Hey, good day everybody. My name is Ash Michael with SmithCare Biotech Inspect Pharma. Welcome to UBS Healthcare Conference, and with me, really excited to have from Viatris, Doretta Mistras, who is the Chief Financial Officer. Doretta, thank you for joining us.
Thank you so much for having me. It's great to be here.
Yeah, 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 kinda give us a high-level thought on, you just reported third-quarter earnings and where the story is, and then we can get into more.
Yeah, thanks, Ash. We're really pleased with the momentum in the business. We remain on track to deliver 2-3% operational revenue growth, excluding Indor. 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 five of six positive pipeline readouts in the first half of this year. Overall, we feel really good about the momentum. 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. Yeah, I wanted to understand, like, some of the pushes and pulls on just the financials, like, going here right now. I think one of the big parts of the focus for you is that the new product launches that you've been kind of articulating as run rating at $450 million-$550 million every year. As we think about next year, maybe if we could talk about that, like, where, what's your line of sight on that? Do you have visibility into what would be the key contributors from that standpoint?
Yeah. From a revenue perspective, we've talked about being generally in that $450 million-$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. 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 liraglutide, Effexor GAD, sotagliflozin, amongst others. We will be able to provide more specifics next year when we give our full-year guidance.
Yeah.
We're pleased with the momentum that we're seeing for new product revenues into next year.
Great, great. Yeah. I want to go over those, like, a couple of quick ones, but maybe just, kinda staying at the high level. If you have line of sight on that, and I guess the other part of, like, 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 extreme factors?
Yeah.
I know, like, Indor effects.
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 Indor, and so, timing around potential reinspection, there. We're also continuing to monitor just ongoing, competitive dynamics in North America and the potential loss of M&P exclusivity in Japan. 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. Yeah. 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 well, like, around $700 million. So when I think about, like, the dynamic for next year, if that becomes—I mean, we do not know where the FX is gonna go, but 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 are?
Yeah. And I just wanna clarify with respect to FX, it's not necessarily a lapping. When we set our outlook at the beginning of the year, we use the prevailing rates of FX at the time. 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. 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.
Mm-hmm.
A little bit. North America, yeah, I think just kind of the pushes and pulls in that. 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?
Yeah. We did see some continued competition in certain generic products, including XULANE LO.
Right.
I would say, the decline in North America was primarily driven by the Indor impact.
Yeah.
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. Offsetting that is, we're continuing to see strong double-digit growth in both Breyna, as well as Uptravi.
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, yeah, what, what's effectively driving that and what's the contributors?
Yeah. We're really pleased with our established brand business in emerging markets. When we look at this, it's really driven by the growth and durability, not only in the work that we've done around lifecycle 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 brand business. On the generic side, that growth has been supported by the stabilization of some of our lower-margin ARV products that had been impacted by Indor. That stabilization has resulted in growth in our generics business as well.
Got it. And then, on the brands side, so yeah, like, this growing price regulation seems to be having a pretty material impact on brands this year. Yeah, like, if you can kind of walk through, like, what is, like, what way do you expect that to go from this side?
Yeah. From a Japan's perspective, in the near term, our legacy portfolio has been subject to just normal price regulations.
Right.
Due to government price regulations in Japan. 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 Aculis deal that we announced several weeks ago is a good example of that. We added pitolisant and Spidea to that portfolio. When we look at some of the pipeline investments that we've made, we expect, anticipate approval on Effexor GAD, Nefopam, as well as solriamfetol. 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. That's good. So a lot of different, you know, positive, upside drivers on the Japan side. I guess the, yeah, like, China has been particularly strong for you, like, especially this year, like, 9% operational growth. Very, very happy to see that. Yeah, I think, like, like, I know you used to talk about this, like, retail versus non-retail, like, where the volume is coming from. What's the latest on that and where are we on the growth of those?
Yeah. Our China business delivered 9% operational growth this quarter. 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.
Mm-hmm.
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. To give you a flavor of our portfolio, we have over 10,000 customers, and that is spread across e-commerce, retail, and the private hospital channel. Over 95% of our portfolio has already gone through VBP. We feel good not only about the commercial team, but our portfolio in China. We continue to see the opportunity for low to mid-single-digit growth in our China portfolio over time.
Got it. Got it. Yeah. Yeah. I know that's where you were guiding to as well this year, right? And then, yeah, I mean, it's come out, like, pretty well. Okay. And then just, yeah, like, going back to the new product contribution, yeah, I, I, you have a few different pipeline programs here that are, you know, starting to shake out. I think the one that I'm particularly excited about is oral meloxicam.
Mm-hmm.
Like, very, very good data. And, like, when I compare it to what external acts, you guys have way better clinical efficacy, faster onset of action. So, like, yeah, 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?
Yeah. 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.
Yeah. So I, any, any early thoughts on, just, like, pricing on that? And I know you've, you've talked about this before, that you're, you know, trying to extend the IP, of where it can be. But, yeah, just, like, ultimately, like, what type of shape can it take?
Yeah. There's a lot there. Let me take it in pieces. Just number one, on the market dynamics, 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. 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. 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.
Think of joint replacements, 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 gonna have to wait for the label.
Mm-hmm.
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. You highlighted some of the points, but number one, both its rapid onset.
Mm-hmm.
Its ability to reduce opioid usage or both benefits. Ultimately, we're balancing that with just ensuring broad and affordable access to patients. We think meloxicam can be a meaningful contributor to our portfolio.
Yeah. And then, I'm assuming, like, that is more of a second half 2026 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 a, like, an early, early year contribution, like, next year versus, like, sort of late, later year?
Yes. 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 in the second half of 2026. In terms of other assets in our portfolio, mentioned Accretide, mentioned Effexor GAD in Japan. We also filed low or low-patch estrogen.
Yeah.
product earlier this quarter. We have a number of opportunities as we think about next year from a new product perspective.
Mm-hmm.
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.
Yeah. Perfect. Yeah. So Accretide, like, that was still under-undergoing the review, right?
Mm-hmm.
That's where we are on that. Okay. That's helpful. Maybe just like, 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. I think it's a pretty good market, but just kind of a heavy cash pay model. Where you're seeing some of the analogs that have come out, like UAD, if you look at it, does that give you a sense on where the uptake can be for 141 or any other?
Yeah. I don't wanna get into specifics around.
Yeah.
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 and these indications can be a meaningful contributor to our overall eye care franchise, which includes Trevia as well as Ryzumvi. If you take a step back and you look at our phase three readouts to date, it suggests that we have the potential for three, this asset has three indications, and it's supported by a favorable safety profile, especially in presbyopia, where we've shown a lowered risk of retinal detachment.
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. We are anticipating filing for presbyopia with the FDA by the end of the year.
Great. Okay. And then maybe on Salatogrel. So yeah, like, where you are on the enrollment timeline and, and can we expect the data?
Yeah. Philippe mentioned this on our earnings call and gave an update on timeline. I will not get into the details. I will just provide a few of the highlights. We are pleased with the progression that we have seen in Salatogrel. We have seen an acceleration in enrollment, and we are kind of on track to enroll about 1,000 patients per month. Based on that, we are on track to complete enrollment, currently targeting towards the end of 2026 for Salatogrel.
Got it. Yeah. So that's great. So that kind of covers the pipeline question that I had. And then, yeah, in terms of where we are on the Indor 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, yeah, just my, like, I'll add this to the mix. It seems like there's a lot of backlog at the FDA maybe because of the shutdown. Does that start to impact the timeline for the reinspection when you eventually get to that?
Yes. With respect to Indor, we feel really good about the progress that we've made with respect to remediation. 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. Ultimately, to your point, we can't control—ultimately the timing is up to the FDA on when they come to re-reinspect. From our perspective, we will be operationally ready for that reinspection in 2026. Also importantly, we've been working on contingency plans by qualifying other sites, adding third-party vendors in order to help de-risk and not rely necessarily on the timing for reinspection.
You have seen some of that with the stabilization of our ARV business.
Right.
This quarter.
Yeah. Great. Yeah. And then, yeah, the enterprise-wide strategic review, I mean, that's a topic, you know, very, very, very big focus for investors, as you can imagine. And, we, 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 2026. Yeah, I think, I believe, if I'm not mistaken, I think you introduced it, like, late last year, this concept. And, yeah, what I'm trying to understand is, like, what's the kind of the organizational momentum that's driving that timeline. Like, why didn't we hear 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, we initiated that process actually towards the end of the first quarter this year. It was about six 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 four years, we've merged two companies. We've divested three assets. We've kind of focused on returning the company to growth. 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. Ultimately, our objective is that whatever changes we put in deliver credible and sustainable cost savings, and we wanna do this work right. We will be in a position to give that clarity in Q1 along with our full year 2026 picture.
Yeah. Yeah, but this is effectively like a multi-year process.
Mm-hmm.
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 a right way to think about it?
That's basically our P&L.
Yeah.
Without getting into the specifics on kind of margins, that's exactly right.
Yeah.
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 multi-year period while also allowing to be able to invest in future growth as well.
Great. Okay. 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 timeline, 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. We're being deliberate about it on a net basis. We still expect to deliver meaningful savings over time. It is really to set ourselves up to deliver sustainable growth going forward.
Great. Great. Awesome. Just a reminder for our 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, yeah, continuing on the capital allocation discussion maybe now. I guess, yeah, I know you've kind of been consistently talking about this 50/25/25 framework of, effectively like BD, dividend, and share repo. As you think about where you are in the story, you can be way more heavily on one versus the other if there is a need. As you look towards 2026, what does that framework look like? Is there anything that is more pressing of a need as opposed to the other?
Yeah. We continue to have a balanced approach to capital allocation, as you said. Over a three-year, three to five-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. It's also important to continue to support the business through business development. I would say it's in two areas. Number one, continued regional support leveraging our OUS infrastructure. The Aculis deal with pitolisant is a great example of that. We're also looking for opportunities to add durable, innovative assets to complement our US business as well.
Got it. Okay. All right. Yeah, I mean, I think it's been an interesting year for business development. I think in a long time, we haven't seen premiums being so low. It's effectively more biotech teams are willing to take the strategic exit, even at a lower premium. When you think about that, does that make you make any kind of a tilt in your thinking towards that, "Oh, this is a right opportunity that, you know, if I don't have to pay premiums?" Particularly for the US assets, we are seeing this more and more.
I mean, there's obviously an exception of MedSerra, but if you keep everything in the rest of the bucket, there seems to be quite a bit of that dynamic happening. How does that influence your thinking in any way?
Yeah. You're absolutely right, Ash. It's been a very dynamic market from a business development perspective, especially here in the U.S. 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. If we find an opportunity at the right valuation and at a reasonable price, it certainly represents a disciplined use of cash.
Great. Yeah. I know you have, like, in the last few years, I guess, like, done more ex-U.S. transactions. Like, do 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, 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. That being said, it's also really important to continue to support our U.S. business as well. 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 Aculis, like, pitolisant, is, I mean, it's a molecule a lot of investors have been livid, just, just on the U.S. side. But, if you can talk about, like, what's the opportunity in the, in the Japan market?
Yeah. There's significant unmet need in Japan currently. There's.
Right.
No approved therapies. We see the opportunity in narcolepsy for both type 1 and type 2. 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. We feel very excited about the opportunity there to leverage our existing infrastructure and provide some growth to our Japan business.
Yeah. Great. Awesome. With that, yeah, 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. We've been continuing to execute on the business, remain on track to deliver our 2-3% 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, five of six positive readouts. We feel good about the momentum on the new product side that we're building into next year. We're continuing to make progress on our Indor remediation, having had the recent meeting with the FDA.
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.
Yeah. Thank you for having us again.