right? ACR.
Yeah, ACR is different than it used to be.
Exactly.
Totally.
Thank you very much. I want to get started on the next session. Michael Yee, Managing Director and Senior Biotechnology Analyst at Jefferies. I'm very happy to have with us here at Gilead Sciences, Johanna Mercier, the Chief Commercial Officer, and I thought that would be quite perfect timing because we're coming away from ASCO. We were just talking about flying from Chicago over here to New York, and a lot of developments going on in oncology for Gilead, as well as, obviously, I want to spend half of this talking about the developments in HIV and all the long-acting developments, which I think is getting a lot more news because some of your competitors are talking about long-acting as well, and I think that's underappreciated.
Maybe just in the first half of our discussion, we have come away from ASCO, and Gilead is obviously knee-deep in breast cancer with TRODELVY, and you had some developments there, as well as in your analyst briefing at ASCO. It was actually a whole slide deck about lung cancer. Could you just talk to the audience about how Gilead sees the commercial future in breast cancer and lung cancer in TRODELVY?
Sure. Thanks, Michael. Hi, everyone. Great to be here. Yeah, as ASCO just kind of ended, it's a great opportunity to talk about where we are with our oncology program. We've come a long way. If you think back less than three years ago, we didn't really have an oncology pipeline or franchise, very energized coming out of ASCO to truly be competitors at the table in many different ways because of the different targets that we have playing out. Specifically to your question, in breast, we launched in second-line metastatic TNBC and are now the standard of care in that setting, which is pretty incredible. We've shown incredible OS data for these women in this line of setting, which is a very aggressive disease.
We also just launched in the U.S. in February, in HR-positive, HER2-negative, and also showing overall survival, so now overall survival data in two breast cancer indications. We also have accelerator approval in bladder in the U.S. We're waiting for confirmatory data in phase III trial to launch not only to continue the launch in the U.S., but also launch ex-U.S. for approvals there. Of course, the lung cancer data that we can talk a little bit more about that we're waiting very excitedly for. A lot going on. I think the HR-positive launch has also been very successful. This is building on the TNBC launch. I have to say that the TNBC launch, this was our first foray into oncology, into breast cancer.
We learned a lot, and we had a couple of bumps in the road, there's no doubt. We feel now that we've really kind of solidify our position, both from a capacity, capability, skill set standpoint, and very excited and energized to see the team come together and cross-functionally and really make a difference for these women in breast cancer. We've seen a really nice uptake in HR-positive since the launch, but actually even before then, right? As we presented OS data at ESMO last fall, we. NCCN Category 1 recommendation in both indications, that's really kind of helped us play out. It's very different when you already have a drug on the market and starting to get experience there, to be able to then just continue that through into another indication, specifically in the community, but obviously being both in breast, that helps as well.
Let's talk about breast cancer. You are obviously approved in triple-negative. Now you just got a label in HR-positive, and over the last six or 12 months, Wall Street was concerned that ENHERTU data a year ago, you know, and assuming they got the label at this point in low HER2, that was going to be a very competitive and compelling offering. Can you talk about what you've been seeing and your confidence about your launch in HR-positive in the face of an HER2 competition?
Sure. First, I would say that the fact that we have OS data in both indications has played out really well for us.
Right.
Number one. Number two is, if you remember, right, within HER2, DESTINY-Breast04 is earlier lines of therapy in HR-positive, HER2-negative versus TROPiCS-02, later lines of therapy. We are obviously studying it to see how do we move forward and up lines of therapy. At this point in time, in that setting, we are definitely seeing good use in that third-line setting, fourth-line setting, and we're seeing in HER2 use a little bit earlier than that.
Like, people looked at them like, "Oh, that's relapse refractory," or, you know.
Yeah.
-later line breast cancer. You're later line breast cancer. Oh, my gosh, that's more compelling. Do you feel like the market is, you know, "Hey, we are getting more third and later line. Don't worry, and HER2 is getting used, but it may or may not be earlier than you," so it's not a direct one-for-one competition?
That's the way I'm looking at it, to be totally honest with you. I also think, you know, just the fact that there are a couple of ADCs in this market really making a difference for these patients is pretty incredible, and so I think we each have a role to play.
Sure.
I think the biggest conversation we're hearing, specifically in HR-positive, HER2-negative, is really sequencing of ADCs. Can you do HER2 to TRODELVY and TRODELVY to HER2? What we've seen so far is a lot of physicians are very open to that, and I think it's a couple of things. Number one is ADCs aren't all the same, right? Specifically HER2 and TRODELVY, these are different targets, number one. Number two is you're also thinking about the payloads, the linkers, et cetera, and the antibodies, all of those pieces are coming into play, therefore, the real-world data that's gonna come through on this is gonna be interesting. Just one point to make specifically to competitive dynamics.
Right
in this space. In TNBC, we are still the only ones that have shown OS in this second-line setting, despite the fact that in HER2 got a bit of a broader label. TRODELVY still differentiates itself, not only because it can be used regardless of IHC status, but also because it's showing very clear overall survival in over 500 patients in these clinical trials. Thus far, TRODELVY's been used in over 20,000 patients around the world. We have really strong data to support not only the efficacy, but also the safety profile and how it's manageable.
Before I shift to lung cancer, I would just ask, you know, how is Gilead feeling about the overall competitive landscape in breast cancer, also from Trop-2? I mean, I guess we're awaiting some data from Merck, as well as the fact that Astra will have some breast cancer later this year. Without getting into too much of the details of those, presumably.
Yeah
could be positive. How do you feel or how are you positioning Gilead, given that, you know, Daiichi data of DXd could have HR-positive breast cancer later this year?
Yeah. I think the fact that there's a couple of Trop-2 ADCs in the marketplace or will be in the marketplace potentially, I think is exciting for Trop-2 ADCs and the difference they can make. I think the one thing I will also say is that not all ADCs are the same. Again, in the Trop-2 setting, we've already seen that, right? We're seeing the safety profiles, the tox profiles of some of these ADCs as being quite different.
Yeah.
I think that's gonna be differentiation, let alone the fact that we're on the market today.
Yeah
Making a difference and getting experience with physicians and with patients, and I think that's gonna make the difference. The safety profile is something with TRODELVY, with neutropenia and diarrhea being the most common side effects, are both manageable side effects that are actually very much in line with how physicians manage chemotherapy side effects.
Yeah.
I think that's something that, what we're seeing physicians and what we're hearing from physicians is they can manage that because they know how to.
Right. Right.
I think if you have ADCs that come into the market with a different profile and potentially ILD on the profile or stomatitis on the profile, I think that's a different profile.
Yeah, yeah.
You've got to think about the risk-benefit-.
Yeah
- profile for these patients.
Now, let me briefly hit on lung cancer. Obviously, this is in development, not commercialized yet. Gilead just had a one-hour presentation on where you guys are going in lung cancer, including with Trop-2 first-line data called EVOKE-02 data coming in the third quarter.
Yeah.
Wall Street should get a look at Trop-2 in lung cancer in first line.
First line.
with KEYTRUDA next quarter. How confident are you that you can be a player in lung cancer? We're still waiting for data of DXd any day now, but that you can be competitive there as well as with TIGIT.
Okay.
Talk about those two things, those are your things, and we'll move on from there.
We're very excited about what's to come, right? We've already shown that TRODELVY can be leveraged across tumors, whether it's breast and bladder. We're looking forward to the lung data, and obviously, everything's, you know, compelled by the science. Having said that, the EVOKE-02 is in a first-line setting. It's a phase II trial. We just finalized patient recruitment, that's exciting for us as we think about potentially presenting it at a Congress in Q3. We also have two phase IIIs, right, that are ongoing.
Yep.
That data we should see within the next 12 months or so. Both in second-line setting and non-small cell, as well as first line. The fact that there is data from a competitive standpoint, I think all boats rise, right? I think there's an opportunity to truly displace chemotherapies. You think about a patient that's in second-line non-small cell lung cancer at this point, all they have to go to now is chemotherapy. There's nothing else. The chemotherapy survival rates are very low. There's a real opportunity to come out and make a difference for these patients. Again, I do think TRODELVY, in its manageable safety profile, is gonna be an interesting differentiator as we think about competition.
When you think about competition in lung, specifically, two things to remember. One is ILD and stomatitis is very different than diarrhea and neutropenia. You know, many lung cancer patients already have ILD or are prone to ILD, let alone if you add a PD-1. If you're gonna add another compound, because we're going towards doublets and triplets.
Yeah
I think that's where TRODELVY can really differentiate itself.
Yeah
Because you know exactly what you're getting and when.
One of the interesting things, again, for the audience to take away from lung cancer is, again, A, first- line is a big market. Much bigger market. There's different dynamics there.
Agreed.
There's also different subgroups, PD-1 positive, PD-1 all- comer.
Yeah.
You are adding on to PD-1 with EVOKE-02 in a first-line setting. That data's in the third quarter. Others, including yourself, are running first-line studies with PD-1 and in combinations with chemo. I won't go into the details of... With chemo combo added on to that or replacing the chemo-
Replacing -
with Trop-2-
Yeah
could be huge. those are, that's a big opportunity and probably not well reflected for.
I totally agree.
for your Trop-2 at this point, so.
I think the idea is the opportunity, I should say, and the vision is to replace chemotherapies-
Yeah, yeah.
in the frontline settings, and not just in lung cancer, but broader.
This is why I think this data in the third quarter is new and underappreciated from this whole ASCO thing, is that, you know, the first early sets of that data we're getting in the third quarter in first line.
I think that's gonna be critical.
Yep, yeah.
Because I think it, you can have read-throughs not only to first-line data in phase III.
Yep
- but also read-throughs to our second line as well.
Exactly. Okay.
Yeah.
Let's talk about HIV.
Sure.
Through all of this, all year long, you know, everyone's talking about oncology, but yet your BIKTARVY numbers crushed the first quarter. And you've had great numbers there. Obviously, you have a long-acting strategy over the next year. Think the phase III PrEP capsid data
Yeah.
is next year, that could totally expand the PrEP market. Talk about maybe the two or three things you think you're excited about in HIV that, you know, maybe we're not appreciating.
Sure, happy to. I think one is the first thing you said, Michael, around, you know, where we are today in the HIV growth and w hat we've done with BIKTARVY as really setting it as a standard of care around the world. You know, as you think about in the U.S. market as well as in Europe, we've grown about three points market share in the last year. This is growing to a 46% market share in the U.S. market . 3% on a very strong base. That really has to do with the differentiated profile that it offers HIV patients. That would be one thing that we will continue.
Swapping, is that taking more share?
I think it's-
New patient growth?
All of the above.
Just all of that.
All of the above.
Okay.
I think that what we're seeing is obviously, it is the first treatment of choice in the naive patient population, so it's getting most of the naive, probably six out of 10, easy.
Six out of 10 easy?
Mm-hmm.
Yeah.
From a switch market, obviously, if you've started on the product, it's harder to switch to the same product, right? We're still seeing about a 40% share in the switch market as well from older legacy products.
Okay.
coming in. BIKTARVY is definitely one of those in the daily oral market. If you think about treatment only, and then we'll get to prevention, to your question.
Yeah.
If you think about treatment, the future is in the long-actings. There's a real opportunity to go from daily oral to longer-acting. There are some first-generation long-actings in the market today, and I think that's the first stepping stone. I do think there's a real opportunity to come to either, you know, Q-weekly orals every couple of months, subQs, and we think lenacapavir is the foundational agent for that. The reason we believe that is because lenacapavir's flexibility is just so incredible, right? You can use it daily oral, you can go up to every six months subQ.
That's why we think in the treatment setting, the market will probably split out about 50/50 by the end of this decade between daily orals, so BIKTARVY will still have a very important role to play, and looking at a variability of the long-acting, whether it's a weekly long-acting or a couple of months.
For me, you think by the end of this decade, this is a bigger number. Usually, I was thinking like people or Gilead, 30% of the market could be amenable to a long-acting. What I think Gilead has been sort of saying is that because we're going to make the long-acting more compelling. P ossibly more than just once-a-month injection, possibly once every three or six, but tell me?
That's right.
Actually, the bNAbs are once every six.
Six.
Like, that's way more compelling, and that's why more of the market could be a long-acting than people are even appreciating. It's not a month, we're talking once every three, or once every six months in a subQ.
Yeah.
It's an IV, but it's fine.
So just-
It's subQ.
The bNAbs are IV.
Okay.
Lenacapavir is a subQ, or oral, or IM. You can really leverage it across the board, depending on what you're partnering with-
Okay
... with it. The only other thing I would say is, when we do the market research and with the patient population, generally speaking, over 50%-60% want something every 2 months in a subQ formulation.
50%-60% want something.
So-
Long-acting.
I think it's the right kind of profile and the simplicity of it. It adds privacy to the treatment for some.
Okay.
Just remember, not everybody likes an injection, and so that's where the daily oral is important as well. We're playing out both, and making sure we can address patient needs, and that's in the treatment market.
What are the options, like in the top 2 or 3 options, when would we get that data?
Yeah, so-
One of those is bNAbs.
Yeah. One of those is bNAbs, which we've just shown data in phase one.
Once every 6-month infusion is what we're talking about here?
Mm-hmm. Yeah.
Yep.
Again, bNAbs is not the ideal, right? Because it's still only 50%.
Yep
the population potentially.
Okay.
It's infusing the patients. I still think there's opportunity.
Yep.
It's proof of concept.
There's a proportion of people who would do that.
Totally.
Yeah.
There's an opportunity for us to continue, and we have about eight, actually, with the bNAbs, 10, but eight other programs that are looking at other partners, so integrase inhibitors, et cetera, to look at different combination-.
Yes
including with a Merck collaboration with islatravir.
You have a long-acting [integrase].
Yeah.
I'll call it a long-acting -
In the very early phase I.
Yeah
-trials.
In a phase I?
Yeah. just remember-
Once a month?
We are looking at a couple of months, actually.
Once every few months, right.
Yeah. We're looking at Q-weekly.
Yeah
Then a couple of months.
Yeah.
Just remember, in virology, it's different than oncology, right?
Right.
Oncology, you can get all the way up to phase III, you don't know still if you have a drug or not.
We're still debating, you know.
Right
... what these Trop-2 are going to show.
Well, exactly.
Right. Yeah.
Versus in virology, once you get your 1B data, you're pretty clear you have a drug or you don't.
Right.
That's where we're trying to move as quickly as possible, and I know this is not... Clearly, commercial had nothing to do with the name of this. At Gilead, what we've decided to do, we were very clear that we were running every single option, and so that's why we have eight different programs in addition to the bNAbs. We have a project called [SPEED]. I know, not original. The whole concept is we're not going to do this the same way we've done it all the time. We want to make sure we get SPEED to patients, and how we do that is basically making sure we're not working through different approval processes to get to phase IA to B to II. I t's really, it's a continuous and everything in parallel. We're doing this very differently than other programs.
The bNAbs and the long-acting bictegravir, you've got this SPEED program behind it. You're definitely internally at Gilead, really trying to push that.
Long-acting lenacapavir.
Long, long-acting lenacapavir.
Yeah.
Yeah. Working on it. Okay.
Yeah, absolutely.
Talk about I think literally in 12 months, you're going to have a phase III -
Yeah
- capsid PrEP. once every six-month injection.
Yeah, we're assuming approval, if all goes well, right, and positive data, we're assuming approval in the HIV prevention market for lenacapavir subcutaneously every six months in the 2025 timeframe approval.
Okay.
You're right on the data.
The date is next year?
Yeah.
Yeah.
We're super excited about that. We think this could be transformational. The reason for that really has to do with the fact that if you think about Truvada generic now, but DESCOVY as well, we've only captured about 25% of the CDC market definition of HIV preventable disease in the U.S.
For the audience, what is DESCOVY doing right now in PrEP s ales?
Sales, I wanna say just about $1 billion.
$1 billion. $1 billion right now with branded DESCOVY once every day.
Yep
PrEP pill.
PrEP pill.
You think that's only doing 25% of the potential market?
I think there's two opportunities.
Okay.
One is, yes, I think we have an opportunity to double the market.
Okay.
These aren't patients, right? These are people that are at risk of HIV, so they don't wanna necessarily take a pill every day. I mean, it's tough enough to take five days of antibiotics, these are really people that don't wanna be reminded. A subQ every six months matches up perfectly with physician visits. These are people that go to the physician's office for STD testing on a regular basis, it matches up perfectly and would be an opportunity for us to really be transforming the HIV prevention market in the future, not only in the U.S., but hopefully much beyond that. The idea is a global launch to really make a difference for these communities. More to come on that, but we think we can more than double the market, let alone the definition of the market we think is wrong.
You probably could. Just simple market research. You have it once every six months. Well, hopefully there wouldn't be any cannibalization of the 1 billion of the daily DESCOVY pills.
I, yeah-
There's a lot of people who don't wanna do daily pills. What percent of those people, the other 75%, you know...
Yeah, we think the market.
would do once every six months?
We think the market will split probably 70/30. 70 long-acting, well, 30 oral.
Okay.
Think about it, the oral market today, DESCOVY itself, I mean, we have a lot of data to support this.
Yeah.
It's not something that's used 365 days a year.
Yeah.
They just don't, because of what I was just explaining earlier, what happens is they almost do it on demand, which is not ideal. From a compliance standpoint, let alone a market transformation, you're looking at definitely a huge opportunity in the prevention market.
Right
to really make a difference.
Actually, some of the market research we looked at, actually, if you go look at your DESCOVY numbers, yeah, there's a compliance factor, too, right? Like, the point is, oh, you think that these people are taking daily pills for prevention, but in many cases, the compliance, I think I heard Gilead said, might be more like 80%.
It's much lower than HIV treatment compliance.
Sure, yeah.
Just because... depending on the country as well, some countries are doing some really interesting things, like a weekend DESCOVY. Not something I would support, but the data doesn't support it either, but that's definitely being done, and so it's really kind of matching up their DESCOVY with their lifestyle.
Is there any plausibility that PrEP can be reimbursed, paid for, expanded beyond just sort of really the U.S.? You mentioned some other countries, but they're probably smaller commercial-
Yeah, we've been working on this already.
Yeah.
I think there's a huge opportunity to market shape, a little bit, and so we've had conversations in countries like Japan, Italy, France.
Yep
... and the U.K., and we think those are probably the markets where we can first have inroads outside of the U.S. I'm not telling you it's gonna be easy. Our current projections actually only include the U.S. because we believe that, you know, we're being.
The infrastructure, the reimbursement-
It's all set up.
the policy is here for it.
Huge opportunity in the U.S., but we actually do think that certain other markets are very open, and I've had conversations with health ministers from these countries, where I think we can make a real difference, and I think they could own it. And honestly, you have to think about low-income markets as well. We can't just do it in the first world countries. We have to go beyond that. Our position is lenacapavir for PrEP would be something that we are thinking as a global launch, not just a U.S. launch.
You would think the particular long-acting, too, in some of these underserved countries.
Absolutely. Well, that's the point, yeah.
They're not, the compliance is gonna be low.
They can get Truvada generic today.
Right, they can get Truvada generic.
That's not the issue. The issue is actually how do you make sure compliance is there for these countries?
Is PrEP getting used outside the U.S., but it's just with the generic? I'm thinking that's actually the problem.
There's a mix of issues. One is stigma.
Okay
to this day. In Europe, Truvada generic is now approved across all the different markets, it's pennies a day.
Yeah.
And, uh-
there's reasonable.
There is in the markets that I was referring to.
Okay. All right
... specifically.
Let's, unless I'm missing something, I wanna obviously hit on CAR- T, which is billions of dollars now, right?
Yeah.
For YESCARTA in second line, one of the things the biotech market's been now chasing is the post-CD19 market. You're asking me...
Interesting, right?
What is the kind of the interesting things, and there's some IPOs and stuff that people are looking at post-CD19 is how YESCARTA has sort of moved upstream and now going to do more than $2 billion. Talk about the developments there. How is that shaping up? You did, obviously, a myeloma BCMA deal as well-
That's right .
... you know, with Arcellx. What do you predict over the next couple of years for your CAR T business? It's not just CD19, it's also BCMA.
BCMA.
Okay.
Well, let's start with YESCARTA. At ASCO this year, we just presented our second- line OS data, so nobody's shown overall survival data in this LBCL setting for the last 30 years. We're very excited about the fact that we're moving up lines of therapy and making a difference. As soon as we got the second- line indication, prior to the OS data, we already saw kind of moving up into third- line. It had impact not only in second, but also in third, right? Giving more confidence to physicians.
Yeah
-to move it up lines of therapy. I think the OS data is just another, you know, another element to add to the confidence of using it earlier versus later. At, you know, at Kite, it's been very clear since the beginning that despite the fact that everybody thought it was science fiction, we believed we could win, and we decided to play to win. That had a lot to do with some decisions we took around manufacturing, capacity, et cetera. The reason I mention this is not only does that make us today, and I believe for tomorrow as well, leaders in cell therapy for LBCL, but it also makes us incredible partners, and that's where the Arcellx deal comes in as well.
Right. now you're able to add the myeloma-
Exactly
-business on top of your infrastructure.
Yeah.
I don't get too details, like.
Yeah, that's right.
... it's gonna be at the same factory.
Yeah
You're basically preparing to launch BCMA over the next couple of years.
We have that expertise, right?
Yeah.
I think the BCMA market, I mean, the data that was presented is also, you know, is also very promising. We believe with the Arcellx, with the manufacturing capacity, with our commercial excellence-
Yeah
that's been established in the marketplace, we have a real opportunity to help these patients as well. The market is large enough for, to have more than one player.
Two players.
Yeah.
Yeah.
Absolutely.
They're moving upstream. CARVYKTI is moving-
Yeah
Upstream. You know, yes, at least over the next few years, there'll be a second option.
Yeah
For you as well out there.
Exactly.
That's also another opportunity. I think the Arcellx deal, the pivotal study has started or is starting.
Yeah.
Gilead is basically gonna run that.
Right.
That's also another late-stage program. With that, we're out of time, thank you very much.
Thank you.
for talking about all of those opportunities. Appreciate it, and we'll continue to track the progress. Thank you.
Thanks, Michael. We're super excited about where we're going.
Thank you.
More to come.