Gilead at TD Cowen Conference: Strategic Moves in HIV and Oncology

On Tuesday, 04 March 2025, Gilead Sciences Inc (NASDAQ: GILD) presented at the TD Cowen 45th Annual Healthcare Conference. The company outlined its strategic plans for 2025, focusing on both opportunities and challenges. Despite facing financial headwinds, Gilead aims to leverage its leadership in HIV treatment and expand its oncology and liver businesses.

Key Takeaways

• Gilead anticipates flat product sales growth in 2025, impacted by the Part D redesign and foreign exchange rates.
• The launch of Lenacapavir for HIV prevention is a key focus, with significant market expansion plans.
• Gilead is strengthening its oncology portfolio, particularly in cell therapy.
• The company aims to address unmet needs in HIV treatment with new, longer-acting options.

Financial Results

• 2024 Growth: Gilead reported approximately 8% year-over-year growth.
• 2025 Guidance: The company expects roughly flat product sales growth, about -0.5%, excluding the impact of the Part D redesign and foreign exchange.
• Part D Redesign Impact: Anticipated to cost Gilead $1.1 billion, with $900 million affecting the HIV business.
• FX Impact: Unfavorable exchange rates are expected to reduce revenue by $250 million.
• Growth Potential: Without the impacts of Part D redesign and FX, growth could be around 5% to 6%.

Operational Updates

• Lenacapavir (HIV Prevention): The PDUFA date is set for June 19, with plans to achieve 75% coverage within six months and 90% within a year.
• Pricing: Lenacapavir will be priced within the current PrEP market range of $24,000 to $26,000 annually.
• LibDelzi (PBC): Launched in August, generating $31 million in revenue, surpassing expectations.
• Cell Therapy (Oncology): Efforts are underway to expand access to cell therapy in community hospitals.

Future Outlook

• HIV Prevention: Gilead is targeting an expansion of the PrEP market to over one million consumers by the mid-2030s.
• HIV Treatment: Development of weekly oral and quarterly/twice-yearly injectable options is ongoing.
• Market Expansion: Strategies are in place to reach Black and Latino men and women through targeted geo-mapping and ethnographic research.
• Cell Therapy: Focus on FACT accreditation to enhance accessibility in community hospitals.

Q&A Highlights

• Lenacapavir Launch: Expected to ramp up gradually, rather than achieving immediate success.
• Market Expansion: Emphasis on reaching underserved populations through strategic initiatives.
• Cell Therapy: Gilead is working to separate cell therapy accreditation from transplant accreditation.

Readers are encouraged to refer to the full transcript for more detailed insights into Gilead’s strategic direction and plans.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Wonderful. Well, good morning, everyone. Tyler Van Buren here, Senior Biotech Analyst at TD Cowan. Welcome again to day two of TD Cowan’s forty fifth Annual Healthcare Conference for next session. Very excited to have a fireside chat with Gilead.

It’s one of the few stocks that has been massively outperforming this horrible market in biotech. And it’s my sincere pleasure to introduce Joanna Mercier, Chief Commercial Officer of Gilead. Joanna, it’s a privilege to have you here. Thank you very much for being here.

Joanna Mercier, Chief Commercial Officer, Gilead: Thanks for having me. Thanks and good morning everyone.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: So, before I get started for those in the audience, if you have any questions throughout the discussion, feel free to go ahead and raise your hand and we’ll do our best to get them asked. But, I want to start with a general question. Gilead’s twenty twenty five guidance as provided during the recent earnings update. Could you just elaborate on some of the assumptions behind the minus I think it’s 0.5% or roughly flat year over year product sales growth excluding Macquarie at the midpoint and how you expect this to evolve over the next few years and potentially translate to earnings growth?

Joanna Mercier, Chief Commercial Officer, Gilead: Yes, sure. So basically, we had a very strong 2024. We grew at about 8% year on year, and that growth was even accelerated as you think about how we kind of closed out last year. As we we believe that as we go into 2025, that demand led volume growth continues to play out and that will continue to drive through Biktarvy, Descovy, our oncology portfolio and, of course, our liver business into 2025. Unfortunately, there’s a couple of headwinds in 2025 that will mask that demand led volume growth, such as the Part D redesign, and that’s valued at about $1,100,000,000 for Gilead.

Most of that is HIV. About $900,000,000 of that is HIV. And then, of course, the FX is impacting everyone. And for us, that’s worth about $250,000,000 So if you were to exclude that, our growth would have been looking more like 5% to 6% in 2025. So that’s really a one year reset because of the Part D redesign.

And as you go into 2026, obviously, then you should see that come through because as it continues to drive, as we grow our HIV business, as we are still in launch mode with Lubdelzi, for example, LEN for PrEP launching mid year with PDUFA date on June 19 and of course building out in 2026 with InedoCell. So a lot more growth to come and that should get pulled through as we go into 2026 as well.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: That’s great. Thanks for that. So very exciting year for the HIV business for Gilead. Several pipeline updates to look forward to, but first, of course, regarding Lonicapavir prevention, naturally upcoming PDUFA on June ’19, a little sooner than expected. Can you just talk about how your conversations with the FDA have gone and what your expectations are for the early stages of the launch?

Joanna Mercier, Chief Commercial Officer, Gilead: Yeah, sure. So June 19 is very much in line with our expectation. It was in within the range of what we were thinking we would get PDUFA as we submitted on December 19. So we got priority review with the FDA. We don’t really discuss, obviously, the interactions that we have with the FDA.

What I can tell you is that, basically, thus far, our interactions are moving exactly in line with our expectations, and we’re confident with our timing for June 19 PDUFA. And we’re incredibly excited about the opportunity to bring something like lenacapavir for prevention to the marketplace. And we obviously have big plans for lanycapavir. We think this is a real unmet need. It’s transformational in nature, and it’s an opportunity to truly redefine the prep market.

Right? The prep market today is about just north of 400,000 consumers today. We believe that that number should probably be well over a million by mid-30s. That’s not going to happen by chance. That’s really with very clear strategies around market expansion, but also with something like LENACAPFRE with the right profile to offer people to really match up with how they currently see physicians today.

They go every six months or so to get tested, HIV, STI. And, obviously, many people today, 95% of the market is on daily oral and a real opportunity to move that to a longer acting. And that’s what the market research clearly states, that there’s an opportunity here. And we’ve had a lot of learnings from past launches, and we’re ready for the launch for June to make sure we can really make a difference and have a really seamless consumer experience. And when I say, I should say customer experience because it’s really both the consumer and the provider and making sure that every time there’s an opportunity for somebody to get PrEP that they get lecapavir, and that’s the intent of our launch.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: So as we think about, the label and just as your sales force communicates to physicians, what are you looking forward to seeing in the label? What are the key points of differentiation? I mean, obviously, 100% prevention, every six month injection is probably all you need. It’s a

Joanna Mercier, Chief Commercial Officer, Gilead: good claim.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: But is there anything else we should be paying attention to?

Joanna Mercier, Chief Commercial Officer, Gilead: Yes. I think that from a label standpoint, we have the PROPUS one data that you just referred to as well as the PROPUS two data. This is the most most diversified clinical trial program in prevention that’s ever been done before. PRPS one is obviously young women, adolescents, and young women. We also have a lot of data for lactating women, pregnant women that just occurred in that setting.

We also have purpose two, which is men having sex with men, transgender, as well as, there’s been, you know, just reported drug use. So we also have information there. So our label should be actually pretty broad as we think about what purpose one and purpose two offers. And I do think it, it’ll be a good message. But I I would also say the science is really important, but I would layer on top of that, the launch of Lenacapavir, you almost have to think a little differently on this one.

Right? It’s not just your typical scientific pharma launch. I think you need to think about it to to a little bit more broadly and almost think a little bit more like vaccines, OTC like, to get to that broader population. At launch, our intent is really to focus on current prescribers of PrEP. And generally speaking, those are the same ones that are prescribing Biktarvy every day.

Right? Those are our HIV treaters but eighty percent of the time. And then, of course, the current consumers of PrEP. Either you’ve been in PrEP in the past, you are thinking about getting on PrEP. Those are the kind of communities that we’re going to target at launch, and then we’re going to build.

That is something that’s going to happen in parallel. I don’t think you’re going to see the benefits of that market expansion day one. I think it’ll be over time. It will be, but very specifically targeted to, for example, Black Latino men, women. These are populations where HIV incidence is much greater in certain areas of The US that just haven’t been exposed to PrEP.

And there’s a real opportunity here to empower them to own their own sexual health. So I think that’s one piece of the puzzle. At the same time, obviously, our number one priority is gonna be access. We need to we know that in PrEP, it’s generally about eighty twenty, 80 commercial, 20% government channels. Government channels should be pretty simple as access to prevention is actually very clear.

From a commercial standpoint, it’s gonna be a build. It’ll be a ramp. And as you think about, you know, coverage, we’re thinking about 75% or so of covered lives by six months, about 90% or so by twelve months. This is quite typical of a launch kind of strategy for access, but it’s also very representative of what we see with Descovy today. So Descovy in prep today has about over 80% unrestricted access in prevention, and we’re kind of leveraging that model as we think about what’s to happen with Lenacapavir.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: That’s very helpful color. What can you say about pricing?

Joanna Mercier, Chief Commercial Officer, Gilead: Not much. What I can say is we haven’t landed on a price to date, but think about it this way. We know that we have to price it within the prep market. So if you think about the prep market today, the branded market is anywhere between $24,000 20 6 thousand dollars annually. And so the intent is to price it within that market range and obviously making and being very clear around the value that Lenacapavir offers that transformational value that needs to be, also represented.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: On Descovy, what’s the latest on compliance? Do you have any numbers there in terms of how how many patients are compliant and whether you’re actually capturing that 24,000, 20 six thousand per year?

Joanna Mercier, Chief Commercial Officer, Gilead: That’s a great point. For Descovy, for any daily oral, I should say, when we look at claims data, adherence is anywhere between 55%. There’s a reason for that. You have a real range of how Descovy is prescribed and how it’s how it’s actually used. You have some people that actually use it daily every single day throughout the whole year.

You have other people that are actually prescribed it on demand, which means you’re four days on, three days off, four days on, three days off, etcetera. And you have some people that is not necessarily the way it’s prescribed, but just states the way they use it, where they use it on their own demand. And so it’s a little bit more along the lines of I you know, my social calendar looks a little heavier here. I’m gonna use it during this week. I might not use it for the next two weeks and then start up again.

And that’s why you get to a number of average about fifty fifty five. As you think about something that is a subcu every six months, you know, you get one injection, you have a % adherence for six months. We believe, I’m not suggesting that would be the same annually. We do think there might be some drop off, but it’s north of 80% pretty easily when you think about it twice going have to go into the office twice a year, which is your regular timing anyway for, generally speaking, this population because they do get tested on a regular basis either every three or six months for HIV and STIs.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: It’s very helpful.

Joanna Mercier, Chief Commercial Officer, Gilead: So real advantage.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Yep. Right?

Joanna Mercier, Chief Commercial Officer, Gilead: And that’s why you see something like one hundred percent efficacy.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Yep. And I want to get to the a follow-up on the building part in a second, but conversion of the existing customers. Just I got to imagine a large percentage of Descovy patients are going to transition to Lenacapavir. How do you think about potentially converting generic Truvada patients?

Joanna Mercier, Chief Commercial Officer, Gilead: So we don’t really separate the two. We believe that there is a real opportunity to think about the market in right today. It’s 95% of the market today is daily orals, 5% is long acting injectable. We believe that somebody who’s on a long acting injectable is already quite open to maybe moving to something every six months instead of every two months. As we think about the largest market opportunity, however, it’s 95% of the daily orals.

And and that’s an opportunity we do believe from the market research, it’s clear that people want long actings. This is not they’re not sick. They’re not patients. They wanna protect themselves, of course. But it’s really tough to even today take a pill every day when you have, hypertension or cholesterol, let alone when you don’t have the disease.

And so about eighty percent or so in the market research has been very clear that longer acting is better in prevention, a little different than in treatment. A little mix is different. And so we do believe we have a real opportunity, both Descovy, currently current consumers, but also Truvada. And if you think about the shares, generics right now are at about 50% share and Descovy is north of forty, forty, 40 five percent share or so. And so, and and that’s been I think the generics are a little bit historical.

Generally speaking, in HIV as well as in prep, you’re really going towards innovation. And that’s what we’ve seen thus far with the switch over to Descovy in the last couple of years. So we think both are real opportunity for us. Okay.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: And a follow-up on expansion. So if Descovy is maybe $1,000,000,000 1 point 5 billion dollars in prep and it’s 40 something percent share with Truvada, fifty percent, I guess you could say if it’s fully branded market, it’s like a $2,500,000,000 3 billion dollars market. Are you guys saying how much longer you think that could be in the next five to ten years with something like lenacapavir? What multiple you’d put on it? Or what other factors other than other patient groups will expand that?

Joanna Mercier, Chief Commercial Officer, Gilead: Yes. So maybe just going back to your market definition, I think you’re right about kind of if you think about 95% daily market, if you were to make it a branded, a total branded market, you’re probably about a $3,000,000,000 kind of market opportunity. And then just think about your adherence, right? If you’re going from maybe 50%, fifty five % adherence to maybe something 80% plus adherence, that’s another 20%, thirty % play. So I think that’s an opportunity.

The market’s been growing in prep. We closed out Q4 of last year at about 16% growth in prevention. And if people are tracking it, that’s been a growth over time. If you think about earlier last year, it’s probably lower double digit and kind of growing into ’sixteen. That doesn’t happen by chance.

That happens with very clear market expansion strategies and tactics. And when we saw the PROSCE one and PROSCE two data at the same time as everybody else, we doubled down on, all the work that we were doing from a market expansion because that only helps us prepare for the launch of lenacapavir, but it also supports Descovy today. So it made a lot of sense for us to do that. And I think that explains a lot of the momentum that we’re seeing right now as we go into 2025 in the prep market. So so as we think about that, I think that should continue.

I think we’re getting a lot of energy and momentum with Purpose one and Purpose two. Anecdotally, people are asking for it. People are talking about it at the provider level as well. I think there’s a lot of excitement. We need to build on that momentum.

And I do think that market growth should continue. So I think it’s current consumer base inclusive of naive people in the community coming on and then kind of building from there.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Okay. One more follow-up because it’s such a hot topic. But as we think about the launch trajectory, obviously converting from discovery early on, you’ll see that. But as we think about like comparing it to something like Biktarvy, Biktarvy was converting a much bigger franchise, right? So you’re going to have like this initial conversion and then you’re going to have this market expansion phase, which is not going to be quite Not

Joanna Mercier, Chief Commercial Officer, Gilead: going to happen at the same time, right? I think two things you need to think about at launch. It’s going to be a ramp. It’s not going to happen overnight like a Biktarvy like. I think the similarities between a Biktarvy launch and a Lenacapavir launch is really best in class kind of opportunities, right?

The differentiation of Biktarvy in the HIV treatment realm, where today it is the standard of care with over fifty percent share, I would think the same way for lenacapavir for prevention, that kind of an opportunity in prep. That’s the similarity. The differences, however, at launch, are also on the ramp because you have a couple of things you need to think about. Obviously, the differentiation is clear, but we still need to get the message out. That’s similar.

You then have access that we talked about a little bit before, right? It’s not going to happen overnight. It doesn’t go from zero to 75, but it’s going to take a little while for us to build out and build access in the commercial realm. We’ve talked about 75% at six months, ninety percent at twelve months. So that’s a ramp.

The second piece of the puzzle is you’re also moving a daily oral market to a sub Q market. And so from an administration standpoint, you need to think of what do you need to make sure we overcome. And so we’re setting up for that. And what I mean by that is most of these HIV, especially that first phase, right, the current consumers, current prescribers, they’ve never really had a sub queue or a long a buy and bill kind of model in the past. And and so that’s why we need to provide optionality.

There’s a lot of learnings here from past launches that didn’t necessarily go the way people were expecting. And I think one of the key learnings there is we have the right profile of drug to match up with physician visits. That’s great. That helps enormously from a capacity standpoint in those clinics. But the second piece of the puzzle is making sure we offer optionality so that a physician can get it.

Right? If you put pen to paper and make a decision to give Lenacapavir, you wanna make sure that your your person in front of me, that consumer gets Lenacapavir, that patient gets Lenacapavir. And the way to do that is making sure we obviously offer lent, buy and bill. They can do that if they want, but there are very few clinics that currently do buy and bill today across The US. So, therefore, we need to make sure there’s an offering of specialty pharmacy.

So we’ve been working with different specialty pharmacies to set up, making sure they have the right capabilities to work through this, and making sure that physician writes a script, the script goes to the specialty pharmacy, the specialty pharmacy does all the background work without anybody seeing it around reimbursement and whatnot. And especially the first couple of months, they will be prior auths that have to be worked through, then making sure they coordinate back with the physician’s office, making sure they understand when the patient’s coming back in, send the product. The physician administers, Lenacapavir, and we’re done. We don’t see you again in six months. And so that’s kinda how we’re suggesting it’s gonna play out.

Probably out of 80% of that administration is going to happen through specialty pharmacy, especially at the beginning. And then buy and bill will build over time, especially with volume. That’s how buy and bill becomes more interesting for providers. But we don’t think that’s going to be in the first couple of years. So that’s just the current kind of play.

And then to your second point of your question, more about market expansion. Market expansion has to do with making sure we go to populations we haven’t had a chance yet to include with prevention. And and currently today in that 400,000 plus or so, about seventy percent or so are white men having sex with men. When you look at HIV incidence in The US and where it is and the the people that are more at risk, it’s actually Black Latino men, as well as women. And so there’s an opportunity for us to really think about where those people are and go where they are.

I think what we’ve done in the past is we’ve gone to those physician bases, those prescribers that currently prescribe treatment, but they don’t go to those offices. So we need to go where they are. So we’re thinking through a little differently, and that’s why it’s gonna take a little bit more time. We’re gonna start it at the same time as the launch, but we’re gonna build over time. And that’s why I would think more that’s more the one year, two year, three year out kind of play as we build through that.

The way we’re thinking about it is also more, targeted. So we’ve done a lot of work around geo mapping in The US to find out where these people are. Right? That’s number one. Then do ethnographic research to understand where do they go.

Do they go see a physician? If so, who? Well, let’s target that physician, which is a little bit turning a launch on its head. Right? Generally speaking, when you do a launch, and I’m gonna use the LibDelsey launch, for example, you launch PBC, You target everybody who prescribes currently PBC, and you make sure that you’re in front of them messaging the differentiated profile that LibDelzi has to offer.

We’re doing it differently for the market expansion. We’re going to go where the consumers are, which is a little different than we’ve done before in the past because we believe that’s the better approach. We’ve tried it the other way. We have to go more targeted. And so that means understanding where they go externally, what’s their digital footprint, making sure we educate and make them aware with that digital social media footprint, so that we build that awareness and get them into the offices where they can go or leverage telehealth if they don’t want to go.

There’s a lot of stigma here, a lot of privacy needs. And so telehealth is also going to be a big play here as well. Okay.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: That’s great color. Thank you very much. Staying in HIV, but moving to treatment, you guys have a lot of studies ongoing daily, weekly, monthly orals, quarterly, twice yearly injectables. You’ve got the Phase two WONDERS trial reading out in the first half with weekly and monthly orals.

Joanna Mercier, Chief Commercial Officer, Gilead: Yeah.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: We’ve got Artistry in the second half, with Bickelen. So where are you guys are you guys starting to prioritize at all amongst all these? Or what’s the current focus? How are you thinking about adding these to your current portfolio?

Joanna Mercier, Chief Commercial Officer, Gilead: Yeah. They all have a bit of a different strategy, but the strategy, the overarching strategy is we believe, and the shares demonstrate this, but we believe we’re leaders today in HIV treatment and we believe we’re leaders, in HIV prevention. Our development of our pipeline and the scientists behind it are really thinking through kind of the unmet medical need as we move forward. In treatment, when you’ve kind of hit the standard of care with Biktarvy, the unmet need now is the longer actings. And as we’ve, you know, basically tried to better understand that need, it’s a little bit of a mix.

There’s some people that want a longer acting in oral. There’s some people that want the injectable. We want to make sure that not only are we leaders today, but that we will remain leaders tomorrow. And so some of that has to do with timing of launches, etcetera. So you’ve touched on a couple, right?

You think about the oral weeklies. We have a couple going on right now. The first one would be in the switch population with the lenislatravir combination with our Merck partnership. That’ll be first to market in the oral weekly setting, so a real nice opportunity for the switch market population. After that, we have a fully owned Gilead weekly oral as well that you mentioned that is with an integrase inhibitor as well as the prodrug of lenacapavir.

That will be both for switch and naive patient population. So different strategy there, right, as you think about what we’re planning for that launch versus the first oral weekly. So both are important. And as you think about penetrating the oral longer acting market and then as you think about some of those injectable, Q3 monthly, Q6, all of those, we believe we have about seven treatment options coming through prior to Biktarvy’s LOE in late two thousand and thirty three. And so some of it are strategies to make sure we think about our lifecycle plan, the innovation that we’re bringing to market.

And but the overarching is the leadership position we have today and making sure we remain leaders tomorrow.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Fair enough. And you mentioned LibDelzi, so I’m going to go straight to that. You guys did that acquisition last year. I would say people have been pretty conservative I think on the launch despite the fact that you have incredible strategic and synergistic overlap. You only needed four months to launch the product.

But curious to hear the latest on that launch and why you have confidence that it could be large enough to contribute to Gilead’s P and L, which is fairly large.

Joanna Mercier, Chief Commercial Officer, Gilead: Yes. So take us back to the Simba Bay acquisition. When we were looking at this one, it made so much strategic sense, right, across our portfolio. It’s not only leveraging the liver footprint that we have, the liver specialists that we currently see in network with, but it also is building something in inflammation that we’ve been you know, we obviously have an earlier pipeline here. And so it was just a perfect fit for us.

About 80% of the prescribers or so in PBC are prescribers we were already visiting for Hep C, Hep B, in some markets in Europe for Hep D as well. And so just you couldn’t ask for a better kind of strategic fit. We also think about Libelzi as a very differentiated profile for PBC. It is a drug that has a differentiated efficacy profile but also a safety profile. It’s not just about the biochemical response, the ALP normalization.

It’s also about reducing pruritus, which is quite differentiated. And, of course, the safety profile is also very differentiated versus current competitors in the marketplace. And so we’re still in launch mode. We only launched last August. I think we reported just about, you know, dollars 31,000,000 in revenues.

This exceeded our internal expectations and I think external ones as well. So we’re off to a very strong start. We’re seeing that differentiation come through. We’ve already surpassed our closest competitors, although we launched a little bit later. And so we’re well poised to continue that and build on that momentum.

And of course, as you can appreciate any launch, a little bit of an access play, especially in rare diseases, and we’re working through that. And despite all of that, even coming through with a really strong Q4. We think there’s more opportunity here. We think there’s more opportunity not only in second line. Patients come in on a not almost annually, so it’s not like everybody comes into the first six months.

So we still think there’s a lot of opportunity for our launch. And as we think about our development program for Libelzy, we’re also thinking about partial responders. What does that look like from anywhere from ALP one one to one six seven? How do you potentially double your addressable patient population? So that’s also a Phase three program that’s ongoing right now.

So that’s how we see that opportunity. And I just want to take one more step back as we think about our therapeutic areas, right? You think about virology or HIV, I should say. You think about oncology, and then you think about our liver slash inflammation franchise. We have three growing franchises in high single digit to low double digit growth percentages in 2024 coming into 2025.

And that’s why we feel with that with the launches, Libdelci, L4P as well as AnitoCell that we haven’t touched on yet in 2026, we feel incredibly well positioned to continue the growth story that we’ve had with Gilead of late.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Three minutes for oncology. So we’re going to touch on Anida Cell. So obviously, the data at ASH for Anida Cell looked great. CR rates that were similar better than what’s been observed with CARVICTI, but no delayed neurotox or Parkinsonism. Hopefully that continues this year as we see subsequent updates mid year and by year end we’ll be comparing the datasets directly.

But maybe you could talk broadly about the cell therapy franchise. It’s experienced some headwinds with your existing commercial products. Could that reverse as we head into the AnitoCell launch in 2026? And what’s your outlook for the AnitoCell launch coming next year?

Joanna Mercier, Chief Commercial Officer, Gilead: Okay. So maybe let’s start with cell therapy today and then we’ll build as we think about AnitoCell. When we think about some of those headwinds, there have been some in class competition, out of class competition, for both Yaskarta and Tacardis. And that is something that Cindy at the, you know, leading the KITE team has been very focused on in making sure that we we are understanding what’s going on, but also understanding where the opportunity lies. And and one of the biggest challenge, and you’ve heard us say this before, is most of the oncology lymphoma patients actually sit in the community.

Close to eighty percent of them are in the community. So for them to get referred into an academic center or an authorized treatment center, it’s there’s big steps there. And that’s been a little bit challenging. So if they’re not going to come to the academic centers, let’s make sure we go to them. And so that’s what Cindy and the team have been working through with, making sure that community hospitals can actually do cell therapy.

And so the first step to that last year was really trying to get FACT accreditation. That FACT accreditation, is really based on transplant, from historically. And so that’s been a little bit more challenging than I originally assumed. And now we’re really trying to separate those two pieces to say, well, let’s get accreditation for cell therapy. And now it’s not just Gilead doing it.

Right? There’s other industry partners on board with that strategy. We need to make sure that if today only two out of ten people, patients are getting offered cell therapy, eight are not. And so there’s a huge market opportunity to grow the class here and make sure that there’s a potential for cure for these patients. And so that’s really what Cindy and the team with other stakeholders, including Koa, including other industry partners, is really trying to make sure we get community hospitals being eligible to be able to treat with cell therapy and obviously trained for it as well so that we can move the class.

And if we can move the class, then all the boats rise. Right? So that’s kind of the first play. And if we do that for cell therapy in lymphoma, then that that leads us as we think about Inuitocell incredibly well. The Inuitocell profile, as you mentioned, is very well differentiated.

You know, you talked about similar efficacy to to the current competitor. I would say, you know, potentially, it has the potential for even to look better because it’s later lines of therapy today in a really good safety profile. We are planning to give an update towards the end of this year in second half, for 2025, and obviously, we’re planning for a launch in 2026 and later lines. We’ve already started with our first patient late last year in the earlier line setting with IMAGINE three trials starting already. And so we’re kind of building that out because we really believe that with the profile of the needle cell, safety for sure, as you’ve just talked with the neurotoxicities that we have not seen yet.

And then as you think about, the the future with the manufacturing opportunity that we have, you know, our turnaround time and our reliability are second to none in the industry and still to this day in holding. And so and that’s the same plan as when you think about UnitoCell. Right? Turning it around vein to vein, maybe fifteen to sixteen days and a reliability that’s over 90% just like it is today with lymphoma.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Wonderful. We’re out of time.

Joanna Mercier, Chief Commercial Officer, Gilead: Look at that.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: So we didn’t get to TRODELVY, but it’s going to continue growing, right?

Joanna Mercier, Chief Commercial Officer, Gilead: Yeah. TRODELVY growing at twenty four percent last year. Standard of care for triple negative breast cancer still growing HR positive and really growing outside of The US as well.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Yeah. And a couple of frontline readouts this year. But maybe to wrap up, I would like to ask you, Joanna, what do you believe is the most underappreciated aspect of the Gilead story by investors right now? And I know that’s probably not a fair question given how well your stock’s doing in this environment.

Joanna Mercier, Chief Commercial Officer, Gilead: Yeah. I I I think that I think in general, people are getting the story of Gilead right now where you have growth across all of your therapeutic areas, how we have a diversified pipeline, how we have a couple of launches that are really exciting launches that are differentiated, and then our operational discipline around OpEx and how we’re making sure that we’re leveraging not just the top line growth but also leveraging the bottom line. Our cash flows are good. They’re very healthy. So I think we’re really well positioned to make sure we create shareholder value and patient value.

Tyler Van Buren, Senior Biotech Analyst, TD Cowan: Wonderful. Joanna, thank you very much for your time.

Joanna Mercier, Chief Commercial Officer, Gilead: Thanks, Tyler. Appreciate it. Thank you, everyone.

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