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Goldman Sachs Annual Global Healthcare Conference

Jun 12, 2023

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Great. Good morning, everyone. Thanks for joining us. I'm Salveen Richter, Biotechnology Analyst at Goldman Sachs, and we're really pleased to have Gilead with us. We have Dan O'Day, Chairman and CEO, as well as Merdad Parsey, CMO. To start here, maybe we'll start with some big picture questions. Can you just give us a 30,000 foot view of where the company stands today and, you know, where the challenges have been, the accomplishments, and then how you think of kind of the forward from here?

Dan O'Day
Chairman and CEO, Gilead

Sure. First of all, Salveen, great to be here and with Merdad, and we're delighted to share some updates on Gilead. You know, at the 30,000 foot level, I think Merdad and I would say that we're really pleased with what's happened over the past four years. I mean, just to remind you what our objectives were, what some of the challenges we had four years ago, we had a, you know, a world-leading virology business. And we needed very much to strengthen that and to continue on that, but also add significant other pillars to our growth. I would say, from a transformation perspective, I'll let Merdad speak for himself, but I think we've really exceeded what we thought we could do in those four years.

A couple of things that I think I'm most impressed the team has done is, they haven't taken their eye off the ball on virology. As we think about our world leading position in virology and returning now to growth last year, excluding VEKLURY, we had an 8% growth last year. In the first quarter of this year, excluding VEKLURY, we had a 15% growth. That's driven, the first quarter of this year, 2/3 by virology and 1/3 by oncology, which roughly equates to what our goal and aspiration is of having 1/3 of our business in 2030 coming from oncology. That's off of now a sizable base. Last year, we had more than $2 billion in sales in our oncology business.

Just the beginning, I think, of our growth rate there, both coming from cell therapy and also from TRODELVY. You know, we're just at the beginning of unfolding what I think is a really powerful portfolio in oncology. We put a lot of capital to work over the past four years on novel assets, and today, I think we're really in the conversation space, if you like, in oncology. Coming off of ASCO, you know, we've got, you know, a leading TIGIT program, which I know we'll get into. We've got a leading, you know, next generation ADC in Trop-2 that's on the market today in breast cancer and in bladder cancer.

We have, you know, other novel mechanisms now that will unpack, including a world-leading cell therapy business as well, that is growing very nicely. At ASCO, we had two overall survival presentations, oral presentations, one with our ZUMA-7 trial in second-line large B-cell lymphoma. Really astounding data on overall survival, and bodes well for changing the paradigm from transplant in the second-line setting. We also had the other overall survival update on our hormone receptor-positive, HER2-negative TRODELVY data, which continues to show really great promise, and we're seeing that as well in our market data as well.

You know, just I know we'll get into other details, but I just couldn't be more impressed by what the team has done by keeping their eye on the ball on virology, building this world-leading oncology program, and also an early inflammation program. Now it's really about execution. It's about quarter-on-quarter execution, which we're focusing on last year and continuing into this year. I think we're just at the beginning, really, of a growth phase for Gilead.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Great. Merdad, did you want to add anything?

Merdad Parsey
CMO, Gilead

All I would add is, I think, one, I didn't think we'd be talking about competing with, you know, Roche and AZ and Merck in oncology four years ago. I think that's where we are, and I'm really looking forward. I think all this investment now we're going to start to see the data, and I think that's what I'm excited about.

Dan O'Day
Chairman and CEO, Gilead

Mm-hmm.

Merdad Parsey
CMO, Gilead

I'm a data junkie, but I think in particular, we have so many readouts coming up over the next couple of years. I'm really excited to be able to share that and turn over some cards.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

With regards to the HIV business, you've highlighted expectations for positive growth for the business, driven by BIKTARVY and long-acting assets. How should we think about the magnitude of the growth here, and where do you see the greatest risk?

Dan O'Day
Chairman and CEO, Gilead

Well, we're now seven quarters back into what we used to see before the pandemic in terms of growth rate of the HIV market overall. It's roughly 2%-3%. BIKTARVY continues to grow extraordinarily well, still, you know, room ahead of us in terms of market share. What I'm most excited about for patients living with HIV or people that could benefit from PrEP, is our long-acting program as we go into the second half of this decade. SUNLENCA or lenacapavir, a once every six-month subcutaneous injection, was launched in highly treatment-experienced patients at the end of last year in both the United States and in Europe.

We truly believe that this is the, potentially the best tool yet we've had in almost three decades that could end the epidemic for everyone, everywhere. The reason for that is, one pill once a day, standards with both BIKTARVY and DESCOVY for PrEP are doing well, but we know that patients living with HIV want options. On the treatment side, we have more than nine programs now as a partner for lenacapavir, and we think, that's really gonna, back to the growth question, provide us with both stability. By the way, I should say that we have really no patent expiries in our HIV business or throughout our business until the early 2030s because of some patent wins that we also had at the end of last year.

We think providing patients with options on long-acting, with a variety of programs that are now in the clinic, that Merdad is managing on the treatment side, will really help us not only maintain our leadership on the treatment side, but grow that over the course of the second half of the decade. What I'm potentially most excited about for the epidemic, and it relates to our growth, is the potential for lenacapavir for PrEP. I mean, today, in the developed world, only about one out of four people are actually on PrEP that could benefit from it, and we think a lot of that has to do with the burden of taking a daily pill. We believe we have two large trials now running in PrEP with lenacapavir as a single agent.

If you can change the paradigm to a once every six months subcutaneous injection, where people at risk or people who can benefit from PrEP literally go see their care provider once every six months, make sure they're HIV negative, get their next round of six-month protection, we believe that market is gonna more than double by the end of the decade on the PrEP side, and will be really important in both the developed world and developing world for ending the epidemic.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

For the long-acting treatment regimens here, the programs are all, you know, fairly early, but where's your key focus now? For PrEP, the phase III is on track for mid 2024. What are you focused on here when we finally see this data set?

Merdad Parsey
CMO, Gilead

Yeah. It's a great way to divide it up. I think, you know, really focusing on PrEP for a minute, it's the PURPOSE 1 and PURPOSE 2 trials, several thousand patients in each, those studies are going well. We're still in the enrollment phase for both trials, so I think the timing will be clearer as we get to completing enrollment. We do anticipate that, as you said, 2024, 2025, we'll be able to both share data and get our regulatory work done. I think that's going really well, and as Dan mentioned, I think that's where we see the power of lenacapavir really in the near term providing some options.

In parallel, we're working on the treatment side with lenacapavir as sort of the backbone to get us to long-acting therapies. Excuse me, as we showed at CROI, we're kicking that off with the bNAb combination, which really lets us get to every six-month treatment. You have lenacapavir plus the bNAbs lasting about six months. We've moved that into phase II, and that's moving ahead nicely. We think the real inflection will come with the small molecules coming forward. We have a number of assets in that in the treatment paradigm coming up. They're fairly early, as you said. The important thing in HIV is that, you know, from a mechanistic standpoint, we're not taking a lot of risk.

We know these molecules will work if you can get to a certain level, in by PK, basically. Between PK and tolerability, I think we'll understand much better what our candidates are. In the long-acting space, there's oral and parenteral. Oral, we're looking at weekly, if not monthly, dosing orally, and then parenterally, we're really looking at two, three months, potentially up to every six months. We have a number of candidates in all of those areas that we're working through. We'll know reasonably early on whether they have the PK, and importantly, whether they have the tolerability to move forward. We're really excited about those programs.

Dan O'Day
Chairman and CEO, Gilead

While we're early, of course, things move very fast.

Merdad Parsey
CMO, Gilead

Yeah.

Dan O'Day
Chairman and CEO, Gilead

In HIV drug development, which is, you know, it's light speed compared to.

Merdad Parsey
CMO, Gilead

Yeah.

Dan O'Day
Chairman and CEO, Gilead

Many other therapeutic areas.

Merdad Parsey
CMO, Gilead

Yeah.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Oncology, in that, in that vein, Daiichi is expected to share data from their phase III TROPION study, Lung01 study, and versus docetaxel, right, in second-line positive lung. What do you see as the read-through from here to non-small cell lung cancer?

Merdad Parsey
CMO, Gilead

Yeah, we have three studies ongoing, two phase IIIs. Our frontline phase II study, I'm gonna have to frontline phase II.

Dan O'Day
Chairman and CEO, Gilead

Quite a focus.

Merdad Parsey
CMO, Gilead

Our frontline, phase II study, we announced that we'll share some data, later this year, from that. That'll be our ability to show our, the performance of TRODELVY in second line lung, a comparable population.

Dan O'Day
Chairman and CEO, Gilead

First line.

Merdad Parsey
CMO, Gilead

In first line. And then our second line study, which is EVOKE-01, is slated to read out next year. That'll be a similar comparison to docetaxel in second line. And then our frontline phase III study is EVOKE-03, and that's the one we're that Merck is operationalizing, and that's going really well. They're enrolling that really, really well. We'll know more about timing once that's fully enrolled, but that's going really, really well. We're really confident with what we have, right? We've probably most important in all of that, is that we think we have best-in-class Trop-2 ADC. First of all, we're already in the market, right?

We have approvals in triple-negative, HR-positive, HER2-negative, the accelerated approval in bladder. The molecule, you know, from a medication standpoint, seems to be holding up very nicely. We have great efficacy, and our tolerability profile is really, you know, is showing familiarity with our practitioners, and they know how to deal with neutropenia and diarrhea, and that's working out well. We think in lung, it's very important. We have not seen ILD, which I think is gonna be a very positive differentiator for us in lung cancer. We're not seeing stomatitis, which the Merck drug that's it much earlier than ours showed about 50% stomatitis, and we don't see that either. We really think we have a best-in-class molecule.

Not only are we way ahead, we're we think we have a best-in-class molecule. Very excited about where we're going.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

When you look at the, at TRODELVY just more broadly, right? Where do you think, maybe you could just help us understand when you say best-in-class, and you look at these competitors out there, where exactly do you think you are kind of best-in-class, and how does that, you know, result in a certain, you know, sales, outlook here?

Merdad Parsey
CMO, Gilead

Yeah, I think, l ook, again, we're approved NCCN Category 1 recommendation for TRODELVY. I think that in breast, in particular, I think gives us a real advantage. In lung, you know, we think we're gonna get to comparable efficacy, but without the ILD, I think that's gonna be very important for us in the long run as we move forward. I think we're really excited about that opportunity. In bladder, assuming we get confirmatory data, you know, I think we've shown nice efficacy, and I think that'll be a good complement to the other therapies that are available. We saw data at ASCO of a combination of PADCEV and TRODELVY in bladder cancer that looked really interesting and exciting.

We showed endometrial data as well. Starting to, you know, our strategy has always been to go broad. We've really been ahead with breast and lung and bladder, you know, you're starting to see these other tumor types where we think we're gonna have efficacy, endometrial being the first of hopefully many, where we're gonna continue to show TRODELVY's potential over the long run.

Dan O'Day
Chairman and CEO, Gilead

The thing that I would add to Merdad's statement, in addition to going beyond breast and bladder and lung into other disease states, the opportunity, because of the profile of what Merdad mentioned for the medicine, to think about it in three drug combinations. Obviously, we're studying combination with PD-1 right now, our TIGIT program, which I know we'll get to, but there's a probability and possibility of bringing TRODELVY into a three-drug combination like a PD-1, TIGIT, TRODELVY. Importantly, because of the profile, bringing it up into earlier lines of therapy, which is obviously what we're looking at.

TRODELVY is really, I mean, just at the beginning, I think, the source of your question of its growth potential and its ability, and it's been largely de-risked because of the very large late-stage phase III programs that we've had. A profile such that bringing up to earlier lines of therapy, which provides even more benefit for patients and more growth opportunity for us, where we could really see that coming both alone and in multiple different combinations within our portfolio and outside of our portfolio.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

On the cell therapy business, as you mentioned earlier, I mean, it's been really nice to see how the autologous assets have performed and, you know, the move to earlier lines. How do you think about further investment here, not just on the autologous side, but also on the next generation, whether it's allogeneic or other approaches, or move into solid tumors? Like, how are you thinking of that, you know, the investment and then just the outlook here for cell therapy?

Dan O'Day
Chairman and CEO, Gilead

Why don't I start, and then Merdad can add? Look, you know, we are now today, clearly the world leading company in cell therapy. You know, I think we've been able to get to that position because of three main things. One is the profile of the process and the cell therapy CAR-Ts that we have. Secondly, the investment, to your point, in manufacturing and the continued investment in manufacturing, because at the end of the day, for cell therapy, where the process is the product, I mean, the ability to have available capacity, but also for that capacity to be a quick turnaround time, makes all the difference for some patients in terms of life and death.

The third component is really setting up the infrastructure needed commercially to get this done, validating the ATC centers. I mean, part of our big objective now is to make sure that we get community referrals, because at the end of the day, even with this extraordinary data that's potentially curative, out to now five years and beyond, in the third line setting and this great OS data in the second line setting, there's a fraction of patients that are being referred today. Really working that referral network is very important. We have a lot to do with what we have in our hands right now to continue to drive growth in cell therapy. To your point, I think, you know, several years ago, some people thought that autologous had a very short lifespan.

Well, it turns out that particularly with being able to reduce the cycle time down to we're really world leading now at 16 days turnaround time, vein to vein. That's seven days manufacturing, seven days of quality release, and two days of transporting either end. We want to bring that down even further. As that comes down, and we have this long survival data and curative potential, the difference between autologous and allogeneic becomes much, much more narrow. Having said that, of course, there's still 50% of patients that we're not getting an effect in, and of course, we want to be on the cutting edge of the next generation technology.

So, we have a variety of programs in our development program by [Systronics], applications that we think might be able to get to those other 50% of patients, CD19, CD20, that aren't responding today. We have collaborations with several companies, including our own house, on the allogeneic approach, you know, should it hit. By the way, also some collaborations on in vivo approaches. We wanna make sure that we're not only world leaders today, but on the next cutting edge of where the technology is gonna go and where the indications go for development. We're exploring it, you know, in areas, you know, obviously, outside of hematological agencies, and we'll see.

We still think the scientific bar is quite high there, if we think we are gonna be able to attack other diseases and things beyond hematological malignancies, it will be done with a broader kind of context in which our Gilead profile brings it. Thinking about, you know, mechanisms we might have within Gilead around the tumor microenvironment and others. That's more of a longer-term play, I think, as we think about CAR-T in other areas. Big investment in the here and now, big investment in kind of next generation CAR-T, thinking beyond just CAR-T into other mechanisms that could enable the immune system to respond more to cell therapies. Do you wanna?

Merdad Parsey
CMO, Gilead

No, I would just add, I think examples of the Kite team staying focused on what's coming are the Arcellx.

Dan O'Day
Chairman and CEO, Gilead

Oh, yeah.

Merdad Parsey
CMO, Gilead

Partnership we did in myeloma and the community partnership.

Dan O'Day
Chairman and CEO, Gilead

Yeah, good point.

Merdad Parsey
CMO, Gilead

On the armored CAR T. I think those are all examples of where, you know, the strategy has been to really stay close to everything and leverage our manufacturing and our know-how there, with the evolving landscape. I think you should look to us to continue to be at the leading edge there.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

You discussed the importance of investment in manufacturing, as you mentioned, but we've seen these bottlenecks that have been playing out for supply. How do you continue to invest there on your own side, but also maybe through partnerships with excessive capacity out there? We just saw J&J do a partnership with Novartis. How are you thinking about supply on the forward?

Dan O'Day
Chairman and CEO, Gilead

We're in a very different position. I mean, today, and we have no capacity constraints right now, and that's in a fast-growing market. That's because of decisions we made three years ago. We teed up, and, you know, it was at-risk monies at the time. We didn't know if second line would be successful, but we knew if second line was gonna be successful, it would be too late to invest at that stage. Obviously, with a bit of prudence in some stage gates, we now have manufacturing facilities at different stages of automation on the West Coast of the United States, East Coast, and in Europe, and we're also supplying Asia out of our West Coast facilities. I think we're in a good position today.

The other thing that we've done in advance of supply constraints is thought about bringing certain critical steps of the process in-house, such as viral vector manufacturing. We're almost at a stage now in our Oceanside facility, where in addition to what we source externally, we'll be doing that internally. I actually think that, yes, we work with partners, but at the end of the day, we're managing that capacity. Very importantly, as the cycle times come down, so as we're able to automate more steps, that has a direct impact upon releasing capacity within our systems. If you can turn a cell around in less than seven days, five days, that automatically gives you a 20% or whatever the number is, increase in capacity.

It's one of the reasons why, to Merdad's point, why the Arcellx deal, collaboration is really interesting to us because it allows us to take an area in multiple myeloma that today has massive shortages in terms of the number of patients that could be treated in the available capacity, and put that essentially into our platform and our system with, hopefully, what will be a, you know, as good or potentially better efficacy, platform. We'll see how that plays out in phase III on an established manufacturing network to allow more patients to benefit from the BCMA therapy moving forward. We'll continue to invest. I don't think there is a lot of, you know, CDMO kind of capacity out there for cell therapy.

We know we have to build it ourselves, you know, I think we're really in a very good position on the manufacturing side.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

TIGIT, you know, at ASCO, post the phase II ARC-7 data, we saw about a three-month drop in median PFS compared to the last interim update. I think you've reiterated your confidence in this program. Help us understand in that context, when you look of, you know, about the competitiveness versus anti-PD-1, and just, you know, overall, I think what we've been seeing in the competitive landscape for TIGIT, your continued confidence in this program? Help us understand, you know, why you're reiterating that?

Merdad Parsey
CMO, Gilead

Yeah, sure.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Yeah.

Merdad Parsey
CMO, Gilead

I think probably just starting on ARC-7, it's really important that, you know, the data set shared in December, we've said and continue to say, was early and immature. You're seeing the data mature, remembering that each arm is only about 50 people, right? This is a small trial that designed to show that domvanalimab adds activity. The PFS estimates are pretty unstable, if you think about it, right? One patient in out of 50 can really move your median a fair bit. So no concern from our standpoint that the median shifts around a little bit. It'll continue to shift around until we get to the final analysis.

No concerns there, because, again, the primary objective of this study is to show that we could add efficacy on top of a PD-1. I think we've shown that clearly at this point, which gives us the confidence on our phase III programs in terms of moving forward. I think we acknowledge that a lot of people are waiting for the Roche data to read out, the SKYSCRAPER data to read out. I don't know how that's gonna read out either. We believe in the biology, whether that study is designed and will show the results that we think it will show, whether it was powered, we'd have to wait and see what the data look like. We're confident we've moved into our phase III trials, and we're moving together aggressively.

A lot of discussion about zimberelimab, you know, for me, for us, PD-1s have shown over and over again that they behave very similarly across the board. There's really no reason to believe that a new PD-1 would behave differently. Indeed, when we look across either real world data in the non-small cell standpoint or even, in cervical data, for example, where we show an ORR that's better than KEYTRUDA, we are very confident in the activity of, zimberelimab. The ability for us to move quickly with zimberelimab, to stay out ahead and to really not lose any time is critical.

We recognize that, one of the advantages we hope to provide is that, the practitioners don't have to choose zimberelimab monotherapy is not something we're going to be, you know, advancing per se, as a revenue generator. Our goal is to really prioritize and be really aggressive with our TIGIT antibody. Our hope is that we can provide people the choice of whether it's durva from PACIFIC-8 or the zim-pembro arms in ARC-10. We wanna make sure we are informing folks about what zim can do, but really give them the choice of a PD-1 inhibitor that they can use in combination with TIGIT. We're really excited, and I think the thing that Dan mentioned, again, the differentiating thing for us is that it's an Fc- null variant, unlike the competition. From a safety standpoint, we're already seeing that play out.

Our hope is that potentially we could see benefit on the efficacy standpoint if we, if the hypothesis plays out, that clearing TIGIT containing cells, effector T-cells, that an Fc intact antibody would do, that by sparing those, we think with dom, we might even see a benefit in efficacy. That's gonna take a while to be able to play out. Certainly, from a safety standpoint, we're really confident that we are showing better safety. For all those reasons, we're really continue to be very bullish on TIGIT and moving forward very aggressively. Last thing I'll say is the AE profile is really giving us confidence that this is something that can be combined more broadly. We really aren't bringing a lot of adverse events to the table with domvanalimab.

Whether that's combining with TRODELVY or other agents, from an IO standpoint, we think there's an ability to increase response rates for patients in a way that doesn't bring a lot of tolerability issues with it.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

With regard to the Roche TIGIT trial, how are you thinking about the impact to your programs if Roche is successful versus if they're not successful?

Merdad Parsey
CMO, Gilead

Well, I think if they're successful, of course, I think it supports what we've seen, what our own data show, and what their data had shown in, CITYSCAPE. I think that's. They're clearly a competitor, we think, you know, and I think it will support the field around the importance of TIGIT. If they don't succeed, it really depends on why. Were they underpowered? Was the study design flawed? I don't know, right, until we see the data. We'll certainly look at that very closely. We have the ability to adapt. If there's something in their data that suggests that we should increase our sample size or something like that, we'll of course, look at those data and decide. It really depends on why they fail.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Great.

Merdad Parsey
CMO, Gilead

If they fail, which I don't think they will.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Perfect. Capital allocation. You've noted you can be selective about M&A. Given the deals you've done over the past several years, when you look at your portfolio and where it stands today, how are you thinking about business development and, you know, M&A in particular? Could you just sketch out, if you are interested, what a potential deal would look like? Is there a size or a, you know, therapeutic area you're most focused on?

Dan O'Day
Chairman and CEO, Gilead

Yeah, sure. You know, again, I'm really impressed by what the team has done. When I think of M&A, I think of acquisitions, but equally, I think of partnerships and licensing arrangements we've had. I think as we've thought about, I mean, first of all, you know, we've put more than $35 billion of capital to work over the past four years in different types of structures and constructs. We're now at a stage where we've more than doubled our, close to doubled our portfolio, but more importantly than the number, we've got really a richness of assets and targets and combinations that give us a risk reward for our portfolio that's drastically different than it was four years ago. It's very late stage rich right now.

You know, we've got 22 phase III trials. We're gonna start another one later this year, 23 phase III trials, which for a company our size is with the top in the industry. We'll now get into a bit more of a, you know, phase IIIs rolling off and new phase IIIs starting as we go into the next. Merdad leads at the company, has a lot of pressure on it within the company. What that means is there's lots of NPV positive projects that are coming to his committee that don't quite cut it. We're clearly putting a lot of focus into long-acting HIV and TRODELVY, [lena], Spectra programs, and then TIGIT and others. It's a very robust, competitive atmosphere now in our portfolio, which I think is important.

Which means that our capital allocation needs to continue to feed that portfolio. Where we have a gap in our organization is probably more late research, early development now, because of all the work we've done in the late stage. Again, the therapeutic areas, we'll stay true to our strategy, which is, you know, virology, oncology, and inflammation. Those will be the three therapeutic areas. You'll see us doing a lot of partnerships and acquisitions supporting that late research, early development. Of course, we'll look at late-stage assets, but we feel we have what we need in-house on a risk-adjusted basis to drive that top-tier growth. We always want to supplement, and we want to make sure we're into the, into a normal, a rhythm and routine and cadence of adding things also from the outside.

I think, you know, you're gonna see both on acquisitions, research, early development focused, and an occasional look at late stage that we think can complement our assets and our portfolio, either alone or in combination, in oncology, virology, or inflammation. In virology, it's less likely that we come across things, so most of it will probably be on oncology or early-stage inflammation. Just a note on inflammation, you know, we really want to be novel in inflammation. We're looking at new targets, new areas, potential combinability products, both within our own research, which has come up with some interesting approaches, but also externally.

I think inflammation is something that's kind of the next leg of the stool that plays out as we go into the 2030s, whereas virology and oncology, you know, leads us between here and the end of the decade commercially, I would say.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Great. Any questions from the audience? Could we get a microphone? Thank you.

Speaker 4

You talked about offering flexibility with your TIGIT asset in terms of which PD-1 to use. I mean, is that a straightforward thing? I mean, you're not going to have to add an arm of, like, KEYTRUDA to ARC-10 or anything like that. You could just show benefit, and then you think doctors and regulators be comfortable with.

Merdad Parsey
CMO, Gilead

I think it's going to be part of a whole, right? There, there won't be any single, you know, thing. We're putting it together to build a broad story, right? Again, the PACIFIC-8 study with durva gives us some data with durva. We'll have data with zimberelimab, and we have that pembro arm. Pembro and zim arm in ARC-10 that, you know, people can look at pembro and zim essentially in the same population in a randomized trial, as opposed to trying to do these cross-trial comparisons. Those things around building the confidence around the comparability of zim, are gonna be our focus to make sure everybody's comfortable.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

One.

Speaker 5

Obviously, the data that was presented at ASCO from the ZUMA trial was really intriguing. Just when you're thinking about bringing these CAR T therapies into earlier lines, you know, there's been a lot of progress there. What do you think remains in terms of educating physicians to begin to utilize it for their patients?

Merdad Parsey
CMO, Gilead

Great question. I think, you know, the ZUMA-7 data that really opened up second line, what happened is a lot of third line patients started getting treated based on that. Now moving into second line, a lot of this is around changing practice and people becoming more comfortable and confident in terms of referring patients to get treated and potentially with these long-term outcomes that look so great. Capacity not being an issue, I believe the longer run is gonna be around really getting people more and more comfortable. There's a lot of work to be done in second line still. There's just a huge need there and a real opportunity to continue to refer patients into the second line.

As that builds up, people will continue to move forward. It's important that I think in the front line, you know, R-CHOP is really effective, and I think it's gonna be really difficult to compete there. For second line and beyond, I think it's wide open.

Dan O'Day
Chairman and CEO, Gilead

There's a subset in patients in the first line.

Merdad Parsey
CMO, Gilead

Yeah.

Dan O'Day
Chairman and CEO, Gilead

Who can't have R-CHOP, I think that's where.

Merdad Parsey
CMO, Gilead

That's where they're going.

Dan O'Day
Chairman and CEO, Gilead

Trials going. I really think, I mean, and I was in the room. I think the fact that the 27% reduction in risk of death with a 57% crossover, because ethically, you had to crossover, will be a really strong, compelling way to. To Merdad's point, I mean, really now working with community oncology to give them the confidence that they can refer patients and get them back for the longer term. You know, I think that's a practice shift we have to change, and we're working with community oncology organizations that have connections into these ATCs in a way that we've never been able to have these conversations before because of the strength of the data.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Maybe one last question. Your inflammation portfolio, if there's an asset or more that you want to highlight, you know, where should we focus?

Merdad Parsey
CMO, Gilead

Alpha-4 beta-7, our oral program, I think is moving forward nicely. We're excited about that. I think beyond that, the rest of the portfolio is earlier, but we're really focusing on novel mechanisms, as Dan said. Part of our hope, especially like with the MiroBio acquisition, is that we can leverage what we've learned on stimulating the immune system in oncology, looking at PD-1 agonists, for example, on the inflammation side, really changing the course of the disease. I think as those start to mature, we'll learn a lot more, and we're excited about that.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Great. Well, thank you very much.

Merdad Parsey
CMO, Gilead

Thank you.

Salveen Richter
Biotechnology Analyst, Goldman Sachs

Appreciate it, Dan, Merdad. Thank you.

Dan O'Day
Chairman and CEO, Gilead

Thanks for having us, Salveen. Appreciate it.

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