Teva Pharmaceutical Industries Limited

Welcome to the Teva Pharmaceuticals Industries Limited Q4 2025 earnings conference call. My name is Alex. I'll be coordinating today's call. If you'd like to ask a question at the end of the presentation, you may press star followed by one on your telephone keypad. I'm going to hand it over to Chris Stevo, SVP, Investor Relations. Please go ahead.

Thank you, Alex. Good morning and good afternoon, everyone. Thank you for joining us on our fourth quarter call. Before I turn it over to our CEO, Richard Francis, I just want to remind everyone that we will be making forward-looking statements on this call. Any statements we make are only as of today, and we undertake no obligation to update those statements subsequently. And if you have any questions about our forward-looking statements, feel free to see the appropriate sections in our SEC forms 10-K and 10-Q. With that, Richard Francis.

Thank you, Chris. Good morning, good afternoon, everybody. Great to have you on the call. Also on the call with me today will be Dr. Eric Hughes, head of R&D and chief medical officer, who will be walking you through some exciting developments in our pipeline. And then Eli Khalif, my CFO, who will go through the Q4 and the full year results. So starting with, as I always do, the pivot to growth strategy and the progress we've made over the last three years. As you know, the foundation is the four pillars, Delivering our growth engines, I think you'll see in the results that we continue to have great momentum around our innovative portfolio of Stedo, Yosedi, and Ejovi. That's some great progress on our innovation, so step-up innovation. You'll see that we filed Olanzapine last year and completed the recruitment of the diary study for dual action rescue inhaler and started our phase three, so if you do pick it up in UC and CD. On that sustained generics powerhouse, good progress. Our aim was to get this business back to stability, and we have done that. And now we see some exciting growth emerging from our biosimilar portfolio, and I'll talk a bit about that. And then focus the business. This is all about making sure we allocate capital to the correct areas to give the best return. And we'll walk you through a bit of the progress we've had on our transformation program, which the aim is to have 700 million net savings by 2027. We made excellent progress in 25, and we're on track to hit the two-thirds by at the end of this year, 2026. So now moving on to the actual results. So please read these results. Now just to orientate you on this slide, the numbers on the left include the Sanofi milestones and the numbers on the right do not. So starting with the revenues. So 5% increase in revenues at 17.3 billion. EBITDA grew 12% up to 5.3 billion. EPS grew 19% to $2.93. and free cash flow was up 16% at 2.4 billion. And our net debt to EBITDA is now at 2.5 times, which is, as you know, our goal for 2027 is to two times. So we're well on our way to do that. Now, a slide that I've shown over the last 12 quarters, actually, to show that our return to growth, which was our strategy part of the pivot to growth strategy when we launched it in 2023. And as you see, we've consecutively done this and we did that in Q4 where the growth was up 11%. Now that did include the milestone from Sanofi. If you take that away, we were slightly down at 1%. But let's look at it over a three year period. So over a three year period, these impressive results, once again, reminding you that we had multiple years of sales decline. And so in 2023, We actually grew the business 4% in 2024, 11%, and then last year, 2%. So we're well on track for our CAGR of mid-single digit, as you can see from the slide there. Now, let's get into a bit of detail as to what's driving these good results. So on the next slide, you'll see the innovative performance is one of the key areas of growth for us. And the study you said, Ina Jovi, hit $3.1 billion for the year. This is up about 35%, so excellent results there. And I'm really pleased to tell you that in Q4, we surpassed $1 billion for our innovative portfolio that you see on the screen here. But in a bit more detail, Estero grew at 34% at $2.26 billion. Yosedi was up 63% at $191 million, and Adjovi continues to perform as up 30% at $673 million. Our generics business was flat, worth noting this excludes Japan from these numbers. Now, I've talked a lot about moving from a pure play generics company to a biopharma company. I think these results show we clearly have done that. And now it's a question of just how much we can keep driving this innovative portfolio and the pipeline that comes through. Now, moving on to a bit more detail, I wanted to talk to you a bit about Estetto. So Estero had a really strong quarter in quarter four. As you can see, $725 million up 40% for the quarter. And for the full year, $2.2 billion up 35%. And this was delivered with good underlying growth. As you can see, TRX is 10%. And there's a 19% rise in milligram volume. This has been driven by both new patients and better adherence. It's worth noting that Esteto XR now accounts for 60% of new patients. Now, very impressive results here. Now, we did have in Q4, these numbers did reflect some year-end inventory stocking and some favorable growth to net. And Ellie will talk a bit more detail about that. But if you actually take that out, then we still grew to 20% in Q4. So once again, the underlying growth of this product is very strong. And because of that, we're giving the guidance of 2.4 billion to 2.5 billion for 2025. I think it's worth noting that if we do hit the upper end of that, then that means we've hit the 2.5 billion a year ahead of schedule. But we'll talk in a bit more detail of the puts and takes to that range. Now, moving on to your study, you said you also had another strong quarter. 55 million, up 28%. And for the full year, up an impressive 63% to 191 million. TRX volume grew an impressive 123% year over year. And it's worth noting that more than 83% of the MBRX was generated by patients transitioning from oral therapies or treatment naive, which confirms that UCEDD is expanding the long-acting injectable market, not just taking share. Another impressive fact on your study is it's the fastest growing long-acting injectable in its category. And because of this momentum, our guidance reflects this. And as you see, we have a guidance of 250 to 218 million for 2026. Now moving on to adjovi. Adjovi had a strong quarter as well, up 43% year on year, 211 million. And for the full year, it's 673 million, up 30%. Once again, for a product that's fairly mature, really strong growth. AJP continues to be number one preventative anti-CGRP injectable in the top U.S. headache centers, and it leads in 30 markets across Europe and international. And this continued growth is driven by, I think, our commercial excellence, our ability to continue to take market share, to manage the pricing and the payer environment in the U.S., and to continue to expand in new geographies. And because of this strength, we're given a guidance of 750 to $790 million. Now moving on to the pipeline. So we talked about the products we have in the market and the excellent progress we made on those, but the pipeline is really exciting here. And I do want to mention this, even though I know Eric will talk a bit about it. The things that I always remind people about this slide is every product we're going to launch has a potential of over a billion. the size of the markets we're entering into are significant, and our entry points into these markets are in the short term. And if you look at the total, the total of the portfolio can be over 10 billion of peak sales. There's an addition to this slide that some of you may not have seen, which is we will be announcing two new indications for DuvaKey2 later this year. Once again, highlighting that is a pipeline in a product. Now moving on to our generics business. Our generics business, our aim was to get this back to stability, and we've done that. And the generics business was flat in 2025 versus 2024. Now, one of the things that I do always highlight is you need to look at the generics business over a multi-year period because of the fact that some years you have more launches than others. That's just part of the business. And as you see here, our two-year CAGR is 6%. But for 2025, the US grew at 2%, international markets 1%, and Europe declined 2%. Now, we continue to see good performance from our biosimilar business, and I think I'll move on to that now to talk you through that. And where we started with the biosimilars over the last three years, we've made tremendous progress. It's worth noting that we now have 10 assets in the market globally, and we're going to launch six additional between now and the end of 2027. Then we have another 10 assets that are going to start launching from 28 beyond. So some impressive numbers here. So the aim was to build a world-leading portfolio, and we've done that. In fact, I think we have the second largest portfolio of biosimilars now in the industry, and we've launched the most biosimilars since 2020. And because of this, we're well on track to grow our biosimilar business by 400 million by 2027. Now, to close out, As you've seen by some of the numbers we've talked about, we're well on track to hit our 2027 guidance. The CAGR, I talked about, we currently stand at 6%. The operating margin, we'll go into a bit more detail, but with the success of our innovative portfolio, we're very confident about 30%. Net debt, debit up two times, we're already at 2.5. And cash to earn is 80%. Ellie will walk you through a bit more detail on that. But with that, I'll hand you over to Eric to talk about our exciting pipelines.

Thank you, Richard. Starting with the slide that Richard went over briefly, you know, one of the things about this pipeline is there's three phase three programs and two burgeoning phase two programs. And, you know, the market potential is big, like Richard mentioned, but more importantly, it's the unmet medical needs that we take pride in and what we're potentially going to address. And finally, I'd like to say that, you know, we planned over five years for submissions, so we're very proud of the fact that we've turned around this innovative pipeline and moved it forward so quickly. But I first want to highlight Olanzapine LEI. You know, we got the submission in on December 9th, and we're looking forward to the EU submission in the second quarter of this year. You know, we've shown that this Olanzapine LEI that can address an unmet medical need in schizophrenia has great safety and efficacy, and we want to discuss that with the health authorities and hopefully get that approval at the end of this year. So something very exciting to look forward to. Next, on our DARI program, our Dual Action Rescue Inhaler, we're very proud of the fact that we finished the targeted enrollment of this study at the end of 2025. And in fact, we're going to continue enrolling it to accelerate the back end of the study. You know, and the most important thing about that enrollment, one of the things that's most difficult is the fact that it has pediatrics, adolescents, and adult patients. So I think that the opportunity here for a differentiated product of a dry powder inhaler and the fact that we have the potential to have adolescents and pediatrics in the label is a true differentiator for this program addressing a large unmet medical need in asthma. And then moving on to Dubuque took a very exciting brand new biologic class that's in development You know, a year ago, we showed really exciting phase two data in both ulcerative colitis and Crohn's disease, posting very good numbers in both with a nice dose response. But now we're excited to be looking forward to the maintenance data in the first half of this year. And the important thing about the maintenance data is that we will show, hopefully, the durability of response. And that's really what people need in ulcerative colitis and Crohn's disease. These are chronic diseases. that people frequently fail on their advanced therapies and need more. So durability in the long term is most important. And just a review, you know, this represents 58 weeks of exposure, looking at two different doses given subcutaneously every four weeks. You know, Richard also mentioned that we started our phase three programs with our partner, Sanofi, the Sunscape and Starscape, you know, started right on time and we're accelerating those programs and executing very well. I'll be looking forward to new indications this year. And then moving on to anti-IL-15. You know, we had a very exciting announcement at J.P. Morgan that Royal T. Pharma provided funding for our program in Vitiligo for a Phase 2-3 program. You know, this is really great external validation of our program. What we believe is a very differentiated product to address a number of unmet medical needs. You know, first in vitiligo, this is something that, you know, systemic therapies are needed for, and that result will be available in the first half of this year. But also celiac disease, we're running our second proof-of-concept study with a biopsy endpoint that will be available in the second half of this year. But in addition to that, you know, alopecia areata, atopic dermatitis, and eosinophilic esophagitis are all possible targets for this very important cytokine. And then on to MROSOMIN. You know, one of the things I've been very impressed with is the rate at which we've been enrolling this study. This is a phase two study looking at, you know, critical endpoints of an important unmet medical need. I always like to remind people the mean survival in this disease after diagnosis is six to 10 years. So this is a very important unmet medical need. We are working hard to make sure that this study not only enrolls quickly, but we will over-enroll to make sure that this phase two program as pristine, as powerful as possible, you know, really potentially capitalizing on the ability to accelerate this approval. And before I get on to my last slide, I just wanted to do a shout out for the Ajovi team at Teva. They've done a great job in generating data in migraine, and it's very satisfying to see our innovation is recognized by the New England Journal of Medicine with a publication this month. This is great work by the team and really got that sort of the approval for the only and first CGRP antagonist to be approved for pediatrics with episodic migraine. So very proud and great work and kudos to the team. But finally, I just want to go over something that we take with great pride. We have a very exciting 2026 coming up with many different milestones. in the R&D organization. The DUBQI-TUG data, as I mentioned, will come out in the first half for anti-IL-15 vitiligo data in the first half and CILAC data in the second half of 2026. We'll be looking for that final event in the asthma exacerbation study of DARI by the end of the year, which would be completing the phase three study. The MRS-SOLMEN will be targeting a futility analysis at the end of this year, even in the face of accelerating and increasing the enrollment in that phase two study. And obviously, we're looking for the anticipated approval of Lantipine LAI at the end of the year. And we'll be talking about our first human data for our anti-PD-1 IL-2. So a really exciting year full of catalysts. We're looking forward to all these milestones. And with that, I'm going to pass it off to Eli Kalise.

Thank you, Eric. And good morning and good afternoon to everyone. I will review our 2025 financial results, focusing on our fourth quarter performance, followed by our outlook for 2026. I would like to start with the following key messages that highlight our consistent execution throughout 2025. First, we delivered solid Q4 and a full year result, driven once again by our fast growing innovative portfolio, which is also driving a meaningful shift in our margin profile. This was our third consecutive year of growth since we launched our pivot to growth strategy. Second, we continue to strengthen our balance sheet with a net debt reduced to approximately 13 billion and the net debt to EBITDA ratio of two and a half times, well on track to achieve our targets of two times and our journey to investment grade ratings. Third, we made significant progress on our transformation programs, achieving 70 million of our planned savings in 2025, staying on track to deliver approximately 700 million savings by 2027, achieving our 30% non-GAAP operating margin targets. And lastly, with our performance in 2025 and outlook for 2026, we are well positioned to achieve our long-term financial targets for 2030. Now moving to slide 28. Before I start with the results, I would like to remind everyone that in the fourth quarter of 2025, CEVA initiated a phase three of UC and Crohn's indication for our Duva-Keto program. As per the collaboration agreement with Sanofi, we received $500 million in Q4 of 2025 for this development milestone. This payment positively contributed $500 million to both our revenue and free cash flow and had a positive contribution to our adjusted EBITDA of approximately $410 million. During this presentation, I will be discussing our results for the quarter and for the full year of 2025, excluding the impact of these milestone payments. In addition to these payments, I will also be excluding any contribution from the Japan Business Venture, which we divested on March 31st, 2025, to help to provide you with a like-to-like comparison of our financial results. Now, starting with our Q4 gap performance. Our Q4 revenue were approximately $4.2 billion, up 2% in U.S. dollars or down 1% in local currency year over year. Our key innovative products, Osteto, Adobe, and Uzedi, continued strong momentum, all meeting or exceeding our guidance for the full year. This strong growth in our innovative portfolio and stable generics was offset by a lower proceeds from the sale of certain product rights compared to Q4 2024. Gap net income and EPS were 480 million and 41 cents respectively, including the payments for the development milestones. Now looking to our Nanga performance. Our non-GAP gross margin increased by 80 basis points year-over-year to 56.2% and resulted in our full-year gross margin at 54.7%, well above the top end of our guiding range. This increase was mainly driven by a stronger-than-expected growth in our key innovative products, mainly Ocedo. Non-GAAP operating margin decreased by approximately 120 basis points year over year to 26.7%, mainly because of the higher plan investment in OPEX to support our innovative growth. Overall, we ended the quarter with a non-GAAP earning per share of 68 cents compared to 70 cents in Q4 2024. Total non-GAAP adjustment in Q4 were 649 million, This included impairment charge of $773 million, mainly related to manufacturing facility in Europe. Our free cash flow in Q4 was approximately $800 million and $1.9 billion for the full year, coming at the higher end of our guidance range, excluding the development milestone related to Duva Quito. Moving to slide 29. We are making significant progress in our Teva transformation programs to deliver targeted savings of approximately 700 million by 2027 through a well-defined and planned effort. During 2025, we achieved 70 million of initial savings, demonstrating solid momentum and execution, and continue to expect roughly two-thirds of our total savings target to be realized by the end of 2026. These transformation efforts, along with the ongoing portfolio shift towards high growth and high margin innovative products, provide a clear path to achieving our 30% operating margin targets by 2027, even as we continue to invest in our business for long-term growth. Now, let me turn to our 2026 outlook. As I mentioned earlier, 2025 was a year of strong progress on our people-to-growth strategy. We delivered revenue growth, expanded profits and margin, invested in our innovative products and pipeline, and made significant progress towards our journey to investment-grade ratings. In 2026, we'll remain focused on continuing this momentum and executing on accelerated growth paths to our strategy, starting with our revenue guidance for 2026. We expect full year revenue of $16.4 billion to $16.8 billion. This represents a range of approximately 1% growth to 2% decline compared to 2025. On a normal base excluding the $500 million development milestone payments and $75 million contribution in 2025 for the Japan business venture, this revenue guidance is consistent with our previous communication. and reflects continued strong momentum in our innovative portfolio, including Osteto, Adjovi, and Uzedi, combined with a low single-digit growth in global generics business. It's expected to largely offset revenue headwinds of approximately $1.1 billion from generic revenue in 2026. We expect non-GAAP gross margin in 2026 to be in the range of 54.5% to 55.5%, showing further improvements over a strong 2025, driven again by the ongoing positive shift in our portfolio mix and a cost savings from our ongoing transformation programs. As a result, and as previously communicated, we expected our non-GAAP operating income and adjusted EBITDA to both growth in absolute dollars and as a percentage of revenue compared to 2025. Our operating expenses are expected to be in the range of 27% to 28% of revenue, with a higher impact of the transformation program cost savings in the second half of the year. We expect finance expenses to be approximately $800 million in 2026, lower than 2025, reflecting reduced debt levels and ongoing deleveraging. Our non-GAAP tax rate is expected to be in the range of 16% to 19%, slightly higher than 2025, which benefited partially from IT-related integration plans and the recognition of certain U.S. tax attributes. This brings us to expected non-GAAP earnings per share range of $2.57 to $2.77. Our 2026 free cash flow is expected to be in the range of 2 to 2.4 billion, representing a strong ongoing improvement in our cash conversion profile and consistent with our long-term targets. Now, lastly, let me provide you with some directions on how we think about quarterly progression in 2026. We expect revenue to gradually increase over the course of the year. with the revenue in the second half of 2026 slightly higher than the first half. Q1 is expected to be light, mainly due to the following. First, a year-over-year decline in our U.S. generics revenue, mainly because of approximately $300 million in generic revenue from Q1 of 2025. That is going away. Second, on Stato, During Q4 of 2025, on top of Ocedo's strong underlying performance, we had the benefit of a year-end inventory build and a one-time growth to net of approximately $100 million. While we expect a strong year-over-year growth for Ocedo in Q1 2026, we expect Q1 revenue to reflect the sequential impact of these one-time benefits. We also expect Ocedo revenue in Q4 2026 to be potentially down year over year due to a different purchasing patterns and pricing environment ahead of the IRA implementation in January, 2027. Our non-GAAP margin are also expected to be gradually ramp up over the course of the year in line with the revenue trajectory as well as savings from the ongoing transformation programs. The one-time revenue dynamics that I just talked about will also impact gross margin Q1 beyond the normal seasonality we see going from Q4 to Q1. Free cash flow is also expected to ramp up over the course of the year. Now, on the next slide, I would like to highlight the strong free cash flow trajectory that we are on. There are three main elements that are going to continue to drive incremental free cash flow. going from approximately 1.9 billion in 2025, excluding Duva-Keithog milestone payments, to more than 3.5 billion by 2030. First, our innovative portfolio is uniquely positioned to continue to grow strongly, driving higher margins and free cash flow. In addition, we are on track to achieve 700 million savings from transformation programs by 2027. We don't stop here, and we'll continue to drive modernization of Steva beyond 2027. Second, we continue to strengthen our balance sheet through working capital and CapEx optimization. And lastly, we continue to deleverage reduction in our debt expected to result in a lower finance expenses by approximately 50% by 2030. And we expect to see a reduction in our legal payments over time. Now, turning to the next slide on capital allocation. Our capital allocation strategy is focused on driving our people to growth strategy. This means keep investing in our key growth drivers and our world-class innovative pipeline. We're also making significant progress towards our targets of two times net debt to EBITDA and then investment-grade credit ratings. This progress is recognized consistently by the major credit rating agencies, including the recent upgrade by S&P and an improved outlook by Moody's. With the progress we have been making, I expect to see us achieving these goals in not too distant future, which also position us very well to thoughtfully evaluate additional ways of returning capital to our shareholders. Finally, Before I conclude my review of our 2025 performance, I would like to recreate our long-term targets. We are clearly on the journey to be a leading innovative biopharma company. With our growing innovative mix, a number of key pipeline developments this year, and our free cash flow trajectory, we are confident about the directions we are on to achieve our 2027 and 2030 financial targets. With that, I will now hand it back to Richard for his closing remarks.

Thank you, Eli. Thank you, Eric. So the next slide I'm going to go on to here is the one Eric showed, but I think it's one that's worthy of being repeated. Really exciting year here for Teva with regards to milestones on our innovative portfolio. We have seven milestones here on this slide. So very proud of that, very proud of what the team has achieved. Obviously, we have some exciting data around vitiligo and anti-L15 and celiac disease. We have the olanzapine launch later this year. We have the duva-ketog maintenance data, the futility analysis, which can accelerate our ability to get to the market with demisomerin, treating this very serious disease. So lots of opportunity here to continue this transition to a world-class biopharma company. Congratulations once again to the R&D team for moving this through so quickly. In just three years, we've progressed this pipeline at record speed. Now, it's because of this pipeline, it's because of the continued strong performance we have in our innovative portfolio that I mentioned earlier and Ellie also mentioned. It's why we're confident about the opportunity to continue to grow Teva top and bottom line and why we think it's an attractive investment opportunity. Because as you can see here, not only do we have a significant headroom for Estedo jovi we have the la franchise with usedi performing well but the lands have been about to join it this year i highlighted the amount of biosimilars that will be launched over the next few years and then as we look forward that pipeline the readouts i've just mentioned will start to come to fruition so we'll be able to continue this momentum going forward to move on to my final slide just to conclude our growth journey continues we have three years of consecutive growth we have a six percent kegar Our innovative brands are growing at double digit, and they have headroom to keep growing. We have near-term milestone readouts, seven in 26. We have a stable outlook for our generics business, and we continue to focus on accelerating our pivot to growth journey. And with that, I'll open the floor to questions. Thank you.

Thanks, Richard. Alex, before you line up the question queue, I just want to remind callers, please limit yourself to one question and one follow-up, and if time permits, we will Be more than happy to answer additional questions from you if you get back in the queue. Thank you.

Thank you. As a reminder, if you'd like to ask a question, please press star followed by one on your telephone keypad. And if you'd like to remove your question, that's star followed by two. As a reminder, please remember to pick up your handset before asking your question. Thank you. Our first question for today comes from David Amselem of Piper Sadler. David, your line is now open. Please go ahead.

Thanks. So I have one question on Osteto and one on Zeti. So helpful color on the guide, but wanted to dig more deeply into the various pushes and pulls regarding Osteto in 2026. Can you talk about net pricing dynamics and what's baked into your assumptions, X, the gross to net favorability in 4Q and X stocking. How should we be thinking about what your assumptions are regarding net pricing as we move through the year? And how should we be thinking about what your assumptions are regarding volume growth, particularly on a per milligram basis? So that's number one. And on Zeti, kind of a similar question. There's a lot of volume growth, obviously, but there's obviously significant government exposure, particularly Medicaid. So how should we be thinking about net pricing there and what kind of assumptions you baked into your Zeti guidance? Thank you.

Hi, David. Thanks for the questions. So let me start with Estero. I think the main problem Point to highlight first here is we're really pleased with the momentum we have with the TRX growth we have with adoption of XR and the continued growth of the milligrams as we saw there at 19%. So the fundamentals are really strong. We see a huge opportunity to continue to grow this from a TRX point of view with the amount of patients who are still untreated. So that fundamental is really strong. I think when it comes to the pricing, I think as we communicated last year, our aim has always been to make sure we get value and access. And so we've been very diligent about that for this year. And so obviously it has got more competitive, but we've taken a very disciplined approach to that. And so I think we maintain that value and access. So I don't think you could think of that as anything that's anything of any significance there. And I think the thing to think about with Esteto is, you know, what we've finished 2025 with some really strong growth both on on our top line as well as on our milligrams and trx and as i said if you back out um that inventory building that the gross net is still very strong performance and so if you look at how we're performing all across this range i think we have a a very strong range here um it does take into account some expectation that there may be some destocking in Q4 in 2026, but we'll see how that plays out. Probably the final thing I'll say on Esteto, just to help give some clarity, if you do look at the range we've got and you back out the inventory build that we had in Q4, the growth of the brand is about, the range is from 11% to 18%. So very strong growth on what is a lot bigger base. So I think that helps answer your question on Esteto. On Yosedi, then As you've seen, very strong growth on Yosedi, really strong growth on TRX, and continued really good change in the dynamics of this market that shows the quality of the product. But to your question, I think it's always important to understand that we have Medicaid and Medicare. And so we have that mix. And obviously, we know one is more profitable than the other. And how that mix plays out, we've taken into account with our guidance and our range. But we see this product's continued momentum, particularly as you look at the TRX being so high. So I think this product, we have a lot of enthusiasm around, but that's the fundamentals around the pricing. We factored them in, and it really comes down to those two channels. Thanks for the question, David.

Thank you. Our next question comes from Louise Chen of Scotiabank. Louise, your line's now open. Please go ahead.

Hi, congrats on the quarter, and thanks for taking my questions here. So my first question was, I wanted to ask you, where you see the greatest disconnect between what you're excited about in your pipeline and what the street is really missing on those products? And then second one, just a follow-up, but instead I wanted to ask you how we should think about modeling 2027 in light of IRA and any other pushes and pulls you see here. Thank you.

OK, thanks for the questions there. So the pipeline, I'll probably tag team this a bit with Eric. Um, what I look, I'll never say anybody's missing anything because everybody is, is very experienced in this business. Um, I do think that our pipeline has come along very fast and thick and fast. Maybe that's called people unaware, but I think the quality of our antibodies, the quality of anti-TL1, the quality of Dubuque 2, I think will show out, um, in the data. So I think, Probably what's going to happen, I'd anticipate, is as we turn over these cards and we see the data, then I think Teva will get recognized for what is a world-class pipeline. But it's probably a bit surprising for people to see just the quality of the pipeline that's emerged in such a short space of time. But maybe I'll hand it to him to give his view on that.

Yes. Thank you, Richard, and thank you, Louise, for the question. You know, I would emphasize something Richard said. I think the speed at which we turn around the innovative portfolio has quite honestly caught people by surprise. You know, we've turned on, you know, a brand-new biologic for Duva-Ketug, which is, you know, probably the best-in-class product for TLNA. We've launched, or we will launch, hopefully, Olanzapine LAI this year. But, you know, don't take our word for it. We've had external validation on four of these five programs. Olanzapine LAI got Royalty Pharma funding. Duva-Ketug was partnered with Sanofi, who saw the value. The DARI program was acknowledged by Abingworth. The Anti-IL-15 program was recently acknowledged again by Royalty Pharma. And even Emerus Solman, you know, we've received fast-track designation and orphan designation. So across the entire innovative pipeline, you know, we've accelerated them, I think, a little bit to the surprise of investors. But just look at the external validation that we've had in the pipeline and take that into consideration of your valuation.

Thank you, Eric. And then moving on to your final question about I think it was sort of asking for guidance on Esteto in 2027, which I'm not going to give. Obviously, we've said we're going to do 2.5 billion for Esteto in 2027. We remain very committed to that. As you see in our range that we have announced today, there's a potential that we will hit 2.5 billion in 2026. So we'll have to see how this plays out. I think the most important thing for Estedo is to keep reminding everybody that 85% of people who suffer from tardive dyskinesia are still not treated. And so the opportunity to keep helping these patients, to bring these patients in and give them therapy, I think is a significant growth driver for Estedo. So we also have the work we're doing on making sure that people can benefit from Estedo XR. And as you can see there, 60% of new patients go on to Estedo XR. And we know that helps with compliance and adherence. which also in turn increases value. So I think we have a lot of value drivers for Esteto, but I really don't want to get drawn into 2027 guidance at this moment. I think what I am hoping people will see is what we have great momentum from 25. We're carrying that into 26, and we'll talk about 27 maybe this time next year.

Thank you for your question. Thank you. Our next question comes from Ash Verma of UBS. Your line is now open. Please go ahead.

Yeah, thanks for taking my questions. Congrats on all the progress. So maybe this first one, how are you thinking about funding the R&D? So increasingly seeing more royalties and or profit shares. Just when you think about it strategically, how do you balance not giving away attractive economics to your partner versus seeing a meaningful increase in your internal R&D spend? as you find a growing pipeline. And then secondly, on the T1A upcoming maintenance data, we've seen some competitors that the maintenance data versus the induction sort of bent up on efficacy measures by high single-digit to mid-teens in terms of percentage points. Is that a fair expectation to have as you look towards your upcoming results? Thanks.

Hi, Ash. Thanks for the question. I'll tag team this with Eric again. But on the R&D funding, I think the question was, how are you going to fund this? Are you going to be giving away value if you keep doing these partnerships? So I think the way we think about it is we have a big late stage pipeline. We have a lot of opportunities to drive significant value creation. And when you have a good pipeline, in my experience, my belief is it's about moving it fast to the market to have patients benefit from it and to get revenue. And so We're moving a big pipeline really quickly here. Now, how does it impact economics? It really doesn't impact economics in any meaningful way for a couple of reasons. One is all these brands will be above a billion. Some of them will be multiple billion brands. The second thing is, which is an interesting fact that I think people miss on Teva, is we're starting out with a company with a very different gross margin than many other biopharma companies. So every time we launch an innovative product, it transforms our gross margin, which transforms our ability to drive EBITDA, to try EPS and cash flow. So as I said, the fact that these are not in any way giving away value in the broadest sense, but even with regard to Teva, they don't because of where we actually start this journey. The other thing I'd also like to highlight on this, we are launching so many products over such a short period of time. that that is the focus we're on. And we're going to have a potential to launch four products in five years. And we're going to actually announce more and more indications. So I think the pipeline is about making sure we move it quickly to the market. But in no way are we giving away value. I'd say we're accelerating value because of the speed we're moving. And then with regard to the key to the TL1A maintenance data, what are our expectations? I'll hand that over to Eric to answer, and then I'll conclude.

Yeah, thanks, Ash, for the question regarding, you know, what we anticipate from the maintenance data of TLNI. So, you know, I'd start off by saying, you know, what's the history we've been telling with regards to Duvacita at Teva? We started by saying that, you know, we found in our in vitro work that we had the most potent antibody, the most selective antibody, and the one that probably has the lowest anti-drug antibodies. I think it's about three to five percent we saw in our phase two study. So, with that, we went into our phase two program that we executed very well at speed. And then we came up with the highest reported numbers for both ulcerative colitis and Crohn's disease in two very well controlled and run studies. So the in vitro translated into a very good result in phase two. So if you translate that into what we anticipate in the maintenance, if you think that we have the most potent, the most selective, the lowest anti-drug antibodies, and that we can execute the study well, I I would hope that when we lock the database, we see great results. So I'm bullish on it. Hopefully that comes true, but we'll see what the data shows.

Thanks, Eric. We stand by the fact that we have and we believe we have the best TL1A. Thank you for the question asked. Next question.

Thank you. Our next question comes from Jason at Gerbery of Bank of America. Your line is now open. Please go ahead.

Hey guys, thanks for taking my questions. One for Ellie, just I didn't catch this, but can you talk about what in 2026 guide sort of what's the gross margin outlook versus the OPEX spend ratio? I think the latter would be in that 27 to 28% range that you guys have talked about historically, but just wanted to make sure that that was confirmed from a modeling perspective. And then just for my follow up on vitiligo, I was trying to maybe understand kind of what we're going to get with this upcoming phase 1b. Will we get VASI 75 scores, you know, through the full evaluable period? Are you expecting most of these 30-plus patients to make it through the full evaluable period? Just kind of wondering how robust that data will be. Thanks.

Thanks, Jason. Thanks for the question. So over to you, Eli, on the gross margin.

Hi, Jason. Thanks for the question. So on gross margin, we end up the year, if we exclude the two milestone payments, at a 50% 4.7% gross margin. We are looking to be in the range of 54.5% to 55.5% in 2026. In terms of the OPEX, there are kind of mainly two dynamics there. First of all, as I mentioned in my prepared remarks, we're going to see a bit higher OPEX, still in the range between 27% to 28% in the first half versus the second half just because of the revenue dynamics. during the year. But there is also another element inside OPEX. We're going to see more reduction in our GNA and actually shifting that reduction in between R&D and sales marketing and able to stabilize it at the range of 27% to 28%. So this one didn't change versus our power communication.

Yeah, and the thing I'd add on to that for you, Jason, is Gross margin is a really exciting story for us because, as you see, as we continue to grow our innovative portfolio, we continue to launch products, that gross margin will just keep going up. It's just going to be a question of how much, but it will keep going up because of the fact that we're changing our portfolio so dramatically. Now, with regard to the VistaLigo data, I'll hand over to Eric.

Yeah, thank you, Jason, for the question. So the data that we're going to be presenting in the first half of 2026 is you know, a single-arm study for patients with vitiligo. It's about 38 patients total. It will have the traditional and known endpoints for this field, which is facial BOSI and total BOSI, so it'll be easily comparable to other treatments out there. And that reminds me, you know, the important thing here is that there are limited treatments for vitiligo today. There's one approved, which is a topple that only covers 10% of your body. And Ones that are in development are the ones that are what we need, things that are systemic and treat not only the face but the entire body, more than just 10%. So one of the exciting things we think about when we talk about our anti-BIO15 program in vitiligo is this has the potential to be a once subcutaneous shot every three months, so a quarterly shot potentially to treat a systemic disease. We're looking forward to that. I think you'll get data that will be able to compare it to other treatments out there in development and approved.

Thanks, Eric. Thanks, Jason, for your questions. Next question.

Thank you. Our next question comes from Chris Schott of J.P. Morgan. Chris, your line is now open. Please go ahead.

Great. Thanks so much for the questions. Just sticking on aisle 15, on the development timelines in Vitiligo, can you just elaborate what exactly you need for that 2031 pathway versus 34? And I guess is there a similar opportunity in Celiac there as well? And if I can just do a really quick one, just coming back to Esteto, I think you were talking about roughly $100 million benefit in 4Q, and it sounds like that's between rebate and inventory. Just as we think about destocking in 1Q, could you just clarify how much of that was inventory and how much was kind of this reversal of rebates? Thanks.

Thanks for the question, Chris. Eric, do you want to start with the anti-IL-15, vitiligo, and celiac?

Sure. So thank you for the question on IL-15. So just to start off with, IL-15 is a key cytokine in a number of different indications I mentioned before. We're working on vitiligo and celiac. I'm excited by both the potential for alopecia areata you know, atopic dermatitis or eosinophilic esophagitis. They're all interesting and important for this cytokine. You know, for vitiligo, we're particularly excited because this is a program that we can move quickly. It has precedence for the regulatory endpoint. It's an endpoint that you can easily measure. You see the results. So that makes it a little bit more easy. And, you know, there's an unmet medical need here. We need systemic therapies, as I mentioned before. So we're thinking out of the box at Teva. We are accelerating this program in a clever pathway of a Phase 2 and Phase 3 study that we can work very quickly with regulators. So, you know, the potential for a once-quarterly dose subcutaneous shot is very exciting to us.

Thanks, Eric. And then on the aesthetic question, Chris, the way to think about that 100 million is the vast majority, the vast majority pretty much was the inventory. So that's why obviously we have a lot of confidence about 2026 on our numbers. So hopefully that helps, Chris. Thanks for your question. Next question.

Thank you. Our next question comes from Uma Rapat of Evercore ISI. Your line is now open. Please go ahead.

Morning, guys. Thanks for taking my question. If I look at the delta versus consensus this quarter, it looks like it's driven by sales and marketing when I take out the one-timer impact of the milestone. And coincidentally, I feel like this is probably the highest sales and marketing spend quarter we've seen in the last three years or so. So I'm curious why that is, especially because it's happening in the middle of the transformation that's underway, number one. Secondly, for 26 guidance, is it fair to say that the Royalty Pharma $75 million payment for Phase 2B is embedded within the EBITDA? And is there any other milestones that are baked into the EBITDA guidance as well from TL1A or anything else? And then finally, on Vitiligo, Opsalura obviously has not necessarily done too well, but as Eric pointed out, has limited coverage. But is it fair to say that on the scores like Opsalura showing about 30% facial VASI 75 score, you would want to be tracking meaningfully north, considering Royalty Pharma is all excited and they're not funding celiac, only doing vitiligo. I'm just curious about your overall take on expectations. Thank you.

Hi, Omar. Thanks for the questions. You got a few into that one question there. So thanks for that. On the sales and marketing and the OPEX, I'll hand that to Eli to talk about.

Okay, Omar. So first of all, about the question about royalty pharma, out of the 75 million, the way that we view it, it's actually going to spread over 26 and 27. with the third out of the 75 going to happen in 26. It's more kind of back-loaded for 26 years. And that's the only thing that's embedded there. We don't have any other, I would say, assumptions in our EBITDA related to TL1A milestones or anything like that. As far as related to the sales marketing, if you actually back out the the higher revenue due to the milestone you can get to kind of a 15.4 percent on sales marketing but going forward next year we're going to see that one actually 16 and why because we are keep investing in our growth engine and which is a stator and actually heading to next year uh building kind of investment into our land that's being launched so we're going to see that one increasing but all in all the old bucket going to be, from dollar perspective, really kind of a flat, but also from percentage perspective, due to the fact that you will see our transformation program going to impact the GNA, as I mentioned, to Jason. And that's kind of a reduction in GNA going to split in between the R&D investment and into the sales marketing.

Thanks, Eli. And look, one thing I'll just add on to the back of that before I hand it over to Eric. if you think about the guidance for this year, the EBITDA range, I think, is showing the value of the programs we put in place, the value of driving our innovative portfolio, the fact that when we talk about our transformation program, it was 700 million net savings after investing in our growth drivers. And so we've allowed ourselves to make sure that we can drive this innovative portfolio, which helps drive our EBITDA, but at the same time, our efficiency programs help also drive the EBITDA. So I think, you know, We're very pleased and proud of the fact that our EBITDA starts with a five in front of it, which I think is important, but we're very mindful of how we spend our money, where we allocate our capital. When it comes to Vitiligo, I'll hand that over to Eric.

Thank you, Umar, for the question. When it comes to what data we've seen with the topical out there today and what's in development, I always want to be competitive on any endpoint that you talk about. You know, hopefully when we walk the database and get that results, we can show that we're competitive against what's available. But again, let's focus again what patients need. They need systemic therapy that's conveniently given. So it's almost inappropriate to compare it to a topical on 10% of your body, but certainly we hope to be competitive.

Thank you.

Thanks, Eric. Thanks for the question, Zuma. Thank you. Our next question comes from Les Salewski of Trust. Your line is now open. Please go ahead.

Good morning. Thanks for the questions and congrats on the progress. I just wanted to focus by a similar side. So what's the launch cadence and expected profitability profile given the U.S. channel and PBM dynamics? And then what are the prerequisites for targeting the 10 new products beyond 2028? And you've previously evaluated or mentioned re-evaluating BD within the space So, you know, what type of, whether it's in licensing, co-development, or tuck-ins, fits your leverage and margin profile today? And has that bar changed given the latest policy dynamics? Thank you.

Hi, Les. Thanks for the questions. So talking about biosimilars, yes, it's an exciting time. And I think the fact that we built the second largest portfolio and continue to add to it in such a short space of time is a testament to the prioritization we put behind it. But to sort of give you a bit of specifics, and when we talk about, we have 10 in the market now, we have six to launch between now and 27. Those six, majority of those will be across both US and Europe, which is important because we haven't actually had a presence in Europe of any significance. And we know that market is a market with quicker update, more predictability, and some very clear returns. So excited about that. And to name just a few, we have Biosumma Prolia, Biosimilar Xtiva, Biosimilar Symphony, Biosimilar ILEA, and Biosimilar Zola. So we have a lot coming through of those markets, and most of those are in both. I think it's Symphony that's just in the US. Now, you highlighted the 10, and you sort of, in your question, it sounded like we had targeted 10. No, we have 10. They are in our pipeline. But we're just going to add to that. So we have 10, which is why I said we can start launching 28 onwards, but we are continually adding to that. And the final part of your question is doing this through partnerships, how does that work out in a gross margin? So we are going to continue doing it through partnerships, and it still is attractive from a gross margin point of view with the right partnership. It's still accreted to our business, our generics business significantly. And that's how we do it. And you'll probably start to see some deals coming through already in the first half of this year as we already build out this portfolio beyond the 26. And then the final thing I'll add on that, this Biosigma portfolio is still coming through thick and fast. And that's going to really help us drive the generics business going forward, both in Europe and in the U.S. But thanks for your question.

Could you repeat your BD question, please?

I essentially just wanted to get a sense of if there's a potential for you to kind of dive a little bit deeper via BD within the space. If there's anything available out there via partnerships that you've previously had, essentially, what's your strategy for that space? Thank you.

So are you asking about biosimilars?

Yeah. So that's what I thought. So that's I think I answered that question well, Les. We'll continue the partnerships. Some of those we already have, you know, good big partnerships with companies that we think we can have the potential to expand those, whether that's MapScience, whether that's Samsung. So I think we're looking at expanding, but also we have other companies that have approached us to be their partner, because obviously the performance we've had in the U.S. has been impressive. We have the fastest-growing biosimilar Humira. We have a very fast-growing business now in the U.S., so I think people are seeing that. But, yes, it will be through partnerships. the majority of it. Thanks for your question, Les.

Thank you. Our next question comes from Dennis Ding of Jefferies. Our line is now open. Please go ahead.

Hey, good morning. Thanks for taking our questions. I had two, if I may. Number one, sort of a big picture question on R&D. What is your R&D philosophy at Teva and I guess how much de-risking do you think we'll get around the R&D platform from the data readouts this year? I'm also curious what else could be planned for 2027 as you advance some of these newer drugs forward. And then number two, just a question around BD. I'm curious as you transition to a novel biopharma company, if your BD philosophy has changed at all? if Teva might be interested in doing acquisitions in, let's say, the classic biotech space rather than what's historically been spec pharma. Thank you.

Thanks, Dennis. Thanks for the question. I'll tag team that with Eric and maybe start on the philosophy of R&D, or maybe we call it the strategy.

Yeah. No, thank you for the question, Dennis. And, you know, this is a very important question. And I think that, you know, the philosophy and the way that we operate at Teva is we are ruthlessly driven by data. You know, we have, first and foremost, a pipeline in phase three and phase two that's, you know, relatively de-risked. I think MRSOMA is probably the lowest on the probability of success. But when you think about our programs, we use known science. We combine it in a way that will execute well and quickly with regulatory approvals. And that's based and driven solely on data. You know, one of the things I've noticed and been able to achieve here at Teva is when we see data, we pivot and we move forward with it. That's something I haven't been able to do in my career in other places. So speed and execution driven by data with this philosophy of known science and de-risk assets is how we will move forward. I think that's baked into every one of our programs at this point.

Thanks, Eric. And let's move on to your next question. And you said, what about BD and as we pivot into a biopharma company? So firstly, thank you for the recognition that we are pivoting. And I think we've pivoted. But anyway, we'll keep showing that with the pipeline as it comes out. But yes, we are actively looking at BD. We think we have a commercial powerhouse of a team. I think you've seen that with the results of Esteto, Yosedi, and Ejovi. And so we want to add to that team. Now, that said, we have, as Eric highlighted, a really exciting pipeline. So the organic growth we have coming through is impressive. So we're not desperate to do BD. We don't have to. At the same time, if it fits into our TA areas of CNS neurology and immunology, then I think it's very synergistic and it makes a lot of sense. So we are very active in that. What is interesting, I think within the last year to 18 months, the amount of approaches we've had has significantly increased. And I think that's because they see Terra as a partner, both from an R&D perspective, the speed which we move things through the clinic is exciting, but also primarily because the commercial capability and muscle we have and the focus we give assets. When we have an asset, whether it's in development, we focus on it really quickly. Whether it's in the market, we focus and we actually drive sales. So I think we'll hopefully be able to talk about something going forward, but we are very disciplined in our capital allocation and we think it's the right asset at the right time at the right price. We'll definitely do it. But because of the pipeline we have that's coming through, we can stick to that in a very disciplined way. And we will because going back to that fourth pillar of the Pivot to Growth strategy, It's about focused capital allocation, making sure we give a good return on that in the short, medium, long term and create value for shareholders. So thanks for your question, Dennis. And I think with that, I think that is the final question. We went over a bit, but I think we did start a couple of minutes late. So thank you for your questions and your interest in Teva. And I look forward to following this up later with our Q1 results. Thank you.

Thank you all for joining today's call. You may now disconnect your lines.