Excellent. Well, listen, thank you guys for joining us. Pleasure to have the new Teva management on the new Teva story, hopefully. So looking forward to this discussion. But just before we begin, maybe turning it over to you, Richard, to kick things off, and we'll jump right into it.
Yeah. Firstly, Uma, thank you for having us. Really appreciate that. And thank you, everybody, for your interest in Teva. So I think maybe as a way of introduction, obviously, Teva, we launched a new strategy, a pivot to growth strategy, in May of this year, and that was a strategy to obviously get Teva back to growth. And that was based on four pillars: deliver on our growth engines; step up innovation; create a generics powerhouse; and then focus the business. And I think we'll go into some of those details of those pillars, but primarily it centers around making sure we maximize the opportunity we have in our innovative business. Our innovative business is, you know, somebody who from the outside came in, I think a very attractive business.
We have products on the market, which I think are gonna drive growth, and we have a great pipeline, which Eric can help me talk a bit about. So I think from a perspective of Teva going forward, there's a really interesting narrative around our innovation business and obviously our generics business, which we're known for being, you know, number one in the world. I think there's a lot of capability to get this business back to more stability and to growth going forward as well. So for me, I think Teva's well-positioned, and we've had two quarters of growth. And that growth has come from the areas that we said we're gonna allocate capital, which is innovation. So what we said we're gonna do, we're doing, and that's delivering the results.
Now, it's early days, but I think that's important when you put a strategy together, that you execute that strategy, and then that strategy starts to deliver what you hoped it would.
Excellent, excellent. So I know there's a lot to go through, and we'll go through it step by step, but, maybe let's kick things off and ask, broadly speaking, because a lot of folks still think it's a very levered situation from a balance sheet perspective, could you just remind us where leverage stands now, and where's your head at in terms of, how you can think about uses of capital with all the cash that's still being generated?
Yeah. So I think we're roughly around, you know, net debt is about $17.6 billion. And so, you know, a ratio of net debt to EBITDA we wanna get to is investment grade, so below two, by 2027. We said that, and we're on track to do that. And, you know, we're paying off about, you know, $1.6 billion a year, and we have free cash flow to do that. So I think that's very important is, this debt is on a downward trajectory, and I think we're very, very comfortable about how we can manage that to 2027. Now, for us, about...
Because we have this growth opportunity, which is, you know, I think, very unique in that we have these products which we're gonna talk about today that we've already launched, AUSTEDO, UZEDY, and AJOVY, that can drive significant growth for the company. How do we, with some of the constraints we have on the balance sheet, as well as on, in the, in the P&L and financing this debt, make sure we can maximize these opportunities? And that's where we're spending a lot of time on making sure we allocate capital correctly. So we have reduced investment in certain parts of the business to make sure we can allocate investment in other parts of the business. Now, from a BD point of view, we're actively back in the BD world.
So, but because of that balance sheet, we have constraints about what we can do, and so most of what we're looking at is in licensing. Because we have a very capable commercial infrastructure, both in the U.S. and in the rest of the world, particularly Europe, which is, you know, under-optimized right now, I believe. And so we can bring some products in. We want those to be late stage, we want those to be de-risked because we don't want to carry risk with our situation we're in right now. We don't, we don't need to, but we can leverage that infrastructure. So that's what we're looking at right now, and that also allows us to do deals which are more in line financially with what we can manage from a balance sheet point of view, as well as-
Right
... a P&L point of view.
Richard, I know you mentioned, I think you guys are a little above three times in leverage right now.
Yeah.
The goal is two times. But for a lot of investors, below three is a critical threshold because a lot of them can own the shares more. Is that a realistic possibility in the next, let's say, 24 months, where you guys could be-
Yeah
... just below 3x in terms of leverage?
Yeah.
Okay, excellent. Maybe as we think about sort of numbers a little. Okay, actually, just before I get into numbers, the other question that's also come up, sort of high level again, so we talked about balance sheet. You could be at sub 3x leverage in the next 24 months, presumably. There's a lot of buzz around the API business. What exactly is happening? Is that being divested?
Yeah.
There's a new management team there. Could you just catch us up on sort of the thought process there?
Yeah, no, and it goes back to the, you know, pivot to growth strategy. And I'll always come back to that, 'cause a good strategy should direct decision-making, capital allocation, and focus. And so when you think about the four pillars, the fourth pillar was focus the company. And when we looked at that, there were two primary goals, which was to make sure capital is allocated to the things that are gonna drive growth, top and bottom line. It also allowed us to look at the TAPI. When we came in, I came in, and the executive team looked at the TAPI business, we thought it was vertically integrated, and it's-
Yeah
... and it's not, right? So in separating it, its primary goal is to drive growth in the company. The API business is not growing. The API market globally is growing at mid-single digit. So for us, it's about to get it back to mid-single digit growth, you know, potentially more. That will help us get Teva back to growth. It'll be another, you know, opportunity for us to drive growth in the top line of the company. We want to start to do that next year. And now, does that give us... You know, as we create a standalone business with its own CEO, it's single-mindedly focused. It's to sell our API and to do our R&D on API for the market.
That gives us growth as a company, and it gives us, it helps drive the pivot to growth. But it potentially gives us strategic optionality, which I think is what people are asking for. I don't wanna get ahead of myself. Let's get the business back to growth. If we start to see a clear line of sight for that, then we've got optionality. Do we, do we keep it? Do we build it? Do we, expand it or, or look at an alternative?
remind me, I think it's $1.5 billion in the top line-
Yeah.
and the margin profile.
It's a $1 billion on the top line. I think the margin, it's accretive to the company, so that's what-
Okay.
I think that's as much as we've said. So it's by the second largest API manufacturer in the world. And, you know, what's interesting is we did a bit of research in our strategy, 'cause we're very detailed as to what people think of our API business. And it's rated as, you know, the customer satisfaction is very high. People like what we do. It's complex. Our service levels are very good. So it's not a business that we're having to sort of, you know, the core components of it are very good. What it needs to be is allowed to be free to operate in a bigger market, and have a management team that's job is: grow this business, grow it in the top line, and help it be accretive to the company.
Got it. AUSTEDO franchise, I know you guys are right around $1.2 billion run rate or so by the end of this year. And my-- obviously, you've talked about over doubling of that franchise over time. But as you can imagine, that's never gonna be linear. Consensus has about sort of 15% year-over-year, and I wonder if you think it's gonna double over time, presumably, the growth near term is more than it will be in the outer years. So is the momentum much more accelerated than how the sell-side models are carrying it right now?
Yeah. No, and look, so in short, yes.
Yeah.
Look, I go back to the, you know, the first pillar on the pivot to growth is deliver on your growth engines. AUSTEDO is a great asset we have. It's a great opportunity. It's an under treated market. There's 780,000 people who have tardive dyskinesia, a fraction of those on treatment. So there's a big opportunity. What we've done is we focused more resources on it. We've built capability in this innovative side, so we've brought people in. And we've seen, as you pointed out, that we're gonna do—we believe we're gonna do $1.2 billion this year, which is a lot different from what people thought we could do. And so I see this as an opportunity we need to keep focusing on. And so there's still a disconnect.
I think it's gonna do $2.5 billion in 2027, and I think other people think it's gonna do less.
Right.
But I think that goes back to a lot of what Teva has to do, is we need to be clear about what we're trying to do, and we need to execute it and show we can do it. And as we do that, maybe people will model it differently. And right now, people are modeling it in a way where there's maybe a bit more. They're taking into account a bit more what we have or haven't done in the past. But for me, this product is gonna continue to grow and grow well, and I think it's gonna be a big driver for our top and bottom line.
Got it. In terms of gross margin, I know there's an expectation that there's slight improvement, not meaningful, but about 100-120 basis points into next year. But this has been under such focus because of that 1Q choppiness that happened.
Yeah.
Do you see sort of modest gross margin improvements, generally speaking, as you think about next year?
Well, I think, you know, definitely, gross margin is gonna continue to improve. I think one of the things to consider when people think about by how much is, the portfolio mix is really important. So as AUSTEDO continues to drive, as UZEDY, our long-acting treatment for schizophrenia, starts to get traction next year, and we continue to drive AJOVY. You know, Q3, it was still double digit, you know, in the 20s, so still good growth. That's gonna continue to happen. That portfolio mix drive gross margin massively. At the same time, there's a lot of things we're doing operationally at Teva-
Yeah
... just to improve our performance in maybe the hard yards, you know. And this comes down to cost of goods, this comes down to procurement, this comes back down to working capital, all the things we need to do. Now, as we do that, what I did mention on one of the strategies or one of the pillars, which is create a generics powerhouse. To do that, we want to improve our manufacturing capability. And what we're gonna do is we're gonna take some of the dilutive or non-profitable products out. Now, what ultimately it does is create more efficient manufacturing network, which improves your gross margin. But the year you do it, you're taking a bit of revenue out, right? Which has its consequences-
Right
... as you create that efficiency. So we have things that are definitely gonna drive our gross margin, and then things that are gonna maybe slow that growth down a bit because we're driving long-term growth margin improvements, and you just have to get on and do it, and don't delay it. But yes, I think the short answer is our gross margin is gonna continue to improve, primarily driven by the fact that we're expanding our innovative portfolio, which is a very different gross margin number-
Right
... in our generics business.
So I wanna get to the innovative in a little more detail, but just before that, in terms of mix, there was, there's a general perception in the marketplace right now that things are stabilizing in the generics landscape. I saw, Rajiv at, Viatris recently say that, "And after so many years, generics have finally stabilized." Is that a perception at Teva as well, that things in the generics land are in a much more stable spot, even relative to, let's say, your time at Sandoz, when things were not so much in a stable spot?
Yeah, no, I've tried to block out those early years.
Okay.
But no. So let me go back to the principles of what makes a stable market and what makes an unstable market. The reality is, there are three purchasers of generic products in the U.S. As somebody launches a generic product, they will do an RFP straight away, regardless if they did an RFP the week before. That's just the power they have. So they have all the purchasing power. The only thing that creates stability is there are either less launches coming through. So if we have a product and we have an agreement, if a new company comes out and launches that product, there is another contracting cycle, even if it was just done a week ago. That's not gonna change. So for me, when we did our strategy, did we anticipate or forecast any stability in the generics market in the U.S.?
No, because we don't control that. What we said is, "That's okay, because we have a very big pipeline in the U.S., and we are improving our manufacturing capabilities. If we execute our pipeline and bring it to the market on time, more often than we've done in the past. It doesn't really matter what the market does, if it's stable, it becomes a bit unstable, because we can weather that, because launches are what drive the opportunity to drive growth and value in generics in the U.S. particularly, and that's what we can control, 'cause we have a big pipeline. Now, whether there are quarters where the price erosion is 5%, the price erosion is 2%, the price erosion is 10%, it'll be what it'll be.
What we need to set up strategically is a way that we can manage that, and you do that through launching, on a continuous basis, more high-value products than—and then whatever erosion there is, you compensate it for launches. So I always say, and I'm doing the, you know, the numbers for next year, I do not forecast anything getting better over short-term or long-term. It is what it is. But we could still have a very good business in the U.S. because we have all three capabilities. We have a great pipeline, at which Eric has put new sort of focus and capability around. We have a great go-to-market model, and we have a supply chain, which is good, and we're gonna make it even better. Those are the three things you need. We've got them. We just need to execute better on them.
The market can do what it needs to do, but we will still grow the business.
Outside of biosimilars, is there a big launch over the next couple of years in generics?
So, look, we cover 85% of drugs that lose their patent, right? Now, we're gonna not do that, cover as much going forward, 'cause we wanna be more focused and focused on the high value. So yes, we cover pretty much everything in the next few years because-
But there's not a Revlimid-like opportunity, for example?
I don't think we communicate what's coming because of, you know, competition, settlements, or legal issues. That said, we are gonna be a bit more clear and communicative about helping people understand what is coming.
Right.
Because I realize that sort of unknown creates people. It makes it difficult for people to model and to forecast what's going to-
Sure.
So we're maybe next year, we're gonna be a bit clearer on that. What I would say is, and you mentioned my prior life, the one thing we have is an enormous pipeline. We have an enormous pipeline, which is what you want. We just got to execute it better. And then as we start to sort of wrap the narrative around, I think we can be a bit clearer on what's coming when, and help people understand what we've done in the past as well. I don't think we communicate maybe as well as what we have launched even this year. So we'll be a bit more clearer to help people model and also how to hold us accountable for what we said we were gonna launch, and have we launched it?
Makes sense. On... And this is the last one on this sort of generics broad topic, but on the biosimilar HUMIRA, I realize there's been some delays. How are you thinking about that into next year now? And has the commercial, potential odds changed in your mind on what that looks like, partially because of the market formation, how it's been so far, but also partially because of the delay?
Yeah, and by the way, I apologize for talking about generics.
Okay.
It's $8 billion of our $15 billion business. It's a great business. And outside the U.S., which is 62% of our generics business, it's growing. It's growing, you know, mid-single digit, and it's growing very well. So we're very proud of it. We just know we can make it better. Now, to answer your question on HUMIRA and biosimilars, you know, firstly, our strategy on biosimilars is to bring a large portfolio of biosimilars to the market, predominantly through partnerships. The reason why, and I've been in biosimilars a long time, is I believe portfolio is really important, is because we can try and predict which is gonna be the big one, which is gonna come on time, where you're gonna get the money, but it's hard, right?
What I do know is every biosimilar we bring to the market will create value, some a lot of value, some less value. But the secret for a company the size of Teva is to bring a portfolio, you know, 15-20 of those to the market over time. What we've shown with Truxima, our rituximab product, we've accumulated a $1.4+ billion of revenue over that period of time, and that's really helped us fuel other things. So for me, you know, it's about the portfolio play. And the reason why we've done it through partnerships is because Eric's got so much innovation to drive. Then we think, well, capital allocation, where's our, where's our real capability line? Can other people do R&D and biosimilars? They can, so why not let them do that?
Stuff that only Eric's team can do in CNS and immunology, we should focus on that. To answer your question on HUMIRA, look, I think, it's sort of, for me, firstly, what I would say is, last year was a tough year in that because everybody launched mid-year, I think contracting and I think payers probably thought about, "Let's just plan for what we can plan for." And so I think 2024 is gonna be more of a year where we'll see actually how HUMIRA develops. Where we play in that, I think is still open for debate because we have to have a successful site inspection of our partner, Alvotech, in Iceland, which is gonna happen, I think, early January. And then based on that, whether we launch in H1 or, or, you know, midsummer, also creates a, I suppose, a variability around forecasting.
What I would say is, we're not relying on HUMIRA to drive growth next year for Teva.
Right.
So what's important for us is Stelara, which comes out of the same site, which is in February 2025, which no one talks about because, you know, HUMIRA is the big one everybody talks about. Stelara is a very big product. There's not many people coming to the market with a biosimilar, so we see that as a really attractive one. And we'll see how HUMIRA plays out, but it goes back to that strategy. You know, is HUMIRA so critical for us to develop, to drive growth in Teva, that we're all over it operationally, but we're not reliant upon it because we have a portfolio play. So that's how we sort of think about it, and that goes back to why our strategy is the right strategy, I think.
Got it. On HUMIRA, especially as it relates to the manufacturing side of it, do you get like what's the level of visibility that you have on how that manufacturing side is going? And is the confidence going up into that January inspection or not?
So obviously, what we've done is we've really strengthened operationally our partnership with Alvotech. So just to give you some idea, so Teva, we have about 30 FDA inspections a year. Thirty-
Right
... around, you know, 54 sites, and we pretty much get through them all.
Okay.
In fact, since I've been here, every one, right? So we know about FDA inspections. What we've set up is a joint steering committee on manufacturing with Alvotech. So going forward now, we're far more involved in that to help them become, you know, you know, what is necessary to get through FDA inspections and to be a good, reliable commercial manufacturer. 'Cause we've done it for, you know—Well, we've been around for 122 years, and we've been manufacturing drugs for a long time. So we're really leaning into that. So when it comes to, are they ready, you know, the mock audit inspections we do for them, we've done all of that.
So we think they're set up for a, you know, a really good inspection, but you never know because each inspection's about, you know, what happens that week to a certain degree. But we feel very confident that the team in place know what they're doing, how to do it, and not just get through an inspection, but to be a good, reliable commercial supplier. So-
Got it.
All good.
All right, so I want to start to get into R&D a little more specifically now, and, and maybe my opening question would be: how this Eric, Richard conversation goes internally? So Eric, so he comes to you and says, "Well, our R&D budget is flat as per consensus next year, but we have all this pipeline.
Yeah.
How do you think about that? But I realize it's a more complex question because Sanofi will be kicking in on-
Yeah
... some of the spend on . Is it realistic to expect there's not a whole lot of R&D build into next year?
So, firstly, it's really important to understand, we developed the strategy together, Eric and the rest of the executive management. And by the way, it's modeled in great detail, the numbers. So everybody knew-
Okay
... build. And so, one of the big parts of that that Eric really leaned into is that as much as we are spending more, a little bit more, we have taken a significant amount out of our generics R&D budget, and we've allocated it to innovative. We've taken a chunk out of biosimilars, and we allocated. So part of this goes back to that fourth pillar: focus the business, allocate capital to what's gonna drive growth. So now, the reason why we've done that in generics is because we're not going after 85% of every drug that loses its patent. We're going after the high-value ones, which I think is about 60%. So Eric can still have a probably still the biggest pipeline anybody's got and have the right amount of funding to do it.
But it is something that we do talk about because we made it very clear that a big pillar of our strategy is to drive our innovative portfolio. We have a great, small, but I think high-quality pipeline, and we've got to make sure we prosecute that really well. And if capital is needed for it, we have to make sure it happens. Part of that's taken from other parts of the business, part of that's partnerships, where we get money and capability. But it is a good discussion. What I would say, and then I'll let Eric talk, is...
And this is what when you develop a strategy across an executive team, when the executive team understand the strategy, some people will say, "Actually, Eric needs more, so I'm gonna have to cut back because we don't want him to cut back on what he's trying to do with that pipeline. Because I want that pipeline to come out because it's gonna fuel my growth." And so it's far more—we're less siloed as an organization. We're far more interconnected from a financial point of view, and I think that's allowed some really good collaborative support, which I haven't seen, to be honest, at some other companies.
But it sounds like you're comfortable with roughly flattish R&D year-over-year, just because of the way the structure was, the deal structure was with Sanofi?
It'll probably go up a bit, but, I mean, it's percentage-wise, so in absolute terms, it'll probably go up a bit. But when we think about percentage, 'cause, you know, I believe we're gonna grow the company, we're gonna grow the company on the top line, and you tend to do, you know, your spend as a percentage of your, your revenue. And so we've started to grow the company this year. We're gonna continue to grow the company next year, and because of that, that allows a certain level of increase in spend. But we're very mindful of that, and so we spend a lot of time on the expenses-
Got it
... 'cause we don't want to let that-
Percent-wise, it's flat year-over-year, is what you're saying?
Roughly.
Okay.
I think, he may get a little bit more. It's not just because we have all this Phase III come together.
Right.
Right? But it's not something which is, I think, you know, hugely significant.
Right. And I keep coming back to this, mostly because I'm a little confused on how the mechanics work. Now that it's 50/50 with Sanofi on TL1A, does that mean they pay a little more next year to make up for the prior expenses, or how does that work? Or is it 50/50 going forward?
That'd be a good idea. So, like, make them pay for what we did in the past.
Could have said that upfront.
Yeah, yeah, we should have done that. No, it's, it's pretty much going forward. So look-
Going forward, okay.
But it starts immediately. So, you know, as and when we get clearance, the FTC and things like that, then theoretically, you know, we could start to invoice them this year. But we're-
I got it.
But it's going forward.
Okay, excellent. Which then takes me into a little more specifics of the trials. I think, ulcerative colitis, Phase II, second half of next year, that's pretty clear. I always get a question or two, is Crohn's also due in second half next year? I know it's one big study, but they'll be reported separately, Eric.
Yeah, so they're both in the study. It, you know, it's both.
TL1A, just to be clear.
Yeah, TL1A, Ulcerative Colitis, Crohn's Disease, are in one basket study. They're both placebo-controlled with various doses, and that are both running simultaneously. Actually, our Crohn's is doing a little bit better than our Ulcerative Colitis most recently. But yes, they're both in the same study. We're targeting for the second half of both, end of next year.
Got it. I think, Eric, I talked to you about it previously as well. There were some questions on... There were initially three dose arms in there, and then the third was discontinued.
Yeah.
That sort of came out right when the collaboration with Sanofi got announced. So, A, did you guys have that discussion with Sanofi folks on the plan changes on doses? And also, what sort of prompted that?
Yeah. So there was a great opportunity here with our evolving biomarker data. As we know more about the molecule and how, well, well ours works, we were able to optimize the study, take out a dose. Sanofi was well aware of it because we were working on that as we were having our discussions with them. So, it was a good opportunity to get it done now so that we can have more patients in the arms that count, and that we can have better data when we have the readout.
Got it. And, I mean, if I think, if I think out loud, I'd be thinking, you know what? There were probably— You guys probably think at a certain dose, let's call it 500 mg, what have you, you're hitting all what you want from a TL1A knockdown perspective. Anything above that may not have had incremental efficacy, could have had higher ADAs. Was there any blinded observation of ADAs that prompted this third dose?
No, no, this is all based on our phase I work and our-
Absolutely.
- in vitro work, and our relative potency. Remember, ours is, when we do those head-to-head comparisons in vitro with the molecules we've made in-house, you know, we have a greater potency, we have a better clearance, we believe, and it's greater selectivity. So all those things add up to, you know, optimizing the study that we've got going right now.
I guess what happens to those patients? Like, how enrolled was it? Like, 10% enrolled, that arm that got dropped, that will not be counted in anything else?
It was just the very beginning. So it-
Okay.
We'll have those in the analysis because, you know, we dosed the patients.
Right.
That's not gonna be a major component of the interim analysis, yeah.
Got it. And when you say interim analysis, you're talking about the induction readouts second half of next year?
The induction and any available maintenance that we have. So you... When you do the cut, you usually have, you know, which your primary statistical analysis plan has, and then whatever is available from the maintenance we should have.
Got it. And the arm that you did discontinue, you can't unblind that, can you?
No. No, not at the-
That was-
We don't want to unblind any of this. Yes, that's correct.
Okay, got it. Also from a maintenance perspective, I know there's two different maintenance regimens every two weeks and every four weeks.
Mm-hmm.
Can you remind us, in induction, is it all monthly or is it every two weeks?
So we always don't want to comment on doses and schedules before we do the presentation, but right now it's based on, you know, what we're seeing in the biomarker data that we've seen in preclinical studies, based on the selectivity of the compound, you know, the longevity of our effect that we think we see. So we want to make it competitive, and we want to optimize it now at the early phase of the study. So that's how we've come to the decision of what the design is now.
Got it. And Eric, one thing that did stand out to me is, both Prometheus and in the Pfizer work, doses were basically approaching somewhere between 500 mg-1,000 mg. Did you sort of have that in mind as you were thinking about the dose plans for your trial? Or... Because I think one question that does come up is: Is it underdosed in any shape or form?
No, you know, in the early days, we designed it on the PK exposure that, you know, what we've seen in our own studies and the potency that we have. So based on the potency, the selectivity, and the fact that we want to have this in a single injection auto-injector, that's the key, key part of it. So relative doses doesn't really actually matter. It depends on the performance of the compound, but having a convenient auto-injector is the key.
Got it.
Yeah.
Wouldn't that put you at sub 400 mg from a dose perspective?
I mean, if you envision a 2-mL auto-injector with, you know, 100, about, you know, 200 mg, you know, you can think about what you get per mL. It's all based on the science, the viscosity, and what you can get in the auto-injector.
Got it. But my understanding is you don't have an auto-injector in phase II right now, but you've, I know you've-
Yeah, all of our phase II is already subcutaneous, so the transition into subcutaneous is not gonna be a big thing.
Well, phase II is subcu, the existing product.
phase II is all subcu, yeah.
Got it. Okay, makes sense. Also, there's questions on biomarker. I believe you guys are- nobody's really definitively established a biomarker in this space-
Yeah.
But my understanding is you have one to the extent there.
No, I think that's a... I'm glad you brought that up, and I'm glad that you stated that there's no really good definition of a biomarker yet. We've actually put a lot of effort into looking at free TL1A assay, which we developed early on. I think we're on our third generation of the assay at this point. We'll present some of that data coming in February from our asthma study and from our SAD and our MAD study, just to, you know, level set what we're looking for and the clearance of free TL1A.
Got it. Have we seen any of that work published for Prometheus or Pfizer, free TL1A knockdowns?
I don't know what their full programs are. I haven't necessarily seen that, a free TL1A from the other competitors.
Okay.
We've been looking at that for a while.
You are referring specifically to your, I think, N=70 asthma study, and you're evaluating-
Yes
... free TL1A knockdown in the serum of those patients?
Yeah, so we're looking at that. That's a phase II proof of concept study. There was an asthma. It failed, but, you know, we want to look at the biomarker work that we have as an ad hoc, post hoc analysis. We'll also look at the SAD and the MAD data. So remember, there's single dose and multiple dose.
From phase I.
From phase I.
There'll be a phase I and a phase II evaluation of free TL1A knockdown.
Correct.
That's in February, where?
I always forget the name of the conference. It's been submitted-
Okay.
But it's in February.
It's been submitted. All right, we've got to find the abstract. Where's my team? Okay, excellent. Okay, that makes sense. And, okay. Okay, excellent. And any additional, changes or any feedback in terms of the scope of the TL1A program? I know it's been referred to as a pipeline within a drug, as part of the new collaboration now,
No, yeah, we're excited about the potential of the compound. I always like to say it's, you know, it's a pleiotropic cytokine that affects many different pathways. You know, one of the other interesting scientific components of it is it's an amplifier. It's not one that's blocking a single thing, absolutely. It's blocking the amplification. So, you know, whether there's a potential safety benefit to that in the long-term future, that's one aspect. But given its large effect, you know, other indications will be important. You know, once the deal is closed with Sanofi, we're chomping at the bit to think about those other indications.
I have two more on TL1A.
Yeah.
One for you, one for you. The one for you is easy. Is it a real TL1A? Because everybody asks me.
Umber, I love when you ask this question. Yeah, it's very real. I've... You know, we've been working on it for 10 years, and, you know, we've have head-to-head stuff that we look at in vitro because we created the other antibodies ourselves. So, we're confident in its activity.
If you were at Vertex, would they also call it a TL1A?... Yes.
I don't wanna comment on Vertex, but yeah, they would probably call it a real one.
All right, excellent. And Richard, one for you is, I think there was a broad perception in the marketplace that the running price was $10 billion for a TL1A. So when you guys did $500 million upfront, plus the some back end, there was a lot of confusion that: Is it a real TL1A? Why would it go for so cheap? So maybe just your thought process-
Yeah
... on that. Not just the upfront, but also the back end. People thought the back end could have been a little more significant, but how were you thinking about that?
So yeah, so look, it goes back to the strategy. What is our strategy? And that should direct every decision. Our strategy is to get Teva back to growth over, you know, a long period. Return to growth, accelerate growth, and maintain growth. To do that, we need assets, and the bigger assets we can get. So for us, you know, TL1A was a great one. So we think about it as something which we truly believe in, then how do we maximize it? Maximize it by pipeline and asset. How do we bring it to the market quicker in broader indications? And then when we get to the market, how do we make sure it gets to peak sales really quickly, and those peak sales are high, right?
Think about all those things, and you think, "Well, actually a partnership could help us," but it's gotta be a company that gives us 50% of the economics, 'cause otherwise we'll just get money, and then we've gotta go out and find a TL1A, or we won't find a TL1A or somebody else.
Right.
Second, we wanna know that that partnership brings capability both in R&D and potentially commercialization. So although we have commercialization rights in Europe and a bit of the U.S., we wanna make sure, we're, you know, we're in it to win it, so we're not messing around with this product. So having the right partner with the right immunology capability, right commercial and R&D, and we get 50% of the economics. So when you think about it from a strategic point of view, I actually think it's a great deal, very clearly thought through. Now, if you think about it, what can you get up front, then I can understand people having that perspective, but we put together a strategy over. It's actually a 10-year strategy we wanna execute on to get the company back to sustainable growth in high-value, innovative products.
So we have something which is really valuable there. And so for us, that's how we thought about it. And I think people discount the 50% of the economics. So if we believe, which we do, this is a multi-billion-dollar product, and probably a bigger product with Sanofi, right? And speed to peak sales, which is another thing that I've always focused on, is it's not what peak sales are, it's how quickly you get to them, right?
Right.
'Cause that creates real value. So you think of all those things together, and you think, "Okay, what do we need to do?" So I think this works out really well for us, and I think those... You know, that's how we make the decision. I don't wanna say it, it's right or it's wrong, but hopefully it's really clear and is strategically aligned with our pivot to growth. So it's not anything that should be confusing. So that's why we did, and that's why I think we've got a great partner, who, by the way, from an immunology point of view, and capability and understanding, came in and really saw the quality of the product we have, even though it's early, and saw the value in it.
And also, they have a desire to make this as big a product as they can, 'cause the timing when this comes to the market obviously fits in with a time when they also want to be driving growth.
Got it. You mean in terms of the immunology infrastructure-
Yeah
... they have? Got it. So I guess I, I didn't realize this, but what you're saying is, had you gone down the path of outright selling it, the valuations could have been very, very different, and the strategic interest could have been very different?
Potentially, but then you have to understand, we are earlier than everybody else.
Right.
So, to sell it at this, I think if you look at the actual numbers, we actually got a really good deal here for where we are in the stage of development, right?
Right.
Now, I think the question then is, well, why don't you wait till you have your full phase II data and then look at the value in that?
Got it.
You know, once again, I go back to it makes sense. You get better valuation, you get more money. But how we slow things down, if we believe this is a big driver for our strategy, in waiting 18 months, two years to do that, when we really wanna be all in right now. Not all in just from a money point of view, but a capability build, and Sanofi bring a lot to the party on that. So for us, you have to weigh all those up together and go, "Okay, we wanna do this now because we believe in it." And going back to the pivot to growth, you know, we're not dealing the margins here. We've gone all in on Stelara resource allocation.
We've gone in on UZEDY, we've accelerated Olanzapine six months in the phase III clinical study, 'cause we've focused on it, allocated capital to it, and we're doing the same with TL1A. It's a very deliberate strategy, and so that's how it plays out. But it's interesting that the, the base rate around TL1A is: Is it a TL1A? Do you have any data? Is, you know... Is it in a- is it subcutaneous, or is it sub... All these... The reality is, the, the one thing that is fact is we, we were and are behind the others, right? So the data we have, you know, wasn't phase II data, so that created a different valuation as well.
Got it.
So then if you have to wait till that, that phase II data comes to get that valuation, that's if you want to either sell it or you want to improve those economics a bit. One is, we're not waiting for this strategy, we're executing the strategy now. So we're dealing with the opportunity in front of us now, and that's, that's how we got to that.
Got it. And where does the consensus stand in your conversations with your partner on phase III plans? Are you ready to start late next year with some interim maintenance data and the induction data, as well as the timelines? Could you have your Phase IIIs done in a year or so behind Merck as well as Roche?
So look, I mean, firstly, we can't do anything with our partners until we get FTC clearance, so we can't really have any conversations.
Oh, that's not done yet?
Yeah.
I didn't realize.
No, well, it's... I don't wanna-
Okay.
Yeah, it's sort of any day.
Mm-hmm.
But just from a, we're not—you can't go into that debate. We had that debate before the deal was signed. They said: "Look, you know, this is a pipeline and product. We wanna go broad, and we wanna go fast." I said, "That's what we wanna do as well." So we're set up, but as soon as that clears, then we do want to leverage that capability they have. We've done a huge amount of thinking. We weren't waiting for this, by the way, 'cause we always had the optionality of going on our own. We had many conversations. I said, "We've set this up to go on our own." So we'd already been thinking about, and Eric's team, about the transition from phase II to phase III, what we needed to do, what potential other indications are.
So we've done a huge amount of work. And obviously, Sanofi saw that when they did their due diligence, but now we can start to really partner on that. And my hope is that with us combined, that we can move quicker, and we can think more broadly. But we need to, you know, sit around the table and have-
Got it
... the discussions operationally.
Has there been any discussions on some sort of high-risk, high-reward opportunities now that Sanofi is paying half of the bill? For example, let's say you start a Entyvio refractory trial. Nobody else is gonna do that. Everyone's gonna do their standard first-line UC trials, but something along those lines, which creates a pocket where no one else can catch up. Maybe the base case can be the trial may fail, but you explore ideas like that.
So look, regardless of Sanofi, and Eric, you can, you can comment. So look, the great thing about, people need to understand when it comes to Teva, we have so much focus on this program and some of others, but we're very focused. Eric and I talk about it a lot. The company talk about it. So we think about this in that way. We think about it in all aspects of where this product could go, because we're sort of a big pharma, but acting with a bit of a biotech mindset on this.
Right
... which is, how do we make this as big as we can? And we're obsessed with it, right? The good thing is, our partner has, with the product that they've got, I just saw another indication come out, you know, they've got a product which they've seen can keep on giving, right? So they understand what success looks like, so they're not sort of trying to... It's not a theory for them. So I think we want to leverage that as well. So absolutely, we think across all of those because going back to our strategy, the reason why we kept it, 'cause we truly believe in it. If we believe in it, we need to think about all of those things, whether consider it high risk or more, I'd say, opportunistic than high risk.
Excellent. Any questions from the audience? I know I have a couple of olanzapine questions. Okay, so maybe on olanzapine front, so again, this is not a generic play, this is a long-acting olanzapine. Phase III data, phase III trial ongoing. I know you've spoken to 2025 readouts. However, we also know that the eight-week efficacy portion reads out potentially second quarter next year. So could you speak to, Eric, the dynamics around, A, will that be press released? Is that a plan for, for you, Richard, as well? Like, when the efficacy portion is done, you put that press release out-
Mm-hmm.
... and speak to the blind safety?
Yeah, so first of all, I got to correct you. We're gonna have a readout in 2024, the second half of 2024, for the full, full data set. And yeah, you're bringing up a good point. So there's a primary endpoint, but then there's the safety database. So the real value is gonna be in how we define the safety of this, the program. So we plan to have a readout in the second half of 2024 that includes the primary endpoint and the 3,600 injections we always talk about. Because, you know, we're really excited about this program. It's a great formulation. It's based on the science that we have in-- on our UZEDY program. You know, it's got a subcutaneous injection.
It's not a deep injection, like, the Zyprexa Relprevv. It rapidly aggregates, and, you know, this—we've shown in vitro that, you know, this is gonna be something that doesn't have these, a release of high PK exposures. But we have to show that, and that's the purpose of having the full data set with safety in the second half of 2024.
So, obviously, there was a prominent issue with Eli Lilly's Zyprexa Relprevv with PDSS. Can you speak to your safety data to date?
Mm-hmm.
And also, is the definition of PDSS well-established? It's the standard definition that all the trials have used.
Yeah, so it's been pretty much well documented, that it's an exposure with high PK that results in an immediate, you know, effect within the first 24 hours after an injection, where you get severe sedation and lethargy after the shot. So we're, you know, fortunately, these are actually patients that we have in a hospital who get these initial injections of Zyprexa of olanzapine. So we have a really good data set, observed patients in the study. To date, we're over 600 patients in the study.
Wow!
We're over 1,400 injections at this point. We haven't seen any PDSS. You know, we'll continue to monitor this very closely. It's great to have this many people already enrolled in the study, so we're gaining data every day.
Yeah, maybe just to add that, I mean, because it goes back to there, there are, and I can understand it, some question marks. Can Teva really drive innovation, both in the commercial products and in the pipeline? This study, we focused on it, we allocated capital, Eric built some capability in the team, and it's, we've brought it forward six months. You know, and that's about trial execution, you know, recruiting centers, recruiting patients. So I think that just shows that we have pivoted to being able to execute on innovation, probably quicker than people thought. And the data readout in H2 of 2024, as opposed to 2025, as you thought, that's a significant difference, which I think also-
Right
... people maybe not have really understood.
When I saw you guys early this year, you may recall, I would not have guessed 600 patients by the end of the year.
Yeah.
So, so clearly, it's tracking so strong, but it also then makes me wonder, has there been discussion with the FDA on alignment around what exactly they need to see to grant you that label, which is different than Zyprexa Relprevv label? Because to the extent they want any additional data, you could potentially enroll a couple hundred more patients in a separate study, whatever have you.
Yeah. So it all depends on the data, but we have had the discussions with the FDA about the study design. They know what our study design is. They know—we know what we need to show and get that good label. So-
Okay
... we'll, we'll see what they do.
These were label-specific discussions, not just approvability .
These were phase III design discussions.
Okay
... about what we would need to show for a label.
Got it. Okay, okay. Excellent. Well, that's all I have. Good luck to you guys into a pretty important clinical data year coming up, and we'll certainly be in touch.
Thanks so much.
Thanks for joining us.
Thank you.
Appreciate the time.
Yes.
Thank you, everybody. Thanks.