Teva Pharmaceutical Industries - Earnings Call - Q3 2025

Executive Summary

• TEVA delivered its 11th consecutive quarter of growth: revenue $4.48B (+3% YoY; +5% ex-Japan BV), non-GAAP EPS $0.78, and adjusted EBITDA $1.39B, with non-GAAP operating margin up 86 bps YoY to 28.9%.
• Broad beats versus S&P consensus: revenue $4.48B vs $4.33B*, non-GAAP EPS $0.78 vs $0.67*, and EBITDA $1.39B vs $1.24B*; strength driven by AUSTEDO (+38% YoY U.S.), AJOVY (+19% LC YoY), and UZEDY (+24% YoY).
• Guidance raised/tightened: FY25 AUSTEDO $2.05–$2.15B (up $50–$100M), non-GAAP EPS $2.55–$2.65 (low-end +$0.05), operating income and EBITDA ranges increased at the low end; total revenue range narrowed to $16.8–$17.0B.
• Strategic catalysts: CMS IRA price-setting concluded in line with TEVA’s expectations, reinforcing AUSTEDO 2027 revenue target >$2.5B and peak >$3B; TEVA will restart TAPI sale process after terminating exclusive discussions.
• Near-term modeling item: management expects a Q4 development milestone from the Sanofi duvakitug Phase 3 initiation (~$250M revenue, ~$0.40 EPS contribution), which is excluded from current guidance.

Values with asterisks (*) are retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well

• Innovative brands drove growth and mix improvement: “our key growth drivers—particularly our innovative medicines—delivered a 33% increase in local currency,” lifting non-GAAP gross margin to 55.3% (+120 bps YoY).
• AUSTEDO momentum and IRA clarity: U.S. revenue hit $601M (+38% YoY), FY25 outlook raised to $2.05–$2.15B; management reiterated 2027 target >$2.5B and peak >$3B following IRA negotiations.
• Margin trajectory intact under Pivot to Growth: non-GAAP operating margin 28.9% in Q3 (on track for 30% by 2027), aided by transformation savings and mix shift to high-margin innovation.

What Went Wrong

• Europe softness: segment revenue down 2% YoY (–10% LC) and segment profit down 19%, reflecting lower generic volumes, price reductions, and fewer proceeds from product-rights sales vs. prior-year comps.
• Free cash flow declined YoY: $515M vs $922M in Q3’24, driven by timing of sales/collections and higher legal settlement payments (within plan).
• International Markets down 9% (–10% LC) YoY, primarily from the Japan BV divestiture; segment profit decreased to $95M from $109M.

Transcript

Operator (participant)

Hello and welcome to the Q3 2025 Teva Pharmaceutical Industries 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.

Christopher Stevo (SVP of Investor Relations and Competitive Intelligence)

Thank you, Alex. Good morning and good afternoon, everyone. In a moment, I'll hand the call over to my CEO, Richard Francis. 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. With that, Richard Francis.

Richard Francis (President and CEO)

Thanks, Chris. 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 Kalif, the CEO of Teva Pharmaceutical Industries. Starting with, as I always do, the pivot to growth strategy, this is a strategy that has guided Teva for the last three years, a strategy based on the four pillars: delivering our growth engines, which is all about driving Austedo, UZEDY, and Ajovy, 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.

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. Adjusted EBITDA up 6%. Our non-GAAP EPS up 14%. These all compared to Q3 2024. Our free cash flow is just above $500,000. 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. This is our 11th quarter of consecutive growth after many years of sales decline.

It's worth noting that Q3 2024 was a particularly difficult comparison year where we had a growth of 15%. To grow 3% over that comp, I think, is a testament to the work we've done on our portfolio and a testament to the teams. This puts us on track for our growth targets we set for 2027 to have mid-single-digit growth. 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. 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. Austedo grew an impressive 38%, reaching $618 million. UZEDY performed strongly, up 24%, reaching $43 million.

Adjovy performed well, up 19% to $168 million. Global generics revenues was up 2%. TAPI was down 4%, reflecting some seasonal volatility. I am going to double-click and go into a bit more detail on all of these areas, starting with Austedo. As you know, Austedo was selected earlier this year for CMS, the 2027 price negotiation. I am pleased to say that agreement that we have concluded is consistent with our midterm expectations for Austedo that we first laid out back in May 2023. 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 Austedo in Q3. It was another strong quarter for Austedo, where the team continues to perform incredibly well.

The U.S. reached $601 million in Q3 2025, growing at 38% Year-over-Year. This is the first time we have passed $600 million. Congratulations to the team for all their hard work in making this happen. It really reflects the understanding this team has of the market. We grew TRx 11%, and we continue to see the increasing penetration of Austedo XR. It is worth reminding everybody again that Austedo XR requires fewer scripts compared to the original Austedo. That is why it is equally important to look at the milligrams dispensed. As you can see, these were up 25%. As you see on this slide, we have highlighted that with 2026 approaching, we have a good sense of Austedo's 2026 formulary position. We continue to reflect the balance between preserving value and maintaining access.

Based on these strong results in Q3, we can increase our revenue outlook for Austedo to $2.05 billion-$2.15 billion for the year. Now moving on to UZEDY, another exciting member of our innovative family. UZEDY 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 were 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 net adjustment. Now, this does not impact our long-term LAI franchise expectations, and we reiterate our peak sales target of $1.5 billion-$2 billion for the franchise. This confidence is rooted in the data. UZEDY's MBRx is significantly above the TRx. As you know, in Q3, we also had an expanded indication for bipolar I disorder.

Now, to give you more guidance on how to forecast UZEDY going forward, the Q4 implied guidance of $55-$65 million provides a cleaner run rate for forecasting going forward due to that gross net adjustment in Q3. I want to take a couple of slides just to talk about the excitement we have around our LA long-acting franchise in schizophrenia. Why do we think this $1.5 billion and $2 billion is achievable? It really comes down to the great work that has been done with UZEDY already. The team here has created great traction, as you can see, with 119% TRx growth. We have a great product profile with UZEDY, and we anticipate having a similar strong product profile with Olanzapine. 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 formulary committees. That puts us in a very strong position. We know and believe there's a significant unmet need in the Olanzapine for long-acting treatment. If you put those two together on this slide, we have the ability with UZEDY and our long-acting Olanzapine to treat up to 80% of patients who suffer from schizophrenia, whether that's mild to moderate with UZEDY or moderate to severe with long-acting Olanzapine. Just to highlight, unfortunately, 4.7 million people suffer from schizophrenia in the U.S. and Europe. The opportunity for both brands is significant. That's hence the reason why our confidence in the $1.5 billion-$2 billion remains strong. Now moving on to Ajovy.

I do love Ajovy. It continues to grow strongly across all regions in what is still a very competitive market. There are some nice data points here. We are the number one preventative CGRP injectable in new prescriptions among the top U.S. headache centers. We are the number one preventative CGRP injectable in 30 countries across Europe and international. We confirm our guidance of $630-$640 million. Now, staying on innovation, I'm going to touch briefly upon the innovative pipeline. As I know, Eric will talk to you about this later, but I'm super excited about this. Why? Because it's near term. These are late-stage assets. Olanzapine, I'll talk to you about the filing of that this year. DARI, the good recruitment that we're seeing to bring that to the market in 2027. DuvaKine, starting our Phase III study. Emrysoma, great recruitment there.

I look across the right-hand side of the slide, and I see the potential of peak sales, and it's over $11 billion. I remind you, that's just for the indications on this slide. We know that DuvaKine and Anti-IL-15 will be pursued in multiple indications. 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. 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 fading 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 were for two-year periods. There is a 1% CAGR for the two years. International markets grew at 3% or 12% on a two-year CAGR. 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.

We're well on track to add another $400 million by 2027 as we forecasted back at the start of the year. 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. Our European pipeline will start to convert into launches and revenues, and biosimilars will be a more significant driver for Teva overall after 2027. Now moving on to the fourth pillar, focus our business. We made significant progress with the Teva transformation program, and this is something we started at the start of this year. We made a commitment to realize two-thirds of the $700 million by the end of 2026. I can tell you we're 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. I'll leave Eli 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 of how we're tracking for the 2027 targets, which we are reiterating today. 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%-4% growth range, consistent with our 23%-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're on track to our 30% margin. This year, we will end around a 27% margin overall. Net debt to 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. With that, I will hand over to my colleague, Eric Hughes.

Eric Hughes (Executive VP of Global R&D and Chief Medical Officer)

Thank you, Richard. Now, as Richard said, we have a healthy late-stage development programs in our innovative medicines. We're doubling down on our efforts to execute these studies on time and efficiently. Now, beginning with Olanzapine 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 DuvaKine program, in partnership with Sanofi, is now initiated. Both our ulcerative colitis and Crohn's disease Phase III studies. Our Emrysoma program has now enrolled the 100 patients that we'll need for our futility analysis by the end of next year. Enrollment continues to do very well. 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. Exciting late-stage programs. Before I go on to those in more specific detail, I did want to have a celebration for the UZEDY team for bipolar I disorder.

We had an approval and an 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 UZEDY, 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, onto Olanzapine LAI. As we've mentioned, we've actually presented the data, both the safety and efficacy of the full program in Phase III at the 2025 PsychCongress annual meeting. It was very well received. Both the safety and efficacy was right where we expected it. Most importantly, we had no cases of PDSS. That submission is planned for the late half of this quarter.

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. 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. 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. Great program, right on track.

As I mentioned before, we're very excited to announce that we have now initiated both the ulcerative colitis and Crohn's disease Phase III programs with our partner, Sanofi, for our DuvaKine program. This is a very exciting program, very large effort by many people. The ulcerative colitis study is called Sunscape, and the Crohn's disease program is called Starscape. What we're really excited about with this program is the way we've designed Phase III. 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.

Finally, but possibly most important of all, the entire program is based on subcutaneous injections. That is loading dose, induction rate, and then maintenance throughout the entire program. It is a really patient-friendly program, and it is designed to execute quickly. I would add, we were the fastest to transition this MOA from Phase II to Phase III. It is all about execution now with a great program. Kudos to the team. On to Emrysoma. I always like to start by saying Emrysoma is enrolling a patient population that is a real unmet medical need. This is multiple system atrophy. 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 is a 48-week design against placebo.

I mentioned 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. We are right on track, and it's going quickly. We are proud that this has received fast-track designation, and we've already got the orphan designation. More to come. 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. 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 is believed to be involved in many different indications that you can see here.

A lot to go with IL-15, but very exciting program, and that also received fast-track designation. With that, I'm going to pass it off to my colleague, Eli Kalif.

Eli Kalif (Executive VP and CFO)

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 continued to strengthen our balance sheet and specifically reduced 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. Lastly, the outcome of the IRA negotiation for Teva is largely in line with our model expectation and further emphasizes our conviction in achieving our revenue targets of $2.5 billion in 2027 and more than $3 billion at peak for Teva. 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 be referring to certain results from Q3 2024 that exclude any contribution from the Japan business venture, which we divested on March 31, 2025, to help you with a like-to-like comparison of our financial results. Our Q3 revenue was approximately $4.5 billion, growing 5% in US dollars or 3% in local currency. Revenue growth was mainly driven by continued strong momentum in our key innovative products, Austedo, Ajovy, and UZEDY, as well as our generics 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. GAAP net income EPS was $433 million and 37 cents, respectively. FX movement during the quarter, including hedging effect, 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 Austedo, leading to an ongoing positive shift in our portfolio mix. Gross margin also benefited, although to a lesser extent, from a shift in ordering patterns for generic Revlimid in our U.S. generics business, leading to some volume shift from the Second Quarter to the Third Quarter, as well as favorable FX effects. 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 $0.78 and an increase of $0.10 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 Teva transformation programs through well-defined and targeted efforts 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 half of it already achieved by the 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 expect an overall cash outflow of $70 million-$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 progress and the process to divest 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's 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 pivotal growth 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 pivotal growth priorities, with solid revenue growth, margin expansion, and cash flow generation despite tough prior year comparables in our generics business. Based on our year-to-date results and with 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 billion and $17 billion.

Our innovative portfolio continues to perform very well, specifically Austedo, driven by strong demand and our commercial execution. With a strong year-to-date performance, we are increasing our full-year outlook for Austedo by $50 million-$100 million to a new range of $2.05 billion-$2.15 billion, reflecting a full-year growth of 21%-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 as softness in certain markets. Moving to the other elements of our financial outlook, with a strong year-to-date performance, we now expect our non-GAAP gross margin to be at the higher end of our guidance range of 53%-54%.

This implies a slightly lower margin in Q4 compared to Q3, mainly due to generic Revlimid 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 the savings from our transformation programs. While we continue to await clarity around potential U.S. tariffs on pharmaceuticals, including the outcome of the ongoing 232 investigation, we are encouraged by the statements so far from the administration regarding possible generics exemptions. Our 2025 guidance continues to already reflect confirmed tariffs that are in place. We continue to expect our operating expenses to be between 27-28% of revenue. Our free cash flow guidance range remains the same, between $1.6-$1.9 billion.

I would like to reiterate that our full-year guidance does not include the development milestone related to the Phase III initiation of DuvaKine, UC, and Crohn 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 remainder 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 $0.40 to the EPS. Now, turning to the next slide. On capital allocation.

Our capital allocation approach remains disciplined and focused on supporting our pivotal 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 the ongoing improvement in our free cash flow, we are on track to reach our 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 investment-grade ratings, our disciplined execution also positions us well thoughtfully 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 targets. The outcome of the IRA negotiation for Austedo further emphasizes 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.

Richard Francis (President and CEO)

Thank you, Ali. 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 signal and have opportunity to do this. Currently, anchored in Austedo, 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 UZEDY, Ajovy, we will continue to drive our product mix and profitability. 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 2025, 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 are advancing our innovative pipeline with near-term and long-term catalysts. Teva transformation is well on track to deliver the $700 million in savings we committed to. With that, I would like to open the floor for the Q&A. Thank you.

Christopher Stevo (SVP of Investor Relations and Competitive Intelligence)

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. Of course, if there is additional time, we are happy to let you back in the queue for more questions.

Operator (participant)

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 Ding of Jefferies. Your line is now open. Please go ahead.

Dennis Ding (Equity Research Analyst)

Hi, good morning. Thanks for taking our questions. Maybe one on Austedo and IRA. Thanks for the comment. I'm glad to see that you're reiterating the long-term Austedo 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.

Richard Francis (President and CEO)

Hi, Dennis. Thanks for the question. 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. We had anticipated.

That we would be in the list, and we would be negotiating with CMS. 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. I'll just reiterate the fact that we believe that we have the ability to hit our $2.5 billion revenue, one because it's in line with what we forecasted. I would also like to remind everybody that tardive dyskinesia remains a highly undiagnosed and undertreated condition. 85% of patients who suffer from this condition are not on therapy.

We see a great opportunity to help those patients and continue to keep growing Austedo in 2026 and beyond, hence reiterating the $3 billion, greater than $3 billion peak sales for Austedo. I think those are the things I'd keep in mind as you think about the future for Austedo. Thank you.

Dennis Ding (Equity Research Analyst)

Thanks, Dennis.

Operator (participant)

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

David Amsellem (Senior Research Analyst)

Thanks. I had a question on Austedo as well. 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. What they've said is that health plans are essentially catching on to that and that there is a potential migration over to the competitor product.

I'm just wondering if you can give us some color on the pricing structure of Austedo XR and if that's having ramifications in terms of access to Austedo XR. That's number one. Secondly, how is that going to inform how you're thinking about commercial contracting for 2026, and the extent to which you might make more concessions on price just to get into a better access position vis-à-vis your competitor? Thank you.

Richard Francis (President and CEO)

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. Just to highlight, Austedo'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. I remind everybody, when we started this journey back in 2023, peak sales of.

Austedo were forecast to be $1.4 billion. As you see, we're going to exceed $2 billion this year. That's down to what we've done as a company and the capability we have built. When it goes to talking about the milligrams per dose, we've been very clear about the benefits of patients taking Austedo XR and how that helps them with compliance and adherence. This is very much in line with also what was put in our Phase III trial to allow physicians to have the flexibility to get to the patients on the optimal dose. What we're seeing is just a natural progression from moving from BID to Austedo 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.

I think I highlighted in my presentation the fact that we're always very thoughtful about how we manage access with value. We've continued to do that with Austedo. We've done that very successfully, by the way, with our other brands in UZEDY and Ajovy. I think we have a really strong capability for doing that. I'll go back to what is driving our confidence in Austedo 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. Those are the two things that we focus on. Thank you for your question, David.

Operator (participant)

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

Jason Gerberry (Equity Research Analyst)

Morning, guys. My question is just on OpEx in 2026.

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 relevant rolloff? My brief follow-up is just, can you comment at all if Austedo XR was included or excluded in IRA? I know that there was a litigation tied to that. I'm just wondering if you can offer any clarity there. Thanks.

Richard Francis (President and CEO)

I'll hand the OpEx question. Thank you, Jason, for the question. I'll hand that to Eli to answer.

Eli Kalif (Executive VP and CFO)

Thanks, Jason, for the question. The way to think about the development of the OpEx for 2026, 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. As much as we actually keep growing and are able to fuel our profit, you will see us in the range between 27%-28%. That will not change. We will actually be able to expand our OpEx as well as our EBITDA. The way to think about it is that around two-thirds of the $700 million in savings will be able to accomplish by the end of 2026 already. We will start to see also part of it impacting our COGS. The main element that will move with COGS will be actually in 2027. I can tell you that most of the savings will be able to accomplish by the end of 2026, most of them related to the OpEx.

And therefore, you should think about the 27%-28% as a run rate.

Richard Francis (President and CEO)

Thanks, Eli. And to answer your second question with regard to whether Austedo XR will be included in the IRA negotiations, the answer is yes.

Operator (participant)

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

Chris Schott (Managing Director)

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. I was just 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. Maybe talk a little bit about just kind of the broader appetite for these API assets in the market right now. Thank you.

Richard Francis (President and CEO)

Thanks, Chris. Thanks for the questions. 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 2023, I can remember explaining to everybody this is a market leader of scale in Europe. The ability to grow this business, we should think of it growing around the 2% CAGR rate, just because of its scale and size. Obviously, I was proved wrong in the last two years as the business grew higher than that. 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. Because of our manufacturing capability, we could step in. Those two things happened. I think what you're seeing this quarter versus the last years 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. We also had supply issues from competitors. Those were no longer the case. That's how I think about it. That's why I go back to think about our generics business over a CAGR, a two-year CAGR, because if you think about a two-year CAGR, these things smooth out. That's how we think about it.

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. That said, one thing I do want to reiterate is our biosimilar business, while getting traction in the U.S. 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. We know that's a mature biosimilar market. Those are things that are going to start to maybe add to that growth in Europe going forward. I hope that answers your question. With regard to TAPI, I'll give that question to Eli to talk about why we started and not keep it. Over to you, Eli.

Eli Kalif (Executive VP and CFO)

Yes, Chris, thanks for the question. Look, we, during all the process, were very transparent. As we mentioned, we actually decided not to progress with exclusive discussion that we had with a certain buyer. The reason for that is that we see TAPI as strategic going forward for Teva in terms of our ability to keep sourcing API. When it is actually moving as a standalone, we need to remember, it is not just kind of a 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-term to our future progress and growth. It is super important. Turned out that certain elements in terms of the discussion did not go according to the terms that we view how the deal should move on.

Therefore, we made the decision. 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 continued attractiveness for TAPI in terms of the landscape. Therefore, we decided to initiate revised strategic review and review the sales process. As I mentioned, we'll keep all updates and provide further updates pending a transaction or any other determination around this process.

Christopher Stevo (SVP of Investor Relations and Competitive Intelligence)

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. 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 inline products and our pipeline.

Richard Francis (President and CEO)

Thanks for the questions, Chris. Next question.

Operator (participant)

Thank you.

Ash Verma (Stock Analyst)

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

Richard Francis (President and CEO)

Hi, Ash. And thanks for your question, starting on the EBITDA, just to sort of remind you, and I think Eli touched upon this in his remarks, the EBITDA is driven by a couple of things next year. 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. These products were all growing. We continue to see great growth rates in those. By the way, we've spoken about this in the past. These are very high gross margin products. That really does help impact the EBITDA. That's one. On one of the slides that Eli and I both showed is on the transformation of Teva and the organizational effectiveness. We're on track to do exactly what we set out to do in 2025.

That means that our guide to hit two-thirds of the $700 million net savings for 2026, we feel highly confident about. If you just put those two things together, that really gives us confidence about our EBITDA. I would probably take this opportunity to then talk about, 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. That is our generics, our complex generics, and our OTC. 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. I think that answers that part of the question. With regard to.

The one on Austedo, 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 Austedo are really strong. It's really important to understand. As you see, with regard to our TRx, our milligrams, our growth rates, I think the team has continued to execute at a high level consistently. I think we've seen that for quarter on quarter on quarter. One of the things I just would mention, and I think I mentioned on the last call. In Q3 2024 and Q2 2024, there was some channel stocking with regard to Austedo XR. That created a slightly different comparison, as well as we had some slight growth and adjustments in Austedo, which are favorable in Q3 of this year.

If you take those out, it doesn't really change the trajectory much of Austedo. I'd always think about looking at Austedo 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. That's the way I think about it. I don't anticipate anything of any significance in quarter four. The one thing that we always manage as well as we can, but it's not completely down to us, is the channel. We've been very disciplined at making sure the channel has the right stock. Obviously, that's something which we don't have complete control over, but we've shown good discipline there. I hope that answers your questions, Ash. Thanks for the questions.

Operator (participant)

Thank you. Our next question comes from Les Sulewski of Truist Securities.

Les Sulewski (VP of Biotech Equity Research)

Your line is now open. Please go ahead. Great. Thank you for taking my questions. We saw the FDA propose new guidance around biosimilars to reduce comparative efficacy study and potentially speed up the approval process. Three questions on this for you. One, how will this updated guidance impact your long-term biosimilar strategy? 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? Third, what further investments do you think are needed to give you a more competitive edge? 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.

Richard Francis (President and CEO)

Okay. Yeah. That was a multidimensional question. Thank you for that, Les. I think I'll start it off, but I'll also lean into my colleague, Eric, here, who obviously is close to that because of the pipeline we have. Firstly, we're pleased with the FDA and that initiation of removing Phase III studies. I think that's the right thing to do. I think that helps. 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. 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. To remind you what that strategy was, our strategy was to have one of the largest portfolios of biosimilars going forward. We were going to do that through partnerships.

We knew 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. We did not want to be initiating and allocating capital to things that may no longer be needed. An example is starting Phase IIIs, which are then no longer needed going forward. I think we sort of thought about where the puck was going. We made a strategy as to where the puck was going. I'm pleased to say I think we've been proven right on that. 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 2027, 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. Europe is a very mature biosimilar market and one I know particularly well. 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. You get an increase in volume and obviously offset some of the decrease in price.

Those are just some of the dynamics. I do believe the U.S. will catch up to that. When you have a broad portfolio and we are launching more in Europe, we are not necessarily beholden to exactly when that happens because of the scale and the size. Maybe, Eric, you could give a bit more detail on your views on this.

Eric Hughes (Executive VP of Global R&D and Chief Medical Officer)

Yeah. I can just give a few points to support what you just said. We work closely with the FDA and have frequent communications with regards to a pretty large biosimilars portfolio. We really anticipated the fact that they were going to be removing Phase III from the requirement for most programs and agree with this decision. The technical assessment really has been proven to be the most important thing when it comes to biosimilars, something we do very well.

This is going to decrease the cost of production and approval of biosimilars. It fits perfectly and facilitates the pivot to growth strategy that we put together in the past. It really supports a lot of the good decisions we have made over the years about how we will do biosimilars at Teva. It was a welcome decision. It was something we were looking forward to and really fits perfectly into the plan.

Richard Francis (President and CEO)

Thanks, Eric. One thing I would just like to add on, and I forgot, is obviously removing the Phase III need reduces costs significantly. 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 generic. I just think that the capital allocation does not disappear and the cost of it does not disappear.

Hence, the number of people coming into the market will, I still think, be restricted based on that. The ultimate is not just can you develop it and manufacture it, do you have an efficient go-to-market capability? I think what we're starting to show in the U.S. and we'll show in Europe is we do have that. That front end is very important when maintaining growth and profitability in your biosimilar portfolio. Thanks for the question, Les.

Operator (participant)

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

Umer Raffat (Senior Managing Director)

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?

Then secondly, to get to your 2027 $2.5 billion in sales, are you assuming volume gains because of this IRA cut versus Ingrezza to get to that number or not? Then finally, obviously, Olanzapine, I feel like, is taking a bit longer than we all anticipated. 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.

Richard Francis (President and CEO)

Hi, Umer, Thanks for your questions. 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.

That is why we remain very confident about our $2.5 billion in 2027. I remind people, greater than $3 billion peak sales. You did touch a bit about, do we see volume gains within this? This is not something we, 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 are going to understand a bit more in January as the first wave of drugs that were negotiated in CMS starts to come through and play out. We will see what are the dynamics that happen there. We will use that to adjust our modeling as we go forward. I hope you, as others, will agree. We are very thoughtful about how we model and how we forecast.

At least over the last two 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.

Eric Hughes (Executive VP of Global R&D and Chief Medical Officer)

Yeah. Thank you for the question, Umer, To start off with, we're right on track with what we plan for the submission of the Olanzapine LAI in this quarter. With regard to your question on the commissioner voucher, that's one of the things we've been reviewing within Teva. One of the great things about Teva is we have biosimilars, a whole portfolio of generics, and innovative medicines. The potential for where we could see a commissioner voucher is broad.

We're reviewing that now and looking to see what the most optimally timed and valuable program is that we seek one of those out for. More to come on that in the future.

Richard Francis (President and CEO)

Thanks, Eric. Thanks for your question, Umer.

Operator (participant)

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

Matt Dellatorre (Vice President and Equity Analyst)

Hey, good morning. Congrats on the quarter and the Austedo agreement. Maybe first on DuvaKine, now that the Phase III IBD studies are up and running, how are you thinking about enrollment timelines and potential data readouts there? Could you comment on any progress on the indication expansion strategy beyond IBD? For instance, could we see proof of concept studies announced over the near term? Maybe just as my follow-up on capital allocation, could you talk about the key priorities in 2026?

As we think about the free cash flow inflection, what are the key points of focus to achieve that full year 2027 guide? Thank you.

Richard Francis (President and CEO)

Hi, Matt. Thanks for the questions. I'll hand the first one straight over to Eric on the Phase III and the potential Phase II.

Eric Hughes (Executive VP of Global R&D and Chief Medical Officer)

Yeah. 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 II to Phase III with regards to this MOA of all the programs out there, which we're very proud of. 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. We're also putting a lot of effort in on how we execute the program with regards to logistics and our vendors that we use. It's been a really great collaboration with Sanofi. I think we're building upon a lot of momentum and success that we have. Going into a Phase III program with a Phase II program that probably had the highest numbers with regards to efficacy and the dataset that we produced, these are all good signals of starting a Phase III program.

When it comes to execution, that's what we're going to focus on right now. I think that we're set up very well to be in the horse race, if not in the middle of it, but hopefully coming up very close to the beginning of it. 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, and multiple indications. You can see many different Phase II 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.

That, in addition to the excitement around different combinations in the future, is also something we've been thinking about heavily. Right now, to begin this discussion, it 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.

Richard Francis (President and CEO)

Thank you, Eric. Now on the next two questions, capital allocation and free cash flow inflection. I'm going to hand those to Eli. 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. Thanks for highlighting that and seeing that.

I'll hand over to Eli to talk about our capital allocation. Going forward.

Eli Kalif (Executive VP and CFO)

Yes, Matt, thank you for the question. 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 2027. 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 keeping investing in our growth driver. The fact that the $700 million of savings is going to actually enable us to drive more efficient COGS with high gross 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. One. We paid for our debt this quarter. From now until October 26, like 13 months, we do not have any maturity. There is a $1.8 billion in October, and there is a $2.8 billion in March, May in 2027, early 2027. 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 million-$250 million that we are going to take out from our run rate, both from financial expenses going forward and pure free cash flow impact. On top of it, our progress on our working capital, you can actually see ourselves running below 4% going from 2027 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. Ability to be able to compete on certain opportunities related to business development that align strategically to our portfolio and to make sure that we are able to provide value to our shareholders. As we move forward to make synergetic activities around that piece, we'll keep looking on, of course, reducing our debt. As we move forward, we might also look on some certain other elements related to capital and shareholder returns. We will, for sure, during 2026, and we hope also in our next earning calls, provide some more colors around that kind of capital returns to shareholders.

Richard Francis (President and CEO)

Thanks, Eli. Thanks, Matt. Thanks for your question.

Operator (participant)

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

Richard Francis (President and CEO)

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.

Operator (participant)

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