Teva Pharmaceutical Industries Limited

Hello and welcome to the Q3 2025 Tether Pharmaceutical Industries Limited Earnings Conference Call. My name is Alex and I'll be coordinating today's call. If you'd like to ask a question at the end of the presentation, please press star followed by one on your telephone keypad. I'll now hand it over to Chris Stevo, SVP, Investor Relations. Please go ahead.

Thank you, Alex. Good morning and good afternoon, everyone. In a moment, I'll hand the call over to my CEO, Richard Francis, But before I do that, it is my duty and my honor to remind you of our forward-looking statements. Today on this call, we'll be making forward-looking statements, and we undertake no obligation to update those statements after today's call. If you have any questions regarding forward-looking statements, please feel free to see our SEC filings under Forms 10-Q and 10-K in the relevant sections. And with that, Richard Francis.

Thanks, Chris, and good morning, good afternoon, everybody. Thank you for joining the call today. On the call today, I'll be joined by Dr. Eric Hughes, head of R&D and chief medical officer, and Eli Khalif, the CEO of Teva Pharmaceuticals. So starting with, as I always do, the Pivot to Growth strategy. This is a strategy that have guided Teva for the last three years. A strategy based on the four pillars, deliver on our growth engines, which is all about driving Esteto, Uceti, and Ejovi, our innovative portfolio, stepping up innovation, which Eric will talk to you about, but the great progress we're making across our innovative pipeline, sustained generics powerhouse, and the work we've done to stabilize our generics business, and then focus the business. And we'll give you an update on where we are with our transformation of Teva, our $700 million cost-saving programs, as well as an update on TAPI. Now moving on to the actual results. Pleased to say this is our 11th quarter of consecutive growth. up 3% in revenue to $4.5 billion, and adjusted EBITDA up 6%, and our non-GUT EPS up 14%. These all compare to Q3 2024, and our free cash flow is just above half a billion. I'm really pleased to say that our net debt to EBITDA is now below three times for the first time since 2016. Now, moving on to the next slide, one of my favorite slides, I have to admit. Um, this is our 11th quarter consecutive growth after many years of sales decline. And it's worth noting that Q3 24 was a particularly difficult comparison year where we had growth of 15%. And so to go 3% over that comp, I think, uh, is a Testament to the work we've done on our portfolio and the Testament to the teams. Now this puts us on track, um, for our growth targets we set for 2027. to have mid single digit growth. So congratulations to the whole team that have made this happen over the last 11 quarters. Now, going down a bit more detail, what's behind this $4.5 billion revenue and 3% growth? Excuse me. This growth was spearheaded by our innovative products, and I'm really pleased to say that they are now worth over $800 million for the quarter, and the growth is 33% year on year. Estero grew an impressive 38%, reaching $618 million. Yasedi performed strongly, up 24%, reaching $43 million. And the Jovi performed well, up 19% to $168 million. Global Genetics Revenues was up 2%. And TAPI was down 4%, reflecting some seasonal volatility. So now I'm going to double click and go into a bit more detail on all of these areas, starting with Estero. As you know, Stedo was selected earlier this year for CMS, the 2027 price negotiation. And I'm pleased to say that agreement that we've concluded is consistent with our midterm expectations for Stedo that we first laid out back in May 2023. And this means that we can confirm with confidence our 2027 revenue target of 2.5 billion and our peak sales target of over 3 billion. Now let's talk a bit more about Stedo in Q3. It was another strong quarter for Esteto, where the team continues to perform incredibly well. The US reached 601 million in Q3 25, growing at 38% year over year. And this is the first time we have passed 600 million. So congratulations to the team for all their hard work in making this happen. And it really reflects the understanding this team has of the market. We grew TRX 11%. And we continue to see the increasing penetration of Esteto XR. And it's worth reminding everybody again that Esteto XR requires fewer scripts compared to the original Esteto. And that's why it's equally important to look at the milligrams dispensed. And as you can see, these are up 25%. Now, as you see on this slide, we've highlighted that with 2026 approaching, we have a good sense of Esteto's 2026 forming position. And we continue to reflect the balance between preserving value and maintaining access. So based on these strong results in Q3, we can increase our revenue outlook for Stedo to $2.5 billion to $2.1 billion for the year. Now moving on to Yosedi, another exciting member of our innovative family. Yosedi continues to perform well. Momentum remains strong. as we continue to address the needs of the mild to moderate patients and those beyond who take risperidone. Revenues are up 24% year over year, and TRX was up a strong 119%. It is worth noting that revenue growth was partially impacted by a one-time Medicaid gross debt adjustment. Now, this does not impact our long-term LA franchise expectations, and we reiterate our peak sales target of $1.5 to $2 billion for the franchise. Now, this confidence is rooted in the data. Your study's MBRX is significantly above the TRX. As you know, in Q3, we also had an expanded indication for bipolar 1 disorder. Now, to give you more guidance on how to forecast your study going forward, the Q4 implied guidance of 55 to 65 million provides a cleaner run rate for forecasting going forward due to that gross to net adjustment in Q3. But I want to take a couple of slides just to talk about the excitement we have around our L.A., our long-acting franchise in schizophrenia. And why do we think this $1.5 and $2 billion is achievable? Well, it really comes down to the great work that's been done with UCEDD already. You know, the team here has created great traction, as you can see, with 119% TRX growth. We have a great product profile with UCEDD, and we anticipate having a similar strong product profile with Olanzapine. But more importantly, the capabilities and the knowledge that has been built here, we have the same people in front of key payers, the same people in front of these key physicians, these key nurse practitioners, healthcare providers, patient associations, the people who look after the forming committees. That puts us in a very strong position. And we know and believe there's a significant unmet need in the olanzapine for a long-acting treatment. If you put those two together on this slide, We have the ability with Yosedi and our long-acting olanzapine to treat up to 80% of patients who suffer from schizophrenia, whether that's mild to moderate with Yosedi or moderate to severe with long-acting olanzapine. And just to highlight, unfortunately, 4.7 million people suffer from schizophrenia in the US and Europe. So the opportunity for both brands is significant. That's hence the reason why our confidence in the 1.52 billion remains strong. Now moving on to Adjovi. You know, I do love a job. It continues to grow strongly across all regions in what is still a very competitive market. And it's nice data points here. We are the number one preventative CGRP injectable in new prescriptions among the top U.S. headache centers. And we are the number one preventable CGRP injectable in 30 countries across Europe and international. And so we confirm our guidance of 630 to 640 million. Now, staying on innovation, I'm going to touch briefly upon the innovative pipeline. As I know, Eric, we'll talk to you about this later, but I'm super excited about this. Why? Because it's near term. These are late stage assets. Alanzapine, I'll talk to you about the filing of that this year. Dairy, the good recruitment that we're seeing to bring that to the market in 27. Dubikita, starting our phase three study. And Rosomum, great recruitment there. But then I look across to the right-hand side of the slide, and I see the potential of peak sales, and it's over 11 billion. And I remind you, that's just for the indications on this slide. We know that dupuquitug and anti-IR15 will be pursued in multiple indications. So we really have strong growth drivers for the future for Teva. Now moving on to our generics business. Our generics business grew 2% over 2024. And this is fueled by launches as well as the growth of our biosimilar and our OTC business. As I reminded you before, we tend to look at this business over a two-year CAGR just because of the inherent timing of new launches that we have in this business. Now, looking at the regions, we had a very strong quarter for the U.S. It grew 7% in Q3, and that was driven by several launches and particularly strong performance of biosimilars, as well as some phasing patterns for our generic Revlimid, which I would like to point out, these will not be repeated to the same magnitude in Q4. Europe declined 5%, mainly due to some tough comparisons the prior year where we had a number of launches and a number of tender wins, which are for two-year periods. So there's a 1% CAGR for the two years. International markets grew at 3% or 12% on a two-year CAGR. But now I'd like to talk to you a bit about our biosimilars because we're entering an exciting period for our biosimilars portfolio. We now have 10 inline assets globally and the potential to launch six more through 2027. So we're well on track to add another 400 million by 2027, as we forecasted back at the start of the year. And I want to remind you that today we're growing strongly in biosimilars without substantial launches or revenues in Europe, which is the largest region in the biosimilar market. And our European pipeline will start to convert into launches and revenues, and biosimilars will be a more significant driver for Arteva overall after 2027. Now moving on to the fourth pillar, focus on business. we made significant progress with the Teva transformation program. And this is something we started at the start of this year. And we made a commitment to realize two thirds of the 700 million by the end of 2026. And I can tell you on track to do that. The reason why I can tell you that is because we're on schedule to hit our 2025 goals. And that sets us up well for the start of next year. But I'll leave Ellie to go into a bit more detail later on in this presentation. Now, before I hand it over to Eric, I wanted to give you an update on how we're tracking for the 2027 targets, which we are reiterating today. So from a revenue point of view, with the IRA negotiations now finalized, our upcoming launches and the stabilization of our generic business, we estimate that 2025 will end the year with a 3% to 4% growth range, consistent with our 23% to 27% mid-single-digit average growth. On OP, because of the work we've done of driving our innovative portfolio, remind you, up 33%. as well as the progress we made on organizational effectiveness, we are on track to our 30% margin. And this year, we will end around the 27% margin overall. And then that EBITDA dropped below three, as I mentioned earlier. By the end of this year, we should be around 2.8, well on track to hit the two times by 2027. And with that, I will hand over to my colleague, Eric Hughes.

Thank you, Richard. Now, as Richard said, we have a healthy late stage development programs in our innovative medicines, and we're doubling down on our efforts to execute these studies on time and efficiently. Now, beginning with Lanzapine LAI, we're on track for FDA submission later in this quarter. Our DARI program for both adults and pediatric patients is on target for enrollment by the end of this year. Our Duva-Ketog program in partnership with Sanofi is now initiated. Both are ulcerative colitis and Crohn's disease phase three studies, Our MRASOMA program has now enrolled the 100 patients that we'll need for our futility analysis by the end of next year, and then enrollment continues to do very well. And finally, our anti-IL-15 program, very exciting program with multiple potential indications in the future where we'll be reading out our celiac and our vitiligo studies proof of concepts in the first half of next year. So exciting late-stage programs. But before I go on to those in more specific detail, I did want to have a celebration for the USETI team for bipolar I disorder. We had an approval and expansion of our label, which we're very proud of. This was an innovative approach by the team using the known and well-characterized pharmacology of USETI plus the safety database that we have in conjunction with efficacy using a modeling and simulation approach to expand that label for patients suffering from bipolar I disorder. A great innovative approach, very efficient execution, and a great opportunity for patients to get treatment for their bipolar disease. Now, on to olanzapine and LEI. As we've mentioned, you know, we've actually presented the data about the safety and efficacy of the full program in phase three at the 2025 SITE Congress Annual Meeting. It was very well received. Both the safety and efficacy was right where we expected it. And most importantly, we had no cases of PDSS. And that submission is planned for the late half of this quarter. So on track and exciting opportunity for patients in the future. Moving on to our dual action rescue inhaler program for asthma, our ICS Saba Phase III program. This is the largest study we've run at Teva to date. Right now we're on track for full enrollment of our adults and our pediatric patients at the end of this year. And remember, the real value here is the fact that in our label we anticipate to get the pediatrics included, which is 25% of the market. And also we'll have a dry powder inhaler, which is a simple device to use. Simply open, inhale, and close. This makes it much more convenient for both adults and particularly the pediatric patients. So great program, right on track. And as I mentioned before, we're very excited to announce that we have now initiated both the ulcerative colitis and Crohn's disease phase three programs with our partner Sanofi for our Guva-Ketoc program. This is a very exciting program, very large effort by many people. The ulcer-required study is called SunScape, and the Crohn's disease program is called StarScape. And what we're really excited about with this program is the way we've designed phase three. It includes an open label feeder arm that will enroll patients very rapidly, since it's open label and they know they get treatment, but that gets to our safety numbers very rapidly in the maintenance. We have a favorable randomization ratio for the patients to active. We have a re-randomization design, which is really a more feasible or favorable design for multiple doses, and it's more reflective of clinical practice. And finally, but possibly most important of all, the entire program is based on subcutaneous injections. That's loading dose, induction rate, and then maintenance throughout the entire program. So it's a really patient-friendly program, and it's designed to execute quickly. And I would add, we were the fastest to transition this MOA from phase two to phase three. So it's all about execution now with a great program. So kudos to the team. And on to Emra Solman. I always like to start by saying Emra Solman is enrolling a patient population that is a real unmet medical need. This is multiple system atrophy. And our differentiated molecule is targeting the very beginning of the alpha-synuclein aggregates. We have a very efficient design. Here you can see that it's a 48-week design against placebo. And I mentioned, you know, enrollment is going very well, and we've already got the first 100 that will be involved in the futility analysis at the end of next year. So we're right on track, and it's going quickly. We're proud that this has received fast-track designation, and we've already got the orphan designation. So more to come. And finally, I just want to touch base on the Anti-IL-15 program. This is another great homegrown antibody and program from the Teva Laboratories. Right now, we've got it in proof-of-concept studies in celiac disease, and importantly, also in vitiligo, which we'll read out in the first half of next year. But the upside possibility here is multiple different indications. Remember, IL-15 is a key cytokine in the activation and proliferation of NK cells and T cells that's believed to be involved in many different indications that you can see here. So a lot to go with IL-15, but very exciting program, and that also received fast-track designations. And with that, I'm going to pass it off to my colleague, Eli Khalif.

Thank you, Eric, and good morning and good afternoon to everyone. I would like to start today with the following key messages that demonstrate our consistent execution over the last few quarters, including in Q3. First, Q3 results were above solid, driven once again by our fast-growing innovative portfolio. As Richard said earlier, this was our 11th consecutive quarter of revenue growth. Second, We continue to strengthen our balance sheet and specifically reduce our net debt to below 15 billion and expanded our EBITDA, leading to the net debt to EBITDA of below three times for the first time since Q3 2016. Third, we have made significant progress in our transformation programs with approximately half of our planned savings of 70 million for 2025 already achieved by Q3. We are on track to deliver approximately $700 million of net savings by 2027 and achieve our 30% operating margin targets. And lastly, the outcome of the IRA negotiation for Orsteddo is largely in line with our model expectation and further emphasize our conviction in achieving our revenue target of $2.5 billion in 2027 and more than $3 billion at peak for Orsteddo. Now moving to slide 30 to review our Q3 2025 financial results, starting with our GAAP performance. Please note that throughout my remarks, I will refer to revenue growth in local currency terms unless otherwise specified. Similar to the last quarter, I will also refer to certain results from Q3 2024 that exclude any contribution from the Japan business venture, which we divested on March 31st, 2025, to help you with a like-to-like comparison of our financial results. Our Q3 revenue were approximately $4.5 billion, growing 5% in U.S. dollars or 3% in local currency. Revenue growth was mainly driven by continuous strong momentum in our key innovative products, Osteto, iJovi, and Uzeti, as well as our generic products in the U.S., including biosimilars. This was partially offset by some softness in European generics, as well as lower proceeds from the sale of certain product rights compared to Q3 2024. Gap net income EPS were 433 million and 37 cents respectively. Ethics movement during the quarter, including hedging effects, positively impacted revenue by 106 million and operating income by 21 million compared to the third quarter of 2024. Now, looking at our non-GAAP performance. Our non-GAAP gross margin increased by 120 basis points year-over-year to 55.3%. This increase was slightly higher than our expectation, driven mainly by strong growth in Osteto, leading to an ongoing positive shift in our portfolio mix. Gross margin also benefited, although to a lesser extent, from a shift in ordering partners for generics revenue in our US generics business, leading to some volume shift from the second quarter to the third quarter, as well as farewell ethics. The strong performance in non-GAAP gross margin largely carried through the non-GAAP operating margin, which increased by approximately 70 basis points year over year to 28.9%. This was partially offset by higher planned investment in OPEX and impact from foreign exchange movements. Overall, we ended the quarter with a non-GAAP earning per share of 78 cents, an increase of 10 cents or 14% year over year. Total non-GAAP adjustment in the third quarter of 2025 was $478 million. Our free cash flow in Q3 was $515 million compared to $922 million in Q3 2024. This decrease was mainly due to timing of sales and collection, as well as higher legal settlement payments, which we have planned for this year, and is reflected in our full-year free cash flow guidance. Moving to slide 31. We are making significant progress in our TAVR transformation programs through a well-defined and targeted effort to deliver sustainable margin improvements without compromising our ability to innovate and invest in our long-term growth. These programs are expected to deliver approximately 700 million of net savings between 2025 and 2027, with roughly two-thirds of these savings to be realized between 2025 and 2026. We are well on track to achieve approximately 70 million of initial savings in 2025, with a half of it already achieved by end of Q3. demonstrating solid momentum and execution. It's important to remember that the transformation we are driving is not just about reducing the spend. It's part of the journey to transform and modernize Teva into an innovative biopharma company and prioritizing resources towards areas that drive growth and innovation. These transformation efforts, along with the ongoing portfolio shift towards high growth and high margin innovative products, provide a clear and credible path to achieving our 30% operating margin targets by 2027, even as we continue to invest in the business. In relation to these programs, we have recorded approximately 190 million year-to-date in restructuring costs and expected an overall cash outflow of 70 to 100 million in 2025. Our guidance for 2025 already incorporated the impact of both expected savings and this cash outflow. Now moving to the next slide for an update regarding our strategic intent and the process to invest TAPI. As we have consistently and transparently shared with you all, we had been in exclusive discussions with a selected buyer for the sale of TAPI. At this time, we have decided not to move forward with those discussions as we were unable to reach an agreement aligned with Teva long-term priorities and interests of our shareholders. While this process did not result in a sale with this initial buyer, recent shifts in the geopolitical environment and market conditions reinforced TAPI attractiveness for potential buyers. We continue to view TAPI as a valuable asset, but it's non-strategic to our P2G priorities. We are now initiating a renewed sale process to explore alternative options and maximize potential value creation. We will provide further updates pending a transaction or other determination. Moving on to our 2025 non-GAAP outlook in slide 33. Our performance year-to-date reflects consistent execution across our pivot to growth priorities with a solid revenue growth, margin expansion, and a cash flow generation despite the tough prior year comparables in our generics business. Based on our year-to-date results and with the two months left in the year, we are tightening our 2025 outlook range for revenue, operating profit, adjusted EBITDA, and EPS. Starting with revenue, consistent with the direction we shared last quarter, we are tightening the full year guidance range to be between 16.8 and 17 billion. Our innovative portfolio continues to perform very well, specifically OSTEDO, driven by strong demand and our commercial execution. With a strong year-to-date performance, we are increasing our full-year outlook for Roseto by 50 to 100 million, to a new range of 2 billion 50 to 2 billion 150, reflecting the full-year growth of 21 to 27% year-over-year. However, as we discussed last quarter, we expect our global generics revenue for the full year to be flat in local currency. compared to 2024. This is mainly due to the tough year comparison deals in the timing of certain launches as well softness in certain markets. Moving to the other elements of our financial outlook. With a strong year-to-date performance, we now expected our non-GAAP gross margin to be at the higher end of our guidance range of 53 to 54%. This implies a slightly lower margin in Q4 compared to Q3, mainly due to generic revenue seasonality, as the majority of our volume allocation was sold by the end of Q3. We're also increasing the lower end of our non-GAAP outlook range for adjusted EBITDA, operating income, and EPS, consistent with our year-to-date results, and expected ongoing strength in our innovation portfolio, along with savings from our transformation programs. While we continue to wait for clarity around potential U.S. tariffs on pharmaceuticals, including the outcome of the ongoing 232 investigation, we are encouraged by the statement so far from the administration regarding possible generic exemptions. Our 2025 guidance continues to already reflect confirmed tariffs that are in place. We continue to expect our operating expenses to be between 27 and 28 percent of revenue. Our free cash flow guidance range remains the same between 1.6 to 1.9 billion. I would like to reiterate that our full year guidance does not include the development milestone related the phase three initiation of Duva-Keto UC and HON indications. That said, to assist you with your modeling, we want to highlight that the expected contribution from this development milestone is dependent on the timing of each of these two studies. Based on the current timelines, we expect to earn one development milestone in Q4 2025, with a reminder expected in Q1 2026. For Q4 2025, we expect the first development milestone to contribute $250 million to revenue and approximately $200 million to EBITDA and free cash flow, net of certain transaction-related costs. This first development milestone is expected to contribute approximately 14 cents to the EPS. Now, turning to the next slide on capital allocation. Our capital allocation approach remains disciplined and focused on supporting our pivot to growth strategy and strengthening our balance sheet. As I mentioned in the beginning, we are consistently reducing our debt while investing in our go-to-market capabilities and innovation. With ongoing improvement in our free cash flow, we are on track to which are net debt to EBITDA target of two times by 2027, and then to sustain around that level thereafter. In addition to our ongoing deleveraging and progress towards an investment grade ratings, our discipline execution also position us well thought to evaluate additional ways of returning capital to our shareholders. Finally, before I conclude my review of our third quarter performance, I would like to reaffirm our 2027 financial target. The outcome of the IRA negotiation further emphasized our conviction and provides additional clarity to deliver on these midterm goals. With that, I will now hand it back to Richard for his closing remarks.

Thank you, Eli. Before I conclude, let me remind you of some of the growth drivers that we have here at Teva. As we expect our innovative portfolio to continue to drive growth beyond 2027, you can see that we have a significant amount of opportunity to do this. Currently, Anchor and Esteto, which we reiterated our target of reaching more than $2.5 billion in 2027 and greater than $3 billion in peak sales based on the conclusion of our IRA negotiations with CMS. Along with the innovative products of Yasedi and Jovi, we will continue to drive our product mix and profitability. but also to build on Eric's remarks, we're preparing for the exciting innovative product launches in the next few years, which should set a foundation for growth in years to come. If you move on to my final slide, just some final thoughts. In Q3, in 25, we continue to deliver on our pivot to growth strategy with the 11th consecutive quarter of growth, growing our innovative franchise at 33%. We have a clear path towards our 30% operating margin and our other 2027 targets. We're advancing our innovative pipeline with near-term and long-term catalysts, and Teva Transformation is well on track to deliver the $700 million in savings we committed to. And with that, I would like to open the floor for the Q&A. Thank you.

Thank you, Richard. Alex, if you could – oh, sorry, Alex. If you could please go ahead with the question queue, and we ask if you could limit yourself to one question and one brief follow-up. And of course, if there's additional time, we're happy to let you back in the queue for more questions. Go ahead, Alex. Thanks.

Thank you. As a reminder, if you'd like to ask a question, that's star followed by one on your telephone keypad. Our first question for today comes from Dennis Sting of Jefferies. Your line is now open. Please go ahead.

Hi, good morning. Thanks for taking our questions. Maybe one on Osteto and IRA. Thanks for the comment. I'm glad to see that you're reiterating the long-term Osteto guidance. I'm curious what additional color you can give in terms of your own internal expectations going into the negotiations and how the negotiated price relates to the current Medicare net price. Thanks.

Hi, Dennis. Thanks for the question. Well, as I mentioned on the call, how it met with our expectations, it was in line with what we had forecast when we set the forecast back in May 2023. So we had anticipated that we would be in the list and we would be negotiating with CMS. And so because of that, that's why we remain very confident about hitting our $2.5 billion revenue. With regard to the latter part of your question about, I think it was net price, we're not going to comment on that obviously for competitive reasons, but I'll just reiterate the fact that we believe that we have the ability to hit our 2.5 billion in revenue. One, because it's in line with what we forecasted, but I would also like to remind everybody that tardive dyskinesia remains a highly under-diagnosed and under-treated condition. 85% of patients who suffer from this condition are not on therapy. And so we see a great opportunity to help those patients and continue to keep growing Estedo in 26 and beyond, hence reiterating the 3 billion, greater than 3 billion peak sales for Estedo And so I think those are the things I'd keep in mind as you think about the future for Stetto. Thank you.

Thanks very much. Thank you. Our next question comes from David Amselem of Piper Sandler. Your line is now open. Please go ahead.

Thanks. I had a question on Stetto as well. So your competitor talked on its call about this dosing creep, if you will. In other words, the per milligram pricing structure and higher doses mean more revenue per patient. And what they've said is that health plans are essentially catching on to that and that there is a potential migration over to the competitive products. So I'm just wondering if you can give us some color on that. the pricing structure of Austeto XR and if that's having ramifications in terms of access to Austeto XR, that's number one. And then secondly, how is that going to inform how you're thinking about commercial contracting for 26 and the extent to which you might make more concessions on price just to get into a better access position vis-a-vis your competitor? Thank you.

Thanks, David. Thanks for the question. I'm not going to talk about what the competitors are saying. I'll focus on what we do here at Teva. And just to highlight, Esteto's growth is much more about treating this underserved market, as I've said in the past, and our ability as a team to constantly execute. And I remind everybody, when we started this journey back in 2023, peak sales of Esteto were forecast to be 1.4 billion. And as you see, we're going to... exceed two billion this year and that is down to what we've done as a company and the capability we have built but when it goes to talking about the milligrams per dose we've been very clear about the benefits of patients taking a steto xr and how that helps them with compliance and adherence and this is very much like in line with also what was put in our phase three trial uh to allow efficient officials to have the flexibility to get to the patients on the optimal dose So what we're seeing is just a natural progression from moving from BID to a steto XR and the physicians having that flexibility to get patients on the right dose. The final part of your question, I think, was about access. And I think I highlighted in my presentation the fact that we're always very thoughtful about how we manage access with value. And we've continued to do that with Sisteto. We've done that very successfully, by the way, with our other brands and Yosedi and Adjovi. I think we have a really strong capability for doing that. But I'll go back to what is driving our confidence in Sisteto is two things. The capability that we have within this team, within Teva, and the underserved market. 85% of patients who could be on therapy are not on therapy. And those are the two things that we focus on. But thank you for your question, David.

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

Morning, guys. So my question is just on OPEX in 2026. And, you know, it looks like the consensus has combined R&D and SG&A kind of at around 4.8 billion, so pretty much flat on a year-on-year basis. Is that consistent with how you see the cost optimizations flowing through the P&L to navigate the Revlimid roll-off? And then my brief follow-up is just, can you comment at all if Esteto XR was included or excluded in IRA? I know that there was a litigation tied to that, and so I'm just wondering if you can offer any clarity there. Thanks.

So I'll hand the OPEX question. So thank you, Jason, for the question. I'll hand that to Ellie to answer.

Thanks, Jason, for the question. So the way to think about the development of the OPEX for 26, we always mentioned that from now onwards, as part of the $700 million savings, part of them will go into COGS, but the majority will go into the OPEX. And as much as we actually keep growing and able to fuel our profit, you will see us in the range between 27 to 28%. That will not change. But we will actually be able to expand our OP as well our EBITDA. So the way to think about it is that around two-thirds of the $700 million on savings will be able to accomplish by end of 26 already. but we will start to see also part of it impacting our COGS. But the main element that will move with the COGS will be actually in 27. But I can tell you that the most of the savings will be able to accomplish by end of 26, most of them related to the OPEX. And therefore, you should think about the 27 to 28% as a run rate.

Thanks. Thanks, Ali. And to answer your second question with regard to Estella XRP included in the IRA, negotiations, the answer is yes.

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

Great. Thanks so much. Just to shift gears a little bit, can you talk a little bit about your EU generic dynamics? I know you're facing some tougher comps there this year, but I was wondering if anything's changed in those underlying markets we should be thinking about as we think about kind of the growth going forward. And just a quick then follow up, I know the TAPI process, just a little bit more color in terms of why restart the process here versus just deciding to keep the assets. It may take a little bit about just kind of the broader appetite for these API assets in the market right now. Thank you.

Thanks, Chris. Thanks for the questions. So going to the EU generics business, if I can take you back to when we started talking about Teva and our generics business back in 23. I can remember explaining to everybody, this is a market leader of scale in Europe. And so the ability to grow this business, we should think of it growing around the 2% CAGR rate, just because of its scale and size. Now, obviously, I was proved wrong in the last two years as the business grew higher than that. But that was down to a couple of factors. One is we had more launches over those years, as well as we had competitors struggling to supply. And because of our manufacturing capability, we could step in. And so those two things happen. And I think what you're seeing versus this quarter versus the last year is sort of a similar theme. What we have is more launches that we had in 2023, sorry, in Q3 2024. We also had some tender wins, which are two-year tender periods. And we also had supply issues from competitors. Those were no longer the case. So that's what I think about. And that's why I go back to think about our generics business over at Kegar. two-year CAGR, because if you think about two-year CAGR, these things smooth out, and that's how we think about it. And as we've had conversations, I always remind people that we think about our generics business going forward in that 2% CAGR period, one, because just of the scale we have. Now, that said, one thing I do want to reiterate is our biosimilar business, while getting traction in the US, we will start now to launch, and we have launched some products, some biosimilars in the EU, and that will start to build momentum. more so post-2027, but we have a good pipeline coming through in Europe, and we know that's a mature, biosimilar market, and so those are the things that are going to start to maybe add to that growth in Europe going forward. But I hope that answers your question. With regard to TAPI, I'll give that question to Ellie to talk about why restart it and not keep it. So over to you, Ellie.

Yes, Chris, thanks for the question. So look, we were, during all the process, we're very transparent. And as we mentioned, we actually decided not to progress with exclusive discussion that we had with a certain buyer. And the reason for that is that we see TAPI as a strategic going forward for Teva in terms of our ability to keep sourcing API when it's actually moving as a standalone. You need to remember, it's not just kind of, you know, business that you have on the shelf and you divest it and you move forward. This is strategic for us going forward and our ability to make sure that we are providing additional value on short-term and long-terms to our, you know, future progress and growth. It's super important. Turn out that certain element in terms of the discussion and didn't went according to the terms that we view how the deal should move on. And therefore, we made the decision. And also, we need to remember that the market condition now changed since we launched this sales process. Recent geopolitical development, as I mentioned, and some trade policies highlight some, you know, continual attractiveness for TAPI in terms of the landscape. So therefore, you know, we decided to initiate revised strategic review and review the sales process. And as I mentioned, we'll keep all update and provide further updates pending the transaction or any other determination around these forces.

Maybe if I can add, just so Eli's not misunderstood there, when he says it's strategic, what he means is they're one of our largest API suppliers, and we need to ensure that any contract we have has the right terms, not just for the purchaser, but also for Teva going forward, both for our in-line products and our pipeline. Thanks for the questions, Chris.

Next question. Thank you. Our next question comes from Ash Burma of UBS. Your line is now open. Please go ahead.

Oh, great. Yeah, thanks a lot and congratulations for the strong update. Maybe just like quickly on the 2026 revenue, I wanted to understand like if you can continue to deliver growth on both these metrics just as a part of your long-term goals. We have revenue rate phasing out, but you have pretty meaningful cost savings outlined and also talked favorably about Australia formulary. And then just as a quick follow-up, so the 3Q of sterile looks pretty strong. Is this primarily like regularly underlying demand, or is there any type of a one-time benefit in this? Normally, you have like a pretty strong 4Q, but with this reiterated guide, it seems like it's indicating a down quarter in 4Q.

Hi, Ash, and thanks for your question. So starting on the EBITDA, just to sort of remind you, and I think Ali touched upon this in his remarks, you know, the EBITDA is driven by a couple of things next year. And I think it's important to understand those. One is our innovative portfolio has real momentum. As I said, it was up 33% in Q3, you know, and these are products we're all growing. So we continue to see great growth rates in those. And by the way, we've spoken about this in the past. These are very high gross margin products. So that really does help impact the EBITDA. that's one and then on the one of the slides that ellie ellie and i both showed is on the transformation of teva and the organizational effectiveness you know we're on track to do exactly what we set out to do in 25 and that means that our guide to two-thirds of the 700 million net savings for 2026 we feel highly confident about so if you just put those two things together that really gives us confidence about our avatar but i would probably take this opportunity to then talk about well we have some other things around our generics business where now we've lost generic Revlimid. There are three components which help us drive our generics business going forward, and that is our generics, our complex stimulus, and our OTC. And as we've mentioned in the past, we have the ability to compensate for that generic Revlimid by the end of 2027 because we have those three different growth drivers and the scale we have in those three different businesses. So I think that answers that part of the question. With regard to The one on Esteto. And I think you talked about the strong Q3 and how does that impact Q4? Was there anything behind that? I think there's just a couple of dynamics in that. Firstly, the fundamentals of Esteto are really strong. It's really important to understand. So as you see, with regard to our TRX, our milligrams, our growth rates, You know, I think the team has continued to execute at a high level consistently. And I think we've seen that for quarter on quarter on quarter. Now, one of the things I just would mention, and I think I mentioned on the last call, you know, in Q3 2024 and Q2 2024, there was some channel stocking with regard to ZOXR. So that created a slightly different comparison, as well as we had some slight gross net adjustments. instead of which are favorable in Q3 of this year. But if you take those out, it doesn't really change the directory much of Estedo. And so I'd always think about looking at Estedo over a yearly period, a multi-quarter period, because I think we've been consistent in hitting our numbers and hitting our targets, and we're very accurate about that. So that's the way I think about it. So I don't anticipate anything a very significant quarter four. You know, the one thing that we always manage as well as we can, but it's not completely down to us is the channel. And we've been very disciplined in making sure the channel has the right stock. But obviously that's something which we don't have complete control over, but we've shown good discipline there. So I hope that answers your questions, Ash, and thanks for the questions.

Thank you. Our next question comes from Les Zalewski of Tourist Securities. Your line is now open. Please go ahead.

Great. Thank you for taking my questions. So we saw the FDA propose new guidance around biosimilars to reduce comparative efficacy study and, you know, potentially speed up the approval process. So three questions on this for you. One, how will this updated guidance impact your long-term biosimilar strategy? And then two, on the opposing side, do you see a scenario of additional competition where we'll ultimately see biosimilar price erosion curves resemble traditional generics? And then third, what further investments do you think are needed to give you a more competitive edge? And I guess ultimately, do you see a scenario where the U.S. reaches a point where the BLA process and the patient access becomes just as favorable versus the EU? Thank you.

Okay, yeah, that was a multidimensional question, so thank you for that, Les. I think I'll start it off, but I'll also lean into my colleague Eric here. He obviously is close to that because of the pipeline we have. So firstly, we're pleased with the FDA and that initiation of removing phase three studies. I think that's the right thing to do. I think that helps. And that's based on data. We have a substantial amount of data now in the development of these biosimilars across many, many products as an industry. And I think this is the right thing to do. Does it change our strategy? Absolutely not. I think it reinforces the quality of the strategy we set out for biosimilars in 2023. And to remind you what that strategy was, Our strategy was to have the largest, one of the largest portfolios of biosimilars going forward. And we were going to do that through partnerships. We do that through partnerships because it allowed us to have the largest portfolio because it allowed an efficient allocation of capital. We also believed at the time that there was going to be uncertainty around what the future regulation was going to be. And so we didn't want to be initiating and allocating capital to things that may no longer be needed. An example is starting phase threes, which are then no longer needed going forward. So I think we sort of thought about where the puck was going. We made a strategy as to where the puck was going. And I'm pleased to say, I think we've been proven right on that. But ultimately, our strategy is about having a large portfolio. As I've just highlighted, we have 10 in the market. We have six we're going to launch by 27, and then we're going to have more going forward. With regard to price erosion, I think a good analog is to look at Europe. And Europe is very mature by a similar market and one I know particularly well. And what you see there is good penetration. You see that there is some price erosion, but it hits a steady state at a certain time, which allows a high level of profitability still within this category. What I'd also highlight from that market, because you did talk a bit about whether the U.S. will replicate it, is you also see an expansion of these molecules and these biologics used in patient populations. Because they are less expensive, they're used earlier in the treatment of these diseases. So you get an increase in volume and obviously upsets some of the decrease in price. So those are just some of the dynamics. And I do believe the U.S. will catch up to that. But when you have a broad portfolio and we're launching more in Europe, you know, we're not necessarily beholden to exactly when that happens because of the scale and the size. But maybe, Eric, you could give a bit more detail on your views on this.

Yeah, I can just give a few points to support what you just said. You know, we work closely with the FDA and have frequent communications with regards to, you know, pretty large biosimilars portfolio. We really anticipated the fact that they were going to be removing phase three from the requirement for most programs and agree with this decision. You know, the technical assessment really has been proven to be the most important thing when it comes to biosimilars, something we do very well. And, you know, this is going to decrease the cost of, you know, production and approval of biosimilars. It fits perfectly and facilitates the pivot to growth strategy that we put together in the past. And, you know, really it supports a lot of the good decisions we've made over the years about how we will do biosimilars. at Teva. So it was a welcome decision. It was something we were looking forward to and really fits perfectly into the plan.

Thanks, Eric. And maybe one thing I'd just like to add on, I forgot it. Obviously, removing the phase three need reduces costs significantly. But I would also like to highlight the costs for developing a biosimilar are still high, a lot higher than any other generic, any other complex. So I just think that the capital allocation doesn't disappear and the cost of it doesn't disappear. So hence, the number of people coming into the market will, I still think, be restricted based on that. And the ultimate is not just can you develop it and manufacture it, do you have an efficient go-to-market capability? And I think what we're starting to show in the U.S. and we'll show in Europe is we do have that, and that front end is very important when maintaining a growth and a profitability in your biosegmental portfolio. So thanks for the question, Les.

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

Morning, guys. Morning, guys. Thanks for taking my question. You said CMS agreements in line with your modeling expectations. Is it reasonable to assume that's about 50% or so in the ballpark? And then secondly, to get to your 2027 2.5 billion in sales, are you assuming volume gains because of this IRA cut versus ingress to get to that number or not? And then finally, obviously Olanspain, I feel like it's taking a bit longer than we all anticipated, but at this point, is there any possibility that you could get a commissioner voucher to accelerate that, or should we not be thinking about that? Thank you very much.

Ayuma, thanks for your questions. So with regard to CMS, it was in line with our expectations that we set out in 2023. You threw out a number there, which I'm not going to comment on, because I think that was maybe trying to tease me out to give you a number. And I'm not going to do that. I just say it's in line. And that's why we remain very confident about our 2.5 billion in 27. And I remind people, greater than 3 billion peak sales. You did touch a bit about do we see volume gains within this? And this is not something we've, without going into the detail of our forecasting model, we go back to capturing more patients, making patients more adherent and compliant and all of those fundamentals. I think what though you have touched upon is something that we're going to understand a bit more in January as the first wave of drugs that were negotiated in CMS start to come through and play out. And we'll see what are the dynamics that happen there and we'll use that to adjust our modeling as we go forward. And I hope, you know, you as others will agree, we're very thoughtful about how we model and how we forecast and at least over the last few years I think we've been pretty accurate in what has been quite a dynamic environment. Now, with regard to olanzapine, I'll hand that one to Eric to comment on whether we could get a commissioner's voucher.

Yeah, thank you for the question, Umar. And to start off with, you know, we're right on track with what we plan for the submission of the olanzapine LAI in this quarter. You know, with regard to your question on the commissioner voucher, you know, that's one of the things we've been reviewing within the TEVA. One of the great things about TEVA is we have biosimilars, a whole portfolio of generics, and innovative medicines. So the potential for where we could see a commission or voucher is broad. So we're reviewing that now and looking to see what the most optimal, optimally timed and valuable program is that we seek one of those out for. But more to come on that in the future.

Thanks, Eric. Thanks for your question, Uma.

Thank you. Our next question comes from Matt Delatore of Goldman Sachs. Your line is now open. Please go ahead.

Hey, good morning and congrats on the quarter and the aesthetic agreement. Maybe first on Dubuque to now that the phase three IBD studies are up and running. How are you thinking about enrollment timelines and potential data readouts there? And then could you comment on any progress on the indication expansion strategy beyond IBD? You know, for instance, could we see proof of concept studies announced over the near term? And then maybe just as my follow up on capital allocation, could you talk about the key priorities in 2026 And as we think about the free cash flow inflection, what are the key points of focus to achieve that full year 27 guide? Thank you.

Hi, Matt. Thanks for the questions. I'll hand the first one straight over to Eric on the phase three and the potential phase twos.

Yeah, so thank you for the question. This is one of the things I'm most excited about, the design that we've put together with Sanofi. It's all about execution now. As I said earlier in my comments, This has been the fastest transition from phase two to phase three with regards to this MOA of all the programs out there, which we're very proud of. So it speaks to our executional abilities in this partnership. The design itself is really designed to make sure that we maximize the enrollment with the feeder arm that will get to our maintenance and increase our safety numbers in the program. It's a very convenient and patient-centric design with regards to subcutaneous treatment and the re-randomization These are all things that will make it ideally suited for patients. And we're also putting a lot of effort in on, you know, how we execute the program with regards to logistics and our vendors that we use. So it's been a really great collaboration with Sanofi. I think we're building upon a lot of momentum and success that we have, you know, going into a phase three program, you know, with a phase two program that was probably had the highest numbers with regards to efficacy. And it's the data set that we produced. These are all good signals of starting a phase three program. So when it comes to execution, that's what we're going to focus on right now. And I think that we're set up very well to, you know, be in the horse race, if not in the middle of it, but hopefully coming up very close to the beginning of it. So that's very well suited. Now, with regards to your question about other indications, it's great to see the excitement around this MOA. I mean, one of the things about it is the fact that it could touch so many different pathways, cytokine signaling pathways in multiple indications. You can see many different phase two programs initiating now. We have a plan with Sanofi, and we'll let you know when those studies start. For now, we're going to keep it close to the chest. But that, in addition to the excitement around different combinations in the future, is also something we've been thinking about heavily. But right now, to begin this discussion is all about the execution of the study, enrolling the study, and making sure that we show the value in ulcerative colitis and Crohn's disease now.

Thank you, Eric. Now on the next two questions, capital allocation and free cash flow inflection. I'm going to hand those to Ali. Before I do, I do like the fact that you've highlighted our free cash flow inflection, because that is something which we are starting to communicate and people are starting to see with the growth of the company, the growth of the innovative, the decrease of the debt, the growth of the EBITDA, that this ultimately changes our free cash flow position. So thanks for highlighting that and seeing that, but I'll hand on to the hand over to Eli to talk about our capital allocation going forward.

Yes, Matt, thank you for the question. So first of all, I'll start with the free cash flow. You mentioned about how we should think about that trend that we mentioned beyond 27. There are three main dynamics there. First of all, it's the mix, right? If you look on the top line and how we're progressing with the top line and how it's going to flow through and convert both for profit and to free cash flow, with the innovative, I would say, portfolio that we have, and we are keep investing in our growth driver. And the fact that the $700 million of savings is going to actually enable us to drive more efficient COGs with high growth margin as well, I would say, to optimize our OPEX. Those two elements are already in progress. There are another two that we need to remember. We paid for our debt this quarter from now until October 26, like 13 months. We don't have any maturity. There's a 1.8 in October and there's a 2.8 in March, May in early 27. You think about 4.5 billion, 4.6 billion with our current weighted cost of capital of our outstanding debt of 4.8%. you get $200 to $250 million that we're going to take out from a run rate, both from financial expenses going forward and pure free cash flow impact. And then on top of it, our progress on our working capital. You can actually see ourselves running below 4% going from 27 onwards on our revenue. All these actually enable us to convert high free cash flow. As far as related to next year capital allocation, We actually looking on more, I would say, an ability to be able to compete on a certain opportunities related to business development that align strategically to our portfolio and to make sure that we're able to provide a value to our shareholders. And as we move forward to make synergetic activities around that piece, we'll keep looking on, of course, reducing our debt. And as we move forward, we might also look on some certain other elements related to capital and shareholder returns. And we will, for sure, during 26, and we hope also in our next earning calls, provide some more colors around that kind of capital returns to shareholders.

Thanks, Sally. Thanks, Matt. Thanks for your question.

Thank you. At this time, we currently have no further questions, so I'll hand it back to Richard Francis for any further remarks.

So thank you, everybody, for participating in the call. We do appreciate your interest in Teva, and we look forward to giving you an update of our full year results early next year. Thank you.

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