Good afternoon and welcome to day two of the Barclays Global Healthcare Conference. My name is Carter Gould, covering U.S. biopharma. I am pleased to welcome Gilead Sciences to the stage. Joining us from the company, Andy Dickinson, CFO. Andy, you're going to make some opening comments, and then we'll launch into Q&A.
Great, thanks. Thank you for having us, and thanks for joining the presentation. Look, at a high level, I'd say it's an exciting period for Gilead. We're moving into kind of the second stage of the restructuring expansion of the company. We have a number of growth opportunities, and we expect accelerating growth through the end of the decade. So, as most of you know, we have the world's largest HIV business, stable, growing long-term patent protection, and a number of product launches that are coming between now and the end of the decade that should drive additional growth. We have the world's leading cell therapy business. It's also a significant growth opportunity. We just are in the process of acquiring a company in liver disease that's exciting, a drug called seladelpar and PBC, which is another big growth opportunity for us.
Then we have an oncology portfolio at Gilead that includes Trodelvy that we're really excited about. So when we kind of put it all together, we see outsized growth relative to the industry, continued diversification of the business, and a very stable and growing business for the foreseeable future with no major patent cliffs. So that's the high-level overview, but we can dig into all the details.
All right, perfect. Let's start on HIV. You're just coming out of CROI. Maybe let's start first with we have some more data on bictegravir, we've got the Artistry data. Can you maybe just kind of help set the stage for your takeaways from that data as you think about bictegravir, sort of the next step, the next wave of assets coming out of Gilead's HIV?
Sure. Yeah. So the Artistry data that Carter's highlighting is a phase II study of bictegravir, which is the market-leading integrase inhibitor that is the backbone of Biktarvy, which is the world's number one HIV regimen and the gold standard today for HIV treatment. We paired bictegravir with lenacapavir, which is a novel HIV integrase inhibitor. It's already approved. And as you know, this novel mechanism can be formulated as a once-daily pill, a once-weekly pill, once-monthly pill, every three months or every six months subcutaneous. So the key is finding partner agents with it. And the data set that you're referring to is a once-daily pill, and this would be a doublet, as I said, of bictegravir and lenacapavir. The data showed great viral suppression, very safe profile. There's a clear market opportunity for patients that are currently on complex regimens.
About 5%-10% of HIV patients are on complex multi-tablet regimens, oftentimes because they have resistance to one of the known mechanisms of action. This would be an obvious candidate for usage in those patients. But we expect the label to be more broad and to be for anyone that is virologically suppressed. And what that means is when if a physician and a patient are looking at moving to a regimen that may include a doublet, we think this gives them a new alternative that could be a much bigger opportunity than the market appreciates. Recognizing that today, the number two treatment regimen in the market is a different doublet, we think we have the potential to displace that and other doublets over time. So it's been exciting.
We're moving into phase III, and it's an opportunity that the market really hasn't paid a lot of attention to yet.
Okay. And when we think about sort of the next wave beyond that or the next drivers beyond that for HIV, the two that we kind of really focus on are neutralizing antibodies. We were just talking about that offstage before, and then PrEP. We'll put PrEP aside for a second. And when we think about the neutralizing antibody data, the small data set, for sure. You had a couple of breakthroughs, but those were kind of explained with different complicating features. I'm sure you'll touch on that. At this point, how are you thinking about that as a product going forward?
Yeah. Well, I'd say there's three areas of growth beyond the daily doublet that I just talked about. One is the once-weekly orals, which we should talk about. We had data at COI. Then, obviously, Lenacapavir for prevention is the largest of the opportunities and incredibly exciting. And then you have the broadly neutralizing antibodies, which is two broadly neutralizing antibodies that are also paired with Lenacapavir. We presented some data last year and then updated data this year at COI. The broadly neutralizing antibodies, at a high level, are really just proof of concept that you can develop an effective every six-month treatment regimen. This is probably a regimen that's not going to be ideal for most patients. You're talking about an infusion of a large amount of protein in the antibodies together with a separate subcu injection of Lenacapavir. But it's great proof of concept.
I mean, to put it in context, though, I think only 50% of the total HIV patients would be appropriate for these two antibodies when you look at their virus and the epitopes that are covered by these antibodies. So it's a small commercial opportunity if there is one. There will be some patients we hear from KOLs that are not adherent, that just for whatever reason don't take their pills, even though we all tend to think that it's easy to take your pills once a day. There are many people with HIV that just for whatever reason aren't able to do it and don't do it.
The interesting feedback to us last year and then again this year from a number of KOLs with the broadly neutralizing antibodies is that they do see a small subset of patients that they think could really benefit from that regimen because they're not adherent on orals. That may change, of course, if we launch other orals that are more convenient for them as well.
So I'm going to come back to the once-weekly in a second. But PrEP, I think, is the most important catalyst for the company this year. You may agree or disagree, but we think it is. And certainly, when you think about the HIV growth, sort of resetting HIV growth over the balance of the decade and into the 2030s, super important. I guess one question I think people struggle with is how big is that opportunity potentially? We've seen Truvada, Descovy go on to become big drugs, face generic challenges. But I think when launching that PrEP opportunity, Gilead did that to some extent with sort of one hand tied behind their back in terms of how aggressive you were going to be.
As you know, different era to some extent, how aggressive are you guys going to be in sort of thinking about this as a commercial opportunity than maybe you did in the early 2010s?
Yeah, that's a really good question. I think we see a much larger opportunity for the long-acting injectables than you could see with the once-daily pills that we launched starting a decade ago. So to put it in context, again, we have lenacapavir as a single agent. Again, this is a drug that's already approved as an every 6-month subcutaneous injection for highly treatment-experienced patients. It's that exact same dose and formulation that's being studied in large phase III studies that we'll read out later this year, and then either both of them later this year or one later this year, one early next year. We expect to launch commercially this product as an every 6-month injection for prevention by the end of next year. And because of the convenience and the every 6-month, we think it will fundamentally open the prevention market in three different ways.
But to provide some context, when Truvada, which was the first oral drug approved for prevention, went generic two and a half years ago or three years ago now, the prevention market was about a $2 billion branded market between Truvada and Descovy, which was another two-drug combination that we also had approved for prevention that's still being used widely today. The market has grown dramatically over the last three years. So we would assume and all of those sales were predominantly in the United States. So kind of broadly, you should think of the prevention market today as a $2.5-$3 billion market only in the United States and growing rapidly. Last year, it was growing north of 20%. This year, it's grown kind of in the mid-teens, but there's still significant growth. And that growth should accelerate dramatically within every six-month subcu.
So the opportunity is, one, that with the every six-month subcu, today, we think that maybe 25%-30% of the patients that should be getting PrEP are on PrEP. We think that will the usage across that group of patients or people at risk of getting HIV will increase significantly. Secondly, we think the way that you think of the market should expand dramatically. So the best way to describe that is the Centers for Disease Control describe the prevention market very narrowly today in the United States as being appropriate for men having sex with men and IV drug users. That's about 1.3 million people, roughly, in the United States that are currently targeted for PrEP.
If, on the other hand, you think of the prevention market as we do, as a market that's appropriate for everyone that has multiple sexual partners or people, for instance, that have STDs, last year alone, there were 13 million people, so 10 times the number of the CDC estimate that were diagnosed with a sexually transmitted disease. So we look at the PrEP market much more broadly. We think the label will, as with the current oral drugs, be broad and be appropriate for anyone that physicians and the patients feel are at risk of getting HIV. And then the third leg of growth is use outside of the United States. So that Europe and Asia are untapped markets. We think that an every six-month prevention, even for government payers, they will look at differently in terms of what it can do because you're ensuring compliance.
Again, with the orals today, Carter, as you know, the orals are incredibly effective at preventing the transmission of HIV. The challenge is that people don't take the pills every day because they don't have HIV yet. The adherence is a real problem, and it leads to less than ideal efficacy. With the injection, you should see incredibly strong efficacy that's guaranteed over a six-month period given the administration.
Very helpful. I appreciate the new color there and some of those metrics. On the one just to circle back and maybe tie up HIV here for a second, on the once-weekly, do you feel like now you've kind of got the regimen you're ready to go forward with? I know you've had a number of options. You've been sort of advancing.
Yeah, I think we have two regimens that we're going forward with, both of which are really exciting. And again, similar to the once-daily doublet that is moving into phase III, these are regimens that we think are probably underappreciated in terms of their attractiveness to patients. So the first regimen that we presented, phase II data at COI, together with our partners at Merck, is a combination of lenacapavir and Merck's islatravir, showed just like our daily doublet, very strong viral suppression, a clean safety profile. Given some of the challenges with islatravir over the last couple of years, we think that physicians in the market will watch closely the safety data over larger longer studies. But we, together with Merck, are moving aggressively into phase III studies.
Even though that's a partnered agent and a partnered regimen, when we model it out and look at how we see the development of that, we see that regimen as being positive to our overall growth in HIV, even though we share some of the economics with Merck for a whole host of reasons that I can get into if it's helpful. Secondly, at COI, we presented phase I data for our wholly owned once-weekly integrase inhibitor that is GS-1720 when you read about it. And again, we showed very potent viral suppression in phase I studies. We're now moving into phase II studies as a once-weekly combination, either with Lenacapavir or a prodrug of Lenacapavir. This will be about 12-24 months behind the program with Merck, but probably has broader commercial potential given that many KOLs really favor an integrase inhibitor as a backbone for therapy today.
So again, it would be an integrase inhibitor, not that dissimilar from bictegravir together with lenacapavir, once weekly, moving into phase II, and then rapidly, we believe, moving into phase III. And again, it goes back to the point that I made earlier that when you look between now and the end of the decade, we should have at least 4 or 5 new product approvals in HIV that will drive outsized growth. And maybe just to put that in context, like today, our guidance for our HIV business for 2024 is 4% growth, which is about 2%-3% growth in the treatment market in all major markets and much higher growth in prevention with an expanding market. We expect with these product launches for that growth curve to accelerate significantly through the end of the decade and beyond.
Very helpful. You alluded to the closing of the CymaBay transaction. Now that the deal's closed, at this point, are we going to hear, I guess, more thoughts on how you guys are thinking about the size of the drug in question here and maybe portray sort of the opportunity, the TAM, and duration, etc., and things like that?
Yeah. And well, we haven't closed the deal yet, so it's coming. But we did get the HSR period passed. You're exactly right. So assuming that the shareholders tender as we expect them to, we'll close it here in the coming weeks, which we're excited about. And we will provide more updates over time. I think when you step back, again, seladelpar is a drug that has an incredibly strong set of phase III data. The application for approval with the FDA is on file and has been accepted. The drug has a PDUFA date in August and a really significant opportunity. So there's about 130,000 patients. This is an orphan disease, which is important for a whole host of reasons in terms of how you think about pricing and also how you think about the impact of the Inflation Reduction Act.
It's a large orphan disease, not that dissimilar from the pulmonary hypertension market that many of you know and that particularly had participated in with Letairis. There's 130,000 patients, we believe, in the United States that would benefit from the treatment, an almost equal number compared to 125,000, and really strong data. So the market opportunity in our mind is larger than the market currently appreciates. We also feel like we're the perfect partner for this agent and can really maximize the value. And the reason is we have the largest liver sales organization globally with our global hepatitis business. So we have the market leading hepatitis C therapies as well as Vemlidy for hepatitis B, which is an outstanding therapy.
We have a hepatitis D sales force in Europe and at some point, well, in the United States, we'll have Hepcludex. 80% of the physicians that treat PBC and that will be prescribing seladelpar are already covered by our sales. So we know the disease. We know the physicians. We have infrastructure in place. There are significant synergies with our existing business and significant upside, we believe, to kind of street models for where this program could go.
Okay. Very helpful. Maybe let's move on to cell therapy. The Kite business had been a pretty robust growth engine for you, a little bit choppier of late. You've talked about some of the headwinds in first half. Second half, I think, is really kind of where the question is for investors, is do we see a return to growth? At this point, how are you thinking about that with confidence in that second half return to growth?
Yeah, absolutely. I mean, it's still a growth business for us. And when you talk about kind of a choppiness, what you're referring to is the United States. Outside of the United States, we still see incredibly strong growth and significant uptake for cell therapy. We also see that in the United States, but there are a couple of headwinds in the United States that have led to more of a flat business over the last three quarters. And we see that changing, doesn't it? So to answer your question specifically, you will see strong growth this year in the cell therapy business, we expect, double-digit growth. It should accelerate in the second half, to your point, as we work through some of these issues in the United States. I should also say and I'll talk about them specifically, but I should also say that long-term, nothing has changed.
I mean, it's very clear when you look at the data in cell therapy. I mean, this is incredible data, transformative for patients. It appears to be curative in most of these hematological diseases. There's no doubt in our mind that uptake of cell therapies will just continue to grow for many, many years from here. You have the potential, of course, in autoimmune neurology and then maybe solid tumors and virology over the longer run. To your question in the United States today, what we're seeing in the authorized treatment centers, which are typically academic centers and large hospitals in large cities, are three different things. One, the transplant centers have more demand than they can satisfy with their existing bed capacity. That's been exacerbated by the uptake of some of the BCMA cell therapies. That will resolve itself over time, but it doesn't happen overnight.
A lot of the largest hospitals that we work with are working on expanding their transplant centers to have more treatment beds available for both the DLBCL, follicular lymphoma, and multiple myeloma markets, etc. The second thing that we're seeing is in some of these hospitals, there is some increased use of bispecifics that have been approved. It's curious given that the bispecifics don't have the same overall survival data that you see with the cell therapies. So there's a lot of education that our team is embarking on to help physicians reinforce with physicians the incredibly strong data from cell therapy and the fact that it's important that patients are given this treatment option. You also see better outcomes if patients are given the treatment earlier in DLBCL.
So reinforcing that using it in second line should lead to much better overall survival over the long run versus kind of third line plus. And then finally, you are seeing some physicians, for whatever reason, put patients into clinical trials instead of using the existing approved cell therapies, which is also we feel inappropriate and something that with education, you can work on over time. So it's a multi-pronged approach. The last thing that we're doing, as you know, is we have a significant program to move cell therapy to community hospitals and community oncology treatment centers. So today, about 20% of the patients in the approved indications come to, at the outset, these large hospitals and academic centers. That remaining 80% in our community, 30% of that 80%, 30 percentage points actually are referred to the academic centers at some point.
So eventually, you get 50% of the patients today in these large academic centers. So we're focused on increasing usage there, but we're also focused on reaching the 50% of the patients that never get to these large hospitals and academic centers to make sure that they have this life-saving therapy available to them. And that is going to take years to kind of move these treatments into the community setting in partnership with the large community oncology practices. So we have a couple of programs underway in Tennessee. I think the next one is in Virginia. We're working with other states. And we'll make slow and steady progress there, we expect.
To be clear, that second-half outlook that you talked about, though, it's not contingent upon a massive inflection in the community adoption?
No, I don't think so. I think the community is probably longer term. There will be some additional uptake in the community this year, but that should grow year after year after year as we move into these efforts. I think the near-term inflection is all about, at the existing authorized treatment centers, getting the class share of cell therapy up above 15%. So today, just to put it in context, about 15% of patients in second line DLBCL, 15%-17%, I think today, are getting cell therapy despite the fact that you have this incredible overall survival data. And for third line plus, as you know, I think it's 42% survival after five years. And these are patients that were almost certainly going to die within weeks before they got their cell therapy treatment. So it's really remarkable data.
Then the second line, again, the overall survival data, I think after three years, if I remember correctly, is 6% from the ZUMA-7 study. They should all be getting cell therapy, is our view. But today, it's only 15%-17%. In the near term, it's all changing the treatment decisions that are being made in these large hospitals and ATCs.
Okay. Maybe move to, I guess, the newest member of your cell therapy kind of pipeline. Certainly, you came into the portfolio not too long ago, and you've had some de-risking phase I data late last year. That's in anito-cell, pivotal data coming later this year. We also had briefing documents for related programs from Legend and Bristol out today. I'm going to ask you the very unfair question around the briefing documents. You probably didn't have a ton of time to review. And how, if at all, that changes how you guys are thinking about anito-cell and its differentiation either on efficacy or on the safety tolerability side?
Yeah. I mean, obviously, we're digesting the briefing documents right now. I think the initial take is the questions are largely what we expected. We need to see the data. I mean, there's some reference to early deaths in this study on treatment versus the comparator. So we'll need to kind of see the data. What I can say is the data that we and Arcellx have seen so far from the anito-cell is incredibly encouraging, both on the efficacy and safety. And remember, our construct is completely different. We have a smaller binding domain called the D domain that is more stable. We get much higher transduction efficiency when we use the viral vector, when we put the viral vector together with the T cells, which means that we can give a lower cell dose.
Our treatment, each one of these cell therapies and of course, you see this more broadly even in DLBCL. They are so different that because you're combining biology and engineering, that it's hard to make any conclusions from one to the other until you actually see the data. So what we've seen so far is we see very good efficacy with the anito-cel, 100% response rates. But we're still waiting to reach kind of the median PFS, as you know, from the early set of phase I patients. We will have the data later this year, similar to ZUMA- 1 for Yescarta. If the data is as strong as we expect, it should be registrationable data. So we'll see when we look at the data. But no, I don't think anything in the briefing documents changes anything for us.
I think you and I were talking in the hallway about the difficulty of the overall survival data where so many of the patients after the cell therapy treatment are crossing over and getting other therapies as well, which can always, as I understand it, confound overall survival analyses. You see this in breast cancer studies all the time. So when we look at it from a macro perspective, given the data that we have and have seen and the competitor data, we think the risk-benefit significantly favors cell therapy. We see cell therapies being taken up more, and we see a big opportunity for anito-cell .
Maybe in the last 90 seconds, I'm going to ask you the rather open-ended question around how Gilead's approaching cell therapy for immunology. We see sort of a gold rush going on, or at least that mentality with people with CD19 programs going after lupus. Update us on kind of Gilead's efforts and how it's thinking about that given the level of competitive intensity catching up immensely.
Yeah. Well, I mean, first of all, we're following the field very closely. We talk to all of these companies. And we have two potentials here. One, we have early-stage mixed-generation programs for CD19 antibody constructs. We have two of them that are different, but they have both a CD28 and 41BB co-stimulatory domains. The data that we're seeing in some of the phase I studies so far in hematological indications looks really great, and the safety data looks great. Those have potential, potentially, in autoimmune, and we could always go in that direction. We're also looking at all the companies that are working in this space. And honestly, I think we're going to follow this space really closely, not just in 2024, but beyond. So the analogy I'd use is BCMA.
When we shut down the Kite BCMA program five years ago, it took us another four years to monitor the space and find our CELEX was the ideal partner. You could see the same thing here. So whether we move forward internally, whether we partner with someone externally, we think we're in a great position to kind of see all the data, watch this evolve, determine whether autologous cell therapies are going to win here. We do think that allogeneic cell therapies and autoimmune may have significant potential. We're watching those companies closely, too. And I think we're positioned as the partner to be able to pull the right therapy in if we see data externally that suggests that someone has the best-in-class opportunity. So more to come on that, but it is an exciting development for sure.
Perfect. Well, there's plenty more we could have touched on for Gilead, but we're out of time. Andy, thanks very much for this opportunity today.
Yeah. Thanks for having us.