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. 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 2025, or how are you guys thinking about 2026, et cetera?
First of all, thank you, and 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 when we can have a lot of people here and get to meet the whole team. Progress in 2025. 2025 has been kind of a—it's been an interesting year. There have been challenges, both internal and external, difficult policy environment and tariffs and things. 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, five positive phase three studies out of six delivered so far this year, which will be launches in 2026 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 a billion dollars in return of capital to shareholders during the course of 2025. We also have done business development and 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's a very important market for us, so we've been doing aggressive business development, looking to support the geographies that are out there. That's been a key priority for us. 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've paid down debt. We've invested in some innovation. 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?" 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 will reinvest into growth into the future. Net net, I think there's been a ton of work done in 2025 to get us ready for 2026 and beyond. We see us moving into a period of sustained predictable growth in 2026 and beyond.
Yeah. Okay. 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, yeah, et cetera.
Yeah. 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. We're looking at the whole company. Again, five 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 to deliver on the current objectives and going forward. It will be meaningful. We will get meaningful savings out of that. Again, I think it'll be very, very important.
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 is some very significant and meaningful cost which we can take out of the organization, be more effective. Again, we expect to realize a lot of those savings, but we will also reinvest some as we move into growth drivers of the future.
Okay. It still sounds like the majority of those savings will fall to the bottom line, and a small portion of it would 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. Can you just update us on the progress around the indoor facility in terms of the inspection timing, et cetera?
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 will happen. 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. I can't give you timing on that, right? It'll also be of course , at their timing. I can't really say. I would absolutely expect that in 2026, we'll reinspect, hopefully in the first half, and move on from there. I will say, hopefully, by the time we get to that reinspection, it's a non-event from a financial perspective. We've been trying to requalify other plants, find third-party vendors around the world.
We want to be able to, regardless of the timing of that reinspection, supply the products that came out of that plant to the US and around the world. Again, for me, the reinspection will not 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. Again, my timeline, it is up to the FDA, will be a surprise inspection, likely to happen next year, hopefully in the early first half of the year, and we will go from there.
Got it. Okay. Last big picture question just around BD and your priorities around capital allocation. Can you remind us what those are? In terms of actual BD and tuck-ins, et cetera, what sort of size are you looking to do? What sort of therapeutic areas, et cetera?
For me, the capital allocation plan, the critical word that we keep saying that's 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. We're going to be balanced. In any one year, we're not necessarily going to be 50/50. One 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 BD a little bit more. 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 in-market, one close-to-market, or assets in Japan that should have an impact as we move into 2026. I would love to get some good in-market, high-margin revenue, growth revenue, particularly in the United States, going forward. 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? 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 a new asset? Maybe it's cardiovascular, maybe it's something else, but curious to hear your thoughts.
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 that'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, in other places, there's some of the biggest organizations in those countries from a healthcare perspective. For me, it's about leveraging the geographic presence that we have. 165 countries. We've got an amazing emerging markets presence as well. 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. Unfortunately, the nature of our portfolio, given that they're off-patent established products, are subject to ongoing price regulation. 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. Why don't we talk a little bit about the pipeline? Maybe again, high level, what are you most excited about and what are some upcoming catalysts in 2026 that we should be focused on?
Let me just make it very high-level , and then Philippe can dig into the pipeline a little bit more. There's some very interesting phase three data that we had, Fast-Acting Meloxicam. We have the XULANE LO-dose patch that we've got good data on. Those are a couple of assets in the United States that we should launch in 2026 or close to there. We're excited about that. I'm also excited about Saladegrow, Cenerimod, the progress we're making there. Philippe can talk a little bit more about that, but we've done a lot to accelerate those clinical development programs. We do have a large, diverse pipeline of assets here. 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, five positive phase threes out of six studies this year and accelerating Saladegrow and Cenerimod, which is really important for us. Philippe, do you want to pick out a couple of products from the pipeline that you'd like to highlight?
Yeah. I mean, I think the one that you didn't mention is Sotagliflozin that we are getting registered and approved around the world currently. We had our first approval in United Arab Emirates, and then we filed in various regions like Canada, Australia, New Zealand, and so on. We're working on filing this drug in the rest of the world. I think the most important asset currently, the one that has had very strong enthusiasm, is Meloxicam or 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 unique PK profile and fast onset of the asset when you compare with Mobic. Mobic is about a four-hour Tmax. Fast-Acting Meloxicam is about 45 minutes. Significant difference there.
From an efficacy standpoint, I think we've seen strong and sustained efficacy that resonated versus placebo in two different pain models, bony and soft tissue. That data, particularly the post-doc analysis versus its competitor, Tramadol, where we show generally greater efficacy, was very well perceived. Last, I think it's the opioid-sparing effect of the drug, both in reduction in doses or usage of opioid, but also in the number of patients that are opioid-free after the treatment. That resonated strongly with physicians. 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. 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. We feel good about our probability of success there. We'll file by the end of the year and get approval sometime next year.
Sure.
Just a quick comment. We're very, very excited about the pipeline, right? There's a number of things coming through, both that are read out in 2025 that we'll read out in 2026 and 2027. 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. 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 2026 and beyond.
I think that makes a lot of sense. 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. I'm just curious how that informs your future experience with Meloxicam. Maybe 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 of the commercial aspects. I think if you look at the data between Journavx and our data, the data looks different. 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. That's a differentiating factor, certainly, versus current assets that are currently marketed. Corinne?
Yeah. Let me start by saying that based on this take-home 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. We've been working over the last few months at 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 competitor's strategy either. 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 and dependence and misuse. We see that Fast-Acting Meloxicam has a real place in the treatment algorithm. It's really differentiated. The market has moved towards a multimodal approach.
The idea with a multimodal approach is that you can cover patients' needs over 24 hours. Now we have an asset, as Philippe mentioned, that works fast, could be used first-line, could be really part of a multimodal approach, right? It can really extend the use of NSAIDs in acute pain. When you look at the market, when you look at market segmentation, the majority of post-operative patients are treated in the outpatient settings, right? They are treated in ambulatory surgical centers for procedures like joint surgeries, joint replacements, or in-office settings for cosmetic surgeries or dental surgeries, right? 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 committees and put on formularies.
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? It seems quite large and maybe also comment on NO PAIN and if that would be a tailwind for you guys.
Right. I'll start with NO PAIN because I mentioned the hospital setting. We'll be looking at, for now, there's no oral therapy included in NO PAIN. We'll see how that evolves. There's been a bit of delay due to government shutdown. We don't know yet which products will be listed. It would be good to have it, but again, the hospital setting might not be our primary focus. 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 the molecule.
Got it. Okay. Number two on the pipeline, just on your asset for Presbyopia, how are you thinking about that commercial opportunity? There is a competitor on the market launching right now. Just how do you position your asset relative to theirs?
From a data standpoint, maybe I can start. We have a different mechanism of action. It is not a biotic, 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 improvement in that setting. That's definitely a differentiator. We think that from a benefit-risk standpoint, our asset, because of its safety profile in particular, looks very good versus the competition. That's where I think we're going to focus the differentiation going forward from a data standpoint.
Yeah, and that's a very important point. I mean, the Presbyopia market is opening up for therapeutics. 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 is, as Philippe said, it will be a differentiated asset because we will not have the same safety profile as the currently approved assets, right? That's going to be important. We certainly feel that we will not have, for instance, risk of retinal detachment, of risk of spasms of the ciliary muscles, right? There is a real place for phentolamine in this indication, Presbyopia. As a reminder, phentolamine is also developed in dim light disturbances.
We also have phentolamine approved under the brand name of Ryzumvi already on the market. These opportunities will expand our eye care business and our when we have set up the capabilities in the US for this business. It's a good opportunity, and I think we're quite bullish about it.
This is going to be a retail product, I'm assuming?
Yeah, 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.
Okay. If we take a step back, you guys have talked about $450 million-$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?
Let me start, and then I can give it to Corinne as well. We've had a lot of approvals for our more complex generics this year, toward the end of the year. They will be major contributors to next year. 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. That will also have significant impact next year. The $450 million-$550 million does not include Meloxicam, does not include XULANE LO Dose that we are launching as well for contraception. It is a base generic type revenue. That's how we measure it. But Corinne, I don't know if you...
No, I just want to say that for 2026, 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'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, X-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 will be launching pretty much in the same time frame.
We have the new asset that we just acquired from Aculys for Japan, Pitolisant , which should be approved also late next year. The indication will be narcolepsy and excessive daytime sleepiness for patients who have sleep apnea. A broad portfolio of products is moving towards the more innovative products that have a longer life cycle.
That was the comment I was going to make is, as we think about the 450, 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.
Yeah. So just a little summary on that. I see 2026 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 2026 as a strong revenue growth year for us.
Got it. 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.