Teva Pharmaceutical Industries Limited (TLV:TEVA)
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43rd Annual J.P. Morgan Healthcare Conference 2025

Jan 13, 2025

Chris Schott
Analyst, J.P. Morgan

Good morning, everybody. I'm Chris Schott from J.P. Morgan, and it's my pleasure to be introducing Teva today at the J.P. Morgan Healthcare Conference. From the company, we have the CEO, Richard Francis. Richard joined Teva, I guess, about two years ago, and it's been a very productive couple of years, great stock performance, and looking forward to hearing from Richard in terms of Teva going forward and the outlook from here, so over to Richard.

Richard Francis
CEO, Teva

Thank you, Chris. Great to be here at J.P. Morgan. Thank you for hosting us, Chris. Looking forward to the questions afterwards. I'm going to take a bit of time just to go through some slides, maybe to help the discussion later. But I think what I want to start with is maybe highlight the fact that when I came here two years ago, it was a very different discussion and narrative around Teva. And I want to say that I'm particularly proud of all the Teva employees around the world who have really focused on our strategy, our pivot to growth strategy, and have driven tremendous change within the company. And I think everybody's seen that change and seen the direction and obviously seen the financials. But first and foremost, I wanted to highlight that.

Now, just to sort of coordinate everybody, because I think it's important, Teva is a global, profitable biopharmaceutical company, and I say that on purpose. We have a growing and exciting innovative business, as we'll talk about with Austedo, Ajovy, and Uzedy. We have a world-class generic business of $9 billion, and we have a very exciting pipeline. Obviously, people saw the data on duvakitug at the end of last year, but we've got some good data on olanzapine, and we've got some exciting programs with ICS/SABA. So there's a lot about this company to be excited about, and obviously, that drives the confidence we have in our revenue and in our forecasting and our ability to drive decent profitability and good cash flow, so I just want to make sure we're coordinated on that, because I think people are still thinking of Teva as a pure generics company.

It is not. It is a global biopharmaceutical company. Now, two years ago, when I came here, as Chris highlighted, it was a different story. We had had sales decline for multiple years. We hadn't focused on our growth assets, particularly our innovative assets. We hadn't spent time focusing on our pipeline. We had a lot of debt to go with, and I think our capital allocation strategy needed improving. So where have we come in less than two years? I think we've come a long way. Seven quarters of consistent good growth, and that's been driven by allocating resources to our innovative portfolio, particularly where you've seen Austedo take off. Uzedy, our new product that we launched for schizophrenia, having great traction. And Ajovy, also driving good growth.

Then the pipeline, which I'm really proud of, and I think Eric Hughes, the head of R&D, is here today, and he should be very proud of it. When we came in, we looked at the pipeline together and we said, "There's some real jewels in here. Let's put some money behind it." Not only if you put money, but it's about capability and attitude, and we've really moved that quickly through the clinic. Then deleverage. We've deleveraged very successfully, paid off a lot of debt, and now we're focusing capital on the right areas of the business to drive the right returns. We achieved all of this because we have a very clear strategy, pivot to growth. It is all we talk about at Teva, and it's all I talk about externally, because as with any good strategy, it drives decision-making and direction.

We have our four pillars. Deliver on our growth engines is about investing behind things that are going to drive growth on the top and the bottom line. This is about Austedo. This is about Uzedy. This is about Ajovy, soon to be partnered with olanzapine and then not to do some future ICS/SABA. Deliver on those growth engines. I think I'll show the tremendous job the team have done. Step Up Innovation is about that pipeline. We've got an innovative pipeline. Let's execute on it, put capital behind it, resources behind it, build capability, and execute. Sustained generics powerhouse. We were predominantly known as a generics company, and we're proud of that. We have a $9 billion business, and we return that to growth.

We were growing in Europe and in international markets, but we returned to growth in the US, so we've stabilized that and then focused the business. It's all about capital allocation. In Teva, we talk about capital allocation all the time. Where we apply capital, does it give us a good return? Does it give shareholders a good return, so this is not about budgeting and resource allocation without that in mind. Now, when I did present with my team the strategy, we had these three stages: return to growth, accelerate growth, and maintain growth, and then the fundamentals below each one of these that was going to drive that, and clearly, deliver on our growth engines in the return to growth is all about investing in Austedo, Uzedy, and Ajovy. Now, this is what we set out to do. This is what we promised in May of 2023.

But what did we actually do? One of the things I've been really keen on doing at Teva has been super transparent, setting clear goals of what we're going to do so shareholders can hold us accountable, and then making sure we work hard to deliver on them. So this is what we said we were going to do. So what did we actually do? Well, we accelerated Austedo considerably. Chris Fox is here as the head of the US and her team. It's not just about resources. It's about capability and attitude and ambition. And I think Austedo has shown when those are put together, what you can achieve. Then obviously, Ajovy has continued to grow across all of our markets, steal market share. And then we have the launch of Uzedy.

So we did those, but I think we surprised everybody with their actual ability to do those so quickly and to drive such a competitive level of performance. We've accelerated our biosimilar portfolio as well, and we're bringing some of those to market, and I'll talk a bit about that later. But maybe two of the things we did over and above the scorecard we set ourselves was we actually accelerated the pipeline. And we did it in difficult areas. And I think having a phase three study in schizophrenia, having one in UC, a phase two in UC and CD, and now one in MSA are not easy studies. I mean, if we could pick TA areas that are easier, I think we would have picked easier ones, Eric, yeah? But we didn't. Those are the ones we had.

Now, you can apply money, but money doesn't drive clinical studies faster. You have to manage them and operationalize them. And I think we've shown in Teva, despite the skepticism that we could drive clinical development, I think we've outperformed in all of those TAs against companies that were considered to be the best. And that just goes down to our maniacal focus on excellence in execution. And then obviously, the generics business. The aim was to stabilize that. We've probably overachieved a bit on that because we've returned it to growth in the U.S. We always had good growth in the E.U. and in emerging markets, but we've returned the U.S. to growth.

So I think where we are to date is I'm really pleased about where we are, and I constantly thank my employees for the hard effort because to change the direction of a company in such a short space of time requires everybody to walk in the same direction. So let me go into a bit of detail about some of these. So Austedo, on track to hit $1.6 billion this year and looking forward to hitting $2.5 billion in 2027. Now, just remind you, when we launched the strategy, peak sales by a lot of people, not you, Chris, peak sales by a lot of people were $1.4 billion, and we're on track to do $1.6 billion this year. Once again, focused, excellent capability, good execution by the team, big ambition. Uzedy, difficult market to launch a long-acting product in schizophrenia, no question.

We have a great differentiated product, gets to therapeutic levels within 24 hours, subcutaneous, prefilled syringe. But it's a tough market. It's a managed area now, but the team has done a tremendous job, and we're on track to hit $100 million this year, so we're going to beat the forecast. And Ajovy, an older product, but we continue to show we can deliver on this. So when you look at our growth engines in innovation, if anybody has ever doubted Teva can commercialize innovative products, I'd like to think the last 18 months have shown we can do it, and I think we can actually do it better than most people. But now let's go to the pipeline because innovation is good, but you've got to replenish it.

I think on the pipeline, particularly pleased, obviously with regard to duvakitug, the anti-TL1A treatment for UC and CD, the announcement we had at the end of last year was tremendous. I'd like to remind everybody that this product, I'm going into more detail, came from the discovery at Teva. The antibody engineering team at Teva, we've been talking about being world-class. I think people doubted it, but now once again, we've shown we've got a great capability within the company. olanzapine, we accelerated that study by nine months. I've been able to actually file that this year and bring it to the market next. And ICS/SABA, or Daria, as we're calling it now, we're up to. I'll talk to you about where we are in the clinical recruitment. Look at this pipeline.

This is a pipeline I think any innovative company would be proud to have because of its quality and its, I would think, relatively high probability of success. So let me go into duvakitug because we're sort of super excited about it, and we just are, right? And I've got to say this. People kept asking me last year, "Do you have a real TL1A?" Yeah, we have a real TL1A, and I think it's actually the best in class TL1A. So maybe that question can be asked of other people now. And with our partner, Sanofi, who have been a tremendous partner, we're really excited about moving this into phase three this year. And I think once again, it underscores our capability to develop complex targeted antibodies with our team.

But let me show you the results because I think these were the ones that impressed everybody as we released them. So as you can see, what I like about this is obviously we have a clear dose response as well, but the level of accuracy in UC and CD is not something I think we have to debate. I remind everybody we were supposed to have an interim analysis at the middle of next year. Because of the work we did to accelerate the phase two study, we did a full analysis at the end. And I'll remind everybody that the Crohn's disease study is the first randomized placebo-controlled study of a TL1A in Crohn's. So not only is that data impressive, it's high-quality data. So why do we think we have a best in class? Because that's obviously what we think and what we've been saying.

Well, because we've designed it to be best in class. So it is by design. High potency, high selectivity, low anti-drug antibodies , which are important in these disease areas because obviously you do cycle through therapies, and knowing you have options after therapies is important. And a rapid, profound, and prolonged suppression of free TL1A. And our safety profile is good because obviously we've had other studies. We had a study in asthma before, so we have good data on this. So very proud of what we've achieved in duvakitug, and now it's about moving to phase three and also looking at other indications because we know that TL1A can be involved in many different diseases, including fibrotic diseases. So listen and more to come in the future. But another one of our pipeline is olanzapine.

And the study completed, so we have a good efficacy readout, and we have no PDSS. To remind everybody, there is no long-acting olanzapine used of any size or volume in the market because of PDSS. And this is a side effect, which gives a black box warning. Now, long-actings are used in schizophrenia for the obvious reasons. They help compliance, which is really important. But there hasn't been the ability to use that for olanzapine, which is the number one molecule that's used to treat schizophrenia. And as you can see, the market size is significant just for people on schizophrenia, just below four million, and the long-acting. But I think that long-acting has been suppressed because there hasn't been a long-acting olanzapine. So really excited about this. Eric's team are going to be filing this this year. We'll be able to launch it next year.

What I would say, the tremendous work that Chris and her team have done in the U.S. on Uzedy, which is our long-acting risperidone, means when it comes to going to market, we're just going to layer that on top. That level of expertise. Forget the synergies in our P&R. The level of know-how, expertise, the physicians, the key opinion makers, the reimbursers, the people in the hospitals doing the D&T committees and the formularies, we've spent two years working with them. That excites me that we're going to have a good launch. Now moving on to Daria, our dual-action asthma rescue inhaler. Now, it took a while for Eric and I to get excited about this because we have so many exciting things in the pipeline. Then we realized actually the probability of success is super high on this.

Very high because we know these two compounds. The demand is high because the guidelines say 10 million Americans should be on this type of inhaler, and we know we have a differentiated inhaler. In fact, because one is we are doing a pediatric study, so 25% of the population is pediatrics, and we will be the only one with a pediatric indication, and the other one, and I go back to my selling days here, is we have a very simple device, so this is a device you just open, and you just inhale. Now, when you're treating children, that's really important, but if we are going to compete against the product that's in the market now, I think this is another differentiator, and we've been making devices for 25 years, so we know how to make these.

So I think we have a market that's been formed by a company that's already in there. And as we come in, we'll clearly be differentiated based on our patient population and our device. So another thing that's going to drive growth around about 2027. olanzapine's coming in 2026, and Daria will come in in 2027. Now, looking at generics because obviously we have a $9 billion generics business, and we're proud of that. I think one in 10 medicines in the United States is a Teva medicine. And as I said, we return this to growth. The importance of this obviously is it drives the company forward, but also it helps throw off cash, which allows us in the short term to pay down our debt, but in the longer term and medium term to fuel our innovation on our pipeline. Now, how have we done this?

Europe and the internationals have always grown and grown well, but the US has been one where we probably haven't launched enough products on time and had the best supply. We've started to turn that around, and we have an incredible pipeline in our US business. And so we're starting to improve the performance of bringing those to market on time more often. And now we've targeted a productivity program throughout particularly our manufacturing network where we have 54 sites. And the aim of doing this is to understand that to be world-class in generics, you have to have a good pipeline. You have to have a good go-to-market model, and then you have to have a good ability to drive efficiencies year on year because you want to be reducing your costs year on year.

If you do that, you can offset some or all of the price erosion. It keeps you competitive, so those are things we're really starting to lean in on. Now, another part of our business which we're excited about is our biosimilar business. Now, our biosimilar business is something that we've strategically decided to do more partnering of because obviously when it comes to capital allocation, which is the fourth pillar of our strategy, you need to allocate capital to where you're going to get the best return and drive long-term top-line growth and bottom-line growth and shareholder value, and clearly, in our innovative pipeline, that's where that is, but we believe with biosimilars, it's about having a broad portfolio, so we're up to 18 now. You've seen a few deals, one deal on Friday, another deal today.

And so the aim is to be launching roughly five or six in the next year or two, and that'll continue to happen regularly year on year. So I think we've got ourselves a good strategy, good capital allocation. We have a good commercial footprint, and this will start to drive growth over the next few years. And the last part of our pivot to growth strategy is focus the business. We decided to separate TAPI, our API business, from Teva. We're going to close that in the first half of this year because although it's a great world-class business, I think the second largest API business in the world, from a capital allocation, you've got to be disciplined. And the reality is if we kept TAPI, we'd probably undercapitalize it, and we'd probably undercapitalize other parts of our business.

So we knew that, so we restricted, and we said, "As good as it is, it has a better home somewhere else, and then we can direct our capital to things that we know are going to drive growth." Which nicely leads me on to capital allocation. Obviously, as we pay down our debt, as we sell some assets, as we drive an increased margin, we're going to end up with more cash, more capital. What do we do with it? Well, we're going to continue to pay down debt. Then we're going to start to invest in the growth drivers: the Austedo, the Uzedy, the Ajovy, soon to be olanzapine, soon to be ICS/SABA, and midterm TL1A. And then we're going to start to continue to invest in our pipeline. We have a drug, ampreloxetine, for MSA. We have an anti-IL-15. We have an anti-PD-1 IL-2.

And then obviously, we're looking at BD. More licensing in. With a pipeline like this, I don't think we need to be too adventurous and take too much risk. I think we've worked hard to get our credibility back at Teva. And so if we do a licensing, there'll be things that fit in, synergistic and fit into our wheelhouse. The targets we gave in 2027, we stick with. We are going to hit these targets: mid-single-digit revenue growth, 30% OP, net debt to EBITDA of two times, and 80% cash conversion. We're on track to do that. We model this. We know what we have to do each year to achieve this. We have these things in place. And then maybe to close, going back to our strategy, everything comes back to our strategy. We look at this every month in an exec committee. We have a KPI.

We have work streams. This is not something we put on a shelf. It has a tagline. This drives every decision and what we do all the time. That is how we've delivered seven quarters of growth. And we've consistently delivered on what we said we're going to do because we're very transparent on what we're going to do, and then we just make sure it happens. And so now we're in the phase of 2025 to 2027. We want to keep the momentum we've got. How do we do that? Well, we keep driving Austedo, Uzedy, and Ajovy. We keep making sure we have the resources to do that and the capability. We keep accelerating our pipeline so we can bring olanzapine to the market in 2026, and we bring ICS/SABA to the market in 2027.

And then aggressively focus on the phase 3 study of TL1A, duvakitug, to make sure we can bring that to the market as soon as possible because clearly there's a big unmet need there. And then we're going to focus on those parts of the generics business that I said so that can be a growth driver for us and also grow the top line and bottom line because we're very committed to that margin expansion.

If we do this on the 2025 to 2027, which I have no doubt we'll do it, plus or minus, then I think we'll hit our targets and put ourselves in a very healthy position for the next phase, which is to sustain that growth in 2028 and beyond, which I remind you is when TL1A duvakitug will kick in, IL-15 will kick in, the ampreloxetine will kick in, and maybe anti-PD-1 IL-2. So with that, I feel like I've talked quite quickly, but there is a lot to talk about Teva. And I know Chris has a lot of questions, so I thought I'd respect Chris's time. Thank you for your time and attention. And I'll hand over to you, Chris.

Chris Schott
Analyst, J.P. Morgan

Great. Appreciate that. And I was hoping Eric's going to join us on stage here as well for the Q&A.

Maybe the one I'll just kick off the Q&A is we're obviously fresh off the TL1A data. It was obviously very strong, very impressive data. Just to reflect on what you saw from that, what were the biggest surprises or learnings as you've had a chance to dig through both the UC and particularly the Crohn's data?

Speaker 3

I've been talking enough. Sure. So yeah, we were very excited to see the data in December. The dose response was one thing that jumps out when we first looked at the data, but also with Crohn's disease, it was really exciting to see such a placebo-controlled study, as Richard said, in Crohn's disease for this MOA, and really a very strong response. So we're digging into the data now in greater depth. But I did want to comment on two things Richard said.

It really was a validation of the fact that the scientists at Teva are very strategic and thorough in their drug discovery. And I'm really proud of the team because the execution of the study was paramount. And we were able to accelerate it and do it with great, robust data sets. So it's all good right now. We're digging into the data now, look at how we're going to choose our doses, do our modeling and simulation. And we've had a whole year to get set up with Sanofi at this point, so we're all ready to go at this point. Can you talk a little bit about the path forward from here?

I know you've talked about 2025 starting with the phase 3, but just what are the decisions and kind of the sticking points here in terms of just getting that move forward, and how quickly can we think about a program progressing once it launches?

Richard Francis
CEO, Teva

Right now, it's all the mechanisms of drug development. We have to really dig into the data, really make sure that we do the modeling simulation to find out where we are on the dose response. Having a nice dose response in the study makes that a more robust analysis. We'll choose that. I think we all have a good idea, but there's a totality of the data we have to look at with our partners. Having that preparation, having our regulatory interactions, but in parallel, getting the entire machinery of two large studies going, targeting this year.

So that's what we're working on. The other most important thing that I think when you see the birth of a pleiotropic antibody that can really affect potentially multiple different cytokine pathways, that's where you have to start thinking about what your other indications is. How do you work with a big partner like Sanofi to really capture the true value of something like that? So we talk about this a lot. It has an effect potentially on amplifying many different pathways and potentially a direct antifibrotic effect. So it really is a very exciting moment for a molecule like this.

Chris Schott
Analyst, J.P. Morgan

Maybe just elaborate on that in terms of the additional directions you can go with this. What's top of mind for you as you consider beyond UC and Crohn's? I know two small indications to start with.

Richard Francis
CEO, Teva

Yeah, I'm not going to get into the specifics of where we're choosing to go right now, but I would like to kind of frame the potential. So if you look at a Humira, a Stelara, a Cosentyx, they're all targeting single pathways. The science of TL1A is it's an amplifier of all these different pathways. So the potential effect is across multiple different mega programs, with the additional potential added benefit of having a direct antifibrotic effect. I've been on many programs where we're always treating the inflammation and hoping we have an effect on the fibrosis. Here, you might have best of both worlds. So the potential is really great.

And I think that is one of the reasons why I think the partnership with Sanofi is so good, because obviously their experience with Dupixent and multiple indications and understanding what it takes to have a pipeline and a product. Not many companies have those. So I think we have a partner who has that experience and has that appetite and ambition. So I think that that's another thing that I think has played out well.

Chris Schott
Analyst, J.P. Morgan

Great. Maybe just one last one on this. Just more broadly, I know some of these immunology categories have the payer pieces maybe sometimes challenging at times. How do you see TL1A maybe more broadly fitting in the treatment paradigm in UC and Crohn's just given what we've been seeing with the IL-23s, etc.? Just help me a little bit about where this fits in.

Speaker 4

Do you want to start?

Should we start?

Richard Francis
CEO, Teva

Yeah, I can start. Well, it's very competitive. The numbers that we've just put out, when you look across the treatment paradigm for UC and Crohn's, it really is at par or better than most of those options you have out there. So there's something to always remember in inflammatory bowel disease. Currently, there are treatments out there, but the bar has not extended too greatly. And these folks cycle through these therapies. You're going to remember that ulcerative colitis, 20%-30% of those people still go on to surgery, and about 70% of the people on Crohn's disease still go on to surgery. So we're not winning yet. And so if you can develop a drug that has good efficacy and it's durable, that's going to be super important for the folks who have the disease. And I think also the safety.

I mean, as I said, we talk about efficacy because it's so impressive, but the safety, if you look at the category and the other MOAs that are here, safety is, and it's a chronic, so you've got to be on it a long time, so the clean, what looks like a very clean profile that we have with duvakitug, I think is also something that's going to play out well, and just with the latest thinking in terms of importance of biomarker here, is that something that how focused are you guys on that? So yeah, so the biomarkers are evolving at this point. I always like to say for a baseline biomarker, we're looking at all the genomics, proteomics, serum biomarkers, and fecal biomarkers. I hope to discover someday a great biomarker for choosing a population.

We actually have a relatively novel biomarker because we also look at free TL1A in our program, and we'll continue to generate data for that, and we have a great assay for that. So the future, hopefully, will find something that really drives decision-making and treatment response. But at the beginning, I'd like to say we're going to treat all comers at this point because you don't want to disabuse someone who's cycled through a bunch of therapies already and failed and not give them another chance at a new MOA. So that's where our thinking is. Someday, I think with our novel biomarkers, we might get something that will help KOLs make decisions.

Chris Schott
Analyst, J.P. Morgan

But the lead-in sounds like it's more just a phenomenon.

Richard Francis
CEO, Teva

It'll take time to get that. You need more data for that.

Chris Schott
Analyst, J.P. Morgan

Okay. Maybe pivoting over to schizophrenia.

Uzedy, you've been off to a great start here as we go through. Just what do you think has enabled the performance you've seen? I think when you launched that, I think there was some skepticism in the market of how do you differentiate. You've obviously proven a lot of folks wrong on that. But what do you think enabled that?

Richard Francis
CEO, Teva

Yeah, no, actually, there was a bit of skepticism around a few things we've done. And I think we've proved quite a few people wrong. But I think part of it is you have to understand the market really well, the patient journey, where it's very fragmented. So not all patients end up in some institutions, some are at home, some are in hospitals and specialty centers. So I think the capability of our commercial team is really, really key here.

Same thing is we have a very differentiated product. And it may be at first glance, it doesn't look like it. Subcutaneous, it doesn't have to get to the fridge, prefilled syringe. But then I think those are all beneficial with this patient population. But then the fact that you can get to therapies you go to within 24 hours. If you think about somebody who's having an episode, they want to be the physician wants to control them as quickly as possible. And on the other therapies, they probably have to either hospitalize them or give them additional oral supplementation to make sure they get the efficacy right because those products don't hit the blood levels as quickly. They don't have to do that. And so I think that's what we've seen is we have a product that has real attributes that the physician needs.

We have a team who understands which people to engage in the decision-making process, and I think that's why we've probably proven everybody wrong, and I think there's more to come. It is a tight market. I mean, it's managed more than ever, so I think for us, it's about making sure we resource it correctly and have the right capability, but I feel very pleased and proud of what the team have done.

Chris Schott
Analyst, J.P. Morgan

The uptake you're seeing, is it mostly patients who are maybe novel to a long-acting, or is there conversion? What's the dynamics of what's going on there?

Richard Francis
CEO, Teva

It's both. I mean, still the majority come from oral, but we also see people come from long-acting. Because if you think about it, it makes sense.

If you're on a long-acting and there's an incident that happens, the physician will think, "Well, I either keep you on that, and I've got to work out how to control you, or I'll use Uzedy, and you'll be controlled within 8 to 24 hours." So I think, but the majority are still in oral, which makes sense. If you're going to switch to a long-acting from an oral, pick the best long-acting, and that's ours. And if you're going to switch from a long-acting, pick the best long-acting, which is ours.

Chris Schott
Analyst, J.P. Morgan

Yeah. Excellent. Maybe moving over to olanzapine.

I guess at this point, given the breadth of the data, your confidence in terms of having a clean label, I mean, you've always had a great data set so far, but in terms of do you feel like you've got to a point with FDA that you're aligned in terms of what you delivered and that you've hit those targets?

Richard Francis
CEO, Teva

Yeah. So I mean, I'll just start with the totality of our program. We have in vitro data that shows that even in the worst-case scenario, if you inject this into serum, it aggregates rapidly. So compared to the competitor out there, which dissolves very quickly, it's night and day. We have a full phase one program where we have a lot of data showing no spikes in PK, very consistent. It's a subcutaneous injection. It's not going in a deep muscular shot.

Chances of hitting a large vessel are, again, lower. Now we have over 100% of our targeted injections that show no PDSS at this point. We've had our type C meeting with the FDA in August. They looked at the program that we're going to be submitting to them, and they think it's reasonable. So I think the totality of what we're looking at, it's very reasonable that it should have a favorable safety profile. And that's what we're going to review with the FDA.

Chris Schott
Analyst, J.P. Morgan

Just thinking about the commercial opportunity for this one, just as more time to digest, how are you thinking about the percent of whether it's the oral olanzapine patients or the ability to maybe convert some patients who might want to be on olanzapine but haven't had an option for long-acting? What's the size of this?

Richard Francis
CEO, Teva

Look, I think in two different areas.

I mean, if you think about it just following the non-olanzapine long-acting market, about 13%-15% of oral patients could switch to long-acting. And we'd be the only long-acting. But I'd always argue, why is the ceiling that anyway in long-acting? I think part of it's about making it physician-friendly. And I think we've shown with Uzedy, and we've shown with olanzapine, I think if it's more physician-friendly, maybe you could raise that amount of conversion. So that's one. I think the important thing for people to consider is also it's not just about how big the market is, what peak sales could be, it's how quickly do you get to peak sales, how quickly do you accelerate. And I keep reminding people that Uzedy's team will be in place for two years.

That's both our managed markets people, our people who are going to sort out formularies, our people who are going to talk to physicians, our MSLs, and they've been talking to them about the same; it's the same technology, so we're talking about Uzedy and that's olanzapine, so our ability to have credibility with all the stakeholders, I think, is already there, and we'll build off that, and that really excites me, and it takes me back to my days when I was in another company where we had a franchise, and you can leverage that franchise because you have credibility and respect, and we have that already in, I think, the community of the physicians we serve.

Chris Schott
Analyst, J.P. Morgan

Great. Maybe pivoting over to some biosimilars. Maybe first on the biosimilar Humira market, just frame a little bit how you're anticipating with obviously a better contracting position this year.

How should you think about the ramp of the product as we go into 2025?

Richard Francis
CEO, Teva

Yeah, I think Humira has been an interesting one, and I think obviously the market sort of changed somewhat with private label as well as the normal channel. I still think it's a pretty complex market with the rebates being given by the originator still, and so I don't think this will necessarily see a sea change in 2025. We'll have to see. I think it's always worth reminding, we position ourselves very carefully as to get contracts that we think are going to drive our pivot to growth, our financials top and bottom line. We're not trying to get market share. We're not trying to just get contracts for the sake of getting contracts, and then why can we do that? And why do we do that?

Because we have, as I said, five biosimilars we're launching in the next year to 18 months. So we have 18 to launch. And we have a big innovative pipeline that we're generating growth. So I think we can be very thoughtful. I think Humira will slowly start to get traction. How much in 2025? I don't really want to predict. I've seen a lot of people be wrong. I think what I tell people is, if it's fast, we will be there to take as much of it as we can within those sort of guidelines. If it's not, it won't impact us, so we can't hit our numbers in 2025, 2026, or 2027. And then obviously we've got Stelara. We potentially have Prolia. We potentially have Simponi. So all those come. There will be slightly different dynamics because not all biosimilars are the same.

Not all originators do the same defense tactics. And so we'll learn a lot and see how those play out. But I think over time, the 18 we launch, I think, gives us good growth. But I don't want to tell you which one's going to be the big one or not. Because in a way, I don't really have to because we're probably okay.

Chris Schott
Analyst, J.P. Morgan

It's a portfolio approach, yeah.

Richard Francis
CEO, Teva

Exactly.

Chris Schott
Analyst, J.P. Morgan

Yeah. Excellent. Continuing along, Austedo. Just maybe first of all, obviously nice momentum of the product. The Part D redesign, how sure have you been kind of thinking about that as we go into 2025 and potential impact to targets?

Richard Francis
CEO, Teva

Yeah. So we've been, because of the Low-Income Subsidy, so we've been phased in. So we've phased in. So the impact in 2025 is relatively minimal. So we don't really talk about it affecting our momentum too much.

So yeah, for 2025, I think the question is more about when do we get put on the list. Did we get put on the list, the IRA? And then when do we get put on the list? And I think, as I've always said, is we planned for being on the list and being impacted in 2027. That's what we gave in our targets. If that doesn't happen and we're not, that's great. If it does happen, we've planned as much as you can plan for something you don't fully understand the size. And then if we're even not on the list, then obviously great. Great. But as you know, at Teva now, the last few years, we don't plan for those things to happen. We plan for what is generally the worst-case scenario, and then we'll deal with the upside if it happens.

Chris Schott
Analyst, J.P. Morgan

Great.

Just as we're kind of heading into the new year, maybe just help us push some polls for '25. What should we be keeping in mind for the business?

Richard Francis
CEO, Teva

So I would say a lot more of the same, which sounds a bit boring, but hopefully you found with the strategy, it's given us real direction and real clarity in what we want to do. So we'll continue driving Austedo, Ajovy, Uzedy. And so look for that and those performances. I think Eric's team is obviously working hard on the phase 2 for duvakitug and the filing for olanzapine. But we now talk every two, three weeks about ICS/SABA, which I'm sure you don't mind. And I think we have 91% of sites recruited. It's a very good place. And now we're talking about Emrysoma for MSA, which we don't talk about because obviously it's a challenging disease.

But we're in the clinic now with phase two. And if we can move that through, which is difficult with that patient population, we can have some interesting data pretty quickly, which I think would get us an accelerated approval because of the condition. So we're sort of focused on the same. Keep driving our growth engines. Keep working through our pipeline and do the hard work that we've done so far on generics and keep building on that. Because I think what we've shown is we have all the ingredients to be world-class at generics again. But it's sort of operations week in, week out. You have to do it. But I think we've shown we're very disciplined. Obviously, divest TAPI. And then I think that obviously creates more clarity for the organization, more focus. That's quite a lot to do in 2025.

But I'd like to think that people think we did a lot of good setup in 2024. And so more of the same should be exciting because it's transformative for Teva. I mentioned we put on nearly $1 billion between in the last two years of our innovative portfolio. The amount of that that drops to the bottom line on profitability is huge. If we keep doing things like that, this company will transform financially. It will give us the ability to continue to accelerate growth and maintain it, as we've said. So those aren't just words on a slide. We've really thought out what does it take to make that happen. And I think for me, I truly believe this is just the beginning. Huge amount of hard work, a lot of things that we have to do.

I think we've shown we're quite good at doing things in parallel. We have a really super talented team who are desperate to get Teva back to where it was. I think so I think it's a positive 2025. We know what we need to do.

Chris Schott
Analyst, J.P. Morgan

Maybe just last couple of minutes here. Just on the BD front, I know you talked a bit about that in the presentation. But as the company's cash flow bit builds, as the de-leveraging occurs, do we think about that accelerating, or is that more just kind of a steady flow of these in-licensing as you talked about? I'm just trying to get a sense of is this kind of how broad do you expect that BD piece to be over time?

Richard Francis
CEO, Teva

Yeah. Look, I think I would always say it's hard times when we're broad.

I think we think about in-licensing, but we really think carefully about capital allocation. So if we think about something that we think, "Okay, that could be something we could do really well with," we think, "Well, I'm going to have to allocate capital to it," which means, "Does that take capital away internally?" So we think carefully about it. Because I think we have a very good organic growth trajectory. That said, I do think we've shown if we found something for Eric in the clinic, his team are really good executing, really good. If we found something in the market, I think both Chris and Richard and Mark, who run the other parts of the world, are really good executing. So look, we're looking hard.

I look at spending a lot of time looking, but I'm not going to be drawn into doing something that I think takes away the momentum and maybe the trust and the credibility that we've put in place in the last two years.

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