Gilead Sciences, Inc. — 2024 Q1

Thanks, Daina. We've got Cindy Perettie here, so we'll go right over to her.

Thanks, Daina. So if I start off with the early line ODAC, I think we believe this is positive for everybody. What it's shown is that people recognize the value of having CAR Ts therapies earlier in their disease. They value the disease-free intervals that they get from that. So we were very happy to see that. I think we were equally as excited to see the second ODAC around MRD, minimal residual disease, as a secondary -- as an additional endpoint. I think the piece around this is that we're really encouraged that the ODAC decision is going to open up the door for us to potentially bring anito-cel to market faster for patients. And we're in the process right now of understanding how the MRD surrogate endpoint can be used with regulatory agencies and the application of our program and so more to come on that front.

Merdad is here, so I'll let him answer.

Thanks, Umer. Let me start by saying we think seladelpar is one of those medicines that will bring a lot of benefit to patients and really some near-term expansion of our liver portfolio and our -- and what we think will synergize with many of the other -- much of the other work that we're doing in liver disease overall.

Thanks, Tyler, it's Merdad again here. So it's a little challenging because I can't share too many details now because we're under embargo for both of those. And obviously, happy to fill in a lot of the blanks once the data are released, and we can talk about it in ASCO. I think for EVOKE-01, we think there are a number of pipeline updates in our ASCO presentations that we have upcoming, which were -- we see as a real change for us and a real evolution of our pipeline overall and our ability to build our oncology pipeline and bring new options for patients.

Thanks, Geoff. This is Dan. We're going to have Cindy Perettie answer that question, if you don't mind. So Cindy, over to you.

So we have 3 products right now, or 3 constructs that are in Phase Ia and b clinical trials. The first one is a bicistronic CD19, CD20 that has 41BB and CD28. The second one is that same construct with fast manufacturing, 3-day manufacturing. And the other one is a CD19 like Yescarta with 3-day manufacturing. So we're looking at all 3 of those in parallel with the goal of picking the winner to advance that rapidly into our pivotal trials. So that's what's coming up next. Obviously, we've shared a lot around anito-cel as well. With anito-cel, we have the iMMagine-1 readout, and we expect to move quickly into earlier lines as it relates to anito-cel, and you'll hear more about that later this year. Hopefully, that answers your question. We certainly have a number of plays in early research, but we would plan to advance our next-generation lymphoma assets quickly. And obviously, with the scale that we have at Kite as well as the integrated fact that we can create the vector as well as the construct in-house.

Thanks, Michael. This is Merdad again. As we've noted, I think, and as you talked about, the EVOKE-01 data in second line will be something that we discuss at ASCO and show those data. And the full data set is -- does motivate us to go forward in lung cancer and including with discussions with regulators. The unmet need in this population is great, and the data give us options, including discussions with health authorities and conducting follow-up trials. We'll be able to share more once the data are provided at ASCO, and so we look forward to having those deeper discussions once we can speak directly to the data.

Salveen, it's Andy. Maybe I'll start with that one. In our prepared remarks, I highlighted that in the near term, we don't expect sizable M&A.

And Salveen, this is Dan. Just to answer the end of your question. I mean, we're always therapeutic area agnostic when we approach these. I mean, first of all, we've got robust portfolios around both urology and oncology and a building portfolio in inflammation. So we look, frankly, across those spectrums. Seladelpar is a great example of finding an opportunity within our liver disease or -- franchise and be able to use that channel. But equally, we'll look for opportunities and synergies that complement our portfolio across therapeutic areas. And that's our approach. We think that makes sense. We look for the most attractive science. And as Andy said, we have a lot in our hands now to work through and to execute on. And so we'll keep the bar very high.

Thanks for the question, James. Well, it's -- I've learned to try to keep away from prognostication. So that's harder to do. We -- look, maybe the way I would put it is we are proud of the fact that Trodelvy is still the only TROP2 ADC that is approved, and that is in large part driven by the important role that Trodelvy plays in breast cancer right now for patients. And we do continue to want to push that, along with the ASCENT-07. We have a number of other trials ongoing to expand our footprint in breast cancer. I think we are right now in TNBC, the leading regimen.

Maybe just to add to that. I would also say that the more options these patients have, these women have, in HR+ in earlier lines of therapy instead of cycling through chemotherapies, the better. So with DB06 results and moving potentially that compound up earlier, it actually allows for Trodelvy to also play a more important and a bigger population than it is today because of the profile of the TROPiCS-02 label. And so we do believe that there's opportunities for this ADC to move up and also differentiate itself versus other ADCs in this marketplace, depends effect profile, the safety profile, not only on the efficacy. And so in light of the IHC-0 setting being really our strong foothold in HR+/HER2-, we believe that will continue, whether that's in later lines of therapy or earlier lines of these studies play out.

Mohit, maybe I'll start and then have others add. First of all, I think just stepping back and thinking about the portfolio that we've built over the past 4 years now more than doubling the size of the portfolio and with significant advances in our HIV portfolio and oncology and with outside of cell therapy. So as we think about growth moving forward, I mean, first of all, I would say on the HIV side of the business, we have to constantly remind ourselves and others that in addition to the treatment market and the potential for long-acting treatment that we have a very robust program on, and we'll update you a little bit more on towards the second half of this year with an analyst event, we've got the PrEP market that is just beginning to kind of be dimensionalized.

Thanks, Simon. It's Johanna. Let me take that one. And I think you're absolutely right. I think the fact that there is more than one competitor hitting the market is great for patients namely around increasing disease awareness around PDC and the fact that there are 2 options available. Having said that, I also feel incredibly confident that seladelpar is well differentiated to potentially be best in disease when you think about the significant impact and clinically meaningful impact we have with the ALP normalization in the clinical jet Phase III clinical trial we've seen as well as the improvement in pruritus which is a key symptom of the disease. And today, there really is no effective antipruritic options for PBC patients. And so all of that put together, in addition to the fact that we believe our footprint, both commercial and medical is incredibly well established when it comes to liver disease. It already covers about 80% of all U.S. PBC prescribers. And with that strong differentiated profile we were just referring to, I don't think those 3 months make a difference. I think really it's about best-in-class launch and that potential with seladelpar that we look forward for our PDUFA date.

Thanks, Charlie. This is Merdad. Frontline is a challenge given the -- what is currently the background standard of care. But as you know, we think that seladelpar is going to bring a lot of benefit to a lot of patients, especially given the pruritus and the potential for getting to patients earlier in their course will be really important for us. And so we have to see how the market starts to respond to the presence of seladelpar in the second line. And recall, I think the other thing to recall or think about is the -- how long people actually get frontline therapy before moving on to second-line therapy, given the efficacy profile of the frontline therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second-line therapy relatively early in their treatment course and making -- moving up formally for registrational trials to the frontline potentially superfluous. So I think we'll see how that plays out in the market. And once we see our label and all those sorts of things, so we'll be able to update more after that.

Brian, thanks, it's Merdad again. And I could talk about this for a long time. Let me -- I'll try to give a very concise answer. The recency assay that's been developed for HIV, it has been studied very thoroughly, and we can, based on the diagnosis at the time of screening, create a profile for anyone who's potentially HIV infected at that time as to how recently they were infected. And I think that's a key part. And that relates to the second part of your question in that the -- we don't, in a sense, need to compare risk behaviors before and after randomization and that we'll be looking at the overall incidence of HIV at the time of screening and then comparing in this counterfactual design with what happens after people start therapy. So I think between those 2 elements and all the discussions we've had with the regulators and the experts in the field, we're confident in that the design will provide the information necessary to get us to approval and for adoption.

Thanks, Terence, for the question. So on the commitment to anito-cel, we're -- as it relates to Parkinson's, we absolutely feel that we're differentiated potentially on both safety and efficacy. As we noted earlier, we have not observed the neurotox that some of the other constructs have observed, and we'll continue to monitor it, but we feel great about the profile right now. And then the efficacy profile, early signals are we think we will be equivalent or could be best-in-class. So we're 100% behind anito-cel and we're looking forward to bringing those data soon.

Yes. No, we feel very confident that we're going to return to growth in the second half of the year, as we stated. I think just as a reminder, we had shared in quarter 4 our guidance was that we'd be flat to slightly down in quarter 1. And part of that is due to the restructure. So we are putting our strategy into play. We feel very confident about the approach we're taking in the U.S. And we now are looking at having almost a fully stacked sales team back out and working hard. I think a piece that we need to talk about as well as the market dynamics. So the things we're observing. We're observing out-of-class competition with the bispecifics, the ATC constraints that we've spoken about in the past based on multiple myeloma constructs coming in. But what we're seeing is a lot of the hospitals and ATCs are working through those constraints, and we feel really confident about the second half of this year.

Thank you, Cindy. This is Dan again. So I appreciate all of you joining. Maybe just a bit of a summary statement. I want you all to know we at Gilead are very focused on the near-term execution and the long-term plans. We'll continue to stay disciplined and agile in our approach. Just as highlights, we've got 54 active clinical programs, no major patent expiries through the end of the decade, a variety of opportunities for growth and a lot more to deliver. On top of that, we are on track to provide updates from 3 Phase III clinical trials for Trodelvy, lenacapavir. We've got the seladelpar PDUFA date in August. Any update on the anito-cel Phase II update with the management we'll have at the end of the year. So rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I'll hand over to Jacquie for closing comments.

Thank you, Dan. To close, just one housekeeping item. I can share that we are tentatively planning to release our second quarter 2024 earnings results on Thursday, August 8. Please note that this is day is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of the second quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter. With that, we'll close our call for today. Thank you.