going around the room. So please, if you have a question, raise your hand and members from the organization, my team will come to you.

So first question, if we can go to Glen from Barclays.

Glen Santangelo from Barclays. Philippe, I just want to follow up on your comments on selatogrel. I think you said you expected the readout in the first half of '27. Should we expect that to hit the market in '28? And then maybe if you can just remind us of the time line on cenerimod as well.

And then I had a second question for Doretta. Just, I was curious about the 2026 guidance in terms of that range, how much of the 12 potential launches expected this year are embedded? How much in revenue do you have embedded within that guidance range this year?

And then lastly, and then I'll pass it over the mic, with respect to the $11 billion in free cash flow, should we still expect half of that to be allocated towards repo? Or Scott, are you willing to do something more transformational? And I'll stop there.

So selatogrel, first off, right, and Philippe can get more into it in a second. But it's an event-driven trial. It's impossible for us to know exactly when the end is. Based on projections and things, it could be into next year. Whether or not it would launch -- depending on when that timing, whether it would launch in '27 or '28, depends on when that study would finish. But I think a conservative view of getting that study done would be early first half of '27. It's possible, again, because it's event-driven, it's not patient number driven. If we hit the number of events this year, then it will be done this year. I don't know if you want to be.

Yes. Let me just add that we are seeing exactly what we wanted to see as part of this study. What will determine really the number of events we need is how they really distribute within the primary endpoint from death to less severe MIs. Based on what we're seeing, based on our projection to Scott's point, we anticipate that we'll get a readout in the first half of '27 and then launch in '28, right? That's our base case at this point.

And cenerimod...

Cenerimod, we anticipate to get the first readout at the very end of this year from OPUS-2 first and then OPUS-1 early next year. So you add a year after that for approval, and that's when we would get it. Now we'll have conversation because we got Fast Track designation with the agency on how to try to get an accelerated review, but that all depends on the data we get from the Phase III study.

And then your second question was capital allocation, share buybacks. As we've talked about, we want to be balanced, and we -- part of the plan to get to 2030 is continue to be balanced in terms of our capital allocation strategy, giving back to shareholders, dividends, share buybacks and then business development.

Any one year, we could lean into one or the other. Last year was a year where there was a lot of volatility, particularly in the first half of the year with the indoor situation, with tariffs and the general macro medical situation, and we decided to lean into share buybacks where the share price was and other things.

This is a year where it feels like or it did feel like until a couple of weeks ago, the markets were very open that there was a lot of assets out there and things were trading, and it was a frothy BD type market. And so there was a lot of opportunities out there that we thought we could lean in. Maybe this will be a year where we lean in a little bit more to business development. But over the 5-year period, I think we're committing to being balanced on both.

Is that 50-50 or 55 -- it's not -- it's never an exact thing, but we're going to try and do both and try to be balanced and manage the company in a way that we think is best based on the opportunities that are out there, share price and other things.

Yes. And with respect to your question on new launch revenue contribution, obviously, we think that these are longer duration durable assets that should have meaningful value for us over our long-range plan or our target. But from a '26 perspective, we've talked about them having little contribution given where they are in their launch phase. So the guidance that we provided does not assume meaningful contribution from these new launches.

Next question. Kyle, can we go to Les, please?

Les from Truist. So I just wanted to drill in a little bit on the long-term guidance. And Doretta, you mentioned the 1% sales CAGR would be tied to BD and then translating to 3 percentage CAGR on the EBITDA side, specifically tied to BD. I just wanted to get a sense of how comfortable you are with that? What's your confidence level to get that 300 basis points there?

And then regarding the portfolio mix, I just wanted to see how that shapes up over that time span, how it evolves over generics branded and the innovative portfolio. And now with Hemanth on board, what are you thinking about priority on the size and momentum of additional deals coming on?

So I think we're providing long-term targets, not long-term guidance, right? I think that was just the terminology there where these are the targets that we see that are combined from the base business and the other opportunities that we have.

I think the BD part is highly doable personally, given what's out there, the number of targets out there, the capital that we have to deploy, the people that we have looking at things. I mean I get inbound every day from companies that are looking for partnerships to be acquired, other things. Hemanth, I think, gets even more than I do.

I think there's lots out there. There's lots in this space that is not -- Lilly is looking for things with a $5 billion-plus peak sales to replace, right? The LOEs that we have from a pharma industry perspective, there's something like $230 billion in LOE between now and then and the big pharma world is looking for big things to replace those LOEs. $500 million, $600 million, $1 billion in sales is great for us, right?

So I think there's a lot of those assets. We want to be focused on things which we're good owners of that we think we can own, we can add value to. We've got, I think, remarkable capabilities in the product line extension value-add side. We've got this big commercial structure out there around the world that can leverage and take molecules worldwide. So the important thing to me is does this asset help us reach our long-term strategy and are we good owners of it?

And I would also say, importantly, we're not relying on one asset. This is over 5 years, and we anticipate doing a combination of both, more durable assets to grow our U.S. and other kind of more innovative areas, but also contributing and continuing to bolster both our established business and our generics business. And so this is really over a 5-year period meant to be a target and a view given how much flexibility we have.

Next question in the room. Kyle, can we go to JP?

I'm JP from Evercore in for Umer Raffat. I have a couple of questions. First, Philippe, on selatogrel. You mentioned people are injecting for the right reasons. And I just kind of want to get a sense of the false positive rate. How is that going to affect the take from the clinical community and the payers?

And then on the deal cadence, you mentioned, is this optionality or you have a lot of visibility already in some of these deals? It's a lot to go. So we just want to get a sense.

So I didn't quite understand last -- do we have a lot of visibility?

Yes, because you're saying you're going to get like a $500 million of EBITDA from acquisitions. The question is do you already have a lot of those? Or it's just optionality that you're calculating on the -- within this?

Yes. I would say we have a lot of discussions, right? Okay. We have a lot of discussions. There's a lot of companies out there. There's a lot of things that we're looking at. This goal of $1 billion to $1.5 billion is over a 5-year period. We're not going to rush and do something which is going to take us away from the strategy that we're laying out. There's lots of things out there, I think. And it's most likely to be not just one thing that we do, but 2 or 3 things over a 5-year period to add that top line, along with keeping the base business going and doing regional deals and other things.

So I think there's a good inventory of companies out there who are looking to have some transaction that can help them accelerate their strategy. And we want to be the company that can help them do that, right? There are some assets we'd be great owners of, other assets that we wouldn't.

So we're really focused not on -- we're focused on 2 things. Does it further the strategy, one. And two, is it something that we can add value by owning. And I think there's lots out there. We talk to lots of people. I get inbound every day, multiple times a day often. On days like today, there'll be multiple inbound.

The other thing -- the first part of the question, I think you were asking about selatogrel. And you mentioned payers, right? I think this is going to be -- and Philippe can get into your actual question. But since you mentioned payers, I mean, I think it's going to be a phenomenally interesting product from a pharmacoeconomic perspective, right? One of the most expensive patients in the world is a patient in the U.S. that has an MI, has substantial damage, survives and lives for another 5, 7 years with significant disability, right? And if you can decrease some of those rates, I think there'll be a tremendous health benefit -- health economic benefit to the United States.

And so depending on what the data looks like, I think given the data positive and given that there's better outcomes of people using the product, I think it's going to be a very, very interesting product to do some of these pharmacoeconomic models with.

Yes. I think from a -- I'll add from a clinical medical standpoint, we are anticipating false positive, as you call them, which is patients that inject for the wrong reason, meaning they don't have an acute MI. There, I think what's important to capture with this data is the safety profile of the drug, right? If there's no downside for the patient to self-inject, then take themselves to the hospital and get checked and make sure that they either had an MI, or didn't have an MI. Do they have damage? Do they have damage? Do they need to get surgery or not? I think that's still important data for us to capture and to present. And medically, I think this will be relevant.

From a clinical study standpoint, it has no implication on the primary endpoint. So this will be captured as part of the primary endpoint. We anticipate a certain number of them. I can tell you that right now, we are pretty much right on what we had anticipated, and we'll go for them. But we need to continue to look at the data and see how it progresses. But so far, we have a good handle on that data.

And I think it will be a relatively easy thing to replace, right, a device which was wrongly injected in the patient, right, that's easy to do.

Next question, Kyle, can we go to the left with David, please?

David Amsellem from Piper Sandler. So regarding deal activity, looking at the U.S., you have your hands in a lot of different therapeutic areas already, and you're looking at pain, you're looking at cardio, you're looking at immunology. So I know you mentioned this criteria specialist-driven therapeutic areas to paraphrase you. But I just wanted to get a better sense of where you're looking?

You did mention deals that potentially could be synergistic, but can you talk to this first wave of deals that you're contemplating and the extent to which those could be synergistic. So that's just a couple on how you're thinking about this.

And then just toggling over to your generics business, it sounds like you're looking for at least in the developed markets, largely a less bad or more stable base environment. I just wanted to make sure I understood your thinking there.

And in other words, how -- if you can quantify pricing erosion and then also quantify contribution from new launches and how that all goes into your assumptions regarding growth, that would be helpful?

So -- and I can talk and then maybe Hemanth can talk as well. Again, I think I'm less concerned about therapeutic area and I'm more concerned about can we be good owners of a particular asset. I think having said that, certainly, cardiovascular pain, immunology would be places that we would look and think there would be not only the benefit of bringing an asset in, but some synergies that we could take advantage of, so we're looking there.

When I look at the areas where I see a lot of companies, a lot of assets where there seems to be things which fit. I think there's a lot in the CNS area, and there's a lot in the immunology area. There's an evolving sort of pain market. So those are areas that are sort of rich for assets right now. But certainly, we would consider where the future internal portfolio is going in doing any deal, not that they'll always line up perfectly, but that's a major consideration on anything that we would do.

Yes. Especially for the U.S., that's the right way to think about it. Ex U.S., obviously, we've got existing strength, right? When we did the Aculys deal, we brought in CNS assets into a market where we had a field force targeting those physicians already, we got immediate synergy. I would say CNS around the world ex U.S. right now, we actually have that strength in multiple different markets. Similarly with cardiovascular, those are 2 big areas for us.

We have to use a slightly different lens for the U.S. because we don't have that infrastructure right now, but there is still a lot we could leverage. So the way Scott talked about it was perfect. I think the discipline as to how we approach those is more important than the actual therapeutic area. We're not going to just do a deal in an area that's going to end there. We have to believe that there's more opportunity beyond that. And that also shrinks the number of those therapeutic areas that probably makes sense.

With respect to generics and your question on the components. So when we think about developed markets, it's the same trends that we've seen. We've talked about kind of mid-single-digit erosion generally offset by new product contributions from our core business that gets us to that kind of stable to low single-digit growth. And then what gets us to the kind of higher -- low to mid-single-digit growth that we've been talking about in our longer-term outlook is the contribution from these more durable kind of value-added assets. But we continue to feel good about just the stability that we're seeing in the core generics market.

Great. Next question, Ash, please.

Ash Verma from UBS. So maybe just on the top line growth outlook that you provided growing at 3% to 4%. I mean historically, you've been doing 2%. So that's good to see the confidence. But just in terms of how you get there, like you outlined that the new product contribution still stays in the roughly $500 million per year, but these value-added products that you're talking about, if you can explain sort of like what sits in that bucket? What's your level of confidence that this can actually sort of uplift that growth?

And then secondly, yes, on the business development side, I mean, a lot of balance sheet firepower that you have. How are you thinking about the size of the asset? Is it you're going after a few select assets that can help fulfill the goal? Or is it more of a string of acquisitions? And then ultimately, are you trying to balance out the growth between the different geographies that you have as a part of the BD initiative?

So from a BD perspective, I would love to add some U.S. assets. I was worried about Japan as a geography and we've had some good things in there, which I think is the third largest market in the world, Japan. U.S. is the largest market, highest margin market in the world, and I would love to be able to add some assets in the U.S. We're always looking to add things in Europe. Of those 60 that we added last year, a lot of them were in Europe.

So I mean, I think for the high-end, high-innovative, high-margin stuff, U.S. tends to be the focus with some ability to take that and launch it internationally. So I think that's what our overall focus is.

Your second -- your first question on BD was?

On revenue growth.

Size of the asset, is it like, are you going off with a string of pearls...

Yes, string of pearls or one? I mean I think we are open to good assets that, again, either fit our internal pipeline or are in an area where we can accumulate some and put together a number of different acquisitions.

I don't know if it's a string of pearls that we're relying on. But I would assume in order to get to that $1 billion, $1.5 billion revenue target, it would likely be 2 or 3 acquisitions of assets would be my guess. And some you would do would be maybe more than one asset with one company. So it may be a company with 2 assets or 3 assets. And so it could be 1 deal. It's more likely 2 or 3 deals. I don't think it's 9 deals are going to get us there. That's not what we're looking at.

Either we're looking for things that are big enough to move the needle. We do have a $14.5 billion revenue base. So they've got to be big enough to move the needle and help get a significant portion of that $1 billion to $1.5 billion. And again, maybe one, but more likely a couple of different things that we would add up.

Yes. Sorry, just one quick thing. I think the larger the deal, the more opportunistic, right? So you can't really -- if you're looking at something that would come and it would make sense and would meet our thresholds, and it could accelerate having to do 2 or 3 deals, but it will be because it fits all of those parameters that we would do it, we're not chasing larger deals in order to make up a number.

The other thing that's important to think about is we look at this both top-down and bottom-up, meaning our organization, all whether they be therapeutic area segments or regional segments are actively pursuing transactions that directly leverage their infrastructure. So there's a natural deal flow for, let's say, small- to medium-sized transactions that come from the business itself in addition to the ones that we look at where we can add new capabilities or do something more meaningful.

So it's not all just a bunch of us sitting in a room saying, here's our deal flow, let's chase these things. A lot of these deals are being developed actually by the commercial organization to drive their own growth in their segments, which is why we get comfortable in both the operational leverage and our ability to get them done.

Remember, of the deals we've done regionally, geographically, a lot of them have been lower innovation or have been limited distribution deals and things like that. I find that, that's changing a little bit. People are coming to me saying, hey, you've got a very good operation in China. We've got some innovative assets. Would you be interested in buying them from China, or buying them from Japan? So we may move into -- so looking for things from an innovation perspective in the U.S., but also, we're going to look for things that are innovative in the strong geographies that we have out there and have some advantage in commercializing.

And from a revenue growth perspective. So I would look at it in 2 buckets. So the first bucket is the $450 million to $550 million, to your point that we've been talking about. Now this is the R&D and new product engine that we've been able to consistently deliver year-over-year. This is our kind of base generics, more complex generics. We're not dependent on any one product to really comprise that, right? We continue to see visibility to be able to deliver that $450 million to $550 million.

In addition to that, we have the bucket of value-added launches, to your point, that contribute that incremental plus or minus 1%. That's comprised of the list of 12 products that both Corinne and Philippe walked through. And I would say it's important to note, even within that bucket of value-added launches, the majority of those assets already have had data associated with them. And so through kind of getting those launched and through the plan that Corinne walked through, we have -- we're either leveraging our regional infrastructure that already exists, or we have a clear commercial plan to be able to execute on them and have them be important drivers for us as we think about the next 5 years.

Next question, Kyle, Matt, please.

Matt Dellatorre from Goldman Sachs. Maybe first on fast-acting meloxicam. Could you share any more on what goes into the $500 million peak sales estimate just in terms of maybe FDA label, pricing, et cetera? And then how you're thinking about the pace of that launch? I think you said base case before about 5 years kind of and it could be either side of that in reality.

And then on selatogrel, there was recently data from CeleCor. They have a similar kind of injectable antiplatelet drug. I realize it's a different mechanism of action, but could you maybe just comment on how you see read-through from that? I know they -- I think they hit on the composite, but not some of like the subcategories there.

So for fast-acting meloxicam, what we're looking at in terms of our commercial approach. As I said, we're going to go after acute pain and really targeting -- have a specialty-led targeting. So we are going to go after specialties that have high-volume patients. We're going to build the sales force about 150 people there. And we hope to get traction early and get to repeat prescriptions relatively fast.

Obviously, access will be important. So the component as well of the forecast is that we get strong commercial access, notably, and that we can really open the possibilities for patients to get on treatment.

The $500 million opportunity is driven by 2 factors. One, a patent exclusivity that would go beyond the traditional 3 years that 505(b)(2) have, right? Potentially 5, potentially more. We actually have filed more patents, right? So we could actually have more protection.

And two, it is driven by us having -- commercializing this fast-acting meloxicam with a partner so that we could expand beyond the initial targeting of postsurgical pain into more general pain, larger population of patients that get prescriptions from PCPs, or nurse practitioners, or dentistry, right? So that's really the -- what's behind this number.

Before we go to selatogrel, you mentioned opioid sparing. I think that's going to be part of the strategy given the strength of the data. Where that shows up in the label depends on discussions with the FDA, which have been very open and transparent. So our expectation is that we are going to be able to exploit and talk about that data exactly how and where we need to finalize our labeling discussions first, but that's an important part of the strategy.

With regard to your question about CeleCor, so just for everyone, it's a similar principle as to what we are doing. It's an antiplatelet treatment that is given prior to medical intervention.

So we see that data as a strong proof of concept for selatogrel. There's significant differences in what they've done versus what we are doing. The intervention is much later than what we are going to do with selatogrel. If you look at their data, you'll see that they basically are giving the drug 90 minutes prior to a PCI intervention. So not a lot of time for the drug to work. But despite that, they were able to show about a 20% risk reduction, which is partly why I'm saying that we are very confident about our ability to get to a 20% risk reduction.

We will be giving our drug a much -- because of the ability to self-inject, the patient can do that much earlier than what you've seen with the CeleCor data. Therefore, we're anticipating even further benefit than what was seen with the CeleCor data.

The data is also -- has a lot of other issues, have to do with statistical issues, the way they've put their endpoint together. I'm not here to debate that. But all I can say -- I can tell you is that, that leads to certain -- that will lead to certain issues with regulators and statisticians. And they also had most of the patients from Europe because it's an ambulance study, right? So the patients were dosed in an ambulance setting, again, much later than what we anticipate with selatogrel and their statistical endpoint is going to be a challenge for them going forward, we believe.

And we had a lot of conversations with our KOLs around this because, as I said, they also see it as a proof of concept. So we looked at that data to see if there was anything that we could learn from it. And we're not changing anything to the study based on that data. It fits well with what we're doing.

Next question up here in the left, Kyle.

This is Ethan on for Chris Schott at JPMorgan. Just starting off, overall, as you look at the growing branded portfolio that you laid out today, how do you think about the infrastructure that you'll need to build out? And any color on the level of spend associated with that?

And then secondly, on selatogrel, how do you think about the magnitude of benefit that you need to see to support that $1 billion peak sales target that you laid out?

Right. So I will start with maybe some of the costs associated with the launch readiness for those new added value and innovative products.

For fast-acting meloxicam, as I already mentioned, we're going to build a specialty sales force in the U.S. that will primarily detail orthopedic surgeons. So it will be focused. It will be in the outpatient settings, right? And the size of sales force will be about 150 reps.

For [indiscernible] for the -- which is our low-dose estrogen patch, we will be detailing OB/GYNs. It's a small population of prescribers and focusing notably on the ones that already prescribe patches. So the sales force around 70 reps.

Now for the cenerimod and selatogrel, first, we have to see the data, right, before we can envision exactly how we're going to build. And obviously, we are not going to stop the infrastructure before we see the Phase III results.

The infrastructure depends on the geography. Launching a number of products, both innovative and value-added in Japan over the next little while. That infrastructure is largely there. There are some incremental investments, but not like you would see in the U.S. The U.S. is the place where we would likely have to build sales forces for these products moving forward.

We do have something like $3.5 billion to $4 billion of cardiovascular sales worldwide. So selatogrel, again, would fit in well to a number of affiliates out there, need to be some build or some partnering and build in the United States. But we do have, from a global perspective, a very significant cardiovascular portfolio.

Right. So most of the build is in the U.S.

And as we talked about our enterprise-wide review, we've talked about the ability to generate $650 million gross savings, but we've allocated a portion of that to really importantly, fund some of these and invest in some of these higher value-added areas that will continue our growth over the longer term.

And then to answer your question maybe on the 20% on the threshold for selatogrel. So the study is powered for 20%, but it's also powered for much less than that, right, risk reduction. And in discussion with our KOLs, they are telling us that they would be satisfied with a 10% risk reduction.

Now would we be satisfied with that commercially? I think that we'll have to see also the rest of the data. It's a benefit-risk equation at this point. But we certainly are targeting at least 20% risk reduction based on what we've seen, based on recent data, based on -- everything points toward a higher risk reduction than that, but we're certainly targeting 20%.

Any additional questions in the room? Go back to, Kyle, I want to go back to Matt, please.

Maybe just in terms of your revenue growth targets across geographies in the base case scenario, can you comment a little bit more on maybe how that compares to your current underlying growth in those segments in '25, just given some of that was divestiture-adjusted, so it's a little bit obfuscated? And then in particular, would you flag any of these as highly derisked targets and then others as maybe more ambitious, if there's anything you could flag on that?

I would say our overall approach to how we thought about our long-term regional targets in those areas is balanced. Obviously, there's a number of pushes and pulls, but we were very thoughtful and deliberate around how we thought about it.

I would say, generally, they're consistent with what we're seeing, a few things to call out. So North America, I would say, is probably slightly higher than what we've seen, benefiting from some of these value-added launches that we've talked about like fast-acting meloxicam and low dose -- our low-dose weekly estrogen patch. I would say emerging markets is probably slightly lower over the longer term, partly because in the immediate term, we're benefiting in those regions from some indoor recovery.

I would say the other area is JANZ. JANZ is one area that we're particularly excited about given the level of focus and investment that we've made in that area. And in that area, we're actually anticipating that region returning to growth, and that's historically been a mid-single-digit decliner for us. And then I would say Greater China and Europe are very consistent with what we've seen historically.

Any other questions? Ash, please?

Just to ask a couple of quick follow-ups here. So maybe on selatogrel. So you mentioned the data monitoring committee, there have been 13 reviews, right? I think what we're trying to understand like is the goal from those reviews primarily looking at the bleeding risk? Or is there any type of a focus on some of the off-target effects that have been seen with other P2Y12s?

And then secondly, on the obesity programs, I think you mentioned some kind of high-level details around that. Can you give us a sense, like is it going after oral, injectable, U.S., ex U.S. market, if there's any specific programs that you could outline, that would be really, really great?

So do you want me to -- yes. So with regard to selatogrel and the safety committees -- safety -- independent and unblinded safety committee. So they are looking at all the safety data. They're not just looking at bleeding. Now bleeding is particularly looked at because it also needs to be adjudicated. Each case would need to be adjudicated. So -- but they are unblinded, they're seeing all the data, they're seeing all the safety data and they're seeing all the efficacy data as well, right? The primary purpose is the safety, but they're seeing everything.

In terms of the off-target effect that you mentioned, selatogrel is the most specific P2Y12 inhibitor out there, and we're not seeing off-target effect with selatogrel at all. So we're not expecting additional side effects that we haven't seen in Phase II, for instance, as well. So that's for selatogrel.

And then the second question was about GLP-1s. So as I'm sure you know, the GLP-1 market is in flux, right? And there's a lot of -- it's very dynamic. So we are keeping an eye on this. And we are developing all GLP-1s, injectables and oral that we think makes sense. So certainly, semaglutide, tirzepatide, absolutely. We have all strengths. We're looking at every presentation.

But the next generation, we are starting to look at, we passed on a couple that we think will not make it, but are investing in others that we think have demonstrated a profile that might make them relevant commercially later on. So we're responding to how the data comes, right, with all these assets.

In terms of where we're doing it, our primary focus is the U.S., right? Because based on our device technologies, we have an advantage there because we can replicate exactly the same device as the originator, which is required in the U.S. It's not required outside of the U.S. So we think we have a differentiated factor there. The U.S. makes sense. That's the larger market.

Now we're also going to launch everywhere else that makes sense commercially, including Canada and certain European countries that will come early in the late 2030s. But the major impact -- late [ 2020s ]. The major impact of this GLP-1 will be in the 2030s for us, right, once we are able to launch in the U.S.

Okay. That's going to conclude our Q&A. If everyone could join us with the management team outside, we'd love to kind of catch up further. Thank you.

Thank you all very much.

Good morning, and welcome to the Viatris Q4 2025 Earnings Call. [Operator Instructions] Please note that today's event is being recorded.

I would now like to turn the conference over to Mr. Bill Szablewski, Head of Capital Markets. Please go ahead.

Good morning, everyone. Welcome to our Q4 2025 earnings call. With us today is our CEO, Scott Smith; CFO, Theodora 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 2026 and various strategic initiatives. Those 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 for 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. When discussing our expectations for 2026, we will be making certain comparisons to 2025 actual or reported results on an operational basis which excludes the impact of foreign currency rates.

With that, I'll hand the call over to our CEO, Scott Smith.

Good morning, everyone. 2025 was a strong year for Viatris and I'm very proud of what we are able to accomplish across all our strategic priorities. The result of all that great work is that we have positioned the company to enter a period of long-term sustainable growth beginning in 2026. Specifically for 2025, we drove strong commercial performance across our global portfolio, continue to stabilize and the strength in our base business and delivered solid results, including $14.3 billion in total revenues representing approximately 2% growth versus '24, excluding the Indoor Impact and adjusted EBITDA of $4.2 billion. We advanced our pipeline, including 5 positive Phase III readouts that made significant regulatory progress on multiple assets. Importantly, we also advanced both in armod and selatogrel on our Phase III trials with full enrollment for both programs expected in 2026.

We prioritize capital return with more than $1 billion in capital returned to shareholders through dividends and share repurchases. We targeted an accretive regional business development, completing 60 regional transactions, including our acquisition of Aculys Pharma in Japan. For our Indore facility, we met with the FDA in November to review our progress and discuss potential timing for reinspection. That timing remains at the agency's discretion, but we'll be ready for reinspection this year. In the meantime, we've built operational redundancies in alternative supply sources.

Finally, we just completed our enterprise-wide strategic review. As a result, we've identified opportunity from across our company to optimize our cost structure, improve our resource allocation and strengthen our operational efficiency. We are expecting to deliver approximately $650 million in gross cost savings over a 3-year period. We plan to reinvest up to $250 million during that same period.

We are creating this reinvestment capacity to invest in areas that enhance the growth profile and long-term competitiveness of the company, such as sharpening our commercial execution and go-to-market effectiveness, advancing our R&D and innovative audits and continuing to build the capabilities we need to enable sustained success. In addition, we've identified 3 strategic imperatives that will shape our future. We will drive our base business by executing successful launches, focusing on supply chain continuity, evolving our generics portfolio over time towards more profitable, higher-margin products and strengthening our established brand portfolio.

We will fuel our innovative portfolio by advancing a pipeline of late-stage in-market growth assets sourced both internally and externally, and we will modernize for sustainable growth by strengthening our technology data and talent capabilities to enable sustained success in a rapidly evolving health care environment.

Together, we expect these actions will accelerate the transformation of Viatris into a more focused, efficient and future-ready organization and position the company to enter a period of sustained revenue and earnings growth beginning in 2026. There's been a lot of work over the last year and really over the last few years to get us to this point. A sincere thank you to the more than 30,000 employees of Viatris for your thoughtful and focused execution. Your contributions make a real difference for a company and for the approximately 1 billion patients we serve around the world every year.

As we look to 2026, we expect another year of strong execution. Specifically, we will be very focused on delivering strong financial performance and driving commercial execution across our businesses, including the anticipated launches of our low-dose estrogen weekly patch in the U.S. and Effexor for generalized anxiety disorder in Japan while preparing for launch of fast-acting meloxicam.

From a pipeline perspective, we are hoping for regulatory decisions for 6 product candidates, including Effexor and Pitolisant in Japan, fast-acting meloxicam, low-dose estrogen weekly patch and resume for presbyopia in the U.S. In addition, we are expecting regulatory decisions for Inpefa in Australia and Canada. We are also expecting a number of meaningful Phase III data readouts this year and to reach full enrollment in several priority Phase III programs.

From a capital perspective, we expect to generate robust cash flow in 2026, which will give us significant financial flexibility to continue with our balanced capital allocation approach. We have also reiterated our commitment to our dividend in 2026. At the same time, we are focused on building a portfolio of growth assets through business development and continued execution of our internal pipeline.

From a business development perspective, we are targeting accretive high-growth end market assets. Finally, with the completion of our enterprise-wide strategic review, we'll focus on evolving and modernizing our organization to strengthen our operating model and ensure sustained growth.

We look forward to sharing more details at our investor event on March 19, including our long-term outlook for revenue and earnings growth and our portfolio strategy across generics, established and innovative brands. We'll also provide a deep look at our R&D capabilities and key pipeline programs as well as our commercial strategy and how we are building the capabilities needed to execute upcoming launches.

To summarize, we believe 2026 is shaping up to be a pivotal year for Viatris, one where strong execution, disciplined capital allocation and the benefit of our strategic review will begin translating into sustained profitable growth and long-term value creation.

Now I'll turn it over to Philippe.

Thank you, Scott. 2025 was an outstanding year from a research and development perspective. We achieved 5 positive Phase III readouts, advanced trial enrollment and delivered numerous regulatory milestones across multiple therapeutic areas, technologies and regions. The strong momentum sets the foundation for what we aim to achieve this year. Our 2026 R&D priorities are to secure 8 regulatory approval for 6 product candidates to progress our innovative portfolio, advanced 6 Phase III development programs and continue to drive our generic pipeline and established brand portfolio, which together accounts for more than 100 new product approvals expected globally in 2026.

At our upcoming investor event, we will share a comprehensive update on our pipeline. Today, I'll focus on high-level updates beginning with regulatory submissions. In Japan, we expect a regulatory decision for Effexor for the treatment of generalized anxiety disorder in March this year. If approved, this will be the first and only treatment for generalized anxiety disorder which would represent an important medical milestone for approximately 8 million Japanese patients estimated to be affected by this condition. The Japanese health authority PMDA is also reviewing the 2G NDAs for pitolisant that we submitted last year. One for excessive daytime sleepiness associated with obstructive sleep apnea and the other associated with Narcolepsy Type 1 and 2. We anticipate regulatory decisions for both indications in the second half of 2026. Pitolisant has the potential to be a first-line noncontrolled treatment option for these indications in Japan.

In the U.S., FDA recently accepted our sNDA for Phentolamine Ophthalmic Solution for the treatment of presbyopia and has signed a PDUFA date October 17, 2026. Phentolamine offer a physiological approach to treating presbyopia that relaxes the Iris dilator muscle to improve near vision without engaging the ciliary muscle, which helps preserve this transfusion.

Data from our VEGA3 pivotal trial will be presented at the American Society of Cataract Refractive Surgery Conference in April and at the Association for Research in Vision and Ophthalmology Conference in May.

Regarding Norelgestromin weekly patch for contraception, the FDA accepted our NDA review late last year, signing a PDUFA date of July 30, 2026. Dispatch addresses an important need for when seeking a reversible transdermal birth control option with lower estrogen exposure and potential best-in-class addition. Results from our Phase III study will be presented at the American College of Obstetrician and Gynecologists Conference in May. We remain excited about our fast-acting meloxicam for the treatment of moderate to severe pain, including postoperative pain, which has demonstrated in clinical trial a reduced need for opioid analgesics.

We recently had a positive pre-NDA meeting with the FDA. Based on the outcome of this meeting, we anticipate submitting our NDA by the end of this month. With regards to sotagliflozin, we successfully simulated multiple filings last year and anticipate a regulatory decision from Australia and Canada later this year. Sotagliflozin is emerging as a best-in-class SGLT inhibitor which we believe uniquely provides early benefit in reducing heart failure-related outcomes.

Consistent with this dual SGLT1 and 2 inhibition, sotagliflozin is the first SGLT inhibitor to demonstrate a significant reduction in MI and stroke.

Turning to brief updates on our Phase III development programs, beginning with cenerimod and SLE, the OPUS-2 study was rolled last year, and I'm pleased to share that we recently put enrollment for the OPUS-1 study. The marks a significant milestone, reflecting the Viatris team's ability to execute on an ambitious recruitment strategy. Importantly, we enrolled a high proportion of patients with high interferon 1 signature. Recall that in our Phase II CARE study, this population demonstrated the greatest treatment effect. If successful, cenerimod has the potential to offer a differentiated oral treatment option for patients with SLE by targeting the S1P1 pathway with the goal of improving disease control while maintaining a favorable safety profile when given in combination with standard of care treatment.

We are also advancing our cenerimod Phase III study in lupus nephritis and our activity randomizing patients into the study. For selatogrel, a potential life-saving self-administered medicine for patients with the history of acute myoclonus infection or heart attack, our enrollment rate in our Phase III trial has accelerated to approximately 1,200 patients per month, and we expect full enrollment by the end of this year. This enrollment for our Norelgestromin Weekly Patch is ongoing and is expected to be completed in the first half of this year. This product candidate complements our U.S. portfolio and pipeline. It is a projecting only perceptive transdermal system designed for women with medical comorbidities, including those with a BMI of 30 or higher, and for those who prefer to avoid estrogen exposure with known safety risks.

Moving to our Phase III study of Nefecon for the treatment of IgA Nephropathy in Japan. We expect a top line readout in the first half of this year. If successful, Nefecon has the potential to become a first-line disease-modifying therapy in Japan for IgA Nephropathy. It is the first targeted release formulation designed to reduce the production of directive deficient IgA 1 at its source in the gut. IgA Nephropathy remains a significant unmet medical need particularly in Japan, disease prevalence is high.

And finally, we are advancing our Influvac High Dose Phase III program, which will present a strategic life cycle extension of our current Influvac vaccine in Europe. Influvac High Dose has the potential to offer patients, particularly those age 60 and older and enhancing immune response compared to the standard dose. The consistent execution of our pipeline over the past year demonstrates the rigor we are bringing to our development programs. I look forward to sharing more on March 19 about our R&D strategy and how we plan to accelerate innovation and increase the value we deliver to the business and to patients worldwide.

Now I'll turn it over to Theodora.

Thank you, Philippe, and good morning, everyone. My remarks today will focus on the key highlights from our fourth quarter and full year 2025 results and our growth outlook for 2026, which we believe will be powered by continued commercial momentum and the anticipated benefits from our strategic review. Building on Scott's comments, we are proud of our team's strong performance in 2025.

Our fourth quarter and full year results reflects disciplined execution across our diversified global business and importantly, strong momentum as we exited the year. We reported total revenues for the fourth quarter of $3.7 billion, up 1% versus the prior year, excluding the Indore impact. This result was driven by strong commercial performance across key regions. In Greater China, growth was supported by demand in our cardiovascular portfolio. And in Europe and emerging markets, growth was driven by the breadth and competitive strength of our portfolio.

Moving to full year 2025 results, we delivered total revenues of $14.3 billion, in line with our expectations and up 2% versus the prior year, excluding the Indore impact. Adjusted EBITDA of $4.2 billion, reflecting solid operating performance, adjusted EPS of $2.35 per share and free cash flow, excluding transaction-related costs of $2.2 billion. Importantly, we prioritized capital return with over $1 billion returned to shareholders, including share buybacks and dividends.

Turning now to our outlook for 2026. We expect to build on our positive momentum exiting 2025 and establish a clear baseline for sustainable growth. We are guiding to approximately 2% total revenue and adjusted EBITDA growth versus 2025. A key enabler of this growth is the company's strategic review which is expected to deliver approximately $650 million of gross cost savings or $400 million of net savings after reinvestment. These cost savings are expected to be evenly balanced between SG&A efficiencies and COGS optimization and phased over a 3-year period, with full run rate benefits realized in 2029.

Importantly, we plan to reinvest up to $250 million of these cost savings into areas we anticipate will drive our future growth. This includes strengthening our commercial execution for near-term launches, advancing our innovative assets and building the capabilities required for success. We believe these efforts will not only strengthen our competitiveness, but also support sustainable growth over the long term.

Now here's what we expect to accomplish in 2026. We are very excited about anticipated launches of Effexor, low-dose estrogen weekly patch and sotagliflozin. These are important strategic launches for us. And while they are not expected to be material top line drivers in 2026, we do anticipate them to be significant financial contributors over the longer term.

Let me now walk you through the building blocks for our 2026 total revenues outlook. We are anticipating new product revenues of $450 million to $550 million which are expected to contribute to strong segment performance. We expect net sales in developed markets to grow 2% versus 2025. In Europe, we expect growth of 4% year-over-year, benefiting from several tailwinds. First, we expect increased contributions from new product revenue, led by Apixaban and paliperidone. In addition, we anticipate continued growth in key markets such as France and Italy, including some supply recovery from Indore. And finally, we expect strong continued performance in some of our key brands like Creon and Brufen.

North America is expected to be flat year-over-year as new product revenues, primarily from complex products, and ongoing strength from existing products such as Breyna, Estradiol TDS, and Xulane are expected to offset certain competitive impacts, including the Isosulfan Blue LOE.

Turning to emerging markets. We expect to grow 6% year-over-year. This is primarily driven by expansion in key growth markets, including Turkey, Mexico, India and Brazil, new product revenue contributions and some supply recovery in our ARV business. These benefits are expected to more than offset pricing headwinds in certain Asian markets.

As it relates to JANZ, we remain focused on returning the segment to growth. Our outlook for this year reflects the expected impacts from government-driven price regulations in Japan and Australia as well as the anticipated impact from the midyear Dymista LOE in Japan. At the same time, we expect to launch important strategic products in 2026, including Effexor and pitolisant to begin supporting future performance for this region.

And lastly, in Greater China, we expect to deliver 3% year-over-year growth, driven primarily by our cardiovascular products that are sensitive to proactive patient choice. Our confidence in Greater China is the result of our ability to continue to maximize our well-established commercial presence across multiple channels. These include retail, private hospitals and e-commerce where we have invested strategically over the past few years and are seeing continued growth, in particular, for certain retail anti products.

Last, as mentioned in our press release, in mid-February, fire occurred in a service area at our oral solid dose manufacturing facility in Nashik, India. Manufacturing at the facility has been temporarily suspended and we expect to resume operations beginning in April. We've considered the potential impact of this incident and the facility shutdown and formulating our 2026 financial guidance.

Moving to the drivers of adjusted gross margin, adjusted EBITDA and adjusted EPS. We expect gross margins to be modestly lower year-over-year, primarily due to anticipated losses of exclusivity and mix shift as supply recovers in our lower-margin ARV business. These headwinds are partially offset by favorable segment mix and higher-margin new product launches. Over time, however, we expect gross margins to benefit from the realization of cost savings and the scaling of our higher-margin products.

Adjusted SG&A is expected to decline year-over-year as a percentage of sales, reflecting the net benefits from our strategic review. Adjusted R&D is expected to be flat versus the prior year as we continue to advance our innovative programs while maintaining disciplined cost management. And finally, in 2025, we benefited from approximately $40 million in TSA income related to divestitures, which will not recur in 2026.

Moving to free cash flow. We continue to expect significant and durable cash generation in 2026. Our cash flow this year will be impacted by transaction-related and restructuring costs from our strategic review, but the underlying cash-generating profile of the business remains robust. We expect to be in a strong financial position in 2026 with over $2.5 billion of cash available for deployment. That includes our excess cash on hand and the net proceeds received to date from the Biocon monetization. This position provides flexibility to deliver on our balanced capital allocation framework.

Our priorities for 2026 include targeting in-market accretive business development while remaining committed to shareholder return. Our plans this year also include paying down a portion of our debt maturities to further strengthen our balance sheet and investment-grade financial profile while reducing leverage back to our 2.8 to 3.2x gross leverage range.

Now a few comments regarding the pushes and pulls of our 2026 guidance. Total revenues are expected to be higher in the second half of the year, driven by normal product seasonality and the timing of anticipated new product launches.

Operating expenses are expected to be more evenly phased between the first and second half of the year, reflecting the implementation of our strategic review and timing of investments. As a result, we expect adjusted EBITDA and adjusted EPS to be more heavily weighted towards the second half of the year. Finally, free cash flow is expected to be lower in the first half of the year. Also, the first quarter is expected to be the lowest quarter for total revenues and adjusted gross margins, driven by product seasonality and mix.

Free cash flow is also anticipated to be the lowest in the first quarter, primarily due to the timing of working capital and onetime operating cash costs as well as transaction-related and restructuring costs and taxes.

In summary, our 2026 outlook reflects continued momentum in the business, disciplined financial execution and a strengthened cost structure that supports both reinvestment and shareholder return. We are entering the year with a growing base, clear priorities and the financial flexibility to execute. We look forward to hosting our investor event in New York City next month where we plan to provide an update on the company's future outlook for growth.

And with that, I'll hand it back to the operator to begin the Q&A.

[Operator Instructions] And today's first question will come from Glen Santangelo with Barclays.

Yes. Just 2 quick ones for me. Scott, at a conference last month, you seem to mention a path to mid-single-digit revenue growth. And I fully understand that's not where we are today, but maybe I was just hoping you could give us a little bit more color on those 6 potential approvals this year, your confidence level in those, which may be most meaningful? And then maybe how that was layered into the guidance, if at all. And then I'll just ask my follow-up upfront. Theodora, I did want to talk about the strategic review. You did mention the release $650 million of savings with $250 million of reinvestment. So if we call it net $400 million of savings over the next 3 years, maybe for modeling purposes, if you could just sort of help us think about the timing of those savings across 3 years.

Thank you, Glen. Thank you for the question. So Doretta is going to address the strategic review cadence and timing, things like that. But I just want to say that we're very pleased with the work that's done. I'm very confident in our ability to deliver the results from the enterprise-wide strategic review. Relative to the mid-single digits path, which is a longer-term path that we have over the next few years. The way that I think we get there when I think about it, this is the way that I look at it in my mind, we've got a base business, and Doretta pointed out in her comments, is growing at 3% this year, grew last year. We've got a growing base business. On top of that, you layer in the launches that are coming '26, and those will be Effexor, Pitolisant and Spydia in Japan, although we launched Spydia at the very end of last year, I consider it a launch product for Japan. Japan is a very important market for us. So 3 very important launches in the CNS space there for us that can really help build on what we have there.

In the U.S., we're hoping to launch low-dose estrogen weekly patch, [indiscernible] Presbyopia and potentially even meloxicam, fast-acting meloxicam, which as Philippe alluded to, we should be filing tomorrow. And so depending on the cadence of that review, we may be launching that. On top of that, we've got a number of data readouts in '26 that are going to be launching in '27 and beyond. We've got selatogrel and cenerimod readouts, which we think are going to be early '27, but we could get 1 or 2 of those readouts in '26. Selatogrel is an event-driven study, so we'll see how that goes. But those are relatively near-term launches, which can provide a lot of -- as we get into the '28, '29, '30 time frame. And then on top of all that, we've got capital to deploy to bring in accretive growth assets portfolio and pipeline. So all those things together give me a lot of confidence that we can get to that mid-single digits in the coming years.

And Glen, with respect to your question around the $400 million of savings, we do expect them to be phased over 3 years. The way to think about it is we anticipate roughly 30% in '26 an additional 30% in '27 and then the remaining approximately 40% in 2028. The sequencing really reflects the timing of how we think about workforce actions and other efficiencies as we fill them into the organization. But importantly, as those savings are phased in, they're expected to support our EBITDA growth and margin expansion over time.

The next question is from Umer Raffat with Evercore.

Maybe 2 here, if I may. First, on the cost cut announcement, the strategic review, could you break down for us the $650 million as it's broken down between COGS versus SG&A versus R&D? And if there's any CapEx associated to get to these, which is not sort of reflected in the $400 million versus $650 million? And then secondly, could you also remind us, what are you assuming for Indore bounce back in 2026? Is there any model in at all in the current EBITDA guidance or not? Because I know there was a $325 million headwind over the course of '25?

Let me just make a couple of comments, and then I'll pass it over to Doretta to give you some of the specifics. In terms of where the $650 million comes from, about 50% of that is coming from headcount reductions at this point in time. The other 50% is coming from COGS efficiencies, inventory management, support structures, not a lot from R&D. There were some medical affairs and some streamlining things, but that's not a major area of focus for us in terms of cost cutting because we're moving forward to execute on a number of pipeline programs.

So that's an area, I think, that we're focused on bringing in more assets and growing. There are some efficiencies there in the way we do it, but it's not an area of major cost savings, again, 50% of head count reductions in the cost efficiency, inventory and sports structures, but I'll pass it over to Doretta to give some more detail.

Right. I think you handled from a cost savings perspective, you mentioned roughly evenly split between operating efficiencies and SG&A. I would state the operating efficiencies and the cost efficiencies are a little bit more back-end weighted as you think about the phasing, just given the timing of implementation, but that should give you a rough sense.

Secondly, with respect to your Indore question, we would -- we assume a little less than 1% of indoor recovery baked into our top line. Just as a reminder, we had done a lot of work over the course of the year to remediate Indore. And there was a portion of Indore that was lenalidomide that was not expected to recur in 2026. And so when you take out lenalidomide and also all the work that we've done over the course of the year, kind of we've remediated and managed through the impact, so it wouldn't have a material impact on our 2026 guidance.

Yes. And I think it's all baked in as we stand, again, we've requalified of the plants, found alternate sources. And so I don't expect any bounce up of when the plant comes back online or bounce down if there's a delay in reinspection. We tried to remediate the full effects of anything that add into our impact on us last year.

The next question comes from Ash Verma with UBS.

Congrats on all the progress. So I just wanted to understand the levels of these restructuring charges versus the net savings you're realizing. So you're effectively spending $700 million to $850 million pretax charges or a $400 million net savings, is this within a typical benchmark range for such cost saving initiatives in the industry? And then secondly, on the fast-acting meloxicam, so yes, this can have a pretty broad set of physician in that you can go after from primary care all the way to surgery settings, pain specialists, et cetera. What do you consider to be your initial focus and where can it go from there? .

You answer the question, and we'll have -- Doretta answer the first part and Corinne will talk about fast-acting meloxicam segments.

Yes. And Ash, let me break this up into 2 parts. So the first piece are the onetime costs that are necessary to achieve the onetime savings, our current estimate. You can think about a general ballpark about over the lifetime of the program, about 1x our gross savings in order to achieve them. We estimate that it will be about $250 million this year, and that's what's baked into that $700 million number you quoted. There are 2 other components to that number that it would be helpful to break out.

Number one, we've talked about the fact that even though we realize the cash proceeds from both the divestitures as well as the Biocon proceeds as cash when it comes to the taxes and other costs associated with those monetizations, they're reported as operational outflows. And so those are the 2 numbers. And so from the Biocon perspective, we received the $400 million of cash. We've included the $110 million of taxes associated with that in that $700 million. And then we still have about $320 million of divestiture-related cash and cost and taxes that are included in that number. So it's really the 3 components you have to think about.

And regarding your question on fast-acting meloxicam, yes, you're right, we are -- there is a broad opportunity in -- for acute pain, moderate-to-severe acute pain, and we are very excited about the potential of meloxicam and the place that meloxicam will play in this market. Just to remind everyone about the size of the opportunity, we see every year in the U.S. 80 million cases of acute pain. And unfortunately, opioids are still prescribed broadly about 50% of prescriptions are opioids. So the way we look at how we're going to enter this market is for us to be -- to make sure that we can guarantee faster uptake for the asset. Well, therefore, we'll focus operative, post-operative and operative acute pain management versus nonoperative pain.

We will build a specialty sales force that will target those physicians in their offices, and like surgeons, orthopedic surgeons, dental surgeries, podiatry giving you like a range of the targets that we will focus on. Beyond this target because you are right, but in pain medication can be prescribed very broadly, including from PCP. So beyond those specialty targets, we will plan on looking for potential partnerships to expand our reach and as we progress with the launch of the product.

And your next question will come from Les Sulewski with Truist.

Congrats on the progress. A couple for me. First on Japan. Can you quantify the regulatory pricing challenges you're seeing across the region? And you noted the Japanese coming to an inflection point. Do the Aculys assets and Effexor provide net growth for the region or more of an offset from erosion due to LOE facing there?

And then on the cost savings side, can you quantify if the remaining costs are tied to discontinued operations or what percentage of the strategic review savings is essentially cleaning up the divestiture tail versus actual efficiency gain in the core business?

And then essentially, as you realize the net savings, ultimately, do you have a kind of a long-term gross margin or EBITDA margin target for the business?

Thanks for the question. Just a little bit on Japan. Japan is a very important market for us. Structurally, Japan is a difficult market traditionally for where we've been over the last few years as a company. There's mandatory price decreases every year on LOE products. And so that's a good part of our portfolio. So we've seen downward pressure. There's a lack of ability to modify our structure from a personnel perspective in Japan, labor laws and things make it very expensive to make changes. So our decision was we've got a well-functioning company. We've got good people there. We've just seen downward pressure on both revenue and EBITDA in Japan because of the structure of the Japanese market, the mandatory price decreases, et cetera. But so we decided to add assets in there.

And I think those assets will turn us from revenue and EBITDA decline to growth as we get into '28 and beyond. So the long-term picture for Japan is much better with the internal development of Effexor GAD. The acquisition of Pitolisant and Spydia and others, which are coming into the -- there's also some other pipeline developments, which should come in the next couple of years. So we're very, very pleased about where we are with Japan now. Very good group of people. We're putting assets into their hands, and we should turn that to growth as we enter '28 and beyond. In terms of the enterprise-wide review?

Yes. And I was just going to add one more impact that's impacting our Japan business this year, we do anticipate the loss of Amitiza midyear. And so in addition to the normal price decreasing -- decreases that we get in that region, that is another factor that's impacting. And you can see that in the trends. But as Scott mentioned, longer term, we feel good about the trajectory of that business.

With respect to the cost savings, we're not currently contemplating any significant divestitures or recuts of our business. As Scott mentioned, this is really about taking a look at our infrastructure, how we're organized, reevaluating the business makeup post the divestitures and making sure that we're set up for success going forward. And though it's not a material change to how we do business today.

You asked also about a little bit of cleanup that we're doing maybe around divestitures. So I think people ask me why now? Why did you do this exercise now? And I think it was really important to do this exercise now, a merger of 2 companies 5 years ago, very different companies. different business dynamics and then 4 major divestitures, biosimilars, women's health care, OTC, API. And a lot of the people associated with those businesses went with the business, right, directly. But then there's a back-end support structure in place to support those business, and we want to make sure that those people are oriented best as possible as we move the business dynamic forward.

So it was really important for us to take a whole list of look at the company, do we have the right people in the right places to move forward? And as Doretta alluded to, this isn't about divesting pieces of the company. This is about us getting more modern, leaner and better able to execute on the base business today. and the innovative portfolio as we move forward.

And the next question comes from Matt Dellatorre with Goldman Sachs.

Maybe first on fast-acting meloxicam. Could you share your latest expectations in terms of the label, in particular, how you expect opioid sparing to be reflected there. For instance, will it be in Section 14, kind of like clinical data inclusion? Or will it be -- could we expect that to be up top in that kind of initial section. And then also any feedback you've received from the FDA thus far ahead of the kind of pending submission? And then maybe on BD, what are your latest thoughts in terms of bringing in or in-licensing maybe a more substantial branded asset versus doing smaller deals? And what would be your comfort level in doing earlier stage, for example, maybe Phase II where less of the value is baked in? And then which verticals would that make the most sense in?

Yes. Let me maybe answer the second question first, and then I'll throw it over to Philippe to talk about fast-acting meloxicam. We're not -- we're looking for in market accretive growth assets, that's what we're really focusing on. We're not looking to acquire early pipeline. We want to support the business today. We've built an internal pipeline that's going to be producing over the next few years. Our folks is finding assets that can help us drive growth in the short term now in the next 3, 4 years. So we're not focused on pipeline assets. Happy to do bigger things as long as they fit as long as we're good owners of them and that we can swallow them. We had 60 regional deals last year, including the ocular to support the base business. But certainly, I'd like to bring in some assets that can have an effect and have some real -- add some real growth and more high-margin revenue particularly to the U.S. but also globally. So that -- we're not focused on pipeline, we're focused on things which can move the needle for us today. Philippe relative to fast-acting meloxicam?

Yes. Just -- so just to reiterate that we've had a pre-NDA meeting with the agency in January, we just received the minutes, and we were waiting for those in order to be able to file. The meeting was -- we will be filing tomorrow. The meeting was extremely positive, we were able to align on all points of discussion we had with the agency, and that's why we're filing tomorrow.

In terms of label implications, I think this will remain a discussion with the agency. However, if you recall, we have very strong data when it comes to opioid sparing and we anticipate that we'll have that language included in the label. Whether it is in the indication section or as part of the clinical section of the label, I think it is future for me to tell you that, but I don't think it really matters at the end of the day as long as it's captured in the label.

And your next question comes from Chris Schott with JPMorgan.

I just want to come back maybe first to the longer-term growth algorithm. I guess if I look at the 3% top line growth this year, or I guess my 2% adjusting for Indore recovery. Is that a good proxy to think about for underlying growth before we consider some of these bigger pipeline readouts in BD, I'm just trying to get a sense of like when you think about building up that mid-singles, is that just kind of like a business that can do 2 or 3 kind of as stands and then we can kind of enhance that as these readouts come through? .

And then my second question, which is maybe elaborating a bit on the BD side, look the comments you just made, a U.S. branded asset could be a focus here. Can you just talk a little bit about the landscape for those? Like how big of an opportunity set is there are you seeing assets that are interesting in market? Or is that one just kind of conceptual. I just want to get a sense of like how broad of an opportunity set do you see for this?

Chris. So first question, let me -- again, let me maybe do it a little bit backwards the landscape of business development. I think there's lots of assets out there. A lot of interesting things. We're looking at lots of things. It's a matter of making sure that it's the right price, the right asset that fits us. But there's lots out there. It seems like 12 months ago, there wasn't much happening from a BD perspective in the pharma world seems to be heating up a little bit. There seems to be more activity and more action. So it feels like a good time to start to really build the pipeline.

BD is not something that you can ever predict to get done at a certain time. It depends on the flow of things, depends on price, depends on availability of assets, but this seems to be a time from my perspective, where there is a significant number of assets out there that are interesting. But I believe we could be good owners of.

In terms of the growth algorithm, the way that I look at the base business right now is it's low single digits growth that we see right now. We have had -- so excluding the impact, the onetime impact of Indore, we've seen 7, 8, 9 consecutive quarters of growth. Sometimes it's 1%, 2%. This is a little bit higher this year at 3%. I see them that 1%, 2% growth. And what we're trying to do is continue to invest in the space, sustain this space do the things we need to keep the base healthy and then add on to it things which can be higher growth, higher margin. And that's our path to getting sustainable higher margin, higher level, mid-single-digit growth in the longer term. We'll get into all of this at the Investor Day as we get into March and give more specifics around it. I don't want to get ahead of ourselves because we're talking to everybody in a couple of weeks. But that's sort of the algorithm on how we can potentially get there.

And the next question is from David Amsellem with Piper Sandler.

So I know you're going to be talking about R&D in a couple of weeks. So I did want to get some more detailed thoughts on how you feel about your internal R&D capabilities. You say you don't want to acquire pipeline assets, you're looking more at commercial stage assets. So just talk generally about your innovative capabilities internally and where you feel you're at particularly as it relates to novel assets. That's number one.

Number 2 is, can you just remind us where you are in your exclusivity runway or potential exclusivity runway for the meloxicam product? And then third question is just on contribution from new revenues this year. Is there any one product in particular that has an outsized impact of the $450 million to $550 million? Or is it spread around pretty evenly?

So internal research and development capabilities, I feel very good at. From an innovative perspective, we've added some late development, and again, even though we're looking from a BD perspective, not necessarily to pipeline right now, but in market assets, we're developing a number of things on our own internally. And I think we have a very strong research and development. It's not really -- it's not really R&D. There's not much research development. We've got a very strong late-stage development group led by Philippe and maybe you want to talk a little bit about those capabilities.

I mean I think we believe we have a strong group can develop drugs from Phase I and IND filing type drugs like the MR146 we have for gene therapy in eye care, all the way down to life cycle strategy for assets like Effexor. So we have the whole gamut of expertise from a development standpoint. We've shown that we know how to do it. And we'll show you as part of the Investor Day details about all this and who we are. We also have a very strong medical affair structure that we are reorganizing as part of the enterprise-wide strategic review to focus more on the innovative portfolio than on the legacy portfolio. But I think all the required expertise is there for us from a development standpoint.

Relative to meloxicam exclusivity, we'll get more into this as we get into the 19th and talk more specifically about meloxicam. It's being filed under 505(b)(2) route. There's exclusivity that comes with that. In addition, there's some uniqueness in the data, which we think we can add significant other more intellectual property protection around that asset. The way that I look at it is I consider it to be a contributor into the 2030s from an exclusivity perspective in the market. But we'll get more into that as we go and get more -- it becomes more granular, right, as we start to file some of this intellectual property and other things, but we have a very strong strategy to extend that exclusivity as long as we can. And again, I think of it as a contributor into the early 2030s.

Just to answer your question around new product revenue, the $450 million to $550 million is really diversified, both in terms of products and geographies. I would call out some of the contributors to we're excited about include octreotide, iron ferric, iron sucrose in Europe. We talked about Apixaban and paliperidone, but I would also call out it is also relatively balanced between products that we have already approved, like a creotide iron sucrose and products that we expect approval for this year.

Maybe to add that we are very excited also about the launch of our branded new products. We mentioned them already in [indiscernible] at a bit recent at the very end of the year for Japan. And in the U.S., low dose estrogen weekly contract dispatch, even though those products will be in the launch year, and not contribute especially in '26, they are important growth contributors in the following years. .

Your next question is from Jason Gerberry with Bank of America.

One for Doretta, I'm struggling a little bit with the '26 guidance relative to '25, right? So your EBITDA goes up about $150 million or so, it looks like that's largely on the cost restructuring dynamics, but you have plus $400 million in revenue versus prior year. It seems like none of that is dropping to the bottom line, but your gross margin degradation is only like 30 bps. So I was just wondering what I'm missing there.

And then on the enterprise review, so it looks like about half is on the cost of goods side, if I understand that. And so maybe if you can unpack that a little bit. Is that mainly like better procurement, reduced facility footprint type of cost, just wondering what you guys are going to be doing differently versus, say, prior years to drive that cost of goods improvement.

So with respect to your question, Chris, on EBITDA, we've always talked about EBITDA stability. We feel good about the momentum and the inflection point that our business has gone, but this year, we're really proud of where we are. We -- just to give you a flavor of some of the components. So we did see a marginal decline in our gross margins. We've talked about the drivers of that, just given the mix, some of these LOEs and some of the recovery coming from our low-margin ARV product also cross the $40 million of TSA income that we don't expect to recover this year on the back of that.

So I would characterize '26 really is a stabilization year, supported by the savings realization with structural expansion really coming more visible as the savings pop in and some of our new products come into account.

Good. And Jason, on the enterprise-wide strategic review, 50% is coming from head cost reduction, not from COGS efficiency, a much more minor pieces coming from COGS efficiency. I think you asked the question the other way around, but it's 50% from headcount reduction across the board and only a much smaller piece in terms of COGS efficiency.

And next question comes from Dennis Ding with Jefferies.

I had one on the enterprise review, the $400 million net savings. I'm just wondering if there could be additional savings upside as you execute on this over the next 1 to 3 years, basically how realistic and or conservative is the $400 million in net savings? And then number two, specifically on meloxicam, what is your base case in terms of meloxicam activity in the U.S. on net revenue? What does the good launch look like to you? And if you internally view the JOURNAVX launch is a good proxy for meloxicam. .

So just a couple of comments, and then I'll ask Corinne to talk a little bit about the comparative launches in the acute pain space. But yes, $400 million is a number we feel good about. We took our time in doing this and wanted to make sure that we can cement that within the organization. Could there be additional opportunities as time goes over the next few years? Sure. That's not something we're saying is going to happen.

The other thing is we talked about the $250 million in reinvestments up to $250 million, depending on the progress of how things go. So we could spend less than that. That could be more net savings than $400 million. But $400 million, I think, is the right number for you to think about and that we're very, very confident that we can deliver.

In terms of meloxicam, a very important product for us. We want to be able to show a very strong launch. I believe and the team we're putting together to be able to launch it. We're looking at partner strategies. We're making sure that it's resourced properly to do well. It's important for us. In terms of launch metrics and what does a good launch look like in the U.S., it's a little hard these days with access concerns and other things, we'll roll that out and talk more about that on the 19th for sure. But if Corinne, you'd like to make any general comments.

Yes, taking very much, yes. And you mentioned one of the competitors in the field. What I'd like to say is that we are going to launch meloxicam where we think we can have the greatest impact and faster. And part of this is linked to our pricing strategy to the part is linked to how we are going to focus on targets, decisions that have the most patients in terms of acute pain management.

Well, JOURNAVX has been launching. I think, have a different time frame in mind. We have a different strategy. So again, our focus is on pickaxes and we'll put it of behind these products that we can be successful with the launch.

And at this time, this concludes today's question-and-answer session. I would now like to turn the conference back over to Mr. Scott Smith, CEO, for any closing remarks.

Thank you very much. And just let me close with this. I think '25 is very, very important -- or '26, excuse me, '25 is a great year. '26 is a very important and pivotal year for us. Our base business is not only stable, but it's growing. We continue to generate strong cash flow, which gives us financial flexibility, and we're expecting multiple launches and pipeline milestones this year. With our strategic review complete, we are building a more focused, efficient future-ready company and we are confident that we are at the beginning of a period of sustained revenue and earnings growth for the company. Thank you very much for your attention.

And this does conclude today's conference. Thank you for attending today's presentation, and you may now disconnect.

Good morning. I'm Chris Schott at JPMorgan, and it's my pleasure to be hosting a fireside discussion this morning with Viatris. We're going to have a quick presentation from CEO, Scott Smith, and then we're going to open up to a Q&A session with the broader management team as well.

So with that, I'll turn it over to Scott.

Thank you, Chris, and thank you, everybody, who is in attendance today. Very nice for you to come. Just let me put this over, forward-looking statement to put on here for a second. We're going to be talking about forward-looking things.

So just before we get started, I'd like to just give a little snapshot about Viatris and who we are as a company. We're not one business. We're actually three separate businesses, a global generics company, an established brands company that owns some of the most iconic brands in the world that you can see up there, and an emerging innovative brands platform.

Over the last 12 months, we've delivered $14.1 billion in revenue, $4.1 billion in EBITDA, and $2.2 billion in adjusted EBITDA, $2.2 billion in free cash flow -- sorry, $2.32 adjusted [ EBITDA ] and $2.2 billion in free cash flow. Currently, we operate in 165 countries. We have 1,400 unique products. And I think what we're most proud of as an organization is the fact that we deliver medicine, provide medicine to over 1 billion people annually every year, which is a pretty amazing feat when you think about 15% of the world's population we service as a company, and we're very, very proud of that. It's a very nice position, or anchor for us to be able to positively affect human health care. And so we take it very, very seriously.

We're also very proud of what we accomplished in 2025. 2025, as most of us know, was a little bit of a volatile year, started off, I think, a little choppy, certainly cleared up towards the end, but was very proud of the organization and what we were able to accomplish. We drove strong commercial execution across our global portfolio. We advanced our pipeline, including 5 positive Phase III readouts out of 6 Phase III readouts, so 5 out of 6, a very good ratio there. Significantly, we also advanced cenerimod and selatogrel in the clinic very substantially in their Phase III programs, and we're getting towards the end of those Phase III programs now.

We prioritize capital return with greater than $1 billion returned to shareholders through dividends and share buybacks. We had targeted accretive regional business development, including the acquisition of Aculys in Japan. We actually did 60 regional business development deals last year to support the base business.

Japan was one of my strategic priorities as a country to be able to put products in. Because of the age of the portfolio, we have a little bit of a declining revenue stream in Japan, and an inability to change workforce size because of labor laws. So it was very important for us to find new, innovative, high-margin products to Japan. And we're very, very happy with what we were able to do there.

We substantially completed the remediation at our Indore facility and met with the U.S. FDA to discuss potential timing for reinspection of that facility. We conducted what we call an enterprise-wide strategic review to help make Viatris more focused, efficient and future-ready. The result of that will allow us to not only reinvest in new parts of the business, but also achieve substantial savings over the cost footprint that we have today. And we were able to do all of that while substantially refreshing both leadership and the Board of Directors during 2025. So I think a year of very substantial accomplishment.

There's obviously much, much, much more to do as we go into '26 and beyond, but I'm very proud of the organization for what they were able to accomplish in 2025. And I think that hard work in 2025 has been -- has set us up to be able to really execute in '26 and beyond, set up for a different type of frame and a different strategic setup for 2026 and beyond.

First of all, we have a number of anticipated high-value launches coming, and Philippe will get into this in more substance, but just a few highlights of those. Sotagliflozin, or what I call sota in most of the rest of the world. We have Phentolamine. We've got Low Dose Estrogen Meloxicam -- sorry, Fast-Acting Meloxicam in the U.S., and in Japan, Spydia, Pitolisant and also Effexor GAD. So we've got a very substantial number of launches in very important geographies for us. And again, Philippe is going to talk a little bit more about the pipeline in just a second.

We've engaged in this strategic wide -- enterprise-wide strategic review, and we'll start to see the real benefit of that playing out in '26, '27, '28, but the start of that will happen in '26, which again, the purpose for that is to make sure that we are fit for purpose, not only for '26, but going forward. And it will -- the net-net of that will be monies to reinvest in different businesses as we move forward and the base business, but also substantial savings to the company as well.

We expect to obviously generate a very significant cash flow during the course of 2026. We can -- with that cash flow, the plan is to be able to continue to return to shareholders, dividends, share buybacks, but also start to really build a portfolio of growth assets through accretive in-market business development in the U.S., and also business development globally as we've been doing for the last few years. And then also, we have a very large number of pipeline milestones coming in 2026. And let me just kick it over to Philippe to talk a little bit about that.

Thank you, Scott, and good morning, everyone. I don't know if the microphone is working. It is.

So as you mentioned, last year, we had 5 positive Phase III results. And based on the strength of the data that we've seen with these assets, we anticipate that we'll be getting approval this year. In addition to these positive results, we acquired Pitolisant and Spydia in Japan. Spydia was launched recently at the beginning of this year. And Pitolisant, we were able to file for both indications, treatment of excessive daytime spininess for narcolepsy and for sleep apnea at the end of the year and anticipate approval this year.

In '25, we also made significant progress with our pipeline, in particular, with cenerimod and selatogrel, where we believe we'll have full enrollment this year for both of these assets. And we're still very confident in the profile of these assets and believe they have the opportunity to answer a significant unmet need. But I'm sure we'll get into more details during the Q&A session.

And so just sort of wrapping up '26, the strength of the base business, together with the benefits of this enterprise-wide strategic review, together with this evolving pipeline, and also our ability to acquire assets to add to the portfolio, are going to take us to a longer-term period of sustainable top line and bottom line growth, which starts in 2026.

And so we're really excited to get into '26. There's been a lot of hard work to get us there and paying down debt and restructurings and other things, but we're very, very excited about the platform that we're going to launch going forward, '26 and beyond.

So with that, I'll turn it back to Chris for the Q&A portion.

So I thought just starting off at a high level. You're about 3 years in the seat as CEO at Viatris. As you think about the business today, I guess, what are you most excited about as you've seen how the business and the portfolio has evolved?

So a couple of things that I'm excited about. First of all, I'm very excited about where we are from a company perspective and an employee perspective around the world, right? There's been divestitures. There's been some restructuring. We've added some skill sets as we move forward. I think we've got a very strong core group of employees worldwide. I'm excited about that.

I'm excited about the leadership team. And you can see -- if you had -- seen a presentation 3 years ago, there's all different faces here. We have refreshed the leadership team. We brought new skill sets in and very, very pleased with the people that we've been able to bring in, the quality of people, the skill sets, et cetera. But sort of what I'm most excited for is just getting into this next 3 to 5 years.

As I said, there's been a lot of hard work to get us where we are today. I see a very strong period of stability for the base business. We have 8, 9, 10 quarters in a row now ex Indore of 1% to 2% revenue growth. So I think we've really stabilized that base business. We've got the cost benefit and the structural benefit of the enterprise review that we're doing. We've got an ability to be able to do business development and add things to the pipeline, and we're going to continue to build the pipeline and our portfolio of growth assets.

And as you can see, we've seen a real acceleration in the pipeline over the last 12 months or so, starting to really yield results in higher margin, higher impact products that we'll be launching in '26 and beyond. And we've got a number of data readouts in '26, which are going to be really important for us. So just the whole setup, I'm really excited for us, for our investors, for our employees to be moving into a period of sustainable top line and bottom line growth over the next 3 to 5 years.

Great. And just building on that, like how are you thinking about the magnitude of that top and bottom line growth and the top line margins, a little bit more color there?

Yes. So I think we're going to get more specific around what those numbers look like, obviously, when we get to the Q4 guide for '26. But again, we've seen this sustainable period of 1% to 2% revenue growth. If you think about the impact of these launches, you think about the impact of accretive in-market business development that we can do during the course of the year, I would expect that to move to sort of mid-single digits from a revenue perspective.

And when we get to the final numbers on enterprise review and those such things, we'll guide on what the bottom line looks like. But the important thing for me is we're no longer going through a period of revenue and EBITDA decline. We stabilized in '25, and we're moving towards a real growth in '26. And we'll be fully transparent and get all the numbers out there at the right time when we're able to do that. But we're very, very excited about where we're going.

On business development, can you just talk maybe about the landscape that you're seeing out there? And I guess, maybe just looking back to '25, is that kind of indicative of what we should expect from Viatris, or those targets and the type of assets you pursue maybe kind of change over time?

Yes. So I think in any 1 year, I think the year before, we did something like 41 regional deals. We did 60 last year. We're going to continue to do those. We've got a very substantial infrastructure globally, commercializing in 165 countries. We need to feed them with new products, and we need to continue that. And we're a very good partner for companies which could maybe see themselves commercializing in the U.S., but not internationally. And so we do have the infrastructure out there. We're very proud of it. It's working at a very high level. We've got large affiliates in places like China and Japan and Italy. And so we're looking to add things there.

From a U.S. perspective, we're looking for accretive in-market assets that we think we can be good owners of, right? And I'm less about what therapeutic area are we really looking at? I'm looking at, can we, as a company, be good owners of those assets? Can we add something that the company that we're acquiring from doesn't? And some of the things that we can do, I mean, we've got tremendous product line extension activities. We got extensive development abilities, which we can add second and third and fourth indications on. We've got access infrastructure. We've got global commercial structure.

And so there are assets out there, which I look at, the sweet spot being in the $0.5 billion to $1 billion peak revenue kind of range. And we're looking for assets that we can then build off of and it can become a cornerstone of of the therapeutic area we go into moving forward. But I'm less concerned about the therapeutic area and more concerned about are we the right -- are we the best owners for that particular asset?

And just the landscape for those type of assets, are you seeing a lot of opportunities?

I think there's a lot of opportunities. Again, when I think back to early '25, and we were struggling internally with some of the things on Indore, there was a lot of discussion around tariffs, obviously, health care policy. It seemed like there wasn't a lot of movement from an M&A perspective. Certainly, as things have changed, and I feel like there's a lot of companies out there.

I think we're in a little bit of a sweet spot as well ourselves. You look at the big pharma LOEs that are going to happen over the next 2 to 3 to 4 to 5 years, and they're multi, multibillion dollars and to replace that, you need big assets. We're looking to add multiple $0.5 billion, $1 billion assets. There's not as much competition for those assets. So I think there's a lot of things out there, which are very doable for us.

Excellent. I know we're also awaiting some details on the company's enterprise-wide review. Can you just talk a little bit about maybe setting the stage of what we should expect here in terms of the scale of this review and the phasing of when those savings could flow through?

It's going to be substantial. It's going to be substantial. Again, when you take a step back and look at why are they doing this, it's not just about saving money, right? We merged in 2020, 2021, we divested 4 major businesses, which were core to our future. And as we took a look at going into '25, the uncertainty in the marketplace, the Indore situation, it seems us to be the right time and we accelerated this idea that we really need to look at the company.

And we need to look at it from this lens. Do we have the right people in the right places to be able to deliver what we need to deliver in '26, '27, '28? Or is this a structure which benefited us in 2021, but is not fit for the future. So we want it to be fit for purpose. And I think there's -- when you divest businesses, and you don't really look at that structure, I think there's a real ability to become more effective and more efficient in a lot of different areas. And I think we're looking at everything, right? We're looking at procurement. We're looking at marketing practices. We're looking at development practices. We're looking at centers of excellence. We're looking at everything in the company.

And the net-net of that, I think, will be an ability to refocus resources on more resource responsive assets, right, that we can grow faster, some of the new pipeline, some of the new things that we're doing. But also, I think there'll be substantial savings, which will help us grow our EBITDA over a period of time.

On that point of reinvestment and just directionally, how much of the gross savings here, should we think about being reinvested in that?

Without giving a ratio, I don't know exactly. I think it will be the portion that drops to the bottom line and savings, I think, will be more substantial than the reinvestment.

Okay. And the reinvestment, we should think about mostly going towards some of these growth assets. Is that?

Growth assets. We've got launches. I think we've got other assets out there that may not be launch assets that may be underfunded in different places. And so we really took a look at the portfolio, all of the 1,400 products and 4,000 SKUs and all that. And it's quite an effort in this company, which is very large and very diverse, and wanted to make sure that we were applying the efforts in places -- the promotional efforts in places that were promotional responsive there will be good return on investment. for us.

Great. Moving maybe to 2026. I know we're going to be getting into guidance fairly shortly. Just early pushes and pulls we should be thinking about for the business entering this year?

Great. Yes. Thanks, Chris. So we're pleased with how the year ended, and we expect that momentum to carry us through as we think about '26. As Scott mentioned, '26 is really shaping up to be a catalyst-rich year for Viatris. And so as we think about the tailwinds, there's a number of things that we're excited about.

Greater China and Europe continue to perform strongly for us. In North America, now that we've lapped Indore, that business is strengthening, really supported not only by the complex generic products that have gotten approved and launched like iron sucrose, Sandostatin, as well as paclitaxel, but importantly, upcoming launches, not only on the complex generic side, but on the branded and innovative side as well.

In Japan, that market is really at an inflection for us, really supported by some of these innovative portfolio that we anticipate launching this year, Pitolisant, Effexor GAD, and Spydia, and then in emerging markets, that business, we should -- we'll start to see contributions from the launch of sotagliflozin in certain key markets there. So a lot to be excited about overall in the business. And then lastly, on the enterprise-wide strategic review side, we should start to see net savings drop to the bottom line starting this year.

Encouraging.

Just a comment -- and I'm the most guilty of person here, but we get so excited about the inflection points, the things we need to invest in the opportunities that we have ahead. We don't, for a second, take our eye off the base business, right? It's $14 billion in revenue and that base business is what leads to the EBITDA and cash flow to allow us to expand the business.

So although we end up -- people are interested and want to talk more about it and we talk a lot about it, my message to the company inside is, first and foremost, we need to keep that base business as stable and solid as possible. And that gives us the opportunity to explore other opportunities.

And just on the headwind side, we have the normal pricing and policy adjustments that are facing our JANZ business. We also expect to have some generic competition due to loss of exclusivity of Amitiza in Japan, and then just normal kind of competitive dynamics in North America and certain markets. But I think the message is when you take a step back and you put all these pieces together, we're pleased with the position that we're in entering in '26, and our focus really is on execution.

I know Indore was a headwind for last year. Just update in terms of where we are with that facility. And I guess, just directionally, how much of a volatility factor should that be in 2026 numbers?

Yes. So you talk about the numbers. But let me -- so sort of the way that I look at indoor and the remediation we're substantially finalized. And it's a little bit of the vanishing zero concept here that on a plant like that with so many -- it's a gigantic plant involved in an incredible amount of manufacturing. There's so many bits and pieces to it that to get to that 100%, right, it takes a while, but we're 90 -- very close to 100% remediated there.

We had a meeting, I think, which was November 4 with the FDA on the process going forward and the timing for them to come and inspect. I mean it's up to them when the reinspection happens, it's not up to us. But for me, the most important point here is by the time they come to reinspect, hopefully commercially, it's a nonevent, right? Whether it's approved or not, we certainly expect it and hope it to be reapproved. But we have found duplicity in where we manufacture things. We found alternate sources. We've had external sources. We built redundancies into the system so that when that comes online, it's not a financial positive or negative.

It doesn't come online. It's more of a reputational positive for us, gives us some flexibility, may allow us some cost benefits to manufacture things in a different way. It's one plan in the network of '26. But we've done the hard work since that we got that import alert to be able to find the redundancies and alternate sources so that we can keep or regain as much of that business as possible.

Excellent.

And I would just say the net effect of that, to answer your question is we see limited volatility as it relates to Indore in terms of our '26.

Okay. Review mirror now for the financials. Capital allocation, come back quickly there. Just how should we think about total capacity for capital allocation over the next few years?

Yes. So I think from -- and again, Indore can get more specific on some of the numbers if we want here, but we're going to have a good capacity in '26. We ended the year in '25 with substantial cash balance. We have negotiated an arrangement with Biocon to monetize our equity position in there, and that will be coming to us. We also expect, of course, substantial cash flows from the business. So I think we're going to have more than usual capacity in the course of '26.

And again, we are, from a free cash flow perspective, $2 billion plus going forward for the next foreseeable 5 years, and that will grow over time. So we think we've got capacity. Relative to capital allocation, I talk about a lot, I see it over the next 3 to 5 years is 50-50 kind of between return to shareholders, through dividends, continuing the dividend, share buybacks and then business development as well. Any one year, we may lean more into one than the other. Last year, we leaned into buybacks given the volatility, the depression in the share price, particularly early in the year, sort of -- and the lack of real business development opportunities that are there.

We sort of leaned into business development -- we leaned into share buybacks and, of course, continue the dividend. This year, maybe one where we lean a little bit more into business development. We need to do both, right? We need to return to shareholders, and we also need to build a portfolio of growth assets with this cash to really have sustainable long-term revenue growth for the company.

And from the earlier comments, it sounds like some of the priorities is U.S., more revenue-generating type of assets. Is that fair? Globally, is there a similar appetite ex U.S.? Or do we see some R&D deals mixed in there as well?

I think, again, we did 60 deals ex U.S. in '25. I would expect that the Hamilton team will do another 60 this year. They're very busy doing this, supporting the business. When I took a look sort of last year, beginning of the year, what are the real strategic priorities to build this business, there were two things that really popped to the top from a commercial perspective for me.

First is the United States. Largest business, highest margin. It's only 25% of our global revenues, which is disproportionately low relative to our peers. And so a real opportunity to build there. And the other one was Japan, where, again, you have a declining revenue base because of the age of the portfolio and government-mandated price decreases, and an inability to change the size of your sales force substantially because of labor laws and things. And so we really set out to bring some assets in there.

We charged up the internal development and developed Effexor GAD for Japan, but we also acquired Aculys and the assets that they have for Japan, Spydia and Pitolisant. And so we think we're going to put a growth profile on Japan going forward as opposed to a revenue decline profile. But certainly, in the short term, we're focused on in market accretive, high-margin U.S. revenue.

Okay. Excellent. Very clear. Moving to the pipeline. Meloxicam, some solid data in acute pain last year. Just remind us how you're thinking about the opportunity for that market?

Maybe we'll ask Corinne to do that, right?

I'm sorry, I didn't -- so I'm remiss. There wasn't enough seats. Philippe, you met before, is our Head of R&D, obviously, Theodora, our CFO; and then Corinne Le Goff, our Chief Commercial Officer, who's in the front row of the microphone up here because there wasn't room. So please, Corinne.

So we are very excited with the Meloxicam data that we are -- and the readout that we had last year. And we look at this opportunity as a very broad opportunity. The market for acute pain, moderate to severe acute pain is really very broad, especially when you're looking for non-opioid pain relief, right? And it's an important point because if you look at the United States, you have about 80 million pain cases every year. And half of those patients still get an opioid despite the known risk of dependence and abuse.

So we see that with a product with like Fast-Acting Meloxicam that acts fast, a very rapid absorption, works very well, high efficacy and has the potential to decrease the use of opioid. It's a very, very strong positioning. In terms of market segmentation, you can make the differentiation between operative pain, so postsurgical pain or non-operative pain. We've generated a lot of data in operative pain, soft tissue and hard tissues. And our focus will be on those patients that are mostly seen in the outpatient setting, or like ambulatory surgery centers for hip replacement surgeries, or knee replacement surgeries, or patients that are seen in-office like dental surgery. So it's a large opportunity. We'll be very focused, and we are very excited about it.

And there's another part of this, which excites me as well, right? So the opportunity is very, very large, the data in and of itself, which is what really is the sort of the life bread of the fuel for products to be successful. When I look at that data and I look at other products, more recent products, I think that data really is outstanding.

No head-to-head. I'm not saying we've done any comparative data. But if you just take a look at the data and see what it says relative to opioid sparing and other things, and it really is a pretty remarkable data. So the combination of that data, which is remarkable with the size of the market, the unmet need, the fact that opioids are still overused, I think creates a tremendous commercial opportunity for us.

And to access that, I guess, just talk a little bit about the investment and commercial infrastructure we need to think about here?

Yes. So we are looking at focusing on those outpatients where you have the largest volume of patients and specifically looking at building an organizational sales force, a specialty sales force that will focus on those targets like orthopedic surgeons, or general surgeons. And we might want as well, and we are in the process of finalizing our commercialization strategy, but we might want to expand our reach on targets like PCPs potentially, or dentists, and we'll do this as a partnership. So we're going to be very disciplined in how we apply our dollars. And what we want is to maximize the opportunity for Fast-Acting Meloxicam, and the value of the asset.

Excellent. Maybe one last one on this one, just IP exclusivity, how do you think about the runway here?

So I can talk to this as well. So we're going to launch and promote Fast-Acting Meloxicam as a branded asset. It's a 505(b)(2). So we have at least between 3 or 5 years of runway, but we also have 5 additional patents that will potentially extend our runway. So again, it's a very strong opportunity for us.

And I don't know that there's a better company in the world to expand that patent estate, given the history of the company and the lawyers that we employ, and the experience that they have at this than us. And so I think we're in a really good position. I look at this as a very strong contributing asset through this decade and into early 2030. And whether that's 2031 or 2034, we don't know yet. We're going to work to expand that. But certainly through the end of this decade, it's going to be an important portfolio contributor for us.

Great. Maybe we can go to cenerimod. Just remind us how you're thinking about the opportunity in SLE, and how you think about this asset maybe fitting in the competitive landscape for the market?

Yes. So in SLE, we remain a significant unmet need, and there's a specific unmet need for an oral treatment, with the right benefit risk profile that can be given on top of standard of care. And that so far is the data that we've seen from cenerimod fits that profile very well.

What is particularly important for cenerimod is that the mechanism of action of the asset is -- fits very well with SLE. It tackles all 3 key pillars of the disease. And we've seen that in Phase II, right? We had 3 Phase II studies at the 4-milligram dose. We've seen robust consistent data that led to the design of the Phase III study. So strong data, strong mechanism of action supporting the use in SLE, and a significant unmet need for an oral treatment that can be used prior to those more aggressive biologic assets that have a different benefit risk profile.

In a different world, Philippe and I were interested in developing an [ S1P ] molecule that we had in SLE, but it never got there, but for reasons other than whether or not it would work. But I think it's a very, very solid mechanism to take into SLE.

What's the timing of the Phase III readout for this one?

Yes. So we fully enrolled the first of the two Phase III studies last year, and we are very close to enrolling the second Phase III study. So we anticipate that the readouts will come towards the end of this year, early next year, and we'll go from there.

You also recently started a Phase III in lupus nephritis for this one. Can you talk about what gave you confidence to go there and how we should think about timing of that data?

Yes. I mean I think lupus nephritis is a similar thought process than with SLE. The mechanism of action of cenerimod fits very well with lupus nephritis as well. In particular, we've seen our best data in interferon1-high patients in more severe patients. And the lupus nephritis patients typically are interferon high and have a more severe disease. So that was important for us to do that.

But before we embarked on lupus nephritis, we had to do a number of clean pharm studies to make sure we could give the data to more renally impaired patients. That data came back last year. And we saw an ability to give cenerimod to all patients with renal, including severe renal impairment, which helped us design the study. It's all-inclusive study, probably the most inclusive study that has been run for lupus nephritis based on the profile and based on the benefit risk we've seen with cenerimod so far. So very excited for -- to see the results of that study as well.

Excellent. Shifting to selatogrel. Can you just talk about the market opportunity here and what's going to be required to build out the market for this one?

Yes. Maybe I'll start with the patient and then I'll ask Corinne to add. I mean we have -- if you look at the U.S., you have about 6 million patients that have a history of MI. And every year, about 1 million patient gets an acute myocardial infraction. So that represents a significant opportunity for us. And again, this is a completely novel approach that addresses the main unmet need, which is the time between the symptom onset and the first time a patient sees a medical professional. So we are very excited about what we're seeing and look forward to showing the data when available. Corinne?

Yes. I really believe that selatogrel will be a paradigm shift in the management of acute MI. And as Philippe said, there is a tremendous unmet need because MI today is responsible for 1/3 of death in developed countries. And you should know that 30% of those deaths occur before the patient has the time to come -- to go to the hospital. So early intervention, self-injection with the patient will be absolutely crucial in setting night. So we are very enthusiastic about the potential of selatogrel.

As Philippe mentioned, it's a large market opportunity. Globally, he gave you the U.S. numbers, but globally, it's -- there are 25 million patients that had an MI. 2 million a year have an incident of additional MI. So it's a large market opportunity. And you need to remember as well that as an organization, we are very well placed to commercialize this asset because we have a very long experience in rescue medicines with products like EpiPen, and we are very well positioned to do the necessary patient education, advocacy, and we will also globally leverage the infrastructure that we have in cardiovascular. So very good assets in our hands and bullish about it.

Absolutely. And although we may have to build some infrastructure in the United States from a cardiovascular perspective, we have $4 billion worldwide in cardiovascular sales. So it fits very well therapeutically, particularly ex U.S., and we've got a large commercial structure out there that's promoting a number of different cardiovascular brands. So it will fit.

And I love what Corinne said, is there a better company to commercialize life-saving self-injection therapy than us. So yes, I think we have -- the data has got to be positive, right? But I think given the unmet need, the paradigm shift, the ability for us to manufacture the devices and sell the devices and all that, I think we're uniquely positioned if there's positive data there to make a real substantial product out of selatogrel.

Maybe one last one. Just what are the challenges about the self-administration here? And is there any real-world data you have from the study showing the ease of actually doing this?

Yes. So I mean, we -- as you can imagine, we look at the blinded data on a regular basis. We have also have unblinded DSMB that looks at the safety data on a regular basis.

I think what I can say, what we're seeing is that we're seeing patients are self-administering. But most importantly, they're self-administering at the right time, which is within the 30 minutes of onset of the symptoms. Early injection to save muscle is extremely important, and we see patients are following that. The next step is for them to take themselves to the hospital after that, to call for an ambulance and all. And they are well trained and they are doing that.

So they are following the process. Things are going well from that standpoint. And then from a safety point of view, I think we've had 13 DSMB [indiscernible] and always continue as unchanged, right? So what -- and from a blinded standpoint, we are not seeing any safety concern at this point. But again, we'll have to wait and see the full data set unblinded. But so far, so good, I would say.

Excellent. And maybe just last question on the new product flow. Just beyond these 3 assets, you think about the new launch portfolio and pipeline, what else are you excited about that we should be thinking about here?

I'll start and maybe Scott can add some. But I think for me, the -- we've had significant successes in our complex generic portfolio last year. So I look forward to seeing that come to market, and I understand it's going well so far. But also, we have a number of additional complex injectables. I would say, [indiscernible] is probably the largest one next year, and we're on schedule to get that approved. So from the base business point of view, this -- I think the complex generics look good.

I would say that we are particularly excited about Pitolisant in Japan. You know Wakix in the U.S. It's doing quite well. So we anticipate that it should do well in Japan as well. And we have a number of other pipeline assets like Nefecon for treatment of IgA Nephropathy in Japan. We anticipate the data early next year -- early this year. And we're also very excited about the opportunity there for Japan. So it's a full pipeline. And I think so far, we've delivered what we said we were going to deliver, and we look forward to doing that again this year.

Do you leave me any room to talk about other products? I was excited about -- he got them all. The only other two that I would say that I think are on our radar that we think are going to be important are Effexor GAD in Japan, first product with that indication in Japan. I think will be a very positive medication for Japanese society and for Japanese patients. And then also what we call XULANE LO, the low-dose estrogen patch, which we should be launching relatively soon. I think we're excited about that. We've got a substantial position in a different patch but the patch low-dose patch, I think, has the potential to have an impact as well. So...

One that I think is quite important is in eye care or presbyopia. We got strong data at the end of the year. We filed and we are anticipating approval this year. I think there's a significant opportunity there as well, especially in light of other dynamics that happened recently on the market. So we're excited about that one as well.

Excellent. Well, I think we're just out of time here. So thanks again for all the updates. And obviously, pretty exciting year ahead. So thanks.

Thank you Chris.

Yes. Thank you.

Okay. Thank you, guys, for being here. Super excited to have Viatris management join us. I think the last time we had you guys, Rajiv used to be a regular, and he would always fly in, and we would just go free style on so many different ANDAs with him. But excited to speak to you. And I feel like when Rajiv would come down every time, there were so many ANDAs that were super interesting, but I feel like this time around, I think it's much more of the strategy and broader conversation on where the story is heading, both from the base business and financials. So Scott, I'll let you kick things off perhaps.

Sure. So when I think about Viatris, I think it's not one business, right? It's for me 3 separate businesses. It's a global generics footprint, which was a Mylan company, sees established products, some of the most iconic brands in the world, the Lipitors, Norvasc, Xanax, Viagra, Celebrex that came through the Upjohn acquisition. And then there's a growing innovative part of the business, right? So I think it's really 3 separate businesses and all of them we want to continue to feed and grow as we move forward.

This year has been -- it's been kind of an interesting year as we were talking before we started here that there were some self-inflicted challenges with Indore and other things that we dealt with at the beginning of the year. There was external challenges from tariffs and policy changes and changes at FDA and other things. And we've sort of worked through a lot of that, and I'm really, really, really proud of where the company sits today.

I think the commercial execution has been excellent in a multitude of geographies so far. I think we've advanced the pipeline significantly with 5 of 6 positive Phase III readouts. We've returned capital to shareholders, about $1 billion -- over $1 billion this year in return through dividends and share repurchases. We've done a lot of business development, supporting mainly our global infrastructure. I think we've done 51 deals last I heard, supporting the infrastructure, a lot of them smaller deals. One of the bigger deals is Aculys, bringing assets into Japan, which is a very, very important market for us.

And we've embarked on this enterprise-wide strategic review to take a look at the company, the structure of the company, the cost of the company, are we fit for purpose for today and tomorrow. And all this work that we're doing in '25 is to help set us up in '26 and beyond for sustainable revenue and earnings growth as we move forward.

So sustained revenue and earnings growth, that's your expectation now and this is not just limited to '26.

No, that's -- our goal is to have sustained and predictable and revenue and earnings growth moving forward. Yes, that's why we're doing a lot of hard work. There's this base business, which is really again, a global generics business and established products business is strong. We've done a lot to reinforce it. We believe there's decent stability there. And on top of that, adding innovative assets and both from our own pipeline, but also externally, we can get to, I think, sustained, again, revenue and earnings growth over the last few years.

Got it. And Scott, when you say sustained revenue growth, maybe for Doretta, for you as well, Street looks at it as a couple of hundred million year-over-year in additional revenues. Is that sort of how -- on a $14 billion revenue. So is that how you guys look at it? Or is the internal expectations to do a little better than that?

The internal expectation is to do better than that for sure, right? So I think when I look at the company, you see this base business, again, which is a couple of businesses put together. But I see $500 million approximately in new revenues every year and you lose $300 million in price declines and other things in the business. And so you see, I think, a sustainable $200 million or so growth from the base business every year.

But then we want to start to invest our capital to bring in assets, support the base business and bring in innovative new assets. We're investing in the pipeline to develop and bring in new innovative assets. So I think the combination of a relatively stable, modestly growing base with adding on innovative revenue and innovative products gives us a larger, more sustainable growth profile.

Got it. So -- and is it fair to say, Scott, as you think about sort of top line growing, let's say, the number is higher, whatever the number, top line grows operating income level growing even more than that?

Yes. I mean we would hope and our goal would be to get some operating leverage, right, to be able to start to move from a 1% growth profile to 3%, 4%, 5% growth profile and stabilize EBITDA and then eventually see some leverage on that as we work through the enterprise-wide plan and other things.

So lots of work to do. I think we've got good goals here that will take the company in a little bit different direction than it's been in the past. And I think there's a bright future in '26 and beyond.

Yes. And I would say it's more -- the increasing operating leverage is more of a -- we're going to evolve to that over time. We're really excited about some of these pipeline assets that have read out that are really approaching launch, whether it's fast-acting meloxicam, XULANE low dose, some of our assets in Japan.

And so operating leverage, especially as you look at the margin profile on some of these assets and some of our more innovative assets, they will require some investment in order to launch. And so...

I see. Because there's -- major Phase III is next year.

It will come -- that operating leverage will come over time.

I see. I see. I see. And if -- could you just remind me, Doretta, the way I was envisioning it was you get some benefit on the OpEx from the cost cuts next year because of the enterprise review. I don't know if that might take some stage time over time.

And some of that will get reinvested into some of these new product launches. But on a net basis, you should see a net benefit to the P&L.

And the benefit accrues over a sort of a 3-year period, at least as we're thinking of it now. You don't get all the benefit of this in year 1, right? You get all the benefit -- the full benefit by the time you get to year 3, but it's stepped up over a couple of years.

Got it. Scott, and I think you've sort of seen this dynamic in your sort of prior roles at Celgene too where I remember REVLIMID-related guidance would go up and operating income was just following it almost 1:1, which is a very different business, obviously.

I guess the question I get asked around the enterprise review is often that, okay, let's say there is a meaningful cost cut, whatever that cost cut is, a, what percentage of that is actually realized on the income statement level is how investors see it? And b, if it's over 3 years, then could the annual impact of this be sub-$100 million for what the actual drop down to the income statement level is?

And I realize numbers are not out there, but I just want to make sure we level set and know what to expect heading into sort of the updates coming out.

So again, we're not getting into exact numbers. I would expect the numbers to be more than you're talking about, right, without getting into exact numbers. I think there'll be more of an effect overall. Again, it's going to be stepped out over 3 years. We're going to get some -- to understand what that total number is, there'll be some reinvestment, but I think the majority of it we're looking to drop to the bottom line.

And again, it's not just about cost savings. It's a little bit for me more about getting the company in the right place and position to be able to grow in the future and do the things it needs to do, execute on the base business, execute on the innovative portfolio and things. So it's an exercise to make sure we have the right people in the right places to be successful today and tomorrow, net-net.

And again, it's the right time for it from my perspective. You had a merger 5 years ago. We've divested 4 major businesses. It's the right time for us to take a look at that cost structure. And I think there'll be some significant cost savings coming out of it. And I don't want to get ahead of ourselves. We -- in a relatively short period of time, I think we'll be in a position to talk to the specifics of exactly what the numbers are, what's the cadence of them, how much is reinvestment, how much is falling back.

What I want to do though is I want to make sure that what we do here is sticky, that it's not just, hey, we're putting out some number and we think we can maybe get it in some year. We want to be exact. We want to identify the exact things that we're going after. We want to be able to trace them. And we want to make sure what we do here is going to hold. We want to make sure, one, that we can get the cost that we say we're going to get over a 3-year period, but also that's sticky and stays and it's really creating a new balance.

Got it. Scott, is it fair to say -- and maybe this is a question for both of you. And Philippe, I have several for you coming. So stay tuned.

No worries. I'm good.

I'm warming you up. Is it fair to say that as you think about the direction the company is going, a, between the cost cuts. So I said some investors are nervous, it's only like $50 million additional per year in terms of savings, and you said it could be better than that. So we'll see when that comes out.

But a, between the cost cut and b, with some of the top line growth and whatever it could drop down on an EBITDA level, do you see a realistic path from about $4 billion EBITDA right now to $4.5 billion. I'm not saying $5 billion, I'm saying $4 billion to $4.5 billion. Is there a very credible path that exists in the not-too-distant future to be able to get to something like that? Because I think that alone could be a very meaningful starting point for the confidence building on the equity side, and that's very valuable to equity investors, obviously.

Absolutely. And so I do -- again, I don't want to put numbers out that are exact, but what we see is where we're going to land on EBITDA for this year, we would expect on an operational basis that we're going to start to move forward and see real EBITDA growth over time over the next 3 to 5 years, our goal would be to have continuous earnings growth during that time.

And do you think that would happen regardless of how the Idorsia cards turn over on selatogrel and cenerimod?

Yes. I mean, yes, I do. I think we're confident in those 2 products. I really like the way that the development plans have accelerated under Philippe and the team. The operationalization of those studies has been very, very good. You never know what the data is going to look like until you turn that card over, but we feel good about it. They're important components of the future.

But again, this idea of a solid base business with capital to not only return to shareholders, right, but also to invest in business development and assets, and we're looking for, again, sort of in-market accretive assets to grow. We can grow earnings and EBITDA over time with or without cenerimod and selatogrel hitting, but we certainly hope that they would.

In-market accretive assets to grow, how much sort of capital deployment ability do you guys have right now?

So again, we're -- of the capital that we're generating, we're looking to do approximately half and half, right, over a period of time. So we're generating free cash flow of $2 billion a year. We're deploying it relatively even -- the way that I view this is that we're deploying our capital evenly over the next 3 to 5 years on things like continuing the dividend, buying back shares and building a pipeline of growth assets for the company. That's what we want to do.

Some years, we're going to lean in a little bit to -- and this was a year that we leaned into sort of shareholder return a little bit given the uncertainty, particularly at the start of the year, the volatility in the markets, tariffs, other things, where the stock price was. Other years, we may lean into the BD part of it. But if you take a look over a 3-, 5-year period, that's substantial capital to deploy to continue to grow the business as well as return to shareholders.

And especially when you think about the types of assets that we've talked about, kind of accretive in market, those transactions also come with profitability and cash flows as well. And so that also helps as you think about capacity.

Makes a lot of sense. JP, anything I missed on the broader base business or the financials before we go to pipeline?

[indiscernible]

Sure. We were really excited about the Aculys transaction. It was an acquisition structured more like a licensing transaction and added 2 CNS assets to our overall franchise, pitolisant and Spydia. These are approved -- Spydia is already approved. Pitolisant is approved here in the U.S. and we're really leveraging our Japanese infrastructure there.

As Scott mentioned, Japan is a really important market for us, especially on the branded side. And when you include this plus some of our other pipeline assets, we filed Effexor GAD there as well, and we have a number of other pipeline assets like Nefecon. We're really building a robust business to change the inflection growth in Japan over time.

Can I just jump on that a little bit, too, we do have a substantial CNS business in Japan. Japan is a very difficult market for a company like ours, right, where you have mandated price decreases every year and an inability to change the size of your workforce because of labor laws and other things in Japan. And so it's a very tricky market for us. Two things you could do, you could sell off the entity, find somebody to take it or build on the base that you have, and we decided to build off the base we have. We have a substantial CNS business there, and we had a couple of assets.

And so turning that from declining revenues to growing revenues over a period of time was really an important strategic imperative for me, and I was really pleased to do that deal. I think we're probably going to do some more in Japan as well as we move forward. And I'd really like to find high-margin, good revenue, U.S. focused as well. So those are the 2 markets that I was really focused on in terms of getting assets and building pipelines and creating growing revenue streams.

Great. Scott, I recall Bill and yourself, Doretta, you has came into our offices several months ago, and we talked about the pain opportunity. And we also talked about the competitor product on the marketplace right now from Vertex. And you had a lot of questions around sort of where that truly fits, et cetera. And I think some of that has played out, which then makes me wonder, as you think about meloxicam yourself, the thesis looks like it's holding true both from the competitor and your side. So sitting here today, how -- what type of opportunity are you seeing with the meloxicam?

Do you want to start with maybe the data, Philippe?

Yes. Maybe I can just give you a sense. I mean these are 2 very different assets with very different data set. I think our data set is very strong and is resonating with KOL and prescribers, particularly in the pain community.

For acute use?

For acute pain, yes. What they particularly like, moderate to severe acute pain is the way we believe the label will read out. But I think they particularly like the fast onset of action, 45 minutes versus 4 hours for Mobic. That's a significant difference. Also faster onset than JOURNAVX as well. Now across trial comparison. So keep that in mind, but the data shows a faster onset for a fast-acting meloxicam. And then the strength of the efficacy data, particularly resonating versus placebo, but also versus the opioid comparator.

And also versus regular meloxicam, do they see the incremental value?

Absolutely. They see them at different molecule. And once we come out with a brand name also, that will further differentiate the asset.

And then last is the opioid-sparing capabilities of the drug. We spent lots of time with FDA defining what the program should look like for us to be able to get an opioid-sparing claim. We were able to hit on both endpoints that were prespecified with the agency. So we feel strongly that we'll be able to get an opioid-sparing claim, which is, again, very different than what else is on the market. So a very differentiated asset that I think will play out differently with an existing safety profile that is well characterized, which is also important.

Right. Scott, are you guys going to put a lot of sampling out there or free drug because that's the type of thing Vertex has done a ton of. Like I'm just trying to think about, are you -- do you want to have a big TRx number out there and then let sales follow? Or do you want to focus on like commercial? How are you managing those 2 dynamics? Because you can play the long game here. You don't have like a $5 billion sales number out there. You may not even have a $500 million number.

But I think -- so a couple of things. Just what you learned from the JOURNAVX launch, I think, is the importance of access, right? And they've struggled a little bit, I think, with the right kind of access footprint and we struggle with the access footprint. Uptake is slow. Where that drug eventually ends, we don't know. But again, I think there's a tremendous opportunity.

When I take a look at the data, I view it and a lot of other people who know more than I do about, the space view it as differentiated data, and it provides us an opportunity to find a unique space for this asset. And we were really pleased when the data came out, and we do see it as differentiated.

We need to really work now on -- to me, the thing that drives your early numbers, right, is access, right? Just what kind of access can you get. And in the U.S., you have to have a thoughtful strategy, and it's not just about pricing, it's about other things as well.

And when is the launch again?

So the filing will likely be...

So the launch is toward the end of next year.

End of next year. So this is...

Towards the end of next year.

Okay. Got it. Okay. So...

[indiscernible] quickly with FDA reviews, which is a discussion we're about to have with them.

So it seems like from a catalyst perspective, there's a lot of stuff in the back half of next year, a, the PDUFA date for this, but also cenerimod as well as selatogrel Phase III readouts. Which one do you guys have higher POS on the lupus trial with an S1P1 or with the antiplatelet for ATS prevention?

Well, it's asking me which child do I like the most, right? But I think generally speaking, you have a P2Y12 inhibitor mechanism of action well...

More validated.

I think in the disease we're looking at -- S1Ps are well established as well in other autoimmune diseases. But I mean, I would say it may be...

Philippe, I guess the question I'm always confused about is these are -- in your antiplatelet trial, you took patients that have had a heart attack. And so they know what it felt like. So now you're giving them this on-demand shot, they can take if they feel like the symptoms are coming on. Are they good at telling if the symptoms are of a heart attack? Or could they be taking it at the wrong time and that induces bleeding episodes to happen? Do you know the bleeding data on a blinded basis?

Right. So I think what's important is the fact that what we are seeing is patients are injecting -- self-injecting, but there's also self-injecting early within -- or less than within 30 minutes of onset of the...

And you say you're seeing based on Phase III or prior?

Based on Phase III -- so patients are self-iningesting. They're self-injecting when they're supposed to do it, which is within 30 minutes. That gives the drug a lot of time to work and differentiate versus placebo between the time of injection and the time the patient ends up at the hospital and is being diagnosed with acute MI.

Interesting. You're not seeing on a blinded basis, bleeding rate tracking higher than you would have thought?

So a blinded basis, we're not. And our DSMB is unblinded, and we've had 13 of them, and they've told us to continue as planned.

Got it. And also, if I may, from an event rate perspective, is it tracking like you would have thought?

Yes. So we are -- both from an enrollment and even rate standpoint, we are exactly where we thought we would be at this point. We're reaching -- we're nearing 1,000 patients per month right now in terms of enrollment. And we've significantly expanded both the number of sites globally that we are enrolling, but also have significantly increased our interaction with KOLs and PIs, which leads to renewed momentum for this study, I would say.

So if the bleeding is not higher and they're taking it within 30 minutes, we know the thing works. Earlier you take it, it just works. I guess what does that mean commercially then, Scott, what are your teams telling you? What -- is this an EpiPen for heart attack?

I mean, again, you see the data and see how it's utilized, but I think viewing it that way is sort of the way...

And that's the commercial positioning?

Yes. And I think what better company in the world to commercialize something, right, which is an emergency use injectable product, right, for an acute issue. And so we look at it that way. We need to see how the data evolves. I think there is an unbelievable amount of opportunity here, the number of MIs that happen on a yearly basis.

I've lost 2 family members myself to acute MI, who both didn't survive their event. And when you take a look at just the actual demographic numbers of the people out there, it's incredible who suffer MI, the tremendous unmet need. And then there's also an opportunity to place these potentially ambulances and other places depending on how we expand the label, depending on what the data looks like. But it's not just the initial patient population. There is the potential. And again, it depends on.

Patients is the system that you could sell it to.

Yes, right.

The same way you -- with EpiPen, right?

Right.

So hospice -- well, in all types of like nursing homes, emergency rooms...

Again, depending on what the label looks like, depending on what your interactions with FDA are, all that's -- but I think there's the potential for this product to have that kind of impact. The kind of impact that EpiPen had on acute anaphylaxis, this could have on MI without question.

Selatogrel gives you time, right? It gives you time to go and get a proper PCI if that's what you need, gives patients time for proper treatment, which -- and time also to reduce the risk on -- the impact on muscle, right?

We're past time, but I do want to end on this because I've always been confused about it. So a patient had a heart attack before, they feel like they're having it again. They feel something in the arm, so they take the shot and they just took it to get to the hospital and they find out more than one vessel was involved. So that needs CABG. If you need CABG, you need to be off the blood thinner. But by having taken the shot, didn't this put you at -- you can't get surgery for 12 hours now?

No, not 12 hours. You wouldn't be able to get a surgery if -- imagine the patient gives a shot, takes a few hours to get to the hospital typically on average. And by the time they get to the hospital, they get the angio and they know they have -- they need...

That's already been 5, 6 hours.

You would be able to proceed with the PCA.

I see. I see. So it's not going to limit CABG.

No.

Okay. Fantastic.

In 20 seconds, I think we went over cenerimod a little bit quickly. I think very highly of that asset, Philippe and I were looking to develop an S1P molecule in SLE in the past at Celgene before other things happened with the company and went a different direction. We think there's proof of concept that this could work very well. And again, an early oral tolerable drug in the space, I think could be game changing.

So that would be the first oral for lupus, I believe.

That would be -- of course, possibly, yes, unless, for instance, TYK2 gets there before we do. But I mean, different proposition in terms of safety risks and tolerability, right?

First new innovative oral drug, right? I mean, they use some oral background meds and stuff and...

And this single trial alone is enough for filing.

We have 2 trials.

Umer

Okay, 2 trials. Okay.

[indiscernible] is ongoing.

OPUS-2 is fully enrolled. OPUS-1 is about to be fully enrolled.

Fantastic. Thank you guys so much for making time.

Thank you.

Fantastic.

Thank you. Thank you.

Good morning, everyone. Let's kick things off. Welcome to the Piper Sandler Healthcare Conference. This is David Amsellem from the biopharma research team, and we're delighted to have Viatris with us. Lots to talk about. We have Doretta Mistras, CFO; and Philippe Martin, Chief R&D Officer. So thanks both of you for joining us.

So I'm going to fire away with lots of questions, and there's lots to talk about. But just starting at a high level, I wanted to get your thoughts on capital deployment. Particularly interested in how aggressively you will look to pursue brand assets. That's been an increasingly visible theme at the company. And how do you balance that versus prioritizing the return of capital to shareholders?

Thanks, David. It's great to be here. So thanks for having us. From a capital allocation perspective, our philosophy has remained consistent. We want to be balanced and disciplined between kind of over a 3- to 5-year period of 50-50 between capital deployment, capital return as well as investment in business development for long-term growth. In any one year, we may lean in, in one area versus the other depending on the opportunities that we have ahead of us. For example, this year, we prioritized capital returns and especially share buybacks just in light of operationally what we had going on and our stock price. But that may change in any given year given what we have. But kind of we want to maintain a balance between being 50-50. From a BD perspective, to your point, we are focused on really, especially in the U.S., adding innovative branded patent-protected higher-margin assets that can really accelerate our near-term revenue and EBITDA growth. And outside of the U.S., we're focused really on leveraging our existing infrastructure. The Awake -- the Aculys transaction that we recently did is a good example of that. We added two CNS assets, pitolisant and Spydia to leveraged our Japan infrastructure. And so it really is being balanced and opportunistic in a disciplined way.

Just a quick follow-up here. Obviously, capital structure and net leverage is an important theme and important to investors. How much would you lever up to in order to execute on a transaction or transactions? In other words, how far beyond that net debt to EBITDA in the 3x range would you go to if you saw something you really liked?

Yes. When we look at transactions, the type of asset really plays an important role in terms of how we think about overall consideration as well as how we think about leverage. We want to be thoughtful around our financial policy. Our focus, as I said, is really on commercial stage branded opportunities. But we always look at assets in the context of our overall financial policy, how quickly we delever in terms of our long-term targets.

And what's your appetite for taking on additional R&D risk beyond cenerimod and selatogrel?

Our focus right now continues to be on commercial stage assets, assets that are in market or nearly approved or commercial stage. To your point, selatogrel and cenerimod, when we in-licensed them, we were in that late-stage phase, and we continue to believe that they have significant potential. And so you're never going to pass up an opportunity if it's a great asset, but that's not currently the focus of our strategy right now.

Got it. Okay. So I have a lot of questions for Philippe on the pipeline. So I wanted to talk about cenerimod, and we're not that far away from the SLE data. But just taking a step back here, I mean, SLE, pretty active development landscape. We have a lot of data readouts in '26 for a range of products. One comes to mind is Biogen, litifilimab. There's also Bristol SotYKtU, just to name a couple. So lots going on in SLE. Where do you see cenerimod and its particular mechanism fitting in within a potentially more varied treatment landscape?

Thank you. So let me start with reminding people that we have two large Phase III studies ongoing for cenerimod in SLE, OPUS 1 and 2. OPUS 2 is fully enrolled and OPUS 1 will follow shortly. The intent there, and we know the preference from physicians and patients in SLE is for an oral treatment that can be given once a day with a differentiated risk-benefit profile. And that's what we're seeing with cenerimod in the data. Importantly, the drug can be given on top, and that's what we're studying on top of standard treatment and without adding more baggage to the safety profile of the existing treatment. So that positioning prior to biologics, the one you mentioned, even the new entrants, we don't expect them to change that dynamic. The positioning before biologics with a drug that has the right benefit risk profile is where I think the largest unmet need is, and where cenerimod fits the best. You added something about mechanism of action. I think mechanism of action of cenerimod fits very well for SLE. It's the only asset currently that goes after multiple mechanism involved in the pathogenesis of SLE. And so we believe that this mechanism is very well fitted for SLE and very well fitted for lupus nephritis as well.

Yes. So let's talk about the Phase II trials. So you have patients in the study with high interferon 1 levels. So -- and that's where you saw, I think, the greatest signal. So talk to how the Phase III trials are designed to account for those learnings in Phase II? And what does that mean for the potential addressable population?

So in Phase II, we have three Phase II studies, right, to remind everybody, we saw consistent strong efficacy data at 4 milligram across all three of those Phase II studies. As you point out, what we saw -- where we saw the largest treatment effect was in the most active severe patients, interferon 1 high patients typically. And these are the patients that you typically see in Phase III. If you look at other Phase III studies that have been run recently or even older studies, you tend to see about 80% or so of patients with high interferon signature. In the Phase II study in the 4-milligram arm, we saw about close to 50% of the patients were interferon 1 high, and these were the patients that responded the best.

Okay. So you've moved cenerimod into a Phase III in lupus nephritis. What was the thought process behind going right into Phase III in lupus nephritis? And maybe help us better understand what Phase II data you can point to that gave you conviction that advancement in LN made sense?

Yes. So I think it's a natural evolution for the asset. We're trying to optimize the life cycle of this asset and starting the lupus nephritis. So any Phase III program is now the right time to do that. We started about 9 months ago developing this program. We had interaction with the FDA and the EMA, and we took their feedback into account, and that led to the Phase III program that we've designed and for which we anticipate first patient by the end of the year. I think what we learned, if you look at the lupus nephritis patient population, it is much more similar to the severe SLE patients that you see in Phase II. They are typically interferon 1 high patients. The mechanism of action looks very similar in SLE than it is in lupus nephritis. And lastly, I think we just generated data recently in a clinical pharmacology study where we showed that cenerimod can be given in patients with any renal function, including patients with severe impairment. And so that is -- that was critical to the decision to move forward into lupus nephritis.

Okay. That makes sense. And certainly, there's a dearth of treatment options in LN that I'm sure played a role in your decision as well.

Yes. I mean it's a similar dynamic as you see in SLE, a lot of biologics that have some level of efficacy, but have some safety baggage pretty immunosuppressive in general. And so having the drug, again, with the right benefit risk profile that can be given before the biologics, I think, is critical in lupus nephritis and is where the unmet need is.

Okay. I wanted to toggle over to selatogrel. Any update on the pace of Phase III enrollment? I think you did talk about this on the third quarter call, but just give us a refresher on where things stand on the enrollment rate of patient enrollment? And should we think of results as a '27 event?

Yes. So we have -- just as a reminder, we have a large Phase III global program going on for selatogrel in -- for the treatment of acute MI. Enrollment is going quite well. We are now seeing -- we're nearing the 1,000 patients per month, and we anticipate that we'll have full enrollment by the end of this year. It is an event-driven study. So whether we're able to report the result by the end of the year or early next -- early 2027, is -- we'll have to see. But I think we're very well on pace to get the enrollment done by the end of the year and results shortly after that.

And there's been some developments in the marketplace. You have CeleCor's zalunfiban with recent data. How are you thinking about probability of success and just the overall market development given zalunfiban's success decreasing the odds of the major adverse composite clinical endpoint compared with placebo at one month. Maybe if you could talk to that.

Yes. So I think I see this as a strong proof of concept for selatogrel. I mean there's -- obviously, there's anything pointing out externally a number of issues with that study. But I think what we've learned is that early platelet inhibition, that concept, which is the same we're using for selatogrel leads to a risk reduction in those patients. They ended up having a 21% risk reduction overall, which is what we sized our study to be for selatogrel. So I think this bodes well for the success of selatogrel. I think what I would point out, what's interesting in the data is the fact that from onset of symptoms to treatment, it was about 90 minutes, 9-0. And so what we're targeting for selatogrel, and what we're seeing is that treatment is within 30 minutes for selatogrel, so much earlier than what you saw with this drug. And the other data point, I think, is important is that between the time of treatment to the time of PCI, it was about 50 minutes, which was very short and gives very little time for the drug to differentiate versus placebo. It will be much longer for selatogrel. So in short, I think this study increased our probability of success. It is strong proof of concept. It solidifies our assumptions. And so we feel good about the potential outcome of that.

That's helpful. So I wanted to move along and talk about your fast-acting meloxicam product. So first, where do you stand with the filing on that and your expectations for the review cycle? And is it an accelerated review for the product possible?

Yes. So we have -- we are scheduling a meeting with the agency, a pre-NDA meeting, we expect it over the next few weeks. And that discussion will have a couple of key discussion points there. One of them is timing of filing and ability for the FDA to grant us accelerated review. We'll be discussing that with them. We'll also be discussing our approach to the label a little bit, specifically around opioid sparing because our data is very strong, and we followed their guidance and recommendations during the development to get to language in the label around opioid sparing. So these will be the two key discussion points with the agency. Depending on the timing of this meeting, we'll be able to file shortly thereafter, so either end of the year or early next year.

So I wanted to take a step back on the meloxicam product. This is obviously very well established NSAID. And certainly, it's important to have more non-opioid alternatives. But help us understand how you're thinking about the use cases or potential use cases here. In other words, are you thinking about it for mainly acute pain? Is it postoperative pain? Is this going to be a hospital product? Is this going to be an office space product. Help us just understand, it might be all those things, but how do you think about that?

Yes. So we're -- to your point, David, we're really excited about the fast-acting meloxicam opportunity. Just to frame the opportunity holistically, there are over 80 million acute pain cases per year and still over kind of about 50% are still use opioids despite the recognized risks of dependence and misuse. Additionally to that, we're seeing a multimodal approach where patients are leaving with multiple options to manage their pain. So in that context, as we think about market segmentation, we're really focused on two areas. One is the outpatient and ambulatory surgical centers where you see high-volume procedures like joint replacements and bunionectomy, and then in addition to that, the kind of in-office physician procedures like central offices and cosmetic procedures. To your point, yes, you do -- in the hospital, there are -- that does play a role in the overall acute pain treatment landscape. But in our experience, we found that to be a more challenging market just given the review -- overall review process. And so our intention at this point, and we'll continue to refine and formalize our strategy close to launch is really to focus on the outpatient and in-office procedure setting.

Okay. That's helpful. Maybe a follow-up to that. Obviously, there's -- just putting opioids aside, there is a whole host of generically available options here, so oral options. So in that vein, where do you think meloxicam -- the rapid-acting meloxicam product will fit within this vast treatment armamentarium, albeit flawed. In other words -- and this sort of leads to sort of a question about payer access. How are you thinking about that?

Yes. And in line with payer access ultimately is pricing. And so we're still in the process of doing that work. Ultimately, a key component of how we think about is going to be the label and the value proposition. And so we'll be in a better position to give that clarity as we get closer to launch. But that being said, our goal really is to ensure two things. Number one, that we're reflecting the value that fast-acting meloxicam can play, but also importantly, that we're getting broad adoption and access for patients.

And I know you can't provide specifics on pricing yet. But there is a potential analog of Vertex' Journavx. So I guess, maybe the best way to ask the question is, is that a good way to think about pricing? Is that the best analog as we think about pricing for fast-acting meloxicam.

I think that's certainly [indiscernible] analog. But it's not the only one, and it's still early. So as we continue to do work, it really is truly a balance between the value proposition, but also broad access to care. And so we'll be in a better position to provide that clarity as we get our label, as we kind of complete filing and get closer to launch.

But I think uptake is also a key component of that decision-making based on the fact that this is a 505(b)(2). And so we will also take that into account, obviously, in our decision around how we price the drug.

Are you going to commercialize the product on your own, or would you want a co-promote partner? I mean there's -- you mentioned [ dental ops, ] and there's orthopedists, and it's -- there's a lot of different call points here. So how are you thinking about commercialization?

Yes. And that is another area we're continuing to evolve, and we'll provide further clarity as we get closer to launch. But we feel very confident in our ability to commercialize fast-acting meloxicam ourselves. Really, we're going to be focused on the kind of high-volume specialists by using a targeted field force where we can really drive adoption. And opportunistically, we will see opportunities to explore other partnerships. But really, that would be driven by an ability to significantly expand the value of the product, and we'll continue to evaluate it, but we continue to have confidence in our ability.

Okay. And just talk real quick to the exclusivity runway, potential exclusivity runway for the meloxicam product?

So we, to Philippe's point, are pursuing meloxicam -- fast-acting meloxicam through the 505(b)(2) pathway. That gives us a minimum of three years of exclusivity, but we're continuing to explore opportunities to extend that. We've already filed additional patent applications with the patent office, and we're in the process of submitting additional ones that, if approved, would extend the life -- the runway. But taking a step back, we have confidence that fast-acting meloxicam will be a meaningful opportunity for us, at least through the decade and potentially beyond that as well.

Wanted to switch gears to MR-141 for presbyopia. So interesting opportunity here, and there are other pharmacologics now that are on the market. So a couple of questions here. One, how are you thinking about the opportunity. And then secondly, how do you see differentiation versus the other new modalities on the market for presbyopia?

So I can start with the opportunity, and then I'll kick it over to Philippe to talk a little bit about the differentiation. So if we take a step back from presbyopia perspective, this is a very large and untapped market opportunity. I think the statistic is over 90% of adults over the age of 45 suffer from presbyopia. And yet from a pharmaceutical perspective, it is a largely untapped market. And we're also seeing a renewed interest in the space, especially given some of the eye drop treatment options that have been approved. We're seeing renewed interest in the category. And so from our perspective, we see our asset as a natural extension to our existing phentolamine kind of franchise. So we have Ryzumvi that's already approved. We're also developing phentolamine in dim-light disturbance. And so we have a strong foundation from which to build on. And so if you combine not only the significant unmet need, but in addition to that, the positive data that we've shown as well as the early market adoption, we really see presbyopia as a growth opportunity for us within our eye care franchise.

And to the second part of question in terms of differentiation versus other assets on the market, I think what's important is that it is a different mechanism of action. It's not a miotic. It doesn't affect the ciliary muscle. And therefore, the issues that see with miotics including the newer ones of lots of headaches being reported as well as potential risk for retinal detachment we're not seeing with phentolamine. The other key aspect is also we're not -- what we're not seeing is a reduced vision under dim light, right? It's actually the contrary, which is a significant issue for patients as well as with the miotics, what you tend to see is patients losing distance vision, and that's also problematic, which we are not seeing with phentolamine. So it's all about the benefit risk profile of the drug for presbyopia, and we believe we have the assets with the most relevant benefit is profile for this indication.

Got it. And I wanted to sneak in one more question. Just talk to the enterprise-wide strategic review, that's something that you talked about on the last call. Ultimately, I guess the question is, where does this lead? Is it manufacturing efficiencies? Is it cut the spend? Is it a bit of both?

Yes. And we really wanted to take a thorough and detailed review just given everything the organization has gone through over the past four years in terms of mergers, divestitures, we really -- the goal of the enterprise-wide review is to really position the company for long-term sustainable revenue and EBITDA growth. And so we looked at everything. So from a commercial perspective, we're looking at our infrastructure and our product mix. We're looking at our R&D, regulatory, medical activities. We're also looking at our sourcing, our manufacturing as well as our inventory levels and all the corporate support functions that look at that with the ultimate goal of being able to invest in the business and support our long-term growth but in an aggregate basis, really deliver net savings over a phased multiyear approach. And we'll be in a position once we were nearing completion to share that early next year.

All right. Terrific. Well, thanks so much, Doretta. Thanks so much, Philippe, and thank you to everyone in the audience.

Thank you for having us.

Hi. Good morning. Welcome to the Jefferies London Healthcare Conference. My name is Dennis Ding, biotech and spec pharma research analyst here at Jefferies. I have the great pleasure of having Viatris up here. It seems like the entire team is up here with me, which is great. Welcome.

So maybe to kick things off, a big picture question. How would you characterize the progress you made in 2025? And how should we think about -- or how are you guys thinking about 2026, et cetera?

So first of all, thank you. Good morning to everybody here, and thank you for having our whole team. It's always good. We have a lot going on. So it's always good we can have a lot of people here and get to meet the whole team. So progress in '25. '25 has been kind of -- it's been an interesting year. There's been challenges, both internal and external, difficult policy environment and tariffs and things but I'll say, I think we made tremendous progress in 2025, very, very strong commercial execution across multiple geographies. We also delivered on the pipeline, 5 positive Phase III studies out of 6 delivered so far this year, which will be launches in '26 and beyond.

We've returned tremendous capital to shareholders this year through dividends and share buybacks. We've done about $500 million in share buybacks and anticipate doing over $1 billion in return of capital to shareholders during the course of '25. We also have done business development added to the pipeline, a couple of assets in Japan. We've acquired innovative assets and brought into the portfolio, Pitolisant and another product in Japan. Japan is a very important market for us. So we've been doing aggressive business development looking to support the geographies that are out there. So that's been a key priority for us.

And we've also been progressing very, I think, very substantially what we call our enterprise-wide strategic review, which is a look at the company, where is our cost, where are our people. I think this is a really good time for us to take a look at this. We have merged as a company. We've divested significant assets. We paid down debt. We've invested in some innovation and having the ability to really look at the company and say, do we have the right people in the right places? Do we have the right resources in the right places to be able to execute on what we're doing today, and execute on what we're going to be doing tomorrow and beyond.

So I think that particular exercise will lead to some very significant cost savings for us as an organization savings, which will be real and also some which we'll reinvest into growth into the future. So net-net, I think there's been a ton of work done in '25 to get us ready for '26 and beyond. We see us moving into a period of sustained predictable growth in 2026 and beyond.

If I can double-click on the enterprise review. Maybe just give us a flavor in terms of how material some of those cost cuts could be, yes, et cetera.

Yes. So I'm not in a position to give an exact figure, but it will be meaningful. We're going to look deep. We're taking our time. We're looking at everything within the organization. We're looking at commercial sales, marketing models. We're looking at R&D, medical affairs, where we're putting our resources there. We're looking at sourcing, manufacturing, inventory levels, corporate support functions. So we're looking at the whole company.

And again, 5 years post merger, this is a really good time for us to figure out and make sure we've got the right sort of organization in place for -- to deliver on the current objectives and going forward. It will be meaningful. We will get meaningful savings out of that. And again, I think it will be very, very important. And for me, the purpose of this is, first and foremost, do we have the right people in the right places to be able to execute. Secondly, I think there's some very significant and meaningful costs, which we can take out of the organization, be more effective and again, we expect to realize a lot of those savings, but we'll also reinvest some as we move into growth drivers in the future.

Okay. So it still sounds like the majority of those savings would fall to the bottom line and a small portion of it will be reinvested.

I would say a majority will fall to the bottom line and a portion will be used for reinvestment is the way that I would characterize it.

Okay. Got it. And then can you just update us on the progress around the indoor facility in terms of the inspection timing, et cetera?

So relative to indoor, we had a very, what I would say, productive meeting with the FDA earlier this month. I think very open good communication between the sides. The reinspection is -- will happen -- so first of all, we're happy with the remediation, that's done. We're more than 90% through that. We're getting right to the end of that. the reinspection from the FDA is, one, will be a surprise reinspection. So I can't give you a timing on that, right? But it will also be of course at their timing and so I can't really say. I would absolutely expect that in '26, we'll reinspect, hopefully in the first half and move on from there.

But I will say, hopefully, by the time we get to that reinspection, it's a nonevent from a financial perspective. We've been trying to requalify other plants, find third-party vendors around the world. So we want to be able to, regardless of the timing of that reinspection, we want to be able to supply the products that came out of that plant to the U.S. and around the world. So again, for me, the reinspection won't be as much of a financial event as it will be good reputationally, get us back online, some cost efficiencies in the network of manufacturing facilities.

But again, my time line, it's up to the FDA, it will be surprise inspection, likely to happen next year, hopefully in the early first half of the year, and we'll go from there.

Got it. Okay. And then last big picture question, just around BD and your priorities around capital allocation. Can you remind us what those are? And then in terms of actual BD and tuck-ins, et cetera, like what sort of size are you looking to do with sort of therapeutic areas, et cetera? .

So for me, the capital allocation plan, the critical word that we keep saying is really, really important is balance, right? We're going to be balanced between dividend share buybacks, giving back to shareholders that way and also investing in a pipeline of growth assets for the future. So we're going to be balanced in any one year, we're not necessarily going to be 50-50, 1 year, you may lean into -- like this year, we've leaned into buybacks and dividend because of the environment and the volatility and uncertainty.

Another year we may lean into a little -- we may lean into BD a little bit more. But for me, we need to do both, right? We need to continue to return to shareholders, but we also need to build a pipeline of growth assets going forward. In terms of therapeutic areas, I'm a little bit agnostic to that. My principle is, are we good owners of these particular assets? Is this something that we can leverage the organization that we have and that we can be really good owners of. We're looking for in-market accretive assets. We did a deal in Japan for a couple of close to market or one end market, one close to market or assets in Japan that should have an impact as we move into '26.

And I would love to get some good in-market high-margin revenue, growth revenue, particularly in the United States going forward. And so we're looking to -- to me, it's the characteristic of the asset. One, is it approved? Is it in market? Is it growing? Will it be accretive to us and can we be good owners of it. Those are the important principles for me as opposed to therapeutic area.

Okay. Which franchises within Viatris do you consider to be one of the strongest ones where you could really leverage like a new asset? Maybe it's cardiovascular, maybe it's something else, but we're curious to hear your thoughts.

So we have a very diverse portfolio, 1,400 approved products in multiple geographies. I look at it from a geographic perspective more than from a therapeutic perspective. I think we've got a very strong organization affiliate in China. It's doing very, very well and producing very, very well and good growth there. We've got a strong commercial organization in Europe, where we have -- if you take a look at the companies that we have in France, in Italy and other places, they're some of the biggest organizations in those countries from a health care perspective.

So for me, it's about leveraging the geographic presence that we have. 165 countries. We've got an amazing emerging markets presence as well. So for me, when I talk about leveraging the organization, it's not as much therapeutically as it is where we have strength on the ground from a geographic perspective.

I would just also mention, Scott, I think to your point, the Aculys transaction that we did was a perfect example of how we're leveraging that infrastructure in Japan. We have great infrastructure there. And fortunately, the nature of our portfolio, given that they're off-patent established products are subject to ongoing price regulation. But with the work that we've done around EFFEXOR GAD, around Nefecon, around these assets, we're leveraging that existing infrastructure to, over time, change the inflection of our Japanese geography.

Great. And then why don't we talk a little bit about the pipeline? Maybe again, like high level, like what are you most excited about? And what are some upcoming catalysts in 2026 that we should be focused on?

So let me make a very high level and then Philippe can dig into the pipeline a little bit more. There's some very interesting Phase III data that we had fast-acting meloxicam, we have the XULANE patch, low-dose patch that we've got good data on. So those are some -- those are a couple of assets in the United States that we should launch in '26 or close to there. So we're excited about that. I'm also excited about selatogrel, cenerimod, the progress we're making there, and Philippe can talk a little bit more about that, but we've done a lot to accelerate those clinical development programs. But we do have a large diverse pipeline of assets here.

And I think Doretta mentioned EFFEXOR GAD for Japan, we've got a number of things and had very, very good productivity out of the pipeline. Again, 5 positive Phase III out of 6 studies this year and accelerating selatogrel and cenerimod, which is really important for us. But Philippe, you want to pick out a couple of products in the pipeline that you'd like to highlight?

Yes. I mean I think the one I would -- that you didn't mention is sotagliflozin, that we are getting registered and approved around the world currently. So we had our first approval in UAE and then we filed in various regions, like Canada, Australia, New Zealand and so on. So we're working on filing this drug in the rest of the world. But I think the most important asset currently, the one that has had very strong enthusiasm is meloxicam, fast-acting meloxicam for the treatment of moderate to severe acute pain. We've seen at congresses significant enthusiasm for the asset. The data resonated, particularly the PK, unique PK profile, and fast onset of the asset when you compare with Mobic.

Mobic is about a 4-hour TMAX, fast-acting meloxicam is about 45 minutes. So significant difference there. From an efficacy standpoint, I think we've seen a strong and sustained efficacy that resonated versus placebo in 2 different pain models, bony and soft tissue. And that data, particularly the post-hoc analysis versus its competitor tramadol, where we show generally greater efficacy was very well perceived. And then last I think it's the opioid-sparing effect of the drug, both in reduction in doses or usage of opioid, but also in a number of patients that are opioid free after the treatment. That resonated strongly with physician in terms of where we are, we'll certainly have a pre-NDA meeting with the agency over the next couple of weeks.

We'll discuss a number of things, including label, including -- we're seeking a broad label, where we'll ensure that the opioid-sparing data is included in the label. But that's obviously up to the agency to decide whether they want to do that. That being said, we've discussed this approach with them throughout development and have generated the data they wanted to see and the data is very strong. So we feel good about our probability of success there. And so we'll file by the end of the year and get approval sometime next year.

So just a quick comment. So we're very, very excited about the pipeline, right? There's a number of things coming through, both in the read out in '25 that will read out in '26 and '27 but sort of the real strength of the company is the fact that we've got $14 billion in revenue, right, which is stable, and we've actually been growing on a quarterly basis. Most quarters, you're seeing growth and so the ability to be able to deliver on that base business, which is established products and global generic business, while developing the pipeline creates a real opportunity for us to grow as we move into '26 and beyond. .

I think that makes a lot of sense. But if I can ask a little bit more on meloxicam. It does sound exciting, but at the same time, a competitor asset, JOURNAVX is on the market. it seems to be a little bit slow in terms of the revenue trajectory. So I'm just curious how that informs your future experience with meloxicam? And maybe like how do you think about the shape of the revenue curve having seen what Vertex is doing currently?

I'll just start, and then Corinne can cover more the commercial aspects. So I think if you look at the data between JOURNAVX and our data, the data looks different. And I think that's part of why our data is resonating with physicians, generally speaking, the opioid-sparing part, as I said, is something that we have been -- that we've worked hard on and have been able to deliver on that data, and that's a differentiating factor, certainly versus current assets that are currently marketed.

Yes. So let me start by saying that based on this clinical profile, as Philippe described, we're excited about the potential of fast-acting meloxicam. It's a broad market opportunity for moderate-to-severe acute pain. And we've been working over the last few months that defining our commercialization strategy, also market segmentation. At this point, we are not providing a peak sales forecast and we are not commenting on our competitors' strategy either.

But what I can tell you is that this market is approximately 80 million cases of acute pain in the United States and half of those prescriptions go to opioids today despite the known knowledge of potential for abuse independence and misuse. And we see that from fast-acting meloxicam has a real place in the twin product algorithm. It's really differentiated. The market has moved towards a multimodal approach. And the idea with a multimodal approach that you can cover patients' need over 24 hours.

Now we have an asset, as Philippe mentioned, that works fast, it could be used first line, could be really part of a multi-model approach, right, and really extend the use of NSAIDs in acute pain. And when you look at the market, when you look at market segmentation, the majority of postoperative patients are treated in the outpatient settings, right? Or they are treated in ambulatory surgical centers, right, for procedures like joint surgeries, joint replacements or in office settings for cosmetic surgeries or dental surgeries, right? So this is our approach. We're going to go where the patients are.

We know that it takes a longer time for the hospital setting to get products reviewed by the P&T communities and put on formularies. So our strategy is to make sure that we can get fast access to meloxicam, focusing on the outpatient settings, focusing on the retail pharmacies where the patients will get their prescriptions.

How are you thinking about access and, I guess, pricing in that market seems quite large. And maybe also comment on no pain and if that would be a tailwind for you guys?

Right. So I'll start with no pain because I mentioned the hospital setting. We'll be looking at -- for now, there is no oral therapy included in no pain. So we'll see how that evolves. There's been a bit of delay due to government shutdown on -- so we are still -- we don't know it yet which products will be listed. It would be good to have it. But again, the hospital setting might not be our primary focus.

And in terms of pricing, as I mentioned, we are working through all the diligence here looking at pricing sensitivity and pricing research. We don't have the full results of that but the strategy will be to price the product so that we can not only demonstrate the value of the asset and not only the asset in terms of reducing the economic burden of opioid use but also making sure that the price point is such that we can have fast access for this -- for the module.

Got it. Okay. And then number two on the pipeline, just on your asset for presbyopia, how are you thinking about that commercial opportunity? There's a competitor on the market launching right round, just how do you position your asset relative to theirs?

So from a data standpoint, maybe I can start. It is -- we have a different mechanism of action. It is not a miotic, so we're not expecting, and we have not seen the safety issues that are typically seen with these drugs, including retinal detachment in particular, but also difficulties in seeing in a more dim light setting, which our drugs actually showed statistical benefit -- improvement in that setting. That's definitely a differentiator. So we think that from a benefit risk standpoint, our asset because of its safety profile, in particular, looks very good versus the competition.

And so that's where I think we're going to focus the differentiation going forward from a data standpoint.

Yes, that's a very important point. I mean the presbyopia market is opening up for therapeutic, it's a vast market because about 90% of Americans above 45 suffer from presbyopia. Some of us wear glasses, but the fact that we now have molecules approved, eye drops is really revitalizing this market segment. The way we look at the market for us, as Philippe said, it will be a differentiated asset because we will not have the same safety profile as the currently approved assets, right? And that's going to be important. And we certainly feel that we will not have, for instance, risk of retinal detachment or risk of spasms of the ciliary muscles, right?

So they are a real place for phentolamine in this indication, presbyopia. And as a reminder, phentolamine is also developed in dim-lit disturbances. We also have phentolamine approved under the brand name of Ryzumvi already on the market. And these opportunities will expand our eye care business that -- in our -- when we have set up the capabilities in the U.S. for this business. So it's a good opportunity, and I think we are quite bullish about it.

And this is going to be a retail product, I'm assuming?

Yes. So it is obviously a product that will be available to patients outside of any ophthalmology clinics. So yes, from that perspective, it will be a retail product.

And if we take a step back, you guys have talked about $450 million to $550 million in new product revenue in 2026. What are the drivers of that? And how big are the contributions from meloxicam and the presbyopia asset?

So let me start, and then I can give it to Corinne as well. So we've had a lot of approvals for our more complex generics this year toward the end of the year. And so they will be a major contributor to next year. So to answer your question, most of the revenues that we anticipate -- new product revenue, we anticipate for next year are already approved this year and are being launched currently. The last one is really Octreotide for which we are anticipating approval very soon from the agency based on where we are in the review cycle. So that will have also a significant impact next year.

The $450 million to $550 million does not include meloxicam, does not include XULANE low dose that we are launching as well for contraception. So it is a base generic type revenue guide. That's how we measure it. But Corinne, I don't know if you have anything?

No, I just want to say that we -- for '26, we feel that the year is setting up nicely that we will have strong new product revenues because first of the products that we have launched in the second half of the year, and we'll see the carryover effect of those launches next year and the products that we are going to launch next year. What is -- not only what's coming up is Octreotide and also a number of innovative assets. So we mentioned EFFEXOR GAD, that would be for Japan. We mentioned sotagliflozin, ex Europe, emerging markets, Canada and so on.

We mentioned that meloxicam potentially could be approved at the end of next year as well as our low dose estrogen weekly patch that we'll be launching pretty much in the same time frame. And then we have the new asset that we just acquired from Aculys for Japan, Pitolisant, which should be approved also late next year and the indication will be narcolepsy and excessive daytime sleepiness for patient who have sleep apnea. So a broad portfolio of products moving towards the more innovative products that have a longer life cycle.

And that was the comment I was going to make is as we think about the $450 million as we continue to evolve our portfolio towards 505(b)(2), longer-duration patented assets the life cycle of those, the launch curves and the life cycle of those products is also going to evolve versus the typical generic life cycle.

So just a little summary on that. I see '26 being a strong year for new product revenue for us but also overall revenue. I think we see the base business being strong as well. So we're looking at '26 as a strong revenue growth year for us.

Got it. And I think that's all the time that we have today. Thank you for all those wonderful comments. We're looking forward to a great 2026.

Thank you.

Good day, everybody. My name is Ash Verma, I cover SMID-cap, biotech and spec pharma. Welcome to UBS Healthcare Conference. And with me really excited to have from Viatris, Theodora Mistras, who is the Chief Financial Officer. Theodora, thank you for joining us.

Thank you so much for having me. It's great to be here.

Yes. So a lot of exciting things happening with your story. I want to learn more about what are the key updates. Maybe if you can just kind of give us a high-level thought on -- you just reported third quarter earnings and where the story is and then we can get into...

Thanks, Ash. We're really pleased with the momentum in the business. We remain on track to deliver 2% to 3% operational revenue growth, excluding Indore. And as we look into 2026, we expect that positive momentum to continue.

We're really focused on executing against our strategic priorities. The enterprise-wide review is ongoing. We've delivered 5 of 6 positive pipeline readouts in the first half of this year. And overall, we feel really good about the momentum.

And then finally, we're also delivering on our capital allocation priorities. We're on track to deliver over $1 billion of capital to shareholders, including $500 million of share repurchases this year.

Great. Awesome. So yes, I wanted to understand like some of the pushes and pulls on just the financials like going here right now. So I think big part -- one of the big part of the focus for you is that the new product launches that you've been kind of articulating as run rating at $450 million to $550 million every year. So as we think about like next year, maybe if we could talk about that, like where -- what's your line of sight on that? Like do you have visibility into what would be the key contributors from that standpoint?

Yes. So from a revenue perspective, we've talked about being generally in that $450 million to $550 million range. And we are not dependent on any one product to generate that contribution. However, as I sit today, when I look at 2026, I think we have strong momentum building in, in terms of our new product revenue. And that's really driven by a couple of factors.

Number one, the continued uptake on our new products that have already launched. That includes iron sucrose, glucagon and paclitaxel as well as anticipated product launches into next year, which include octreotide, Effexor GAD, sotagliflozin amongst others. And so we'll be able to provide more specifics next year when we give our full year guidance, but we're pleased with the momentum that we're seeing for new product revenues into next year.

Great. Great. Yes. And I want to go over those like a couple of quick ones. But maybe just kind of staying at the high level, so that like if you have line of sight on that. And I guess the other part of like the -- where the base business erosion has been, is there any change in that or sort of like the low single digit, what you were facing, just excluding some of the extremeous factors, I know like Indore FX.

So we feel good about the momentum that we're seeing into 2026. Just to articulate some of the pushes and pulls when you're such a big and dynamic business. Number one, continued positive trends in China, Europe and emerging markets. We expect that to continue. We've talked about the new product momentum and the timing associated with that. We're also continuing to execute around Indore and so timing around potential reinspection there.

And then we're also continuing to monitor just ongoing competitive dynamics in North America and the potential loss of Amitiza exclusivity in Japan. But when you put all that together from an overall picture perspective, we expect to see continued kind of growth into next year.

Got it. Got it. Okay. Yes. I guess, I mean, if you think about like the top line, like where this year has been shaking out pretty well for you, there seems to be a fair bit of FX tailwind on that as like around $700 million. So when I think about like the dynamic for next year or so like if that becomes -- I mean, we don't know where the FX is going to go, but like if that becomes essentially like a headwind, but you do have the new product revenue coming in and sort of where the base business erosion is, like net-net, when you combine those factors, do you think like the top line growth can continue at the same momentum that you have?

Yes. And I just want to clarify with respect to FX, it's not necessarily a lapping. So when we set our outlook at the beginning of the year, we use the prevailing rates of FX at the time. And as we move through the year, we compare our actuals to the prior year. Based on what we've seen in 2025, FX has been a tailwind for us. And assuming that rates continue to hold at current rates, we expect that momentum to continue into 2026.

Got it. Okay. All right. Perfect. So maybe we talk about some of these like different geographies a little bit. So North America, yes, I think just kind of the pushes and pulls in that. And I know you called out like just increased competition in North America. Is that to like a specific product, like group of products? Just where is that coming from?

Yes. We did see some continued competition in certain generic products, including Wixela. But I would say the decline in North America was primarily driven by the Indore impact. So when we look at the overall portfolio, we're not seeing any specific pockets of weakness and pricing erosion is generally in line with our expectations. And offsetting that is we're continuing to see strong double-digit growth in both RNA as well as Yupelri.

Got it. Okay. All right. And then if we switch over to the emerging market side. So there, I mean, you have a lot of strong growth, both from the brand and generic side, I've been looking at it. So, yes, what's effectively driving that and what contributed?

We're really pleased with our established brands business in emerging markets. And when we look at this, it's really driven by the growth and durability not only in the work that we've done around life cycle management, but it also reflects our strong branded marketing infrastructure and just the general brand equity that our products have in those regions.

When you look at it from a market perspective, we're seeing strong growth in Turkey, Mexico and emerging Asia on the established brands business. On the generic side, that business -- that growth has been supported by the stabilization of some of our lower-margin ARB products that had been impacted by Indore. And so that stabilization has resulted in growth in our generics business as well.

Got it. And then on the JANZ side, so yes, like this going price regulation seems to be having a pretty material impact on JANZ this year. Yes, like if you can kind of walk through like what -- where do you expect that to go from this side?

Yes. So from a JANZ perspective, in the near term, our legacy portfolio is -- has been subject to just normal price regulations due to government price regulations in Japan. And so our focus really in Japan is continuing to add innovative, durable assets to that portfolio in order to stabilize and return that business to growth because Japan is a key strategic market for us.

The Aculys deal that we announced several weeks ago is a good example of that. We added pitolisant and Spydia to that portfolio. When we look at some of the pipeline investments that we've made, we expect anticipated approval on Effexor GAD, Nefecon as well as sotagliflozin. And then if you take a slightly longer-term perspective, the potential of cenerimod and selatogrel also have the potential to really transform and stabilize the region and return the region to growth over time.

Got it. Okay. Okay. That's good. So a lot of different positive upside drivers on the Japan side. I guess -- yes, like -- I mean, China has been particularly strong for you, especially this year, like 9% operational growth, very, very happy to see that. Yes, I think like -- I know you used to talk about this like retail versus nonretail like where the volume is coming from. What's the latest on that? And where are we on the growth of those?

Yes. So our China business delivered 9% operational growth this quarter. And it was really driven by, to your point, our diversified commercial model across multiple channels as well as the fact that our portfolio benefits from brands that have strong demand for proactive patient choice.

Just -- and I would also note, however, that we did see some benefit this quarter from just normal customer purchasing patterns, and we do expect that to normalize in Q4. But to give you a flavor of our portfolio, we have over 10,000 customers, and that's spread across e-commerce, retail and the private hospital channel and over 95% of our portfolio has already gone through VBP.

So we feel good not only about the commercial team, but our portfolio in China, and we continue to see the opportunity for kind of low to mid-single-digit growth in our China portfolio over time.

Got it. Got it. Yes. Yes. I know that's where you were guiding to as well this year, right? And then -- yes, I mean, it's come out like pretty well. Okay. And then -- so just yes, like going back to the new product contribution. Yes, you have a few different pipeline programs here that are starting to shake out. I think the one that I'm particularly excited about is oral meloxicam, like very, very good data. And like when I compare it to [indiscernible], you guys have way better clinical efficacy, faster onset of action. So like, yes, I'm curious to understand like what is the feedback that you're hearing on that program? And what type of potential does it have?

Yes. And it's still early. We just released data earlier this year, but thank you. I would echo and agree, Ash, that we are really excited about the opportunity in fast-acting meloxicam. We view this as a broad market opportunity, and there's a real need in moderate to severe acute pain for a non-opioid alternative. And our profile, I think, stacks up well to be able to capitalize on that opportunity.

Yes. So any early thoughts on just like pricing on that? And I know you've talked about this before that you're trying to extend the IP of where it can be. But yes, just like ultimately, like what type of shape can it take?

Yes, there's a lot there. So let me take it in pieces. So just number one, on the market dynamics, and Corinne went into this a little bit on our earnings call last week. There are 80 million acute pain cases annually in the U.S. each year. And opioids still make up over 50% of prescriptions despite the risk of dependence and misuse. Additionally, in the market, what we're seeing is we're starting to see a shift, and we're seeing a multimodal approach where generally patients that are being discharged are being prescribed several options to be able to manage their pain. And so we see fast-acting meloxicam playing a critical role in that area.

From our perspective, what we're currently targeting is both the outpatient and ambulatory kind of centers. So think of joint replacement bunionectomies and then as well in more of the kind of office procedures, i.e., cosmetics and dental. From a pricing perspective, it's still early. Ultimately, we're going to have to wait for the label. But just to give you a sense of how we're thinking about it, really, we're focused on the value that fast-acting meloxicam can bring.

And you highlighted some of the points. But number one, both its rapid onset and its ability to reduce opioid usage are both benefits. But ultimately, we're balancing that with just ensuring broad and affordable access to patients. But we think meloxicam can be a meaningful contributor to our portfolio.

Yes. And then I'm assuming like that is more of a second half '26 launch as well, right? And then I think a couple of other ones that you mentioned. So maybe if you can give me a little bit of a sense like which ones you think might have like an early year contribution like next year versus like sort of later year?

Yes. So you are correct. We are targeting -- I mean, ultimately, it will depend on FDA approval. We anticipate filing fast-acting meloxicam by the end of the year. We are asking for accelerated approval, but it will be sometime kind of during the second half of 2026.

In terms of other assets in our portfolio, mentioned octreotide, mentioned Effexor GAD in Japan. We also filed our low-patch estrogen product earlier this quarter. And so we have a number of opportunities as we think about next year from a new product perspective, both in our traditional kind of base generics business as well as some of these more kind of durable 505(b)(2) more innovative assets.

Perfect. Yes. So octreotide, like that was still undergoing the review, right? That's where we are on that. Okay. So that's helpful. So maybe just, I guess, one thing that I wanted to understand is that for some of the other pipeline programs that you have, like for presbyopia, MR-141.

So yes, I think it's a pretty good market, but just like kind of a heavy cash pay model. So where you're seeing some of the analogs that have come out like UAT, if you look at it, Yes, just -- does that give you a sense on like where the uptake can be for 141 or any other?

Yes. And I don't want to get into specifics around competitor uptake. What I can share is that we're encouraged by the positive readouts that we've seen in phentolamine, both in terms of dim light disturbances as well as presbyopia. And we think that this asset in these indications can be a meaningful contributor to our overall eye care franchise, which includes Tyrvaya as well as Ryzumvi.

If you take a step back and you look at our Phase III readouts to date, it suggests that we have the potential for 3 -- this asset has 3 indications, and it's supported by a favorable safety profile, especially in presbyopia, where we've shown a lowered risk of retinal detachment. And so specifically, just given the broad market, the kind of unmet need as well as the early market adoption given some of these other assets in the market, we think that this could be a meaningful contributor to our portfolio over time. And we are anticipating filing for presbyopia with the FDA by the end of the year.

Great. Okay. And then maybe on selatogrel. So yes, like where you are on the enrollment time line and when can we expect the data?

Yes. So Philippe mentioned this on our earnings call and gave an update on time line. So I won't get into the details. I'll just provide a few of the highlights. We are pleased with the progression that we've seen in selatogrel. We've seen an acceleration in enrollment, and we're kind of on track to enroll about 1,000 patients per month. And so based on that, we're on track to complete enrollment currently targeting towards the end of 2026 for selatogrel.

Got it. Yes. So that's great. So that kind of covers the pipeline question that I had. And then, yes, in terms of where we are on the Indore warning letter if you can give us a sense like what are the remediation steps like what's done, what's remaining? And then there would be like a reinspection, which I'm assuming that you would want to request from the FDA.

And yes, just like I'll add this to the mix. It seems like there's a lot of backlog at the FDA may be because of the shutdown. So does that start to impact the time line for the reinspection when you eventually get to that?

Yes. So with respect to Indore, we feel really good about the progress that we've made with respect to remediation. And I would say kind of standing where I am today, we feel like we're largely complete with our remediation efforts. We also recently had a productive and transparent meeting with the FDA, where we not only discussed our remediation plan, but also the plan for reinspection. And ultimately, to your point, we can't control -- ultimately, the timing is up to the FDA on when they come to reinspect.

From our perspective, we will be operationally ready for that reinspection in 2026. But also importantly, we've been working on contingency plans by qualifying other sites, adding third-party vendors in order to help derisk and not rely necessarily on the timing for reinspection. And you've seen some of that with the stabilization of our ARV business this quarter.

Yes. Great. Yes. And then yes, the enterprise-wide strategic review. I mean that's a topic very, very big focus for investors, as you can imagine. And so we've heard like some of that from you, but I think like ultimately, what the latest training that kind of like Scott mentioned on the call as well that we will get this in 1Q '26.

So yes, I think -- I believe, if I'm not mistaken, I think we introduced it like late last year, this concept. And yes, what I'm trying to understand is like what's the kind of the organizational momentum that's driving that time line? Like why didn't we here sooner on like a specific number, let's say, this year versus you're finally going to get the specific outline of the financials by next year time frame?

Yes. And specifically as it relates to the strategic review, so we initiated that process actually towards the end of the first quarter this year. So it was about 6 months ago. And it really has to do with just given the breadth and extensiveness by which we're going about this, we want to do it in a thoughtful and deliberate way.

When you think about what we have done over the past 4 years, we've merged 2 companies. We've divested 3 assets. We've kind of focused on returning the company to growth. And so we really felt like now was the appropriate time to take a look at everything comprehensively and make sure that we're set up for sustainable future growth.

What does that mean? Scott went into some of the areas that we're looking into, but we're looking into our commercial infrastructure and new products, our R&D, medical and regulatory activities, our manufacturing and supply chain, including inventory optimization as well as the corporate functions that support that.

And ultimately, our objective is that whatever changes we put in deliver credible and sustainable cost savings, and we want to do this work right. And so we should be -- we will be in a position to give that clarity in Q1 along with our full year 2026 measure.

Yes. But this is effectively like a multiyear process. And is it right to think about it like the kind of the order of where there is more room for improvement on the margin side is like commercial, R&D and costs. Is that the right way to think about it?

That's basically our P&L. So without getting into the specifics on kind of margins, that's exactly right. We think there's opportunity in both our supply chain and our manufacturing as well as our commercial infrastructure. Ultimately, the goal is to deliver meaningful cost savings over a multiyear period while also allowing to be able to invest in future growth as well.

Great. Great. Okay. I know you've also just touched on this briefly on the earnings, like redistributing these savings. If you can expand on that, like what effectively -- like what would be the time line? Or is there anything specific that you have in mind in terms of how to distribute those savings back?

We'll be able to provide more clarity in the first quarter, but it really is investments in order to be able to fund our future growth. That includes some of these positive pipeline readouts that we've already had. That includes investments in our innovative pipeline, including selatogrel and cenerimod. But we're being deliberate about it. On a net basis, we still expect to deliver meaningful savings over time, and it's really to set ourselves up to deliver sustainable growth going forward.

Great. Great. Awesome. Just as a reminder for audience in the room, if you have any questions that you want us to cover, feel free to send them to me by the QR code, and I'll take it from here at the end of the session.

So just continuing on the capital allocation discussion maybe now. So I guess, yes, I know you've kind of been consistently talking about that this 50-25-25 framework of effectively like BD dividend and share repo. And as you think about where you are in the story, you can be way more heavily on one versus other if there is a need. So as you like look towards 2026, what does that framework look like? Is there anything that is like more pressing of a need as opposed to other?

Yes. We continue to have a balanced approach to capital allocation, as you said. And over a 3- to 5-year time frame, we've talked about allocating about 50-50 between business development and capital return. This year, in 2025, we leaned more heavily into capital return. As I mentioned, we're on track to return over $1 billion via share repurchases and dividends.

But it's also important to continue to support the business through development. And I would say it's in 2 areas. Number one, continued regional support, leveraging our OUS infrastructure. The Aculys deal with pitolisant is a great example of that. But we're also looking for opportunities to add durable innovative assets to complement our U.S. business as well.

Got it. Got it. Okay. All right. And then, yes, I mean, I think it's been an interesting year for business development. So I think in a long time, we haven't seen premiums being so low. So it's effectively more biotech seems like are willing to take the strategic exit even at a lower premium. And when you think about that, like does that make any kind of like a tilting your thinking towards that, oh, like this is the right opportunity that if I don't have to pay premiums and particularly for the U.S. assets, we are seeing this more and more than -- I mean, there's obviously an exception of Nxera, but if you keep everything in the rest of the bucket, there seems to be quite a bit of that dynamic happening. So does that influence your thinking in any way?

Yes, you're absolutely right, Ash. It's been a very dynamic market from a business development perspective, especially here in the U.S. And we see that as an opportunity as well. Our focus from a business development strategy, as I mentioned, is overall accelerating our company growth by investing in durable, higher-margin innovative assets that can accelerate our growth.

The U.S. is an attractive market right now, especially for commercial and in-market assets. There's a lot of opportunity. And if we find an opportunity at the right valuation and at a reasonable price, there is -- it certainly represents a disciplined use of cash.

Great. Yes. I know you have like in the last few years, I guess, like done more ex-U.S. transactions. Like the feedback that you get from investors, is there more of an appetite for investors that they won't want you to do U.S. deals? Or how is that?

I think it's been a balance of both. About 75% of our business is outside of the U.S. And so we have significant infrastructure there that is easy to leverage. But that being said, it's also really important to continue to support our U.S. business as well, and we see significant opportunity to add these durable higher-margin innovative assets to our U.S. portfolio as well.

Great. And then this recent transaction on Aculys like pitolisant, I mean it's a molecule a lot of investors are familiar with just on the U.S. side, but if you can talk about like what's the opportunity in the Japan market?

Yes. There's a significant unmet need in Japan. Currently, there's no approved therapies. And so we see the opportunity in narcolepsy for both type 1 and type 2, and we're on track. We've already filed pitolisant in one indication, and we're on track to file for the second indication as well. And so we feel very excited about the opportunity there to leverage our existing infrastructure and provide some growth to our Japan business.

Yes. Great. Awesome. So with that, any closing remarks that you want to make, and we can wrap it up.

Yes. Thanks, Ash. Hopefully, you've heard from me today that we're really proud of the progress that we've made. We've been hard at work this year, as Scott mentioned, this has been a year of execution. And so we've been continuing to execute on the business, remain on track to deliver our 2% to 3% operational revenue growth. We've made significant progress on our enterprise-wide review. We anticipate being in a position to disclose the details early next year.

We're executing on our pipeline, 5 of 6 positive readouts, and we feel good about the momentum on the new product side that we're building into next year. And we're continuing to make progress on our Indore remediation having had a recent meeting with the FDA. And so when you look at that collectively, I feel really good about the position that we're currently in going into 2026.

Excellent. Thank you so much for joining us.

Thank you for having us again.

Good morning, and welcome to the Viatris Q3 2025 Earnings Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Bill Szablewski, Head of Capital Markets. Please go ahead.

Good morning, everyone. Welcome to our Q3 2025 earnings call. With us today is our CEO, Scott Smith; CFO, Doretta Mistras; Chief R&D Officer, Philippe Martin; and Chief Commercial Officer, Corinne Le Goff.

During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2025 and various strategic initiatives. These statements are subject to risks and uncertainties. We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to the most directly comparable GAAP measures.

When discussing 2025 actual or reported results, we will be making certain comparisons to 2024 actual or reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the 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 reported results to our expectations, we're making comparisons to our 2025 financial guidance.

With that, I'll hand the call over to our CEO, Scott Smith.

Good morning, everyone. We delivered another strong quarter by focusing on our 2025 strategic priorities, driving strong commercial execution, advancing our pipeline, returning capital to shareholders through dividends and share repurchases, pursuing in-market business development opportunities and advancing our enterprise-wide strategic review to identify opportunities to deliver meaningful net cost savings, a portion of which we anticipate reinvesting in the business to fund future growth. Our fundamentals remain solid, giving us good momentum as we head into year-end, momentum we expect to carry into 2026.

Before we dive into the details of the quarter, let me provide an update on our strategic review. For context, the work we've done over the past 5 years, strengthening our balance sheet, divesting noncore assets and investing in innovation has set the stage for the strategic review as a natural next step in our evolution. We've made significant progress since we announced the initiative in February. We continue to perform a detailed analysis of the totality of our business. As part of our analysis to date, we've identified areas for potential operating efficiencies, including our commercial sales and marketing model and product mix, our R&D, medical and regulatory activities, our sourcing, manufacturing and supply chain, including inventory optimization and how our corporate functions provide support.

Looking to the future, we envision a company that delivers sustained profitable growth by focusing on 3 key areas: a global generics business that will continue to evolve towards more profitable, higher-margin complex products, an established brands business that will be strengthened by continuing to add brands that leverage our global capabilities, and an innovative brands business that will be expanded by building a portfolio of late-stage or in-market growth assets sourced both internally and externally.

We anticipate being able to deliver meaningful net cost savings over a multiyear period while also being able to reinvest a portion of the savings back into the business to fund future growth opportunities. We look forward to sharing more details, including quantification of the net cost savings and reinvestment opportunities at our planned investor event in the first quarter of 2026.

Now let me share a few highlights from the quarter. This quarter's commercial performance was strong across our portfolio, particularly in Europe, emerging markets and the Greater China region. We delivered 1% operational revenue growth, excluding Indore, in line with our expectations, reflecting continued execution across our businesses, primarily driven by the benefit from foreign exchange and supported by our strong operational performance, we are raising our full year guidance range across certain key financial metrics, including total revenues, adjusted EBITDA and adjusted EPS.

At our Indore facility, our initial remediation activities are substantially complete. We recently met with the FDA to review progress and discuss potential timing for reinspection. While timing remains at the discretion of the agency, we have built and continue to build operational redundancies by requalifying other sites and adding third-party vendors for products originally manufactured at Indore. Importantly, we continue to make progress on advancing our pipeline. Here are some of the highlights. We are excited about our fast-acting meloxicam. The acute pain market in the U.S. is significant, and we believe we can offer a differentiated alternative for patients seeking non-opioid pain relief. We expect to submit our NDA by the end of the year and are already working on our go-to-market strategy. Our low-dose estrogen weekly patch is now under FDA review following the filing of our NDA late in Q3 with a decision expected in mid-2026 and a launch soon thereafter.

For sotagliflozin, we've already made filings in multiple markets around the world and expect to file in more countries by the end of the year. For selatogrel and cenerimod, Phase III enrollment for both programs is progressing well. In addition, we've initiated a Phase III program investigating cenerimod for the treatment of lupus nephritis with enrollment of our first patient anticipated by the end of the year. We continue to view both selatogrel and cenerimod as transformational treatments with blockbuster potential and are beginning to plan for commercialization. We are excited about our recent acquisition of Aculys Pharma in Japan, adding 2 innovative CNS assets, pitolisant and spydia to our portfolio. This strengthens our presence in Japan, a strategically important market for us and leverages our CNS infrastructure and expertise.

Business development and M&A remain key strategic levers to accelerate growth, enhance shareholder value and create meaningful impact for patients. Through regional business development, we continue to pursue opportunities to strengthen our generics and established brands portfolios while building our presence in innovative brands that can benefit from our global scale, capabilities and infrastructure.

In parallel, we are evaluating targeted strategic M&A opportunities, particularly in the U.S., focused on commercial stage accretive transactions designed to expand our business and further enhance the company's long-term growth profile. We're balancing investment in growth with return of capital to shareholders through dividends and share repurchases. Year-to-date, we've returned more than $920 million to shareholders, including $500 million in share repurchases. This puts us firmly on track to return over $1 billion in capital for the year. Overall, we're very encouraged by the progress we're making, taking bold actions that are intended to strengthen our foundation, expand our capabilities and position Viatris for long-term profitable growth. We believe we're building a company that's more agile, more innovative and better aligned with the opportunities for tomorrow.

Now I'll turn it over to Philippe.

Thank you, Scott. We've had another strong quarter progressing our entire R&D pipeline globally and securing product approval in key markets worldwide. Our late-stage programs are advancing at a very strong pace, beginning with our fast-acting meloxicam. Over the past 2 months, we've participated in the American Society of Anesthesiology and the PAINWeek Medical conferences, generating strong enthusiasm among the pain health care community on our Phase III data. Several important data points from our presentations and KOL discussion underscore the product's distinct clinical profile. First, its pharmacokinetic profile and the speed of onset. This is demonstrated by faster Tmax and higher Cmax compared with Mobic. Specifically, fast-acting meloxicam achieved a Tmax of approximately 45 minutes versus approximately 4 hours for Mobic.

Second, its strong and sustained analgesic efficacy with statistically significant pain relief over 48 hours versus placebo, confirming durable pain control in both soft tissue and bony surgical models.

In post-hoc analysis, fast-acting meloxicam showed greater overall pain relief over 48 hours and faster pain relief than its opioid comparator, tramadol, across both surgical models. And third, its opioid-sparing effect as demonstrated by a significant reduction in opioid use, and a significantly higher number of opioid-free patients compared to placebo, indicating significantly reduced reliance on opioids for pain management. Our goal, subject to FDA agreement, is to include a reduction in opioid use as part of the product label. We anticipate submitting an NDA by year-end through the 505(b)(2) pathway, bearing any unforeseen delays related to the U.S. government shutdown.

Turning to MR-141 in presbyopia. We plan to submit an sNDA by year-end. For MR-142 in dim light disturbances, the second Phase III study is well on its way with full recruitment and top line results expected in the first half of 2026. Our NDA for our low-dose estrogen weekly patch for contraception was submitted in late Q3 ahead of the government shutdown. Approval is expected by mid-2026. In addition, our next-generation norelgestromin-only patch is currently in Phase III with results expected in 2027.

We've also submitted additional regulatory application in recent months for sotagliflozin in Canada, Australia and New Zealand with filings in Mexico and Malaysia expected by year-end. Recent data presented at the ESC Congress further highlights sotagliflozin's early benefit in reducing heart failure-related outcomes when initiated before discharge following a hospitalization for heart failure. Compared with selective SGLT2 inhibitor trials, the benefit observed with sotagliflozin in the SOLOIST study cohort distinctly differentiates sotagliflozin with the class.

Particularly when it comes to reducing cardiovascular death, worsening heart failure and all-cause mortality. Consistent with this dual SGLT1 and SGLT2 inhibition, sotagliflozin is the first SGLT inhibitor to demonstrate a significant reduction in MI and stroke. In Japan, we have several near-term opportunities as we continue to steadily and strategically build our innovative pipeline. Our JNDA for effexor for general anxiety disorder currently under review by the PMDA is progressing well with approval anticipated in the first half of 2026. The Japanese Phase III data supporting this submission was recently published in the Journal of Psychiatry and Clinical Neurosciences.

The recent addition of pitolisant aligns with our strategy to acquire derisked assets supported by positive Phase III data. Pitolisant with its well-established profile has made a meaningful impact for patients in the U.S. and Europe.

It is approved for treating excessive daytime sleepiness or cataplexy in adult patients with narcolepsy in the U.S. and Europe. Additionally, it is approved for excessive daytime sleepiness associated with obstructive sleep apnea in Europe. We remain on track to submit 2 JNDAs for OSAS and narcolepsy during Q4 this year. Our Phase III trial of Nefecon for the treatment of IgA nephropathy is fully enrolled with results expected early next year. IgA nephropathy represents a significant unmet medical need in Japan with limited treatment options available. Our Phase II trial of tyrvaya for dry eye disease in Japanese patients was consistent with the global Phase III results. We expect to initiate the Phase II trial in Japan in the very near future.

Turning to our complex generics pipeline. We've continued to secure approval for many of our generic products globally. We expect to receive FDA approval soon for octreotide. This will mark our fourth injectable FDA approval this year, joining iron sucrose, paclitaxel and liposomal amphotericin B, underscoring our strategy to expand the generics portfolio with technically complex, high-value products.

And finally, let's cover the progress we've made with selatogrel and cenerimod. Selatogrel enrollment continues to accelerate, now approaching 1,000 patients per month, keeping us on track to complete enrollment next year. At the recent ICC Great Wall of China and ESC Congresses, KOLs emphasize the risk associated with patient delay in symptom recognition and the need for early intervention, reinforcing the potential of selatogrel's novel approach in providing early, rapid self-administered treatment for suspected MI. For cenerimod in SLE, patient enrollment in OPUS-2 will close this month, followed shortly by OPUS-1.

We anticipate our Phase III readout around year-end 2026. Recent insights from KOL interaction at ACR highlighted the importance of the S1P access in the pathogenesis of SLE and continue to validate cenerimod's differentiated mechanism of action, which acts on B and T cells as well as antigen-presenting cells and dampens both innate and adaptive immunity.

In addition, cenerimod's mechanism of action is also highly relevant to lupus nephritis, and we've, therefore, initiated a Phase III program in this indication. Our first patient enroll is anticipated by year-end with full enrollment expected around the end of 2027. Phase III study is the most inclusive lupus nephritis study so far, inclusive of patients with active histological lupus nephritis Class III, IV and V, with eGFR down to 15 milliliter per minute and with a broad background therapy with or without antimalarial or Benlysta. In closing, we've made significant strides advancing our pipeline. We are seeing the results of focused execution and scientific discipline as well as meaningful scientific engagement across our entire R&D pipeline from generics to established brands and innovative assets.

Now I'll turn the call over to Corinne.

Thank you, Philippe. Our portfolio strategy is taking shape, fueled by the positive pipeline momentum we have seen this year. Today, I'll highlight a few of the more significant near-term commercial opportunities. As we shared last quarter, we remain excited about our fast-acting meloxicam. The moderate to severe acute pain market is substantial, and there remains a clear unmet need for fast, sustained and meaningful non-opioid pain relief.

Let me share more on the broad market opportunity and how it's shaping our commercial strategy. There are approximately 80 million acute pain cases per year in the U.S. And going forward, the incidence is expected to grow at a 2% CAGR due to an aging population and an increased number of surgeries and medical procedures. These patients are predominantly seen in outpatient and ambulatory surgical centers for procedures like gallbladder removal, joint replacements, hernia surgery or bunionectomy or in procedure-focused offices for cosmetic or dental surgeries.

Now switching to the evolution of the treatment landscape. Opioids currently account for roughly half of all acute pain prescriptions despite the known risk of dependence and misuse. Tramadol remains one of the most prescribed opioids for acute pain. There is, therefore, a strong demand for safer alternatives, combining strong efficacy with an established safety profile. In fact, current treatment guidelines show a strong consensus to minimize opioid use and prioritize non-opioid multimodal pain management strategies that include acetaminophen and NSAIDs. NSAIDs make up a substantial proportion of the total acute pain prescription volume because of their low addiction risk, short-term tolerability and anti-inflammatory effects. We believe fast-acting oral meloxicam is well positioned as a differentiated option among currently available NSAIDs for moderate to severe acute pain. Since receiving the data in May, our teams have been working hard to further shape our go-to-market strategy.

We are progressing well with launch planning, including branding, positioning, prescriber segmentation, channel strategy and pricing and payer dynamics. We are taking a targeted approach to market segmentation, focusing on settings where fast, effective alternatives to opioids are most needed. We plan to leverage our own specialty sales team and are exploring partnerships to expand reach across key prescriber segments, which will enable us to go to market more efficiently and cost effectively. We anticipate being in a ready position to launch pending the FDA review cycle. We are also very focused on launch preparations for our low-dose estrogen contraceptive patch. This weekly patch fills an important need for women seeking a lower dose estrogen option for contraception. It also offers advanced patch technology as demonstrated by potential best-in-class patch adhesion performance observed in our Phase III study. We expect this product will be another meaningful contributor and we are planning towards a launch in the U.S. in the second half of 2026. Outside the U.S., we have made major strides in building out our innovative brand portfolio in Japan with the acquisition of Aculys.

The addition of Pitolisant and Spydia further expands our portfolio of innovative CNS products, which will be complemented by Effexor for generalized anxiety disorder. These innovative assets, plus the many others in our late-stage pipeline combined with the strength of our generics and established brands portfolios position us well to positively impact patients' lives and create value for the business.

Now I'll turn it over to Doretta.

Thank you, Corinne, and good morning, everyone. I am pleased to report that we had another strong quarter, underscoring the continued performance of our broad global portfolio of generics and brands. My remarks this morning will focus on key highlights of our strong financial performance, significant free cash flow generation, capital allocation activities year-to-date and the outlook for the rest of this year. Focusing on our third quarter results, total revenues were $3.76 billion, which were down approximately 1% versus the prior year. Excluding the Indore impact, we delivered operational revenue growth of approximately 1% versus the prior year. In developed markets, net sales were down 5%, primarily driven by the Indore impact.

Breaking the segment down further. In Europe, our business continues to deliver consistent and durable performance, growing approximately 1% this quarter. The generics business continues to perform solidly and was up 5% year-over-year. This was primarily driven by new product revenues in key markets such as France and Italy. And within our branded business, solid growth in EpiPen, Creon and our Thrombosis portfolio helped to partially absorb the anticipated competition on Dymista. As anticipated, our North America business decreased 12% versus the prior year, primarily as a result of the Indore impact and competition on certain generic products. However, we continue to see double-digit growth in certain products such as Breyna and Yupelri as well as benefits from new product revenues, such as iron sucrose.

In emerging markets, net sales increased approximately 7% versus the prior year. This was primarily driven by continued strength in our established brands across key markets, including Turkey, Mexico and Emerging Asia. And the growth in our generics business was primarily driven by stabilization of supply for certain lower-margin ARV products.

In Janz, net sales decreased approximately 9%. Results were primarily driven by expected impact from government price regulations as well as a change in reimbursement policy that impacted off-patent brands in Japan. We also saw competition on certain products in Australia. Lastly, we continue to see positive momentum in Greater China, where net sales exceeded expectations and grew 9%. This was primarily driven by our diversified commercial model and increased demand for our brands that are sensitive to proactive patient choice. Net sales again benefited from the timing of customer purchasing patterns, which we expect to moderate in the fourth quarter.

Moving to the remainder of the P&L. Adjusted gross margin of 56% in the quarter was in line with our expectations. As anticipated, margins were impacted versus the prior year due to the Indore impact. Operating expenses were essentially flat versus prior year. This was as a result of increased R&D spending driven by accelerated enrollment in our selatogral and cenerimod clinical trial programs, which was offset by the continued benefit in SG&A from our 2025 cost savings initiatives.

We continue to generate strong and durable free cash flow. This quarter, we generated $658 million of cash, which includes the impact of transaction-related costs. Excluding this impact, free cash flow would have been $728 million. Our significant free cash flow has enabled us to execute on our capital allocation plan.

Since our Q2 call in August, we have repurchased an additional $150 million of shares, which brings our year-to-date total repurchases to $500 million, achieving the low end of our full year range. Including dividends paid, we have returned more than $920 million of capital this year to our shareholders, and we remain on track to deliver on our commitment of returning over $1 billion of capital this year. With regards to business development, the Aculys transaction highlights our ability to leverage our global infrastructure to strengthen our commercial portfolio in Japan through disciplined business development. The $35 million upfront payment is expected to be expensed as IP R&D in the fourth quarter.

Now a few comments on our updated outlook and phasing for the remainder of the year. We are raising and narrowing our 2025 financial guidance ranges across certain metrics, primarily driven by foreign exchange as well as share repurchases completed year-to-date. Our outlook is supported by the continued strength of our underlying business performance. With respect to anticipated phasing in the fourth quarter relative to our third quarter results, total revenues are expected to be lower across all of our segments due to normal product seasonality, resulting in our third quarter revenues being the highest quarter of the year.

Gross margins are expected to be stable, and SG&A is expected to increase due to investments in our pipeline and upcoming launches to drive future growth. Lastly, free cash flow is expected to step down due to the timing of interest payments and the normal phasing of capital expenditures.

As we close out the year, we expect the underlying positive fundamentals of the business to continue. As normal course, we will provide our outlook for 2026 in the first quarter of next year, along with our Q4 and full year results. However, from where we sit today, there are several dynamics to consider as we think about next year.

These include timing of approvals and uptake from recently launched products, competitive dynamics in North America and potential loss of exclusivity for Amitiza in Japan. Investments supporting our pipeline and launch preparedness to drive future growth and the implementation of our enterprise-wide strategic review.

In summary, we remain encouraged by the underlying fundamentals of our global business and the continued execution of our disciplined and balanced capital allocation plan.

As Scott mentioned, we plan on hosting an investor event during the first quarter of next year, where we expect to provide our strategic and financial outlook, an update on our pipeline and portfolio and details on our enterprise-wide strategic review.

With that, I'll hand it back to the operator to begin the Q&A.

[Operator Instructions] And your first question comes from Les Sulewski with Truist.

A couple for me. So first, perhaps maybe give us an update, if you could, on the Indore resolution situation.

And then Second, if you look at through the branded portfolio across the regions, specifically 2 products that stand out in 3Q, one being the uptick in Lipitor, are you able to capture some of the share from the recent generic recall? And then second, what's driving the uptick in EpiPen given the options patients now have with the nasal spray and then also some shortages across that board.

And then third, are there any key Paragraph IV challenges that you're facing into next year?

Les, let me -- I'll answer the Indore question and then pass it on. So I have to say, we're very pleased with where we are from a remediation perspective. We're largely remediated at this point. We recently had a productive and open meeting with the FDA relative to not only the remediation process but reinspection. Timing of the reinspection is with the FDA. It's not under our control, likely they'll show up unannounced at some point in '26 and reinspect.

But I think it's really important to know that we've built redundancies by qualifying other sites and adding third-party vendors to try and decouple revenues from products on the import alert list and the Indore reinspection because the timing is out of our control. So I think the Indore remediation is going very, very well. And we just -- as I said, just recently talked to the FDA and had a very constructive meeting. I'll pass it over to Doretta.

Great. Thanks. With respect to our branded regions. Number one, on Lipitor, that's really driven by the strength of our brand outside of the U.S., in particular, in China. We've talked about the strength of our portfolio there, especially in cardiovascular and all the work that we've done in terms of the channels that we operate, the strength of our brand has really continued to drive performance on Lipitor. With respect to EpiPen, we are, to your point, seeing solid performance in this year. I would say our share has remained relatively stable.

It's around 24% to 25% in the market. But to call out a couple of areas where we're seeing some strength. Number one, we relaunched EpiPen in Canada. We -- with the shift of commercial rights from Pfizer back to us. And secondly, we're seeing strong growth in Europe, and that's really led to the strength in EpiPen.

We're going to the next question, I just wanted to reemphasize, not only do we have a stated performance Lipitor in China, but the China affiliate in general had very strong third quarter and has a very -- had strong so far year-to-date this year. So we're very pleased with our progress in China.

And your next question comes from Matt Dellatorre with Goldman Sachs.

Maybe on fast-acting meloxicam first, could you comment on any feedback thus far from the FDA regarding the potential for an opioid-sparing label. And how significant do you guys view that from an access and pricing perspective? And then could you comment on the partnership strategy to reach the broader market, including how do you guys think about the split in value between the channels that you will cover versus other segments that you might partner. And how much you structure a deal like that?

And then maybe just quickly on capital allocation. Could you maybe speak to the key priorities next year? Scott, I know you mentioned U.S.-based BD. Just curious, would that be mostly midsized licensing deals? And how should we think about just kind of balance sheet capacity for those potential deals?

I'll kick it over to Philippe to talk a little bit about meloxicam and then I can finish up with not only where the partnership discussions are, but also capital allocation priorities for '26.

Thanks, Scott. Thanks, Matt, for the question. So on fast-acting meloxicam, opioid-sparing specifically to your question. We've designed the Phase III study in collaboration with the FDA and designed the study in order to be able to get opioid-sparing language in the label. As you know, the data that came out of the 2 Phase III studies in both models in terms of opioid-sparing is very strong. And so we feel very encouraged with our ability to get opioid-sparing language in the label. We have a pre-NDA meeting with the agency over the next few weeks where we'll be discussing this as part of the meeting. It's one of the topics we'll be discussing. But like I said, I think from a labeling standpoint, we've done everything that can be done with very strong data to be able to get opioid-sparing in the label.

In terms of meloxicam partner, you're a little bit ahead of me in terms of segmentation and who covers what. We're involved with some discussions with potential partners, and we're working through that and what that would look like. Those are all sort of individual discussions and the specifics would depend on what partner we land with if we do land with the partner there. So we're actively involved in exploring discussions there. We also feel completely good to take this ourselves and commercialize ourselves. We've got the right people. We've got great data, and we've got resources behind it to make a great launch. So we would only go into a partnership if we thought it was significantly additive to the overall value. And then in terms of our capital allocation priorities going to into '26, let me just -- there's a word that I try and use all the time here, and that's balanced, right?

We're going to continue to be balanced in terms of our capital allocation. As I've talked about many times over a 3-, 5-year period, we're going to try and be 50-50 returning capital to shareholders, but also trying to build a portfolio of growth assets. And so we'll be involved in business development as well. I love the deal that we did with Aculys in Japan. Japan is a key strategic priority for us. We put a couple of innovative assets in there to launch in '26. And we're going to continue to look for things for assets that we could be good owners of. I would love to be able to find some in-market accretive U.S.-based innovative products to add to the portfolio. And we're working hard on it. And again, but we're -- overall, we're going to continue to be very balanced in terms of our capital allocation between return to shareholders and also doing business development.

And it depends a little bit -- every year is going to be a little bit different. This is the year so far, we've leaned into share buybacks given the uncertainty in the environment, the share price and other things. And other years, we may lean into business development a little bit more, but we want to be able to do both return and also build growth assets to sit on top of the strong base business we have to really return to long-term profitable growth for the company.

And next question comes from Chris Schott with JPMorgan.

Just 2 for me. Maybe just coming back to the enterprise-wide strategic review. Just any more color you can provide on the quantum of expense reduction we should be thinking about here? And when you mentioned reinvestment, is that a majority of those savings, a small portion? Just any -- just kind of directional color of just how we should think about that flow through? I know we're going to get more color next year, but just anything you can provide today.

And maybe, Scott, just building on the comments you just made about the balanced approach to capital deployment. You mentioned this year is more of a capital return year. And just when you look at kind of the range of BD opportunities out there, balancing the stock price, like should we think about '26 looking more like '25, where it is more kind of capital return? Or directionally, does '26 look more like that 50-50 balance that you're targeting over time?

Yes. Thanks, Chris. So in terms of quantum, I don't want to get into quantum of savings at this point in time. We will be very, very clear and transparent relative to the quantum of savings that we get from the enterprise-wide review when we get into Q1, either at the call or through an investor event, but we'll be very, very clear about that. We're working hard on that. We think the quantum of savings is going to be significant. We believe we're going to be able to deliver meaningful cost savings over a multiyear period. And so we expect it to be pretty significant. Right now, we're sort of focused on commercial sales, marketing model, product mix, R&D, medical and regulatory activities, sourcing, manufacturing, supply chain, inventory optimization, corporate support functions. So it's a large project. We're looking at the whole organization, and we expect to be able to deliver meaningful cost savings, and we'll get into the exact quantum of those as we as we get into Q1.

And we won't only talk about the quantum, but we'll also talk about phasing. We'll also talk about the magnitude of reinvestment, et cetera, at that event, either with the call or in the investor event. I do not see reinvestment being the majority of savings. I think it will be -- certainly, the minority will be likely putting more into savings and dropping to the bottom line than reinvestment, but there will be some significant reinvestments as well.

So this is not about redistributing as much, as it's about finding the savings and then making sure we're looking after the base business and looking after our future growth as well.

The last question was balance. So what's '25 going to look like from -- '26, sorry, from a capital allocation perspective, we'll have to wait and see what that year looks like, what opportunities are there, where the stock is trading at. Again, I don't look at it on a yearly basis. I look at it sort of over a longer period, a 3- to 5-year period that we want to be very balanced in returning that capital allocation.

As things evolve, again, as we get into guidance for '26, we may talk a little bit more about that. But again, I want to continue to be able to do both, return to shareholders, but also build a portfolio of assets that are going to fuel our growth in the future.

And your next question comes from [ Dennis Ding ] with Jefferies.

This is [ Li Wenwen ] for Dennis Ding. Our question is about meloxicam. What is your overall confidence in the self-ramp and peak sales potential? And if there's anything to be learned from competitor journavx [ slow ] launch?

Yes. So I think just let me comment and then maybe Philippe can talk a little bit about the data. But we're very excited about meloxicam. The combination of the data and the people we have on board, I think we can do a very significant launch here. Whether peak sales, $0.5 billion, I think that's in the right sort of range. But we'll be more clear about that again as we get into '26 and get ready for launch. We do not have a label on that yet. So part of that -- I think there's great potential here. We can be more specific what those peak sales look like once we understand what the label looks like once the full plans together.

I will say we've got an excellent team on this right now. They've launched multiple blockbusters before. We feel very, very good not only about the data, but our ability to commercialize this asset. We're going to commercialize it as if it's a branded product, it's got -- we think there's significant exclusivity there. We're looking to expand that exclusivity. And we expect meloxicam to be a very meaningful contributor to our portfolio for the rest of this decade at a minimum and maybe longer than that. So we're very excited about it.

And your next question comes from Umer Raffat with Evercore ISI.

Congrats on the quarter. This is JP for Umer. A couple of questions on meloxicam and the presbyopia medicine. Meloxicam, as you finalize your planning, what kind of payer guidelines engagement are you thinking? Is it going to be a multimodal pain pathways? Or how does it work versus traditional retail channels. And on presbyopia, is this going to be more of a cash pay optometry play initially? Or do you see a path to broader reimbursement and physician adoption as the category matures?

Philippe. So let me start with meloxicam. I think what we've experienced both from, I think, a payer, but also from a KOL standpoint is the fact that this is the pain -- the acute pain market has moved to a multimodal approach where, generally speaking, patients are discharged with a couple of medications. And that we believe we'll be able with the data we have to leverage that trend within the market. So our data supports that positioning.

And -- I'm not sure what I -- can't recall on the second question was.

Second question on presbyopia.

Prebyopia and payer channels and commercialization. So we'll hand that over to Doretta.

Yes. Thank you. And we're still working through both not only our presbyopia but also our dim light disturbance strategy as we get closer to commercialization. But taking a step back, we view this more as a portfolio approach. When you couple that with tyrvaya that's already in the market as well as ryzumvi, we have the opportunity to really create a portfolio of assets that tailor to the front of the eye. But we're ultimately still working through the commercialization strategy. Given the indication, it is natural to assume there will be a large cash pay component to it, but we'll be able to provide more details as we get closer to commercialization.

Yes. We're very pleased with the direction we're going with the Eye Care group. We've got some new leadership on that team. A couple of positive readouts, obviously, this year in presbyopia and dim light. And we'll see what those labels look like. But we're putting -- starting together a portfolio of assets in the eye care area and starting to get some critical mass in terms of that particular group.

And your next question comes from Ash Verma with UBS.

Congrats on all the progress. So maybe one for Scott. So for the strategic review, I know you don't want to comment on the quantum of savings. But just in terms of the order of priority here, is that the right way to think about how you spend it out as in thre's more potential for savings from commercial, followed by R&D and then COGS?

And then secondly, for Doretta, so as we think about like the top line for 2026 versus 2025, can you talk about the pushes and pulls? I see at this guidance of '25 midpoint, you have $350 million of FX tailwind. So that laps next year? And then in terms of the new product contribution, do you think that you can deliver the sort of the [ reference ] you've been at the $450 million to $550 million.

Yes. So let me take the enterprise-wide strategic review, and then we'll pass it around the table here to answer your question. So Ash, thank you very much for the question. We're not trying to -- we're trying to be as open and honest and transparent as possible with the enterprise strategic review and where we are. We're not trying to be cute with it. The reason we're not giving a quantum is because it's a big project. It's a big company.

We're looking at everything. We want to be able to not only identify it, but we want to be able to trace it back and lock it down with the individual groups that we're working with there so that we come with a number that's accurate, sustainable and durable, and we can hold on to that number over a number of years. So we're trying to make sure that not only do we identify things but we understand and map out the activities needed to be able to really realize those savings.

In terms of the things that we're looking at, sales and marketing, R&D, operations, corporate support. I think probably the largest quantum can come from our sourcing, manufacturing, supply chain, inventory optimization. There's a significant amount that can come from corporate support as well. And some of the commercialization and the way that we're commercialized and the way that we need to not only sort of prepare for today and be able to continue to deliver today, but we want to be able to understand the functions that we need to be able to commercialize in the future. So we want to be fit for purpose for today and for tomorrow with this.

It's not just about realizing cost savings. It's also about evolving our model to be more effective going forward as well. So we really look forward to being in a place to talk exactly about the quantum of exactly where it's coming from, what the phasing is by year, with the reinvestment opportunities on things, and we're going to be able to do that in Q1. But we're not trying to -- again, to be cute here. We're trying to be accurate. We're trying to be thoughtful, and we're trying to make sure that we give numbers that we can deliver on.

With respect to your question around 2026 revenue, without getting into specific guidance, our focus this year is really finishing the year strong. We're very happy with the momentum that we're seeing in the business. We remain on track to deliver the 2% to 3% operational revenue growth for the year, excluding Indore. And we expect the underlying positive fundamentals that we're seeing in the business to continue into 2026. And as I think about the pushes and pulls to your point, number one, continued performance in our commercial business, including Europe, China and emerging markets, it's also going to depend on the timing of approvals and uptake of recently launched products as well as the competitive dynamics in North America and the potential loss of exclusivity for amitiza in Japan. But as normal course, we will provide our outlook for 2026 in the first quarter of next year.

With respect to your second question around new product revenue and how that ties into 2026. We've talked about the $450 million to $550 million without getting into specifics, we will provide that next year. We are also seeing positive momentum of our new product revenues going into 2026 just based on the number of opportunities not only that have gotten approved like iron sucrose but the ones that are currently under regulatory review, including octreotide.

And so we will provide more information next year when we provide our full year.

And I feel -- personally, I feel very good about '26 and the new product revenue. A lot of the approvals this year were back ended in the back half of the year. We've got some more approvals to come. We've got a lot of launches coming in '26 as I went through earlier, that are going to be catalysts. So I feel very, very good about where our new product number is going to be for '26.

And your next question comes from David Amsellem with Piper Sandler.

So just some pipeline questions, brand pipeline questions. So just back to presbyopia, can you talk to how you see differentiation versus the other modalities that have come on the market. So that's number one.

Number two, on cenerimod. Just wanted to get more insight into your thought process regarding running the study now in lupus nephritis. Is that informed by any additional analyses of earlier data? Or is it something of potentially a hedge to the extent SLE isn't successful? Just wanted to get your thought process there. And then lastly, on the rapid acting meloxicam, can you just remind us how you're thinking of your IP/exclusivity runway for that product?

So let me hand it to Philippe for presbyopia and cenerimod.