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

May 14, 2024

New York Stock Exchange US Health Care conference_presentation 31 min

Earnings Call Speaker Segments

Jason Gerberry

analyst
#1

[Audio Gap] in your healthcare conference in Las Vegas. I'm pleased to be introducing our next company presenter, Teva Pharmaceuticals. We've got CEO, Richard Francis, and Eric Hughes, Head of Global R&D. My name is Jason Gerberry. I cover SMID-cap biotech and specialty pharma and so gentlemen, thanks for joining.

Jason Gerberry

analyst
#2

Richard, maybe I'll start with a high-level point. You came on board, you had a Capital Markets Day in May of last year, emphasizing sort of a Pivot to Growth, your predecessor put out a lot of fires, stabilize the base. Then you come in, now that things were -- the foundation was stabilized and you're looking to drive that Pivot to Growth, where do you see since, kind of, laying out that edict about a year ago, the company having progressed? Maybe you just want to highlight those key points and then we'll go from there.

Richard Francis

executive
#3

Okay. So firstly, thank you, Jason, for having us, appreciate it. So yes, it was a year ago, almost -- I think it was last week that we launched the Pivot to Growth strategy. I think it can -- it's fair to say that it was received with a huge amount of skepticism after 5 or 6 years of decline. But in the Pivot to Growth, we laid out some very clear guidance as to why we're going to grow and what it was going to take, and we'll talk about that today, but it was around driving our innovation in our branded business to drive our pipeline. Eric is going to talk a bit about that, getting our generics business back to stability and growth, and then allocating our capital to do those things in a very efficient way, so we can manage the bottom line and obviously service the debt. So -- and I say it was met with a lot of skepticism because I think that the way you introduced it, which I would appreciate, did make it, sort of, sound like it was destiny, but I can tell you, the last year has been a lot of hard work because to do all those things in parallel has taken a huge amount of focus by the organization, and I think the organization has really benefited from having a clear strategy of what we're going to do, where we're going to focus, what we're not going to do and where we're not going to allocate capital. And I think maybe a year on, I think the reason why there's a lot less skepticism and maybe some enthusiasm bubbling up is because our products, which we've launched are innovative ones AUSTEDO grew 67% in Q1, UZEDY's on a good momentum and AJOVY's going to hit 0.5 billion this year, step up innovation. Eric, I think announced the olanzapine study, which we'll talk about, the TL1A, recruitment is going really well. We're in the clinic with ICS/SABA. We're talking about IL-15 now. And then generics, I mean, everybody, as much I keep telling people, I think the generics is a good business because of the volatility in the past, I think people were skeptical. And now we've seen that all our regions grew, and we grew that business globally at 8%. And so I think what's happened is we focused on those 3 key pillars, and we've executed, and I think one of the things that I wanted to get the company known for is we do what we say we're going to do. And I think that's where we are. And I think there's opportunity for this for a lot more, we'll talk a bit about that. But I think we've come a long way in a year. And obviously, the final piece was to focus on the capital will be going to obviously divest TAPI, our API business. We're in the process of doing that, and we hope to close on that in the first half of next year. So I think we've shown we can do a lot of things in parallel, and we can do them well. Now we've just got to keep doing them and continue to do that over the coming years.

Jason Gerberry

analyst
#4

Yes. I think investors have gotten to your point about AJOVY is that a better line of sight on growth drivers. At that Capital Markets Day, you talked about maybe pairing back certain generic R&D spend, using that to fund the innovative side of the house. You've done a few financing type of deals to spare the P&L. Those are my words, not yours. But -- so how important is it for you that you can, kind of, show investors that low- to mid-single-digit top line growth, but also pair that with EBITDA growth. Because I think that's probably one of the fundamental debates right now around Teva's, what is the right multiple and there's this wide chasm if you look at the peer group. And so it seems like EBITDA growth would be an important component of that, if you're going to drive the next leg of growth from a stock perspective.

Richard Francis

executive
#5

Yes. I mean, look, maybe I can help on the debate. It's a higher multiple, okay? But why is it a higher multiple? So to touch on the point you raised, which are good areas of debate. I think we've shown with four quarters, we've grown the top line in four quarters, which by the way, hasn't been done for a very, very long time. And I think the fact that, that has been well received, but not maybe significantly is because I think we've shown people we can do that and people expect us to do that, which is good that we've managed to get some people to believe that in a year. But going back to some of the things that we talked about -- you talked about there, the financing and how do we grow the bottom line. I think to start with that bottom line question first, we've committed to the 30% operating margin in 2027. What I've continuously said is we're not going to do that in a linear way. It's going to be slowing and it's going to gain momentum. Why is that? Well, that's because we're investing in so many things now because we have so many opportunities. We have AUSTEDO, UZEDY, that's just been launched. We have AJOVY, we have in Phase III, ICS/SABA, we have TL1A in a very accelerated Phase II, and we have olanzapine just concluding its Phase III. We want to move those -- all of those assets. We want to invest as optimally as we can because that creates long-term value. And we don't want to hedge and just edge them along because we're trying to be so conscientious about hitting an operating margin, which I believe we're going to hit absolutely in 2027. So for that, we sort of spur for riches, so we want to invest in them, that does put pressure on the EBITDA, that does put pressure on the operating margin in the short term, but this is a plan in 2027. So I don't even think 2027 is that far out. So I think what I'd like people to take is we are financially very, very aware of what we're doing, we're in the weeds of it. And so what we've done is based on that strategy of invest in the things that are going to drive value in the short, but definitely the medium and long term. And to do that, do that thoughtfully in a way that allows us still to service our debt very well because we want to get that down. And so that's the way to think about it, very committed, I believe the 30% is absolutely achievable. But that's how we need to think about it. And I do understand people want us to grow EBITDA and EPS and we will, but it just won't be as fast in the short term because we have the opportunities in front of us.

Jason Gerberry

analyst
#6

Okay. I guess the core component of Pivot to Growth is, sort of, the stabilization of the generics business and as we think about maybe this business, say, the U.S. generics business, how much of this is just U.S. pricing perhaps moderating in terms of the rate of erosion and getting some benefit on REVLIMID on a year-on-year basis versus the ability to execute on a new product portfolio. I think at the Capital Markets Day, you talked about being better at taking advantage of these complex higher value products, right? So that would probably encompass HUMIRA, Sandostatin LAR and Korlym, these types of products, like -- so that's more of a future outlook type of thing for second half, but maybe if you can help us get a better feel for what's going on in the generics.

Richard Francis

executive
#7

So look, it's a good question because I think the generics -- the U.S. generics business, sort of, it has more share of voice than maybe it should. Let me explain why. 65% of our generics business is ex U.S. and it grows at mid-single digit or double digit, so that's a good business. Now the U.S., I can understand, has attracted a bit of attention because it's been volatile. And that volatility is, I think, concern people. Now what we've said is to reduce that volatility to get it back to consistent and consistent growth. We need to launch more products on time than we had in the past, and we need to supply that market better both in making sure we supply things on time in full and have better cost of goods. Those things we're working on, and we've been working on pretty hard in the last year. I think we're starting to see a bit of traction. Those two things don't happen within a year because you're changing manufacturing base, SKUs. And in the pipeline, Eric can talk a bit about what we've done to make sure we launch our generics more effectively on time. But we definitely have made progress. So the U.S. to me is a business, which has stabilized and will be stabilized going forward. And the question is, what's the growth that we can attribute to that over time, and the way we do that is we keep launching our complex generics on time more often. We keep improving our manufacturing and supply base. And those are the fundamental basic things we need to do and that's not rocket science, but to do it on the scale we're doing it, we've got to get a lot better than we were and we are, but we still have a lot of opportunity to get better. But maybe Eric can talk a bit about the pipeline and why we are getting better.

Eric Hughes

executive
#8

Yes. So one of the things, too, is the generics business is a huge business we have with a lot of pipeline products. One of the things we've done, we've focused the groups, we prioritize the programs and it makes a big difference when you have a high-value program and you have people urgently jumping on it when they're coming to the finish line. So that urgency, the kind of focus we give on the high priority program, it's almost like applying like an innovative mindset to the generics group. So that actually makes a huge difference in how we can execute time things and launch on time, first time, first time, right. So I think that makes a big difference.

Richard Francis

executive
#9

Yes. And just to pick up, we got 13 complex generics being launched this year and next year and probably a similar amount we'll publicize that for '26 and '27, but the ones in '26 and '27 should come to the market more optimally than the ones we're working on this year because we're going to get better. And so we've got a lot in our pipeline. We've never had an issue with our pipeline that we've had an issue in executing our pipeline.

Jason Gerberry

analyst
#10

So you mentioned earlier deserving of a higher multiple, I think, getting to investment grade, getting the leverage down, probably will it impact that for you guys. And so you've gotten the leverage down to about 3.45, I believe, on the last quarter update. Talk about the TAPI divestiture, right? Because when we think about this business, a, what are the variables that sort of gate transaction, and when we think about the multiples out there, it's difficult to find multiples. I simplistically tell people they're not going to sell it for a multiple less than they trade at. So I'm just kind of curious if you can maybe address those points.

Richard Francis

executive
#11

I'll try as best as I can. So look, I think, firstly, we are making great progress on the debt. I mean, we're doing that regardless of TAPI, and I think people have seen that and seen our discipline at that. So I think people have a very clear line of sight how we get to investment grade in 2x. And now ironically, we're getting challenged as to whether we should get our debt down that low, but it's another question probably. But with regard to TAPI. So TAPI is an excellent business. And the more we've actually focused that business by separating it from a management, has its own CEO, CFO, executive management team, allowing it to operate in the global API market, which is worth $85 billion and growing about 6%, 7%. I think we see huge opportunity. And because of that, there's 2 things which make me think of is going to get a higher multiple, I won't tell you the multiple but a high multiple -- or good multiple is because it has probably one of the best margins in the sector, and it has it because it works across all platforms, all technology platforms, super complex as well as simple and it has a great reputation for supply and quality. And those are things that people want when it comes to API. And so the start of -- sorry, in last year, we started to refocus the business to look externally for business. And already, the traction we have for CDMOs as well as -- actually the pharma companies has increased significantly. So I think, for me, it is a business, which a carve-out that's doing -- I think it's doing okay. It could do a lot better if it was solely focused on doing that. And I think people, strategic buyers as well as nonstrategic buyers should see that. But let's see that -- how that plays out. I don't want to get drawn into, this is the value, this is what it could be. I clearly think it's going to -- it has good value, but we'll see how that plays out. But there were no sort of gating as to this has to happen. This has to happen. That business, and we've gone deep into it. We've set it up to divest. We've done all the work. So we have everything aligned, so I think we're in a position to do well on that, but that's when we'll wait and see.

Jason Gerberry

analyst
#12

From a timing standpoint, how important is it to get that business back to top line growth before you choose to sell it so that you can ensure you get fair value? Or is it maybe there's scarcity value in certain of the APIs that you have in the portfolio that make the timing optimal?

Richard Francis

executive
#13

So firstly, we're back to growth already. Q1, so great Q1, so we've done that. I mean we're going to accelerate it. I think I can say that we are going to accelerate that throughout the year. And that obviously helps. But I think if you look into the business. It's going to be nice that it's growing because it's going to go show the strategy we put behind TAPI is working. But the quality of our business stands out quite clearly, in my view, so people are going to look to buy that can see the value that, that business could have long term -- medium to long term. And I think the fact that it's growing will help. But I think that just the depth of quality there would probably doesn't need that, but we want to do it because it grows our numbers this year, and we should be doing it, and we can do it.

Jason Gerberry

analyst
#14

Yes. Okay. And you mentioned from a capital deployment standpoint, some questions that you get around, do you need to go all the way to 2x, right, versus make some investments in the business. So maybe -- what's your latest thought there in terms of being able to selectively deploy and perhaps bring in some additional assets. Teva was probably arguably underinvested from an R&D standpoint from, say, 2017 to 2022 or do you feel like you have enough on your plate and de-leveraging remains the focus. And if anything, any deal you is going to be light on the upfronts.

Richard Francis

executive
#15

So yes, I mean, it's a lot of what you said, actually. We are going to get ourselves down to 2x because we committed to do it. And I don't think Teva should give targets and not stick to them. I don't think we have the credibility to start changing. And so we need to do what we say we're going to do, and we will. We do have actually a really exciting pipeline, this late stage, but other things that are emerging are TL -- IL-15 that Eric spoken about the drug for MSA as well. So I think we have quite a bit, but we are looking and we're looking very hard for other assets to either in-license in because we have a platform that can be leveraged more, and I think we have the ability to do licensing deals even with our current balance sheet. But that will be determined on, they've got to be good assets. We don't really have an appetite for carrying too much risk because of the past and those are hard things to find. And we want them to be accretive to the top and bottom line pretty quickly because we don't want to carry something because we've got enough good stuff in our pipeline to carry. So that just makes it hard. But that's the focus we've had for just under a year and we're building that up. And don't forget the deleverage is going to happen pretty quick. And so it could be accelerated with TAPI, but it is, sort of, picking up momentum as we speak every quarter. So we've got to get prepared for our balance sheet to be in a healthier position to then buy things. They don't want to wait the balance sheet to look good and then we go out and shopping. We're actively shopping now.

Jason Gerberry

analyst
#16

Okay. Before we jump to the fun part of the discussion, which is pipeline, just remind us where you are in cleaning up the residual litigation issues or legacy issues. I think there's probably one legal matter of focus, which was the COPAXONE PAP legal matter. So just if you can kind of level set there and sort of what might be a range of outcomes?

Richard Francis

executive
#17

So yes, we're at the closing stages of that one. So I think we've already had that in our financials accrued. So I think we're in a good position to be able to close that out. So I feel very good about that. I think that's going to be done in the next -- I suppose, I'm dealing with governments and lawyers. I don't want to be too -- but I think we -- we have everything we need to make that something which is now going to be in our rearview mirror. So maybe that's a quarter or two.

Jason Gerberry

analyst
#18

Okay. Well maybe shift...

Richard Francis

executive
#19

Now the fun stuff, yes?

Jason Gerberry

analyst
#20

Yes, the fun stuff. So you just had a recent olanzapine pipeline update. And I guess as we think about -- I think you guys highlighted it, there's a clear mismatch in terms of LAI share versus oral molecule share for this moleculanzapine, which is -- it seems like the go-to agent for a psychiatrist when schizophrenic patients are, I guess, more symptomatic or more severe in their disease. So -- how are you thinking about just the general value proposition as more data accrue in-house? And when I look at the LAI market, I see a couple of $500 million products and then a monster product in Vegas. So what do you see as like the key variable to being on either side of that spectrum from a product profile standpoint?

Eric Hughes

executive
#21

I can start off and going to talk a little bit more about the market size. But for me, olanzapine, first of all, you're right. It's a go-to drug that psychiatrists use quite regularly. It's been around. They know how well it works. It is for more maybe severe or complex patients that they use it for, and it does control symptoms relatively rapidly. I think the interesting thing going forward is there is a more or greater appreciation of the importance of LAIs in the control of patients. LAIs give you a long-term exposure that's easily given. You don't have to worry about the [ adherence ] that patients have with oral medications like we all have. So those things have great benefit for patients, less relapses, less worsening in their disease, less hospitalizations. These are all very good things for patients for the longevity with their disease and their control. So that's one first and foremost. UZEDY is a great example of that where it's a product that has a great product profile. It's very easy to use and can be used by psychiatrist very easily in the clinic. Olanzapine, we want to get there as well. olanzapine is a drug that -- as I said, they know it controls patients well, but they have no options. Right now, they just have an LAI that has a black box warning. And we really designed our program to address that issue. So now we've got -- we're converting what is a intramuscular injection to a subcutaneous injection and a nice convenient formulation for once a month dosing, which is something they just don't have today. So it gives them a great option in the future. So for me, it's 2 things. And Rich, you can talk about the market size. But for me, olanzapine has no options right now. It's a market. We've done this before with UZEDY. We're going to do this again with olanzapine in a field where there's no other options. So we're really excited about that.

Richard Francis

executive
#22

Yes. I mean the I think the amount of patients on LAI is about 13%, 14% right now. And I think that's forecast to grow 6% a year. Now there are no patients on olanzapine long-acting because of the black box warning. So if you think about the most prescribed oral medication for schizophrenia doesn't have a long-acting then I think you could say the long-acting market will grow. But regardless of that, I think if you use the analog of how many patients were from oral to long-acting then I think that's a good analog of what could happen for the all patients who are on olanzapine and moved to long-acting. So I think there's a huge unmet medical need, that's clear. And I think, for us, I think we're well positioned because we're out there with UZEDY, which we launched last year. So we either launched olanzapine, if everything is successful, unlikely the end of '25, maybe but more likely quarter 1 of '26. We've had our teams out there, all our commercial teams, our payer teams, MSLs out there for nearly two years, using the same technology, with UZEDY is we're going to use for olanzapine. So I think -- and the one thing we didn't have with UZEDY is we didn't have any prelaunch. The company wasn't geared to why to do that. And so I think this allows us to prepare the market, make sure they understand it and get things set up. So I think olanzapine has a significant opportunity to help the Pivot to Growth and keep driving the top and bottom line.

Jason Gerberry

analyst
#23

So fair to say on the analog exercise that this product could be significantly bigger than UZEDY?

Richard Francis

executive
#24

Yes. I think so absolutely just because UZEDY is a better long-acting version of risperidone and there's other long-acting version of risperidone and UZEDY, as I said on the earnings call, we're getting good momentum because of its unique profile and it gets to therapeutic dose within 24 hours, which is seen as a big unmet medical need for physician. We thought it's going to be important, but it's a lot bigger. So I think if we take UZEDY as having good momentum, but yet the unmet medical need we thought that was fulfilling was good, but we think olanzapine's filling a lot bigger unmet medical need. So I do see it as a more significant product.

Jason Gerberry

analyst
#25

And what would you say to the contention from some psychiatrists that like the candidate for olanzapine LAI is the patient that doesn't need concomitant metformin to mitigate the weight gain some of the metabolic liability with olanzapine. So the idea of putting someone on an LAI in general is the compliance, right? Like there are patient that has a difficulty adhering to oral therapy, right. So from what I hear, at least, if someone is going to be a candidate, I don't want to have to [indiscernible] some concomitant oral therapy to go along with it. So is that the right way to think about it? And is there a haircut factor then to think about for this olanzapine market that are getting in this concomitant medication?

Eric Hughes

executive
#26

Yes. So the metabolic profile of olanzapine is very well understood. It's going to probably be the same for us with long-acting injectable. So that's a decision whether to use the metformin patient-by-patient basis, whether you need that or not. So it's not an unknown. It's something we can manage easily with the patients today. And I think that that's -- like I said, a patient-by-patient decision by the physician. So I don't see that as a big impediment. It's the value of the subcutaneous once a week -- month injection, which really is the value of the product.

Jason Gerberry

analyst
#27

Yes. There's a lot of focus on PDSS in your update, but can you talk about the rest of the safety profile? Is that something that mirrors the oral therapy, what you've observed? Is that something you can comment on?

Eric Hughes

executive
#28

Yes. I think that the safety profile, we'll see is very similar to what you see with olanzapine. The first cut of the data shows that. We haven't seen any PDSS, we've gotten 2,722 injections to date, so we're about 80% of our target right now. So we're confident that it is exactly what we predicted. I think the side effect profile is consistent with olanzapine.

Jason Gerberry

analyst
#29

We talked a little about this a little bit on the earnings call, but you have an adjudication committee that looks at these PDSS events and can you talk a little bit about that just to ensure that you don't see a false positive and cater the remaining 20%?

Eric Hughes

executive
#30

Yes. So that's a good point. So proactively, we set up on a adjudication committee. So if anyone has even a slight appearance of what a PDSS would look like, which is this lethargy and sedation within about 24 to 48 hours after the injection, we'll be monitoring. And remember, these folks were actually in the hospital when they started the olanzapine so we have hourly coverage of these patients in a well observed setting. We're very confident in the data we're collecting. One of the things I liked about the study when we did the first cut of the data for the primary, it was very clean. There was no surprises. The data lock went very well, the efficacy was right where we thought it was going to be. So our predictions were right on. So that just tells me that not only are we running the study well and that we're doing all the special monitoring, but we can have some confidence in that data. So yes, I don't think we're going to have any missteps when it comes to seeing or not seeing PDSS.

Jason Gerberry

analyst
#31

Okay. Maybe TL1A, we have about 5 minutes, so probably some quick hitters here for me. Do you and your partner have internally discussed, I imagine predefined kind of benchmarks for what's clinically sufficient or meets the standard to be competitive as it pertains to this decision to move forward with? And to what extent does having an auto-injector teed up to go into Phase III in a timely manner. How does this all play together as you kind of look to play catch up and be there early in the market formation with TL1A.

Eric Hughes

executive
#32

Yes. So we clearly have objectives for what the efficacy [indiscernible] we see. And we also have better-than-expected objectives. The key, though, is what you said, moving forward as quickly as possible. And our Phase II study, this just this last month, we've enrolled 29 patients. We're only halfway through the month. So we are accelerating the enrollment of this study really, really well, and I'm very proud of the team on that. So we do have objectives and we clearly will have an auto-injector at the time of launch. The goal is to have a single shot injection each time the patient has to get a shot in an auto-injector form. So everything you need for a good launch we're setting up at this point. And we're working very closely with Sanofi. The collaboration we have with them is one of the best I've seen. And we have a great management team that's running collaboration with. I think we have like 10 sub-teams working together every week at this point. So that ability to be ready for Phase III is key. And I keep saying this each of the investor meeting is that the timing of the deal was good for both sides, but it was more important about the execution and the ability to catch up and make sure that we're in the fight here. So really, it's going very well. Enrollment is great, and we're being prepared for Phase III.

Jason Gerberry

analyst
#33

Okay. And then maybe with the biosimilar HUMIRA and the Evernorth Cigna update, maybe just talk about how you think through the potential for pull-through here of a private label product? And is -- what are the similarities or maybe dissimilarities from what we're seeing with Sandoz really getting a huge inflection in market share, who also had a private label deal with a large insurer. So I think a lot of people are connecting the dots and seeing how a way they've been able to do and then you add on the fact that you have interchangeability with the high concentrate form. It seems like there's some excitement, that at least there's some optionality in the numbers this year that people, perhaps or maybe you internally, hadn't maybe thought about at the beginning of the year.

Richard Francis

executive
#34

So look, I think on a high level, first, I said the biosimilar market would change and 2023 wouldn't be the defining year. And I think it shown that that's not -- that is true that it has become quite more dynamic in the last couple of months. I think -- so that's good, and that's -- and we're definitely going to benefit from that. I think the challenges we still had is we didn't contract early because we weren't here in January. So we've had to come into a bit more of a crowded area. But yes, we have that private label setup. We have other agreements that we're working on through the normal channels. So I think we are more optimistic about the whole biosimilar market, the fact that the PBMs, the payers have started to think of this as, I think, more of a significant opportunity to save money over the long term, and now they're taking control rather than being on the back foot with rebates, et cetera. So I really like that. So I think that plays out well for all our biosimilars. We're bringing 6 to the market before '27, so we did risk-adjust the numbers in the 2024 guidance for HUMIRA, but I'm not going to be optimistic or pessimistic about it because we have to see how all this plays out. There's more opportunity, I think, because of how people are changing their mind, but that's got to have traction and actually lead to a shift in units and making sales. And we're going to find that in Q2 and Q3. So long term, I'm very optimistic. This year, it looks like it may get more traction because of some of the changes, but we wait and see.

Jason Gerberry

analyst
#35

With interchangeability itself, one of the things that we've heard from like payers is that I don't have to send your doctor letter like a lot of the friction that goes along with getting someone on a non-interchangeable biosimilar is not an issue now. So the contract becomes effective, I think July or June, something like that with Evernorth. So mindful you weren't there at the beginning, but why the cautious tone perhaps for the second half?

Richard Francis

executive
#36

Because I think that's just -- I am not cautious, I got it measured -- measured as my new phase on that. Because look, there's a lot of history with Teva. I think we're not -- we're measured, I don't underplay things. I think we leaned forward. We did $2.5 billion for AUSTEDO. We said we were going to recruit TL1A and catch up with the other. We generally do what we say we're going to do, but I -- where we are in control, we will always lean in. Where we're aligned on other people to do things, we are a bit more measured because all these things are encouraging, but they all have to then follow through and flow through into things happening. So I think for me, it's less cautious, it's more measured because -- and then when we have more clarity on that, then I think we'll be showing that we're happy to lean into numbers and start talking about numbers.

Jason Gerberry

analyst
#37

Okay. Great. Well, I believe we're at time. So thank you, gentlemen, for joining us, and good luck to rest of your meetings today.

Richard Francis

executive
#38

Thank you Jason. Thanks for having us. Appreciate it.

Eric Hughes

executive
#39

Thank you.

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