Good morning, and welcome to day two of the Barclays Global Healthcare Conference. My name is Carter Gould, Senior Biopharma Analyst. Please welcome Gilead to the major screen here. Merdad, if you probably can't see it or maybe you can, you're about 20 feet tall, you're behind us.
No, I didn't see anything at all.
... still agreeing to do the chat even though you couldn't be here in person. Merdad Parsey, CMO of Gilead, and excited to do a Q&A here. Merdad, I wanna give you the opportunity if you wanted to make any opening comments first.
Well, first, Carter, I really apologize. I was looking forward to joining you all, and, I threw out my back and have been essentially unable to walk for the past couple of days. I'm really sorry not to be there in person, and, look forward to chatting this morning. Hopefully, it's worth motivating me.
Great. didn't know if you wanted to make any additional comments, or we can just hop into Q&A from this point.
Look, maybe I'll just say, you know, as most of you know, we've been on a journey at Gilead. It's been a great few years since I've joined. It's been, what? About 3.5 years for me and about four years for Dan. Hopefully everyone's starting to see the transformation. We're partway through, and we're really excited about where we are and where we're headed with the expanded portfolio beyond HIV into oncology and growing our information business as well. Happy to be talking with you today and catch everyone on here.
Perfect. Okay. Maybe to get started, I wanna touch on HIV first. I think we've just kinda come up on the anniversary of your HIV deep dive. You made a you know, progress on a number of fronts. Sunlenca approved, first off. I'd say congratulations there. But that was I mean, that's really just the start of sort of this next wave of opportunity for Gilead in HIV. I guess the opening question here is, as you think about combination approaches, whether it's treatment, whether it's PrEP, how has that evolved over the past year? Maybe you can talk about some of the progress you've made on that front.
Yeah. Great. Thanks. Yeah. It's been quite a busy year for us. As you know, we view the HIV long-acting space as really important to where we wanna be and what we wanna offer for people within the HIV on the treatment side and for on the PrEP side. Of course, when I think about it that way, it's really important in the past year now that we have Sunlenca approved for treatment of highly treatment-experienced individuals that really sort of validates our pathway to on the path to PrEP for lenacapavir. Of course, on the treatment side, looking for that partner to match up with lenacapavir for long-acting.
To your point, we are pursuing it both on the oral approach, where we're hoping to get at a minimum once weekly, maybe as long as once monthly oral therapy. On the parenteral side, trying to get to every three months or hopefully again longer as we move forward. With those goals in mind, you've seen also our the CROI data we presented on the bNAb data for the long-acting HIV therapy, which allows us to dose every six months. That was a 1B study, we'll be moving that into phase II. On the preclinical space, we added two instances to the development portfolio.
Those are looking very promising, and we're really excited about getting those into the clinic as quickly as possible. Overall, we have a number of programs in the early stage. The thing that's important to remember when we talk about those is that those programs, we can determine their suitability for this long-acting approach very early on in their development cycle, right? Really phase I, because we know that these mechanisms are effective. The question we have to ask in these is the PK in humans what we hope it can be to give us that long-acting exposure?
Are we able to get tolerability when we're thinking about parenteral, for example, subcutaneous formulations, the tolerability that allow us to match it up with lenacapavir and have an offering for people who want something that is long-acting. We should be seeing data emerge from certainly the studies that are already in the clinic, the molecules that are already in the clinic, and then we have all these follow-on molecules. Our approach is gonna be take a fairly broad number of programs in, looking for the optimal molecule that will allow us to move into the phase two and beyond area. We're really excited about how things have progressed over the past year or so.
Look forward to sharing more data, hopefully, as it starts to emerge.
Okay. Just wanted to follow up on one or two aspects there. As we think about whether it's the orals or the long-acting injectables, I think the way you portrayed it, I think is kinda how we think about it, right? The plethora of phase I data and early-stage data allow you to make some calls there. If you think about those later-stage studies, could we see Gilead take multiple oral combinations into phase III, or will there be just an inherent prioritization and you're gonna pick one or some small number to advance into later-stage studies?
Yeah, I think we'll be open to that depending on the characteristics of what we see. I think it'll be really a data-driven decision. Like, our preference will be to move, you know, find the one, right? The molecule that will get us the right combination to move forward. If we have to make trade-offs, we'll certainly consider doing more than one molecule. It'll be very much a data-driven decision as we start to see what the PK looks like and what the tolerability looks like.
Okay. Maybe this is a good segue to move on the PrEP side a little bit there. I think what's overlooked a bit is PURPOSE one and two are not that far away. These were, you know, sort of the key PrEP studies. And having lived through sort of the DISCOVER data coming out and a lot of the discussion then, are there key learnings in terms of event rate? Which I think, you know, going back to DISCOVER, I think we had been all anchoring on PrEP studies that were far long ago. Maybe people are better kind of with a better expectation of kind of where event rates are today, but also just representation.
I guess it's really a broader question around learnings from Discover as you think about PURPOSE 1 and 2, just given the importance to the portfolio.
It's such an important question, Carter. I think you're right. A lot of people have forgotten how the field has evolved and how important it is. Look, we're really focused on that issue. We want to make sure both from a, you know, for people living with HIV, for the community as well as for the regulators, that we are able to present data that really is applicable to all the people we're trying to serve. As you remember, as you mentioned and as you were discussing DISCOVER was really focused on men and women, sorry, men and transgender women, who were having sex with men. Those are the populations that were being studied.
We've really built the PURPOSE program to be much, much broader than that, very intentionally. You know, I think it's probably the most diverse group of people gonna be enrolled in a trial ever for evaluating PrEP. Not only do we have men and transgender women who have sex with men, but we've also included people with who are at risk of HIV who weren't in the DISCOVER population. Cisgender women, people who inject drugs, adolescents, are really included in these trials as well. In addition to diversity in terms of background. We are really focused on making sure that we have Black, Hispanic, Latino, transgender, non-binary people enrolled in the trials so that we can make sure that we can provide that information to everyone.
There are four PURPOSE trials, really focused on trying to make sure we cover all of our bases. one and two will be the primary large approval trials, but three and four will allow us to expand the data to include women in the U.S., people who inject drugs. I think that that will, that's certainly our goal and we're working very hard to do it, very intentional on our as we go forward.
Just real quick follow-up, then we can move on. Just we should think about PURPOSE one and two as being either the regulatory package and then the rest are supportive. Okay, great. Perfect. That's a great segue. Now we can move to sort of COVID. In late last year, you sort of announced your plans with sort of the next iteration after the success with remdesivir. You are moving into, I guess Oaktree when it came out, there's been a lot of questions around, you know, sort of this setting. I'd love for you to kind of just talk through sort of, you know, your conviction here, given, I mean, enrollment challenges, endpoint challenges involving disease backdrop. I mean, standard risk has not been for the faint of heart.
you know, what gives you conviction here to move forward?
No, it's a great point that you're making. We've definitely gone in with our eyes open. I think maybe the place to start is our conviction around the molecule GS-5245. Given from an activity standpoint, it's related to remdesivir in terms of the target and the part of the virus that we're inhibiting. We're really confident in the molecule itself. The challenge, as you point out, is really the epidemiology right now and the course of the disease. You know, in our...
The way we think about it is that we, with a molecule like GS-441524, and we believe that the need continues to be out there for mechanisms, over time to provide treatment to people who get infected, that we have an obligation to move this program forward with the uncertainties that you lay out. I think they really fall into two major categories. The first is the course of the pandemic and how many cases there actually will be. We've watched as long as we have how the caseload has been changing and the intensity of the disease has been changing. That can change at any moment, right? We're aware of that. We wanna be prepared. We don't wanna react.
We wanna be prepared so that if there is another wave, if there is a more severe version of COVID, that endemic or pandemic, that we have our sites open and our studies ready to go. The second is the design of the trial and how we look for events and how we're powered and what the endpoints are. Both the standard and the high risk, we talk to the regulators a lot to make sure that we're on the same page with them. More to the point, from a pure study design standpoint, we don't know what the event of that rate is going to be anymore. I think that is the major challenge, and I completely acknowledge that.
The way we've designed the study to have interim checks to be pursuing the events, to evaluate the event rates as we go along. That way we can modify primarily the sample size depending on the underlying event rate, based on our assumptions. If they're lower, we would upsize the study. If they're higher, we might be able to pull it in. I think with those, that approach, hopefully we'll be able to get there. Of course, I completely acknowledge that it will be a challenge. I think I would not everyone should expect that it's going to be challenging to enroll. I don't think we have an option, right?
I think it's something that we feel obligated to do, and hopefully we'll be able to provide another treatment for people.
Okay. We've got about 10 minutes left, and I think there's no area of work that's had more of a transformation since, you know, you joined than the oncology side of the business. I guess maybe to start on Trodelvy, I'm gonna ask you to. It's sort of unfair given, you know, where you sit, but given, you know, in the early days of the HER2-negative launch, just how Trodelvy's sort of coexisting with Enhertu. Is that sort of playing out as you expected? And maybe talk about that positioning in that IHC 0 population?
Yeah. Look, we're really happy with the data that you've all seen and the OS benefit we've shown. It's only been a month, so I think it's really important to keep that in mind. We're very pleased with how things are going for a month, but it's probably too early to give to really understand directionality. I think it's important though, I think implicit in your question is sort of this competition between Enhertu and Trodelvy. Actually, I think the biggest competitor we have right now is chemotherapy.
I think all of us have the opportunity to go help patients who are we can demonstrate a survival benefit with Trodelvy and have physicians not use chemotherapy and instead use something that has demonstrated OS benefit. That's probably the biggest challenge right now is awareness and getting the caregivers to transition from chemotherapy to these newer agents and Trodelvy.
Okay. As we think then about, you know, Trodelvy's potential, relevance in lung and being able to move into earlier lines, the commentary there against chemotherapy, I think is apt. On, on one hand, there's still sort of that view, on the other hand, you haven't seen the ILD that some of your competitors have. Kind of given that balance, how do you think about the ability to move into earlier lines of lung? Is that a possibility? Just some kind of balance there.
Yeah. It's, it's a spot on question. You know, I think that if you think about the patients who are not getting chemotherapy today, certainly, for those patients, we're gonna need to demonstrate, I think, an efficacy profile that's gonna be compelling. Having said that, it's also important to note that with Trodelvy, the adverse event profile we see is neutropenia and diarrhea. Those are things that oncologists are used to managing. It is different than managing ILD, which can be more challenging. For us, I think that if we can demonstrate a meaningful benefit on top of, say, PD-1 inhibitors in parts of the population, that and we bring manageable adverse events along, I think that can still be compelling.
In other groups, though, these are patients who are getting chemotherapy even in the front line. The question really becomes both, the tolerability of either combining and in the long run, our hope of potentially substituting for chemotherapy, and really bringing an adverse event profile with Trodelvy that is not dissimilar from what people are experiencing right now. Hopefully brings a substantial benefit, which we're really, we feel that is highly likely given the profile we've seen with Trodelvy so far. I think you're absolutely right that tolerability is gonna be very important, especially in front line.
That's why we're doing some of the second line work where we're doing to make sure that we have the right dose as we go forward and the tolerability in combination with chemotherapy is gonna be there. I think that'll all set us up really nicely for those front line studies.
Okay. I guess with that in mind, how should people in the room sort of think about read-through from the TROPION-L ung01 and good and bad competitive, but also potentially de-risking for the.
Yeah. Our conviction on Trodelvy is really high. It is driven by, you know, ourMultiple approvals already with Trodelvy in bladder and triple-negative and HR-positive. You're absolutely right. We know that Trop-2 directed ADCs are showing really exciting efficacy across the board with our own data as well as what others are seeing. We have a lot of conviction there. I think that's part of why we're moving so aggressively into the space, moving forward in front line non-small cell, as well as some second line work that we're doing. You know, lung is very important for us.
If I add to that, then what we're doing with the TIGIT program, you know, we are taking a very all-in approach with lung cancer, both with Trodelvy and with Domvanalimab, which is another. I consider ourselves really fortunate to have two highly, you know, two molecules that we have a lot of conviction in and have a high probability of success in lung cancer. I think that makes our portfolio fairly unique in terms of having that, those combinations available to us. So, with the TIGIT asset, moving those forward aggressively as well, I think will leave us in a good place to be data-driven in our approach.
That's a very good lead in to as we think about potential read-through from competitor TIGIT data. I guess the pointed question there is what a negative result in SKYSCRAPER, coming up from Roche would mean for you and the program on your side?
Yeah. you know, I've been around long enough not to read through too much positive or negative read from other people's trials. you know, the real question is why? If they had a challenge, and I think understanding study design and patient population issues. We are approaching our program, you know, with really aggressively. I think remember that our approach is going to be using a PD-1 instead of a PD-L1. We really wanna see what the data looks like in the SKYSCRAPER data as they roll out to really decide, you know, what we're gonna do about it. I'm again, really very bullish in terms of the data we've seen so far.
Remember that we'll be showing more ARC-7 data coming up this year, and I think that should show, you know, we should have 150 patients worth of data in that dataset with longer follow-up times, more mature data. Hopefully that will continue to bolster our efforts with TIGIT moving forward. We're gonna be driven by our own data. That's how we've designed our studies, and that's what we'll be moving forward with. Of course, we'll look at those data, but understanding why they failed would probably be the more important thing to make sure that we don't make their mistakes in there. I don't want to say they're making mistakes.
If there's something in there from a design standpoint that we can learn from, we incorporate it.
Just to be clear, the updates that we're gonna see at ASCO for that program will be above and beyond data that have already been presented. Okay.
Yes. Yeah. The data we showed in December was an earlier data cut. It was about 130-135 patients, so not everyone who had been enrolled. Many who had been enrolled had just been enrolled in August, so they hadn't gone on the scan. At ASCO, we should have data from all 150 patients who enrolled. We should have had, you know, the opportunity to have two scans. All the more mature data from the initial 135. All those data together, we'll be able to see the best data and additional information from those subjects as we go forward. I'm excited to see those data myself, and we'll be excited to share them with everyone.
Okay. In these final minutes, I wanted to ask you a bit of an overarching question. Kinda it feels like, I think with success, certainly the success the stock has had and sort of the portfolio having kind of advanced the past four years, it feels like a lot of people are kind of taking stock of all the changes within Gilead. You know, as we talked about, the portfolio is meaningfully different than it was four years ago. Can you talk about this point, kind of, you know, the process evolution? You know, sort of where we are in sort of overhauling that pipeline? How you feel about sort of the different bets you've made, I guess, holistically within oncology?
Yeah, it's been quite a journey. You know, I think I would say we're, you know, we're not done with our journey. I think there's more work to be done. Our focus right now, I would say largely is to ensure that we're building up our earlier stage portfolio for the long run. We don't wanna be in a situation where we have to find late-stage assets. We'll always be opportunistic about late-stage assets. We really wanna set ourselves up for success in the long run and take this to a number of early investments for a variety of programs. Really the phase 1, phase 2, and that's both in oncology and inflammation, right? You saw through the MiroBio acquisition.
All of these are designed to build a portfolio for 2026, 2027, 2028. I hope to be talking to you guys about phase 3 studies with some of those assets in a few years to come. I think we'll always be opportunistic on the later stage side. If there's something that looks great, we have the capacity and the capability to do it now. Our team build-up has gone incredibly well in terms of building our oncology team. I'm really proud of the team that we've put together and what they've been able to accomplish in such a short time. Probably like me, there have not been a lot of instances where a company's been able to do what we've done. We're really proud of this work and we're not done.
We have a lot more to do. We're excited about continuing on the journey.
Perfect. We're out of time. Thank you very much for joining us. Best of recovery on the back.
Thank you so much.
Thank you very much.
Take care. Thank you.