Morning. Welcome to the Jefferies Healthcare Conference in New York, day one. My name is Dennis Thain, biotech analyst here at Jefferies. I have the great pleasure of having Teva here with us. Welcome. 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.
I'll start?
Sure. Yeah. 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 four key areas. Fueling our innovative medicines, advancing our pipeline and innovation in that space, kind of underscoring our heritage in generics and becoming a powerhouse and continuing that journey. Lastly, focusing our business and our effort and our investment. We've advanced in all four of those pillars and have made some amazing strides in kind of building new capabilities. Foundationally, we've had nine consecutive quarters of growth and kind of returning to that. Now we're entering that next phase of acceleration between 2025- 2027. It's an exciting time.
Our key assets from a commercial perspective, Austedo and AJOVY, continue to be really key drivers. In parallel, Eric can speak to kind of where we're at with the pipeline and some really, really exciting advancements there as well.
Yeah. Just to add, two and a half years ago, we started a journey rebuilding and focusing on our innovative medicines to step up in innovation. We have a modern drug development matrix system in place with great leadership. We really doubled down on what is a good pipeline or a great pipeline at Teva. I'm very proud that we have now three phase 3 programs running. Our olanzapine LEI program for schizophrenia, our Duvakitug program that's partnered with Sanofi, a first-in-class biologic that has shown great data over the last two years. Finally, our DARE, our dual action rescue inhaler program. Three programs with what I believe is a high probability of success at this point. That's on top of the pipeline that we're working on.
It was a great way to start the pivot to growth with the innovative part. It capitalized on a lot of great talent across the company for generics, biosimilars, and the innovative pipeline.
Right. I think Ozethro has been a huge powerhouse and a huge driver for the business. Even outside of that, you guys have made amazing advancements in the pipeline with the TL1A, et cetera. Right? Maybe we can focus a little bit on Ozethro. 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?
Yeah. I think we've been very clear about the significant opportunity. I think a big part of this is understanding the unmet need. If you look in the U.S. alone, there's around 800,000 patients with TD, the biggest indication. The majority of those are not diagnosed, so about 15%, and then about 5%-6% on treatment. It's a really, really kind of underserved patient population with significant opportunity. 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.
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 Hughes has been with our XR formulation, which has made a massive impact in patients being able to start on one pill once a day across all of our doses along with a titration kit. It is lifecycle management in its finest in a product that was long launched and rebuilding kind of that brand with very specific and surgical investment.
How should we think about Austedo and the competitive landscape there within Ingrezza?
Yeah. I mean, I think to have two 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. 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. Neurocrine, when they reported at Q1, they mentioned that their Part D formulary inclusion increased from 50% to 60% of covered lives. How should we think about that as it relates to Austedo? 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. Since we've been in this space, that's been part of our strategy. One of our goals was to make sure from a patient level that individuals that had coverage could afford their medicine. We're really proud to say that for folks that have coverage, they pay on average less than $10 a month out of pocket. Really, really meaningful. This has been part of our journey all along.
Okay. 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?
No real updates. I mean, I think the bottom line is we're in the throes of it and we're prepared. We will keep you posted as soon as there's news to share, which we expect to be around November.
Okay. As it relates to the $2.5 billion in 2027, there is a little bit of, I guess, hesitancy or skepticism around Austedo reaching that number in 2027 given the IRA situation. Can you just, what is your message to investors in helping them get comfortable with the growth trajectory so that you get to $2.5 billion even with the IRA?
Yeah. I mean, simply put, we've factored it into our plan. It could be a little bit more, it could be a little bit less. I think the direction of travel is we still believe in growth and the opportunity based on some of the things I outlined relative to the market dynamic.
Okay. Got it. If we can shift over to the long-acting drug, the long-acting olanzapine, just talk about what you saw in Q1 and the outlook for this year.
Yeah. We're excited about long-acting olanzapine. I think this has been an amazing advancement in the LEI space and a much, much more favorable product with lots of advantages. We hear this from physicians as well. 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. It offers an opportunity for clinical efficacy, the fastest and easiest way to get a patient controlled. 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. We continue to advance that. We have taken a good bit of the risperidone class, which is the space that we play.
We're looking to expand that usage in paliperidone and some of the other best-in-class LEIs and take some of that share.
Okay. There's obviously a lot of investor focus around the long-acting olanzapine. What kind of learnings do you have from Ozethro? How could you apply that to the long-acting?
That's a great question. This is our sweet spot, quite frankly, because now that we've built the know-how in Austedo 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. 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 LEIs. I think it's a meaningful thing. We look forward to having leadership across two 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?
Yeah. I mean, we'll see. I think the bigger opportunity is really having more utility for LEIs. Unfortunately, they're not as used as widely in the U.S. as they are even in Europe. I think getting physicians in a headspace to have that conversation with patients to make that opportunity available to them for more control is really, really meaningful. 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. Across that, some of the patients that present more agitated will do better on olanzapine. That's where physicians are thinking about it across the continuum of opportunity. Really meaningful and very broad coverage with the combination.
Okay. When the long-acting olanzapine gets approved, how do we think about the shape of the launch trajectory for that drug? Should we be using UZEDY as kind of like a proxy for that, or do you expect a little bit faster uptake?
Yeah. I think it depends. I think right now, I would recommend using olanzapine as the slope. We expect that given the investment that we've already made in the market, that that will be discussions. I think there's some pent-up demand. You can probably speak to this from a physician perspective. People are excited about olanzapine because they know the molecule. It's well-trusted. People know what to expect. We'll kind of plot that out as we go.
Yeah. I agree that Austedo is doing well. 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 is more complex or there's more mood characteristics to their schizophrenia, they need a different option. 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 is that now that we have better injections like Austedo 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. To that point, having the ability now to impact relapses, impact hospitalization, and eventually use LEIs to have more of an impact on the progression of the disease is the real goal. I think most physicians would now acknowledge that there's accumulating data that more people should be on LEIs. 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 who are struggling with schizophrenia.
Yeah. The data would show that being on an LEI 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. When they relapse over and over, it creates a deficit in their gray matter and their ability to function, kind of their brain space. We know this and the data supports that. That's the case that we're going to make is, listen, go to an LEI much earlier. It allows for control. Ultimately, that patient has a meaningful net outcome.
Great. Eric, can you just clarify just on the long-acting olanzapine? Just as you file for approval and you're in labeling discussions, talk about the dynamics with the label and the monitoring requirements and how important that is commercially.
Yeah. I always like to step back and talk about what is the science behind the olanzapine LEI. 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. Why does it limit the use? It's because it requires you to be monitored for four 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. 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.
Even ours, even in the liquid, just forms an aggregate and controls the early release. In vitro, it's a night-and-day comparison. We've done tons of phase one studies. We've never seen a spike in the PK. I should say it's that spike in PK that causes, it's believed, the sedation syndrome, the PDSS. We don't see that in any of our phase one. We have finished the phase three study all the way out in the long-term follow-up. We've seen none of it after 3,400 injections at this point. 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. FDA has worked with us to design the studies. We've agreed on the targets. There will always be, at the end of the day, a review with FDA.
We think the label will be favorable. It is critical that we do not have that monitoring after the injection. I think the data supports that.
Yeah. Okay. That's very helpful. You guys gave $1.5 billion-$2 billion peak sales guidance between Ozethro 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. I don't believe there's a reason for it at this point.
Yeah. Our base case does not include monitoring.
Okay. Okay. If we can shift over to the pipeline, specifically the TL1A, it's a very exciting molecule, kind of like pipeline and a product. We see a lot of interest among investors in that mechanism. Remind us what you showed in UC and Crohn's and what really drives the confidence that this could be a blockbuster asset.
Yeah. It is a very exciting molecule. It's a whole new biologic class. Just to kind of level set everyone, the interesting thing about it, it's blocking a site to kind of amplify as many different pathways in the inflammatory process. 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 the proof of principle that blocking and amplifying cytokine can actually impact a singular disease. The next step is now going to define sentinel indications, whether it's a type 2 or a non-type 2 or even a fibrotic indication. That will then unlock many different indications potentially in the future. There is a long way to go. 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. We're blocking the inflammatory signal, but we're also allowing clearance of the TL1A through the natural body's homeostatic mechanism to inflammation. It's differentiated on its potency. It's differentiated on its selectivity. It also has very low antidrug antibodies. In our phase two study, it's been 3%-5% in that study so far. That's very encouraging for a durable response in the future. Finally, I'd 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.
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. The effect of the molecule has been maintained irrespective of whether you're naive or experienced the treatment. That's super important in a chronic disease area where people usually fail about 50% of the time after two years on a biologic. They need durable things that can treat people who have been previously treated. It's very exciting for people with inflammatory bowel disease.
What's the next data update from the phase two? I believe there may be maintenance data in the second half of this year. Is that fair?
Yeah. 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. We'll be seeing a new cut of the data. We'll finish the study around December. You'll look at data probably in the first half of 2026.
First half of 2026.
Yeah. That durability of response. Yep.
Okay. Can you just help frame for investors what to expect going into that maintenance data? Should we expect efficacy or remission to slowly degrade over time or generally be durable? Could responses even improve over time? How should we think about it?
I always have to make sure the data is blinded at this point. 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. We're really hopeful that, yeah, we keep a good high maintenance rate. That's what's going to be important for patients in the future.
Okay. As you think about additional indications, what's high up on your priority list? When can we hear more about that?
Yeah. I can tell you how we think about it. First of all, as I mentioned in the strategy, you want to be able to define classes so they can guide your further development. 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, is it a good market to get into? Is there an unmet medical need with patients? Is there value in what you're going to look at? Is it got an endpoint that's easily defined and rapid to do? Speed is the other component. All those things add up to how we're going to choose our sentinel indications. Then we'll work down the list for all the further indications after that.
I believe the priority here would be in ulcerative colitis and Crohn's and moving that ahead into phase three. In terms of these other adjacent indications, should we expect multiple clinical trials in those indications at the same time? Would they happen in over-staggered fashion? Would you have to wait for other kind of proof of concept data before expanding into third, fourth, and fifth indications? How should we think about the cadence of that?
Yeah. First and foremost, we're starting that phase three 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 a drug, usually when you go into new indications, you're going to have to do a phase two study. That's what I think you should expect when you come to the next step. Because you want to be able to 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 three. That's a little bit ways off.
As we define the dose, the PK/PD, and the modeling across indications, you'll be able to accelerate that more. Now, I think you should expect a robust phase two development before you go into phase three.
Yeah. Makes sense. In terms of safety, maybe talk a little bit about what you saw in phase two. As you think about these other indications, is there any kind of upside to the dose given what you've seen in safety?
Yeah. That's a great point. I should always remind everyone of this. In the safety cuts that we did on our phase two study, the rate of AEs in placebo and active were the same. They were 50% each. We've seen no other AEs reported more than 5%. That's very encouraging. The idea of moving forward quickly, that's going to be helpful. It'll 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. 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. That's something we pay very close attention to. One of the interesting theoretical things about this program, though, is it's an amplifier.
You're maintaining actual the baseline ability to respond in any one cytokine pathway. We're blocking the amplification. Whether that gives you a safety benefit in the future, I don't know. It's an intriguing possibility.
Okay. Got it. Lastly, on TL1A, maybe talk about the impact of some of these other anti-TL1A drugs in development that use more infrequent dosing. Some people view that as kind of the next wave of antibody development. Do you have a comment about that and maybe the competitive positioning of your TL1A?
Yeah. 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 that we have probably the biggest differentiation right now because we bind it in a different way, as I mentioned before, the selectivity, blocking the inflammatory pathway while maintaining the normal body's homeostatic pathway. I think that's one of the biggest differentiators. There's all kinds of tricks you can do and different antibody designs. I think the next wave, and this is well down the pathways, are combinations, bispecifics using this target. I think that's another exciting possibility in the future.
Yeah. Okay. Can you remind us of the DARE 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. Our DARE, our dual-action rescue inhaler, this one gets me excited because there are 11 million people who have asthma exacerbations every year in the US. The GINA guidelines already say we should be using combination therapies for that. Most people are still using just an albuterol inhaler for their asthma exacerbations. The clinical evidence is that you should be getting a combination with some steroid when you have an asthma exacerbation. As a physician, I'm really proud and hell-bent 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 a history of developing inhalers at Teva. We are 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 three study. That way we'll have a very good, I hope, in the future, a label that covers everybody, including the kids. 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. When you're having an asthma exacerbation, when you maybe are a little panicked and you want to make sure you have an easy-to-use device, I think this DARE device that we've developed, I think, is very good just for that. We're excited to be on track with our enrollment. I think we're targeting enrollment by the end of this year. It's an event-driven study.
We are calculating probably by the end of next year, we should have enough events as asthma exacerbations to lock the database. We are excited about it. I think it is a huge and important unmet medical need that we are well positioned to address.
Do you see any kind of upside to enrollment and exacerbations? I'm not sure if you commented on your assumptions for the exacerbation rate and things like that.
Yeah. We do modeling practically every week about the enrollment rate that we're seeing and the exacerbation rate we're seeing. Our models still shoot for about the end of next year for the number of events that we need. Right now, everything's 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. 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 three?
Yeah. 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. It is well known to everyone what the effect size should be. We're targeting that.
Okay. Last question because we do have one or two 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.
Yeah. 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 that we can really well understand what the implications are. We're in a pretty good place. We have eight manufacturing sites in the U.S. A good bit of our manufacturing serves the U.S. market. That is very meaningful. We have limited exposure to China and India from a manufacturing perspective. We will sort out Europe as it happens. We have a very clean line of sight of some of the levers that we would pull. We have so far managed 2025 really assertively and are in a good place 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 2025 or even 2026?
Yeah. 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 US in case you do have to shift some of the manufacturing?
Yeah. We are still evaluating that because we have, as you might imagine, a very broad array of products. We have to be thoughtful about that and are looking for that value proposition of our most important products and making sure that we do not have any supply interruptions and all those things. It is a much more three-dimensional look on that.
Yeah. Okay. Perfect. 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.
Hey. Thank you so much. Yeah. Nice to meet you.
Thanks a lot. Appreciate it.
Thanks.
Hey. Good to see you. Yes. You.