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$17.64 +0.20 (+1.15%) At close · Oct 9
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Investor Update · 2026-03-19

Viatris Inc (VTRS) March 2026 Investor Update Transcript

Concluded Mar 19, 2026 Audio replay Verified speakers
Mar 19, 2026 2:10:45 64 turns
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2026-03-19
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2:10:45
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Verified speakers 2:10:45 Audio
Operator

Ladies and gentlemen, please welcome Head of Capital Markets, Beatrice, Bill Szebluski.

Bill Szablewski Head of Investor Relations

Good morning, everyone, and welcome to our Beatrice Investor Event. I'm Bill Szebluski, 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'll 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 risk 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, Karine Lagoff. Our Chief Strategy Officer, Hemath Varghese. And our Chief Financial Officer, Doretta Mestris. And with that, now I'd like to hand over today's presentation to Scott.

Thank you, Bill. Thank you very much, and thank you all for being here today. We're very excited about getting going here, talking about what's been accomplished to date, where we sit today and where we're going, particularly over the next three to five years. We're very, very excited about the position the company's 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 five years to get the company in the position it is today. We've merged two companies, divested four 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 a 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 a more focused, more efficient, more future-ready organization. If we take a look at where we sit today, we're a strong, diversified, global healthcare company. We actually have three 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, Lipitor's, Norvast, 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 UPS, 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 a billion patients annually with our medication, which is a pretty remarkable statistic. It makes us the most far-reaching company in the healthcare 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 healthcare, so something we're very, very proud of. We also have 27 manufacturing, 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, discipline execution, evolving the portfolio towards durable, higher margin, generic products, 505 B2s 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, you know, 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 based 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 percent total revenue growth, 7 to 8 percent adjusted EBITDA growth, 9 to 10 percent 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 scenario mods, and the addition of accretive business development. But I can't emphasize enough how important that solid-based business, which we've now turned to growth, is for what our future prospects look on. What we do with Scenario Mods, a lot of business development builds off that solid base that we've managed to create over the last couple of years. Joretta's 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 to other drivers to the long-term combined targets that we have for 2023. So that'll 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've 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 a 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's going to talk about that and how we not only continue to support the base, but also pivot to innovative products as well. Hamath 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's 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 values. So those are the four major portions of the presentation today. The first one is, as I say, on Pipeline, and Philippe Martin 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 at Vietras. It's 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 singularly responsible for the development of some very significant molecules in the world today. Remicade, Simpia, Otesla, Zimposi, just to name a few. So Philippe has been the engine behind the research and development of a number of blockbuster drugs. and we hope he continues to do that the same. His job is to continue to focus on the pipeline again, the base pipeline, continuing to drive there, but also starting to bring in more and more innovative products into that pipeline. So without further ado, Philippe.

Thank you, Scott. All right, good morning, everyone. It's a real pleasure to have the opportunity to go over Viatris R&D capabilities and pipeline. So first, let me start by saying that in R&D, we look at our portfolio in three 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 myelin heritage. Our value-added medicine is the second area. That includes established brands and 505 B2s, 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 Silatogrel, Sinerimod, or Pitolison 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, as I said, over the last couple of years, we've added significant talent to our innovative platform through the Adorsia and AcuLis acquisition. Together they bring proven experience in developing and bringing innovative medicines to market. Now, importantly, these talents covered all phases of development, from IND to approval and lifecycle management. So when you combine these 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 Zulane and Zulane low dose. This deep knowledge also applies to our innovative portfolio. It's an important success factor for some of our innovative assets, like Celadogrel 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 505B2 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 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, complex molecule, having these capabilities is critical in order to show API sameness. So we have many successes, including very recently in this area, and some of these successes are highlighted on this slide. Now, in addition to complex injectable, As I just mentioned, we have three additional key areas that will power our future growth in complex generics. And for these three areas, we're 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 are uniquely positioned for success with our integrated device, drug device development and peptide formulation expertise. The same applies to our oligonucleotides, where we will leverage the same capabilities, but in this case, in particular, our strong chemical 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 affair 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 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 four anticipated regulatory decisions, starting with Effexor in GAD, Generalized Anxiety Disorder, in Japan in the first half of this year. But next I will focus on our new-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 the clinical profile that we've seen is highly competitive. We were able to demonstrate that fast-active 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 a profile superior to its opioid comparator tramadol in two 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 Zulane and our estrogen patches. We are developing weekly, small, thin, discrete patches that have best-in-class adhesion. These patches are designed for today's patient's need, and in particular for patients seeking reduced or no estrogen exposure, which limits 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 a progesting-only patch for which phase three 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 pitolicent in two different indications in Japan, sodagliflozin in Canada and Australia, and data readout for Nefecon in IgA nephropathy in Japan. So next, I will focus on our two most innovative assets, Celadogrel and Cenarimod. So let me start with Celadogrel. Sedalogrel is a P2Y12 inhibitor that is being investigated for patient self-administered emergency treatment of recurrent MI 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 anti-platelet treatment. There is 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 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 two is ideal for emergency treatment. We saw a robust and rapid effect that is of short duration, but that is long enough to give patient 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 clopidogram. We did not observe any major bleeding events as part of the study, and that despite the fact that most of the patients were on background dual antiplatelet therapy. We believe that this is explained mechanistically by the high selectivity observed with celadogrel, 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 a spa Cilatogrel was also granted fast-track designation by the agency So to be eligible, patients need to have a qualified MI 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 celadogrel one-to-one and then followed until they have an event. An event is defined as an injection of either celadogrel or placebo. This is an even-driven study. The primary endpoint is death from any cause within seven days, or non-fatal AMI within two 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 salatogrel. Remember time is muscle so early intervention is key. So the primary safety endpoint is the occurrence of type 3 or 5 treatment emergent bleeding event according to the BARC definition within two 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 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. And so SMI 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 Senerimod. Senerimod 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 male to severe, depending on which organ of the body are affected. Limited treatment options exist. They're ranging from old immunosuppressant, often combined with oral corticosteroids, to more recent biologics. Overall, a 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 a higher unmet need that remains in the treatment of SLE. particularly for an 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, Scenermod 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 three 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 we've seen that in two other T-cells and B-cell-driven autoimmune diseases like MS and ulcerative colitis. Now, we've generated robust data for scenario mode in SLE patient. that demonstrates a highly competitive and, importantly, very consistent profile across three phase two studies at the chosen dose of four milligrams. Let me focus on the largest data set, which is our phase two B care study that has shown a robust and consistent profile across all endpoints with the four milligram dose, which was the highest dose tested, and the dose that has the most optimal benefit risk profile. Regarding the primary endpoint, modified slidide 2K at six months, we saw a clinically meaningful and nominally statistically significant effect with the four milligram dose. The secondary endpoint, which was SRF4, response at six months was consistent with what we saw in the modified slidide 2K. Now, what was particularly important and impressive is that we saw an increased response in treatment effect in the pre-planned analysis investigating patient with interferon-1 high signature. Regarding the safety profile, we observed an optimized S1P profile. Particular importance, scenario mode was not associated with any increased risk of SAEs or infection And opportunistic infection And that disinfection remained a major concern for physician and SAE patients So based on this robust profile and consistent profile We initiated a large confirmatory pivotal program called OPUS consists of two identical studies. They are multi-center, double-blind, placebo-controlled studies. In each study, approximately 420 moderate-to-severe SLE patients receiving concurrent SLE background therapy will be randomized one-to-one to either scenario mode or placebo for 12 months. The primary endpoint is SI4 a month 12 compared to baseline. And patient will be stratified in three different stratas, including one with interferon 1 high, low. Importantly, we have a forced 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 mg 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 synonymal 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 two phase two studies, we've modified some of the inclusion criteria. In particular, we are enriching the population for patients that are interferon-1 high. We have a target of 70%, and the 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. These entry criteria have generally been used in Phase III studies across the board. the primary endpoint is also now at one year the data i was showing before was at six months for the phase two study and one year is what is expected for a pivotal study in sle but importantly that will allow our four milligram dose to reach full effect by one 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 non-responder. So as I said, the studies are now fully enrolled with an interferon one high percentage exceeding 70%. We anticipate results for both study by the first half of 2027. We've also initiated an additional phase three 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 Viatrix's 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 back to Scott.

Thank you. And we're just going to leave Philippe's last slide on here just for a second, And that's 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, 505B2s, 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 Impefa. And we've got some of the value adds, particularly in the U.S., well, effector GAD in Japan, we've got Gwenlo, we've got a fast-acting lock scan, 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 of the generic side, four of five in 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 in 505 B2s 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 Saneramon and Saladigro last. 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. We need to make sure that we launch the Gwinlows, the Meloxicams, the PressBOBs, others as maximally as we can. We'll get to the launch of Snaremont and Saladogrel, and we'll hopefully see some data later this year, 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 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 two years that Corinne's been with us. She came, joined in April 24. She's a very accomplished biotech and pharmaceutical executive. of 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, it says here, but that was really pharmacy, where we worked together 25 years ago.

I was hoping you wouldn't say the years, but good morning, everyone. Today, I want to do three things. I will talk about the strength and the durability of our best 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 Viatrice 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. you 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 five 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 start with Europe. In Europe our promoted brands continue to drive growth growth, and we also recognize as a generics leader, notably in key countries like France and Italy, and that's because of the breadth of our generics portfolio offering. In North America, we have very successfully gained leadership in complex generics. You have some examples here with Vixella and Brenna. 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 to 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-managed 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 branch 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. Veritry is a high-performing, constantly-renewing platform. Every year, we aim to replace 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 up 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 growth margin profile. And most importantly, we continue to shift the portfolio towards complex generics that drive more durable revenues than other small molecules. And we anticipate, in the US, an increase of 35% in the number of complex generic launches in the coming years. So in developed market, 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 cooperative positioning but also on the strengths 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 demands 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 brands track records, as well as engagement with those brand loyal patients through self-paid 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're able to successfully retrain 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 investment sense to the disciplined commercial execution, the established brand's portfolio is expected to deliver low-single-digit growth through 2030. So I have reviewed the strengths of the best 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, Viatrice 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 Viatrice 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 Scenario Mode and Sera2Grel 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 roadmap. 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 viatries and we decided to invest in building a more innovative portfolio. You remember we acquired last year AcuLis with two assets in CNS, Speedia and Pitocent. We are We are anticipating the approval of FXO for generalized anxiety disorders soon, and as you can imagine, our launch readiness is well underway. And we are planning to launch Neficon in IHDA 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. This fast-acting meloxican 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 was about 2 to 3 percent 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 post-operative pain, mainly. and we will 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 non-surgical pain and a larger patient population in emergency medicine, in dentistry, or with PCPs or NPs. We believe the potential peak neck cells for fast-acting melaroxicam is up to $500 million and is driven by a patent exclusivity beyond three 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 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 source for detailing OBGYNs, targeting in priority current patch prescribers. We believe that 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 the BMI above 30. And we believe that peak net sales of our women's health portfolio with those two patches in the U.S. could be potentially more than $400 million in total. Let me talk about selenary mode. We are, as Philippe mentioned and as Scott mentioned, very excited about this opportunity. First of all, 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 tricky to diagnose 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 serenade mode 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 multi-pronged 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 Selimod Global Picnic sales potential is over a billion dollars 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 MAI. Now, the addressable population here for Sajjewa is large. Globally, there are more than 20 people who already had an MAI recently. And the global incidence of MAI is about 3 million people per year, 800,000 in the U.S. only. Now, 20% of the people who survive will have another AI. And sometimes a year, a couple of years later, maybe five years later, and this despite being treated on maintenance therapy. We anticipate first targeting these patients who can recognize the symptoms of MAI because they already had one. And once you had one, you know what it feels like. We are focusing on preparing for this paradigm change to position Silatogrel as an acute rescue therapy. And I want to emphasize here that VR-Trace has deep cardiovascular expertise around the world and a lot of experience with self-administered acute-risk communications. 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 picnic sales potential is over a billion dollars and potentially more with potential subsequent life cycle indications. So to conclude the commercial section, I want to leave you with three messages. First, Beatrice benefits from a resilient, diversified generics and established brand foundation that we believe is positioned for durable and profitable growth. Two, Beatrice 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 four years. And the commercial organization is primed to deliver. Thank you very much. Scott?

Thank you. So I think Corinne made a great case outlining the commercial case behind some of the value-added medicines and salada growth scenario. Mod, I get a lot of questions, you know, why were those two assets, Saladigro and Saneramod, why were you so interested in them? And, you know, 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 in other places so depending on what the safety profile looks like when we when we get that database if the safety database is appropriate we could expand the indications to many other indications this could be a you know but and it's got a long IP runway by the time we get to the end of that we could be in five six seven different you know potential indications it plays in rheumatology, dermatology, neurology, GI. So it's a very, very well understood, broadly applicable immunomodulatory mechanism of action that really gives it tremendous potential. Focused 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 to different places. And in terms of salatogrel, You know, 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. You know, it's something that is near to me. Two family members on my wife's side have both died of acute MI in their first instance. A tremendous amount of risk to the other members of her family because of the genetic profile of those people. you know but but one one acute mi incident every 40 seconds in the united states with very little in terms of acute treatment and 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 it 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 is 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 Slidergrill and Scenarimod. So thank you, Corinne, for outlining that case. You know, 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 him H. So I'm going to ask Gage 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, had played in different markets. Again, we have three businesses, generics, established products, and innovative. The generics has a value-added component to it. And we were lucky to come across Ameth, who has experience in all of those areas. 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 it's really going to be critical in helping us build the portfolio as we go forward. H, thank you.

Thanks, everybody. I'm 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.

Speaker 5

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 up front. Drive the base business, invest in the innovative portfolio, modernize for growth. You're gonna hear that over and over again, because everything we talk about is really building towards that. And what I really wanna 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 Karine, I'm gonna start with the current business and the platform we have as a foundation for where we plan to grow. So as has been said already, Vietras uniquely positioned as a global health care company, able to deliver value across the entire spectrum of medicines. But more importantly, as Karine highlighted in her section, a key differentiator for us is not only having global reach, but our deep regional market expertise. 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's invested heavily in technologies, respiratory, patches, sterile injectables. Over several years, it 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 a billion patients a year and a well-established capability to build value from intellectual property. And 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 lifecycle. Provides a strong platform for sustainable growth. So I'll reiterate again. Drive the base business, invest in an 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 portfolio across three broad product categories generics established brands and innovative brands, as each has unique characteristics, market dynamics, and drivers for growth. Vutras 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 a global platform to give us the broadest reach possible. In established brands, Kareen 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 under leveraged 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 Beatrice 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 five 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 the 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, the 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 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 Vietras' 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 BDE has been a long-course strength of Vietris and continues to be foundational to our base business. And that's what I meant by Vietris 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 will 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 mid-size 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 Karina 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 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 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 five years is to deliver an incremental $1 to $1.5 billion in incremental revenue and $500 million in EBITDA to help evolve the company's core portfolio and deliver long-term, durable growth for the future. With that, I'll turn it back over to Scott.

Thank you, H. Chris. 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 a billion to a billion and a half 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 allows us to do those deals. And so we're going to do that. We did one sort of innovative deal last year and that was the Accuilus 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, you know, the targets, you know, where we go, the way the targets were built, you know, 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 of the organization globally, highly, highly doable. So, you know, very excited about that. So the next step, 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 healthcare experience, two decades of leadership advisory and capital markets expertise. Over the course of her career, she's advised transactions over a quarter trillion dollars, I see from the sheet here, which is pretty remarkable, $240 billion. And prior to joining Vietris, she was Manning Director at Citi and also Goldman Sachs before that. So without further ado, thank you, Doretta.

Thank you for that introduction, Scott. Good morning and welcome again to everyone that's here in the room and for those that are listening in. I am Doretta Mistris, the CFO of Vietris. 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 Beatrice 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 Beatrice. Today, we have a company with a strong balance sheet and a solid foundation for long-term performance. As we look ahead, we believe Beatrice 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 Soladigrel and Scenarimod. 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 Haymoth 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 Beatrice, 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 two percentage points. These include potential contributions from Soladigral and Sanerimod, 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. JANs 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, multi-channel, 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 Soladigril and Scenarimod. 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 in 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 two 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, continued 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 the 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 discipline strategy is a strong balance sheet. Since the formation of Vietris, 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 to intend to operate within our gross leverage target ratio of 2.8 to 3.2 times. 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 Slatter Girl and Sanerimod, as well as selective, disciplined business development. Today, Beatrice stands with a stronger foundation, with durable cash flow, and meaningful levers to drive additional growth. As you heard from our leadership team this morning, we have laid out a credible, focused, and achievable plan. ONE THAT POSITIONS US TO DELIVER SUSTAINABLE GROWTH AND VALUE CREATION FOR PATIENTS AND SHAREHOLDERS. SO WITH THAT, THANK YOU, AND I'LL TURN IT BACK OVER TO SCOTT.

THANK YOU, DORETTA, AND THANK YOU TO ALL THE PRESENTERS FOR THE PRESENTATIONS TODAY. LET ME JUST GO TALK A LITTLE BIT ABOUT THE INVESTMENT CASE BASED ON EVERYTHING THAT YOU'VE HEARD. And then we're going to go a couple 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 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 Blockbuster, Saladigrall, and Sanerimod. 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 Salado Grown and Sinaramod and 0% from an EBIT perspective in 2030. Where those two molecules of 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 in our efforts around 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, and we can buy back as needed. But we can also build a portfolio of growth assets That's 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 months ago as chief legal officer, Peter, who is not here, but our chief supply officer, and Laura, 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 into 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 six new independent directors added since 2020 or 2022, sorry. We've added just in the last few months both Frank D'Amelio and David Simmons, both significant experience in the farm 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 five 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.

Bill Szablewski Head of Investor Relations

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 Glenn from Barclays.

I would just wait for the.

Bill Szablewski Head of Investor Relations

Thank you.

Speaker 11

Yeah, thanks. Glenn Santangelo from Barclays. Hey, Philippe, I just wanted to follow up on your comments on Saladigrille. 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 timeline on Sanerimod as well. And then I had a second question for Doretta. 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 over the mic, with respect to the $11 billion in free cash flow, should we still expect half of that to be allocated towards repo? Or, Scott, are you willing to do something more transformational? And I'll stop there.

So Saladogrel, 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 that 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.

Yeah, 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.

Any scenarios?

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 3 study.

Your second question was capital allocation. Share buybacks. As we've talked about, we want to be balanced. Part of the plan to get to 2030 is to continue to be balanced in terms of our capital allocation strategy, giving back 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 and that there was a lot of assets out there and things were trading. 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 would be a year where we lean in a little bit more to business development. But over the five-year period, I think we're committing to being balanced on both. So 50-50 or 55-40, 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 the way that we think is best based on the opportunities that are out there, share price and other things.

Yeah. 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 for these new launches.

Bill Szablewski Head of Investor Relations

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

Speaker 8

Good morning. Thank you. Les from Truist. So just wanted to drill in a little bit on the long-term guidance. And Dorada, you mentioned the 1% sales CAGR would be tied to BD and then translating to 3% 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 Hemant on board, what are you thinking about priority on the size and momentum of additional deals coming on?

So I think we're providing long-term targets, not long-term guidance, right? I think that was just the terminology there, where these are the targets that we see that are combined from the base business and the other opportunities that we have. I think the BD part is highly doable, personally, given what's out there, the number of targets out there, the capital that we have to deploy, the people that we have looking at things. I mean, I get inbound every day from companies that are looking for partnerships to be acquired, other things. Hamath, I think, gets even more than I do. I think there's lots out there. There's lots in this space that is not, you know, Lily's looking for things with a $5 billion-plus peak sales to replace, right? The LOEs that we have from a farm industry perspective, there's something like $230 billion in LOE between now and then. And the big farming world is looking for big things to replace those LOEs. $500 million, $600 million, a billion dollars in sales is great for us. 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, you know, the important thing to me is, you know, does this asset help us reach our long-term strategy, and are we good owners of it?

And I would also say, importantly, we're not relying on one asset. This is over five 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 five-year period meant to be a target and a view, given how much flexibility we have.

Bill Szablewski Head of Investor Relations

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

Speaker 2

How are you guys? Thank you for the details today. Very welcome. I'm JP from Evercore in Fort Romero-Fat. I have a couple of questions. First, Philippe, on the center and Solatrigal. 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 lofty goal, so we're just going to get a sense.

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

Speaker 2

Yes, because, you know, you're saying you're going to get like a $500 million from acquisitions. The question is that you have you already have a lot of those Or it's just optionality you calculating on the way in that this yeah, I would say we have a lot of discussions, right?

Okay We have a lot of discussions. There's a lot of there's a lot of companies out there. There's a lot of things that we're looking at You know this the school of a billion to a billion and a half is over a five-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'm you know, I think and and And it's most likely to be not just one thing that we do, but two or three things over a five-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. There's some assets we'd be great owners of, other assets that we wouldn't. So we're really focused not on, you know, we're focused on two 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. You know, the other thing, the first part of the question, I think you were asking about Saladagro, and you mentioned payers, right? I think this is going to be, and Philippe can get into your actual question, but since you mentioned pairs I mean I think it's it's gonna be a phenomenally interesting product from a from a pharmacoeconomic perspective right one of the most expensive patients in the world is a patient in the US that has an MI has substantial damage survives and lives for another five seven years with significant disability right and if you can decrease some of those rates I think there'll be a tremendous health benefit the health economic benefit to the United States and so you know depending on what the data looks like, and I think given the data positive and given that there's better outcomes of people using the product, I think it's gonna be a very, very interesting product to do some of these pharmacoeconomic models with.

Yeah, I think 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 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 don't they have damage do they need to get surgery or not i think 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're pretty much right on what we had anticipated, and we'll go from there. But we need to continue to look at the data and see how it progresses. But so far, we have a good handle on that data.

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

Speaker 2

Thank you very much.

Bill Szablewski Head of Investor Relations

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

Speaker 5

Thank you, David Amselen 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 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, or at least in the developed markets, largely, you know, a less bad or more stable base environment. I just wanted to make sure I understood your thinking there. And in other words, if you can quantify pricing erosion and then also quantify contribution from new launches and how that all goes into your assumptions regarding growth, that would be helpful.

So, and I can talk, and then maybe Hamath can talk as well. Again, I think I'm less concerned about therapeutic area and more concerned about can we be good owners of a particular asset. I think having said that, certainly, you know, cardiovascular pain, immunology would be places that we, you know, 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 and doing any deal. Not that they'll always line up perfectly, but that's a major consideration on anything that we would do.

Yeah, especially for the U.S. that's the right way to think about it. But ex-US, obviously we've got existing strength, right? When we did the Oculus 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-US right now, we actually have that strength in multiple different markets. Similarly with cardiovascular, those are two big areas for us. We have to use a slightly different lens for the US 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 make sense. Great.

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.

Bill Szablewski Head of Investor Relations

Great. Next question, Teddy. Ash, please.

Speaker 10

Hey, Ash 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, yeah, 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 that you're going after a few select assets that can help fulfill the goal? or is it more of a string of acquisitions? And then ultimately, are you trying to balance out the growth between the different geographies that you have as a part of the BD initiative?

So from a BD perspective, I would love to add some U.S. assets. I was worried about Japan as a geography. 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 that's what that's what our overall focus is. Your second your first question on B.D. was on revenue growth. I mean, you know, 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 billion, billion and a half revenue target, it would likely be two or three 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 two assets or three assets. And so it could be one deal. It's more likely two or three deals. I don't think nine 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 to $1.5 billion. And again, it may be one, but more likely a couple different things that we would add up.

Sorry, let me just do 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 could be, that would come and it would make sense and it would meet our thresholds and it could accelerate having to do two or three deals, but it will, 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, 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.

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 for China or buying them from Japan? So we may move into looking for things from an innovation perspective in the U.S., but also we're going to look for things that are innovative and the strong geographies that we have out there and have some advantage in commercializing.

From a revenue growth perspective, I would look at it in two buckets. So the first bucket is the 450 to 550, 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. We continue to see visibility to be able to deliver that 450 to 550. 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'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 five years.

Bill Szablewski Head of Investor Relations

Next question, Kyle. Matt, please.

Operator

Great. Thanks, guys. Matt Del Torre 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've said base case before. It's about five years, and it could be either side of that in reality. And then on Saladogrel, there was recently data from Celicor. They have a similar kind of injectable antiplatelet drug. to realize there's a different mechanism of action, but could you maybe just comment on how you see read-through from that? I think they hit on the composite, but not similar like the subcategories there. Thank you.

So for Fast-Tacking 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 a self-force of 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 two factors. One, a patent exclusivity that would go beyond the traditional three years that 505B2s have, potentially five, potentially more. We actually have five more patents, right so we could actually have more protection and two it is driven by us having commercializing this this fascic myoxic and with a partner so that we could expand beyond the initial targeting of post-surgical pain into more general pain larger population of patients that get prescriptions from PCPs or nurse practitioners or you know dentistry right so that's really the what's behind this number before we go to a lot of girl we you mentioned

opioid sparing I think that's gonna 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 expectations that we are going to be able to exploit and talk about that data exactly how and where we need to finalize our labeling discussions first, but that's an important part of the strategy.

With regard to your question about SELICOR, 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 Celadogrel. 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 Celadogrel. 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 percent risk reduction, which is partly why I'm saying that we are very confident about our ability to get to a 20 percent 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 CEDECOR data. Therefore, we're anticipating even further benefit than what was seen with the CEDECOR data. Their data also has a lot of other issues that 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 tell you is that that will lead to certain issues with regulators and statisticians. And they also had most of their patients from Europe because it's an ambulance study, right? So the patient were dosed in an ambulance setting. Again, much later than what we anticipate with And their statistical endpoint is going to be a challenge for Them going forward, we believe. And we had a lot of conversation with our KOLs around this because as I said, they also see it as a Proof of concept.

Speaker 1

So we looked at that data, see if there was anything that we could learn from it and and we're not changing anything to the study based on that data it it it fits well with with what we're doing this question up here in the left call thank you hi this is Ethan on for Chris shot at JPMorgan thanks for taking our questions 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 Solada Grill, how do you think about the magnitude of benefit that you would need to see to support that $1 billion peak sales target that you laid out? Thank you.

All 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 Hacking Meloxicam, as I already mentioned, we're going to build a specialty sales force in the US that will primarily detail orthopedic surgeons, so it will be focused. It will be in the outpatient settings, right? And the size of the stats will be about 150 reps. For Gwinlow, which is our low-dose estrogen patch, we will be detailing OBGYNs. It's a small population of prescribers and focusing notably on the ones that already prescribe patches. So the source was around 70 reps. Now, for the scenario mode, first we have to see the data before we can envision exactly how we are going to build. And obviously, we are now going to start building infrastructure before we see the first few results.

The infrastructure depends on the geography. Launching a number of products, both innovative and value you add it 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 US. The US is the place where we would likely have to build sales forces for these products moving forward. We do have something like three and a half to $4 billion of cardiovascular sales worldwide. So Soledigrol, 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, of a very significant cardiovascular portfolio.

So most of the build is in the U.S., you're correct.

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

And then to answer your question maybe on the 20 percent, on the threshold, sorry, for Silatogrel, so the study is powered for 20 percent, 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 the 10 percent 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.

Operator

But we're certainly targeting 20%. any additional questions in the room go back to Colin go back to Matt please thank you thanks thanks guys again maybe just in terms of your revenue growth targets across geographies in the base case scenario can you 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 was a little bit obfuscated and then in particular would you flag any of these as highly de-risked targets and then others as maybe more ambitious? If there's any you could flag on that.

I would say our overall approach to how we thought about our long-term regional targets in those areas is balanced. Obviously, there's a number of pushes and pulls, but we were very thoughtful and deliberate around how we thought about it. I would say generally, they're consistent with what we're seeing. a few things to call out. So North America, I would say, is probably slightly higher than what we've seen, benefiting from some of these value-added launches that we've talked about, like fast-acting meloxicam and 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 JANs. JANs 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.

Bill Szablewski Head of Investor Relations

Any other questions? Teddy Ash, please.

Speaker 10

Just to ask a couple of quick follow-ups here. So maybe on SolaraGrel, so you mentioned the data monitoring committee. There have been 13 reviews, right? I think we're trying to understand, 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, US, ex-US market, if there's any specific programs that you could outline that would be really, really great? Thanks.

So with regard to 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. But they are unblinded. They're seeing all the data, they're seeing all the safety data, and they're saying 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, Silatogrel is the most specific P2Y12 inhibitor out there, and we're not seeing off-target effect with Silatogrel at all. So we're not expecting additional side effects that we haven't seen in phase two, for instance, as well. So that's for CELATOGRAL. 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 make sense. So certainly semaglutide, tirzepatide, absolutely. We have all strength. 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 of this GLP-1 will be in the 2030s for us, right, once we're able to launch in the U.S.

Bill Szablewski Head of Investor Relations

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 all very much.

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