Q1 2024 Teva Pharmaceutical Industries Ltd Earnings Call

Operator: Hello and welcome to the first quarter 2024 Teva Pharmaceuticals Industries Ltd earnings conference call. My name is Alex, and I'll be coordinating the call today. If you'd like to ask a question at the end of the presentation, please press Star followed by 1 on your telephone keypad. And I will hand it over to your host, Ran Meir, Head of Investment Relations. Please go ahead.

Hello, and welcome to the first quarter of 2020 for Teva Pharmaceuticals Industries Ltd Earnings Conference call. My name is Alex and I'll be coordinating the call today.

Speaker Change: If you'd like to ask a question at the end of the presentation. Please press star followed by one on your telephone keypad.

Speaker Change: And I'll hand, it over to your host Vanman head of Investor Relations. Please go ahead.

Ran Meir: Thank you, Alex. And thank you, everyone, for joining us today. We hope you have had a chance to review our Q1 results press release, along with the press release announcing positive Phase III results from OLANZAPINE LAI trial, both issued earlier this morning. Copies of these press releases, along with the slides presented during this call, are available on our website at ir.tevapharm.com. Please review our forward-looking statements on slide number two. Additional information on this statement and our non-GAAP financial measures can be found on our earnings release and in our SEC Forms 10-K and 10-Q. To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's first quarter results and business performance, recent events, and our focus and priorities going forward. Then, Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, will discuss progress on our innovative pipeline. Our CFO, Eli Kalif, will follow up by reviewing the first quarter financial results in more detail. Please note that today's call will run for approximately one hour. And with that, I will now turn the call over to Richard. Richard, if you would, please.

Vanman: Thank you Alex and thank you everyone for joining us today.

Ran Meir: We hope you have had a chance to review our Q1 results press release, along with the press release announcing positive Phase 3 results from our Lanzapin LAI trial, both issued earlier this morning. Copies of these press releases, along with the slides presented during this call, are available on our website at ir.tevapharm.com. Please review our forward-looking statements on slide number two. Additional information on this statement and our non-GAAP financial measures can be found on our earnings release and in our SEC Forms 10-K and 10-Q. To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's first quarter results and business performance, recent events, and our focus and priorities going forward. Then, Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, will discuss progress on our innovative pipeline. Our CFO, Eli Kalif, will follow up by reviewing the first quarter financial results in more detail.

Vanman: We hope you have a chat.

Vanman: To review, our Q1 results the press release, along with the press release announcing positive phase III results from Olanzapine Eliana trial.

Vanman: Both issued earlier this morning.

Vanman: Copies of these press releases along with the slides presented during this call are available on our website at IR that type of farm dotcom.

Vanman: Please review our forward looking statement on slide number two.

Vanman: Additional information on these statements and our non-GAAP financial measures.

Can be found on our earnings release and in our SEC forms 10-K and 10-Q.

Ran Meir: To begin today's call, Richard Francis, Teva's CEO, will provide an overview of Teva's first quarter results and business performance, recent events, and our focus and priorities going forward. Then, Dr. Eric Hughes, our Head of R&D and Chief Medical Officer, will discuss progress on our innovative pipeline. Our CFO, Eli Kalif, will follow up by reviewing the first quarter financial results in more detail.

Speaker Change: To begin today's call Richard today's call Richard Francis Devotee O will provide an overview of first quarter results and business performance.

Speaker Change: <unk> events, and our focus and priorities going forward.

Speaker Change: Then Dr. Eric Hughes, our head of R&D, and Chief Medical Officer will discuss progress on our innovative pipeline.

Speaker Change: Our CFO, Eric Lee will follow up by reviewing the first quarter financial results in more detail.

Ran Meir: Please note that today's call will run for approximately one hour. And with that, I will now turn the call over to Richard. Richard, if you would, please.

Speaker Change: Please note that today's call will end up organically, one hour and with that I will now turn the call over to Richard Richard If you will.

Richard Francis: Thank you, Ran, and good morning, everybody. I'm glad you could join us this morning. I'm excited to talk to you about our results for Q1 2024. Just to remind you, this is a year today, almost, since we launched the Pivot to Growth Strategy. A strategy designed to get Teva back to growth, and I'm pleased to say that this is our fourth quarter in a row of continuous growth. The strategy is clearly having some effect, and I'll go into a bit of detail as to why that is and what's driving it. But just to remind you a bit about the strategy, it's based on four pillars, step up innovation, deliver on our growth engine, step up innovation, create a sustainable generics powerhouse, and focus our business. I'll walk you through what we've achieved on each of these areas, but obviously, we are starting to show that we can really commercialize innovative products. We are starting to show that we can take products through the clinic, and I think we'll talk a bit about OLANZAPINE and the fact that we brought that to the clinic nine months ahead of schedule. And we're showing good growth in our generics business. And then I'll finish with a talk about [inaudible] and how we got that back to growth.

Richard Francis: Thank you Ron and good morning, everybody I'm glad you could join US this morning.

Richard Francis: I'm excited to talk to you about our results for Q1 2024. Just to remind you, this is almost a year today, almost, since we launched the Pivot to Growth Strategy. A strategy designed to get Teva back to growth, and I'm pleased to say that this is our fourth quarter of continuous growth. The strategy is clearly having some effect, and I'll go into a bit of detail as to why that is and what's driving it. But just to remind you a bit about the strategy, it's based on four pillars, step up innovation, deliver on our growth engine, step up innovation, create a sustainable generics powerhouse, and focus our business. I'll walk you through what we've achieved in each of these areas, but obviously, we are starting to show that we can really commercialize innovative products. We are starting to show that we can take products through the clinic, and I think we'll talk a bit about Olanzapine and the fact that we brought that to the clinic nine months ahead of schedule. And we're showing good growth in our generics business. And then I'll finish with a talk about Tappy and how we got that back to growth.

Richard Francis: To talk to you about.

Richard Francis: Paul.

Richard Francis: Results for Q1 2020 for just to remind you that a year today almost since we launched that pivot to growth strategy.

Richard Francis: Strategy designed to get back to growth and I'm pleased to say that this is our fourth quarter in a row of continuous growth. So.

Richard Francis: The strategy is clearly, having some effect and I'll go into the detail as to why that is and what's driving that.

Richard Francis: But just to remind you a bit about the strategy, it's based on four pillars, step up innovation, deliver on our growth engine, step up innovation, create a sustainable generics powerhouse, and focus our business. I'll walk you through what we've achieved in each of these areas, but obviously, we are starting to show that we can really commercialize innovative products. We are starting to show that we can take products through the clinic, and I think we'll talk a bit about Olanzapine and the fact that we brought that to the clinic nine months ahead of schedule. And we're showing good growth in our generics business. And then I'll finish with a talk about Tappy and how we got that back to growth.

Richard Francis: But just to remind you a bit about the strategy is based on four pillars step up innovation deliver on our growth engine step up innovation quite a sustainable generics powerhouse and focus our business.

Richard Francis: Look you through what we've achieved on each of these areas, but obviously, we are starting to show that we can really commercialize innovative products.

Richard Francis: We are starting to show that we can take our products through the clinic and I think we'll talk a bit about olanzapine and the fact that with the product to the clinic through the clinic nine months ahead of schedule.

Richard Francis: And we certainly are showing good growth in our generics business.

Speaker Change: And then I'll finalize.

Speaker Change: Talk about tap in how we got that back to growth.

Richard Francis: But before I do that, I wanted to start with some exciting news on OLANZAPINE, a long-acting treatment for schizophrenia, which is in the clinic. We have the data readout on the efficacy of this study, and it met its primary and secondary endpoints on all dose groups versus placebo. So, we're very excited about this, and all doses were generally well-tolerated, safe, and there were no cases of PDSS. Obviously, the full submission of the safety database will be available in the second half of this year, but this is really an important milestone for us, as well as the patients who suffer from this terrible condition. Now, just to reiterate why we are excited about it, I'll move on to the next slide and just to sort of coordinate you, on the left-hand side of this slide you'll see all the oral molecules that are used to treat schizophrenia. And as you can see, the largest of these is OLANZAPINE, which treats moderate to severe. But also, as you can see on the right-hand side of this slide, there is no effective long acting of OLANZAPINE.

Speaker Change: But before I do that I wanted to start with some exciting news on Olanzapine long acting treatment for schizophrenia, which is in the clinic.

Speaker Change: We had the.

Speaker Change: The data readout on the efficacy of this study.

Speaker Change: And it met its primary and secondary end points on all dose groups versus placebo. So very excited about this and all jokes doses were generally well tolerated safe and there were no cases of PSS. Obviously, the full submission of the safety database will be available in the second half of this year.

Richard Francis: Obviously, the full submission of the safety database will be available in the second half of this year, but this is a really important milestone for us, as well as the patients who suffer from this terrible condition. Now, just to reiterate why we are excited about it, and to sort of coordinate you, on the left-hand side of this slide, you'll see all the oral molecules that are used to treat schizophrenia. And as you can see, the largest of these is olanzapine, which treats moderate to severe. But also, as you can see on the right-hand side of this slide, there is no effective long acting of Olanzapine.

Speaker Change: But this is a really important milestone for ourselves as well as the.

Speaker Change: Patients who suffer from this condition.

Speaker Change: Now just to reiterate why we are excited about it but I'll move on to the next slide and just to sort of coordinated on the left hand side of this slide Youll see all the oral molecule used to treat schizophrenia and as you can see the largest of these is olanzapine, which treats moderate to severe.

Speaker Change: But also you can see on the right hand side of this slide there is no effective long acting treatment.

Richard Francis: So, there's a significant unmet medical need. And that's why we're so excited about this product and bringing it to the patients who clearly will benefit from it. So, more news on that from Eric later in the presentation. Now, to dive into the results. So, the results, cost of currency, we are up 5% in revenue, up 12% in adjusted EBITDA, 18% in non-GAAP EPS, and our net debt now stands at 3.38. So, a good start to the year, and because of that, we are reconfirming our 2024 financial outlook. So, let's go into a bit more detail on all of these numbers. When it comes to driving this revenue, what I'm pleased to say is the fact that we're hitting it in all our business sectors. So, when it's innovative medicines, whether it's generics or this TAPI API, we're seeing good growth. And as you can see, it started with 67% growth. It's a really good start to the year. 18% on AJOVY, and our global generics business is growing at a really healthy 9%. And TAPI API is back to growth at 2%. So, let me go into a bit more detail on all of these.

Speaker Change: <unk>, so there's a significant unmet medical need and that's why we're so excited about this product and bringing this to the patients who clearly will benefit from it so more news on that from Eric later in the presentation.

Eric: But now to dive into the results. So the results in constant currency were up 5% and revenue up 12% and adjusted EBITDA, 18% and non-GAAP EPS and our net debt now stands at 338. So a good start to the year because of that we are reconfirming our 2000.

Eric: 24 financial outlook.

Speaker Change: So let's go into a bit more detail.

Speaker Change: On all of these numbers so.

Richard Francis: When it comes to driving this revenue, what I'm pleased to say is that we're hitting it in all our business sectors. So when it's innovative medicines, whether it's generics or this TAPI API, we're seeing good growth. And as you can see, it started with 67% growth. It's a really good start to the year. 18% on Jovi, and our global generics business is growing at a really healthy 9%. And TAPI API is back to growth at 2%. So let me go into a bit more detail on all of these.

Speaker Change: When it comes to driving this revenue won't I'm pleased to say is the fact that way hitting it in all our business sectors innovate innovative medicines, whether it's generics or there's tapis API, we're seeing good growth and as you can see it said it was 67% growth is a really good start to the year, 18% on a josie.

Richard Francis: 18% on Jovi, and our global generics business is growing at a really healthy 9%. And TAPI API is back to growth at 2%. So let me go into a bit more detail on all of these.

Speaker Change: In our global generics business is growing at a really healthy, 9% and tap the ate guys back to growth at 2%.

Speaker Change: So let me go into a bit more detail on all of these.

Richard Francis: So, starting with AUSTEDO, AUSTEDO continues to perform really well. $282 million for quarter one, up 67% versus quarter one 2023, and a good strong TRX growth of 28%. And because of this momentum, we are confirming our guidance of $1.5 billion for 2024. But this momentum gives me more confidence and more excitement around our long-term goal, which is to get to $2.5 billion in revenue by 2027. And I just wanted to use this slide to remind you, everybody, of the potential we have around this product, unfortunately, because so many patients are yet to get on treatment. And that is why we started our Direct-to-Consumer campaign at the start of this year, to make those people aware that there is an opportunity to help address this difficult condition, and they just need to seek help with that situation.

Speaker Change: So starting with instead of instead of continues to perform really well $282 million for quarter, one up 67% versus quarter, one 2023, and a good strong T Rx growth of 28% and because of this momentum we are confirming our guidance of $1 5 billion for 2024.

Speaker Change: But this momentum gives me more confidence and more excitement around our long term goal, which is to get to $2 5 billion of revenue by 2027 and I just wanted to use this slide to remind you everybody of the potential we have around this product. Unfortunately, because so many patients are yet to get on treatment and that is why we started our direct.

Richard Francis: And that is why we started our Direct-to-Consumer campaign at the start of this year, to make those people aware that there is an opportunity to help address this difficult condition, and they just need to seek help with that situation.

Consumer campaign that started this year to make those people aware that there is an opportunity to help address this difficult condition and they just need to seek help with that position.

Richard Francis: So, very encouraging start to the year with AUSTEDO, and we look forward to that momentum continuing. Now moving on to the second part of our innovative portfolio, which is AJOVY, once again, good continued growth of 18%, and we're growing particularly strongly in Europe and international markets. But what pleases me about this product is that we continue to show market share gains both in the U.S., Europe, and international markets, showing the competitiveness of Teva sales and marketing when we have a product like this. So, I'm very pleased that - and once again, I'm reconfirming the guidance of half a billion for 2024. Now, moving on to UZEDY, the newest member of our innovative family. So, we launched this product last year, and the momentum continues to build. We continue to see good access when it comes to fee-for-service in Medicaid.

Speaker Change: Very encouraging start to the year with instead of and we look forward momentum continuing.

Speaker Change: Now moving onto the second part of our innovative portfolio, which is a josie once again, good continued growth of 18% and we're growing particularly strongly in Europe and international markets.

Speaker Change: What pleases me about this product as we continue to show market share gains both in the U S Europe and international markets, showing the competitiveness of Teva sales and marketing when we have a product like this.

Richard Francis: So I'm very pleased that, and once again, I'm reconfirming the guidance of half a billion for 2024. Now moving on to Yosetti, the newest member of our innovative family. So, we launched this product last year, and the momentum continues to build. We continue to see good access when it comes to fee-for-service in Medicaid.

Speaker Change: So very pleased that once again I'm reconfirming the guidance up half a billion dollars for 2024.

Speaker Change: Now moving onto you said is the newest member of our innovative family.

Speaker Change: We launched this product last year and the momentum continues to build.

Speaker Change: We continue to see good access when it comes to a fee for service and Medicaid, we're working with Medicare.

Richard Francis: We're working with Medicare. The hospitals continue to expand their coverage, and we're seeing good reordering from our hospitals. And this is driven by, once again, this very favorable product profile. We recently had the Association of Psychiatrists meeting in the U.S. last week, I believe it was. And the feedback continues to be really strong, particularly about this ability to get therapeutic doses within 24 hours without any oral suplement. So, good momentum. And once again, I can confirm that the guidance of $80 million is something we will be confident in achieving. Now moving on to a slide which gives me a lot of pleasure to talk about, which is our generics business. Just to sort of orientate you, remember 65% of our business is outside the U.S. and we should continue to see continued good growth in Europe of 5% and international markets 16%. But I have to say I'm particularly pleased about the U.S. and the growth of 8% there.

Speaker Change: The hospital has continued to expand that.

Speaker Change: Coverage and we're seeing good order of reordering from our hospitals.

Speaker Change: And this is driven by once again very favorable product profile, we recently had the.

Speaker Change: Especially in a cycle, that's I consciously team in the U S last week I believe it was.

Richard Francis: And the feedback continues to be really strong, particularly about this ability to get therapeutic doses within 24 hours without any oral substance. So, good momentum. And once again, I can confirm that the guidance of $80 million is something we will be confident in achieving. Now moving on to a slide which gives me a lot of pleasure to talk about, which is our generics business. Just to sort of orientate you, remember 65% of our business is outside the US and we should continue to see continued good growth in Europe of 5% and international markets. But I have to say I'm particularly pleased about the US and the growth of 8% there.

Speaker Change: Feedback continues to be really strong, particularly about this ability at therapeutic doses within 24 hours without any oil supplements.

Speaker Change: Good momentum and once again.

Speaker Change: I can confirm that the guidance of $80 million, we will be confident to achieve it.

Now moving onto slide which gives me a lot of pleasure to talk about which is our generics business.

Speaker Change: Just to sort of orientate, you remember, 65% of our business is outside the U S and we should continue to see continued good growth in Europe of 5% and international market of 16%, but I have to say, particularly pleased about the U S and the growth of 8%.

Speaker Change: Now I think.

Richard Francis: I think this highlights, once again, the Pivot to Growth strategy and the focus we've placed on our generics business to make sure we can bring products to the market more regularly and on time, and we have a good supply chain that has a good cost of goods. I think this is just the start. We've got work to do, but this is very encouraging. I'm very pleased, and I want to congratulate the team on this. Now moving on to another part of our business which we're excited about, and that's our biosimilar business. We're excited to be in a position in quarter two to be launching our biosimilar HUMIRA and SIMLANDI, and we're getting good interest from payers, the PBMs, and the channel with regard to this. We're also pleased with the fact that our biosimilar STELARA is also approved, and we'll be launching that in February of 2025. But it is worth pointing out that we have a portfolio of biosimilars, and we'll be launching six by 2027. So, this is really an opportunity to support the Pivot to Growth strategy from a biosimilars perspective.

Speaker Change: This highlights once again, the pivot to growth strategy and the focus we placed on the generics business to make sure. We can bring products to the market more readily on time and we have a good supply chain that has good cost of goods. I think this is the start we've got work to do but this is very encouraging I'm very pleased and I want to congratulate the team on this.

Richard Francis: We're excited to be in a position in quarter two to be launching our biosimilar Humira and Similadi, and we're getting good interest from payers, the PBMs, and the channel with regard to this. We're also pleased with the fact that our biosimilar Stellara is also approved, and we'll be launching that in February of 2025. But it is worth pointing out that we have a portfolio of buyers, and we'll be launching six by 2027.

Speaker Change: Now moving on to another part of our business, which we're excited about and that's our Biosimilar business. We are excited to be in a position in quarter two to be launching all biosimilar humira and similarly in that and we're getting good interest from the payers the pbms and the channel with regards to this.

Speaker Change: Also pleased with the fact that our Biosimilars Dilaura is also approved and we'll be launching that in February of 2025.

Speaker Change: But it is worth pointing out that we have a portfolio of biosimilars.

Speaker Change: We'll be launching six by 2027. So this is really an opportunity to support the pivot to growth strategy from a biosimilar perspective.

Richard Francis: So, this is really an opportunity to support the pivot to growth strategy from a biosimilars perspective. Now, moving on to step-up innovation. I won't go into this in great detail, because Eric will, but philanthropy is something I've already touched upon. But the one thing I would like to highlight on this slide is the capability building and the execution ability that we have at Teva. Alanzapine was recruited nine months ahead of schedule. TL1A is recruiting incredibly well in UC and CD. And we've got ICS-SABR off to a good start, and that is now supported by the partnership we have with Launch Therapeutics and Abingworth. So we understand these assets are important to the patients who need them, and we're focusing on them. And we're showing that focus can deliver performance. But I want to take a little minute now to talk to you a bit about our capabilities in CNS, because obviously, I talk a lot about Esteto, Ysidio, Jovi, and rightly so. And Alanzapine will get a lot of attention today, but we are building out a very good pipeline when it comes to CNF.

Richard Francis: So, this is really an opportunity to support the pivot to growth strategy from a biosimilars perspective.

Richard Francis: Now, moving on to step-up innovation. I won't go into this in great detail, because Eric will, but - and OLANZAPINE I've already touched upon - but the one thing I would like to highlight on this slide is the capability built and the execution ability that we have at Teva. OLANZAPINE was recruited nine months ahead of schedule. TL1A is recruiting incredibly well in UC and CD. And we've got ICS-SABA off to a good start, and that is now supported by the partnership we have with Launch Therapeutics and Abingworth. So, we understand these assets are important to the patients who need them, and we're focusing on them. And we're showing that focus can deliver performance. But I want to take a little minute now to talk to you a bit about our capabilities in CNS, because obviously, I talk a lot about AUSTEDO, UZEDY and AJOVY, and rightly so. And OLANZAPINE will get a lot of attention today, but we are building out a very good pipeline when it comes to CNS.

Speaker Change: Now moving onto step up innovation.

Speaker Change: I won't go into this in great detail, because Eric well, but an olanzapine I've already touched upon but the one thing I would.

Speaker Change: Like the highlights on this slide is the capability build and the execution ability that we have at Teva Olanzapine was recruited nine months ahead of schedule <unk> recruited incredibly well in UC and CD and we've got Ics that are off to a good start and that is now supported by the partnership we have with launch there.

Richard Francis: And we've got ICS-SABR off to a good start, and that is now supported by the partnership we have with Launch Therapeutics and Abingworth. So we understand these assets are important to the patients who need them, and we're focusing on them. And we're showing that focus can deliver performance. But I want to take a little minute now to talk to you a bit about our capabilities in CNS, because obviously, I talk a lot about Esteto, Ysidio, Jovi, and rightly so. And Alanzapine will get a lot of attention today, but we are building out a very good pipeline when it comes to CNF.

Speaker Change: Computing and not being one.

Speaker Change: We understand these assets are important to the patients who need them and we're focusing on the island.

Speaker Change: And that focus can deliver performance.

Speaker Change: I don't want to take it a little minute now to talk to you a bit about our capabilities in CNS, because obviously I do talk a lot about instead of you said you're in a JV and rightly so.

Speaker Change: And Olanzapine will get a lot of attention to date, but we are building out a very good pipeline when it comes to CNS and we will be giving you more information on this as we move forward, but once again building a real foundation to Teva in CNS.

Richard Francis: And we'll be giving you more and more information on this as we move forward, but once again, building a real foundation for Teva in CNS. Now moving on to our final pillar, which is focused on the business around TAPI. Now, we obviously announced at the start of this year that we will be divesting TAPI, our API business. And I'm really pleased to succeed that the team, with this freedom to operate outside of Teva and in the global $85 billion API market, they've really started to deliver and got off to a good start with 2% growth. I see this momentum growing and this performance increasing because of the interest we've got from CDMOs, and the interest is based on the fact that we have a broad technology base and our credibility for quality and supply reliability is clearly something that they're interested in. So, good news and more to come, I think, on TAPI throughout the year. To close on something that is important to us, which is about how we operate as a company and how we contribute to society.

Speaker Change: Now moving on to our final pillar, which is focus the business around tapping that we obviously announced the start of this year that we would be divesting county.

Speaker Change: <unk> business and I'm really pleased to say that the team.

Speaker Change: With this freedom to operate outside.

Speaker Change: Of Teva and in the global $85 billion API market. They really started to deliver got off to a good start with a 2% growth.

Richard Francis: I see this momentum growing and this performance increasing because of the interest we've got from CDMOs, and the interest is based on the fact that we have a broad technology base and our credibility for quality and supply reliability is clearly something that they're interested in. So, good news and more to come, I think, on TAPI throughout the year, to close on something that is important to us, which is about how we operate as a company and how we contribute to society.

Speaker Change: I see this momentum growing and this performance increasing because of the interest we'd go from C. D. M OS and the interest is based on the fact that we have a broad technology base and our credibility of quality and subsequent supply reliability is clearly something that they are interested in so.

Speaker Change: So good news and more to come I take on choppy throughout the year.

Speaker Change: To close on something that is important to us.

Speaker Change: Which is about how we operate as a company and how we contribute to society.

Richard Francis: We launched our sustainability goals in 2023, and I just wanted to give you an update on how we are progressing. So, with regard to healthy people, we launched seven programs to increase access to medicine across the globe. Healthy planet, we've reduced our carbon emissions by 27% versus 2019. And when it comes to how we conduct ourselves in our business, being ethical and compliant, 100% of people have completed their training, and that was achieved in 2023. Now with that, I'll conclude my section, and I'd like to hand over to Eric Hughes, Head of R&D. Over to you, Eric.

Speaker Change: We launched our sustainability.

Speaker Change: Sustainability goals in 2023, and I just wanted to give you an update of how we progress so with regards to healthy people, we launched seven programs to increase access to medicine across.

Speaker Change: Across the globe healthy planet, we've reduced our.

Speaker Change: Carbon emissions by 2027 by 27% versus 2019, and when it comes to how we conduct ourselves and our business being ethical and compliance are 100% of people who completed their training and that was achieved in 2023.

Speaker Change: Now with that I'll conclude my section and I would like to hand over to Eric He was head of R&D obituary.

Eric: Thank you Richard.

Eric Hughes: Thank you, Richard. As Richard mentioned, we're very excited that today we announced the positive primary endpoint readout of our OLANZAPINE LAI program. It also met its secondary endpoints - key secondary endpoints. I thought I'd start off today by describing and reminding you of the study design and where we are in executing the study today. Remember, the study has an eight-week period. It's a randomized placebo-controlled study with three dose arms, and today we are talking about the primary readout at the end of that eight-week period. The study also includes a 48-week follow-up for safety that is now being executed with our full randomized patient size of about 675 subjects, so slightly over-enrolled. So, it's important to note that that second half of the study will be read out for safety in the second half of the year. So, when it comes to the primary efficacy endpoints, we are very excited to see that we met clinical significance and statistical significance on our primary endpoint using the PAM score. You can see that the score was between 9.7 and 11.3 points in change from the baseline score.

Eric: As Richard mentioned, we're very excited that today, we announced the positive primary endpoint readout of our <unk> <unk> program. It also met its secondary.

Eric Hughes: I thought I'd start off today by describing and reminding you of the study design and where we are in executing the study today. Remember, the study has an eight-week period. It's a randomized placebo-controlled study with three dose arms, and today we are talking about the primary readout at the end of that eight-week period. The study also includes a 48-week follow-up for safety that is now being executed with our full randomized patient size of about 675 subjects, so slightly over-enrolled. So it's important to note that that second half of the study will be read out for safety in the second half of the year. So when it comes to the primary efficacy endpoints, we are very excited to see that we met clinical significance and statistical significance on our primary endpoint using the PAM score. You can see that the score was between 9.7 and 11.3 points in change from the baseline score.

Eric: Endpoints are key secondary endpoints.

Eric: Start off today by describing and reminding you of the study design and where we are in executing the study today remember the study has an eight week period is a randomized placebo controlled study with three dose arms and today, we are talking about the primary readout at the end of that eight week.

Eric Hughes: The study also includes a 48-week follow-up for safety that is now being executed with our full randomized patient size of about 675 subjects, so slightly over-enrolled. So it's important to note that that second half of the study will be read out for safety in the second half of the year. So when it comes to the primary efficacy endpoints, we are very excited to see that we met clinical significance and statistical significance on our primary endpoint using the PAM score. You can see that the score was between 9.7 and 11.3 points in change from the baseline score.

Eric: The study also includes a 48 week follow up for safety as it is now being executed with our full randomized patient size of about 675 subjects slightly over enrolled.

Eric: So it's important to note that that second half of the study will be read out for the safety second.

Eric: Second half of this year.

Eric: So when it comes to the primary efficacy endpoints were very excited to see that we met clinical significance and statistical significance on our primary endpoint using the Pan score you can see the store was between $9 seven and 11 three points in change from baseline.

Eric Hughes: That's the change from baseline to week 8. So, right where we expected the efficacy to be and clearly efficacious on all three dose groups. Importantly, we are also up to about 80% of our total target injections at this point, and we see no PDSS. So, the injections were well tolerated throughout the study. I should mention that the key secondary endpoints include the clinical global impressions for schizophrenia scale and the personal and social performance scale, which for all doses achieved clinical significance. I would also like to say that this study illustrates our ability to execute and accelerate our programs in the innovative space. We brought this study out - up by nine months, so a real good job by the clinical team. Moving on to AUSTEDO, we continue to do great work informing our patients and our investigators about TB. We are running a study, a real-world observational study called Impact TB, and this is something that we're very proud of, where it's looking at both the patient voice and the caregiver perspective on what the impact of tardive dyskinesia is.

Eric: Find a score that's the change from baseline to week eight so right, where we expected the efficacy to be.

Eric: Clearly applications on all three dose groups importantly, we are also up to about 80% of our total target injections at this point and we've seen no <unk>. So the injections were well tolerated throughout the study I should mention that the key secondary endpoints include the clinical global impressions for schizophrenia.

Eric: Our scale and the personalized social performance scale with all both for all doses achieved clinical significance.

Eric Hughes: I would also like to say that this study illustrates our ability to execute and accelerate our programs in the innovative space. We brought this study out by nine months, so a real good job by the clinical team. Moving on to Aceto, we continue to do great work informing our patients and our investigators about TB. We are running a study, a real-world observational study called Impact TB, and this is something that we're very proud of, where it's looking at both the patient voice and the caregiver perspective on what the impact of tardive dyskinesia is.

Speaker Change: I would like to also say that this study illustrates our ability to execute.

Speaker Change: <unk> accelerated our programs and the innovative space. We brought this study out.

Speaker Change: Nine months, so a real good job by the clinical team.

Speaker Change: Moving onto et cetera.

Speaker Change: To do great work informing our patients our investigators about.

Speaker Change: T D. We are running a study in a real world observational study called impact PD and this is something that we're very proud of where it is looking at both the patient voice, let me sort of give a perspective on what the impact of tardive dyskinesia.

Eric Hughes: This study is the largest study for tardive dyskinesia ever, and it includes a wide range of ages, race, and ethnicity, severities in their baseline movements, and their treatment experience that's being run in 23 states in the United States. As I mentioned, we're developing a scale that really is measuring both what the patients tell us and what the caregivers see when it comes to tardive dyskinesia. So, understanding tardive dyskinesia is our goal, and educating our patients and caregivers is our mission. The first set of data will be announced or presented at the Psych Elevate meeting later this month. Now, moving on to asthma. Asthma is a significant patient population. It's a very important chronic illness in the U.S. and around the world, and the majority of these patients use rescue inhalers. There still is over 10 million asthma exacerbations every year, and we've learned now that combination rescue inhalers are what's needed. In fact, the guidelines - the GINA guidelines, have changed to the point where that's the recommendation for asthma exacerbations. That's the combination of both a beta agonist and a steroid. And that's why we're excited about our program, TEV-'248. This is a combination rescue inhaler using ALBUTEROL and FLUTICASONE, two well-known medications by our treating physicians. And the important thing is that this is a differentiated device.

Speaker Change: This study is the largest study for tardive dyskinesia ever and includes a wide range of ages recent ethnicity severities in their baseline movements and their treatment experience that's being run in 23 states in the United States as I mentioned, we are developing a scale that really is measuring both.

Speaker Change: What patients tons and with the caregivers see when it comes to tardive dyskinesia. So understanding tardive dyskinesia is our goal and educating our patients and caregivers.

Speaker Change: Mission.

The first set of data will be.

Napster presented at the second elevate meeting later this month.

Eric Hughes: Now moving on to asthma. Asthma is a significant patient population. It's a very important chronic illness in the U.S. and around the world, and the majority of these patients use rescue inhalers. There are still over 10 million asthma exacerbations every year, and we've learned now that combination rescue inhalers are what's needed. In fact, the guidelines, the GINA guidelines, have changed to the point where that's the recommendation for asthma exacerbations. That's the combination of both a beta agonist and a steroid. And that's why we're excited about our program, TEV248. This is a combination rescue inhaler using albuterol and fluticasone, two well-known medications by our treating physicians. And the important thing is that this is a differentiated device.

Speaker Change: Now moving on to asthma asthma is a significant patient population, it's a very important chronic illness in the U S and around the world and the majority of these patients use rescue inhalers.

Speaker Change: Still is over 10 million asthma exacerbations every year.

Speaker Change: We've learned now the combination rescue inhalers are what's needed and in fact the guidelines.

Speaker Change: The Gina guidelines have changed to the point, where that's the recommendation for asthma exacerbation and Thats a combination of both.

Speaker Change: Beta agonists and a steroid.

Eric Hughes: It's a dry powder inhaler, and that's important for when it comes to taking care of pediatrics patients, and that's what we're targeting in this study. You know, we're excited that we started our Phase III study at this point. Enrollment's going well, but it's great to collaborate and Launch Therapeutics will help to accelerate the program even further and importantly, get those patients in the pediatric population going in the study. So, very exciting to be delivering in the future a new treatment for asthmatic exacerbations in accordance with the GINA guidelines. Moving on to my last topic, the ANTI-IL-15 program. This is a very important program because the first indication we'll be taking this compound into is celiac diseas. Now, IL-15 is a key cytokine in the pathology of celiac disease. When these patients eat gluten, it causes an inflammatory reaction that releases IL-15 and activates inter-epithelial lymphocytes. It's a large patient burden in the U.S., about 2 million patients. Only about half of those patients are diagnosed. But the important thing to remember is that 50% of these patients still have symptoms even while taking a gluten-free diet. 20% of these patients never even respond to a gluten-free diet.

Speaker Change: And that's why we're excited about our program <unk> $2 48. This is a combination of rescue inhaler and using albuterol and Fluticasone, two well known medications via our treating physicians and the important thing is that this is a differentiated device, it's a dry powder inhaler and that's.

Speaker Change: Important for when it comes to taking care of pediatric patients and that's what we're targeting in this in this study. We're excited that we started our phase III study. This point enrollment is going well, but it's great to have collaborated with <unk> therapeutics.

Speaker Change: Hope to accelerate the program, even further and importantly get those patients in the pediatric population going in this study so very exciting to be delivering in the future and new treatment for asthmatic exacerbations in accordance with a G. Gina guidelines.

Speaker Change: Moving on to my last topic. The anti IL 15 program. This is a very important program because where our first indication will be taking this compounded two celiac disease now IL 15 is a key cytokines in the path biology of celiac disease. When these patients.

Eric Hughes: This is a very important program because the first indication we'll be taking this compound into is celiac. Now, IL-15 is a key cytokine in the pathology of celiac disease. When these patients eat gluten, it causes an inflammatory reaction that releases IL-15 and activates inter-epithelial lymphocytes. It's a large patient burden in the U.S., about 2 million patients. Only about half of those patients are diagnosed. But the important thing to remember is that 50% of these patients still have symptoms even while taking a gluten-free diet. 20% of these patients never even respond to a gluten-free diet.

Speaker Change: <unk> E Hooton causes an inflammatory reaction that release of IL 15, and activation interest the DLA will emphasize if a large patient burden and were in the U S. About 2 million patients only about half of those patients are diagnosed with the important thing to remember that 50% of these patients still have symptoms.

Speaker Change: While seeking a gluten free diet, 20% of these patients never even respond to a gluten free diet and 50% of these patients still want treatment beyond a gluten free diet.

Eric Hughes: And 50% of these patients still want treatment beyond a gluten-free diet. So, that's why I'm excited about our ANTI-IL-15 program. I've shown you before that we have a very potent antibody that rapidly reduces free IL-15 levels and keeps those levels suppressed out to almost 80 days. We are exploring the compound in celiac patients right now. We're enrolling a patient at the end of - a study by the end of this year. Looking at a celiac challenge study where we give a single dose of TEV-'408 and then two weeks later start a gluten-free diet for 14 weeks. So, we're very encouraged to see the results of this study, hopefully soon. And the important part about the study is really focused on the symptoms of the patients. Really, are we impacting what they feel when they eat gluten-containing food? So, we think we have a potentially differentiated product. It's a high affinity ANTI-IL-15. It suppresses IL-15 rapidly, and it has low immunogenicity today.

Speaker Change: So thats why im excited about our anti IL 15 program I've shown you before that we have a very potent antibody that rapidly reduces.

Speaker Change: Free IL 15 levels and keeps those levels suppressed after almost eight days.

Speaker Change: Exploring the compounded CLEC patients right now we are enrolling a patient by the end of a study by the end of this year looking at our Celiac Challenge study where are we getting a single dose of <unk> and then two weeks later start a gluten free diet for 14 weeks. So were very encouraged to see the.

Eric Hughes: So we're very encouraged to see the results of this study, hopefully soon. And the important part about the study is really focused on the symptoms of the patients. Really, are we impacting what they feel when they eat gluten-containing food?

Speaker Change: This study.

Speaker Change: Really soon.

Speaker Change: And the important part about this study is really focus on the symptoms of the patients really are we impacting what they see.

Eric Hughes: So we think we have a potentially differentiated product. It's a high affinity anti-IL-15. It suppresses IL-15 rapidly, and it has low immunogenicity today.

Speaker Change: Equally.

Speaker Change: Containing food.

Speaker Change: So we think we have a potentially differentiated product, it's a high affinity anti IL 15.

Speaker Change: <unk>.

Speaker Change: IL 15 rapidly and it has.

Speaker Change: Immunogenicity today.

Eric Hughes: So, my final thought is I just wanna talk about, you know, we're achieving our milestones and accelerating them where we can. We've shown that our OLANZAPINE LAI today has achieved its primary endpoint. We'll be curious or hopeful to see the final set of safety data on our injections in the second half of this year. [inaudible], our anti-TL1A program is right on target. The enrollment is going very well for both ulcerative colitis and Crohn's disease. And we'll be looking for that interim analysis in the second half of this year. I just mentioned our anti-IL-15 program, enrolling our celiac patients this year in our proof of concept study. I'm very excited for the end of this month or next month when we see the first patient in our anti-PD1 IL-2 program in oncology. And finally, we're enrolling our Phase III study now and working to accelerate our program for our dual action rescue inhaler for asthma. So, there is a lot coming, and we're looking forward to keeping you updated. So with that, I'm going to pass it off to Eli and - take it away.

Speaker Change: Sure.

Speaker Change: So on my final slide I, just wanted to talk about.

Speaker Change: Achieving our milestones and accelerating them, where we can.

Speaker Change: Shown that our <unk> today has achieved its primary endpoint will be curious are hopeful to see the final set of the safety data are injections. The second half of this year.

Speaker Change: On to our <unk> program is right on target with the enrollment is going very well for both ulcerative colitis, and crohn's disease and won't be looking for that interim analysis in the second half of this year I just mentioned our anti IL 15 program enrolling our celiac patients. This year in a proof of concept study I'm very excited for the end of this month.

Eric Hughes: And we'll be looking for that interim analysis in the second half of this year. I just mentioned our anti-IL-15 program, enrolling our CREAC patients this year in our proof of concept study. I'm very excited for the end of this month or next month when we see the first patient in our anti-P1 IL-2 program in oncology. And finally, we're enrolling our phase 3 study now and working to accelerate our program for our dual action rescue inhaler for asthma. So there is a lot coming, and we're looking forward to keeping you updated. So with that, I'm going to pass it off to Eli and take it away. Thank you.

Speaker Change: For the next month, where we see the first patient in our anti PD, one or IL two program in oncology and finally, we're enrolling our phase III study now and working to accelerate our program for our dual action rescue inhaler for asthma. So a lot coming and we're looking forward to keeping up you updated so without.

Eli Kalif: Thank you, Eric, and good morning and good afternoon to everyone. I'll begin my review of our Q1 2024 financial results with slide 29, starting with our GAAP performance. The total revenue for 2024 was $3.8 billion, an increase of 4% in U.S. dollars and 5% in local currency terms, compared to the first quarter of 2023. The increase was mainly driven by broad-based growth from generics products across all our segments globally, including strong contributions from generics sales made in the U.S., and continuing strong growth in AUSTEDO as well as AJOVY in our Europe and international market segments. This was partially offset by lower revenue from COPAXONE as well as from [inaudible], our distribution business in the U.S. In Q1 2024, we recorded a GAAP operating loss of $218 million compared to an operating loss of $13 million in the same quarter last year. The increase in operating loss was mainly due to higher impairment of tangible assets and other items, as well as higher sales and marketing expenses in the first quarter of 2024, partially offset by higher gross profit, lower legal settlement and lost contingencies, and lower intangible asset impairment in the first quarter of 2024. As part of Teva's people-to-growth strategy, we have decided to divest our generic business in Japan, which is part of Teva's international market signal.

Speaker Change: I'm going to pass it off the early and take away.

Speaker Change: Thank you, Eric and good morning, and good afternoon to everyone. I'll begin my review of our Q1 2024 financial result, with slide 29, starting with our GAAP performance.

Speaker Change: Thank you.

Speaker Change: When you said before were $3 8 billion, an increase of 4% in U S dollars and 5% in local currency terms compared to the first quarter of 2023. The inquiry was mainly driven by broad based growth from generic products across all our segments globally.

Speaker Change: <unk> strong contribution from generics have been made in the U S continued strong growth as well as the jewelry.

Speaker Change: Europe and international market segment.

Speaker Change: Partially offset by lower revenue from Copaxone as well as from under our distribution business in the U S.

Eli Kalif: In Q1 2024, we recorded a gap operating loss of $218 million compared to an operating loss of $13 million in the same quarter last year. The increase in operating loss was mainly due to higher impairment of tangible assets and other items, as well as higher sales and marketing expenses in the first quarter of 2024, partially offset by higher gross profit, lower legal settlement and lost contingencies, and lower intangible asset impairment in the first quarter of 2024. As part of Teva's people-to-growth strategy, we have decided to divest our generic business in Japan, which is part of Teva's international market signal.

Speaker Change: In Q1, 2024, we recorded a GAAP operating loss of 280 million compared to an operating loss of $13 million in the same quarter last year.

Speaker Change: The increase in operating loss was mainly due to higher impairment of tangible assets and other items as well as higher sales and marketing expenses in the first quarter of 2024, partially offset by higher gross profit lower legal settlement and loss contingencies and lower intangible assets impairment.

Speaker Change: In the first quarter of 2024.

Speaker Change: As part of Teva pivot to growth strategy, we have decided to divest our generic business in Japan, which is part of the international market segment, the assets and liabilities in relation to this business who are classified as held for sale and.

Eli Kalif: The assets and liabilities in relation to this business were classified as held for sale in the first quarter of 2024 and resulted in an impairment charge of approximately $600 million this quarter. We currently expect the business to be sold within the next year. Moving to Gartner Law, which was $139 million and a gap loss per share of $0.12 this quarter compared to a loss per share of $0.20 in Q1 last year. The lower gap net loss was mainly due to higher net losses related to a non-controlling interest, which resulted from higher tangible asset impairment related to the business that was classified as health care for sale. Turning to slide 30. You can see the total NAN gap adjustments in the first quarter of 2024 were $688 million compared to $661 million in Q1 2023. A notable non-GAAP adjustment includes legal expenses of $406 million, mainly related to estimated provisions recorded in connection with certain litigation cases in the U.S. Other notable adjustments include amortization, purchasing tangible assets of $152 million, the majority of which is included in cost of sales, and, as I just mentioned, the impairment of tangible assets of approximately $600 million related to the business held for sale. Now moving to slide 31, a review of our NANDGAP performance.

Eli Kalif: The assets and liabilities in relation to this business were classified as held for sale in the first quarter of 2024 and resulted in an impairment charge of approximately $600 million this quarter. We currently expect the business to be sold within the next year. Moving to GAAP net loss, which was $139 million and GAAP loss per share that was $0.12 this quarter compared to a loss per share of $0.20 in Q1 last year. The lower GAAP net loss was mainly due to higher net loss related to a non-controlling interest which resulted from higher tangible assets impairment related to the business that was classified as held for sale. Turning to Slide 30, you can see that total non-GAAP adjustments in the first quarter of 2024 were $688 million compared to $661 million in Q1 2023. A notable non-GAAP adjustment include legal expenses of $106 million mainly related to estimated provisions recorded in connection with the certain litigation cases in the U.S. Other notable adjustments include amortization, purchase intangible assets of $152 million, the majority of which is included in cost of sales, and as I just mentioned, the impairment of tangible assets of approximately $600 million related to the business held for sale.

Speaker Change: In the first quarter of 'twenty 'twenty, four and resulted in an impairment charge of approximately $600 million. This quarter. We currently expect the business to be sold within the next year.

Speaker Change: Moving to GAAP net loss.

Speaker Change: Which was $139 million and GAAP loss per share was 12 cents this quarter compared to a loss per share of <unk> 20 in Q1 last year.

Eli Kalif: The lower gap net loss was mainly due to higher net losses related to a non-controlling interest, which resulted from higher tangible asset impairment related to the business that was classified as health care for sale. Turning to slide 30. You can see the total NAN gap adjustments in the first quarter of 2024 were $688 million compared to $661 million in Q1 2023. A notable non-GAAP adjustment includes legal expenses of $406 million, mainly related to estimated provisions recorded in connection with certain litigation cases in the U.S. Other notable adjustments include amortization, purchasing tangible assets of $152 million, the majority of which is included in cost of sales, and, as I just mentioned, the impairment of tangible assets of approximately $600 million related to the business held for sale. Now moving to slide 31, a review of our NANDGAP performance.

Speaker Change: The lower GAAP net loss was mainly due to higher net loss related to our non controlling interest which resulted from higher tangible assets impairment related to the business that was classified as held for sale.

Eli Kalif: You can see the total NAN gap adjustments in the first quarter of 2024 were $688 million compared to $661 million in Q1 2023. A notable non-GAAP adjustment includes legal expenses of $406 million, mainly related to estimated provisions recorded in connection with certain litigation cases in the U.S. Other notable adjustments include amortization, purchasing tangible assets of $152 million, the majority of which is included in cost of sales, and, as I just mentioned, the impairment of tangible assets of approximately $600 million related to the business held for sale. Now moving to slide 31, a review of our NANDGAP performance.

Speaker Change: Turning to slide 30.

Speaker Change: We can see that total non-GAAP adjustment in the first quarter of 2024 were $688 million compared to $661 million in Q1 2023.

Speaker Change: Notable non-GAAP adjustments include legal expenses of 106 million mainly related to estimated provisions recorded in connection with certain litigation cases in the U S either.

Speaker Change: Other notable adjustments include amortization of purchased intangible assets of $152 million. The majority of which is included in cost of sales and as I just mentioned the impairment of intangible assets of approximately $600 million.

Speaker Change: The business held for sale.

Eli Kalif: Now moving to Slide 31 for a review of our non-GAAP performance. As I mentioned earlier, our first quarter revenues were approximately $3.8 billion, an increase of 4% in U.S. dollars or 5% in local currency terms compared to Q1 of last year. Our non-GAAP gross profit margin was 51.4% compared to 49.1% in Q1 2023. This increase in our gross margin was mainly driven by improvement in our portfolio mix, including strong continued growth in AUSTEDO as well as decrease in our operational costs. As expected and in line with the normal seasonality and revenue progression between the quarters, we started the year with a lower non-GAAP gross profit margin. For the full year of 2024, we continue to expect our non-GAAP gross margin to be between 53% to 54%. Our gross margins will gradually improve as we progress throughout the year driven by continuous improvement in our portfolio mix with a strong growth in our innovative portfolio and continuation of the ongoing cost optimization program. Moving to non-GAAP operating margin in Q1 2024, which was 23.4% compared to 21.4% in Q1 2023. This increase was mainly driven by higher non-GAAP gross margin, as I just explained. This was partially offset by higher sales and marketing expenses as a percentage of revenue, reflecting our increased investments to support our key growth engines, including promotional activities related to AUSTEDO, in line with our Pivot to Growth strategy.

Speaker Change: Now moving to slide 31.

Eli Kalif: As I mentioned earlier, our first quarter revenues were approximately $3.8 billion, an increase of 4% in U.S. dollars or 5% in local currency terms compared to Q1 of last year. Additionally, Arnan Gap's gross profit margin was 51.4% compared to 49.1% in Q1 2023. This increase in our gross margin was mainly driven by improvements in our portfolio mix, including strong continued growth in Osteto, as well as a decrease in our operational costs. As expected, and in line with the normal seasonality and revenue progression between the quarters, we started the year with a lower non-gap gross profit margin. For the full year of 2024, we continue to expect our NAND gap gross margin to be between 53% to 54%. Our gross margins will gradually improve as we progress throughout the year, driven by continuous improvements in our portfolio mix, with a strong growth in our innovative portfolio and continuation of the ongoing cost optimization program, moving to a non-gap operating margin in Q1 2024, which was 23.4% compared to 21.4% in Q1 20 This increase was mainly driven by a higher non-gap growth margin, as I just explained. This was partially offset by higher sales marketing expenses as a percentage of revenue, reflecting our increased investment to support our key growth engines, including promotional activities related to settling in line with our people to growth strategy.

Speaker Change: For a review of our non-GAAP performance.

Speaker Change: As I mentioned earlier, our first quarter revenues were approximately $3 8 billion, an increase of 4% in U S dollars or 5% in local currency terms.

Speaker Change: Compared to Q1 of last year.

Speaker Change: Our non-GAAP gross profit margin was 51, 4% compared to 49, 1% in Q1 2023. Please.

Speaker Change: This increase in our gross margin was mainly driven by improvement in our portfolio mix, including strong continued growth sito as well as decreasing our operation.

Speaker Change: As expected and in line with enormous seasonality and revenue progression between the quarters. We started the year with a lower non-GAAP profit growth gross profit margin.

Eli Kalif: For the full year of 2024, we continue to expect our NAND gap gross margin to be between 53% to 54%. Our gross margins will gradually improve as we progress throughout the year, driven by continuous improvements in our portfolio mix, with a strong growth in our innovative portfolio and continuation of the ongoing cost optimization program, moving to a non-gap operating margin in Q1 2024, which was 23.4% compared to 21.4% in Q1 20 This increase was mainly driven by a higher non-gap growth margin, as I just explained. This was partially offset by higher sales marketing expenses as a percentage of revenue, reflecting our increased investment to support our key growth engines, including promotional activities related to settling in line with our people to growth strategy.

Speaker Change: For the full year of 2024, we continue to expect our non-GAAP gross <unk>.

Speaker Change: Margin to be between 53% to 54%.

Speaker Change: Gross margin will gradually improve as we progress throughout the year driven by continuous improvements in our portfolio mix with strong growth in our innovative portfolio and continuation of the ongoing cost optimization program.

Speaker Change: Moving to non-GAAP operating margin in Q1, 2024, which was 23, 4% compared to 21, 4% in Q1 2023.

Speaker Change: This increase was mainly driven by higher non-GAAP gross margin as I. Just explained this was partially offset by higher as those marketing expenses as a percentage of revenue, reflecting our increased investments to support our key growth engines, including promotional activities related to a sale in line with our pivot to growth.

Eli Kalif: This was partially offset by higher sales marketing expenses as a percentage of revenue, reflecting our increased investment to support our key growth engines, including promotional activities related to settling in line with our people to growth strategy.

Eli Kalif: We ended the quarter with a non-GAAP earnings per share of $0.48 compared to $0.40 in Q1 2023, mainly driven by higher operating income. The next slide shows our continuing effort to transform and optimize our global manufacturing and operating footprint to drive efficiencies. During 2023, we closed three sites to bring our total footprint down to 49, and we have plans to continue this progress. By the end of 2025, we expect to close or divest four additional sites with a goal to bring down the total number of sites to between 40 to 42 sites by 2027. So, we are really focused on continuing to optimize our operations to drive efficiencies and improve margins. Turning to free cash flow on Slide 33. Our free cash flow in the first quarter of 2024 was $32 million. As a reminder, Teva's free cash flow tends to face headwinds at the start of the year due to the timing of annual bonus payments paid out in the first quarter of every year. In addition, our free cash flow for Q1 was also impacted by changes in certain working capital items. Today, we are reaffirming our 2024 free cash flow guidance, which we provided in January. Our 2024 free cash flow is expected to be in the range of $1.7 billion to $2 billion, and we expect it to pick up during the next three quarters driven by ramp up in our profitability, as I mentioned earlier, and as we continue to drive working capital improvement.

Speaker Change: <unk>.

Speaker Change: We ended the quarter with a non-GAAP, earning per share of 48 compared to <unk> 40 in Q1, 2023, mainly driven by higher operating income.

Speaker Change: The next slide.

Speaker Change: Shows our continuing effort to transform and optimize our global manufacturing and operating footprint to drive efficiencies.

Speaker Change: In 2023, we closed three sites, bringing our total footprint down to 49.

Speaker Change: And we have plans to continue this progress by.

Speaker Change: By the end of 2025, we expect to close or divest four additional sites.

Speaker Change: With a goal to bring down the total number of sites to between 40 to 42 sites by 2027.

Eli Kalif: So we are really focused on continuing to optimize our operations to drive efficiencies and improve margins. Turning to free cash flow on slide 33, our free cash flow in the first quarter of 2024 was $ 32 million. As a reminder, Teva's free cash flow tends to face headwinds at the start of the year due to the timing of annual bonus payments paid out in the first quarter of every year. In addition, our free cash flow for Q1 was also impacted by changes in insertion working capital items. Today We are reaffirming our 2024 free cash flow guidance, which we provided in January. Our 2024 free cash flow is expected to be in the range of $1.7 to $2 billion, and we expect this to pick up during the next three quarters, driven by a ramp-up in our profitability, as I mentioned earlier, and as we continue to drive working capital improvement.

Speaker Change: So we're really focused on continuing to optimize our operations to drive efficiencies and improve margins.

Speaker Change: Turning to free cash flow on slide 33.

Speaker Change: Our free cash flow in the first quarter of 2024 was $32 million as a reminder, free cash flow 10 faced headwinds at the start of the year due to the timing of annual bonus payments paid off in the first quarter of every year. In addition, our free cash flow for Q1 was also impacted.

Speaker Change: But changes in certain working capital items.

Eli Kalif: We are reaffirming our 2024 free cash flow guidance, which we provided in January. Our 2024 free cash flow is expected to be in the range of $1.7 to $2 billion, and we expect this to pick up during the next three quarters, driven by a ramp-up in our profitability, as I mentioned earlier, and as we continue to drive working capital improvement. Turning to slide 34.

We are reaffirming our 2024 free cash flow guidance, which we provided in January. Our 2024 free cash flow is expected to be in the range of $1.7 to $2 billion, and we expect this to pick up during the next three quarters, driven by a ramp-up in our profitability, as I mentioned earlier, and as we continue to drive working capital improvement.

Speaker Change: Today.

Speaker Change: We are reaffirming our 2020 for free cash flow guidance, which we provided in January our 2020 for free cash flow is expected to be in the range of $1 7 million to $2 billion and we expect it to pick up during the next three quarters driven by a ramp up in our profitability as I mentioned earlier and as we continue to drive.

Speaker Change: Working capital improvement.

Eli Kalif: Turning to Slide 34, our net debt at the end of Q1 2024 was $16.7 billion compared to $16.6 billion at the end of '23. Our gross debt was $19.6 billion compared to $19.8 billion at the end of 2023. The decrease in our gross debt was mainly due to exchange rate fluctuations of $193 million. Our net-debt-to-EBITDA slightly improved coming at 3.38 times for Q1 2024, mainly due to higher EBITDA. Subsequent to the quarter close, in April 2024, we repaid $956 million of our senior notes at maturity. At the end of March 31st and as of today, there is no amount outstanding under the $1.8 billion revolving credit facility. Last week, Teva entered into an amendment to our revolving credit facility to update the company's maximum permitted leverage ratio under the RCF for a certain period. Under the amendment terms of the RCF, the company's leverage ratio shall not exceed 4 times in '24 and '25 and in the first quarter of '26, 3.75 times in the second, third and fourth quarter of 2026, and 3.5 times in the first quarter of 2027 and onwards.

Eli Kalif: Our net debt at the end of Q1 2024 was $16.7 billion, compared to $16.6 billion at the end of 2023. Our gross debt was $19.6 billion, compared to $19.8 billion at the end of 2023. The decrease in our gross debt was mainly due to exchange rate fluctuations of $193 million. Our net debt to EBITDA slightly improved, coming at 3.38 times 4Q1 2024, mainly due to higher EBITDA. Subsequent to the quarter close in April 2024, we repaid $956 million of our senior notes at maturity. At the end of March 31st, and as of today, there is no amount outstanding under the $1.8 billion revolving credit facility. Last week, Teva entered into an amendment to our revolving crate facility to update the company's maximum permitted leverage ratio under the RCS for a certain period. Under the amendment terms of the RCS, the company's leverage ratio shall not exceed four times in 2024 and 2025 and in the first quarter of 2026; 3.75 times in the second, third, and fourth quarters of 2026 and two and a half times in the first quarter of 2027 and onward.

Speaker Change: Turning to slide 34, our.

Speaker Change: Our net debt at the end of Q1, 2024 was $16 7 billion compared to $16 6 billion at the end of 'twenty three.

Speaker Change: <unk> was $19 6 billion compared to $19 8 billion at the end of 2023. The decrease in our gross debt was mainly due to exchange rate fluctuation of $193 million.

Eli Kalif: Our net debt to EBITDA slightly improved, coming at 3.38 times 4Q1 2024, mainly due to higher EBITDA. Subsequent to the quarter close in April 2024, we repaid $956 million of our senior notes at maturity. At the end of March 31st, and as of today, there is no amount outstanding under the $1.8 billion revolving credit facility. Last week, Teva entered into an amendment to our revolving crate facility to update the company's maximum permitted leverage ratio under the RCS for a certain period. Under the amendment terms of the RCS, the company's leverage ratio shall not exceed four times in 2024 and 2025 and in the first quarter of 2026; 3.75 times in the second, third, and fourth quarters of 2026 and two and a half times in the first quarter of 2027 and onward.

Speaker Change: Our net debt to EBITDA slightly improved coming at 338 time for Q1 2024, mainly due to higher EBITDA.

Speaker Change: Subsequent to the quarter close in FY 2024, we repaid $956 million of our senior notes at maturity.

Speaker Change: At the end of March 31, and as of today. There is no amount outstanding under the $1 8 billion revolving credit facility.

Speaker Change: Last week <unk>.

Speaker Change: We entered into an amendment to our revolving credit facility to update the company's maximum permitted leverage ratio under the Rcs for a certain period.

Eli Kalif: Under the amendment terms of the RCS, the company's leverage ratio shall not exceed four times in 2024 and 2025 and in the first quarter of 2026; 3.75 times in the second, third, and fourth quarters of 2026 and two and a half times in the first quarter of 2027 and onward.

Speaker Change: Under the amendment terms of the Rcs, the company's leverage ratio should not exceed four time in 'twenty four 'twenty five and in the first quarter of 26 three.

Speaker Change: 375 times in the second third and fourth quarter of 2026, and three and a half times in the first quarter of 2027 and onwards.

Eli Kalif: Now, let's turn our attention to our 2024 non-GAAP outlook on Slide 35. As we guided in January, when we initially provided our full year outlook, we had expected our revenue and earnings to progress gradually throughout the year. That continues to be our expectation as we reported today. For the full year of 2024, we continue to expect our revenue to be between $15.7 billion to $16.3 billion. We are also reaffirming our 2024 non-GAAP outlook for operating income, EBITDA, earnings per share and free cash flow as provided in January. Like I said earlier, our non-GAAP gross margin is expected to be between 53% to 54% for the full year, and we expected the gradual pickup in margins in the second quarter, with a further progress in the second half of the year, in line with the revenue trajectory and the portfolio mix, as well as improvement from our ongoing cost optimization program. In addition, we continue to make deliberate and thoughtful investments in our innovative portfolio and to progress our key pipeline assets to drive both the short and long-term growth for the company.

Speaker Change: Now, let's turn our attention to our 2024 and non-GAAP outlook on slide 35.

Speaker Change: As we guided in January when we initially provided our full year outlook, we had expected our revenue and earnings to progress gradually throughout the year that continues to be our expectation as we reported to date.

Speaker Change: For the full year of 2024, we continue to expect our revenue to be between $15 7 billion to $16 3 billion.

Speaker Change: We're also reaffirming our 2024 and non-GAAP outlook for operating income EBITDA earnings per share and free cash flow is provided in January.

Eli Kalif: Like I said earlier, our NANGAP gross margin is expected to be between 53% to 54% for the full year, and we expect a gradual pickup in margins in the second quarter, with further progress in the second half of the year, in line with the revenue trajectory and the portfolio mix, as well as improvement from our ongoing cost optimization program. In addition, we continue to make deliberate and thoughtful investments in our innovative portfolio and to progress our key pipeline assets to drive both short and long-term growth for the company.

Speaker Change: Like I said earlier, our non-GAAP gross margin is expected to be between 53% to 54% for the full year and we expect that the gradual pickup in margins in the second quarter with a further progress in the second half of the year in line with the revenue trajectory and the portfolio mix.

Speaker Change: Well as improvement from our ongoing cost optimization program.

Speaker Change: In addition, we are continuing to make deliberate and thoughtful investments in our innovative portfolio.

Speaker Change: And to progress our key pipeline assets to drive both the short and long term growth for the company.

Eli Kalif: Similar to gross margin improvement, we also expected to see leverage in operating expenses as a percentage of revenue in line with the ramp up in the revenue as we progress throughout the year. With this, I conclude my review of Teva's results for the first quarter of 2024. And now, I will hand it back to Richard for a summary.

Speaker Change: Similar to gross margin improvement, we also expect to see leverage in operating expenses as a percentage of revenue in line with the ramp up in the revenue as we progress throughout the year.

Speaker Change: With this I conclude my review of <unk> results for the first quarter of 2024, and now I will hand, it back to Richard for a summary.

Richard Francis: Thank you, Eli. Thank you for that. And so, based on what we've told you today, we continue to be confident about hitting our 2027 guidance: 30% operating income margin; net debt, 2 times; and cash-to-earnings, 80%; and a CAGR of mid-single digit. The reason why we remain confident about that I can highlight on the next slide, it comes back to the execution of our strategy. As we laid out over a year ago, we had a plan to return to growth, accelerate growth and sustain growth. As you can see, we've made good progress on return to growth, focusing on our growth engines, our biosimilars and getting our generics business back to performance. To accelerate that we clearly have laid the foundation for that with the OLANZAPINE readout today and our focus on ICS/SABA. We also have highlighted the number of biosimilars we have coming by 2027. So, I think the momentum we're getting around Pivot to Growth continues to grow and so that we remain optimistic about the future. With that, I welcome to take questions from people on the phone. Thank you.

Richard Francis: Thank you Elliot thank you for that and Sophie <unk>.

Richard Francis: Based on what we told you today, we continue to be confident about hitting our 2027 guidance, 30% operating income margin that that two times and cash to earnings 8% and a cake a mid single digit.

Richard Francis: So this is why we remain confident about that I can highlight on the next slide.

Richard Francis: Comes back to the execution of our strategy.

Richard Francis: As we laid out over a year ago, we had a plan to attend to growth accelerate growth and sustained growth as you can see we've made good progress on returned to growth focusing on our growth engines are biosimilars and getting our generics business back to performance.

Richard Francis: As you can see, we've made good progress on returning to growth, focusing on our growth engines, our biosimilars, and getting our generics business back to performance. To accelerate that, we clearly have laid the foundation for that with the olanzapine readout today and our focus on ICS-SABA. We also have highlighted the number of biosimilars we have coming by 2027. So I think the momentum we're getting around Pivot2Growth continues to grow, and we remain optimistic about the future. With that, you're welcome to take questions from people on the phone. Thank you.

Richard Francis: To accelerate that we clearly have laid the foundation for that with the Olanzapine readout today and I'll focus on Ics save we also have highlighted the number of Biosimilars, we have coming by 2027. So I think the momentum we're getting around the pivot to growth continues to grow and so we remain optimistic about the future.

Speaker Change: With that I'll welcome to take questions from people on the phone. Thank you.

Operator: Thank you. As a reminder, if you'd like to ask a question, you can press Star followed by 1 on your telephone keypad.  Our first question for today comes from Umer Raffat of Evercore ISI. Your line is now open. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Monday asked a question press star one on your telephone keypad.

Speaker Change: Our first question for today comes from.

Unknown Executive: Of Evercore ISI. Your line is now open. Please go ahead.

Umer Raffat: Good morning, guys. Thanks for taking my question. Congrats on the Phase III efficacy portion of the readout. I had three questions today, all three very trial specific, if that's okay. First, I know the efficacy delta you're showing, placebo-adjusted, is about 9% to 10%. I know when Lilly ran their long-acting OLANZAPINE, they were more in the mid-teens camp. Can you perhaps speak to what it is that clinicians want to see? Obviously, PDSS far trumped any sort of trial to trial differences in placebo-adjusted efficacy, knowing that you also got the low-teens in one of the arms. Secondly, I know the trial that we just saw is acute phase of the study and patients roll over to the safety. Is there any separate plans for a maintenance study as well? I think Lilly ran that when they ran the long-acting OLANZAPINE. I'm curious if that impacts the indication.

Unknown Executive: Good morning, guys. Thanks for taking my questions and congrats on the phase III efficacy portion of the readout I had three questions today.

Unknown Executive: All three trials specific if that's okay first.

Unknown Executive: I know the efficacy delta, you're showing placebo adjusted there's about 9% to 10%.

Speaker Change: I know when Lily ran there are long acting olanzapine. They were more in the mid teens camp can you perhaps speak to what it is that clinicians want to see obviously PD SS far Trump any sort of trial the trial differences in placebo adjusted efficacy knowing that you also got to low teens, but one of the arms Secondly, I.

Eric Hughes: Obviously, PDSS far trumps any sort of trial-to-trial differences in placebo-adjusted efficacy, knowing that you also got to low teens in one of the arms. Secondly, I know the trial that we just saw is the acute phase of the study, and patients roll over to safety. Is there any separate plan for a maintenance study as well? I think Lily ran that, but they ran the long-acting olanzapine. I'm curious if that impacts the indication.

Speaker Change: I know the trial that we just saw the acute phase of the study in patients rollover to the safety is.

Speaker Change: Is there any separate plans for a maintenance study as well I think Lily ran that but they ran the long acting olanzapine I'm curious if that impacts the indication and then finally.

Umer Raffat: And then finally, I noticed when you guys developed UZEDY, which is a oral - which is a long-acting risperidone, there were some trial conduct issues which led to FDA issuing a CRL because of some dosing errors and documentation issues, et cetera, volume of injection. And at the time, all the efficacy analyses ended up having to get either sensitivity analyses or potentially have to run a trial all over. Could you speak to how the trial conduct look different in this study in the efficacy portion versus the way UZEDY Phase III was ran? Thank you very much.

Speaker Change: I noticed when you guys developed use Eddie which is the oral long I'm, sorry, which is a long acting risperidone.

Speaker Change: There were some trial conduct issues, which led to FDA issuing a <unk> because of some dosing errors and documentation issues et cetera volume of injection.

Speaker Change: And at the time, all the efficacy analyses ended up having to get either a sensitivity analyses or potentially have to run the trial over could you speak to how the trial conduct look different in this study in the efficacy portion versus the way. It uses Eddy phase III was Ryan. Thank you very much.

Ryan: Thanks, Thanks, Steve and thanks for your questions.

Speaker Change: Straight to Eric over to you, yes. So thanks for the question. So let me take the third one first.

Richard Francis: Thanks, Umer. Thanks for your questions. I'll hand that straight to Eric. Over to you.  So that was an issue around common problems you see in schizophrenia problems, studies where you sometimes get patients double counted. We learned a lot from that issue in that study. We corrected that, and we actually monitored that extremely closely in the ongoing study. I would say that our ability to conduct these studies is clearly one of the best in the industry. We brought this one up by nine months and accelerated it very, very well, and we reviewed all the data very carefully. So that should not be an issue going forward.

Richard Francis: Thanks, Umer. Thanks for your questions. I'll hand that straight to Eric. Over to you.

Eric Hughes: Yeah. So, Umer, thanks for the questions. Let me take the third one first, the CRL. So, that was an issue around common problems you see in schizophrenia problem studies where you sometimes get patients double counted. We learned a lot from that issue on that study. We corrected that and we actually monitor that extremely closely in the ongoing study. I would say that our ability to execute these studies is clearly one of the best in the industry. We brought this one up by nine months and accelerated it very, very well. And we've reviewed all the data very carefully. So, that should not be an issue going forward. Now, with regards to the deltas that we saw on our primary endpoint, that's the change in the PANSS score from baseline to week eight. So, to be very blunt, these were deltas that exactly where we expect them to be. We were very pleased to see that the placebo behaved the way it should, which is something that is challenging in these studies every year, but ours seem to be run very well with regards to the lack of response in placebo and the delta we saw on each of the three doses. So, you'll see that, that actually is very consistent with these exposures of OLANZAPINE across many different studies.

Eric: So that was the issue around.

Eric: Common problems you see in schizophrenia studies, where you sometimes get patients with double counted we learned a lot from that.

Eric: The issue on that study, we corrected that and we actually monitor that extremely closely and the ongoing site I would say that our ability to execute these studies clearly.

Eric: One of the best in the industry. We brought this went up by nine months and accelerated very very well and we are.

Eric: Reviewed all the data very carefully so that should not be an issue going forward now with regards to the delta that we saw on our primary endpoint. That's the change in the Pam score from baseline to week eight so to be very blunt. These were delta is exactly where we expect them to be but we're very pleased to see that the placebo behaved the way it should.

Eric Hughes: Now, with regard to the deltas that we saw on our primary endpoint, that is, the change in the PAM score from baseline to week eight. So to be very blunt, these were deltas exactly where we expected them to be. We were very pleased to see that the placebo behaved the way it should, which is something that is challenging in these studies every year, but ours seems to be running very well with regard to the lack of response in placebo and the delta we saw on each of the three doses. So you'll see that that actually is very clear with these exposures of olanzapine across many different studies.

Eric: Which is something that is a challenging in these studies every year, but ours are seem to be run very well with it with regards to the lack of response in placebo and the Delta that we saw on each of the three doses. So youll see that that actually is very consistent with these exposures of olanzapine across many different studies now.

Eric Hughes: So you'll see that that actually is very clear with these exposures of olanzapine across many different studies. Now, with regard to what healthcare professionals would look for, you know, these are clinically significant changes. These are the expected deltas that a patient or an investigator would want to see to be able to treat their patients. The real benefit here is, you know, we're getting the efficacy of olanzapine with just a single dose once a month in an easy subcutaneous injection. So that's the real benefit of the program, and we're excited to see the results today.

So you'll see that that actually is very clear with these exposures of olanzapine across many different studies.

Eric Hughes: Now, with regards to what the HCP would look for, these are clinically significant changes. These are the expected deltas that a patient and an investigator would want to see to be able to treat their patients. The real benefit here is we're getting the efficacy of OLANZAPINE with just a single dose once a month in an easy subcutaneous injection. So, that's the real benefit for the program and we're excited to see the results today.

Eric: With regards to with the HCP will work for these are clinical clinically significant changes. This is these are the expected delta is that a patient and investigator would want to see to be able to treat their patients. The real benefit here is we're getting the efficacy of olanzapine with just a single dose once a month and an easy.

Eric: Subcutaneous injection. So that's the real benefit for the program and we're excited to see the results today.

Umer Raffat: Super helpful. Thank you very much. Thanks, Umer.

Umer Raffat: Super helpful. Thank you very much.

Richard Francis: Thanks, Umer.

Speaker Change: Super helpful. Thank you very much.

Operator: Thank you. Our next question comes from David Amsellem from Piper Sandler. Your line is now open. Please go ahead.

Speaker Change: Thanks Sundar.

Speaker Change: Thank you.

Speaker Change: Next question comes from David <unk> from Piper Sandler.

David Amsellem: Hey, thanks. So, just a couple of questions on biosimilars. So, first, can you talk to - and I apologize if I missed this earlier, talk to the impact or how you're thinking about the impact of SIMLANDI as we move through the year with the Evernorth/Accredo contract? So, how should we think about that? And then secondly, I know, AbbVie had talked about trying to enter into multi-year contracts. I think their phrase was with teeth. How are you thinking about how aggressive they're going to be over the long term in defending the brand? And what you think that means for adoption of HUMIRA biosimilars? So, that's the second question.

David: Your line is now open. Please go ahead.

David: Hey, Thanks, So just a couple of questions on.

David: Biosimilars.

David: First can you talk to and I apologize if I missed this earlier.

David: Yeah.

David: <unk>.

David: Or how are you thinking about the impact.

David: <unk>.

David: <unk> as we move through the year with the with the ever North.

David: Accredo.

David: Contract. So how should we think about that and then secondly.

David: I know you talked about.

David: Trying to.

David: Into multi year contracts I think their trades was with teeth. How are you thinking about how aggressive they are going to be over the long term and defending libre.

David: The brand and what you think that means for <unk>.

Richard Francis: How do you think they're going to be over the long term in defending the brand and what you think that means for the adoption of Humira biosimilars? So that's the second question. And then lastly, on the Solara biosim, can you talk to, and I know it's early, and this is sort of a next year question, but talk to how you're thinking about how that market is going to behave in terms of how aggressive the innovator is going to be with contracting and how you're thinking about adoption next year, particularly given that you're going to be launching very early on in biosimilar market formation. Thank you

How do you think they're going to be over the long term in defending the brand and what you think that means for the adoption of Humira biosimilars? So that's the second question.

David: Adoption of Humira Biosimilars. So that's the second question and then lastly on the solar of I assume.

David Amsellem: And then lastly on the STELARA biosim, can you talk to - and I know it's early and this is sort of a next year question, but talk to how you're thinking about how that market is going to behave in terms of how aggressive the innovator is going to be with contracting and how you're thinking about adoption next year, particularly given that you're going to be launching very early on in biosimilar market formation? Thank you.

David: Can you talk to and I know, it's early and this is sort of a next to your question, but talk to how you're thinking about how that market's going to behave.

David: In terms of.

David: How aggressive the innovator is gonna be with contracting and how you're thinking about adoption next year.

David: Particularly given that youre going to be launching very early on and Biosimilar market formation. Thank you.

Richard Francis: Thank you, David. Thanks for the question. So, I'll take those. So, how do we think about SIMLANDI this year? I think, firstly, we're excited to bring this to the market in Q2. What I would say and it sort of builds a bit into your second question, the interest we're getting from payers and PBMs is very high. And I think there's been a change in the market versus last year where there's an appetite to really utilize the benefit that biosimilars bring to the market with containing healthcare costs long term. So, I think that dynamic is playing out. We, obviously, built a certain amount of SIMLANDI into our forecast for the year. It was risk-adjusted, because there's many uncertainties, and obviously, we are launching this at this moment not at the start of the year. So, from a contracting point of view that is something to take into account. But I would say we remain optimistic about it. Let's see how it plays out.

Speaker Change: Thank you David Thanks for the thanks for the question. So I'll take those so how do we think about <unk>. This year I think firstly.

Richard Francis: So how do we think about Simlandi this year? First of all, we're excited to bring it to the market in Q2. What I would say, and this sort of builds a bit into your second question, the interest we're getting for pairs and PBMs is very high. And I think there's been a change in the market versus last year, where there's an appetite to really utilize the benefit that biosimilars bring to the market in terms of containing healthcare costs long term. So I think that dynamic is playing out. We obviously built a certain amount of Simlandi into our forecast for the year; it was risk adjusted because there are many uncertainties. And obviously, we are launching this at this moment, not at the start of the year. So from a contracting point of view, that is something to take into account. But I would say we remain optimistic about it. Let's see how it plays out.

Speaker Change: We're excited to bring this to the market in Q2, what I would say and it sort of builds a bit into your second question. The interest we're getting from payers and Pbms is is very high and I think there's been a change in the market versus last year, but theres, an appetite to really utilize the benefits of biosimilars bring to the market with kantar.

Richard Francis: So I think that dynamic is playing out. We obviously built a certain amount of Simlandi into our forecast for the year; it was risk adjusted because there are many uncertainties. And obviously, we are launching this at this moment, not at the start of the year. So from a contracting point of view, that is something to take into account. But I would say we remain optimistic about it. Let's see how it plays out.

Speaker Change: <unk> healthcare costs long term, so I think that dynamic is playing out.

Speaker Change: We obviously built.

Speaker Change: A certain amount of sort of some land into our forecast for the year. It was risk adjusted piece, there's many uncertainties and obviously we are launching this.

Richard Francis: So from a contracting point of view, that is something to take into account. But I would say we remain optimistic about it. Let's see how it plays out. And as for your last question, how do we think about Stelara? Well, that's, you know, interesting on two levels. One is internal.

So from a contracting point of view, that is something to take into account. But I would say we remain optimistic about it. Let's see how it plays out.

Speaker Change: At this moment not at the start of the year. So from a contracting point of view that as something to take into account.

Richard Francis: And I think to your last question, how do we think about STELARA? Well, that's interesting from two factors. One is internal. So, we have got the approval. So, we're not going to be in the position where we are with biosimilar HUMIRA coming to the market later. We'll be coming to the market at the start, as you pointed out. That means we can have discussions with the payers, the PBMs six months ahead of coming to the market, which is obviously beneficial. The other factor is, and I think this just shows the dynamic nature of the market, we talked about no penetration to the market last year with biosimilar HUMIRA, in general. And now, we're starting to see what I think is a more dynamic situation where things are changing and we're definitely hearing that from the payers and the PBM. So, I believe there's a change in appetite and there's a change in strategic thinking. But we'll have to see how that plays out. I think I've been consistent in saying I don't have a crystal ball on that - on this. And that's why I think having a broad portfolio that you bring to the market is a sensible approach. But I would say optimistic both for this year and optimistic for next year. Thanks for your question. Thank you.

Richard Francis: And I think to your last question, how do we think about STELARA? Well, that's interesting from two factors. One is internal. So, we have got the approval. So, we're not going to be in the position where we are with biosimilar HUMIRA coming to the market later. We'll be coming to the market at the start, as you pointed out. That means we can have discussions with the payers, the PBMs six months ahead of coming to the market, which is obviously beneficial. The other factor is, and I think this just shows the dynamic nature of the market, we talked about no penetration to the market last year with biosimilar HUMIRA, in general. And now, we're starting to see what I think is a more dynamic situation where things are changing and we're definitely hearing that from the payers and the PBM. So, I believe there's a change in appetite and there's a change in strategic thinking. But we'll have to see how that plays out. I think I've been consistent in saying I don't have a crystal ball on that - on this. And that's why I think having a broad portfolio that you bring to the market is a sensible approach. But I would say optimistic both for this year and optimistic for next year. Thanks for your question.

Speaker Change: But I would say we remain optimistic about it and let's see how it plays out.

Speaker Change: And I think to your second your last question, how do we think about the law as well.

Richard Francis: So we have got the approval, so we're not going to be in the position where we are with Biosimu-Humira coming to the market later. We'll be coming to the market at the start, as you pointed out. That means we can have discussions with the payers, the PBMs, six months ahead of coming to the market, which is obviously beneficial. The other factor is, and I think this just shows the dynamic nature of the market. We talked about no penetration into the market last year with Biosimu-Humira in general. And now we're starting to see what I think is a more dynamic situation, where things are changing. And we're definitely hearing that from the payers and the PPM. So I believe there's a change in appetite, and there's this change in strategic thinking. But we'll have to see how that plays out. I think I've been consistent in saying I don't have a crystal ball on that or this. And that's why I think having a broad portfolio that you bring to the market is a sensible approach. But I would say optimistic, both for this year and for next year. Thanks for your question.

Speaker Change: Interesting from two factors one is internal so we have got the approval. So we're not going to be in the position, where we are with Biosimilar humira coming to the market later, we'll be coming to the market and start as you pointed out that means we can have discussions.

Speaker Change: With the.

Speaker Change: Pay as the Pbms six months ahead of coming to the market, which is obviously beneficial.

Speaker Change: The other factor is and I think this just shows the dynamic nature of the market, we talked about no penetration into the market last year with Biosimilar Humira as a general.

Richard Francis: And now we're starting to see what I think is a more dynamic situation, where things are changing. And we're definitely hearing that from the payers and the PPM. So I believe there's a change in appetite, and there's this change in strategic thinking. But we'll have to see how that plays out. I think I've been consistent in saying I don't have a crystal ball on that or this. And that's why I think having a broad portfolio that you bring to the market is a sensible approach. But I would say optimistic, both for this year and for next year. Thanks for your question.

Speaker Change: And now we're starting to see what I think is a more dynamic situation, but things are changing and we're definitely hearing that from the payers and the pbms. So I believe there's a change in appetite and is this change in strategic thinking, but we'll have to see how that plays out I think I've been consistent in saying I don't have a crystal ball on that.

Speaker Change: On this and that's why I think having a broad portfolio that you bring to the market as a sensible approach, but I would say optimistic both for this year and optimistic for next year. Thanks for your question.

David Amsellem: Thank you.

Operator: Our next question comes from Ash Verma of UBS. Your line is now open. Please go ahead.

Speaker Change: Thank you.

Ashwani Verma: Our next question comes from Ash lymphoma of UBS. Your line is now open. Please go ahead.

Ash Verma: Hi, thanks for taking our questions. Congrats on all the progress. So, I have two. Just a quick follow-up on biosimilar HUMIRA. Do you think the Sandoz biosimilar HUMIRA infection is primarily because of CVS using an exclusionary contracting against the branded drug? And do you believe you can drive similar level of uptake just based off Cigna offering a $0 co-pay for biosimilars and not necessarily getting into exclusionary contracting? And then, on TAPI, I see on your website, you do provide like the API for semaglutide and tirzepatide injectables. Like, what is your level of scale here? And is that something that could be off interests to the GLP-1 players that are looking for significant supply expansion? Thanks.

Ashwani Verma: Hi, Thanks, Thanks for taking my question and congrats on all the progress. So I have two just a quick follow up on Biosimilar Humira do you think the Sandoz Biosimilar Humira inflection is primarily because of Cvs using an exclusionary contracting against the branded drug and you believe you can drive similar level of ups.

Ashwani Verma: Take just piece of Sigma offering.

Ashwani Verma: Zero dollar co pay for Biosimilars and not necessarily getting into exclusionary contracting and then unhappy I see on your website you do provide like the API person with new diet in precipitate Injectables and what is your level of scale here.

Speaker Change: Is that something that could be of interest to the GNP. One players that are looking for significant expansion.

Richard Francis: It was good to talk. So, with regard to contracting, and this sort of goes back to my comment earlier about it being just very dynamic. It's really changed, I think, versus last year. So there are many different opportunities that are emerging, both in the normal channel and in this private label, and that's evolving almost weekly. So I think for us, that's encouraging. I don't want to try to predict how that's going to play out, whether people are going to mirror other people, because I think it's quite individual. I think the bigger picture, which I am encouraged by, is this appetite for biosimilars as a whole. And I think, you know, that plays out well for, obviously, us. It plays out well, I think, for patients and society in reducing costs in the long term. And I think everybody was waiting to see if something like this could happen. I don't think one swallow makes a summer, but I do think this is really interesting and good progress. So that's how I would probably phase that.

Richard Francis: Thanks, Ash. Thanks for your call. It was good to talk. So, with regard to the contracting and it sort of goes back to my comment earlier about, it's just very dynamic. It's really changed I think versus last year. So, there are many different opportunities that are emerging, both in the normal channel and in this private label, and that's evolving almost weekly. So, I think for us that's encouraging. I don't want to try and predict how that's going to play out, whether people are going to mirror other people, because I think it's quite individual. I think the bigger picture, which I am encouraged by, is this appetite for biosimilars as a whole. And I think that plays out well for obviously us, it plays out well, I think, for patients and society in reducing costs long term. And I think everybody was waiting to see if something like this could happen. I don't think one swallow makes a summer, but I do think this is really interesting and good progress. So, that's how I would probably phase that. But obviously, when we speak in the next quarter earnings, I think we'll have more data and we'll continuously update you.

Speaker Change: <unk>.

Speaker Change: Thanks, guys. Thanks, Thanks for your call. It was good to talk.

Speaker Change: So with regard to the contracting and so it goes back to my comment earlier about it's just very dynamic, it's really changed I think versus last year. So.

Richard Francis: So there are many different opportunities that are emerging, both in the normal channel and in this private label, and that's evolving almost weekly. So I think for us, that's encouraging. I don't want to try to predict how that's going to play out, whether people are going to mirror other people, because I think it's quite individual. I think the bigger picture, which I am encouraged by, is this appetite for biosimilars as a whole. And I think, you know, that plays out well for, obviously, us. It plays out well, I think, for patients and society in reducing costs in the long term. And I think everybody was waiting to see if something like this could happen. I don't think one swallow makes a summer, but I do think this is really interesting and good progress. So that's how I would probably phase that.

Speaker Change: There are many.

Speaker Change: Different opportunities that are emerging.

Speaker Change: Both in the normal channel and then this private labels a civil being almost weekly so I think for US that's encouraging I don't want to try to predict how that's going to play out whether people are going to mirror other people.

Richard Francis: I think the bigger picture, which I am encouraged by, is this appetite for biosimilars as a whole. And I think, you know, that plays out well for, obviously, us. It plays out well, I think, for patients and society in reducing costs in the long term. And I think everybody was waiting to see if something like this could happen. I don't think one swallow makes a summer, but I do think this is really interesting and good progress. So that's how I would probably phase that.

Speaker Change: Because I think it's quite individual.

Speaker Change: I think the bigger picture, which I am encouraged by is this appetite for biosimilars as a whole and I think that plays out well for obviously us it plays out well I think the patients and society, reducing costs long term I think everybody was waiting to see if something like this could happen.

Speaker Change: I don't think one swallow it makes the summer, but I do think this is really interesting and good progress.

Richard Francis: So that's how I would probably phase that. With regard to the API and what you just raised there, I think that we don't go into specifics of each individual API and the potential for us to supply those and capacity. We obviously have hundreds of APIs that we manufacture and develop. So it's more complex than that. So that's probably the best way I can answer that question. But thanks for the questions, Ash.

So that's how I would probably phase that.

Richard Francis: With regard to the API and what you just raised there, I think that we don't go into specifics of each individual API and the potential for us to supply those and capacity. We obviously have hundreds of API that we manufacture and develop. So, it's more complex than that. So, that's probably the best way I can answer that question. But thanks for the questions, Ash. Thanks.

Richard Francis: With regard to the API and what you just raised there, I think that we don't go into specifics of each individual API and the potential for us to supply those and capacity. We obviously have hundreds of API that we manufacture and develop. So, it's more complex than that. So, that's probably the best way I can answer that question. But thanks for the questions, Ash.

Speaker Change: So that's how I would probably face that but obviously when we speak next quarter and he is I think we'll have more data and we will continuously update you with regard to the API and what have you just raised that I think that we don't go into specifics of each individual API and the potential for us to supply those in <unk>.

Speaker Change: <unk>.

Speaker Change: We obviously have hundreds of API that we manufacture and develop.

Speaker Change: So it's it's more complex than that so that's probably the best way I could answer that question.

Speaker Change: Thanks for the questions.

Ash Verma: Thanks.

Operator: Our next question comes from Balaji Prasad of Barclays. Your line is now open. Please go ahead.

Speaker Change: Thanks.

Speaker Change: Yeah.

Speaker Change: Our next question comes from <unk> Prasad of Barclays. Your line is now open. Please go ahead.

Balaji V. Prasad: Hi, good morning, and thanks for the questions. So, a couple from me and apologies if some of these have been asked before. Richard, I had the opportunity to speak to half a dozen neurologists recently. The general feedback I got was that docs allowed to use AUSTEDO, and they do want to use it for some other indications, too. Generally, I think the feedback is that the insurance has been a challenge. And so, I want to get your experiences with payers and if there is scope for the commercial team to do better, one. And two, can you also speak about the areas where you see off-label use or off-label potential for AUSTEDO and any plans around it? That's one. Two, on the biosimilar side, I couldn't but have noticed that management commentary on biosimilars had softened in the last couple of months. Now that you are - the approvals of SIMLANDI and SELARSDI are behind you, would you want to revisit your expectations around biosimilars? And how would SIMLANDI play through into your '24 guidance, seeing that it's been reaffirmed even after the approval? Thank you.

Balaji V. Prasad: Hi, good morning, and thanks for the questions. So a couple from me and apologies. If these have been asked before.

Richard Francis: Richard, I had the opportunity to speak to half a dozen neurologists recently. The general feedback I got was that doctors love to use Osteo, and they do want to use it for some other indications, too. Generally, they think the feedback is that the insurance has been a challenge, and so I want to hear your experiences with payers and if there is scope for the commercial team. And two, can you also speak about the areas where you see off-label use or off-label potential for a studio and any plans around that? That's one. Two, on the biosimilar side, I couldn't but have noticed that management commentary on biosimilars had softened in the last couple of months. Now that the approvals of Simlandi and Celarsity are behind you, would you want to revisit your expectations around biosimilars, and how would Simlandi play through into your 24 guidance, seeing that it's been reaffirmed even after the approval? Thank you.

Balaji V. Prasad: Richard I had the opportunity to speak to offer doesn't neurologist recently, the general feedback I got was that golf loud to use of <unk> and <unk>.

Balaji V. Prasad: I do want to use it for some other indications to generally think the feedback inside the insurance has been a challenge and so I want to get to your experience with payers and Dennis called for the commercial team to bring them on.

Speaker Change: And two can you also speak loud the areas, where you'll see off label use are off label potential from a studio and any plans around it.

Richard Francis: That's one. Two, on the biosimilar side, I couldn't but have noticed that management commentary on biosimilars had softened in the last couple of months. Now that the approvals of Simlandi and Celarsity are behind you, would you want to revisit your expectations around biosimilars, and how would Simlandi play through into your 24 guidance, seeing that it's been reaffirmed even after the approval? Thank you.

Balaji V. Prasad: One.

Balaji V. Prasad: Two on the Biopharma side, I can but I noticed that management commentary on Biosimilar that self fund in the last couple of months now that you are the approvals from London to largely behind you would you want to revisit your expectations around Biosimilars and how it would seem landing played through into 'twenty four guidance, saying that theres been reaffirmed even after that.

Richard Francis: Thanks, Balaji. Thanks for the questions and the interest. So, on the first question, the insurance challenge, actually we're in a very good place with AUSTEDO and we're actually in a very good place with XR. So, I don't think insurance is an issue and access is an issue. Now there's obviously pockets of that that can be different. So, depending on who you speak to, there can be. And I think XR is still lagging a bit behind our BID, but it's closing fast. But I think that's not something that I discuss regularly with the team, and by the way, it's not something I give them to make an excuse on when it comes to driving this business forward. So, hopefully that answers that question. With regards to off-label, obviously, I don't want to get into any discussions on that. I think we always want to make sure that our product is used within its label. So, probably that's as much as I'll say.

Speaker Change: Thank you.

Speaker Change: Thanks, <unk>, thanks for the questions and interest.

Speaker Change: So on the first question.

Speaker Change: We enjoyed challenge actually we're in a very good place with instead of.

Speaker Change: And we're actually in a device a place with Exxon.

Speaker Change: So I don't think insurance is an issue and access is an issue that theres, obviously pockets of that that can be different. So it depends on who you speak to that can be and I think exxon is still lagging a bit behind.

Richard Francis: But I think that's not something that I discuss regularly with the team. And, by the way, it's not something I give them an excuse for when it comes to driving this business forward. So I hope that answers that question. With regard to off-label, obviously, I don't want to get into any discussions about that. I think we always want to make sure that a product is used within its label. So probably that's as much as I'll say.

Speaker Change: But it's but it's closing fast, but I think that's not something that I discuss directly with the team and by the way, it's not something I'd give them an excuse on when it comes to driving this business forward. So hopefully that answers that question with regards to off label. Obviously, you know I don't want to get into any discussions on that I think we always wanted to make sure their products used with.

Richard Francis: So probably that's as much as I'll say. With regard to biosimilars, I'm smiling here because I don't think my language is interpreted as softening from the past; it's more about I think I consistently said, this is an emerging market, this is dynamic, how this is going to play out, I don't want to try and predict, because it can change all the time. It rarely happens, but maybe I was right on that one because it changed very quickly, quite recently.

So probably that's as much as I'll say.

Richard Francis: With regard to biosimilars, I'm smiling here because I don't think my language is interpreted as softening in the past. It's more about - I think I consistently said this is an emerging market. This is dynamic. How this is going to play out? I don't want to try and predict, because it can change all the time. It rarely happens but maybe I was right on that one because it changed very quickly, quite recently. So, I think maybe I was more - my language was more around how this market will evolve. And as I said, I don't have a crystal ball. That is becoming clearer now and that's probably why you're here. One, we have an approval of two of our biosimilars. So, that's certainty, which I may not have had when we last spoke. The second thing is I do believe there's a change in the market. Now, we'll see how that plays out across the whole market, but it does seem to be people are making interesting moves and the conversations we're having seem to have more purpose and energy than they've ever had. But we'll have to see how that plays out. It's interesting, but for us, it's about, once we start to get contracts, once we start to shift volume and once we start to get revenue that's meaningful then we know there's been a significant change. And I think we'll see how that evolves as we go through the quarters of this year. But Balaji, thanks for your questions. Thank you.

Richard Francis: With regard to biosimilars, I'm smiling here because I don't think my language is interpreted as softening in the past. It's more about - I think I consistently said this is an emerging market. This is dynamic. How this is going to play out? I don't want to try and predict, because it can change all the time. It rarely happens but maybe I was right on that one because it changed very quickly, quite recently. So, I think maybe I was more - my language was more around how this market will evolve. And as I said, I don't have a crystal ball. That is becoming clearer now and that's probably why you're here. One, we have an approval of two of our biosimilars. So, that's certainty, which I may not have had when we last spoke. The second thing is I do believe there's a change in the market. Now, we'll see how that plays out across the whole market, but it does seem to be people are making interesting moves and the conversations we're having seem to have more purpose and energy than they've ever had. But we'll have to see how that plays out. It's interesting, but for us, it's about, once we start to get contracts, once we start to shift volume and once we start to get revenue that's meaningful then we know there's been a significant change. And I think we'll see how that evolves as we go through the quarters of this year. But Balaji, thanks for your questions.

Speaker Change: This label, so I'm, probably not as much as I'll say with regard to Biosimilars.

Speaker Change:

Speaker Change: I am smiling here, because I don't think my.

Speaker Change: By languages interpreted a softening in the past it's more about I think I've consistently said this is an emerging market. This is dynamic how this is going to play out I don't want to try and predict because they can change all the time.

Speaker Change: It really happens, but maybe I was wrong on that one because it changed very quickly quite recently.

Richard Francis: So I think maybe I was more, my language was more around how this market will evolve. And as I said, I don't have a crystal ball that is becoming clearer now. And that's probably why you hear one; we have approval for two of our biosimilars, so that's certainty, which I may not have had when we last spoke. The second thing is, I do believe there is a change in the market. Now we'll see how that plays out across the whole market. But it does seem that people are making interesting moves, and the conversations we're having seem to have more purpose and energy than they've ever had. But we'll have to see how that plays out. You know, it's interesting. But for us, it's about once we start to get contracts, once we start to shift volume, and once we start to get revenue that's meaningful, then we know there's been a significant change. And I think we'll see how that evolves as we go through the quarters of this year. But, Balaji, thanks for your question.

Speaker Change: So I think maybe I was more my language is more around how this market will evolve and as I said I don't have a crystal ball that is becoming clearer now and that's probably why you here. One we have an approval of two of our bus and most of that certainty, which I may not have had when we last spoke the second thing is.

Richard Francis: The second thing is, I do believe there is a change in the market. Now we'll see how that plays out across the whole market. But it does seem that people are making interesting moves, and the conversations we're having seem to have more purpose and energy than they've ever had. But we'll have to see how that plays out. You know, it's interesting. But for us, it's about once we start to get contracts, once we start to shift volume, and once we start to get revenue that's meaningful, then we know there's been a significant change. And I think we'll see how that evolves as we go through the quarters of this year. But, Balaji, thanks for your question.

Speaker Change: I do believe there is a change in the market that we'll see how that plays out across the whole market, but it does seem to be people, who make an interesting moves in the conversations we're having seem to have more purpose and energy than they've ever had but we'll have to see how that plays out.

Speaker Change: It's interesting but for us it's about once we start to get contracts. Once we start to ship volume of one we start to get revenue less meaningful than we know there's been a significant change and I think we will see how that evolves.

Richard Francis: But, Balaji, thanks for your question.

Speaker Change: So as we go through the quarters of this year.

Speaker Change: But blotchy thanks for your questions.

Balaji V. Prasad: Thank you.

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

Speaker Change: Thank you.

Speaker Change: Our next question comes from Jason <unk> of Bank of America.

Jason Gerberry: Hey, guys. Thanks for taking my questions. First one for me is just on your 2024 guide. And I'm wondering really sort of what are the key variables to getting to the high end or even blowing through your guidance. It seems like with HUMIRA, there's some upside optionality, but you guys are taking a conservative stance just on how that will get adopted. And I guess you have some exclusive generics that either haven't launched yet or haven't gotten market share on, like, SANDOSTATIN LAR and KORLYM. So, that's maybe an upside lever. So, just wondering if you can comment on those dynamics if you'd agree with that characterization. And then, secondly, just on the OLANZAPINE LAI program, you have 20% of injections left. I'm just curious, the agreement with the FDA, was there any margin for error if you had a single PDSS event? I think the background rate was like 0.1%. So, just kind of curious, like, if you got unlucky and there was like a single case, can you still avoid having the black box warning? Thanks.

Speaker Change: <unk> is now open. Please go ahead.

Jason: Hey, guys.

Jason: For taking my questions.

Jason: First one for me is just on your 2024 guide and I'm wondering really.

Jason: What are the key variables to getting to the high end or even blowing through.

Jason: Your guidance it seems like with Humira Theres, some upside optionality, but you guys are taking a conservative stance just on how that all get adopted and I guess you have some exclusive generic that either haven't launched yet or haven't gotten market share like sand is that now they are in korlym. So that's maybe.

Jason Gerberry: And then secondly, just on the Olanzapine LAI program, you have 20% of injections left. I'm just curious, the agreement with the FDA, was there any margin for error if you had a single PDSS event? I think the background rate was like 0.1%. So just kind of curious, like, if you got unlucky, and there was like a single case, could you still avoid having the black box warning?

Jason: And upside lever. So just wondering if you can comment on those dynamics, if you'd agree with that characterization and then secondly, just on the Olanzapine Lai I program, you have 20% of injections left I'm just curious the agreement with the FDA was there any margin for error. If you had a single PDF. That's event I think the background rate with like <unk>.

Jason: So 0.1% so it just kind of curious like if you got unlucky and there was like a single case can you still avoid having the black box warning.

Richard Francis: Thanks, thanks, Jason. I'll take a stab at the first one. And maybe Eli can join in, and then I'll hand over to Eric.

Thanks,

Richard Francis: Thanks, Jason. I'll take a stab at the first one and maybe Eli can join, and then I'll hand over to Eric. So, look, I think you sort of actually framed it really well. We have a bit of a range because we need to see how the biosimilars plays out. We have some product launches coming up as you've highlighted in the U.S. Timing [inaudible] those, we have to see how those play out. And then, we have to see how the momentum of our business plays out. So I think, all of those - some of those things we're waiting to happen, and as they start to happen, we'll get more clarity and I think that gives us more opportunity to narrow the range if that is what was required. But we think about in a similar way to risk-adjusted biosimilars. We risk-adjusted some of our new product launches because they are brd on timing and various other factors. And because of that we think that's the prudent thing to do. As that changes and we get more certainty, we will come back very quickly and help you understand what that means and whether that means that the range narrows. Maybe, Eli, would you like to add anything more?

Jason: Yes.

Speaker Change: Thanks, Thanks, Jason.

Speaker Change: I'll take a stab at the first one.

Speaker Change: And maybe how they can join in and then I'll I'll hand over to Eric. So look I think you you sort of ask you framed it really well.

Speaker Change: We have a bit of a range because we need to see how.

Eric: The Biosimilars plays out we have some product launches coming up as you've highlighted in the in the U S.

Eric: Timing and uphold those we have to see how those play out and then we have to see how the momentum of our business plays out. So I think all of those some of those things we're waiting to happen and as they start to happen will get more clarity and I think that gives us more opportunity to narrow the range. It if that is.

Eli Kalif: So look, I think you sort of framed it really well. We have a bit of a range because we need to see how. But we think about it in a similar way to you. We've risk-adjusted, Biosymbolists, some of our new product launches because they're based on timing and various other factors. And because of that, we think that's the prudent thing to do. As that changes and we get more certainty, we will come back very quickly and help you understand what that means and whether that means that the range narrows. Maybe, Eliyahu, would you like to add anything more?

Speaker Change: Wyatt.

Speaker Change: But we think about it in a similar way to you we've risk adjusted.

Eliyahu: So as we've risk adjusted some of our new product launches because they are based on timing and various other factors because we think that's the prudent thing to do as that changes and we get more certainty. We will come back very quickly to help you understand what that means and whether that means that that was the range narrows. Maybe early would you like to add anything more.

Eli Kalif: No, I don't have anything to add. Thanks.

Richard Francis: I did a good job then. I'll hand that one to Eric down on the second one.

Speaker Change: No I don't have anything to add.

Eric Hughes: Yes. And there was a question about the PDSS and what our discussions with the FDA. So, the discussions we had were around 3,600 injection. That would be the point at which FDA was open to the discussion around not having this as a black box warning. We monitor this very closely and I think it's important to start by saying what's the scientific support and rationale and then what's the clinical data. Scientifically, it's very important to note that this is a completely different formulation. It's a subcutaneous formulation, not an intramuscular injection, which will might hit deep vessels. But on top of that, our formulation rapidly aggregates and keeps the API contained almost immediately after injection, then it has a slow release. So, that supports the notion that we should not see PDSS. We have not seen it. Now, as you mentioned, we're up to about - let's see, we're up to about 2,700 injections now. So, we're over the 80% mark. We haven't seen it. If we see one, there would be a negotiation with FDA. The important thing is that we have an adjudication committee. So, we should not see accidental PDSS at this point. And I think the science supports no PDSS. Great, thanks.

Eric Hughes: Yes. And there was a question about the PDSS and what our discussions with the FDA. So, the discussions we had were around 3,600 injection. That would be the point at which FDA was open to the discussion around not having this as a black box warning. We monitor this very closely and I think it's important to start by saying what's the scientific support and rationale and then what's the clinical data. Scientifically, it's very important to note that this is a completely different formulation. It's a subcutaneous formulation, not an intramuscular injection, which will might hit deep vessels. But on top of that, our formulation rapidly aggregates and keeps the API contained almost immediately after injection, then it has a slow release. So, that supports the notion that we should not see PDSS. We have not seen it. Now, as you mentioned, we're up to about - let's see, we're up to about 2,700 injections now. So, we're over the 80% mark. We haven't seen it. If we see one, there would be a negotiation with FDA. The important thing is that we have an adjudication committee. So, we should not see accidental PDSS at this point. And I think the science supports no PDSS.

Speaker Change: Uh huh.

Speaker Change: I'll hand that one to Eric down on the second one yes. There was a question about <unk> and what our discussions with the FDA. So the discussions we had were around 3600 injection that would be the point at which <unk> was open to the discussion around not having that sort of a black box warning.

Eric Hughes: We monitor this very closely and I think it's important to start by saying whats the scientific support and rationale and then what's the clinical data scientifically. It is very important to note that this is a completely different formulation. Its a subcutaneous formulation is not an intramuscular injection, which will might hit deep vessels, but on top of that are.

Eric Hughes: Scientifically, it's very important to note that this is a completely different formulation. It's a subcutaneous formulation, not an intramuscular injection, which might hit deep vessels. But on top of that, our formulation rapidly aggregates the API contained almost immediately after injection, then it has a slow release. So that supports the notion that we should not see PDFs. But we have not seen it. Now, as you mentioned, we're up to about 2,700 injections now. So we're over the 80% mark. We haven't seen it yet. If we see one, that would be a negotiation with the FDA. The important thing is that we have an adjudication committee. So, you know, we should not see accidental PDFs at this point, and I think the science does not support PDFs.

Eric Hughes: Formulation rapidly aggregate and keeps the API.

Eric Hughes: Contained almost immediately after injection and then it has a slow release so that supports the notion that we should not see PFS, we have not seen it now as you mentioned, we're up to that trial.

Eric Hughes: So that supports the notion that we should not see PDFs. But we have not seen it. Now, as you mentioned, we're up to about 2,700 injections now. So we're over the 80% mark. We haven't seen it yet. If we see one, that would be a negotiation with the FDA. The important thing is that we have an adjudication committee. So, you know, we should not see accidental PDFs at this point, and I think the science does not support PDFs.

Eric Hughes: They were up to about 2700 injections is now so we're over the 80% Mark we havent seen it if we see one that have been negotiated with FDA. The important thing is that we are in adjudication committee. So.

Eric Hughes: We should not see accidental tds's at this point and I think the science supports no pds.

Jason Gerberry: Great, thanks.

Operator: Our next question comes from Yifeng Liu of HSBC. The line is now open. Please go ahead. Good morning.

Operator: Our next question comes from Yifeng Liu of HSBC. Your line is now open. Please go ahead.

Speaker Change: Great. Thanks.

Yifeng Liu: Our next question comes from <unk> Lee of <unk>.

Yifeng Liu: Good morning. Thanks for taking my questions. I've got three questions. The first one is on OLANZAPINE LAI. Could you just give us an update on the regulatory timelines and whether you have interest in filing outside the U.S.? Second one is on TL1A. Just could you talk about your kind of thinking about leveraging diagnostic tools and specifically companion diagnosis upon your product launch or as it goes later in the pipeline? And the third one is on biosimilar. Biden administration recently has some news about substitution without interchangeability. I just wonder upon your next probably six or more biosimilar launch, how that will play a role in your plan? And whether that's going to change anything in the studies you run? Any color on that would be great. Thank you.

Yifeng Liu: Thanks for taking my questions. I've got three questions. The first one is on all-lens PLAI. Could you just give us an update on the regulatory timelines and whether you have interest in filing outside the U.S.? The second one is on Tier 1A; you talk about you're kind of thinking about leveraging diagnostic tools and specifically companion diagnosis upon your product launch or as it goes later in the pipeline. And the third one is on biosimilars. The Biden administration recently had some news about substitution without interchangeability. I just wonder, upon your next six or more biosimilar launches, how that will play a role in your plan and whether that can change anything and the studies you run. Any comment on that would be great. Thank you.

Yifeng Liu: <unk> the line.

Speaker Change: It's now open. Please go ahead.

Speaker Change: Good morning, and thanks for taking my questions.

Yifeng Liu: Three questions.

Yifeng Liu: The first one is on Olanzapine NII could you just.

Yifeng Liu: Give us an update on our regulatory timelines and whether you have interest in filing outside the U S.

Yifeng Liu: The second one is on Taylor Taylor I I'm just.

Yifeng Liu: Could you talk about your kind of thinking about leveraging diagnostic tools, specifically a companion diagnosis.

Yifeng Liu: Upon your product launch one or as it goes later in the in the pipeline.

Yifeng Liu: The Biden administration recently had some news about substitution without interchangeability. I just wonder, upon your next six or more biosimilar launches, how that will play a role in your plan and whether that can change anything and the studies you run. Any comment on that would be great. Thank you.

Yifeng Liu: First one is on Biosimilar.

Yifeng Liu: By then and administration recently has some news about substitution without interchange ability I just wonder upon your next.

Yifeng Liu: The six that were more biosimilar launch how that would play a role in your plan and whether that kind of change anything in the studies you run on any color on that would be great. Thank you.

Richard Francis: Okay. Yifeng, thank you for the questions. I'll hand the first two to Eric and then I'll take the third one.

Yifeng Liu: Okay.

Yifeng Liu: Thank you for the questions I'll hand, it first to Eric and then I'll take the third one sure. Thank you for the question so with regards to Olanzapine.

Eric Hughes: Sure. Thank you for the question. So, with regards to the OLANZAPINE LAI program, plans in the future, we're still running the long-term follow-up. We'll hopefully be presenting that data at the Congress in the second half of this year. Other thing is to drive submissions. We're planning to do the submission early in 2025 with our stability data and our product preparedness. So, that's the general timelines for OLANZAPINE program. With regard to TL1A and diagnostic tools, so we'll need to see the data. We're going to have our interim analysis the second half of this year. We are including all different biomarkers that we could interrogate with regards to serum biomarkers, biopsy biomarkers, proteomics and genomics on predicting response at brline or on treatment, and we also have the free TL1A. So, we have lots of data that we'll need to look at. If we find a diagnostic or a predictive value that could really help the program, we'll certainly use that. But our goal is to treat all comers at this point because these patients need all the options they can get in both ulcerative colitis and Crohn's disease. And the last question, I think you're going to handle with regards to the changes in the biosimilars plans by the FDA.

Eric Hughes: Program plans in the future, we're still running the long term follow up will hopefully be presenting that data at a congress in the second half of this year other things drive submissions were planning to do the submission early in 2025 with our stability data on our product.

Eric Hughes: Preparedness, so that's the general timelines for our launch.

Eric Hughes: Program.

Eric Hughes: With regards to <unk> and diagnostic tools, so we'll need to see the data we're going to have our interim analysis.

Eric Hughes: Half of this year, we are including all different biomarkers that we could.

Eric Hughes: Interrogate regardless of serum biomarkers biopsy, Biomarkers proteomics and genomics on predicting response at baseline or on treatment and we also have the free tier when I. So we have lots of data that will need to look at if we find a diagnostic or predictive value that could really help the program will certainly.

Eric Hughes: If we find a diagnostic or a predictive value that could really help the program, we'll certainly use that. But our goal is to treat all comers at this point because these patients need all the options they can get in both ulcerative colitis and Crohn's disease. And the last question, I think you're going to address with regard to the changes in the biosimilars plans by the FDA. Yeah, no, so around interchangeability.

If we find a diagnostic or a predictive value that could really help the program, we'll certainly use that. But our goal is to treat all comers at this point because these patients need all the options they can get in both ulcerative colitis and Crohn's disease. And the last question, I think you're going to address with regard to the changes in the biosimilars plans by the FDA.

Eric Hughes: <unk> use that but our goal is to treat all commerce at this point because these patients need all the options. They can get and both also close in Crohn's disease and the last question I think youre going to handle with regards to the changes in the Biosimilars plans by the FDA, yes, no so around it.

Richard Francis: Yeah. No, so around interchangeability, I think this is something that's being discussed, but it actually hasn't been concluded. So, it's been proposed, but it has - it needs to go to and it requires legislation to change for this to happen. So, I think this - I'd say, let's see how this plays out. Obviously, when it comes to substitution and allowing biosimilars to have a fast-track uptake for patients and payers in society, we would support that. But there's a long way to go. So, I think this is just in its embryonic stage, and we'll have to see how that plays out. And as there's more clarity, I'll update you on subsequent calls. All right. Thanks very much.

Richard Francis: Yeah. No, so around interchangeability, I think this is something that's being discussed, but it actually hasn't been concluded. So, it's been proposed, but it has - it needs to go to and it requires legislation to change for this to happen. So, I think this - I'd say, let's see how this plays out. Obviously, when it comes to substitution and allowing biosimilars to have a fast-track uptake for patients and payers in society, we would support that. But there's a long way to go. So, I think this is just in its embryonic stage, and we'll have to see how that plays out. And as there's more clarity, I'll update you on subsequent calls.

Richard Francis: Yeah, no, so around interchangeability, I think this is something that's being discussed, but it actually hasn't been concluded. So it's been proposed, but it has, it needs to go, and it requires legislation to change for this to happen. So I think this, I'd say, look, let's see how this plays out. Obviously, when it comes to substitution and allowing biosimilars to have a fast-track uptake for patients, payers, and society, we would support that. But there's a long way to go. So I think this is just in its embryonic stage, and we'll have to see how that plays out. And as there's more clarity, I'll update you on subsequent calls.

Richard Francis: Interchange ability I think this is something that's being discussed but it actually hasnt been concluded.

Richard Francis: So it's been proposed but it has it needs to go to and it requires.

Richard Francis: Legislation to change for this to happen so I think this.

Richard Francis: I'd say, let's see how this plays out obviously when it comes to substitution.

Richard Francis: And allowing a bus a list to have a fast uptake for patients and payers and society, we would support that.

Richard Francis: But.

Richard Francis: It's a long way to go so I think this is Justin it's embryonic stage and we'll have to see how that plays out and as there's more clarity.

Richard Francis: Update you on subsequent calls.

Yifeng Liu: All right. Thanks very much. Thanks for your call.

Yifeng Liu: All right. Thanks very much.

Richard Francis: Thanks for your call.

Speaker Change: Alright, thanks very much.

Operator: Our next question comes from Thibault Boutherin of Morgan Stanley. Your line is now open. Please go ahead.

Speaker Change: Okay cool.

Thibault Boutherin: Our next question comes from a T bolt.

Thibault Boutherin: Yes. Thank you. So, three questions. The first one, just a quick follow-up on biosimilars long term and your in-house pipeline. You mentioned the change in dynamics and how things are opening up for biosimilars. Is that changing in any way your willingness to invest in the kind of next generation of pipeline asset that you're developing internally? Second question, just on the OLANZAPINE and market potential, I mean, I think you gave in the past kind of $400 million to $800 million potential for UZEDY. And given the broad use of OLANZAPINE and clearly your excitement on the asset, is it fair to think about blockbuster potential for OLANZAPINE injectable? And last question, just on the reduction in the number of sites. We saw interest in the industry for biologic capacity elsewhere. So, is there an opportunity for you to potentially divest these sites or monetize these sites reduction exercise, or is it just expected site closures? Thank you.

Thibault Boutherin: Boatsman of Morgan Stanley.

Thibault Boutherin: Your line is now open. Please go ahead.

Speaker Change: Yes. Thank you. So a quick question on the first one just a quick follow up on Biosimilar that was long term annual in house pipeline.

Thibault Boutherin: Mentioned, the changing dynamics and how things are opening up for Biosimilars is that is that changing in any way a willingness to invest in the kind of thing generation of pipeline that said thats still developing.

Thibault Boutherin: And then second question just.

Thibault Boutherin: On the or is that or is it the opinion.

Thibault Boutherin: Sure I mean, I think you gave in the past to kind of 400 to 800 million the loss potential I'll use it.

Thibault Boutherin: And given the broad use of what ends up being and Kelly your excitement on the assets.

Thibault Boutherin: You know, is it fair to think about blockbuster potential for the long-zap injectable? And last question, just on the reduction in the number of sites, we saw interest in the industry for biologic capacity elsewhere, so is there an opportunity for you to potentially divest these sites or monetize this site reduction exercise, or is it just expected site closures?

Thibault Boutherin: Is it safe to think about the blockbuster potential for <unk>.

Thibault Boutherin: And is that an injectable.

Thibault Boutherin: And last question just on the redemption of all sites, we still interest in industry.

Thibault Boutherin: Biologic capacity and just lastly is there the opportunity for you to potentially da Vinci Si So many times.

Thibault Boutherin: Addiction exact size.

Thibault Boutherin: Or is it just.

Richard Francis: Okay. Thank you, Thibault. Thank you for those questions. So, let me start with the first one, the biosimilar one. I think it was around capital allocation. Do you see the change in dynamics mean that we would invest more in internal development? I think first and foremost, capital allocation occurs when we partner as well. So obviously, we - it's a lot less than when we do it internally, but I just want to make sure you're aware that we do allocate capital to our pipeline that is partnered, but it's less. I think we're in a very fortunate position at Teva because of the makeup of our business. And as you've seen from the innovative pipeline that we have that allocating capital to this and accelerating this through the clinic, I think really drives potential to bring life-changing medicines to the market, but also helps us drive value for shareholders. So, I think, we're always talking about our capital allocation. We take that into account as things change in our business, but I see nothing that creates a sizable shift in the strategy we have right now.

Thibault Boutherin: Yes.

Speaker Change: Thank you.

Speaker Change: Okay. Thank you Tito thank you for those questions.

Richard Francis: So let me start with the first one, the biosimilar one. I think it was around capital allocation. Do you see the change in dynamics mean that we would invest more in internal development? I think, first and foremost, capital allocation occurs when we partner as well. So obviously, it's a lot less than when we do it internally. But I just want to make sure you're aware that we do allocate capital to our pipeline that is partnered, but it's less. We're in a very fortunate position at Teva because of the makeup of our business. And as you've seen from the innovative pipeline that we have, allocating capital to this and accelerating this through the clinic, I think, really drives the potential to bring life-changing medicines to the market but also helps us drive value for shareholders. So I think we're always talking about our capital allocation. We take that into account as things change in our business, but I see nothing that would create a sizable shift in the strategy we have right now.

Teva: So let me start with the first one the Biosimilar one.

Richard Francis: I think it was around capital allocation do you see the changing dynamics mean that we would invest more in internal development I think first and foremost kept on vacation because when we partner as well so obviously we.

Richard Francis: But I just want to make sure you're aware that we do allocate capital to our pipeline that is partnered, but it's less. We're in a very fortunate position at Teva because of the makeup of our business. And as you've seen from the innovative pipeline that we have, allocating capital to this and accelerating this through the clinic, I think, really drives the potential to bring life-changing medicines to the market but also helps us drive value for shareholders. So I think we're always talking about our capital allocation. We take that into account as things change in our business, but I see nothing that would create a sizable shift in the strategy we have right now.

Richard Francis: It's a lot less of them when we do it internally, but I just want to make sure you whether we do allocate capital to a pipeline that is partnered but it's less I think.

Richard Francis: We're in a very fortunate position of Teva because the makeup of our business and as you've seen from the innovative.

Richard Francis: Pipeline that we have that allocating capital to this and accelerating this through the clinic I think really drives potential to bring life changing medicines to the market, but also helps us drive value for shareholders. So I think we're always thoughtful about our capital allocation, we take that into account as things change in our business, but I see nothing.

Richard Francis: We take that into account as things change in our business, but I see nothing that would create a sizable shift in the strategy we have right now. Then I think you moved on to olanzapine, and what's our prediction around this, and could this be a blockbuster? Look, I'd go back to start with. There's clearly an unmet medical need there. There's no long-acting olanzapine, as we've seen in the data, and clearly, a big percentage of patients would benefit from a long-acting olanzapine, and we get the same feedback from healthcare physicians, which is one of the reasons why I think the study was so well recruited because people wanted to be part of it.

We take that into account as things change in our business, but I see nothing that would create a sizable shift in the strategy we have right now.

Richard Francis: Then, I think you moved on to OLANZAPINE and what's our prediction around this and could this be a blockbuster. Look, I go back to start where there's clearly an unmet medical need there. There's no long-acting OLANZAPINE as we've seen in the data and clearly a big percentage of patients would benefit from a long-acting OLANZAPINE and we get the same feedback from healthcare physicians, which is one of the reasons why I think the study was so well recruited because people wanted to be part of it. I think when it comes down to giving guidance, obviously, we want to do a bit of work in understanding the dynamics of the environment and we will come back and maybe give some bookends up to that later, as we've done with AUSTEDO in the past. So, it's something which we're open to do, but we want to give that more time and obviously we wanted to get the safety and efficacy readout under our belts before we started to do that.

Richard Francis: That creates a sizable shift in the strategy, we have right now.

Richard Francis: Then I think you moved onto Olanzapine and what's a prediction around this and could this be a blockbuster.

Richard Francis: Go back to start with is clearly an unmet medical need that theres no long acting olanzapine.

Richard Francis: We've seen in the data and clearly a big essentially patients.

Richard Francis: Benefit from a long acting long acting lines opinion, and we get the same feedback from health care physicians, which is one of the reasons why I think the study was so well recruited because people want it to be positive.

Richard Francis: I think when it comes down to giving guidance, obviously, we want to do a bit of work and understand the dynamics of the environment, and we will come back and maybe give some guidance later, as we've done with Estedo in the past, so it's something that we're open to doing, but we want to give that more time. And obviously, we wanted to get the safety and efficacy readout under our belts before we started to do With regard to the divestment of sites and monetizing that, first, I'd say we've always done that.

I think when it comes down to giving guidance, obviously, we want to do a bit of work and understand the dynamics of the environment, and we will come back and maybe give some guidance later, as we've done with Estedo in the past, so it's something that we're open to doing, but we want to give that more time. And obviously, we wanted to get the safety and efficacy readout under our belts before we started to do

Richard Francis: When it comes down to giving guidance, obviously, we wanted to do a bit of work in understanding the dynamics of the environment and we will come back and maybe give some book ends up to that later as we've done with instead of in the past so it's something which we're open to do but we want to give them all the time and obviously, we wanted to get the safety and efficacy readout on drop out.

Richard Francis: With regards to divestment of sites and monetizing that, first I'd say we've always done that. Teva runs very good sites and the fact that we're reducing our sites is more about our strategy, not about the quality of those sites, the quality of the people who operate in those sites. And so, on a regular occurrence, we divest and we sell our sites and people find them very attractive. I think obviously, you're talking about the changing environment around biologics and capacity. And so, that's something that may make manufacturing sites easier to sell, but we'll see how that plays out over the next few years. Hopefully that answers all your questions, Thibault. Thank you for them, and appreciate the interest.

Richard Francis: We started to do that.

Richard Francis: With regards to divestment of science, and monetizing that especially outside we've always done that.

Richard Francis: You know, Teva runs very good sites. And the fact that we're reducing our sites is more about our strategy, not about the quality of those sites or the quality of the people who operate those sites. And so, on a regular occurrence, we divest, and we sell our sites, and people find them very attractive. I think, obviously, you're talking about the changing environment around biologics and capacity. And so, you know, that's something that may make manufacturing sites easier to sell. But we'll see how that plays out over the next few years. Hopefully, that answers all your questions, Thibault. Thank you for them, and I appreciate the interest. Yeah,

Richard Francis: Teva runs very good sites and the fact that we've reduced our sites is more about our strategy not about the quality of those sides of the quality of the people who are operating those sites and so on a regular occurrence, we divest and we sell our sites and people finding very attractive I think obviously you were talking about the changing environment around biologics and capacity.

Richard Francis: And so you know.

Richard Francis: Some think that.

Richard Francis: May make manufacturing sites easier to sell but we'll see how that plays out over the next few years.

Thibault Boutherin: Yeah, perfect, thank you.

Richard Francis: Hopefully I answered all your questions to you, but thank you for them and I appreciate the interest.

Operator: Our next question comes from Chris Schott of JP Morgan. Your line is now open. Please go ahead.

Speaker Change: Yeah perfect. Thank you.

Chris Schott: Our next question comes from Chris Schott of Jpmorgan your.

Chris Schott: Great. Thanks very much. Just two questions for me. I mean, first, just on the International Markets, and just a two piece here. Can you just elaborate particularly what markets are driving the healthy growth we're seeing here as you just think about that business as a whole? And I think as part of the prepared remarks, you talked about the Japanese generic business that you're divesting, and just give us some sense of how large and the growth profile of that piece?

Chris Schott: Your line is now open. Please go ahead.

Chris Schott: Great. Thanks, very much just two questions for me first just on the international markets and just the two piece here can you just elaborate particularly what markets are driving the healthy growth. We're seeing here is just think about that business as a whole and I think it's part of the prepared remarks, you talked about the Japanese generic business that you're divesting and just give us some sense of how large.

Chris Schott: And then, my second question was just coming back to TL1A. I kind of hear you in terms of the need for broad therapies given the unmet need in this space, but it does seem like a number of the KOLs we speak to are also excited about potential for a biomarker-driven approach to help better identify patients. So, I guess, sort of to get my hands around, do you see the biomarker piece as something that's kind of secondary and that the studies will be kind of broad all comers and that you'll kind of see how the biomarker sorts out? Or do you see there's a potential to differentiate on biomarkers? Because again, I'm just - I'm trying to balance that out of like kind of entrenched therapies, people want something that's a little bit different versus still, again, a lot of unmet need here. Thanks so much.

Chris Schott: Growth profile of that piece and.

Chris Schott: And then my second question was just coming back to tier one.

Chris Schott: Pierre you in terms of the need for broad therapies, given the unmet need in this space, but it does seem like a number of the Kols. We speak to are also excited about potential for a biomarker driven approach to help better identify patients.

Chris Schott: It was sort of on my hands around do you see the biomarker piece is something that's kind of a secondary and that the.

Chris Schott: The studies will be kind of brought all comers in that you'll kind of see how the biomarker sorts out or do you see there's a potential to differentiate on biomarkers because again I'm just I'm trying to balance that out of like I'm kind of entrenched therapies people want something that's a little bit different versus still again, a lot of unmet need here. Thanks, so much.

Richard Francis: Hi, Chris. Thanks for the questions. So, with regard to your two on International Markets, actually, the encouraging thing about International Markets is we have growth across all of them. And we've had growth across all of them for the time I've been here. A credit to the team and the quality of the team. We have done a bit of focus on investing capital and resources more specifically and I think that's really helped International Markets. But there's not one that stands out and I think that's why we're delivering consistent quarter-on-quarter growth in International Markets because of that. That's first. Just to - with regard to the Japanese business, we're not stepping out of Japan. We're divesting part of our generics business. And that goes back to, once again, to our capital allocation where we can make sure we're giving capital where we can generate a good return. And we have the ability to be thoughtful about that at Teva because of our scope in geographies and businesses we have. So, that's how that plays out in Japan. And now with TL1A, I'll hand that over to Eric to answer.

Speaker Change: Hi, Chris Thanks for the questions.

Richard Francis: So with regards to your two in international markets actually.

Richard Francis: The encouraging thing about in special markets as we have growth across all of them Oh, we've had growth across all of them for the time I've been here a credit to the team and the quality of the team we have done a bit of focus on investing capital and resources and more specifically and I think that's really helped international market.

Richard Francis: But there's not one that stands out and I think that's what why we're delivering consistent quarter on quarter growth in international markets because of that.

Eric Hughes: And I think that's why we're delivering consistent, quarter-on-quarter growth in international markets because of that. Just with regard to the Japanese business, we're not stepping out of Japan; we're divesting part of our generics business. And that goes back to, once again, our capital allocation, where we can make sure we're giving capital where we can generate a good return. And we have the ability to be thoughtful about that because of our scale. geography, and the businesses we have. So that's how that plays out in Japan. And now with TO1A, I'll hand that over to Eric to answer.

Eric Hughes: So first just to let you know where do I go out to the Japanese business.

Eric Hughes: Stepping out of Japan, with divesting part of our generics business and that goes back to once again to our capital allocation and where we can make sure with the kidney capital, where we can generate a good return and we have the ability to be thoughtful about that are tougher because of our scope.

Eric Hughes: Geographies and businesses, we have so that's how that plays out in Japan and that would tell one out I'll, let I'll hand that over to Eric to answer yeah. Yeah. Thank you for the questions about Biomarkers and Tijuana.

Eric Hughes: And now with TO1A, I'll hand that over to Eric to answer. So, you know, there are a number of important things to consider when you're talking about biomarkers. For one thing, in my experience with biologics and the discovery of biomarkers, it does take large numbers of patients to really understand and be confident in the biomarkers' effect. To date, we haven't seen significant deltas based on biomarkers. I'd like to see much bigger deltas based on many more patients. But certainly, it's possible to identify biomarkers that are predictive of response at baseline. And more importantly, you can find strong ones that are predictive of treatment. So we're focused on speed.

And now with TO1A, I'll hand that over to Eric to answer.

Eric Hughes: Yeah. Thank you for the question about biomarkers and TL1A. So, there's a number of important things to consider when you're talking about biomarkers. For one thing, in my experience with biologics and discovery of biomarkers, it does take large numbers of patients to really understand and be confident in biomarkers' effect. To date, we haven't seen significant delta brd on biomarkers. I'd like to see much bigger delta brd on many more patients. But certainly, it's possible to identify biomarkers that are predictive of response at brline, and more importantly, you can find strong ones that are predictive on treatment. So, we're focused on speed. We're focused on making sure that people have options for these patients. Like we said, these patients cycle through treatments for ulcerative colitis and Crohn's disease and they need options that last. So, I don't want to disabuse patients of a possible treatment choice in the future. So, the choice, we'll always look for these biomarkers, but it's going to take much more data than we have today.

Eric Hughes: A number of important things to consider when you're talking about Biomarkers for one thing and my experience with biologics in discovery of Biomarkers. It does take large numbers of patients to really understand and be confident in biomarkers effect.

Eric Hughes: To date, we haven't seen significant delta based on Biomarkers I'd like to see much bigger.

Eric Hughes: Alta based on many more patients, but certainly it's possible to.

Eric Hughes: Identify biomarkers that are predictive of response at baseline and more importantly, you can find strong ones that are predictive on treatment. So we're focused on speed, we're focused on making sure that people have options for these patients like we said you know these patients cycle through a treatment for ulcerative colitis, and crohn's disease and the need ops.

Eric Hughes: We're focused on making sure that people have options for these patients. Like we said, these patients cycle through treatments for ulcerative colitis and Crohn's disease, and they need options that last. So I don't want to disabuse patients of a possible treatment choice in the future. So the choice, we'll always look for these biomarkers, but it's going to take much more data than we have today. Thanks, Eric. Thanks for the questions, Chris.

We're focused on making sure that people have options for these patients. Like we said, these patients cycle through treatments for ulcerative colitis and Crohn's disease, and they need options that last. So I don't want to disabuse patients of a possible treatment choice in the future. So the choice, we'll always look for these biomarkers, but it's going to take much more data than we have today.

Eric Hughes: That one so I don't want to disabuse patients of a possible treatment of choice in the future. So.

Eric Hughes: Joyce will always look for these biomarkers, but it's going to take much more data than we have today.

Chris Schott: Thanks, Eric. Thanks for the questions, Chris.

Chris Schott: Thanks, Eric.

Richard Francis: Thanks for the questions, Chris.

Operator: Thank you. Our final question comes from Glen Santangelo from Jefferies. Your line is now open. Please go ahead.

Speaker Change: Thanks, Eric Thanks for the questions Chris.

Glen Santangelo: Thank you.

Richard Francis: The question comes from Glen Santangelo from Jefferies. Your line is now.

Glen Santangelo: Yeah. Thanks for taking my question. Hey, Richard, I just want to shift gears for a second. In your prepared remarks, it kind of seemed like you were incrementally excited to talk about the generics business this quarter. And when you look at the results, obviously, solid growth across all your geographies. Maybe could you just give us a little bit more details maybe about product launches that maybe driving that growth and how we should think about maybe organic volumes in that business and pricing just so to help us assess the durability of these recent trends? And maybe as my follow-up, I'd ask about REVLIMID specifically. I know that created some volatility in the results in 3Q and 4Q last year brd on your contracts for that business. And so, I was curious if you could just give us an update there as well. Thanks.

Glen Santangelo: Please go ahead.

Glen Santangelo: You know, in your prepared remarks, it kind of seemed like you were increasingly excited to talk about the generics business this quarter. And, you know, when you look at the results, obviously, solid growth across all your geographies. Maybe, you know, could you just give us a little bit more details maybe about product launches that may be driving that growth and how we should think about maybe organic volumes in that business and pricing, just so to help us assess the durability of these recent trends. And maybe as my follow-up, I'd ask about Revlimed specifically. I know it created some volatility in the results in 3Q and 4Q last year based on, you know, your contracts for that business. And so I was curious if you could just give us an update there as well. Thanks.

Glen Santangelo: Yes, Thanks for taking my question, Hey, Richard I, just wanted to shift gears for a second.

Glen Santangelo: Prepared remarks, it seemed like you were incrementally excited to talk about the generics business this quarter and when you look at the results obviously solid growth across all your geographies, maybe could you just give us a little bit more details maybe about product launches that may be driving that growth and how we should think about maybe organic.

Glen Santangelo: And maybe as my follow-up, I'd ask about Revlimed specifically. I know it created some volatility in the results in 3Q and 4Q last year based on, you know, your contracts for that business. And so I was curious if you could just give us an update there as well. Thanks.

Glen Santangelo: Williams in that business and pricing just to help us assess the durability of these recent trends and maybe as my follow up I am asking about Revlimid, specifically I know that created some volatility in the results in <unk> and <unk> last year based on based on you know your contracts for that business and so I was.

Richard Francis: Okay. Thanks for the question, Glen. I suppose I can't hide my excitement. And look, what's behind it? And I appreciate the question. So, I think I said at the outset when I arrived here about the generics business at Teva having all the components to be a great business, which is why we use sustainable powerhouse as a pillar, pillar three of our strategy. But that is not shying away from committing to something by calling it a powerhouse. The reason why we could do that is we have an extensive pipeline of generics at Teva. We have a great high-quality manufacturing footprint and we have great go-to-market model. The reality was not all of those are working in perfect harmony and they're still not, to be honest, but we're making big progress. And I think some of that comes down to new product launches that you've seen in Q4, that you've seen this year and you will see more this year. Hopefully, we don't always rely on some other people to give us approval for those. That's one. And the second thing on our supply chain, our supply chain is becoming more efficient and more able to deliver what is an ever-increasing demand.

Glen Santangelo: Curious if you could just give us an update there as well thanks.

Speaker Change: Okay. Thanks, Thanks for the question Glenn.

Richard Francis: I appreciate the question. I think I said at the outset when I wrote here about the generics business at Teva having all the components to be a great business, which is why we use Sustainable Powerhouse as pillar three of our strategy. We are not shying away from committing to something by calling it a powerhouse. The reason why we could do that is we have an extensive pipeline of generics at Teva. We have a great, high-quality manufacturing footprint, and we have a great go-to-market model. The reality was that not all of those were working in perfect harmony, and they're still not.

Richard Francis: M I.

Richard Francis: I suppose I can't hide my excitement.

Richard Francis: And look what's what's behind it.

Speaker Change: I appreciate the question so.

Richard Francis: I think I said at the outset, when I write about the generics business to Teva, having all the components to be a great business, which is why we use sustainable powerhouse is a pillar pillar three of our strategy because that is not shying away from committing to something like calling a powerhouse. The reason why we could do that is we have an extensive.

Richard Francis: Pipeline.

Richard Francis: Generics at Teva, we have a great high quality manufacturing footprint and we have a great go to market model. The velocity was not all of those work in perfect harmony and that's still not to.

Richard Francis: So, those are the things that make me excited. I don't think this is a linear projection. We're doing some hard work to make this happen. And I think each year we'll get better and better and better, but we have the ingredients. And for me, this was the quarter that we started to see some of those things come together. And I don't think it will be, as I said, a clear path. To your second about REVLIMID, as you know we don't split out product sales. But I think REVLIMID is a good example of the fact that when we get it right in R&D, when we get it right in our approach into the market first, we can maximize an asset. So, I think that is something which we're benefiting from this year, but we're also benefiting from some of our other launches that we've talked about on other calls. So, thanks, Glen. Thanks for your question and I appreciate it.

Richard Francis: To be honest, but we're making big progress and I think some of that comes down to the new product launches.

Richard Francis: <unk> seen in Q4 that you've seen this year and you will see more of this year.

Richard Francis: Hopefully, we don't always will rely on some other people to give us approval for those.

Richard Francis: That's a long time, the second thing on our supply chain, our supply chain is becoming more efficient.

Richard Francis: We're able to deliver what is an ever increasing demand. So those are the things that make me excited.

Speaker Change: This is a.

Richard Francis: Linear projection.

Richard Francis: We're doing some hard work to make this happen and I think each year will get better and better and better, but we have the ingredients and and for me. This was the quarter that we started to see some of those things come together.

Richard Francis: Hum.

Richard Francis: And I don't think it will be as I said, a clear path to a second about revlimid.

Richard Francis: As you know, we don't split out <unk>.

Richard Francis: Sales I think Revlimid is a good example of the fact that you know.

Richard Francis: When we get it right in R&D, when we get it right and our approach into the market first we can maximize the asset.

Richard Francis: So I think, you know, that is something which we're benefiting from this year, but we're also benefiting from some of our other launches that we've talked about on other calls. So thanks, Glen. Thanks for your question, and I appreciate it. Thank you. Thank you to everybody. I think that the time is up now. I'd like to thank everybody for their participation and their interest in Teva Pharmaceuticals. I look forward to giving you an update for quarter two later in the year. Thank you.

So I think, you know, that is something which we're benefiting from this year, but we're also benefiting from some of our other launches that we've talked about on other calls. So thanks, Glen. Thanks for your question, and I appreciate it.

Richard Francis: So I think that is something which we are benefiting from this.

Richard Francis: This year, but we also benefiting some of some of our other launches that we've talked about on other calls.

Richard Francis: Thanks, Glenn Thanks for your question and I appreciate it thank you.

Thank you. Thank you to everybody. I think that the time is up now. I'd like to thank everybody for their participation and their interest in Teva Pharmaceuticals. I look forward to giving you an update for quarter two later in the year. Thank you.

Glen Santangelo: Thank you.

Richard Francis: Okay. Thank you for everybody. I think the time is up now. I'd like to thank everybody for their participation and their interest in Teva Pharmaceuticals. I look forward to giving you an update for quarter two later in the year. Thank you.

Richard Francis: Yeah.

Speaker Change: Okay, well. Thank you for everybody I think that the time is up now I'd like to thank everybody for their participation and their interest in Teva pharmaceuticals.

Speaker Change: Look forward to giving you an update.

Richard Francis: Quarter to later in the year. Thank you.

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

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