Presentation

Operator

Good morning, everyone, and welcome to the Viatris Q4 and full year 2024 earnings call. (Operator Instructions)
Please also note today's event is being recorded. At this time, I'd like to turn the conference call over to Bill Szablewski, Head of Capital Markets. Sir, please go ahead.

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 Le Goff.
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. These statements are subject to risk 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 2024 actual or reported results, we will be making certain comparisons to 2023 actual or reported results on a divestiture adjusted operational basis, which excludes the impact of foreign currency rates and also excludes the proportionate results from the divestitures that closed in 2024 and 2023 from the 2023 period.
When discussing our expectations for 2025, we will be making certain comparisons to 2024 actual or reported results on a divestiture adjusted operational basis, 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.

Good morning, everyone. 2024 was an important year for Viatris across all three of our strategic pillars.
We saw growth in our base business increasing our new product revenues to $582 million. We completed our planned divestures to simplify and streamline our organization. We returned approximately $825 million in capital shareholders through dividends and share repurchases. We retired approximately $3.7 billion of debt and achieved our long-term gross leverage target. And we expanded our innovative portfolio with 3 new products Selatogrel, Cenerimod and Sotagliflozin, or Sota to help build our pipeline of the future.
We finished 2024 with a full year revenue growth of 2% on a divestiture adjusted operational basis in line with our guidance. On a reported basis, we had total revenues of approximately $14.7 billion, adjusted EBITDA of approximately $4.7 billion and adjusted EPS of $2.65 per share. Free cash flow is approximately $2.6 billion excluding divestiture-related taxes and transaction costs. All in all, a very good year.
Before we dive into our 2025 priorities, I want to give you an update on the remediation efforts at our facility in Indore, India, and the estimated impact for this year. The FDA inspected the facility in June. Following the inspection, we immediately began implementing a comprehensive remediation plan to address the FDA feedback.
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. I assure you we take these matters very seriously, as well as our commitment to quality across our entire network.
We recently traveled to Indore 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.
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 US, including lenalidomide. The FDA made exceptions subject to certain conditions for 4 products based on shortage concerns. We recently finished interactions with the FDA about potential additional product exceptions, and we do not expect any additional exceptions will be granted at this time.
While product continues to be shipped from the facility to markets outside the US, we currently anticipate some impact on other markets, including parts of our ARV business and emerging markets and to select generic products in Europe. We currently estimate the negative impact on 2025 total revenues to be approximately $500 million and on 2025 adjusted EBITDA to be approximately $385 million. 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.
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.
From a pipeline perspective, we have 10 unique molecules in Phase III clinical development across our portfolio, and we are expecting 6 Phase III readouts this year, including meloxicam, which is being developed as a potential opioid sparing treatment in acute pain. In addition, we expect to achieve several important late-stage development milestones for our three innovative assets Selatogrel, Cenerimod and Sota.
To preserve the ongoing continuity of the development programs for Selatogrel and Cenerimod, we have updated certain terms of our original global research and development collaboration with Idorsia. Under the updated terms, we will receive the rights to additional territories for Cenerimod, including important markets in Asia.
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 a Idorsia's remaining development cost obligation. We continue to be excited by the promise of these two assets and we will take full control over the development to help ensure development timelines remain on track. 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 3 to 5 years, and then any given year, we may prioritize one over the other.
In 2025, we are prioritizing returning capital to shareholders. We will continue to support our dividend and are targeting at least $500 million to $650 million in share repurchases this year. 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. From business development perspective, we will target a creative regional opportunities that leverage our unique commercial and R&D infrastructure and capabilities.
Finally, we've begun an enterprise-wide initiative to review our global infrastructure and identify additional cost savings. We expect this program to deliver OPEC savings in 2026 and beyond. Later this year, we'll hold an investor day to talk about our long-term outlook, how we are advancing our base in innovative pipelines, and the progress we are making on our enterprise-wide review.
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 Indore. 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.
Now, I'll turn it over to Philippe to share an update on how we are advancing our pipeline.

Thank you, Scott. Our based business pipeline continues to be highly diversified across core generics, complex generics, and novel products.
This robust and deep pipeline representing approximately 100+ emissions annually is the backbone of our ability to deliver more than $450 million in new product revenues for each of the last 5 years. We made great progress in '24, delivering $582 million in new product revenues, setting us up very nicely to hit our target range of $450 million to $550 million in 2025.
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 liraglutide. Glucagon was approved last year and is actively being launched.
These are difficult to develop and difficult to manufacture medicines, and we are proud of the scientific and development expertise we have built in this area. We plan to continue to leverage this differentiated platform as we further advance our base business pipeline.
In parallel, we're getting these complex injectables to approval, we are also very focused on progressing our novel and life cycle management programs. We have a number of Phase III readouts anticipated in 2025.
The most near-term opportunity is Effexor for generalized anxiety disorder in Japan. We announced positive top line results of our randomized double-blind placebo-controlled Phase III study last year and recently received positive results from the Phase III open label long-term extension required for approval in Japan. We anticipate filing our submission in the first half of this year.
Another key program is for Xulane low dose, which is a transdermal patch that is being developed to offer women a low dose estrogen combination birth control option. We expect our Phase IIIII readout in the first half of this year.
We received positive results from our first meloxicam Phase III bunionectomy study and are feeling optimistic about our development program as we await our second Phase III readout in herniorrhaphy, which is anticipated later this year. 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.
Now, moving to our innovative pipeline, beginning with Eye Care. We are continuing to advance our ophthalmology programs with these three key registrational readouts expected in 2025. We are on track to receive top line data for our MR139 of Pemecrolimus Phase III study for blepharitis in the first half of this year. We also have recently completed enrollment for our Phase IIIII study evaluating MR-141 for Presbyopia and expect to receive top line results in the first half of this year.
Additionally, our partner recently received fast track designation from the FDA for their investigational new drug application for MR-142, which is being developed for the treatment of visual loss in low light conditions associated with Keratorefractive Surgery. A substantial subset of these patients has night driving impairment for which there is no label treatment, thereby supporting the fast track designation. The development of this asset is also progressing well and we anticipate completing Phase III enrollment and receiving top line results in the first half of this year.
And Selatogrel and Cenerimod, we continue to be focused on increasing and accelerating trial enrollment enrollment for both SOSMI and Opus. Recruitment for Opus is well under way with plans to complete enrollment in the second half of this year.
We continue to submit data from the Phase II care study for publication and 3 abstracts have recently been accepted for presentation at 2 major congresses. Lupus 2025 and Pena 2025 discover the multifaceted immunomodulatory properties of Cenerimod and subgroup analysis from the Phase II care study on quality of life and impact on fatigue.
Regarding Selatogrel, the SOSMI trial is progressing according to previously communicated timelines. We have scaled up trial recruitment and increased awareness of the study. We are continuing to build on our legacy in this space and actively engage key opinion leaders and the broader cardiovascular community at key medical meetings around the world.
Moving to Sotagliflozin, we are pleased with the recent publication in The Lancet Diabetes and Endocrinology. This data provides strong evidence of Sotagliflozin's clinical benefit in reducing major adverse cardiovascular events or MAC in patients with Type 2 diabetes, CKD, and high cardiovascular risk.
The findings show that Sotagliflozin significantly and meaningfully reduces maize versus placebo, demonstrating early and broad cardiovascular protection in this population. Sotagliflozin 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 SGLT-2 inhibitors.
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. We will be leveraging the dossier that led to FDA's approval and expect registration in these markets starting in 2026.
To recap, our R&D strategy is grounded in being disciplined about executing our near-term programs while preparing for the future. We have a strong focus on advancing our base business and innovative pipelines across multiple fronts with important complex generics approval, Phase III data readouts, and key development milestones in our novel and innovative pipelines all expected this year. 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.

Thank you, Philippe. I'd like to start by outlining our three commercial priorities in 2025.
First is driving the best business. 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 brain portfolios. 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. 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. The fundamentals of our business are strong, and we are confident we will deliver the expected $450 million to $550 million in new product revenues.
Our third priority is preparing the future business. We are building upon our strong commercial infrastructure by enhancing our innovative product commercialization capabilities and expertise across key markets. And we are developing global commercialization strategies for innovative and novel pipe and assets.
Turning to our outlook for the year. As we heard from Scott, we are expecting an approximate $500 million revenue impact related to Indore, affecting mostly the US and emerging markets. In 2025, we expect total revenues to decline approximately 1%.
Now, let's dive into the geographic segments starting with Developed Markets.
Europe is expected to grow year over year. I want to highlight some of the key positive drivers behind this anticipated performance. First, we expect new product launches in both our brand and generic portfolios, including carryover benefits from the [adovastatinacetamide] combination and rivaroxaban. Then the continued performance of our thrombosis's portfolio as well as key brands like [Crayon and Bruin]. And finally, we anticipate further volume growth in key markets including Italy and France and strong generic performance across our diverse portfolio.
North America is expected to decline year over year, which is driven by the Indore impact and expected competition on certain generics, including Xulane, [leytrium acetate], and [prednisolone]. Our focus is to continue to capitalize on the strength of our complex generics portfolio with a stable contribution of products like Dixella and Breyna, as well as continuing the growth trajectory of promoted brands like Yupelri. And we are actively planning for several new launches during the course of the year in the complex infectable 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, 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.
Moving to [Gens], 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. While we are forecasting [Gens] 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.
Japan is a key market, and we are well underway preparing for the future. We are building our commercialization plans around the number of innovative and novel assets such as Effexor for generalized anxiety disorder, Nefecon, Cenerimod, Selatogrel, and Sotagliflozin.
And lastly, in Greater China, we expect to deliver year-over-year growth in 2025 stemming from the continued patient demand for a portfolio of iconic brands addressing chronic diseases that are more and more prevalent in China's growing aging population. Our significant presence and leading organization in China, as well as our commitment to patient access, allow us to meet expanding healthcare demands. In addition, we expect to deliver on our pipeline with new product launches of Dymista and Breyna in China.
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. Overall, we are confident we will be able to deliver on our 2025 commitments to 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 the Doretta.

Thank you. 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.
We reported 2024 total revenues of $14.7 billion, which was up 2% year over year. This reflects growth across all segments and new product revenues of $582 million, which was at the high end of our increased range.
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. As it specifically relates to the fourth quarter, total revenues of $3.5 billion were in line with our expectations and grew 1%.
We saw continued momentum and growth across China, developed markets, and emerging markets. Our global generics business grew 2%, driven by new product launches and complex products. Gross margins were in line with expectations and moderated in the fourth quarter due to expected segment and product mix.
We had a strong quarter of free cash flow totaling $685 million excluding the impact from divestiture costs and taxes. 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.
Now that we've closed the year, we are also providing an estimate of our 2024 results on an ex divestiture basis. These estimates exclude the benefit from the divested businesses totaling approximately $490 million in total revenue and $255 million in adjusted EBITDA.
Moving to our plan for 2025, I'll summarize the key drivers to give you a full picture of the year ahead.
Given the continued strength of the dollar, we have assumed an FX headwind of approximately 2% to 3% on total revenues. As a reminder, approximately 75% of our revenues occur outside of the US. Excluding the impact of Indore, we expect our operational revenues to benefit from continued momentum and strong fundamentals, primarily in Europe, China, and emerging markets. These trends give us confidence in the continued strength of our base business going forward.
And as you heard from Scott with respect to Indore, ongoing remediation has been an all hands effort and is a top priority for our organization. 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.
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. We estimate an impact of approximately $500 million to 2025 total revenue and $385 million to adjusted EBITDA. This includes estimated penalties and supply disruptions of approximately $100 million, which we believe are mostly short-term in nature.
Lenalidomide, which after discussions with the FDA was not granted an exception, 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. 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. We believe this impact to be short term and expect to recapture some of this volume in the future. In emerging markets, we anticipate our lower margin ARV business to experience certain disruptions over the short term, and we estimate an impact on total revenue of approximately $125 million.
Moving to the drivers of gross margins and our adjusted EBITDA and EPS guidance. We expect gross margins to be impacted by Indore, normal based business price erosion, and an increase in some product supply costs. Partially offsetting this impact is the expected benefit from segment mix.
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. Total operating expenditures are expected to decline as we work to optimize the portfolio and reduce stranded costs associated with the divestitures. Our guidance assumes a reduction of approximately $150 million predominantly benefiting SG&A.
And with respect to Idorsia, as Scott mentioned, we have amended the collaboration agreement. As a result, we expect to incur an incremental R&D expense of approximately $100 million in 2025. 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 Cenerimod. We expect our effective tax rate to increase by 150 basis points in 2025 due to anticipated impacts from Pillar Two.
A few points on our expectations for free cash flow and cash available for deployment in 2025. We expect strong free cash flow generation of approximately $2 billion, which takes into account IndorE remediation and foreign exchange totaling approximately $300 million. 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.
Consistent with our stated strategy, we continue to prioritize capital return in 2025 with a focus on share repurchases. As such, we expect to repurchase between $500 million and $650 million throughout the year, preserving flexibility to the upside. 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. Total revenue is expected to be higher in the second half, driven by the back weighted launch of new products and normal product seasonality.
We expect operating expenses to be evenly phased between the first half and second half. 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. 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 Indore related products and volume and seasonal impacts in Europe and [Gens].
Finally, we will continue to be disciplined with our financial policy 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. 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. We look forward to updating you each quarter on our progress and being available for your questions.
And with that, I'll hand it back to the operator to begin the Q&A.

Question and Answer Session

Operator

(Operator Instructions)
David Amsellem, Piper Sandler.

So, first, I guess on the warning letter and the remediation, I guess any time there is a warning letter, you can't help but wonder 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, to endure and not something that you're worried about in terms of 483s and potential warning letters at other sites. So, that's number one.
Number two on Cenerimod and Selatogral, just given your comments on enrollment, can we assume that these are going to be '27 events in terms of the data? It doesn't look like '26 may happen, but I just wanted to get your thoughts there regarding the timing of Phase III.
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? Are you looking more at returning capital to shareholders and comfortable with the current business? I guess just a bigger picture question in terms of where you want to take the company?

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 Indore 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 issues there for us to be able to handle no warning letter issued there at all. So that was, that's closed out in terms of Carroll Park.
The third facility is in Nasha, India, and there was an inspection there. The classification of that is pending. 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 with all the relevant health authorities. So that's where we're staying. We're waiting to hear back on (inaudible), but everything else is in compliance at this point in time.
And again, this is the Indore situation was was 1 out of 26 facilities in our network, an important one, not to diminish that, but 1 of 26 within the network. I'll go to capital allocation again and I'll kick it over to Phillipe to talk a little bit about Cenerimod.
A lot of growth, our capital allocation plans have not changed at all. Over the next 5 years, we plan to allocate 50% to shareholders, dividends, share buybacks, 50% to business development, and that business development will be both supporting regional business development, accretive transactions to build our revenue and our dividend, also innovative programs to add to the pipeline.
In any one year, our priorities may be a little bit different. I think our priorities this year are a little more focused on on return to shareholders. We're going to be a little more aggressive on the share buybacks. As we said in our prepared remarks, $500 million to $650 million and buybacks at a minimum for this year, but we'll also look for some business development things which can be creative and help build our revenue and EBITDA streams.

And to Scott's point, the $1 billion of capital we've announced. Even with that number, we are maintaining strategic flexibility going forward to evaluate all options for capital that includes additional share buybacks, that includes accretive business development and the ability to continue to delever if we deem if we'd like.

And this is Philippe with regard to Selatogrel and Cenerimod. Yeah, the data is expected late 2026 for both programs. 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 that late 2026 timing for the data.

Operator

Ash Verma, UBS.

So I wanted to understand the implications for 2026. So typically, these type of warning letters can take a minimum of 2 years to resolve. I know you said that (inaudible) was already going to go off, but did you have some offsets planned for it already? And then secondly, just with today's update, I mean right now, the stock is trading 12% to 15%, down in pre-market. Why not be more aggressive on the buyback beyond what you've guided here?

So the remediation efforts in Indore are, I would say, more than halfway done. We expect to be done as we get to the late spring, early summer with the radiation at that point, we'll ask the FDA to come in and reinspect 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. We were unable to do so. We looked for alternate sources of Lenalidomide and continued to do so.
However, Lenalidomide is scheduled to hit a secondary patent cliff, I'll say, or expected to the economics of it, expected to significantly diminish as we get into January of '26. So from a Lenalidomide 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 and as part of our revenue in EBITDA, but it was an event that was going to happen within within 10 to 12 months. We are looking high and low for alternate ways to be able to fill that. At this point, we don't have any.

So with today's update right now, the stock is trading sort of mid-teens down in pre-market, why not be even more aggressive on the buyback here beyond what you've guided.

I think what we're trying to say here, our sector leading cash flows give us tremendous flexibility to do a number of different things. We are planning right now to give back between $1 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 million to $650 million as a minimum for this year, but we will balance that as and we'll balance that share buyback relative to some business development opportunities, regional and creative deals that can help us build some more revenue in EBITDA. But certainly, in consideration will be increasing that the share buyback program if the stock remains under pressure.

Operator

Chris Schott, JP Morgan.

Maybe first, can you just elaborate on the scope, the 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 Indore and 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 Indore and how much of that's coming from some of the factors that you cited?

This cost initiative was something that we had in our heads for a little while. If you think about the cadence of the pattern of the company 4 years ago, there was a merger of two large global companies. And then since then, we have divested 4 major businesses in terms of biosimilars, women's healthcare, OTC, API business, and given all that, I think it's really good timing.
And then with the Indore 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 and not only from a cost efficiency standpoint, but also are we fit for purpose for being able to deliver our goals in '25, '26, 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 where our resources are allocated and make sure that we are organized best for today and for the future.

And to your question, Chris, around gross margin, there were a couple of components as I mentioned, that were factoring into the step down. The largest component is Indore just given the high margin nature of both the penalties as well as Lenalidomide, the margin impact of Indore is about kind of close to 80%. margin. And then, in addition to that, we just have normal kind of based business price erosion and increase in some product supply costs and that has been offset with kind of benefits from just ongoing segment mix in our business.

And just to follow up on your first question, I think I missed the part around 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 the effect of 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.

Operator

Jason Gerberry, Bank of America.

So just for me, maybe I missed this, but why does the Indore facility issues have an impact on revenues outside the United States? And then my second question, just thinking about your generic pipeline assumptions for 2025, what are you thinking in terms of a, I know this isn't like a new product issue, but like, is generic Symbicort a headwind in 2025 due to competition? And how would you frame maybe the risk profile and aggregate of the pipeline contribution this year versus last year's pipeline contribution?

So just on the first question, I think when you get a situation like Indore and a warning letter and an active remediation that's ongoing right now, that active remediation sometimes can cause you to have a pause in manufacturing supply issues in certain cases. Even though the product can go into Europe, there might be shortages of certain products as we work through that plan and remediate.
We look for alternate sources of products while we're doing the remediation so you can see some some shortages with some products, but certainly not across the board and it's very specific to product and location, but it has to do with the remediation of the facility. And again, we've got a network of 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 Indore.

Why don't I cover to your question around new product revenue, Chris, kind of our confidence in the $450 million to $550 million. We do think this is a de-risk number. We're confident in our range. Our history shows that we have 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 products. And in addition to that, we have several complex products, one of which Glucagon 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.

And on your question specifically -- this is Corinne. On your question specifically on on generic [symbicort]. So Breyna, I want to mention that we are very pleased with the performance of Breyna. And we continue to believe that Breyna will be a key contributor to our revenues and to our complex genes portfolio in 2025. So, this is our our assumption going forward.

Operator

(Operator Instructions)
Umer Raffat, Evercore.

First, Scott, Doretta, for you. At the conference in January, you guys talked about for the Indore warning letter, you guys mentioned it's 11 products and 4 of the 11 were exempt and more could get exempt, so most folks listening in just assuming what, hundreds of products in this company, 11 of them, so probably not so much. But the type of EBITDA hit we learned about today, considering also that you knew generic (inaudible) was one of them, I'm just curious about the thought process around how you guys communicated that to investors previously.
And secondly, on the Idorsia deal, I'm just curious what's the new information you've learned perhaps on a blinded basis for the ongoing trials which drove the decision to put in another $100 million which was technically what Idorsia 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.

Yeah, so relative to disclosure, JP Morgan, it was a very dynamic situation at that time. There were some products which were excluded, others in which we had an agreement from the FDA that we could go ahead and ask for exclusion and put our case together why. So, we were unsure exactly what that would look like. We were also exploring alternate forms of Lenalidomide from other companies to help fill that shortage gap So it was a very dynamic situation at that time.
We didn't even have a good view on exact whether Lenalidomide 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, for me at JPMorgan 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 what exactly that list would look like and what exactly the impacts would look like that I could share that.
And I think it's only been in the last couple of days that it's been very clear to us what the US and non-US impacts are including Lenalidomide. I think the distortion that you see in terms of the magnitude from a revenue and EBITDA perspective is because specifically of Lenalidomide and the profit profile of that particular product.
Idorsia, Philippe, do you want to just address what the status of those programs and what gives us confidence to continue to invest in them?

Yeah, so certainly, we like what we see. We have had significant interaction with the KOLs and and various PIs as well. The momentum 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 Selatogrel I think, as I've said previously and this is continuing.
What is particularly important is that we're seeing the patient self-injecting, self-injecting at the right time, which is within 30 minutes of the onset of symptoms, and then following up and taking themselves to the hospital for injection. 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.

And 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 positive, as Phillipe said, not that we obviously the data is blinded. We haven't seen any data that would direct us in a way, but just the way that everything was progressing, it felt to us like these programs are getting more important to us rather than less.
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 it 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, be able to get in Cenerimod 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. It just seems to me like the right time to do it and a very beneficial situation for us at that nature.

For Cenerimod, just briefly, the rate of Interferon-1 high in Japan is extremely high. For SLE, it's very close to 100%. So having access to that population for Cenerimod specifically is quite important.

Both from a research perspective and from a commercial perspective, yeah.

Operator

Balaji Prasad, Barclays.

Firstly, curious about the investor day, you have your task clear for you in getting Indore clear, new complex generics launches on track, and some of the key pipeline events seem to be geared for late '25 or 2026. So what would the focus of the investor day be? Is it more of incremental updates or are you envisaging a strategic shift? That is one.
Two, probably a minor follow up on Indore, it's reassuring to see that you're 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're ready for an inspection?

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. 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 reinspection by the end of this year or early into 2026. That's our baseline 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 3 main things that we really like to focus on. What does our long-term revenue, EBITDA and EPS outlook look like? You know this is a year in '25, certainly an unexpected challenge in terms of what we have an Indore and moving up the loss of real economics and Lenalidomide, 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 5 years. We want to talk about the pipeline, both the innovative pipeline and what's happening, where are we progressing, what are the enrollment rates look 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, 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 not final numbers likely, but certainly we can give a very good progress update on where we are with that.

And just to clarify a point, all the Phase III 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.

Operator

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.

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 Indore, significant impact here on '25. But you know the base business is strong, as I mentioned earlier, we would have 3% growth in top line, 2% growth EBITDA if it wasn't for the Indore situation. Again, we take it seriously, we're working hard on it, but I'm very excited about the future.
As we head into '25, we're focused on driving strong commercial execution. We're advancing not only the base pipeline, but our innovative pipeline as well. We're prioritizing capital return '25 with a focus on share repurchases. We're executing our remediation plans for Indore, and we're beginning an enterprise-wide initiative to review our global infrastructure and identify even additional, even more additional cost savings. We are very committed to doing the hard work in '25 to drive sustainable growth in '26 and beyond. And look forward to talking about all this and more and giving an update on Indore and everything else as we get to our investor day a little bit later this year. So, thank you again for your attention.

Operator

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.