Teva Pharmaceutical Industries Limited (TEVA) Q1 2026 Earnings Report, Transcript and Summary

Hello, and welcome to the Teva Pharmaceutical Industries Limited Q1 2026 Earnings Conference Call. My name is Alex. and I'll be coordinating today's call. [Operator Instructions]. I'll now hand it over to Chris Stevo, SVP, Investor Relations. Please go ahead.

Thank you, Alex. Good morning and good afternoon, everyone. Thank you for joining us on our first quarter call. I'd like to note that before we posted our press release this morning on earnings, we also posted a press release on the Emalex transaction as well as the slide deck relating to that transaction. And you can find those materials in the same section as you can find our earnings materials. Before I turn the call over to our CEO, Richard Francis, I want to remind everyone that we will be making forward-looking statements on this call. The company cautions investors that any forward-looking statement involves risks and uncertainties and is not a guarantee of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. These factors are described in our earnings press release and our most recent 10-Q and 10-K filed with the SEC. Any statements we make are only as of today, and we undertake no obligation to update these statements subsequently. With that, Richard Francis.

Thanks, Chris. Good morning and good afternoon, everybody. Thank you for joining the call. On the call with me today will be my colleague, Dr. Eric Hughes, Head of R&D and Chief Medical Officer; and Eli Kalif, the Chief Financial Officer. So starting with, as I always do on the Pivot to Growth strategy slide. And we launched this Pivot to Growth strategy 3 years ago, and it's based on 4 pillars: deliver on your growth engines, step up innovations, sustain generics powerhouse and focus the business. And as you will see through the rent presentation today, we've made great progress across all of these pillars. On deliver your growth engines, you'll see AUSTEDO and UZEDY and AJOVY continue to drive good, solid growth. Step up innovation, you'll hear from Eric about the exciting pipeline we have and some data readouts and milestones we have this year. Our sustained generics powerhouse, you'll see the growth to start -- to see the growth of the emergence of our biosimilar portfolio and lastly, focus our business. You'll see that we remain dedicated allocating our capital to the highest return opportunities. And Eli will walk you through some of this and also give you an update on the organizational effectiveness work we've done and how we are on track to achieve our $700 million of savings in 2027. But before I do that and to pick up on what Chris has just said, I'd like to talk a bit today about the announcement we made on the acquisition of Emalex Bioscience. This is the first acquisition under the Pivot to Growth strategy. And with this acquisition of Emalex we take ownership of ecopipam, a first-in-class asset with compelling efficacy and favorable tolerability in Tourette syndrome. Now to let you know a bit about Tourette's. This is a serious life-altering pediatric neurological disorder with limited good options today. So this is a market of serious unmet medical need where current therapies really do not satisfy the need. They either have efficacy, but have challenges with tolerability or they don't quite have the efficacy, but they have the tolerability profile. That's because of that failure, that only about half of patients are actually treated and a few of them, 1/3 stay on therapy after 1 year. So we see this as a clear opportunity to help patients expand the market, something we have successfully done with AUSTEDO and UZEDY. And as you know, we have strong CNS capabilities at Teva, whether that's in sales, marketing, market access, patient services, and we believe leveraging these will help drive penetration and growth. It's well noting that this transaction is highly aligned to our Pivot to Growth business development strategy. ecopipam has a derisked mechanism, strong pivotal data, no major development overhangs and orphan dynamics that support attractive pricing, to ensure this is a high-quality, value-accretive asset that accelerates our shift towards innovative revenue and profitable growth without compromising our balance sheet discipline. Now I'm just going to just give you an insight into the next slide, the treatment landscape because this will explain why we're so excited about ecopipam. Patients generally start on behavioral therapies. And if these fell, families are left with difficult choices. They either have alpha-2 antagonist, which are generally safe, but maybe do not offer the efficacy for many patients. The next step is antipsychotics, which can be effective, but come with meaningful metabolic and neurologic side effects that lead many families to discontinue or even avoid them all together. I think we can understand there would be a real hesitation in putting a 10-year-old on an antipsychotic for the next decade. That is not a sustainable long-term solution for a chronic pediatric condition. ecopipam changes that equation. It delivers meaningful efficacy with a good side effect profile, positioning it to become a preferred late-line therapy, and we fully expect pricing to reflect that value. Now on the next slide, you'll see some of the transaction details. Now I'll leave this for Eli to go through in more detail. But one area that I want to highlight is that the asset carries a gross margin significantly above our corporate average and that it has no impact on our ability to hit our 2027 targets and those beyond. Now with that, I'm going to move into the quarter 1 results. So we had a good start to the year, solid performance driven by continued strength of our innovative portfolio, and you'll see the growth of AUSTEDO, AJOVY and UZEDY in a couple of slides. Our revenues came as expected, down 1% or up 7%, excluding both the Japan divestment and including generic REVLIMID. It's great to see that we are able to mitigate the decrease in generic revenues also as planned and as I shared with you in the past few months. So the figures. Revenue down 1%, as I said, at $4 billion, adjusted EBITDA up 2%, reaching $1.1 billion, non-GAAP EPS grew 2%, reaching $0.53. Free cash flow grew 76%, reaching $200 million. Net debt to EBITDA is now at 2.42x. It's worth noting these all compared to Q1 2025. But let's double click and go into a bit more detail on what's behind this $4 billion. As you can see, strong growth of our innovative portfolio. All of these grew 41% instead of -- in coincidence we also grew 41%, up to $578 million. UZEDY's strong performance, up 62% at $63 million. And AJOVY also performed well, growing at 35% to $196 million. Our generics revenue performance was as expected, down 13%, excluding Japan, or flat, excluding both the Japan and generic REVLIMID. Now I want to walk you on to the next slide. I think this is a really interesting slide. This shows the transition that's been taking place at Teva from a pure-play generics company to a world-leading biopharma company. And as you can see, this is pretty significant and the speed of change is significant. Since 2022, the amount of revenue that's been driven by our innovative portfolio is up from 9% to over 20%. And as you can see by this slide, we continue to see this grow to 2030 and beyond. What is an important aspect that I always draw people's attention to is the gross margin and how our gross margin is fundamentally changing at Teva because of this portfolio shift. And as you see in 2030, we anticipate a gross margin of above 60%. Now let me dive into the individual products, starting with AUSTEDO, another strong quarter in -- for AUSTEDO in the U.S., reaching $559 million, up 41% year-over-year, with global results marrying that growth. Now growth has been driven by a combination of TRx, where we had a 13% growth and milligram growth of 20%, reflecting new patient growth and improved adherence. We continue to see the benefit from the shift towards once daily AUSTEDO XR, which now represents over 60% of new patients. And it's clear that the convenience and simplicity of AUSTEDO XR are proving to be major drivers of the franchise durability. It is worth noting that as we talked about in Q4, where we had some buildup of inventory in the channel, that has not all been drawn down in Q1. Now for AUSTEDO, we're reiterating our guidance of $2.4 billion to $2.55 billion for the year. Now moving on to UZEDY. Q1 performance for UZEDY was strong with revenues up 62% year-on-year and underlying growth driven by continued prescription growth of 75% TRx. Now this all reflects the fact that we have a very strong product profile, subcutaneous, low volume, no loading dose between therapeutic levels within 24 hours. But it also highlights the excellent commercial capabilities we have in the United States. Now I'm pretty proud of some numbers that I'd like to highlight. So since UZEDY has -- was launched, it's nearly doubled the market share of risperidone LAI from 5% to 9%. Now this is a massive accomplishment to drive such a change in what has been a static market for so long. So congratulations to the team. We also now to see expansion into the combined market of Risperidone and [ paliperodone ] LAIs. It's worth noting that UZEDY is positioned as the of LAI choice with over 86% of its NBRx is coming from patients transitioning from orals and those who are naive to antipsychotic drug therapy. And once again, we are reiterating our guidance for the year. Now I can't talk about UZEDY without talking about the upcoming launch of olanzapine, where we're very excited about this. Now let me explain why we're so excited. Well, the significant global opportunity is clear. Olanzapine currently holds 19% of the oral market, but lacks a viable long-acting options for a patient population that would meaningfully benefit from one. Second, as I've just described with UZEDY, this is an area where we will have clear synergies, sales force, market access, MSLs, patient services, et cetera. But more than that, we have real know-how the team has built up know-how over the last 3 years with UZEDY. And as you see on this slide, the investigator excitement is palpable. People are really looking forward to the launch of this product as there is a clear unmet medical need. Now moving on to AJOVY. AJOVY is a great example of how well we execute commercially innovative products globally. And despite being a late entrant to the crowded CGRP injectable market, AJOVY has steadily grown consistently outpacing the overall injectable market, as you can see from the figures on this slide. Where we launch, we generally end up as what -- #1. And as you can see on the slide, Q1 growth was driven primarily by the U.S. and ex U.S., Europe, particularly where we had market share gains, volume growth and valuable growth when it comes to access. Now moving on to our pipeline. I always struggle not to talk about this in great detail because I know Eric likes to talk about it, but I am excited about it. What I will just say is, we have 7 milestone readouts this year. We always started the year with duvakitug maintenance data which we thought was excellent. But now we're going to have the anti-IL-15 vitiligo data in Q2. And then in H2, it's really a lot of data readouts coming through, whether that's the futility analysis on emrusolmin, whether that's the anti-IL-15 data and celiac disease, whether that's the DARI conclusion of our Phase III results, whether that's the launch of olanzapine LAI or whether that's the first in human PD-1 IL-2. But the worth noting is that these will all add up to over $10 billion of peak sales. Now moving on to our generics business. Moving into the third pillar of our Pivot to Growth strategy. This performed as planned. Global generics were down 13%, mainly due to generic REVLIMID or flat if you take out generic REVLIMID. Now looking at the U.S. we were down 28% or up 10% excluding REVLIMID, and this increase was driven mainly by the higher revenues from our portfolio of biosimilar products. EU was down 1% due to seasonality of some of our products as well as launches and international markets was down 9%, excluding Japan. Now as I've just mentioned, the generic growth in the U.S. was -- has now started to be driven by our biosimilar portfolio. So let me give you sort of a review of where we are. We currently have 11 biosimilar products on the market, 4 more, which will be covering $16 billion of originated brand sales expected between now and 2027 and another 9 more after that, covering $58 billion of originated brand sales. So what does that mean? It means we have increased our portfolio by over 50% in the last 3 years, and it's starting to have a meaningful impact on our generics business. It is worth noting that we start to be launching biosimilars on a regular basis in Europe. So to conclude and before I hand it over to Eric, I want to reiterate our 2027 financial targets on the Pivot to Growth journey. Revenue mid-single digit, non-GAAP operating income of 30%, net debt to EBITDA of less than 2x and cash to earnings of 80%. And with that, I will hand over to my colleague, Eric.

Thank you, Richard. And as Richard mentioned, I do like to talk about this slide for 2 good reasons. One, there's a big impact we can make for patients across a number of different indications. And two, this represents 4 submissions over the next 5 years. And when the deal closes for the Emalex deal, that would be 5 submissions in the next 5 years, a real accomplishment for the teams at Teva and the R&D group, and we're very excited about this future potential for our pipeline. First, I want to talk about olanzapine LAI. I have a little bit of a late-breaking announcement. We just did our EU submission just yesterday and we'll be looking forward to the validation of that acceptance by the EU in the coming months. So very exciting. The team did a great job at accelerating that submission. And as you know, we've done the submission for the FDA back in December, and we believe the process of the review is going as planned, and we're looking forward to that approval by the end of this year. Now on to the dual action rescue inhaler program, our DARI program in Phase III. I'm very excited that we've now completed the enrollment of the large Phase III program called FLAIR. This is -- we enrolled over 2,700 patients. And more important thing about this large study is we have a very large sample size of both pediatrics and adolescents in this study, which is a very important component of this program because 25% of the patients with asthma are pediatrics and adolescents. And our unique dry powder inhaler is uniquely positioned to be really advantageous for this patient population. I'm also happy to report that over 60% of the events had occurred at this point. So we're on track for end of the year completion of events for this study. Moving on to our first milestone that we announced in our press release back in February for duvakitug. That was our maintenance data. And just as a review, remember, this study looked at ulcerative colitis and Crohn's disease patients with an induction period of 14 weeks and they rolled over into a maintenance period for 44 weeks. Now maintenance is very important because this is a chronic disease and patients who suffer with it cycle through therapies frequently. So having a drug that can maintain its response and continue on for years is very important. So we were very excited to see that the data at our 44-week time point showed great maintenance. We had ulcerative colitis patients maintaining 55% on of their -- or 56% of their response at 44 weeks for ulcerative colitis. And for Crohn's disease for the endoscopic response, they maintain 55% of that response at the high dose. And it's also nice that we had a dose response between the low and high dose. And that you should remember, this is given subcutaneously every 4 weeks from maintenance. So patient-friendly and good results. But how does that compare? We're excited to see data here that we think is best in class. But when you look across the entire landscape, this has the potential to be best in disease. So you can see that our numbers stack up favorably when you do a cross-study comparison against, TL1A is in development, anti-IL-23s that are approved and the JAKs that are approved. So favorable. We're very hopeful and excited to see what the results of the Phase III program look like. So the fundamentals of duvakitug are very strong. The antibody has high potency, high selectivity and immunogenicity. We've shown in our induction data that we have very favorable results of that 14-week induction period, all given subcutaneously. And the safety profile continues to be strong and favorable. And then we've recapitulated those results with strong maintenance data out to 44 weeks now, again, with good safety, with Q4 dosing and all subcutaneous, so the fundamentals are there, and that brings us to the last slide on duvakitug the Phase III study. We're working very closely with our partner, Sanofi. I'm happy to report that the study is on track and has started well, and we're looking to accelerate this program. The SUNSCAPE and STARSCAPE programs, I think, will be incredibly important for defining this class of molecule. Now moving on to another Teva born and raised antibody from our labs in Sydney is our anti IL-15 program. This program is now currently in 2 proof-of-concept studies for vitiligo and celiac disease. The exciting thing about this molecule, similarly to duvakitug. It has the potential to be approved someday in multiple different indications. So we're looking at vitiligo and celiac today with alopecia areata, atopic dermatitis and eosinophilic esophagitis are all possible things in the future for this molecule. And just as a review of what we're expecting this year, we have a proof-of-concept study running in vitiligo. One thing to take away from this study, which it should emphasize, what I think will be a potential great product profile is the fact that we're running a 24-week study, but only has 2 shops given subcutaneous once at day 0 and once at week 12. And then we'll have a week 24 readout for the VASI score, which is the endpoint for registration in vitiligo. Those results will be coming out at the end of this first half. And then in the second half, our celiac disease program will read out. Again, showing the product profile, this is a single-dose study with a readout after 12 weeks of therapy. And here is a classic proof-of-concept study where we give a dose of either active or placebo, and we challenge the patients with 6 weeks of gluten, about 3 grams per day. So -- and then at 8 weeks, we will get the biopsy. And what we'll be looking at and reporting in the second half is the protection of the gut from damage according to the villous height-to-crypt depth ratio on an endoscopic biopsy. So a very exciting program. I think moving forward to the data, and that's going to be the first half for vitiligo and the second half for celiac. And finally, the last program I want to just mention because I think it's such an important indication for multiple system atrophy, our emrusolmin program. This is a differentiated small molecule, brain-penetrant molecule that attacks the alpha-synuclein at the very genesis of the pathogenic aggregations. We're on track. The enrollment is going very well. In fact, we're going to over enroll this study to make sure it's robust, while keeping at arm time and we're on track for the futility analysis at the end of this year. Again, we have orphan designation and Fast Track designation from FDA. So I'll just want to end with our very exciting slide about the milestones that we're achieving this year. First, I mentioned to duvakitug readout in maintenance, we thought there was great data showing the value of duvakitug. The anti-IL-15 program mentioned the vitiligo in the first half readout and then celiac disease in the second half. The DARI program fully enrolled Phase III program on track for the final readout and final exacerbation by December. Emrusolmin, we're on track to the futility analysis. The olanzapine LAI program is under FDA review now, and we did our submission just yesterday in the EU. And finally, we'll be having IL-15 -- PD-1-IL-2 data at the end of this year. So it's a great year. I appreciate all the work that's being done in R&D and the extra effort everyone is putting into this. And with that, I'm going to pass it off to Eli Kalif.

Thank you, Eric, and good morning and good afternoon to everyone. I would like to start my review of Q1 '26 results with the following key messages: First, we started the year with a solid first quarter results driven by continued strength in our innovative portfolio. Second, the increasing mix of our innovative revenue, along with our transformation programs give us the confidence to improve margins throughout 2026 and on track to achieve our 30% operating margin target in '27. Third, we continue to monitor the geopolitical situation in the Middle East. Our operations remain uninterrupted with no material impact on our 2026 guidance. And lastly, our capital allocation strategy remains focused on driving our pivot to growth strategy and creating a shareholder value. The agreement to acquire Emalex and the potential share buyback program reflects our ongoing commitment to the disciplined approach for capital allocation. Now moving to Slide 35. Before I start with the results, I would like to remind everyone that our Q1 '25 financial results included approximately $75 million revenue contribution from the Japan business venture which was divested on March 31, 2025. For like-to-like comparison, I will exclude the contribution of this business from last year when discussing our financial results for this quarter. Now starting with our Q1 GAAP performance. Our Q1 revenue were approximately $4 billion, up 4% in U.S. dollars or down 1% in local currency compared to Q1 '25. Our key innovative product, AUSTEDO, AJOVY and UZEDY continued to show strong momentum, largely offsetting lower generics due to the loss of revenue from generic REVLIMID that we had expected. GAAP net income, EPS were $360 million and $0.31, respectively. Turning now to our non-GAAP performance. Our non-GAAP gross margin in Q1 '26 was 52.9%. This gross margin performance was better than our expectation, mainly driven by continued strong growth in our key innovative products and a favorable product mix within generics. Non-GAAP operating margin decreased approximately 50 basis points year-over-year to 24%, mainly due to higher planned investment in sales and marketing to support our innovative growth. Overall, we ended the quarter with a non-GAAP EPS of $0.53 compared to $0.52 in Q1 '25. Our free cash flow in Q1 was $188 million, up from $107 million last year. As I shared on our previous earnings call, our Q1 '25 results included approximately $300 million revenue contribution from our generics REVLIMID. Excluding this contribution, and the divestment business in Japan, our revenue increased by 7% in local currency and adjusted EBITDA by 28% in Q1 '26. On Slide 36, I would like to remind everyone of the margin trajectory I showed last year in May and how we plan to go from approximately 26% operating margin in '25 to our 30% target in '27. This represents approximately 400 basis point improvement over 2 years, driven by our continued portfolio shift towards high-growth and high-margin innovative products as well as $700 million of cost savings expected from our transformation program and despite the impact of losing revenue from our generics REVLIMID in 2026. In 2025, we made significant progress towards these goals by improving our underlying operating margin to 26.8%, which was ahead of our initial expectations for 2025. Moving to Slide 37, we continue to make progress on our margin expansion journey in '26 with a solid start in the first quarter. Overall, we are transforming Teva into a structurally higher gross margin business with a growing innovative portfolio mix and the transformation of our manufacturing cost base. In addition, our OpEx transformation allow us to keep operating expenses as a percentage of revenue stable, as we reinvest significant savings from our G&A towards our innovative portfolio and pipeline to position us for both the short-term and the long-term growth. Moving to Slide 38. We're also making significant progress in our Teva transformation programs to deliver sustainable margin improvement. During Q1, we continued to execute on our targeted programs and remain on track to achieve approximately 2/3 of our total $700 million savings target to be realized by the end of 2026. In relation to these programs, we have already recorded approximately $205 million in restructuring costs in 2025 and cash outflow of approximately $100 million. In Q1 '26, we recorded an additional restructuring cost of approximately $25 million. And for the full year of 2026, we expected cash outflow of approximately $90 million to $100 million, all of which are already incorporated in our guidance. These transformation efforts, along with our ongoing portfolio shift towards innovative products, gives us the confidence to grow underlying EBITDA in '26 and in '27 and to achieve our 30% operating margin target by 2027. Now on Slide 39, let me provide some additional details on our agreement to acquire Emalex with a couple of key messages. First, as Richard highlighted earlier, Emalex is highly aligned with our Pivot to Growth strategy. Second, we are maintaining a strong balance sheet with no change to our 2027 leverage target of 2x net debt to EBITDA. Now turning to the key terms of this transaction. The upfront consideration is $700 million in cash with additional commercial milestones of up to $200 million. We expect the transaction to close in late Q2 or early Q3, subject to customary closing conditions. Moving to the financial impact. We expect the product to have a gross margin profile of approximately 80% subjected to regulatory approval and launch in 2027. I will discuss changes to our 2026 financial guidance to reflect these acquisitions on the next slide. But importantly, we expected Emalex to meaningfully contribute to our revenue growth and margin expansion after ecopipam is launched and scaled and be accretive to our non-GAAP EPS starting in 2028. And finally, we remain on track with our 2027 financial targets, including our 30% operating margin. We expect the higher operating expenses related to Emalex in 2027 to be absorbed by the initial revenue uptake from ecopipam following its launch as well as additional efficiency measures. Now let me turn to our 2026 outlook on Slide 40. As I mentioned earlier, we had a solid start to the year with a strong underlying revenue, margin, cash flow performance in Q1. largely offsetting tough comparison related to generics REVLIMID revenue last year. We're also excited about Emalex acquisition, which is expected to further sense and build upon our strong commercial infrastructure in the CNS space. Based on our Q1 results and our visibility into the rest of the year, we are reaffirming our 2026 outlook range on an underlying basis, excluding, Emalex for all financial metrics provided on our Q4 earnings calls, including growing our EBITDA in 2026. However, even though Teva is acquiring 100% of Emalex shares, we expect the acquisition will be treated as an asset deal. And therefore, the upfront consideration of $700 million will flow through R&D line as IP R&D expenses in the P&L. We also expected approximately $75 million of additional operating expenses in 2026 related to Emalex starting Q3, including the transaction costs. The changes to our 2026 guidance range for operating profit, EBITDA and EPS are slowly reflecting this additional $775 million expenses related to the acquisition. There is no change to our free cash flow guidance range of $2 billion to $2.4 billion. Excluding the Emalex acquisition, our effective tax rate outlook range of 16% to 19% also remains unchanged. Moving on, we continue to expect 2026 non-GAAP gross margin to be in the range of 54.5% to 55.5% during the year. Our operating expenses are expected to be in the range of 27% to 28% of revenue, with the first half of the year higher than the second half, reflecting planned investment in the first half, along with the higher impact of the transformation program cost savings in the second half of the year. Now with the expected operating expenses and the transaction costs related to Emalex, we expected our operating expenses for 2026 to be towards the higher end of our 27% to 28% range. Lastly, let me provide you with some directions on how to think about quarterly progression for the rest of 2026. We continue to expect revenue to gradually increase over the course of the year. Also the Q1 revenue were slightly better than our expectation due to a less-than-expected destocking in the channel and timing of some orders from Q2 to Q1. Since the inventory levels in the channels remain elevated, we may see these dynamics evolve during the rest of the year. In addition, as mentioned last quarter, we expected AUSTEDO revenue in Q4 '26 to be down year-over-year due to the different purchasing patterns and pricing environment expected ahead of the IRA implementation in January '27. The Our non-GAAP margins are also expected to gradually ramp up over the course of the year, in line with the revenue trajectory as well as savings from the ongoing transformation programs. However, we expect margins to be stable in Q4 versus Q3, reflecting the anticipated channel dynamics related to AUSTEDO in Q4, 2026. Lastly, our capital allocation strategy remains focused on driving our Pivot to Growth strategy. Over the last few years, we have made significant progress to strengthen our balance sheet and are now at a short distance from our target leverage of 2x net debt to EBITDA and achieving an investor-grade credit profile. We believe we are well positioned to achieve these goals and our execution has been recognized by the major credit rating agencies. The progress we have been making allows us to continue to invest organically in our innovative portfolio and pipeline as well as provide flexibility to execute thoughtful and accretive business development to create a long-term shareholder value as we are doing with Emalex. In addition, our Board of Directors has instructed the management to plan for a share repurchase program that may be implemented subjected to meeting applicable legal requirements. The timing and the exact amount of repurchase will be subjected to further board approval and will be dependent on the various of other factors, including market conditions, share price and other investment opportunity aligned with our Pivot to Growth strategy. We believe this potential use of capital will further enhance long-term shareholder value while preserving financial flexibility to continue to invest in our business and to execute on our Pivot to Growth strategy. With that, I will now hand it back to Richard for his closing remarks.

Thank you, Eli. So moving on to this slide. I just wanted to once again reiterate why we are excited by our Emalex deal and why it fits perfectly with the strategy of Pivot to Growth and the criteria we laid out for business development? Let me just go through those. First, it is a rare neurological asset squarely within our core therapeutic focus area. Second, it's a natural fit for our CNS franchise, leveraging the commercial infrastructure and capabilities we already have in place. Third, it is financially accretive, driving revenue growth starting in 2027, margin expansion begin in 2028 and creating both strategic and financial optionality over time. Fourth, the risk profile is highly attractive. Pivotal studies are complete. The program is well understood and the regulatory filing is expected in the second half of 2026. And finally, this transaction has no impact on our commitment to 2x net debt to EBITDA by 2027. To summarize, this is exactly the type of disciplined, value-creating transaction. We said we would pursue. I'm very excited about the impact this is going to have for patients who today have very limited treatment options. Before I conclude, let me remind you of some of the drivers that we believe make Teva an attractive investment and how our Pivot to Growth strategy continues to execute as planned, transforming Teva into a leading innovative biopharma company. We expect our innovative portfolio to continue driving growth well beyond 2027. It's currently anchored by AUSTEDO, which we are reiterating our target of reaching more than $2.5 billion in 2017 and over $3 billion peak sales, along with our innovative products UZEDY and AJOVY, we'll continue to drive our product mix and profitability. And as I said, we are also preparing for the exciting innovative launches coming up, starting with olanzapine this year. And then for my concluding slide, the growth journey continues. Innovative brands, double-digit growth for upcoming launches Emalex's attractive acquisition of first-in-class neuroscience treatment aligned with our strategy and financial targets, near-term value unlocking milestones from our world-class pipeline, a stable outlook for our generics powerhouse, accelerating the Pivot to Growth strategy. And with that, I would like to open the floor to questions. Thank you.

Thank you, Richard. Alex, while you're queuing up the callers, [Operator Instructions].

[Operator Instructions] Our first question for today comes from Louise Chen of Scotiabank.

Congratulations on the quarter I wanted to ask you about your Emalex acquisition. And if you could give more color on the synergies with your CNS franchise, especially on the pediatric side. And then as a follow-up, how do you think about the peak sales potential of this asset? And what kind of assumptions support that thought?

Louise, thank you for the question. So yes, so when it comes to ecopipam, we're very excited about this asset because of this significant unmet medical need. Now there are about 100,000 children, pediatrics, who suffer from Tourette's, only about 50,000 of those actually go into therapy. And as I said, less than 30% stay on therapy after 1 year. So clearly, there is a significant unmet medical need. As I sort of talk about this, this probably makes you very familiar with the work we've done with AUSTEDO and to a certain degree, UZEDY. So then going back to the part of your question around what are the synergies. So we clearly have synergies in many aspects of our business from patient services to managed markets to MSLs and to a certain degree, to our sales force. We will have to put in place a small pediatric sales force to focus on ecopipam. That said, it is worth noting just the deep expertise we have in movement disorders here at Teva, we have with neurologists and we have with the psychiatric community. So I think for that reason, we're very excited about the fact that we can really offer some meaningful hope to what is a very different condition for children. With regard to your question around peak sales, I'll just go back to this is a significant opportunity. And as we get closer to launch this product, we'll start to give an idea of what we think this could be. But I think at this moment, as we're still thinking about the unmet medical need, the lack of treatment options and a significant unmet medical need from a patient perspective. Thank you for your question, Louise.

Our next question comes from Glen Santangelo of Barclays.

I mean, Richard, clearly impressive growth in the innovative portfolio. And I think in your closing remarks, you reiterated the greater than $2.5 billion in sales number. for AUSTEDO in '27. And I'm just trying to sort of reconcile some comments you made earlier this year about '27, where you expected low single-digit growth. And when we unpack this quarter and you normalize for FX and the Japan business venture and generic REVLIMID, this looks like a 7% growth quarter to us. And I was wondering, Eli, if you could maybe confirm that. And then I'm trying to reconcile the growth rate in the business currently versus your expectation for that low single-digit growth in '27. Not that you want to guide on '27 at this point, obviously, but we're looking down the pipe and you see olanzapine coming in, now you have ecopipam, which may be a modest contributor next year. I'm just trying to reconcile all the big moving pieces around how we should be thinking about the balance of this year and the growth rate into next year?

Glen, thanks for your question. I'll try and sort of unpack it. And I think what I'm hearing is maybe -- and maybe if you can advise me is that maybe you're feeling that we could be slightly conservative towards 2027? Is that the question?

Yes. Yes. It just kind of feels Richard, that you're growing much faster than that at this point and you're expecting maybe some modest growth in AUSTEDO next year with some contribution from your pipeline next year. I'm just trying to reconcile your thoughts around that low single-digit expectation for next year.

Okay. Now I get it. Okay. So thanks for that clarification. So I think when it comes to let's start specifically with AUSTEDO. I think as I pointed out and as Eli pointed out, there's a few moving parts here. And one of those, and probably the biggest moving part is how the IRA impacts us sort of pre IRA, which is Q4. What happens to our inventory, what happens to the channel? Will there be a drawdown because of the pricing change in 2027. It's hard to understand and predict that. So I think for one of those reasons -- for that reason, I think we have to be thoughtful at AUSTEDO and see how this plays out. Do we have any conservatism and concern and worry about the untreated patient population that still need to go on AUSTEDO. Do we have any worry about our ability to execute and get more patients on to AUSTEDO, onto the right dose, onto the right compliance adherent programs? No, absolutely not. We remain very, very confident about the long-term growth of AUSTEDO, and that's why I reiterated the $3 billion peak sales. It's just a bit of timing there, Glen, and just seeing how that plays out. With regard to some of the other growth drivers, UZEDY and AJOVY, soon to be olanzapine, as you know, we tend to like to really get a couple of quarters under the belt to really understand what this looks like. So we don't sort of get ahead of ourselves. So that's what we're thinking about. So I think maybe as we talk about 2027 guidance, will come to the end of the year and be able to give clarity on that. But I think 1 quarter is -- we're pleased with the quarter, but let's get some more quarters under our belt before we start predicting what the future could be. So hopefully, that helps you. But I'm pleased that you see the strength in the underlying innovative business. And let's talk about what that could be in '27 and beyond. But maybe for me to conclude, I'd say it is a bit beyond '27, '28, '29. I hope you can see the opportunity for us to keep growing this company, keep growing our innovative portfolio and keep growing our gross margin and thus keep growing our EPS. Thanks for the question, Glen.

Our next question comes from Matt Dellatorre of Goldman Sachs.

Congrats on the strong quarter and the deal announcement. Maybe first on capital allocation broadly. If we think about free cash flow of $2.5 billion to $3 billion over the next several years, could you maybe comment on what you see as a fair base case at this point on how you might allocate across potentially additional BV now, maybe share repurchases and then further debt pay down. And then maybe one on the branded pipeline. What is the latest expectation for the indication expansion strategy for duvakitug? And is there anything that you're particularly focused on from a competitive landscape perspective this year or over the coming months?

Thanks for the question, Matt. And clearly, as I'm suffering from some sore throat, I'm going to quickly take a break and hand the capital allocation to Eli and then the 2 new indications to Eric. Over to Eli.

Okay. Thanks for the question, Matt. So look, we ended the quarter with $3.7 billion cash on the balance sheet. If you think about midpoint for this year, like $2.2 billion free cash flow, we generate almost $200 million already it's like another $2 billion to build, so it's get you like to the $5.7 billion, considering the closing on Emalex, it go to $5 billion and we have another tranche by October to pay like $1.8 billion. So most likely we're going to be north than $3.2 billion by end of the year, a very strong balance sheet from our perspective. So as we move forward and we keep growing our EBITDA and totally transforming our gross margin projections looking on $2.4 billion to $3 billion kind of run rate beyond, I would say, '26 on free cash flow. What we actually announced this morning about the buyback, this is basically kind of a part of a natural evolution of our capital allocation, which really focuses us now on maximizing shareholder value. It's basically giving us kind of creating additional optionality to the management to allocate capital. And we are able to do it because the balance sheet become more stronger. What we're going to see going forward, we're going to see maybe another 1 or 2 deals with a couple of hundreds of millions. We are not actually going to do something bigger than that in the short term. If something will come in front of us, then we'll require any other financing. We still have our revolver, like, $1.8 billion that we are not utilizing -- we're -- as I mentioned, we are growing EBITDA and we're growing our free cash flow. And so anything around that, I would say, a quantum, it should not actually depart us from our 2x net debt to EBITDA. But the rationale here is to come to the 2x net debt to EBITDA and then going forward, looking on our debt management in order to make sure that we have enough flexibility to grow the business.

Thank you, Eli. And now, Eric, on the 2 new indications for duvakitug.

Yes. Thank you, Matt, for the question. So duvakitug, as we always say, has a great potential across many different indications. We and Sanofi bucket these possibilities in T2, non-T2 and fibrotic indications. And we have a very clear pathway on how we choose those based on market size, scientific justification and regulatory chances of success as well as speed. So we've aligned on those indications. We'll be announcing those before the end of the year. I think that's great excitement around that. One of the things I'm glad to see, though, right now is the effort and the speed in which we're interrogating the Phase III programs in the inflammatory bowel space, the opportunity there is massive. And I think we are highly differentiated from the other molecules out there, and that's the great success that we've been focused on so far. But we will be announcing those. I think that the indications across this field will advance quickly. Thank you.

Our next question comes from Dennis Ding of Jefferies.

I have 2 on the Emalex transaction. So your slides don't really mention anything about the adult population, but the Phase III hit on both peds and adults as a secondary. So I'm curious if you expect a broad label that covers both peds and adults. And how meaningful can that be on the TAM beyond the 50,000 children that you noted that are on therapy. And if you can maybe also comment on the efficacy in the adult-only population as well. And then as a follow-up, can you just help us narrow down pricing? I mean you mentioned rare in your slides, but that's still fairly broad.

Thank you, Dennis. What was the last part, pricing? Okay. So I'll tag team the first one with you, Eric. So just to be clear, this is a pediatric treatment, ecopipam for pediatric Tourette's, so to be clear about that. And if you look at the patient population, the majority are pediatric. So hopefully that answers your question. When it comes to pricing in rare and orphan, yes, we think because of the significant unmet medical need, we think about the size of the population that we think that allows us to have a pricing within the range that is normal for orphan and rare I hope that answers your question. Dennis, do you want to add something to it, Eric?

Yes. And yes. Thanks, Dennis. About the question about adults. It was a small population of adults in the Phase III study. Those efficacy results trended along with the pediatric results. But I would build on what Richard said, the efficacy in the pediatrics is particularly important because when you're thinking about a novel mechanism like this, a D1 receptor antagonist and the profile of safety, particularly for the pediatric population. There's no weight changes, there's no metabolic findings, there's no extrapyramidal signal that you would see with a D2 receptor antennas. This is a product that can deliver a great efficacy profile. But the more important is that, the safety for the pediatric population is something we're very proud to be part of, and I think that's the true value.

Our next question comes from Jason Gerberry of Bank of America.

I've got a generics pipeline question. So Teva has a settlement to launch generic TYVASO nebulizer this year but has chosen not to launch for business reasons, but I'm wondering if the company would reconsider, given that, that drug and dosage format are set to launch in the large IPF category, I think some analysts have that being a $4 billion to $5 billion indication. And I think a license would give you sole source as a generic for pre extended period of time. So just wondering what's going on there. Is it simply difficult to get a generic approval. And then as my follow-up, I noticed on your slides with the IL-15 for vitiligo, it's now listed as accelerated path 2031 time to BLA versus before it was a range of '31 to '34. So have you had a regulatory interaction, are you confirmed now on that accelerated path?

Jason, thanks for the question. With regards to the generic pipeline, we don't talk about our generic pipeline for competitive reasons as well as legal and others. So I'm sorry, I can't really give you any more color to that. But I'll let Eric give you some color on the anti-IL-15.

Yes. Thank you, Jason, for noticing. That was a change that we made for this announcement. It's really driven by the fact that the team is executing. We have a very clear pathway in which we're going to design our Phase II, Phase III study. So it's greater confidence in our execution at this point. But thank you for noticing.

Our next question comes from Umer Raffat of Evercore ISI.

I just thought I would spend a little bit of time on the Emalex acquisition as well. Maybe first, unlike in a traditional pharma company where you sort of inherit a range of molecules, which have their own expiries. I feel like the advantage you guys have is you get to decide how you want to stack on the LOEs. And I guess my first question is knowing that this molecule is an old Merck drug or there's probably not a composition patent and the method of use is also likely pegged to early 2030s because of some of the earliest work done in Tourette's in back in 2014. I guess my question is, is it really just orphan exclusivity? And would that effectively become an overlapping with AUSTEDO IPs? That's #1. And #2, how -- is there any preliminary FDA feedback on whether the duration of trials run so far it's sufficient to satisfy them on suicide ideation and neuro side disorders in general?

Thanks for the questions. So we expect ecopipam to be covered by orphan drug exclusivity. So that gives us 7 years from the date of FDA approval. So that sort of takes us into the 2033, 2034 time lines. But in addition, Emalex is granted patent expiring in 2035 curing methods of treating Tourette syndrome using ecopipam. Now this pattern is likely to be eligible for patent term extension and Emalex has filed an additional application covering methods of treating Tourette syndrome, which could expire in 2043, if granted. So -- and then going back to your comment, on AUSTEDO XR, we also believe without going into the detail that we have a clear path of patent extension into the 2040s as well for the XR formulation. So I think that, I think we feel pretty good. But when it goes on to the FDA question. I'll hand that to Eric.

Yes. Thank you, Umer, for the question. So yes, there is a long development history and a very large data package that's associated with this molecule. It actually started with Schering-Plough, a company I used to work at and then went on to Merck. But the -- focusing on the Tourette's program. This program includes 2 well-controlled studies. Remember, there was a Phase II study that showed on treatment responses and changes from baseline in the [ AIMS ] score and then there was a randomized withdraw Phase III study that showed a great persistence compared to placebo, both statistically significant and powerful. And that database from orphan disease is robust. It doesn't meet all requirements, but from an orphan disease, we're fairly confident that on top of the history of the compound is satisfactory for approval. Now according to -- I mean, to address your specific question about suicidality. The rates of suicidality were extremely low, just a handful, and it was actually balanced within the placebo-controlled parts of these studies. So -- and more importantly, the studies were run very carefully with lots of measures on many different aspects, particularly suicidality, extrapyramidal syndrome and with this intense monitoring, there was actually no signal at all with regards to suicidality and any changes from baseline. And more importantly, on the extrapyramidal syndrome. There was no disorder or signal of motor events in this. And the reason I bring all this up is that they were very thorough studies in a placebo-controlled way that shows that there's no weight gain. There's no metabolic changes. There's no extra extrapyramidal syndrome -- symptoms of motor dysfunction that you see. This highly differentiates it from the D2 receptor antagonist that, as a parent, I would not normally want to put a pediatric patient on a molecule like an antipsychotic that causes that sometimes permanent changes. So the profile of the D1 agonist is very, I think, conducive of this patient population, the side-effect profiles, very well tolerated. And more importantly, if you have an efficacious drug that the patient can actually stay on, that's the important thing. It doesn't matter what your efficacy is if the patient can't continue. In fact, their long-term 1-year study in the open-label extension at the 1 year, 66% of the patients stayed on drug compared to 20% or 23% of a normal antipsychotic treatment. So though, the totality of this information, I think, is favorable, and I think that would be appreciated by regulators.

Our next question comes from David Amsellem of Piper Sandler.

A couple for me. So on Emalex, just piggybacking the last question, do you think that there will need to be a REMS here regarding suicidal ideation or potentially other risks. Just wanted to get some color on your thought process there. And then as you think about other indications, I believe Emalex had a program in restless leg syndrome. I believe it was augmentation. So can you talk about what you're planning to do there? And then lastly for Richard, I think you've alluded to in terms of M&A strategy, in terms of building the neuroscience pipeline, looking at that more inorganically either by M&A, whereas immunology, you're going to focus more on organic development. Is that still the case? Or are you taking more of a flexible approach as you think about those 2 verticals?

David. Thanks for the question. I'll hand the first 2 to Eric.

Yes. Thank you for the question,. So we don't see this program having a REMS. Given the class of these drugs, you might expect the black box for suicidality, but that's typical of this class of medications. We haven't made a final decision on the restless legs syndrome indications, but that's something we can entertain in the future.

And then to the question of M&A, you're right, David, we tend to talk about neuroscience inorganically, and we tend to talk about immunology more organically from a pipeline point of view. That said, it always goes back to what is our goal at Teva to create a world-class biopharma company and to make sure we are creating value for patients and shareholders, and it comes back to capital allocation and what is the most appropriate way to allocate capital. And so while those themes are true, we still look and scour and think about how we can really add to this Pivot to Growth strategy on a continuous basis. Being very disciplined in what we do and how we do it, both internally and externally. When you have a pipeline internally, you do have to allocate capital. And we think about that as disciplined as you would externally. But broadly, you remember correctly, and that fits with our strategy. Thank you.

Our next question comes from Chris Schott of JPMorgan.

Congrats on the acquisition. I just had 2 here. Maybe first on the Emalex acquisition. I know you're not going to comment on peak sales. But any comments on how we should think about the ramp post approval here, given unmet need? I'm just trying to get my hands around, are there payer dynamics that could result in a slower ramp? Or is this something that could go relatively quickly just given the market as it exists today? Second one for me was just going back to AUSTEDO and kind of quarterly gating dynamics. I totally understand what you're saying about 4Q. But can you just talk about the next few quarters? It seems like there was some destocking that was expected this quarter that maybe didn't fully occur? Is there anything we should just be keeping in mind for 2Q and 3Q that could result in maybe growth rates that are below the underlying volumes, et cetera. So anything there would be great.

Chris, yes, thanks for the questions. So with regard to Emalex, I'm not giving peak sales guidance, but giving ramp-up guidance. So look, I think we go back to, I think, what you've identified in your question is a significant unmet need in a patient population, which is pediatric, which obviously gets a lot of focus and attention. That said, as usual with Teva, we like to be very thoughtful and diligent and really understand what this could look like. There is a big unmet need. We are excited about it. So I don't want to be too coy, but when it comes down to the things you've touched upon, which are around, patients going on to therapy, good access, appropriate access. Those are the things we like to think through. So I think your excitement, which I sense within the question is appropriate, but we'll need a bit more time before we start to sort of give you a real line of sight on that. With regard to AUSTEDO, yes, so we just didn't see the drawdown in Q1 that we expected. So how does that play out, probably plays out a bit into Q2 and Q3. But then there's the fundamental question about Q4. So we just have to see how this goes. What I always go back to, when I'm having these conversations internally is, okay, but what are we doing on the leading indicators, the TRx, the milligrams all the things we're doing around our coverage, new prescribers, the depth of prescribing. And all of those indicators are looking very much on track. So I feel very good about that because my line of sight is the $3 billion plus. It's not so much the short term, I feel we have that line of sight clearly laid out. But that's how I think about how does that play out to Q2 and Q3, just keep those in mind, underlying indicators are good. Destocking -- let's see how that plays out in Q2. And then we'll give you some probably more indications as we get that data in Q2 ourselves to say this is how we think it could trend for the rest of the year. So I hope that helps, Chris. Thanks for the question.

Our next question comes from Ash Verma of UBS.

So just in terms of the $700 million payout for BV that you're doing, how does that change your time line to get to investment grade debt. Is that something that can still be achieved this year? And then just as a follow-up, with the geopolitical developments in the Middle East, is that creating any kind of an impact on your shipping or freight cost or any challenges in terms of getting materials in and out of different geographies?

Ash. I'll hand both of those over to Eli.

Ash, thanks for the question. So first of all, nothing going to change in terms of trajectory to reach investor grade this year. And the $700 million, actually, it's a number that will flow as expected from the nature of the deal to the IP R&D line, as well from our balance sheet from a cash perspective. But according to our trajectory on growing EBITDA this year, and keep generating cash. We don't see this 1 impacting on all those metrics that we need to achieve to become investor grade. And on the other element, look, we are monitoring very closely in the situation on the conflict with Iran in the Middle East. And I can tell you that there was kind of a few elements, call it, nominal increase on some spend related to transportation and some energies, but this one are very minimal, and we're able to monitor it and everything that considering our cost base for '26 is already in the range in our guidance.

Thanks, Eli. Thanks, Ash. Next question, I think a final question I believe.

Our final question for today comes from Leszek Sulewski of Truist.

Just one for me on the IL-15. So what's your confidence level for the upcoming vitiligo readout and later celiac, given the Sanofi and Amgen readouts? And then second on that, how competitive do you think the data has to be versus what we've seen from the dual inhibition approach of the IL-2, IL-15?

Thanks, Les. Thanks for the question. I'm going to hand that straight to Eric.

Yes. Thank you for the question. So the IL-15 program, I think the target is becoming more and more validated at this point. I think that the bar here is to look at what Phase II results and Phase III results have been most recently for the oral JAKs. Those are systemic treatments at this point. And I think the most recent data is a good target. Remember, we're coming out with 24-week data, always compare the times because the endpoints -- the disease matures on treatment over time. So we're going to be showing you a 24-week data. So I choose that probably from the Phase II and the Phase III results. And I think our program had the chance to be competitive and also have the chance to be a systemic therapy that's easily taken every quarter as a subcutaneous shot. So that really is a differentiating profile from what's being developed now.

Thanks, Eric. I think that concludes today's call. Thank you for all your questions and interest in Teva. We look forward to giving you an update again in Q2. Thank you very much. Bye-bye.

This concludes today's conference call. Thank you all for joining.