Awesome. Thank you very much for joining us to day. My name is Mohit Bansal. I am one of the biotech and pharma analysts here at Wells Fargo, and I am joined by Dr. Dietmar Berger, Gilead's Chief Medical Officer. Thank you very much, Dietmar, for joining us today for the first time.
Thanks for having me. Yeah, of course.
Awesome. Gilead has been a regular. This is fifth year in a row at Wells Fargo Conference, first time for Dietmar. We are excited to have some R&D discussions here.
Yeah.
Dietmar, let us just talk a little bit about the pipeline focus right now. It does seem like you have a mix of, obviously, building on HIV, where you have a leadership, and then oncology, some datasets coming in, immunology as well. Talk a little bit about when you look at the internal portfolio and some of the assets you acquired earlier this year, where is the focus internally is, and then what do you see the most exciting stuff out there?
Yeah. No, thanks for that question. The current management team at Gilead, they joined seven years ago. There was a clear realization that we want to diversify. That's been our strategy for some time, and we've clearly highlighted, yes, we have a clear stronghold in virology, and there's diversification in virology as well. That's important to us. Then there's really this expansion into oncology and into inflammation.
From a portfolio perspective, we have made good progress in all three areas. On the virology side, there is this focus on both HIV treatment and prophylaxis, and we can really talk about how that is progressing. For example, we have just launched the combination of bictegravir and lenacapavir as a daily oral, for a very specific patient population. That is the Bixlenvo launch, where we have presented data on the islatravir-lenacapavir combination as a once-weekly oral. We are also working on longer duration treatment options, all the way up to once every six months treatment options. Then we have obviously the PrEP portfolio, HIV prevention portfolio, where, for example, we have submitted for the once-weekly lenacapavir, we have launched the once every six months, and we have clinical trials for the once every 12 months. Beyond that, we look more broadly at virology and antivirals as an opportunity.
Then in oncology, we have to think about that in two ways. One is obviously, the cell therapy portfolio with Kite. That is also one of the acquisitions that you mentioned. That is the Arcellx acquisition that brings anito-cel fully into Gilead. That is where we have strong data in the fourth line plus multiple myeloma setting. We also have a study ongoing in the second to fourth line, and we are also preparing for studies in earlier lines, for example, in the first line setting. We are hoping for approval in this fourth line plus setting towards the end of the year. We think that is a really important opportunity because we feel anito-cel is a very differentiated option. Beyond that, with the Kite portfolio, with the CAR T-cell portfolio, we are also focusing on next generation CAR Ts, for example, bispecific CAR Ts, CD19, CD20.
We are also looking at how can we expand that from oncology also into inflammation and neuroinflammation. We are also working on in vivo CAR T as an option, but that is a longer-term perspective, which is important. The current focus and standard of care, and that is where also the opportunity is really the ex vivo autologous. Then on the non-cellular therapy side, that is where we have another acquisition also.
That is where we ha ve the Tubulis acquisition that brings TUB-040 into our portfolio, which is ovarian cancer-focused, which had data with a 60% objective response rate at ASCO which really confirms the underlying concept of a new linker technology, also new payload technology, very stable linker, really confirmed with a strong efficacy and also good tolerability. Of course, early days, but we will explore that further, and we want to move that rapidly also into phase III studies in ovarian cancer. There is a whole portfolio behind that of ADCs from Tubulis. Besides that, obviously, we have TRODELVY.
With really meaningful growth rates in breast cancer and also additional data coming, for example, in endometrial cancer, for example, in the adjuvant triple-negative breast cancer setting and also in small cell lung cancer and a whole slew of cooperative studies beyond that. In oncology, we are also trying to broaden the portfolio and really focus on tumor drivers, ADCs, some more targeted mechanisms with that portfolio, and we are making good progress there. On the inflam side, and I want to say inflam plus liver side, obviously you have Livdelzi as a marketed product, which is also making good headway from a commercial perspective. We have additional data with the IDEAL study, which takes us into an even earlier treatment paradigm.
Also thinks more about normalization of ALT values, normalization of liver function, which we believe can give us a better long-term trajectory and which really increases the market size, roughly doubles the addressable patient population. Beyond that, we have on the inflammation side an array of what I consider really interesting molecules. We have an oral alpha-4 beta-7, where we are looking forward to present data later this year. We have an IRAK4 inhibitor, which we tested in cutaneous lupus, where we also will present the data later this year. We also have an IRAK4 degrader that is in early studies. We are focusing also on STAT6 degradation.
The final acquisition I want to talk about is really the acquisition of gamgertamig, which is a BCMA T-cell engager, which takes us into autoantibody-driven disorders like think immune thrombocytopenia, think autoimmune hemolytic anemia and other types of autoantibody-driven disorders. So overall, I would argue, we have worked heavily on improving the portfolio and thinking about how can we drive further differentiation, patient benefit, and then eventually also revenue across the virology portfolio, the oncology portfolio, and then also the inflamed portfolio. I am really encouraged by where we are at this stage and how we can deliver against that.
Got it. Very helpful. Thank you very much for this overview. There is a lot going on at Gilead. I want to briefly touch upon the HIV before moving into the pipeline side of things. Even HIV as a pipeline. Talk a little bit about the decisional think about intramuscular PrEP here. Is it more driven by yearly dosing versus intramuscular? Because initially we thought the subcu would be the preferred choice, but then intramuscular, kind of like some doctor prefers intramuscular. So, what are you seeing in the marketplace? Or is there any reason to believe intramuscular method of administration is more suitable for a longer-acting PrEP?
I think more broad in HIV, it is really about optionality, right? You find people who are very informed about both treatment and prevention and who have clear preferences, right? For us in prevention, it's really important to be a leader in the prevention market.
Right.
We achieve that by having those different options. We see DESCOVY with really stellar growth rates as a daily oral option for prevention. We see the prevention market growing, right? We think it's under-penetrated at this point. We have more than 500,000 people on PrEP. CDC says the addressable patient population, the population of people qualifying for PrEP, should be more like 2.2 million, right? So we feel there's a real growth trajectory, and obviously DESCOVY playing a key role as a daily option, then Yeztugo as a once every six month subcutaneous option. We have filed for a weekly option, weekly oral lenacapavir as an option. We hope for approval of that in the beginning of next year, first quarter of next year. Then we have a clinical trial ongoing for the Yeztugo as an injectable once every year.
That type of optionality we feel is really important. When I go out, when I talk to people at sites, for example, there's a real excitement about the once every year. People go, "Oh, this is like a vaccine. I can go in like once a year and can get my shot and really have the effective prevention that I know from Yeztugo." Yes, you're right, that's an intramuscular injection. Some people prefer that. Some people prefer the subcutaneous, which is Yeztugo once every six months, right?
Right.
Other people don't want injections at all. That's where the weekly lenacapavir would come in or the daily DESCOVY. Having that optionality we feel is really important.
Got it. That makes sense. For Yeztugo, these different approaches, intramuscular, oral, you are taking the PK/PD type approach here rather than full trial. Talk a little bit about, if you can talk about regulatory discussions for the oral filing and should we see this filing as risky per se because it doesn't have a proper phase III clinical trial behind this? Or do you think PK/PD is enough based on your discussions here?
In our experience, the FDA, as really a kind of a trailblazing agency in this field, has been very interested in model-informed drug development and very interested in kind of exposure effect relationships, right? One of the beauties of virology development is that you can very effectively model the type of coverage you need in order to both prevent an infection and also in order to treat the virus. In the prevention setting, you've got two different things, right? You've got the lenacapavir weekly. That's where we've already submitted for approval. That submission is entirely based on two things. One, the modeling.
Right.
The modeling-informed drug development, really understanding the PK. Second, also the experience we have with Yeztugo.
Right.
Because remember for Yeztugo, we already have a bridging option.
Right.
Which is an oral therapy that you can give weekly that can bridge, for example, if somebody misses their once every six month Yeztugo injection. They can go and take the pills for a couple of weeks and then go to their next injection.
Right.
Based on that experience and that label that already exists, it was only a smaller step to then get to the weekly lenacapavir prevention option, like the entire weekly oral option. I don't look at this as riskier than any other type of submission. Obvio usly, we had extensive discussions with FDA. Obviously, I will not comment on what FDA will do, but we are in active discussions with them about that, and I'm really encouraged by the experience that we have with Yeztugo , with the bridging option already, and then the PK data. Then for the once every year treatment, you're right, that is a phase III study, and that phase III study has eventually a PK primary endpoint.
It is really about getting to those lenacapavir systemic levels in circulation that we know will effectively prevent. We want an effect that is similar to what we have seen with Yeztugo once every six months. We know with the dose that we use in the once every 12 months, we get very similar or even higher levels of lenacapavir in circulation than we get with the once every six months.
Okay.
We are very confident about that target coverage and very confident about that preventive efficacy. We are really looking forward to seeing the data sometime next year.
Got it. Exciting. Thank you for that. Now let us just switch to treatment a little bit. I think earlier this year you showed every four month data because I think you need multiple drugs. You already have one drug, which can be every six months or maybe every year with the intramuscular delivery, but you need an integrase inhibitor to combine with that. The one you are taking forward is, I think we have seen data for every four month. What profile do you want to see? It has to be every six months, or it can be every quarter. How do you think about the next generation of HIV?
Yeah. Great question. There are some really important points there that you mentioned already. First of all, again, the same component of optionality and really having different offers for patients becomes important here in the treatment setting, very similar to the prevention setting. You want to have your daily, your weekly, monthly, once every six months. You want to have that type of optionality. How do we get there? On the treatment side, we always need combinations.
You've got a higher viral load, so you always need combinations. That's one important component. The other important component is, BIKTARVY has set the bar so high from an efficacy perspective, from a perspective of forgiveness if you miss a dose, from perspective of resistance, that that becomes your gold standard. We don't want to compromise on that type of profile, right? That's very similar to that then gives you really what you want to see, with, for example, your once every six months, right? You want a high level of efficacy. You want a really positive profile when it comes to resistance, right? You don't want to see a lot of resistance development. You want a high level of convenience as well, right?
You want to have these really good characteristics, and you need the combination. When we think about once every six months, we have one component of the combination already, which is lenacapavir. Lenacapavir is already approved as a once every six month treatment called SUNLENCA.
Right.
Which is for the highly treatment experienced patients in combination with other antiretrovirals. We want a once every six month treatment approach that, for example, has an integrase inhibitor. That we're working on the combination of a long-acting integrase inhibitor, which is called GS-3242. That's the integrase component plus lenacapavir every six months. Working actively on that. We know already that the integrase inhibitor GS-3242 can cover for four months.
We're doing that, we're exploring that in a dose escalation study. Just from a PK perspective, you need these higher doses to then cover the longer period in time, right? We're confident that we can get to once every six months with GS-3242, but that's currently an ongoing area of study. We'll know that roughly by the end of the year.
We will move that combination into phase II to get to the once every six months treatment with an integrase inhibitor and a capsid. Again, what we are really looking for is high level of efficacy, low level of resistance or no resistance, right? Then the type of forgiveness and convenience that we see with a drug like BIKTARVY.
Got it. Very helpful. Maybe let us just move on to anito-cel a little bit here. I mean, [Pedufy] is coming as well. The question we get a lot is that, as of now, it does look the safety is the differentiation versus CARVYKTI at this point. How comfortable you are that we really know the profile of the drug that we are not going to see a delayed neurotoxicity there or anything, in subsequent data set? Or, obviously mechanistically, there is a reason there, but again, what do you say to someone who says, "Oh, it does take one or two cases and probably" Or you say that probably you are not going to see those cases at this point?
Yeah. You are talking about exactly the safety profile. From a differentiation perspective, we have not seen, for example, the delayed neurotoxicity, the Parkinsonism, the Guillain-Barré. We have also not seen the enterocolitis, for example, that some of the competitor products have seen. We think that is really based in the mechanism and the on/off characteristic at the receptor and the inflammatory conditions that can raise with some of the competitor molecules. The key argument, I think, is the timeline.
Okay.
Those types of side effects with the competitor drugs have been seen within the first 100 days, usually after treatment. We now have north of 400 patients who have been treated with anito-cel, with observation periods like one data set with a median observation period of 15 months, another one, two patients all the way out to 38 months after treatment. We have not seen a single case—
Right.
—so far of either the delayed neurotoxicity or the enterocolitis. We should have seen those.
Right.
You have got very substantial numbers of patients that have gone through those first 100 days. I feel very encouraged by that. The safety profile is really differentiated, versus some of the other treatment approaches out there, where you see rates all the way up to 10% of these long-term irreversible side effects. That is where people are really concerned about those, and we see a clear differentiation and a clear opportunity. Besides that, obviously, you want to see really good efficacy, and that is also where I am very encouraged by the objective response rates, the PFS data that we are seeing, and also the MRD data, the minimal residual disease data that we see that really predict strong long-term outcomes with anito-cel.
Got it. Very helpful. Thank you for that. I want to move a little bit on I&I, the exciting area where you do not get any credit right now, but again, everybody is looking forward to those data sets, both for IRAK4 and alpha-4 beta-7. Talk a little bit about that. This is a new area for you as well, so there has to be a bar for you to move forward. How you are thinking about when you look at the data, what would make you make a go, no-go decision on those assets there?
Yeah. I think the inflammation portfolio has emerged very nicely. As discussed, it has been a longer-term strategic priority for Gilead. You now see that some of the early bets that were taken, some of the molecules that have also come out of research, are actually moving forward in the portfolio. You will see, I think, quite meaningful news flow for our I&I portfolio during the second half of this year. Obviously these data will be at conferences, and I will not give you a prediction of the data.
Okay.
But just talk a little bit about hypotheticals. First of all, I think they're really meaningful targets we're working on. Some of those are highly validated, others are still in validation. But when you think about an alpha-4 beta-7, for example, that's a very validated target. ENTYVIO, as an injectable, is a molecule that's a backbone in inflammatory bowel disease.
Right.
So we have an oral e mvistegrast currently in clinical trials. We have completed the phase II analysis, and we are looking forward to present that data at a conference later this year. Thinking about it is a validated target. It is a real backbone. It is differentiated both from an efficacy and a safety perspective, which is really important. You can think about this moving forward in different ways. If we assume that we are maintaining efficacy, and that is an assumption, we need to show you the data.
Right.
If we assume we are maintaining efficacy, then there is discussion about how can you develop that as a backbone in monotherapy, and then how can you also think about combinations.
Right.
There is an efficacy ceiling currently in inflammatory bowel disease, and people start talking more about combinations. There are obvious combination partners because there are various orals currently in development that could be potential combination partners. I think, for example, for the alpha-4 beta-7, once we have shown you the data, we should discuss more. In principle, you need to think about monotherapy development and combination development. Talking about that portfolio, we also have the IRAK4 inhibitor edecesertib, which has been in a phase II-A study, which is the study we call the COSMIC study. Again, we are looking forward to share the data. That study was in cutaneous lupus. There, we've already communicated that we will move the drug forward —
Right.
— into the next study, which would be a phase II-B. We will show you the data, but you can already deduct that—
Yeah.
—we're excited about the data, we're moving it forward. That will really validate also IRAK4 inhibition as a target—
Yeah.
—and an important mechanism. We're also following up, obviously, with an IRAK4 degrader which we have in an early study at this point in time. The other piece of data I am excited about is we had the Ouro acquisition that brought the BCMA T-cell engager into our portfolio, gamgertamig. Now GS-O336. There we have already shared data in immune thrombocytopenia with really good efficacy and also really good durability of efficacy. So looking forward to sharing more data at a conference later this year in immune thrombocytopenia. We have also communicated that we are planning to move forward with gamgertamig in phase III in 2027 in ITP and in autoimmune hemolytic anemia. So overall, when you look at that picture in inflammation, we do see the portfolio moving forward, and I think there are some really meaningful opportunities there.
Got it. So it kind of reminds me of early days of HIV. You had TRUVADA, you used SUSTIVA, partnered with someone else. Could that be our case here? You talked about partnerships. There are others out there. You would be open to those kind of partnerships if the answer was.
Definitely. This will all be data-driven.
Right.
I think these are discussions that we absolutely need to have once we have shown you the data and once you can really get a better picture of what we actually have. When you think about an area like inflammatory bowel disease, the current standard of care is obviously biologic monotherapy.
Right.
Of course, people go through different types of therapy and then they arrive at the biologics. We see this, as I said, in these experienced cases of patients, we do see this efficacy healing, and patients deserve that we do better.
Right.
That is where we have to think about combination therapy. That is why also now with the different biologics mechanisms—
Right.
—we can think about which mechanisms would make sense to combine, and I think that has to be part of the discussion.
AbbVie management, he was right here right before you, so they were saying the same thing, basically.
Yeah.
Exactly the same thing. Thank you for that. Let us just talk about Tubulis, right? That is an asset, which again, I do not think people really understand this really well, but you are really excited about this asset and more so excited about the unique linker technology they have. Talk a little bit about that because you keep talking about how this technology can actually make you go into previously undruggable areas and all that. Can you help us understand this a little bit and what excited you there?
We have been working with Tubulis for some time as a research collaboration. That is why our research team really understands the details of the chemistry and the linker technology and all of that. That detailed understanding has helped us a lot to assess the Tubulis opportunity. There are really two things here. One is what they call their P5 technology, which is how is the linker connected to the antibody.
The P5 technology leads to very stable linkage, and that we believe leads to less of the toxin, less of the payload in circulation, and a better kind of tolerability profile, which then also allows us to get to higher doses and higher doses specifically at the target, specifically in the tumor. That we believe is more broadly applicable for the Tubulis portfolio. Then they have a second technology, which they call the Alco5 technology, which really focuses on how is the payload connected to the linker.
The current technology focuses on specific binding technologies, this is entirely different. This is via hydroxyl binding. That gives us basically a lot of variability and different opportunities on the toxin side. We have different toxins in our chemistry pockets, Tubulis has different toxins that they have been exploring. That also allows us to potentially move away and move beyond the current topoisomerase type payloads.
Right.
People are already asking about as we see more and more ADCs in the oncology space, should you actually do topo inhibition after topo inhibition? No, you shouldn't because you develop resistance, right?
Right.
Thinking about different types of payloads also becomes really important. We were excited about Tubulis as a technology platform for both the linkage and for the payload technologies. TUB-040, which is the front-runner molecule, gave us really good validation because what we see and what we presented at ASCO is a high response rate, 60% objective response rate in an unselected population, platinum-resistant ovarian cancer.
Right.
That gives us a good basis to explore that further, to explore the platinum-resistant ovarian cancer space. The target here is NaPi2b. 85% of ovarian cancer patients show high expression of NaPi2b in their tumor. There's good reason to believe that this could be an unselected approach with high efficacy. We also saw good tolerability, which that is important if you want to go earlier in the treatment paradigm, for example, to platinum-sensitive ovarian cancer. That's where you need the possibility to combine with chemotherapy and the tolerability profile that we've seen based on this very stable linkage we feel really encourages us to think about the earlier lines of therapy as well. TUB-040 is the front runner. There's another molecule already in the clinic, which is called TUB-030.
Right.
which targets another tumor antigen, which is called 5T4, which is broadly expressed on different tumor types. We are exploring the same technology with different targets. And there are other molecules behind that we will also put into clinical testing. Beyond the initial TUB-040 focus on ovarian cancer, NaPi2b, for example, is also expressed in non-small cell lung cancer at lower levels. We need to think about the biomarker-driven program there, companion diagnostic, et cetera, which we are doing in parallel. There is just a broader push than with our oncology portfolio, with the addition of Tubulis and with the ADC opportunity.
Awesome. When you look at the internal portfolio right now between HIV, Tubulis, I&I, anito-cel and all that, and even in vivo we did not talk about, do you think you have enough on your plate right now? Do you think you have enough for the goals of diversification and growth you have for the next decade and all? Or is there anything, any—
Yeah.
—area you want to go in?
I believe we have made really good progress with our diversification efforts.
Right.
You see how the virology portfolio is moving forward, how the oncology portfolio is getting broader and focusing on more direct tumor targeting, focusing on proximity-based approaches like ADCs, like T-cell engagers, focusing on tumor drivers. In inflam, we've got some very meaningful targets that we're addressing. I think we're at a stage at this point, where we even need to prioritize.
Right.
Right? I've always said that's actually a good thing.
Yeah.
Right? You want to move the best molecules forward. You want to have a portfolio that's really focusing on higher probability of success and also higher reward that can really translate into patient benefit, but also into revenue, right? We're at that stage where we need to prioritize, and I think that's a good thing. But we will continue to look for additions that are compelling in those therapeutic areas. We are already supplementing our portfolio with earlier stage—
Right.
—opportunities. That's like our standard ongoing business development.
Right.
We also have really good molecules coming out of our internal research. Our research group had also made great progress over the last five years, in those different areas, virology, oncology and inflam. We're really trying to boost the portfolio both internally but also externally. The key will be to have more shots on goal early, but then also to have the data that allow us to then kill those programs early and then to prioritize and move only the most important ones forward.
Awesome. Thank you for this. One last question, which I ask every management team. Fast-forward one year, 2027 Wells Fargo conference. I hope you are here, I hope I am here. What would make you look back at the year and say, "It was a great year for us?
I think we're at this point where we really also need to execute and deliver, right? 2026 was a year we really focused on shaping the portfolio, bringing new molecules, both internal and external, into the fold. We have some, and we had some very meaningful readouts. We have a number of launches. Actually, for Gilead, an unprecedented number of launches. We just launched Bixlenvo.
Yeah.
Right? We're now working on the lenacapavir prevention on a weekly basis for next year. We're focusing on islatravir, lenacapavir. We had the TRODELVY first line launches.
Right.
Really nice growth there with TRODELVY. Looking forward to our anito-cel launch. I think it will be a great year if we can deliver on those, and then if we can look at the portfolio development, for example, in inflammation, in oncology, also in virology, that really give us a path forward from a portfolio perspective and allow us to really prepare for the future.
Awesome. On that high note, thank you very much, Dietmar. I really appreciate it.
Thanks, Mohit. Thank you. Pleasure.