A n overview of where the business stands today, including your core infectious disease and oncology franchises, key priorities, and how you're thinking about the forward strategy for the company.
Yeah, thank you, Salveen, and delighted to have this chance to communicate with all of you, along with Johanna. Look, I think we are definitely making continued progress on our transformation journey that we started about five years ago. It's an arc of you know of many years. And even as we navigate some of the recent Trodelvy phase III readouts, that I know we'll speak about in lung cancer and bladder cancer, we are making steady progress relative to sustainable and diversify our business over time. I mean, I would just point to you know the most recent quarterly call, where our commercial front is very strong and our virology business continues to be our cornerstone.
Our clinical portfolio is larger than ever, better equipped than ever to withstand different types of readouts in the portfolio. And importantly, and I think this is important, we have no major patent expiries until Biktarvy LOE in 2033. Maybe just a little bit more on that, Salveen. On the commercial front and, you know, Johanna's team and Cindy's team are just really doing a strong job. Our quarter one base business grew 6% year-on-year, excluding Veklury. That's 9 consecutive quarters of year-on-year growth. Biktarvy continues to be the gold standard in HIV treatment. It's up 10% with 49% market share. Our oncology sales, importantly, are exceeding $3 billion now in an annualized rate. That's more than 13% of our overall revenue.
And importantly, you know, we've treated more than 50,000 patients across that portfolio, including being the world-leading company with Kite and cell therapy. Maybe just to talk a little bit about the clinical front. You know, our diverse pipeline now has 54 clinical programs, 16 of those are in phase III. Maybe just a couple of highlights from what's happened even since the quarter. Most recently, we added inflammation with the acquisition of the CymaBay and seladelpar, with the PDUFA date coming up in August. We're very enthusiastic about that being, you know, our first kind of, you know, major inflammation medicine and also in the sweet spot of our liver customer interactions. In HIV, we've got nine lenacapavir combinations for long-acting treatments and five trials in PrEP.
That's one of the things we'll focus on for the second half of the year. One of the first of those trials will be reading out. In oncology, we continue to learn more about the totality of our portfolio, including Trodelvy. We have earlier line, you know, programs in tumor types where we believe there might be even greater effects from what we've seen in later lines in triple-negative breast cancer and, and hormone receptor-positive, breast cancer, but also the signals we've seen in second-line lung, and in later-line bladder. So we have programs in first-line metastatic triple-negative breast cancer, chemo-naive, HR+ or HER2-negative, and first-line non-small cell lung cancer as well. And our Arcus partnership expands modalities in lung cancer and in gastric cancer.
And then finally, in cell therapy, we continue to make important headway with a curative class of therapies, both in large B-cell lymphoma and also importantly for our partnership with Arcellx in multiple myeloma, including, you know, when we announced recently the phase III design for that compound. And we'll also give an update on the iMMagine-1 study, the later lines of therapy in the second half of this year. So we've got a lot going on, and we will continue to evolve the company, learn from different readouts, but really, I believe we're in a very strong position relative to our overall transformation that we started many years ago.
Great. Let's, let's start with one of your core franchises, HIV. You've guided to about 4% growth in 2024 and no growth in 2025, recognizing the impact of Part D redesign. Could you walk us through the key assumptions underlying this guidance, and where do you see potential upside to downside risk? And if you could provide any color beyond that too, that would be helpful.
Sure. Maybe I'll take that one. So thanks, Salveen. Basically, before we jump into 2025, it's, I think, important to talk a little bit about commercial performance for HIV thus far, and if you think about the last couple of years, we've been growing at mid-single-digit growth, and that's in line with the guidance that we've given in 2024 as well, that you referred to about the 4% or so. As you think about what's driving that, it's really a couple of things. Number one, the market obviously sustainable in HIV treatment, double-digit growth in HIV prevention, and then of course, as Dan mentioned, you know, Biktarvy continuing to grow at 10 points year on year, but also growing share and about 3% or so year on year on a very large base. So that's really the drivers of that growth.
As you think about the Part D redesign in 2025, that obviously will have an impact mostly on our HIV business because of the Part D molecules that we have there, not just Biktarvy, but of course, all the legacy molecules as well. That impacts about 20% or so of our U.S. HIV business, and the way we're looking at it is that the growth that we would have seen normally with HIV is gonna be offset by that Part D redesign, and it's like a stepping stone after that to growth in 2026. If you look at our overall total revenue in 2025, we still expect to see growth.
That'll be driven by lenacapavir, potentially, as we think about a launch as early as late 2025, so that's around the corner, as well as seladelpar with a PDUFA date of this August. That'll, that'll really truly drive growth in 2025 as well. And of course, our oncology portfolio with Trodelvy and Yescarta really pulling that through. So that's what we're thinking about in 2025. So it's a little bit of a bump, and as we think about our overall, like the next five years through to 2030, we do believe that it's still a positive CAGR for HIV, despite these IRA bumps, mainly the 2025 and potentially 2028, in light of the Part D renegotiation. And that we believe is probably the earliest that Biktarvy could be set up for that negotiation process.
So those are the pieces that we're looking at within our HIV business, with a very strong portfolio in our HIV pipeline to support it and to support that renewed growth, right? As we think about it, both in prevention as well as in treatment.
Let's dig a little bit deeper into this long-acting portfolio. So you will have long-acting PrEP, which represents the key growth driver for the HIV business in the second half of the decade. How do you view this upcoming Phase III readout by year-end? And could you sketch your strategy to expand the market beyond current PrEP users? And how difficult will it be to then grow this market beyond improved adherence and duration of use? And maybe just to add to that, how you think about then the overall growth for long-acting PrEP in 2026 and beyond, assuming some cannibalization of Descovy sales.
Okay, so a lot of pieces in there. So let me, let me try to break it down, and if I miss anything, Dan.
Sure.
Please jump in. Basically, if you think about our trials, we have five trials, two of which are really critical from a regulatory standpoint for filing, which is PURPOSE 1 and PURPOSE 2 . These are trials with lenacapavir twice-yearly injection. You asked about de-risk, how de-risk they are. A couple of things. One is lenacapavir through Sunlenca is already approved in the marketplace today for heavily treatment-experienced, very small patient population, high in medical need, but currently approved by the FDA in a twice-yearly form. So that would be one piece of the puzzle. So we know that this molecule is safe and effective.
The piece that I would also say for the PURPOSE 1 and 2 trials is the way the trials are designed. They're designed with a counterfactual background, and I'm not going to go into great details, but it basically is lenacapavir versus the background of HIV incidence as well as as well as in the secondary endpoint, looking at lenacapavir versus Truvada. And either one of those actually are really important for us. So you could either win on the primary endpoint or the secondary, or both, and that's the agreement that we have with the FDA today, just because that counterfactual design is so different than what we've done in the past, and we felt that was the best way forward and most ethical way forward, right? We can't do a prevention trial and with placebo at this point in time.
So it was really important to us to make sure that all populations were safe through these trials and make sure that we set ourselves up for success. So we feel that we are incredibly well-positioned with both PURPOSE 1 and 2. We need both to file. One, we expect as within the second half of 2024, and then PURPOSE 2 , either late 2024, early 2025, and that's why we assume a launch in Q4 of next year. As you talk about your strategy, and kind of what we're thinking about the market today, where we're going and the expansion of it, I think it's really important to understand where the market is today and where we believe it can be. And today, the CDC defines the market for prevention at about 1.2 million people.
The estimate is actually congruent with their definition of what that looks like. Their definition is anybody who's sexually active, more than one sexual partner, anybody who's been tested for an STD, should be having discussions around prevention. So if you think about just the STD market in itself, last year alone in the U.S., there were 13 million prescriptions, not testing, diagnosis of STDs in the U.S. Now, I'm not suggesting that the market is 13 million per se, but I do believe it's a lot larger than 1.2. In the market that's been defined today by the CDC, we've only penetrated about 1/3 of that market, and that's because, think about it, these are not patients.
These are individuals, that are potentially at risk for HIV, and so taking a pill every single day is not the easiest thing to do. And so we believe lenacapavir twice-yearly injection is transformational in this marketplace. And that's not because of what we think, it's actually what the communities think. It's the research that's been done in these communities to truly understand the needs and the wants, and this is really answering that need. And so that's why we believe it's so transformational. We don't think all of this happens overnight, right? We think that, as much as a third of that penetration is today, most of that is Descovy or Truvada generics. We believe that actually that market can grow up to 50%-60% penetration with something like lenacapavir twice yearly in the market.
The way we're going to do that is a step approach. Obviously, today, the use of prevention, HIV PrEP, is mainly used in men having sex with men, white MSM, commercial marketplace. We believe there's a lot more people that have a right to PrEP and need PrEP, and that really is the Latino, Black communities, with. That's where you're seeing high levels of HIV incidence. [audio distortion] Populations in different ways. So we have to think a little differently than maybe what we've done in the past with Descovy. And we do believe that'll be a step approach. So low-hanging fruit is the people that are currently on once-daily pills today, and then kind of building that out to other communities that would really benefit from prevention.
So that's kind of the play with an impact that we believe with lenacapavir that can be really, truly, transformational. The growth of this market, you've seen it every time there's a new entrant. Every time Descovy came into the marketplace or the twice-monthly came into the marketplace, a competitor of ours, we were looking at growth in 20%-30% range. We believe that will happen again, if not more exponential than that, with something like lenacapavir. So that's kind of the plan as to how we're going to approach it, and that's basically, it's going to take a little time. It's not going to happen all but we do believe between 2025 and 2030, we can really reach these communities that truly deserve PrEP.
Beyond phase III PrEP data by year-end, what do you view as the key value-driving, long-acting updates on the treatment side in 2024 and 2025?
Sure. We have a lot going on right now, as you can appreciate. So obviously, PrEP being the most transformational from a prevention standpoint. But we've also shown just recently, in the first half of 2024 at CROI, we've shown some great data with bNAb and lenacapavir, and that would be twice-yearly treatment for HIV. That would be the first to market, as we believe today. These are infusions, so a little bit different, and I'll be honest with you, I was the first to kind of push back a little bit. Did we really think that HIV patients would want these infusions? And as talking with investigators, talking with KOLs, they were lining up for these clinical trials because a lot of patients in HIV do not want to be reminded that they have HIV.
So we think this is actually going to be a really important play. We also had data at CROI showing our oral weeklies. We have two combinations there. One, lenacapavir with islatravir, with our Merck collaboration, and then following that one, a lenacapavir integrase inhibitor combination, which also is going to be once weekly. And then last but not least, we also have a once-daily combination of bictegravir and lenacapavir for virologically [audio distortion] PrEP and treatment experience to optimize patients' regimen there. That data shown, let alone data coming in the second half, that is pretty exciting as well. That's looking at monthly, Q3 monthly, and Q6 monthly. Sorry, I didn't mean to.
No, sorry. Reshifting over to the oncology vertical, you've reiterated the goal of 1/3 of revenue coming from the oncology business by 2030. How confident are you in this target, including in the context of potentially solid HIV growth, if the long-acting strategy is successful, and what assets need to play out in the portfolio for you to achieve this?
I'll take that one, and Johanna, feel free to add. But, I think that, you're right in your question to point out that the stronger we do in HIV, because it's a revenue goal, it's 1/3 of our revenue, you know, the more ambitious our oncology plans have to be. I think that's good for a company our size to have those types of ambitions, and we do believe, you know, we have a lot to do in HIV still. I mean, back to Johanna's point about redefining the PrEP market, I'll just remind you that, I mean, there's about 1/3 of patients with HIV that don't have their virus currently under control, and a lot of that has to do with not having the right treatment option for those patients.
So I think there's real opportunities to continue to grow that HIV, both treatment and prevention, over the course of that. Having said that, we remain, we remain convinced that our target of 1/3 of sales goals from oncology is achievable without the need for additional BD and including potential growth of our HIV business. And that is because that goal was put in place in a probability-adjusted way. And many of our programs in oncology, either whether phase II or phase III currently, you know, have a probability of around 50% or so when you look at that. And so while some things will hit and some things won't, there are a variety of different ways for that oncology portfolio to develop between now and it's six years from now, 2030, to achieve that goal.
I would just note that right now, you know, our sales are already more than 1/3 of the way there to that goal. So in quarter one, they represented about 13% of our business. So we are really making [audio distortion] Overall, it's roughly split, split between [audio distortion] the totality of our growth on our base business. And then finally, I'll just note that we're not going to do anything unnatural to hit this goal, right? The goal was always intended as directional, to highlight the scale and scope of our oncology ambitions. And, you know, again, we see a path forward. We're going to continue to be pragmatic about how we drive growth in both HIV and oncology, and the emerging franchise of inflammation, moving forward.
A question here on Trodelvy. The Keytruda combo data and frontline metastatic non-small cell lung cancer continues to look encouraging post the ASCO update with PFS. How are you thinking about the differentiation of this combo versus Keytruda monotherapy and Keytruda chemo combo? And when could we see initial data from the ongoing phase three study?
So I'll start with that one. The Trodelvy data with pembro is very interesting, and that's part of what we showed, to your point, at ASCO with EVOKE-02 in the phase II program, that further supports kind of what we're doing in phase III with EVOKE-03 in that first-line setting. This is for PD-L1 positive patients, and we do think that it's about raising the bar, right? The bar both on efficacy as well as safety. And that's where even our EVOKE-01, even though we missed the primary endpoint on that, what we did see there is really strong safety and clearly a very strong activity of Trodelvy.
And so pulling that through, we do believe that in addition to pembro, that might be the best combination to really bring that efficacy play as well as the safety play versus chemotherapy or something like docetaxel, which I think is very hard on these patients. And so that's the way we're thinking about it. I think we have a real opportunity with Trodelvy, not just you know, with the combination with pembro, but as you think about other segmentations of this marketplace and other studies that have played out here, we do really believe Trodelvy is differentiated versus others, versus other ADCs. They're not alike. We've seen that time and time again, and both on the safety profile as well as potentially on efficacy. We've seen that with histologies.
Trodelvy's activity is very strong across squamous and non-squamous and distant, and so that's a really important piece of the puzzle as you think about non-small cell lung cancer, 'cause both of these histologies need to get coverage for us to kind of push that bar. More to come on that. As for timing, we haven't shared timing yet, but obviously, looking for more updates twenty [audio distortion]
Could you also speak to the strategy in the second line setting post the ASCO update?
Yeah, maybe I'll give a little bit of an update there, and I think it gets back to also your question, Salveen, on the overall oncology ambition. You know, as I speak about the second line, it's important to note to what Johanna just mentioned, that every single Trodelvy trial that we've run in difficult to treat patients, later line settings in both lung, bladder, and breast, we've seen an effect. I mean, we're obviously disappointed when we don't hit the primary endpoint, and we understand from a regulatory standpoint, the challenges that presents. But specifically on second-line non-small cell lung cancer, you know, we think it's interesting for patients who, you know, this is coming out of ASCO, you've all now seen the data in a bit more detail.
We'll continue to follow that trial, by the way, and those patients in those trials. But it's quite interesting, particularly for patients who did not respond to their last anti-PD-1 therapy, and that represented around 70% of the patients in the trial. So we're gonna continue to engage, and we already did at ASCO, and we'll continue to with KOLs. We're gonna engage with regulatory authorities, understanding, you know, eyes wide open, that without a primary endpoint, it's an uphill climb. You know, we'll be guided by those discussions over the coming months and keep you informed. But I would just note that, you know, back to this consistent message of efficacy, and Johanna mentioned also the safety in this population, second-line lung.
We saw that numerical improvement in OS across both histologies, so both squamous and non-squamous, which is interesting. I do believe, as we look at the Trop-2 ADCs, that we're seeing a consistent difference between Trop-2 ADCs. In other words, if you've seen one Trop-2 ADC, you've seen one Trop-2 ADC in terms of both some of the efficacy parameters, but also some of the safety and side effects. We also saw in the study meaningful OS improvement. Granted, we missed the primary endpoint of around 3.5 months in patients who didn't receive their last PD-L1, and the 12-month OS rate was about 46.6%. So there are signs there, and we'll continue to have dialogue, but it also informs, importantly, w e have to do what's right for patients, obviously, first and foremost, but informs the rest of our strategy.
It informs how we think about Trop-2 ADCs in later lines, chemo-experienced patients, versus now, as you know, the thrust of our program moving forward is to move up into more chemo-naive or chemo-less experienced patients. So I think that presents, I think, a real opportunity to see how these Trop-2 ADCs will behave in those earlier line settings, from both the tolerability standpoint, the ability to think about combinations earlier on, but also thinking about their efficacy being enhanced as we earlier go earlier into lines of therapy.
Could you also level set us on how you're thinking about the Arcus partnership and key assets that you have under that portfolio, and what the strategy is separately for Kite going forward, beyond the Arcellx partnership in multiple myeloma from both a commercial and developmental perspective?
Yeah. Why don't we split? Do you want to start, Johanna, with Arcus.
And you'll cover Kite?
And give it to Kite? Yeah, that'd be good.
Perfect. Let me start with that. The Arcus collaboration is a really strong one, and we're excited about these novel mechanisms that they're investigating and that we're obviously very involved with. The couple of things to highlight is obviously at ASCO, there was a couple of updates, namely the phase II gastric, showing really strong PFS, which supports the trial that we're doing in gastric, in upper GI, with dom. And so that's something that's exciting for us because of a couple of things. One is, we just announced earlier this week that patient enrollment is complete, and so now the study is just rolling out.
The other piece of the puzzle for me that's the most exciting as a commercial person is there's a real opportunity here to be first to market. Assuming success of this trial is to be first to market in this segment of patients that really need more therapies and more efficacy here. So we're excited about that opportunity. There also was some earlier data in third line plus setting for colorectal cancer with etruma. That's also interesting. We still have to understand the value of each component, the contribution, but that's something obviously moving forward as well.
I think the biggest highlight, I would just say, with the Arcus collaboration is really the opportunity to you know play and collaborate with certain assets, but also wait and see some of the data as it evolves so that we can make certain decisions, and with the right data sets for us to move forward as well. So really great collaboration, great science, and obviously very exciting moving forward as there's a lot around the corner.
Yeah, thanks, Johanna. I'll just add that, I mean, these are novel mechanisms that they carry the risk they carry with it. But, you know, as we think about our oncology ambitions, we're gonna stretch ourselves on some of these mechanisms, and we did so, as you know, with magrolimab, and obviously, you know, that didn't show an effect. But we also have this balance with cell therapy, with the broader Trodelvy program, and now some really novel assets within our Arcus partnership that, you know, we're enthusiastic about and being a leader in certain indications there as well. So, a nd then to expand your question, about Kite, and you specifically asked beyond our Arcellx partnership. Yeah, I'll just remind folks that, you know, we clearly have a world-leading position in cell therapy.
We understand the challenges even more so now of changing practice. The practice of medicine is really what we're changing with CAR T therapy, particularly when it comes to large B-cell lymphoma. I mean, the data are really extraordinarily compelling when you think about the curative nature of this in second line and beyond large B-cell lymphoma. And yet still today, we only have about 2 out of 10 eligible patients receiving CAR T therapy. And those numbers differ outside the U.S. and inside the U.S., and there's different mechanisms within the U.S. that provide some additional challenge to changing some of this practice of medicine. So in particular, in the United States, you know, we need to get to the community expansion.
Today, about 80% of second-line large B-cell lymphoma patients start in community networks, and the ability to get those referred to centers is taking some mind shift and mindset change. And also bringing those centers closer to the community is really important. So we need to expand the use of CAR T-cell therapy in the community with community patients. We need to win the treatment decision at the authorized treatment centers. And the other thing I think that puts us in a very good position to be able to do that is the manufacturing improvements. We've recently received FDA approval for an improved process of 14 days turnaround time. I mean, that's important for so many reasons. First and foremost, for patients, because many of these patients are very ill and time is of the essence.
Secondarily, in terms of the referral from the community, having that be as efficient as possible and being able to have the turnaround as efficient as possible is very important. And finally, from the overall business of cell therapy, having a shorter turnaround time, you know, improves our opportunity to get returns on the business over that period of time as well. So we are firmly committed to large B-cell lymphoma. I would just say, and you asked your questions excluding Arcellx , but we're also very, very committed and we believe we have a potential differentiated product in the anito-cel with multiple myeloma. We'll get more data on that later this year. And then finally, we're not stopping there. We're developing a deep and broad pipeline on next-gen lymphoma pipelines, dual targeting, bispecific, armored, optimizing manufacturing.
You know, as a leader, we, we take our role seriously in making sure we stay ahead of the innovation curve. We're also looking at solid tumors in an exploratory way and looking for ways to think how we might be able to have an effect on solid tumors, and then, of course, in autoimmune conditions as well. Lots more to come on cell therapy, and over to you.
Great. One last question here on business development. You've noted that meaningful M&A is unlikely in the near term post the CymaBay deal. What lessons have you learned from the recent deals in terms of how you think about future BD? And help us understand where you would see if you were to look the potential for most value now from both a market perspective and a synergy perspective.
Yeah, absolutely. Look, I think we're always learning lessons. I mean, actually, for the decades I've been in this industry, we're learning lessons, and you have, you have, when you reach hard for changes to medical practice, there are times when you will fall short, and there's times where you will exceed your expectations. And that's true both on the internal pipeline and also on M&A. So but what I would say is, you know, we always look at our capital deployment, and, and how we're deploying that capital across the range of opportunities for that, and looking back and looking forward at that. But Gilead is a very different company than it was five years ago.
I mean, just to put it into context and with all respect to the legacy of Gilead, outside of virology, we had a very thin pipeline, and we were investing kind of in the mid-teens percent of revenue on R&D. So at that time, we made a decision to both diversify the company and to increase our overall investment. You know, we've done that, and now we're in a period of really being able to optimize that moving forward. But the essence of the strategy was to build that diversification, first of all, not lose our edge in virology. And I think, you know, everything that Johanna had mentioned before about the work the team has done in both treatment and prevention in HIV and beyond has been nothing short of impressive.
But we now have built up real competencies within the organization around oncology and inflammation. So we're in a very different spot today. We have a robust internal portfolio in phase I and phase II that we often don't get a chance to speak about, with novel mechanisms in oncology that have come out of our own research, research lab or out of collaborations, and likewise in inflammation. So as we have a lot to do currently within our portfolio, and the bar is very high even within the company for things to hurdle into late-stage programs, we'll continue, of course, scan the environment and look for things that really fit into our portfolio, like CymaBay or seladelpar, or other things that fit into our early-stage portfolio that enhance that appropriately.
So, well, I believe that, you know, we'll continue to look at smaller deals, think mid-single-digit billions on average every few years, CymaBay-type deals, smaller collaborations that fill our earlier stage portfolio. But you're not likely to see us engage in any sizable, like, Immunomedics-sized deals in the near term. We'll be flexible, of course, but that's not our base case because of the breadth of the portfolio that we have today. So we're in a very different position than we were, and we're learning every day. I mean, we're responding to events and shifting and adapting our organization, and we have a lot more to do in this, if you like, in the next stage of our transformation journey.
Great. Well, with that, Dan and Johanna, thank you so much for joining us. Sorry we couldn't see you in person.
Thank you very much for having us.
Thank you.
Bye.
Take care.