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

Good morning, everyone, and thank you for joining this session of the Morgan Stanley Global Healthcare Conference. I am Thibault Boutherin. I'm part of the European Pharma Equity Research Team based in London. Before we start, I need to refer to important disclosures. Please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. And if you have any questions, please reach out to your Morgan Stanley sales representative. So for this session, I am delighted to have with me Richard Francis, CEO of Teva. Thank you for joining us today. We will shortly start the Q&A. But before that, Richard, I would like to start with some introductory comments on the outlook and situation for Teva today.

Okay. Well, thank you very much for having me. It's a pleasure to be here. So maybe introductory comments. So for those of you who have heard me talk a few times, I start off with referring to our strategy, the Pivot to Growth strategy. We launched our strategy over 14 months ago. And that was a strategy to get Teva back to growth. It's based on 4 pillars: deliver on our growth engines; step up innovation; create generics powerhouse; and focus the business. I think over the last 14 months and maybe in the last 18 months in total, we made really good progress and delivered on our growth engines. AUSTEDO grew 32% in Q3. UZEDY's launch is going well. AJOVY is going to be $0.5 billion this year. On step up innovation. The second pillar, Eric, who's with me today, has done a great job and his team in pulling our pipeline forward. So we've accelerated our TL1A, and we'll have a readout at the end of this year. Olanzapine study was accelerated by his team, and we'll have the safety data in the remainder of this year. We've got ICS/SABA in the clinic, MSN in the clinic, IL-15 in the clinic. So a great job there. Generics powerhouse, pillar 3, I think, we turned the generics business to growth in the U.S. It obviously grows in Europe and international. So I think we are seeing a stabilization and actually a growth of that business. And then finally, focus the business. We announced, obviously, that we're going to divest TAPI, our API business, and that's progressing really well because obviously, focus the business about allocating capital, things that are going to fit the strategy and TAPI as good a business as that is. We think they'll do better as a stand-alone, competing in the full API market. So progress, I think, is good. I think we've got a good trajectory. We've raised our guidance for 2024 at our last earnings. And so we're doing well, but we've got to keep doing well.

Thank you. Okay. So let's focus maybe on one of the most important growth driver at the moment, which is AUSTEDO. So the product has been performing very well since you announced your midterm plan. You increased investments behind the product. Profile has been improved with a once-daily formulation, you recently simplified the decision process. So from here, what are the levers to continue to accelerate the growth of this product may be starting here?

Yes. So I think AUSTEDO is a great example of a focused strategy where we put not just money behind it, but we built capabilities. So the team we have in the U.S. that's driving AUSTEDO is world-class. And that's why we've seen this rather dramatic acceleration of the business, and we've managed to continue that going. But the levers we have, there are many, obviously, we did the more obvious ones. We increased the sales force size. But then we are now working on -- we introduced a titration pack, which is very important to make sure patients end up on the appropriate dose to get the full efficacy and that obviously ends up with generally a higher dose, which helps the product as well. But then other things around adherence and compliance, which were not particularly good programs or any program we had in place. We've put those all in place. And so when I think about -- and then we did a direct-to-consumer. And when you think about AUSTEDO, I think the reason why we're so optimistic about it's long term is because there's a huge amount of patients still untreated. So we've done DTC to bring them in. We have been expanded and high-performing sales force, which captures a lot of those patients, helping educate the physician. And then on the -- making sure the patients go on the right dose, adhere to it and kind of compliant with it, we put multiple programs in. So when you think about the growth trajectory of this product to have all of those things as levers to pull is quite unusual, and we have those. And so I think we believe we can keep driving this growth -- significant growth, with growth we've got into the future. And so we're very fortunate about that. And that's the same sort of competency capability that we've put on UZEDY, we put on olanzapine, we put on ICS/SABA as well.

Very well. And specifically on the tardive dyskinesia market, when you think about the competitive landscape and where you are also in the penetration of the patient population, what is the focus right now? Is it to focus on growing this market and increasing the penetration? Or do you start to think about, okay, it's about taking share from your competitor -- from your main competitors in this market?

So like right from the start, we've been very focused on what we do, controlling what we do, how we execute, grow the market, how we find those patients, adherence, compliance, all the things I said, we're very focused on it, and we will continue to be. That said, that has led to us being a lot more competitive. And I think it has led to us in recent data to show that actually, we are capturing more patients than our competitor, but it's not about -- our focus is on -- we picked the long-range plan. We need to drive for AUSTEDO, and we go after that and we build a plan to do that. That happens to have made us very competitive and seems to be that we're out competing the competition right now. But because the market is so untapped, we don't have to take market share. It's just a byproduct of what we...

Understood. That's clear. Let's talk maybe a little bit of IRA and AUSTEDO in this context. So we now have the list of drug for IRA in 2026, and the discount negotiation have been published. So maybe if you can start by giving us your view on the reform and the impact that you are seeing and how you're thinking about this. And on AUSTEDO, in particular, there is a risk that it could be included on the 2027 IRA negotiation list. So if you could also touch a little bit on this and how you're thinking about this?

Yes. So look, I think it's -- it was good to see the dates come out on the first wave of products with the IRA. So it gives us a bit more clarity. I always say a bit because you see the numbers at the top, you don't understand the impact on the net prices they already had. So you have to read the tea leaves a bit, but at least we have more data. I think for us, for AUSTEDO, we had assumed that we were going to be in the IRA within our long-range plan. Now the question is, are our assumptions correct and we have to go through that evaluation to understand were they optimistic or were they conservative or too pessimistic, and we're going through that now. But we had included it, whether we end up in -- being impacted in '27 or '28, we'll find out in February next year. Our assumption was we would be impacted in '27, but we'll wait and see.

And before we switch to some of your other innovative products, I just want to spend maybe a little bit of time on the generics business.

Isn't it nice that you said on your other innovative product. I just want to spend time on that. We better squeeze in the generic.

Exactly. Exactly. Among the innovation. So yes, so you have [indiscernible] for generics in Q2, in particular, very strong across regions. So just if you could help us understand how sustainable this is and kind of come back on the driver of this performance for the generic business in Q2 and even in a few quarters really.

Yes. No, look, I mean I think -- so I'm glad you recognized it. So our generics business has performed really well, actually for the last few quarters. I do want to remind everybody that 65% of our generics business is outside the U.S., and that has performed well for many, many, many quarters. So what we've seen in our last few quarters that we've got the U.S. to stabilize and actually more than stabilize and grow as our whole global generic business is growing really well. I think it grew at 11% in Q3. So -- and how have we done that? It goes back to that strategy, the third pillar. The third pillar was to create generic powerhouse. How do we do that? How do we do that? We make sure we have a full pipeline that we bring to market on time. We have good manufacturing, good COGS and good supply chain and we have a good commercial execution. We're working on all of those 3 levers for the last 18 months. We've made progress across all of them. There's still a lot more work to be done. But I think what you're seeing in the numbers here is the output of that performance. So I feel that we made a quicker impact on our generics business I anticipated, but we've got to keep this one going. But because we have the strategy in place, we have the plans in place, I'm confident that we can, whether we'll be having 11% quarters every quarter, I can't promise that, but the direction of travel will be positive.

That's very clear and encouraging. And just a little bit on the U.S. generics business, in particular, here, again, I ask you this question, I asked you this question last year, I'm going to ask again and see the...

If I have the same answer...

So did something fundamentally change in the U.S. generic business because it's been 2 years that we've clearly seen an improvement across players and the price in particular, has been much more sustainable. So are we seeing less cyclicality here as something fundamentally change? Are we just still in a good part of the cycle?

Look, I think it's an environment probably has at a moment where price erosion has been less. Not that we have a plan for that, so we don't financially plan for that because we don't control it. But I think what Teva has done is we have managed to bring more generic products to the market? Because I think what you rely on is launching new products and launching high-value products, which have less competition. And we have work to do that consistent really well. But I think what you've seen is we've done that better than we have in the past, and I think that's helped us. Our focus now is continue to do that year-on-year. And that is hard because the products we're launching now, the work -- a lot of that work has been done over the last 9 years. So anything you have to correct, you have less time to correct it. But that's a journey we're on. We have clear plans to do it. So I think from the U.S. point of view, we do not rely on the environment being favorable on pricing or not favorable. We control what we control, which is launching as much as we can on time. And then the other thing, we're working hard on our supply chain, making sure our supply chain delivers and maximize the opportunity because we have upside if we can manufacture more products and at the same time, do that more effectively and efficiently in reducing COGS because that will help obviously offset cost of price erosion and improve our gross margin.

Very clear. And last question on generics, GLP-1. One of your competitors has been kind of very vocal about the ambition in GLP-1 in particular, the kind of second generation of molecules semaglutide, and you already have Victoza, generic Victoza so you're already a player in this market. So if you could just maybe talk a little bit about how you're thinking about this market? Are you interested in the next generation. And in particular, if you could address the very important point on manufacturing because it's going to be challenging to build the capacity to address this market.

So look, I think -- so firstly, obviously, we're very pleased that we launched Victoza. We got off to a good start with that launch. And we are excited about the remainder of the year. We obviously have a launch coming up next year as well with Saxenda. As we think about the broader picture on GLP-1, yes, we do want to be part of that opportunity. Maybe watch different from that competitor -- I don't know who it is, I think I have an idea. We're in a different situation at Teva. As you pointed out, we have a big innovative pipeline. We have an innovative business that is growing fast. So we have a lot of opportunity to grow this business, both on profitability and on our top line. And so how we allocate capital, we need to be thoughtful about the return we're going to get on that. And because we are not a generics company, we're a pharmaceutical company with a generics business and innovative business, we have to think about that. And so we do think the GLP-1 is an opportunity. We've obviously clearly taken this one, and we'll take one next year, and we have the bigger ones we're working on. But it's not something that we have to direct a huge -- we want to be directing a huge amount of capital to because we have AUSTEDO, AJOVY, UZEDY, olanzapine, ICS/SABA, TL1A, IL-15 MSA, PD1-IL2 and we have 7 biosimilars before '27. So we have a lot of things to manage and the opportunity cost of going extreme on anything has to be thought through. So I think that's where we're probably different from your typical generics company.

Understood. Let's talk a little bit of a biosimilar as well. So you have biosimilar Humira, partnered with Alvotech, there's been a lot of progress on this front. You have signed a deal with Quallent Pharma, which is a private distributor of the Cigna Group. And then Express announced recently -- Express Scripts announced recently that branded Humira will be removed from the formulary starting in January '25. So if you could just talk through your expectations for this year and next year for this biosimilar, both on the private label deal with Cigna, but also on the kind of more usual channels of...

So look, I think overall, at a high level, I think the biosimilar market in the U.S. is heading in the right direction, and it's becoming a lot more positive because of the things you've said, I think the private label, the brand being delisted, I think, shows maybe a strategic intent for the payers and the PBMs to really benefit from the opportunity that biosimilars brings to the market. I think for us, we came to the market late because of the challenges we have with our biosimilar Humira. But that said, we've got ourselves a private label, and we're getting good coverage. I think that makes me optimistic about how we head to the year-end. I think for us, probably '25 is where we start to focus a bit more because as the brand gets delisted, has those conversations that we've started to have with Humira because we've come to the market late, mature, we can start to plan more for '25. At the same time, we're starting to have -- we'll start to have conversations on Stelara, biosimilar Stelara with those same payers and PBMs. And because they have learned a lot, but they work with us on biosimilar Humira, I think '25 does create a good opportunity for us in our biosimilar portfolio. And then we have another 5 biosimilars to launch between now in '27. So I think it will keep progressing. I don't think it will be a smooth path in the U.S. because it's a fragmented health care system. So it's not like Europe where a government makes a decision and then it happens. But the direction of travel is really positive. And so I feel good about that.

Very well. And if you could just talk a little bit about the economics. Any difference in economics for you between private label and the kind of traditional channel of going to the PBMs and being prescribed and so on? Or is it similar economics? .

It's similar economics.

And you just touched on Stelara and more specifically, if you could talk about your expectation for the same kind of situation we've seen with Humira, also occurring with Stelara, so basically the structure of these private label deals and if you are part of these discussions today on Stelara?

Well, we got an agreement to launch Stelara in February, and we cannot -- part of that agreement is we cannot work with the payers and the PBMs until 6 months prior to that. So we're just about to approach that. The good thing is those payers and those PBM we're going to talk to, we've been talking to for the last 4 months about Humira. And by the way, we talked to them all the time because we're the largest supplier generics in the U.S. So they know us really well, but we can't actually get into specifics until that 6-month time line is a lapse. But look, it goes back to my earlier comments, they've changed a lot. I think their approach to biosimilars has changed a lot. That's a positive thing. I think Stelara will benefit from that -- biosimilar Stelara. And I think we'll benefit from the fact that we launched biosimilar Humira. We've learned a lot. And so I think that will be different from what we experienced with biosimilar Humira. But you never know to until it actually happen.

Moving back to innovation now. And long-acting injectable olanzapine for schizophrenia. So very encouraging headline data, if you could just remind us when are we going to see more detailed data? And then if you could give us some insight on the commercial strategy, if you're planning to target certain switch patients who are on oral olanzapine as a starting point?

So yes, we're very excited about our long-acting olanzapine. I was just informed today by my colleague, Eric, we have completed 99% of injections without PDSS. So we have 1% to go. So I think that's very positive, but we'll have that full data set sometime towards the end of the year, and we'll obviously announce that, but that's very important because that will differentiate us, obviously, from the product to the market, which is a news because of [Indiscernible]. So then the question where do the patients come from? I think it's -- the assumption is that the majority will come from oral olanzapine, which is 20% of the schizophrenia market. I do believe, and we're doing a lot more research now that some of the patients who are on long-acting schizophrenia products now probably would have chosen long acting olanzapine if it's been available, but they didn't. We don't know how big that is. But I think the opportunity from switching oral to our long acting is significant. As I said, 20% of the schizophrenia market is olanzapine. It is the most used molecule. So excited about that. The other thing I would say is we launched UZEDY, obviously, our long acting Risperidone and that's doing very well. But the people we talk to, the physicians we talk to, the payers we talk to, the D&T committees, and the hospitals we talk to, the pharmacies we talk to, the PBMs we talk to, are all exactly the same. And so we built up a good momentum and a good relationship with UZEDY, and so as olanzapine comes along, I'd like to think we'll have a good launch because we have this relationship, we have the target team, we have the segmentation done. We have the patient programs in place. And so I think we're well positioned.

And to come back on this ambition to switch all patients. Can you just talk a little bit about how we should think about access and reimbursement, given that payoffs might be a bit reticent to kind of reprice category, a drug category or class of drugs that has been [generalized] before.

Yes. So look, I think that's a fair point. I mean you have to have a differentiated product. So I think that it's a managed area now, and that makes it harder, no question. But I think what we've proven with UZEDY in a sector which has a lot of long acting. The product attributes of UZEDY, which is you get to therapeutic doses in 24 hours and then supplement all medication required and the subcutaneous injection. Those are significant positives which allowed us to get access even with the pressures. I think olanzapine should follow in that suit because there is no long acting olanzapine. So as much as those pressures exist, I think we'll have to be mindful of how we discount. I think we've -- and I've often talked about UZEDY, we have not got the access that we initially planned for because we have not agreed to the discounts that we've been asked for. That said, it hasn't slowed our trajectory of UZEDY because physicians want to use it. I think if you bring a product that meets a big unmet need, the payers will have to understand that. Now there's a negotiation, but I feel well -- I think we're in a good position with olanzapine because the excitement around is considerable. I mean as much as we -- Eric's team accelerated the Phase III study through just good execution, good operational, I think he would -- part of it was the excitement of the community wanting to have a long-acting available. And so I think that will also play out.

Perfect. And you mentioned all the synergies on the commercial side and market access and everything that you have with UZEDY. So when you think about the incremental investment required to kind of make sure injectable olanzapine is a success, can you just talk a little bit about that?

Yes. Look, I don't really expect that much. That said, I do always think about capital allocation is really important. And what we showed with AUSTEDO is we did not try to be clever. It was under resourced in the past. I mean we resourced it heavily in line with what we thought it could achieve. But that means we have to take resources from other parts of our business. So I don't see olanzapine require it anymore. But if we do think the opportunity is even greater than we thought then we all resource it appropriately. We won't try to be too clever, and then we'll take resource from other parts of the company. And we've shown we can do that well. We managed the P&L well, we manage the OpEx well because we make choices.

Very well. And spending a bit more time on UZEDY. You mentioned very encouraging launch trajectory. And there was one other injectable [indiscernible] in the market [indiscernible] which was not a big product, but recently [indiscernible] decision kind of stop investing behind this product. So just could it be helpful in the short term in terms of having a bolus of patients switching, could that help you beat your target? Or is it just not that relevant in terms of competition?

So I think there's 2 things I'd say there. One, it just shows that the strategy we have, which is we make sure we create a good value proposition, and we make sure we get paid for that value. And we stick to that, I think it's really important because then you create a long-term product, which can be invested in. So we've done that. I think yes, we have picked up some of those groups, but it's not a significant part. I think we've been -- where UZEDY gets its business from is still primarily orals and other long-actings and that just happens to be one of them. But it wasn't a significant part of the market. So we didn't target those areas to go after it. That would have been inefficient.

Understood. Yes, and I just wanted to spend a bit of time on AJOVY, which is your migraine treatment. If you could talk a little bit about the dynamic on the market, potential impact from the new oral therapies, I mean, they've been in market for some time. Yes, maybe starting here.

Yes. So look, I think AJOVY is, I think, a product which I sort of -- I enjoy seeing our performance on it because if you see across both Europe, international and the U.S. we have grown our market share considerably, which shows even in competitive market we can perform really well. And I think that is being reflected in AUSTEDO, UZEDY and AJOVY. So when it comes to commercializing innovative products, we are good. We are focused and we are good. Now AJOVY is going to be predominantly grown, I think, in the foreseeable future by international markets and European markets where it's growing well, less so in the U.S., mainly because of the pricing pressures we have in the U.S., and we've talked about that before. To answer your question on orals, the orals have come into the market. But the injectable market is still growing about 6%. So across all of our regions, we see good opportunity. Obviously, the orals do -- they take away some growth from injectables, but at the same time, they expand the market. And people who got the orals, but then some of them actually fail or want to get back on to injectable or want to be on injectable. So I think we see AJOVY as a continued growth driver in Europe, International and maybe less so in the U.S., but let's see how that plays out.

So you are also thinking about biosimilar and biosimilar development. And when we look at a product like AJOVY of this size, which is a sizable product, but at the same time from a biosimilar company and kind of looking for an opportunity, maybe it's not necessarily going to be on their radar. So how should we think about the life cycle of a [biologic] like this that may be the challenge in terms of having a return investment for biosimilar companies to try to make a copy of it. .

A copy of AJOVY?

Yes.

Well, [indiscernible], we're not going to copy it. Look, I think...

I mean what I mean is basically is the big size of this drug going to be enough to cease challenges from biosimilars. And so if not, how should we think about the life cycle of a [Indiscernible]...

Yes. No, look, it's an interesting question. So I think the way we look at biosimilars, and I think other companies would what targets for biosimilars. I mean, if you look at the biologics coming off patent, I mean some of them are going to be $34 billion annual sales. And people with my optimistic thinking, AJOVY is going to getting into those numbers. And so when you come down as we do when we look at the biosimilars, we want to go after, AJOVY will never get on to that list, because there's so many biologics that are coming off patent that are multibillion dollar. And so I think for that -- the way we look at it, and obviously, I was at another company before, it's you just go down the list and you project sales and you see where they're going to go and then you start to invest. And because the biologics is such a big part of treatments across many TAs now, it's a huge list to go after. And you tend to see the cutoffs around about $2 billion. You don't really want to be going much below that. But then the biosimilar development part they may change, maybe Phase III studies will be needed, maybe any patient studies may be needed. If that changes, that reduces the cost and then products below $2 billion, [indiscernible] could come in. So it's going to be quite dynamic. But I don't think AJOVY will be a target for other people -- too many bigger products above it.

Yes. That's clear. A little bit about the pipeline, and obviously, TL1A, which is very exciting. If you could elaborate a little bit about the expectation for the potential of the asset class maybe to start with. And then specifically on your assets, what do you think you have to demonstrate with the top line data in order to be competitive in that space with other assets also emerging.

So I think for the asset class, look, I think what I've learned is -- and you see Crohn's, this is -- as much as we see the development and introduction of new products, it's still a -- the level of efficacy is still -- there's still a huge unmet need and people cycle through these treatments a lot and a lot of these patients will end up with surgery. So I think there's a significant opportunity for a new class like TL1A to come in because of the lack of satisfactory products right there now. So I think for us, we're very optimistic. We do think we have the best TL1A, We're very passionate about that. We have good data on that to back up why we think that. But obviously that will play out when all the Phase IIIs are completed. To answer your question about Phase 2, obviously, we're going to announce we've accelerated that. We're going to announce our top line data at the end of this year. And I think you asked me what do we expect to see?

No. No. Do you think you have to demonstrate whether that in terms of efficacy, in terms of safety, where do you think you -- compared to the Phase II data we have out there, what do you want to see in order to be confident in the competitive profile of the product?

So look, I think we think a bit less about what other people have done. You come up with your own profile that you need to see when you have a Phase II. I do think we're a different product to them in our specificity, our potency and our neutralizing antibodies. And so we discussed that internally what we need to see to move forward. I think comparing Phase II is not a particularly good methodology. I think for us, it's about knowing what we think we have to see to move into Phase III. And then at Phase III, those are the numbers that we really can.

That's clear. Maybe a word on the ICS/SABA that you're developing. When you look at [Indiscernible] forecast for the one driving the market in this category from AstraZeneca, [indiscernible], it's around $1 billion expected by consensus. So I just want to know, obviously, it's going to depend on the Phase III data that you're generating. But beyond efficacy and safety, there's something else that is differentiated about your drug or the device that could give it an advantage compared to the Astra's product?

Yes. No, I mean, look, it's -- I think I have to talk about this. You normally want to come to the market first, but where there's a market formation required, it's not a bad thing to come second. And to follow AstraZeneca, who have a good reputation in respiratory, I think it's not a bad company to follow, who are creating this market. And then we come in, obviously, 2 to 3 years later. So differentiation is key, to answer your question. But I think we have 2 clear things that differentiates. One, which is fundamental, we will have a pediatric license, which is 25% of the population. And the second is we will have a simpler device. And I think those 2 things give us an opportunity to take a nice piece of the pie that will be there as we come to launch. And obviously, we'll also grow the market. The fact that we will have a pediatric indication, we'll have a simpler device. I think -- and we'll have a share of voice that helps expand the market beyond what Astra has done. So I think this is something we're really excited about. The one because we know the clinical development has a high probability of success because we know these 2 products work, and we know how to make devices. So we're pretty sure it's going to work in the clinic. And we know the market is going to be formed because we're following somebody for creating it. And we know we're differentiated because we're going to have a pediatric indication. So for me, I think this is -- we're very excited about it, hence reason why I'm constantly talking to Eric about accelerating the study and move into the clinic quicker like we did with olanzapine and TL1A.

Perfect. Just a word about the organization and shaping the business, you're working currently on divesting the API business. And without going into too much specifics, is there a scope for other -- this type of transformative corporate action for Teva. Do you consider at this stage that the organization is already close to be fully streamlined?

So look, I think we constantly look at our business to understand where the growth drivers both on our top and bottom line, where should we be allocating capital. So I think we did those at the start with Pivot to Growth and we identified some aspects, TAPI being one that we had some geographies we also targeted. Because they weren't going to fulfill the long-term strategy of the company. And I think we should -- that's good business to do that, we'll do that every year. And anything we think is not going to help us achieve our long-term growth, but it is absorbing resources and capital, and there's other parts of our business that could do with that resource of capital, we want to make those decisions. So it's quite dynamic. And I think what we've shown at Teva is we've made a lot of those decisions very quickly, but very effectively, and it hasn't disrupted the momentum of the business at all. And I think that's a capability and competency, which I haven't seen before in a company, and we want to build on that. It's very -- we want to think of the company as dynamic. We adjust continuously based on the opportunity, and we don't want to get into restructuring, all those things that you do when you lived with something imperfect for too long. If it's not perfect, there's a better opportunity, we'll make a decision now. And the organization are very comfortable with that, particularly as they see the benefits of doing that. I mean to invest heavily in AUSTEDO last year, without changing really materially the cost structure, we had to remove investments significantly from one part of the organization. And we have to do that really quickly, and we did it really quickly and seamlessly. And now the organization are well aware of that, that's how we operate.

I think we go to the end of the time. So thank you very much for your presence and for taking the time today.

Thank you. It's enjoyable to be here. Appreciate it.