Viatris at Goldman Sachs Conference: Strategic Shifts and Challenges

On Monday, 09 June 2025, Viatris Inc. (NASDAQ:VTRS) presented at the Goldman Sachs 46th Annual Global Healthcare Conference, outlining its strategic initiatives amidst operational challenges. The company’s CEO, Scott Smith, emphasized the strength of its base business and future growth prospects, despite ongoing manufacturing issues at its Indoor facility. Viatris is strategically pivoting towards innovative products while managing capital allocation through dividends and share buybacks.

Key Takeaways

• Viatris has bought back over $300 million in shares as part of its capital allocation strategy.
• The company faces a $500 million revenue impact in 2025 due to issues at its Indoor facility.
• Viatris is focusing on innovative, patented products to drive future growth.
• The company is conducting an enterprise-wide strategic review to optimize its cost structure.
• Viatris is actively managing potential tariff impacts on its U.S. pharmaceutical supply chain.

Financial Results

• Share Buybacks: Viatris has repurchased over $300 million in shares, balancing returns to shareholders with business development investments.
• Revenue Composition: Currently, 60% of Viatris’s products are branded, with 40% being generic. Only 1% of its portfolio is patent protected.
• Indoor Facility Impact: The company anticipates a $500 million revenue impact in 2025 due to Indoor facility issues, with $140 million already impacting Q1.

Operational Updates

• Base Business Strength: Viatris has achieved consecutive quarters of operational revenue growth, excluding Indoor plant issues.
• Manufacturing Network: The company operates 25-26 manufacturing plants, with 8.5 billion doses produced annually in the U.S.
• Pipeline Progress: Positive Phase III readouts for Effexor in Japan, Zulane Low Dose, Meloxicam, and a dim light vision product highlight pipeline advancements.

Future Outlook

• Strategic Direction: Viatris aims to increase its focus on patented innovative products by 2030, alongside its existing base business.
• New Product Pipeline: Fast-acting Meloxicam is set for a filing by year-end, with potential fast-track approval. Selatogrel and Sonarimod studies are progressing with data expected by late 2026 and 2027, respectively.

Q&A Highlights

• Tariffs: The company is assessing potential tariff impacts on its supply chain, particularly for low-margin generics.
• MFN Executive Order: Minimal current impact expected, with future considerations for new patented products.
• Meloxicam: Positive Phase III results show promise for commercialization in the acute pain market.

For further details, readers are encouraged to refer to the full transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Operator: You good? Here we go.

Unidentified speaker: Great. Well, thank you everyone for joining us. We’re very pleased to have Beatrice today. And with us, we have Scott Smith, CEO Doretta Mistras, Chief Financial Officer Corinne Lagoff, Chief Commercial Officer and Philippe Martin, Head of R and D. Maybe, Scott, before I jump into questions, I’ll just hand it over to you to kind of make some opening remarks and then kind of frame the current year.

Scott Smith, CEO, Viatris: First of all, thank you for having us. And we brought a full team with us here, I think, showing the importance of where we are as a company right now. Just a few themes that I want to run through for where we are this year. First of all, we talk a lot about the base business. We’ve got the base business is very strong.

Aside from some manufacturing issues that we had at a plant called Indoor, We’ve had eight or nine consecutive quarters of operational revenue growth, and we’ve really been executing on our new product revenue. Last year, we were well above the initial guidance in terms of total new product revenue. So the base business is strong and thriving. We have some issues in terms of managing the operations part of it, which we’ll talk about and how we’re remediating that and getting through that. But the base business is running very, very strong.

We’ve been delivering on our capital allocation strategy. We’ve been paying the dividend. We’ve been buying back shares. We’ve bought back just a little bit over $300,000,000 at this point in time and share buybacks. We’re also looking at business development, and we’re looking at immediately accretive business development, very importantly.

So we want to be able to help build the revenue and EBITDA picture for the company. We’ve also had a very strong focus on our pipeline, and Philippe will talk a little bit about that as we go through this. We have when we started the year, we had 11 different programs in Phase III. Four of those have read out so far, all four positive, including Effexor for generalized anxiety disorder in Japan, Zulane Low Dose, Meloxicam in acute pain and a product for dim light vision from our an asset for an asset in our eye care division. So, you know, very, very strong focus this year on the pipeline, and things have been going very, very well, and the execution has been very strong.

We’ve also initiated a, what we call, an enterprise wide strategic review. And we’re taking a look at the cost, where do we have people in the right places, what are the processes that we’re using. It sort of feels, I guess, like the right time to be doing this. We merged four point five years ago. We’ve divested four separate businesses.

Now it’s time to really take a look. Do we have the right people in the right places to be able to deliver in ’25 and ’26 and beyond? So that’s really important as well. Also, as I mentioned, we’re we’re working hard to do the remediations in indoor. That’s coming along at or ahead of schedule.

We will look to ask ask the FDA to reinspect midyear this year. So everything is coming along there. And if if you think about those things that building the base business, you know, looking for accretive business development, delivering on the pipeline, making sure that we’re we’re doing what we need to do from a deficiency standpoint in terms of the operations and manufacturing and really looking at the company enterprise wide and seeing where do we have the right people and the right cost. All those things, those are the hard work in ’25 that goes into what we expect to be sustainable revenue and EBITDA growth in ’26 and beyond. And I think a little bit, ’24 was a year where we did a lot of debt paydown, closing our divestitures, those sorts of things, getting strengthening the balance sheet.

’25 is about executing on the pipeline and understanding the organization. We’ve got new new leadership in place, and we really need to take a look at the company fulsomely to make sure that we’ve got the right people in the right places. And then ’26 and beyond should be about revenue growth, sustainable revenue and EBITDA growth going forward.

Unidentified speaker: Great. Great. Maybe kind of digging a little bit further into the kind of the longer term perspective. Where do you see Viatris heading in 02/1930? And kind of what do you guys most focus on from an execution perspective over the next twelve to eighteen months kind of to power that growth?

Scott Smith, CEO, Viatris: Yes. So two things that really we’re starting this year, right, the pipeline and taking a look at the company from enterprise wide strategic review perspective. One of the the company is about 60% branded products, about 40% generic products. But of those branded products, most of them are are past LOE. Only 1% of our current portfolio is patent protected.

And what we want to do is we want to continue to sustain that base that fuels, right? We see a path to 1%, two %, three % revenue growth, some EBITDA leverage off the existing base, but we want to add to that with the capital that we’re generating, patented innovative products as well as products add to the base business. We want to be able to do both. But as we as we evolve towards 2030, I would see us having a larger portion of the pipeline in innovative products, which have a more predictable, longer revenue stream than what we’re doing currently. So, you know, I think we would see a company that maybe looks a little bit different geographically.

We may put different people in different places depending on where our opportunities are. You would see a portfolio that would have more innovative products. We’re not walking away from the base at all. We wanna keep that base, but but a portfolio that has more innovative products and one in which we will, again, be focused on capital allocation, giving back to shareholders and also looking to build the portfolio and the pipeline through business development.

Unidentified speaker: Great. You’ve touched on this enterprise wide strategic review, and you’ve noted plans of hosting a potential investor event in the second half to kind of frame the long term strategy. Could you maybe touch a little further on what are the key aspects of this review? What would you give us at the end of end? Could we see long term guidance of some

Scott Smith, CEO, Viatris: So just on the strategic review first. As I mentioned, the company is about four and a half years old. We did all these divestitures. And know, when you do a divestiture, often, the people who are directly associated with that business go with to go to the other company. But still, you know, you’re left with the company that we need to make sure is fit for purpose going forward.

Right? So we’re looking at all aspects aspects of what we’re doing. We’re looking at our manufacturing network. We’re looking at our commercial structure. We’re looking at how we purchase things.

We’re looking at, like, everything that the company does and trying to make sure that it’s the most efficient, effective, cost effective setup that we have. And, again, to me, it’s not just about a cost cutting exercise. It’s about making sure we’ve got the company that’s fit for purpose for business today and also is able to execute on the business going forward. I think that’s really important. I’m assuming there’s gonna be some cost benefits that come out of this, but that’s not the main focus.

The main focus is to make us a really more effective company going forward. In terms of, having an Investor Day, one of the bits of feedback that I received from a lot of investors and a lot of people is, you know, don’t get out ahead of yourself. Make sure that you understand the environment, where you’re going, what you’re doing. It is a little bit of a volatile environment from a policy and a tariff perspective right now. So if things settle down, you know, we would look to initiate that that investor event second half of the year.

We’d want to give investors a view of what the long term health of the company looks like, what our strategies are, a bit of a deeper dive into the pipeline and certainly, deeper dive into this enterprise wide review, what does it mean and where what’s the new cost structure of the company look like?

Unidentified speaker: Great. Well, that’s a great segue to my next question on tariffs, which is what is your guys’ base case right now in terms of likelihood, timing and scope of potential pharma tariffs?

Scott Smith, CEO, Viatris: That’s that’s a great question. Maybe you can tell, you know, tell me. You know, I I I’ve spent some time over the past month or so in Washington. We’ve got connections to both the administration and to congress, and I’ve had direct communication with with both. And it’s very uncertain as to exactly where this is gonna land.

Certainly, one of the, you know, key talking points that I’ve had when I’ve been talking to members of Congress is this idea of tariffs, particularly on generic products, right, could lead to major supply issues going forward. Although we produce 50% of our products for The U. S. In The U. S, Fifty Percent we don’t, I would say approximately 50% of our portfolio in The U.

S. Operates at 20 margin or less. And so tariffs could lead to, you know, major supplies. It’s not just us. It’s the generic industry in general.

And, you know, one of the one of the real points of discussion is this idea that 90% of the products of the pharmaceuticals that are in The US market, right, that are dispensed in The US marketplace, 90% are generics. And yet, generics account for about 1% of the total health care cost in The US. So it’s not a place where you’re gonna get depending on what they wanna solve for for tariffs. It’s not an area where you’re gonna get particular cost savings. And I think the congressmen I’ve talked to are very, very wary around the idea of supply shortages for patients and things like that, and we’re very committed to making sure that patients have access to our medications.

So, yeah, I don’t know where it’s all going to land. I don’t know if there’s going be an exemption for pharmaceuticals. Certainly, there’s an understanding both, I think, at the administration level and in Congress that tariffs on generics could be, very detrimental to U. S. Health Care.

Doretta Mistras, Chief Financial Officer, Viatris: And just a refresher, Scott mentioned about 50% of the products that we manufacture in The U. S. Are made in The U. S. The key countries that we import from are Ireland and India.

But also about 25% of our business is in The U. S. So 75% of our business is outside of The U. S. And then in addition, we have about eight manufacturing eight facilities in The U.

S. Between manufacturing, R and D and packaging in totality, that kind of sums up to about 8,500,000,000.0 doses annually that we manufacture here in The U. S.

Scott Smith, CEO, Viatris: And we do have manufacturing network, 25, 20 six active plants. And so we are able, depending on if there is a tariff structure, we’re able to move things around a little bit to try and minimize the impact. So we’re, you know, we’re in a place where we’re, you know, trying to think deeply around what the tariffs could look like, how they impact us, how can we find ways to make sure patients get access to our medication even in a tariff environment. But there’s only so much work you can do until you know exactly what the tariff situation is going to be.

Unidentified speaker: Great. Great. Maybe just sticking on policy for a second. Obviously, Trump’s MFN executive order a few weeks ago was a big focus for the industry and has been kind of an overhang on the sector. Do you guys have any thoughts on kind of how or if that will get implemented?

And and then in terms of Beatrice’s specific exposures, it it seems fair to say that you guys probably have somewhat limited exposure to something like that.

Scott Smith, CEO, Viatris: Yeah. So I don’t know exactly how the legislation is gonna get implemented. It’s it’s it’s vague at this point in time in terms of what the details look like. There was an attempt in the first Trump administration to do do go this direction, and it was held up in the court. So I don’t know the viability of of of this particular policy and whether or not it’ll actually be enacted in The US.

In terms of the effect of Viatris would be, I think, very minimal. As I said, 99% of our portfolio has been through LOE. Only 1% is patented. So I see very little impact on the current business. I think we may have to do some thinking.

Thinking. If it is enacted, we may have to do some thinking around new products, patented products that come in, launch sequence, pricing, global consequences of pricing and launch sequencing and some of those things. So, current impact, not very much. Future impact, potential. But we’re trying to think through all that.

And again, you need the details of the legislation before you can go too far. Right?

Unidentified speaker: Right. Right. Maybe just one last one before shifting to the pipeline. The indoor facility, I think you said, is on track for the midyear kind of resubmission to the FDA. Could you just walk us through kind of what are the next steps there once you guys do that?

And then how should we think about modeling? Obviously, generic Revlimid will be off in ’26, but how should we think of kind of like a a kind of, you know, boost in terms of revenue and EBITDA next year?

Scott Smith, CEO, Viatris: Yeah. So we’re we’re we’re so we are on track. We’re going through the remediation of the whole plant. You know, most of us here have been there and or at least a couple of us have been there personally and and, you know, checking out, making sure the remediation is going, you know, according to plan, making sure people are getting the right messages around around it. You know, the the impact is in you know, I’d sort of look at it in around three separate buckets, as you said.

Generic Revlimid, likely gone. Right? There are some fines and things associated that are onetime that won’t be recurring. And the rest of it, once Indore is up, and we’re also qualifying other plants to be able to produce those products and things, we’ll be able to recoup some of that. It takes time.

You don’t recoup it immediately. There’s competition out there supplying that drug. So you have to come in. You have to gain back the market share. But certainly, some of that will be part of our going forward enterprise.

Doretta Mistras, Chief Financial Officer, Viatris: We’ve talked about an approximately $500,000,000 impact from indoor this year. It is expected to be slightly more first half weighted than second half weighted. We saw about $140,000,000 impact in the first quarter. I would expect we would expect the second quarter to be in and around that same amount. But to Scott’s point, as we look into ’twenty six, Revlimid is about 40% of that 500,000,000 that was anticipated to kind of go away anyways.

About $100,000,000 is due to the penalties and the short term supply disruptions that we anticipate to be resolved, and then the remainder is what we’d be looking to kind of recapture over time.

Unidentified speaker: Got it. Great, great. Maybe with that, kind of shifting to the pipeline. You guys recently had several kind of positive Phase III data sets. One of those was or two of those were in pain, which created some buzz in terms of just kind of other competitive assets that are on or reaching the market.

Obviously, this is a huge market, but there are nuances just given opioids, generics, etcetera. Maybe just give us a brief background on kind of what this asset is and how it’s potentially differentiated versus the other assets that are out there? And then what is the kind of forward commercial strategy and maybe potential opportunity?

Operator: Thank you. Yes, I’ll start and then I’ll pass it over to Corinne. So clearly in acute pain, there’s a significant unmet need for treatment that is at least as effective or more than the current opioids, but has a safety profile that doesn’t have the well known side effects of neoprene. I think that’s really what the profile that we’ve demonstrated in phase three across two different models of pain. We’ve been able to show a significant and statistically meaningful reduction in acute pain versus placebo.

As part of the study design, we also had an opioid arm, tramadol given fifty milligram given every six hours to make sure that we could test the sensitivity of the bottle. But we’ve also done a post hoc analysis where we looked at the effect of fast acting meloxicam versus tramadol. Across both studies we were consistently superior in terms of pain reduction, which is something that other treatments including the most recent ones have not been able to demonstrate as part of their phase three trial. So I think this is very strong data that shows that not only we have an efficacy superior to tramadol, fifty milligram every six hours. But if you look at the dosage of opioids that that we use, it’s the equivalent is about 40 or morphine equivalents, which is about two four than hydroxycodone twenty milligram, which is typically can be sometimes the other opioid that’s used.

So very potent opioid dose that was used there which shows that really truly the efficacy demonstrated in this two phase three study was very strong. And on top of it and importantly, after a lot of discussion with the agency, we added endpoints around reducing the use of opioids. Where we’re able to reduce the use of opioids when patients are meloxicam and we show clinically meaningful statistically significant effect across both studies, across both pain models. So the profile came as strong as one would have liked as part of these two phase three studies. Safety profile was also very favorable.

We saw an incidence rate of adverse events that was comparable to placebo. So benefit risk for this acute pain with meloxicam fast acting is is is very strong. We plan on using this data and filing by the end of the year. We’ll have conversations with the agency around fast track and and and to get the drug approved faster based on the unmet need, and we’ll go from there.

Corinne Lagoff, Chief Commercial Officer, Viatris: So we’re going to commercialize this asset as a branded product. And based on those very positive results, think we feel that the product can compete very effectively in the acute pain, moderate to severe market. Just to give you an idea of the sizing of this market, you have in The US every year between seventy to eighty million cases of of acute pain. And half of those patients still rely on opioids despite the fact that, you know, it is very well known that the use of opioid has abuse potential. So we feel that with a profile like high, fast acting meloxicam, we can offer what the market demands, which is a non opioid as effective therapy with a very well characterized and established safety profile.

The way we’re going to commercialize this, of course, we’re going to look at the postoperative segment both inpatient and outpatient, but, potentially, we can go broader than this depending on the label we we we’re gonna get. Because, you know, the you you can think of the treatment of acute pain in many settings, including dental pain, labor pain, you know, osteo you you know, postoperative pain as already mentioned. So, potentially, a large market that we can address, we will build a specialty sales force team to to address this market, but we will also be able to leverage the current infrastructure that we have in institutions and notably in terms of contracting.

Scott Smith, CEO, Viatris: So Corinne talked a little bit about the patient numbers. The eighty to ninety million, you said?

Corinne Lagoff, Chief Commercial Officer, Viatris: Yes. Seventy to eighty.

Scott Smith, CEO, Viatris: Seventy to eighty. The last I saw valuation of the marketplace was twenty twenty twenty two data, which suggested the acute pain market in The United States was $44,000,000,000. 20 2. So it’s a very large market. And clinical development, and Philippe knows this better than I do, sometimes you get surprised, right?

You have this study that doesn’t work or sometimes you get data that’s better than expected. I think we were very, very pleased with the quality of the study and quality of data to come out. And it gives us a very, very nice platform to be able to launch this product and given the strength of the data. Great. Great.

Unidentified speaker: And maybe just kind of lastly on meloxicam. Given this is a fast acting formulation, how should we think about, you know, IP and your guys’ patent protection?

Operator: Yes. So it’s a we’re gonna file using a five zero five v two pathway, and we also are in the process of we have patent pendings, and so once the the patent situation is is resolved, you know, we have more visibility there. We’ll we’ll get it on.

Unidentified speaker: Yep. Great, great. Maybe shifting to selatogrel. You know, this represents a really interesting kind of emergency therapeutic option for heart attack that clearly addresses a major unmet need. But obviously, there’s questions around patients’ ability to administer it in an emergency situation.

Could maybe could you just maybe comment on what you’ve seen so far? I think you’ve commented on this on the last earnings call, but the patients are doing this correctly. Really, what other kind of data have you seen so far, and when will we get an update there?

Scott Smith, CEO, Viatris: Yeah. We’re getting

Operator: often a question around this aspect. Think the so just start the studies going very well. We get good momentum. We’ve expanded to study globally. We are reaching 800 sites around the world.

So that part is going well. In terms of what we are seeing with the data, I think what we’re seeing is that patients are self injecting on time, which is it is important that the patient is self inject as as soon as they start getting symptoms of acute MI or heart attack. And what we see is that patients typically self inject within a half hour to an hour, which is extremely important in the sense that p two y twelve inhibitors, is one of, have been shown to be particularly efficacious very early on in the acute MI process when the thrombus is still made of platelets. Right? The evolution of the thrombus then moves away from from from platelets, and that makes the p two y twelve less less effective.

So we’re seeing that. What we’re also seeing is that patients are able to recognize the symptoms of a heart attack or acute MI properly, typically just chest pain, but they are self injecting based on on those symptoms. And what we are also seeing is that these patients are able to take themselves typically, the worry is that they self inject and don’t call to get proper diagnosis. We’re not seeing that. We’re seeing patients are are well trained and are able to to take themselves to the hospital and get proper diagnosis.

In terms of the type of acute MI we’re seeing, I think we’re there was also another assumption, and what we’re seeing is that type of acute MIs observed in the studies are on par with the assumptions that we had at the beginning of of the study. So, that’s particularly important for the primary endpoint. Talking about the primary endpoint, we wanted to see a twenty percent reduction in in risk, twenty percent risk reduction, and we’ve started the study that way. We think that’s somewhat conservative and that there’s room for us. And then finally, safety profile, you know, we’ve had over 10 independent DMCs at this point.

They’ve always told us to continue unchanged. They are unblinded to the data. We’re not seeing an increased risk of bleeding at this point or severe bleeding at this point. Study is still ongoing obviously. So the assumptions that we had put together at the beginning of the study are playing out in a way that that gives us confidence about what’s about to happen.

Scott Smith, CEO, Viatris: Very, very interesting asset, I think. And we need to wait on the data and see if the data but, you know, if the data is positive and we get to registration. I don’t think there’s any better home for this asset, any company that’s better than us, given our history with the injectable self administered rescue medicine. The fact that we’ve got that we’ve commercialized assets like that globally. We’re currently in 165 countries, and we’ve got tremendous experience with self administered medication.

So I think I’m very excited about the data. If the data looks good and positive, we’ll at least do registration. I think this could be a very, very important product for us.

Unidentified speaker: Great. And then late twenty six is that that’s still kind of the base case?

Scott Smith, CEO, Viatris: Yeah. It’s still

Operator: the the the base assumption.

Scott Smith, CEO, Viatris: Event driven study. So could could be before or after because it’s on events, not not standard in terms of, number of patients enrolled and and and and then, you know, going to the endpoint. So because it’s event driven, it it the the timing could vary a little bit, but the assumption is still end of twenty six.

Operator: Great. Great.

Corinne Lagoff, Chief Commercial Officer, Viatris: And as Scott said, we will be ready to commercialize this asset. It’s a market that we will be developing. There are like about if you look at just US and Europe, you have about two million acute MI every year, right, and maybe nine million to ten million patients living with who had an MI previously. So we’ll be targeting those patients, identifying those patients early on, educating patients and the medical community as well on how to recognize symptoms and we will be deploying, a specialty sales force, visiting cardiologists both in the hospital setting and in office. And in terms of access, think it’s a question we get.

If you look at this population of patients who have acute MIMO, about half of them are Medicare patients and the second half commercial in The U. So we expect that we’ll get relatively fast access considering the need. If you think in terms of the value proposition of the asset, the type of risk reduction, relative risk reduction we’re gonna see, added to, the reduction of, negative outcomes post MI will be very important in defining the value of these assets. So we are pretty bullish about it.

Unidentified speaker: Great. Great. Maybe switching over to to the capital allocation strategy. So I mean we know Viatris was formed with kind of a stated goal to transition the company’s business model to a capital return focused company through dividends and repurchases. Clearly, is obviously a really important aspect for you guys.

But maybe kind of just frame for us how you think about the balance of capital return versus investing more in the company, business development.

Scott Smith, CEO, Viatris: Yes. So we’ve talked generally going forward, getting the debt paid down and then having sort of a fifty-fifty capital allocation, 50% back to shareholders and dividend and share buybacks and the other 50% of business development. That may be different any one year. This is a year where there’s a lot of volatility, external volatility, macro volatility. So we’re leaning in.

And certainly, the first half of the year, we’ve leaned in share buybacks a little bit. Other years, there may be more business development opportunities. I think we’re looking for things I’m very excited about sort of the midterm pipeline that we have, the Solatigrels, Sonarimod, soda for Glosens and other things. But I think from a business development perspective, we want to look for more near term assets, either sort of in market or very proximal to being in market. We want to make try and do accretive deals that are going to add both to our revenue and our EBITDA going forward.

Unidentified speaker: Great. You mentioned Sonarimod. We saw a really interesting mixed but interesting Phase II data there. How are you guys thinking about the development of that asset? I mean, obviously, you’re in lupus now.

We know that’s historically a tricky space, but maybe how you kind of think about POS for that Phase III?

Operator: Yes. So I think to your point, we’ve we’ve the the the development of cinemas, we’ve done three phase two studies, and I think what we’ve seen across these three phase two studies is a consistent profile for the four milligram dose, which is the dose we’re we’re taking to phase three. The lower dose did not work as well as the four milligram dose, which is what what you do dose range finding for. So I think the profile that is emerging both from a benefit risk profile looks particularly attractive for an oral drug that can be given in combination on top of standard of care and prior to more aggressive biologic therapy. What we’ve seen in the phase two also is that the drug seems to work better in a more severe population, in a patient population with an interferon-one high signature.

And that’s the type of patients we are recruiting in reaching the phase three program for. We’re targeting about eighty percent of those patients, which is typically what has been seen eighty percent, eighty five percent with the most recent phase III trial in this indication. We’ve also learned quite a bit from phase II and we’ll be implementing a number of changes. For instance, primary endpoint is no longer at six months, it’s at one year, which is in favor of the drug, in favor of the treatment effect versus the placebo. We also have to implement a steroid tapering mandatory, which will reduce the the overall placebo response rate for for the for the for the study.

So we have two large studies. Enrollment is going well. Enrollment is anticipated to be finalized around the end of the year, and and then it takes about a year to readout.

Scott Smith, CEO, Viatris: You mentioned probability of success, right, when asking that question to Philippe. And one of the things I think that’s always important when you’re developing assets and plays into the probability of success is, do you have experience developing these types of assets before? Philippe was a lead developer on S1P molecule, which is in the market for multiple indications now. So I think that helps give us a good chance to pull this over the line, SLE.

Unidentified speaker: And are you guys thinking about broader indication expansion for this asset?

Operator: Well, certainly, yes. I mean, one natural evolution is lupus nephritis from SLE. I think that’s that’s one particular area that that we are embarking on. Probably, to a success there is, is pretty high based on on mechanism of action and, what we know so far. So

Scott Smith, CEO, Viatris: These s one p molecules have broad immunomodulatory activity. Right. We’ve seen them work in IBD. We’ve seen them work in MS. We’ve seen them work in a lot of different places.

So there’s there’s there’s a lot of different indications that we can take this in. We can follow-up lupus nephritis. But depending on, you know, once you see the initial data, it may take us down some other routes as well. Great.

Unidentified speaker: And late twenty six also for that is okay. And then maybe kind of lastly on the pipeline. You guys have an ocular portfolio, and we just saw recent positive Phase III data. Maybe just kind of briefly touch on what we recently saw? And then what would you highlight from this portfolio in terms of kind of next steps and where the major opportunities are?

Operator: Yes. So we built we’re in the process of building a pretty broad portfolio in in ophthalmology or eye care. We just had our first readout this year in patients that have dim light disturbances after refractive surgery. These are patients that typically cannot drive or cannot function during under low or dim lights. And what we’ve shown in our phase three study is that we saw a significant functional improvement in these patients in their ability to drive and their ability to function under these low lights.

So we think there’s nothing approved for these types of treatment. We’ve had no conversation with the agency on how to design this and what is relevant and what kind of questions we should be asking these patients in the patient’s reported outcome. So we feel that this data can make a difference for these I don’t know if you want to add to your side?

Corinne Lagoff, Chief Commercial Officer, Viatris: Yes. So I mean if you just look at the number of keratorefractive surgeries every year, it’s about eight hundred thousand in The U. S, so potentially a large market. Now I would say post surgery, most of these patients will have visual aberrations in dim light conditions and sometimes it will result by itself. But in twenty five percent of patients, one month after the surgery, they still have those disturbances and this is a chronic condition.

So this would be the first FDA approved product to address this issue and I think potentially could be a very interesting market to address that.

Scott Smith, CEO, Viatris: The eye care division itself has gotten off commercially to a little bit slower start than we had initially anticipated. I think Corinne has done a lot of work to reform that group. We’ve got new leadership there from an overall perspective, from a commercial perspective, from a sales perspective. We’re taking a look at that group, seeing how we can be more effective. We just had a positive readout.

We’ve got two more phase three readouts for eye care coming this year. So I feel very, very hopeful that the eye care group will be a major contributor to the company going forward over the next five, ten years. We just have some work to get it going in the right direction, but I think we’ve done some of that work, and I’m excited about the future.

Unidentified speaker: Great. Well, with that, we are out of time, but thank you guys very much for joining us.

Scott Smith, CEO, Viatris: Thank you very much.

Doretta Mistras, Chief Financial Officer, Viatris: You for having me.

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