Teva Pharmaceutical Industries Limited (TEVA) Earnings Call Transcript & Summary

Good morning. Welcome to the Jefferies Healthcare Conference in New York, Day 1. My name is Dennis Ding, biotech analyst here at Jefferies. I have the great pleasure of having Teva here with us. Welcome.

So maybe to -- I think there's a little bit of feedback, but maybe just help level set us in terms of where the business is right now and how the business has evolved over the last several years and some of the investments that you have put into it, maybe also layer in some of the targets that you guys have set out recently at your R&D Day.

You want to start?

Sure. Yes. So we have been on an amazing journey, and it's been a really fun time to be part of the company. Our pivot to growth started in 2023 and really focused on growth and kind of pivoting, quite frankly, in 4 key areas. So fueling our innovative medicines, advancing our pipeline and innovation in that space, kind of underscoring our heritage and in generics and becoming a powerhouse and continuing that journey. And then lastly, focusing our business and our effort and our investment. We've advanced in all 4 of those pillars and have made some amazing strides in kind of building new capabilities. Foundationally, we've had 9 quarters of consecutive quarters of growth and kind of returning to that. And now we're entering that next phase of acceleration between 2025 and 2027. So it's an exciting time. And our key assets from a commercial perspective, AUSTEDO, UZEDY and AJOVY continue to be really key drivers. And in parallel, Eric can speak to kind of where we're at with the pipeline and some really, really exciting advancements there as well.

Yes. Just to add, 2.5 years ago, we started a journey of rebuilding and focusing on our innovative medicines to a step up in innovation. We have a modern drug development matrix system in place with great leadership. And we really doubled down on what is a good pipeline or a great pipeline at Teva. I'm very proud that we have now 3 Phase III programs running, our olanzapine LAI program for schizophrenia, our duvakitug program that's partnered with Sanofi, a first-class biologic that has shown great data over the last 2 years. And then finally, DARI, our dual-action rescue inhaler program. So 3 program with what I believe is a high probability of success at this point. And then that's on top of the pipeline that we're working on. So it was a great way to start the pivot to growth with the innovative part, and it capitalizes on a lot of great talent across the company for generics biosimilars and the innovative pipeline.

Right. I think AUSTEDO has been a huge powerhouse and a huge driver for the business. And even outside of that, you guys have made amazing advancements in the pipeline with the TL1A, et cetera, right? So maybe we can focus a little bit on AUSTEDO. I mean you mentioned $3 billion or more than $3 billion in peak sales. Can you just talk about the pushes and pulls to that number, the timing of that, et cetera?

Yes. So I think we've been very clear about the significant opportunity. And I think a big part of this is understanding the unmet need. So if you look in the U.S. alone, there's around 800,000 patients with TD, the biggest indication. And majority of those are not diagnosed, so about 15% and then about 5% to 6% on treatment. And so it's a really, really kind of underserved patient population with significant opportunity. And if you take a beat off of Q1, for instance, we had about 40% growth, 23% in TRxs. This is the kind of cadence and rhythm that we've been in with this investment. We've invested quite a bit in direct-to-consumer and driving awareness because of this massive population. We've also filed in Europe, and we'll get feedback here later this year on that opportunity there and what that looks like. And so in totality, we think that there's going to continue to be significant growth in this space, both from TRxs and the advancement in kind of our approach from Eric shop has been with our XR formulation, which has made a massive impact in patients being able to start on 1 pill once a day across all of our doses along with the titration kit. So it's life cycle management and its finest in a product that has -- was long launched and rebuilding kind of that brand with very specific and surgical investment.

And how should we think about AUSTEDO and the competitive landscape there with Ingrezza?

Yes. I mean I think to have 2 products in this space is really a good fortune. We're delighted. I think they're on the same journey as us in that we want to try to get as many patients treated as possible. So I look at it as less about the companies being competitive and more having a competitive approach against getting more patients diagnosed and treated.

Okay. And Neurocrine, when they reported Q1, they mentioned that their Part B formulary inclusion increase from 50% to 60% of covered lives. Like how should we think about that as it relates to AUSTEDO? And does that change the competitive dynamic on the ground at all?

I don't believe it changes the competitive dynamic. We have really broad coverage and have -- since we've been in this space, that's been part of our strategy is one of our goals was to make sure from a patient level that individuals that were -- had coverage could afford their medicine. So we're really proud to say that for folks that have coverage, they pay on average less than $10 a month out of pocket. So really, really meaningful. So this has been part of our journey all along.

Okay. And then obviously, AUSTEDO is part of the IRA drug pricing negotiations. Can you just comment a little bit about how you see that going and if there's any updates from that -- on that end?

So no real updates. I mean I think the bottom line is we're in the throes of it, and we're prepared, and we will keep you posted as soon as there's news to share, which we expect to be around November.

Okay. But as it relates to the $2.5 billion in 2027, there is a little bit of, I guess, like hesitancy or like skepticism around AUSTEDO reaching that number in 2027 given the IRA situation. So can you just -- what is your message to investors and helping them get comfortable with the growth trajectory so that you get to 2.5 even with the IRA?

Yes. I mean, simply put, we factored it into our plan. And it could be a little bit more, it could be a little bit less, but I think the direction of travel is we still believe in growth in the opportunity based on some of the things I outlined relative to the market dynamics.

Okay. Got it. And then if we can shift over to the long-acting injectable UZEDY. Just talk about what you saw in Q1 and the outlook for this year.

Yes, we're excited about UZEDY. I think this has been an amazing advancement in the LAI space and a much, much more favorable product with lots of advantages. And we hear this from physicians as well. So I think the clinical value proposition is there. Physicians also tell us that sustainability on orals for this specific patient population is very, very difficult. They're not compliant. So it offers an opportunity for clinical efficacy, the fastest and easiest way to get a patient control, a physician can dose them in their office today and maybe by this evening but certainly by tomorrow at the same time, they're feeling relief. So we continue to advance that. We have taken a good bit of the risperidone class, which is the space that we play, and now we're looking to expand that usage in paliperidone and some of the other best-in-class LAIs and take some of that share.

Okay. There's obviously a lot of investor focus on the long-acting olanzapine. So what kind of learnings do you have from UZEDY? And how would you apply that to the long-acting?

That's a great question. And this is our sweet spot, quite frankly, because now that we've built the know-how in UZEDY and really, really understand the patient journey, which is a big part of this very, very complicated system, we will layer olanzapine right in on that. So from a market access perspective, from our field teams, both on the medical side as well as on the commercial side, we're really poised to be able to understand this and to meet physicians where they are and trying to help them understand kind of what patients would be appropriate for LAIs. And so I think it's a meaningful thing, and we look forward to having leadership across 2 compounds that we think we can cover about 60% of the patients that are currently on orals.

Can you kind of take a step back and talk about risperidone versus olanzapine just in general, like how those are used and with the long-acting, how much share can you actually capture?

Yes. I mean we'll see. I think the bigger opportunity is really having more utility for LAIs. Unfortunately, they're not as used as widely in the U.S. as they are even in Europe. And I think getting physicians in a head space to have that conversation with patients to make that opportunity available to them for more control is really, really meaningful. And I think we look at the continuum of care across UZEDY and olanzapine as UZEDY really being the gold standard in risperidone and olanzapine being the gold standard for the olanzapine molecule, which is about 20% of the oral. So across that, some of the patients that present more agitated will do better on olanzapine, and that's where physicians are thinking about across the continuum of opportunity. So really meaningful and very broad coverage with the combination.

Okay. And when the long-acting olanzapine gets approved, how do we think about the shape of the launch trajectory for that drug? And should we be using UZEDY as kind of like a proxy for that? Or do you expect a little bit faster uptake?

Yes. I think it depends. And I think we're -- right now, I would recommend using UZEDY as the slope but we expect that given the investment that we've already made in the market that, that will be discussions. And I think there's some pent-up demand, and you can probably speak to this from physician perspective but people are excited about olanzapine because they know the molecule. It's well trusted. People know what to expect. So yes, we'll kind of plot that out as we go.

Yes, I agree that UZEDY is doing well. We were -- I'm pleased to see that the product profile that we always thought was very good would be well received, applying that to olanzapine where there's really no options for those folks. And for patients who need an option that either more complex or there's more mood characteristics to their schizophrenia, they need a different option. And as Chris said, physicians know the molecule. They know how it works, how it can really get schizophrenic symptoms under control. Having said all that, I think the most important thing that now that we have better injections like UZEDY and our long-acting olanzapine that are subcutaneous, don't require any supplemental oral medications that are easy to use in the clinic that in a busy clinic, you don't have to worry about all this stuff. You want to just get people on treatment as well as possible. So to that point, having the ability now to impact relapses, impact hospitalizations and eventually use LAIs to have more of an impact on the progression of the disease is a real goal. I think most physicians would now acknowledge that there's accumulating data that more people should be on LAIs. I mean it is, I think, a better way of treating patients with schizophrenia because adherence is just difficult, it's difficult for everyone, including people are struggling with schizophrenia.

Yes. The data would show that being on an LAI is super important to, as Eric just said, decreasing hospitalizations and relapses, which is very significant for this patient population and ultimately affects their ability to function. And when they relapse over and over, it creates a deficit in their gray matter and their inability to function kind of their brain space. And so we know this and the data supports that. That's the case that we're going to make is, listen, go to an LAI much earlier. It allows for control and ultimately, that patient has a meaningful net outcome.

Great. And Eric, can you just clarify just on the long-acting olanzapine, just as you file for approval and you're in labeling discussions, like talk about the dynamics with the label and the monitoring requirements and how important that is commercially?

Yes. So I always like to step back and talk about what is the science behind the olanzapine LAI. I mean it was designed to avoid PDSS. This is this post-injection delirium and sedation syndrome that with the currently available long-acting injectable really limits the use. And why does it limit the use is because it requires you to be monitored for 4 or so hours after the injection, which is really -- that's a problem. It's that monitoring that keeps people from being able to use it. So ours is a different formulation completely. It's a subcutaneous injection as opposed to an intramuscular injection. The formulation itself, even in the worst-case scenario, and we've presented all this data, if you were to inject the different formulations, in the worst case scenario, right into the serum and measure the dissolution, the other molecule goes into the solution very rapidly and immediately. And even -- ours even in the liquid just forms an aggregate and controls the release. So in vitro, it's a night and day comparison. We've done tons of Phase I studies. We've never seen a spike in the PK. And I should say it's that spike in PK that causes it's believed the sedation syndrome, the PDSS. So we don't see that in any of our Phase I. And now we've finished the Phase III study all the way out in the long-term follow-up, and we've seen none of it after 3,400 injections at this point. So the totality of the data that we've created today, scientifically, it's very unlikely, in my mind, almost impossible to have these side effects. But FDA has worked with us to design the studies. We've agreed on the target. So it will always be at the end of the day, a review with FDA but we think the label will be favorable, and it's critical that we don't have that monitoring after the injection. I think the data supports that.

Yes. Okay. That's very helpful. And you guys gave $1.5 billion to $2 billion peak sales guidance between UZEDY and your long-acting olanzapine. If the FDA were to require monitoring, would you change that guidance? Or is that already kind of accounted for?

I mean, for one thing, we don't think we're going to have the monitoring. There's -- I don't believe there's a reason for it at this point.

Yes. Our base case does not include monitoring.

Okay. Okay. And if we can shift over to the pipeline, specifically the TL1A. It's a very exciting molecule, kind of like pipeline and a product, and we've seen a lot of interest among investors in that mechanism. So remind us what you showed in UC and Crohn's and what really drives the confidence that this could be a blockbuster asset?

Yes. So it is a very exciting molecule. It's a whole new biologic class. And just to kind of level set everyone, the interesting thing about it, it's blocking a cytokine that amplifies many different pathways in the inflammatory process. So an amplifier that can affect many different things is intriguing for many different indications. For me, ulcerative colitis and Crohn's disease was really just a proof of principle that blocking and amplifying cytokine can actually impact the signal or disease. So the next step is now going to define sentinel indications, whether it's type II or a non-type II or even a fibrotic indication, that will then unlock many different indications potentially in the future. So there's a long way to go, and it's -- we're going to have excitement showing all these different things in the future. There's differentiation about our duvakitug, which is the fact that it's the most potent molecule in this class. It also targets molecules and maintains the decoy receptor. So we're blocking the inflammatory signal but we're also allowing clearance of the TL1A through the natural body is a homeostatic mechanism to inflammation. So it's differentiated on its potency. It's differentiated on its selectivity. It also has very low antidrug antibodies. In our Phase II study, it's been 3% to 5% in that study so far. So that's very encouraging for a durable response in the future. And then finally, I have to say that we've shown -- we've posted and reported the highest numbers of placebo-adjusted effects in both ulcerative colitis and Crohn's disease. And even more exciting, when you look at the subgroups of treatment-experienced patients, that's people who have failed multiple types of biologics or small molecules versus people who are naive to treatment, numerically, our treatment experienced patients were actually even slightly higher. So the effect of the molecule has been maintained irrespective of whether you're naive or experienced a treatment. And that's super important in a chronic disease area where people who usually fail about 50% of the time after 2 years on a biologic. They need durable things that can treat people who have been previously treated. So it's very exciting for people with inflammatory bowel disease.

What's the next data update from the Phase II? I believe there may be maintenance data in the second half of this year. Is that fair?

Yes. So the data that's brewing right now is we finished up that cut after the induction phase of the study at the end of last year. It's a 44-week long-term follow-up. So we'll be seeing a new cut of the data. We'll finish the study around December. So you'll look at data probably in the first half of '26.

First half of '26?

Durability of response, yes.

Okay. And can you just help frame for investors what to expect going into that maintenance data? Should we expect efficacy or like remission to slowly degrade over time or generally be durable? Or could responses even improve over time? Like how should we think about it?

So I always have to make sure the data is blinded at this point. So I have no idea. I mean, certainly, there's been encouraging results already for this class that maintenance can be continued throughout the long-term follow-up. So we're really hopeful that, yes, we keep a good high maintenance rate. That's what's going to be important for patients in the future.

Okay. And as you think about additional indications, what's high up on your priority list? And when can we hear more about that?

Yes. I can tell you how we think about it. So first of all, as I mentioned in the strategy, you want to be able to define classes so they can guide your further development. So T2 versus non-T2, I think, is going to be the most important next step. We choose indications on a number of different factors. One, does it -- is it a good market to get into? Is there an unmet medical need with patients? So is there value in what you're going to look at? Is it got an endpoint that's easily to define and rapid to do; and speed is the other component. So all those things add up to how we're going to choose our sentinel indications, and then we'll work down the list for all the further indications after that.

And I believe the priority here would be in ulcerative colitis and Crohn's and moving that ahead Phase III. But in terms of these other adjacent indications, should we expect like many -- like multiple clinical trials in those indications at the same time? Would they happen over a staggered fashion? Would you have to wait for other kind of proof-of-concept data before expanding into third, fourth and fifth indications? Like how should we think about the cadence of that?

Yes. So first and foremost, we're starting that Phase III studies in ulcerative colitis and Crohn's disease with Sanofi this year. We're very excited about that. They're moving very quickly, which I'm really pleased with the partnership. Now when it comes to the other indications, these will start to be running in parallel. In large programs where you're defining the safety and efficacy of the drug, usually, when you go into new indications, you're going to have to do a Phase II study. So that's what I think you should expect when you come to the next step. So because you want to be able to get into -- define your dose as well as possible. As we learn more and more about these molecules, you'll be able to speed that process up of other indications. Someday, we might be going straight into Phase III. That's a little ways off. But as we define the dose, the PK/PD and the modeling across indications, you'll be able to accelerate that more. But now I think you should expect a robust Phase II development before you go into Phase III.

Yes. Makes sense. In terms of safety, maybe talk a little bit about we saw in Phase II and as you think about these other indications, is there any kind of upside to the dose given what you've seen in safety?

Yes. So that's a great point. I should always remind everyone of this. In the safety cuts that we did on our Phase II study, the rate of AEs and placebo and active were the same. They were 50% each, and we've seen no other AEs reported more than 5%. So that's very encouraging. So the idea of moving forward quickly, that's going to be helpful. It also be helpful someday when you do combinations. You have a nice MOA that is safe and well tolerated, lends itself to other different development pathways. So the safety looks really good at this point. As with always in these programs, the things you worry about are long-term opportunistic infections. We don't see that at this point but that's something we pay very close attention to. One of the interesting theoretical things about this program, though, is it's an amplifier. So you're maintaining actual the baseline ability to respond in any one cytokine pathway, and we're blocking the amplification. So whether that gives you a safety benefit in the future, I don't know but it's an intriguing possibility.

Okay. Got it. And lastly, on TL1A, maybe talk about the impact of some of these other anti-TL1A drugs in development that uses more infrequent dosing. Some people view that as kind of the next wave of antibody development. So do you have a comment about that and maybe the competitive positioning of your TL1A?

Yes. So it's great that there's so much interest in this class. I think that speaks to the fact that I think people really believe that this is a great pathway to hit. There's all different ways you can attack a problem with a cytokine, extending your PK profile, extending your exposure. I think we have probably the biggest differentiation right now because we find it in a different way, as I mentioned before, this selectivity, blocking the inflammatory pathway while maintaining the normal body's homeostatic pathway. I think that's one of the biggest differentiators. So there's all kinds of tricks you can do in different antibody designs. I think the next wave, and this is well down the pathways or combinations bispecifics using this target. So I think that's another exciting possibility in the future.

Yes. Okay. And then can you remind us of the DARI program, what that is and how big the opportunity is?

Sure. No, this is a very exciting thing. You can probably add to what I say. But DARI, our dual-action rescue inhaler, this one gets me excited because there's 11 million people having asthma exacerbations every year in the U.S. And the GINA guidelines already say we should be using combination therapies for that. Every -- most people are still using just an albuterol inhaler for their asthma exacerbations. And the clinical evidence is that you should be getting a combination with some steroid when you have an asthma exacerbation. So as a physician, I'm really proud and I'm hell on making sure that people get the right treatment. We have, I think, a differentiated device. We have a dry powder inhaler, very easy to use, very well designed. We have 25 years of history of developing inhalers at Teva. And we're running the largest study in asthma. It's the largest study we've run at Teva. This is 2,000 people. It includes pediatrics, adolescents and adults in the Phase III study, so that we'll have a very good, I hope, in the future, a label that covers everybody, including the kids. And the device is particularly helpful for kids. It doesn't have to use a spacer or have to have any kind of coordination in your breathing. So when you're having asthma exacerbation, when maybe you're a little panicked and you want to make sure you have an easy-to-use device, I think this DARI device that we've developed, I think, is very good just for that. So we're excited to be on track with our enrollment. I think we're targeting enrollment by the end of this year, and it's an event-driven study. So we are calculating probably by the end of next year, we should have enough events, asthma exacerbations to lock the database. So we're excited about it. I think it's a huge and an important unmet medical need that we're well positioned to address.

And do you see any kind of upside to enrollment and exacerbations? Like I'm not sure if you commented on your assumptions for the exacerbation rate and things like that.

Yes. So we do modeling about practically every week about the enrollment rate that we're seeing and the exacerbation rate we're seeing. And our models still shoot for about the end of next year for the number of events that we need. So right now, everything is on target. We put a lot of effort in making sure that we get the pediatric and the adolescent numbers up because that's usually the hardest populations to enroll but I think we're doing a good job on that as well.

How should we think about the data card flip late next year in terms of what's clinically meaningful? What do you hope to see? What do you think would be a successful Phase III?

Yes. So I mean, we're targeting exactly what we've seen with other programs that have it because there's a lot of data. These are the good old albuterol and fluticasone that we have in the device. So it's well known to everyone what the effect size should be, and we're targeting that.

Okay. And last question because we do have 1 or 2 minutes left. Just broadly, talk about the tariff exposure at Teva. How much of the business is in the U.S.? And just any kind of mitigation measures that you guys are contemplating about?

Yes. I mean this is one that we obviously are very involved in. And Sharon, who's in the room here with us is running a task force for us internally so we can really well understand what the implications are. We're in a pretty good place. We have 8 manufacturing sites in the U.S. A good bit of our manufacturing serves the U.S. market. So that's very meaningful. We have limited exposure to China and India from a manufacturing perspective. And so we'll sort out Europe as it happens, but we have a very clean line of sight of some of the levers that we would pull. And we've so far managed 2025 really assertively and are in a good place for -- as things evolve throughout the rest of this year.

Can you comment on the level of inventory that you have in the U.S. already and if that's enough to go through the balance of '25 or even '26?

Yes. For a lot of the products that we felt would be more at risk, we have taken inventory in advance. So we're in a really good place.

In terms of manufacturing capacity, how much is left in the U.S. in case you do have to ship some of the manufacturing.

Yes. So we're still evaluating that because we have, as you might imagine, a very broad array of products. So we have to be thoughtful about that and are looking for that value proposition of our most important products and making sure that we don't have any supply interruptions and all those things. So it's a much more 3-dimensional look on that.

Yes. Okay. Perfect. Well, thank you guys so much for being here with us. Hope you guys have a great day of meetings.

Thank you.

Thank you so much.