Q2 2026 Teva Pharmaceutical Industries Ltd Earnings Call
Speaker #1: Hello everybody, and welcome to the Q2 2026 Tever Pharmaceutical Industries earnings conference call. My name is Elliot, I'll be coordinating your call today. If you would like to ask a question during today's event, please press Star followed by 1 on your telephone keypad.
Operator: Hello everybody, welcome to the Q2 2026 Teva Pharmaceutical Industries earnings conference call. My name is Elliot. I will be coordinating your call today. If you would like to ask a question during today's event, please press star followed by one on your telephone keypad. I would now like to hand over to Christopher Stevo. Please go ahead.
Operator: Hello everybody, welcome to the Q2 2026 Teva Pharmaceutical Industries earnings conference call. My name is Elliot. I will be coordinating your call today. If you would like to ask a question during today's event, please press star followed by one on your telephone keypad. I would now like to hand over to Christopher Stevo. Please go ahead.
Speaker #1: I will now lift the hand over to Christopher Stevo. Please go ahead.
Speaker #2: Thank you, Elliot.
Speaker #3: 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.
Christopher Stevo: Thank you, Elliot. Good morning and good afternoon, everyone. Thank you for joining us on our Q2 call. Obviously, our materials are posted to our website this morning, so please see those. Before I turn the call over to our CEO, Richard Francis, I would 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.
Christopher Stevo: Thank you, Elliot. Good morning and good afternoon, everyone. Thank you for joining us on our Q2 call. Obviously, our materials are posted to our website this morning, so please see those. Before I turn the call over to our CEO, Richard Francis, I would 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: These factors are described in our earnings press release and are most recent Forms 10Q and 10K filed with the SEC. Any statements that we make are only as of today, and we undertake no obligation to update these statements subsequently.
Speaker #1: Hello, everybody, and welcome to the Q2 2026 Teva Pharmaceutical Industries earnings conference call. My name is Elliot, and I'll be coordinating your call today.
Speaker #3: With that, Richard Francis.
Speaker #2: Thanks, Chris, and good morning and good afternoon, everybody. Thank you for joining the call today. And on me, joining me the call today will be Dr. Eric Hughes, Head of Global R&D and Chief Medical Officer, and Ellie Khelif, our Chief Financial Officer.
Speaker #1: If you would like to ask a question during today's event, please press star, followed by 1, on your telephone keypad. I will now hand over to Christopher Stevo. Please go ahead.
Richard Francis: Thanks, Chris, and good morning and good afternoon, everybody. Thank you for joining the call today. 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 the slide I always start with, the Pivot to Growth slide, our strategy that we launched in 2023 that is based on these four pillars. We will summarize how we have performed against these four pillars in Q2. Just to give you a quick overview. On deliver 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 is worth reminding you that the innovative portfolio is reshaping our financial profile with stronger revenue growth, margins, and free cash flow.
Richard Francis: Thanks, Chris, and good morning and good afternoon, everybody. Thank you for joining the call today. 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 the slide I always start with, the Pivot to Growth slide, our strategy that we launched in 2023 that is based on these four pillars. We will summarize how we have performed against these four pillars in Q2. Just to give you a quick overview. On deliver 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 is worth reminding you that the innovative portfolio is reshaping our financial profile with stronger revenue growth, margins, and free cash flow.
Speaker #2: Thank you, Elliot.
Speaker #2: Now moving on to the side hour we start with, the pivot to growth side. Our strategy that we launched in 2023 that's based on these four pillars.
Speaker #3: 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.
Speaker #2: We'll, we'll summarize how we've performed against these four pillars, in Q2. But just to give you a quick overview, on delivering our growth engines, Esteto, Jovi, and Yoseti all delivered strong Q2 performance, and we are raising our full-year revenue guidance for these products.
Speaker #3: 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.
Speaker #3: 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.
Speaker #2: 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, our pipeline, this year will provide eight major milestones.
Speaker #3: 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.
Richard Francis: As we move on to the second pillar, step up innovation, our pipeline this year will provide eight major milestones, and this now includes ecopipam pipeline, and this gives us the potential for five submissions over the next five years. With regard to creating a 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. On our final pillar, focus the business. I think we made great progress on our capital allocation. We have had one of the agencies upgrade us, Fitch, to investment grade, and we see the other two 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 are expecting to launch next year if the FDA approves.
Richard Francis: As we move on to the second pillar, step up innovation, our pipeline this year will provide eight major milestones, and this now includes ecopipam pipeline, and this gives us the potential for five submissions over the next five years. With regard to creating a 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. On our final pillar, focus the business. I think we made great progress on our capital allocation. We have had one of the agencies upgrade us, Fitch, to investment grade, and we see the other two 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 are expecting to launch next year if the FDA approves.
Speaker #2: And this now includes EcoPipan, and this gives us the potential for five submissions over the next five years. With regard to creating a generic powerhouse, biosimilars are becoming a growth platform within generics.
Speaker #3: With that, Richard Francis.
Speaker #2: Thanks, Chris, and good morning and good afternoon, everybody. Thank you for joining the call today. And on me, joining me the call today will be Dr. Eric Hughes, Head of Global R&D and Chief Medical Officer, and Ellie Khelif, our Chief Financial Officer.
Speaker #2: 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, focus to business, I think we make great progress on our capital allocation.
Speaker #2: Now, moving on to the side—now we start with the pivot to growth side. Our strategy, which we launched in 2023, is based on these four pillars.
Speaker #2: We've had one of the agencies of greatest fit to ingress and grade, and we see the other two doing this in the not-too-distant future.
Speaker #2: We'll summarize how we've performed against these four pillars in Q2. But just to give you a quick overview, on delivering our growth engines, Austedo, Ajovy, and Uzedy all delivered strong Q2 performance, and we are raising our full-year revenue guidance for these products.
Speaker #2: We also allocated capital to the acquisition of Amalex, and we closed that deal in June, and we're expecting the launch next year if FDA approves.
Speaker #2: 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 Tever accessible to more investors.
Richard Francis: 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. Moving on to the financials. I'm really proud of this slide. You may ask why, but let me walk you through why. We have stable revenues despite nearly 8% of headwinds from generic Revlimid last 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 generic Revlimid. We're actually growing our EBITDA, obviously excluding the Amylyx acquisition, and our free cash flow is up 31% as a result of our disciplined capital allocation. If I go on to the next slide, I'll give you a bit more detail.
Richard Francis: 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. Moving on to the financials. I'm really proud of this slide. You may ask why, but let me walk you through why. We have stable revenues despite nearly 8% of headwinds from generic Revlimid last 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 generic Revlimid. We're actually growing our EBITDA, obviously excluding the Amylyx acquisition, and our free cash flow is up 31% as a result of our disciplined capital allocation. If I go on to the next slide, I'll give you a bit more detail.
Speaker #2: 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, our pipeline, this year will provide eight major milestones.
Speaker #2: 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.
Speaker #2: Now, we have stable revenues despite nearly 8% of headwinds from generic Revlimid, last year over year. We're growing our profit, margin as well, 80 basis points.
Speaker #2: And this now includes Ecopipan, and this gives us the potential for five submissions over the next five years. With regard to creating a generic powerhouse, biosimilars are becoming a growth platform within generics.
Speaker #2: Improving gross margins year over year driven by strong innovative growth despite this loss of generic Revlimid. We're actually growing our EBITDA obviously excluding the Amalex acquisition.
Speaker #2: 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, focus to business, I think we make great progress on our capital allocation.
Speaker #2: 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.
Speaker #2: We've had one of the agencies of greatest fit to ingress some grade, and we see the other two doing this in the not-too-distant future.
Speaker #2: As you can see, the innovative portfolio has had a strong quarter, up 43% year on year. Esteti up 40%, Yoseti up 43%, and Ajovi up 56%.
Richard Francis: 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 generics Revlimid contribution versus 2025. If I now go into a bit more detail, starting with AUSTEDO, a core growth driver here. This is another strong quarter. In the US, revenue reached $676 million, up 33% year-over-year, and global revenue up 40%. Demand remains 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, strengthening convenience, adherence, and long-term durability. Because of this strong quarter, we're now increasing our outlook by $50 million at the midpoint, so it's now $2.45 billion to $2.6 billion.
Richard Francis: 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 generics Revlimid contribution versus 2025. If I now go into a bit more detail, starting with AUSTEDO, a core growth driver here. This is another strong quarter. In the US, revenue reached $676 million, up 33% year-over-year, and global revenue up 40%. Demand remains 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, strengthening convenience, adherence, and long-term durability. Because of this strong quarter, we're now increasing our outlook by $50 million at the midpoint, so it's now $2.45 billion to $2.6 billion.
Speaker #2: We also allocated capital to the acquisition of Amalex, and we closed that deal in June, and we're expecting the launch next year, if FDA approves.
Speaker #2: Generics is down 15%, and this is largely due to lower generic Revlimid contribution versus 2025. But if I now go into a bit more detail, starting with Esteto, a core growth driver here.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: This is another strong quarter. In the US, revenue reached $676 million up 33% year over year, and global revenue up 40%. And demand remains strong, with TRX up 14% and milligram growth up 21%, supported by new patient starts and adherence.
Speaker #2: Now, we have stable revenues despite nearly 8% of headwinds from generic Revlimid last year, year over year. We're growing our profit margin as well, by 80 basis points.
Speaker #2: Improving gross margins year over year, driven by strong innovative growth, despite this loss of generic Revlimid. We're actually growing our EBITDA, obviously excluding the Amarex acquisition.
Speaker #2: Esteto XR now represents over 60% of new patients, strengthening convenience, adherence, and long-term durability. And because of this strong quarter, we're now increasing our outlook by $50 million at the midpoint, so it's now $2.45 billion to $2.6 billion.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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%.
Richard Francis: 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 a year early. 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. 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. That was reflected in our TRx and NBRx 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 it has now gone from 5% to nearly 10%.
Richard Francis: 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 a year early. 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. 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. That was reflected in our TRx and NBRx 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 it has now gone from 5% to nearly 10%.
Speaker #2: But I think more importantly, we see continued momentum, and a significant untreated population that still could benefit from Esteto, and hence our confidence in greater than $3 billion of peak sales.
Speaker #2: Generics is down 15%, and this is largely due to lower generic Revlimid contribution versus 2025. But if I now go into a bit more detail, starting with Astero, a core growth driver here.
Speaker #2: Now moving on to Yoseti. Yoseti continues to grow with strong momentum. It is the fastest growing long-acting injectable treatment for schizophrenia amongst atypical LAIs.
Speaker #2: This is another strong quarter. In the US, revenue reached $676 million up 33% year over year, and global revenue up 40%. And demand remains strong, with TRX up 14%, and milligram growth up 21%, supported by new patient starts and adherence.
Speaker #2: Revenue grew 43% to $77 million in Q2 based on strong demand. And that was reflected in our TRX MOT up 63% year over year.
Speaker #2: The commercial execution has been impressive, and this can be seen with Yoseti nearly doubling the risperidone long-acting share, and it has now gone from 5% to nearly 10%.
Speaker #2: Austedo XR now represents over 60% of new patients, strengthening convenience, adherence, and long-term durability. And because of this strong quarter, we're now increasing our outlook by $50 million at the midpoint, so it's now $2.45 billion to $2.6 billion.
Speaker #2: And Yoseti is capturing nearly 80% of the risperidone LAI market. And because of this strong performance, we're increasing the outlook by $15 million at the midpoint, so the new guidance is $270 million to $290 million.
Richard Francis: UZEDY is capturing nearly 80% of the risperidone LAI market. Because of this strong performance, we're increasing the outlook by $15 million at the midpoint. The new guidance is $270 million to $290 million. This continued excellent execution has given us great confidence in the upcoming launch of olanzapine, which I'll move on to. Olanzapine represents a meaningful next growth opportunity with FDA action and US launch anticipated in Q4 of this year. The unmet medical need is significant. Olanzapine holds roughly 20% of US oral prescriptions, while olanzapine LAI use is less than 1% of the LAI market. 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, nurse practitioners, or some of the long-term care facilities.
Richard Francis: UZEDY is capturing nearly 80% of the risperidone LAI market. Because of this strong performance, we're increasing the outlook by $15 million at the midpoint. The new guidance is $270 million to $290 million. This continued excellent execution has given us great confidence in the upcoming launch of olanzapine, which I'll move on to. Olanzapine represents a meaningful next growth opportunity with FDA action and US launch anticipated in Q4 of this year. The unmet medical need is significant. Olanzapine holds roughly 20% of US oral prescriptions, while olanzapine LAI use is less than 1% of the LAI market. 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, nurse practitioners, or some of the long-term care facilities.
Speaker #2: 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 a year early.
Speaker #2: 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 US launch anticipated in Q4 of this year.
Speaker #2: But I think more importantly, we see continued momentum, and a significant untreated population that still could benefit from Astero, and hence our confidence in greater than $3 billion of peak sale.
Speaker #2: The unmet medical need is significant. Olanzapine holds roughly 20% of US oral prescriptions, while Olanzapine LAI use is less than 1% of the LAI market.
Speaker #2: Now moving on to Yosedi. Yosedi continues to grow with strong momentum. It is the fastest growing long-acting injectable treatment for schizophrenia, amongst atypical LAIs.
Speaker #2: Now, we know this market. We can really leverage the synergies with Yoseti, but also the deep knowledge of the schizophrenia market, whether that's physicians, patients, nurse practitioners, or some of the long-term care facilities.
Speaker #2: Revenue grew 43% to $77 million in Q2, based on strong demand. And that was reflected in our TRX MOT up 63% year over year.
Speaker #2: The commercial execution has been impressive, and this can be seen with Yosedi nearly doubling the risperidone long-acting share, and it has now gone from 5% to nearly 10%.
Speaker #2: 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 Yoseti, gives us a compelling path to an expected peak sales of $1.5 to $2 billion of revenue.
Richard Francis: 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 an expected peak sales of $1.5 to $2 billion of revenue. 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, we lead in many of the markets despite entering late. Q2 global revenue reached $244 million, up 56% year over year. The US revenue grew 83%, driven by improved contracting, favorable gross to net, and market share gains. Ex-US momentum remains 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.
Richard Francis: 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 an expected peak sales of $1.5 to $2 billion of revenue. 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, we lead in many of the markets despite entering late. Q2 global revenue reached $244 million, up 56% year over year. The US revenue grew 83%, driven by improved contracting, favorable gross to net, and market share gains. Ex-US momentum remains 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.
Speaker #2: And Yosedi is capturing nearly 80% of the risperidone LAI market. And because of this strong performance, we're increasing the outlook by $15 million at the midpoint, so the new guidance is $270 million to $290 million.
Speaker #2: Now moving on to Ajovi. Ajovi 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.
Speaker #2: Now, this continued excellent execution has given us great confidence in the upcoming launch of Olanzapine, which we will now move on to. Olanzapine represents a meaningful next growth opportunity, with FDA action and U.S. launch anticipated in Q4 of this year.
Speaker #2: Q2, global revenue reached $244 million up 56% year over year. The US revenue grew 83% driven by improved contracting, favorable growth to net, and market share gains.
Speaker #2: The unmet medical need is significant. Olanzapine holds roughly 20% of US oral prescriptions, while Olanzapine LAI use is less than 1% of the LAI market.
Speaker #2: XUS momentum remains 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.
Speaker #2: Now we know this market. We can really leverage the synergies with Yosedi, but also the deep knowledge of the schizophrenia market, whether that's physicians, patients, nurse practitioners, or some of the long-term care facilities.
Richard Francis: The range is $850 million to $870 million. Looking beyond 2026, we see a clear path to $1 billion peak sales for AJOVY. Moving on to the newest member of the innovative family, ecopipam, 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. The unmet medical need is clear. There are 100,000 pediatric patients who live with Tourette syndrome. Only 50,000 are treated, only 20% to 30% remain on therapy after one year. This shows there is a real need for a product like ecopipam with compelling efficacy and favorable tolerability.
Richard Francis: The range is $850 million to $870 million. Looking beyond 2026, we see a clear path to $1 billion peak sales for AJOVY. Moving on to the newest member of the innovative family, ecopipam, 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. The unmet medical need is clear. There are 100,000 pediatric patients who live with Tourette syndrome. Only 50,000 are treated, only 20% to 30% remain on therapy after one year. This shows there is a real need for a product like ecopipam with compelling efficacy and favorable tolerability.
Speaker #2: And looking beyond 2026, we see a clear path to $1 billion peak sales for Ajovi. Now moving on to the newest member of the innovative family, Ecopipine.
Speaker #2: Our direction of travel is clear—to deliver a best-in-class launch that expands treatment options and reinforces our leadership in LAIs. Olanzapine, together with Yosedi, gives us a compelling path to an expected peak sales of $1.5 to $2 billion in revenue.
Speaker #2: 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 the potential launch in the first half of 2027.
Speaker #2: Now, moving on to Ajovi. Ajovi generates 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.
Speaker #2: 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 one year.
Speaker #2: Q2 global revenue reached $244 million, up 56% year over year. U.S. revenue grew 83%, driven by improved contracting, favorable gross-to-net, and market share gains.
Speaker #2: So this shows there is a real need for a product like Ecopipine 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 Esteto, Yoseti, and soon-to-be long-acting Olanzapine.
Speaker #2: XUS momentum remains 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.
Richard Francis: We're well positioned to execute on this, leveraging our CNS capabilities and the experience we've garnered with AUSTEDO, UZEDY, and soon to be long-acting olanzapine. This moves on to a slide which I've never been able to show before, actually, in my rather long career. I apologize for the small font, we had to get everything on one slide. What this highlights is just the innovative pipeline we have and our potential to launch one asset per year for the next five years, transforming Teva into a leading biopharma company. The near-term launches are clearly sequenced. Olanzapine in 2026, ecopipam in 2027, followed by DARI, emricasan, and duvelisib through 2028 to 2030, obviously all subject to regulatory approvals.
Richard Francis: We're well positioned to execute on this, leveraging our CNS capabilities and the experience we've garnered with AUSTEDO, UZEDY, and soon to be long-acting olanzapine. This moves on to a slide which I've never been able to show before, actually, in my rather long career. I apologize for the small font, we had to get everything on one slide. What this highlights is just the innovative pipeline we have and our potential to launch one asset per year for the next five years, transforming Teva into a leading biopharma company. The near-term launches are clearly sequenced. Olanzapine in 2026, ecopipam in 2027, followed by DARI, emricasan, and duvelisib through 2028 to 2030, obviously all subject to regulatory approvals.
Speaker #2: 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 one slide.
Speaker #2: And looking beyond 2026, we see a clear path to $1 billion peak sales for Ajovi. Now moving on to the newest member of the innovative family, Ecopipone, a first-in-class opportunity with compelling efficacy and favorable tolerability in Tourette syndrome.
Speaker #2: And what this highlights is just the innovative pipeline we have, and our potential to launch one asset per year for the next five years, transforming Teva into a leading biopharma company.
Speaker #2: A serious pediatric neurological disorder with limited treatment options. We've already filed with the FDA with the potential launch in the first half of 2027.
Speaker #2: The near-term launches are clearly sequenced: Olanzapine in 2026, Ecopipine in 2027, followed by Dary, Emresolmun, duplicated through 2028 to 2030. Obviously, all subject to regulatory approvals.
Speaker #2: 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 percent remain on therapy after one year.
Speaker #2: But looking up to 2035, we see further upside from the additional indications that we've announced there for duplicated, as well as the additional indication of anti-R15, as well as our TSLIP IR13.
Richard Francis: Looking up to 2035, we see further upside from the additional indications that we've announced today for duvelisib, as well as the additional indication of Anti-IL-15, as well as our TSLP/IL-13. We also are pursuing more business opportunities as well. Business development opportunities, that is. Moving into our pipeline slide. I'll try and be short on this, allow Eric to talk more through this, 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 our Anti-IL-15, we saw the vitiligo data. We're going to see the select data in the second half of the year. We've got these near-term launches with olanzapine and ecopipam filed. DARI's progressing well. We've announced two new indications for duvelisib. Together, all these assets represent over $10 billion of peak sales.
Richard Francis: Looking up to 2035, we see further upside from the additional indications that we've announced today for duvelisib, as well as the additional indication of Anti-IL-15, as well as our TSLP/IL-13. We also are pursuing more business opportunities as well. Business development opportunities, that is. Moving into our pipeline slide. I'll try and be short on this, allow Eric to talk more through this, 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 our Anti-IL-15, we saw the vitiligo data. We're going to see the select data in the second half of the year. We've got these near-term launches with olanzapine and ecopipam filed. DARI's progressing well. We've announced two new indications for duvelisib. Together, all these assets represent over $10 billion of peak sales.
Speaker #2: So this shows there is a real need for a product like Ecopipone 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 Astero, Yosedi, and soon-to-be long-acting Olanzapine.
Speaker #2: We also are pursuing more business opportunities as well. Business 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.
Speaker #2: 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.
Speaker #2: 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 one slide.
Speaker #2: We've got anti-R15. We saw the vitiligo data. We're going to see the celiac data in the second half of the year. We've got this near-term launch with Olanzapine and Ecopipine.
Speaker #2: And what this highlights is just the innovative pipeline we have, and our potential to launch one asset per year for the next five years.
Speaker #2: Filed Dary is progressing well. We've announced two new indications for duplicated. 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 Ecopipine to this slide, as well as the two new indications of duplicated.
Speaker #2: Transforming Teva into a leading biopharma company. The near-term launches are clearly sequenced. Olanzapine in 2026, Ecopipone in 2027, followed by Dairy and resolvement due to Q2 through 2028 to 2030.
Richard Francis: Although I have realized we said that before, and that was prior to actually adding ecopipam to this slide, as well as the two new indications of duvakitug. I must remember to update it. Now, what does this all do for Teva? Well, 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 to 16.8 billion this year. Our portfolio is shifting towards higher value innovation, with innovative revenue expected to reach 22% of total revenue in 2026, up from 9%. You can see where it's heading to 2030. Now, with regard to margins, we are creating stronger margins, with gross margins expected to expand from 54% to more than 60% by 2030 plus. This is once again fueled by our innovative portfolio. Now moving on to our generics business.
Richard Francis: Although I have realized we said that before, and that was prior to actually adding ecopipam to this slide, as well as the two new indications of duvakitug. I must remember to update it. Now, what does this all do for Teva? Well, 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 to 16.8 billion this year. Our portfolio is shifting towards higher value innovation, with innovative revenue expected to reach 22% of total revenue in 2026, up from 9%. You can see where it's heading to 2030. Now, with regard to margins, we are creating stronger margins, with gross margins expected to expand from 54% to more than 60% by 2030 plus. This is once again fueled by our innovative portfolio. Now moving on to our generics business.
Speaker #2: Obviously, all subject to regulatory approvals. But looking up to 2035, we see further upside from the additional indications that we've announced there for duplicator, as well as the additional indication of anti-R15, as well as T-slip IL13.
Speaker #2: So I must remember to update it. Now, what does this all do for Teva? Well, 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 to $16.8 this year.
Speaker #2: We also are pursuing more business opportunities as well. This is 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: We've got anti-R15. We saw the vitiligo data. We're going to see the celiac data in the second half of the year. We've got this near-term launch with Olanzapine and Ecopipone filed.
Speaker #2: And this is, once again, fueled by our innovative portfolio. Now moving on to our generic business. Now, generic business is down 15% versus Q2 2025.
Speaker #2: Dairy is progressing well. We've announced two new indications for Duplicator. So together, all these assets represent over $10 billion of peak sales. Although I realize we said that before, and that was prior to actually adding Ecopipone to this slide, as well as the two new indications for Duplicator.
Richard Francis: Now, 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 remains stable. Global generics was down 2%, the US up 1%. Our ex-US decrease mainly was due to lower product launches this year and a softer cough and cold season. While 2026 is expected to be somewhat softer, we can 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. One 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. Biosimilars are transforming our generics portfolio.
Richard Francis: Now, 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 remains stable. Global generics was down 2%, the US up 1%. Our ex-US decrease mainly was due to lower product launches this year and a softer cough and cold season. While 2026 is expected to be somewhat softer, we can 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. One 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. Biosimilars are transforming our generics portfolio.
Speaker #2: But I don't think that tells the full story. If you exclude generic Revlimid, our generic business remains stable. Global generics was down 1%. And our ex-US decrease mainly was due to lower product launches this year and a soft cough and cold season.
Speaker #2: So I must remember to update it. Now what does this all do for Teva? Well, 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 to $16.8 this year.
Speaker #2: While 2026 is expected to be somewhat softer, we can continue to see a stable generic business capable of delivering 1 to 2% annual growth over the long term, supported by a steady flow of our new product launches.
Speaker #2: I remain very excited about the future of our generic business. And one of the main reasons I'm confident is the growth rate that is starting to emerge from our biosimilar portfolio and pipeline.
Speaker #2: 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.
Speaker #2: Let me move on to this now. So biosimilars are transforming our generic portfolio. Before Pivot to Growth, we had three biosimilars. Today, we have 15 in the market.
Speaker #2: Now, with regards to margins, we are creating stronger margins, with gross margins expected to expand from 54% to more than 60% by 2030 and beyond.
Richard Francis: Before Pivot to Growth, we had three biosimilars. Today, we have 15 in the market. 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 US, two out of our five products are ranked number one. Our third is neck and neck, and I believe soon to become a number one. In the EU, where we have just launched three biosimilars, early signs are very positive. We continue to seek partnering to increase this portfolio. I believe we are becoming the partner of choice because of this excellent execution. Based on our current momentum, we are on track to exceeding our $800 million by 2027.
Richard Francis: Before Pivot to Growth, we had three biosimilars. Today, we have 15 in the market. 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 US, two out of our five products are ranked number one. Our third is neck and neck, and I believe soon to become a number one. In the EU, where we have just launched three biosimilars, early signs are very positive. We continue to seek partnering to increase this portfolio. I believe we are becoming the partner of choice because of this excellent execution. Based on our current momentum, we are on track to exceeding our $800 million by 2027.
Speaker #2: 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 US, two out of our five products are ranked number one, and a third is neck and neck, and I believe soon to become number one.
Speaker #2: And this is once again fueled by our innovative portfolio. Now moving on to our generic business. Now generic business is down 15% versus Q2 2025.
Speaker #2: In the US, in the EU, where we have just launched three 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.
Speaker #2: But I don't think that tells the full story. If you exclude generic Revlimid, our generic business remains stable. Global generics was down 2%. The US up 1%.
Speaker #2: And our ex-US decrease mainly was due to lower product launches this year and a soft cough and cold season. While 2026 is expected to be somewhat softer, we can continue to see a stable generic business capable of delivering 1% to 2% annual growth over the long term, supported by a steady flow of our new product launches.
Speaker #2: 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 2027 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 converse earnings of 30%, 80%.
Richard Francis: To conclude, before I hand over to Eric, we're on track to hit our 2027 financial growth targets of mid-single revenue growth, non-GAAP operating income target of 30%, a net debt EBITDA below 2%, and cash converse earnings of 80%. With that, I will hand over to Eric.
Richard Francis: To conclude, before I hand over to Eric, we're on track to hit our 2027 financial growth targets of mid-single revenue growth, non-GAAP operating income target of 30%, a net debt EBITDA below 2%, and cash converse earnings of 80%. With that, I will hand over to Eric.
Speaker #2: I remain very excited about the future of our generic business. And one of the main reasons I'm confident is the growth rate that is starting to emerge from our biosimilar portfolio and pipeline.
Speaker #2: And with that, I will hand over to Eric.
Speaker #2: Let me move on to this now. So, biosimilars are transforming our generics portfolio. Before Pivot to Growth, we had three biosimilars. Today, we have 15 in the market.
Speaker #1: 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.
Eric Hughes: Thank you, Richard. Moving on to our first slide here. I know Richard showed this briefly, I first want to just say it's become very complicated, but it's become very complicated in a great way. We're looking at five potential submissions over five years. I'll just highlight a few important things on this slide. We've now added ecopipam, which was submitted in June, for Tourette syndrome, and we've now added two new indications for duvakitug. That's hidradenitis suppurativa and fibrostenotic Crohn's disease. Two very important indications that I'll get into with a little bit more detail later on. 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 Q4 of this year.
Eric Hughes: Thank you, Richard. Moving on to our first slide here. I know Richard showed this briefly, I first want to just say it's become very complicated, but it's become very complicated in a great way. We're looking at five potential submissions over five years. I'll just highlight a few important things on this slide. We've now added ecopipam, which was submitted in June, for Tourette syndrome, and we've now added two new indications for duvakitug. That's hidradenitis suppurativa and fibrostenotic Crohn's disease. Two very important indications that I'll get into with a little bit more detail later on. 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 Q4 of this year.
Speaker #2: 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 US, two out of our five products are ranked number one.
Speaker #1: We're looking at five potential submissions over five years. And I'll just highlight a few important things on this slide. We've now added Ecopipine, which was submitted in June, for Tourette syndrome.
Speaker #2: And our third is neck and neck, and I believe soon to become a number one. In the US, in the EU, where we have just launched three biosimilars, early signs are very positive.
Speaker #1: And we've now added two new indications for duplicated. That's hydrogenitis suppurativa and fibrostenotic Crohn's disease, two very important indications that I'll get into with a little bit more detail later on.
Speaker #2: 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.
Speaker #1: 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.
Speaker #2: To conclude, before I hand over to Eric, we're on track to hit our 2027 financial growth targets of mid-single-digit revenue growth, non-GAAP operating income target of 30%, and a net debt to EBITDA below 2x, and cash conversion earnings of 30% to 80%.
Speaker #1: We've had our EU MAA accepted earlier this year, and we've just presented a number of different abstracts at the PsychElevate conference and the PAGE conference.
Eric Hughes: We've had our EU MAA accepted earlier this year, and we just presented a number of different abstracts at the Psych Congress Elevate conference and the PAGE conference. 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 ecopipam. Now, one of the things that gets me excited, first, that this is a mechanism, a brand-new first-in-class mechanism of a D1 antagonist. Even more importantly, this is the first dedicated launch for treatment for Tourette syndrome. 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'm proud of the fact that we have two well-controlled studies, the phase II showing a decrease in the tic syndrome, not only statistically significant, but clinically meaningful reductions.
Eric Hughes: We've had our EU MAA accepted earlier this year, and we just presented a number of different abstracts at the Psych Congress Elevate conference and the PAGE conference. 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 ecopipam. Now, one of the things that gets me excited, first, that this is a mechanism, a brand-new first-in-class mechanism of a D1 antagonist. Even more importantly, this is the first dedicated launch for treatment for Tourette syndrome. 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'm proud of the fact that we have two well-controlled studies, the phase II showing a decrease in the tic syndrome, not only statistically significant, but clinically meaningful reductions.
Speaker #1: So all things are go right now on Olanzapine LAI, and we're looking forward to an approval at the end of this year. Onto Ecopipine.
Speaker #2: And with that, I will hand over to Eric.
Speaker #1: Thank you, Richard. Now, moving on to our first slide here. I know Richard showed this briefly, but I first want to just say it's become very complicated.
Speaker #1: Now, one 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.
Speaker #1: But it's become very complicated in a great way. We're looking at five potential submissions over five years. I'll just highlight a few important things on this slide.
Speaker #1: We've now added Ecopipam, which was submitted in June, for Tourette syndrome. And we've now added two new indications for dupilumab. That's hydrogenated super Teva and fibrostenotic Crohn's disease.
Speaker #1: 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.
Speaker #1: I mean, I'm proud of the fact that we have two well-controlled studies: the phase two showing a decrease in the tic syndrome, not only statistically significant, but clinically meaningful reductions.
Speaker #1: 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.
Speaker #1: And we also showed in phase three a decrease in the relapse rate. It's both significantly statistically and clinically with a 50% reduction. See, they're all very good signs, but most importantly, this is a treatment that is well tolerated and durable.
Speaker #1: 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 year.
Eric Hughes: We also showed in phase III a decrease in the relapse rate, both significantly statistically and clinically, with a 50% reduction. These are 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 remained on treatment with a sustained tic reduction, and we're looking forward to that approval next year. Something to look forward to. Now, moving on to our DARI program, the dual-action rescue inhaler for asthma. We've fully enrolled this study, over 2,700 patients, which includes pediatrics, 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. This is a really great program for patients with asthma.
Eric Hughes: We also showed in phase III a decrease in the relapse rate, both significantly statistically and clinically, with a 50% reduction. These are 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 remained on treatment with a sustained tic reduction, and we're looking forward to that approval next year. Something to look forward to. Now, moving on to our DARI program, the dual-action rescue inhaler for asthma. We've fully enrolled this study, over 2,700 patients, which includes pediatrics, 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. This is a really great program for patients with asthma.
Speaker #1: And we've 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.
Speaker #1: 66% of the patients in the long-term follow-up remained on treatment with a sustained tic reduction. And we're looking forward to that approval next year.
Speaker #1: 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 pediatrics, adolescents, and adults.
Speaker #1: On to Ecopipone. Now, one of the things that gets me excited first is that this is a mechanism—a brand new, first-in-class mechanism—of a D1 antagonist.
Speaker #1: 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.
Speaker #1: We're a 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.
Speaker #1: I mean, I'm proud of the fact that we have two well-controlled studies: the phase two showing a decrease in the tic syndrome, not only statistically significant, but clinically meaningful reductions.
Speaker #1: 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.
Eric Hughes: 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 rescue inhaler with a dry powder inhaler that's easy to use and with a label that includes pediatrics potentially. Now moving on to duvakitug. Very exciting this year. We had our publication of our induction data in The Lancet for both two 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 it's kudos to their great work. Congratulations to the team. Now furthermore on duvakitug, our phase III program being run with our partner, Sanofi, is right on track. Our SUNSCAPE and STARSCAPE program in ulcerative colitis and Crohn's disease.
Eric Hughes: 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 rescue inhaler with a dry powder inhaler that's easy to use and with a label that includes pediatrics potentially. Now moving on to duvakitug. Very exciting this year. We had our publication of our induction data in The Lancet for both two 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 it's kudos to their great work. Congratulations to the team. Now furthermore on duvakitug, our phase III program being run with our partner, Sanofi, is right on track. Our SUNSCAPE and STARSCAPE program in ulcerative colitis and Crohn's disease.
Speaker #1: We'll be providing a great treatment with a dual action rescue inhaler with a dry powder inhaler that's easy to use. And with a label that includes pediatrics potentially.
Speaker #1: And we also showed, in Phase 3, a decrease in the relapse rate. It's both statistically and clinically significant, with a 50% reduction. See, these are all very good signs.
Speaker #1: Now, moving on to duplicated. Very exciting this year. We had our publication of our induction data in the Lancet for both two parallel manuscripts for ulcerative colitis and Crohn's disease.
Speaker #1: But most importantly, this is a treatment that is well tolerated and durable. Sixty-six percent of the patients in the long-term follow-up remained on treatment with a sustained tic reduction.
Speaker #1: It's great to see the teams work, being recognized by such a high-impact journal. And kudos to their great work. So congratulations to the team.
Speaker #1: 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.
Speaker #1: But now, furthermore, on duplicated, our phase three program being run with our partner, Sanofi, is right on track. Our SunScape and StarScape program and ulcerative colitis and Crohn's disease.
Speaker #1: We have fully enrolled this study with over 2,700 patients, which includes pediatrics, adolescents, and adults. We're right on track to see that final event. This is an event-driven study.
Speaker #1: But today, we're very proud to announce the fact that we're adding two new indications into our research that includes hydrogenitis suppurativa, which will unlock that non-T2-based indication group.
Speaker #1: 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.
Eric Hughes: Today, we're very proud to announce the fact that we're adding two new indications into our research. That includes hidradenitis suppurativa, which will unlock that non-T2-based indication group, and fibrostenotic 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. 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 two indications next. First, hidradenitis suppurativa. This is an area I've worked in before. It's an important unmet medical need. This is a result of painful inflammatory abscesses that form in skin folds in the body. These people suffer in silence. 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.
Eric Hughes: Today, we're very proud to announce the fact that we're adding two new indications into our research. That includes hidradenitis suppurativa, which will unlock that non-T2-based indication group, and fibrostenotic 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. 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 two indications next. First, hidradenitis suppurativa. This is an area I've worked in before. It's an important unmet medical need. This is a result of painful inflammatory abscesses that form in skin folds in the body. These people suffer in silence. 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.
Speaker #1: It's addressing an unmet medical need—answering the need and the treatment that is dictated in the guidelines. We'll be providing a great treatment with a dual-action rescue inhaler, using a dry powder inhaler that's easy to use.
Speaker #1: And fibrostenotic 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.
Speaker #1: 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 two indications next.
Speaker #1: And with a label that includes pediatrics potentially. Now, moving on to duplicator. Very exciting this year. We had our publication of our induction data in the Lancet for both two parallel manuscripts for ulcerative colitis and Crohn's disease.
Speaker #1: First, hydrogenitis suppurativa. This is an area I've worked in before. It's an important unmet medical need. This is a result of painful inflammatory abscesses that form in skin folds in the body.
Speaker #1: It's great to see the teams work, being recognized by such a high-impact journal. And it's kudos to their great work. So congratulations to the team.
Speaker #1: These people suffer in silence 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 have been approved, but there's a long way to go with the amount of efficacy we can achieve.
Speaker #1: But now furthermore on duplicator, our phase three program being run with our partner Sanofi is right on track. Our Sunscape and Starscape program and ulcerative colitis and Crohn's disease.
Eric Hughes: There are treatments out there that have been approved, but there's a long way to go with the amount of efficacy we can achieve. Anti-TL1A 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. 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 hidradenitis suppurativa as well. There's a lot of scientific rationale here, and it's an important market that we can grow in. In addition, we talked about fibrostenotic Crohn's disease. This is a very important aspect of people with Crohn's disease.
Eric Hughes: There are treatments out there that have been approved, but there's a long way to go with the amount of efficacy we can achieve. Anti-TL1A 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. 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 hidradenitis suppurativa as well. There's a lot of scientific rationale here, and it's an important market that we can grow in. In addition, we talked about fibrostenotic Crohn's disease. This is a very important aspect of people with Crohn's disease.
Speaker #1: But today, we're very proud to announce the fact that we're adding two new indications into our research. That includes hydrogenated super Teva, which will unlock that non-T2-based indication group.
Speaker #1: Anti-T1A 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.
Speaker #1: And fibrous stenotic 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.
Speaker #1: So the pleiotrophic effects of T1A therapy might really be suited well for this. It's also important to note that 15% of people with IBD actually have hydrogenitis suppurativa as well.
Speaker #1: 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 two indications next.
Speaker #1: 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 fibrostenotic Crohn's disease.
Speaker #1: First, hydrogenated super Teva. This is an area I've worked in before. It's an important unmet medical need. This is a result of painful inflammatory abscesses that form in skin folds in the body.
Speaker #1: Now, this is a very important aspect of people with Crohn's disease. We've already posted phase two data with great efficacy in our phase two study with duplicated.
Eric Hughes: We've already posted phase II data with great efficacy in our phase II study with duvakitug, but now we're looking at even worse cases of Crohn's disease. 50% of people with Crohn's disease have this fibrostenotic component, and this is where fibrosis, inflammation, and edema causes almost total obstructions of the gut. This leads to more hospitalizations, more surgeries, increased healthcare costs. It's really a driver of some of the worst parts of Crohn's disease. We're very happy to advance the science. No one 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. I'm very excited to be exploring this indication with duvakitug.
Eric Hughes: We've already posted phase II data with great efficacy in our phase II study with duvakitug, but now we're looking at even worse cases of Crohn's disease. 50% of people with Crohn's disease have this fibrostenotic component, and this is where fibrosis, inflammation, and edema causes almost total obstructions of the gut. This leads to more hospitalizations, more surgeries, increased healthcare costs. It's really a driver of some of the worst parts of Crohn's disease. We're very happy to advance the science. No one 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. I'm very excited to be exploring this indication with duvakitug.
Speaker #1: These people suffer in silence. 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.
Speaker #1: But now, we're looking at even worse cases of Crohn's disease. 50% of people with Crohn's disease have this fibrostenotic component. And this is where fibrosis, inflammation, and edema causes almost a total obstruction of the gut.
Speaker #1: And there's art treatments out there that have been approved, but there's a long way to go with the amount of efficacy we can achieve.
Speaker #1: Anti-T1A 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.
Speaker #1: This leads to more hospitalizations, more surgeries, increased healthcare costs. It's really a driver of some of the worst parts of Crohn's disease. So we're very happy to advance the science.
Speaker #1: No one 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.
Speaker #1: So the pleotrophic effects of T1A therapy might really be suited well for this. It's also important to note that 15% of people with IBD actually have hydrogenated super Teva as well.
Speaker #1: So I'm very excited to be exploring this indication with duplicated. Now, moving on, we showed some great data from our proof of concept study earlier.
Speaker #1: 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 fibrous, stenotic Crohn's disease.
Eric Hughes: 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 off by saying, first and foremost, it was great to see the patient's perception of their disease change. 75% of the patients reported an improvement in their facial vitiligo, and here I'm showing two patients who gave a special consent to show the results that they've seen in this study. Remember, these two patients just had two 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.
Eric Hughes: 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 off by saying, first and foremost, it was great to see the patient's perception of their disease change. 75% of the patients reported an improvement in their facial vitiligo, and here I'm showing two patients who gave a special consent to show the results that they've seen in this study. Remember, these two patients just had two 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.
Speaker #1: Last month, with patients with vitiligo and our anti-IL-15 program, I always like to start off by saying first and foremost, it was great to see the patients' perception of their disease change.
Speaker #1: Now, this is a very important aspect that people with Crohn's disease—we've already posted Phase 2 data with great efficacy in our Phase 2 study with duplalimab.
Speaker #1: So 75% of the patients reported an improvement in their facial vitiligo. And here, I'm showing two patients who gave a special consent to show their results that they've seen in this study.
Speaker #1: But now we're looking at even worse cases of Crohn's disease. Fifty percent of people with Crohn's disease have this fibrous, stenotic component. And this is where fibrosis, inflammation, and edema cause almost total obstructions of the gut.
Speaker #1: Now, remember, these two patients just had two shots of our anti-IL-15 antibody. And over 24-week period, you can see quite a change in both the woman on the left and the gentleman on the right.
Speaker #1: This leads to more hospitalizations, more surgeries, and increased healthcare costs. It's really a driver of some of the worst parts of Crohn's disease. So, we're very happy to advance the science.
Speaker #1: Almost total depigmentation of the cheeks on the woman, filled in very nicely over 24 weeks. And then the patient on the right, some dramatic changes from total depigmentation with a darker skin color.
Eric Hughes: Almost total depigmentation of the cheeks on the woman, filled in very nicely over 24 weeks, then the patient on the right, some dramatic changes from total depigmentation with a darker skin color. These are results that change the perception of a patient and is very conveniently done with just two shots. But, as happy as I am about the perception change for the patients, we also met the important regulatory endpoints. The numbers we posted for the F-VASI 50, the F-VASI 75, and the T-VASI 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. We're moving at speed. We're excited to see the data, and we're moving as quickly as possible. Finally, I'll just mention what's coming up next.
Eric Hughes: Almost total depigmentation of the cheeks on the woman, filled in very nicely over 24 weeks, then the patient on the right, some dramatic changes from total depigmentation with a darker skin color. These are results that change the perception of a patient and is very conveniently done with just two shots. But, as happy as I am about the perception change for the patients, we also met the important regulatory endpoints. The numbers we posted for the F-VASI 50, the F-VASI 75, and the T-VASI 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. We're moving at speed. We're excited to see the data, and we're moving as quickly as possible. Finally, I'll just mention what's coming up next.
Speaker #1: No one 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.
Speaker #1: So these are results that change the perception of a patient and is very conveniently done with just two shots. But as happy as I am about the perception change for the patients, we also met the important regulatory endpoints that the numbers we posted for the FVAV 50, the FVAV 75, and the TVAV are very competitive for systemic therapies in this area.
Speaker #1: So I'm very excited to be exploring this indication with duplicator. Now moving on, we showed some great data from our proof earlier. Last month, with patients with vitiligo and our anti-IL-15 program, I always like to start off by saying first and foremost, it was great to see the patients' perception of their disease change.
Speaker #1: And this really drove the fact that we went right into our phase two B3 study. Which will be executed and started this year. So we're moving at speed.
Speaker #1: So, 75% of the patients reported an improvement in their facial vitiligo. And here I'm showing two patients who gave special consent to show the results they've seen in this study.
Speaker #1: 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.
Speaker #1: Now remember, these two patients just had two shots of our of concept study 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.
Eric Hughes: We'll have a readout in the second half of this year in our second celiac proof of concept study. This study is important because it's actually looking at biopsy results after a gluten challenge. 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 villi in the gut, and where you have this nice, high surface area of villus that absorbs nutrients in the gut. When a patient with celiac disease takes gluten, there's almost a complete destruction of that normal villus as you see on histology. We hope to see in this gluten challenge by the biopsies that in fact we protect the villi from that destruction when we use the Anti-IL-15 treatment. We're looking forward to the readout.
Eric Hughes: We'll have a readout in the second half of this year in our second celiac proof of concept study. This study is important because it's actually looking at biopsy results after a gluten challenge. 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 villi in the gut, and where you have this nice, high surface area of villus that absorbs nutrients in the gut. When a patient with celiac disease takes gluten, there's almost a complete destruction of that normal villus as you see on histology. We hope to see in this gluten challenge by the biopsies that in fact we protect the villi from that destruction when we use the Anti-IL-15 treatment. We're looking forward to the readout.
Speaker #1: 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 villi in the gut.
Speaker #1: Almost total depigmentation of the cheeks on the woman, filled in very nicely over 24 weeks. And then the patient on the right, some dramatic changes from total depigmentation with a darker skin color.
Speaker #1: So these are results that change the perception of a patient and is very conveniently done with just two shots. But as happy as I am about the perception change for the patients, we also met the important regulatory endpoints that the numbers we posted for the FVASE50, the FVASE75, and the TVASE are very competitive for systemic therapies in this area.
Speaker #1: And where you have this nice high surface area of villus that absorbs nutrients in the gut, when a patient with celiac disease takes gluten, that there's almost a complete destruction of that normal villus on that you see on histology.
Speaker #1: And we hope to see in this gluten challenge that by the biopsies that, in fact, we protect the villi from that destruction when we use the anti-IL-15 treatment.
Speaker #1: And this really drove the fact that we went right into our phase two B3 study. Which will be executed and started this year. So we're moving at speed.
Speaker #1: 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 celiac, potentially based on that data.
Eric Hughes: That will be the second half of this year, but I think this will be a great advance for patients with celiac, potentially based on that data. 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 duvakitug. We did the filing for ecopipam, our new player on the field. Then we also showed the vitiligo data just recently for our Anti-IL-15 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. emrusolmin is on track to have the futility analysis at the end of the year.
Eric Hughes: That will be the second half of this year, but I think this will be a great advance for patients with celiac, potentially based on that data. 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 duvakitug. We did the filing for ecopipam, our new player on the field. Then we also showed the vitiligo data just recently for our Anti-IL-15 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. emrusolmin is on track to have the futility analysis at the end of the year.
Speaker #1: We're excited to see the data, and we're moving as quickly as possible. Finally, I'll just mention what's coming up next. We'll have a readout in the second half of this year.
Speaker #1: 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 duplicated.
Speaker #1: We did the filing for echo pipeline, our new player on the field. And then we also showed the vitiligo data just recently for our anti-IL-15 program.
Speaker #1: 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 villi in the gut.
Speaker #1: We'll have the celiac data in the second half of this year. DARE is on track for that last event, that last exacerbation by the end of this year.
Speaker #1: And we'll have that data to talk about in the early part of 2027. The MRSOM is on track to have the futility analysis at the end of the year.
Speaker #1: And where you have this nice high surface area of villus that absorbs nutrients in the gut, when a patient with celiac disease takes gluten, there's almost a complete destruction of that normal villus that you see on histology.
Speaker #1: 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.
Eric Hughes: We're looking forward to the approval of olanzapine LAI at the end of this year, then we'll have some anti-PD1-IL2 human data by the end of this year as well. Very exciting. We keep executing, and we're looking forward to all these events this year. With that, I'm going to pass off to my colleague, Eli Kalif.
Eric Hughes: We're looking forward to the approval of olanzapine LAI at the end of this year, then we'll have some anti-PD1-IL2 human data by the end of this year as well. Very exciting. We keep executing, and we're looking forward to all these events this year. With that, I'm going to pass off to my colleague, Eli Kalif.
Speaker #1: 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, Ellie Colise.
Speaker #1: And we hope to see in this gluten challenge that by the biopsies that, in fact, we protect the villi from that destruction when we use the anti-IL-15 treatment.
Speaker #2: 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.
Eli Kalif: Thank you, Eric, good morning and good afternoon to everyone. I would like to start my review of Q2 2026 results with the following key messages. First, we delivered a solid Q2 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. 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. Moving to slide 34. Before I discuss our Q2 results, let me briefly recap the Emalex Biosciences acquisition, which closed in June. As Richard highlighted earlier, ecopipam further strengths our position in CNS, where we already have strong commercial and development capabilities.
Eli Kalif: Thank you, Eric, good morning and good afternoon to everyone. I would like to start my review of Q2 2026 results with the following key messages. First, we delivered a solid Q2 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. 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. Moving to slide 34. Before I discuss our Q2 results, let me briefly recap the Emalex Biosciences acquisition, which closed in June. As Richard highlighted earlier, ecopipam further strengths our position in CNS, where we already have strong commercial and development capabilities.
Speaker #1: So we're looking forward to the readout. That will be in the second half of this year. But I think this will be a great advance for patients with celiac, potentially based on that data.
Speaker #2: 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.
Speaker #1: 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 duplicator.
Speaker #1: We did the filing for echo pipeline, our new player on the field. And then we also showed the vitiligo data just recently for our anti-IL-15 program.
Speaker #2: 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.
Speaker #1: We'll have the celiac data in the second half of this year. DARE is on track for that last event, that last exacerbation, by the end of this year.
Speaker #1: And we'll have that data to talk about in the early part of 2027. The MRSOM is on track to have the futility analysis at the end of the year.
Speaker #1: 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.
Speaker #2: Now, moving to slide 34. Before I discuss our Q2 results, let me briefly recap the MLX Bioscience acquisitions which close in June. As Richard highlighted earlier, echo pipeline further strengthened our position in CNS, where we already have strong commercial and development capabilities.
Speaker #1: 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, Eliyahu Kalif.
Speaker #2: Thank you, Eric. And good morning and good afternoon to everyone. I would like to start my review of Q2 2026 results with the following key messages.
Speaker #2: 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.
Speaker #2: First, we delivered 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.
Eli Kalif: From an accounting perspective, as we discussed last quarter, the transaction was treated as an asset acquisition. As a result, we recorded the $724 million as IPR&D expenses during the Q2. This included the upfront cash consideration, net liabilities acquired, as well as the transaction cost. The upfront consideration flow through cash flow from investment activities, therefore does not impact free cash flow. As I go through our Q2 performance, I will be making reference to the Emalex-related impact on our financials to provide a better view of our underlying performance. Starting with our Q2 GAAP performance on slide 35. Q2 revenues were approximately $4.1 billion, down 1% in US dollars or 3% in local currency compared to Q2 2025.
Eli Kalif: From an accounting perspective, as we discussed last quarter, the transaction was treated as an asset acquisition. As a result, we recorded the $724 million as IPR&D expenses during the Q2. This included the upfront cash consideration, net liabilities acquired, as well as the transaction cost. The upfront consideration flow through cash flow from investment activities, therefore does not impact free cash flow. As I go through our Q2 performance, I will be making reference to the Emalex-related impact on our financials to provide a better view of our underlying performance. Starting with our Q2 GAAP performance on slide 35. Q2 revenues were approximately $4.1 billion, down 1% in US dollars or 3% in local currency compared to Q2 2025.
Speaker #2: This included the upfront cash consideration, net liabilities acquired, as well as the transaction cost. The upfront consideration flow through cash flow from investment activities and therefore does not impact free cash flow.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Now moving to slide 34. Before I discuss our Q2 results, let me briefly recap the MLX Bioscience acquisition, which closed in June. As Richard highlighted earlier, echo pipeline further strengthened our position in CNS, where we already have strong commercial and development capabilities.
Speaker #2: Now, starting with our Q2 gut performance on slide 35. Q2 revenues were approximately 4.1 billion, down 1% in US dollars or 3% in local currency compared to Q2 2025.
Speaker #2: This decrease was largely driven by lower generics, mainly generics Revelmid, and was largely offset by continued strong growth of our key innovative products, Ocedo, Ajovy, and Euzeti.
Speaker #2: From an accounting perspective, as we discussed last quarter, the transaction was treated as an asset acquisition. As a result, we recorded $724 million as IP R&D expenses during the second quarter.
Eli Kalif: This decrease was largely driven by lower generics, mainly generic Revlimid, and was largely offset by continued strong growth of our key innovative products, Otezla, 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 2026 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 Emalex-related expenses of $726 million. Excluding Emalex, 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 H1 of this year to support our innovative growth. Overall, we ended the quarter with a non-GAAP EPS of $0.02.
Eli Kalif: This decrease was largely driven by lower generics, mainly generic Revlimid, and was largely offset by continued strong growth of our key innovative products, Otezla, 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 2026 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 Emalex-related expenses of $726 million. Excluding Emalex, 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 H1 of this year to support our innovative growth. Overall, we ended the quarter with a non-GAAP EPS of $0.02.
Speaker #2: Gap net loss and loss per share were 576 million, and 49 cents, respectively. Turning now to our non-gap performance. Our non-gap gross margin in Q2 26 was 55.4% and increased of 80 basis points, reflecting a strong growth in our innovative portfolio.
Speaker #2: This included the upfront cash consideration, net liabilities acquired, as well as the transaction cost. The upfront consideration flows through cash flow from investing activities and therefore does not impact free cash flow.
Speaker #2: 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.
Speaker #2: Non-gap operating margin was 9%, including the impact of MLX-related expenses of 726 million. Excluding MLX, our non-gap margin would have been 26.6%, slightly below Q2 last year.
Speaker #2: Now starting with our Q2 gut performance on slide 35. Q2 revenues were approximately $4.1 billion, down 1% in US dollars or 3% in local currency compared to Q2 2025.
Speaker #2: 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-gap EPS of 2 cents, the impact from MLX on APS was 61 cents, without which our non-gap EPS would have been 63 cents.
Speaker #2: This decrease was largely driven by lower generics, mainly generics, 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.
Eli Kalif: The impact from Emalex 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 2025 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 generic Revlimid. 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. 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.
Eli Kalif: The impact from Emalex 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 2025 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 generic Revlimid. 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. 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.
Speaker #2: 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 generics Revelmid.
Speaker #2: Turning now to our non-gap performance. Our non-gap gross margin in Q2 26 was 55.4% and increased of 80 basis points, reflecting a strong growth in our innovative portfolio.
Speaker #2: Our financial results this quarter reflected a strong underlying performance, if you exclude the impact of generics Revelmid. Moving to the next slide. As a reminder, our operating margin expansion to 30% is driven by two structural elements.
Speaker #2: Non-gap operating margin was 9%, including the impact of MLX-related expenses of $726 million. Excluding MLX, our non-gap margin would have been 26.6%, slightly below Q2 last year.
Speaker #2: The first is the portfolio shift towards higher growth, higher margin innovative products. The second is our transformation programs. Altogether, this is approximately 400 basis points of improvements since we announced this programs in May last year.
Speaker #2: Mainly reflecting higher planned investment in sales and marketing in the first half of this year to support our innovative growth. Overall, we ended the quarter with a non-gap EPS of 2 cents, the impact from MLX on APS was 61 cents, without which our non-gap EPS would have been 63 cents.
Speaker #2: Despite the impact of generics Revelmid. This is our core of our financial transformation, moving from a company historically driven by generics to a biopharma company.
Speaker #2: 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 generics Revelmid.
Eli Kalif: This is our core of our financial transformation, moving from a company historically driven by generics to a biopharma company. We continue to make progress to achieve these targets, as reflected in our 2026 guidance. Moving to slide 37. Looking at the H1 of 2026, the underlying business continued to demonstrate the strength of our strategy and execution. As you can see, the H1 revenue performance reflects strong growth in our innovative portfolio and biosimilars, offsetting more than $600 million of revenue impact from generic Trevamil. Our non-GAAP operating margin in the H1 also demonstrate ongoing improvements in our gross margin profile. As I highlighted last quarter, we expected higher operating expenses in the H1 of this year versus the H2, mainly due to the timing of planned investment to support our growing innovative portfolio and upcoming launches.
Eli Kalif: This is our core of our financial transformation, moving from a company historically driven by generics to a biopharma company. We continue to make progress to achieve these targets, as reflected in our 2026 guidance. Moving to slide 37. Looking at the H1 of 2026, the underlying business continued to demonstrate the strength of our strategy and execution. As you can see, the H1 revenue performance reflects strong growth in our innovative portfolio and biosimilars, offsetting more than $600 million of revenue impact from generic Trevamil. Our non-GAAP operating margin in the H1 also demonstrate ongoing improvements in our gross margin profile. As I highlighted last quarter, we expected higher operating expenses in the H1 of this year versus the H2, mainly due to the timing of planned investment to support our growing innovative portfolio and upcoming launches.
Speaker #2: 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 continued to demonstrate the strength of our strategy and execution.
Speaker #2: Our financial results this quarter reflected a strong underlying performance if you exclude the impact of generics Revelmid. Moving to the next slide. As a reminder, our operating margin expansion to 30% is driven by two structural elements.
Speaker #2: As you can see, the first half revenue performance reflects strong growth in our innovative portfolio and biosimilars, offsetting more than 600 million dollars of revenue impact from generics Revelmid.
Speaker #2: Our non-gap operating margin in the first half also demonstrates ongoing improvements in our gross margin profile. As I highlight last quarter, we expected higher operating expenses in the first half this year versus the second half, mainly due to the timing of planned investment to support our growing innovative portfolio and upcoming launches.
Speaker #2: The first is the portfolio shift towards higher growth, higher margin innovative products. The second is our transformation programs. Altogether, this is approximately $400 basis points of improvements since we announced this programs in May last year, despite the impact of generics Revelmid.
Speaker #2: This is our core of our financial transformation, moving from a company historically driven by generics to a biopharma company. We continue to make progress to achieve these targets as reflected in our 2026 guidance.
Speaker #2: 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.
Eli Kalif: We expect OpEx to normalize with operating leverage and higher impact of the transformation program savings in the H2. Moving to slide 38. Our balance sheet continues 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 Q2, our net debt was $12.9 billion with a net debt to EBITDA ratio of 2.8 times. Excluding AMLX, our net debt to EBITDA would have been 2.3 times, well on track to achieve our 2 times target by 2027. As we continue to pay down our debt, it is expected to result in significantly lower finance expenses by 2030.
Eli Kalif: We expect OpEx to normalize with operating leverage and higher impact of the transformation program savings in the H2. Moving to slide 38. Our balance sheet continues 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 Q2, our net debt was $12.9 billion with a net debt to EBITDA ratio of 2.8 times. Excluding AMLX, our net debt to EBITDA would have been 2.3 times, well on track to achieve our 2 times target by 2027. As we continue to pay down our debt, it is expected to result in significantly lower finance expenses by 2030.
Speaker #2: 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.
Speaker #2: Moving to slide 37. Looking at the first half of 2026, the underlying business continued 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 generic Revlimid.
Speaker #2: At the end of Q2, our net debt was 12.9 billion, with the net debt to EBITDA ratio of 2.8 times. Excluding MLX, our net debt to EBITDA would have been 2.3 times.
Speaker #2: Our non-gap operating margin in the first half also demonstrates ongoing improvements in our gross margin profile. As I highlight last quarter, we expected higher operating expenses in the first half this year versus the second half, mainly due to the timing of planned investment to support our growing innovative portfolio and upcoming launches.
Speaker #2: Well on track to achieve our two times target by 2027. As we continue to pay down our debt, it is expected to result in significantly lower finance expenses by 2030.
Speaker #2: At the same time, we have continued to transfer our working capital management. Driving significantly improvement as the percentage of revenue resulting in lower cash conversion cycle.
Eli Kalif: 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 a long-term earnings and free cash flow growth. As you can see on the next slide, our execution is intrinsically recognized by our leading credit rating agencies. In May, Fitch upgraded Teva to an investment-grade rating, marking Teva return to IG for the first time since 2017. This was our third upgrade from Fitch in less than two years, underscoring Teva transformation journey. About two quarters ago, S&P and Moody's had also upgraded Teva 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.
Eli Kalif: 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 a long-term earnings and free cash flow growth. As you can see on the next slide, our execution is intrinsically recognized by our leading credit rating agencies. In May, Fitch upgraded Teva to an investment-grade rating, marking Teva return to IG for the first time since 2017. This was our third upgrade from Fitch in less than two years, underscoring Teva transformation journey. About two quarters ago, S&P and Moody's had also upgraded Teva 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.
Speaker #2: 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 pivotal growth strategy driving EPS and free cash flow.
Speaker #2: These efforts, combined with the fast growing innovative portfolio, and transformation programs, are expected to drive a long-term earnings and free cash flow growth. As you can see on the next slide, our execution is intrinsically recognized by our leading credit editing agencies.
Speaker #2: Over the last few years, we have made significantly improved our leverage profile. At the end of Q2, our net debt was $12.9 billion, with the net debt to EBITDA ratio of 2.8 times.
Speaker #2: In May, Fitch Upgrade Teva to an investment grade rating. Marking Teva return to IG for the first time since 2017. This was our third upgrade from Fitch in less than two years, underscoring Teva transformation journey.
Speaker #2: Excluding MLX, our net debt to EBITDA would have been 2.3 times, well on track to achieve our two-times target by 2027. As we continue to pay down our debt, it is expected to result in significantly lower finance expenses by 2030.
Speaker #2: About two quarters ago, S&P and Moody's had also upgraded Teva rating and Outlook respectively. This upgrades are another validation of our disciplined execution and stronger financial profile.
Speaker #2: At the same time, we have continued to transfer our working capital management. Driving significantly improvement as the percentage of revenue resulting in lower cash conversion cycle.
Speaker #2: 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 40.
Speaker #2: These efforts, combined with the fast growing innovative portfolio, and transformation programs, are expected to drive a long-term earnings and free cash flow growth. As you can see on the next slide, our execution is intrinsically recognized by our leading credit editing agencies.
Eli Kalif: Now turning to our 2026 outlook on slide 40. Based on our solid H1 results and visibility into the H2, 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 three products, AUSTEDO, AJOVY, and UZEDY. With the H1 of performance, we are increasing the combined guidance of these products 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.
Eli Kalif: Now turning to our 2026 outlook on slide 40. Based on our solid H1 results and visibility into the H2, 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 three products, AUSTEDO, AJOVY, and UZEDY. With the H1 of performance, we are increasing the combined guidance of these products 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: In May, Fitch Upgrade Teva to an investment grade rating. Marking Teva return to IG for the first time since 2017. This was our third upgrade from Fitch in less than two years, underscoring Teva transformation journey.
Speaker #2: First, our innovative portfolio is performing strongly across all three products, Osedo, Ajovi, and Uzedi. With the first strong half of performance, we are increasing the combined guidance of these products by approximately 150 million at the midpoint, reflecting a combined 2026 revenue outlook of approximately 3.7 billion.
Speaker #2: About two quarters ago, S&P and Moody's had also upgraded Teva rating and Outlook respectively. This upgrades are another validation of our disciplined execution and stronger financial profile.
Speaker #2: 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 40.
Speaker #2: 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 generics Revelmid and the divestment Japan business.
Eli Kalif: On the other hand, we expect our global generics revenue for the full year to be flat to down low single digits in local currency compared to 2025, excluding the impact of generics revenue and the divestment Japan business. This is mainly due to fewer high-value launches in 2026, 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 AMLX 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.
Eli Kalif: On the other hand, we expect our global generics revenue for the full year to be flat to down low single digits in local currency compared to 2025, excluding the impact of generics revenue and the divestment Japan business. This is mainly due to fewer high-value launches in 2026, 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 AMLX 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.
Speaker #2: 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.
Speaker #2: This is mainly due to a fewer high value launches in 2026, lower seasonal on OTC, and increased competition in some markets. Moving to the other elements of our financial outlook.
Speaker #2: 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.
Speaker #2: We continue to expect 2026 non-gap 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.
Speaker #2: First, our innovative portfolio is performing strongly across all three products—Orcedo, Ajovy, and UZeti. With the strong first half of performance, we are increasing the combined guidance for these products by approximately $150 million at the midpoint, reflecting a combined 2026 revenue outlook of approximately $3.7 billion.
Speaker #2: This is at the higher range on our overall 2027 to 2028% OPEX reflecting a deliberate investment we are making to support our growing innovative portfolio and our biosimilars.
Speaker #2: 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 generics Revelmid and the divestment Japan business.
Speaker #2: Our guidance range for the operating income and EBITDA reflect this higher growth investment in OPEX and also a less verbal ethics expected in the second half.
Eli Kalif: Our guidance range for the operating income and EBITDA reflect this higher growth investment in OpEx and also a less favorable FX expected in the H2. Let me provide you some additional thoughts on our quarterly phasing for the rest of the year. Overall revenue is expected to decrease over the rest of the year. For AUSTEDO, we continue to see elevated levels of inventory in the channels and expected normalization of this excess inventory in the next two quarters. We also continue to expect AUSTEDO revenue in Q4 2026 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.
Eli Kalif: Our guidance range for the operating income and EBITDA reflect this higher growth investment in OpEx and also a less favorable FX expected in the H2. Let me provide you some additional thoughts on our quarterly phasing for the rest of the year. Overall revenue is expected to decrease over the rest of the year. For AUSTEDO, we continue to see elevated levels of inventory in the channels and expected normalization of this excess inventory in the next two quarters. We also continue to expect AUSTEDO revenue in Q4 2026 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.
Speaker #2: 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.
Speaker #2: This is mainly due to a fewer high value launches in 2026, lower seasonal on OTC, and increased competition in some markets. Moving to the other elements of our financial outlook.
Speaker #2: For Osedo, we continue to see elevated levels of inventory in the channel and expected normalization of this excess inventory in the next two quarters.
Speaker #2: We continue to expect 2026 non-gap 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.
Speaker #2: We also continue to expect Osedo 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.
Speaker #2: 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.
Speaker #2: This is at the higher range on our overall 2027 to 2028% OPEX reflecting a deliberate investment we are making to support our growing innovative portfolio and our biosimilars.
Eli Kalif: 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. On non-GAAP margin, we expected improvements in the H2 in line with the 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 margin 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 capitals to our shareholders through a buyback when appropriate.
Eli Kalif: 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. On non-GAAP margin, we expected improvements in the H2 in line with the 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 margin 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 capitals to our shareholders through a buyback when appropriate.
Speaker #2: Our guidance range for the operating income and EBITDA reflect this higher growth investment in OPEX and also a less peripheral ethics expected in the second half.
Speaker #2: On non-gap margin, we expected improvements in the second half. In line with the 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 Osedo, our operating margin are expected to improve sequentially in Q4 driven by the OPEX savings.
Speaker #2: 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.
Speaker #2: For Orcedo, we continue to see elevated levels of inventory in the channels and expected normalization of this access inventory in the next two quarters.
Speaker #2: 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 equative BD opportunities along with the optionality of returning capitals to our shareholders through a buybacks when appropriate.
Speaker #2: We also continue to expect Orcedo revenue in Q4 2026 to be down year over year, due to the expected changes in purchasing patterns and pricing environments ahead of the IRA implementation in January.
Speaker #2: 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.
Speaker #2: 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.
Eli Kalif: 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.
Eli Kalif: 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.
Speaker #2: On non-gap margin, we expected improvements in the second half. In line with the 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 Orcedo, our operating margin are expected to improve sequentially in Q4 driven by the OPEX savings.
Speaker #2: 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.
Speaker #2: 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 capitals to our shareholders through a buybacks when appropriate.
Speaker #2: With that, I will now hand it back to Richard for his closing remarks.
Speaker #1: Thank you, Ali. So once again, I want to just highlight the fact that we are at a really exciting time at Teva. Living on our acceleration phase of the pivot to growth strategy.
Richard Francis: Thank you, Eli. Once again, I want to just highlight the fact that we're at a really exciting time at Teva, delivering 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. 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. To conclude, we continue on our growth journey. Three themes are very clear. In a critical year for Teva, we delivered exactly what we said we were going to do.
Richard Francis: Thank you, Eli. Once again, I want to just highlight the fact that we're at a really exciting time at Teva, delivering 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. 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. To conclude, we continue on our growth journey. Three themes are very clear. In a critical year for Teva, we delivered exactly what we said we were going to do.
Speaker #1: 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.
Speaker #2: 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.
Speaker #1: 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.
Speaker #1: So in the near future, our incremental goal will come from the next generation of innovation, but we'll have much more to come after that.
Speaker #2: 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.
Speaker #1: And so to conclude, we continue our growth journey three themes are very clear. In a critical year for Teva, we delivered exactly what we said we were going to do.
Speaker #1: Our pipeline is advancing at speed. And our ruthless discipline 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.
Richard Francis: Our pipeline is advancing at speed, our ruthless discipline capital allocation, we believe, is what sets us apart. With that, I look forward to answering some of your questions with the team here. Thank you very much.
Richard Francis: Our pipeline is advancing at speed, our ruthless discipline capital allocation, we believe, is what sets us apart. With that, I look forward to answering some of your questions with the team here. Thank you very much.
Speaker #2: With that, I will now hand it back to Richard for his closing remarks.
Speaker #1: Thank you, Ali. So once again, I want to just highlight the fact that we are at a really exciting time at Teva. Living on our acceleration phase of the pivot to growth strategy.
Speaker #1: Thank you very much.
Speaker #3: While Elliot's queueing up the questions, I just want to remind everyone if you could try to ask one question and one brief follow-up and we'll be happy to take you back into the queue.
Christopher Stevo: While Elliot's queuing up the questions, I just want to remind everyone, if you could try to ask one question and one brief follow-up, we'll be happy to take you back into the queue if you want to ask subsequent questions, just so as many people get a chance to ask questions as possible. Elliot, whenever you're ready, we can go ahead.
Christopher Stevo: While Elliot's queuing up the questions, I just want to remind everyone, if you could try to ask one question and one brief follow-up, we'll be happy to take you back into the queue if you want to ask subsequent questions, just so as many people get a chance to ask questions as possible. Elliot, whenever you're ready, we can go ahead.
Speaker #3: 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.
Speaker #1: 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.
Speaker #1: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you would like to withdraw your question, please press star followed by two.
Speaker #1: 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.
Operator: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you would like to withdraw your question, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. As a reminder, if you're using a speakerphone, please remember to pick up your handset before asking the question. First question comes from Jason Gerberry with Bank of America. Your line is open. Please go ahead.
Operator: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you would like to withdraw your question, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. As a reminder, if you're using a speakerphone, please remember to pick up your handset before asking the question. First question comes from Jason Gerberry with Bank of America. Your line is open. Please go ahead.
Speaker #1: When preparing to ask your question, please ensure your device is unmuted locally. And as a reminder, if you're using a speakerphone, please remember to pick up your handset before asking the question.
Speaker #1: 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.
Speaker #1: And so to conclude, we continue our growth journey three themes are very clear. In a critical year for Teva, we delivered exactly what we said we were going to do.
Speaker #1: First question comes from Jason Gerbery with Bank of America. Your line is open, please go ahead.
Speaker #4: Hey guys, thanks for taking my question and congrats on the quarter. So I just wanted to follow up. So strong performance on Osedo. I think you mentioned 60% new patient start share.
Jason Gerberry: Hey, guys. Thanks for taking my question and congrats on the quarter. I just wanted to follow up. 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 WAC price drug, that the payers will be observant of the fact that they shouldn't be using the IRA negotiated price point to advantage the competitor drugs. Just wanted to get your overall sense there. Just as my brief follow-up, any comments on the tariff update in the US and how the supply chain's configured to potentially manage that risk. Thanks.
Jason Gerberry: Hey, guys. Thanks for taking my question and congrats on the quarter. I just wanted to follow up. 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 WAC price drug, that the payers will be observant of the fact that they shouldn't be using the IRA negotiated price point to advantage the competitor drugs. Just wanted to get your overall sense there. Just as my brief follow-up, any comments on the tariff update in the US and how the supply chain's configured to potentially manage that risk. Thanks.
Speaker #1: Our pipeline is advancing at speed. And our ruthless discipline 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.
Speaker #4: Trying to get a sense of your confidence level going into next year, that Osedo won't be disadvantaged in formularies as a lower whack price drug.
Speaker #1: Thank you very much.
Speaker #3: And while Elliot's queueing up the questions, I just want to remind everyone if you could try to ask one question and one brief follow-up, and we'll be happy to take you back into the queue.
Speaker #4: That 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.
Speaker #3: If you want to ask subsequent questions, please do so, but we want as many people as possible to get a chance to ask questions. So, Elliot, whenever you're ready, we can go ahead.
Speaker #4: And just as my brief follow-up, any comments on the tariff update in the US and how the supply chains configured to potentially manage that risk.
Speaker #1: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you would like to withdraw your question, please press star followed by two.
Speaker #4: Thanks.
Speaker #1: Thanks, Jason. So could you repeat the last question I just missed it?
Speaker #1: When preparing to ask your question, please ensure your device is unmuted locally. And as a reminder, if you're using a speakerphone, please remember to pick up your handset before asking the question.
Richard Francis: Thanks, Jason. Could you repeat the last question? I just missed it.
Richard Francis: Thanks, Jason. Could you repeat the last question? I just missed it.
Speaker #4: Yeah, sorry. The last question was just any thoughts on Trump's proposed tariffs in the US and how the supply chain is configured to mitigate that risk.
Jason Gerberry: Yeah, sorry. The last question was just any thoughts on Trump's proposed tariffs in the US and how the supply chain is configured to mitigate that risk.
Jason Gerberry: Yeah, sorry. The last question was just any thoughts on Trump's proposed tariffs in the US and how the supply chain is configured to mitigate that risk.
Speaker #1: The first question comes from Jason Gerbery with Bank of America. Your line is open; please go ahead.
Speaker #1: Okay. Thanks for the question. Jason, so I'm glad you sort of recognized the strong performance of Osedo up 40%. I do want to maybe slightly correct you I think you said 60% of new starts.
Richard Francis: Okay. Thanks for the question, Jason. I'm glad you recognized the strong performance of AUSTEDO at 40%. I do want to maybe slightly correct you. I think you said 60% of new starts. The 60% I referred to is 60% of new AUSTEDO starts are 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. Then to your question on the payer dynamics for 2027. I think this is something that we've spent a lot of time looking at. There's a few obvious scenarios that can play out this way.
Richard Francis: Okay. Thanks for the question, Jason. I'm glad you recognized the strong performance of AUSTEDO at 40%. I do want to maybe slightly correct you. I think you said 60% of new starts. The 60% I referred to is 60% of new AUSTEDO starts are 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. Then to your question on the payer dynamics for 2027. I think this is something that we've spent a lot of time looking at. There's a few obvious scenarios that can play out this way.
Speaker #4: Hey guys, thanks for taking my question, and congrats on the quarter. So I just wanted to follow up—strong performance on Orcedo. I think you mentioned 60% new patient start share.
Speaker #1: I just want to the 60% I refer to is 60% of new Osedo starts are on the Osedo XR. Just as a clarification. That said, we still have very good TRX growth and very good milligram growth.
Speaker #4: Trying to get a sense of your confidence level going into next year, that Orcedo won't be disadvantaged in formularies, as a lower whack price drug, that the payers will be observant of the fact that they shouldn't be using the IRA negotiated price point.
Speaker #1: Highlighting the impact that Osedo 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 pair dynamics for 2027.
Speaker #4: 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 US and how the supply chains configured to potentially manage that risk?
Speaker #1: I think this is something that we've spent a lot of time looking at. There's a few obviously scenarios that can play out this way.
Speaker #4: Thanks.
Speaker #1: Thanks, Jason. Could you repeat the last question? I just missed it.
Speaker #1: But it's worth highlighting that all Medicare plans are required to cover IRA negotiated products in their part D formularies. That'd be like obviously Osedo XR.
Richard Francis: It's worth highlighting that all Medicare plans are required to cover IRA negotiated products in their Part D formularies. That'd be, obviously, AUSTEDO XR. Based on that, I think, and 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. How this impacts revenue, we're not really talking about that. We've highlighted the fact that when we give guidance on the company, we'll get more data as we go through. We end up having more discussions with some of the payers towards the end of the year. Remain very confident about that.
Richard Francis: It's worth highlighting that all Medicare plans are required to cover IRA negotiated products in their Part D formularies. That'd be, obviously, AUSTEDO XR. Based on that, I think, and 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. How this impacts revenue, we're not really talking about that. We've highlighted the fact that when we give guidance on the company, we'll get more data as we go through. We end up having more discussions with some of the payers towards the end of the year. Remain very confident about that.
Speaker #4: Yeah, sorry. The last question was just any thoughts on Trump's proposed tariffs in the US and how the supply chain is configured to mitigate that risk.
Speaker #1: And so based on that, I think and based on the product profile and the significant patient demand as well as the physician excitement around Osedo XR, I think we remain confident in our ability to continue to make sure we can capture significant amount of patients as we move into 2027.
Speaker #1: Okay. Thanks for the question. Jason, so I'm glad you sort of recognized the strong performance of Orcedo at 40%. I do want to maybe slightly correct you I think you said 60% of new starts.
Speaker #1: I just want to the 60% I refer to is 60% of new Orcedo starts are on the Orcedo XR. Just as a clarification. That said, we still have very good TRX growth and very good milligram growth.
Speaker #1: 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.
Speaker #1: 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.
Speaker #1: Highlighting the impact that Orcedo 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 pair dynamics for 2027.
Speaker #1: But remain very confident about that. And I'd just like to highlight what I said in my notes. Very committed and to the above 3 billion of pixels based on the significant untreated patient population and clearly the momentum that we have around the brand and the execution of the team.
Richard Francis: I'd just like to highlight what I said in my notes, very committed 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. This news has only just come out, so we're digesting this and understanding what that could look like. I would also point out that we do have a number of factories in the United States, six. I think we're one of the largest generic manufacturers in the US. We have a bit of time to work this one out and understand what the administration is trying to do.
Richard Francis: I'd just like to highlight what I said in my notes, very committed 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. This news has only just come out, so we're digesting this and understanding what that could look like. I would also point out that we do have a number of factories in the United States, six. I think we're one of the largest generic manufacturers in the US. We have a bit of time to work this one out and understand what the administration is trying to do.
Speaker #1: I think this is something that we've spent a lot of time looking at. There's a few obviously scenarios that can play out this way.
Speaker #1: But it's worth highlighting that all Medicare plans are required to cover IRA-negotiated products in their Part D formularies. That would be like, obviously, Orcedo XR.
Speaker #1: Now with regard to your second question on the recent announcement from the administration on the Tump tariffs. Obviously, this news has only just come out.
Speaker #1: 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, six.
Speaker #1: And so based on that, I think and based on the product profile and the significant patient demand as well as the physician excitement around Orcedo XR, I think we remain confident in our ability to continue to make sure we can capture significant amount of patients as we move into 2027.
Speaker #1: And I think we're one of the largest generic manufacturers in the US. But we have a bit of time to work this one out and understand what the administration is trying to do.
Speaker #1: And as you can imagine, we've always been in close discussions with the administration, being such a contributor to the healthcare system in the United States.
Speaker #1: 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.
Richard Francis: As you can imagine, we've always been in close discussions with the administration, being such a contributor to the healthcare system in the United States. Thanks for your question.
Richard Francis: As you can imagine, we've always been in close discussions with the administration, being such a contributor to the healthcare system in the United States. Thanks for your question.
Speaker #1: So thanks for your question.
Speaker #1: 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.
Speaker #4: Thank you.
Jason Gerberry: Okay. Thank you.
Jason Gerberry: Okay. Thank you.
Speaker #1: We now send to Umar Rafat with Evercore ISI. Your line is open, please go ahead.
Speaker #1: But remain very confident about that. And I'd just like to highlight what I said in my notes: very committed to the 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.
Operator: We now turn to Umer Raffat with Evercore ISI. Your line is open. Please go ahead.
Operator: We now turn to Umer Raffat with Evercore ISI. Your line is open. Please go ahead.
Speaker #4: Hi guys. Thanks for taking my question. I just wanted to spend a second on the aisle 15 ahead of the celiac readout. And just drill down a couple of dimensions.
Umer Raffat: Hi, guys. Thanks for taking my question. 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 7 April, which means they should've been done by early June, with the week 8 endpoint. 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 I-B 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?
Umer Raffat: Hi, guys. Thanks for taking my question. 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 7 April, which means they should've been done by early June, with the week 8 endpoint. 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 I-B 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?
Speaker #4: One, I believe the last patient in was April 7th, which means they should have been done by early June. With the week eight endpoint.
Speaker #1: 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.
Speaker #4: 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.
Speaker #1: 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, six.
Speaker #4: 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 one B exploratory celiac study.
Speaker #1: I think we're one of the largest generic manufacturers in the US, but we have a bit of time to work this one out and understand what the administration is trying to do.
Speaker #4: 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?
Speaker #1: And as you can imagine, we've always been in close discussions with the administration, being such a contributor to the healthcare system in the United States.
Speaker #4: 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 you're already completed celiac study?
Umer Raffat: 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? Thank you very much.
Umer Raffat: 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? Thank you very much.
Speaker #1: So thanks for your question.
Speaker #4: Okay. Thank you.
Speaker #4: Thank you very much.
Speaker #1: We now turn to Umar Rafat with Evercore ISI. Your line is open, please go ahead.
Speaker #1: Thanks for the question, Umar. I feel you're almost as demanding as I am with regard to wanting to see results as fast as possible.
Richard Francis: Thanks for the question, Umer. I feel you're almost as demanding as I am with regard to wanting to see results as fast as possible. With that, I'll hand it over to Eric to answer.
Richard Francis: Thanks for the question, Umer. I feel you're almost as demanding as I am with regard to wanting to see results as fast as possible. With that, I'll hand it over to Eric to answer.
Speaker #4: Hi, guys. Thanks for taking my question. I just wanted to spend a second on the aisle 15, ahead of the celiac readout, and just drill down on a couple of dimensions.
Speaker #1: But with that, I'll hand it over to Eric to answer.
Speaker #5: Thank you, Umar. 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.gov and the changes you see there don't always correlate to when we're doing the database lock.
Speaker #4: One, I believe the last patient in was April 7th, which means they should have been done by early June. With the week eight endpoint.
Eric Hughes: Thank you, Umer. Thank you for the very specific and up-to-date question. First, the question about the enrollment. The enrollment that you see on clinicaltrials.gov and the changes you see there don't always correlate to when we're doing the database lock. That's the simple answer I have there. There's nothing slow or fast about it. It's just as it is. We'll have that data in H2 of this year. With regards to the question about the biomarker in the first POC. That was a FABP, a fatty acid binding protein. I think I got that right. Free acid binding protein. And that's a biomarker that's not uncommonly used to measure gut inflammation.
Eric Hughes: Thank you, Umer. Thank you for the very specific and up-to-date question. First, the question about the enrollment. The enrollment that you see on clinicaltrials.gov and the changes you see there don't always correlate to when we're doing the database lock. That's the simple answer I have there. There's nothing slow or fast about it. It's just as it is. We'll have that data in H2 of this year. With regards to the question about the biomarker in the first POC. That was a FABP, a fatty acid binding protein. I think I got that right. Free acid binding protein. And that's a biomarker that's not uncommonly used to measure gut inflammation.
Speaker #4: 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.
Speaker #5: So that's a simple answer I have there. 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.
Speaker #4: 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 one B exploratory celiac study.
Speaker #5: With regard to the question about the biomarker in the first POC. So that was FSBP free acid binding protein. I think I got that right.
Speaker #4: 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?
Speaker #5: Free acid binding protein. And that's a biomarker that's not uncommonly used to measure gut inflammation. And that separation we saw from placebo versus active upon that gluten challenge is really exciting to me to see that because that really indicated that we're having an impact.
Speaker #4: 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 you're already completed celiac study?
Eric Hughes: That separation we saw from placebo versus active upon that gluten challenge. It was exciting to me to see that because that really indicated that we were having an impact. One of the things I always like to mention, if you speculate or overread the data, not only did we protect the gut with this biomarker by that readout, but it seems you actually get better from the baseline. Whether we are treating a smoldering celiac in those patients is something fun to speculate about. It was this free acid-binding protein in that study. Your final question was the amount of gluten challenge we're giving in the biopsy study that's going to read out in H2 of this year. We're giving 3 grams every day for six weeks.
Eric Hughes: That separation we saw from placebo versus active upon that gluten challenge. It was exciting to me to see that because that really indicated that we were having an impact. One of the things I always like to mention, if you speculate or overread the data, not only did we protect the gut with this biomarker by that readout, but it seems you actually get better from the baseline. Whether we are treating a smoldering celiac in those patients is something fun to speculate about. It was this free acid-binding protein in that study. Your final question was the amount of gluten challenge we're giving in the biopsy study that's going to read out in H2 of this year. We're giving 3 grams every day for six weeks.
Speaker #4: Thank you very much.
Speaker #5: And one of the things I always like to mention if you speculate or overread the data, not only did we protect the gut with this biomarker by that readout, but it seemed to actually get better on from the baseline.
Speaker #1: Thanks for the question, Umar. I feel you're almost as demanding as I am when it comes to wanting to see results as fast as possible.
Speaker #1: With that, I'll hand it over to Eric to answer.
Speaker #5: Thank you, Umar. 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.gov and the changes you see there don't always correlate to when we're doing the database lock.
Speaker #5: So whether we are treating a smoldering celiac in those patients is something fun to speculate about. So it was a free acid binding protein in that study.
Speaker #5: 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.
Speaker #5: So that's a simple answer I have there. 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.
Speaker #5: So we're giving three grams every day for six weeks. That's significant challenge. In that study and I think that the team thought about there's various different ways you can do it, but that's a significant kind of amount.
Speaker #5: With regard to the question about the biomarker in the first POC. So that was FSBP free acid binding protein. I think I got that right.
Eric Hughes: That's a significant challenge in that study. I think that the team thought about it. 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. Hopefully that answers all your questions.
Eric Hughes: That's a significant challenge in that study. I think that the team thought about it. 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. Hopefully that answers all your questions.
Speaker #5: I'm always impressed to see that we can enroll patients that are willing to do that. So hopefully that answers all your questions.
Speaker #5: Free acid binding protein. And that's a biomarker that's not uncommonly used to measure gut inflammation. And that separation we saw from placebo versus active upon that gluten challenge is really it was exciting to me to see that because that really indicated that we were having an impact.
Speaker #1: Thanks for the question, Umar. Next question.
Richard Francis: Thanks for the question, Uwe. Next question.
Richard Francis: Thanks for the question, Uwe. Next question.
Speaker #2: We now send to Luis Chen with Scotiabank. Your line is open, please go ahead.
Operator: We now turn to Louise Chen with Scotiabank. Your line is open. Please go ahead.
Operator: We now turn to Louise Chen with Scotiabank. Your line is open. Please go ahead.
Speaker #5: And one of the things I always like to mention if you speculate or overread the data, not only did we protect the gut with this biomarker by that readout, but it seemed to actually get better on from the baseline.
Speaker #6: Hi, thanks for taking my question. Congrats on the quarter. I wanted to ask you about your biosimilars opportunity. You seem to be talking about that more.
Louise Chen: Hi. Thanks for taking my question. Congrats on the quarter. 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. Is there anything in the US market that's changing here, any potential actions from the regulators or payers on the horizon that could open up this market even more? Thank you.
Louise Chen: Hi. Thanks for taking my question. Congrats on the quarter. 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. Is there anything in the US market that's changing here, any potential actions from the regulators or payers on the horizon that could open up this market even more? Thank you.
Speaker #6: 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.
Speaker #5: So whether we were treating a smoldering celiac in those patients, it's something fun to speculate about. So it was a free acid binding protein in that study.
Speaker #6: And is there anything in the US market that's changing here? Any potential actions from the regulators or payers on the horizon that could open up this market even more?
Speaker #5: 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.
Speaker #6: Thank you.
Speaker #1: Hi, Luis. 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.
Richard Francis: Hi, Louise. Thanks for the question. 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. I think there are a couple of reasons why I'm excited. One is just the performance of the team we have in the US in the market. To give you some context, we have not always been first to the market. What we've shown and what I highlighted today is 2 out of our 5 products in the US market are number 1, and I think a third one's about to become number 1. That just shows, I think, our capability, which leads a bit into part of your second question, what is changing in the US market? Well, actually, nothing really is changing. It's actually a very difficult, complex, fragmented market.
Richard Francis: Hi, Louise. Thanks for the question. 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. I think there are a couple of reasons why I'm excited. One is just the performance of the team we have in the US in the market. To give you some context, we have not always been first to the market. What we've shown and what I highlighted today is 2 out of our 5 products in the US market are number 1, and I think a third one's about to become number 1. That just shows, I think, our capability, which leads a bit into part of your second question, what is changing in the US market? Well, actually, nothing really is changing. It's actually a very difficult, complex, fragmented market.
Speaker #5: So we're giving three grams every day for six weeks. That's significant challenge. In that study and I think that the team thought about there's various different ways you can do it, but that's a significant amount.
Speaker #1: 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 US in the market.
Speaker #5: I'm always impressed to see that we can enroll patients who are willing to do that. So, hopefully, that answers all your questions.
Speaker #1: 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 two out of our five products in the US market are number one.
Speaker #1: Thanks for the question, Umar. Next question.
Speaker #1: And I think a third one's about to become number one. And that just shows I think our capability. Which leads a bit into part of your second question.
Speaker #3: We now turn to Luis Chen with Scotiabank. Your line is open. Please go ahead.
Speaker #1: What is changing in the US 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?
Speaker #6: Hi. Thanks for taking my question. Congrats on the quarter. I wanted to ask you about your biosimilars opportunity. You seem to be talking about that more.
Speaker #6: 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.
Richard Francis: Why do I sound somewhat positive about that? I'm not. What I know is with Teva, 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. I think that's why you're seeing my excitement about the performance we have in the US. If this changes, I think that will be a positive as well because we'll benefit from that. We have more and more products coming to the US. Now in Europe, where we really have been starved of biosimilars, now we start to launch them in Europe.
Richard Francis: Why do I sound somewhat positive about that? I'm not. What I know is with Teva, 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. I think that's why you're seeing my excitement about the performance we have in the US. If this changes, I think that will be a positive as well because we'll benefit from that. We have more and more products coming to the US. Now in Europe, where we really have been starved of biosimilars, now we start to launch them in Europe.
Speaker #1: I'm not, but what I know is with Teva, 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.
Speaker #6: And is there anything in the US market that's changing here? Any potential actions from the regulators or payers on the horizon that could open up this market even more?
Speaker #1: And I think that's why you're seeing my excitement about the performance we have in the US. If this changes, I think that will be a positive as well because we'll benefit from that.
Speaker #6: Thank you.
Speaker #1: Hi, Luis. Thanks for the question. So you're right, we are excited—I am excited—about the biosimilars. We've been working hard to get the portfolio and to get this to market.
Speaker #1: But we have more and more products coming to the US. Now in Europe, where we really have been starved of biosimilars, and now we start to launch them in Europe.
Speaker #1: 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 US in the market.
Speaker #1: 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 are saying that we can do that.
Richard Francis: 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 are saying that we can do that. The reason why in totality I'm excited is as you put these 15 biosimilars 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. That's where my enthusiasm lies. I hope we'll have a lot more data points to highlight that. Maybe to conclude, we did set ourselves a target for $800 million by 2027. As I said today in the call, we're well on track to exceed that already. Thanks for the question, Louise.
Richard Francis: 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 are saying that we can do that. The reason why in totality I'm excited is as you put these 15 biosimilars 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. That's where my enthusiasm lies. I hope we'll have a lot more data points to highlight that. Maybe to conclude, we did set ourselves a target for $800 million by 2027. As I said today in the call, we're well on track to exceed that already. Thanks for the question, Louise.
Speaker #1: 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 two out of our five products in the US market are number one.
Speaker #1: So the reason why in totality I'm excited is as you put these 15 biosimilars together and other 14 that are coming through in more partnerships we're doing, I think this will be a major growth driver for our generics business as a whole.
Speaker #1: And I think a third one's about to become number one. And that just shows I think our capability. Which leads a bit into part of your second question.
Speaker #1: What is changing the US 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?
Speaker #1: 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.
Speaker #1: I'm not, but what I know is with Teva, 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.
Speaker #1: As I said today in the call, we're well on track to exceed that already. So thanks for the question, Luis.
Speaker #1: And I think that's why you're seeing my excitement about the performance we have in the US. If this changes, I think that will be a positive as well because we'll benefit from that.
Speaker #2: We now turn to Dennis Ding with Jefferies. Your line is open, please go ahead.
Operator: We now turn to Dennis Ding with Jefferies. Your line is open. Please go ahead.
Operator: We now turn to Dennis Ding with Jefferies. Your line is open. Please go ahead.
Speaker #7: Hey, good morning. I had a question on celiac. So you guys have talked about using Forte's phase one B as the bar on VHCD.
Dennis Ding: Hey, good morning. I had a question on celiac. You guys have talked about using Forte Biosciences' phase I-B as the bar on Vh:Cd, but that was 0.127 placebo-adjusted and had very wide error bars. This is actually a two-part question. Number 1, why shouldn't we use the CALYPSO data as the bar, which is around, I think, 0.4 to 0.45? Number 2, 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? Thanks so much.
Dennis Ding: Hey, good morning. I had a question on celiac. You guys have talked about using Forte Biosciences' phase I-B as the bar on Vh:Cd, but that was 0.127 placebo-adjusted and had very wide error bars. This is actually a two-part question. Number 1, why shouldn't we use the CALYPSO data as the bar, which is around, I think, 0.4 to 0.45? Number 2, 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? Thanks so much.
Speaker #1: But we have more and more products coming to the US. Now in Europe, where we really have been starved of biosimilars. And now we start to launch them in Europe.
Speaker #7: But that was 0.127 placebo adjusted and had very wide error bars. So this is actually a two-part question. Number one, why shouldn't we use the Calypso data as a bar, which is around, I think, 0.4 to 0.45?
Speaker #1: 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 are saying that we can do that.
Speaker #7: 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?
Speaker #1: So the reason why in totality I'm excited is as you put these 15 biosimilars together and other 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.
Speaker #1: 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.
Speaker #7: Thanks so much.
Speaker #1: Over to you. All right.
Speaker #7: Yeah. Thank you, Richard. So Dennis, we're using the bars that we can report against. I'm sorry. Forte is the one that's reported the number of 0.127.
Richard Francis: Over to you, Eric.
Richard Francis: Over to you, Eric.
Eric Hughes: Thank you, Richard. Dennis, we are using the bars that we can report against. I am sorry. Forte is the one that has reported the number of 0.127. The CALYPSO data, I am not sure if that is something readily available to us right now. 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 studies. 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 are 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.
Eric Hughes: Thank you, Richard. Dennis, we are using the bars that we can report against. I am sorry. Forte is the one that has reported the number of 0.127. The CALYPSO data, I am not sure if that is something readily available to us right now. 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 studies. 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 are 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.
Speaker #1: As I said today in the call, we're well on track to exceed that already. So thanks for the question, Luis.
Speaker #7: 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 to.
Speaker #3: We now turn to Dennis Ding with Jefferies. Your line is open. Please go ahead.
Speaker #7: I think the important thing is that you have to remember these are all somewhat artificial gluten challenge studies. They are different from study to study.
Speaker #7: Hey, good morning. I had a question on celiac. So you guys have talked about using Forte's phase one B as the bar on VHCD.
Speaker #7: 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 six-week challenge with a pretty good burden of gluten.
Speaker #7: But that was 0.127 placebo-adjusted and had very wide error bars. So, this is actually a two-part question. Number one, why shouldn't we use the CALYPSO data as a bar, which is around, I think, 0.4 to 0.45?
Speaker #7: 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 one that's documented the most, and I think is the most comparable, is the Forte result of 0.127 that you mentioned.
Speaker #7: 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?
Eric Hughes: The one that is documented the most, and I think is the most comparable, is the Forte result of 0.127 that you mentioned, and that is the delta between placebo and active. I am still kind of saying that that is going to be what we are going to measure ourself against with regards to results that we have access to. The CALYPSO data, I am not familiar with that. I am not sure if that was posted or is available right now. Maybe we can follow up with you on comparing that. There is a lot of different things we are 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. A lot to come there, but I think we are going to stick with comparing to Forte at this point.
Eric Hughes: The one that is documented the most, and I think is the most comparable, is the Forte result of 0.127 that you mentioned, and that is the delta between placebo and active. I am still kind of saying that that is going to be what we are going to measure ourself against with regards to results that we have access to. The CALYPSO data, I am not familiar with that. I am not sure if that was posted or is available right now. Maybe we can follow up with you on comparing that.
Speaker #7: 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.
Speaker #7: Thanks so much.
Speaker #1: Over to you. All right.
Speaker #7: Yeah. Thank you, Richard. So Dennis, we're using the bars that we can report against. I'm sorry. Forte is the one that's reported the number of 0.127.
Speaker #7: 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.
Speaker #7: 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 to.
Speaker #7: 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 two and three studies, but also experiential or symptomatology data.
Eric Hughes: There is a lot of different things we are 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. A lot to come there, but I think we are going to stick with comparing to Forte at this point.
Speaker #7: I think the important thing is that you have to remember these are all somewhat artificial gluten challenge studies. They are different from study to study.
Speaker #7: 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 six-week challenge with a pretty good burden of gluten.
Speaker #7: So a lot to come there, but I think we're going to stick with comparing to Forte at this point.
Speaker #1: Thanks, Eric. Thanks for the question, Dennis.
Richard Francis: Thanks, Eric. Thanks for the question, Dennis.
Richard Francis: Thanks, Eric. Thanks for the question, Dennis.
Speaker #7: 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 one that's documented the most—and I think is the most comparable—is the FORTE result of 0.127 that you mentioned.
Speaker #2: We now turn to David Anselm with Piper Sandler. Your line is open, please go ahead.
Operator: We now turn to David Amsellem with Piper Sandler. Your line is open. Please go ahead.
Operator: We now turn to David Amsellem with Piper Sandler. Your line is open. Please go ahead.
Speaker #5: Thanks. So one on 408 and then one on EchoPipe. 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.
David Amsellem: Thanks. One on TEV-'408 and then one on ecopipam. On TEV-'408, particularly with Forte Biosciences getting acquired, I wanted to get your thoughts, Eric Hughes, on how you view TEV-'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 TEV-'408. That's a broad question and I guess multiple indications encompassing vitiligo and celiac and maybe others. Secondly, on ecopipam, 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? Thanks a lot.
David Amsellem: Thanks. One on TEV-'408 and then one on ecopipam. On TEV-'408, particularly with Forte Biosciences getting acquired, I wanted to get your thoughts, Eric Hughes, on how you view TEV-'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 TEV-'408. That's a broad question and I guess multiple indications encompassing vitiligo and celiac and maybe others. Secondly, on ecopipam, 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? Thanks a lot.
Speaker #7: 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 results that we have access to.
Speaker #7: 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.
Speaker #5: 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.
Speaker #7: 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 two and three studies, but also experiential or symptomatology data.
Speaker #5: And then secondly, on EchoPipe, 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?
Speaker #7: So a lot to come there, but I think we're going to stick with comparing to Forte at this point.
Speaker #1: Thanks, Eric. Thanks for the question, Dennis.
Speaker #3: We now turn to David Anselm with Piper Sandler. Your line is open. Please go ahead.
Speaker #5: How do you think about that and particularly considering that those agents are generically available? Thanks a lot.
Speaker #5: Thanks. So one on
Speaker #7: 408, and then one on EchoPipe. 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.
Speaker #1: Okay. Do you want to start on anti-IL-50?
Richard Francis: Okay. Do you want to start on anti-IL-15?
Richard Francis: Okay. Do you want to start on anti-IL-15?
Speaker #7: Yes. Okay. Thank you for the question. So first, maybe discuss the competition and how we approach the development of anti-IL-15 versus how Forte has approached it.
Eric Hughes: Yes. Okay. Thank you for the question. First, maybe discuss the competition and how we approach the development of anti-IL-15 versus how Forte Biosciences has approached it. There's nothing wrong with the two different approaches. You can hit the receptor like Forte Biosciences has done, or you can hit the ligand like we have with an anti-IL-15. There's a couple 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. We just, by strategy, do it a different way. 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.
Eric Hughes: Yes. Okay. Thank you for the question. First, maybe discuss the competition and how we approach the development of anti-IL-15 versus how Forte Biosciences has approached it. There's nothing wrong with the two different approaches. You can hit the receptor like Forte Biosciences has done, or you can hit the ligand like we have with an anti-IL-15. There's a couple 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. We just, by strategy, do it a different way. 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.
Speaker #7: There's nothing wrong with the two different approaches. You can hit the receptor like Forte has done, or you can hit the ligand like we have with an anti-IL-15.
Speaker #7: 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.
Speaker #7: 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.
Speaker #7: And then secondly, on EchoPipe, 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?
Speaker #7: 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.
Speaker #7: 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.
Speaker #7: 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 one point over time.
Speaker #7: How do you think about that and particularly considering that those agents are generically available? Thanks a lot.
Eric Hughes: That gives us a good idea of how much activity we are seeing at any one point over time. We've shown the suppression of free IL-15 for out to 80 or 90 days on a single dose. That really drives an evidence-based way of choosing your dose selection and schedule. That's why we are interrogating a dose given once every 3 months. This is a quarterly shot that we're developing as a subcutaneous shot. There's just strategic differences. Whether one 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-give subcutaneous shot every 3 months. Those are the biggest differences I see. It's great to see the acquisition. It shows the value people are putting in these indications like vitiligo and celiac disease.
Eric Hughes: That gives us a good idea of how much activity we are seeing at any one point over time. We've shown the suppression of free IL-15 for out to 80 or 90 days on a single dose. That really drives an evidence-based way of choosing your dose selection and schedule. That's why we are interrogating a dose given once every 3 months. This is a quarterly shot that we're developing as a subcutaneous shot. There's just strategic differences. Whether one 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-give subcutaneous shot every 3 months. Those are the biggest differences I see. It's great to see the acquisition. It shows the value people are putting in these indications like vitiligo and celiac disease.
Speaker #7: So we've shown the suppression of free IL-15 for out to 80 or 90 days on a single dose. So that really drives evidence-based way of choosing your dose selection and schedule.
Speaker #1: Okay. Do you want to start on HL50?
Speaker #7: Yes. Okay. Thank you for the question. So first, maybe discuss the competition and how we approach the development of anti-IL-15 versus how Forte has approached it.
Speaker #7: That's why we are interrogating a dose given once every three months. This is a quarterly shot that we're developing as a subcutaneous shot. So there's just strategic differences whether one is better than the other.
Speaker #7: There's nothing wrong with the two different approaches. You can hit the receptor like Forte has done, or you can hit the ligand like we have.
Speaker #7: When the anti-IL-15, there's a couple of things that we consider strategically when we design molecules. We like to go after the ligand. It's clean.
Speaker #7: We don't know. I'm just very confident in our modeling and simulation of how we'll move forward with a simple to give, subcutaneous shot, every three months.
Speaker #7: 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.
Speaker #7: So 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.
Speaker #7: 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.
Speaker #7: I'm fairly confident these will be indications to grow just like we saw psoriasis grow, just like we saw atopic dermatitis. Once we get good treatments that are easy to give, they will be used in the market will increase.
Eric Hughes: I'm fairly confident these will be indications that grow just like we saw psoriasis grow, 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. That's your first answer. For ecopipam, the positioning of ecopipam, right now, people go through these first behavioral treatments for Tourette syndrome. They try off-label drugs like guanfacine and other treatments that aren't approved but actually have some modest effect. They're not great, but they're well-tolerated. They advance onto antipsychotics, which have activity, but their tolerability is poor, particularly in a pediatric population. The differentiation, the thing we're bringing to the table with ecopipam 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.
Eric Hughes: I'm fairly confident these will be indications that grow just like we saw psoriasis grow, 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. That's your first answer. For ecopipam, the positioning of ecopipam, right now, people go through these first behavioral treatments for Tourette syndrome. They try off-label drugs like guanfacine and other treatments that aren't approved but actually have some modest effect. They're not great, but they're well-tolerated. They advance onto antipsychotics, which have activity, but their tolerability is poor, particularly in a pediatric population. The differentiation, the thing we're bringing to the table with ecopipam 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.
Speaker #7: 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 one point over time.
Speaker #7: So that's your first answer. For EchoPipe, the positioning of EchoPipe right now, people go through first behavioral treatments for Tourette's disease. Then they try off-label drugs like guaifenesin and other treatments that aren't approved, but actually have some modest effect.
Speaker #7: 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.
Speaker #7: That's why we are interrogating a dose given once every three months. This is a quarterly shot that we're developing as a subcutaneous shot. So there's just strategic differences, whether one is better than the other.
Speaker #7: They're not great, but they're well tolerated. Then they advance onto antipsychotics, which have activity, but they're tolerability is poor, particularly in a pediatric population.
Speaker #7: We don't know. I'm just very confident in our modeling and simulation of how we'll move forward with a simple-to-give, subcutaneous shot every three months.
Speaker #7: So the differentiation, the thing we're bringing to the table at EchoPipe is a brand new mode of action. It's a D1 antagonist. It's much more tolerable.
Speaker #7: So 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.
Speaker #7: We believe in our hands it was very tolerable in the phase threes and phase two studies. And we think that at first, they might not be first-line therapies, but over time, when people see the tolerability and the efficacy, that it would probably advance over time.
Speaker #7: And celiac disease. I'm fairly confident these will be indications to grow just like we saw psoriasis grow, just like we saw atopic dermatitis. Once we get good treatments that are easy to give, they will be used in the market will increase.
Eric Hughes: We think that at first, they might not be first-line therapies, but over time, when people see the tolerability and the efficacy, that it would probably advance over time. That's how I see the order of entry and the value proposition that we have with ecopipam.
Eric Hughes: We think that at first, they might not be first-line therapies, but over time, when people see the tolerability and the efficacy, that it would probably advance over time. That's how I see the order of entry and the value proposition that we have with ecopipam.
Speaker #7: So that's how I see the order of entry and the value proposition that we have with EchoPipe.
Speaker #7: So that's your first answer. For EchoPipe, the positioning of EchoPipe right now, people go through first behavioral treatments for Tourette's disease. Then they try off-label drugs like glyphenacine and other treatments that aren't approved but actually have some modest effect.
Speaker #1: Yeah. 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's syndrome.
Richard Francis: 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, I think that highlights why they're not treated. That theory is further endorsed by the fact that only 20% to 30% remain on therapy. 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. Either way you look at it, I think there's a big unmet medical need for an efficacious, safe, well-tolerated product.
Richard Francis: 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, I think that highlights why they're not treated. That theory is further endorsed by the fact that only 20% to 30% remain on therapy. 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. Either way you look at it, I think there's a big unmet medical need for an efficacious, safe, well-tolerated product.
Speaker #1: 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.
Speaker #1: 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.
Speaker #7: They're not great, but they're well tolerated. Then they advance onto antipsychotics, which have activity, but they're tolerability is poor, particularly in a pediatric population.
Speaker #1: Or some of the other drugs don't work that effectively. So either way you look at it, I think there's a big unmet medical need for an efficacious safe well-tolerated product.
Speaker #7: So, the differentiation—the thing we're bringing to the table with EchoPipe—is a brand new mode of action. It's a D1 antagonist. It's much more tolerable.
Speaker #1: And I combine that with the expertise we have in the US with the Stedo Ysedi and Ajovy as to how to treat certain patient populations.
Richard Francis: I combine that with the expertise we have in the US with AUSTEDO, UZEDY, and AJOVY to how to treat certain patient populations, and our experience with psychiatrists and neurologists. 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.
Richard Francis: I combine that with the expertise we have in the US with AUSTEDO, UZEDY, and AJOVY to how to treat certain patient populations, and our experience with psychiatrists and neurologists. 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.
Speaker #7: We have in our hands this. It was very tolerable in the Phase 3 and Phase 2 studies. And we think that at first, they might not be first-line therapies, but over time, when people see the tolerability and the efficacy, that it would probably advance over time.
Speaker #1: And our experience with psychiatrists and neurologists. 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.
Speaker #7: So that's how I see the order of entry and the value proposition that we have with EchoPipe.
Speaker #1: Yeah. 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's syndrome.
Speaker #5: We now turn to Ash Verma with UBS. Your line is open. Please go ahead.
Operator: We now turn to Ash Verma with UBS. Your line is open. Please go ahead.
Operator: We now turn to Ash Verma with UBS. Your line is open. Please go ahead.
Speaker #8: Great. Yeah. Thanks for taking our questions. Can you talk about the TL1A new indication? Just for the fibrostenostic Crohn's indication that you mentioned, what type of addressable market is that in terms of US and European patients?
Speaker #1: Only 50% are treated, and I think that highlights why they're not treated. I think it goes to the fact that there isn't a product that gives efficacy and safety.
Ash Verma: Great. Yeah, thanks for taking our questions. Can you talk about the TL1A new indication, just for the fibrostenotic Crohn's indication that you mentioned? What type of addressable market is that in terms of US and European patients? 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 HiSCR 50 as the primary endpoint? Thanks.
Ash Verma: Great. Yeah, thanks for taking our questions. Can you talk about the TL1A new indication, just for the fibrostenotic Crohn's indication that you mentioned? What type of addressable market is that in terms of US and European patients? 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 HiSCR 50 as the primary endpoint? Thanks.
Speaker #1: 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.
Speaker #8: And then for HS, what would be the development path and trial design look like? Is it typical phase two, phase three with a focus on high score 50 as the primary endpoint?
Speaker #1: Or some of the other drugs don't work that effectively. So either way, you look at it, I think there's a big unmet medical need for an efficacious safe well-tolerated product.
Speaker #8: Thanks.
Speaker #1: Hi, Ash. Thanks for the question. I'll hand that one to Eric. You having a busy day today.
Richard Francis: Hi, Ash. Thanks for the question. I'll hand that one to Eric. You're having a busy day today.
Richard Francis: Hi, Ash. Thanks for the question. I'll hand that one to Eric. You're having a busy day today.
Speaker #7: Yeah. So thanks for the question. The two indications, I'm very excited about these two indications. And just to review how we think about the indications with our partner, Sanofi.
Speaker #1: And I combine that with the expertise we have in the US with the Stedo Yosedi and Ajovy as to how to treat certain patient populations.
Eric Hughes: Yeah. Thanks for the question. The two indications, I'm very excited about these two indications. 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 four benchmarks we use when choosing it. Why then HS and fibrostenotic Crohn's disease? Well, HS. 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 duvakitug that has potential effects on multiple different pathways. 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 go into.
Eric Hughes: Yeah. Thanks for the question. The two indications, I'm very excited about these two indications. 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 four benchmarks we use when choosing it. Why then HS and fibrostenotic Crohn's disease? Well, HS. 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 duvakitug that has potential effects on multiple different pathways. 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 go into.
Speaker #1: And our experience with psychiatrists and neurologists. 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.
Speaker #7: First, the scientific justification has to be the market opportunity. The possibility of regulatory success, and of course, the speed. Those are the four benchmarks we use when choosing it.
Speaker #7: So why then HS and fibrostenotic Crohn's disease? Well, HS, there's a lot of great science around the fact that TL1A is up-regulated in these disease areas.
Speaker #7: We now turn to Ash Verma with UBS. Your line is open. Please go ahead.
Speaker #7: The fact that TH1 and TH17 cells are involved, you need a drug like Dovetitug that has the potential effects on multiple different pathways. And then you add in the fact that there's a potential direct effect on fibrosis.
Speaker #8: Great. Yeah. Thanks for taking our questions. Can you talk about the TL1A new indication just for the fibrous tenostic Crohn's indication that you mentioned?
Speaker #8: What type of addressable market is that in terms of US and European patients? And then for HS, what would be the development path and trial design look like?
Speaker #7: 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.
Speaker #8: Is it typical Phase II, Phase III, with a focus on high score 50 as the primary endpoint? Thanks.
Eric Hughes: 15% of patients who have IBD also have HS. 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-end medical need. The market opportunity is definitely there. I think we have a good chance on the probability of success, and it's something that we can execute very quickly. Usually, these primary endpoints are around 16 weeks. That's how we'll approach it, most likely. At this point in the development, we'll do a traditional Phase IIb study that will drive a Phase III program. That's what the timelines are we're looking at for HS. Now, turning to fibrostenotic Crohn's disease, this is another one I really think is a great idea.
Eric Hughes: 15% of patients who have IBD also have HS. 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-end medical need. The market opportunity is definitely there. I think we have a good chance on the probability of success, and it's something that we can execute very quickly. Usually, these primary endpoints are around 16 weeks. That's how we'll approach it, most likely. At this point in the development, we'll do a traditional Phase IIb study that will drive a Phase III program. That's what the timelines are we're looking at for HS. Now, turning to fibrostenotic Crohn's disease, this is another one I really think is a great idea.
Speaker #7: So there's a lot of science and reason to believe that this HS is another market that's growing. You see this out there with the competition.
Speaker #1: Hi, Ash. Thanks for the question. I'll hand that one to Eric. You having a busy day today.
Speaker #7: Yeah. So thanks for the question. The two indications I'm very excited about these two indications. And just to review how we think about the indications with our partner Sanofi, first, the scientific justification has to be the market opportunity.
Speaker #7: 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.
Speaker #7: And it's something we can execute very quickly. Usually, these primary endpoints are on 16 weeks. That's how we'll approach it. Most likely. And at this point in the development, we'll do a traditional phase two B study that will drive then a phase three program.
Speaker #7: The possibility of regulatory success, and of course, the speed. Those are the four benchmarks we use when choosing it. So why then HS and fibrous stenotic Crohn's disease?
Speaker #7: Well, HS, 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 Duvetitug that has the potential to impact multiple different pathways.
Speaker #7: So that's what the timelines are looking at for HS. Now, turning to fibrostenotic Crohn's disease, this is another one I really think is a great idea.
Speaker #7: This is an area that's great unmet medically. There's no approved therapies for the indication of fibrostenotic Crohn's disease. And this is really one of the main drivers of the complications of Crohn's disease where you have a potential obstruction.
Speaker #7: 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, not to mention the fact that 15% of patients who have IBD also have HS.
Eric Hughes: This is an area that's a great unmet medical need. There's no approved therapies for the indication of fibrostenotic Crohn's disease. This is really one 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. If you can have a drug that potentially not only blocks the inflammation, but really starts to work on these majorly obstructive fibrotic and demented lesions in patients with Crohn's disease, that's a major differentiator for a drug launching into IBD. 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.
Eric Hughes: This is an area that's a great unmet medical need. There's no approved therapies for the indication of fibrostenotic Crohn's disease. This is really one 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. If you can have a drug that potentially not only blocks the inflammation, but really starts to work on these majorly obstructive fibrotic and demented lesions in patients with Crohn's disease, that's a major differentiator for a drug launching into IBD. 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.
Speaker #7: You have hospitalizations. You have increased costs and 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 edematous lesions in patients with Crohn's disease, that's a major differentiator for a drug launching into IBD.
Speaker #7: 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.
Speaker #7: 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.
Speaker #7: 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.
Speaker #7: 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.
Speaker #7: And at this point in the development, we'll do a traditional phase two B study that will drive then a phase three program. So that's the timelines are looking at for HS.
Speaker #7: So when I think about the opportunity here, it's not just scientifically unlocking fibrosis. It's driving a better label a broader opportunity for patients and a broader opportunity for the market for the company.
Eric Hughes: When I think about the opportunity here, it's not just scientifically unlocking fibrosis, it's driving a better label, a broader opportunity for patients, and a broader opportunity for the market for the company. That's the thinking behind the two indications. I think that they're spot on.
Eric Hughes: When I think about the opportunity here, it's not just scientifically unlocking fibrosis, it's driving a better label, a broader opportunity for patients, and a broader opportunity for the market for the company. That's the thinking behind the two indications. I think that they're spot on.
Speaker #7: Now, turning to fibrous tenotic Crohn's disease, this is another one I really think is a great idea. This is an area that's great unmet medical need.
Speaker #7: So that's the thinking behind the two indications. I think that they're spot on.
Speaker #7: There are no approved therapies for the indication of fibrous stenotic Crohn's disease. And this is really one of the main drivers of the complications of Crohn's disease, where you have a potential obstruction.
Speaker #1: Thanks, Eric. Thanks, Ash. I think we have time for one more question. Is that right? Yeah.
Richard Francis: Thanks, Eric. Thanks, Ash. I think we have time for one more question. Is that right? Yeah.
Richard Francis: Thanks, Eric. Thanks, Ash. I think we have time for one more question. Is that right? Yeah.
Speaker #5: Our next question comes from Sneha Muthai with Barclays. Your line is open. Please go ahead.
Operator: Our next question comes from Sneha Mutha with Barclays. Your line is open. Please go ahead.
Operator: Our next question comes from Sneha Mutha with Barclays. Your line is open. Please go ahead.
Speaker #7: You have hospitalizations. You have increased costs and 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 edematous lesions in patients with Crohn's disease, that's a major differentiator for a drug launching into IBD.
Speaker #7: Yeah. This is Glenn Santangela. I think you got the name wrong. But essentially, Ellie, I just had two quick questions for you if I could.
Glen Santangelo: Yeah, this is Glen Santangelo. I think you got the name wrong. Essentially, Eli, I just had two quick questions for you, if I could. Essentially, last quarter, I think you talked about the AUSTEDO inventory sort of issues. 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. I think you suggested that those inventory levels remain sort of elevated. How should we think about that in Q3 and Q4 within the guidance expectations that you laid out? Secondly, I did want to ask about EBITDA.
Glen Santangelo: Yeah, this is Glen Santangelo. I think you got the name wrong. Essentially, Eli, I just had two quick questions for you, if I could. Essentially, last quarter, I think you talked about the AUSTEDO inventory sort of issues. 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. I think you suggested that those inventory levels remain sort of elevated. How should we think about that in Q3 and Q4 within the guidance expectations that you laid out? Secondly, I did want to ask about EBITDA.
Speaker #7: I mean, essentially, last quarter, I think you talked about the Austedo inventory sort of issues. And I thought the expectation was that those inventory levels would come down a little bit this quarter.
Speaker #7: 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?
Speaker #7: 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.
Speaker #7: So when I think about the opportunity here, it's not just scientifically unlocking fibrosis. It's driving a better label a broader opportunity for patients and a broader opportunity for the market for the company.
Speaker #7: And then secondly, I did want to ask you about EBITDA. I mean, given the strength and the innovative brands this quarter and how well you did on revenues and gross margin, you maintain the EBITDA guidance.
Glen Santangelo: Given the strength in the innovative brands this quarter and how well you did on revenues and gross margin, you maintained the EBITDA guidance. I was just kind of curious if there was anything different in terms of your expense outlook that's worth calling out, given that you maintained that EBITDA guidance. Thanks so much.
Glen Santangelo: Given the strength in the innovative brands this quarter and how well you did on revenues and gross margin, you maintained the EBITDA guidance. I was just kind of curious if there was anything different in terms of your expense outlook that's worth calling out, given that you maintained that EBITDA guidance. Thanks so much.
Speaker #7: 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.
Speaker #7: So that's the thinking behind the two indications. I think
Speaker #1: Thanks, Eric. Thanks, Ash. I think we have time for one more question. Is that right? Yeah.
Speaker #7: Thanks so much.
Speaker #1: Hi, Glenn. Richard, thanks for the question. I'll start with the Stedo and then I'll hand to Ellie for the EBITDA question. So with regard to this inventory you're right, yeah, we had that inventory building Q4 2025.
Speaker #7: Our next question comes from Sneha Muthay with Barclays. Your line is open. Please go ahead.
Richard Francis: Hi, Glen. Richard, thanks for the question. I'll start with AUSTEDO, then I'll hand to Eli for the EBITDA question. With regard to this inventory, you're right. Yeah, we had that inventory build in Q4 2025. We're expecting a drawdown. We saw some of that drawdown occur in H1 of the year, but not fully complete. We need to see the rest of that come down in H2 of the year in Q4. Just to reiterate, what I think we've also been saying is how will Q4 inventory levels play out anyway, knowing that the IRA price effectuation comes in in Q1 2026. I think that sort of is something that we also are keeping in mind when we think about guidance and AUSTEDO. I go back to the fundamentals. Is the TRx good? Yes.
Richard Francis: Hi, Glen. Richard, thanks for the question. I'll start with AUSTEDO, then I'll hand to Eli for the EBITDA question. With regard to this inventory, you're right. Yeah, we had that inventory build in Q4 2025. We're expecting a drawdown. We saw some of that drawdown occur in H1 of the year, but not fully complete. We need to see the rest of that come down in H2 of the year in Q4. Just to reiterate, what I think we've also been saying is how will Q4 inventory levels play out anyway, knowing that the IRA price effectuation comes in in Q1 2026. I think that sort of is something that we also are keeping in mind when we think about guidance and AUSTEDO. I go back to the fundamentals. Is the TRx good? Yes.
Speaker #5: Yeah. This is Glenn Santangela. I think you got the name wrong. But essentially, Ellie, I just had two quick questions for you if I could.
Speaker #1: And we're expecting the drawdown. 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.
Speaker #5: I mean, essentially, last quarter, I think you talked about the Austedo inventory sort of issues. And I thought the expectation was that those inventory levels would come down a little bit this quarter.
Speaker #1: And Q4. And then to just to reiterate what I think we've also been saying is how will Q4 inventory levels play out anyway? Knowing that the IRA price fluctuation comes in in Q1 2026.
Speaker #5: 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?
Speaker #1: And I think that sort of is something that we also are keeping in mind when we think about guidance and the Stedo. And then I go back to the fundamentals.
Speaker #5: And then secondly, I did want to ask about EBITDA. I mean, given the strength and the innovative brands this quarter and how well you did on revenues and gross margin, you maintain the EBITDA guidance.
Speaker #1: Is the TRX good? Yes. Are the milligrams growth good? Yes. Is our breadth and depth of prescribers good? Yes. So I think that gives us obviously confidence about where the product's heading, why we feel confident about 3 billion plus in peak sales.
Richard Francis: Are the milligrams growth good? Yes. Is our breadth and depth of prescribers good? Yes. I think that gives us obviously confidence about where the product's heading, why we feel confident about $3 billion-plus of peak sales. Just those are dynamics as we manage through this inventory, both the early part of it from Q4 2025, and understanding how that's going to play out in Q4 of this year. On the EBITDA, I'll hand that one to Eli.
Richard Francis: Are the milligrams growth good? Yes. Is our breadth and depth of prescribers good? Yes. I think that gives us obviously confidence about where the product's heading, why we feel confident about $3 billion-plus of peak sales. Just those are dynamics as we manage through this inventory, both the early part of it from Q4 2025, and understanding how that's going to play out in Q4 of this year. On the EBITDA, I'll hand that one to Eli.
Speaker #5: 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.
Speaker #1: But just those are 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.
Speaker #5: Thanks so much.
Speaker #1: Hi, Glenn. Richard, thanks for the question. I'll start with the Stedo and then I'll hand to Ellie for the EBITDA question. So with regard to this inventory, you're right.
Speaker #1: And then on the EBITDA, I'll hand that one to Ellie.
Speaker #1: Yeah. We had that inventory building Q4, 2025. And we're expecting the drawdown. We saw some of that drawdown occur in the first half of the year, but not fully complete.
Speaker #7: Thanks for the question. Yes. So look, as I mentioned in our prepared remarks, and you saw from the slides, the three main products, Austedo, Ajovia, and Nuzedi, the midpoint now moving to 150 million.
Eli Kalif: Thanks for the question. Look, as I mentioned in our prepared remarks and you saw from the slides, the three main products, AUSTEDO, AJOVY, and UZEDY, at the midpoint now moving to $150 million. Net-net-net, what you see on the top of our top line, you see a midpoint of $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, this is a really strong performance, mainly when you think about the context on the tough prior year comps with removing $1.1 billion revenue and $700 million equivalent EBITDA from Revlimid.
Eli Kalif: Thanks for the question. Look, as I mentioned in our prepared remarks and you saw from the slides, the three main products, AUSTEDO, AJOVY, and UZEDY, at the midpoint now moving to $150 million. Net-net-net, what you see on the top of our top line, you see a midpoint of $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, this is a really strong performance, mainly when you think about the context on the tough prior year comps with removing $1.1 billion revenue and $700 million equivalent EBITDA from Revlimid.
Speaker #1: And so we need to see the rest of that come down in the second half of the year. And Q4. And then to just to reiterate what I think we've also been saying is how will Q4 inventory levels play out anyway?
Speaker #7: And but net, net, net, what you see on the top of our top line, you see a midpoint of 75 million. And this is related to kind of an offset that we see due to some softness in generics, as I mentioned.
Speaker #1: Knowing that the IRA price effectuation comes in Q1 2026, and I think that is also something we are keeping in mind when we think about guidance and the Stevo.
Speaker #7: All in all, it's very important to remember this is a really strong performance mainly when you think about the context on the tough prior year comps with removing 1.1 billion revenue and 700 million dollars equivalent EBITDA from revenue.
Speaker #1: And then I go back to the fundamentals. Is the TRX good? Yes. Are the milligrams growth good? Yes. Is our breadth and depth of prescribers good?
Speaker #1: Yes. So I think that gives us, obviously, confidence about where the product's heading and why we feel confident about $3 billion-plus in peak sales.
Speaker #7: Now, if you go through the range, on the EBITDA that we're saying it, we need to understand that I mentioned that we're going to be at a higher range of the OPEX, around 28%.
Eli Kalif: If you go through to the range on the EBITDA that we're sustaining, 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 and biosimilars are performing. Also, we had a slightly bit on less favorable FX, I will mention.
Eli Kalif: If you go through to the range on the EBITDA that we're sustaining, 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 and biosimilars are performing. Also, we had a slightly bit on less favorable FX, I will mention.
Speaker #1: But just those are 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.
Speaker #7: And this is related to some continuous investment that we are doing in order to make sure that our innovative portfolio and both similar are performing.
Speaker #1: And then on the EBITDA, I'll hand that one to Ellie.
Speaker #4: Thanks for the question. Yes. So look, as I mentioned in our prepared remarks, and you saw from the slides, the three main products, Austedo, Ajovy, and Nuzeti, the midpoint now moving to 150 million.
Speaker #7: And also, we had a slightly a bit on less terrible FX, I will mention. And some other inlines of cost that we had in our first half and going to have in the second half.
Eli Kalif: Some other in-license costs that we had in our H1 and are going to have in the H2. You saw the Polpharma Biologics announcement on Ocrevus and small here, small there. It's kind of a maybe very small 20, 30 basis points on the total if you look on annual revenue. This is all dynamics related to investment, related to supporting our innovative and biosimilars portfolio.
Eli Kalif: Some other in-license costs that we had in our H1 and are going to have in the H2. You saw the Polpharma Biologics announcement on Ocrevus and small here, small there. It's kind of a maybe very small 20, 30 basis points on the total if you look on annual revenue. This is all dynamics related to investment, related to supporting our innovative and biosimilars portfolio.
Speaker #4: And but net, net, net, what you see on the top of our top line, you see a midpoint of 75 million. And this is related to kind of an offset that we see due to some softness in generics, as I mentioned.
Speaker #7: You saw the pool pharma announcement on Alcrovus and small here, small there. So it's kind of a maybe very small 20, 30 basis point on the total if you look on annual revenue.
Speaker #7: But this is all dynamics related to investment, related to supporting our innovative and biosimilars portfolio.
Speaker #4: All in all, it's very important to remember. This is a really strong performance. Mainly when you think about the context on the tough prior year comps, with removing 1.1 billion revenue and 700 million dollars equivalent EBITDA from revenue.
Speaker #1: Thanks for the question, Glenn. And I've realized actually we're actually going to take some more questions there. Some two more questions. So next question.
Richard Francis: Thanks for the question, Glenn.
Richard Francis: Thanks for the question, Glenn.
Eli Kalif: Thanks, Richard.
Eli Kalif: Thanks, Richard.
Eli Kalif: I've realized, actually, we're actually going to take some more questions there. Two more questions. Next question.
Eli Kalif: I've realized, actually, we're actually going to take some more questions there. Two more questions. Next question.
Speaker #4: Now, if you go through the range on the EBITDA that we're stating, we need to understand that I mentioned we'll be at the higher range of the OPEX, around 28%.
Speaker #5: May not send too much delatory with Goldman Sachs. Your line is open. Please go ahead.
Operator: We now turn to Matt Dellatore with Goldman Sachs. Your line is open. Please go ahead.
Operator: We now turn to Matt Dellatore with Goldman Sachs. Your line is open. Please go ahead.
Speaker #8: Great. Good morning, guys. And thanks for squeezing me in. Maybe coming back to TL1A, it seems like you guys are leaning kind of fairly heavily into these fibrosis-heavy diseases.
Matt Dellatorre: Great. Good morning, guys. Thanks for squeezing me in. Coming back to TL1A, it seems like you guys are leaning fairly heavily into these fibrosis-heavy diseases. 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? Eric, you touched on this briefly, but I guess how should we think about FSCD in the sense of would this be primarily a differentiator on your CD label? Or could it be a separate indication, different label? Maybe just briefly touching on the commercial side. I know you guys are prepping for two major launches over the next 12 months with elagolix and ecopipam.
Matt Dellatorre: Great. Good morning, guys. Thanks for squeezing me in. Coming back to TL1A, it seems like you guys are leaning fairly heavily into these fibrosis-heavy diseases. 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? Eric, you touched on this briefly, but I guess how should we think about FSCD in the sense of would this be primarily a differentiator on your CD label? Or could it be a separate indication, different label? Maybe just briefly touching on the commercial side. I know you guys are prepping for two major launches over the next 12 months with elagolix and ecopipam.
Speaker #4: And this is related to some continuous investment that we are doing, in order to make sure that our innovative portfolio and biosimilars are performing.
Speaker #8: 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?
Speaker #4: And also, we had a slightly better and less terrible FX, I will mention. And some other in-lances costs that we had in our first half and are going to have in the second half.
Speaker #8: And then Eric, you touched on this briefly, but I guess how should we think about FSCD in the sense of would this be primarily a differentiator on your CD label or could it be a separately indication different label?
Speaker #4: You saw the pooled pharma announcement on Ocrevus. And small here, small there. So it's kind of a maybe very small 20, 30 basis point on the total if you look on annual revenue.
Speaker #4: But this is all dynamics related to investment, related to supporting our innovative and biosimilars portfolio.
Speaker #8: And then maybe just briefly touching on the commercial side, I know you guys are prepping for two major launches over the next 12 months with LEI olanzapine and Ecopipam.
Speaker #1: Thanks for the question, Glenn. And I've realized actually we're actually going to take some more questions there. Some two more questions. So next question.
Speaker #8: Maybe just walk us through launch preparations so far and what you guys are just most focused on from an execution perspective for both those launches.
Matt Dellatorre: Maybe just walk us through launch preparations so far and what you guys are most focused on from an execution perspective for both those launches. Thank you.
Matt Dellatorre: Maybe just walk us through launch preparations so far and what you guys are most focused on from an execution perspective for both those launches. Thank you.
Speaker #8: Thank you.
Speaker #7: May not send to Matt Dellatorre with Goldman Sachs. Your line is open. Please go ahead.
Speaker #1: Hi, Matt. Thanks for the questions. I'll let Eric start with the TL1A duplicated. Over to you, Eric.
Richard Francis: Hi, Matt. Thanks for the questions. I'll let Eric start with the TL1A duvakitug. Over to you, Eric.
Richard Francis: Hi, Matt. Thanks for the questions. I'll let Eric start with the TL1A duvakitug. Over to you, Eric.
Speaker #6: Great. Good morning, guys. Thanks for squeezing me in. Maybe coming back to TL1A, it seems like you guys are leaning kind of fairly heavily into these fibrosis-heavy diseases.
Speaker #7: Yeah. So thanks for the questions, Matt. And first to start with the TL1A, the choice of HS and fibrous Crohn's disease, first and foremost, they are inflammatory diseases with a major fibrotic component to it.
Eric Hughes: Yeah. Thanks for the questions, Matt. First to start with the TL1A. The choice of HS and fibrostenotic Crohn's disease. First and foremost, they are inflammatory diseases with a major fibrotic component to it. These are great ways to get into this field and show whether we're having a true effect. We still have to prove that TL1A has that anti-fibrotic 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 anti-fibrotic or fibrotic diseases such as IPF or something like that. Right now, we need to prove the principle, and these are great indications because on the way to learning those things, we will show great value in indications that have a high unmet medical need.
Eric Hughes: Yeah. Thanks for the questions, Matt. First to start with the TL1A. The choice of HS and fibrostenotic Crohn's disease. First and foremost, they are inflammatory diseases with a major fibrotic component to it. These are great ways to get into this field and show whether we're having a true effect. We still have to prove that TL1A has that anti-fibrotic 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 anti-fibrotic or fibrotic diseases such as IPF or something like that. Right now, we need to prove the principle, and these are great indications because on the way to learning those things, we will show great value in indications that have a high unmet medical need.
Speaker #6: 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?
Speaker #7: 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 anti-fibrotic effect, but these are great avenues to get in there and learn.
Speaker #6: And then, Eric, you touched on this briefly, but I guess how should we think about FSCD in the sense of, would this be primarily a differentiator on your CD label?
Speaker #7: Once we've shown that, yes, maybe we could in the future go to truly only anti-fibrotic or fibrotic diseases, such as IPF or something like that.
Speaker #6: 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 two major launches over the next 12 months with LAI olanzapine and Ecopipam.
Speaker #7: 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 great value in indications that have a high medical need.
Speaker #6: Maybe just walk us through launch preparations so far, and what you guys are most focused on from an execution perspective for both those launches.
Speaker #7: Now, going on to the question of fibrous Crohn's disease and what is our hope 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.
Eric Hughes: Going on to the question of fibrostenotic Crohn's disease and what is our hope 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. That's the intention of those. That really could differentiate us within the space of inflammatory bowel disease. That's the intention there. The question about the launch of the ecopipam and our preparations, maybe, Richard, did you want to take that?
Eric Hughes: Going on to the question of fibrostenotic Crohn's disease and what is our hope 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. That's the intention of those. That really could differentiate us within the space of inflammatory bowel disease. That's the intention there. The question about the launch of the ecopipam and our preparations, maybe, Richard, did you want to take that?
Speaker #6: Thank you.
Speaker #1: Hi, Matt. Thanks for the questions. I'll let Eric start with TL1A tuberculosis. Over to you, Eric.
Speaker #7: 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 there. And then the question about the launch of the Ecopipam and our preparations maybe Richard, did you want to take that?
Speaker #5: Yeah. So thanks for the questions, Matt. And first to start with the TL1A, the choice of HS and fibrous non-crohn's disease. First and foremost, they are inflammatory diseases with a major fibrotic component to it.
Speaker #1: Yes. No. We do, as you framed it, Matt, have two 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.
Richard Francis: Yes. No, we do, as you framed it, Matt, have two 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. 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. The team has put a huge amount of effort into preparing for this, which is why we're very optimistic and enthusiastic about our ability to really help these patients who need a long-acting therapy for these severe schizophrenia patients. I think I'm very confident and looking forward to seeing that launch.
Richard Francis: Yes. No, we do, as you framed it, Matt, have two 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. 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. The team has put a huge amount of effort into preparing for this, which is why we're very optimistic and enthusiastic about our ability to really help these patients who need a long-acting therapy for these severe schizophrenia patients. I think I'm very confident and looking forward to seeing that launch.
Speaker #5: 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 anti-fibrotic effect, but these are great avenues to get in there and learn.
Speaker #1: Thinking about how best to approach it, but that preparation is really being 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.
Speaker #5: Once we've shown that, yes, maybe we could in the future go to truly only anti-fibrotic or fibrotic diseases, such as IPF or something like that.
Speaker #5: But right now, we need to prove the principle and these are great indications because they're on the way to learning those things. We will show great value in indications that have a high medical need.
Speaker #1: And so the team has put a huge amount of effort into preparing for this, which is why we're very optimistic and enthusiastic about our ability to really help these patients who need a long-acting therapy for these severe schizophrenia patients.
Speaker #5: Now, going on to the question of fibrous non-crohn's disease and what is our hope 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.
Speaker #1: So I think very confident and looking forward to seeing that launch. With regard to Ecopipan, based on the timeline of the FDA, this will probably could come out in the later part of Q2 next year.
Speaker #5: 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 there. And then the question about the launch of the Ecopipam and our preparations maybe Richard, did you want to take that?
Richard Francis: With regard to ecopipam, based on the timeline of the FDA, this will probably could come out in the later part of Q2 next year. Once again, the asset's being transacted, we have it. We've been working and thinking about this for some time when we got close to the transaction. 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. 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. Very excited about that. I think the timing actually works out.
Richard Francis: With regard to ecopipam, based on the timeline of the FDA, this will probably could come out in the later part of Q2 next year. Once again, the asset's being transacted, we have it. We've been working and thinking about this for some time when we got close to the transaction. 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. 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. Very excited about that. I think the timing actually works out.
Speaker #1: So once again, the assets being transacted, we have it. We've been working and thinking about this for some time when we got close to the transaction.
Speaker #1: Yes. Now, we do, as you framed it, Matt, have two major launches we're very excited about. I think with regards to olanzapine, I think it's worth noting that we've been preparing for this launch for some time.
Speaker #1: 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?
Speaker #1: How do we educate the physicians on a new therapy? This probably sounds very much like the things we've been saying around a setup because it is.
Speaker #1: Thinking about how best to approach it, but that preparation is really being 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.
Speaker #1: 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.
Speaker #1: And so the team has put a huge amount of effort into preparing for this, which is why we're very optimistic and enthusiastic about our ability to really help these patients who need a long-acting therapy for these severe schizophrenia patients.
Speaker #1: 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.
Richard Francis: These are over a year apart, we've got to get used to this because as I said in my remarks, we'll be launching a new product every year. This is a muscle that we've been building. We're enthusiastic about it. We're not in awe of it. We're leaning into it. I think you'll see an excellent launch of ecopipam, obviously, we'll give you more updates as we get closer to that. Thanks for your questions, Matt. Next question. I think, is this our last question? Yeah, this is our last question. Who is it? Next to last question. Next to last. We have two more. The penultimate. All right. Okay. Next question, please.
Richard Francis: These are over a year apart, we've got to get used to this because as I said in my remarks, we'll be launching a new product every year. This is a muscle that we've been building. We're enthusiastic about it. We're not in awe of it. We're leaning into it. I think you'll see an excellent launch of ecopipam, obviously, we'll give you more updates as we get closer to that. Thanks for your questions, Matt. Next question. I think, is this our last question? Yeah, this is our last question. Who is it? Next to last question. Next to last. We have two more. The penultimate. All right. Okay. Next question, please.
Speaker #1: So this is a muscle that we've been building. We're enthusiastic about it. We're not in awe of it. We're leaning into it. And so I think you'll see an excellent launch of Ecopipan, but obviously we'll give you more updates as we get closer to that.
Speaker #1: So I think very confident and looking forward to seeing that launch. With regard to Ecopipan, based on the timeline of the FDA, this will probably could come out in the later part of Q2 next year.
Speaker #1: So thanks for your questions, Matt. Next question. I think is this our last question? Yeah. This is our last question. So who is it?
Speaker #1: So once again, the asset's been transacted. We have it. We've been working and thinking about this for some time when we got close to the transaction.
Speaker #1: Next to last. We have two more. All right. Okay. So next question, please.
Speaker #1: 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?
Speaker #5: Our next question comes from Chris Schultz with JP Morgan. Your line is open. Please go ahead.
Operator: Our next question comes from Chris Schott with J.P. Morgan. Your line is open. Please go ahead.
Operator: Our next question comes from Chris Schott with J.P. Morgan. Your line is open. Please go ahead.
Speaker #1: How do we educate the physicians on a new therapy? This probably sounds very much like the things we've been saying around a status because it is.
Speaker #6: Thank you so much for squeezing me in. Just this is a Caterina on for Chris, just two very quick ones. So first, just on a Jovy, guidance for the years 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.
[Analyst] (J.P. Morgan): Thank you so much for squeezing me in. This is Ekaterina on for Chris, just two very quick ones. 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? Then just on Europe very quickly, coming in a little later than expected. Just again, anything to call out there, and how should we think about results in the H2 for Europe? Thanks.
Chris Schott: Thank you so much for squeezing me in. This is Ekaterina on for Chris, just two very quick ones. 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? Then just on Europe very quickly, coming in a little later than expected. Just again, anything to call out there, and how should we think about results in the H2 for Europe? Thanks.
Speaker #1: 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.
Speaker #6: And then just on Europe, very quickly, coming in a little later than expected, just again, anything to call out there and how should we think about results in the second half for Europe.
Speaker #1: 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.
Speaker #6: Thanks.
Speaker #1: All right, Caterina. Thanks for your question. So on a Jovy, I'm very pleased with the performance of this. And as I said, this is across all markets.
Richard Francis: Hi, Ekaterina. Thanks for your question. On AJOVY, we're very pleased with the performance of this, and as I said, this is across all markets. We've got good growth in international, good growth in Europe, and good growth in the US. Yeah. As I highlighted in my remarks, in the US there is some favorability on the contracting and what we've done there on gross to net, but there are also market share gains in the US. 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. That, I think, gives us an underlying good trajectory across all regions, but some good work done. I'll always remind people, when we started this journey with Pivot to Growth, AJOVY had been forgotten about. Now we're talking a billion-dollar asset.
Richard Francis: Hi, Ekaterina. Thanks for your question. On AJOVY, we're very pleased with the performance of this, and as I said, this is across all markets. We've got good growth in international, good growth in Europe, and good growth in the US. Yeah. As I highlighted in my remarks, in the US there is some favorability on the contracting and what we've done there on gross to net, but there are also market share gains in the US. 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. That, I think, gives us an underlying good trajectory across all regions, but some good work done. I'll always remind people, when we started this journey with Pivot to Growth, AJOVY had been forgotten about. Now we're talking a billion-dollar asset.
Speaker #1: So, this is a muscle that we've been building. We're enthusiastic about it. We're not in awe of it. We're leaning into it. And so, I think you'll see an excellent launch of Ecopipan.
Speaker #1: So we've got good growth in international, good growth in Europe, and good growth in the US. As I highlighted in my remarks, the US, there is some favorability on the contracting and what we've done there on gross to net, but there's also market share gains in the US.
Speaker #1: But obviously, we'll give you more updates as we get closer to that. So, thanks for your questions, Matt. Next question. I think—is this our last question?
Speaker #1: This is our last question. So who is it? Next to last. We have two more. All right. Okay, so next question, please.
Speaker #1: 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.
Speaker #1: So that, I think, gives us an underlying good trajectory. Across all regions, but some good work done. I've always remind people, when we started this journey with Pivot to Growth, a Jovi had been forgotten about.
Speaker #7: Our next question comes from Chris Schultz with JP Morgan. Your line is open. Please go ahead.
Speaker #8: Thank you so much for squeezing me in. Just this is a Katerina on for Chris, just two very quick ones. So first, just on a Jovy, guidance for the years 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?
Speaker #1: And now we're talking a billion-dollar asset. I think that's credit to the teams across all three of the regions. They've been able to do that.
Richard Francis: I think that's credit to the teams across all three of the regions to be 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. We have more and more to come into Europe, which is a very attractive biosimilar market, and it's one that I've been disappointed that we haven't been in.
Richard Francis: I think that's credit to the teams across all three of the regions to be 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. We have more and more to come into Europe, which is a very attractive biosimilar market, and it's one that I've been disappointed that we haven't been in.
Speaker #1: 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.
Speaker #8: 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?
Speaker #8: Thanks.
Speaker #1: 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.
Speaker #1: All right, Katerina. Thanks for your question. So on a Jovy, you're very pleased with the performance of this. And as I said, this is across all markets.
Speaker #1: So we've got good growth in international, good growth in Europe, and good growth in the US. As I highlighted in my remarks, the US, there is some favorability on the contracting and what we've done there on gross to net, but there's also market share gains in the US.
Speaker #1: On the positive side, we are launching more biosimilar. They've only just started, so we haven't really seen the traction of those, but we have more and more to come.
Speaker #1: Into Europe, which is a very attractive biosimilar market and is one that I've been disappointed that we haven't been in, but we've done a lot of work on this portfolio and we'll be bringing more and more biosimilar to the market in almost year on year, as I said, we have 14 more to launch, and we're going to consistently add more to that portfolio.
Speaker #1: 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.
Richard Francis: We've done a lot of work on this portfolio, and we'll be bringing more and more biosimilars to 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. Hopefully that answers your questions, Ekaterina, but thanks for the question. Do we have one more? I'm a bit confused. Nope, we don't have any more. Thank you everybody for your time and attention today. Thanks for the questions, and thank you, as always, for the interest in Teva.
Richard Francis: We've done a lot of work on this portfolio, and we'll be bringing more and more biosimilars to 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. Hopefully that answers your questions, Ekaterina, but thanks for the question. Do we have one more? I'm a bit confused. Nope, we don't have any more. Thank you everybody for your time and attention today. Thanks for the questions, and thank you, as always, for the interest in Teva.
Speaker #1: So that, I think, gives us an underlying good trajectory. Across all regions, but some good work done. I always remind people, when we started this journey with Pivot to Growth, a Jovi had been forgotten about.
Speaker #1: And we'll end up with a portfolio mid-30s, close to 40, that's our ambition. So hopefully that answers your questions, Caterina, but thanks for the questions.
Speaker #1: And then I think we have one more. I'm a bit confused. Nope, we don't have any more. So thank you, everybody, for your time and attention today.
Speaker #1: And now we're talking a billion-dollar asset. I think that's credit to the teams across all three regions. They've been able to do that. Now you also asked a question around Europe.
Speaker #1: Thanks for the questions, and thank you as always for the interest in Tever.
Speaker #1: 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.
Operator: Ladies and gentlemen, today's call has now concluded. We'd like to thank you for your participation. You may now disconnect your lines.
Operator: Ladies and gentlemen, today's call has now concluded. We'd like to thank you for your participation. You may now disconnect your lines.
Speaker #1: 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.
Speaker #1: On the positive side, we are launching more biosimilar. They've only just started, so we haven't really seen the traction of those. But we have more and more to come.
Speaker #1: Into Europe, which is a very attractive biosimilar market and is one that I've been disappointed that we haven't been in, but we've done a lot of work on this portfolio.
Speaker #1: And we'll be bringing more and more biosimilars to the market in almost year-on-year, as I said, we have 14 more to launch. And we're going to consistently add more to that portfolio.
Speaker #1: And we'll end up with a portfolio mid-30s, close to 40, that's our ambition. So hopefully that answers your questions, Katerina. But thanks for the questions.
Speaker #1: And then I think we have one more, a bit confused. Nope, we don't have any more. So thank you, everybody, for your time and attention today.
Speaker #1: Thanks for the questions. And thank you, as always, for the interest in Teva.
Yeah.