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Earnings call · FY2023 Q4
Executive readout · one minute
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Management tone
Confident
Net tone +62 · low hedging
Forward guidance
2 guided metrics
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Stated verbally and extracted from the transcript.
| Metric | Period | Guided | Basis |
|---|---|---|---|
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New product revenue
2024
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$450M – $550M | — | |
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Free cash flow
2024
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$2.5B | — |
How the reported period landed and where the business moved.
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Good morning, everyone. Welcome to our Q4 2023 earnings call. With us today is our CEO, Scott Smith; President, Rajiv Malik; CFO, Sanjeev Narula; and CFO Elect, Doretta Mistras. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2024 and various strategic initiatives. These statements are subject to risks and uncertainties. We will also be referring to certain actual and projected non-GAAP financial measures. Please refer to today's slide presentation and our SEC filings for more information, including reconciliations of those non-GAAP measures to the most directly comparable GAAP measures. When discussing 2023 actual results, we will be making certain comparisons to 2022 results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the results from the divested biosimilars business and proportionate results from the divestitures that closed in 2023 from the 2022 period. When discussing our expectations for 2024, we will be making certain comparisons to 2023 results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the results of the divestitures that closed in 2023 from the 2023 period. With that, I'll hand the call over to our CEO, Scott Smith.
Good morning, everyone. 2023 was an outstanding year for Viatris in which we delivered strong operational results, streamlined the company, and finished the year with our third consecutive quarter of operational revenue growth. I am pleased to say that as we begin 2024, I could not be more excited about the future ahead. We are already executing on our vision for our next chapter. We continue to generate strong free cash flows. This provides us with the flexibility to balance returning capital to shareholders through share repurchases and dividends while continuing to fuel our base business and make strategic investments in future growth. As I've said, in addition to continuing to develop the three core therapeutic areas that we previously identified: ophthalmology, dermatology, and GI, we are also going to be opportunistic in seeking out assets that fit our company well and have the potential to contribute significantly to our future revenue growth. Today's announcement that we've entered into a global research and development collaboration with Idorsia is a great example of this approach in action. We are bringing in two late-stage potential blockbuster assets with long-dated patent protection, and we are connecting Idorsia's proven, highly productive drug development team and innovation engine with our own strong existing infrastructure and experience. We believe that together, we will be able to execute on the potential of these global assets and any future assets as we work to deliver on our goal of building a more durable, predictable portfolio based on our strong base business. We believe that Selatogrel and Cenerimod can become meaningful components of Viatris' business over the long term. I'll talk more about the deal in a moment, but first, 2023. We finished the year strong with full-year results in line operationally with our 2023 adjusted guidance. Importantly, our fourth quarter results represent our third consecutive quarter of operational revenue growth, giving us good momentum going into the new year. We expect that momentum to continue into 2024 and beyond. In 2023, we delivered total revenues of approximately $15.4 billion, adjusted EBITDA of approximately $5.1 billion, and free cash flow of approximately $2.4 billion. We have already completed certain of our divestitures and are on track to complete all remaining divestitures by mid-year, subject to final regulatory approvals. Turning to 2024. Today, we are sharing our full-year guidance ranges for total revenue, adjusted EBITDA, free cash flow, and adjusted earnings per share. Adjusted EPS will increasingly become an important metric to reflect earnings growth and balanced capital allocation for us in '24 and beyond. From a capital allocation perspective, we continue to pay down debt and expect to reach our long-term gross leverage target this year. We are maintaining our dividend for 2024. We completed $250 million in share repurchases earlier this year. Our Board of Directors has provided us with an additional $1 billion in share repurchase authorization to use at the appropriate time, bringing our total authorization to $2 billion, of which we have used $500 million and have $1.5 billion in authorization remaining. And earlier today, we announced a significant global research and development collaboration. Diving further into our Idorsia announcement, we are very excited about this new partnership. The agreement combines Viatris' financial strength and worldwide operational infrastructure with a portfolio of novel assets that we believe will provide the foundation for accelerated top-line growth. Viatris will receive exclusive global development and commercialization rights to two assets: Selatogrel, a potential life-saving self-administered medicine for patients at risk of recurring heart attacks, and Cenerimod, a novel immunology asset that has the potential to be a first-in-class oral therapy for the treatment of SLE, with potential broad application across multiple other autoimmune diseases. The global collaboration also includes future optionality to expand the collaboration with additional pipeline assets in a transaction that minimizes near-term P&L impact and provides significant upside following Phase 3 readouts and regulatory approvals. The addition of Selatogrel builds on Viatris' existing global cardiovascular franchise and our deep knowledge and expertise in self-administered medicines for acute life-threatening conditions. Cenerimod has the potential to be a cornerstone asset in Viatris' immunology platform, an area where I personally and our Chief R&D Officer, Philippe Martin, and others at Viatris have deep development and commercialization expertise. The agreement also highlights Viatris' capability to identify depth and secure high-growth assets in areas of unmet medical need, and do it in a way that reinforces our disciplined approach to capital allocation. We will be hosting an R&D event on March 27 in New York City to discuss the collaboration with Idorsia and other elements of the company's pipeline in more depth. Before I move on, I want to take this opportunity to welcome Doretta Mistras, who will become our new Chief Financial Officer on March 1. Doretta joined us in January as CFO Elect. She has been spending valuable time getting to know the company even better than she already did as a former Deputy Adviser. I'm pleased to have Doretta coming on board for what I expect to be an extremely successful next phase of Viatris. She'll share a few comments later in the call. But now let me turn the call over to Rajiv as we continue our discussion of our strong fourth-quarter and full-year 2023 results and our expectations for 2024.
Thanks, Scott, and good morning, everyone. As we close Phase 1 of our strategy, I'm incredibly proud of all that we have accomplished. We simplified but more importantly, stabilized the base business. We continue to deliver on our strong pipeline and are in the final stages of reshaping the company with remaining divestitures being on track. We believe that the stability of our core business and our deep pipeline positions the company very well for continued growth into '24 and beyond. Let me talk to you a bit more about what we believe makes our core business stable. It is driven by the consistent and steady performance of our brand business, the sustainability of our generics portfolio, and our ability to continue to bring to market our organic pipeline consisting of high-margin, durable, and complex products. Let me further expand this into three elements. First, our Brand business, which makes up about two-thirds of our portfolio, grew 1% in '23, supported by brands like Yupelri and Effexor. We expect our branded portfolio to continue to build upon the success of 2023 and show moderate growth. Next is our Generics business, which now also includes our complex generics and makes up the remaining one-third of our revenue. This business was flat in 2023 and is expected to show slight growth in 2024. The geographic and portfolio diversity, which includes a number of high-value complex products such as Wixela, Breyna, and Xulane, rendered this portfolio inherently stable. The third driver of our stable base is our ability to execute on our pipeline. This is the third consecutive year that Viatris has delivered at least $450 million in new product launches. In 2023, we made significant progress across our complex injectables, select novel products, and eye care pipelines. We launched Breyna, the first generic Symbicort and Lisdexamfetamine among others. The FDA accepted our NDA filing application for glatiramer acetate depot injection. We received FDA approval of Ryzumvi, an eye drop for the treatment of pharmacologically-induced mydriasis. And we received positive topline results for our Phase 3 trials of Yupelri in China. We also received positive topline results for our Phase 3 trial of Tyrvaya in China and subsequent NMPA acceptance of our NDA. For 2024, we are excited to continue to deliver on our deep pipeline and execute on several key launches that will expand access to patients. For example, from our complex injectables portfolio, we expect to be an early entrant with our Sandostatin LAR product, liraglutide, a generic for Victoza, as well as iron sucrose, a generic for Venofer. From our eye care pipeline, we expect to launch Ryzumvi. And from our novel pipeline, we are excited to bring to market our once-monthly, glatiramer acetate depot for patients with multiple sclerosis. We are pleased to present our latest data this week at a key medical conference. We also continue to be laser-focused on progressing our other pipeline assets, many of which are in Phase 3 stages such as Xulane low dose, Meloxicam, and Effexor GAD. We are especially excited about advancing our eye care pipeline that has several programs in Phase 3 aimed at addressing vision-related disorders such as Presbyopia, Night Vision disturbances, and Blepharitis. Let me now turn to the commercial segments and our expectations for 2024. In '24, we expect total revenues to grow approximately 2%, which includes approximately $450 million to $550 million in new product revenue. Starting with Developed Markets. In '23, Developed Markets declined by 1%. Our European business for the third consecutive year demonstrated operational net sales growth led by Italy and Spain, alongside contributions from new product launches. This helped us offset the decline in North America due to the expected impact of increased generic entrance to performance and higher competitive pressures on certain complex products, including Wixela and Xulane in the first half of the year. For 2024, we expect this segment to grow, with both Europe and North America expected to grow 3%. Europe's growth is expected to be led by our strong brand portfolio including Brufen, EpiPen, and products from our Thrombosis portfolio. In addition, we anticipate further growth in key markets, including Italy and France, and strong Generics performance aided by new product launches. North America is expected to grow by 3%, driven by the exciting new launches of GA Depot, Liraglutide, and Sandostatin LAR. Furthermore, we expect to further strengthen our position in respiratory products like Wixela and Breyna. Yupelri is expected to continue its growth trajectory and grow by double digits. For the Eye Care portfolio, we expect further gains in 2024, resulting from the continued prescription growth in Tyrvaya as we expand access through patient fulfillment, coupled with the launch of new product, Ryzumvi. The Tyrvaya TTC campaign launched in October has shown early indications of both increased patient responsiveness and performance as quarter four non-bridge prescriptions were up 18% quarter-over-quarter. Emerging Markets had another strong year, delivering 7% year-over-year operational growth in '23. These better-than-expected results benefited from strength across our broader generics portfolio and stronger-than-expected performance from brands like Dymista and Viagra, led by markets such as Turkey, South Korea, and Southeast Asia. Going into 2024, we are projecting this segment to grow by 6% year-over-year, primarily driven by our branded business. Moving to JANZ. Full-year '23 came in below our expectations due to the continued impacts from the government-driven price regulations in this region, which we expect to continue into 2024. We anticipate partially offsetting the pricing dynamics with the ongoing strong volume growth from our three brands, including Amitiza, Creon, and Effexor, as well as optimizing our Generics business. This segment is expected to decline by 8% in 2024. Greater China performed ahead of our expectations for the full-year 2023, delivering 2% growth, driven by strong performance of our retail channel in China. This is a result of our ability to adapt our business model to the evolving market dynamics. Going forward, we will leverage our investments to further expand the self-pay patient market and our brand equity in this channel, which we expect will help absorb some of the impacts from the government-implemented health care policy regulations. With these dynamics in mind, we have modeled a 2% year-over-year decline for 2024. Before I conclude, I want to take the opportunity to thank the management team for their partnership over the years and all our employees who have helped us build a strong global platform. I'm very pleased with where we are today in Viatris' journey, and the strength as well as stability of our core business, which is now nicely set up for continued growth from here onwards. With that, I'll hand the call over to Sanjeev.
Thank you, Rajiv, and good morning, everyone. 2023 was another strong year across total revenue, adjusted EBITDA, and free cash flow. Our results were in line or better than our expectations. We believe that the foundation we built sets the company up to deliver on our strategy and future growth outlook. Our guidance, as updated in November, included a full-year contribution from the divested businesses. As a result of certain transactions that closed in 2023, we're adjusting our guidance on total revenue and adjusted EBITDA by $35 million and $20 million, respectively. Adjusted EBITDA included $105 million of acquired IP R&D, primarily related to upfront licensing payments. Please note, we do not include acquired IP R&D in guidance for future periods, as it cannot be reasonably forecasted. Free cash flow was impacted by approximately $235 million associated with the divestitures, including transaction costs and taxes. Excluding this impact, free cash flow would have been $2.64 billion on a full-year basis. This was the third consecutive quarter of operational revenue growth, and we continue to see solid performance across Developed Markets, Emerging Markets, and our Greater China segment. Excluding the impact of divestitures, revenue grew over 1%. During the last earnings call, we noted that adjusted gross margin would moderate in Q4 due to the timing of segment and product mix. On a full-year basis, adjusted gross margin came in at the high end of our expectation at 59.1%, driven by strong brand performance. Adjusted SG&A and R&D included certain investments we made in Q4 to support future revenue growth. We had another strong year of free cash flow generation, reflecting our underlying operational performance and continued priority on cash optimization initiatives. Free cash flow in the fourth quarter was impacted by transaction costs and taxes related to the divestiture. Excluding these items, it would have been $454 million. It is important to reiterate that gross proceeds from the divestiture benefit cash flow from investing activities, while the related taxes and transaction costs are included in cash flow from operating activities. The strong free cash flow generation over the last three years exceeded $7.5 billion and has enabled us to deliver on our financial commitments. This included a debt paydown of greater than $6.6 billion and a return of approximately $1.8 billion of capital to shareholders. These positive actions taken by the company reinforce our continuing commitment to an investment-grade rating and an expectation of increasing the return of capital to our shareholders. For 2024, our guidance includes the estimated full-year results from the divestitures that have not yet closed. The expected timing of closing of divestitures will impact reported results for the next few quarters. We will provide future adjustments to guidance as remaining divestitures close. The anticipated driver for 2024 total revenue guidance includes growth of approximately 2% operationally versus 2023 and expected new product revenue of approximately $450 million to $550 million, and growth from our Eye Care division. As a reminder, guidance currently includes approximately $1.1 billion of total revenue on a full-year basis from the remaining divestitures. The driver for adjusted EBITDA includes contributions from new product launches and revenue growth, moderation in gross margin relative to '23 levels due to anticipated product and segment mix, and increased R&D primarily related to the Idorsia collaboration. The estimated adjusted EBITDA from the remaining divestitures is approximately $320 million on a full-year basis. We expect to generate approximately $2.5 billion in free cash flow in 2024 before any divestiture costs and taxes. Lastly, we're providing adjusted EPS guidance as a measure of our expected earnings growth moving forward. Estimated shares outstanding include the benefit of share buyback executed earlier this month. Now a few comments about anticipated phasing this year. Total revenue is expected to be higher in the second half due to the launch of new products and normal product seasonality. Taking into account the phasing of revenue, margins, and investments, we expect adjusted EBITDA and free cash flow to be evenly phased between the first half and second half. In general, free cash flow tends to be lower in quarter two and quarter four due to the timing of semiannual interest payments. In the revenue guidance walk, the 2023 adjusted number of $15.2 billion excludes the result of divestitures that closed in 2023 and includes anticipated foreign exchange headwinds. We expect reported adjusted EBITDA to be impacted by the benefit of approximately 2% total operational revenue growth, estimated impact of foreign exchange, divestitures that closed in 2023, and Idorsia R&D investment and the impact of IP R&D. Taking these items into consideration, we expect adjusted EBITDA for the base business to be stable this year. We have pivoted to a more balanced capital allocation approach. This includes a focus on capital return and business development. The Idorsia R&D collaboration represents a disciplined approach, with a modest upfront payment of approximately $350 million. The license structure serves to minimize and share the future development expenses for the program while providing potentially significant upside economics. The Board has maintained the annual dividend policy of $0.48 per share in 2024. Earlier this month, the company has repurchased approximately $250 million in shares of common stock. The Board of Directors has increased our existing share repurchase authorization by an additional $1 billion. We anticipate excess cash will be used opportunistically for additional buyback in the future. Lastly, we expect to continue to strengthen our balance sheet with debt paydown of approximately $3.5 billion this year to reach our long-term growth leverage target. Before I close, I want to take this opportunity to thank all of our colleagues around the world and a special shout-out to my finance team for their extraordinary work over the last four years. I'm extremely proud of what we've accomplished together. I would be remiss if I did not acknowledge our management team and the Board of Directors for the opportunity to serve as the Chief Financial Officer of Viatris. Viatris is in its strongest financial position here. The foundation is solid and will ensure its ability to make a real difference in patients' lives for many years to come. Now, I'd like to turn it over to Doretta.
Thank you, Sanjeev. It's an honor to be here, and I look forward to working with Scott and the rest of the management team to execute on the company's growth strategy and capital allocation priorities. Prior to joining Viatris, I had the benefit of working with the team as an adviser. I have helped companies across the health care industry drive shareholder returns for the past 20 years. This gives me a strong appreciation for the unique position that Viatris is in today to create significant value for our shareholders, given the diversity of the business and the stability of the cash flow. With our gross leverage target in sight, I believe the company is striking the right balance with respect to business investment and capital returns. I expect that with the strong foundation we have, coupled with thoughtful capital allocation, we will be a strong adjusted EPS growth story in the future. As Scott mentioned, the Idorsia collaboration is a great example of the kinds of deals we'll continue to evaluate. This collaboration has the potential to enhance our growth profile by delivering a strong portfolio of branded, patent-protected assets targeting significant unmet patient needs while leveraging our capabilities in therapeutic areas where we have differentiated insights. Additionally, the transaction was structured in a way that deploys capital judiciously and creates the potential for asymmetric returns for our shareholders relative to the quantum of capital deployed. Now, I'd like to turn it back over to the operator for Q&A.
Just had a question on business development, just building on some of the comments from the prepared remarks. Just as you think about business development opportunities, how do you think about balancing R&D deals that may come with a bit more risk like we saw today? It could be a nice opportunity upside, but have some risk with them versus maybe more in-market transactions or in-licensing of already approved drugs that might have potentially lower returns, but a bit more certainty? I'm just trying to sense, is there a bias one way or the other? Are you seeing more opportunities in one bucket versus the other?
Thank you, Chris, for your question. We are exploring various opportunities to expand our portfolio. This includes licensing, partnerships, and mergers and acquisitions focused on in-market assets. Additionally, we are considering broader licensing agreements. Specifically, we are looking at two Phase 3 assets that are relatively low-risk and have significant blockbuster potential. Doretta mentioned the potential for asymmetric returns, which I believe applies here. Regarding Phase 3 assets, we also have the capacity to influence the development and registration strategies, as well as the commercial strategy moving forward. There are several advantages to pursuing these options at this stage. Overall, we will explore all kinds of opportunities to effectively build our portfolio in the future. I would also like to emphasize that the strong foundation we established in 2021, 2022, and 2023, and continue to build into 2024, positions us well to seek suitable business development opportunities for future growth.
Just maybe to build on Schott's question. Scott, what should we expect at this upcoming R&D Day? I mean it seems you've been pretty clear that the hope was always to use half the available free cash flow towards business development? And do you still expect that to be the case? Or based on your time in the seat, do you see more opportunities maybe than what you originally thought? Or because now it seems like you laid out your preferred therapeutic areas, and we're buying outside of that. I'm just kind of curious to get your take on the market for these assets and what you're planning at a high level to discuss at R&D Day.
So I think, first of all, thank you for the question, Glen. Our capital allocation plan is not changing. Going forward, we plan to deliver returns to shareholders through share buybacks, which we've initiated in '24, and done $250 million in dividends while also looking for business development opportunities. As I've said many times before, we're going to look into core therapeutic areas such as dermatology, GI, and ophthalmology, but we're also going to be opportunistic outside of those areas to find assets that fit what we do best. Regarding these two assets, I think they fit what we do very well. We have $2.5 billion in global cardiovascular revenue. Therefore, I think Selatogrel fits very well into our pre-existing expertise, and it can play across multiple different therapeutic areas, including dermatology, GI, neurology, and rheumatology. I believe these two assets fit our portfolio very well. Again, we're going to look at our three core areas while trying to be opportunistic for opportunities outside of that. As for what we're going to cover at R&D Day, we're going to focus on a deep dive into the two assets we're discussing, Selatogrel and Cenerimod. We are also going to talk about other opportunities in our pipeline that we're developing, including Eye Care and other items in the pipeline. It will be a full pipeline review, but we will focus heavily on Selatogrel and Cenerimod, including insights from KOLs.
Maybe I just ask Sanjeev a quick follow-up on the guidance. In your slides, it seems, and I think you sort of commented on this a little bit, that we should expect revenues to be higher in the second half of the year versus the first half of the year. I'm assuming that excludes the impact of divestitures. So I just wanted to confirm that. But you also suggested that EBITDA and cash flow would be evenly phased sort of first half versus second half. I was wondering if you could just sort of comment a little bit on the cadence of how we should expect this year to play out.
Thank you, Glen, for the question. So you're right. The revenue for the businesses currently includes the uncertainties surrounding the divestitures that didn't take place as yet, and I had included full-year impacts of that in my prepared remarks. During this year, on the total business, before any divestment, the second half is going to be higher in revenue, and that's just a function of how the business is structured. The new product revenue that Rajiv discussed, around $450 million to $550 million, will occur primarily in the second half. That's one factor. The product seasonality, which we have in Europe, takes place in the second half of the year. This is simply a function of some of these products. Regarding gross margin, you will expect a little bit of moderation in the second half, and that is again due to segment and product mix, as the pricing impact happens in the later part of the year, thereby affecting gross margin from there. Typically, expenses will ramp up in the second half of the year, which takes effect on the outcomes. When you combine all those factors, we will have adjusted EBITDA and cash flow that will be evenly phased. Keep in mind though that cash flow, when looked at on a quarter-to-quarter basis, tends to be lower in quarter two and quarter four due to our semi-annual interest payments. This drives that trend, which explains the decline in quarter four last year and quarter two last year versus quarter one and quarter three. So that's the overall perspective on cash flow trends. It's worth noting that as and when these divestitures close, we will provide guidance updates based on the expected timing of those closures so you can better assess the impact.
So while I don't want to front-run your R&D Day, clearly, I want to understand the deal announced today. Firstly, with both Selatogrel and Cenerimod, I'd love to understand the differentiation. While you look at the acute MI landscape, there are a couple of approved drugs, including Activase. So help us understand the gap in the current treatment and how much more rapid or short-acting Selatogrel is versus current treatment. Also same question on Cenerimod, too. Just following up on this, I see that Idorsia will contribute around $200 million in the next three years. Is it fair to assume that Viatris will also be contributing an equal amount?
Yes. Thank you very much for the question, Balaji. We'll be contributing as well, but I'm not saying it's equal. Both companies will contribute, with Idorsia contributing up to $200 million in the development programs moving forward. Regarding product differentiation, I'd like to turn it over to Philippe Martin, our Head of R&D, to discuss some of the distinctions he sees at a high level. We will dig into this further at the R&D Day later in March, but just to provide a couple of initial insights, I'll hand it over to Philippe.
Thank you so much, Scott. Yes, just to target Selatogrel, I think at a high level, Selatogrel targets the crucial time between symptom onset and the first medical attention. That's a time where currently, there is really no treatment for these patients, and that's a critical time when the heart muscle can be impacted. So that's clearly different positioning in the treatment paradigm for Selatogrel. For Cenerimod, we've seen strong Phase 2 data that supports a differentiated and highly competitive benefit-risk profile. We have fast track designation for this asset. Together with Selatogrel, I would say that both assets have strong regulatory interactions that bode well for their future.
To add quickly to what Philippe mentioned, part of the excitement surrounding Cenerimod is its broad immunomodulatory capacity. It’s initially aimed at SLE, but similar S1P molecules may expand to multiple areas, including IBD and dermatologic conditions. This potential makes it ripe for real indication expansion once we get through the first indication, so we're excited about that as well.
Once again, the next question comes from Nathan Rich.
Can you hear me now?
I can hear you now. Yes.
Perfect. This is Sarah Conrad on for Nate. I just had a quick question on the Eye Care franchise. So ahead of your second eye care launch, Ryzumvi, in the first half. How are you approaching the commercial launch? And can you give us any details on plans to drive uptake? And then when we're modeling this, how should we model the product ramp compared to Tyrvaya and the timing of the associated expenses?
Thank you for the question. Let me hand it over to Rajiv to discuss specifically about the eye care division and Tyrvaya, and I'll comment afterward.
Yes, thanks. I think we started with the DTC program, as we informed in the last Q3 earnings. We started with the DTC program in October; during quarter four, non-bridge prescriptions saw about an 18% increase. So all indications are very solid, and we are seeing that expansion of access. We continue to be optimistic about this with the follow-on launch of Ryzumvi earlier this year. Again, we will see a little bit more momentum behind that. More importantly, all the pipeline programs that we acquired along with this continue to progress well, as we have indicated earlier.
In terms of the ramp for Tyrvaya, clearly, the expenses we incur tend to follow the DTC program as we speak for the year. Revenue growth as these prescriptions increase will also show improvements, meaning each quarter is expected to exceed the previous quarter for modeling purposes.
Just a comment from me on the Eye Care division: We're very early in this process. We're in the launch phase of Tyrvaya, our first product. We’re about to launch the second product very quickly here. A whole pipeline of assets, five or six further products are in development that we can roll out. Thus, we’re hopeful and aspirational about how this Eye Care division will impact our business moving forward. We're eager to see more data regarding the effects of DTC and expect further ramp in this sector, but we’re excited regarding the entire business overall.
Yes. Congrats on all the progress. I had two questions. One on the pipeline. So for Selatogrel, for the Phase 3 readout, do you think this is a big binary risk type of program? Also, as a commercial opportunity, how do you expect patients to accurately identify their heart attack symptoms and self-inject under an emergency situation? Second, I wanted to get your thoughts on the FTC examination going into PBMs and wholesaler business practices concerning putting undue pressure on generics. What do you expect to come out of this process? And do you believe generic pricing could get favorable as a result of this?
Thanks, Ash. So regarding Selatogrel, I believe there are approximately 6,000 patients already enrolled in the Phase 3 program. Looking at Phase 2 data and the current status of Phase 3, we think it's relatively de-risked as an asset. As for the detailed question you asked on patient self-diagnosis and self-injection and identifying patient subsets, those details will be addressed at our R&D Day on March 27. We will discuss the development programs, regulatory strategy and our commercial strategy in detail then.
Concerning the FTC inquiry, I believe we've already seen some stabilization as far as pricing is concerned. Obviously, when such an investigation is underway, there’s a decent amount of oversight. I believe our customers now recognize that our industry has almost hit rock bottom in pricing and that’s leading to drug shortages, alongside other concerns gaining attention. Our interactions with customers have shifted from focusing solely on cost to valuing availability, consistent supply, product quality, and new products. Thus, I believe this is likely to bode well for the overall health of the generics industry.
So just have a couple. First, just wanted to pick your brain a little more on how you’re thinking philosophically about business development. Oyster Point was an outright acquisition. This is more of a risk-sharing type of arrangement. So the question is, is this transaction you announced today more indicative of what you’re looking for in the future in terms of smaller upfront payments with milestones and royalties? How philosophically are you thinking about that? Or are you casting a wide net?
Thank you, David, for the question. Given my past experiences, I've been involved with well over a hundred deals, and the majority are related to partnering and licensing of some sort. We have an extraordinarily strong base and global reach from a commercial perspective in this company. So I think pursuing in-licensing and partnering assets works especially well for us. However, we're looking to cast a wide net, considering all options for building the portfolio while utilizing our capital effectively. We'll engage in M&A but also focus on licensing and partnerships. In the end, while we might lean towards lower upfront, risk-sharing agreements, we will adapt our strategy based on finding impactful assets that drive business and align with our solid base business growing a couple of percent annually. Ultimately, we aim to find durable, sticky, long-term revenue streams.
To your second question, regarding the U.S. or Generics portfolio, we've examined our global portfolio. We maintain two-thirds as brand and established brands. Each market has unique needs that we address for the next few years. Over the past few years, in the U.S., we closely assessed our Generics portfolio. Our aim has been to ensure access to affordable and quality products, leading us to rationalize the number of products exceeding 300–400 that were not maintaining economic sensibility. We focus on high-value complex products where we can create impactful access, such as Wixela, Breyna, and complex injectables. We continue refining our approach wherever we can create a substantial difference in access at competitive prices.
Just wanted to follow up on the BD strategy and mindful that you have a presence in sort of cardiology outside the U.S. I guess, like, what investors would see is that most of the value in innovative brands tends to occur in the U.S. market. So is the thinking here that you would be in potentially four or five therapeutic areas and that this will require an investment in more deals and scaling up to compete in those categories? Understanding that companies in the I&I space are making significant investments to be competitive, which you could appreciate from your time at Celgene. So I'm trying to think through what this will look like from a P&L investment standpoint and further BD to be competitive in these therapeutic areas.
First, from my perspective, the most challenging aspect of this business is locating impactful assets that we can develop into blockbusters with patented long-term revenue streams. Creating the commercial structure around that is comparatively easier if we secure impactful assets. We are committed to looking for opportunities in our core therapeutic areas while being opportunistic for assets fitting our structure that allow us to compete effectively across areas. We are also dedicated to investing in assets that deliver durable revenue streams and are committed to prioritizing risk, maintaining a disciplined growth strategy. We will deploy our resources to the most promising indications that align with our core competencies, paving the way for growth into multiple therapeutic areas. In closing, 2023 was an outstanding year for Viatris that has continued our momentum as we enter the next phase of our strategic plan. I expect 2024 will be a transformational year for our company as we continue to deliver on our base business while building on our current strengths and adding new capabilities that will enable us to deliver on our future. With our ability, beginning in 2024, to use our substantial free cash flow to both return capital to shareholders and to make strategic investments to grow our business, we are truly evolving into the strong and unique company that we have envisioned. Before we close the call, I want to take a final moment to personally thank both Rajiv and Sanjeev for whom today is their last earnings call with Viatris. Rajiv has been with the company since 2007 and has been integral in building the company that we have today. He will remain as a member of the Board of Directors. Sanjeev has helped the company to successfully execute our Phase 1 strategy since 2020. Thank you both for your tremendous leadership and dedication and service to our company. Thank you.
Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.
SEC filing · Item 2.02
Filed Feb 28, 2024 · complete as-filed document
SEC periodic report
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