Analyst Day. I think the timelines are close enough to ASH, but this is dedicated specifically to HIV. And is there any specific focus for you guys just in terms of products?
I think the focus is really on where we see the PrEP market going with the expected lenacapavir. So it's going to be equally divided between treatment and PrEP, to be clear. But, you know, primary focus is with the incredible PURPOSE 1 and PURPOSE 2 data for lenacapavir for HIV prevention that came out earlier this year, talking about the data and our expectations for the launch of lenacapavir, which is now expected next summer. T he summer of 2025, a little bit earlier than previously expected, and why we believe that is so transformative for HIV prevention. And then on the treatment side, it's really an opportunity for us to highlight all of the new programs that we have, many of which are in phase III, phase II, there are a number in phase I, and how we see the HIV treatment market evolving over the coming years.
Your point of, like, how do you go from Biktarvy, which is clearly the gold standard in HIV treatment, and develop additional therapies that are equal in efficacy to Biktarvy, but may offer added convenience for people across the globe that have HIV? And as part of that, we'll start sharing some clinical data, both clinical and preclinical data, in terms of these long-acting programs and why we're so excited. I think overall we have in HIV treatment nine or ten programs that are in the clinic or very close to the clinic and try to give people an update on all of the different combinations that we're looking at.
So, and I want to go through the post-Biktarvy, the financials through Biktarvy, LOE, as well as the PrEP market.
Sure.
But maybe, I guess, let me just go more linearly or let's just go more linearly. Let's start with near-term, the PrEP opportunity. Could you remind us, GSK Apretude launch was not that great. Obviously, lenacapavir data is a lot better. However, does that tell us that this is not exactly a launch that will go kind of like how Biktarvy went? Is that a reasonable way to think about it?
I don't think, I mean, I think we expect a very strong launch. I mean, the clinical data for PURPOSE 1 and PURPOSE 2 is transformative for HIV prevention. So, you know, you're on the competitor launch that, as you acknowledge, hasn't gone that well. And it's a product that has a very small piece of the PrEP market. When you look at the PrEP market today, there are two orals that are approved, both of which were Gilead products, one of which is now generic. They have about 96% of the market, 4% of the market for the one long-acting therapy that's available. But you have to remember that therapy is injected intramuscular. There are two intramuscular injections that are required either every month or every two months. And it doesn't fit the treatment schedule. It's unpleasant. It's very painful for patients.
And they have better options, frankly, with the daily orals that are available today. You fast forward to lenacapavir, and you now have an every six-month subcutaneous injection that matches in terms of timing the frequency at which people at risk of getting HIV tend to go see their primary care physician or their physician in any event. And you have data that is really game-changing in terms of the PURPOSE 1 study. As you know, we had 100% efficacy. And in PURPOSE 2, 99.9% of people did not.
Could you guys facilitate a switch from your existing franchise?
Yeah, I think we can. Yeah, absolutely. And that's the focus in the short run. So the PrEP market, for those of you that don't know the HIV PrEP market, there's about 400,000-450,000 people on HIV prevention today. The vast majority of those I've said are on the daily orals that Gilead developed. And that's a small fraction of the people that should be on HIV prevention in the.
400,000.
400,000-450,000 people today. If the market were branded today, if the entire market were branded today, again, when Truvada went generic over three years ago, it was about $2 billion of revenue for us. The market's grown dramatically, the PrEP market, since that time, even though it's still very early in its development, we believe, not only in the U.S., but globally. Today, if you kind of fast forward, we think it's probably, if the whole market were branded, about a $3.5 billion market. The vast majority of people that take HIV prevention don't take their pills every day. So when you kind of run it through your model and you adjust for compliance, let's say that with the long-acting, you have a 20%-40% compliance or adherence uplift. Obviously, the incredible clinical data that we have supports a strong price.
There's probably less discounting in the future, given that Descovy was more heavily discounted in order to maintain parity access with Truvada in the United States. It's a big opportunity for us outside of the gate, just focusing, to your point, on people that are currently using PrEP.
How much of the 400,000 are on your brands right now, on the Descovy?
It's almost 50% are on Descovy, and the remaining, you know, whatever it is, 52%-56%, depending on your data, are on mostly Truvada and then a very small percentage on Apretude.
So if the market is $3.5 billion in branded dollars, and let's just call it $4 billion or so compliance adjusted, $4 billion-$5 billion compliance adjusted, you have half of that right now, which could be transitioned, and then you go after the rest and grow it.
Yeah, and you go, yeah, absolutely. I mean, our goal is to transition the entire market as quickly as possible. I mean, back to your question of why do some launches go well and some don't go well. And you know this better than I do. There are countless examples in the history of kind of the pharmaceutical. I mean, and one of the best ones is in HCV. If you look at telaprevir versus the next generation HCV therapies, and it's not a great analog, but there's, you know, the same thing was true in pulmonary hypertension with the Flolan, which was an early inconvenient molecule that had $300 million-$400 million in sales. And then you have Actelion launching Traclear, which became a massive market. So that is, in general, how we see lenacapavir for PrEP.
It really has the potential, not only with its clinical data, but with its convenience to transform the prevention market in the same way that, you know, generally our HCV therapies transform the HCV market, even though there were other therapies available when they launched.
Got it. And if there's a question on PrEP that I feel like has not come up at all in the conversations is Merck is putting out data on a one pill once a month, which you guys are probably very familiar with, because it's the same scaffold as islatravir, which you guys were partnered on previously. It's the.
It's islatravir, yeah.
It's islatravir.
Yep.
I'm curious how you guys think about that one pill once a month, any risks with that or not. My personal concern is CD4 counts with that, but I'm just curious.
Yeah, and we're still partnered with Merck on its islatravir. So we actually have a weekly oral combination of lenacapavir and its islatravir that is in phase III studies. Look, I do think that there probably is an opportunity for once-monthly oral and prevention as well. And we're also working on that. So I think the much bigger opportunity is the every six-month subcutaneous and then the every year subcutaneous. So I'll save some of this for our discussion at the HIV Day next year.
I see. So you guys have a once-monthly oral as well for PrEP?
I mean, we've already formulated lenacapavir as a once-daily, once-weekly pill. We believe we can formulate it, you know, pretty clearly as a once-monthly oral and then as an every three-month and every six-month subcutaneous. I think the big for us with lenacapavir for prevention now, you know, not only will we look at long-acting orals, but we will also look at longer-acting injectables. So if you really get to.
So a weekly oral would land as well for PrEP?
Absolutely.
Is that in trials?
No, we haven't started any studies. I mean, so that's the, I mean, the question is really the commercial opportunity and where patients want to go. So this is something that, again, I'll leave our commercial team and our R&D team can speak to this more next week. But there are a number of opportunities there. Overall, you know, at a high level, we think the lenacapavir every six months is the perfect opportunity for the vast majority of patients that need PrEP. And the next big step will potentially be an every year injection.
But if needed, could you have a very quick transition referencing lenacapavir data and then having a?
That's a good question. We look at that closely. It's probably too early to say anything in terms of the, you know, the regulatory path, given that lenacapavir is already approved now, both for treatment as an every six-month subcutaneous and we believe soon to be approved for prevention. So more to come on that question.
Got it. So if the underlying business is growing, let's call it low single digits, and with PrEP coming on board, is mid-single digits the right number from growth perspective? I know consensus is kind of like at 3% or so through 2030. 3-ish percent is probably the average. How do you think about that? Granted, 2025 has different dynamics, but I'm talking about.
Yeah, 2025 has different dynamics with Part D reform. Look, I mean, if you look at the third quarter, we updated our guidance for our HIV business this year to grow 5% this year. So, and that's a combination of the growth in treatment and the growth in prevention with Descovy. So, you know, I do think kind of that directionally is the right way to think about the business through the end of the decade and beyond.
Mid-single digits.
Yeah, I mean, directionally and the PrEP launch has potential to drive that higher. The treatment market is very clearly in all major geographies growing 2%-3% each year, just in terms of the incidence of HIV. And then the PrEP market is growing much faster. And you saw an acceleration in growth of the PrEP market in the third quarter that may have been because of the increased awareness from the lenacapavir studies. But the PrEP market has the potential to grow much, much more than the treatment market and to drive the overall growth, you know, through the end of the decade and beyond in a way that's consistent with what you've seen in the last couple of years.
I mean, the other thing to say, Umer, is, you know, if you look at the last three years of our HIV business, the business has performed incredibly well. So what we saw in the third quarter and the updated guidance for 5% growth this year in the HIV business is not at all inconsistent with what you've seen over the last couple of years. The business just continues to really, really perform well.
So, Andy, as you guys do the HIV Analyst Day, we're starting to get more visibility on PrEP, now the next gen treatments as well, to lay the path well beyond Biktarvy, which is technically a conversation into the 2040s, perhaps, or approaching that. Would you guys ever consider putting out some sort of long-term guidance talking about what the EPS power of the company could look like?
I mean, we talk about it and debate it. I mean, obviously, there's always the long-term guidance can be a double-edged sword in terms of my experience, our CEO's experience of what we've seen companies do when they put themselves in that position. I do think it's fair to say that, and we've provided guidance that, you know, that we expect to have a positive CAGR through the end of the decade and beyond. So just to step back with the HIV business, Biktarvy does not go generic until the end of 2033. It's December of 2033 at the earliest that you could see Biktarvy go generic. Between now and then, we could have up to seven launches. We'll continue to innovate new products. And you have, that's just seven launches in treatment potentially. And then you have the PrEP growth as well.
So there is no doubt there's, I mean, this is an $18+ billion business for us that's growing, as you said, kind of currently at mid-single digits. And we've got this incredible PrEP launch in front of us that we expect to kind of redefine the HIV prevention market, not only in the U.S. and beyond. So you should see, you know, meaningful growth in our HIV business. I guess the key take, one of the key takeaways we think from the HIV Day coming up will be that people will have a better sense of the stability and durability of our HIV business beyond the Biktarvy patent cliff.
Got it. Okay. Maybe, and I want to transition to some of the other parts of the business as well. Maybe a quick one on the all-oral, the Biktarvy plus lenacapavir combination.
Yeah.
I guess the one question I wonder is a similar question I asked GSK a while back. No nuc, how do you think about the risk of that in an all-oral regimen? Wouldn't you want to have a nuc?
I think.
Or is it not the only option?
It's not the only option. First of all, Biktarvy will continue to be the standard of care for patients that are diagnosed with HIV. So for those that don't follow the market, 50% of the patients with HIV in the United States currently take Biktarvy. I think it's 60% or 70% start on Biktarvy. There are, and Biktarvy is, you know, the clinical data, the real-world data. It's just incredible. There are no limitations with Biktarvy. The doublet that we are developing includes bictegravir as the integrase backbone, which we think is the most important, and lenacapavir as an HIV capsid backbone. Both of those independently have very high barriers to genetic resistance. And so we are comfortable that that is an incredibly powerful combination as a doublet. It's really more of an opportunity for switch.
I mean, if you, you know, there is one doublet available today that has about 10% of the market. You know, this is an opportunity for patients that for whatever reason want a doublet to have another option of the doublet, which we believe contains the two best molecules in HIV treatment. So, you know, our scientists, we wouldn't, I mean, maybe to answer your question, we wouldn't put forward the doublet if we didn't think it would deliver outstanding efficacy and safety.
And the clinical data in the phase II study supports that. So the very strong phase II data, we're in phase III studies now. But, you know, there's a big part of today's market that is on a doublet in both the U.S. and in Europe. And this gives them what we think will likely be a better option. And of course, then there will be a series of additional long-acting options that come that many people may want to switch on to as well.
Got it. Let's transition to the oncology business. A couple of things there. I think the first one is maybe just for folks that may have missed it. There's always like market speculation that comes up from a BD perspective as well. But I think one of the comments you made at the start, which I think you guys have been pretty consistent on, is the scope of BD is limited to small to mid-sized transactions. And that's kind of the direction you guys are going.
Yeah, yeah, I mean, that's absolutely right. I mean, look, when I say, and it's more small transactions, I mean, the.
Small transactions.
I mean.
sub-$3 billion or in that.
CymaBay was like a $4 billion transaction. We still view that as a small transaction. We generate a lot of free cash flow. You saw us generate $4.3 billion of free cash flow in the third quarter alone. You know, I mean, our cash position is very strong. It grows significantly over time. I mean, this is more about the quality and depth of the portfolio that we have today versus what we had. When I think of the Kite acquisition as an $11 billion acquisition, that was more mid-size. Immunomedics was a much bigger acquisition at $21 billion. It is unlikely that we do any deals like that. That's really not our focus given the quality and depth of the portfolio today.
Got it. That makes sense. I ask also because there's always like street speculation that comes up on you guys and some of your partners and if it would make sense to consolidate the economics. I know anito-cel, for example, on the Arcellx, that's a program that gets a lot of street attention, but also some amount of speculation as well on sort of from a Gilead BD perspective as well. So could you just remind us just the broad strategy on the ecosystem you guys operate in?
Sure.
The focus is really on external innovation in some of the other areas rather than consolidating economics.
Yeah. I mean, we have dozens of really important partnerships with great partners across the globe, and we're expanding that over time. One of the most prominent and one that we are incredibly excited about is our partnership on anito-cel, you know, with Arcellx. And that's a partnership that's structured to really benefit both companies, and you've seen that. So all of our partnerships, we really work on creating a unique structure for each individual partnership that should benefit both companies. The mindset is always you have to align interests and create value for both companies in order to deliver a great result. And I think that's exactly what we've done there. The, you know, there's always the question of do you consolidate those over time? That's not our base case.
It shouldn't be your base case because we structured this to create significant value for both companies over time. Of course, we'll always look at it. We have a very open discussion with our partners. But, you know, it also comes at any time you think about that, again, just speaking generally, you know, my colleagues and I would always have to consider what are the alternative uses of that capital. So there are times where that could make sense for you to do that. But the base case is that you're using your capital to further diversify and bring in other similar opportunities. I will say.
Find time out of these partnerships.
Yeah, exactly. Exactly. I mean, and you know, anito-cel, though, is an incredible cell therapy construct. There will be additional data presented at ASH next week that we are very excited, and I know our colleagues is excited to share. It clearly appears that it has the potential to be the best in class BCMA cell therapy, not only in terms of efficacy, but also in terms of safety. And it appears based, I mean, we have treated over 140 patients to date. And every which way we look at it, we believe that this looks like a really special cell therapy.
Andy, not to take you down the wheelhouse of sort of the clinical trial design conduct nuances, but there is this school of thought out there that the Legend trials were not as intense on steroids. They were very, very light on steroids, and then the Arcellx trials were very intense on steroids, and maybe that's what explains some of the differences. I'm sure that topic's come up. What do you think you hear on that?
Yeah, we look at that. I mean, we look at it closely. I mean, the other thing that you hear is that there are some later- or later-line patients in one. I think from our perspective, when we look at it, there's not that big of a difference we see in terms of response rates between fourth-line and fifth-line patients. For instance, where you really see a difference are the patients that have extramedullary disease. And I'll get back to your question on steroids. You know, from our vantage point, the patients that have been treated by Arcellx with anito-cel overall are sicker and have more advanced disease generally, and you still see phenomenal efficacy. You know, in terms of kind of the pretreatment, you know, we've looked at it.
I think our belief is that the difference in the side effect profile, which you're really alluding to, is less about pretreatment and much more about the unique engineering of the D-domain binder that Arcellx has in the cell therapy. And what it really, there's always been this debate about the length of time that the binder binds to the ligand and the potential for tonic signaling. And the D-domain binder, which is, you know, very different than your typical kind of antibody binder, as I understand it, has a very short kind of binding and synapsis that we believe likely leads to this, the better safety profile.
So we'll see over time. But, you know, I know there's a lot of debate. At the end of the day, the data is really remarkable. You'll see next week more data, larger data set in longer treatment in patients. So I expect people will have more information to look at as they look through it. But I think it's more likely the construct and less likely the protocol for treatment.
So if it is best in class, are you guys thinking this is a peak sales that approaches $5 billion in those types of ranges, the types of numbers J&J put out?
Yeah, I mean, well, I mean, it's pretty simple. What we've said publicly is that the second- line plus opportunity for BCMA CAR-Ts is a $12 billion+ opportunity in second line multiple myeloma. I mean, maybe the other way to think about it, Umer, as you know, is we have about $2 billion of sales today with Yescarta and Tecartus in predominantly DLBCL, but also follicular lymphoma and a couple of other smaller indications. Those are much, and that's only 15% of the people getting those cell therapies that should be getting them in the United States. It's higher in Europe.
In multiple myeloma, there appears to be a much greater pull from physicians for curative cell therapy. And the multiple myeloma market is, you know, at least two times as big as the DLBCL market. So when you kind of think of the BCMA multiple myeloma opportunity in the context of what we're already doing with Yescarta and DLBCL, it's not hard to imagine a cell therapy getting to $5 billion and plus in sales.
Got it.
So again, I'm not providing specific guidance, but.
Makes sense.
You know, what I can say is we said earlier this year at our CAR-T Day that we think the second line plus opportunity for CAR-Ts is $12 billion+ , and I think that's consistent with what you've heard from some of our competitors.
Got it. So speaking of Yescarta, one of the things I noticed was a 7% drop quarter-over-quarter, and if I looked at U.S. more specifically, it goes from $250 million down to $208 million, which kind of got me worried a little bit. Can you speak to that dynamic? Is it just competition from other antibodies or other CAR-Ts, or is it something else happening?
It's both. I mean, I think that what's really happening is that you're not seeing the increase in CAR-T class usage in the United States that you should see with what appear to be curative regimens. And to put it in context, where I mentioned earlier, I mean, for those of you that don't follow CAR-T, I mean, you're looking at data with CAR-T in lymphoma patients that have been through at least two other therapies, in many cases, three or four other therapies. They have months to live, and 40%-50% of these patients appear to be cured after five years. It's incredible data. Only despite that, given some of the complexities of CAR-T treatment, and in particular, the fact that most of the treatment is done in academic centers or large city hospitals, only 15% of the patients in the U.S.
That should be getting CAR-Ts are getting CAR-Ts. If you contrast that to France, for instance, 40%+ of patients are getting CAR-T in second- line plus in DLBCL. So that's the real challenge. And you know, and so our job is to further the CAR-T penetration, not only in the academic centers, but in the community where 80% of the patients are today. And that doesn't happen overnight. And we need to get that 15% usage in the U.S. to 40% or 50% usage over time. In the meantime, to your point, there is increased competition both from one other CAR-T player in particular that now has greater manufacturing capabilities and availability and from some of the bispecifics. In each center, it kind of varies in terms of what's driving it.
The other thing that you see is there are lots of cell therapies that are in clinical studies that are competing for capacity at the transplant centers. And then finally, the multiple myeloma cell therapies, as they become more and more available, they're also competing for some of the beds in the treatment centers.
Is that Novartis competition on the CAR-T side?
No, it's more J&J and BMS in terms of the BCMA and the.
Okay, sorry. I thought I'm back on the Yescarta side.
No, no, no. No, I think that, I mean, the vast majority, if you look at lymphoma and Yescarta, the vast majority of the competition is between Yescarta and Breyanzi today.
And Breyanzi.
And then you have the bispecifics. Maybe just to kind of step back though in terms of, so in the short run, what we've said is you likely see kind of flat quarter-over-quarter sales in the fourth quarter. You'll see modest growth overall in 2024. But we do very much believe that the cell therapy business is a significant growth business over the next five years, 10 years, and 15 years. And that's not just anito-cel. That's our Yescarta franchise, the next generation of Yescarta. We also have cell therapies in I&I indications that we're moving into the clinic. And in glioblastoma, there's a really exciting cell therapy that we license from Penn. So there's a lot of growth drivers, but there will be both in the fourth quarter and in certainly at least in the first half of next year, continued headwinds in the U.S.
The other thing I should say, Umer, is the business is still growing beautifully outside of the U.S. We are seeing increased competition in some of the major geographies in Europe as well. But there's a significant push on our side to continue to build out our CAR-T sales and marketing effort outside of the major geographies in the U.S. and Europe.
Could some of these headwinds we're seeing in CAR-T business also replicate on Trodelvy next year with the ENHERTU competition?
I mean, it's a different, completely different dynamic, but we're already, you know, there's already, you know, Trodelvy has always faced stiff competition. With the ENHERTU launch, has been facing stiff competition. I, you know, again, we like cell therapy. We still see Trodelvy as a significant growth franchise for us over time.
In 2025 as well.
Yeah, it should grow in, yeah. And again, we'll provide more specific guidance. But the oncology business should continue to grow not only in 2025, but beyond. And that's both Trodelvy and cell therapy. We also have some important data readouts with Trodelvy in breast cancer, including in earlier lines, triple negative breast cancer, either coming out later this year or next year. We'll see if you could provide a significant further growth opportunity there.
When we look at ENHERTU and triple-negative, getting that indication overlap, could that meaningfully change competition and competitive dynamic next year?
It could, it will change the competitive dynamic, and we think it's manageable.
Okay, that will be baked into the guidance.
Yeah. And again, the data, for those of you that don't follow Trodelvy that closely, I mean, the data in triple negative breast cancer and the hazard ratio that you saw in the phase III studies with Trodelvy is really remarkable, as you know. So it's a very high bar for any competitor, including ENHERTU. And we feel really good about our competitive position there. The same thing's true in triple negative breast cancer, where I think we have strong data. There is more competition. I'm sorry, not in triple, in hormone receptor positive breast cancer, there's strong competition as well. But, you know, when you step back, again, short-term headwinds in terms of additional competition. In the long run, Trodelvy is very much a growth driver for us, not only in breast cancer, potentially also in lung cancer and endometrial cancer.
Got it. So then I guess as I think about next year, Part D reform hitting you in HIV, which takes the growth down over there. Oncology, you expect growth on cell therapy and Trodelvy, regardless of the competition. But the net-net overall for Gilead top line, could you remind us the thought process?
Yeah, I mean, we'll give more specific guidance early next year, but we expect the business to grow overall. I mean, the key next year is if you look at the growth of the business prior to the overlay of Part D, you should expect to see strong growth in the business, just like you did in 2022, 2023, and this year so far. So just to remind people, our base business grew 8% in 2022, 7% last year, so far this year, and you saw it in third quarter, relatively similar growth, very strong growth, including in the HIV business. All of that will carry forward into 2025. You then have the overlay of the Part D reform, which will offset most, if not all, of the growth in the HIV business. That has been our guide.
So the overall business will grow, but the growth in that year is obfuscated, so to speak, by the Part D reform. And then in 2026 and beyond, you'll be able to see that growth kind of from a year-over-year basis again.
Okay, so you do expect overall business to grow next year?
Yes.
Okay. I'll tell you why I was sort of really focusing on this, Andy. So the overall business growth, at least as per consensus numbers, is like sub-$500 million, more like $300 million to $400 million year over year, net of all the Part D reform and all of that. However, oncology growth is $500 million, meaning the oncology growth being modeled by consensus for next year exceeds the overall growth for the business.
Now, oncology is primarily, I'm thinking Trodelvy and cell therapy. Both of them have this competitive dynamic going on. So I guess I'm just thinking and trying to stress test the model. Could there be a scenario where Trodelvy's kind of flat because of ENHERTU competition and then cell therapy could theoretically have a flat scenario as well? And if those dynamics happen, then there's not growth next year. I guess will the low end of the guidance range try to incorporate some of those challenges as well?
Yeah, I mean, I guess what I'd say is you have to hold some of those questions until we provide specific guidance. I mean, all I can say is what I've already said, which is that we have three separate franchises, all of which we expect to grow overall through the end of the decade and beyond. And, you know, the other thing maybe just to highlight in terms of your question is we have two launches, one of which is underway with seladelpar that should drive growth really that you'll see meaningfully starting in 2025.
There is growth in the third quarter. There'll be growth in this quarter, but it's harder to see as you move through all the step edits and to get patients on this rare disease therapy. And then obviously the launch in HIV of lenacapavir for HIV prevention is coming a little bit earlier than expected. So that will go into our calculus as well.
So that's late next year?
It was late next year and now we've updated our guidance to highlight that we expect to launch lenacapavir in the summer, so we're, you know, making significant progress in terms of PrEParing the regulatory filings and having very productive discussions with regulators.
Got it. Excellent. On seladelpar, if there's one confusion I've had is I know there's a sales expectation. I think consensus is at about a billion or so. I think there was an 8% royalty to J&J or.
This was peak sales?
Peak sales, yeah. A billion or so. There was an 8% royalty. I think that was baked in. But that royalty sale that happened from J&J for only $300 million really, really confused me because that implies peak sales are materially less than that. And I was not sure what happened.
Yeah, well, I think, I mean.
Or is it the imperfections of the royalty market?
Yeah, it's more of a. I mean, that's more of a question for J&J on their view. I mean, obviously, I mean, we paid $4.3 billion for the company. We've said consistently that we think PBC is a much bigger opportunity than the market appreciates based on historic sales. I've talked a lot about the analog of the pulmonary hypertension market. These are very similar markets, similar size, similar pricing, large orphan disease. So, you know, that was a great. I mean, the royalty sale is simply just a great opportunity for us to clean up a royalty at a price that we found very attractive relative to our expectations. So, you know, I can't speak for J&J in terms of what they were thinking. It was great. It's a company that we've had a long relationship.
Were you guys surprised about the price you were getting?
I mean, I don't know that we were surprised, but I mean, it was a price that worked for us, right? It worked for them and it worked for us. So I think it truly was a win-win. I mean, look, they're a very sophisticated company and a longtime partner of Gilead. We have nothing but great things to say about them and their team.
Got it. Maybe in the last few minutes, some of the programs that are a bit more under the radar beyond HIV, beyond some of the core programs, alpha-4 beta-7, are you guys, how are you guys sort of messaging around that, the oral?
Yeah, we have an oral small molecule, alpha-4, beta-7 that we've developed. We believe it has best-in-class profile. It's in phase II studies. Now, it's actually one of many inflammation immunology molecules that we've developed that are in phase II studies and that there really isn't a lot of attention paid to them. The alpha-4, beta-7, obviously it's a validated target with the Entyvio sales. There's one oral small molecule competitor that Eli Lilly recently purchased. You can imagine, as with all of our molecules, we do a lot of benchmarking in terms of making the molecules and looking at them.
I think when we look at the selectivity profile of our molecule and the selectivity for alpha-4 beta-7, if I remember correctly, as well as the potential for once a day, once daily dosing, which we think this molecule will likely have, we're really excited about it. It may be something that we want to partner with another large company at some point in terms of looking at combination therapy, so a lot of what we're doing in immunology, if you look at the, whether it's our IRAK4 programs, we have a TPL2 program, alpha-4 beta-7. These are all small molecules that could potentially be combined with other molecules in the I&I space and potentially taken forward as combination therapies.
The oral GLP-1, I think your messaging has been very guarded. Let's take it to the.
Yeah, it should continue to be guarded.
Standard GLP-1-like scaffold. We'll see how the phase I profile looks.
Yeah, I mean, it's a unique molecule that just started phase I. It crosses the blood-brain barrier, which could be, it could be something that's a positive. It could be a big liability in this space. So we are in the middle of the phase I study. We'll have data next year into 2026, depending on kind of where this goes. Again, we've said consistently, we've set cautious expectations here. It's a phase I molecule. It's a very competitive space. I think our CEO has said, you know, we would only take it forward if we think it has potential to be best in class. And even then, if it goes forward, we'd probably try to find a partner for it, given kind of the commercial effort that would need to be behind it in the metabolic space.
Got it. Andy, I've heard buzz in the industry that this molecule hung out in preclinical for longer than usual, which theoretically would mean there was something around safety that was being navigated around. Is anything like that?
No, I think it was more of just how we were allocating our resources over time. Yeah, and prioritizing. I wouldn't read anything into that. I mean, look, the alpha-4 beta-7 has been in our pipeline for a long time too. And, you know, it's all about making sure that we're allocating our R&D dollars to the programs that we think have the highest probability of success and make the most sense for us. So, yeah.
Got it. Maybe last minute, the quick one for me is, and if there's any questions from the audience, we'll take those as well. But my last one is, can you remind us the TAF case? Where do we stand now? Is there like a Supreme Court date that's getting posted?
The Supreme Court decision in California should come later this year. So just to remind people.
Without a hearing.
I believe there will be an oral argument and then you'll get the decision.
When you say late next year or.
Yeah, next year. I'm sorry. I'm sorry. I'm already moving. Yeah, I'm already moving into 2025. Sorry, sorry. Yes, thank you.
The decision is late 2025.
Yeah, I think I don't know what we've said specifically. I think that the briefing documents in the Supreme Court have been filed. Where we are right now is there are a number of amicus briefs that are being filed, which is really encouraging. Again, you continue to see groups even outside of the pharma industry filing amicus briefs saying that this theory of action makes, you know, doesn't make sense, would be really problematic, not only for the pharmaceutical industry, but others. The other thing, you know, we entered into a settlement agreement with the federal cases, which gives you a very good sense. So again, we have utmost confidence at the end of the day that California Supreme Court should throw out these cases and the causes of action. The fact that the Supreme Court took it for review, we find, you know, is really encouraging.
There's a lot of support from other companies. And then again, worst case scenario, you see kind of what happened in the federal cases. This is very manageable from our perspective. So the federal cases were settled.
Is there any hearing coming up in any case prior to the Supreme Court?
No, I think all the cases, if I remember correctly, all the cases have been put on stay until both the federal settlement is finalized, and that requires we have the ability to, you know, the settlement is not binding on Gilead until we get, I believe it's 96% or 98% of the plaintiffs in the federal case to sign onto it. I think we're close, but not quite there, and then on the state cases, as I understand it, they're all stayed pending the Supreme Court review.
Excellent.