Teva Pharmaceutical Industries Limited Sponsored ADR Aktie

Hello, everybody, and welcome to the Q3 2026 Teva Pharmaceutical Industries Earnings Conference Call. My name is Elliot, and I'll be coordinating your call today. [Operator Instructions]

I would now like to hand over to Christopher Stevo, Head of Investor Relations. Please go ahead.

Thank you, Eli. Good morning and good afternoon, everyone. Thank you for joining us for our third quarter earnings call. As usual, our materials are posted to our website this morning, so please feel free to see them there.

And before I turn the call over to our CEO, Richard Francis, I'd like to remind everyone that we'll be making forward-looking statements on this call. The company cautions that 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 Forms 10-Q and 10-K filed with the SEC. Any statements that we make are only as of today, and we undertake no obligation to update those statements subsequently.

However, I will now undertake the obligation to give you our CEO, Richard Francis.

Thank you, Chris. Good morning, and good afternoon, everybody. Thank you for joining the call. With me talon this call will be Dr. Eric Hughes, Global R&D and Chief Medical Officer and Eliyahu Kalif, CFO.

Now moving on to the next slide. as do I start with the pivot growth strategy and the four pillars. We launched in 2023, and I'm going to give you an update in Q3 is the progress we've made against this strategy. Starting with delivering our growth engines. You'll see that the invite portfolio continues to perform well. The set out Jobstl delivering strong Q3 performance and our innovative portfolio is up 33%, and we're raising full year guidance across all of these products. Now the importance of these products can be seen in our financials, and you'll see that our revenue is stronger, our margins and our free cash flow also becomes strong.

Now looking to the second pillar, step-up innovation. You see that we have eight major milestone readouts this year, but also we've seen some good progress. And we prove Welte was a significant amount of rent to Teva as well as the patients stopping in schizophrenia. We also have good progress in Ecopia we have FDA fast track designation for our anti IL15 candidate select disease. And so looking ahead, we have four additional potential submissions over the next five years.

With regard to an announcement we made earlier in the week are Solman after an independent data monitoring committee met on a prespecified interim futility analysis, we have discontinued the Phase II study. That's got to point out there were no safety concerns. Now while this outcome was not what I hoped for, and I'm deeply disappointed for the patients we are hoping to serve and the position to help us on this journey. I'm particularly proud of the team and the effort we put into this program. What we have learned and will take forward with even more determination.

Now another change to our pipeline that happened before the earnings was regard to BioXcel and the acquisition of BXCL501. This is an asset that we think is going to further strengthen our neuroscience franchise and our psychiatric portfolio. There's a big unmet medical need, we believe, in treating agitation at home, and we think this in the hands of Teva could really help these patients with this unmet need.

Now moving on to Sustained Generics POWERHOUSE. Biosimilar, as you'll see throughout the presentation of becoming a significant growth drives now at Teva in our genomics business, we have 15 products in the market and 16 more in our pipeline and more opportunities to expand this. And actually, earlier today, you may have seen in the press release, we show we have further strengthen our partnership with Samsung with two FDA pro and TNF alpha biosimilars.

On the final pillar on capital allocation, with the latest S&P upgrade, Teva has now achieved an investment-grade status across all three major rating agencies, reflecting the continued strength of our financial profile. We also in this last quarter, we financed $4.9 billion of senior notes. We think about doing that. And then with regard to EDS conversions to ordinary shares in the New York Stock Exchange, we've now opened up the opportunity for broader investment access to Teva.

Now starting with what I think was the highlight of Q3 for us, which was the launch of WELTRUZA and the approval of Motus. Now this is a milestone to cover, but more importantly, a milestone on a basket patients living with schizophrenia. Let's be clear, I start with the patient. Schizophrenia is a devastating disease and every relapse can have a significant impact on patients and their families. With WELTRUZA brings a proven olanzapine efficacy in a once-monthly subcutaneous injectable for the opportunity to help patients stay on treatment and reduce relapses.

WELTRUZA is the first and only long-acting injectable with no loading dose, no oral supplementation or post-injection monetary. And because of this, we believe Voltus can make a real difference to patients suffer from schizophremia. So what's the opportunity? Well, on the next slide, you can see that significance.

With 2.2 million people who are diagnosed with Skip in the U.S., approximately 1.7 million are treated and approximately 20% of the prescription are for all alacrity. We all know that olanzapine has a well-established efficacy and then safety profile, and that is going to through the strong foundation for worse. But also, as we all agree that our commercial organization is very well positioned to succeed with Virtusa building on the great work that has been done over the last three years with used, and I'll go into that in more detail later.

But when you combine these two products, we have a portfolio designed to invest a board spectrum of unmet needs with Justin Morteza, highly differentiated and yet complementary. They're anchoring the two proven molecules of risperidone and olanzapine. And because of this, we have confidence in achieving the peak sales of $1.5 billion to $2 billion.

But now let's move on to the financials. Now Q3 2026 reflects Teva's transition to a biopharma company. And the factor in the numbers here. So let me walk you through that. So revenues declined 2%. But our gross margin grew to 58.7%. That's up 345 basis points. Our EBITDA grew 7% and our non-GAAP EPS was up 10%. Now I remember way back in 2023 when I presented the first quarter's and our gross margin was approximately 48%. So this really shows the substantial progress we've made in transitioning this company from a pure pay generics to a biopharma company.

Now this isn't a one quarter effect. Reflects deliberate choices we have made to transition the business. We set out in 2023 to become a biopharma company, and these results show that the transformation is happening. And what I'd highlight is there is more to come. Now these results include IPR and impact, and Ellie will present and explain in a few minutes.

Now moving on to the next slide. Our total revenues of $4.4 billion Innovative was up 33% year-on-year, as I mentioned, sera was up 21% globally at $751 million. The study was up 96% at $85 million, and GP was up 61% at $269 million. generics were down 16%, and this was largely due to the low contribution of generic revenue.

But now let me go into a bit more detail. So on to Astera. Astella reached a $2.5 billion target one year ahead of schedule. Really, really proud of this, and congratulations to making this happen. So revenues in the U.S. were up to $727 million, up 21%, and the fundamentals remain strong. U.S. TRx grew 18% and milligram dispense grew 23%. Now given this strong momentum, we increased our outlook by $75 million at the midpoint, so I said will now be $2.55 billion to $2.65 billion. So congratulations to them on that.

I would like to highlight that the opportunity for better remains strong. You see that the market growth content remain new patients with 85% of patients not treated, we see a strong opportunity to keep growing this product to greater than $2 billion of Poetas we previously communicated.

Now moving on to say. The study is the poses growing oreoschizophrenia. Revenues grew 96% to $85 million in Q3, and the underlying demand remained strong with Terex IT up 62% year-over-year. Now the excellent commercial execution is expanding the market. you steady nearly doubling with burden LAI share from 5% to 10% and capturing approximately 83% of Risperdal LAI. It is worth noting that if you remember back to 2025 Q3 and Q4, we did have some one-off negative impacts were keeping that in mind when we plan forward.

That said, we increased our outlook on used by GBP 20 million at the midpoint, another range of $290 million to $310 million. It probably doesn't need pointed out, but I will that this continued excellent execution gives us a solid foundation on which Donatos.

Now moving on to AJOVY, continues to expand its global leadership in migraine, continue to outperform the injectable market and lead in many markets where we have launched. Global revenue reached $269 million, up 61% year-over-year with strong momentum across many markets. In the U.S., revenue grew 89%, while ex U.S. momentum remains strong, supported by volume growth as well as market share gain. Because it is strong momentum. We will increase our outlook by GBP 85 million at the midpoint, so raising it to $930 million to $960 million.

Now I'd like to point out this doesn't happen by chance. And if you remember, when we started on journey in 2023, he was talking about a Josie reinvigorated it. And I think this reflects something broader that et cetera. We do things with intent and we execute with intensity. And that's why looking beyond 2026, we see a path to greater than $1 billion of pales good.

Now moving on to a couple of new products in our pipeline that I touched upon earlier. Firstly, ECoPipeline. This is a first-in-class opportunity for Traton combining compelling efficacy and favorable tolerability in a seriastic pediatric neurological disorder with limited treatment options. There are 100,000 pediatric patients who live with toutsyndrome would be 50,000 are treated but unfortunately, only 20% to 30% remain on therapy after one year. We hope to help that and help to help these patients in each children. Our next key milestone is obtaining regulatory approval, which we anticipate in Q1 2027.

Now moving on to the latest addition to our innovative pipeline with the assets that we acquired from Box, which is BXCL501. This is expected to address another clear unmet need for patients experience acute agitation of home, extending our patient focus in neuroscience and bringing potential benefits to nearly 7 million patients. The XTR 501 could be the first at-home fomenfor acute agitation and in regulatory approval, adding another different opportunity and significant value to our neuroscience portfolio. This order also highlights another example of disciplined capital allocation, funding different assets, whichever and have real value. Now my colleagues will go into more detail on capital and BXCL501 next week at our R&D Day.

Now moving on to the next slide. When we talk about growth and we talked about the impressive growth in Q3, it's worth pointing out that we have a decade long runway of growth catalysts. And as you can see here, we have a maturing pipeline that I will talk about in more detail next week. We actually look at 2030 beyond, it really does get quite suggested this slide, and that is a very exciting opportunity for Ceban for potential investors.

Now moving on to the next slide, a slide which we've talked about in the last couple of years. But now we see starting to see some of these products actually come to the market. Obviously, we've spoken about Virtusa. We've spoken about the near-term opportunity in Q1 for Ecopipedown. Now we've added BXCL501. So we have a pipeline here that we are confident to deliver over $10 billion of sales tevagoing forward. But we'll give more detail on this at our R&D day.

Now moving on to the generics business. Now to not powerhouse we're going to have is resilient beyond Revlimid, which is exciting. And let me share the fundamentals that drove this. If you take away generic Revlimid, Global Generics business grew 1%, with the U.S. down 3% and EU up 7%; in emerging markets, down 4%. Now we expect our generics business to be flat to slightly up in 2026 and but we continue to be positive about the long-term growth trajectory of this business, 1% to 2% over the long term.

Now I remain very optimistic about the future of our generics business and the main reason the growth rate is really around our roughly expanding by portfolio pipeline. So now if I move on to that, we see this clearly on this -- it's one of the fastest-growing biosimilar businesses we have there. We set out to achieve $800 million of sales by 2027. Well, and I'm in a position to tell you today that we're going to do that in 2026, a year ahead of schedule. And at the same time, we're expanding our portfolio from nine assets in 2024 to 15 today and potentially 18 in 2027.

But it's worth noting this is not simply about adding assets. We are deliberately shifting our portfolio towards biosimilars and increasing important growth driver for our genomics business. And what's important, it's not just about the portfolio. It's how we execute it. And as you can see, 3 out of the 5 U.S. Bisnis right #1, while in Europe, we are building a leading positions across several important markets.

On to the next slide. We're going to continue on this journey, expanding our portfolio and bringing these biosims the markets in both the U.S. and Europe. And as you can see here, we have the potential to be 31+ already, but I've also realized that this slide is already out of date. Because of the deal we announced today with Samsung, so it should be 32. So apologies for that, but it does really reflect the speed we move out at Teva. So based on this the solid foundation of innovation and the portfolio transition of generics business with biosimilars. I can move on to the next slide. We say we are firmly on track to achieve our 2027 targets that we laid out back in 2023.

And with that, I'm going to hand over to Eric.

Thank you, Richard. We're going to have my first slide. I just want to review really quickly the progression of our innovative growth drivers. This is led by a trio of neuroscience products for the approval of well-run and now the hopeful approval in 2027 of ecopyptane for Tres disease. And then finally, our new drug dexmedetomidine that is being used for the treatment of agitation we're looking for a PDUFA date in Q4 of this year. So really a great spearhead leading with our neuroscience portfolio.

But following on to that is our burgeoning innovative pipeline in immunology, moving off with Day, which will be ending our Phase III study soon with our last exacerbation hopefully around the end of this year. We're also progressing Dovato. It's obviously in Phase III at this point but also price Syncona's disease, but we'll also be initiating hydrogenate Supertea and proposimatic Crohn's disease with our partner Sanofi.

And then finally, our IL-15 program, we have exciting new data this year in our proof-of-concept study in Vitiligo and Citi disease. So a real engine of growth for our innovative drivers.

On the next slide, though, the Rio fell of the ball today is well chosen. This is a fantastic product for patients with schizophrenia, building upon the known efficacy of elonzapine, but we really delivered on the label with no loading dose, no oral supplementation and no post-injection mono. I just have to give a shout out to the R&D team for doing such a great job in his development. And I appreciate that our data set was so well received by the FDA to give a label that really gives something that patients can use in the future. So two risks to the team.

But on the next slide, I just want to really go, there's been a lot of momentum just since the last earnings call in Q2. Since then, we have the announcement of the priority review at ecopitan. We had the submission of the IND for the hydrogenated Supertea study and for dupatetub. We announced and shared some top line data that showed clinically significant changes in our gluten challenge for Signal disease. We have presented our Virgo data at the EADB conference in September. We achieved the futility analysis for Emerson.

Unfortunately, that didn't turn out the way we wanted. Team did a great job in executing the study, and we'll review the worlds of data that we've produced to see how we're bringing that program forward in the future. But really, the luxuries was a big announcement on October 8. And then finally, we presented at UEGW due to keep to data on the maintenance data, how we started the entire year, bring it full serve on presenting that great data for duties. So lots of momentum just in the last quarter. So we're very proud of that work.

And if I could go to the next slide. So you can see we're marching down the catalyst that we had outlined at the very beginning of the year, VTech an IL-15 Day Emerson. Now we're adding Weltreza, and we'll be talking about PD-12 and dexmedetomidine in the future R&D meeting next week.

And finally, I'm just going to end with the fact that I was going to be quick today because we'll be talking a lot more about some deep dives into our pipeline, some new programs and new data that we'll present next week on November 11 at our R&D Day. I hope people can call in and listen to the webcast if you need more details, just visit our website or write to us.

And with that, I'm going to pass it off to Elie. .

Thank you, Eric, and good morning and good afternoon to everyone. I would like to start my review of Q3 '26 results with the following key messages: first, sustaining innovative growth momentum. We expect it to continue to deliver strong product mix growth supported by disciplined commercial execution and focused investment while transforming to a high-margin profile.

Second, continue to maintain credible test to 30% operating margin by 2027, capture the full benefit of the transformation program, including structural cost savings, productivity improvements, and operating leverage from a more favorable growth and product mix while actively mitigating generic revalued earning erosion.

And lastly, execute a disciplined capital allocation strategy. Preserve financial flexibility, while prioritizing debt reduction and sustained execution on our financial policies, resulting in investment-grade profile. Targeted business development investment with acceleration of innovative R&D and focus on shareholder return.

Now starting with our Q3 GAAP performance on Slide 30. Before I discuss our Q3 results, let me briefly explain why we also reflected the IP R&D impact. IP R&D can result in a significant upfront and milestone expenses related to investments and externally acquired or licensed pipeline assets. Given this transaction-driven nature of these expenses, starting with Q3 26 represent the impact of this transaction on our results to provide a clearer and more comparable view of our underlying operating performance.

Q3 revenue were approximately $4.4 billion, down 2% in U.S. dollars and in local currency compared to Q3 '25. This decrease was largely driven by lower generics products, many general revenue and was largely offset by continued strong growth of our key innovative products, Steel, Ajei and Zed. GAAP net profit and profit per share were $273 million and $0.20, respectively.

Turning now to our non-GAAP performance. Our non-GAAP gross margin in Q3 '26 was 58.7%, an increase of 345 basis points, reflecting a favorable mix of products with strong growth in our key innovative products, partially offset by lower revenue from generics products, mainly generic revenue. and GAAP operating margin was 31.7% to 182 basis points above Q3 last year. This increase in operating margin was mainly due to a higher gross margin partially offset by higher planned investments in sales and marketing to support our innovative growth and launch preparation for Witsawell as by capital gain from the sale of property in Europe.

Overall, we ended the quarter with a non-GAAP EPS of $0.86, 10% higher compared to Q3 '25. Our free cash flow in Q3 was in line with our expectations at $495 million slightly below last year. In October 26, we repaid approximately $1.8 billion of our debt maturity. As of today, no amounts are outstanding under our revolving credit facility.

To provide you with some additional color our Q3 '25 year-to-date results included approximately $1 billion revenue and $730 million EBITDA contribution from our gnlrevenue. Our Q3 '25 results included $430 million revenue and $300 million EBITDA contribution from generics ovens. Excluding these, our financial results year-to-date and for this quarter reflects a strong underlying performance.

Moving to the next slide. As a reminder, our operating margin expansion to 30% is driven by two structural elements. The first is a portfolio shift towards higher growth higher-margin innovative products; and second are the Teva transformation program. We continue to make solid process with our day-to-day operating margin, reaching 28% on our updated 2026 guidance of 27.8% to 28.2%, all excluding for IP R&D expenses.

Looking ahead to 2027, we expect a further 180 to 220 basis points of improvement, driven by the full expected impact of our transformation program and continued innovative growth while compensating for generic submit erosion. This is the core of our financial transformation, moving from the company historically driven by generics to a bar from a company.

Moving to Slide 32. I Focused financial management has been an important source of cash creation for us. And importantly, it has allowed us to redirect capital towards high-return opportunities. From 2022 through 2026 improvements in net working capital generated approximately $1.3 billion of incremental cash with additional approximately $160 million from lower interest expenses Together, that represents roughly $1.5 billion of cash generation that we have been able to redeploy into the business, including accelerating our innovative pipeline and investing in our broader priorities.

Looking forward, we see the opportunity to continue these dynamics between 2027 to 2030, we expect to generate an additional of approximately $500 million to $900 million from net working capital together with approximately $1.4 billion to $1.6 billion from interest expense savings, bringing the cumulative opportunity to approximately $3.4 billion to $4 billion.

By the end of 2030, we expect to reach negative net working capital as a percentage of revenue. And importantly, as the business grows, this becomes increasingly powerful we are freeing up capital and reinvesting it in higher rates of return, while continuing to grow and create further capacity for investments. At the same time, we remain focused on maintaining the right balance sheet. We have repaid approximately $12 billion of debt since 2019 and remain on clear as for the net debt to EBITDA to time by the end of 2027.

With approximately $2.7 billion expected free cash flow in 2027 compared with less than $1 billion of annual maturities from 2028 to 2030 and approximately $2.5 billion of free cash flow expected in 2030, we believe we have a significant financial flexibility to continue investing in our growth while maintaining appropriate leverage. So this is really a reinforcing cycle. Disciplined financial management generates cash. That cash is reinvested into a higher return to growth opportunity and then the business growth we create even greater capacity to invest.

Now turning to 2026 outlook on Slide 33. Based on our strong performance year-to-date, and the visibility into the remainder of the year, we are raising our full year revenue guidance range to $16.7 billion to $17 billion, which is an increase of $175 million to our midpoint. We're also updating our outlook range for operating profit, adjusted EBITDA, EPS and free cash flow. As Richard mentioned earlier, the acquisition of DXC 501 from BioXcel is now closed. Further reminder of the deal terms. The agreement provides for $57.5 million upfront payment as well, up to $67.5 million in potential contingent payments linked to the timing of expected FDA approval and certain sales milestones.

Let me provide some color on our guidance assumptions, starting with the revenue. First, our innovative portfolio continued to perform strongly across all three products, offer, Ajovy and Use. We are increasing the full year guidance for all the three products with asset now expected $2.55 billion to $2.65 billion, a job at $930 million to $960 million and user at $290 million to $310 million. We expected our global generics revenue full year to be flat to slightly up in local currency compared to 15%, excluding the impact of generic Revenue and the divested Japan business.

We continue to expect 2026 non-GAAP gross margin to be in the range of 54.5% to 55.5%. We now expect 2026 operating income to be in the range of $3.8 billion to $2.9 billion, with an operating margin of 22.6% to 23.1%. Excluding IP R&D, this range will be between 27.8% to 28.2%.

Our operating expenses continue to reflect the deliberate investments we are making to support our growing innovative portfolio and biosimilars. Our guidance for operating income and adjusted EBITDA reflects this continued growth investment in OpEx, with adjusted EBITDA now expected to be in the range of $4.23 billion to $4.42 billion. Excluding IP R&D, this range will be between $5.1 billion to $5.3 billion. We continue to expect finance expenses to approximately $800 million and a tax rate in the range of 20% to 23%.

Our diluted EPS guidance is now $1.92 to $2.11, and we are also increasing our guidance for free cash flow to be in the range of $2.1 billion to $2.4 billion for the full year. Now let me provide you some additional thoughts on Q4. For set, we continue to expect revenue in Q4 2026 to be down year-over-year, due to expected expense exchanges in the purchasing patterns and the pricing environment ahead of the IRA implementation in January. In addition, we are preparing for the Q4 launch of Citrus. Since the initial volume is expected to be large sample of vouchers as we establish the payer coverage, we continue to expect no major revenue contribution in Q4.

Over the last several years, we have consistently delivered on our commitments and made significant progress across our key financial metrics. Today, we are not providing detailed 2027 guidance outlook, but looking ahead, we expect this momentum to continue with a mid-single-digit growth on revenue CAGR from '23, '27. We outlined on Slide 69, more comprehensive information about our financial trajectory.

Moving to the next slide on capital allocation. Over the last few years, we have made significant progress in strengthening our balance sheet. This progress allow us the financial flexibility to invest in our innovative portfolio and pipeline evaluating value-accretive business development opportunities, along with the optionality of returning capital to shareholders through buybacks when appropriate.

And lastly, I would like to briefly touch on our transition to a direct ordinary share listing on the New York Stock Exchange. We believe this change is making Teva shares more traceable to a broader investor base. who are now able to buy ordinary shares directly in a serious manner and strengthening our position in the U.S. capital market. Together with our recent return to investment grade credit ratings from all three major rating agencies, this represents another important milestone in our financial transformation.

We believe this transition reflects the momentum we are building through our pivotal growth strategy and further enhance our ability to invest for long-term growth and create shareholder value.

With that, I will now hand it back to Richard for his closing remarks.

Thank you, Ali. So in summary, Teva is now a more focused high growth by a pharma company and our Pivot code strategy is delivering. The growth engine of our innovative portfolio is accelerating state, SEDI and Adobe are growth drivers, and we're excited by the recent FDA approval of Weltoza. In the near future, our incremental growth will come from the next generation of innovation.

And to conclude on the next slide, as we continue our journey, three themes are clear. In a pivotal year for TAVR, we delivered as promised. Our pipeline is advancing with speed. Our disciplined capital allocation is what sets us apart. And to build on what Eric said, we are looking forward to seeing you at our R&D Day next week in New York City.

With that, I'll open the floor to questions. Thank you. If you would like to ask a question.

Sorry, Ali, before you get ready. I just wanted to remind people if you just try to limit yourself to one question and one follow-up. And if you have additional questions, we're happy to have you back in the queue and we'll answer his many a time for me. Sorry, go ahead, Elie.

[Operator Instructions] Our first question today comes from Jim Choi with Evercore ISI. Please go ahead.

I wanted to touch up on 2 things here. First, the last slide has this interesting disclosure on a possible 57% to 58% gross margin in 2027 and I believe that's a new disclosure, which is up quite nicely from the full year 2026 of about 55% gross margin. My question is this, if Osteo is flattish next year because of IRA implementation -- can you speak to what enables that 200 bps to 300 bps in gross margin expansion, which is presumably not branded business driven?

Second, speaking of Astea more specifically, I just wanted to run some math with you. First, -- we heard Gilead mention about $1.5 billion in IRA impact of Biktarvy, which represents something between 1/4 to 1/3 of Biktarvy's Medicare exposure. So considering Osteto's Medicare exposure is about $1.5 billion, is it reasonable to assume something like $0.5 billion or so in IRA exposure for AUSTEDO into next year?

Thanks for the question. And I appreciate the fact that you look through all of the slides in the appendix. Thank you for that. So I'll hand over to Eli to talk a bit about the gross margin. But I think one thing I'd say on a high level is when we did disclose the direction of travel with our gross margin back at our Capital Markets Day, I think what you're seeing is the fact that the transition to a biopharma company is accelerating that because our portfolio is transitioning presenter scale combined with some of our efficiency trials. But I'll hand that to Elie to give you a bit more context.

Thank you, Omar, for the question. We did mention in the past that 57% to 58%. And while keeping the 27%, 28% OpEx get us to the 30% OP, but that's just kind of the high level. But what I will mention is the following. If you look on just this quarter, we see able to be above 58% compared to last year, the same quarter was a bit above this 55%. This is kind of a 350 basis points and mainly coming from the innovative shift that we have on our revenue mix.

What we want to see next year, and to remind everybody, we have the $700 million on consumer on saving, around 2/3 of it is actually related to OpEx, and we are going to actually utilize it noogizing this year, but the rest of the program is more kind of a backlog-related to our network optimization, which is going to impact our cost.

So if you think about us ending the year close to, I would say, in the high range of 55.5%. You get 200 basis points at the midpoint of the 57%, 58%, onto 100 basis points going to manufacturing and optimization of our costs and 100 basis points on to our innovative revenue shift.

And look, one thing I'd say about trajectory gross margin upwards, it will just keep continuing. It's just a question of by how much, but it will continue because of the transformation of our portfolio because of the transformation and the launches we have coming up.

Now to answer your second question, Umer. Generally speaking, yes, you're right. So that's probably the first thing to say. Without getting into guidance, consistent with our past practices, we will provide guidance in '27 next year. But yes, we have a high degree of confidence that instead of will achieve $2.5 billion next year and greater than $3 billion of peak. 2027 was always a year we planned for. We have strong fundamentals offsetting the IRA impact. And so that's what gives us the confidence in that.

I'd say, just to give any more broader context, what's really changed is the company is having a portfolio of vibrant addition to setter. So once again, not given guidance in 2027, we expect Teva's revenues to grow again. Besides used gene were now adding Motus any good Pipa and then potentially make the XL 501. So our portfolio of innovation allows us to continue to grow beyond '27 -- in '27 and beyond, and that allows us to grow our margins. So I think it's a good question.

I appreciate you also because it's multi-let it fundamentally comes back with the execution of the pivot-to-growth strategy, the execution of leaving us to a biopharma company with a fast-growing innovative portfolio. Thanks for the question.

We now turn to Douglas with HC Wainwright.

Maybe two questions on AUSTEDO and AJOVY. First, in terms of Osteo, I noticed you've continued to have an acceleration in terms of the milligrams per patient. And I'm just curious, some of that is obviously just coming from natural migration to X -- but I'm curious, within the XR franchise alone, sort of how much continued traction have you had I know you're not -- patients are generally not getting to the 36.6% that was in the Phase III trial? And how much of a focus is it to sort of get patients ultimately to that level?

And then just in terms of AJOVY, where we've sort of had the franchise really renewed growth recently. I'm just curious when you think about the prospects what you're necessarily seeing in the U.S., it looks like you're doing better on a revenue standpoint per patient, sort of how you see share shaking out you've definitely taken share from Aimovig over the long term and how much growth will come from U.S. versus ex U.S?

Okay. Firstly, thank you. I think it's the right word for the coverage. So I appreciate that. And thank you for your questions. So let me try and pick them off. So firstly, I'm going to start with state. So you talked about the milligrams growth there, 22%, Q3. I don't mean sort of how that has happened is a couple of things. Firstly, there was the launch of XR, but then there was also the launch of the ability to get a titration pack through prescription because one of the things about Astellas you need to say trade up to the optimal dose, to get efficacy. So having a titration pack prescribed and then having XR once a day just makes that process simpler. And so that's what we really. We haven't actively going to drive conversion from for we've let the physician make that choice.

So but because of the fact that those two things are in place, we've seen that continuously improve, which is good for the patients because we want to have the patients on the most efficacious dose. And one of the challenges and opportunities with the state is that people start to feel letracy pretty quickly, but we want to make sure they go out to something that is most optimal for them, but that's a position to use the titration pack and exon do that. So that's the fundamental of that, and we see continued good progression of that this year and going forward.

Now on to your question around JV, I think, was around about the U.S. performance and how strong that is and then the rest of the world performance. So let me sort of talk you through the U.S. performance first. CS performance and it goes back to what I said in my opening remarks, this is about a focused execution on delivering a strategy at a brand level. What do we want to do globally and what do we want to do locally and what capabilities do we need to put around what resources and what choices do we need to make. And I think in the U.S., we've seen the work with the team and make decisions on making sure we have the right access and the right value. And when you do that as well as the growing market share, then we have the ability to disconnected.

Then with regard to the rest of the world, you have the opportunity. And as you've seen that we continue to grow in Europe and international markets and above market, significantly above market. And because of that and growing market share. And so if we do that, we continue to see the revenue growth. I think what this highlights because I know this is an unusual situation, but we focus capability and the right resources and the right ambition expectations, we can vitalize a brand.

And I think we've seen that with the job. And so that's why we remain confident that we're going to exceed $1 billion in peak sales, which sounds obviously like a big number, particularly when we started our conversations maybe four years ago. Hope I answered your questions.

We now turn to Glenn and with Barclays. Your line is open. Please go ahead.

Richard, just two things I wanted to hit on quickly. when you talked about sort of the biosimilar launch slide, you sort of commented how congested it's becoming. But as I'm sure you're aware, you've seen a bunch of incremental litigation in the space, for example, Janssen seeking a PI on SIMPONI and Genentech bringing a suit on XOLAIR and a lot of concern around ENTYVIO and the launch timing there just sort of given the IP at Takeda.

And I'm just kind of curious how Teva thinks about navigating all that potential litigation making the decision on whether to launch these products because on that slide, it seems like you have some incremental contribution coming in '27 from these drugs.

And then secondly, I did want to ask about '27 related to Eco-Pan and BXCL501. I'm sure you're going to touch on this at the R&D Day next week, but I'm just kind of curious at a high level, are you expecting any type of reasonable contribution from those two drugs in the second half of '27. And I'll stop there.

Dan, thanks for the questions. So on the biosimilars one with regard to litigation. Yes, that's pretty much the business we're in when it comes to genetician biosimilars, as you know. We want to bring these products to the market and people want to mitigate and stop us doing that. So it's sort of it's not a surprise to us. Obviously, we would like that not being in place, but we strategically plan and we financially plan with realism. So when we think about our portfolio of 32, we take into account the puts and takes.

And I think when I started on this journey, high set to people who ask me which is going to be the most successful biosimilar so I don't know because there's too many variables, IP litigation, launch timing, amount of competitors, price erosion, et cetera. But when you have a portfolio you become -- you allow yourself to manage those risks in a more thoughtful way that allow you to continue to grow. And because of that, I feel very confident of the direction we're on with our biosimilar business. I think what's important noting now, we are reaching a certain momentum in scale that this is going to fundamentally change the portfolio of our generics business. And I think that's something for people to maybe double click and recognize. So I think that's one.

The other thing I'd say on a biosimilar business is, to some degree, doesn't follow all the traditional rules. As I said, 3 out of 5 of our Biocenters in the U.S. are #1, we were not #1 to the market. So that just shows you it's not as straightforward as people think, and I like that. And the same in Europe. We've come to Europe late in many instances, but we're also showing that we can be #1 in those markets because of the capability and the infrastructure we have in place. So I think biosimilar you'll hear us talking more about what we're going to keep expand that portfolio, and litigation will come and we'll deal with that as and when it comes, but it won't do rareness.

Now on Ecopia and BCXL 501 Look, I've got to ensure you turn up next week, so I can't tell you anything. All I'd say it's a good question and the right question. And we'll start to give you some insight into why we're excited about these two products. where we'll give you any guidance on that? You have to wait and see, but I'm glad you're starting to focus on those because I think in our hands, as we've shown, we can really drive value. We just had that conversation on -- but I think when you look at pipeline with a significant unmet need and you look at the BCXL501 with a significant unmet even agitation. I think we're very excited about what we could do with those. So apologies, but I see you in York next week.

Our next question comes from David Amsellem with Piper Sandler.

So actually, you have a couple of ecopipane questions, more longer-term focus. So you didn't provide peak sales potential for the product. And your slide, unlike other products in the pipeline or recently approved. So maybe just a question on how you're thinking qualitatively about how impactful this product could be? How are you thinking about access dynamics, mix of Medicaid versus commercial? And how long do you think it's going to take to get good access any pricing analogs that you can help us with in terms of how to think about that? And then do you think this is a product that could slot in ahead of the approved antipsychotics that are commonly used. I know that's a bunch, but it's obviously an important driver going forward.

Thanks, David. Thanks for the question. No, it's a really good question, and I'll Vericast we'll talk about that third line moving ahead of antipsychotics. But I think you've touched upon on all the variables there that we're thinking about. So First off, there is the fact that we've got to think about what is the appropriate price for such an innovative product that's going to bring companion efficacy and good tolerability and safety. And we did a lot of work on that now because obviously, that is a very important factor in this equation. And so that's another reason why we don't want to talking about sales and peak sales because we want to get that work done, and we want to make sure that as though as it can be.

So as we've said in the past, the pricing will reflect something on the air autumn nature where there's a significant unmet need in the pediatric population. The second thing that comes down to then is access and how do we want to approach access. And now, as you know, we are very thoughtful about access and we think about the long-term value of the product and how you have to be thought in what you do with regard to access around that. And so we're working through that.

With regard to the medicating and commercial, the mix is a bit different here. So I think we're looking at more commercial plans on this product, which, as I stated in the past is a change for us because we spend a lot of our time doing in Medicaid and Medicare. So I think that's how I would think about it. But I'll hand over to Derek, but what I would say is when I get to speak to physicians and when I actually has spent to patients, and I've actually even come across some people suffer from to that. Then there is a clear opportunity for an efficacious and safe and well-tolerated product to move ahead of antipsychotic. But maybe I'll hand that to Dr. Eric.

Thank you, Richard. So I think that the value of a capitan comes down to the data sets that we've generated to date. There's two well-controlled studies, both in the Phase II and Phase III now, a one with a 30% reduction in the tick experience for the patients and a 50% reduction in the relapse rate. So great data, but more importantly, the site profile was favorable, I think, where you saw very good tolerability in metabolic effects, good activity for their ticks and no abnormal movement disperse. So when I think about how physicians might use this in the future, sure they might step through what they do today with alpha generic receptor agonist, which is off label, then they might go on antipsychotics.

But I think when they get used to what the profile is, of equal pipeline? And I guess the -- understand the -- both the efficacy and the safety profile, it will move up in that list of the possibilities out there. I think that, that long-term efficacy, remember, only that mid-20s to people stay on their therapies today. And our long-term follow-up, 66% of the patients staying on the drug for at a year. So I think the profile ones get used to it. Will move up in that format.

Thanks, Eric. Thanks for the question, David.

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

So one question for Eric. Just what does the time line look like for Teva's efforts to advance a TL1A bispecific into the clinic? I know you guys have some efforts that had been ongoing preclinically. So anything you can update there in terms of time line? And then my follow-up question is just, does the U.S. government agreement exclude Teva from some of the generic tariff headline proposals or I don't know what to call it exactly, but does the agreement provide exemption from any generic tariff risk.

So I can start to answer the question on the T1 bispecifics. So I'll disappoint you after that. I'm not going to tell you much because we have an R&D day next week. And we may be talking about bispecific programs with our TLA. And I would mention that we are one of the first in the TL1A space. We have a very potent Tito selective drug with well antibody antidrug antibodies in full Phase III. But I think that our scientists are the experts in CNA. We'll hear more about that next week.

Jason, with regard to your question on generics, and on the agreement with the U.S. government, as they laid out I think some time ago, it's a two-year time frame, they've put in place to come to some sort of agreement, and so there's nothing that's been concluded there. But as you can imagine, a company like Teva is always at the table. And so as and when we get more information, we'll let you know.

We now turn to Louise Chen with Scotiabank.

Congratulations on the quarter. I wanted to ask you first, what's your latest thinking on M&A and business development. And then secondly, if you could talk about your R&D philosophy a little bit more in the efficiency, which you move products to your pipeline?

Luis, thanks for the question. So M&A. So what we think about is efficient deployment of capital for the time and obviously, we're thinking about that a lot, and we have been thinking that in the last few years, despite that people thinking today wasn't going to come. And what I mean by today is another improving balance sheet, investment grade. And as Elias pointed out, an opportunity for the company to really generate some free cash. And so obviously, we know our balance sheet is going to start to improve significantly.

Because of that, we were always planning for this day. I hope you are something that people start to realize. We do plan long term for ever, we start to think about what can be around the corner. And so yes, we do think about more business development deals we think about potentially but it has to be one that we feel that is good value. It drives the long-term value of the company, puts us on a sustainable footing to become a world-class biopharma company.

And I think hopefully, you've seen with the deals we've done we're very thoughtful about how we deploy capital externally and making sure we do things that we know will drive good accretion short term as well as long term. And so that's our philosophy. The balance sheet gives us a bit more flexibility, but our discipline will not change.

Now on the R&D plastic, you get Salomao. I'm not to give them a headline -- so yes, thanks for the question.

I think it's a pretty simple strategy and philosophy we have. We'll talk about it more next week, but it's really about using known science to increase your POS speed and execution at the weather not AI and its disciplined capital and using partnerships where you can increase your bandwidth and your funding. So it's straight up simple, but you have to execute it.

Thank you for the question. Next question.

We now turn to Dennis Ding with Jefferies. Please go ahead.

Two questions, if I may. One on Voltus. So you frame the market as 2 million in the U.S. diagnosed and 20% on oral olanzapine. So you're essentially implying the TAM is around 400,000. But how does the TAM change given many patients don't tolerate olanzapine because of weight gain and then they eventually discontinue? And while Trust likely we'll have a similar side effect profile. So where do you see well Trusa being realistically used? And I guess in a way, I'm asking if you have an estimate for how many patients have shown efficacy on olanzapine, tolerate the weight gain but are also showing evidence of noncompliance. So that's question number one.

And then question number two, for biosimilars. Can you please clarify again and confirm on Slide 20 that you're looking to launch a biosimilar Symphony in the U.S. in 2027. And I'm just wondering because how are you thinking about the litigation aspect here as a barrier for a U.S. launch? And the reason we ask is because the four-day bench trial that J&J has against Biothera starts March 2028. And I'm assuming your partners Benson will be scheduled around the same time frame. So just help me reconcile the timing differences here? And if what you're implying is that you'll be aggressive in pursuing a settlement to ensure 2027 U.S. biosimilar Symphony launch?

Okay. Thanks, Dan. Thanks for the question. So I will face the first one with Eric. But the way that we think about it is -- the reason why olanzapine commands such a large portion of the market in schizophrenia is because it is very efficacious and is seen as the gold standard when it comes to efficacy. So while you've identified some of the metabolic challenges it has when it comes to managing schizophrenia when patients have evischizoplenia, efficacy is the #1 priority. And that's why olanzapine has maintained that segment of the market.

So obviously, when it comes to sophisticated compliance becomes key and that's why we think more choose comes in. So in a way, we're not dealing with that the side effects, they're already known and people are picking a lane because the efficacy both the physician and the patient. But I'll let Eric give more context to that.

Yes, I'll add a little bit on the color of that. Well, Thus, its value is it's known efficacy and its known safety profile. So as a hysician, you're using something but bringing something new to it with the LAI. So market approximately already uses alone. That's how well known it is and how use they are of using it. So bringing that convenience and that hopefully added benefit of lower relapses and better adherence within LAI is really the value proposition here. I think that's really defined it very easily for a physician to choose who should get it.

And I'd add that we've done the same thing with and a coated space of risperidone here we're launching into a market for LAIs that really has no viable alternative at this point.

Thank you, Eric. And then when you go on to the question that you had on the biosimilar Symphony, when we talk about launch readiness, we talk about the ability to be able to launch. We may not launch and that depends on a number of factors. But we always set ourselves up that we are in a position to launch if possible. And so that's the way to think about it. And obviously, IP litigation can go in many different ways. But what I always insist upon is we are ready, so things do go the way we find them or we hope that they do, and we are there to make sure this access is made available to patients.

Our next question comes from Dan Clark with Leerink Partners.

Wanted to ask my first question on the Offset slide. You mentioned there are new capabilities in place to support MFP effectuation next year. Can you just give some color on what those are and sort of how those might impact either sales or kind of price next year?

And then my second question, just a little more clarity on how you're thinking about the timing of Weltzer revenue next year. Should we think about that being more year as you work to secure access? Or any color you could provide there would be very helpful.

Thanks, Dan. Thanks for the question. So starting in reverse order. Onwards, revenue expectations are in the latter half of the year. Let me explain a bit why. So we've launched in this quarter, and this is all about making sure we get access and familiarity with the product both in the hospital forms and with the physicians. Now as you may be aware that we have the majority of our patients in Medicaid and Medicare. And so to get access to batteries, we have to get access on Medicaid for Marisa. And that is something which is limited by each plant.

And so some -- we'll do that at launch and some will do that six months, nine months, 12 months. At 12 months, we'll have about 85% of Medicaid coverage. So access is one of the big, very limiting factors and Obviously, then we have Medicare, but it's really Medicaid. Now the things we do on the inputs to make that happen is we have sampling, and we have hospital forms to make sure the hospital formers have it on.

But ultimately, it comes down to that. That means you're not going to see revenue of any particular value in the first half of next year. But as a lot of those states come on board, then we see the opportunity to positions to start using volts more broadly. So that's why we say the second half of next year. And obviously, that changes significantly for the full year in 2028. But that's how I think about it.

What we will do is make sure we update you all on some of things I call the input or the leading metrics around TRx, around excess breadth of use by physicians, debt of use by physicians. But we feel very confident in where we're having more trust because of the things that Eric has mentioned around the product profile, the unmet medical need. On the fact that we have a really strong capability with used.

And then on ASTEDA,I think the question was around what capabilities have we bought to minimize the impact of the IA and the fluctuation of that. It's really doing a bit more of the same. And that we've been planning for this for some time. So we're not certainly walking into 2027 unprepare we've been preparing this for multiple years, as we said, on the primate growth strategy in 2027. We knew this was going to happen or '23, '27. We knew this was going to happen. So we've been building capability putting our strategy around this.

So I think we're well placed. That goes down to many factors around how we manage the patients, how we manage specialty pharmacy, how we manage access and we manage multiple parts of the patient journey. And those are put in place some time ago. And so that gives us a level of confidence that we can keep growing this product to over $3 billion in time. And so '27 is just really a stage on the gene to that. And as I repeat, we always plan for 2027. And so in no way we are daunted by the challenges out of us.

We now on to Joseph Thome with TD Securities.

Maybe one on the commercial side first. Just as you're seeing about the LAIs, obviously, one of the benefits can be time on therapy and increased compliance. What are you seeing in terms of real-world used refill rates, any kind of patient time on therapy. And has that matched your kind of expectations ahead of launch?

And then maybe one on the pipeline. We've seen a few Celiac data sets this year, how is Teva balancing kind of speed to market versus competition? And also signing off perfectly with the FDA on what endpoints they want in clinical trial success?

So thanks for the question, Joe. So on the compliance and adherence, I can't give you any sort of specifics to Altus. And what we see with the other long actions in the market is there is increased, as you imagine, compliance and adherence. You go from having a daily pill or multiple pills to have an injection once a month on your side case once every two months, then obviously, compliance and adherence increases pretty significantly. So we think that is a benefit, obviously, for the patients on the realizing that efficacy. But obviously, the continuation of therapy.

And by the way, compliance with adherence, I'm sure you know is really important in schizophrenia because every relapse you have actually damages the brain. So the effectiveness of the medication after that starts to slightly go down. So you want to avoid anything. So compliance with adherent are key, which is why when you have a product like you said, but it's easy to use, easy to administer, no loading dose, just to bid levels within 24 hours, it gets you significantly because they want our patients to comply. And we see the same opportunity for three or so I don't have any details that maybe we'll look into that and see if we can find some data set, but it seems to be very clear from what we've seen with yes.

Thank you for that question. Now moving on to CAC in the pipeline. I'll offer that one to talk a bit about that and our approach to that.

Yes. And thanks for the question on CLECs it's a broader question on FDA endpoints and speed to market. our teams take advantage of all possible ways of speeding things up. I know there's been a lot of change in the biosimilar space that we were a part of the conversation very early on, and we've been a part of the conversation with accelerating normal Phase III programs where we use one to two fatal trials. We always look at every option depending on the science tells us.

The disease, we're moving very quickly in that space with the data that we've generated recently. -- our proof of concept. So that's driving our conversation on how to design our Phase II and our Phase III. And we're getting a little bit more of that next week. But we certainly have really honed in on what we're going to think those CBEC design studies are going to be. At the same time, we're moving very quickly into I, which is a very clear endpoint and pathway to registration. Thanks for your question.

Elliot, excuse me, I just kept to apologize, we have time only for one more question, but we can follow up with the sell-side analysts afterwards as we discussed before. So please stay tuned, and we can take any additional questions after the call. So we could have our last question, please, Elliot.

Of course, our last question comes from Chris Schott with JPMorgan.

Maybe just a two parter around how we're thinking about investments going forward. I when we look at R&D programs like the T-slip IL-13 or maybe any other broader immunology type programs you'd look at. Would you look to partner these like you did with the TL1A or do you feel like these are assets that Teva can now move forward on their own given the broader kind of footprint, investment opportunity, et cetera, that you have on the branded side?

And maybe just a second part to that, I know you said a futility with Enroll Solan. Would you take another bet like that of kind of a high risk, high return asset? Or has the BD shift also move towards more derisked assets given the evolution of the company?

Thanks, Chris. Thanks for the question. So on TS13, the way we think about it, and you will hear a bit more of this next week at the R&D day is pretty simple. I would be fine science that works well prosecuted aggressively and quickly, and we'll work out the money on the way to speak. But what does that mean is we stay respectful of our commitment to increase shareholder value and to be respectful of margins.

But at the same time, because of where we start from a gross margin point of view, we have more flexibility than most companies. And so that's how we think about it. Do we need to find the financial with? We'll see as that plays out. We'll see how many indications that could go, we'll see how many people want to be proud of that, whether that's financing or other companies. I think that just shows the optionalities we have at Teva to deal with products, which are multiple indications and exciting areas. So that's one.

On the second part, which is on the.

Yes. Does that stop us going after those maybe no probability of success as it going forward?

Yes. I suppose it's a simple answer to that. And then the question was probably, well, why did you do this one? Well, when can I came together back in 2023, we looked at it and can actually the ability to actually get to this point we have today, require very little capital. We actually understood the size pretty well actually, this could have a chance unlesbecause of that, we actually went forward and did it.

So the capital allocation was a big part of it. We didn't have to, there was no opportunity cost for doing this one, so to speak. Going forward, we don't see the need to do that. We want to focus on things which have a higher probability of success. That is our R&D strategy. That is our BD strategy. And that's how we think we can consistently give good returns to our investors over a long period of time, by really been talking about capital allocation and risk.

Thanks, Chris. Thanks for your question. And I think that's the last question. So I want to thank everybody for that. interest in Teva and the continued interest in Teva. And I look forward to meeting many of you in New York at the R&D Day next week. Thanks very much.

Thank you, everyone. Thank you, Elliot.

Ladies and gentlemen, today's call has now concluded. We'd like to thank you for your participation. You may now disconnect your lines.

Hello, and welcome to the WELTRUZA approval conference call. My name is Alex. 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 short notice to discuss the U.S. FDA approval of WELTRUZA, olanzapine LAI. The materials are posted to the website this morning, and the press release is also on our website. And before I turn the call over to Richard Francis, I'd like to remind everyone that we'll be making forward-looking statements on the 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 Forms 10-K and 10-Q filed with the SEC. Any statements that we make are only valid as of today, and we undertake no obligation to update those statements subsequently.

And with that, Richard, the floor is yours.

Thank you, Chris. Thank you, everybody, for joining the call. On the call today will be Eric Hughes, Head of R&D and Chief Medical Officer. And then for the Q&A, I will be joined by Chris Fox, EVP, our Executive Vice President of U.S. Commercial; and Eli Kalif, Chief Financial Officer.

So moving on to the next slide. And the next slide, please. Once again, it's great to be having a call with you where we talk about the execution of our pivot to growth strategy, a strategy we started back in 2023, a strategy that was designed to move Teva from a pure-play world-class generics company to a world-class biopharmaceutical company. And I think we made incredible progress. And if you remember, it was a 3-phase strategy. The first was to return to growth. We've done that over the last 3 years. The second phase was to accelerate growth. And that acceleration was going to come through delivering on our growth engines, our innovative products that we have in the market that we often talk about, but it was also about really bringing an exciting pipeline to the market. And I'm really excited today that we're in a position where we can start to talk about that step-up innovation and see our pipeline start to materialize.

Now if you go on to the next slide. 2026 has already been a year of acceleration, you could say. We've had a number of milestones already this year, the duvakitug maintenance data, the ecopipam accepted by the FDA and given priority review, the Anti-IL-15, you saw some data in vitiligo and recently in celiac disease. But today is all about WELTRUZA. And it's a special day for patients, for physicians and for families that some of their members have schizophrenia. And as Teva, we're really proud to be able to bring WELTRUZA to the market to help this patient population in coping with that condition. So exciting for us at Teva, exciting that it's a year where we keep bringing new data, new opportunities to drive this long-term acceleration of Teva.

But with that, I know everybody is excited to hear about the data. So I'll hand over to Eric.

Thank you, Richard. I really appreciate it. And if I could have the first slide, we're -- I have to start off by saying we're just delighted by the approval of WELTRUZA by FDA. And I just want to start off by saying this begins with the patient. Patients with schizophrenia, it's a devastating disease for patients, and it can be a devastating disease for their families as well. But the most important thing is that we do have treatments for schizophrenia. And what WELTRUZA will bring, we hope, is that chance of decreasing relapses because we're going to take advantage of the long-acting injectable for them. So this relentless progression of negative, positive and cognitive symptoms over years, we want to prevent those relapses, which should cause the hospitalizations and cause the progression of their disease. So we've thought about the patient from day 1, and we believe that we're really achieving a great thing for them today.

Coming to the next slide. This patient population is not insignificant. There's 2.2 million people in the U.S., about 1.5 million of them get treated and 20% of all those patients who get treated are on an oral olanzapine. Olanzapine is a known treatment for schizophrenia. It has powerful efficacy and a known safety profile. And our Teva commercial organization is set up to succeed here. We have a deep understanding of the patient journey, which is very complex. We have been doing and detailing these patients and caregivers with our UZEDY program, and we're building upon that great expertise. As I mentioned, olanzapine has a demonstrated safety profile, and we have go-to-market capabilities that are, I think, leading in the industry.

But let's get to WELTRUZA on the next slide. WELTRUZA really epitomizes the R&D strategy at Teva. We choose unmet medical needs that need to be addressed. We innovate based on the formulation. We brought and built upon the known safety and efficacy of WELTRUZA, we innovated with the formulation by design to differentiate it for the market. We executed the study with high velocity by accelerating the program 6 to 9 months, and that brought in an on-target submission, which then led to an approval that was right first time. So this is our plan. This is how we build upon known science and accelerate it to bring a treatment for unmet need in patients. So we're very proud of this, and I think this is a winning paradigm for our company.

Next slide. So what gets us so delighted and elated at Teva this morning? Well, WELTRUZA builds upon the known efficacy and safety of olanzapine, I said. This is a tried and true treatment for schizophrenia. And as I mentioned, that's 20% of the oral market right now for patients. But we innovated on it. We brought a once-monthly subcutaneous dose that is no loading dose, no oral supplementation and no post-injection monitoring. These are the critical attributes of what we needed to achieve, and we delivered on that completely with this label that we have gotten approved by the FDA. So I'm very proud of the work that the R&D organization has done and the work that we're collaborating with our commercial colleagues to make sure that we get this treatment to patients as quickly as possible. So we're very excited by all the results that we have achieved to date. And this really fills a long-standing gap in care. There are no other alternatives for long-acting injectables that are viable compared to WELTRUZA. So we think that we really are addressing an unmet medical need with the innovations from our labs.

Next slide. And I want to bring it back to the patient on this last slide. I said that the most important thing is preventing relapse. That's what long-acting injectables continuously show that when you get rid of the problem of adherence, adherence is the problem of breakthrough in relapse with these powerful drugs. By bringing an easily used subcutaneous injection that's once a month we're chipping away at that adherence problem. And you can see in our follow-on study from SOLARIS in period 2 out to about a 1-year follow-on, only 4% of the patients relapse. This is a critical element of what we want to help patients do, get a treatment that's easy to use, well known and efficacious, but take away that problem of adherence with a subcutaneous injection once a month. So we're very proud of this. We have great hope for patients in the future, and we're looking forward to getting this out as widely as possible.

And with that, Richard, I'll hand it back to you.

Thank you, Eric, and thank you for walking through that. And we finish on this slide. I just want to give you a bit of context to this slide. This is the image that you will be seeing around with regard to WELTRUZA. We are doing a direct -- a DTC campaign with drug WELTRUZA. And we're doing this because we believe that we have created a real opportunity for these patients, as Eric has mentioned, and the physicians to start treating their patients differently with this molecule. And to do that, we want to make sure people are aware of it, most physicians are aware of it. Patients are aware of it. Their loved ones are aware of it. So it gives them the chance to get back into that office and have a discussion with their physician and the physicians are also aware of it. So be prepared to see this.

And this builds on -- for many of you who know us, this builds on the capability that we built with AUSTEDO, where we had to remobilize a patient population with tardive dyskinesia and help physicians start to treat those patients differently for the first time in a long time. So good capabilities that Eric mentioned, we already have in schizophrenia, but good capabilities around how do we mobilize this patient population to help them understand there is a new treatment out there.

And with that, I will now open it up for Q&A.

[Operator Instructions] Our first question for today comes from Joseph Thome of TD Cowen.

Congratulations on the approval. Maybe just as you think about the perfect patient for WELTRUZA versus UZEDY, I guess, do these patients fit in sort of nice targeting boxes for you? Or do you think there's going to be overlap? I guess how do you think about that? And second, our physicians do indicate that they want to use LAIs more in practice, but sometimes there's some logistical hurdles at the site. Obviously, the differentiation on monitoring will be great. But can you talk a little bit more about what Teva is doing to make sure the physicians have a good first experience at the prescribing site for WELTRUZA?

Thanks, Joe. Thanks very much for the call. Very much appreciate it. And I know Eric will be itching to answer that one because I think you'll hear that we very, very much thought about the value proposition, what physicians need from LAIs, what they expect that they may not have got and also what you talk about the co-positioning of these 2 products. So I'll hand over to you, Eric.

Yes. So thanks for the question. I heard 2 things there. Who do we envision starting on WELTRUZA versus UZEDY? Well, the first and most obvious places to start with those who are on an oral risperidone can take UZEDY and those who are on an oral olanzapine can start WELTRUZA. I think that's a natural selection that's already out there in the field. What we're delivering though, to your second point, is something that they haven't had before, an injection that is easy to give to a patient, it's subcutaneous. It doesn't require any loading doses. It doesn't require any other supplemental oral medication. So a lot of the hurdles of an intramuscular injection, a complicated way of starting it, we've removed that and given them something that really is a great treatment option for patients. That's the unmet medical need, and that will also address the basic problem of relapse due to non-adherence. So we've removed a lot of those barriers and the natural place that I think that the patients will come from is those oral options that they're on already. Remember, 20% of the oral market is olanzapine, and we're providing the first best option that's really viable for a long-acting injectable.

Thanks, Eric. Is there anything you'd like to add to that, Chris Fox?

Sure. Absolutely. Good morning, everyone. Yes, this is a really exciting time for us, and I love the nature of your question of how do we instill a more better experience with LAIs. This is something that we've been partnering with Eric and his team on because we know that this was such an untapped need. And you can see that even as an example with UZEDY and how we're growing that market because there is starting to be more anticipation of how LAIs specifically prevent relapses as Eric showed in the data and provide a much better experience, not just because of the no loading dose and no oral supplementation, but also it prevents irreversible function decline when these patients have breakthrough symptoms or are non-adherent on an oral.

So we've been preparing for this launch, I got to say, for a long time. It's been well over a year. We had an extraordinary nationwide launch meeting last week and doing exactly that, our go-to-market and really the education that we're going to use specifically on olanzapine, but also co-located with UZEDY. I think we're in a unique leadership position to be able to cover most of the schizophrenic patients, about 80% across this continuum of oral olanzapine patients and oral paliperidone and risperidone patients with UZEDY. So we're really excited. We've got lots of work to do, but we have the right tools and now importantly, the right franchise in UZEDY and WELTRUZA.

Our next question comes from Umer Raffat of Evercore ISI.

This is Mike DiFiore in for Umer. Congrats on the approval. Two questions for me. One, are you able to disclose the pricing at this juncture? And number 2, just given that if you look back at oral branded olanzapine, Zyprexa, I think it reached around $5 billion in worldwide peak sales. Would you be able to comment whether that potential could be reached with olanzapine LAI? Or do you have any at least preliminary comments on what you expect for oral to LAI conversion?

Thanks, Mike. Thanks for the question. So to answer the first question, the wholesale at the WAC price is $3,950 to give you that. And then to the second question, which was touching upon the opportunity here, which is a good question. And I think it's probably based on the product profile that Eric just walked through as well as the label that we have. Look, we put down in our forecast $1.5 billion to $2 billion for UZEDY and WELTRUZA. I think there's a lot of enthusiasm around WELTRUZA because of the product profile that Eric just talked about. I think for us, it's about making sure we get out there and do what Chris Fox said, make sure people have an understanding where these products can be used, how effective they are, how they fit into their clinics, patients can benefit from the compliance and the adherence. And if that plays out well, then obviously, we're going to have an ability to hit those targets of $1.5 billion to $2 billion.

But I think you probably know, Mike, from talking to us in the past, we tend to think about this in a very thoughtful way. We want to see how this plays out. It is a very managed area, managed care. And so we've got to be thoughtful about that. And so let's get started. Let's get the excitement turned into prescriptions. Let's get patients on this drug. Let's get hospital formularies listing it. Let's get Medicaid to have on their formularies first. And then I think we can talk about what the ambition could be in the long run. But I'm glad you see it as a big step forward for the treatment of schizophrenia patients. So thank you for that.

Our next question comes from Louise Chen of Scotiabank.

Congratulations on the approval. I just wanted to ask you on payer coverage. When do you expect that to ramp up? And what are the different stages here? What is the out-of-pocket cost per patient? And then the other thing I want to ask you about as we think about modeling the sales, I know the progression will be later on in 2027. But how should we think about gross to net and that progression and also margins for the product?

Yes. So thanks, Louise. I'll probably start to frame a bit and then hand over to Chris Fox on this one. But from a payer point of view, as we've spoken about in the past, this is about firstly getting Medicaid on board state by state. And as you may well know, these do start at different times. So day 1, we get some Medicaid and then some take as much as 12 months, even some beyond that. And we think we'll have about 85% coverage at the end of the first year. Medicare is harder, and that's about negotiation. And as you've seen with UZEDY, we are all about making sure that we get value and access. And we understand that we have a valuable product because of the product profile, and we want to make sure that is appreciated.

So I think that's how we think about it. And that's partly also why to touch on your point of revenue, we don't see significant revenue in H1 next year because this is about getting all the Medicaid states on board, getting into the hospital formularies, getting some good breadth of use from physicians and then actually some depth. And that's why you're seeing it in the second half of the year. So that's how we think about it, and that's how you should model it. That's how it comes to payer access. It's mainly in Medicaid and Medicare. There is a small amount, which will be in commercial. And then maybe I'll hand over to Chris to talk a bit more about, one, things about the out-of-pocket, but also the comprehensive services that we have to ensure that patients can get access to this. So over to you, Chris.

Thanks, Richard. Great question. We are modeling this similarly, as Richard just said, our approach is to really balance very wide access with preservation of value. And so it's really important to start with those Medicaid patients. And as Richard elegantly articulated about the process, it is state by state. And so that's something that we'll look to address much like we did UZEDY. The out-of-pocket for patient is very different based on their coverage and if they're dual eligible, all of those things. And the team has built a really extraordinary kind of patient hub to be able to help that. And so it's a very bespoke service that allows for us to optimize their experience and give them access as early as possible.

And I think the other big thing I'm excited about is very rarely do we get to launch another product so co-located with the current product, and that's UZEDY. So we have lots of synergies in this space, both in our experience with providing those patient services, prescriber services as well. And as importantly, as Eric pointed out, this deep understanding of the patient journey. So how do they go from oral and get on an LAI? All of those things are such an important part of that. Access is a big part of it, but all of those other surround sound things contribute to that experience as well. So we're excited to apply the learnings and the knowledge that we have and help support patients. Thank you for the question.

Our next question comes from Les Sulewski of Oppenheimer.

Congrats on the approval. I have 2, one on distribution and one on the funnel of patients. So on the distribution side, given the refrigeration aspect, how are you setting up distribution in buy-and-bill versus specialty pharmacy? And when do you expect the permanent J-code? And then second, on the funnel of patients, you sized the LAI suitable patients at 20% of the oral population. Can you perhaps just walk us through the first year patients come from? Is it rep product switches, recent hospital discharges or the stable oral patient group?

Les, thanks for joining the call. I'll hand those straight across to Chris Fox. So Chris, on the distribution, you had that and then on the funnel of patients, which will be the first to come across to WELTRUZA.

Yes. Sounds great. Yes. So we assume that based on all the market research that we've done that an oral olanzapine patient that is not compliant for a variety of reasons would be a perfect olanzapine LAI patient. From what physicians tell us, they're very, very familiar with the molecule, and they really appreciate the efficacy and the control that it gives them. So in our discussions, leading up to this and the market research that we've done, we see that opportunistically as the perfect place to start. And we'll see where that goes from there. I mean some of the experiences that we've had on UZEDY is that once patients and physicians get experience, they then start to archetype for themselves what that looks like and what the perfect patient profile is. And so that's something that we'll be interested in keeping you guys updated on.

But we certainly think that, that's going to be where we start and where we go from there. And I think that this is going to be a very broad opportunity, as Eric said, given that oral olanzapine represents about 20% of the total patients. On the distribution question, just general code. So we don't have to wait for a J-code, and we expect to launch as we did with UZEDY. So we will have products available sample and hospital kits as well. So physicians can have those experiences and then get the product in channel in the next couple of weeks and get patients on therapy. Thanks for the questions.

Our next question comes from David Amsellem of Piper Sandler.

So if you take a step back and look at the LAI antipsychotic space, I think the share of all LAIs is somewhere in the teens. So I guess my question here is, as you think about this product, can you give us a sense of where you think its share of the market could be in terms of percentage of oral olanzapine switches? Do you think that share could ultimately be higher in terms of percent of LAI to oral? So that's #1. And then as you think about market expansion down the road, any comments on bipolar mania? I know oral olanzapine also is used quite significantly in mania. So any thoughts on that program?

Thanks, David. Thanks for the question. We sort of -- a lot of people ask this question. When we think about it, you said the teens, it actually varies -- it's around about 13% to 14% the LAI market and slightly higher in Europe, by the way, worth noting. But -- that is obviously a non-olanzapine because as Eric pointed out, there is not a used long-acting olanzapine on the market right now. So an analog could be, well, that will -- the same will happen in olanzapine. So 13% transfer to LAIs. That's a very crude way of looking at it. But obviously, that is something that's already happened, and that's fairly significant. Would that change with olanzapine LAI, would it be the same? Would it be lower? Would it be higher? We'll wait and see.

What we do know and what I think Chris Fox highlighted is to the market research we see, there is significant demand for this. And I think Eric mentioned it in his opening remarks. Compliance is key when you have severe schizophrenia. And they have been anticipating having an effective monthly treatment for some time, combined with the fact that, obviously, this has no loading, getting to therapeutic levels very quickly, et cetera. So I think that makes us feel optimistic. But if you're sort of trying to model it, David, I'd say, yes, 13% is a good analog. Let's see how it plays out. In Europe, it's slightly higher. But this creates still a very significant opportunity for us.

On the bipolar mania, I'll hand that to Eric and maybe he can give some context of that.

Yes. Thank you, Richard. And thank you, Dave, for the question. We have been thinking about bipolar and other things that we can do in life cycle management. So I think that with this launch, we'll continue to double down on what we can do in the future, but that's certainly one of the things we've been thinking about. As you know, we got the same indication for UZEDY before, and that was on a modeling simulation basis. I think we'll probably be running a study if we do it for olanzapine LAI, but certainly a good opportunity.

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

So for me, I'm just curious how the sales force is going to be prioritizing the 2 LAIs now? And will UZEDY still get a lot of attention now that there's this new shiny toy in the portfolio? So that's question 1. And then my second question is just what are you guys assuming for drop-off to patients who go on to olanzapine LAI due to elevated metabolic risks, which are just the risk associated with this API. How do you think about the drug and stay time? I don't know if there's learnings you can take from like oral therapy olanzapine versus other atypicals as weight and other metabolic parameters go in the wrong direction. I just wonder, is there kind of a higher discontinuation rate for patients who start olanzapine versus other atypicals?

Jason, thanks for the questions. I'll hand those to Chris and Eric. And starting, Chris, on the sales force prioritization, how do they -- the shiny toy, what happens there?

I love it, and it is a shiny toy for sure. But so is UZEDY, I got to say. We love both of these products, and I think they serve different needs. But in total, as I said before, I think we can cover about 80% of the schizophrenia patients offering them an LAI that they otherwise wouldn't have had that option. And we have been meeting with the sales force. They're super prepared. They can do both of these really, really well. 80% of the docs that we call on today already will be targets for WELTRUZA. And so it's a really, really nice synergy. And as you probably can tell, I'm very excited about it, but our reps and management are too. They really have honed their craft and are doing an extraordinary job of understanding the patient flow and the office flow.

They know all of these physicians, and I think that creates a really beautiful slip stream for us to step in and offer them a new alternative, all the while validating the patients that are appropriate for UZEDY and supporting them with both of these tremendous assets. So we think we have a great advantage of having a lot of synergies in this space from a know-how and also from a physician certainty.

Eric, I'll turn it over to you.

Yes, thanks. And the question was about the AE profile of oral olanzapine and the rate at which people drop off or manage that. Well, although that sounds like a bad thing, the great thing about WELTRUZA is we're building upon a known foundation of olanzapine. People know -- physicians know how to use it. They know what to expect. They know how to monitor their patients. Our side effect profile is identical to the oral. So we're adding an innovation and a benefit on top of what they already know. So that isn't going to be the biggest barrier. What the positive is that we're bringing them something that actually makes it more convenient to give the drug in a more efficient way so that we remove the problem of adherence. So I'm particularly excited by that 4% relapse. That's 96% of the people who are stable are staying on the drug because it's working. So that's how I think most physicians will approach it.

Our next question comes from Ash Verma of UBS.

This is Di on behalf of Ash and just congrats on the news. I have a couple on the launch trajectory. Can you give us some like, I guess, product analog that we can look for, for the like launch trajectory? And then the second thing is you mentioned the -- like oral conversion to LAI could be like 13%. I just wonder like do you have a split between -- like patient split between like conversion from oral versus from other LAI agents? And my last question is just on the gating factors like what are some of the gating factors for the launch given that, I guess, the meaningful contribution won't come in until like second half next year?

Yes. Thanks for the question. So I think when it comes to the launch trajectory, I think the way we'll -- to think about it is it's about getting a few things in place. First is about getting the coverage. And so that's Medicaid, making sure you get the Medicaid states on board. And as I mentioned earlier, that's a slight rate limiting step because some will do it in day 1 and some will do in 6 months and some in 12 months and some even in 18 months. And that's just the procedure they have. You need Medicaid for physicians to start to use it in any volume. So we'll do that. We're good at doing that. We know how to do that. We did that with UZEDY. The other one is to get hospital formularies because obviously, many of these patients will end up in the hospital. So once again, we've done that with UZEDY. We know who the people are in the hospital formulary committees. So we know where we need to go.

The other is the physicians. And as Chris eloquently pointed out, UZEDY sales force commercial teams call on these 80% of these physicians all the time. So I think that gives us a good opportunity for a good trajectory. The trajectory should be thought about use of our samples, scripts, hospital formularies, how many physicians use it, what's the breadth of physicians and then what is the depth of physicians. So that's -- the reason why we talk about launch trajectory in those ways versus revenue is because as I've highlighted that rate-limiting step of payer access, which means that it's really the second half of next year that we'll see meaningful revenue come through. But you'll see all those leading indicators of volume of script either TRx and the factors and the use of the sampling and the factors which will be able to articulate why we believe this will be a very good launch. But obviously, that's something which we will be mentioning on all our quarterly earnings calls.

The second, where do these come from? Is it oral? Is it LAIs? I think predominantly, it will come from orals because people on oral olanzapine will want to who -- compliance is key for them or in their physicians' eyes or the patient's eyes will want to move across to WELTRUZA. So what we've seen on all others is that the patients who are on the molecule already because the physician has chosen olanzapine for a reason. And I think Eric highlighted most of the time they'll pick it because of its efficacy. And so we see the majority of patients coming from oral olanzapine onto LAI. Will some come from other LAIs? That's possible because maybe they were put on that because of compliance reasons, but think of it in that way.

And then I think you said gating factors. I think probably go back to the gating factors are coverage, Medicaid and hospital formularies. But those we've planned out, and I hope you felt from Chris Fox's answer. The thoroughness of the preparation of this launch is excellent. But the thoroughness of this preparation through a team who are already in this market, I think, just makes it even more impactful. So hopefully, those answer your questions. I don't think I missed anything. Apologies if I did.

Our next question comes from Umer Raffat of Evercore ISI.

Congrats on the approval. I have 3 quick ones, if I may. Perhaps first, for Eric. Eric, is there a post-marketing requirement? And if you could also speak to the underlying tech because the label does get into the PDSS cases, but it always is constantly keeps saying it was on another extended release of olanzapine. So could you just speak to your technology and the Medincell platform as well?

And then for you, Chris, and perhaps Richard as well, I noticed the pricing philosophy Teva used on UZEDY was, a, it was not flat pricing; and b, the range across doses was anywhere from $2,000 to $7,000. On this one, it's flat pricing, first of all, but also the price is kind of like in between at $3,750. And I understand Relprevv is not a comp because that pricing is from 2010, but how should we think about that? And why is it flat pricing? And I mean, because UZEDY, you can ramp up to almost to $7,000. So I'm just trying to think out loud about this price point.

Okay. Umer, thanks for the question. I'll start with Eric. We can talk about the post-marketing question and the Medincell technology, which I think you'll love to talk about. And then I'll hand over to Chris Fox, who can talk about the pricing that you've mentioned, Umer.

Yes. Thank you, Umer. Thanks for the question. And with regards to the post-marketing commitments, there's no particular post-marketing commitment other than monitoring for any suspected PDSS in the future, which is something we'd be doing anyway through our pharmacovigilance. So that's probably the only thing we'll be doing in the background doing expedited events reporting if that's coming up, but nothing particularly unusual about that. The second thing about the technology, I think that in our discussions with FDA, they saw the value of what we're bringing to the table with this technology. Remember, it's a subcutaneous injection that rapidly aggregates under the skin. It was specifically designed to make sure that the safety profile was good.

And in fact, some of that data, if you look deep into the label, is mentioned there. There is a mention of the fact that this other product, that's an injectable version of olanzapine has a dissolution rate in 24 hours of 91%, while I believe the number for WELTRUZA is 7% over 12 hours in an in vitro assay. So that was actually a fantastic data to have in the label to really point out what the value of the formulation is that theoretically brings to the patient. So no significant post-marketing commitments and the technology is highlighted in the label compared to another product out in the market.

And with that, I'll pass it over to Chris.

Thanks, Umer, for the question. Very astute observations. And I would say that we really thought about this differently than UZEDY and mainly because UZEDY can come in 1 or 2 months. So when thinking about WELTRUZA, we still use the same principle of striking that right balance by having as broad of access as we can while value preservation. And we didn't want to unknowingly disincent someone from using the dose that they need because of pricing. And so this was the best way to go. We do, as you can appreciate, massive market research on this to try to get this right. And we feel like this reflects the innovation and also will ensure that we get the best adoption and access across the board. Thank you for the question.

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

So thank you. So thank you, everybody, for joining the call. I do appreciate you giving us your time. I'd just like to reiterate, we are very excited here at Teva as we continue to execute on our pivot to growth strategy, particularly on our drive to create a world-class biopharma company by launching innovative products on a regular basis. As you saw, we have 5 submissions in 5 years. And so we really have some momentum here. And what Chris and her team have done in commercializing these products, I think, should give people a lot of optimism as to what we can do with WELTRUZA.

And just to remind, many of the questions today have been around the huge unmet medical need there is in schizophrenia, particularly for a long-acting olanzapine molecule and particularly one with the product characteristics that Eric has clearly highlighted. So for me, somebody has been in this industry a long time, and I know I speak on behalf of my colleagues, it's a real privilege to bring something to the market that allows patients suffering from this very difficult condition to have an improved quality of life that they so desperately want and for physicians to help them treat those patients. So very proud, and I look forward to giving you an update of how we do with the launch at our various quarterly earnings. But for me, very excited. Thank you for your time, and wish you all a good weekend.

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

Welcome to the BofA Global Healthcare Conference. It's my pleasure to be introducing Teva Pharmaceuticals and President and CEO, Richard Francis. My name is Jason Gerberry, I'm a Pharma Analyst at BofA. I'll be joining this presentation via tele-presence, unfortunately, but my colleague, Richard Wagner is on-site in person. So the two of us will go through this presentation. So first off, Richard, apologies for not being able to be there in person this year.

That's okay. Good to have you on the screen, Jason.

Great. Well, maybe we can start with a few overarching general questions around Teva's strategy, capital allocation, given the company's recent improvement in its credit profile and overall, just the evolution of the business in the portfolio. So I thought it would be helpful to start with now that Teva has reached investment grade with three credit rating agencies, how does that change the view how the criteria for assets that the company might consider for future BD transactions. I know in the past, there was a laser focus on improving the debt profile. So does this in any way change how you think about maybe capacity? Can the company maybe be more opportunistic on the BD front? So maybe I think that would be a good place to start.

Yes. Okay. Thank you. So the fact that we got a credit rating of investment grade from all three of the credit rating agencies. And we did that to remind people a year ahead of when we said we would. We said we'd do that by the end of '27, so we did that a month or so ago. And an important aspect to which I'm sure everybody knows, but I'm quite proud of, and I know my CFO, Eliyahu Kalif, who sits here is very proud of, is you get a credit rating upgrade, not because you paid down the debt only is because you've actually show a future direction of your EBITDA. And so when you look at net debt to EBITDA and where the company is going, they actually think, okay, it's not that we pay down debt and now what. It's the future of the company looks a lot better. And why does it look a lot better and why is the EBITDA going to grow? And we'll talk a lot about that. So I think that's important for people to understand because I always say that, that metric of investment grade highlights our disciplined capital allocation to pay down debt, but our capital allocation within the company to grow our revenue, to grow our show that, that journey of financial stability and I'd argue opportunities there.

So that's one point, which I think is important to there's another milestone, another metric that we set out to do and we've done ahead of when we do it, and there's others we can talk about. The other one is to that how do we allocate capital now and do we do BD. And we had four capital allocation criteria, pay down debt, invest in our growth drivers, which is our commercial products, AUSTEDO, UZEDY, AJOVY and product launches. Third one was develop our pipeline, which is very exciting and do BD. And the fourth one was return capital to shareholders. So as you've highlighted, pretty much #1 is gone because we have a chunk of that this year and early next year. And as we've also seen, Eli and the team refinanced some of our debt a few weeks ago, and we did that at a really good rate because we're a good company. We're investment grade. So a lot of things have improved in that side, which allows us now to think about how do we want to deploy the capital to those other three areas.

And -- so a few things we have. Yes, we are very active in BD. And although we've only done one transaction at [indiscernible] , which I think was a good transaction, and it was very synergistic with what we do. That's based on the fact that we have a very disciplined approach to value and return on that capital. And although we've been in discussions with other assets and companies, we don't feel it's the right price and the right return for us, we won't do it. And we can be disciplined in that one because I think we've come from quite a difficult position, a balance sheet position. And so we're thoughtful.

And the second thing is we have a great organic pipeline, which allows us to be choosy about what we bring in. And as you know, we also potentially could be getting an asset BioXcel, which is in bankruptcy, and we've been looking at that for some time. So we will do more. We do look at a lot, but if the price is right, we won't do it. And those transactions could get bigger. But we do -- and Eric Hughes, -- he's Head of R&D, [indiscernible] is here. We do look at what we're buying and is it better than what we have and, if it is, then we can do it and then we'll have to stop doing something internally. We're very agnostic about where our pipeline comes from.

But definitely, we are planning, Jason, for the world, where our balance sheet starts to build cash on it because it will very quickly. Just the refinance of the debt, we're probably going to save $400 million of finance expenses next year. So that just shows you the progress that's cash. And so we're planning for what we can look at what size those deals can be in 2 years' time versus now. And so we're planning for them now, hoping to get some good deals, but being mindful of price. We're also planning for what those could look like in 3 or 4 years where our balance sheet is very different. But we have a great pipeline, which we'll talk a lot about. And so it's not a must, its a and/or.

Okay. Great. Maybe as we think about where you will be opportunistic to look to add more substrate, if you will, into the pipeline, are investors right to think that Teva's strategic priority is more on the brand side versus the generic side in terms of where you'd look to support with any BD investment? And within brands, I would imagine the focus remains within your kind of core therapeutic area footprint. But if you could provide any color in terms of how you're thinking about areas where there may be a higher priority to augment?

Yes. I think you're broadly right. I mean the capital allocation for in-licensing and BD will be predominantly innovative and it will be predominantly in CNS neurology and more specifically, if we can in and around the areas we operate psychiatry, for example, movement disorders, things like that. And then also potentially immunology because of our immunology pipeline that's come through. So you're right there.

I would add, though, that we have been and we will continue to look at rare disease and rare disease will be more agnostic as to what TA that is in because we think rare disease is an area where it's based on core competencies, pricing, supply chain, go-to-market model. Those things that we think we have. We've built with AUSTEDO, we're going to expand with ICA pipeline, and we think that's we can leverage, but that's to be the right asset, the right price. That's just one nuances.

I would say that we still do deploy capital to our Generics business. It's more biosimilars. So you've seen us do deals on biosimilars partnering, so that will continue because we're 29 biosimilars now in our pipeline or 15 on market, 14 in our pipeline, and we want to keep expanding that. So we will be allocating capital to that. But the far majority of the capital will be to the innovative side, as you say.

Okay. And you've mentioned a couple of times now, just some of the success stories in terms of drugs that you guys have internally developed via Duvakitug or the IL-15 antibody. So how should investors think about Teva's internal drug discovery capability, right? And how do you -- I guess, how do you benchmark productivity of the organization? And the success of this part of your business relative to, say, other established biopharma companies?

So look, I think the difference, I think, with us first is, we think of our R&D as little R, capital D. And so that's an interesting differentiator, but let me explain what that means. When we do discovery, we do discovery on things that we believe have a high probability of success in our hands. And so let me explain. So we will not discover a new target. We will not discover a new MOA, we won't do that. What we've done, and you've seen with TL1, anti-TL1A and anti-IL-15 is -- we will -- because of our amazing discovery team that focus on antibodies, we will understand what targets we believe have been validated, but an antibody has even not been optimized to have the maximum efficacy, tolerability and safety, despite people making that antibody. We like that approach.

And so productivity-wise, we like that approach because we think we significantly derisk the assets straight away because we know the target is relevant, we know the target works, right? Well, I think our secret sauce is we can then make a TL1A that's better than anybody else's. And I think we've shown that, and we'll make an anti-IL-15 better than anybody else, and we'll show that. And we'll make TSLP IL-13 better than anybody else, and we'll show that Q1 next year. And that's not arrogance, that's because we invest so much time and effort in building capability in antibody engineering, which is something that a lot of people don't do. They discover antibodies and targets, which is great, but we believe the work and the capability we built in developing antibodies that are more sophisticated, can add real value, real value.

I think we all saw that already in TL1A. And I think that will start to permeate more as more data comes out. So from a productivity point of view, Eric and I, Head of R&D, talk a lot about probability of success. We both don't like taking big bets on capital. And so he set up his team in a way that allows us to have significant wins while reducing the risk associated with those. As in, when I came in and spoke to him 4 years ago, TL1A, even I and I'm pretty uneducated in science, knew TL1A was an exciting target. We had a really good one, Anti IL-15, look, I realizeed that. And so okay, yes, these are derisked. Now how do we make the best and can we make the best, that's our capability. So that's where our productivity is really good.

The other side is on CNS. I think one core aspect to Teva is we know what we don't know. There's a level of humility in the company. So do we think we can discover the new treatment for Alzheimer's and Parkinson's despite how much we desperately want to? No. What do we think other people in academia and biotech around the world could discover some of the trends for CNS and some of the distressing disorders? Yes. Do we look and monitor them and talk to them constantly? Yes, because that's where we think we can leverage that ecosystem, which is so broad and wide, and so many people are trying different things. And then when we think to the same principle, as I mentioned earlier, things are derisked because that MOA, that target, that pathway is validated, we will go in, and we will partner with them.

That said, sometimes we are so focused on making sure we have the right risk, as you saw with ICA pipeline with Tourette's, we followed that company for two years. And although we saw some really good data in Phase II, we still didn't feel comfortable enough to allocate capital into Phase III. And I think if you put all that together, I've never thought about looking at it, but I would say our productivity is very high, but it's based on the fact that we purposely think about probability of success and we purposely think about how do we make sure these assets have a very high likelihood of getting to market.

And so I think we've -- but I haven't actually done the analysis, but that's how we think about it. So which is why Jason, I think we've ended up in this position where we have this late-stage pipeline that everybody is quite excited about and excited because I think everybody has a view that's quite a lot of it could come to market. And if it does come to market, that could be a meaningful inflection in the growth of Teva, both on the top and bottom line, and so it becomes really material.

Got it. The industry is moving fast, and there's a lot going on. We hear from pharma companies about leveraging AI to get better compounds into the clinic. China is a source of drugs that pharma companies are able to get through structured license transactions with lower upfront cost. So there's favorable trade-offs there, ways to augment the portfolio and the pipeline. Do you see kind of leaning into all those avenues kind of in the future as now that you've kind of transitioned the company through this phase of coming out of like higher leverage and legacy litigation profile into now looking at this as a growth company. I'm kind of curious how you think about the next 5 years and sort of the pipeline of evolution.

Yes. So a couple of things is, firstly, yes, I think Eric and [indiscernible], Head of M&A and BD. They were both in China again in August. So we visit China. We're very agnostic as to where the science is. And I think it's another strength we have because I think people have gone to China, but it's more gone to China because of either failures or because somebody has moved faster, because we have that little R approach, we just follow with great science. And that could be West Coast, East Coast, that could be China, that could be Europe. We don't really care. All we know is we're looking for it. And it doesn't have to be something.

And by the way, we're not precious about our own pipeline. The pipeline is what products we bring to market, if it's internal, okay, if it's external, okay, not one is not better than the other, absolutely not. And I think that's another key area, which is a focus. The other thing I'd say is, as we look at all of that, and don't forget, we got some really interesting things like our PD-1 IL-2, by the way, we can have data at the end of this year on, which will also show our antibody engineering capabilities into an area where people have maybe thought PD-1 IL-2 has had their day. Once again, I think it goes back to the quality of the engineering, but I haven't seen the data, we don't have data yet, but let's see. But we did a deal with Fusan to accelerate that. So they're working on that study in China.

So we think super creatively about how do we get the data. And that's another thing, from a company point of view, we sort of have a mindset like a biotech, which is we need data, and we need it fast and we need it cheap because capital is important. And so how do we get data fast? Eric run clinical studies really quickly and effectively. So I get to readout. So we know it works, it doesn't work. If it works, lets accelerate it, and I'll come back to that.

But as we think about AI, as we think about all these things, the other thing I'd remind people is we have two assets in our pipeline, Duvakitug and Anti-IL-15. They all are multiple indication assets. So Duvakitug, we now have four indications. We'll probably add another four. I mean we've got a list of 20-plus so maybe more. And then Anti-IL-15, we have Vitiligo and Celiac disease, alopecia will follow and then whether we have atopic dermatitis and some other areas are logical. So suddenly, we have two pipelines and products in a small company, which is game changing.

So while we look at all the things around partnerships, opportunity in CNS in different parts of the world, we will constantly do that. But I think people need to recognize we have a very significant pipeline based on two assets. Also, which have multiple indications, and they are showing to be very safe and tolerable, which allows you to go into other indications. So that makes it very exciting.

So I think those are the things that we sort of consider, but I think -- do we consider all those different areas? Absolutely. But we have to balance it. We have a pretty good pipeline now. And I remind people that we'll probably have 5 launches in 5 years -- the next 5 years, and we'll probably have a lunch every 12 to 18 months after that, if you believe vitiligo will work, Celiac disease will work and the two new indications in Duvakitug, which I think there's a high likelihood they will work because they're validated and actually, Merck have come out with data that shows it does work.

So those launches are going to happen. And then the final thing I'll say on that is, when you're looking from an investor point of view, we're going to keep launching innovative products, which have 90-plus percent gross margin onto a business currently that has a 55% gross margin. So to work out your debt. It's not hard to work out the math that what -- if we're disciplined on OpEx, what would drop to the bottom line. So I gave you more than you asked for there, Jason, but hopefully, it's helpful.

Definitely, definitely. Maybe we'll shift the pipeline and the IL-15 program, which had some interesting data recently. I guess at a high level, you talked about discipline on OpEx on the one hand. But you've also been very creative on how you funded both this and Duvakitug, right, between the partnership with Sanofi, the Royalty Pharma and Blackstone type of transactions for these two assets. And so, it begs the question as the company's financial health improves, and as you move along with the IL-15 program, you said it's a pipeline in a drug, right? Is there a natural inflection point where it makes sense to find a partner for an asset like this and get this through a Phase IIb where you've established dose in a real strong proof of signal that is -- I guess, the registrational endpoint in these populations? Just kind of curious how you're thinking about how you take some of these assets forward within the confines of your kind of current R&D constraint versus perhaps over time, we can see kind of a meaningful step up in R&D investment.

Yes. So I think this comes back to one very, very important principle we have at Teva. And once again, its about how we think about assets and R&D, is the first important principle is if we have something we believe works, our job is to get it to market as fast as possible. That's the #1 principle. As fast as possible in as many indications as possible. When I came here -- and by the way, and we'll work out the financing, it's sort of the crude way I look at it. So if you got it, it works, move fast across every indication, we'll work at the financing, and I'll come back to -- when I came to the company, I remember talking with Eric about these products. And I can remember, speaking to CEOs who are fortunate enough to have pipelines in one product. And I said to , if there's anything you would have done differently, what would you have done? And they said, if I knew were you now, I've done all the indications parallel straightaway. Right now obviously, that's extremely -- can't do. You need to have safety tolerability and play things out.

But the principle was there, which is if I knew what I had, I would have just gone even faster and harder. So I remember that. And so for us is, when we go about Duvakitug, 8 indications, 10 indications Il-15, 2 indications, 5 indications says, yes, we're going to do more and we do them fast whether the science is logical, where we have that probability of success rationale, I said at the start. And then we out the financing.

And by the way, working out the financing is the easy part of it. Finding the drug that works is so, so hard, finding a drug that works in multiple indication is -- I really missed the time has happened to me in my career. And I'm older than I would like to be. So I recognize that the financing will workout. And so that's what we do. We think about how do we find it. Now on Anti-IL-15, the question is, do we need to find more financing? Well, firstly, we have Royalty Pharma, who I think a really good judge of an asset, with the due diligences they've done and they do.

And so I think we're in a good place. I think always the way I think about it is how do we maximize an asset, which is how quickly you bring it to market and then how do you maximize it in the market. And once again, I constantly think about that. And I think, well, is that more financing? Is that more capability? Is it partnerships? And all of those in play, and I see none of those as a weakness. All of them should be in place, a different play for a different time. And if you're constantly flexible and agile on that, I think you'll maximize things. And that's all about how do you maximize, create return on the capital, to create something that creates shareholder value. So I suppose the punchline is dynamic and fast.

Understood. Okay. So, maybe just thinking about these market opportunities, Celiac and Vitiligo, you guys have put out some peak revenue projections. I think investors struggle to know how big these markets can truly be. I think rightly so, right, because they're just -- there's the lack of advanced therapies. We just don't know how these markets will evolve over time. I would almost characterize your peak sales guidance as a placeholder, a conservative placeholder. So maybe just talk about how you're thinking about both these settings. They are kind of new spaces for advanced therapies. Are there any analogs that gets you excited when you think about like the potential of these different disease areas?

Yes, it's interesting. Just to give you a bit of context of how the narrative changed. So when we went into Vitiligo and Celiac disease, it was celiac disease -- is it disease? Is it druggable? Will anybody take it and pay for it? Vitiligo, really people suffer from? To, now $1 billion of peak sales seems super conservative and come on. Now obviously, Celiac, I think we have over 4 million patients. Actually, not too dissimilar from Vitiligo, but if you break it down as to how many will be treated. So the rationale for people to challenge us on our peak sales is valid, right?

What I did on the pipeline is say that every product in our pipeline has $1 billion of peak of potential sales. Whether some are going to be a lot more, I wasn't trying to make that point. I was trying to say that we have over $13 billion of sales in our pipeline, which I think is highly probable, if you just take $1 billion for each.

Now to your point, we're getting challenge on Celiac, Should be a lot more and Vitiligo could be more than $1 billion. And my answer to that is, as we get closer to market, and we understand product profiles, patient populations, then yes, I agree that the number is wrong, how wrong? We can see. But then I'll remind people if we have a 55% gross margin and with the size of the company we are, if Celiac is $1 billion, Vitiligo is $1 billion, Duvakitug in all indications is $1 billion, which is probably all hugely conservative. It's an absolute game changer for us.

And so in a way, I like this question because it should bring people back to what if I just model what I think is conservative, it still looks like an amazing outcome from a value creation story. Now will we start to frame a bit more what we think these could -- what could happen in these indications? Absolutely. But we're not in an IPO fundraising event here to try and actually create excitement about it. We're trying to give something which is quite methodical and predictable and say this is what we think. This is how it will evolve because I think we built a lot of credibility at Teva. And so why we want to get people excited about the future, we want to do that in a way that builds on that credibility and that thoughtfulness.

And I feel the time is getting right because now people are challenging me quite a lot. So I'm thinking, okay, we need to update, and we will do. Whether it will be seen as ambitious as what people want, we'll see. But with that on that, I would say I don't think we -- I think whatever we've commercialized, we have beaten everybody's expectations considerably, even ambitious ones. So don't ever think what we say about these rough guidances ever takes away from our desire to do the utmost best we can when we launch drugs.

Okay. You mentioned speed earlier in terms of advancing some of these assets. And I wanted to come back to the Celiac time line, 2034 time to a FDA submission. And so as I think about in my mind, at least, like something like an adaptive Phase II/III design and potentially an ability to use gluten challenge in a pivotal study. Like these are factors that could probably shave years off of that development time line. So am I at least conceptually in the right ballpark in terms of thinking about some of the variables as you approach FDA and have a negotiation, not looking for you to front run your development plan and all that. But as I just think about some of the possible swing factors in the development time line, are those two of the major ones?

Look, I think you touched upon something which is quite sensitive for us and quite emotional. So it's a good thing. So we believe we can run studies faster than anybody, right? So your challenge is good and a fair challenge. And what I mean by that is even the work that we're doing on Eric's team had done on Vitiligo, he started to move and plan for success even we have no data. So the speed of that transition into the Phase II study will be faster than anybody has ever done, because we plan for that. We didn't wait, have a committee check it out and then move, we've already done it.

And the Phase II and you see in CD and Duvakitug Phase II, was the shortest transition time ever done. And that's working with a partner who probably doesn't work as fast as we do. So our ambition to do everything really fast is actually there. So your challenge is a fair challenge. And Eric gets quite a lot when we're in these meetings. What we do say is I don't think anybody is going to challenge our speed on Vitiligo because we know that regulatory pathway. We know exactly what is expected. We know exactly what the FDA want from a primary endpoint, everything. So super clear. So that's just execution. And Eric and Teva have executed really, really, really well.

So we will be as fast as physically possible. And we'll be faster than anybody has ever done it, I guarantee. On Celiac, we're still trying to work through, we'll be in discussions with the FDA about what are those things you said. And I think we'll be exploring all of those opportunities because we want to bring it to the market as fast as possible. But we do have to work with the FDA to get there. We don't want to be in a position where we run a study and we go out to the FDA and they go, "Well, not quite comfortable with these endpoints are not quite comfortable with it. So I think in this situation, we have to go a bit slow to go fast.

Once we get down, we've got a lot of credibility now with the FDA. I think once we get that, then we go fast, and we do some things if we can, like you said, to be really creative. But you need to get that body on board. And that's where we're in that position. And look, no one has developed a drug in Celiac disease. So that's exciting, but also that throws up these challenges. It won't be the same in Alopecia. It won't be the same in Atopic Dermatitis. It won't be the same as the two new indications we've got in Duvakitug because there's a path we're already there. So yes, you should expect us to be the fastest.

Okay. Maybe on Duvakitug, just one because I do want to prioritize the 2027 launches, but I think everybody is in wait-and-see mode at the moment on Merck's Phase III data that are going to be coming here in the coming months, and you're actually in meetings with Merck yesterday and where they defined, I think, success is being efficacy on par with top tier biologics in the inflammatory bowel disease setting. Would you characterize things similarly, do you think that, that's sort of the right way to be thinking about what success looks like another MOA, perhaps different obviously, like antifibrotic properties and just efficacy matching perhaps the IL-23s in the IBD setting?

So look, I think what we saw in the Phase II for our data for Duvakitug was, we saw -- and you can't cross compare, but I think everybody has certainly did. We saw really impressive efficacy data in the induction and the maintenance. So I think efficacy is good. It could be differentiator for us? Could it be a differentiator within the class and just within the indication? I think it possibly could. I think one area that is really important which I would highlight is safety and tolerability.

The ability to make sure this is safe and well tolerated is for a chronic condition is really, really important. And many of the products here do have either black-box warning or monitoring requirements. So that, an added burden. So I could argue, if it was similar efficacy to top tier, it would still be differentiated on safety and tolerability. But the way we look at our asset is we think there is a potential that it could push that efficacy, but we'll have to wait and see for the Phase III. But I do think because of the failure rate in CD and Crohn's disease, and the amount of cycling that goes on, there is a desperate need for a new MOA. And so I think TL1A would do very well with comparable efficacy of the top-tier biologics with that safety and efficacy -- safety and tolerability profile because of the cycling that happens, unfortunately.

Okay. Maybe Olanzapine LAI. If you can just give us a sense of how the regulatory review is going. Is everything on plan? I think the label and the monitoring requirement is so critical to the value proposition of your drug relative to Eli Lilly's LRAP. So just wondering if you can speak to sort of the continuity of the review and the review team and anything we should know about?

So the review is following the time line you'd expect. So there's nothing unusual in that and the communication and the cadence of that. And that's all I'll say.

Yes. So I guess ahead of the year-end approval decision, I wonder if you can just talk a little bit more. You've talked in a few or Teva as a company has talked about the evolution of payer coverage as being kind of a really important thing for investors to be mindful of in 2027 and probably 2028. So I guess, on the one; hand, you flagged variable adoption as like a key uncertainty when speaking about the cadence of the launch inflection. But on the other hand, I think you said in the past that with UZEDY, there were delays, and you weren't able to hit the ground running, whereas you should be able to hit the ground running with Olanzapine. So I'm trying to put these two ideas and I guess, maybe is the timing of this not -- can be reconciling like the Part D contracting cycle, some of the dynamics that we need to be mindful of when we think about sort of how Olanzapine should realize it's going payer pick up next year?

Yes. So look, I think we may give some more clarity. So Olanzapine will have a really good launch. I think we have a really good launch. And it will a launch better than UZEDY. I think people tell me UZEDY was a good launch. So it will be better than UZEDY, and it will be a really good launch. What I am making sure people fully understand is the payer environment. And the payer environment in the U.S. means because of this patient population, we have to get Medicaid first. People cannot prescribe it unless it's on Medicaid's formally, and Medicaid is done state by state. So we have to go -- in some states, we look at day 1 and some states will look at it in 6 months' time, and they won't look at it before and some 9 and some 12. We'll have about 86% coverage at 12 months of Medicaid. But we have to still visit every state when they allow things to be put in the formulary, negotiate and get it on. So that's just a rate-limiting factor, okay?

And so that doesn't mean we're not going to get have our sampling program out there, does not mean we won't be expecting to see good TRx. That does not mean we won't expect to see a good breadth of physicians already prescribed Olanzapine and a good depth as well within those physicians. So our aim is good TRx, good breadth, good debt, with good inclusion in hospital formularies, good usage of our sampling program like very good usage and then getting Medicaid on board. That's the -- those are the things. So I think the input metrics, we're really excited about. And I think investors should be ambitious around what we should do, no question.

The revenue, I say, will probably come in more meaningfully in the second half of next year just because of the fact that we'll be sampling and we won't actually be getting access. And so we just can't generate. What I want to do is make sure we generate a lot of scripts, a lot of usage, a lot of breadth and a lot of depth and it becomes an integral part of psychiatrist prescribing. That's the work we do. That creates long-term value. And the other thing to remind people, we're not going to contract with Medicare. Well, we're highly unlikely to because we -- they'll probably ask for a discount which we don't think reflects the value of the product as with UZEDY. And so that means physicians do have to fight through that reimbursement and ask for it to get it.

Now they do that already with UZEDY. So I think they've become pretty good at that. And I think Olanzapine is an easier ask because there is no other long-acting Olanzapine that's used. But just those are the things to come. So I don't want to anyway to think we are conservative on hedging. We're going all in. But when it comes to revenue, those are the things that are the gating factors you just can't change and so people should think about that when they're modeling.

Yes. Okay. Maybe in the last couple of minutes, ICA pipeline and the launch in Tourette's. This is, since the acquisition of a product that you haven't yet outlined a peak sales parameter for yet, maybe just thinking about -- I guess, as I think about this category, you've got essentially some generics that you may have to cycle through prior authorization considerations, drug pricing is such a wide range of outcomes potentially, right? So I fully understand why you haven't guided. But maybe if you can offer a little bit of context as you head into the launch of that and how you're just going to be thinking about sort of the pricing and access dynamics in a category like this that's historically been a generic end market?

Yes. Look, I mean, it's -- I'm super excited by ICA pipeline, one because in [indiscernible] You don't get opportunities to launch things that can make a meaningful difference to children. As a father of three, that actually excites me a lot of that, children in their development stage have Tourette and that is horrendous. And so to be a part of that is pretty amazing and inspiring. Now there are 100,000 children who suffer for Tourette's in the U.S., 50,000 do have some sort of therapy, whether that's psychotherapy, whether that's using an off-label drug, that's not efficacious but safe or use an antipsychotic, which has efficacy but has obviously a safety and tolerability issue.

So 50% end up on therapy, they don't stay on therapy long, 20% to 30% only stay on therapy after a year. So it's a clearly massively unsatisfied market. And when you actually speak to parents and physicians, they really, really are excited about having a treatment that was designed for Tourette's and has the efficacy and the safety that children will be able to take it. So I think the expectation that we're setting around is pretty significant.

Now, to one of your points, a pivotal part of this is pricing and access. And so we're doing a lot of work now to understand what is the the appropriate pricing for the value we're bringing to an unmet medical need, but balance that with value and access, which we always do is, what is the value we think and what is the access. We need something which you have to balance. So that makes us very excited about it. Maybe as we start to conclude some of those decisions, we can start to give a range of what this could look like, but we're still in the thick of that.

And as I'm sure you seem to be aware. We want to make that decision, particularly around price, we will live with for a long time. So we want to be really based on the latest data, the latest conversations, and we know we can launch is in Q1. We have a bit of time still on that one. But people should be excited as I am about it. And the other thing I'd say is it leans on all our capabilities. Patient identification, physician education, patient mobilization, all of those things we did with the Tourette's, with AUSTEDO and so in patient services, specialty pharmacies, this is the thing we know how to do really well. We're going to apply that to ICA pipeline. And so that should also help us get off to a good start.

Great. Well, I'm imagining you're seeing red zeros in front of you for a time left on our fireside chat.

I haven't actually got any red zeros. Can we see -- I mean, if you're all seeing red zeros, then I think you need to see a physician.

Well, if there's time for one quick other question, right? U.S. Generics broadly, 2026 was a rebasing year as Generic lenalidomide come out of the portfolio effectively. So at times, you framed U.S. Generics as maybe more of the problem child in the Teva portfolio. I'm just curious, as we sit here today, your confidence level that this business is maybe more stabilized now and maybe there is even a pathway to return to growth.

Yes. Look, I never would have call it, a problem child. I think people consider a problem child, as I said, again, I was a father of three, you never highlight the one is a problem child, although you know it. By the way, my kids watch it, none of you have problem children. It's just bad parenting I've understood that creates a problem child. If I had one, which I clearly don't, in case they listen.

But going back to the Generics business. So look, our Generics business, definitely we took it from 5 years, 6 years of decline to now we have a 3-year CAGR of growth, and I think we've shown everybody in the U.S. and outside the U.S. that we've been able to grow this business and fundamentally change some of the things around manufacturing, supply chain, the ability to launch on time in full and reshape the portfolio to more biosimilars. So we've done a lot of hard work.

I think one of the things we're seeing this year actually is we're probably getting a bit more traction than we thought. So our biosimilar business is performing well. We've started to launch in Europe. We're performing very well in the U.S., and that's performing well and some of the new products we've launched in the U.S. are also performing a bit better than we thought.

And so I think I probably said a few months ago that our Generics business was going to be flat to maybe slightly down. It's probably going to be flat to slightly up now based on those strategic decisions we made, which is to improve our product launches. We've done that, and they seem to be bearing some fruit in some recent launches this year. And our biosimilar, we put that portfolio together. We've launched it, and we're actually performing better in our markets that we're in and then we anticipated, which I have been talking about for some time, but it's becoming pretty material, and that's why I think more optimistic for this year about our Genrerics business and our Generics business in the U.S.

Great. Well, thank you, Richard, for joining us and enjoy the rest of your conference.

Thank. That was good to talk to you. Thank you. Bye-bye.

Thank you, everyone, for joining us. Again, I'm Chris Schott from JPMorgan, and it's my pleasure to be hosting this conversation with Richard Francis, CEO of Teva.

It's obviously been a really amazing story the last few years as you've transformed the company.

So we're going to just kick off some bigger picture questions, and then we'll dig into some details on the product portfolio pipeline, and we'll leave a few minutes for questions at the end. So with that, Richard, maybe just a bigger picture question. I think you're coming up on your fourth year as CEO of Teva. There's obviously been a lot of progress across the portfolio. Can you talk about the biggest changes you've seen at the organization as you've kind of transformed the company and just how you think about the positioning of the company going forward?

Well, firstly, thanks, Chris, for hosting. I appreciate it and giving the early session in. That's a pretty -- that's a question we could spend 45 minutes talking about, but I'll try to make it as succinct as possible. And I think if I just make some sort of simple headlines is, so when we started this -- and probably the reason you didn't cover us back then was we are a pure-play generics company, and you probably had big question marks as well. And with Pivot, we said we're going to become a world-class biopharma company. Now that seemed like a hard leap of faith for anybody to believe. But when you think about what we've done, it's really been focused on accelerating our innovative business and stabilizing our generics business and fundamentally changing our portfolio.

And it comes down to the 4 pillars we have, deliver on our growth engines, step up innovation, create generics powerhouse and focus the business. And so the biggest change has been by taking a pure-play generics company and making it now a very credible and one of, I think, the most exciting biopharma companies. But to do that takes substance.

And so deliver on our growth engines, all the products we have in the market right now are growing at double digit. Our innovative business grew 40% in Q2 and a lot of long-term potential growth there. Step up innovation. Eric Hughes of R&D. When people didn't think we could do R&D, we now have, I think one of the most attractive and I would say, good risk profile late-stage pipelines out there. And our generics business, not only do we stabilize it, we grew it, and we've changed the portfolio with biosimilars there very quickly. And then the final part was focus the business, that capital allocation. And I think what the conversations we have is about where do you allocate capital, where is the best return short, medium and long term.

And if you look at this transition over the last 4 years, we haven't changed our OpEx as a percentage of revenue at all throughout that period really, which means we've had to reallocate capital to do all those things that I've said because it takes money to launch innovative products, it takes money to put things through the clinic.

So I think the biggest change has been the strategy, but the execution of the strategy quarter-on-quarter, which I think is one of the things we have to show people is a strategy which is very detailed was still questioned that we've executed. And I'd like to think we've become known as a company that does what it says. And we're quite transparent about what we want to do, so we can be measured against it, which is a bit uncomfortable. But I think if anybody reads to any transcripts, we're super consistent. And we know that when people don't believe the targets we have, we know we have to achieve them to get belief. But now I think we have that momentum.

In terms of where we are in that journey, do you feel like you've got the right people in place and the right assets in place that we think of this as more a sustained growth story from here? Or are we still kind of in the transition process, I guess, for the organization?

I think it's more the former. I mean it's quite extraordinary. So I've been doing pharma for 35 years. And when I look at what Teva has in front -- what we have in front of us now from an innovative pipeline, it's extraordinary. And I sort of pinch myself sometimes. What I mean by that?

Well, we have duvakitug TL1A, which we now have in 4 indications in the clinic -- well, 2 indications in the clinic, about 2 more about to go in. So we have a pipeline in a product, which I've never had, by the way. I've heard other CEOs talk about it.

And then we have anti-IL-15, which we've shown some data in celiac disease and vitiligo. And we know there's 2 other indications we can go to. So that's another pipeline in product. So we have 2 products which are pipeline in product, but then we have our late-stage olanzapine, ecopipam, DARI. So we have -- and I think you mentioned that we basically have a launch every year for the next 5 years and then probably a launch every 18 months for the considerable future.

So for me, it is exactly what you said. I think we just have a story now where if we can keep executing, I'd even argue to plus or minus, we will still keep growing this company top and bottom line, which means we keep creating value for shareholders. And I think that part is clearer than it's ever been. So we were talking before and people say to me, have I missed the boat? And I say, absolutely not. You haven't because you missed the good upside, but those are really hard yards, all that transformation we had.

Now it's really hard, but it's execution of things we know are really good, and we know we will create value. We know are coming. We know olanzapine is coming, ecopipam is coming, DARI is coming, duvakitug is coming, anti-IL-15 is coming. So we know those, we just got to execute. So for me, hard work still, but probably a far clearer line of sight to that continued growth story.

Great. I know this is a transition year of sorts, 2026 with generic Revlimid. When you think about the growth profile of Teva 2027 plus, like how should we think about the growth for the business from here?

Yes. I think it's -- so it's a growth business. So we'll keep growing. And I think we've talked about around the mid-single digit. I think we talked about in our Capital Markets Day. But I don't think that really tells the whole story. Growth is one. But -- but what I've realized and if anybody is new to the Teva story, the thing to focus on is a weird line in our P&L, which is gross margin. If you look at the gross margin. So when I started, the gross margin was 48%. It's now trending to 55%.

Now the reason why that's maybe this area of opportunity is because when we talk about revenue growth, gross margin, but if your revenue growth is fundamentally driven by an innovative portfolio, which is gross margin in the 90% and you keep managing your OpEx in a disciplined way, then you have to grow your EBITDA, then you have to grow your EPS and you have to grow your cash flow, which I think I'm not as good on the finance as you are, Chris.

So that means you create shareholder value. And so I really mean that. And so for me, the growth story is one on revenue. But how does that translate to creating value for shareholders? Well, it's because we're going to change the gross margin. We're going to change the operating margin. We're going to change our cash flow and EPS. And we talked about that for 2030. I mean here's an interesting stat I quickly read up on this morning. I think our innovative sales at the end of 2022 were $1.2 billion, right? We're sort of already tracking at $1 billion quarter now. That's a fundamental change in a very short period of time.

And that's just going to be magnified as we go forward. So the revenue growth is one, but the type of revenue we're growing, I think, is a really exciting part.

And it seems like there's a number of companies, I think, have attempted to the transition that you've now done. And does seem like when I look at where you were on margins and when I look at like a full biopharma company, there's a long way to go, and that seems like that's exciting growth story.

And that's why I think sometimes people forget because you're so you're just not used to looking at -- when I was at Biogen, I can't remember. I think the margin was ridiculous like 98%, right? So we just thought that was the norm. So here, the weakness is actually our strength. It's our secret sauce because if we can be disciplined in what we do, how we allocate capital and keep launching, keep growing, and we're very good at commercializing products. To your point, the 55% becomes a 60%. The 60% becomes a 65%, then we'll talk about where it hits the ceiling, but it's a long way away.

Yes, absolutely. Speaking of targets you put out there, can you just talk about on the operating margin front, progress you're making? I know at the time, it seemed like a very kind of aggressive target you gave for 2027, you're a long way there. But just where are we in that journey? And how do I think about the second part of that question, the cadence of operating margin expansion as we look beyond 2027?

Yes. So 2027, we said we're going to do 30% operating margin. We said you say everybody couldn't quite back in the math on that. And it was hard to back in the math. But there's probably 2 key areas which have made it a high degree of confidence we know it's going to happen despite leading generic Revlimid, which I think we should get a bit of credit for is the portfolio once again has changed dramatically.

So as we keep executing on AUSTEDO, AJOVY, UZEDY, we launch olanzapine, these are high-margin products, and we're very good at selling. The portfolio mix changes, which changes the gross margin, which obviously with disciplined OpEx management will hit your OP. That's one. But then the other thing is, as much as we are disciplined on OpEx, we've gone after our cost structure very aggressively in the last 2 years.

And by the way, I'm sometimes asked internally, when will the efficiency programs start? And I say they'll never stop I'll never stop because it's about capital allocation. And some things deserve -- give a good return on capital now. But in 3 years' time, there'll be something that we will do more and this can be made more efficient. So ROE, we're saving $700 million of costs after investment by the end of '27, and we're well on track to do that. So portfolio and $700 million of savings gives us a high degree of confidence we're going to hit the OP of 30%.

But I think your question, which have been asked more and more is, okay, but what is it going to go going forward.

So 2 things I'll say on that. Firstly, when I looked at top pharma, whatever that is, 10, 12 companies, their OP margin, not many were above 30%, which surprised me because they don't have an $8 billion generic business? So I was struggling to understand that. So firstly, we're up to 30% OP, I think based on our mix, that's an achievement. Where can it go? Well, obviously, can go higher, no question. What we need to manage and what we're thinking about as a team is, do we want to set a target on that? Do we go to give a line of sight? Because one of the questions I'm getting with investors is, we like what we've done with operating margin, but you have a really rich pipeline. Don't sacrifice the pipeline for short-term operating margin. And I understand that. And I think we're trying to work out how we manage that. At the same time, I've become somebody who realizes that you can't keep -- you don't want to offer a return to investors in the future because as I sort of say to myself, tomorrow never comes.

So you've got to give people return, I think, on a consistent basis, maybe more in the future ,but I think still some in the short and medium term, particularly with Teva to keep this belief and momentum. So operating margin will go up. We haven't given target. We're thinking about whether we need to do a new 2027 type of thing for '30, '31, '32. And we're still in that debate.

Yes. It seems like the story to me becomes more top line at some point as we go through that process. You mentioned the branded pipeline, and we're going to go through those specific assets in a minute. But broadly speaking, can you talk about the R&D capabilities of the company? Because I know that's one thing I get from investors is a little bit of skepticism about how does this company go from a generic company to having all these branded assets now. So can you talk a little bit as you look at that organization, you've grown that organization, the capabilities that are within?

A really good question. And I sort of remind people, which I've always believed is companies don't have capability, people have capability and people have to be in companies. And so when we were at Teva, I was working -- obviously work close with Eric Hughes, our Head of R&D, I can remember, literally February 2023, its Saturday and he showed me the pipeline and I'm like, how do we have a TL1A? How do we have -- it's what we do, but it's just not been prosecuted. And Eric, congratulations to him. He built a great capability of both in R&D. And so we had some great talent internally that hadn't been invested in and haven't been given resources. So we resourced that. And then we brought people in from the outside who we now have the capability.

So I think our R&D team is world-class because the people are world-class. Despite people saying, well, Teva, can you do innovative? I do remind people about COPAXONE and some other things Teva did, but I understand that muscle may be atrophied a bit, but we have very talented people. And so then the other thing I'd say is 2 things is all our antibodies come out of our R&D facility or research facility in Sydney. And I'd argue that our antibodies, and we'll talk more about this over the next probably 12 to 18 months, are by design the best antibodies.

And I know that seems an extraordinary statement, but I think we're seeing that with TL1A, duvakitug in the data. We'll see that with anti-IL15 in the data. We have a TSLP IL-13 coming into the clinic in Q1 which I think you'll start to see how cool that is. And then our PD-1 IL-2, which we will have data at the end of this year, which people say, well, everybody has done the PD-1 IL-2. It's not as simple as that. It's how you engineer it that creates the opportunity.

I don't know what the results will be, but I think that another one will show that our engineering capability, I would say, is probably the best of anybody because people don't spend time on engineering an antibody. They just find an antibody, make it, target something and get efficacy. We spend a lot of time saying what is the optimal way from a manufacturing yield, neutralizing antibodies, things that maybe seem a bit trivial, but longer term, I think, add real value.

And I know you talked about this a little bit, but on that balancing of investment that you have these capabilities, you've got a pipeline that's now maturing. I think one of the differences, I think, of those top 10 or 12 biopharma companies versus Teva is percent of revenue that goes into R&D. How do you think about that line item in the P&L trending over time? Is that something you can manage and you'll find resources? Or do we have to think about that as maybe offsetting some of this gross margin expansion over time?

In a way, it can be all of the above. But maybe I can tell you how we think about it, Teva. So we think about capital allocation as firstly, really, really seriously. So we didn't talk about resources. We don't think about talk about budget. We talk about capital. So if you get given capital, you have to give a return on the capital. Hence, the reason why our efficiency program has been so hard -- we've driven that so hard is because we think there are some things we do in the company that don't justify having capital because they are just -- they're relatively low value things. So let's not try to do them exceptionally well. It's just do them enough to help the company operate.

But when you think about it, it's interesting, what I said to us is you get capital when you can give a return on it. So right now, if you look at our investment in innovation, if you take into account the partnerships we have and financing with Royalty Pharma, et cetera, our percentage versus revenue is probably towards the higher end of the industry if you gross it up, right? But what I also say is I'm very happy, not that this would happen, but just to make my point, in a year that we spend nothing on R&D because if the assets don't deserve the capital, why would you give them capital?

And I say to Eric all the time, we only give -- apply capital to assets in our pipeline if we generally give a return. If we don't, there are no pet projects. And the joke we have is if he's not willing to invest his bonus in it, we're not going to invest our capital. But I think that's really important because I have been at companies where too much the budget is their budget every year.

And I don't believe that should be the case. I think we have a lot of exciting assets, these products in the pipeline. And that's challenged us to say, do we grow our OpEx base a lot and explain to people, well, maybe the 30% is hard to do. And we thought, well, no, we're not going to renege on our promises. And two, there's capital elsewhere that we can invest in. And doing the deals with Royalty Pharma, Blackstone, 2 things that appeal to me on that, which I didn't fully understand at the time. One is the way they validated the science was brutal. I mean that was like a colonoscopy.

So when they came going, your anti-IL-15 was great. That's good. It might have good due diligence. And they take some of the risk, which I think is a very sensible thing to do. Same with Blackstone, same with Abingworth. So we get validation, we get the capital. And now we can go across all of these indications at speed because another question you could ask me and probably will, is why aren't you diluting your return because you don't own it at all. So 2 things I did the analysis, and I realized most of the top 20, 30 drugs in the world have a royalty stream because they weren't invented in big pharma, which is another challenge to why R&D gets so much money if things are invented elsewhere.

The second thing is go back to my gross margin comment, we're at 55%. So if you give up 2% royalty or 3% royalty, it makes that difference. But the third thing I said to the team, I said, having 100% of a pie, piece of a pie that arrives late across less indications, if you do the analysis and have more indications, you arrive a year early, the difference is just gigantic.

So it's a no-brainer. So ours is the principle we have in R&D, we have a good asset. We move as fast as we possibly can or work out the finances later. But it's so hard to find good assets in my career to see a pipe like this. We're not going to mess around, get it to market as fast as possible, maximize it, and we'll manage the capital allocation on that journey.

Great. Maybe just pivoting into the branded portfolio. AUSTEDO obviously grown very nicely these last few years. The other questions we get is just how much more room is there for this one to continue to grow? So where are we in terms of -- I know it's -- you're pushing the doses higher, the penetration rate is still low. But just -- is this still a business that we can think about a lot of growth going forward?

We can, yes. And the fundamentals are, to your point is extraordinary. 85% of patients with tardive dyskinesia are still not treated. And so there's a huge opportunity to treat more patients. The other things that we've made real traction on is, firstly, we have introduced titration for patients so they can titrate easier. That helps them end up on a more efficacious dose, more sort of in line with the clinical trials. And we put together adherence and compliance programs.

And while we've heard about those many times throughout our career, the difference they make are meaningful. So a lot of patients still coming in, making sure those patients get on to the optimal milligrams, making sure they adhere to that and the compliance to that. You attack all of those, you can fundamentally keep driving this asset for many years, which is why I say greater than $3 billion peak sales is something that when I look at those elements is very achievable.

Yes. Competitive landscape, have you seen any changes at all as you think about your closest competitor here?

Look, it's a really competitive market. And so I think we know that there are 2 of us in it. It's very competitive. What I always say is -- it's about making sure we capture a good share of the patients coming in. We mobilize those patients to come in. We educate the physicians to identify tardive dyskinesia. And we keep doing that well. And I think because it's something untreated, then everybody can grow. It is competitive. But for us, that's about making sure we perform really well. We're good at operational excellence. We have the right levels of capital deployed to do that. But it's about execution on -- and I think we've shown since the start of Pivot to Growth, we have executed quarter-on-quarter very well, and that's a muscle that we're very good at, but we're not complacent. It's competitive, and so we've got to be mindful of that.

Can you just talk a little bit about 2026 results for this one? I know there's been some inventory dynamics. But just think about underlying growth. What's the trend been for AUSTEDO?

Yes. So to explain to people AUSTEDO, there's a bit puts and takes. So the channel filled up a bit at the end of last year Q4, which you try your best to control, but you cannot ship product, which we told everybody should flow out this year. It is slowly, slower than I would do if I manage that inventory. There you go. And so that's going to make the comparison of Q4 this year and Q4 last year will probably be down with another part of that is what's going to go back to wholesalers, knowing that we have the IRA '27 discount, one would like to think they have drawn down their stock even more so they then take stock at the new price. So those are the things that I think the things to think about AUSTEDO, that quarter 4 is an interesting quarter. We keep communicating that will be down.

Now your question is what is the in TRx and all those things. I think we're still showing that we're very competitive in TRx, very competitive on the milligram growth because that's important. If you look at all our quarterly earnings, the milligram growth is happening on-quarter, I think we're up 20% last quarter. And then adherence and compliance is improving. So all of those things I talked about are all heading in the right direction. And sometimes I say to the team, I say, how can we keep getting better on compliance and adherence? How can we start quicker? And I forget that you have to do this through all the specialty pharmacies, all the patients. And while you can hit some very effectively, there's still a big patient base that hasn't got all of those programs at an optimal level. So the good thing is I can see this having an impact for many years to come.

So your confidence overall of that $3 billion longer-term target seems.

Well, look, I mean, I think we've been talking for quite a few years. I don't put out targets without really having an ability to understand how we're going to deliver them. There's no hope in that. We've got a very structured execution on what is needed to make it happen. Is it hard? Yes. Do we tend to achieve our targets? Absolutely. So yes, I have a high degree of confidence.

Great. Maybe elsewhere in the branded portfolio, AJOVY has been another success story of the company. Can you just talk a little bit about what's enabled Teva to drive the growth here? I mean, I typically think about franchises like this that launch and maybe slow a bit, but had to reinflect you've clearly reinflected it. So what's enabled that? And another maybe similar question, like what's the path from here for AJOVY?

Yes. So AJOVY is a great example. I mean it's sort of a bit -- there's some similarities to AUSTEDO. So Teva, we had, when I came in, very few growth opportunities. And one thing we're really, really good at is prioritization. The prioritization when it's done really well, means you just don't do other things. It's a really brutal prioritization. So we said AUSTEDO has to hit $2.5 billion. There's no. Let's not debate it. If you're either on the bus, you're off the bus, but once we hear, let's make it happen.

And AJOVY said, well, this is in the twilight of its life. Well, don't see that. I looked at the market and said, no, there's more to come. And by the way, it has to do better. And if we're going to be good and innovative, we have to show we can do it across all 3 regions. So part of it is just saying, we have to do better and now let's build a plan to make sure we do better. We didn't allocate a lot more capital. We gave a lot more focus, a lot of different expectations, and we worked at what we have to do better. And so what has surprised me though, because to your point, you rarely reinvigorate a brand. We've not reinvigorated. We've accelerated it, and we continue to.

So now, which is extraordinary, we talk about AJOVY being a $1 billion brand. I think most people can put that. I think we even have to think about what is the long-term target for that because the growth rate you saw in Q2 was extraordinary across all regions. So -- but I think what to do that growth, we have to take market share. We have to grow above the market in every region. So we grow way above the market. I think the market grows at 6%. And as you saw, we're growing at 20% across all of us. So we're taking market share. And that's just excellent execution against some of the biggest pharma companies out there.

Excellent. Just shifting over the pipeline. olanzapine LAI, I know we're heading into a PDUFA. Can you just maybe just to start with framing the opportunity here for olanzapine. It's one that we're pretty excited about, but just maybe just to set the stage for the conversation.

Yes. So olanzapine is exciting. So olanzapine molecule is the most used molecule to treat schizophrenia patients. It's 20% of patients on olanzapine. Now olanzapine doesn't have a long-acting treatment that's used really. And obviously -- so you have 20% of the patients who have a severe schizophrenia and olanzapine is the treatment of choice, but compliance and adherence becomes key because if you have any lack of compliance, you then have a breakthrough and that can lead to a hospitalization, and it can be pretty devastating for the patient. So they need long-acting. And so when you think about the opportunity, the way to sort of maybe an analogy you can build is, well, in the non-olanzapine market, what happened?

So when long-actings were approved, 13% of patients moved across. So you could just say, well, if that is just replicated, 13% of olanzapine patients move to the long-acting olanzapine from Teva. That creates a pretty significant opportunity. You could argue people do challenge me, but more patients come to a long-acting olanzapine because of that need for compliance and adherence.

I say, yes, that could be the case. But if you just think about it being 13% and you think about what that looks like, that's where we get to the $1.5 billion to $2 billion franchise we just said in olanzapine. And although I get challenged sometimes, is that not enough? I said, well, if you plug that into your models, it's a game changer for us still. And if we do better, we're pretty transparent and coming back and saying, but it's still a challenging market from a Medicaid and Medicare. It's very managed very aggressively. So -- but I think we see a clear line of sight to that range.

Great. On that dynamic of the challenging payer environment here, how should we think about the launch curve for this one and getting access to the payers here?

Yes. So the most important thing is to create long-term value, right? So this is not about cutting a deal with particularly Medicaid at any cost. And I think just to let everybody know, we have not cut a deal with Medicare on UZEDY, and we're 3 years into a launch because the discounts they want, we do not think are -- reflect the value of the product. And so we have done our deals with Medicaid because you have to do Medicaid state by state. But Medicare, we haven't. And so that means physicians ask for UZEDY. And they get it because it's a schizophrenia patient and they explain why UZEDY is needed versus other long-acting.

So for olanzapine, to go back to the question, we want to get Medicaid covered as quickly as possible. That depends on the state. Some are day 1, some are within 3 months, some are 6 and some are 12. I think after 12 months, 85% of the market, Medicaid should have us listed, but it's almost -- we can't speed that up.

So the way to think about the launch is we're not going to have a significant amount of revenue -- we don't have revenue really this year. There'll be a bit of stocking in the first half of next year, not a lot because we're not trying to get access through Medicare, [indiscernible]. So it will be TRx, hospital formularies, sampling programs, how many physicians have used us, what is their breadth, what is their depth. That's what we're going to go after because that creates sustainable value.

And then you'll start to see the revenue kick in, in the second half of next year. And then we'll have the right value and access balance -- and then I do think at some point, I don't quite know when Medicare will come and say, with UZEDY and olanzapine, we should probably cut a deal because now you have such a scale. And then we'll probably have a sensible conversation, I hope. But that's the way to think about it. And I think what I encourage investors to look at is we'll be transparent. What is our TRx, what is our breadth? What is that -- so you can see the leading indicators because that's what I'm focused on. And then I think we've got, okay, I can see how this is going to create value. I don't want to chase the dollars to sacrifice value long term.

But we should -- in terms of revenue, though, we should think of a pretty modest revenue this year, but even first half of next year, just this year.

Absolutely.

Maybe just one other one that's on UZEDY. Can you just compare and contrast a little bit if we're trying to just think about that launch and how that progressed versus how you're envisioning olanzapine playing out?

Yes. So I'll be pretty I'll be pretty bold on this one. So olanzapine is going to launch so much better than UZEDY, right? Just a lot, lot better. That's how we've said it internally, and I've looked at the graphs and looked at everything we've done, and we're aligned in that as a team. And the reason we're aligned is because we have that UZEDY muscle.

So I can't -- we're in the offices of physicians every day. We're in the hospitals. We know the people on the D&T committee. We know the nurse practitioners. We know the long-term care institutions. We know where everybody is. So we need to maximize that, and we are going to maximize that. So the launch curve will be very different, and it will be a better launch than UZEDY.

And the other end of the story, I look at J&J and the franchise they have in long-acting atypicals. Why can't this be a much bigger franchise for Teva than $1.5 billion to $2 billion?

I'd say, look, without say that you can't, it could be. But there's a lot of work we have to do to make that even possible. The way that it has changed, though, is when those product launched, there was no management of schizophrenia patients, literally none. Every schizophrenia patient got when they needed, and so there was no managed care. The world is very, very, very different now. And so I think that's one and how that is managed. So -- but look, I don't want to say things -- could it be bigger? It absolutely could. I want to get through the first 18 months and then probably we'll have that conversation. But I remind people, if we still tap out in this $1.5 billion to $2 billion, at the margins we've got, that's a game changer for Teva.

I got asked last week, and you may even ask me, so I'll get ahead of it. Celiac, $1 billion, that seems a bit modest with the amount of people who have celiac disease. And they go, well, look, I haven't really gone into the details of forecasting celiac. But if it's $1 billion, it's another game changer for us, right? And so it goes back to that gross margin at the start we talked about when you keep layering on high-margin products, should olanzapine and UZEDY be bigger than $2 billion? Could be. But from a value creation, let's cross that vision a few years because we're going to create so much value in the short term on those, if you want to call them.

Conservative targets.

Measured targets.

There we go. There we go. You've got another launch next year with Tourette's as well. Talk a little bit -- this is the first kind of acquisition we had seen Teva do in some time. What attracted you to this asset? And how you think about the landscape you're entering there?

Yes. So this is I'm super excited about this asset. One, because you can get emotionally attached to things. And as a father, 3 children, when I learn about Tourette's and I learned that it impacts many people in the development phase of their life, it is huge, and it's really, really quite sad. I mean it's devastating for patients -- for the child as well as the parents.

And so when you see the efficacy of this product, you think this is something you can really transform. And when I look at what treatment is currently there, first, it's obviously psychotherapy, then it's off-label use of a product, which doesn't really have efficacy. And then you go on to actually schizophrenic products, which do have long-term side effects. If you have a child, as a parent, I don't want to put my child on a schizophrenia product. I know it's going to have some long-term effects because it has some modest efficacy in Tourette's. So I think we have this untapped market.

So while I'm excited, firstly, that's sort of almost impact we can have on people's lives. The second thing is there's 100,000 children who suffer from Tourette's, 50% -- 50,000 on therapy. Of those, only, I think, 20% to 30% stay on therapy after a year. That tells you everything about both the efficacy and the tolerability. And then when I think about what we've done in AUSTEDO, what we've done in UZEDY, where we've attracted patients back into the office, we've educated physicians. We've educated caregivers with Tourette's. That's a playbook we can apply exactly to ecopipam. And I have to say this is a patient community that has no support because those indications in the psychiatric drug were add-ons way later. And it's such a small patient population that really looked after them.

When we went to the Physician and Patient Association meeting, the excitement about a treatment designed for them, not an added indication later for them with a company dedicated to CNS and neurology was palpable. So I feel this could be an amazing opportunity to transform lives and a great revenue driver for us over the forthcoming years.

The payer environment for this one, anything unique about this we should be watching?

That's a good question. Look, I think there's an opportunity here to get the right value on this product. We want to think carefully about that. So we're doing a lot of work now because obviously, this can launch in Q1 next year. But it is a pediatric orphan and you can think about the opportunity that you can have a price that is associated with the pediatric and an orphan. So I think -- but once again, go back to what I said on olanzi, we want to make sure we have the right access and the right value. This isn't all about access. This isn't all about value.

It's that balance. And we've done that well on AJOVY. We've done that well on UZEDY, and we've done that well on AUSTEDO in a very competitive. So we're applying that same skill set to this. But yes, it is a different pricing than probably we're used to.

Yes. On the TL1A, you've mentioned a few times, I'm just watching this immunology landscape and it's evolving quickly with lots of different modalities and great for patients in terms of improving standard of care. When you think about that asset, maybe talk about how you think about it competitively versus other TL1As and then maybe more holistically with where this fits into the IBD landscape overall?

Yes. Well, I think firstly, for people new to the story, our TL1A is better than everybody else's, which is what people in my position tend to say. But the reason why it goes back to what I said right at the start, our antibody engineering team in Sydney, this is our fourth TL1A. I remind people of that. And the other 3 were good, but we kept work on making it better. So we know we have more potency, better specificity, neutralizing antibody. We know all the things we have better because, by the way, we made the other antibodies. And so we know what they did. So we know we have the better one. The Phase II, I think, showed that. Now you can't cost compare, I know, but I think most people saw and said, it looks like you are the better one.

So I think we're better by design. not by luck. And so I think in the TL1A field, that will give us a competitive advantage. I think TL1As will play out very well because they're very safe and well tolerated. And people forget in IBD, it's a nasty condition, you see in CD. But there are a lot of products which either have black box warnings or have to have some safety monitoring. I think, Eric, I heard there's like 7,000, 8,000 patients are treated with the TL1A. And it's a very well tolerated and safe antibody. So I think we have that. So I think TL1A will be used because it's an efficacy and its safety and tolerability higher after treatment dynamic.

And I think that's something which people aren't fully appreciating because physicians want to use things that are efficacious and can be tolerated. You can be on them a long time, combine that with low neutralizing antibodies. So I think TL1As will be used a lot. I'd like to think that we'll be the most used TL1A because we're the best TL1A.

Absolutely. On the topic of combination therapy, it seems to be kind of an emerging theme. How does Teva think about combos? It seems like given the safety of the drug, it could be a great combination kind of candidate, I guess?

Yes. It's interesting, Eric, my Head of R&D, keeps educating me on this. He says, first, you got to get a drug to work. And if you have a drug that works really well, that is amazing. And the fact that people are moving about a combination bispecific, trispecific. One is that when you have a safe efficacious, anything you add to it, if it the assumption is it makes it more efficacious and doesn't touch the safety and tolerability, which is a bit sort of hopeful. And then what does it give on efficacy that it damages the other side of the equation.

So I think, firstly, a lot has to play out over many years. And the other thing that I have been educated on is every bispecific is different. And so I go back to our PD-1 IL-2. So when I started talking about that 3 years ago, we said PD-1 IL-2 been tried that don't work or not good enough. And what I realized is people literally take a PD-1 and IL-2 and put them in a syringe, and that's a combination. That's bispecific. And then you can engineer them together, and that's the same as everybody else's. But then we know how you engineer them together. is important. So going back to TL1A. Look, we have bispecifics in our pipeline. We have trispecifics in our pipeline. We have many things. We don't talk about them because what we're looking to understand is, does it improve the benefit risk profile and what is the need?

And let's see how TL1A comes out in these conditions. If it gives a really good level of efficacy, one could argue, do you really want to tackle with that. But we're open to it, but I think that has a long way to play out. And the thing I'll pitch is we're about to move into the clinic our TSLP IL-13. Now I think people say, well, other people have TSLP IL-13. And I'll say, wait until you see the engineering on our TSLP IL-13 is extraordinary. And I think what people are going to understand is the enhanced engineering we have at Teva means people need to start looking at the capability of that engineering and how that differentiates a single asset or a bispecific or trispecific and it can be very, very different.

In the last couple of minutes here, maybe we'll talk about the generic business for a few minutes here. I know a lot of moving pieces this year with Revlimid and some of the headwinds there. Just talk a bit about the growth you envision for the generics and how we maybe bridge from what we're seeing in the business today versus the longer-term outlook for that franchise?

Yes. So I always find it 4 minutes left of 45, we get to generics 3.5 years ago.

It was a transition of the business.

Yes, exactly. The questions, I suppose, are really -- and by the way, it's right. There should be that all it's about value creation and what the business is doing. That said, our generics business, I first remind people, it was declining before 2023. And then we grew it. And that is a phenomenal turnaround. And we did that through executing better on both our pipeline, bringing things to market more often on time and being in the first wave that creates value. We improved our manufacturing and our supply chain because we weren't supplying all that we could. We did that. And then our commercial model, we were more disciplined in how we actually price our assets in the market.

So we did those. And that's a muscle we keep building on. Now I've always said our CAGR going forward is 1% to 2%. That's partly because I wanted to just model it on that and it's not down, it's not up. It is what it is. It does -- it throws off a good amount of cash. It really helps us give scale and manufacturing, that gives us presence around the world to maximize our innovative, does a lot of good things. The reality is we've done a lot of great work on our portfolio, and we've now got 15 biosimilars in the market.

And when we started the conversation, I think we had 3 or something 4. We have another 14 in the pipeline, and we're going to add to that at real pace. What that does is it changes the makeup of our generics portfolio. It moves it into a more heavy biosimilar, which biosimilars traditionally have a more stable revenue. They have a better gross margin, so more predictability.

And so I think maybe the generics questions when we next sit down will be, can you help us understand, is it really 1% or 2% growth and maybe it could be more. But for us, it's about changing our portfolio, changing the manufacturing, changing our supply chain. We've done a lot of good work there. So I do see that as being more of a growth driver going forward, which is helpful and important, still outweighed by the innovative, but we have made some good progress.

And maybe last question, other one has changed quite a bit the last few years. How do you think about deploying capital from here? I know the first few years as CEO, I know there was a lot of debt paydown on the other side of that. How do we balance of more tuck-in acquisitions like we've seen versus the dividend versus repo? How are you balancing all those?

Yes. So I mean, look, I think it's interesting once again, the last question is on debt. You see the first question. But what I think what we've done on debt and go back to your question on R&D investments and how we do this, I hope people take away is we are really focused on capital deployment. We've got to pay down debt, but we've got to keep investment grade like drivers. It's not -- let us pay down debt, then we'll do this. We have to do both. We have to be dynamic. And we've done that.

And we've got investment grade across all 3 rating agencies, a year ahead of when we said we'd go to. So I think that's a real testament to not only pay down the debt, but how they see where we're heading. what we always said there are 4 things we're going to do, pay down debt, invest in our growth drivers, AUSTEDO, the launches, invest in our pipeline, do BD and then return capital to shareholders. Now the #1 is gone because we paid down our debt.

So we're left with the other 3. And those are still relevant. We've got a lot of products to launch. We have to do that. We've got a pipeline to feed. We are going to do more BD. We're actively looking all the time.

But as you saw with Emalex and you probably saw with BioXcel, we have a view on what we should pay for things. And because we have a good pipeline, we're disciplined and a lot of things we don't get to the price that sellers want, and so we walk away. It goes back to our discipline on capital allocation. And then on the fourth point, we will return capital to shareholders. But on that, just to measure manage expectations, we don't see the dividend being a good allocation of capital because we have too many growth drivers. And I think that's where we need to invest. And then on buybacks, we think about I don't think about this as a yearly, we do that. We think about when we think the stock -- if we buy the stock, it will give a return on that acquisition of that stock. And we think about it that way.

So it will be when we see that happening and because I think at the end of the day, we have to give a good return on capital. And as long as it does that, then if we do that, then I think we're going to create value return for the shareholders as well. So that's how we think about it...

Excellent. Well, think about it. Thank you for joining us today.

Thanks, Chris. Appreciate it.

Thank you.

Good morning, everyone. Thank you for joining this session of the Morgan Stanley Global Healthcare Conference. For those of you who don't know me, I'm [ Theresa Capilla ], European pharma research analyst here at Morgan Stanley, and I'm joined by my colleague, Adithya Venkat at MS.

And I'm very pleased to have Richard Francis and Eric Hughes here today, the CEO and Head of R&D of Teva. But thank you very much for joining us.

Thank you for having us.

So before we get started, please note that this presentation is for Morgan Stanley institutional clients and employees.

For all important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your MS sales rep.

And I apologize for how many times I'm going to say that over the next 30 days. So perhaps we get started, Richard, before we go into detail, perhaps you could start with introductory comments as to where we are in the Teva story today, progress on the Pivot to Growth strategy and the outlook from here.

Okay. I'll try and be brief because I could spend the whole time talking about that. So where we are in the story, to answer that first part of the question.

So Pivot to Growth, we started in 2023. It was a 3-part plan: return to growth, accelerate growth and maintain growth. So we're in the second chapter or phase, you could say. So I would say there's a lot more to come, and we'll be explaining why there's a lot more to come.

But I think over this period of time, what we've shown is we've started with the ambition of transforming Teva from a pure-play generics company into a world-leading biopharma company. And very quickly, over 3.5 years, that has become something which seems slightly unbelievable in 2023 to something that is very believable now just because if you look at the products we have, the pipeline we have, the momentum we have, then we clearly are executing well on that ambition.

Now the Pivot to Growth strategy, and I see many familiar faces in the audience here, so you're used to me being quite boring about this. But I think the repetition is why we've done it well. Pivot to Growth is based on 4 pillars: deliver on our growth engines, step up innovation, create generics powerhouse and focus the business, focus capital. We've been executing this seamlessly for the last 3.5 years.

It will be executed seamlessly going forward for the next, I'd say, 7 at least because we have a clear idea of how we can create shareholder value, how we can continue to grow the top line and the bottom line. And a lot of that comes from the fact that we've taken some innovative products, AJOVY, AUSTEDO and UZEDY and accelerated them and made people start to model them in a way that they would have modeled them before in their calculations.

And that's because we are really, really good at commercializing products. And with step-up innovation, which I'm sure Eric will get a lot of questions on, and you should rightly so, we've taken a company that was questioned whether you could develop innovative products and move them into the clinic and then move them through the clinic.

And I think we've done that. And I think in most metrics, we are upper quartile. So that means that the first pillar is we can sell stuff. And the second pillar, we're developing stuff very quickly, and I think some really unique assets, and we'll talk about the readouts we have this year. And clearly, those 2 show a lot of potential to create a lot of growth on the top and the bottom line going forward.

And then on the third pillar, we've gone from a declining generics business to one that's now stabilized and over the last year has accelerated or grown, and we add more and more biosimilars to that.

And then finally, let me take you 2 minutes is we've returned to capital allocation from a deal-making perspective. And so we've obviously done that with our first deal with Emalex, which I think we've seen as being strategically aligned to what we said we're going to do, be in the CNS space. It's very synergistic.

I think we're going to be able to turn that asset into an asset [indiscernible] are going to fulfill those financial requirements that I've laid out. And then because my CFO is looking at me now, I must mention the fact that we've done 2 other things, which is actually today is a big day for us. So we've taken ADS shares and converted those to ordinary shares.

So those will be -- will allow more investors to have access to the Teva opportunity, which I think is still significant going forward. And then the final thing, which I think relates to something which we never talk about anymore, which we did talk about a little bit at the start of my tenure, which is debt.

So there's a good thing about debt. Our debt has gone down considerably. And because we've become investment grade now across all 3 rating agencies, over a year ahead of when we said we were going to do that, we did a refinancing last week where we were hugely oversubscribed.

And I think we got that financing done in a very short period of time at a very good price. And that reflects, once again, all the other things I've said because obviously, that's looked at very closely. So congratulations to the team who did that last week. So there's a lot within that. I'm sure we can go deeper, but maybe the fact there's a lot within it is why I am so convinced that the value creation story that we've started has a long way to run with Teva.

And before we get into the innovative portfolio in more detail, perhaps if we just touch on tariffs. So President Trump has proposed 100% tariffs on imported generics from August 2028, rising to 200% a year later.

So since Q2, you announced some agreements with the administration around U.S. manufacturing. So how has that changed how you think about the tariff exposure? And could Teva's existing U.S. footprint ultimately become somewhat of a competitive advantage?

So obviously, the interesting thing is a very dynamic world we live in geopolitically in most areas actually. And I think what Teva has shown is that we have a real capability to maneuver within that world.

But to your specific point on tariff, yes, we have -- I think we have the largest generic manufacturing footprint in the United States. I think that gives us an advantage on that one level. But I also think we've shown with our work with the administration, both through things we've done with HHS and IRA as well as the potential deal we're going to close with the administration that you saw at the White House a couple of weeks ago that I think we have the ability to work well with this administration because we're a unique company.

We bring, I think it's close to $40 billion of savings to the U.S. every year, as well as the fact that we bring innovative. So I think our seat at the table gives us a significant share of voice.

But is it a competitive advantage? As we work together, you will find I am more measured. I don't lean into things too much. Let's see how it plays out. I think we're in a strong position right now. But I would also say that the changing dynamics of our portfolio, particularly around biosimilars, probably lends itself to also helping us in that more challenging environment.

Very clear. So perhaps we start on AUSTEDO and the 2027 outlook. So to my understanding, Teva continues to target $2.5 billion of AUSTEDO sales next year, which is roughly in line with the midpoint of your revised guide.

So how should we think about volume growth next year to offset pricing headwinds? And how much could volume provide a tailwind versus your guidance?

So I think everybody is trying to sort of get me, and I can understand why, to sort of give guidance for 2027 on AUSTEDO, but I did give guidance for 2023 on AUSTEDO. So I gave it really ahead of schedule at $2.5 billion.

Look, the way I think about it, the first way I want people to always think about how I answer this question, I answered this question with $3 billion. This product will do over $3 billion, and that's the most important thing to be thinking about. What it does in '27 is just a journey on that road to $3 billion, okay, greater than $3 billion. What will it be? Well, obviously, we've seen good momentum this year with AUSTEDO.

The team in the U.S. is doing a great job. Where we will be next year with AUSTEDO, we will give guidance on that. I think I'd remind everybody that the untreated population tragically is still really, really high when it comes to tardive dyskinesia.

Our performance, our capability to capture patients, to get them onto therapy, to have them on the optimal dose, as well as to make sure they adhere and stay compliant, is improving all the time. That is why I feel so confident about getting over $3 billion. So when it comes to 2027, we'll talk closer when I have more data from Q3 and Q4 and talk to you about where I think the volume is going to come from, where I think we're going to end up from a revenue point of view.

But I would remind everybody that it looks like now where we are with our guidance at the midpoint, we're going to hit our $2.5 billion a year early. We hit our $2.5 billion AUSTEDO a year early. We have investment grade across all 3 rating agencies a year early. There's a lot of things that we do that people didn't think we could do, and we do them earlier.

When it comes to the Phase III studies on many of our assets, we put them through the clinic, or Eric has, a lot quicker. So that's maybe how I'd answer AUSTEDO, a lot more opportunity, think of it as $3 billion plus, and then work back from there.

Understood. And perhaps we can touch on competition for AUSTEDO, too. So Neurocrine has stepped up investment behind INGREZZA and says it's capturing the majority of new patient starts. So are you seeing any changes in AUSTEDO new start trends or prescribing behavior, and any changes in the competitive landscape?

Look, it's a very competitive area, particularly as our competition relies on the asset so heavily. So it's very competitive. We recognize that. I think what we've shown throughout this 3.5 years of really just driving AUSTEDO on a different trajectory than anybody could have foreseen is we're very good at execution. We're very good about our capital allocation, what we need to spend versus what others spend, to make sure we get the right return on that, and we're focusing on that.

And I think we've shown that we can perform very competitively within that market. And I don't really get into too much more detail about that. I used to sell pharmaceuticals, and I was always told, "Don't talk about the competition." So I'm standing [ pat ] with that.

We stand by what we said we're going to do on guidance, and I go back to we're going to do more than $3 billion. It is competitive. We don't ignore that. And we're very thoughtful about how we allocate resources, but also how we elevate our performance and our execution, because I think the team can execute better every year with the resources they have or with even extra resources.

Perhaps we could move to AJOVY, which has been a bright spot. It continues to outgrow the injectable CGRP market and take share, and guidance has already been raised this year.

So as oral [indiscernible] CGRPs continue to take share. How sustainable is the outperformance? And how important do you think the quarterly dosing is? And maybe you can touch on exceeding the $1 billion target?

So for AJOVY, yes, so isn't this extraordinary that we're sat here talking about AJOVY reaching $1 billion. And 2.5 years ago, we weren't talking about AJOVY doing anything.

And I say that because I think it goes back to a lot of things we do at Teva, which has been incredibly focused, incredibly operationally driven when it comes to performance.

And we saw that we had an asset in AJOVY that was underperforming that could perform better. But to perform better, it needed to capture market share and outperform the market and outperform competitors who are some 3 big competitors. And we had to do that across every one of our regions.

Now it has surprised me how well we've done, if I'm really honest, because at the same time we're driving AUSTEDO, we launched UZEDY. So to do this consistently well across all of our regions, I think just shows the capability that we have geographically, but in a hugely competitive, not just in the injectable competition, but as you highlighted, the oral. How far can it go?

Look, the ambition we always have was we'll grow ahead of market. And we are growing way ahead of market right now. How long we keep that going? We'll see. I think we're going to have to start to give new guidance on AJOVY again because we seem to be catching up to the $1 billion very quickly.

And so we'll probably do that to let people understand where that could go, and they can model that. But I'd take it back to Teva can sell innovative products really, really, really well because we're really focused. We're very performance-focused.

Because of that, all of our assets, whether AJOVY, UZEDY or AUSTEDO perform -- outperform in their particular segment.

Perfect. Let's switch to UZEDY. So it's performed very strongly in the U.S., as you've highlighted. But what is the latest sort of play with ex-U.S. launches? How should we think about the international opportunity for UZEDY? And when should we expect an update?

Yes. So I think UZEDY, I think, another great example of Teva going into a super competitive market, genericize some big brands in there. How can you actually do well in that? I think 2 things is great product developed by Eric and his team, which meets medical unmet need significantly from the ability to be subcu, get to therapeutic doses within 8 to 24 hours.

And you don't have to have any concomitant adjunctive therapy at the same time, so you can be released from the hospital and institution, but still competitive. And now people are talking about modeling this in a very different way. Can it go to Europe? That's a more of a challenging one because of pricing and where we get the pricing.

I think that probably leads on to olanzapine, which you're probably going to ask me about anyway. But olanzapine, we see as definite opportunity to have a European launch. But once again, we've got to be very selective because 2 things is we want to make sure it's been appreciated for the value it brings.

And also, we want to make sure that ties in with some of the political questions you asked me earlier about MFN and how do we manage that. But I think we have a -- we're pretty confident we have a path to launch olanzapine in the rest of world. UZEDY, we never built it into our forecast. So it was never baked in. And I think that's the right thing to do.

But cumulatively, those 2 will do $1.5 billion to $2 billion. And now I think I'm getting a few questions on whether that is the right number, should it be higher? But let us launch olanzapine, let us get that to the market and let us keep driving UZEDY, and then we can talk about whether we should change that.

You did preempt my next question, which was on olanzapine and the launch. So how should we think about the launch dynamics? You previously mentioned no meaningful revenues in Q4 '26, first half of '27. Consensus is modeling roughly $210 million next year. So how comfortable are you with that? And what do you see as the biggest determinants of uptake in year 1?

Yes. So maybe in reverse order. I'm not going to comment on the $200 million.

[ Oh, okay ].

Because, yes, I've got to stay true to that. We'll talk about that when we give guidance. How do I think about that? How confident that I feel about this? Despite my measured approach on many things, I'm super excited by olanzapine. Why? Because of UZEDY. To take UZEDY into the market that was so congested, to have such a strong performance in where the competition, the share of voice, the pricing dynamics, the access dynamics was so tough, and to do so well.

And we'll talk about some of the metrics on that. We are the leading LAI now in risperidone. We have doubled that market in the time we've been there. So when you take olanzapine, which -- so we've got all that muscle we've built up. So we have that capability. We have that institutional knowledge.

We have -- we know the physicians, the patients, the payers, the nurse practitioners.

We know where everybody is. We have a very, very good commercial team, a very good MSL team. We put olanzapine into their hands, which is far more straightforward. There is no real competition. The unmet need is huge because people want to be more compliant. So my ambition is that we have a really good uptake. Now to revenue, what does that mean? In Q4, I want people to start sampling it. I want to make sure we get access on to hospital formularies as quick as we can.

And that's how we should measure sort of Q4, Q1, Q2. The rate-limiting step is Medicaid. We have to get Medicaid, and that's state by state, as many people know. Some will get at the start, some will get after 6 months, 9, 12.

I think after 12 months, we have about 85% of the market with Medicaid, but that is a rate-limiting step. The way to think about it is TRx, the sampling.

And so I think we'll be able to communicate really early on how well we're doing. But I'm not going to hedge on this. We want that curve to be a curve that really takes off. But we will not be getting that access with Medicare because we think that will require us to give discounts that we don't think are appropriate for the value the product brings.

And so it will be Medicaid, and we'll have to work slowly and hard on Medicare. I think in time, maybe the year after with UZEDY and olanzapine together, that will create enough size that Medicare would want to do a more rational deal. So those are things to consider, but very, very excited. Very excited about the product and the offering for these patients.

By the way, with UZEDY and olanzapine, we'll cover mild to moderate to severe. So about 85% of the schizophrenia population. And we're in those centers all the time right now. And I can tell you the enthusiasm for UZEDY is high, but the enthusiasm for olanzapine is definitely palpable.

And staying with the franchise before I turn to Adi to talk on generics. Consensus for your combined UZEDY and olanzapine at peak is kind of at the top end of your guide of $1.5 billion to $2 billion.

And given some of the comments that you've made around higher oral olanzapine use, long-acting penetration potentially in Europe, how should we think about the pushes and pulls on that target, particularly what drives upside?

Yes. Look, I think a lot of this comes down to -- look, there's reasons those people, very smart people, are thinking about this could be at the higher end because olanzapine needs a long-acting, needs a severe patients.

So the reason that you could argue that the LAI market right now is about 13% to 14%. Olanzapine should probably be higher than that. But we'll have to see how that plays out. It's also about making sure that at some point, we do get access through Medicare because that will open up a lot more.

And in Europe, we do target getting in a number of countries, but at the right price. So I think there's reasons to believe we could be at the higher end. I'd like to take it step by step. And then we build the P&L, we build our future financial modeling on what we think is going to happen, so we know what we can spend.

As that changes, we can adapt that. But I'm not going to [ lie ], there's reason to be optimistic. I just want to maybe get a first year under my belt before we can start to talk about changing numbers.

Perfect, Adi?

Richard, Eric, thanks a lot for your time. So probably pivoting towards generics. So in terms of outlook this year, ex Revlimid, you're obviously expecting it to be down flat to low single digits.

So there's obviously reflecting fewer high-value launches, softer OTC and increased competition there. So in terms of the moving parts, what changes get you back to that 1% to 2% longer-term growth aspiration for the entire generics franchise?

Yes. Thanks for the question. So it's actually pretty simple. It's based on portfolio and our portfolio is changing pretty quickly in generics.

So if you think about it, the last 3 years, we've performed, I think as a generics business, from a decline in it for 5 years to a growth, the 3-year CAGR growth. And we've done that through improving our number of launches, improving our manufacturing, and making sure our supply is good, and improving our go-to-market model and executing.

The big change that's coming up is our portfolio is changing because we're having more and more biosimilars. I think we are, I think, probably pretty much every asset we have. I think we're one of the best-performing biosimilar companies in the United States.

I think you can see that with SIMLANDI. You can see that with Epysqli, some other products we have. So our portfolio is changing. And the reason why that's exciting is because we've had our performance in generics, which I think has been really, really solid without having that.

Now we're starting to add biosimilars to it. The U.S. is doing one. We're now starting to add more and more to Europe, and that's going to keep accelerating. And so we have -- I think we have 11 in the market now. And I think between now and the end of the decade, we're going to be adding roughly another 9 and with more partnerships coming on.

So we have about 29 in our portfolio now, 26-29.

So that's the big change. And that's why I do think the outlook probably could be a bit more optimistic. But once again, I want to get things done. I want to execute on the biosimilars in Europe. I want to keep the trend going in the U.S. But the portfolio change is significant, and I don't think that should be underestimated.

And probably just sticking on the biosimilars, as you mentioned there. So you're well on track to exceeding $800 million in 2027 and another 14 biosimilars, as you mentioned, coming along to market.

So in terms of your different state of play within Europe where penetration is just starting to pick up and your uptake in the U.S. has probably been a lot more modest in aspect. Where is the biggest upside coming from in terms of the biosimilars opportunity today? And what particular pipeline assets through towards 2030 should investors be focusing on there?

Yes. So it's interesting. So I think, firstly, the fact that we're not in Europe. So as we go into Europe, as you highlighted, it's relatively straightforward.

I mean, there are different market archetypes. So some are contracted, some actually have to go to the hospitals. But we know that.

I mean we're -- outside biosimilars, we're pretty much #1 in most markets. So we know how to do that. We know how to go through the channel. So as we get a biosimilar, we tend to -- we've already seen this year, we tend to be the best at launching.

And even when we don't launch first, we often end up #1. The U.S. actually, I think you've maybe scored us down a little bit. I think in the U.S., we are performing really well, even when we come to the market late.

And that's because it's a super complex market in the U.S., but Teva operates in every aspect of the generic biosimilar market, like every aspect, at a national level, at a regional level. And because of that, I think that capability has allowed us to execute far better in our biosimilars than most other people.

And I think, don't forget, we said we're going to do $800 million by the end of '27, it's '26. That's another one we've done a year early.

And by the way, at the time, that was seen as ambitious. So I'm excited by both because I think our -- the muscle we had to apply to biosimilars, we just didn't have the biosimilars. Now we're getting them. I think you see the Teva generics muscle being applied to those.

So I'm super excited about the U.S. biosimilar market. I know other people are struggling. We're not. We see opportunity in that complexity. And in Europe, I think we can build on the capability and just the scale we have there.

Very clear.

Shall we switch on to, sorry, onto the pipeline. So do you want to get time in [ for Eric ] . I know Eric's been sat here patiently.

So maybe we can switch to duvakitug in UC and Crohn's.

So in June, Merck reported positive data, as I'm sure you know, but did not describe the benefit as clinically meaningful. And the recently published Phase II RELIEVE data for duvakitug looked competitive across induction and maintenance.

So how should we think about duvakitug versus the competitors in UC and Crohn's and perhaps talk on the time lines to market?

Yes. So thanks for the question. And it starts with the science for me. For duvakitug, we have shown, in our own hands comparing molecules, that we have the most potent molecule. We have the most selective molecule when it comes to the decoy receptor, and we have the lowest antidrug antibodies that we've reported out compared to others that have been reported.

So the fundamentals were there. Then we ran a fantastic Phase II program for both ulcerative colitis and Crohn's disease. And again, we reported the highest numbers for this class out there right now. So it's been a great execution. And then finally, we had the maintenance data this year. That was our first milestone for 2026. And that, again, showed maintenance that was competitive across the landscape of ulcerative colitis and Crohn's disease. So right now, our data is very good. We've executed rapidly, and we're working very closely with Sanofi to run our Phase III program.

So it's a very competitive molecule. I think that we've shown that we can accelerate things very quickly and be in the race. So when you think about time lines for ulcerative colitis, first for that one, we're within an 18-month window, we believe, when it comes to our competition.

So that shouldn't impact it. What will impact it is what the data looks like at the end of the day. So data is really king. The efficacy is king. When it comes to Crohn's disease, we're actually right -- I'd say we're right in the middle of the pack.

In fact, we have probably the best Phase II data when it comes to the execution and the dose response that we saw. So I'm very excited by the program. I think that it's a molecule that can stand on its own 2 legs.

Perfect. And with UC and potentially Crohn's moving more towards a combination market, which some of your competitors are pursuing, how should we think about long-term UC Crohn's combination? And does Teva plan to initiate or pursue a combination strategy?

Yes. So combination is something I've done my entire career thinking about how to increase the efficacy while maintaining the safety.

So there's a long way to go at this point. Right now, we're really focused on making sure the monotherapy lives up to its potential. You have to remember this class of molecules is a totally new class. It's blocking a cytokine that's an amplifier of many different pathways and even might have a direct impact on fibrosis.

So monotherapy has an incredible runway right now for discovery and to see what the efficacy is. Having said that, we do a great job in our Sydney lab in Australia when it comes to antibody engineering, protein engineering.

Bispecifics are something we are focused on. And since we're one of the innovators in TL1A, I think that TL1A is a great example of what could become a backbone for potential future therapies. But again, we have to make sure that, that great safety profile of TL1A is maintained that we'll discover that through these programs that are in development right now. But I think that's just going to be an upside in the future.

Very clear. And Teva, Sanofi have initiated TL1A trials in HS. To my understanding, other competitors have also posted positive data here. So how should we think about TL1A biology in HS? Is this -- or does this have potential to be a first-line drug? Or would you see it more second-line refractory?

So HS or hidradenitis suppurativa, which I practiced quite a lot over the years, is a fascinating area of discovery right now.

HS is a pretty devastating disease in fact, it really impacts your quality of life. And it's highly underappreciated. It's about 1% of the population. And it really can be -- it's painful, it's disfiguring. It can be socially isolating to have HS.

And we have a long way to go when it comes to the efficacy in it. There are a couple of biologics that are approved today, and there's a lot of small molecules as well in development. But this indication has a long way to go. It's going to be a market that grows over the years.

Now when you think about TL1A for HS, I'm very excited by it. It fits a lot of our criteria, scientific rationale, speed, regulatory possibility of success, and market potential. But specifically for TL1A, HS is an inflammatory disease that has many different cytokine pathways in it, Th1, Th17, that includes 23s, 17s, and TNFs, and also that has a big fibrotic component to it, too.

So what better MOA would be than TL1A, which impacts multiple cytokines and covers many of those things. So those programs out there that are hitting specific targets can be effective. But I'm excited to be doing a study to show that the pleiotropic aspects of TL1A can really actually add benefit.

Perfect. And perhaps we can switch to ecopipam. The NDA was filed in June with potential launch in the first half of '27. If we can touch on the Phase III D1AMOND data, how should we think about the absolute efficacy versus D2 antipsychotics, particularly if ecopipam ultimately moves earlier line? And I think you've referenced 2 additional indications beyond Tourette. Perhaps you could touch on where you think the biology suits that.

Yes. To start off, we've done the submission in June, and now we've announced that we received priority review.

So that was a really exciting addition to the news flow when it comes to ecopipam. Now, when it comes to what the value of ecopipam is, this is a brand-new first-in-class molecule for a D1 antagonist. So comparing that to D2s, it's a very different world.

The D2 antagonists like Haldol or Abilify, they are hitting D2s that create a lot of side effect profiles, metabolic, weight gain or -- and other aspects of actual movement disorder. So when you're thinking about someone who has Tourette's disease, a child who has it, you can try behavioral modifications. You can try off-label uses of things that don't have tremendous efficacy.

But you can imagine if you're facing the choice of using D2, all these potentially irreversible aspects, that shows you the unmet medical need. So in contrast, in our studies where we've looked at this D1 antagonist, ecopipam, we've really shown that we don't see those side effect profiles.

So when you're looking for something that has a great treatment effect, something with a favorable safety profile is something people need. So to your point, what's the added benefit? We've shown that we had about a [ 30% ] effect compared to placebo.

So a good efficacy when you look at it right off the bat in Phase II. And then we also showed the durability of the response in the Phase III study where 50% reduction in relapse rate.

And those people, when we looked at them for another year, went on 66% of them stayed on the drug for a year. That's the real problem for D2 antagonist where 20% to 30% can only tolerate it for that long. So I think that we have something that we can really deliver that will help patients.

Perfect. And then, Richard, perhaps we could touch on M&A strategy moving forward post Emalex. What are the biggest gaps that Teva are looking to fill? And would it still be a neurology, immunology focus or will you broaden therapeutic areas?

Yes. I mean -- thanks for the question. I wouldn't say we have gaps. I think it's more -- can we put more fuel on the fire. And so -- but in a thoughtful way from capital allocation. So I think, obviously, CNS is key, and you saw that with Emalex, you see the opportunity to build on our capability.

You saw the potential deal with BioXcel and I think a thoughtful capital allocation, very synergistic if that happened. Immunology is a big opportunity we can build on. We do have respiratory as we're launching. We'll have the data on DARI end of this year, start of next year.

And so we'll be launching that probably in '28. And so that creates opportunity to maybe put products around that. And then we have announced that we want to do rare diseases because we think rare diseases is something that we could be very good at when it comes to executing on that. If they fit in those 2 TAs, that's great. If they fall out of it, we'll be okay also because we think that rare disease is about a capability and competency of supply chain reimbursement, white glove service, things like that, as opposed to the actual TA.

So that's how we think about it. But we don't have a desperate need to do anything because you heard about the pipeline. I mean we didn't touch upon anti-IL-15 with vitiligo and celiac disease. We may do that in the last couple of minutes, but that has another probably a few indications. Duvakitug has probably another 4 or 5 indications.

So I think our pipeline is attractive. I think what we think is we have really good momentum as we get capital, where can we allocate that to get a really good return on that capital. And I think it will still be nice, thoughtful in-licensing, maybe some small M&A if we think the right company comes up.

But we're in a position where we don't have to do anything. But I do think anything we can do to give to either Eric or to the commercial team, I would like to because they're so good at what they do.

And you somewhat preempted my last question. But perhaps you could help us understand or touch on what you think investors are missing about the Teva story? Or is there a particular asset or drug you think we should be focused on that we're not?

I'm really careful too. That's a very, quite provocative question too.

You can say sell-side analyst there. What am I missing, not investors?

Okay. Because I think some of the investors in the room here, and I thank them for being investors. For the ones who aren't, you have an opportunity now to maybe be investors.

But I think the sell-side analysts, I think -- look, I think Teva is unique, so that makes it a bit difficult to look at sometimes.

But I think what people are missing is we have got through some really, really, really tough years, and we did everything we said we're going to do financially and operationally, and we did it better than anybody thought. We're now moving into, I wouldn't say, easy years internally because we put a lot of pressure on ourselves to keep optimizing our opportunities.

But we have all these launches. We've got the muscle both in R&D. We've got the muscle in BD. We've got the muscle in commercial. And we're just going to keep building on that. So I would say the direction of travel from a return to shareholders is clear.

The debate is how much. But I think to have Teva in your portfolio is a great asset to have in your portfolio because I do think we have a clear path to keep growing shareholder value. And so I think what we may be missing is just how many innovative launches we have.

We have 5 launches in 5 years, all innovative. We don't count emrusolmin, which we don't talk about until we get the data because it's a high risk. But even with that, we've got five.

And then after that, we probably almost have a launch a year post-2030 because of the multiple indications duvakitug and IL-15. So we have a company that's growing tremendously fast, and we have multiple indications coming out. We're thoughtful about what assets we tuck in from an M&A point of view, BD.

So I'd like to think that maybe rather than missing anything is maybe to double down on the analysis and start to model it and realize actually, there is a good return here. Maybe just the question is how much.

Okay. Perfect. Thank you. Thank you, Richard. Thank you, Eric. Thank you to everyone in the room.

Thank you.

Hello, everyone, and thank you for joining us today for the IL-15 Celiac Disease Phase 2a Topline Results Conference Call. My name is Sami, and I'll be coordinating your call today. [Operator Instructions] I'll now hand over to your host, Christopher Stevo, Head of IR, to begin. Please go ahead, Christopher.

Thanks, Sami. Good morning, and good afternoon, everyone. Thank you for joining us for the celiac disease results for TEV-'408 (Anti-IL-15). The materials are posted to our website this morning in the Investor Relations section, as always, please see those.

And before I turn the call over to Richard Francis, I'd like to remind everyone that we'll 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 Forms 10-Q and 10-K filed with the SEC. Any statements that we make are only as of today, and we undertake no obligation to update these statements subsequently. Now it is my pleasure to give you Richard Francis.

Thank you, Chris. Good afternoon and good morning, everybody, and I do appreciate you joining the call. Today marks another major step forward for Teva as we continue to execute on the pivot to growth strategy, a strategy that was launched 3.5 years ago to transform Teva from a world-class pure-play generics company into a world-class biopharma company.

Now as many of you will know in the conversations and interactions we've had, a major part of this was expanding our innovative portfolio. In fact, that was pillar 2 of the 4 pillars of the strategy. This was about stepping up innovation. And I think you'll see today that we continue to make great progress on stepping up innovation here at Teva. Go on to the next slide.

We set out this year to have 7 milestones. We had to update that, and it became 8 milestones as we have the transaction and ecopipam came into our pipeline. But for a world-class biopharmaceutical company, I think this is a very impressive lineup that we have here. We have made significant progress on executing on these milestones.

Already, we've had the duvakitug maintenance data. As I mentioned, we've had ecopipam when the NDA was accepted. We've had the top line results of vitiligo. And as of today, you'll be hearing from Eric about the celiac disease 2a top line results.

But I will remind you, there's still quite a lot more to come this year with the DARI, emrusolmin, olanzapine LAI anticipated approval in Q4 and finally, the Anti-PD-1/IL-2. So what does this all mean for Teva? If you go on to the next slide.

It means we have an opportunity to have 5 submissions in 5 years. And it's worth pointing out that these products and these programs and their indications have the potential to generate over $10 billion of sales for Teva going forward.

Now for any company, that would be significant. But for a company of Teva's size, I think this really creates an opportunity to create a biopharma company that has a growth trajectory for many years to come and create real shareholder value.

I'd also like to point out that 2 of the assets in this -- on this chart, duvakitug (anti-TL1A) and anti-IL-15 are products where we have multiple indications, so often referred to as a pipeline in a product. And we've clearly shown this is possible with the 2 new indications that were announced earlier this year for duvakitug.

And now we have the second data for anti-IL-15 of celiac disease backing off the data we gave you a quarter ago with vitiligo. So lots to be excited about, 5 submissions in 5 years of assets that all have the potential to achieve over $1 billion in peak sales and some considerably more. creates a really exciting time for Teva to continue on this growth trajectory, both on top and bottom line. But I know you want to get into the data. So without further ado, I'm going to hand you over to Dr. Eric Hughes, Head of R&D and Head of our CMO. Over to you, Eric.

Thank you, Richard, and it's great to be here and have the chance to talk about some new data and our pipeline. I'm really excited to be here and talk about this next step in our IL-15 program.

Just to start off first, celiac disease, it's a very important disease. 1% of the population in the U.S. and EU are affected, and that's up to 5.1 million people. But most importantly, 50% of these people, even if they can strictly adhere to a gluten-free diet still have symptoms. And there's currently no therapies for these folks.

So this is a very important disease. I think it's unmet medical need, and it's something that is highly overlooked, I think, and underserved at this point. We'll talk a lot about normal gut villi that you see here on the right of the slide, where you have nice normal villi where it is a high surface area to absorb nutrients.

But in celiac disease, this architecture is highly blunted in the gut. And this is a basic pathophysiology of the disease. Moving on to give you a little bit more flavor to understand the data we'll talk about today. As I mentioned, there's normal gut villi with these finger-like projections. And the basic pathology in the disease process is the exposure to gluten, which causes a stress response in the epithelium of the gut lining.

This leads to a release of IL-15, a key cytokine in the pathogenesis of the disease. And that release drives the migration and proliferation of pathogenic into epithelial lymphocytes. These are the cells that rush into the gut lining and cause the inflammation and ultimately, the destruction of the villi.

And you can see on the right-hand side, again, a gut epithelium that's blunted with its villi, lower surface area, poor ability to absorb nutrients and infiltrated with many different lymphocytes.

So that's the basic pathology. And I think it's a very important aspect to remember because one of the things I'll harp on today is that these anti-IL-15 therapies, including [ours], are really driving at a disease modification.

We are, by definition, changing the course of the disease with these treatments.

Moving on to the first slide of our data. I just want to start from the beginning. This, again, as Richard mentioned, a homegrown antibody from the labs of Teva, just like our duvakitug program. It's the same scientists who do a great job at designing these antibodies. And just like duvakitug, we're focusing on the fundamentals of drug development throughout the process. And we start with our antibody. how does it compare to other antibodies we've created in our labs based on the IP of other competitors.

And you can see here that we're more potent by 2 different assays, considerably up to 50x more potent when you look at different assays. And on the bottom, in a transgenic IL-15 mouse, we can suppress IL-15 in a greater extent in a directional comparison to these other antibodies. So again, the fundamentals of the antibody is higher affinity, better suppression preclinically.

Now Teva also did something completely unique in the field right now. Years ago, we took a population of macaques, nonhuman primates -- and about 1% of macaques actually spontaneously develop celiac disease. So that was a great opportunity in a nonhuman primate preclinical model to see what effect does anti-IL-15 therapies do. And you can see here quite clearly on the left, there's some histology of the gut on monkeys that were challenged with gluten and either treated with placebo or TEV-'408. And you can see quite clearly that the normal architecture that you see on the lower part is dysregulated and disturbed on the top.

And you can see in a quantitative fashion that, that villous height to crypt depth, that actual measure of the blunting of the histology in the monkeys really showed a strong effect. We also showed that the intraepithelial lymphocytes were in a statistical fashion also decreased.

In the monkeys, you also actually saw a decrease in the serology of the anti-gluten antibodies and transglutaminase antibodies. So a really strong preclinical signal that, in fact, anti-IL-15 really is a disease-modifying antibody.

Now moving on to now some human data. When we started our Phase I program, which is pretty extensive, you can see that we looked at a nice PK profile from low to high doses. We observed a half-life of approximately 38 days, which really extends the capability of the molecule to be in a more broad schedule out to 3 months. And you can also see on the right-hand side, when you look at the 2 top doses, we suppressed the free IL-15 considerably, almost below -- well, essentially below the level of detection out to 80 or 90 days. So again, the fundamentals of the antibody are strong, long half-life and clear target engagement up to 80 or 90 days in healthy volunteers.

I'll also note something that the team did extraordinarily well, and that's the follow-up. We have a follow-up out to 2 years in our Phase I program. So again, the antibody itself is strong. The preclinical data has been unique and strong. And the Phase I data is probably the most extensive I've ever seen in a program at this stage. Now moving on to our first celiac study.

Remember, we actually are going to be talking about data from our second celiac challenge study, but our first one showed some very encouraging data. It was a safety study in celiac patients.

We also looked at a number of biomarkers. And I thought one of the most interesting biomarkers that we looked at and we've talked about before was this FABP, this fatty acid binding protein. And what you can see here quite clearly is that patients who received placebo and then were challenged with gluten showed a bump in the fatty acid binding protein. And the fatty acid binding protein is a marker of gut inflammation and health. So when you see a release of that, you show that there's -- you're inferring that there's inflammation going on.

So those people who received placebo had a bump. But then the patients who received TEV-'408, you can see that not only they didn't get a bump, -- but if you overread the data, you can actually see an improvement over time, and it goes below their baseline.

And this is very encouraging. Obviously, we're protecting the gut according to this biomarker from the challenge of the gluten. But also the curious possibility here is that we're actually treating smoldering disease that was at the baseline of the patients to begin. So that was another bit of data that we are very excited about in our first celiac patient challenge study.

What we learned from that study, we actually rejiggered and the team did a great job in executing this next study, this Phase 2a study challenging celiac patients in. Again, this was in 50 patients randomized 1:1 to placebo or active. Again, we gave a single dose on day 1 and 2 weeks later started a 6 weeks challenge. And I want to emphasize that. Remember, everything you see today is a single dose of TEV-'408. That's all we gave in this study, there was a challenge of 8 weeks. And we'll be following these folks out to week 80.

But the important thing in this study that was differentiated from the first study is we did a 6-week challenge, and this study has biopsies in it. The first one is just a safety and biomarker study.

This one has biopsies. And as I mentioned, it's 50 patients, 3 grams per day for 6 weeks. The primary endpoint is the villous height to crypt depth ratio, which is important when we think about Phase II and Phase III.

We also look at intraepithelial lymphocytes and a number of other biomarkers. So now getting on to the actual data today. So we were super encouraged. The joke I wanted to make today that the study was so well run that even the statisticians were happy.

So everything went in the right direction on the study. Here, I'm just going to be talking about the primary and key secondary endpoints. But when it comes to the primary endpoint, villous height to crypt depth, we had a very robust study design. We protected the gut. When you look at the placebo dropped to 0.88 on the ratio when compared to the TEV-'408, you can see it only went down to 0.43. So the important point here is that the delta is 0.45. And that is numerically a very high reported result in one of these challenge studies.

So that villous height to crypt depth actually showing a protection of the damage to the gut epithelium is key. I would then point you to the right-hand side where we're looking at the count of the intraepithelial lymphocytes. So the count of these pathogenic cells for every 100 enterocytes.

And this is one of the basic ways of measuring celiac disease. And here, again, you can see basically the TEV-'408 didn't move at all. The placebo went down by a remarkable -- I mean, the number of cells went up by a remarkable 27.6 with a delta of 27.23.

So that's an extremely robust, again, statistically significant effect. I'd also mention that the primary endpoint was not only statistically significant, but the threshold of 0.4 was met, which is clinically meaningful.

So these are -- in such a relatively small study, remarkable results showing a very robust response. And then the last thing I'd just highlight on this slide, too, was we've seen the trends in the symptoms actually in the study.

We looked at the celiac disease symptom diary, which is the standard PRO, and we see a clear trend towards protection from symptoms. So when it comes to actually thinking about what a patient will experience, that's important as well. So these are the key aspects of how we're going to move forward in Phase II and Phase III.

So again, it was very well-tolerated treatment. Overall, you'll see in the future presentations of the data that it's a very favorable safety profile. So how does that compare to other proof-of-concept studies and gluten challenges out there.

Right now, we think that we're looking very favorable. Remember, we -- with a single dose, saw statistically and clinically meaningful change on the villous height depth with this challenge. You can see here other compounds in development, slightly smaller studies without necessarily a statistical change on this endpoint. So we're very pleased with the results. Again, the power of a single dose over 3 months is another evidence that the compound based on its fundamentals, its potency, its PK, its target engagement is doing what we expect it to do. So when you think about celiac disease and what it represents, there's 1.6 million people already diagnosed out there.

There's no options for therapy for these patients. And the peak sales and the possibilities here are high. There's no pharmacotherapy out there. I challenge people to say that gluten-free diet is good enough for these patients out there.

50% of these patients don't respond to a gluten-free diet anyways. And we saw clinically significant and clinically meaningful results today with a single dose. And this builds upon what we've already shown earlier this year.

I was very pleased with the results in vitiligo. That, again, was a 2-dose study over 24 weeks. And I'd just remind you of the results we saw in 2 representative patients here who saw themselves or experienced much improved skin.

That's a remarkable another clinical study that shows we have activity. And just to summarize about how many -- how much data we're accumulating at this point. We've had, as I mentioned before, a very robust Phase I study, including 115 patients that went out to 2 years. We had our first celiac challenge patient -- challenge study in Ib where we learned and saw encouraging biomarkers.

Today, we talked about very robust challenge data with biopsy endpoints that are key for our development into Phase II and then Phase III that we'll build upon. And then we also had the vitiligo data. So all of these have been accumulating our confidence in the target, our confidence in the safety.

It's been very well tolerated to date and no concerning signals have been identified. We're moving forward as quickly as possible and very excited by the program. And that reminds me -- where do we go from here?

Right now, we are working very diligently on getting our vitiligo study initiated this year, our Phase II/III seamless design. We will also be next focusing on bringing this exciting data we had today to FDA and other regulatory authorities to design the next step for celiac disease. That's going to be our next focus.

But in the future, we can imagine parallel work with other targets. There's a natural progression in thinking about Alopecia Areata, Eosinophilic Esophagitis and even potentially Atopic Dermatitis in the future, which we have preclinical data to support.

So again, we've shown, again, another clinical efficacy point today that really builds this as a pipeline and a product as a key cytokine in multiple different indications.

And finally, I'll just wrap up by saying, again, this program like duvakitug is a homegrown antibody from the labs of Teva.

We build upon fundamentals, developing very potent antibodies that have favorable PK that can be used and shown in strong preclinical data now in celiac and vitiligo that we have a very safe and potentially highly effective molecule that's convenient for patients to take once every quarter.

So we have Fast Track designation in celiac disease. We'll move into Phase II as quickly as possible when we take this data to FDA. We've already engaged with FDA on vitiligo and have a seamless design moving very quickly to start this year. In the future, we'll look at expanding indications, as I mentioned, but the data today highly support moving forward in celiac disease. So I appreciate your attention. I think now I can hand it over to Chris, and we'll probably take some questions.

Thanks, Eric. And before I hand it over to Sami to start the Q&A session, I just want to remind people to please keep their questions as brief as possible, one question and then one follow-up if need be.

And if they have any further questions, you're more than welcome to get back into the call. And also, I want to remind people that Eli, Richard and Eric are all joining for the Q&A session now for your questions. And with that, Sami, please go ahead.

[Operator Instructions] Our first question comes from David Amsellem from Piper Sandler.

So 2 quick ones for me. So I wanted to better contextualize the change in villous height to crypt depth here. You had a 6-week gluten challenge. So I guess my question here is, can you talk about the magnitude of that gluten challenge in terms of how much gluten you're introducing and duration of gluten exposure and how that ties into worsening of villous height to crypt depth over time?

And the reason I'm asking is because we did see data for other agents such as the Forte Biosciences agent. I believe that was a 2-week gluten challenge, and it looked like they had stabilization on villous height to crypt depth. So I'm just wondering here is how you would contextualize this slowing of, I guess, for lack of a better term, disease progression here.

So that's number one. And then number two, also a question for Eric is, how should we think about the kind of symptomatic assessments that you may look at in future studies, be it Phase IIb or registration quality studies and help us better understand what you're going to be looking for both in terms of GI symptoms and non-GI symptoms. It might be early to answer that, but I figure I'd ask anyway.

Great. Thank you, David, for the questions. And let me take them one by one here. So the villous height crypt depth measurement and the amount of gluten challenge, both the dose and the duration. So this is a little bit of the art and the science of these gluten challenge studies. There's no one absolute answer.

When it comes to Teva, we learned, we did a 14-day challenge the first time with 3 grams, and we did a 6-week challenge the second time. The important thing here is you want to have a strong enough signal with the amount of gluten you use, but you have to do it in a way that people can finish the study.

So if you've known anyone who has a gluten-intolerant or celiac disease, 3 grams is what we gave. That's essentially a slice of normal bread. And some people, that is almost impossible to tolerate. It's very challenging. So you have to be able to have a patient population that is sensitive but tolerable to that dose. And then you have to choose a duration dose that people can tolerate. From our learnings and our experience, the team did an excellent job at executing the study, getting the people to the end of the 6 weeks and then getting the biopsy at that time is really kind of threading the needle here. So there's -- my answer is there's no one defined way in which you do this, but it's the way in which you execute and the team's excellence and their ability to really learn and pivot and design and execute the study is really the key here.

You can see from our data that the 3 grams for 6 weeks and then making sure we finish the study well gave a great signal-to-noise ratio. So we -- I think we -- the team hit it right on the head. But again, other people do it different ways. It's all about execution at this point. And my final thing on this is these are challenged studies.

These are somewhat atypical in the dose that we give because we want to get a signal and show the potential of the compound. When you go into Phase II and III, if you do what we call a SIG study, which is a simulated inadvertent gluten exposure study, those are probably going to be lower doses.

So there's more physiologic and inadvertent exposures in the real world. So this is a well-designed study showing the signal and the power of the compound. And that's why we chose 3 grams per day for 6 weeks. Now your other question, the symptoms. And I think the symptoms are super important because that's what the patient will experience. I think the FDA appreciates that symptoms are important in the patient experience and the fact that we should change and improve the gut histology of the patients.

That's why both of those will be included in Phase II and Phase IIIs moving forward. We use the celiac disease symptom diary, which I believe is pretty much becoming the standard at this point for how we measure that.

That's a measure that includes abdominal pain, diarrhea, nausea, bloating and fatigue. Fatigue is usually separated differently from the quantitative components of the measurement, but those are the symptoms that are most important for people with celiac disease.

Certainly, the people I know, those are the critical ones. So you can -- we'll talk about our symptoms in the future presentations, but we do see a very nice trend in how we protect people from those symptomatology that they experience. Thank you for your question.

Our next question comes from Louise Chen from Scotiabank.

This is Corey Rosenbaum on for Louise. Congrats on the data. Can you just discuss how the positive celiac disease and vitiligo data from earlier in the summer inform your confidence in TEV-'408's potential across other IL-15-mediated diseases? And secondly, I know the study enrolled adults with celiac disease. How are you thinking about development in pediatric and adolescent populations and what would need to happen before expanding into those groups?

Thanks, Corey. And your first question is how does this add to our confidence in the program in general was the first question?

In other potential indications.

Yes, I'm sorry. Yes. So yes, so IL-15, you can see is pretty much a key driver of a lot of these surface diseases. You'll see programs across the landscape now developing across the dermatology and GI space.

I think there's a lot of pull-through from vitiligo, celiac disease to Alopecia Areata. I think most people would assume that there's going to be a strong pull-through to that. I believe, as I mentioned before, eosinophilic esophagitis will be important.

It's encouraging to see other companies going to atopic dermatitis and even like lichen planus, which are other surface indications, topicological dermatologic indications that are important. Obviously, atopic dermatitis is very big, and I've mentioned that before.

Lichen planus is an underappreciated disease that has no therapies as well. So there's the world of indications for anti-IL-15 therapy as the safety continues to be strong, keeps opening up. So I think that this is another inflammatory program that has a long way to go in multiple different indications. Now a very important question about pediatrics. So that's a great question. Certainly, people with celiac disease started developing it frequently early in their life. In fact, it's frequently underdiagnosed early in life.

For these programs at this point, we'll have to continue to develop the safety, prove the efficacy in the adult population. And most certainly, we'll be developing along the way pediatric programs as the FDA requires. So that would be probably a future indication that we certainly look forward to. Thank you for the question, Corey.

Our next question comes from Dennis Ding from Jefferies.

This is Anthea on for Dennis. Congrats on the great data. Could you talk a little bit more about the regulatory path for celiac and your initial thoughts around that? And how you're thinking about mucosal damage prevention versus mucosal healing?

And then secondly, how are you thinking about developing this yourself versus partnering out with -- to a pharma company to co-develop similar to TL1A.

Eric, maybe you want to take the first 2 and then asking the same thing.

So yes, I'll do the first 2, and I'll probably pass the partnering out to Richard. But Anthea, thanks for the question. So the regulatory path, I'm not going to give too much clear detail right now because we are going to be going to the FDA with this new data soon.

And that will be a negotiation. I think that in general, when it comes to celiac development, I've mentioned many times before that it's going to be a component of these biopsy readouts and the symptoms. I think that regulators see the value in both because you want to make sure that you're disease-modifying the basic pathology of the disease. like I believe anti-IL-15 can do. But more importantly, you want to make sure the patients feel and experience a better quality of life. And I think that that's why I highlighted the symptoms today trending in the right direction, which is very encouraging.

So those 2 things will be used. I think that when you think about different study designs in the future, I think that one of the things that's becoming more commonplace is this idea of low-level inadvertent planned exposures to low levels of gluten. And I think that's probably the best way to move forward. But that's something we need to still discuss with regulators at this point.

And the question of prevention versus healing, that's a more broad question. I think that's something we also have to be discussing about how far can we drive a label. I personally have an aspiration that this should be all comers, people who want to be able to have a normal diet.

And so beyond just the people who don't respond to gluten-free diets, I think there's a great value in being able to travel and live your life the way you want it to be. So those are the discussions we have to have with regulators and make sure that how we design the Phase II and III studies achieve those goals. And let me pass off the last question about partnering to Richard.

Thanks for the question, and thanks for Eric. as you've seen over the last few years, Teva has developed an excellence in commercial execution across a number of therapy areas. And so based on that capability, based on understanding these disease areas through the work we're doing in clinical development, we have no plans to partner these products.

As you saw by some of the partnering we did on financing with Royalty Pharma, we're in a position to develop these in multiple indications all the way through to launch. Thank you for the question.

Our next question comes from Melanie Fong from Bank of America.

This is Jason on for Melanie. Maybe just Richard -- Eric, can you talk a little bit about what you want to learn from Phase II? Do you want to explore another dose? Or are you looking for evaluating the impact of the drug with longer gluten challenge and longer treatment exposure?

Just trying to get a rough sense of what we can learn incremental in Phase II. And when I look at the placebo effect to your gluten challenge, minus 0.9 on the measure, it looks like historically, it was like minus 0.2 to minus 0.6. So your gluten challenge seems to be maybe having more of an impact on patients.

And so I assume all the patients in this Phase II were able to stick it out in this trial. But as you think about longer trials, I'm just wondering how you employ gluten challenge with the goal of keeping patients in the study.

Great. Thanks, Jason. So yes, what do we want to do in Phase II? And again, we need to take the data we have right now and have this discussion with the regulators. But certainly, my goals are -- I'll fall back on the fundamentals. We want to make sure that we recapitulate and show symptom improvements and biopsy results. So that's why this study today was so important. We have a very good idea of what we can do with regards to those endpoints.

We'll want to make sure we push the duration more and more because we have to start building up the safety database and the duration of therapy and follow-up so that we can have the safety database for the submission. So -- and we'll do more than one dose because we have to do dose ranging to fulfill our commitments with regulators and understand the modeling and simulation on dose.

Those are the fundamentals and dose is the most important thing when it comes to a submission success. So those are my goals in Phase II, and then we'll recapitulate those in Phase III. You don't want to change too much along the way because we want to make sure that you're going to succeed. So that will be our next steps with our discussions with the health authority.

Now according -- back to your question about the gluten and the robustness of the study design. Yes. So as I mentioned before, there's -- in these studies where it's a pretty strong dose of gluten, you want to balance your signal to the ability to complete the study so that you really have a good comparison. This study was run very well. The majority of subjects got all the way to the end, and we had a good comparison. It was balanced between placebo and active. So that's why we're confident in the numbers we were able to generate today.

When we talk about the Phase II and the Phase III and this thing I keep talking about this simulated inadvertent gluten exposure, getting that dose right that it's tolerable over a very long duration of time, but also give you the signal you need is going to be the important next step.

And we're already in discussions with our experts, and we'll have that discussion with the regulators next. Thanks for the question, Jason.

Our next question comes from Matt Dellatorre from Goldman Sachs.

Congrats on the positive results. Maybe just on the multi-dose Phase II that you're going to start shortly, I guess, what's a reasonable base case for time lines for that study? And then time lines also for moving into Phase III? And then I guess, as we think about the target profile for that next Phase II and ultimately the Phase III, I guess, would repeating this level of VHCD ratio be viewed as success?

And then in terms of benefit on symptoms and the celiac disease symptom diary score, could you quantify how -- what kind of impact would you want to see there? Is that -- would that be a quantified number that you would share? And then, Eric, you did also mention you want people to have a normal diet and be all comers.

So I just wanted to clarify, would patients who have gluten disease or celiac disease, would they -- after taking this therapy, would many of them actually be able to kind of just live a normal life in terms of the diet?

Okay. Thanks, Matt. You got a lot of questions here, but I'll get them one by one. So I'm going to first disappoint you on the first one. So the duration of the Phase II and the time lines of the Phase II, that's going to be really dependent on the design we settle on with FDA. So I can't really comment on how fast it is, and that would also trickle over to what I envision for the Phase III. So this is going to be a step-by-step process. We'll do Phase II and Phase III. That's about all I know today.

But that we can update you in the future about how our discussions go. How I would generate or how I would measure success when it comes to the biopsy. In general, 0.4 change on the biopsy of villous height to crypt depth is considered clinically meaningful. So that's pretty much the answer I can give today.

And I hope to see that in a study design in the future. It's a little bit more challenging when you do long-term low-dose studies to get that amount of change, but that's certainly what we want to -- our aspiration is.

When it comes to the symptoms diary, the CDSD measurement, I'm looking for a statistically significant change in symptoms. That would be the simple goal there. And the PROs will tell us whether their experience, their quality of life is improving. I mean we'll probably add other PROs in the future to demonstrate the true value to people's lives. And I think that gets to your last question about all comers. I speak sometimes a little bit too passionately about celiac disease because I think that certainly, in my experience and my training back in the '90s, I was taught that this was all in the minds of the patient, which is obviously completely wrong.

So when it comes to who should have access to a treatment like this, I think, obviously, people who don't respond to a gluten-free diet, which is 50% of the population right there, certainly deserve a treatment. But I believe the folks who have to change their entire life and think about this in every needle of the day deserve something that can free them up from that.

And I think that that's going to be the important discussions in the future when we talk about PROs with health authorities and make sure that we answer that question for health authorities about what the value is for all people who have celiac disease. Thanks, Matt.

Our next question comes from Ash Verma from UBS.

Congrats on the progress here. So just trying to understand the next steps here. How much of dose finding work do you need to do in a Phase II? Is it more sort of tinkering the level of gluten that you would give?

Or is it actually looking at different levels of the dose that you're providing for the drug? And then in the maintenance setting, could the dose be different compared to the induction data that you've shown today?

Great. Thanks, Ash. Great question. So when we're talking about the Phase II dose ranging, that is dose ranging of the drug. And I can't get into too much specifics here because it will probably be highly dependent on how we have our discussion with regulators.

But as you always do, you need to have dose ranging so that you have a strong understanding of your dose and response ratio. I mean I would argue we have a very good dose response model already that has been developed with free IL-15 and other biomarkers across the program for a long duration. So we're going into Phase II with a lot of knowledge built on a lot of great fundamental science that the Teva team has already done. So it would be most likely or will be a dose ranging of the drug itself and not necessarily the gluten. Your second question when it comes to maintenance.

One of the things that I think differentiates our programs from others right now is we went right into it without a loading dose, we're planning on 2 every 3 months. So I don't think that has to change necessarily for maintenance. I want to make this as simple and as convenient for patients as possible, and we started there.

So I wouldn't back up or regress in the convenience of the program at this point. So I think that a simple shot every 3 months is what we'll focus on going forward.

[Operator Instructions] Our next question comes from Umer Raffat from Evercore ISI.

Can I touch up on 2 quick points. First, first, the sample size, 50 patients went in. How many patients are informing the analysis that's being shown?

Secondly, the biopsy results that we're looking at, were they centrally read? And was the biopsy orientation perfectly vertical?

And then third, I understand the gluten background is 3 grams a day. Other trials have as much as 8 grams a day, which impacts how much placebo deteriorates. So as we think about the effect size and the absolute numbers we're comparing, should we be comparing percentage numbers?

Should we even be comparing versus trials which have much more gluten background per day? I'm just trying to put this all into perspective on the interpretability of this data set today.

Great. Thanks, Umer. Let me go one by one. So the first one, the sample size. So 50 patients in the study, the vast majority of patients got through to the end, and they were balanced between placebo and active. So the comparison and our confidence in the data are very high. The biopsy orientation, you're absolutely right. When you do the reads of the villous height to crypt depth, you always have to make sure and the pathologist knows this, that you have to slice -- what you measure has to be a slice through the entire length of villous.

So you have to make sure that you're seeing -- they're always in different orientations when you slice the data -- the tissue, but you always have to make sure you have a clean slice from the very tip all the way through to the crypt of that villous.

So you have to have a clean measurement when you do this. And then obviously, the intraepithelial lymphocytes is more straightforward where you count the number of IELs to enterocytes.

So that's a pretty standard way of doing it, and we make sure that our pathologist is well versed in that. And then your final question is about the gluten. And I'm not really sure exactly what you were asking.

Was it the interpretability? I know that there's been a lot of questions about the dose in different challenge studies. If it was the interpretability in these POC studies with these relatively high doses of gluten, I really do think it's a little bit of an art and science. You have to make sure that you have a dose and a population of people who are responsive but not intolerant of gluten that you get the right people in and that you have the right duration and that you have the right support to get them through the study.

So that's the combination of why we settled on this population 3 grams per day for 6 weeks. And I think at the end of the day, it shows that the drug does the effect that we need for Phase II and III.

Our next question comes from Luisa Hector from Berenberg.

I have a couple. Eric, I'm curious what you would expect to see in the longer-term follow-up of the Phase IIa? Would you expect a kind of waning when there is damage -- or are the placebo patients sort of permanently worse off?

And then a question on what the FDA might require. Do you have sort of a minimum number of patients that need to be on a maintenance dose for 12 months?

So what are the requirements there? And can you get to that without doing a gluten challenge all the way?

Great, Luisa. Thank you. Fantastic question, is particularly interesting in the sense that we do have a long-term follow-up in this study. And I expect this question from many others, but what is the actual long-term effect of this treatment?

We -- our responsibility -- my responsibility is to make sure that we dose the compound based on the best data we have. So we can clearly show that we can suppress IL-15 for 90 days. And that's why we're going to stick with a Q3-month dosing or quarterly dosing.

But the effect might be longer lasting than that. In fact, we do suppress these cells for a while after dosing, and we will continue to gain information like we have throughout the entire program about the recovery of the cells and the kinetics of this entire effect.

So there's a possibility it can last longer. I think that we have a very robust data set that tells us quarterly dosing will work now. But we will get more data in this follow-up to see how the patients do, what they're feeling long term, and we'll have more to talk about in that follow-up maintenance that you mentioned.

But the possibility exists that since we're disease-modifying potentially, that effect might last longer than we even anticipated. So great point. I think that's just more data will determine what that -- the true answer is. So the follow-up is important. Now your question about what's required.

The basics of any program is traditionally, you have 300 patients at 6 months and 1,000 or 1,400 patients total in the safety database. Those are generalities for each program.

So usually, when you have a strong effect like this, statistically, you might be able to go smaller, but really safety will drive the long-term submission time lines. I hope that answers your question, Louise.

We currently have no further questions. So I'd like to hand back to Richard for some closing remarks.

Thank you, and thank you, everybody, who took the time to dial in to the call today. Really appreciate your interest in Teva. I would remind you of some of the comments I made earlier in the presentation about 2026 being an exciting year as we progress on our pivot to growth strategy.

We've had a number of readouts, which we have conference calls for. But just to remind you, we still have quite a few to come. Obviously, there will be the completion of the DARI study in asthma.

We will also have the futility analysis for -- and we're fastly approaching the opportunity to be launching our long-acting olanzapine into the market in Q4 as well as now the exciting news that we have priority review for ecopipam and the ability to launch that early in 2027.

So some great progress here at Teva on our innovative portfolio, some great progress by Eric and his team, and I want to congratulate and thank him for that. And I look forward to connecting with many of you over the next few months to highlight some more interesting milestones from Teva. Thank you. Goodbye.

This concludes today's call. We thank everyone for joining. You may now disconnect your lines.

Hello, everybody, and welcome to the Q2 2026 Teva Pharmaceutical Industries Earnings Conference Call. My name is Elliott. I'll be coordinating your call today. [Operator Instructions]

I would now like to hand over to Christopher Stevo. Please go ahead.

Thank you, Elliot. Good morning and good afternoon, everyone. Thank you for joining us on our second quarter call. Obviously, our materials are posted to our website this morning. So please see those. .

And before I turn the call over to our CEO, Richard Francis, I'd like 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 forms 10-Q and 10-K filed with the SEC. Any statements that we make are only as of today, and we undertake no obligation to update these statements subsequently.

With that, Richard Francis.

Thanks, Chris, and good morning and good afternoon, everybody. Thank you for joining the call today. And on me joining me on the call today will be Dr. Eric Hughes, Head of Global R&D and Chief Medical Officer; and Eli Kalif, our Chief Financial Officer. .

Now, moving on to decide how we start with the pivot to growth side. Our strategy that we launched in 2023 just based on these 4 pillars. We'll summarize how we've performed against these 4 pillars in quarter 2. But just to give you a quick overview on delivery on our growth engines, AUSTEDO, AJOVY and UZEDY all delivered strong Q2 performance, and we are raising our full year revenue guidance for these products. It's worth reminding you that the innovative portfolio is reshaping our financial profile with stronger revenue growth, margins and free cash flow.

As we move on to the second pillar step-up, innovation in our pipeline this year will provide 8 major milestones, and this now includes ecopipane, and this gives us the potential for 5 submissions over the next 5 years. With regard to creating the generics powerhouse, biosimilars are becoming a growth platform within generics. We now have 15 products in the market and 14 in our pipeline, and we see additional opportunities through further partnerships.

And on our final pillar, focused the business, I think we made great progress on our capital allocation. We've had 1 of the agencies of greatest Fitch to Ingresso grade, and we see the other 2 doing this in the not-too-distant future. We also allocated capital to the acquisition of Amylyx. We closed that deal in June, and we're expecting the launch next year if FDA approves.

And then finally, the conversion of the ADS to ordinary shares and the ability to list on the New York Stock Exchange should make investing in Teva accessible to more investors.

Now, moving on to the financials. Now, I'm really proud of this slide and you may ask why, but let me walk you through why. Now we have stable revenues despite nearly 8% of headwinds from generic REVLIMID loss year-over-year. We're growing our profit margin as well, 80 basis points. improving gross margins year-over-year driven by strong innovative growth despite this loss of genetic REVLIMID. We've actually grown our EBITDA, obviously excluding the Amylyx acquisition. And our free cash flow is up 31% as a result of our disciplined capital allocation.

Now if I go on to the next slide, I'll give you a bit more detail. As you can see, the innovative portfolio has had a strong quarter, up 43% year-on-year. AUSTEDO, up 40%; UZEDY, up 43% and AJOVY, up 56%. Generics is down 15%, and this is largely due to lower generic contribution versus 2025.

But if I now go into a bit more detail, starting with the AUSTEDO, a core growth driver here. This is another strong quarter. In the U.S., revenue reached $676 million, up 33% year-over-year and global revenue up 40%. Our demand remained strong with TRx up 14% and milligram growth up 21%, supported by new patient starts and adherence. AUSTEDO XR now represents over 60% of new patients, strengthen convenience, adherence and long-term durability. And because of this strong quarter, we are now increasing our outlook by $50 million at the midpoint. So it's now $2.45 billion to $2.6 billion.

It's worth noting that the midpoint there is $2.5 billion, which was the target we gave ourselves for 2027. So we have a chance of beating this year early. But I think more importantly, we see continued momentum and a significant untreated population that still could benefit from AUSTEDO, and hence, our confidence in greater than $3 billion of peak sales.

Now moving on to UZEDY. UZEDY continues to grow with strong momentum. It is the fastest-growing long-acting injectable treatment for schizophrenia amongst atypical LAIs. Revenue grew 43% to $77 million in Q2 based on strong demand, and that was reflected in our TRx up 63% year-over-year. The commercial execution has been impressive, and this can be seen with UZEDY nearly doubling the risperidone long-acting share and has now gone from 5% to nearly 10%. And UZEDY is capturing nearly 80% of the risperidone LAI market. And because of this strong performance, we are increasing the outlook by $15 million at the midpoint, so the new guidance is $270 million to $290 million.

Now, this continued excellent execution has given us great confidence in the upcoming launch of olanzapine, which I'll now move on to. So olanzapine represents a meaningful next growth opportunity with FDA action and U.S. launch anticipated in Q4 of this year. The unmet medical need is significant. Olanzapine holds roughly 20% of U.S. all prescriptions while olanzapine LAI uses less than 1% of the LAI market. Now, we know this market. We can really leverage the synergies with UZEDY, but also the deep knowledge of the schizophrenia market, whether that's physicians, patients, nest practitioners or some of the long-term care facilities.

Our direction of travel is clear to deliver a best-in-class launch that expands treatment options and reinforces our leadership in the LAIS. Olanzapine together with UZEDY gives us a compelling path to expected peak sales of $1.5 billion to $2 billion of revenue.

Now moving on to AJOVY. AJOVY demonstrates our ability to execute in competitive innovative markets wherever they may be. We continue to outpace the injectable market growth, and we lead in many of the markets despite entering late. Q2 global revenue reached $244 million, up 56% year-over-year. The U.S. revenue grew 83%, driven by improved contracting, favorable gross to net and market share gains. Ex U.S. momentum remained strong, supported by volume growth and leading brand shares across Europe and international markets. Because of this strong quarter, we're increasing our outlook by $90 million at the midpoint. So now the range is $850 million to $870 million. And looking beyond 2026, we see a clear part to $1 billion peak sales for AJOVY.

Now moving on to the newest member of the innovative family, a first-in-class opportunity with compelling efficacy and favorable tolerability in Tourette syndrome, a serious pediatric neurological disorder with limited treatment options. We've already filed with the FDA with a potential launch in the first half of 2027. Now, the unmet medical need is clear. There are 100,000 pediatric patients who live with Tourette syndrome, only 50,000 are treated, and only 20% to 30% remain on therapy after 1 year. So this shows there is a real need for product like with compelling efficacy and favorable tolerability. Now, we're well positioned to execute on this, leveraging our CNS capabilities and the experience we've garnered with AUSTEDO, AJOVY and soon-to-be long-acting olanzapine.

Now, this moves on to a slide, which I've never been able to show before actually in my rather long career. And I apologize for the small font, but we had to get everything on 1 slide. And what this highlights is just the innovative pipeline we have and our potential to launch 1 asset per year for the next 5 years, transforming Teva into a leading biopharma company. The near-term launches are clearly sequenced, olanzapine in '26, in '27, followed by DARI and the Q2 '28 to '30. Obviously, all subject to regulatory approvals. But looking up to '35, we see further upside from the additional indications that we've announced that for dubicictid as well as the additional indication of anti-I15 as well as our. We also are pursuing more business opportunities as well as development opportunities that is.

Now, moving into our pipeline slide. I'll try and be short on this and allow Eric to talk more through this, but there are some points which I think are worth mentioning. One is, this is a near-term pipeline with many catalysts, as I mentioned in my opening remarks. With agile, we saw the Vitiligo data where we're going to see the CDEC data in the second half of the year. We've got this near-term launches with olanzapine and filed. DARI is progressing well. We've announced 2 new indications for Ducato. So together, all these assets represent over $10 billion of peak sales, although I have realized we said that before, and that was prior to actually adding to this slide as well as the 2 new indications of, so I must remember to update it.

Now, what does this all do for Teva? Will it fundamentally transforms our growth profile. Our growth is really accelerating with revenue moving from $4.9 billion in 2022 to an expected $16.5 billion to $16.8 billion this year. And our portfolio is shifting towards higher value innovation with innovative revenue expected to reach 22% of total revenue in 2026, up from 9%, and you can see where it's heading to 2030.

Now, with regards to margins, we are creating stronger margins with gross margins expected to expand from 54% to more than 60% by 2030 plus. And this is once again fueled by our inhibitive portfolio.

Now, moving on to our generics business. Our generics business is down 15% versus Q2 2025. But I don't think that tells the full story. If you exclude generic REVLIMID, our generic business remained stable. Global Generics was down 2%, the U.S. up 1%, and our ex U.S. decrease mainly was due to lower product launches this year and the cost and cold season. While 2026 is expected to be somewhat softer, we continue to see a stable generics business capable of delivering 1% to 2% annual growth over the long term, supported by a steady flow of our new product launches.

I remain very excited about the future of our generics business. And 1 of the main reasons I'm confident is the growth rate that is starting to emerge from our biosimilar portfolio and pipeline.

Let me move on to this now. So biosimilars are transforming our generics portfolio. Before pivot to growth, we had 3 biosimilars. Today, we have 15 in the market. And in the next few years, we expect to double it. It's not just the size of our portfolio, it's the execution. In the U.S., 2 out of our 5 products are ranked #1, and our third is neck and neck, and I believe, soon to become number one. In the U.S. -- in the EU, where we have just launched 3 biosimilars, early signs are very positive. We continue to seek partnering to increase this portfolio, and I believe we are becoming the partner of choice because of this excellent execution. And based on our current momentum, we are on track to exceeding our $800 million by 2027.

To conclude before I hand over to Eric, we're on track to hit our financial growth targets of mid-single revenue growth, non-GAAP operating income target of 30% and a net debt to EBITDA below 2% and cash conversion earnings of 80%.

And with that, I will hand over to Eric.

Thank you, Richard. Now moving on to our first slide here. I know Richard showed this briefly, but I first wanted to just say it's become very complicated, but it's become very complicated in a great way. We're looking at 5 potential submissions over 5 years. I'll just highlight a few important things on the slide. We've now added ecopitane, which was submitted in June for Tourette syndrome. And we've now added 2 new indications for Duvaqetob. That's hydrogenitis superteva and fibrosenatic Crohn's disease. Two very important indications that I'll get into with a little bit more detail later on. But it's great to see this pipeline and we're executing on it every day.

First, I'll start with olanzapine LAI. We are on track for the action date in the fourth quarter of this year. We've had our EU MAA accepted earlier this year. And we just presented a number of different abstracts at the psych Elevate Conference and the Page conference. So all things are go right now on olanzapine LAI, and we're looking forward to an approval at the end of this year.

On to ecopitane. Now, 1 of the things that gets me excited first, that this is a mechanism, a brand-new first-in-class mechanism of a D1 antagonist. But even more importantly, this is the first dedicated launch for a treatment for Tourette syndrome. So I think that's going to be a very important aspect of this launch with disease awareness and providing a new treatment for a large unmet medical need.

I mean, I'm proud of the fact that we have 2 well-controlled studies, the Phase II showing a decrease in the tick syndrome, not only statistically significant, but clinically meaningful reductions. And we also showed in Phase III, a decrease in the relapse rate, statistically and clinically with a 50% reduction. Since they're all very good signs. But most importantly, this is a treatment that is well tolerated and durable. 66% of the patients in the long-term follow-up remained on treatment with a sustained tick reduction, and we're looking forward to that approval next year. So something to look forward to.

Now, moving on to our DARI program, the dual action rescue inhaler for asthma. We have fully enrolled this study over 2,700 patients which includes pediatric, adolescents and adults. We're right on track to see that final event. This is an event-driven study. Our forecast is at the end of this year, and we'll be able to present that data in the early half of 2027. But this is a really great program for patients with asthma. It's answering an unmet medical need, answering the need and the treatment that's dictated in the guidelines.

We'll be providing a great treatment with a dual action retail with a dry powder inhaler that's easy to use and with a label that includes pediatrics potentially.

Now, moving on to Duvaqito, very exciting this year. We had our publication of our induction data in Nolans for both 2 parallel manuscripts for ulcerative colitis and Crohn's disease. It's great to see the team's work being recognized by such a high impact journal and kudos to their great work. So congratulations to the team.

But now furthermore on Duviqita, our Phase III program being run with our partner, Sanofi, is right on track. Our Sunscape and Starscape program in ulcerative ions Crohn's disease. But today, we are very proud to announce the fact that we're adding 2 new indications into our research that includes hydrogeni superativa, which will unlock that non-T2-based indication group and fibrosin Crohn's disease, which unlocks the fibrotic bucket of indications, but also expands and doubles down on our intention and labeling for IBD in the future. So this is a very exciting announcement that we're doing with our partner, Sanofi. I'll get into a little bit more about the importance of these 2 indications next.

First, hydrogen super tivo. This is an area I've worked in before. It's an important unmet medical need. This is a result of painful inflammatory abstasies that for skin folds in the body. These people suffer in silence with many different aspects of the disease can be disfiguring and really impact their daily life. It's not uncommon. It's about 1% of the adult population. And there's -- there are treatments out there that had been approved, but there's a long way to go with the amount of efficacy we can achieve.

Anti-1 therapy in this area, I think, is perfectly suited. It's a complex disease with multiple different pathways involving both Th1 and Th17 cells, and it has a significant fibrotic component to it. So the pleiotropic effects of TL1A therapy might really be suited well for this. It's also important to note that 15% of people with IBD actually have hydro genius supertiba as well. So there's a lot of scientific rationale here and it's an important market that we can grow in.

In addition, we talked about fibrosynotic Crohn's disease. Now this is a very important aspect of people with Crohn's. We've already posted Phase II data with great efficacy in our Phase II study with duvacitub. But now, we're looking at even worse cases of Crohn's disease. 50% of people with Crohn's disease have this fibrostynotic component. And this is where fibrosis, inflammation and edema causes almost total obstructions of the gut. This leads to more hospitalizations, more surgeries, increased health care cost. It's really a driver of some of the worst parts of Crohn's disease.

So we're very happy to advance the science. No 1 has been approved for this indication at this point. And I think this is showing our confidence in Crohn's disease and how we want to double down and make that label as patient-friendly as possible. So I'm very excited to be exploring this indication with duvaqito.

Now moving on, we showed some great data from our proof-of-concept study earlier last month. with patients with vitiligo and our anti IL-15 program. I always like to start out by saying, first and foremost, it was great to see the patient's perception of their disease change. So 75% of the patients reported an improvement in their facial vitiligo. And here, I'm showing 2 patients who gave a special consent to show the results that they've seen in the study. Now, remember, these 2 patients just had 2 shots of our anti IL-15 antibody. And over a 24-week period, you can see quite a change in both the woman on the left and the gentleman on the right, almost total depigmentation of the cheeks on the women filled in very nicely over 24 weeks. And then the patient on the right, some dramatic changes from total deep implementation with a darker skin care.

So these are results that changed the perception of a patient and is very conveniently done with just 2 shots. But as happy as I am about the perception change for the patients. We also met the important regulatory end points. The numbers we posted for the 50, the F 75 and the T body are very competitive for systemic therapies in this area. And this really drove the fact that we went right into our Phase IIb/III study, which will be executed and started this year, so we're moving at speed. We're excited to see the data, and we're moving as quickly as possible.

And finally, I'll just mention what's coming up next. So we'll have a readout in the second half of this year and our second Celiac proof-of-concept study. This study is important because it's actually looking at biopsy results after a gluten challenge. So remember, the basic pathology of Celiac disease is the fact that when you have an immune reaction to gluten, there's destruction of the normal bile in the gut and where you have this nice high surface area of villus that absorbs nutrients in the gut when a patient with CIC disease takes gluten that there's almost a complete destruction of that normal villus on -- as you see on histology. And we hope to see in the scrutiny challenge by the biopsies that in fact, we protect the villi from that destruction when we use the anti-IL-1 treatment. So we're looking forward to the readout. That will be the second half of this year, but I think this will be a great advance for patients with CAC potentially based on that data.

So on my final slide, I just want to walk through the fact that we are marching through our milestones in 2026. We showed the maintenance data first this year for duvaqito. We did the filing for Ecopytan, our new player on the field. And then, we also showed the vitiligo data just recently for our anti-IL-5 program. We'll have the Celiac data in the second half of this year. DARI is on track for that last event, that last exacerbation by the end of this year, and we'll have that data to talk about in the early part of 2027. Emera Solman is on track to have the futility analysis at the end of the year. We're looking forward to the approval of olanzapine LAI at the end of this year, and then we'll have some anti-PD-1 IL-2 human data by the end of this year as well. So very exciting. We keep executing, and we're looking forward to all these events this year.

And with that, I'm going to pass off to my colleague, Eli Kalif.

Thank you, Eric, and good morning and good afternoon to everyone. I would like to start my review of Q2 '26 results with the following key messages: First, we delivered a solid second quarter results, driven once again by the continued strength of our innovative portfolio. Second, with the increasing mix of innovative revenues, together with our transformation programs, we remain on track to achieve our 30% operating margin target by 2027.

And lastly, our disciplined capital allocation strategy and the execution is increasingly recognized by the leading credit rating agencies, including the recent upgrade to investment grade by Fitch.

Now moving to Slide 34. Before I discuss our Q2 results, let me briefly recap the MLX Basins acquisition, which closed in June. As Richard highlighted earlier, further strengthens our position in CNS, where we already have strong commercial and development capabilities. From an accounting perspective, as we discussed last quarter, the transaction was treated as an asset acquisition. As a result, we recorded a $724 million as IP R&D expenses during the second quarter. This included the upfront cash consideration, net liabilities acquired as well as the transaction costs.

The upfront consideration flow through cash flow from investment activities and, therefore, does not impact free cash flow. As I go through our Q2 performance, I will be making reference to the MLX related impact on our financials to provide a better view of our underlying performance.

Now starting with our Q2 GAAP performance on Slide 35. Q2 revenues were approximately $4.1 billion, down 1% in U.S. dollars or 3% in local currency compared to Q2 2025. This decrease was largely driven by lower generics, mainly generics reveled and was largely offset by continued strong growth of our key innovative products, AUSTEDO, AJOVY and UZEDY. GAAP net loss and loss per share were $576 million and $0.49, respectively.

Turning now to our non-GAAP performance. Our non-GAAP gross margin in Q2 '26 was 55.4%, an increase of 80 basis points, reflecting a strong growth in our innovative portfolio. Non-GAAP operating margin was 9%, including the impact of MLX related expenses of $726 million. Excluding MLX, our non-GAAP margin would have been 26.6%, slightly below Q2 last year, mainly reflecting higher planned investments in sales and marketing in the first half of this year to support our innovative growth.

Overall, we ended the quarter with a non-GAAP EPS of $0.02. The impact from MLX on EPS was $0.61, without which our non-GAAP EPS would have been $0.63. Our free cash flow in Q2 was strong at $622 million, up 31% versus last year. To provide you with some additional color, our Q2 '25 results included $318 million revenue and $223 million EBITDA contribution from our generic REVLIMID. Our financial results this quarter reflected a strong underlying performance if you exclude the impact of generics REVLIMID.

Moving to the next slide. As a reminder, our operating margin expansion to 30% is driven by 2 structural elements. The first is a portfolio shift towards higher growth, higher margin innovative products. The second is our transformation program. Altogether, this is approximately 400 basis points of improvement since we announced this program in May last year, despite the impact of generic REVLIMID. This is our core of our financial transformation, moving from a company historically driven by generics to a bar from a company. We continue to make progress to achieve these targets as reflected in our 2026 guidance.

Moving to Slide 37. Looking at the first half of 2026, the underlying business continues to demonstrate the strength of our strategy and execution. As you can see, the first half revenue performance reflects strong growth in our innovative portfolio and biosimilars, offsetting more than $600 million of revenue impact from generics REVLIMID. Our non-GAAP operating margin in the first half also demonstrate ongoing improvements in our gross margin profile.

As I highlighted last quarter, we expected higher operating expenses in the first half of this year versus the second half, mainly due to the timing of planned investments to support our growing innovative portfolio and upcoming launches. We expect OpEx to normalize with operating leverage and higher impact of the transformation program savings in the second half.

Moving to Slide 38. Our balance sheet continued to improve and this is a key enabler of our Pivot to Growth strategy, driving EPS and free cash flow. Over the last few years, we have made significantly improved our leverage profile. At the end of -- our net debt was $12.9 billion, with a net debt-to-EBITDA ratio of 2.8x. Excluding MLX, our net debt-to-EBITDA would have been 2.3x, well on track to achieve our 2x target by 2027. As we continue to pay down our debt, it is expected to result in significantly lower finance expenses by 2030. At the same time, we have continued to transform our working capital management, driving significant improvement as a percentage of revenue, resulting in lower cash conversion cycle. These efforts, combined with the fast-growing innovative portfolio and transformation programs are expected to drive long-term earnings and free cash flow growth.

As you can see on the next slide, our execution is increasingly recognized by our leading credit hedging agencies. In May, Fitch upgrade Teva to an investment-grade rating, marking Teva returned to IG for the first time since 2017. This was our third upgrade from Fitch in less than 2 years, underscoring Teva transformation journey. About 2 quarters ago, S&P and Moody's has also upgraded our rating and outlook, respectively. These upgrades are another validation of our disciplined execution and stronger financial profile.

With our continued transition to an innovative biopharma company, we are well positioned to get additional rating upgrades. Now, turning to our 2026 outlook on Slide 4. Based on our solid first half results and visibility into the second half, we are raising the midpoint of our full year revenue guidance range by $75 million, and reaffirming the outlook range for operating profit, adjusted EBITDA, EPS and free cash flow.

Let me provide you some color on our guidance assumption starting with the revenue. First, our innovative portfolio is performing strongly across all 3 products, AUSTEDO, AJOVY and UZEDY. With the first strong half of performance, we are increasing the combined guidance of this product by approximately $150 million at the midpoint, reflecting a combined 2026 revenue outlook of approximately $3.7 billion and growth of approximately 17% over 2025.

On the other hand, we expect our Global Generics revenue for the full year to be flat to down low single digit in local currency compared to 2025, excluding the impact of generic REVLIMID mid and the divestment Japan business. This is mainly due to a fewer high-value launches in '26, lower seasonal on OTC and increased competition in some markets.

Moving to the other elements of our financial outlook. We continue to expect 2026 non-GAAP gross margin to be in the range of 54.5% to 55.5%. In addition to the MLX related expenses this year, our operating expenses are expected to be approximately 28% of the revenue for the full year. This is at the higher range on our overall 27% to 28% OpEx, reflecting a deliberate investment we are making to support our growing innovative portfolio and our biosimilars. Our guidance range for the operating income and EBITDA reflect this higher growth investment in OpEx and also a less expected in the second half.

Now, let me provide you some additional thoughts on our quarterly phasing for the rest of the year. Overall revenue is expected to be increased over the rest of the year. For AUSTEDO, we continue to see elevated levels of inventory in the channel and expected normalization of this excess inventory in the next 2 quarters. We also continue to expect AUSTEDO revenue in Q4 '26 to be down year-over-year due to the expected changes in purchasing patterns and pricing environments ahead of the IRA implementation in January.

In addition, we are preparing for a Q4 launch for our olanzapine LAI. Since the initial volume is expected to be largely samples or vouchers as we establish a payer coverage, you should expect no revenue in Q4. Our non-GAAP margin, we expected improvements in the second half, in line with revenue as well as higher savings from ongoing transformation programs, while gross margin are expected to decline slightly in Q4 versus Q3 due to the anticipated revenue dynamics related to AUSTEDO. Our operating margins are expected to improve sequentially in Q4, driven by the OpEx savings.

Moving to the next slide on capital allocation. Over the last few years, we have made significant progress in strengthening our balance sheet. This progress allow us the financial flexibility to invest in our innovative portfolio and pipeline, evaluating value-accretive BD opportunities, along with the optionality of returning capital to our shareholders through a buyback when appropriate.

And lastly, I would like to briefly touch on our planned transition to direct ordinary share listing on the New York Stock Exchange. We believe this change will make Teva shares more accessible to a broader investor base. who will be able to buy ordinary shares directly in a seamless manner in addition to the potential inclusion in the leading indexes. We look forward to completing this transition in September and believe it represents another example of our focus on creating a long-term shareholder value.

With that, I will now hand it back to Richard for his closing remarks.

Thank you, Eli. So once again, I want to just highlight the fact that we are at a really exciting time at Teva delivering on our acceleration phase of the pivot to growth strategy. As you can see from this slide, we have multiple opportunities to drive the revenue in the short term, medium and long term, and this innovative portfolio is very extensive. I'd also like to add the number of biosimilars we'll be adding as we start to launch these into the market. as well going forward.

So in the near future, our incremental growth will come from the next generation of innovation, but we'll have much more to come after that. And so to conclude, we continue our growth journey. The themes are very clear. In a critical year for Teva, we delivered exactly what we said we were going to do. Our pipeline is advancing at speed and our with disciplined capital allocation we believe, is what sets us apart.

And with that, I look forward to answering some of your questions with the team here. Thank you very much.

And while Elliott is queuing up the questions, I just want to remind everyone if you could try to ask 1 question and 1 brief follow-up, and we'll be happy to take you back into the queue if you want to ask subsequent questions, but just so as many people get a chance to ask questions as possible. So Elliot, whenever you're ready, we can go ahead.

[Operator Instructions]

First question comes from Jason Gerberry with Bank of America.

Congrats on the quarter. So I just wanted to follow up. So strong performance on AUSTEDO. I think you mentioned 60% new patient start share. Trying to get a sense of your confidence level going into next year that AUSTEDO won't be disadvantaged in formularies as a lower WACC price drug, the payers will be observant of the fact that they shouldn't be using the IRA negotiated price point to advantage the competitor drug. So I just wanted to get your overall sense there. And just as my brief follow-up, any comments on the tariff update in the U.S. and how the supply chain is configured to potentially manage that risk? .

Thanks, Jason. So could you repeat the last question? I just missed it.

Yes. Sorry, the last question was just any thoughts on Trump's proposed tariffs in the U.S. and how the supply chain is configured to mitigate that risk?

Okay. Thanks for the question, Jason. So I'm glad you sort of recognize the strong performance of AUSTEDO of 40%. I do want to maybe slightly correct you. I think you said 60% of new starts. The 60% I referred to as 60% of new AUSTEDO starts on the AUSTEDO XR, just as a clarification. That said, we still have very good TRx growth and very good milligram growth, highlighting the impact that AUSTEDO XR does have on the ability for patients to get on the optimal dose and adhere and comply better.

And then to your question on the payer dynamics for 2027. I think this is something that we spent a lot of time looking at. There's a few obviously scenarios that can play out this way. But it's worth highlighting that all Medicare plans are required to cover negotiated products in their Part D formularies. That would be like obviously AUSTEDO XR. And so based on that, I think based on the product profile and the significant patient demand as well as the physician excitement around AUSTEDO XR. I think we remain confident in our ability to continue to make sure we can capture a significant amount of patients as we move into 2027. Obviously, how this impacts revenue, we're not really talking about that. We've highlighted the fact that we'll give guidance. When we give guidance on the company, we'll get more data as we go through. And obviously, we end up having more discussions with some of the payers towards the end of the year. But we remain very confident about that.

And I'd just like to highlight what I said in my notes, very committed and to above $3 billion of peak sales based on the significant untreated patient population and clearly the momentum that we have around the brand and the execution of the team.

Now, with regard to your second question on the recent announcement from the administration on the Trump tariffs. Obviously, this news has only just come out, so we're digesting this and understanding what that could look like. But I would also point out that we do have a number of factories in the United States. I think we're 1 of the largest generic manufacturers in the U.S. But we have a bit of time to work this 1 out and understand what the administration is trying to do. And as you can imagine, we've always been in close discussions with the administration being such a contributor to the health care system in the United States. So thanks for your question.

We now turn to Uma Raffat with Evercore ISI.

I just wanted to spend a second on the IL-15 ahead of the Celiac readout and just drill down a couple of dimensions. One, I believe the last patient in was April 7, which means they should have been done by early June with the week 8 end point. So I'm just trying to understand sort of the timing of data. I would have thought it could have been as early as today, perhaps along with earnings. I realize that's not what the expectation was, but just wanted to understand the timing and sort of where you are in data analysis. .

Also, there's some prior disclosure you've shown on a Phase Ib exploratory celiac study, which shows this separation versus placebo. But the biomarker that it was shown for on the Y-axis was not laid out. What was the biomarker?

And then finally, could you remind us what's the amount of gluten per day background that's being used in your ongoing celiac study or your already completed celiac study?

Thanks for the question. I feel you're almost as demanding as I am with regard to wanting to see results as fast as possible. But with that, I'll hand it over to Eric to answer.

Thank you, Umer. Thank you for the very specific and up-to-date question. So first, the question about the enrollment. So the enrollment that you see on clinical drives. The changes you see there don't always correlate to when we're doing the database lock. So that's the simple answer. I have this. So there's nothing slow or fast about it. It's just as it is. So we'll have that data in the second half of this year.

With regards to the question about the biomarker in the first POC, so that was an FSB free acid binding protein. I think I got that right, free acid binding protein. And that's a biomarker, it's not uncommonly used to measure gut inflammation, and that separation we saw from placebo versus active upon that gluten challenges. Really, I mean, it was exciting to me to see that because that really indicated that we're having an impact, and 1 of the things I always like to mention, if you speculate or overread the data, not only did we protect that got with this biomarker by that readout, but it seems to actually get better on -- from the baseline. So whether we are treating a smoldering celiac those patients is something fun to speculate about. So it was this free acid binding protein in that study.

And then your final question was the amount of gluten challenge we're giving in the biopsy study that's going to read out in the second half of this year. So we're giving 3 grams every day for 6 weeks. That's a significant challenge in that study. And I think that team thought about there's various different ways you can do it, but that's a significant amount. I'm always impressed to see that we can enroll patients that are willing to do that. So hopefully, that answers all your questions.

We now turn to Louise Chen with Scotiabank.

I wanted to ask you about your biosimilars opportunity. You seem to be talking about that more. And just curious if you could give us a little bit more color on why the growth opportunity is becoming more meaningful now to you? And is there anything in the U.S. market that's changing here any potential actions for the regulators or payers in the horizon that could open up this market even more?

Louise, thanks for the question. So you're right, we are excited. I am excited about the biosimilars. We've been working on this hard to get the portfolio and to get this to market. And I think there are a couple of reasons why I'm excited. One is just the performance of the team we have in the U.S. in the market. And to give you some context, we have not always been first to the market. But what we've shown and what I highlighted today is 2 out of our 5 products in the U.S. market are #1. And I think a third 1 is about to become #1. And that just shows, I think, our capability, which leads a bit into part of your second question, what has changed in the U.S. market?

Well, actually, nothing really is changing. It's actually a very difficult complex, fragmented market. And why do I sound somewhat positive about that, I'm not. But what I know is with ever because of our reach and our scale and our scope of what we do, we're able to navigate what is a very fragmented complex market. And I think that's why you're seeing my excitement and about the performance we have in the U.S. If there's changes, I think that will be positive as well because we'll benefit from that. But we have more and more products coming to the U.S.

Now in Europe, where we really have been starved of biosimilars. And now, we start to launch them in Europe. What we're seeing is the first indications are that when we launch them, as you would expect, once again from Teva, which is a major player in all European markets, our ability to perform very well early on early signs of saying that we can do that. So the reason why in totality I'm excited is, as you put these 15 biosims together, another 14 that are coming through and more partnerships we're doing. I think this will be a major growth driver for our generics business as a whole. And so that's where my enthusiasm lies, and I hope we'll have a lot more data points to highlight that. And maybe to conclude, we did set ourselves a target for $800 million by 2027, as I said today on the call. We're well on track to exceed that already. So thanks for the question, Louis.

We now turn to Dennis Ding with Jefferies.

I had a question on celiac. So you guys have talked about using 4 Phase Ib as the bar on CD but that was 0.127 placebo adjusted and had very wide error bars. So this is actually a 2-part question. Number one, why shouldn't we use the CALYPSO data as a bar, which is around I think 0.4 to 0.5 million?

And then number two, if you can comment on the interpretability of your data, if you get, let's say, 0.15, 0.2 or 0.3, if you would consider that clinically meaningful? Or is there anything else in your data disclosure that you should point us to?

Over to you, Eric?

Yes. Thank you, Richard. So Dennis, we're using the bars that we can refer it against. I'm sorry. Forte is the 1 that's reported the number of 0.127. The CALYPSO data, I'm not sure if that's something readily available to us right now. So if we can get that data, that would be great to compare it to. I think the important thing is that you have to remember, these are all somewhat artificial gluten challenge they are different from study to study.

We designed a study that we think will give a nice result based on a single dose. Remember, we're doing a single dose looking at a 6-week challenge with a pretty good burden of gluten. The important thing is that we see that delta between the placebo, which should change the most. And hopefully, the active will stay similar.

So the 1 that's document is the most and I think is the most comparable is the forte result of 0.127 that you mentioned, and that's the delta between placebo and active. So I'm still kind of saying that that's going to be what we're going to measure ourselves against with regards to the results that we have access to.

The CALYPSO data, I'm not familiar with that. I'm not sure if that was posted or is available right now. So maybe we can follow up with you on comparing that. There's a lot of different things we're going to get -- we're going to learn from this study, not only the biopsy data, which is critically important for determining how we set up the Phase II and III studies, but also experiential or symptomatology data. So a lot to come there, but I think we're going to stick with comparing to forte at this point.

We now turn to David Amsellem with Piper Sandler.

So 1 on 408 and then 1 on ecopypane. On 408, particularly with Forte getting acquired, I wanted to get your thoughts, Eric, on how you view 408 mechanistically versus compounds that focus on CD122 and act on IL-15 and IL-2? And how you think those agents may or may not have an advantage with respect to 408. So that's a broad question. And I guess, multiple indications encompassing vitiligo and celiac and maybe others. .

And then secondly, on ecopitane, can you talk to positioning in the marketplace? As you think about D1 antagonism activity, do you think that there's potential that this could be used ahead of the currently approved antipsychotics that are primarily D2 acting? How do you think about that and particularly considering that those agents are generically available?

Okay. Eric, do you want to start on the NGL50?

Yes. Okay. Thank you for the question. So first, and maybe discuss the competition and how we approach the development of anti IL-15 versus how Forte approach it. There's nothing wrong with the 2 different approaches. You can hit the receptor like Forte has done or you can hit the leg and like we have with. There's a couple of things that we consider strategically when we design molecules. We like to go after the ligand. It's clean. You hit the free ligand and the cytokine in the system.

When you hit a receptor, you run the risk of creating some off-target complications doing that. So we just by strategy, do it a different way, but there's nothing wrong with either way. One other more subtle thing that you can do when you hit the ligand is you can measure target engagement. We measure the free anti-IL-15 level in the system. So that gives us a good idea of how much activity we are seeing at any 1 point over time. So we've shown the suppression of free IL-15 for out to 80 or 90 days on a single dose. That really drives evidence-based way of choosing your dose selection and schedule. That's why we are interrogating a dose given once every 3 months. It is a quarterly shot that we're developing as a subcutaneous shut.

So there's just strategic differences. Whether 1 is better than the other? We don't know. I'm just very confident in our modeling and simulation of how we'll move forward with a simple to get subcutaneous shot every 3 months. So that -- those are the biggest differences I see.

It's great to see the acquisition. I mean, it shows the value people are putting in these indications like vitiligo and celiac disease. I'm fairly confident these will be indications that grow just like we saw psoriasis growth, just like we saw atopic dermatitis. Once we get good treatments that are easy to give, they will be used and the market will increase. So that's your first answer.

For, the positioning of ecopipane, right now, people go through those first behavioral treatments for Tourette disease, then they try off-label drugs and like glyphenesene and other treatments that aren't approved, but actually have some modest effect. They're not great, but they're well tolerated. Then they advance on to antipsychotics, which have activity, but the tolerability is poor, particularly in a pediatric population. So the differentiation, the thing we're bringing to the table at is a brand-new mode of action. It's a D1 antagonist. It's much more tolerable. We believe in our hands. It was very tolerable in the Phase III and Phase II studies.

And we think that at first, they might not be first-line therapies, but over time, when people see this tolerability and the efficacy that it would probably be advanced over time. So that's how I see the order of entry and the value proposition that we have with.

Yes. And if I can add to that, Eric. I think the numbers back it up. As I said, there's 100,000 pediatric patients who suffer from Tourette syndrome, only 50% are treated. And I think that highlights why are they not treated. And I think it goes to that -- there isn't a product that gives efficacy and safety. And then that theory is further endorsed by the fact that only 20% to 30% remain on therapy.

And once again, an assumption around that is I'm not sure parents want their children to be on antipsychotic long term or some of the other drugs don't work that effectively. So either way you look at it, I think where there's a big unmet medical need for an efficacious safe, well-tolerated product. And I combine that with the expertise we have in the U.S. with AUSTEDO, UZEDY and AJOVY to how to treat certain patient populations and our experience with psychiatrists and neurologist. And I think that's why we have a lot of excitement around how we can help these patients, these children with this very distressing condition.

We now turn to Ash Verma with UBS.

Great. Can you talk about the TL1A new indication just for the fibronostics indication that you mentioned, what type of addressable market is that in terms of U.S. and European patients? And then for HS, what would be the development path and trial design look like? Is it typical Phase II, Phase III with a focus on high 50 as a primary end point?

Thanks for the question. I'll hand that 1 to Eric, you are having a busy day today.

Yes. So thanks for the question. The 2 indications I'm very excited about these 2 indications. And just to review how we think about the indications with our partner, Sanofi, first, the scientific justification has to be there, the market opportunity, the possibility of regulatory success, and of course, the speed. Those are the 4 benchmarks we use when choosing it. So why then HS and fibrosinotic cronies. There's a lot of great science around the fact that TL1A is upregulated in these disease areas, the fact that Th1 and Th17 cells are involved, you need a drug like do we keep to that has potential effects on multiple different pathways.

And then you add in the fact that there's a potential direct effect on fibrosis. All those things add up to the fact that HS is probably a very good indication going to, not to mention the fact that 15% of patients who have IBD also have HS. So there's a lot of science and reason to believe that this is a good treatment. HS is another market that's growing. You see this out there with the competition. It's a high unmet medical need. This will continue to grow. So the market opportunity is definitely there.

I think we have a good chance on the probability of success, and it's something we can execute very quickly. Usually, these primary endpoints are around 16 weeks. You can -- that's how we'll approach it most likely. And at this point in the development, we'll do a traditional Phase IIb study that will drive then a Phase III program. So that's what the timelines are looking at for HS.

Now, turning to fibrostynatic Crohn disease. This is another 1 I really think is a great idea. This is an area that's great unmet medically. There's no approved therapies for the indication of fibrostononic Crohn disease. And this is really 1 of the main drivers of the complications of Crohn's disease, where you have potential obstruction. You have hospitalizations. You have increased costs, increased symptomatology.

So if you can have a drug that potentially not only blocks the inflammation, but then really starts to work on these majorly obstructive fibrotic indemitist lesions in patients with Crohn's disease, that's a major differentiator for a drug launching into IBD. So hopefully, someday, we're not just talking about turning off inflammation in Crohn's disease, we're talking about changing the structure and the major complications within the disease.

So when I think about the opportunity here, it's not just scientific unlocking fibrosis, it's driving a better label, a broader opportunity for patients and a broader opportunity for the market for the company. So that's the thinking behind the 2 indications, I think that they're spot on.

I think we have time for 1 more question. Is that right?

Our next question comes from Sneha with Barclays.

Yes. This is Glen Santangelo. I think you got the name wrong. But essentially, Elliot, I just had 2 quick questions for you, if I could. I mean essentially, last quarter, I think you talked about the Osteo inventory sort of issues. And I thought the expectation was that those inventory levels would come down a little bit this quarter, but it seems like that wasn't the case. And I think you suggested that those inventory levels remain sort of elevated. So how should we think about that in 3Q and 4Q within the guidance expectations that you laid out?

And then secondly, I did want to ask about EBITDA. I mean given the strength in the innovative brands this quarter and how well you did on revenues and gross margin, you maintained the EBITDA guidance. And I was just kind of curious if there was anything different in terms of your expense outlook, that's kind of worth calling out given that you maintain that EBITDA guidance?

Glenn, Richard, thanks for the question. I'll start with the stat and then I'll hand to Eli for the EBITDA question. So with regard to this inventory, you're right, we had that inventory build in Q4 2025. And we're expecting to draw down. We saw some of that drawdown occur in the first half of the year, but not fully complete. And so we need to see the rest of that come down in the second half of the year and Q4.

And then just to reiterate what I think we've also been saying is how will Q4 levels play out anyway, knowing that the IRA price effectuation comes in, in Q1 2026. And I think that sort of is something that we also are keeping in mind when we think about guidance in AUSTEDO.

And then I go back to the fundamentals, is the TRx good? Yes. Is the milligram is growth good? Yes. Is our breadth and depth of prescribers good? Yes. So I think that gives us, obviously, confidence about where the product is heading, why we feel confident about $3 billion plus in peak sales. But just those are the dynamics as we manage through this inventory, both the early part of it from Q4 '25 and then understanding how that's going to play out in Q4 of this year.

And then on the EBITDA, I'll hand that 1 to Eli.

Thanks for the question. Yes. So look, as I mentioned in our prepared remarks and you saw from the slide the 3 main products, AUSTEDO, AJOVY and UZEDY at the midpoint now moving to $150 million. But net-net-net, what you see on the top of our top line, you see a midpoint of EUR 75 million, and this is related to kind of an offset that we see due to some softness in generics, as I mentioned.

All in all, it's very important to remember, like this is a really strong performance mainly when you think about the context on a tough prior year comp with removing $1.1 billion revenue and $700 million equivalent EBITDA from REVLIMID. Now, if you go to the range on the EBITDA that we said, and we need to understand that I mentioned that we're going to be at the higher range of the OpEx, around 28%, and this is related to some continuous investment that we are doing in order to make sure that our innovative portfolio in biosimilars are performing. And also we had slightly a bit on less, I will mention, and some other in-lines costs that we had in our first half and going to have in the second half. You saw the announcement on OCREVUS and small here, small there. So it's kind of a maybe a very small 20, 30 basis points on the total, if you look on annual revenue. But this is all dynamics related to investment related to supporting our innovative and biosimilars portfolio.

Thanks for the question, Glen. And I have realized actually -- we're actually going to take some more questions there. So 2 more questions. So next question.

We now turn to Matt Dellatorre with Goldman Sachs.

Great. Maybe coming back to TL1A, -- it seems like you guys are leaning kind of fairly heavily into these fibrosis heavy diseases. So I guess maybe how far could you go in that direction in terms of additional fibrotic indications? Are you going to kind of see how these play out and then go from there?

And then Eric, you touched on this briefly, but I guess, how should we think about in the sense of would this be primarily a differentiator on your CD label? Or could it be a separately indication different label?

And then maybe just briefly touching on the commercial side. I know you guys are prepping for 2 major launches over the next 12 months with olanzapine and EcoPPAM. Maybe just walk us through launch preparations so far? And what you guys are just most focused on from an execution perspective for both of those launches?

I'll let Eric start with TL1A 22. Over to you, Eric.

Yes. So thanks for the questions, Matt. And first, to start with the TL1A, the choice of HS and fibers Crohn's disease, first and foremost, they are inflammatory diseases with a major fibrotic component to it. So these are great ways to get into the field and show whether we're having a true effect. We still have to prove that TL1A has that antifibrotic effect. But these are great avenues to get in there and learn. Once we've shown that, yes, maybe we could in the future go to truly only antifibrotic or fibrotic diseases such as IPF or something like that. But right now, we need to prove the principle. And these are great indications because -- on the way to learning those things, we will show the great value in indications that have a high unmet medical need.

Now, going on to the question of fibrostenotic Crohn's disease, and what is our for what those will do in the future? I believe and I hope to have that as a labeled indication someday if we show good results. So that's the intention of those. So that really could differentiate us within the space of inflammatory bowel disease. So that's the intention.

And then the question about the launch of the ecopipane and our preparations, maybe, Richard, did you want to take that?

Yes. No. We do -- as you framed it, I had 2 major launches, we're very excited about. I think with regard to olanzapine, I think it's worth noting that we've been preparing for this launch for some time, thinking about how best to approach it, but that preparation has really been high quality, not just because of the team's thinking because we're out in the market every day, understanding the physicians, the patients, the payers, the intricacies of this market. And so the team has put a huge amount of effort into preparing for this, which is why we are very optimistic and enthusiastic about our ability to really help these patients who need a long-acting therapy for these severe schizophrenia patients. So I think very confident and looking forward to seeing that launch.

With regard to icopipane, based on the time of the FDA, this will probably could come out in the later part of Q2 next year. So once again, the asset has been transacted. We have it. We've been working and thinking about this for some time when we got close to the transaction. And we think this falls into our wheelhouse again. It's a rare disease, undertreated patient population, how do we get these patients motivated to seek therapy, how do we educate the physicians on a new therapy. This probably sounds very much like the things we've been saying around AUSTEDO because it is. And so that capability and that knowledge will leverage significantly.

Obviously, putting the resources in place and getting the right people in place, we're very good at that. The unmet need is significant. So very excited about that. And I think the timing actually works out, these are over a year apart. And we've got to get used to this because as I said in my remarks, we'll be launching a new product every year. So this is a muscle that we've been building. We're enthusiastic about it. We're not in all of it. We're leaning into it. And so I think you'll see an excellent launch of. But obviously, we'll give you more update as we get closer to that.

So thanks for your questions, Matt. Next question, I think is this last question? This is our last question. So who is it.

Our next question comes from Chris Schott with JPMorgan.

Just this is a Catarina on for Chris. Just 2 very quick ones. So first, just on AJOVY guidance for the year is coming up nicely. Just how much of this is volume versus price? And any other kind of color you can provide in terms of the trends you're seeing for that product? And then just on Europe very quickly, coming in a little lighter than expected. Just again, anything to call out there? And how should we think about results in the second half for Europe?

Thanks for your question. So on a go, we're very pleased with the performance of this. And as I said, this is across all markets. So we've got good growth in international, good growth in Europe and good growth in the U.S. As I highlighted in my remarks, in the U.S., there is some favorability on the contracting and what we've done there on gross to net, but also market share gains in the U.S.

We've also got market share gains in Europe and in international markets. And it's important to note that we are growing above the market in all of our regions. So that, I think, gives us an underlying good trajectory across all regions, but some good work down. I always remind people, when we started this journey with pivot to growth, AJOVY had been forgotten about. And now we're talking $1 billion asset. I think that's credit to the teams across all 3 of the regions that they've been able to do that.

Now, you also asked a question around Europe and the softness in Europe. And I think this goes back to something I mentioned also is we don't have as many high-value launches as we had last year. We also had a very low cough and cold season, and we have a particularly significant portfolio in cough and cold, so that impacted us.

On the positive side, we are launching more biosimilars. They've only just started, so we haven't really seen the traction of those. But we have more and more to come into Europe, which is a very attractive biosimilar market and is 1 that I've been disappointed that we haven't been in. But we've done a lot of work on this portfolio, and we're bringing more and more biosimilar to the market almost year-on-year. As I said, we have 14 more to launch, and we're going to consistently add more to that portfolio, and we'll end up with a portfolio mid-30s, close to 40%. That's our ambition. So hopefully, that answers your questions, Katherine, but thanks for the questions.

And then do we have 1 more, a bit confused? No, we don't have any more. So thank you, everybody, for your time and attention today. Thanks for the questions, and thank you, as always, for the interest in Teva.

Ladies and gentlemen, today's call has now concluded. We'd like to thank you for your participation. You may now disconnect your lines.

Hello, and welcome to the IL-15 vitiligo Phase Ib 24-week Efficacy Results 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.

Thanks, Alex. Good morning and good afternoon, everyone. 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 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. And any statements we make are only as of today, and we undertake no obligation to update these statements subsequently.

And with that, Richard Francis.

Thanks, Chris. Good morning, good afternoon, and thank you, everybody, for joining the call. Today, I'm very excited to share with you our anti-IL-15 vitiligo Phase Ib 24-Week Efficacy Results. And today, joining me on the call is Dr. Eric Hughes, Head of R&D and Chief Medical Officer, who will go through the details of the results. And then at the end, we'll have a Q&A to answer your questions.

Now the slide you see up, today is very exciting, the milestone on our pivot to growth journey as this slide highlights the progress we've made in transforming Teva into a world-leading biopharma company. As you see by what's in front of you on this slide, that 2026 is a year of milestones. Originally, we had expected 7, but with the addition of ecopipam's NDA filing, we now have 8 key events expected this year. Now, in that context, I'm really proud to talk about today's anti-IL-15 Phase Ib Results in vitiligo.

But I remind you, besides today's news, we have already shared the duvakitug maintenance data for UC and CD in Phase II in February. We also acquired ecopipam and filed it with the FDA a few weeks ago. And I'd like to remind you that we have many more milestones coming up in the second half of this year with Phase IIa top line results for Celiac for anti-IL-15. DARI will have its pivotal Phase III readout. And then for emrusolmin, futility analysis of the Phase II. And I'm also excited about the potential to launch olanzapine at the end of this year. And then finally, we have the anti-PD-1/IL-2 data coming up right at the end. So a lot of exciting data coming out from our innovative pipeline. So a really key year as we transition to a world-class biopharma company.

Now if we go to the next slide, the reason why this is really important to create value and sustainability for Teva is, if you look across this pipeline from olanzapine to ecopipam to DARI to duvakitug to emrusolmin to anti-IL-15, all of these have the ability to be billion-dollar products in their indications. And in fact, any one of which could be transformational to Teva.

As you can see by this slide, the size of the potential markets that they are entering into is significant and growing. We have a high-quality pipeline that is well positioned. We continue to drive our innovative portfolio for growth for many years to come. I do remind you that we expect our innovative portfolio to generate $3.5 billion of revenue in 2026. So everything on this slide will be building upon this already fastly growing platform.

I'd also like to point out that 2 programs on this list, anti-IL-15 and TL1A duvakitug will have multiple indications. And for anti-IL-15, as I hand over to Eric, I know he'll talk to you about vitiligo data, but also talk to the potential this product has in other indications.

So with that, I'll hand over to Eric.

Great. Thank you, Richard. And it's great to be here on the call today to talk about this exciting new data we have for our anti-IL-15 program. So if I can have the first slide.

Vitiligo is an important disease. It's an autoimmune disease that destroys melanocytes because of an immune reaction. It's a pretty common disease. It's about 0.5% to 2% of the global population. So many people are afflicted with this and many are undiagnosed still.

There is a psychological burden to the disease. It's not just a skin discoloration. It can cause anxiety, depression and social isolation. The only FDA-approved treatment right now is a topical that covers less than 1% -- less than 10% of the body surface area. So what's really needed is new treatments that are systemic in nature to treat the whole body because it's not just the face, it's the entire body that can be affected.

Come to the next slide. So why is IL-15 important? Well, it's a key Cytokine in the pathogenesis vitiligo. What happens is keratinocytes under stressful conditions, which are a number, can cause the secretion of IL-15. And it's that IL-15 localized in the dermis itself that drives the production and residence of CD8-positive T lymphocytes that are cytotoxic, and they attack the melanocytes and destroy those cells that cause the pigment within the skin. So with our antibody, blocking that IL-15 signal, blocks the continued proliferation and resonance of these cells in the skin, which will impact the destruction of the melanocytes and potentially have the potential to be a disease-modifying treatment. So it's a very exciting biology and a real targeted therapy for vitiligo.

On the next slide. So what differentiates our anti-IL-15 antibody? Well, first, it's, we believe, the most potent anti-IL-15 antibody out there. It was very well designed by our own labs at Teva. So it's a Teva-born molecule, same team that made duvakitug made this molecule. And its half-life is very long. So it's a clinically relevant dosing. You can see that you have a 38-day half-life, which is very important when it comes to the convenience for patients.

And that 38-day half-life that you see on the left-hand side of this slide translates into strong target engagement that you see on the right hand of the slide. This graph is showing the suppression of free IL-15 level in the serum. And what you can see here is a remarkable target effect where rapid reduction below the limit of quantitation happens within 1 or 2 days. And then at the top dose, you can see here, there's suppression below the limit of quantitation up to 80 to 90 days.

So clearly, with the half-life and the target engagement we see, the potential for dosing every quarter, that is once every 3 months is a strong possibility for this molecule. So we're very excited about this. The potential of a very easy to give safe molecule that's a subcutaneous shot once a quarter.

Come on the next slide. So let me do a little bit of a tutorial on how we measure -- yeah, go back one, how we measure the VASI score. So if we go back one more slide. Go back one slide. And forward one.

Okay. Well, I'll just start with this slide. So going over the study design. This is a proof-of-concept Phase Ib study. It was designed where we give one dose at day 0 and then one dose at week 12. And so over a 24-week period, which is the endpoint of the study, we've only given 2 shots of the medication subcutaneously. So it's looking at about 38 patients, and we looked at VASI scores of both Facial-VASI and Total-VASI.

It's important to note that 66% of the patients in the study actually had skin involvement that was greater than 10% of their body. And we will be monitoring the subjects out to 80 weeks. So a simple study looking at a conveniently given subcutaneous shot with an endpoint at 24 weeks. If I can go to the next slide. Here, going to this slide I was referring to before, just a quick tutorial on how we look at and measure a Facial-VASI and Total-VASI. It's a fairly simple methodology, but it's actually very reproducible with our dermatologic investigators.

And when you look at the Facial-VASI, it's a simple measure of using your fingertip, looking at the number of areas or the surface area involved in the face. So you use a fingertip, look at the areas of depigmentation, count up the number of fingertips and then multiply that by the level of involvement at each going from 0 where there's full pigmentation to 100% where there's no pigmentation, and you multiply that and get a score. In a similar way, you do the Total-VASI, which is a -- using a hand, which is about 1% of your surface -- body surface area, and you use the number of hand counts to quantitate the Total-VASI and again, multiply it by the extent of involvement in those areas. And that gets you to these 2 scores. These are regulatory endpoints that can be used for a Phase III study.

If we go to the next slide. Now getting to the exciting part, looking at the data that we saw in this study. Those patients with a Facial-VASI score from baseline to 24 weeks after just 2 shots of the treatment achieved a 42% response rate for Facial-VASI50. That's a 50% improvement in their facial score. And then the Facial-VASI75, where 75% of your face improves, those people or about 21% of the population achieved that. And then with Total-VASI, which is a 50% improvement of your total body, 7% achieved that. So we're very happy with these results.

This is very consistent with other Phase II studies with other oral systemic treatments. But for me, actually, the most interesting and satisfying fact was not only did we get these regulatory endpoints, but when you ask the patients what they thought their skin did during the study, the response was pretty impressive. With the Facial Patient Global Impression Change score, which is a validated score in vitiligo, 75% of the patients in the study said that their facial skin improved. And half of those were much to very much improved. And then when you look at the Total Patient Global Impression score change, 55% of those patients said that their skin improved.

So I've done work in dermatology before. And I think that the regulatory endpoints, we're glad to see we achieved a very competitive profile, but it's even more important that a patient who's looking at their skin every day and thinks about this on a daily basis, actually thought that their skin is perceived as improving was very impressive. So we're very happy to see that. And I think that will drive a lot of patient satisfaction with a potential treatment in the future.

Come to the next slide. So how does this compare? So one of the things that we have been mentioning is we want to be compared to systemic therapies. Upadacitinib is an oral JAK therapy that was actually just got a positive opinion from the CHMP, I think, just last week. When we look at the Facial-VASIs and the T-VASIs compared to that at 24 weeks, I think that they're comparable, if not favorable. So 42% compared to 38% and 39% for the Facial-VASI50. For the Facial-VASI75, we see a 21% versus 19% and 14%, and a Total-VASI of 7% versus 6% and 11%. So this is very encouraging for what we think about the effect that we're seeing.

And it's important to remember, our product is a shot once every quarter. And it has, to date, a favorable safety profile. When you compare that to an oral JAK that has to be given each day and then has a certain black box warning in their label, we think this is a good value proposition for patients given the convenience and hopefully, the safety that we show in the future.

If I can go to the next slide. One thing we did for today, which I'm very thankful for, 2 of the patients in the study, they're not representative of everyone. These are 2 patients that said they had very much improved skin on their face. They were kind enough to consent and give us a permission to use the pictures from their baseline to their week 24 time point. And what you can see first on the left-hand side, this woman had significant hypopigmentation with a wide area of her face. You can see almost loss of pigmentation completely.

And then at 24 weeks, you see a considerable improvement in that discoloration she had, particularly on her cheeks and her nose and above her brow. On the -- gentleman on the right, similarly, with a slightly darker skin saw a clear repigmentation on the brow, around the nares and around the mouth as well. So this is pretty -- to me, a dramatic effect where you can see even on the normal picture, the changes that you can see in the color of the skin. So I think this can have a huge impact on a person's quality of life and all the troubles that they run through in their mind every day when they're looking in the mirror.

So we're very proud of that, and we're very happy that these people were kind enough to let us use their pictures today. Like I say, a picture is worth a thousand words, really puts the numbers in perspective. Go to the next slide. So one thing we think about vitiligo, what is the opportunity here? And what's the level of unmet medical need we see in vitiligo? Well, today, before any systemic therapies are even available, we think there's about 4.1 million people in the U.S., EU, U.K. and Japan. And the targeted group, the therapies that these will -- the patients will be targeted for is about 2.7 million.

And currently, there's no approved treatment for that systemic therapy right now. But it's important to note, there's analogs in dermatology that really drive what we think will happen in the future. Psoriasis and atopic dermatitis are great examples where a disease area that was probably underappreciated 15 to 20 years ago as safe and effective biologics came out really drove the advance and the size and the understanding of the unmet medical need.

So psoriasis obviously grew to a very significant population, same thing with atopic dermatitis. We think that there is the potential that as we have better therapies like we hope we're developing here, we will drive the development of this market and really create a disease awareness when new therapies come out. So we're excited by the future opportunities here. So if I can have the last slide.

I'm sorry, I did want to mention too, anti-IL-15 is a very important cytokine, not only for Vitiligo, but there's a lot of crossover and carry through with other diseases such as Alopecia Areata. We have evidence preclinically of Atopic Dermatitis, but also in gastroenterology, such as Celiac disease and Eosinophilic Esophagitis. And that reminds me that, remember, we'll have our proof-of-concept study in Celiac disease readout in the second half of this year. But there's a lot of great potential for Anti-IL-15 therapy across multiple disease areas, and we're excited to be looking at those in the future.

So if I can have the next slide. Now we believe we have a differentiated product. This is an internally developed anti-IL-15. We believe it has the highest potency of the anti-IL-15's in development right now. It has a prolonged half-life of about 38 days, which will allow us a convenient dosing every quarter based on our data today and our target engagement biomarker data as well. I think the data today are encouraging. I think it's in line with the systemic therapies that have been also seen in Phase II. We're moving forward with our Phase II program this year.

And I also should mention that it's been very well tolerated, really no safety signals seen to date, and we're very happy about that. So we've already met with the FDA. I'm very happy to say that we're now incorporating feedback from them into our Phase II study, and we're very excited to get that going this year. As I mentioned, in the second half of this year, we'll also have the proof-of-concept data readout from our Celiac study. And we're excited in the future to be expanding into other indications that are a natural fit for anti-IL-15 therapy.

And with that on the next slide, I'm going to pass it back to Chris and we'll entertain questions if anyone has them. Thank you.

Thanks, Eric. And while Alex is preparing the queue for the Q&A, [Operator Instructions] and with that, Alex, please go ahead with the first question.

[Operator Instructions] Our first question for today comes from Dennis Ding of Jefferies.

Just one for me. On the long-term follow-up data, do you expect a big rebound in IL-15 once you stop the drug like you saw in the PK study? And how do you think that could manifest in safety? And given the durability of the IL-15 knockdown, I'm curious if there's a plan to approach dosing differently for induction and maintenance, and a 6-month dosing could be possible for maintenance?

Thank you, Dennis, for the question. So first, I'll talk about the long-term follow-up. So one of the things that our team has done which I'm very proud of, they did extensive follow-up even of our Phase I study. So we took some of our Phase I studies up to like 400 days. And we've actually characterized the suppression of IL-15 and then the recovery, as well as other things like NK cells. So we have a very good sense of the suppression level, the rebound and then it comes back to baseline.

And there's no associated AEs with the rebound of the IL-15. And in fact, that's really consistent with just the way in which the body recovers the homeostatic levels of NKs and the effects of IL-15. But it all comes back to baseline, and we would follow that out for a long period. And that's exactly why we follow the patients in this study out to 80 weeks. So we'll have a very good data set. I think the regulators appreciate long-term follow-up. So we're confident in how the drug works and how the body responds to it.

Now you mentioned in your other question about, I believe, in an induction dose and a maintenance dose. We're approaching this program with no induction dose. We are starting right off with the dose, and we're going to continue that way. I think that given the characteristics of the disease pathology, the loading dose is probably not necessary because I think we're shutting down the IL-15 within just a few days with the doses we're using, and that's probably not going to be necessary even in the fact that there's an exuberant expression within the skin. I think that the way that we're setting the program is the most convenient for patients, just the one subcutaneous shot and then continue that same shot every quarter. That convenience, and I think the biology indicates that, that's a good pathway to go.

Our next question comes from Matt Dellatorre of Goldman Sachs.

Congrats on the positive data. Maybe first on efficacy. Clearly, the data compare favorably to the oral JAKs. [ I'm just ] curious maybe what you're seeing in the early washout period, what you think you might be able to achieve on F-VASI at 48 weeks. It looks like RINVOQ did maybe 23% to 25% on a non-adjusted basis, F-VASI75. And then realized you guys just use a single dose here, should we expect you to do further dose finding in Phase IIb? Or are you all happy with this specific dose?

Great. Thanks, Matt, for the question. Yes. So your first point, and you broke up a little bit there. So correct me if I got the question wrong. But I think your first question is what would you expect at 48 weeks. So if you look at programs out there and the data that's been published and what our expectations are here, when you think about Vitiligo and how the disease happens, T-cells go in there and kill off the melanocytes. And then when you stop that destruction, the melanocytes have to then repopulate into the skin.

Usually, they come back from germinal centers at the hair follicle. So it takes time for these cells to come back and then recolor the skin. So the reason I bring that up is that time is something that helps you. So from 24 weeks to 48 weeks, we do expect -- we'll have to obviously test this, but we do expect the -- these scores to increase. You've seen that in other Phase II programs as well and Phase III programs.

So that's expected. There is a time element to the recovery, I believe, in Vitiligo. So that's my answer for the 48 weeks. With dose finding, this is a proof-of-concept study. We looked at one dose. Of course, we will be doing a dose-ranging study in our Phase IIb, and then that will rapidly transform into a Phase III study. One of the things that we're working on right now and have discussed with FDA is a seamless study design, which is a rapid way in which we can progress this compound quickly and use the known endpoints very efficiently.

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

Just wanted to follow up on the dose question. So you outlined the PK/PD data in healthy volunteers, 5 doses and then show the 2 doses on the free IL-15 levels. Can you clarify which of those doses you studied in the Phase Ib? Just, kind of, wanted to get a sense of are you leaving efficacy on the table? And as you look at doses in Phase IIb, have you studied that dose level 2 that appears to have the maximal free IL-15 suppression levels in this study, or if that's planned to be evaluated in the subsequent Phase IIb?

Thanks for the question, Jason. So I can't tell you the dose today. That will be presented in the congresses for the proof-of-concept study. But to your question about how do we approach Phase IIb now? This is a proof-of-concept single dose. We will be doing dose ranging. And that's important because I frequently obsess around our modeling and simulation. There is dose optimization we can do for the dose between the data we have on our PK, the data we have on our free IL-15 and the data we have on our NK cell reduction. So all those together, I think I'm pretty confident in how we're going to select the doses for Phase II.

Our next question comes from David Amsellem of Piper Sandler.

So on the percentage of patients with total body surface area coverage of over 10%, I think you said it was that 66% of patients in the Phase Ib that had over 10% coverage. What's your expectation or what should we expect regarding those patients in the Phase IIb? Is it going to be all comers? Or is it going to be patients with over 10% BSA coverage? That's number one. And then secondly, with that 2/3, 1/3 mix in the Phase Ib, how do you think that may have influenced the data on T-VASI and F-VASI that you had disclosed this morning?

Sure. So I'll answer the last question first. So we didn't see any effect on the baseline level on efficacy. It was very similar across the board. Getting back to the question of what do you expect to come into a Phase IIb study. So when I look at the publications out there today, looking at some of the studies had different baseline factors. In general, you see about 60%, 70% of the patients greater than 10% from what I see.

When we design the Phase II, it's going to be very clear. The baseline factors will include greater than 0.5 on the Facial-VASI, plus greater than 5 on the Total-VASI. So I think that's consistent with all Phase III programs at this point and what I think is expected by regulators at this point. So the population here reflected what we'll probably see in the future and our baseline factors will be based on a 0.5 Facial-VASI with a 5 on the Total-VASI.

Our next question comes from Louise Chen of Scotiabank.

Congratulations on the data. So I wanted to ask you if you think there are any read-throughs from your data today to your upcoming Phase IIa Celiac disease readout and any of the other products that you mentioned on Page 16 of your presentation? And then I also wanted to ask you, is there an opportunity to combine your drug with other Vitiligo drugs that are on the market?

Great. Louise, thank you for the question and comment. I'm just writing my notes down here. So Louise, first, your first question on the read-through. So I think most people in the field when they look at vitiligo, they would say Alopecia Areata goes hand-in-hand with vitiligo. So I would like to think that we have a decent shot when we do those studies, but it needs to be shown still. That's just the potential.

I also think there's a read-through with Celiac disease. I mean IL-15 is a key cytokine when it comes to Celiac disease. We have some great preclinical data in nonhuman primates. We have some great target engagement data. We had our first proof of concept in Celiac patients where we showed fatty acid binding proteins clearly differentiating between active and placebo. The second study that we'll read out at the second half of this year for proof of concept with the biopsies, I think, hopefully, will show similar effects. We still have to see the data.

But I do think there's quite a bit of read-through with these related diseases. In fact, many people who have Vitiligo frequently have Alopecia. People who have Celiac disease frequently have Vitiligo. So there is a lot of crossover, I believe, between the 2 -- the number of indications that we're looking at. And your other question was an interesting one about the use of combination therapies. That's a very interesting question.

I don't know whether you could add a JAK to an IL-15. I mean they're vastly different mechanisms. The exciting part about IL-15 is it's really potentially impacting the disease process itself. That is the T-resident memory cells where you're decreasing those and affecting them within the skin. And that could be theoretically a prolonged effect. JAKs, for example, are much more immediate tamping down and a broad tamping down of the inflammatory response in the moment. So that's a very interesting possibility. Theoretically, since there's such different mechanisms, you could do that.

I think you have to prove the safety and efficacy. But potentially a more interesting possibility is there is a study out there where there was an Anti-IL-15 that showed minimal activity in vitiligo, but with UVB light therapies, they showed a pretty dramatic effect, which scientifically might make sense because you're getting rid of the cells that are destroying the melanocytes, then you're adding that stimulus. This is purely speculation, but there is some data out there that suggests that, that might actually be something to study in the future.

Our next question comes from Chris Schott of JPMorgan.

I just want to come back to the Phase II Celiac data. Can you just help set some expectations here on what type of benefit you're hoping to see in that indication? And when we start to think about maybe the broader suite of indications beyond vitiligo and Celiac, is your plan to kind of maybe fully derisk these first 2 indications before you expand? Or should we start think about Teva starting to scale up some of those other indications that you lay out in the slides that's kind of in parallel with these first 2?

Thanks, Chris. Yes, great question. So the Celiac study is a -- that we'll read out in the second half of this year, it is a study in approximately, I think it's about 50 patients. It's a placebo-controlled study. It's a gluten challenge proof-of-concept study. So this is an important study to give us a sense of what effect are we actually having on the gut histology. So in this study, we dose them with either placebo or active. And then 2 weeks later, and it's just a single dose, 2 weeks later, we challenge them with 8 weeks of a gluten diet.

And then we do a biopsy at baseline and then we do a biopsy at the end of the 8 weeks. And the important thing, as I mentioned, is to give us a sense of are we affecting the gut lining when people are exposed to gluten? This is important because that will drive our understanding of the endpoint in our registrational studies because that will likely be a combination of both the gut histology and a patient-reported outcome. So the proof-of-concept study that will read out later this year in Celiac disease is just that. It's somewhat of an artificial study, but it tells us whether we have a true effect on a very important outcome.

That's an effect on the histology of the gut. And we'll use -- I would level set everyone that we'll use whatever publications are out there to compare our effect on that crypt depth to villous height ratio. That's going to be the most important readout of that study. Then your second question was what are we thinking about other indications for this. So I think that I have an order in my head to me. It's vitiligo, Celiac with Alopecia Areata, probably all going in simultaneous development. So it's just a matter of speed, and that's what we're trying to do the best here at Teva is to move very quickly. So we'll do probably those 3 in parallel, and I think we're moving pretty quick on them right now.

Our next question comes from Ash Verma of UBS.

This is Di on behalf of Ash. One question. Do you see any notable difference between the active and stable vitiligo patients just in terms of like response rate?

Yes. Great question. So we did look at that. We did have both active and stable. And just for everyone's knowledge, active is -- if they've had any change within the previous 3 months before the study, stable is considered anything that hasn't changed in the previous 3 months before the study. We looked at that, and they're very small numbers at this point when you start dividing up the study. Numerically, actually, the stable looked a little bit better than the active, but that has to be studied in a greater sense in the future with bigger numbers. But actually, it was kind of encouraged by the fact that it's stable, or slightly better.

Our next question comes from Umer Raffat of Evercore ISI.

I have a couple here, if I may. Just to clarify some of the things you've mentioned, Eric. First, let me start off on some of these efficacy comparisons versus some of the JAK studies. So the JAK studies were enrolling Total-VASI 5-plus only if they had failed a topical steroid or it was active disease. And I think you just touched on it, Eric, where some patients were stable, some were active because then they were stable, the JAK study enrolled 10-plus Total-VASI.

So could you remind us what percentage of patients were 10-plus just so that we're looking at apples-to-apples when doing some of the comparisons, number one. Secondly, on dosing, from your experience so far, how are you thinking about whether it's serum IL-15 inhibition, which is a key driver, or whether NK reduction is a key driver? And I ask because if it's IL-15, presumably you can get to deeper efficacy with monthly dosing, whereas if it's NK, which I suspect it may be, theoretically, the PD last 6 months, it doesn't have to be quarterly. So I'm just trying to understand quarterly because it seems to me like either it's monthly or it's every 6 months. So I'd love to get your take on that.

Yes, Umer, thank you. Great question. So the first one was who had greater than 10-plus on the percentage? Is that what you're asking in the study?

[Indiscernible]

I'm sorry, you broke up there, Umer. Can you just repeat that again?

Yes. I'm sorry. I was just wondering, is the vast majority of patients that were 10-plus?

There was 66% of the patients had greater than 10% of their body. So it was a majority. And from when I look at the literature, that's usually what many of the Phase II and Phase III studies had enrolled before. So very similar to what we should see in the future. Your second question is actually super interesting. I think it's a great one to speculate a little bit with you on. When I look at the data and I look at NK cell reduction, which you're correct, the NK cell reduction goes down and it takes a number of weeks to months to recover back to baseline.

The IL-15 is more rapid. And the IL-15 actually drives those effects on NK cells. Now when it comes to thinking about dose duration for vitiligo, remember, it's not necessarily the NK cells that are driving the pathology. It's the T-cells, the resident memory T-cells in the skin. So I feel like I have to stick with determining a dosing based on the free IL-15 suppression, not the NK cell reduction because I think the kinetics of the NK cell reduction may be true, but unrelated to what the effects are on the T-cells. So I have to go by the target engagement of the IL-15 that I measure -- we measure in the serum.

So that's how I differentiate it. I mean if you were to make a link between NK cells and actual vitiligo, you could potentially go longer. But I don't think that that's the way we're going to go forward now. We're going to base it on the 3-month suppression of free IL-15. I hope that answers your question.

So maybe just [Audio Gap] more on a multi-dose basis, perhaps on a more frequent monthly or so, should we expect deeper efficacy if free IL-15 is the driver here?

I certainly believe there's a potential that this is a disease-modifying treatment. Remember, this is not just a drug stopping an inflammatory process. It's stopping the signal that brings the T-cells to the epidermis. So if you're getting rid of the cell that's actually causing the disease, that could be a prolonged effect over time. And if that's persistent, that would potentially have a greater and greater effect over time. We have to show this, but it's basically a completely different way of treating it in many ways.

At this time, we currently have no further questions. So I'll hand it back to the management team for any final remarks.

So thank you, everybody, for your interest today and calling in. Once again, I just want to reiterate, we're excited about the progress we're making not only with anti-IL-15 in vitiligo, but the progress we're making on transforming Teva into a world-leading biopharma company. And as I pointed out at the start, this is just the second of 8 milestones this year.

So a lot more to come on this journey, very exciting times. And once again, we appreciate your interest, the inquiry, but there's a lot more to come. So I think, keep your diaries free because there'll be more calls like this coming up. Thank you.

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

Okay. Great. Great. Well, good morning, everyone, and thank you for joining us. My name is Matt Dellatorre, and I'm a biopharma analyst here at Goldman Sachs. And we're really excited to kick off the conference this morning with Teva Pharmaceutical, where I'm joined by Richard Francis, the company's CEO.

Richard, thank you for being here.

My pleasure, Matt. Good to be here.

Maybe just to kind of kick us off, give us an overview of where Teva stands today, including your core franchises, both branded and generic, your key pipeline priorities and just how you're thinking about the outlook and strategy for the company over the coming years.

Well, thanks for that question. So the outlook and the strategy for the next coming years is more of the same. So we sort of go back to the foundations of Pivot to Growth, the 4 pillars: deliver on our growth engines, step up innovation, create generics powerhouse and focus the business, which is all about capital allocation. And we've been executing that religiously for 3.5 years, and I think you've seen the results of that.

But specifically, I think the way for people to think about it is when you talk about the branded business, if you think about delivering our growth engines, we have, I think, put AUSTEDO on a clear path to more than $3 billion of peak sales, which I think was something which took a bit of time for people to realize was possible and now people see that. And we had good growth last year, good growth this year, good growth in Q1, and we're on track for our full year guidance. And then UZEDY continue to grow that extremely well, both on TRx and on revenue. And AJOVY, the one that everybody forgot about, we've now said it's going to be a $1 billion product. So I think we have those, soon to be joined by olanzapine, our long-acting product for schizophrenia, which is based on the same long-acting technology as UZEDY. So excited to bring that to the market in Q4.

So if you think about those first 3, those first 3 products, AJOVY, UZEDY and AUSTEDO, they've been growing our innovative business over 30% last year. Soon to be joined by olanzapine. And then next year, we're going to be launching ecopipam, our product for Tourette's that we did a business development, the acquisition of Emalex. So those 2 are another growth drivers. And then obviously, in 2028, we have DARI, dual-action rescue inhaler, as well as potentially emrusolmin for MSA. So from a branded point of view, you can see just some fundamental good foundations for growth. And then we'll talk about the pipeline later, what could be added to that. But if you just think about those, that's good.

And then the step-up innovation, the Pillar 2, I think we've really reenergized the pipeline, and we'll probably talk about duvakitug, anti-IL-15, emrusolmin for MSA and the multiple indications we have on duvakitug?in our target as well as for anti-IL-15. So we're really excited that we continue this growth beyond '30 into '40. And then that's the sort of the branded innovative business, which people didn't realize that we had 3.5 years ago, and now everybody has seen the potential of it.

And then on our generics business, we've turned that around from a volatile and somewhat declining business to a growing business, and we've significantly increased the amount of biosimilars we have. We now, I think, have 10 in the market. We have the second largest -- third largest portfolio in the world, and I think we'll soon be the second. And so we have a clear path to creating a generics business, which has a significant amount of biosimilar portfolio within that.

And so I think -- and then the final thing is, which you didn't really ask, but I'm just giving you a bit of a monologue here, so I apologize, Matt, is focus the business. And so capital allocation to drive that has been really a core capability that we've built whether it's the acquisition of Emalex, whether it's some of the partnerships we've done with Blackstone or Royalty Pharma to accelerate our pipeline or whether it's making sure we grow our in-brand products with the right sales and marketing. I think we've shown we can do that in a very disciplined way. And then obviously, we did announce in Q1 that we're going to have the potential to do buybacks in the future because as and when we see a good return on capital because we think that's a good thing for shareholders.

Great. Great. Yes, I want to dive in on capital allocation in a moment. Maybe before we do that, though, the stock has doubled since we were here last year. You speak with investors regularly. In your view, what do you feel is the most underappreciated part of the business still, if any?

Well, yes, there's no if, any, I think. Look, I'm pretty measured, so I'm sure this -- don't discount this too much, but I think it's all undervalued. But let me break it down because that feels like -- it feels like a trite answer. It doesn't mean to be. So when I think about -- if you think about our generics business, let's start with that. So we've taken that to stable over the last -- well, actually grown over the last 3 years, and we've changed the portfolio, and we're bringing biosimilars into the U.S., bringing biosimilars into Europe. But not only bringing in, we're actually becoming a market leader in many of the biosimilars we bring. And I'd just remind everybody that SIMLANDI, our biosimilar Humira, will, I think, soon be #1 biosimilar in the U.S. We launched that 2 years late, and I think we are 11th to the market. That just shows timing is good, and I'd always want to be first, but it's how you manage that very complex market and what capabilities do you have, what scale do you have.

So I think our generics business because the surge of biosimilar portfolio coming through, I think, is probably underestimated as an opportunity for not just stability but value creation in the future. But then the more obvious one is, I think as people have caught up with the innovative story at Teva, they -- it's sort of moving so fast, they can't quite catch up. So the AUSTEDO, we had the IRA overhang, that got taken away, and then people have to sort of ground themselves on this $3 billion, which we've told them about before, and I went, "Okay, $3 billion," "greater than $3 billion." And then I think if I just talk about AUSTEDO, UZEDY, olanzapine, AJOVY and ecopipam, those 5 products, because in our hands, the amount that they can grow, I don't think they're valued with that growth trajectory on them by anybody out there, maybe by you, but not by many people out there. Because I think what we've shown over 3 years, we can execute regardless of the product profile, where it's competitive area like migraine or schizophrenia. So I think that part is really still has some valuation.

But probably the sole biggest is I don't think there's any value in our pipeline or not enough. And I think if you look at DARI, which has a super high probability of success, but we'll know at the end of this year, and you look at anti-IL-15 and you look at duvakitug and you look at emrusolmin, I mean we have 7 readouts this year. So I think this will be the year that people start to go, "Okay, tell me more about this pipeline." And we're already hearing a lot of people wanting to talk about anti-IL-15, duvakitug new indications because I think people are starting to realize we're very good at picking the products to move into the clinic, and we're very good at engineering antibodies. And so because of that, I think people now need to know a bit more about it. But those, I think, are drastically undervalued.

So I think those are the elements of it. And look, I'm comfortable with that. I used to be quite uncomfortable with being undervalued. But as you say, we doubled from here from last year, and we'll see where we end up next year. But our stepping stone is in the execution we know we need to do to continue to create growth, top and bottom line, EPS and create shareholder value, is very clear in our minds. And we know what we need to do. And even if you risk adjust some of that, I think we still end up in a very, very good place.

Great. Great. Maybe going back to capital allocation. You highlighted this a moment ago. This has been a major theme for you all in first half. You had the announcement of the Emalex acquisition. You all did 2 funding deals with Royalty Pharma and then Blackstone for your kind of innovative products. A month ago, you announced investment-grade credit rating, the first of -- I guess, 3 more -- potentially 2 more coming up. And then also the potential authorization of a share repurchase program with earnings.

So clearly, you guys are taking a diversified approach to capital allocation, and you've been making a lot of progress. So maybe, I guess, the question here is just walk us through maybe the underlying strategy that kind of ties that all together and then how should we think about the next few years in terms of that strategy? Does it evolve? I think you mentioned a moment ago, more of the same. But I guess how should we just think about how that kind of stuff is going to look over the coming years?

Yes. So I think -- I'm really proud of our approach to capital allocation. So we talk about capital allocation at Teva all the time. We don't talk about resources. We don't talk about budget. We talk about capital, and that capital has to work for us. And that was really important because when we started this journey 3.5 years ago, we couldn't increase our OpEx. So we had to reallocate capital, and we reallocated it based on it could give us a return. And where we took it from was not going to give us a return, and maybe that gave us a negative. So we have to balance that out. So we became very clear about if we do something, we do it meaningfully. And any things in Teva that have capital, they have to earn the right to have capital. So that's everything. So that's a different mindset than I've ever experienced any other company, and that's on purpose.

So when we think about the things you said, if you just think about those, so we have not really increased our percentage of revenue OpEx since I've been here. We've transformed our pipeline, the funding of our pipeline. We've transformed the funding of our innovative products, and yet we haven't changed that. That's capital allocation. Because we have to take it from one place, we have to put it in another. And we do that, and we do it in pretty big numbers. I mean it's not a little bit here, a little bit there. We move big amounts of capital. We did that while we religiously paid down debt. So we're paying down debt.

And people forget that now we're investment grade, which is for one of the rating agencies, nearly 2 years ahead of when we said we're going to do that, right? And these are pretty hard markets, these rating agencies. And I think in the next quarter or 2, we'll get the other 2. So that shows when they look under the hood. And they really evaluate the vital signs of the patient, they're saying this is on a good trajectory. So I think we've done that.

And then we've made the decisions around partnerships. And to get partnerships, by the way, which I think are on good terms. So the partnerships we have with Royalty Pharma and the partnership with Blackstone, I think they're really good terms for us and they are good terms for Blackstone. But nobody got a good deal from Teva. It was a fair deal. And that's because of the quality of our assets and the quality of our strength of our positioning and our finance at that point. So I think that's one.

And then the Emalex Biosciences deal we did, I just remind people, we said we're going to do a deal like that, between $500 million and $1 billion derisked asset, that had its Phase III results, that we could put into our machine and we could make it a great success, but we don't want to put capital at risk with the turnover of Phase III results. So we did what we said we're going to do. And I think that's going to be a pretty good return on capital. So we have done a lot. Going forward, I anticipate a bit more of the same, and we're constantly looking at our long-range plan, how we allocate capital. But we do want to make sure we're building our pipeline. We've got a lot of indications of duvakitug, anti-IL-15, to fully push those through.

But you'll also see some potential deals like Emalex coming through again, but they've got to be right. They've got to be the right risk profile for us. But we know that our balance sheet is improving quite dramatically over the next few years, and our cash flow is going to improve dramatically. So we're planning for what that means, which is also why we talked about potential buybacks, that we've got to think about this capital is coming, let's not have it when it arrives and go, "What do we do with it?" We're planning for what money we're going to have and how we're going to allocate that now, which means we can do it in a more controlled fashion.

But hopefully, people will see we're so disciplined in the past. As we go forward, it will be more of the same, but in a really disciplined way. We have to get a return on the capital deploy. And we always think for long-term value creation, but I think we're very mindful of the fact that long term is becoming shorter now. And for Teva to keep proving us to be a rising star, we want to keep showing that we can give a good return on capital long term.

Great. Great. So I think you kind of answered this, but -- and we'll talk about the Emalex deal a little bit more in detail. But how are you thinking about kind of the cadence type and size of maybe further BD going forward? And are you guys seeing a lot of kind of opportunities like Emalex, which maybe went a little bit under the radar, but then when you guys announced it, people were like, "Okay, this is highly strategic for you guys, fits that kind of mold that you highlighted"? Is there a lot more opportunities out there like that?

There are, but it's super -- so I mean, look, I mean, I always joke, you got to kiss a lot of frogs to find a prince. And I'd say I was kissing a lot of frogs. And -- so although it was well received, we have been looking at many companies in the last 3 years. And I can tell you, we've been in situations where we haven't been able to get to a price because once again, go back to our discipline on capital allocation, we won't pay something that we don't think is going to be a good return on that capital and good return for shareholders' capital. So there are a lot out there, but we follow -- as a team, we work incredibly well. So as myself; Eric Hughes, Head of R&D Alan Littman, the Head of BD; obviously, Eli Kalif, CFO. And then depending on where it is, it could be one of the regional heads, often Chris Fox, who's based in the U.S. So we're very tight. We take BD at the executive level. We don't -- that's not delegated. We do it because we see the importance of it for driving value.

But yes, I think there's more out there, but it's got to be the right price. There's so many times that I have boards who think their assets worth more than -- it was that their company is worth more. And actually, just of the things we have looked at that I have a different value, none of them have transacted. Maybe I was more right than they were, but I think it's a tough world we live in and to get a return on capital, commercializing products in the U.S. and Europe, it's really hard now, really hard. And I think biotech companies need to really think about can they really compete in this very challenging commercial environment -- challenging payer environment and what return can they give their investors on their capital and how quickly can they do it? And I think I tried to help them understand that, and it's not too easy.

But we're on. We keep looking. We're constantly talking about it. And hopefully, we'll be able to do some more. But, one, we've got to be mindful of how much we can take in because commercially, we're launching a product every year. And often, these are synergistics, that's good like ecopipam will be. But at the same time, you can't necessarily plan it. Some deals come along. You get three together, and sometimes you go through a period where you just can't find the right one.

Great. Maybe switching to the pipeline. You guys are entering a busy catalyst period starting kind of midyear, and we're going to see, I guess, the IL-15 data probably in the coming weeks in vitiligo. And so I think there's a lot of excitement around on the pipeline. Maybe kind of just working through that pipeline chronologically in terms of the next launches. The next one is long-acting olanzapine, where there's a lot of excitement in terms of pent-up demand in that market for a long-acting option for that molecule. You all have a 4Q PDUFA.

I guess what are you guys most focused on from a commercial readiness perspective, given you have UZEDY already on the market? And then kind of given your latest interactions with the FDA, how are you guys feeling on the regulatory side in terms of the label being clean and potential AdCom or something like that?

So I mean on the -- I'll do it in reverse because it's quicker. So from the FDA, we're still in a part of the process where there's not a huge amount of communication. I think that we've had has gone well. I wouldn't necessarily read anything into that because it's sort of more of the administrative type. I think now we're entering the period where it gets a bit more interactive. But we feel really confident about the data set, the quality of the data. I mean, over 4,000 patients have now been injected and there is no PDSS. So I think we feel very comfortable. They have a really important product for a very needy patient population. But there's probably more to come on that, Matt, as we're now into a period where there will be more discussions.

From a readiness, this is one of those where we've spent a huge amount of time and effort on it. I mean we have UZEDY, which is in the market. We're talking to the same physicians. We're talking to them, the same nurse practitioners, the same formulary committees in hospitals, the same payers, it's Medicaid and Medicare predominantly. So we're in these every single day, and we built a huge amount of credibility. So we've done really well with UZEDY because we're very credible when we go to all of these different stakeholders. And I think we've become known as -- I think we're now considered to be one of the top three psychiatric companies in the world, right, from only a few years ago.

I tell you that because as we launch olanzapine, that's very different from when we launched UZEDY. So now we're launching olanzapine with all of those relationships, all of that understanding. And we clearly know there is a lot of enthusiasm around olanzapine. Don't forget there are a lot of Phase III sites in the United States as well, so people have practical use. But that capability we have in that team, I think, is exciting. We are working hard to make sure, from day 1, we create access to olanzapine.

I think the one thing I'd say is, and I've made sure people understand this, there's not going to be any meaningful revenue this year because there'll be a bit of stocking. But -- and even next year, I think H1, I wouldn't anticipate too much. Because first, we need to get into the Medicaid. So we just get on all the Medicaid. Some will adopt it straight away, and some have time lags, and so we need to get through that. And then on Medicare, we think that's going to be -- as it was with UZEDY, it still is, a long negotiation. So the reason why I tell people about that is that doesn't mean I don't think we'll get a lot of prescriptions. I think we'll get a lot of prescriptions. We'll get a lot of sampling. I think people will use this a lot. But to the point where it becomes a real revenue driver will be a bit later because we won't agree to deals that are not in line with the value and the premium we place on this product, which I think is important for long-term value creation. We did that with UZEDY. We showed we have discipline.

But I'm really excited about olanzapine for a couple of things. One, there's obviously -- it's going to help us create a $1.5 billion to $2 billion franchise. But also when you speak to psychiatrists and when you speak to nurse practitioners, there is a patient population so in need of a long-acting -- don't forget, these patients when they have an episode, their brain is slightly damaged and the ability for that molecule to work as effectively as it did before goes down. So every episode you need to stop because the long-term ability to have an efficacious treatment would decline otherwise. So there's a real, real need here. And I feel that -- I feel very privileged to be in a position that we launch something where physicians know the molecule, they think it's the most efficacious, they want to use it, they just don't have a long-acting. So I'm really excited about that launch and the potential that can have to create this $1.5 billion to $2 billion franchise.

Great. So maybe think about it kind of taking off mid-'27, kind of second half of '27?

Yes. And I think we've got credibility. We show -- we saw what we did with UZEDY. We did not do any deals with Medicare. We didn't think they value the product. And maybe they will this time. Okay, this one will come to the table. I think they'll take time. So I think that just means we have to grind through it. But we do know physicians will go through a prior auth. They will demand the product because they demanded UZEDY, and olanzapine has a far bigger unmet medical need there. But that's the right way to think about it, yes.

Okay. Great. I guess simultaneously, you'll be launching ecopipam from the Emalex deal in Tourette's syndrome. It seems like base case assumptions are probably like a mid-'27 launch or perhaps late '27 launch. You all have highlighted clearly synergies with your existing neuro franchise. You'll add a pediatric sales force, though. Maybe -- I guess, maybe kind of walk us through the broader how we should think about synergies with your existing commercial infrastructure. And then how should we think about the indication expansion strategy? I think there was potential that it could be used in stuttering, but just kind of high-level thoughts on the longer term?

Yes. So I mean, that's another one I'm really excited about. I mean the unmet medical need in Tourette's is huge. I mean there's 100,000 pediatric children who have Tourette's, 50,000 are on therapy, so half aren't. The ones on therapy don't stay on it long because you tend to end up an antipsychotic, which -- I think we're both parents. If your child has Tourette's, you don't necessarily want to put them on antipsychotic to deal with Tourette's. So there's a real -- they may start on it, but they don't stay on it. So they drop off very quickly. So we think there's a real unmet need here for a safe and efficacious product.

So I feel -- so it's another one, I feel super excited about the fact that I can, as a father, bring something to what is a very destabilizing condition for people in their formative years with a real unmet medical need. So I think -- and if you think about it, 100,000, 50,000 on therapy, not very good at staying on therapy. That feels a bit like AUSTEDO. It feels like the muscle we built with AUSTEDO, underpenetrated, how do you create awareness, how do we make sure patients start and stay on the right therapy. That's something which we've built that muscle up really well in AUSTEDO, which I'd say is hard, probably harder because they have schizophrenia, they also have AUSTEDO, they also have tardive dyskinesia. But we've got that capability.

So I feel we can make a really big impact on this. We are doing -- there's a lot of synergies, but we also do want to have a good launch. So as you said, we're having a pediatric team put together.

And then for the other indications, just to let everybody know, from a deal perspective, the deal was done on Tourette's. So anything that comes through that's stuttering the others, that will be an upside. But I didn't model that into the case from a capital allocation and return on capital. But we'll definitely look at that. And we'll also look at life cycle management, is there a way we can, even for Tourette's, improve the product offering for the children?

Great. Maybe switching to DARI for asthma, which kind of flies a little under the radar. This could be another, I guess, potential launch next year as well, late '27, early '28.

Probably early '28.

Early '28. [indiscernible] from a clinical perspective, and you all have highlighted a differentiated device and broader label than the current competitor product from AstraZeneca. So it creates kind of an attractive commercial setup. I guess, assuming we see positive Phase III data in early '27, walk us through, I guess, the key points of execution from a commercial perspective and how confident you are in achieving that potential, I think, $1 billion in peak sales you all have highlighted?

Yes. So we should have -- we have the potential to have some data this year. The Phase III will finish. Obviously we could have some data this year. I think it's just a question of -- it's an exacerbation study, so if that's all done. But it will be finished this year, whether we have -- I'd like to think that we could announce something, but we'll see. Then I think we're thinking about developing altogether. I think I sort of conceded to the fact that it's probably '28 that we'll launch this. But we'll see.

But in a way, it's interesting when you're launching olanzapine this year, ecopipam next year. DARI, the year after might not be a bad little cadence. And we could have emrusolmin for MSA in '28 as well. So it'd be not that I do like this. If they come along, we'll launch them, but that spread might not be too bad. But going back to your question of, look, this is a super -- it's another one that's really unmet medical need. I think over 5,000 people in the U.S. die every year because they don't have a dual-action rescue inhaler. So this is really serious. I think Astra is out there forging the market, creating the market. And I think it takes a lot to change the market, to change prescribing behaviors. So I think I'm glad we're following them. They can put the muscle, and they're a good respiratory company. They have a legacy there.

But I do think the fact that 25% of patients are pediatric patients, and we will have the pediatric indication, and we have a very simple device. So for me, the way I get to -- and I think I've said up to [indiscernible] 10 million patients in the U.S. [indiscernible] I mean there's nowhere near that now. So as that starts to come through, the pediatrics will come on us. And if we get 25% of that market, I think you're between $500 million and $1 billion. And then we'll probably start to encroach into the non-pediatric because we just have a very simple device. And I think in asthma, the simplicity of the device in many indications has been shown to be very important.

But I think DARI to me is one of those that will just, I think -- it won't be a spiked launch. I think we'll have some excitement around olanzapine and ecopipam and potentially emrusolmin and duvakitug. I think DARI will be slow and steady, but it will go on for a long, long, long time and be one of those, maybe a bit similar to AJOVY that just keeps on giving, and become sort of your hard-working portfolio opportunity. But that's why, to think about it, we're going to have to put a bit of resource behind that because it's not synergistic with any of our neurology or immunology.

You could argue there's a tiny bit of pediatric overlap with ecopipam. I don't think so. I'm not -- I don't try to be too precise on synergy there. I want to make sure we get the right launch. But that's also where I think we look at building around the DARI to make sure we have the right sales and marketing share of voice there, but being thoughtful about how much money we put behind it, knowing that it's one that's going to take time.

Great. Maybe switching to TL1A, kind of your crown jewel in some sense of the pipeline. The data to date, both induction and maintenance in IBD, suggests a potentially best-in-class profile, particularly in Crohn's disease. And so I realize this is a highly competitive space, and you all are making limited disclosures ahead of potential developments. But you did recently announce the $400 million Blackstone funding deal, and you're expected to disclose additional Phase II proof-of-concept studies indications later this year. Maybe without spilling all the details, give us a sense of maybe what's happening kind of behind the scenes and how we should think about the pace and the breadth of this development over the next, say, 2 to 3 years?

Yes. So let me start. It's an important question because -- so firstly, ourselves and our partner, Sanofi, feel that duvakitug has massive potential. So let me be really clear on that. That doesn't mean just in IBD. I think we both think it has significant potential there, but we think across multiple indications. So the good thing is we're very aligned on the fact that we think this is -- as a pipeline and a product, and we want to go after it like that. We will be announcing 2 new indications this year and starting them this year. That is the aim. But then we'll have more indications to come.

And that just goes to show that we believe, like some other companies who have a TL1A believe, this is a multiple indication asset. So I think just the ambition we have around this with Sanofi is very much aligned. And I really see us pursuing this in many indications over multiple years. And the good thing about it is it's -- okay, we believe it's very efficacious in IBD, but if you look at its safety and its tolerability, it's excellent. So if any product you're going to move into multiple indications, it's a product that has the profile. And as I speak to Sanofi about it, they have a very similar product in DUPIXENT, which is efficacious and very safe, and that allowed them to go into other indications. So I think we have a partner who understands this. So the ambition is there. We'll probably start to see some news flow on that. But let's not have any question about the ambition of it.

And I'd just remind you, in IBD, I think the market when we launch is now predicted to be between $35 billion and $40 billion, right? And that market is super unsatisfied. You can talk about efficacy, but I think we'll come out, and I think we'll still have either a leading efficacy in both Crohn's and UC, but we'll definitely have the best safety profile and tolerability. We won't have monitoring and won't have black box because, I mean, I think there's already been so many thousands of patients treated with the TL1As.

So I think people are probably discounting where TL1A fits in the treatment path. I think it will be a lot higher up, a lot quicker than people think just because it's efficacious and it's safe. And why would you not do something that doesn't require monitoring and doesn't have concerns about a black box? So I just remind people in IBD, I think, think about the size of the market when we launch in '29 and think about a profile like that.

Great. There's going to be a number of readouts this year from competitors. Maybe most notably, Merck will have Phase III data in UC. And they're also supposed to share Phase II proof-of-concept data in SSc-ILD, which could kind of give the field insights in terms of, I guess, the impact on fibrosis and maybe open up another category for the class. I guess how important are competitor readouts to your guys' development program and strategy? And is there anything that you guys view as particularly important for your program?

Look, I like the fact that they're all doing the work they're doing. I mean, I suppose I think about it, I'm not a scientist, so this will probably make Eric cringe a bit, but I think about our competitors are doing these proof of concepts, I believe categorically, we have the best TL1A by design. So it's by design, it's not just emotional. It's by design. And the level of potency, specificity, and neutralizing antibodies, so it's fact. And that's why you saw the difference in induction and maintenance in UC and CD. So because of that, I look forward to the data being turned over because those proof of concepts, in a way, are proof of concepts.

So as soon as we see those, then -- just to let you know, we have listed out, I don't know, 10 to 15 indications that have the potential scientifically. And whether they all come up, they don't because other things come out, other targets come out and more relevant. So things move around a bit, but there's real scientific rationale. So as these turn over, then I think it will give us a real insight. But maybe then that allows us to think about moving to indications where we know we have the best TL1A. So if their TL1A has good data, we know we're the best TL1A. So that gives us an interesting opportunity.

Great. Maybe now switching to IL-15. You all have your proof-of-concept vitiligo data in the coming weeks. And then celiac disease in second half following your $500 million funding deal with Royalty Pharma. Clearly, you and Royalty have seen positive results in vitiligo already. But maybe walk us through how differentiated a profile we should expect here relative to some of the current treatments in vitiligo, the oral JAKs, for instance? And I guess, what drives your level of confidence in celiac?

So look, I mean, that -- touching on vitiligo. So I haven't seen any data. So we're going to have it in a few weeks, so we'll see that. But the sort of the product profile that we have, the TPP is -- there's rationale to think we'll be more efficacious. But let's just say we are in the boundaries of efficacy that's out there. We're an injection that's once every 3 months. And we have -- and if we have what we believe we'll have is a very good side effect and safety profile. So we're not a topical that has to be applied twice a day. We're not something which has to be monitored or something that may come out with a black box. So every 3 months, we're safe and tolerable and the same efficacy. Now will the efficacy be better? I don't know. But if you just put it like that, I think for a dermatologist and a patient, it's a bit of a no-brainer. I've sold products that are more or less differentiated than that, and there's a real opportunity.

On the celiac, I think we'll see that data in the second half of the year. I think that will be really interesting to see whether this is an opportunity to sort of modify the disease and not just treat the symptoms. And so I think people are now starting to understand how big the celiac market is and how big the opportunity is. So I think that data will be really important. And I think that could -- it's amazing as we've run that study, the level of interest has increased significantly because people don't understand the severity of celiac in the severe patients and how that really destabilizes their life. So I think this is another -- a bit like vitiligo, no one knew about that market, and now they see that as a multibillion-dollar market. I think celiac will be a lot, lot bigger. But we'll have that data in the second half of the year. And I think that will be some really high-quality data with some endpoints that I think will really stimulate the market.

But I would add that in between that, we have a futility analysis on emrusolmin for MSA. So no news, but if it keeps going, there's some news there. We have the Phase III readout of DARI towards the end of the year. We have the PD-1 IL-2 readout in oncology, first-in-human data, the dose escalation study, at the end of the year as well, and we launch olanzapine. So I think we have -- and then we'll launch 2 more indications in duvakitug. So we have sort of 7 readouts and 2 more announcements. So I think from a reposition, we've always said we are transforming Teva from a pure-play, world-class generics company to a world-class biopharma company. I think that's already happened.

When I look at your notes and other people, people are already saying that. But I think this year will be the actual -- the final paragraph that underlines this is a world-class biopharma company and now how do we think about it from a value, how should we value it, how should we value the multiple, what multiple should it be on and what is its earnings going to be, top and bottom line, what is its cash flow going to be in 2030? Because those things will have changed dramatically with Teva in the next few years. And I'd encourage people to look at that.

Great. Well, with that, Richard, thank you for joining us. It's really exciting, and we look forward to all the updates in the coming months.

Thanks, Matt. We appreciate you hosting us. Thank you very much.

Jason Gerberry, I cover biotech and pharma. Pleased to be introducing Teva Pharmaceuticals and Eric Hughes, EVP, Global R&D and Chief Medical Officer. So Eric, thanks for joining us.

Good to be here. Thank you for having us.

So I thought I'd focus the discussion initially just on some corporate strategy matters, and you did recent Royalty and Blackstone deals. And so how should investors think about sort of those deals as a template for the future? You also did your first BD deal as well. So how you're thinking about capital deployment, but also giving up economics on certain drugs to expedite those through development? Are these in part done given you have margin targets and there's a desire to ensure that you deliver on those. So maybe we could start there.

Well, thanks again for having me. And yes, there's a fundamental way in which Teva is approaching our deals. So we have a relatively robust late-stage pipeline with a relatively high POS. So the way to create value is to go at pace. So these deals are really just the way in which we can -- I'd like to say, future-proof some of our programs. We've done deals on 4 of the 5 programs we've got. And what that does is gives us the gun powder to go really quickly. So we've done a deal with Royalty Pharma on olanzapine LAI. We did an Abingworth deal with DARI. We did a Blackstone deal with duvakitug. Now we've done the Royalty Pharma deal with anti-IL-15. And what that does is it keeps us unconstrained on speed. So the teams have really leaned into it. And you can see we've executed on these programs.

There's another fundamental part about that is that acceleration to get the launch a couple of years forward, to get launch going quickly, the value there is far greater than any cost that we're seeing in these deals. So that's one thing. And also, we're sharing the risk. So that -- those deals, they're sharing risk with us. So for us, it's a natural thing we'll lean into. Whether we do more in the future, it all depends, but it's all about unconstraining the speed in which we can develop the drugs.

To that end, right, you have the -- I'm going to botch the name, ecopipam right? So now you've got a launch opportunity in '27. You've got olanzapine LAI, which effectively is launching in 2027. You've got DARI, which launches probably sometime in '27 as well. I don't know if this is by design, but are you kind of like leveraging these deals to have a new indication or a new drug that launches every year through the end of the decade?

Yes. So I mean, just to sum it up, that's with ecopipam added to the list, that's 5 submissions in the next 5 years. So that's a fantastic runway on relatively derisked programs. So yes, the deals help just executing that with speed. And so we don't have to worry about any ups and downs in our budget. We're just moving quickly because that's going to generate the vast majority of the value on these programs. It's frustrating to see in my prior lives prioritizing programs. If you have to prioritize your programs, there's programs you shouldn't be doing. So we know that these programs all should be moving forward as quickly as possible.

Okay. There's a lot of focus on the upcoming IL-15 data that you're going to have for vitiligo. That's -- remind us that's a Phase I study, single-arm where you'll be looking at -- basically, the clinical endpoints are VASI based on face and body. But maybe if you could just educate us a little bit in terms of what you can glean from these single-arm studies? Are these proof of concept in your mind that inform pivotal study as a next step?

Yes. Yes. So the anti-IL-15 program for vitiligo, there's a lot to unpack here. The first thing I'd say is it's a great opportunity for our molecule. When we compare our molecules to others out there in the competition, we believe we have the most potent. It has a half-life of 38 days. We were focused on every 3 months giving a dose, a subcutaneous dose every 3 months. So there's a large convenience factor for the potential in vitiligo. Now getting to vitiligo, vitiligo, I think, is an underappreciated indication. This is more than 3 million people in the U.S. and the EU right now. And in my experience in dermatology conditions, patients are motivated. And although maybe vitiligo is underappreciated now, it's just like psoriasis 15 years ago where people didn't think there was any need for treatments there, and that's grown into a massive market.

So I think there's a great opportunity here. Patients are motivated. And when it comes to the anti-IL-15 program, there's only been one molecule approved. It's a topical JAK that can only treat 10% of your body and vitiligo is a whole body disorder. So systemic therapy is what's needed. There's oral JAKs that are being developed right now. That's a daily pill you take and there's the baggage of the JAKs with their profile. So we come in, I think, with a very good option for patients where you have a good safety profile with -- we hope, good efficacy that's going to be stacked up against the JAKs, but then there's a convenience factor after that. So if you get a very well-tolerated, safe treatment with a subcutaneous shot every 3 months, you're now treating those patients who need systemic therapy conveniently.

So the study is a proof of concept. It's 24 weeks. In those 24 weeks, you get only 2 shots of our anti-IL-15 one on day 0 and one at 12 weeks. And we follow them for the normal endpoints, the facial VASI you mentioned. So facial VASI 75 is the regulatory endpoint and the total VASI -- and the patients we brought in the study are very similar to the patients you see in a normal registrational program. So you have a certain level of facial VASI at baseline and a certain amount of total body. And that's important because the topical that's out there was targeted really to a more mild population. These systemic therapies are now at the moderate to severe level.

Your comment about like comparing this to psoriasis and maybe 20 years ago, psoriasis. I'm curious how well in the medical literature is segmentation characterized for those with more moderate-to-severe disease or perhaps a facial component to disease. I imagine these are going to be the most highly motivated to seek out systemic treatment. So I wonder from that 3 million, is this 20%? Is this 50% that have this perhaps more severe disease phenotype that would be motivated to treat?

Yes. I mean I can't give you a number today. But as we've seen, that will progress. The more disease awareness there is, the more that people learn that there's treatments, the numbers just keep growing. So it will start, obviously that people who are most disturbed by the facial things that you see in your hands and your arms are also disturbing the patients. But that number will continue to grow in my experience, where it will be probably a bigger market than we anticipate right now.

I think psoriasis is 30% on advanced therapy. So that could be potentially a proxy for 1 million patients?

Yes and that's how it starts. Yes. So the more severe, you can use that as a proxy, but then you'll see the more moderate people look for treatments.

So 24-week endpoint, that's about halfway through what will be a Phase III endpoint, which would be a full year. Can you talk a little bit about how this disease manifest over a 52-week period. Is it more of a slower onset. It takes time to accumulate to show clinical benefit in a clinical trial. So what I'm asking ultimately is what can investors -- how to think about 24-week data and stacking that up in terms of the clinical benefit. Other drugs see at 24 versus 52 week?

Yes. So yes, traditionally, in this disease area. So to start off with, actually, that's one of the nice things about this indication. It's a very clear pathway to registration. It's been shown how we do this. We know what we have to do. So if you're in a good molecule, you can move quickly. So traditionally, you do about 24 weeks in your Phase II, so you can get your signal, get an idea of where you're going. But to your point, it does continue to get better in general. When you look at the JAKs and you look at the topical JAKs, and it gets back to the disease mechanism.

So vitiligo is a destruction of the melanocytes that produce the color in your skin. And when you shut down the T cells that are causing the destruction, it takes time for those monocytes to then repopulate the skin. They usually grow out from the follicles and then repigment. So there's probably going to be a defined theoretical rate at which it gets better. So although Phase II is a 24-week readout and you should see an effect by 24 weeks, it will continue to get better at 48 weeks as those melanocytes continue to repopulate the skin. So we expect that to happen as well.

Okay. So I imagine there's going to be a desire for investors to benchmark this to upadacitinib, which is the oral JAK that's out there. And so does an oral JAK work faster on this disease versus, say, how IL-15 might work? And so -- because that could be relevant to how you look at 24-week data.

Yes. So that's a good point. There's a total difference in the activity of these different classes. So JAKs are more immediate, fairly broad suppression of the immune response. IL-15, the cytokine is a key cytokine in the way that vitiligo and celiac disease behave. IL-15 is driving the expansion and the migration of these intraepithelial lymphocytes into the skin. So while JAKs is a daily suppression in a broad sense of the inflammation, IL-15 could be considered potentially in the future as a disease modifier where you're blocking the cytokine that's driving those pathogenic cells into the skin and then preventing them from being resident in the skin. So you're stopping the cells from even being there. So that could be more of a long-term effect potentially, but it could be really modifying the disease pathology. So they're very different and IL-15 is a little bit more targeted in the way that it's going to be treating vitiligo.

Okay. So a couple of quarters ago, there was the potential to file this if everything went well 2031 to 2034, now it's 2031. So I'm wondering is what's changed now being 2031? Is it that you feel more confident about the data and how fast you can recruit a study because people will be excited about what the drug offers? Or is there something different about how you're thinking about trial design that could be faster?

Yes. So I think that's all of the above. And I think that the key thing is that we hit an inflection point where we have a very extensive Phase I program for this molecule that we've been running. We've been running proof-of-concept studies in celiac disease, and we're seeing the biomarkers we need to believe and we're confident in the dose and the exposure. We have defined the PK/PD when you're looking at free IL-15, which we measure uniquely in this program as well as the NK cells. So we have a very good idea of the dose range that we need to interrogate and like you had alluded to, vitiligo is a very clear pathway. And the endpoints that we see in the absence of any safety issues, we can move very quickly here, knowing where we need to go. So it's a totality of the data we're seeing and the confidence we have in the pathway forward. And that's largely why we structured the Royalty Pharma deal on vitiligo because it's something you can easily calculate.

Okay. And then you also have celiac as an indication to develop for this drug. And does the royalty deal contemplate financing for celiac? And the -- I think the trial that's ongoing is a gluten challenge type of study. So what can be gleaned from that? I know investors will look to with this mechanism, Amgen had a less potent drug that didn't work in the clinic. And how much confidence you can glean from this type of study? And I believe that the measurement you look at is what villous atrophy efficacy measure. Is that a registrational endpoint?

Yes. So yes, there's a lot there. And you're right, we based the deal with Royalty Pharma on the vitiligo, but the long-term payout, it does include the total package of IL-15. But getting to the disease itself, celiac disease and vitiligo are very similar in the driving characteristics. So you can think of the skin as the outward-facing epithelium and the gut is the inward-facing epithelium. And it's these T cells that the IL-15 are expanding and driving to these surfaces. So there's a lot of overlap. In fact, many -- there are a certain number of patients who have both diseases at the same time. So there's a lot of evidence that our anti-IL-15 is working in both of the diseases. I mentioned that we're very potent, have a great half-life.

But we've also done a lot of preclinical work, especially in celiac disease where we actually looked at nonhuman primates where 1% of those animals actually generate celiac disease. And we've done some great preclinical work with the molecule that shows that you can block the migration of those pathogenic cells into the epithelium, reverse antibodies and actually really protect their gut. And we're seeing -- we saw that in our first proof-of-concept study with our celiac program, where looking at a biomarker called FABP, fatty acid binding protein, we protected the gut from actual insults with the molecule. And in fact, over time, if you overread the data a little bit, you can actually think that we are treating an underlying smoldering celiac disease patients had. So that was a really strong biomarker data and the first proof of concept.

But the second one that we'll read out in the second half of this year is a placebo-controlled proof of concept and 50 patients, and we're looking at biopsies of the gut, at the baseline and 8 weeks after a 6-week challenge with 3 grams of gluten. So that will be a great proof of concept showing that we can achieve that regulatory endpoint to answer your question, both you want to show gut histology changes and you want to show patient-reported outcomes in a Phase III study. So those 2 things will have a very good sense going into Phase II and III with celiac after this study.

Okay. I'm realizing that my entire discussion guide is all about your branded efforts, but I wanted to step back and just ask how are you spending your time between the branded R&D effort versus the generic R&D effort? And as we think about Teva, which has a lineage in generic pharmaceuticals, I'm just sort of wondering where the R&D effort really is being put? Is it more of a selective approach? In this year, Revlimid coming out of the numbers, right? You rebased your U.S. generics business, which is very small now as a percentage of your total business. But I just wonder on the go-forward R&D operation and where you're spending your time, just curious if you can kind of frame that.

Yes. So the fun thing for me is I've got all of it under -- in my shop in R&D. So I've got a Head of Biosimilars, I've got a Head of Generics and I've got a Head of Innovative Medicines. And it's been a great experience over the last 3 years because one of the things I found -- I always kind of thought this was true, but I really have found that there's a lot of synergies that we get out of the knowledge base from our generics work from our biosimilars that we apply every day to our innovative group. So I will say this, I've been saying this for 3 years. We have one of the best device groups I've ever seen. I've been in a lot of big pharma companies. This group really knows how to make devices. We actually can make other people's devices better.

We have extraordinary formulation capabilities. And you throw that on top of this wonderful discovery we have in Sydney, where they make excellent antibodies. They can protein engineer anything. So when I have a problem on formulations, frequently, I don't go to my innovative head. I go to my generics head. If I have a device problem, I talk to the generics guys. And the production and the biologics capabilities that we have from biosimilars and our knowledge base there can easily be applied to all these programs. So there's a lot of synergies for me.

If I could squeak in one generics question then, right? Like when we think about the GLP-1 opportunity, right, there's seemingly some parallels to insulins in my mind, right? So basal insulins, price came down, no generic could ever be sold at scale at the pricing that was where it evolved to. The concern with GLP-1s is that pricing is coming down and is expected to come down even more such that when sema or tirzepatide is available generically with the patents, can you make money in that business and put all the money into making that at scale? So where do you guys stand? You've never went after insulins as it pertains to GLP-1, which is the hot topic within generics.

Yes. So I mean, I'll just kind of speak off the [ culture ] here a little bit about GLP-1s. We've actually gotten the first GLP-1 generics approved. I think that's a very strong business case for us to move forward, treating them as generics. I know we got a lot of questions 2 or 3 years ago about you should getting the GLP-1s, you should be innovative in that space. We consciously didn't do that, and that was actually an excellent decision because a lot of the investment we would have had to put into a GLP-1 program would be taking away from the opportunities we have in all this other pipeline. So I think I'm happy to look back and say that was a great move. We played the way we should play in GLP-1s, and that's what we'll do.

Okay. Let's shift gears to your TL1A program and really good data, maintenance data in both UC and I don't think you have the maintenance data yet in Crohn's, but you have the UC data.

We have both.

Okay. Maintenance and both. Now as we look ahead, there's a couple of dynamics playing out. We're seeing competitor combinations in the I&I world and Merck has Phase III data for its TL1A. So where is your focus in terms of development and thinking ahead to like the next step because I&I is a very dynamic marketplace. And so do you think single agent has a pretty viable opportunity in front of it? Or do you see kind of the space evolving more to combos and you want to like establish a solid monotherapy profile and then ultimately playing for combinations?

Yes. So I'll start off by saying I&I is a great space to be in. I mean it's got one of the largest growth potentials of all therapeutic areas, so does neuroscience. So our focus at Teva in neuroscience and I&I is a great place to be. And we've built a lot of muscle now, not only in the development space, but in the commercial space as well. So getting on to what the opportunity here for duvakitug is. I'll start off with the basics. The fundamentals are great on duvakitug. We think we have the most potent TL1A. We have the most selective TL1A. We have the lowest antidrug antibodies that have been reported out there right now. We had numerically the best induction data in both Crohn's and ulcerative colitis in the TL1A space. And now we just showed the maintenance data as our first milestone this year, again, showing numerically very high numbers, not only best-in-class, potentially best in disease.

So the opportunity for monotherapy for duvakitug is big. We're great to have the Phase III studies going with Sanofi. They're ahead of schedule on the enrollment at this point. We're going to continue to press making sure that we launch on time and within the pack. I think that ulcerative colitis will be in the magical 18-month window of launch. We will also probably be maybe second in the Crohn's disease space. So we're right in there. And I think at the end of the day, efficacy is king. So I'll answer your question about combination therapies, but monotherapy has so much to be shown to show going into the launch of this new class of drug. It's a totally new biologic class because remember, people with Crohn's disease and ulcerative colitis frequently, about half of them fail their therapy after 1 year. And this is a chronic disease.

There's over 4 million people with IBD, and they're all cycling through therapy as they fail. 20% of ulcerative colitis still get surgery, 70% of the people with Crohn's disease are still getting surgery. So there's a lot we can do for these people right now with a new monotherapy class. So that's a focus. Having said that, looking towards the future, I'm a guy who always believed in combination therapies across multiple therapeutic areas. I think there's a lot of opportunity there. As we bring together different classes, TL1A actually right now looks like a great class to combine with because the safety profile is strong at this point. And if that continues, combining it in different ways is a great idea.

That's all envisioned within the Sanofi partnership. If you were to, say, advance a molecule with bispecific properties that targets both TL1A and say, integrin or some other common mechanism. Is that all envisioned and that would roll up within the Sanofi partnership?

So we're free to do that. And they're actually doing that, and we're actually doing it as well. So it's actually a pathway we both can interrogate. And to be honest, our group in Sydney is very good at it. We're filing an IND for TSLP and IL-13 at the end of this year. And that knowledge base and our ability to combine these different drugs. Remember, we make all these biosimilars, too. We can bring many things together very rapidly in a very robust plan.

Just want to be clear here. So if Sanofi were the one to develop it, right, would that be a risk to you now that they can move forward with their bispecific? Or is that envisioned within the partnership? And...

I don't want to get into the details of partnership, but there's freedom to operate, yes.

Okay. Maybe -- with respect to Phase II proof-of-concept studies, where are you guys at in terms of exploring other indications? I know some competitors are. If you can just remind us where the effort is.

That reminds me of IL-15 too, but I'll do TL1A first. So we've already have our plans together for the next 2 indications with Sanofi, we will be announcing it probably later this year. But the way we approach it is for TL1A, I mean, it's so interesting this class where it's an amplifier of many different cytokine pathways. It's not just hitting one, it's an amplifier. So the potential is in -- we call it T2s, non-T2 or even fibrotic disease areas because this is also a unique class and the fact it has a direct potential impact on fibrotic cells. So that's something we always kind of hoped anti-inflammatories would do, but this one has a potential direct effect. So we bucket them in those big categories, and we're going to be choosing our indications in a way that follows the science, has the biggest market potential, maybe builds the label as broadly as possible and as quick as possible to develop.

Okay. Your alpha-synuclein, the oral agent, it's easier to say than emrusolmin.

Emrusolmin, that's correct.

So you got a Phase II futility analysis later this year. And so it's a really tough-to-treat population. It's been a great drug for drug development for others. And so I just wonder the significance of surviving a futility analysis, right? Because we should expect the control arm, the placebo group to pretty rapidly deteriorate. So if you can survive a futility analysis, can you speak to that and how that derisks this maybe versus other disease categories where you survive a futility analysis?

Yes. So there's a number of good points you made there, and it starts with the disease area itself. So it is a very rapid disease. You can see these people decline very quickly in a study. There's some differentiating factors here. I think that you mentioned it being a kind of a graveyard for drug development. I think that we have to make better molecules. And I think emrusolmin is the first molecule, which is a small molecule. It's brain penetrant, and it gets to the very genesis of this alpha-synuclein protein aggregate. It blocks it at the very beginning. It's not an antibody that's trying to mop up the stuff that's been released and is killing other brain cells. So it's great that we've seen some trends in efficacy with antibodies out there, but I'm hopeful that a small molecule that gets to the very upstream genesis of the problem could have a significant impact.

But again, this is a high unmet medical need. They progress very quickly. The futility analysis will tell us whether we're in the game. So I wouldn't belittle it and -- but we're moving very quickly. We're making sure that this study is as robust as possible with big sample size because if it hits, this would be the one -- my regulatory guy and I say all the time, if it works, we'll be the first one to ask for accelerated approval because these people need treatment desperately. 50% of them are in a wheelchair at 5 years, most of them have passed away by 10.

So the injectable options, which are RNA targeted and I believe there is some antibody approaches.

There's RNA targeting, there's antibodies and there's actually also an iron chelator, I think, out there.

I don't think the antibodies are using any sort of brains shuttling technology. The RNA-targeted questionable as intrathecal injections, whether they're crossing -- getting in the brain, right? So the premise here that an oral agent is the best approach to crossing blood-brain barrier and achieving target knockdown, which you can't measure in a clinical setting.

Yes. So you're pointing out all the challenges of this disease area right now and why a small molecule that's brain penetrant is really -- has the potential to have hopefully the greatest impact. All the other ones have a challenge. Certainly, antibody penetration across the blood-brain barrier is a challenge. And that has a long way to go.

Okay. Well, looking forward to the update there. You also have Phase III data in asthma for DARI, a program that doesn't get a lot of discussion.

I'm glad you brought it up.

It seems very derisked, right? You take a steroid and a SABA and we've got validation for that approach from AstraZeneca's AIRSUPRA. Maybe talk a little bit about your Phase III design, how it's different and how you see your approach is ultimately differentiated versus AIRSUPRA?

Yes. So I really like this program because it illustrates a lot of the great things that we can do at Teva. Teva makes a lot of inhalers. We're very good at developing them. They're a lot harder than you think. And this actually DARI inhaler epitomizes what we do best. And we put 2 drugs in a dry powder inhaler, advanced technologies. It makes a device that's very easy to use. You just click it open and you inhale whenever you want and close it up. This is in contrast to an MGI, metered dose inhaler, which is the typical spray that you inhale -- you have to inhale and coordinate at the same time. And sometimes you have to use a big spacer if you're a little kid and you can't inhale, right? So it really is a convenient device.

It doesn't require a lot of cleaning. It's easy to use, and it's particularly well suited for kids. So getting to the study, which is a great, big study that Teva is running that's got pediatrics, adolescents and adults in it. So it's probably the biggest study that had all 3 patients population in it. It will get us a good label because remember, 25% of the entire population is pediatrics, and you'll have a great device. So we'll let the market be developed by our competitors, but we'll come in, I think, with a better label and a better device.

Where are the guidelines now on ICS/SABA?

So that's actually -- I'm glad you brought that up. This is the first time I've ever launched or developed the drug -- in the guidelines. So that's a great place to be.

[Technical Difficulty]

Well, we're at time. Thank you Eric for joining us.

Thank you very much.

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.

All right. Good morning, everybody. Why don't we get started for our first presentation? We're very excited to host Richard Francis. He's the President and CEO of Teva Pharmaceuticals and we do have Eli Kalif, they are the front row. If you just want to raise your hand and show everybody. And we got Chris Stevo and Sanjeev Sharma representing the IR team. So we're happy that everyone could sort of join us.

Well, it was -- 2025 was a gigantic year for Teva, not only financially, I mean, a lot of accomplishments in the pipeline. So maybe as a good place to start, Richard -- I'm sorry, before I should have did that. Before we do that, I probably should introduce myself. Sorry, this is the first presentation of the conference, so I'm just warming up.

I'm Glen Santangelo. I'm the analyst at Barclays that covers the stock. So please feel free to follow up. If anyone has any interest in the name afterwards, we'd be happy to spend some time with you.

So Richard, thank you for joining us. We're excited that you guys could kick it off. Maybe as a good place to sort of level set the conversation, maybe you can sort of walk through some of those 2025 highlights, not only financially, but you had a lot of key pipeline updates. So maybe that's a good place to start talking about some of the accomplishments of last year, and then we can sort of dive right in?

Absolutely, yes. So thank you for hosting us. I always appreciate it. Good to talk to you. So '25 was a very important year. We've started the transition of Teva from a pure-play generics company to a biopharma company. We started that in 2023, the pivot to growth strategy. And I think we really gained momentum. And I think the way that's best exemplified is probably in this idea that transition to an innovative company sounds great on paper, and it sounds a great way to drive long-term value creation, but it's about the math, does it play out that way.

And last year, our innovative portfolio was over $3 billion, and it grew at 35%. So real momentum across all our leading brands, AUSTEDO, UZEDY and AJOVY. And so I think fundamentally, you've seen that drive down through the P&L. Our gross margin has changed, our ability to drive EBITDA and ability to drive EPS and create real shareholder value. So I think the skepticism could it be done has passed now. And I think now the questions always are, how quickly can you move this? How quickly can the transition of the portfolio continue? And what does the end game look like? And that's starting to now come to fruition with the pipeline.

And so although we had some -- we made great progress on the pipeline, really '26, it becomes sort of the breakout year. We have 7 milestones for '26. We have -- we started the year with the duvakitug maintenance data, which once again, I think, position it as the best TL1A out there. Q2, we're going to have the first data in anti-IL-15 in vitiligo. In Q3, we're going to have the anti-IL-15 data in celiac disease. In Q3, we're also going to have the futility analysis of emrusolmin in MSA, so a go and no go.

And then in Q3, we'll also have the readout of our dual-action rescue inhaler in asthma. And also in Q3, we'll launch olanzapine, our long-acting treatment for schizophrenia that joins its sibling, UZEDY which is doing really well on the market. And then in Q4, we have the first-in-human data on our PD1-IL2. So that doesn't sound much like a pure-play generics company. But that's sort of so -- 2025 now was a really good year. But as in Teva, it's all about the next year, and it's all about making sure we nail it in '26.

Yes. Well, I mean, so many good things to talk about in '25. And before we start diving into some of your branded drugs, I mean, is there anything that disappointed you last year? Anything that maybe was a little bit less than what you thought or I don't know if there was any sort of negative surprises?

Look, I mean, I'm generally quite a glass half full, half empty type of guy. As people who work with me, it's probably quite depressing sometimes. So I'm always looking for what is more. So I think there's things we could have done better across our business. But if I really step back and look at it objectively, we've moved the company on many parallels, whether it's our generics business, whether it's our biosimilar business, whether that's our manufacturing cost base, whether it's our innovative. So I think we've moved things in parallel at speed across quite a large company. So I think I'm very pleased with that.

So I think for once, I'm not saying we couldn't do things better, I think they're more in the margins. And I think one of the things I was particularly proud of is we started this organizational effectiveness, this cost efficiency program, and we achieved our goal in '25 when we started it, and that set us up well for '26 to achieve 2/3 of the $700 million. So when I reel off the things we've done, probably the one thing actually and I think about it, I would have liked to have done some BD. I would have liked to in-license something. But we have a real focus on capital and the return on capital deployed. We have a good organic growth engine. We can do a lot organically. We'd like to add something to it, but it's got to be the right price, and it's got to fit in. And if ultimately it isn't, we're good at holding the line and staying disciplined.

Okay. All right. So why don't we dive into your branded portfolio now? Why don't we start with AUSTEDO, 30% growth 3 years in a row. I mean, that's probably surprising to you, right? I mean, essentially, you crossed $3 billion right now in your 3 branded products, but with AUSTEDO, obviously, is the majority of that. So maybe that's a good place to start. And what's sort of given you the ability to grow maybe much faster than you would have expected, right?

I mean, I seem to remember you guys put out that $2.5 billion goal in 2027, and we seem to be getting there faster than expected. So maybe could you talk a little bit about some of that brand strength and maybe what's driving that to help us kind of assess the durability of that recent trend?

Yes. No, look, I think it comes down to 2 particular areas. One would be what is the market opportunity? So I think that plays an important part. And then, what is our focus on our capabilities? So the market opportunity as much as this is still surprising, 85% of patients who are diagnosed with tardive dyskinesia are still not on therapy. It's a very dynamic market where people come on and they come off. And so the opportunity to drive real growth and change people's lives is huge still.

So that's the sort of market dynamic. And I think what we've done and a lot of what we do at Teva is about applying real prioritization, real focus, having clear expectations, applying the right level of resource, having a great team with great capability, but clear expectations setting. So when we set the $2.5 billion in '27, for me, that was one where the organization then had to step up and say, okay, let's work back. What do we need to achieve in '23, '24 and '25 to get there?

And so a really talented team, super focused, and that team keeps getting better. It's very impressive. And so great market. Excellent execution. And as you say, we may get to the $2.5 billion ahead of -- a year ahead, which sort of is quite surprising to many who obviously, as you said, didn't believe it was ever going to happen. But I think that's a testament to understand the opportunity, applying the right resources and executing flawlessly.

Could we talk about the XR transition in there as well because that's having a pretty -- we see it having a pretty big impact on the pricing, right, which I'm sure there's a margin that's associated with that? If you could just sort of talk about maybe where we are in that transition process?

Yes, it's a good point, Glenn. Thanks for bringing it up. So obviously, we have this patient dynamic, lots of new patients coming in, but also we launched the XR formulation once a day. What that has allowed patients to do is to titrate to a more efficacious dose easier because they do that easier, they end up on a higher sort of average dose. Still, by the way, less than the Phase III clinical trials. There's still some way to go, but we have seen that. And if you look in all our quarterly results, we do emphasize the growth in milligrams per patient. And it's been in the 20% for quite some time.

So the opportunity to bring more patients in is that the opportunity to get those patients on XR, which helps them get on to a more optimal dose, which helps them be more compliant and adherent. If you think about that, there's so many opportunities we have to keep growing the brand. But as you've highlighted, the milligrams does correlate to value. So that is a value driver. And we still have a long way to go to get patients -- majority of patients on XR and majority of patients on the optimal dose. So I see -- that's why when we talk about the greater than $3 billion for the asset, we have a high degree of confidence in that and I think people are starting to also get confident in achieving that number.

And when I think about the guidance for this year, $2.4 billion to $2.55 billion from memory, right, that kind of implies only 6% to 13%. I say only after 3 years of compounded 30% growth. So I get that. It feels like it continues to be an underpenetrated opportunity. It feels like we got the ongoing XR tailwind. It feels like maybe there's some competitive share gains. And I don't know if you want to talk about the competitive dynamics of that market, but it still feels like there's a lot of those tailwinds that are kind of still in your favor and maybe we're seeing the deceleration of growth from the law of large numbers, some pricing in there, but I don't know if you want to just sort of touch on that?

Yes. So it's -- so a couple of things to focus on there is as you saw, we had a really big Q4. In Q4, we highlighted that we had about $100 million benefit from the channel stocking in and a bit of gross to net, mostly the channel stocking in. So that sort of sucks out of Q1. And so if you take that out and reverse that out, we've grown at between 11% to 18% this year, 18% at the high end. And I think 18% off a 30% compound growth, as you said, it should come down because we're growing off a bigger base. So I still think it's really healthy.

The one thing I take the opportunity to highlight this year and people ask about the range, part of that is because we had destocking in Q4, but also part of it is we're not quite sure how it's going to play out in Q4 this year with the IRA price being initiated in Q1 of '27. So are people going to have different inventory levels in Q4? Maybe. So we'll see how that plays out. We're watching what the other -- the first wave of IRA drugs have done. We've got a good idea. But that just to help people understand that range. It's less about new patients coming in, less about our ability to execute. It's more about those dynamics, which are hard to predict.

I think just sort of moving on, it feels like to me a little bit AJOVY and UZEDY, they sort of get lost in the shadow of AUSTEDO. I don't know if there's any high-level commentary you want to make on those 2 drugs because they continue to be great growth drivers for the company. And now I think your branded revenues are up to almost 20% of the total revenues, and they're meaningful contributors as well. I don't know if there's anything you wanted to add on that front?

Yes. No, I think it's really important, actually, I'm glad you brought up. So firstly, let's take UZEDY. UZEDY is a long-acting risperidone schizophrenia product. And when that was launched, expectations, I think, generally were really low. And that's probably fair enough, big incumbent brand in that sector, other brands, genericized. So really, really difficult competitive environment. We've come in, I think the high end of the guidance this year is $280.

So really shown a great product, great product profile and well executed, what a brand can do. So I think actually, this shows -- this is -- this really shows the capability that we have in our team to take a difficult market to understand the dynamics of it, to have the strategic thinking to understand the price and the access is a really important sort of ratio. And so I think UZEDY, people need to look at it and go, wow, what is done because we're going to talk about olanzapine probably shortly. And then that's the franchise of $1.5 billion to $2 billion.

And then AJOVY, I think it just shows what commercial products can do in Teva's hands. So AJOVY was sort of given up on. The injectable CGRPs, the orals have come in, the market has gone, it's very competitive, big players across all of our regions, we continue to grow at double digit, over 20%, and we're taking market share. How do we do that? Same thing. Great focus, great planning, great execution. Those fundamentals we're good at. So I'd say, AUSTEDO, UZEDY and AJOVY have a lot in common. It's about excellence in planning, understand the market execution, which is worth talking about because when we talk about olanzapine, DARI, duvakitug, all the products that are coming to market, we will launch them really well.

Okay. We're going to talk about olanzapine, duvakitug and the rescue inhale in 1 second, but I just have one last question before we move to the pipeline. You have a world-class generics business. We talk about it a lot. I don't know if there's sort of any high-level commentary you want to make with respect to pricing trends. We have biosimilars now sort of flowing through there. Maybe the cadence of those biosimilar launches a little slower than maybe you would have thought. I don't know where we stand, but it's such an important component because of the cash flow of your business that it generates that enables you to do all this other sort of R&D and business development activity. Any high-level generics commentary and then we'll...

Yes, absolutely. Once again, I think sometimes if you look at generics on its own, there's some really impressive results to talk about, but we've talked about some other exciting areas. But let me talk about generics. So this is quite a volatile business. But in the 3 years, we've generated a CAGR in the mid-single digits across the whole business. And it's one of the largest in the world. So it's a big business to do that over.

I think some of the exciting things we've done that are ahead of us now to come is we have a biosimilar portfolio of 28. We've launched 10 now. We have 10 on the market. We're going to launch another 6 by '27. We're going to launch the rest starting '28 going forward. We're going to keep adding to that. So now we have the second largest biosimilar portfolio. So if you think about all that growth and performance we've driven in our generics business, it's been without biosimilars. So I think if you think about this, it's like thinking a car that is getting even more efficient, a really, really good engine, and we're applying biosimilars to it. That's the turbo.

So I think we're setting ourselves up for, I think, a very positive future for our generics because we've changed the portfolio and we've changed the manufacturing network. So we're going to start to see our COGS coming down, which allows us to protect our gross margin. So a lot of good things, and that does allow us to keep fueling the pipeline, which we'll talk about because we have a really big broad pipeline and it's late stage. So we need to fund that.

Okay. Let's move on. On the TL 1A, you obviously just published the 44-week data. That looked probably stronger than I think most people were expecting and so I mean, what was your sort of interpretation of that data readout? Does that make you incrementally more bullish? And any high-level thoughts as you're embarking on these Phase III trials?

Yes. Look, we were always bullish because we know we've made the one -- the best TL 1A, and we made it by design. So we didn't fall into having the best. We designed it to be the best, and it is the best induction and maintenance. And so I think the frame is and I'll ask people to think about, we don't think we have the best TL 1A to compete with TL 1As in UC and CD. We think we now have an asset that will compete across [MOAs] . So we think because its efficacy, its safety and its tolerability, no monitoring, we believe there'll be no black box.

So we think this could be really a big player in UC and CD. So for us now, I think Sanofi posted $2 billion to $5 billion of peak sales in UC and CD, and we sort of took that. I challenge whether that's ambitious enough, but we'll wait. And I always remind people if it's the $2 billion, which I struggle to understand why, it's a game changer for Teva, but it won't be based on the efficacy of the data we're seeing.

So I mean, I think when you announced that Sanofi partnership, some people were surprised, right? And now we've had the Blackstone sort of partnership announced more recently. Could you just touch on that quickly on why you did that?

Yes. No, that was a Royalty Pharma partnership. So look, I think the key principle for people to understand is, and it's a key belief we have at Teva is we have a great pipeline, but pipelines, in my view, is all about bringing to the market as fast as possible. That is the sole link. Bringing to the market as fast as possible, you create significant value. That's our job. Now we happen to have a really, really exciting big pipeline with many indications. Duvakitug could end up in 5 to 10 indications, right? So we have big ambitions.

Anti-IL-15 is going to be in 3, possibly 4 and 5. And so for us, it was all about let's not get stuck in the rounding error of what this financing can do long term for multibillion-dollar assets. Let's just get it to the market as fast as possible. And that's our key principle. And I think what you've probably seen in 3 years is a company that seems to have no pipeline innovative to have now one of their busiest late-stage pipelines. And so that's our approach, move fast, get it to market, create value, create shareholder value and maximize that patent life.