Q4 2024 Viatris Inc Earnings Call
Speaker Change: Good morning, everyone, and welcome to the Viettress Q4 and full year 2024 earnings call.
Speaker Change: All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
Speaker Change: After today's presentation, there will be an opportunity to ask questions.
Speaker Change: To ask a question, you may press star and 1 on a touch-tone telephone. To withdraw your questions, you may press star and 2.
Please also note that today's event is being recorded.
Speaker Change: At this time, I'd like to turn the conference call over to Bill Szablewski, Head of Capital Markets. Sir, please go ahead.
Speaker Change: Good morning, everyone. Welcome to our Q4 2024 earnings call. With us today is our CEO, Scott Smith, CFO, Doretta Mistras, Chief R&D Officer, Philippe Martin, and Chief Commercial Officer, Corinne Goff.
Speaker Change: During today's call, we'll be making forward-looking statements on a number of matters, including our financial guidance for 2025 and various strategic initiatives.
Speaker Change: We will also be referring to certain actual and projected non-GAAP financial measures.
Speaker Change: 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 2024 actual or reported results,
Speaker Change: We will be making certain comparisons to 2023 actual reported results on a divestiture-adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results
Speaker Change: from the divestitures that closed in 2024 and 2023 from the 2023 period.
Speaker Change: When discussing our expectations for 2025, we will be making certain comparisons to 2024 actual or reported results on a divestiture-adjusted operational basis.
Speaker Change: which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 2024 from the 2024 period. We may refer to those as changes on an operational basis. With that I'll hand the call over to our CEO Scott Smith.
Scott Smith: Good morning everyone. 2024 was an important year for VHRS across all three of our strategic pillars.
Scott Smith: We saw growth in our base business, increasing our new product revenues to $582 million.
Scott Smith: We completed our planned divestitures to simplify and streamline our organization.
Scott Smith: We returned approximately $825 million in capital to shareholders through dividends and share repurchases.
Scott Smith: We retired approximately 3.7 billion dollars of debt and achieved our long-term gross leverage target.
Scott Smith: And we expanded our innovative portfolio with three new products, Solatigro, Sonarimod, and Sodavoglozin, or Soda, to help build our pipeline of the future.
Scott Smith: We finished 2024 with a full year revenue growth of 2% on a divestiture adjusted operational basis in line with our guidance.
Scott Smith: On a reported basis, we had total revenues of approximately $14.7 billion.
Scott Smith: adjusted EBIT of approximately 4.7 billion dollars and adjusted EPS of two dollars and sixty-five cents per share
Scott Smith: Free cash flow is approximately $2.6 billion excluding divestiture related taxes and transaction costs.
All in all, a very good year.
Scott Smith: Before we dive into our 2025 priorities, I want to give you an update on the remediation efforts at our facility in indoor India and the estimated impact for this year.
Scott Smith: The FDA inspected the facility in June. Following the inspection, we immediately began implementing a comprehensive remediation plan to address the FDA feedback.
Scott Smith: The necessary corrective actions are well underway, including, but not limited to, related personnel actions, and we have engaged independent third-party subject matter experts to support our efforts.
Scott Smith: I assure you we take these matters very seriously, as well as our commitment to quality across our entire network.
Scott Smith: We recently traveled to Indoor to review the progress. I can tell you we are more than halfway through our efforts. We expect to be completed in a few months, at which time we anticipate asking the FDA to conduct a re-inspection of the facility.
Speaker Change: received a warning letter and import alert from the FDA at the end of December. The import alert affects 11 actively distributed products in the U.S., including lenalidomide. The FDA made exceptions subject to certain conditions for four products based on shortage concerns.
Scott Smith: We recently finished interactions with the FDA about potential additional product exceptions
Scott Smith: and we do not expect any additional exceptions will be granted at this time.
Scott Smith: While product continues to be shipped from the facility to markets outside the U.S., we currently anticipate some impact on other markets, including parts of our ARV business and emerging markets, and to select generic products in Europe.
Scott Smith: We currently estimate the negative impact on 2025 total revenues to be approximately 500 million dollars and on 2025 adjusted EBITDA to be approximately 385 million dollars.
Scott Smith: To meet the needs of the patients we serve, we are working closely with our customers to mitigate any supply disruptions, including potential site transfers and third-party arrangements.
Scott Smith: Turning our attention to our 2025 priorities, we are very focused on continuing to drive our base business with strong execution across commercial markets and we are expecting several notable new product launches this year.
Scott Smith: From a pipeline perspective, we have 10 unique molecules in Phase III clinical development across our portfolio, and we are expecting six Phase III readouts this year, including from OxCam, which is being developed as a potential opioid sparing treatment in acute pain.
Scott Smith: In addition, we expect to achieve several important late-stage development milestones for our three innovative assets, Solatogro, Sonarimod, and Soda.
Scott Smith: To preserve the ongoing continuity of the development programs for Saladigrel and Sanerima, we have updated certain terms of our original global research and development collaboration with Eidosia.
Scott Smith: Under the updated terms, we will receive the rights to additional territories for SINARMOD, including important markets in Asia.
Scott Smith: A reduction in certain contingent milestone payments, which will help improve the long-term economics of these assets, and certain other considerations in exchange for assuming a portion of IDORSIA's remaining development cost obligation.
Scott Smith: We continue to be excited by the promise of these two assets and we'll take full control over the development to help ensure development timelines remain on track.
Scott Smith: From a capital allocation perspective, we said that we expect our approach to be equally balanced between capital return and business investment over the next three to five years, and then any given year, we may prioritize one over the other.
In 2025, we are prioritizing returning capital to shareholders.
Scott Smith: We will continue to support our dividend and are targeting at least 500 million to 650 million in share repurchases this year.
Scott Smith: As we progress through the year, we expect to have additional flexibility, and as a reminder, we still have $1.5 billion in share repurchase authorization available to us.
Scott Smith: From a business development perspective, we will target accretive regional opportunities that leverage our unique commercial and R&D infrastructure and capabilities.
Scott Smith: Finally, we have begun an enterprise-wide initiative to review our global infrastructure and identify additional cost savings.
Scott Smith: We expect this program to deliver OPEX savings in 2026 and beyond.
Scott Smith: Later this year we'll hold an Investor Day to talk about our long-term outlook, how we are advancing our base and innovative pipelines, and the progress we are making on our enterprise-wide review.
Scott Smith: Overall, I'm proud of what we accomplished in 2024, and I'm very confident in our future. We have our arms around the situation at Indoor.
Scott Smith: In 2025, we have significant opportunity to drive our base business, execute on our pipeline, return capital to shareholders, and position ourselves for growth in 2026 and beyond.
Scott Smith: Now I'll turn it over to Philippe to share an update on how we are advancing our pipeline. Philippe?
Philippe: Thank you, Scott. Our base business pipeline continues to be highly diversified across core generics, complex generics, and novel products.
Speaker Change: This robust and deep pipeline, representing approximately 100 plus submissions annually, is the backbone of our ability to deliver more than $450 million in new product revenues.
Philippe: for each of the last five years. We made great progress in 24, delivering $582 million in new product revenues.
Philippe: setting us up very nicely to hit our target range of 450 to 550 million in 2025.
Philippe: This is a particularly important year from an R&D and scientific execution perspective as we expect to receive approvals on a number of complex injectables that we have been steadily and strategically developing.
These include iron sucrose, octreotide, and arachnotide.
Glucagon was approved last year and is actively being launched.
These are difficult to develop and difficult to manufacture medicines.
Philippe: And we are proud of the scientific and development expertise we have built in this area.
Philippe: We plan to continue to leverage this differentiated platform as we further advance our base business pipeline.
Philippe: In parallel with getting these complex injectables to approval, we are also very focused on progressing our novel and life cycle management programs.
Philippe: We have a number of Phase III readouts anticipated in 2025.
Philippe: The most near-term opportunity is Effexor for generalized anxiety disorder in Japan.
We announce positive top-line results.
Philippe: of our randomized, double-blind, placebo-controlled Phase 3 study last year, and recently received positive results from the Phase 3 open-label, long-term extension required for approval in Japan. We anticipate filing our submission in the first half of this year.
Philippe: We expect our Phase 3 readout in the first half of this year.
We received positive results.
from our first Meloxicam Phase III brinionectomy study.
Philippe: and are feeling optimistic about our development program as we await our second Phase III readout in hernial rafi, which is anticipated later this year.
Philippe: We believe that this novel, fast-acting oral formulation of meloxicam has the potential to be an important opioid-sparing treatment option for patients with acute pain.
Philippe: Now moving to our innovative pipeline, beginning with iCare. We are continuing to advance our ophthalmology programs with these three key registrational readouts expected in 2025.
Philippe: We are on track to receive top-line data for MR-139 of P. mecolomus, Phase III study for blepharitis in the first half of this year.
Philippe: We also have recently completed enrollment for our Phase III study, evaluating MR-141 for presbyopia and expect to receive top-line results in the first half of this year.
Philippe: Additionally, our partner recently received fast-track designation from the FDA for their investigational new drug application for MR-142.
Philippe: which is being developed for the treatment of visual loss in low-light conditions associated with keratorefractive surgery.
A substantial subset of these patients
Philippe: has night driving impairment for which there is no labelled treatment.
thereby supporting the Fast Track designation.
The development of this asset is also progressing well.
Philippe: And we anticipate completing Phase 3 enrollment and receiving top-line results in the first half of this year.
Philippe: For Theladogrel and Senerimod, we continue to be focused on increasing and accelerating trial enrollment for both SOS-MI and OPUS.
Recruitment for OPUS is well on the way.
Philippe: with plans to complete enrollment in the second half of this year.
Philippe: We continue to submit data from the Phase II care study for publication, and three abstracts have recently been accepted for presentation at two major Congresses.
Lupus 2025 and Panlar 2025.
Philippe: Discover the multi-faceted immunomodulatory properties of scenario mode and subgroup analysis from the phase 2 care study on quality of life.
and Impact on Fatigue.
Philippe: Regarding Thaladogrel, the SOS-MI trial is progressing according to previously communicated timelines.
Philippe: We have scaled up trial recruitment and increased awareness of the study.
Philippe: We are continuing to build on our legacy in this space.
Philippe: and actively engaged key opinion leaders and the broader cardiovascular community at key medical meetings around the world.
Philippe: Moving to sotagliflozin. We are pleased with the recent publication in the Lancet Diabetes and Endocrinology.
These data provide strong evidence.
Philippe: of Sutter Glyphosate Clinical Benefit in Reducing Major Adverse Cardiovascular Events, or MACE.
Philippe: in patients with type 2 diabetes, CKD, and high cardiovascular risk.
Philippe: The findings show that sotaglifrazine significantly and meaningfully reduces MACE versus placebo.
demonstrating early and broad cardiovascular protection in this population.
Philippe: Glyphosate is the first SGLT inhibitor to show significant reduction in both MI and stroke, highlighting the potential role of SGLT-1 inhibition in reducing ischemic events.
An important distinction from selective SGLT2 inhibitors.
Philippe: We are now collaborating with our partner Lexicon to explore next steps, including a potential label expansion to increase patient access as we continue to remain on track for our regulatory submissions starting in 2025 in key ex-US markets.
Philippe: We will be leveraging the dossier that led to FDA's approval and expect registration in these markets starting in 2026.
Philippe: To recap, our R&D strategy is grounded in being disciplined about executing our near-term programs while preparing for the future.
Philippe: We have a strong focus on advancing our base business and innovative pipelines across multiple fronts.
Philippe: with important complex generics approval, phase 3 data readouts, and key development milestones in our novel and innovative pipelines, all expected this year.
Philippe: And we are continuing to actively build our GLP-1 pipeline and supply chain, which we will share more information about at our upcoming Investor Day.
With that, I'll hand it over to Corinne.
Corinne: Thank you Philippe. I'd like to start by outlining our three commercial priorities in 2025.
First is driving the best business.
Corinne: 2024 was a strong year. All commercial segments grew year over year operationally. We aim to continue this momentum with focused execution in every aspect of the business to maximize the potential of our broad, generic and brand portfolios.
Corinne: This means continued attention on delivering high customer service levels and leveraging our global healthcare gateway and regional capabilities and infrastructure to expand patient access.
Our second priority is to execute our product launches.
Corinne: We're expecting a number of new products coming this year, such as our complex injectables. In total, we are tracking more than 150 generic launches globally, and our aim is to ensure commercial success for each launch.
Corinne: The fundamentals of our base business are strong and we are confident we will deliver the expected $450 to $550 million in new product revenues.
Our top priority is preparing the future business.
Corinne: And we are developing global commercialization strategies for innovative and novel pipeline assets.
Turning to our outlook for the year.
Scott Smith: As we heard from Scott, we are expecting an approximate 500 million revenue impact related to indoor, affecting mostly the U.S. and emerging markets.
In 2025, we expect total revenues to decline approximately 1%.
Scott Smith: Now let's dive into the geographic segments, starting with developed markets.
Scott Smith: Europe is expected to grow year over year. I want to highlight some of the key positive drivers behind this anticipated performance.
Scott Smith: First, we expect new product launches in both our brand and generic portfolios, including carryover benefits from the Atova Statinicity Mic combination and Reverox Adan.
Scott Smith: Then, the continued performance of our thrombosis portfolio, as well as key brands like Crayon and Brufen.
Scott Smith: And finally, we anticipate further volume growth in key markets including Italy and France and strong generic performance across our diverse portfolio.
Scott Smith: North America is expected to decline year-over-year, which is driven by the indoor impact and expected competition on certain generics including zulan, glutaramic acetate, and prednisolone.
Scott Smith: Our focus is to continue to capitalize on the strengths of our complex generics portfolio with a stable contribution of products like Vixella and Brenner, as well as continuing the growth trajectory of promoted brands like Upillery.
Scott Smith: And we are actively planning for several new launches during the course of the year in the complex injectable space, including iron sucrose and octreotide, plus glucagon, which we are in the midst of launching.
The emerging market segment is expected to grow year-over-year.
Scott Smith: primarily driven by further expansion of our cardiovascular portfolio in Latin America, as well as expansion in key markets such as Turkey, India, Korea, Brazil, and emerging Asia, and volume growth on our overall base portfolio.
Scott Smith: Moving to GENTS, similar to 2024, this year we expect continuing impacts from government-driven price regulations in Japan and Australia, as well as from a change in Japan's reimbursement for off-patent brands that accelerated generic conversion.
Scott Smith: While we are forecasting GEMS to decline in 2025, we continue to benefit from ongoing strong volume growth from key brands and the expansion of our generic business, including through ongoing business development efforts.
Scott Smith: Japan is a key market and we are well underway preparing for the future.
Scott Smith: We are building our commercialization plans around a number of innovative and novel assets, such as Effexor for generalized anxiety disorder, Nefecon, Senerimod, Selatogrel, and Sotagliflozin.
Scott Smith: Our significant presence and leading organization in China, as well as our commitment to patient access, allow us to meet expanding healthcare demands.
Scott Smith: In addition, we expect to deliver on our pipeline with new product launches of Dymista and Breda in China.
Scott Smith: By continuing to maximize our well-established commercial presence across multiple channels, including e-commerce, retail, and private hospitals, we expect to be able to absorb the impacts from potential government-implemented healthcare policy regulations.
Scott Smith: Overall, we are confident we will be able to deliver on our 2025 commitments.
Scott Smith: through driving the base business and executing our new product launches while preparing for successful future innovative launches.
With that, I'll turn the call to Doretta.
Doretta: Thank you, Corinne. Building on the team's comments around our operational performance, I'll briefly highlight full year and fourth quarter results. As a reminder, my commentary on our financial performance will be on a divestiture-adjusted operational basis.
Doretta: We reported 2024 total revenues of $14.7 billion, which was up 2% year-over-year.
Doretta: This reflects growth across all segments and new product revenues of $582 million, which was at the high end of our increased range.
Doretta: Adjusted EBITDA was $4.7 billion which benefited from adjusted gross margins of 58% also at the high end of our range driven by strong brands and complex generics performance.
Doretta: As it specifically relates to the fourth quarter, total revenues of $3.5 billion were in line with our expectations and grew 1%.
Doretta: We saw continued momentum and growth across China, developed markets, and emerging markets.
Doretta: Our global generics business grew 2% driven by new product launches and complex products.
Doretta: Gross margins were in line with expectations and moderated in the 4th quarter due to expected segment and product mix.
Doretta: We had a strong quarter of free cash flow totaling $685 million excluding the impact from divestiture costs and taxes.
Doretta: Our free cash flow and proceeds from the divestitures were used to pay down approximately $1.4 billion in debt, which enabled us to achieve our gross leverage target, ending the year at approximately 2.9 times.
Doretta: Now that we've closed the year, we are also providing an estimate of our 2024 results on an ex divestiture basis.
Doretta: These estimates exclude the benefit from the divested businesses, totaling approximately $490 million in total revenue and $255 million in adjusted EBITDA.
Doretta: Moving to our plan for 2025, I'll summarize the key drivers to give you a full picture of the year ahead.
Doretta: Given the continued strength of the dollar, we have assumed an FX headwind of approximately 2 to 3 percent on total revenue.
Doretta: As a reminder, approximately 75% of our revenues occur outside of the U.S.
Doretta: Excluding the impact of Indoor, we expect our operational revenues to benefit from continued momentum and strong fundamentals, primarily in Europe, China, and emerging markets.
Doretta: These trends give us confidence in the continued strength of our base business going forward.
Speaker Change: And as you heard from Scott, with respect to Indoor, ongoing remediation has been an all-hands effort and is a top priority for our organization.
Speaker Change: We take the quality of our products very seriously and are making progress on the remediation plan, including the transfer of products across internal sites and with third parties where deemed possible and appropriate.
Speaker Change: Discussions with the FDA and our customers have been ongoing and have evolved to a point where we now have clarity on the products and scope and the anticipated associated financial impact, which we have included in our guidance.
Speaker Change: We estimate an impact of approximately $500 million to 2025 total revenue and $385 million to adjusted EBITDA.
Speaker Change: This includes estimated penalties and supply disruptions of approximately $100 million, which we believe are mostly short-term in nature.
Speaker Change: Limalidomide, which after discussions with the FDA, was not granted an exception.
Speaker Change: is the largest product impacted and represents approximately 40% of the total revenue impact and 50% of the total adjusted EBITDA impact given its margin profile.
Speaker Change: Also, based upon the existing settlement agreements with generic manufacturers, we expect this product will face significant additional generic competition in early 2026.
In Europe, we expect limited impact to select generic products.
Speaker Change: We believe this impact to be short-term and expect to recapture some of this volume in the future.
Speaker Change: In emerging markets, we anticipate our lower-margin ARB business to experience certain disruptions over the short term, and we estimate an impact on total revenue of approximately $125 million.
Speaker Change: Moving to the drivers of gross margins and our adjusted EBITDA and EPS guidance.
Speaker Change: We expect growth margins to be impacted by indoor, normal base business price erosion, and an increase in some product supply costs. Partially offsetting this impact is the expected benefit from segment mix.
Speaker Change: As it relates to our outlook for SG&A and R&D, we are taking a disciplined approach to managing our expenses and allocation of resources.
Speaker Change: Total operating expenditures are expected to decline as we work to optimize the portfolio and reduce stranded costs associated with the divestitures.
Speaker Change: Our guidance assumes a reduction of approximately 150 million predominantly benefiting SG&A.
Speaker Change: And with respect to IDORSIA, as Scott mentioned, we have amended the collaboration agreement.
Speaker Change: As a result, we expect to incur an incremental R&D expense of approximately $100 million in 2025.
Speaker Change: In exchange, we have received a $250 million reduction in contingent milestones, of which $200 million is from future development milestones.
We have also gained additional territory rights for Cinaramon.
Speaker Change: We expect our effective tax rate to increase by 150 basis points in 2025 due to anticipated impacts from Pillar 2.
Speaker Change: A few points on our expectations for free cash flow and cash available for deployment in 2025.
Speaker Change: We expect strong free cash flow generation of approximately $2 billion, which takes into account indoor remediation and foreign exchange totaling approximately $300 million.
Speaker Change: Net of taxes and transaction costs associated with the divestitures, we estimate that we'll have approximately $1.7 billion available for deployment throughout the year.
Speaker Change: Consistent with our stated strategy, we continue to prioritize capital return in 2025 with a focus on share repurchases.
Speaker Change: As such, we expect to repurchase between $500 and $650 million throughout the year, preserving flexibility to the upside.
Speaker Change: With the approved annual dividend policy of $0.48 per share, we expect to return over $1 billion of capital to shareholders, nearly 70% of our available capital.
Now, a few comments regarding phasing of our guidance.
Speaker Change: Total revenue is expected to be higher in the second half driven by the back-weighted launch of new products and normal product seasonality.
Speaker Change: We expect operating expenses to be evenly phased between the first half and second half.
Speaker Change: Taking into account phasing of revenue and margin, we expect Adjusted EBITDA and Adjusted EPS to also be more heavily weighted towards the second half.
Speaker Change: And as we think about the sequential quarterly roll forward, we expect the first quarter levels to step down from the fourth quarter, attributed to lower net sales from indoor related products and volume and seasonal impacts in Europe and Jams.
Speaker Change: Finally, we will continue to be disciplined with our financial policy.
Speaker Change: and remain in a very strong position given the breadth and diversity of our global portfolio, strong-based business fundamentals, expected significant free cash flow generation, and efficient low-coupon fixed-rate capital structure.
Speaker Change: Looking ahead, we have laid out a clear and transparent plan for this year, and I have confidence that our strong foundation will position us for long-term success.
Speaker Change: We look forward to updating you each quarter on our progress and being available for your questions.
Speaker Change: And with that, I'll hand it back to the operator to begin the Q&A.
Speaker Change: Ladies and gentlemen, we will now begin the question and answer session.
Speaker Change: To ask a question, you may press star and then 1 on your touch-tone phones if you are using a speakerphone. We do ask that you please pick up the handset before pressing the keys.
To withdraw your questions, please press star and 2.
Speaker Change: Once again, that is star and then one to join the question queue.
We'll pause momentarily to assemble the roster.
Thank you. Thank you.
And our first question today comes from...
David Amsellem from Piper-Stanler. Please go ahead with your question.
David Amsellem: Hey thanks, have a few. So first I guess on the on the warning letter and the remediation, I guess anytime there is a a warning letter you you can't help but wonder
Speaker Change: Are there potential issues with quality control at other facilities? So, I guess, can you just talk about your level of confidence that this is something that is contained?
Speaker Change: to endure and not something that you worried about in terms of 483s and potential warning letters at other sites. So that's number one. Number two, on Sinaramon and Silatigrel, just given your comments on enrollment, can we...
Speaker Change: Assume that these are going to be 27 events in terms of the data. It doesn't look like
Speaker Change: 26 may happen, but I just wanted to get your thoughts.
Speaker Change: And then just lastly, just given your comments on capital deployment and your past comments and activity on M&A, I guess my question here is, going forward, what does Viatris want to be longer term? I mean, do you want to lean more into brands?
Speaker Change: Are you looking more at returning capital to shareholders and comfortable with the current business mix? Just, I guess, just a bigger picture question in terms of where you want to take the company. Scott, thanks.
Speaker Change: So, thank you, David. Thanks for the questions and good morning. So, first of all, your first question around security and thoughts around other facilities. There were three facilities inspected in 24. We've talked about indoor here where we got the warning letter and import alert. There was also an inspection in Carroll Park in Australia and that has been closed out. I know with voluntary...
Speaker Change: to handle, no warning letter issued there at all. So that's closed out in terms of Carroll Park. The third facility is in Nashik, India.
and there was an inspection there.
The classification of that is pending.
Speaker Change: And so we're waiting to hear back there. All other facilities within the network, and there's 26 facilities in our network, all other facilities are within acceptable compliance status.
Speaker Change: with all the relevant health authorities. So that's where we're staying. We're waiting to hear back.
Speaker Change: Nashik, but everything else is in compliance at this point in time. And again, this is the indoor situation was one out of 26 facilities in our network. An important one, not to diminish that, but one of 26 within the network. I'll go to capital allocation again, and then I'll kick it over to Philippe to talk a little bit about Sonarimod and Salada Grill. Our capital allocation plans have not changed at all.
Speaker Change: In any one year, our priorities may be a little bit different. I think our priorities this year are a little more focused on return to shareholders. We're going to be a little more aggressive on the share buybacks.
Speaker Change: As we said in our prepared remarks, $500 million to $650 million in buybacks at a minimum for this year, but we'll also look for some business development things which can be accretive and help build our revenue and EBITDA streams.
And to Scott's point, the $1 billion of capital we've
Speaker Change: We've announced, even with that number, we are maintaining strategic flexibility going forward to evaluate all options for our capital. That includes additional share buybacks, that includes accretive business development, and the ability to continue to delever if we deem necessary.
if we'd like.
Speaker Change: And this is Philippe with regard to Celadogrel and Cinerimod. Yeah, the data is expected late 2026 for both programs.
Speaker Change: As I mentioned, enrollment is going very well for both programs, so it could be a bit earlier than that if the trends continue, but right now we're keeping that late 2026.
Timing for the data.
Speaker Change: And our next question comes from Ash Verma from UBS. Please go ahead with your questions.
Speaker Change: Thanks for taking my question. So I wanted to understand the implications for 2026. So typically these type of warning letters can take a minimum of two years to dissolve.
Speaker Change: I know you said that RevoluMid was already going to go off, but did you have some...
Speaker Change: offsets planned for it already. And then secondly, just with today's update, I mean, right now the stock is trading 12 to 15 percent down in pre-market. Why not be more aggressive on the buyback beyond what you've guided here? Thanks.
Speaker Change: I'm sorry, Ash, would you, let me answer the first question. I got, it was a little bit garbled on the second part of your question, I'll answer that. So, the remediation efforts in Indoor are, I would say, more than half way done. We expect to be done as we get to the late spring, early summer. With the remediation at that point, we'll ask the FDA to come in and re-inspect the facility. We, relative to lenalidomide, we talked extensively with the FDA and thought we had a really good case to get it on the exempt list because of the critical nature of that particular medicine.
Speaker Change: We were unable to do so. We looked for alternate sources of lenalidomide and continued to do so. However, you know, lenalidomide is scheduled to hit a secondary patent cliff, I'll say, or expected to, the economics of it are expected to significantly diminish as we get into
Speaker Change: It's January of 26, so from a Lyn & Lynemeyer perspective, this just brought that event up earlier for us, 10 to 12 months earlier. I certainly would have liked to have that capital to deploy as part of our revenue in EBITDA, but it was an event that was going to happen within 10 to 12 months.
Speaker Change: We are looking high and low for alternate ways to be able to fill that. At this point, we don't have any.
Speaker Change: So with today's update, right now the stock is trading sort of mid-teens down and pre-market. Why not be even more aggressive on the buyback here beyond what you've guided?
Speaker Change: Thank you, Ash. Great question. I think what we're trying to say here, you know, our sector of leading cash flows give us tremendous flexibility to do a number of different things.
Speaker Change: We are planning right now to give back between a billion and 1.2 billion to shareholders through dividend and for share buybacks. We definitely will evaluate where the share price is and is there an opportunity to be even more aggressive than that. I think we look at that 500 or 650 as a minimum for this year, but we will balance that, you know, as Doretta said, we'll balance that share buyback relative to some business development opportunities, regional
Speaker Change: Revenue and EBITDA, but certainly in consideration we'll be increasing that the share buyback program if the stock remains under pressure.
Thank you. Thank you.
Thank you. Thank you.
Speaker Change: And our next question comes from Chris Schott from J.P. Morgan. Please go ahead with your question.
Chris Schott: Great, thanks so much. Just two for me. Maybe first, can you just elaborate on the scope?
Chris Schott: Maybe size and timing of the enterprise review you mentioned on the call. I'm just wondering, is this something that's part of just ongoing efficiency efforts or something more substantial potentially?
And then my second question was on indoor and...
Chris Schott: gross margins. Can you just walk through a little bit when we think about the year over year step down in gross margins, how much of that's coming from indoor and how much of that's coming from some of the factors that you cited? Thank you.
Speaker Change: Good morning Chris and thanks for the questions. I'll take on the first one and then I'll kick it over to Doretta to talk about the margins. This cost initiative was something that we had in our heads for a little while. If you think about the cadence or the pattern of the company, four years ago there was a merger of two large global companies.
Speaker Change: And then since then we have divested four major businesses in terms of biosimilars, women's health care, OTC, API business.
Speaker Change: And given all that, I think it's really good timing, and then with the indoor situation coming this year, I think it's a really good time for us to take a look at the enterprise. Do we have the right cost structure? Do we have the right people in the right places?
Speaker Change: And not only from a cost-efficiency standpoint, but also are we fit for purpose for being able to deliver our goals in 2025, 2026, and beyond. So I think it's a perfect moment for us to really take a look at our structure, how we're organized, where our resources are allocated.
Speaker Change: and make sure that we are organized best for today and for the future.
Speaker Change: And to your question, Chris, around gross margin, there were a couple of components, as I mentioned, that were factoring into the step-down.
Speaker Change: and the high margin nature of both the penalties as well as lenalidomide, the margin impact of indoors about
Theodora Mistras, Glen Santangelo, Umer Raffat, Nathan Rich
Speaker Change: product supply costs and that has been offset with kind of benefits from just ongoing segment mix in our business.
Speaker Change: And just to follow up on your first question, I think I missed the part around timing. And we have already initiated discussions internally around this. We're bringing some external people in to help with this. This will be an exercise that really will be focused on the first half of this year. I think the positive effect from a cost-benefit perspective will most likely be more fully realized in 26, but it's something that we have already initiated.
Thank you.
Speaker Change: Our next question comes from Jason Gerberry from Bank of America. Please go ahead with your questions.
Speaker Change: Hey guys, thanks for taking my questions. So, just for me, maybe I missed this, but why does the indoor facility issues have an impact on revenues outside the United States?
Speaker Change: What are you thinking in terms of a, I know this isn't like a new product issue, but like, is...
Speaker Change: generic Simba court headwind in 2025 due to competition and and how would you frame maybe the risk profile in aggregate of the pipeline contribution this year versus last year's pipeline contribution? Thanks.
So just on the first question, I think...
Speaker Change: It has to do with the remediation of the facility, and again, we've got a network of facilities here from a manufacturing perspective, 26 globally, and we look for alternate sources when we have a shutdown for remediation or a slowdown for remediation like we do at Indoor.
Chris Schott: Why don't I cover to your question around new product revenue, Chris, kind of our confidence in the $450 to $550.
Chris Schott: We do think this is a de-risked number. We're confident in our range. Our history shows that we have kind of consistently delivered or even exceeded our range. Just to give you a flavor of a little bit of the components, about 20% of that new product range we estimate is from already approved
Chris Schott: And in addition to that, we have several complex products, one of which GlucaGun was already approved and is in the process of being launched. So obviously, this is a diverse portfolio, there's pushes and takes, but we have confidence in that range.
Chris Schott: And on your question specifically, this is Corinne, on your question specifically on generic symbi-symbi-GOF, so...
Chris Schott: Brenna, I want to mention that we are very pleased with the performance of Brenna, and we continue to believe that Brenna will be a key contributor to our revenues and to our complex generics portfolio in 2025, so this is our assumption going forward.
Speaker Change: Once again, if you would like to ask a question, please press star and 1 using a touch-tone telephone. To withdraw your questions, you may press star and 2.
Chris Schott: Our next question comes from Umer Raffat from Evercore. Please go ahead with your question.
Umer Raffat: Hi guys, thanks for squeezing me in. Two, if I may. First, Scott, Doretta, for you, at the conference in January, you guys talked about, for the indoor warning letter, you guys mentioned it's 11 products
Umer Raffat: And 4 of the 11 were exempt and more could get exempt. So most folks listening in just assume, you know what, hundreds of products, hundreds of products in this company, 11 of them, so probably not so much.
Umer Raffat: But the type of EBITDA hit we learned about today, considering also that you knew Generic Revelment was one of them, I'm just curious about the thought process around how you guys communicated that to investors previously.
Umer Raffat: And secondly, on the Eidosia deal, I'm just curious, what's the new information you've learned, perhaps on a blinded basis for the ongoing trials?
Umer Raffat: which drove the decision to put in another $100 million which was technically what Adorcia was going to contribute to the R&D. And I acknowledge they couldn't get their licensing deal done, but just curious about your thought process as well.
Speaker Change: Yes, so relative to disclosure, J.P. Morgan, it was a very dynamic situation at that time.
Speaker Change: You know, we didn't even have a good view on exactly whether lenamide would be excluded or not until just a few days ago. So it's been very dynamic. We thought we had a great case because of the importance of the medication. It just did not materialize. And so, you know, for me at J.P. Morgan to start to say, well, there's this product and not that product, without being able to give the whole picture, I think, gets to our credibility. What was really concerning to me was to be accurate, to be credible, to when I understood
Theodora Mistras, Theodora Raffat, William Szablewski, Theodora Raffat, Theodora Raffat,
Thank you very much.
Speaker Change: had significant interaction with the KOLs and various PIs as well, the momentum.
Speaker Change: of the studies is very high at this point in development. We've had multiple IDMCs or safety committees as well, safety committees and blinded to the data.
and the feedback has been very positive to date.
specifically to Thelada Grail, I think.
You know, as I've said previously, and this is continuing...
Speaker Change: What is particularly important is that we are seeing the patient self-injecting.
Speaker Change: and then following up and taking themselves to the hospital post-injection.
Speaker Change: So the study is really progressing as we would, as intended, and as designed originally. So we, that gives us some level of confidence for the future.
Umer Raffat: And Umer, if I can just add to that, I mean, it became apparent to us during the course of 24 that these were going to be very important programs, the feedback we were getting from sites and others was very, very positive, as Philippe said, you know, not that we, obviously, the data is blind and we haven't seen any data that would direct us in a way, but
Umer Raffat: Just the way that everything was progressing, it felt to us like these programs were getting more important to us rather than less.
Umer Raffat: And given what was going on with our partners, we thought the idea of making sure that we can enhance the data integrity, transfer these programs to our ownership even more quickly, I think was important given the importance of these programs to our future revenue growth. And also at the same time, being able to expand our geographic footprint, being able to get Sanaramod into important markets for Asia where we've got very substantial infrastructure already and increase the long-term economics by reducing sales and regulatory milestones.
Umer Raffat: be like the right time to do it, and a very beneficial situation for us at Nature's.
Speaker Change: For SINEMA, just briefly, the rate of interferon-1 high in Japan is extremely high. For SLE, it's very, very close to 100%.
Speaker Change: So having access to that population for SINERMA specifically is quite important. Both from a research perspective and from a commercial perspective.
Thank you.
Balaji Prasad: And our next question comes from Balaji Prasad from Barclays. Please go ahead with your question.
Speaker Change: Good morning, everyone. Thank you for the questions. Two from me. Firstly, stories about the investor day. You have your tasks clear for you in getting indoor cleared, new complex generics launches on track.
Speaker Change: That is one. Two, probably a minor follow-up on indoor. It's reassuring to see that you are in control. Is there any commitment from the FDA on the timelines for reinspection in terms of service level from the time you tell them that you are ready for an inspection? Thank you.
Speaker Change: So that one first, it's difficult to predict the FDA during times of certainty and during times of uncertainty may be a little bit even more difficult. You know, our base plan calls for the remediation to be finished in the next couple of months for us to request over the summer, and hopefully we can get a re-inspection by the end of this year or early into 2026. That's our baseline.
Speaker Change: Timelines that we're looking at definitely contingent upon what happens within the federal government And I don't know if there's going to be changes to the cadence and flow and resources put behind those sorts of inspections But that's the base case that we're going with. In terms of our investor event for later this year, I think there's three main things that we really like to focus on.
Speaker Change: What does our long-term revenue EBITDA and EPS outlook look like?
Speaker Change: You know, this is a year in 25, certainly an unexpected challenge in terms of what we have in Indore and moving up the loss of real economics and lanolinamide, but it sets us up to be able to do the hard work this year to grow in 26 and beyond. And so we want to be able to show that picture, talk about the revenue EBITDA EPS projection that we see over the next five years. We want to talk about the pipeline, both the innovative pipeline and what's happening,
Speaker Change: like the base business pipeline and what's in there and how that's coming, the complex generics. There's a lot of important things. I'd like to talk about a comprehensive GLP-1 strategy that we're going to execute and implement globally. And finally, we'll be in a good position to really, you know, in a few months to talk to you about this enterprise-wide cost initiative that we are entering into and what we see the benefits of that and with not final numbers likely, but certainly we can give a very good
and where we are with that.
Speaker Change: And just to clarify a point, all the phase 3 readouts for this year will occur in the first half of this year. So we should be able to share most of that data with you during the investor day.
Great. Thank you.
Speaker Change: And ladies and gentlemen, with that, we'll be concluding today's question and answer session. I'd like to turn the floor back over to Scott Smith, CEO, for closing remarks.
Speaker Change: Thank you very much and thank you for everybody on the call. Obviously a little bit of a difficult situation, one that we take very seriously. We have our arms around the situation of Indoor, significant impact here on 25.
Speaker Change: We are very, very committed to doing the hard work in 2025 to drive
Speaker Change: sustainable growth in 26 and beyond. And look forward to talking about all this and more and giving an update on Indoor and everything else as we get to our Investor Day a little bit later this year. So thank you again for your attention.
Speaker Change: And ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We do thank you for joining. You may now disconnect your lines.