Viatris Inc. ($VTRS)

Earnings Call Transcript · March 19, 2026

NasdaqGS US Health Care Pharmaceuticals Special Calls 139 min

Earnings Call Speaker Segments

Operator

Operator
#1

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

William Szablewski

Executives
#2

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.

Scott Smith

Executives
#3

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?

Philippe Martin

Executives
#4

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.

Scott Smith

Executives
#5

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...

Corinne Le Goff

Executives
#6

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?

Scott Smith

Executives
#7

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.

Hemanth Varghese

Executives
#8

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.

Scott Smith

Executives
#9

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.

Theodora Mistras

Executives
#10

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.

Scott Smith

Executives
#11

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]

William Szablewski

Executives
#12

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

Analysts
#13

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.

Scott Smith

Executives
#14

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.

Philippe Martin

Executives
#15

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.

Scott Smith

Executives
#16

And cenerimod...

Philippe Martin

Executives
#17

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.

Scott Smith

Executives
#18

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.

Theodora Mistras

Executives
#19

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.

William Szablewski

Executives
#20

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

Leszek Sulewski

Analysts
#21

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?

Scott Smith

Executives
#22

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?

Theodora Mistras

Executives
#23

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.

William Szablewski

Executives
#24

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

Unknown Analyst

Analysts
#25

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.

Scott Smith

Executives
#26

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

Unknown Analyst

Analysts
#27

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?

Scott Smith

Executives
#28

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.

Philippe Martin

Executives
#29

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.

Scott Smith

Executives
#30

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.

William Szablewski

Executives
#31

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

David Amsellem

Analysts
#32

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?

Scott Smith

Executives
#33

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.

Hemanth Varghese

Executives
#34

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.

Theodora Mistras

Executives
#35

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.

William Szablewski

Executives
#36

Great. Next question, Ash, please.

Ashwani Verma

Analysts
#37

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?

Scott Smith

Executives
#38

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?

Theodora Mistras

Executives
#39

On revenue growth.

Ashwani Verma

Analysts
#40

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

Scott Smith

Executives
#41

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.

Hemanth Varghese

Executives
#42

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.

Scott Smith

Executives
#43

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.

Theodora Mistras

Executives
#44

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.

William Szablewski

Executives
#45

Next question, Kyle, Matt, please.

Matthew Dellatorre

Analysts
#46

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.

Corinne Le Goff

Executives
#47

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.

Scott Smith

Executives
#48

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.

Philippe Martin

Executives
#49

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.

William Szablewski

Executives
#50

Next question up here in the left, Kyle.

Ethan Brown

Analysts
#51

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?

Corinne Le Goff

Executives
#52

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.

Scott Smith

Executives
#53

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.

Corinne Le Goff

Executives
#54

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

Theodora Mistras

Executives
#55

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.

Philippe Martin

Executives
#56

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%.

William Szablewski

Executives
#57

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

Matthew Dellatorre

Analysts
#58

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?

Theodora Mistras

Executives
#59

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.

William Szablewski

Executives
#60

Any other questions? Ash, please?

Ashwani Verma

Analysts
#61

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?

Philippe Martin

Executives
#62

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.

William Szablewski

Executives
#63

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.

Scott Smith

Executives
#64

Thank you all very much.

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