Conference Transcript - GILD 2026-05-19

Brian Abrahams, Analyst — RBC Capital Markets

started. Welcome back, everyone. I'm Brian Abrams, Senior Biotech Analyst here at RBC Capital Markets. We're really pleased to have our next featured company, Gilead Sciences, represented by their Chief Medical Officer, Dietmar Berger.

Operator

Dietmar, thanks again for joining us.

Dietmar Berger, Other

Yeah, thanks for having us. Pleasure to be here.

Brian Abrahams, Analyst — RBC Capital Markets

So a lot to cover. So I'll kick it off and maybe just start with Tridelby, because I know we're going to see a big data point this year on evoke 03 can you talk a little bit more about i guess what you're looking for out of those results in particular what specific efficacy thresholds on pfs or os do you think this trial would need to to show in order to justify the positioning of a of a trop 2 adc in front line how are you thinking about the competitive landscape overall here um And really, just what should we be looking for?

Dietmar Berger, Other

Tridelby is obviously our drop-2 ADC, where we had positive data recently in first-line triple-negative breast cancer. That's the Ascent 3 and O4 study. And that's where we're looking forward also to hopefully get an approval later this year for that setting. And Evoque 03, the study that you're talking about, is a study in first-line PD-L1 high, non-small cell lung cancer. very straightforward study design you basically have pembro as the standard of care and you add to delvey to that right um so what we want to see in this setting um this is an early analysis so yes pfs is going to be mature os is going to be earlier but what we really want to see is like a significant pfs benefit right and then of course we will follow the study longer um for os as well um this would be if the study is positive this would be the first time that you really see meaningful benefit of a combination in this setting on top of pembrolizumab um but also when you think about it um these people are currently treated depending on how quickly the tumor grows either with pembrol or also with the addition of chemotherapy so there is benefit in with chemotherapy for these people and that's where an adc obviously can maximize that benefit um also with with uh good tolerability and and that's what we're hoping to see right and and that would be a meaningful addition obviously to what we can do with trodelvi we also have ongoing studies you know in endometrial cancer for example and um and you know a variety of other studies in different tumor types from a competitive perspective yes there are other molecules targeting trop seems like more and more people are following more and more companies are

Brian Abrahams, Analyst — RBC Capital Markets

following in your guys's footsteps.

Dietmar Berger, Other

Yeah, CHOP2 as a target is just one good target for ADCs. With Trodelvi, we have the biggest data set, right? And people are really comfortable with Trodelvi. That's also what we see in breast cancer, both in hormone receptor positive and triple negative breast cancer. The level of comfort that people have with a drug, the confidence with the efficacy is really there that's why we've seen year over year also an increase um with tridelvy 37 percent right and um and that's really testament to yes there's there's good use there's increasing use and and that's where the evoke 03 will add to what we can do with tridelvy got it um and then maybe kind of staying on on the solid tumor front um you recently acquired a private company, Tubulus, and I know we're going to see some updated data at ASCO.

Brian Abrahams, Analyst — RBC Capital Markets

What excited you most about that asset? I mean, to what degree was it the data, the unmet need, the overall technology that they have, and what should we be looking for at ASCO?

Dietmar Berger, Other

Yeah, we've been, I mean, obviously, we just spoke about Joe Delvey, so we have a lot of experience in adcs and we've been scouring yeah the planet pretty much for what's your next level innovation in in adcs um and what we saw in tubulus is you know both a really interesting front runner molecule but also really interesting and differentiated platform um and the platform is a completely different um linker and payload technology they call this the p5 platform which is really more you know how is the antibody connected to the linker and then there's the alco5 platform which really more how is the linker connected to the payload right and both of these are really novel chemistry and allow for kind of features of molecules that we had not seen before for example the p5 platform allows for really stable linkage which means you don't get the systemic toxicities whereas the alco5 platform allows for really combinatorial activity with different payloads so completely novel payloads that we can utilize that either come out of our medicinal chemistry or that come out of out of tubeless so so we really like the platform and we knew a lot about the platform because we worked with tubeless on novel molecules since two years we had an ongoing project with them so we understood the platform really well and then on top of that their front runner molecule is top 40 which is a nappy 2b directed adc where at esmo last year esmo 2025 they presented in our view really convincing data in platinum resistant ovarian cancer so they had like a 50 to 60 percent objective response rate they had like a 90 percent disease control rate on the basis of roughly 50 patients which we found really encouraging when you think about the current standard of care with Bev and chemo is roughly 25 to 30 percent objective response rate so we saw a real benefit and that benefit together with a really positive tolerability profile right again going back to the really stable link which biologically it makes sense to then see less side effects and good tolerability and and we didn't see any of the kind of the the major side effects that you see with some of the other adcs whether it's neurotox or um eye toxicity or intestinal toxics and this was all really tolerable so that benefit that combination was really important to us on top on the platform okay great and then maybe i guess speaking of companies that you acquired um you recently gained full rights to

Brian Abrahams, Analyst — RBC Capital Markets

an Edo cell. I guess, how confident are you on the efficacy side that we're going to continue to see similar response rates and a PFS tail that looks comparable to what other CAR-Ts have seen? And as you kind of move on the safety side, as you move into the earlier line population, including newly diagnosed myeloma, how do you expect the safety differentiation to evolve in a patient population that maybe has cleaner baseline organ function and less prior treatment exposure. I guess it will be quite as prominent.

Dietmar Berger, Other

Yeah, I know the Anidocell is obviously the BCMA CAR-T, where we already had rights to and really acquired the entire company, the entire Arcelix, both Anidocell, but then also the platform, the D-domain binders were really important, these smaller binders that i think really make a difference and allow us to also go into in vivo car t and apply them differently in in different areas so that's it so that was part of part of the the decision um but having you know full ownership of the commercialization and also full ownership of the future development was really important to us right um so you're talking you're asking about how confident we are with regards to you know the differentiation i have to say i'm very confident in that regard. And that's based on, you know, the early efficacy data that we see, which is really more, you know, myeloma responses. Of course, we don't have the long-term tail. You're talking about the long-term, you know, PFS and OS tail. But what we do have is an early indicator, which is measurable residual disease or MRD. So how deep is the response and how much do you really reduce the myeloma load in those in those patients and mrd is a really good predictive parameter and the mrd data for anidocell are just you know better than anything that's out there so i'm i'm actually i'm a hematologist right i'm really looking at um these data are really attractive and i think you know are a positive signal regarding really good long-term outcomes Now, on top of that efficacy, what you also see with anidocell is, I think, unprecedented safety in myeloma. We're not getting any of the kind of the longer-term severe neurotoxicities, no Parkinsonism, no Guillain-Barré, none of the enterocolitis effects also that you see with some of the CAR-T approaches in myeloma. So we feel there's really good differentiation with a needle cell from both an efficacy and a safety perspective. Obviously, you know, Imagine 1, that's the study in 4th Line Plus that we're currently discussing with regulatory authorities with potentially an approval towards the end of this year. That's the initial indication. Then Imagine 3 is a study that takes us into 2nd to 4th Line. um that study is ongoing really looking forward to to seeing those data and then we're currently in planning for even earlier lines so so thinking newly diagnosed uh myeloma both both the transplant eligible and um transplant ineligible patient population right so really taking this also into early alliance because um we are more and more in myeloma speaking about long-term outcomes even speaking about is there a possibility to even have like cures in advance for these patients and that's what you reach in earlier lines right so you want to see out of imagine three or is there some degree of follow-up data that would inform the decision to go into first line um no i think we're confident enough about the drug that really we are in planning stages is for first line at this point right and imagine three will give us i think really meaningful data in the second to fourth line setting so really working late line fourth line plus second to fourth and then early lines but you know we're very committed to the overall a needle cell program okay good maybe shifting gears to ini um on the earnings call you mentioned that the alpha 4

Brian Abrahams, Analyst — RBC Capital Markets

beta-7 inhibitor 1427, that we're going to see some data in the near term there. I guess, what excites you most about this asset? What would you want to demonstrate in this early to mid-stage point in its development to move it forward? And what do you think are the key differentiating elements versus the other oral alpha-4 beta-7s, which have maybe shown some signals, but maybe were a little bit more mixed?

Dietmar Berger, Other

Yeah, let me step back first and really say when you think about how the Gilead portfolio is shaping up, we've said for some time that, you know, we're focused on virology, oncology, and inflammation slash immunology.

Brian Abrahams, Analyst — RBC Capital Markets

That's finally really maturing now.

Dietmar Berger, Other

And yes, I look at this as one signal, and I think a strong signal, that, you know, the inflammation portfolio is also coming together, right? So we have HIV with long-acting. We've got other virology assets. That's the underlying virology strategy, also in different types of hepatitis, et cetera. You've got the oncology strategy. We talked about Trodelvi. We talked about tubulis and now also about the cell therapy portfolio. And then in inflammation, there is really an emerging portfolio for Gilead. We currently have more than 10 molecules in the inflammation portfolio, and three of them are in phase two. So granted, somewhat earlier, but when you think about those molecules that are currently in phase two stages, we're really looking forward then also to data readouts. There's the oral alpha-4 beta-7, which I'll talk about in a second, you know, for IBD, which I think is a really interesting molecule. There's an IREC-4 inhibitor. It is assertive, which is also in phase two. and then there's a TIPL-2 also for IBD. So there is an emerging portfolio that I think is really interesting, also addressing really important targets in immunology. Getting to alpha-4, beta-7, that's a validated target, right? And TIPL-2 is out there as one of the backbone therapies in inflammatory bowel disease, in Crohn's and colitis. um what people really like about antivio is the balance of efficacy and safety it's an efficacious approach that shows really good safety as well right it's an injectable right and as we're moving also more and more to orals in ibd therapy you've got the il-23s you've got the you've got other molecules that are going oral um it's really interesting to think about what can an oral alpha 4 beta 7 actually do and obviously what we are hoping uh to see right we we have the the phase 2 study in-house and and we'll communicate the data later this year at a medical conference um what we're really hoping to show is obviously differentiated efficacy and safety with the added um convenience of the oral right and that's why i think that we have a real opportunity and let us show you the the data first and then we can talk about you know what can we do with this with this type of molecule but i'm really encouraged about you know what i see in the inflammation portfolio and how they come in together and alpha 4 beta 7 is one component of that okay do you think about that as a potential monotherapy or is that potentially combinable with some of your other assets yeah and i i want to stay in the hypothetical right because we haven't communicated the data yet um but in principle everything is possible right alpha 4 beta 7 antivio uh is there as a monotherapy um and there are obviously also combination approaches and what we currently see in ibd and inflammatory bowel diseases is most people you know start with some type of monotherapy and of course you know they have to go through different steps before they go to the biologics yeah um but there are patients where we have an efficacy ceiling with the monotherapies where you really have to think about combinations okay but it's really those patients that that it's not that i would believe everybody would go on combination

Brian Abrahams, Analyst — RBC Capital Markets

and that's where it's important uh to have data especially if you think about developing a backbone therapy where you have data with different iterations right monotherapy and combination but a lot is possible so let's show you the data okay looking forward to that um and And then speaking of data in the relatively near future, you guys are looking, you know, you've had a successful launch with Yes2Go so far, and it's only early days, but you're already looking at next-generation versions. And I know you have a once-yearly study, Lenacapravir study ongoing that's intramuscular. um tell us a little bit about i guess how you selected the right formulation to move into uh the phase this phase three study and then just what has the fda said will be the bar for bioequivalence that you think you need to hit uh to be sure that you are comparable to yes to go whose efficacy is really unprecedented and that there aren't any sort of outlier patients at week 50 or 51 that might drop below uh the the necessary exposure yeah so it's really important

Dietmar Berger, Other

to to realize what we're talking about here is prevention yeah so you're not thinking about hey there's a there's a virus that right can develop resistance over time this is more like you prevent an infection as a person is exposed to a virus so so your typical resistance discussion in that point is very different for the prevention setting right and that's where really the understanding that we have developed with lana capivir with the s2 go is very important we can absolutely model um what type of level like serum level eventually of lana capivir we need in order to protect right in order to get that prevention and i know i think as a public and we exactly we have those pk data and what we can do is we can model if you wanted to have that level of coverage over a year what type of starting dose would you need right because you form a depot and then over time obviously you get lower and lower levels right and we need to have those 52 weeks full coverage at the levels that we've seen with the s2 go once every six months and we've modeled that And we're very confident that with a once-every-year injection that we use in Purpose 365, which is the Phase III study, where we've already completed recruitment, that the levels we need, that we will actually have those throughout the full year. Actually, what we know at this point is we think even at the end of the 52-week period, the levels we will still see are higher than the levels that we see with the S2 go subcutaneous once every six months. And we were able to get to a slight change of the formulation, which then is used in the intramuscular injection that we use in the once every 12 month application. And that's where the FDA then has also agreed to a PK based study. So the Purpose 365 study has endpoints around PK and around safety, and we basically need to demonstrate these levels over time, and we need to demonstrate safety. And we believe we can do that.

Brian Abrahams, Analyst — RBC Capital Markets

And do you anticipate that the market will shift from every six months, sub-Q years to go to annual IM?

Dietmar Berger, Other

What we've learned about the prevention market is that people really like optionality, right? And that's also what we see now. We see really good adoption of Descovy, right, which is a daily oral. We also see, as you all know, really good adoption of Yes2Go, which is the once every six months injectable, right? And we've just updated our predictions for this year, where we expect Yes2Go to be a blockbuster by the end of the year. What we do get back from people in the community is they're really excited about the once every year option. and they liken it to this is simply i get my one shot once a year like a vaccine and then i'm protected and then we're always saying yeah but be aware it's not a vaccine right it's actually better than a vaccine because you get much better protection levels so there's a lot of excitement around it um it would be hard for me to predict now whether how the market will develop but i do believe it's going to be a really important option for people um with who want prevention right and i think one of the big um positives around this type of prevention is um you really don't have

Brian Abrahams, Analyst — RBC Capital Markets

to think about you know forgiveness or gaps in prevention or anything like with an oral the key benefit uh is really you're done one shot once a year and you're protected for the entire year and that's what people see um let's shift gears from hiv prevention to hiv treatment you have a number of next generation both completely proprietary as well as partnered assets that are continuing to emerge um so maybe just starting on the uh it's like slatravir lenacapravir uh once weekly oral i guess what were you looking for out of those data to dictate the regimen's potential role yeah the the obviously we'll have data from our island one

Dietmar Berger, Other

and two studies which is a weekly treatment um later this quarter so really looking forward to that these are studies in already virologically suppressed people yeah so these are people who are for example on big tarvi which is currently absolutely the standard of care um who then switch to isletrovir plus lenacapavir to a once-weekly oral treatment option um victor v basically you know everybody's biologically suppressed so we want to see that same level of suppression right we do not want to compromise on efficacy and we do want to see that same level obviously with with good tolerability um that's also you know then positioning is lateral vln clearly into the switch market right um about 20 percent of people um on big tarvey for example per year you know want to switch to something else um that's where is lateral vln would be a really important option right and and that's how we're looking forward to to the data got it and then for your own potential wholly owned weekly oral I guess, what characteristics are you going to be prioritizing versus lenacapavir for a potential capsid in that regimen and just some of the PK properties, timelines that you envision for that to move forward? Yeah, we do want to develop a wholly owned combination. We believe an integrase inhibitor plus a capsid inhibitor is a really strong option for that. um high barrier resistance exactly high barrier of resistance so so we're currently in the process of you know from our large portfolio of integrase inhibitors and capsid inhibitors and capsid inhibitor pro drugs we're currently selecting the two combination partners um and then we're looking forward to bring those into the clinic and we'll obviously communicate around those plans as soon as we finalize them got it and then speaking of long acting i guess even even longer acting i know you guys are looking at um the potential for an every six months injectable

Brian Abrahams, Analyst — RBC Capital Markets

on the treatment side um and you've had some encouraging early data i think it was at croy for 32 42 yeah um i know historically it's been tough to get integrases dosed high enough in a sub-q to have multi-month durability without running into tolerability issues like injection site reactions but it seems like so far so good with 32 42 i guess where do you stand with the ongoing dose escalation work and what gives you confidence that the higher doses will have the durability to get to your goal of every six months every six months and and you won't run into any safety compromises yeah so so again um optionality is really important that's how we're

Dietmar Berger, Other

looking also at the treatment space and then we're talking about these these different options For the once every six months, we also have an injectable option, right, with lenacapivir and two broadly neutralizing antibodies, where we're planning to start the phase three later this year. For the integrase inhibitor-based option with 3242, as you said, we have the PK data that we presented some of that at CROI. And this is a dose escalation study. So what we know for sure right now is once every four months. Four months, yeah. and the even higher dosing cohorts are still ongoing from a modeling perspective from what we've seen from a safety perspective so far we're confident that we can get to the once every six months which which but of course again we need to see the data eventually and you're right you know it hasn't been easy to get to that once every six months integrase inhibitor offering but we're confident that 3242 will potentially provide a path forward excellent well unfortunately we're out of time but dimar thank you so much for being here and thanks everyone thanks a lot