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spk11: Hello and welcome to the Teva Pharmaceutical Industries Limited Q2 2024 earnings call. My name is Alex, 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 one on your telephone keypad. And I'll hand it over to your host, Ran Mir, SVP, Head of Investor Relations. Please go ahead.
spk07: Thank you, Alex, and thank you everyone for joining us today. We hope you have had a chance to review our Q2 results press release. which was issued earlier this morning. Copy of the press release, along with the slides presented during this call, are available on our website at ir.tevafarm.com. Please review our forward-looking statements on slide number two. Additional information regarding these statements and the non-GAAP financial measures is available 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 second quarter business performance with recent events and 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 Khalif, will follow up by reviewing the second quarter financial results and our updated financial outlook in more detail. Please note that today's call will run approximately one hour. And with that, I will now turn the call over to Richard. Richard, if you would, please.
spk12: Thank you, Ran, and good morning, everybody, and thank you for joining us on our Q2 2024 earnings call. So I'd like to start by talking to you about the pivot to growth strategy, and it's just over a year since we launched this pivot to growth strategy. And as you know, the foundation of it was four pillars, deliver on our growth engine, step up innovation, sustain generics powerhouse, and focus the business. and I'm pleased to say we've made great progress over the last year. To live on our growth engines, we have driven, we continue to drive Esteto and Yosedi and Ejovi from a revenue point of view, and I'm pleased to say that we've launched Simuladi up by a similar Humira. With regards to step-up innovation, Eric and his team have done a great job in bringing this pipeline through quickly. We're pleased to say that Olanzapine is now at 95% of target injections completed with no PDSS. And also there's some good news on TL1A with the acceleration of that and top line results expected in Q4 this year. We'll also, Eric, we'll also start to highlight a bit more about ICS-SABA and we're pleased to introduce a new member of our pipeline family, a treatment for MSA, where we'll go into in more detail later on. On the third pillar, sustained generics powerhouse, as you'll see, we've made, continue to make good progress here as well with good growth across all regions. And then finally, focusing our business and our capital allocation with regards to TAPI, we have the second quarter of revenue growth, and we're well on our way with the process of divestment there, which I'll go into in a bit more detail later on. So now, is the pivot to growth delivering on what we set out to do? And as you can see by this slide, I believe it is. We've had six quarters of continuous growth culminating in the quarter two that we're going to walk you through today. of a strong 11%. So clearly, this strategy is helping the company align and get focused and drive revenue growth. Now, to go into a bit more detail on these numbers, as you can see by this slide, revenue is up to 4.2 billion 11%, adjusted EBITDA up to 1.2 billion 4%, and our non-GAAP BPS up to $0.61, up 9%. Because of these strong results, I'm pleased to announce we're going to increase our guidance for the year and that will be across revenue EBITDA and EPS and Ellie will go into a bit more detail of the specifics of that but obviously we're very pleased to announce that today now going to a bit more detail as to what's driving that 11 what I'm pleased is that this has been driven across all of our businesses as you can see from this slide our innovative business continues to perform well and grow quickly But you'll also see that our generics business growing at 14%, and I'll walk you through how this is growing across all regions, is also a major contributor. And then finally, TAPI API growing at 5% means, once again, we've returned this business to growth, and this is our second quarter of growth, and this gives us a lot of confidence for the rest of the year. Now get into even more detail on some of these areas, starting with Stedo. really excellent performance by Esteto. So congratulations to the team behind this. Really proud of what you've done. $407 million revenue, 32% revenue growth, and TRX at a strong 30%. And because of this good, strong performance, we're raising guidance from $1.5 billion to $1.6 billion for the year. So very pleased about the progress we've made on Esteto. Now, Just to give you some updated news on Estero, we completed the family with regards to every dosage form having a once a day. And this is a nice sort of completion of the circle that allows the patients who are titrating to have an even more simplistic dosing regimen. So congratulations to the team for bringing that to the market. As we move on to Jovi, Jovi continues to grow strongly at 12%, driven primarily by European business and the international markets. But what I continue to be impressed with is the competitiveness of all of our regions. We're growing market share across all of our regions, US, Europe, and international markets. As I've highlighted before, this just shows the quality of the team we have at Teva when it comes to driving these innovative products in even very competitive markets. Now I'd like to move on to the newest member of our family, Busetti. And we're very pleased with the momentum that we have with UCEDD. What we're seeing is this really favorable product profile continues to attract new physicians and excite them. And as I've mentioned before, from a patient perspective, the subcutaneous needle is obviously something they welcome versus the IM. But also what we're noticing is the practical nature of the administration. The fact that this product doesn't have to be kept refrigerated. But most importantly, that this can be administered to a patient and they receive, get to therapeutic dose within eight to 24 hours. And physicians love that. And so this is what is allowing us to compete very effectively and to take market share in the risperidone long-acting market. So pleased with the progress we're making there and confident for the rest of the year. Now, excuse me, as I move on to my, the last part of the growth drive is deliver on our first pillar, I move on to the biosimilars. And as you know, we launched our similarity, our biosimilar Humira in Q2 of this year. And we're really pleased with the progress we've made. We've fully stocked the channel. We're getting good and growing coverage with our payers. And also we set up a private label with Qualent. So I think we're well set for this to generate some performance in Q3 and Q4 of this year. But building on this, we're also pleased that we got approval from the FDA for our biosimilar of Stelara. And this will be launched in February of 2025. But now we have approval. This gives us the opportunity to start to prepare for this launch in February 25. Now, it is worth pointing out on this slide also that excited we are about these two products. We do have another five in the pipeline that are coming in the near term. So as you can see that a biosimilar strategy is gaining momentum and it will contribute to the pivot to growth strategy and allow us to grow top. and bottom line. Now, moving on to the second pillar, step-up innovation. Eric's going to talk a lot about this later, so I'll try not to steal any of his thunder. What I will do is just highlight the significant progress that has been made. This is now becoming a deep pipeline that's exciting. We'll talk a bit about Lanzapine and obviously TL1A, but it's nice to start to see some data points in the future emerging on TL1A and TPD1IL2. We're also working hard to accelerate ICS-SABA. And as I said earlier, we're pleased that we're bringing a much needed medicine to the MSA community in a phase two study that's starting later this year. So very excited about the work Eric and his team have done. Now I'm going to go into a couple of these assets to sort of highlight why we're excited about them from a commercial point of view. So starting with are ICS-SABA. As you can see, this is a big market. There's 13 million people who suffer from asthma in the U.S., and the recommendations of the guidelines, the GINA guidelines, are that people should be on a combination therapy. So that's exciting, obviously, because ICS-SABA is a combination therapy. But what is interesting is we will be differentiated in the fact that we have a pediatric indication and a patient-friendly device. Now, just to sort of give you some grounding on the numbers here from a pediatric indication, asthma is the most common chronic disease when it comes to children in the United States. It also accounts for more hospitalizations than any other chronic illness in this patient population. So clearly, there's an opportunity for us to help these people, and that's what we're energized to do with ICS-SABA. Hence, we're trying to drive this to the market as quickly as possible. pipeline product that we're very excited about and there's a lot of discussion about is olanzapine. And the reason why we're excited about it is obviously the opportunity, there's a large market of 5 billion for long-acting antipsychotics. What's interesting is there is no long-acting olanzapine that's used in any quantity at all. And that's because they haven't had the right product profile. We believe in olanzapine, our long-acting olanzapine, we will have the product profile that has efficacy, safety, and tolerability all in one. It will also have similar attributes to Yasedi, which the ability to reach therapeutic doses quickly, so avoiding oral supplementation, so making it very user-friendly for the physician. And that's why we're seeing the excitement amongst the psychiatric community. So now moving on to our third pillar, which is creating a and sustainable generics powerhouse. So as you see here, 40% growth globally, but all regions contributing very strongly, particularly pleased to see the US at 16%. But as you can see, 8% and 22% for international markets, strong growth across all of our regions. Now moving on to TAPI, our final pillar of our strategy, which is focusing on capital. The aim was to get TAPI management team up and running and focused on driving this business. As I've said in the past, it's an $85 billion market. We have a great business with TAPI, and the question is keeping it focused, could we get it back to growth? We have done that for the second quarter. We're seeing continued strong traction across the CDMO community, and the divestment process is on track, and we're targeting completion by H1 in 2025. So that concludes my presentation for today. I'm going to hand over to Eric, who's going to walk you through that exciting pipeline that I spoke about.
spk04: Thank you, Richard. Starting with our late-stage innovative pipeline, first I'd like to talk about anti-TL1A, our program in inflammatory bowel disease, also known as DUVA-KETOG. This is a study that we accelerated. We randomized our last patient on July 5th, and that gives us about a three-month acceleration, which we're excited to say that we can now produce top-line data in the fourth quarter of this year. Moving on to Olanzapine LAI, we've also accelerated this program by nine months, and we'll be presenting our phase three data in the second half of this year at a conference so that we can review the exciting data we announced earlier this year. Finally, ICS-SABA, our dual action rescue inhaler that Richard mentioned, We're working very diligently to keep our phase three study on time, which we're doing a good job right now, and we're on target for our second half of 2026. But as usual, we'll always work hard to accelerate that program as well. So an exciting late stage program that we've got going here at Teva. Now, one of the things we announced this month as well is something that I'm particularly proud of is our Joby program in pediatrics. we finished our pediatric study in an episodic migraine, the SPACE study. And this was a well-controlled, robust study of approximately over 200 patients for treatment of eight weeks. And we're very pleased to say that we achieved primary and secondary endpoints that showed a significant reduction in our monthly migraine days compared to placebo. And this was very consistent with what we saw in the adult population with no emergent safety signals. So it's very encouraging to see in a more fragile population the safety and the efficacy continue to be shown for adjovi. We continue in our pediatric adolescent program in chronic migraine. So we hope to someday bring this treatment to children around the world in our label, but more to come. Now moving on to a new program that Richard had mentioned, and that's in MSA, multiple system atrophy. This is a devastating fatal and neurodegenerative adult disease. It's characterized by autonomic failure, cerebellar ataxia, and Parkinsonism. It's particularly devastating to think that in five years, 60% of these patients become wheelbound, and by 12 years after diagnosis, few of the patients are still living. It's an orphan disease of about 65,000 patients in the G7, and there's currently no available treatments for this terrible disease. Our program, MRSulman, is an important program that targets the alpha-syniculin aggregates that drive the disease pathology. Now, it's important to remember, this is an orally administered small molecule. It's brain penetrant. That means it gets to not only the membrane-bound alpha-syniculin aggregates, but also the intracellular forms. And that's important because MRSulman has the potential to be a disease-modifying treatment. It blocks the early aggregates, destabilizes them, creates less toxic early aggregates, and drives them into monomeric form. It also blocks the formation of the larger aggregates as well. So really important action, and we're very excited to be starting a phase two study in the second half of this year. Now moving on to another program that we're excited to show progress in. That's our anti-PD-1 IL-2 Atenokine program. This is an exciting program because it brings together two important aspects of the immune system, targeted therapies to the PD-1 T cells, but bringing an attenuated IL-2 to those cells. So that's really bringing a powerful cytokine signal to the cells to fight tumor cancer, tumor cells. So this is an important thing. The goal here is to not only activate these T cells, but avoid the cytotoxic toxicity of high doses of IL-2. And you can see in this ex vivo study to the left that when you look at melanoma cells with human PBMCs, we have great activity for the PD-1 IL-2, but also an additional activity if you combine it with a drug such as Keytruda. So we're very excited. We've screened our first patient in the study and more to come in the future. So as Richard mentioned, we're progressing our innovative pipeline both early and late. Starting with Olanzapine LEI, I mentioned we accelerated it by nine months. We'll have the full safety database complete by the second half of this year, so we're on target. Duva-Ketug is now moving forward. We accelerated by three months, and we're going to be looking for those top-line results in the fourth quarter of 2024. Our anti-IL-15 program is now fully enrolled, a POC study for celiac disease, and we've opened a new IND for vitiligo, and we'll be finishing up our Phase I work the second half of this year. Our anti-PD-1, as I mentioned, anti-PD-1 IL-2, as I mentioned, has now screened its first patient. We're looking for full enrollment by 2026 of part one. And our dual action rescue inhaler, ICS Saba, we're on target for patient recruitment. We'll work to accelerate that program as well, but we're on target for the second half of 2026. And finally, Ambrosol, I'm particularly proud to be getting a phase two study started this year. And with that, I'll pass it off to Eli Khalif.
spk08: Thank you, Eric, and good morning and good afternoon to everyone. I will begin my review of our Q2 2024 financial results with slide 26, starting with our GAAP performance. Revenue in the second quarter of 2024 were $4.2 billion, an increase of 7% in U.S. dollars or 11% in local currency terms compared to the second quarter of 2023. This increase in revenue, was mainly driven by growth from Generics products across all our segments globally, including strong contribution from Generics Revlimid and the launch of Generics Victoza in the US, and strong continued growth from Osteddo. In Q2 2024, we recorded a gap operating loss of 5 million compared to an operating loss of 654 million in the same quarter last year. This improvement in the second quarter of 2024 was mainly driven by higher revenue and gross profit, as well as lower legal settlement and loss contingencies and goodwill impairment charges compared to the same quarter last year. Gap net loss in Q2 2024 was $846 million and a gap loss per share was $0.75 compared to the net loss of $872 million and a loss per share of $0.78 in Q2 of last year. The lower net loss in the second quarter of 2024 was mainly due to the lower operating loss that I just discussed, partially offset by higher income taxes related to the settlement agreement we announced in June with the Israeli tax authorities to resolve all pending litigation for the company's taxable years from 2008 until 2020. Turning to slide 27, you can see that Total non-GAAP adjustment in the second quarter of 2024 were $1.5 billion, similar to Q2 2023. A notable non-GAAP adjustment this quarter includes corresponding tax effects and unusual tax items of $503 million, mainly related to the settlement agreement with the Israeli tax authorities I just mentioned. Other notable adjustments include a goodwill impairment charge of $400 million related to our TAPI reporting units based on Teva's people to growth strategy assumption and our planning for the investment. Now moving to slide 28 for a review of our NANGA performance. As I mentioned earlier, our second quarter revenue were approximately 4.2 billion, an increase of 7% in U.S. dollars or 11% in local currency terms compared to Q2 of last year. Our non-GAAP gross profit margin was 52.9% compared to 52.2% in Q2 2023 and 51.4% in the first quarter of 24. This increase in our non-GAAP gross profit margin, both compared to last year and the first quarter of 2024, was mainly driven by expected improvement in our portfolio mix, mainly from strong continued growth from Mostedo, as well as a decrease in our operation costs. As we progress through the rest of the year, we expect our gross margin to continue to improve in the second half, driven by continuous improvement in our portfolio mix with a strong continued growth in our innovative products and continuation of our cost optimization program. Moving to non-GAAP operating margin in Q2 2024, which was 25.3% compared to 26.1% in Q2 2023. This decrease in gap operating margin in the second quarter of 2024 was mainly due to higher sales and marketing and R&D expenses as a percentage of revenue reflecting our deliberate investment to support our key growth engines, including promotional activities related to assetto and investment in our late stage pipeline assets, both in line with our pivot to growth strategy. These were partially offset by our higher growth margins. We ended the quarter with a non-GAAP earning per share of 61 cents compared to 56 cents in Q2 2023, mainly driven by higher operating income and lower financial expenses. Now, moving to slide 29. As communicated in the beginning of this year, we are making a thoughtful and deliberate investment to support our growing innovative portfolio, as well as progress and accelerated our key pipeline assets. As you can see, this is reflected in our first half results. A continuing improvement in our portfolio mix and a disciplined cost management in driving our margin expansion, as well as enabling us to invest in our business to drive short-term and long-term growth. Looking at the rest of 2024, we expect to see operating leverage in the second half of this year, in our revenue and continue to expect operating expenses to be in the initially provided range of 27 to 27.5% for the full year. Turning to free cash flow on slide 30. Our free cash flow in the second quarter of 2024 was $324 million compared to $632 million in Q2 2023. The decrease in the free cash flow in the second quarter of 2024 resulted mainly from changes in working capital items due to revenue growth, including a negative impact from accounts receivable due to timing of collections and accounts payable, higher tax payment, as well as higher proceeds from divestitures of business and other assets in the second quarter of last year. Today, we are reaffirming our 2024 free cash flow guidance. which we initially provided in January. Our 2024 free cash flow is expected to be in the range of 1.7 to 2 billion. And we expected it to continue to pick up during the second half of the year, driven by higher revenue and profitability, as well as working capital improvements. Turning to slide 31. Our net debt at the end of Q2 2024 was 16.4 billion. Our gross debt was 18.6 billion compared to a 19.8 billion at the end of 2023. The decrease in our gross debt was mainly due to repayment of 956 million of 6% seniority notes at maturity in April 2024 and the positive impact of 247 million from exchange rate fluctuations. Our net debt to EBITDA slightly improved, coming in 3.3 times for Q2, 2024, mainly due to higher EBITDA. As of June 30th, and as of today, there is no amount outstanding under our 1.8 billion revolving credit facilities. Now let's turn to slide 32 to our 2024 non-GAAP outlook discussion. As Richard highlights earlier, and as I reflected on the first half of this year, we have made a solid progress in terms of our revenue. This includes solid momentum in our key growth engine, especially Oceto, which continues to see strong demand supported by our focus on investment. In addition, our core generics business continues to perform very well across all our markets, and we also expected Copaxone revenue to be better than initially guided in our provided guidance in January. Therefore, to reflect our revenue performance in the first half, along with expected development in the second half of 2024, we're raising our 2024 full-year revenue guidance to $16 billion to $64 billion. This reflects an increase of $200 million at the midpoint of our previous guidance range. Accordingly, we're also raising the lower end of our 2024 non-GAAP outlook for operating income and EBITDA by $100 million and lower end of the earning per share guidance by $0.10 to be between $2.30 to $2.50. We continue to expect our non-GAAP gross margin to be between 53% to 54% for the full year with a gradual pickup in the margin in the second half of the year in line with our revenue trajectory and portfolio mix. as well as improvement from our ongoing cost optimization program. Like I mentioned earlier, we expect to see operating leverage in the second half of the year and our operating expenses to be as initially provided range of 27 to 27.5% for the full year. Coming to free cash flows, we continue to expect free cash flow to be between 1.7 to 2 billion for the full year. With this, I conclude my review of several results for the second quarter of 2024. And now, I will hand it back to Richard for a summary.
spk12: Thank you, Eli. And I'd just like to take the opportunity to reiterate our 2027 financial guidance. We aim to grow at mid-single-digit revenue. The operating margin at 30% we're committed to, net debt to EBITDA two times and cash flow to earnings of 80%. So once again, we reiterate our commitment to that. Now, if I move on to our confidence in that and what drives that is the pivot to growth strategy. And as you know, the first period of time was 23 to 24 to return the company to growth. And as I showed on my earlier slide, we've done six quarters of growth and we continue to believe we will be returning to growth and have the opportunity to continue on that journey because of the work we're doing and the results we're seeing with Esteto, Yosedi, and Jovia, and also the generics business, as well as the biosimilar pipeline starting to come through. We believe that allows us to also position ourselves for 25 and beyond to continue that growth and accelerate it based on some of the exciting programs that Eric has talked about, but also the fact that in those products I've mentioned, Esteto and Yosedi, we have... growth that we predicted and we've communicated as well that we think can drive beyond 25. so with that we've remained very optimistic about the future and i'd like to close the presentation and now open it up to questions and answers thank you as a reminder if you'd like to ask a question please press star followed by one on your telephone keypad if you'd like to remove your question you may press star followed by two our first question for today comes from ash firmer of ubs
spk11: Your line is now open. Please go ahead.
spk06: Great. Good morning. Thanks for taking my question. And I have two. So just on the API business, it's good to see back-to-growth dynamics here. Can you talk broadly about what's the composition of this business? Is it small molecule heavy, large molecule, or peptide, or any flexibility to switch the mix? And it seems that the demand trends are very different depending on which segment you're in, so that would have some significant implication on the divestment proceeds. And then secondly, on Osterro, I wanted to ask, like, do you expect to be on the CMS list for 2027? Thanks.
spk12: Great. Thanks, Sash. Thanks for the questions. I always appreciate it. So with regard to TAPI, I think what I can say is the exciting thing about TAPI is it works across all technologies and platforms. So it's the second largest API manufacturer in the world with extensive R&D and manufacturing capabilities. So we touch every aspect of API across all platforms and technologies, which has allowed us to return it to growth quickly because obviously we can work with many partners, CDMOs, as well as actually pharmaceutical companies. So we feel very confident that that part of our business is well positioned for growth for this year, as well as beyond when it's separated. With regard to Esteto and your question about, I think, the IRA and the pending change in the payer landscape, what I would say, when we put the pivot to growth strategy together in last year and we communicated our $2.5 billion target for Esteto in 2027, If you remember, we communicated that we took into account IRA at that point. And so we have included that within our forecast going forward. Now, it's a dynamic situation. And as we get more information, obviously, that gives us more clarity on what we plan for and the assumptions we've made. So that answered that second part of the question. I think I will add, though, as you've seen by the presentation today, both from Eric and myself, you know, we have a lot of assets as well coming through. We have USEDI, which is gaining momentum. We have Alanzapine that's coming to the market. We have ICS Saba that's coming to an exciting market that's differentiated. And then we have, obviously, in a slightly longer midterm, we have TL1A. So I think, hopefully I've answered your question clearly on Esteta, but I also would like to highlight, too, everybody that we have an innovative pipeline that is maturing very quickly, and that also helps us maintain our growth trajectory. Thanks for your questions, Ash.
spk11: Thank you. Our next question comes from Balaji Prasad of Barclays. Your line is now open. Please go ahead.
spk00: Hi. Good morning, everyone, and great to see the all-round growth across all business segments. Two questions from me. Firstly, on our state of Richard, you have commented and you have spoken about the efforts that you have been doing in revamping this business. Maybe it's a good time to kind of revisit and help us understand what's working here and where do you see scope for further improvement in the field with regard to diagnoses or spreading the knowledge. Two, on Simlandi, I think what we are seeing latest is like 20% have 20% of market share. We are yet to see Simulandi starting to impact this and accelerate the trend. So you did call out that you expect to see launch in Q3 and Q4. And your partner has commented upon purchase orders booked for 1.1 million units, approximately 10% of the market. So could you quantify what that means in terms of impact for Teva? Thanks.
spk12: Thanks, Balaji. I appreciate the questions. So on Estedo, what keeps driving the momentum and the performance. I think I've sort of mentioned this past, but it is worth reiterating. We have a great team. We put together an absolutely great team, world-class team here. We've given that team the resources necessary to execute the plans that they have. And that execution is getting better quarter on quarter. You know, some of the plans this team put in place last year, we're only going to start to really gain traction this year. And there are other things that have been done by this team that will gain momentum. DTC is one of them, bringing more of these undiagnosed patients into the office. But that's merely just one of them. There's many things this team are doing around the channel, effectiveness, adherence, getting patients onto therapy, onto the right dose. but it really comes back to a world-class team who know what they're doing. So that gives me a lot of confidence that this trajectory that Esteta is on can be maintained. Now, with regard to Simlandi, we did launch in Q2, as you pointed out, and we have had significant interest from the channel and the payers. So what I've communicated in my presentation is, We're well set. We have the channel stocked. We've had good interaction and we're getting ever increasing coverage with the payers. And now it's down to us to try and pull that through, working with our partners to pull that through. And I think that's when we're going to get more clarity on how effective we are at doing that and the market is of switching from the brand to the biosimilars in Q3 and Q4. So I'd say there's more to come on that as we play out the rest of the year. But we're excited by the opportunity. And as I keep communicating, we have a portfolio here. And we're going to keep bringing this portfolio to the market. I think the U.S. market is going to continue to mature and become more dynamic and more receptive to biosimilars. We've seen that start this year. I envision that will continue throughout the rest of this year and years going forward. So we remain excited about how biosimilars and our portfolio can help drive pivot to growth. Thanks, Balaji.
spk11: Thank you. Our next question comes from David Amselem from Piper Sandler. Your line is now open. Please go ahead.
spk02: Hey, thanks. So I wanted to drill down more on operating leverage, not so much for the back half of this year, but longer term. So in terms of spend, you've got eventual launch of LAI Olanzapine. So there's launch spend there. obviously investments in Osteto. And then, of course, you're talking about further investment in R&D. So can you just talk about the trajectory of spend longer term and how that fits in with your ability to drive significant operating leverage as we move through next year and longer term? So that's number one. And then secondly, can you talk more broadly about your neuroscience business and specifically how M&A fits into that. You have a leverageable asset with your sales organization. So how much of that is a priority as opposed to just focusing on cultivating the pipeline? So help us understand your thought process there. Thank you.
spk12: Thanks, David. Thanks for the question. So on operating leverage, a couple of things that just help sort of frame it. Firstly, we have a lot of opportunity at Teva to drive growth. And I think as I've communicated in the past, you know, we've made a decision to invest in that to make sure we can take this opportunity and maximize it. And that's both across the products we have in the market, Esteto, Uceti, Jovi, and soon to be Olanzapine, as well as the pipeline that Eric's team are bringing through quickly. Now, Just a couple of things to build on what you said. Obviously, when it comes to launching Olanzapine, we already have the infrastructure, the sales force, everything in place with UCEDD. So that's a beautiful synergy we have there. So as we launch some of these products, we see probably maybe an incremental increase in S&M, but nothing of any major because we have this CNS-focused sales force that we can leverage. So I think that's one thing to understand. The other thing is, We have thought very carefully about how we accelerate our pipeline and how, in some cases, we've partnered with people to do that because we're conscious that we do want to achieve leverage. We do want to get to the 30%, and we believe we've developed a path to do that. other thing i'd add in which i did have on one of my slides but i didn't talk about is we're also increasing the performance in the efficiency within our manufacturing base which obviously is a significant cost base and so we put together a value-added program we call values acceleration program sorry which is all about driving down cogs driving efficiency driving improvement in networking capital you know all the fundamentals but we're going after that with a real vigor so that's also going to be able to improve our gross margin which will help obviously fall down the p l and obviously to highlight you know we've we've hired matt shields our new head of manufacturing tgo who comes with a great wealth of experience of putting programs like that in place so that's another area so that's why we believe we remain confident about hitting the 30 margin and Um, also I'd like to add on that, you know, we do have, um, significant growth in these products in Pestero, in Busetti, in Olanzapine, in ICS Sabra. And I think, you know, that's where also people need to understand how that with a different gross margin falls down the P&L. Now to move on to your second question about our neuroscience business. Um, we're very excited about it. Uh, we're very excited about the capability and I think we've had a few questions around. this about how we've managed to really drive the performance of Estedo, also the performance of Ejovi in a very competitive market, and the acceleration and the momentum we've got behind Yesedi. So that is an asset, and I think you described it as that, our sales organization, our commercial team, and we are looking to add to that. So let me be very clear, we are. But we're pretty choosy. We're very mindful of Teva's position, Teva's balance sheet, and the opportunity we have organically. So we want to make sure whatever asset we bring in, it is complementary from a financial perspective as well as complementary from a capability perspective. And so we are looking, but we want to make sure we do the right decision because we think we have good momentum, we're on the right track, and so we want to make sure that it's additive to that. So that's the answer to your second question, David, and appreciate your questions.
spk11: Thank you. Our next question comes from Jason Gerbery of Bank of America. Your line is now open. Please go ahead.
spk03: Hey, guys. Thank you for taking my questions. First one's just on generic revelment. It's clearly a big contributor from what I can gather. And so how should investors think about the sort of size of this product. They're going to need a model. This is revenue that will need to be replaced in 2026 when the limited competition dynamics come to an end. And along those lines, I'm seeing like in the first half non-GAAP adjustments of about $270 million for contingent considerations on future royalties tied to generic revenue limits. So can you walk through the accounting on that? Is that just sort of for planned future royalties over the next year and a half while the product is subject to limited competition? So those are my questions. Thanks.
spk12: Okay, Jason, thanks for the questions. I'll start and maybe give Elliot a chance to also contribute so you don't have to just continuously listen to me talk. So we're pleased about, firstly, let me just say we're pleased about our generics business, 14% growth globally. And we have a big business, as I've mentioned many times in the past in Europe and international, and that's growing at 8% and 22%. So really proud of that and congratulations to the team. And I want to make sure we appreciate that. Now moving on to the US, which obviously we saw significant growth. Now, part of that is driven by Revlimid, the continued good performance there. But I do want to remind everybody that we have launched a number of complex generics into the market this year, and that also drives growth. as well as we launched Victoza in Q2. And obviously Victoza is an exciting opportunity, the first GLP-1 into the market. And so that's received a lot of attention. And so also that's helping us drive growth. We also do have just underlying good performance in our generics business as we manage our supply chain better than we've done in the past. So I think all those fundamentals sit together. Now, we are aware that in Revlimid, there is going to come a point where this does come to an end. And because of that, we're focusing really hard on making sure we bring our high value complex generics to the market on time more often. And I think you've seen some progress on that. And we have more of them to come, hopefully this year. as well as early next year. We also have our biosimilar portfolio, which I've highlighted earlier, is six biosimilars to come to the market. So as we put those together with the improvement in the operation efficiency of our base generics business, I think we have the ability to minimize the impact of Revlimid when that product has more competition. So that's the way we view it and we're planning for it. So I think we feel that we're in a good place. We have to keep executing, of course. But with that, I'll hand it over to Eli to answer more of that specific question around the royalties.
spk08: So Jason, as you saw last quarter and this quarter, actually year to date, we are around 238 million on the adjustment on the continuous consideration. This quarter is 174. This is coming strictly from the fact that, you know, based on accounting rules, you need to forecast. and actually the that's the ability that you have on the balance sheet which is coming from a legacy acquisitions as you know and and this is just a reflection of our forecast thanks jason thanks for the questions thank you our next question comes from omri effroni from opco your line is now open please go ahead hi guys and congrats for the recording
spk05: I was wondering if you have, if you can give some more color about the BFC model market in the United States, because last time we talked, the market wasn't opening up because the PBM rebates, and I was wondering if some movement has been taken in the market.
spk12: Hi, Amrik. Good morning. I didn't quite catch that question clearly. Maybe if you could repeat it, that would be helpful. Thank you.
spk05: I was wondering if Teva has seen some movement in the biosimilar market in the United States. Because last time we talked, the biosimilar market was pretty slow, and I was wondering if the dynamics have changed.
spk12: Yeah, I got it. Thank you for that. Thank you for repeating. So the dynamics have changed. And it continues to remain dynamic. So we have seen more of an appetite for the PBMs and the payers to embrace the opportunity of biosimilars. That said, it is a complex market in the U.S. and how you take that and how you drive that through the channel to the physician to the patient is variable. I think what is most important for me is, as we've seen it with some of the deals that we've done on private label and other things, the pairs and the PPMs and the channel are really looking at biosimilars in a different way. And I think they're seeing this as a strategic opportunity to help them manage costs better and help them give access to these important therapies to patients. But it's dynamic, and I use that word specifically because it is constantly changing, and so I don't think this is necessarily a straight line. I think we'll end up at a place where it becomes very settled, but I think we're still on that journey.
spk05: Okay, got it. Maybe I'll follow up.
spk12: Yep, go ahead.
spk11: Apologies. Our next question comes from Uma Rafat of Evercore. Your line is now open. Please go ahead.
spk10: Hi, guys. Thanks for taking my question. I have a couple here, if I may. Perhaps first, Richard, I know you spoke to the Austedo dynamic, but could you remind us, is it about half of it which is Medicare? Because I was trying to think about potential IRA inclusion in 2027. And if half the sales have a 25% price cut, wouldn't it mean Osteto could be flat in 2027? So I'm just trying to think about the $2.5 billion number, and maybe that's broadly the ballpark, not precisely to the dot, but just wanted to put that in perspective. Secondly, on TL1A, could you confirm there was not any interim analysis? Thank you very much.
spk12: Hi, Emma. Thanks for the question. I'll answer the first part, and then I'll let Eric answer the other one, just so Eric can talk. I don't want him to go through the hour without talking. So answering the question on Esteto, look, I think as I said in my first comments, we have taken into account the IRA with Esteto. We thought about that long and hard last year because when we set the $2.5 billion, we knew that would be be challenged for many reasons, and so we wanted to be sure. Now, so we have taken into account. Now, one of the things you've highlighted is we don't know how this is going to play out accurately, and we're going to learn a lot in the next few weeks, and we're going to learn a lot in the next six months. and that allows us to refine the assumptions we made and those predictions we made. But I feel confident because of the fact that we took it into account right at the start, and I think that was the most important thing. So as that becomes even clearer and more accurate, we'll come back to you, Uma, and everybody else to give you an update on that. But I feel we're in a good position. With regard to the TL1A, I'll hand that to Eric. So over to you, Eric.
spk04: And thank you, Omer, for the question. And I can confirm there's been no interim analysis for our TL1A program. The study remains blinded. We're just very excited that we're able to accelerate the enrollment, get the full data set going so that we can bring that into 2024 in the fourth quarter. You know, this is agreed upon by our DMC, and we're excited just to accelerate the program so we have a full data set by the end of the year.
spk10: Thank you so much.
spk12: Thanks, Uma. Appreciate the question.
spk11: Thank you. Our next question comes from Glenn Santangelo of Jefferies. Your line is now open. Please go ahead.
spk13: Yeah, thanks for taking my questions. I just wanted two quick ones for me. First, I wanted to follow up on the strength of the generics business. I mean, Richard, you obviously called out, you know, the contribution from Revlimid, Epinephrine, and Truxamide. I think you also, you know, mentioned Victozin, the press release, but that seems like it was launched, you know, right before the end of the quarter. And so I'm just trying to think about the growth outlook in the second half of the year in the generics business relative to the first, just sort of given the unique characteristics of the Rev Limit Agreement, you know, offset potentially by, you know, the recent launch of ICTOSA and maybe what's going on with Simlandia, et cetera. So if you could just sort of frame the second half for us versus the first half. And then my second question maybe is for Ellie. I'm just kind of curious if you can give us a rough sense of the profitability characteristics of the TAPI business, you know, so we can maybe start to get some working assumptions about the potential proceeds from this divestment in 2025. Thanks.
spk12: Thanks for the question, Glenn. So I'll start with the first one on generics and then hand over to Ellie. So I think you've highlighted a number of the variables which have made the performance of our generics business in the US strong and perform well. And I think, you know, as Elliot highlighted, that is part of why we're raising our guidance for the year is our generics business is performing well across the globe as well. So I think we remain confident that the strategy we're executing around our generics business is playing out well. I would also like to highlight And I think it's well understood that when it comes to Revlimid, the majority of sales occur in Q2 and Q3. And so obviously you see the slowdown there from a Revlimid contribution in Q4. But at the same time, we've got Victoza that we've launched and we've seen a good start to that. And we have some other complex generics that we're going to be launching in Q3 and Q4. So our aim going back to the strategy is always to keep focusing on our pipeline and bring it to the market as fast as possible. But to answer your question, yeah, the guidance has been moved because of some of our innovative products, but also our generics business. Over to you, Eli.
spk08: Yes, so we are in a very mature process, I would say, with the API. And we will come with more better updates in the next quarter. And we are not providing actually any prediction about the proceeds because we want to respect the process with the potential buyers and our advisors that are helping us in this transaction. So we just need to be a bit patient.
spk12: Thanks for the questions, Glenn.
spk11: Thank you. Our next question comes from Chris Schott of JP Morgan. Your line is now open.
spk01: Please go ahead. Great. Thanks so much for the questions. First question was just on the biosimilar Stelara market. Assuming given the launch next year, you're starting to have some pair discussions. I'm just wondering if you see any similarities or relevant differences we should think about relative to how biosimilar Humira shaped up. My second question was then on the olanzapine LAI opportunity. Can you just elaborate a little bit more about how you're thinking about the market development and specifically, do you think of this as largely a conversion of oral olanzapine or as an opportunity to convert existing LAI products? And maybe a second part to that olanzapine question, there does seem to be a lot of enthusiasm for the muscarinics that are going to be launching in 25 and 26. Does that factor at all in terms of how you think about an uptake for olanzapine LAI if physicians are kind of excited to try a new mechanism and they're tougher patients? Could that be a hurdle at all to getting penetration with olanzapine LAI? Thanks so much.
spk12: Thanks, Chris. Appreciate the questions. So starting with... biosimilar of Stellara. I think a couple of things that I think play out here is one, from our perspective, I'll talk to them from our perspective and from the markets. From our perspective, we know we're going to be able to launch in February 2025. We've had approval from the FDA, and so that allows us to plan effectively. We probably didn't have that luxury in the past with biosimilar Humira because of the challenges we faced, as you know. Now, we can't start talking to payers until six months prior to February because that's part of the agreement. But there's many things that we have learned through biosimilar Humira, as well as the time we'll have for the team to plan for that. So I think that sets us up better. With regard to the market, how is that going to play out? What I've learned from my time launching lots of biosimilars, particularly in Europe as well, is no one biosimilar is the same. That said, I would say the people, the PPMs, the payers, the channel are becoming more knowledgeable and have an increasing appetite for the benefit of biosimilars. And that will play favorably for Stellara. So I think the market's changing, becoming more receptive. We're getting more experience in how to bring these products to the market in this dynamic market. So I think that gives us a positive encouragement for how we can launch Stellara Now, moving on to the olanzapine opportunity. You're right. There is a lot of excitement around this. And the reason why there's a lot of excitement is, you know, olanzapine is the number one prescribed molecule for treating schizophrenia. And it's the number one because it's considered the most efficacious. But there isn't a long acting that meets the needs of the physicians. And so that hence the excitement. Now, you ask where it's going to come from. Is it going to come from oral olanzapine or are we going to start switching some of the other long actines? I think, you know, our going in assumption is it's going to come from the orals because obviously a patient that's on olanzapine oral, they haven't been able to go into a long acting because they don't have that availability. And we see that as a simple opportunity. Will there be some of the long actines that could come across if they need more efficacy? I think that's probably the answer to that is yes. How much? Uh, we'll see, and, and we're building more and more of an understanding as we've got these positive results through, and we go into the market to understand how physicians think about this. So, but that's my initial answer to that question. And then with regard to some of the new, uh, uh, mechanisms of action coming through. You know, I'll start and then I'll hand over to Eric, but, but one of the things we've seen in, as we gain knowledge with launching your setting to this market, and I think we're getting really good knowledge of this physician community and the patients. as well as some of the research we're doing on olanzapine, is these molecules are trusted and understood. They do what they're required to do, and olanzapine particularly is considered to be incredibly efficacious in helping patients control their schizophrenia. So I think in these conditions, understanding what works and where they have experience plays out significantly. But I'll hand that over to somebody who's probably more educated on it, to Eric, to further answer it.
spk04: Yeah, thank you, Richard. And it's exciting to see, you know, developments in the schizophrenia space. It's always good for patients. But, you know, to emphasize some things that Richard said, you know, the value in Zeti and Olanzapine LEI is the long-acting injectable and the fact that they're, you know, well-known, tried and true medications that physicians use. So that change won't happen overnight. I think the value that we're watching and the science of where it treatment of schizophrenia is going is in these easily convenient, easily used, convenient injectables that are easy for the patient to take. So that's the value, and I think that that will stay for quite a while.
spk12: Thanks, Eric. And Chris, thanks for the question.
spk11: Thank you. Our next question comes from Yifeng Liu of HSBC. Your line is now open. Please go ahead.
spk09: Thank you for taking my question. I've got two. The first one is on your sort of early stage innovative assets. Just wonder, how are you thinking about these assets? Is the collaboration with Sanofi on TL1A something to refer to in the future? Or are you also thinking about doing the whole development in-house? My second question is on the guidance. So in the event of the TL1A possible phase three, happening. So is there any sort of milestone in the current guidance update? Thank you.
spk12: Okay, thanks for the question. So we are very excited about our innovative pipeline and as Eric's outlined, I think just to clarify something, the TIL 1A is in partnership with Sanofi. So the development of that into phase three will be the phase three execution will be done by a partner, Sanofi, which we're very excited about because of their experience. With regard to the guidance, there are no milestones in this guidance for this year because we'll actually be moving into phase three next year. And as per our agreement that we announced, any milestone will occur once we enter phase three. So if that does happen, that will be happening in 2025. But thanks for your questions.
spk11: Thank you. At this time, we currently have no further questions. So I'll hand back to Richard for any further remarks.
spk12: So I'd just like to thank everybody for dialing in and having the interest in Teva. We very much appreciate that. And thank you for your time and look forward to giving you an update on the performance of Teva and Pivot to Growth in Q3. Thank you. Bye-bye.
spk11: Thank you all for joining today's call. You may now disconnect your lines.
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