Gilead Sciences, Inc. (GILD) Earnings Call Transcript & Summary

Yes. The concept of a bridging therapy before a transplant or a CAR-T therapy in myeloma has been around for some time, right? Because when I look at larger data sets for example from EBMT or CIBMTR of the [ large ] transplant regimens, when you go into a transplant or a CAR-T cell with a lower tumor load, a lower myeloma load, the outcomes of the transplant or the CAR-T cell therapy are better, right? So you're trying to bridge before the transplant. You can use different things for bridging. Classically, people have used chemotherapy for bridging. So now to use another type of therapy for bridging, for example, [ GPCR5D ] based is a very reasonable approach. It will not impact the transplant, right? For the transplant, you still want the most effective and most tolerable approach, right? If anything, going in with another kind of biologic or ADC or any type of therapy like that means that the focus on safety in your transplant will be even higher, right? So I don't think it's taking away anything. I think if it will help to improve the long-term outcomes after CAR-T, then I think it's a good thing.

Okay. And how should we think about gating steps to seeing the broader development plan for anito-cel. Obviously, you teed up iMMagine-2, already, but in terms of really kind of maximizing the opportunity for anito-cel, are there -- is it getting past the filing, et cetera, before we kind of see the plan to move up into earlier lines?

It's obviously a stepwise approach, right? Let's get to the data for iMMagine-1 first. You know that we're looking at earlier lines, right? For example, at second, third line, then eventually we'll also look at first line. But the exact time lines and approach for that we will communicate once we have done the first step.

Okay. And on the market in '26, but still no color on when you're going to file?

No.

Okay. Great. All right. Maybe as you think then about the broader oncology portfolio, you kind of teed up already some of -- an update coming on Trodelvy. I kind of thought about this year as a little bit more of an execution year for Trodelvy. Some of the prior years have been a little bit more data rich. So I guess where should investors focus on the Trodelvy side this year? Should it be more on things like ASCENT-07, where we've been interested, but maybe you've talked -- haven't talked about as much? Or is it really then more about novel combos coming down the pipe?

No. We will have -- you're right, a lot of the kind of the Phase III opportunities for Trodelvy are currently set up. It will be important to see the data around those. So there is an execution component to that, but there's also a component of how does -- based on data for Trodelvy, how will the market size shape up, right? Obviously really happy about ASCENT-03 and 04 because that takes us firmly into the first-line setting. Obviously, we need to get the filings and approvals done but there's a real potential in the first-line setting to make a difference for patients, but also to really grow the market, obviously, because many patients don't make it from first line to second line. Having that first-line opportunity will increase the addressable patient population and will also increase duration of therapy. So there's a real opportunity around that with some cannibalization, obviously, in second line once you go into first. But then beyond that, as you said, there's ASCENT-07, which takes us into the first-line hormone receptor positive, HER2 negative setting, which is a larger patient population, but also with more competition. So it will be really important at one point to see the data. We have not communicated the exact time lines for that because these are event-driven studies. But they have been ongoing for some time. So really focusing on bringing that to a close and then thinking about how does that stack up versus competition obviously in that area. And then we have ASCENT-05, which is currently still recruiting, which is in the adjuvant setting. So that will take us even earlier. And Trodelvy, at this point in time, triple-negative breast cancer has been a real mainstay and a real focus area for the drug. So that's an important piece. Beyond that, you have non-small cell lung cancer, EVOKE-03, which is ongoing and also small cell lung cancer, which is currently recruiting. In small cell lung cancer, we also have breakthrough therapy designation. So these are additional opportunities, and we also got the endometrial study ongoing. So there is an overall package, which we're also supporting with additional cooperative group studies, et cetera. So there will be really good news flow around Trodelvy for years to come.

Okay. And should we expect that development program to continue to enlarge? Or do you feel like it's sort of settled business now for -- in terms of how broad you're thinking about it?

I think we're set up for the key opportunities, but Trodelvy has quite a few years before LOE. So really trying to maximize the opportunity and some of it will be data driven, what we see in those ongoing studies.

Maybe circle back. I guess, since we came up with the questions, you did have another deal in the CAR-T space that got announced, you acquired Interius in vivo CAR-T platform. Can you talk a little bit about how you see that fitting in within the portfolio? I think, obviously, Kite has such a strong track record of success kind of out of the gates. And I think there's been a lot of questions around what's next for the CAR-T platform. To what extent does Interius kind of address that? Or maybe just put that in the context of the other kind of innovation efforts within the CAR-T portfolio?

Yes, it's a great question because I feel at Kite, there has been a lot happening. But you really need to put the different pieces together to really understand where the journey is going. We've spoken for some time about headwinds, obviously, with the current product portfolio. And we're working intensively to address that, right? We're working to open up opportunities in the outpatient setting, for example, with the current portfolio, and then we've already spoken about anito-cel as an addition to the portfolio that really will put us firmly, we hope, on a growth trajectory. Beyond that, we have a refocused effort on research and bringing new products forward at Kite. We have spoken at ASCO, for example, and also about EHA, about -- at EHA about next-generation CAR-T approaches, for example, bispecific bicistronic CD19, CD20 CAR-Ts, which would be a next generation for the current indications in leukemia and lymphoma, but also be a next generation based on efficacy and tolerability that we're thinking about for inflammatory conditions, right, say, lupus, for example, or also for neuro inflammatory conditions, right? Those are early efforts at this point in time, but what we're seeing in early data, and we've communicated some of that is really encouraging. We also have spoken about taking CAR-T cells into the solid tumor setting. We presented some data, for example, in glioblastoma that are early together with the University of Pennsylvania, the group there. But that are directionally really interesting. And then on top of that, we're investing now in in vivo CAR-Ts, really to make sure that that's an area we also focus on. We also understand that we can also lead in, right? Because that could be a disruptive move, the in vivo CAR-T progression could be disruptive for the current autologous CAR-T approaches. And with the Interius acquisition and also with different other acquisitions around, for example, technology and IP, we are in a leadership position for that and want to be in a leadership position for that development as well. Again, it's about covering different avenues and developing a more consistent vision that consists in how can we really focus on the current portfolio and bring that forward and optimize? How can we add to the portfolio with a anito-cel and CD19, CD20 and grow into different areas like inflammation? And then how can we cover our bases and really lead also on the in vivo CAR-T side.

Maybe last question on oncology. I think we just kind of hit the 2 major thrusts. I think when people think about Gilead Oncology, what else are people missing? What else is there going on that maybe we haven't talked about or even touched on yet?

Yes, there's obviously an earlier portfolio. We've pruned some of that earlier portfolio more recently because we felt that we had done enough evaluation around those molecules. But we will bring more molecules into the oncology portfolio. For example, there is a CCR8 molecule that targets regulatory T cells. There's different other like early portfolio molecules in Phase I that we've currently developed. One of the questions around the oncology portfolio, and we're thinking about that also from an internal research perspective and from a business development perspective is how do you make this really a sustainable portfolio over the long term, right? We have a really nice trajectory at this point between anito-cel and what we've seen with Trodelvy and the Trodelvy data, but we need more sustainable portfolio behind that. So we're working on the internal portfolio with different mechanisms. A lot of it is early, but we're also looking actively from a business development perspective.

Maybe switching gears to immunology. I think from the outside looking in, it's -- I think immunology has been one of those TAs that's been listed for quite some time. I think from the outside looking in, it's been sometimes difficult to discern exactly what the Gilead strategy has been or to the extent that you guys might focus there in terms of BD, you highlighted some of the earlier-stage assets there. What does it take to win in immunology, particularly if you're going to focus sort of organically?

Yes. The -- I'm fully behind the strategy of virology, oncology inflammation, right? And as we're going through the portfolios, you understand that these different components are at very different stages, right? Industry-leading virology, I think really good trajectory for oncology, earlier portfolio in inflam. So your question is exactly right. What does it take to win? Currently, there is a portfolio of around 10 molecules in this early inflam portfolio. Some of them in Phase II like the oral alpha-4-beta-7 or the IRAK-4 inhibitor. We will, of course, focus on developing that early portfolio. And then there are some other early molecules like, for example, the STAT6 degrader, the IRAK-4 degrader that have the potential to become real drivers for the portfolio. But again, it's early, right? We're talking about Phase I stage molecules at this point in time. So it's really about how can we further build a sustainable portfolio in inflam as well. Some of it may be development of the early molecules. We also have very active research efforts ongoing in inflammation. But it's also about how can we build a commercial portfolio. At this point in time, we have Livdelzi. We're grouping liver and inflammation together internally, which is on a good trajectory in PBC, and we're thinking about how can we further develop that. And some studies are also ongoing to increase the addressable patient population. But then we will actively look also and see are there other anchor assets that we can bring into the immunology portfolio.

Okay. And I guess, as we've been approached that alpha-4-beta-7 readout. I guess as you think about it, you've obviously been in inflammation for a long time, as you think about sort of the trajectory of things like IBD, do you see that ultimately moving into a combination MOA kind of market, which it hasn't been historically. It feels like we've been talking about that for a decade, but haven't really moved the ball forward there. So would it be things like an oral alpha-4-beta-7 or other kind of mechanisms here? I guess, trying to pick your brain a little bit in terms of how you see major markets like IBD that Gilead historically has focused on.

I think there are two areas that I would like to focus on with that. One is, of course, there's a move to orals, right, in the IBD setting. And you see that also with competing mechanisms, right? You see oral IL-23, you see oral TL1A, you see oral JAKs, right? So that move to oral is very clear. There's no oral alpha-4-beta-7 at this point in time. So that's a really good addition to that, and we'll need to see the Phase II data, obviously. But then combination is an area that people are asking about, right? Because we have not been able with the current monotherapy approach to break the efficacy ceiling. And there are some early combination data that give us some hope that combinations could actually be necessary and could help to break that efficacy ceiling. And then having an oral alpha-4-beta-7 could be a cornerstone of that combination strategy. And there are obvious combination partners. Some of them we have internal. So we currently have 4 molecules in the IBD space that we're evaluating and some of those could be internal combinations. But we are also open to look at external combinations, right, with some of the very established mechanisms in the field.

Okay. And maybe just -- we've got about a minute left here. And only because you guys haven't talked about it in a while, just sort of the latest updates on how you're thinking about your GLP-1 program. Obviously, there's been some competitor oral data? And if that, in any way, has kind of evolved your thinking around your internal program?

That molecule comes out of the really strong chemistry and research efforts at Gilead and they came up with this molecule. It's currently in evaluation in Phase I, right? And obviously, what we want to see is we need to identify the dose, obviously, and then we want to see what's the impact on obesity and diabetes. So that's currently ongoing. I don't have anything new to tell you at this point in time, but the molecule is in active early development.

Perfect. I'll have to leave it there. Plenty going on at Gilead beyond the Yeztugo launch, but great to talk to you, Dietmar. Thanks for the time.

Thanks very much, Carter.