Thanks for joining us, everybody. I'm Terence Flynn, the US biopharma analyst here at Morgan Stanley. Before we get started, for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. Very pleased to be hosting Gilead this afternoon, sorry. And we have joining us, Dan O'Day, the company's Chairman and CEO, and Andy Dickinson, the company's CFO. Thank you both for taking time out of your day to join us.
Pleasure.
I really appreciate-
Thanks for having us.
Appreciate the time. Maybe we'd start, I thought, high level on kind of strategy. Obviously, you know, you've both been in the seat for several years now, and you've been reshaping and diversifying the company's portfolio and pipeline. So as you look out, maybe just help us think about that transformation journey that you've taken as a company, and what's the next phase here for Gilead? And, like, do you think you've made all the necessary investments, or is there more work to do as you look at the next, you know, medium to longer term here?
Yeah, great. Thanks, Terence, for that opportunity. Happy to start and have Andy add, so thank you for your interest in Gilead as well. When I came to the company around five years ago now, I think the team and I set across a strategy to look at a more sustainable, diversified Gilead for the future, right? That was our objective. And within that context, you know, that meant sustaining, and actually, I think we've made a lot of progress not only sustaining, but growing our HIV business, but diversifying then into other therapeutic areas as well. So core to that strategy and to your point, Terence, I mean, you know, we made key investments that have allowed us to kind of make really a lot of progress along that journey.
Everything I'm gonna speak about now is a result of those key investments. The first one is, you know, virology and HIV in particular. And obviously, the recent news on len for PrEP is extraordinary for people that could benefit from PrEP, and also for the company as we think about our longer-term ambitions in HIV. It allows us to kind of rethink the entire PrEP market from both a market size, market share, adherence standpoint, and so it's really a whole different lens at the PrEP market. And of course, within that virology sustainability comes then the long-acting treatment market, which we'll update you on a little bit further at an investor event later this year.
But suffice it to say that we're really encouraged by the variety of options that we have across that long-acting treatment market, from even an alternative to a once-daily oral, to a once-weekly oral, to potentially a once-monthly oral, to once every three and six-month subcutaneous injection. So over the course of this period of time, when we think about that sustainability part, with the kind of the nearest major patent cliff being 2033 with Biktarvy, and by that stage, having a very less concentration risk on Biktarvy because of everything I mentioned, we see this growth potential in our sustainable business well into the late 2030s. And then at the same time, on a diversification strategy, we spent, you know, a lot of time diversifying the portfolio. Let me first just talk about clinically where we're at.
So we're at a portfolio now that has 36 clinical stage trials going on right now in oncology and inflammation. We have 16 others in virology. And what you see here is, I think, you know, a real opportunity to think about our portfolio in a very different way than you did five years ago. And just talking about some of the, you know, the near-term issues, we've got, you know, Trodelvy, an earlier line to breast cancer, lung cancer, and some other indications. When I turn my attention to cell therapy, in addition to the work we still have to do with Yescarta and Tecartus, the opportunity in multiple myeloma is significant.
I mean, a large market with a differentiated product, with our partner, Arcellx, with a world-class manufacturing, delivery, turnaround time organization on multiple myeloma. Then, you know, maybe the last thing I'll say is, you know, on the portfolio, and then I'll turn to kind of the commercial and near-term launches, is that we built up a phase II portfolio in oncology and inflammation. It's very different than five years ago, with some very, very interesting kind of novel mechanisms in there in inflammation, alpha-4 beta-7, TYK2, and then in oncology, CCR8. Those things are going to come through the pipeline as we continue to look at also supplementing that appropriately with some bolt-on M&A and BD. On the commercial side, again, I think the organization has really focused on delivering quarter after quarter.
You've seen it in our results and our base business, which is the way we kind of measure the durability of our business moving forward. We're really excited about the upcoming potential launches that we have on top of our strong base business that's going on right now. I'd point your attention to seladelpar, now called Livdelzi, still rolling off my tongue almost completely. I think a really significant opportunity in PBC with a differentiated product, and Andy can dimensionalize that a little bit more as we continue the dialogue. Getting ready for lenacapavir for PrEP, and getting ready for multiple myeloma. So we have a lot, and I would say the pull through on the cell therapy business with Yescarta and Tecartus, we're still in the first couple of innings there on the commercial side.
So we're keenly focused on delivering that commercial execution. All of this against the backdrop of a changing investment landscape in the business. We appropriately, I think, invested significantly over the past few years to create this clinical and commercial reliability, sustainable and diversified machine. But now you see our discipline at this level is leveraging our P&L, particularly in the operating margin expense, and delivering now to the bottom line, like you saw in the second quarter. While you know, we'll continue to invest in the business, we're at a level now that you can see the leverage that's coming to our model. So bottom line is, you know, I think the journey is not done. We have more to do.
We're five years into probably a decade-long transformation, but the progress is tangible, and we're committed to that.
Okay, great. Great way to start it off and frame everything. I guess the, you know, one area is you have been active in business development, including, you know, seladelpar was, I think, the most recent one. How important is that on the forward now, or do you feel like you have enough substrate, you know, through what you've done and also your internal pipeline to kind of run at steady state from here?
Yeah, let's get Andy.
Yeah, I'm happy to jump in and start. Again, thanks for having us. I'd say the simple way to think about corporate development is that the next five years and beyond will be, in terms of both the amount of capital allocated to corporate development and the types of deals that we do, different by definition. Part of it all goes back to Dan's point, that five years ago, we had to rebuild the pipeline from the ground up, and we had to really lean into external opportunities, both ordinary course licensing and acquisitions. You fast forward to where we are today, we have a much deeper, richer pipeline that Dan alluded to. We have a number of programs coming up through the pipeline, many of which have been developed internally.
I'll use an example, our oral alpha-4 beta-7 in immunology that is in phase two. We have a TYK2 inhibitor. We have a number of programs that will require additional resources that we're excited about that supplement our deep late stage pipeline. So we will add to it over time, but it'll be more ordinary course licensing deals. We'll keep doing that. As things come into the portfolio, other things will be coming out of the portfolio. We'll maintain the tension in the portfolio to make sure that we're taking the most promising programs forward, and we will supplement it with M&A over time. I think the seladelpar acquisition from CymaBay is a great example of the types of deals that we wanna do. Late stage, de-risk, high probability.
We believe it's a misunderstood market that has significant potential for us to develop roughly over the next decade and maybe beyond, as we think about life cycle extension and a lot of synergies in that deal, so you know, we had to build out the rest of the company, but you know, if you just step back today, we now have three growing franchises. We have a growing HIV business that's gonna see additional growth, both in PrEP and long-acting treatment. You have a liver disease portfolio with hepatitis and now Seladelpar and PBC, where the hepatitis, viral hepatitis business has stabilized. It's even been growing a little bit. Now, you layer on meaningful growth from Seladelpar, and you have a growing oncology business, both in Kite and here.
We will add to all of those through corporate development, but again, at a, you know, probably a slightly slower pace and certainly using much less capital, I would expect, going forward, than what we had to do to rebuild it over the last five years.
Yeah, well said.
Okay. Okay, great. You know, there's a transition at the CMO level at Gilead now. So what are you looking for in terms of filling that position? Kind of qualities, experiences, as you think about the next hire you're gonna make, a pretty important role.
Yeah, terrific. I wanna thank Merdad. I think, you know, the first five years of the journey, you know, his skill set around, you know, deep experience in development, early development, late development across therapeutic areas, helped us build the portfolio side of the business, but equally, kind of the infrastructure within the business. You know, we now have a very, very, functional business outside of HIV, which was Gilead's sweet spot in oncology, in inflammation, in all the disciplines we need to be successful, both clinically and commercially. So as we think about kind of, you know, the baton handing off to the next CMO, it'll be somebody who's got, you know, very strong experience in development, late stage development across the therapeutic areas that we are focused on.
Somebody who can take, you know, an organization that is still relatively new in some of those new therapeutic areas and refine those and bring them to a state of excellence that we need them to be at to deliver. I'm really pleased with the level of inbound interest. It's been extraordinary. I think it says a lot about what the team has done at Gilead over the past five years. And so we're well into the interview process, and, you know, we're looking for this transition sometime later this year or early next year, so stay tuned.
Okay. Okay, great. Okay. I guess more on kind of the business side of things, probably more, a question for, for Andy. Just, you guys have already commented on the Part D headwinds as we think about 2025, and again, I think, Dan, you maybe alluded to this. How are you thinking about operating margins for next year? I mean, you mentioned, you know, a lot of the ramp is gonna happen, so seems like, you know, any leverage would be driven by kind of top-line growth, but, would love your perspective here as we get closer to 2025.
Yeah, I mean, we do expect to have top-line growth next year. Some of that will be masked by the Part D reform. I mean, again, to put it in perspective. As I said, we now have three growing franchises. The base business grew 8% two years ago, 7% last year, 6% plus this year. You should see accelerating growth with all the launches through the end of the decade. All of that will give us leverage, and then you overlay, as Dan mentioned, the rigorous cost containment. Now that we have our expense base at a level that we think allows us to sustain innovation and maintain growth and new product launches over time, you see significant expense moderation over the last three quarters.
The second quarter, Terence, as you know, is a great example of we beat on the top line by 3%. Our expenses came in 12% below expectations, and we beat on the bottom line by 25%. We had a 47% operating margin, which had improved, I think, from 42% the prior quarter. It just gives you a sense of how much leverage we have in the model. So, even though, you know, to your point on 2025, some of our growth will be offset by the Part D reform next year, and then we'll grow right through it. Beyond that, we still, you know, are targeting growth in the bottom line. So more to come, we haven't provided guidance yet for 2025, as you know, but we're always thinking about...
You know, we're entering a new chapter going forward of not only growing the top line, but also pulling it forward on the bottom line for the benefit of our shareholders.
This was always planned.
Yes.
I mean, Andy and I always had this plan that in order to get to the sustainability and diversification, there was this period of time of, you know, somewhat overinvestment, and then, now we're in the optimization kind of leverage standpoint.
Okay.
So this is what we expected to be, now we're implementing and executing on that.
How does the dividend fit into that, if you're getting more leverage on the bottom line, higher free cash? Like, how do you think about dividend growth?
Yeah, we've been entirely consistent on the dividend. We're, you know, we have a strong dividend. We expect to grow the dividend over time. You've seen that. You know, and I mean, we're committed to the dividend. We'll continue to grow it. Nothing's changed on the dividend. I think we generate so much free cash flow in our business, and you've seen it vary over the years, but anywhere from $8 billion-$12 billion a year in the last five years, if I remember correctly. Our cash builds back up quickly. You see that, you know, post the CymaBay acquisition. You'll see that through the rest of the year. It gives us a lot of flexibility. We target returning at least half of that to shareholders every year through the dividend and share repurchases. But over time, and it...
Kind of tying it back to my earlier comment on, you know, we will do additional BD and corporate development, but our cash will build up so quickly. We may have opportunities to return additional cash to shareholders, either through opportunistic, you know, one-time dividends or share repurchase, but all of that will be determined by kind of the board down the road. But, you know, there's no doubt we are very healthy from a financial perspective, and we see kind of with the accretive, the strong growth profile going forward, that should absolutely continue.
Okay. Great. Maybe moving on to, you know, lenacapavir, obviously, very exciting data in PrEP, as you talked about, Dan. The second study, PURPOSE 2 , is coming out here, I think, later this year, early next year. It is a slightly different population, and so I think one question people have is just how to think about efficacy in this population versus the PURPOSE 1 trial and any, you know, differences we need to consider as we get ready for the next readout.
Yeah, absolutely. And look, I think when we design this total PURPOSE program, there's five studies in the program. It is the most comprehensive program in terms of looking at people that could benefit from PrEP over that period of time. And I'm proud of the organization that, you know, we led and started with perhaps where the need is greatest, sub-Saharan Africa, among cisgender women, and seeing that 100% efficacy. It's hard to overstate the enthusiasm and the impact potentially for public health. Now, the entirety of the PURPOSE program... And it bodes very well for the other PURPOSE programs. So, you know, the PURPOSE programs, and PURPOSE 2 in particular, is designed similarly to PURPOSE 1.
In other words, the objective is to show a difference between lenacapavir twice a year versus background HIV infection rate. I won't get into all the dynamics, but you've seen Purpose One, and you know that system works and that trial design works. Now, while the background HIV incidence rate for Purpose Two we expect could be lower amongst this population of largely men that have sex with men in different countries than Africa, we still think that given the profile of lenacapavir, that will bode very well against whatever the background rate is. And the secondary endpoint is comparison of lenacapavir to Truvada, where we know there's always adherence challenges with taking a once daily pill. So that data will come late this year, early next year. That forms the filing package.
You know, most experts that we talk to at IAS and elsewhere say, "You know, we already know the product is there, but regulatory-wise, we'll need both of those to file and move ahead." So I think we're, you know, we remain very optimistic about the impact this could have for the HIV epidemic across the world. Again, I would just point out that we really, with this PURPOSE program, have to rethink the way you think about PrEP, because today it's used in a really very small percentage of the population that could benefit. It's almost completely United States, it's urban areas, it's MSM communities, and it's those that are educated and kind of in the know, and that's roughly around, give or take, around 400,000 people that benefit from PrEP.
So the opportunity to think about market size expansion, new populations, new prescribers, new geographies, connected with market share, Descovy and Len, connected with adherence, which today is roughly plus or minus 50%, and that's hard to get your arms around because of the use of PrEP on demand and the oral setting, but we know that the adherence will go up significantly from where it is today to what we saw, for instance, in the PURPOSE 1 study. So there's lots of ways to build out the concentric circles of how this PrEP market expands over the coming years.
Yeah. Okay, great. One input, there's some questions on just pricing. Obviously, you have a set point with Sunlenca in the treatment side. Now you have the same drug in the prevention side. These are different markets, and as you said, different kinda segments, likely different, you know, payer mix, et cetera. So how do you approach that pricing decision, on the PrEP side, given you already have an established price in the treatment?
Right. So we haven't discussed exactly, obviously, how we're gonna price Len for PrEP yet, but what we have said is we're not going to use the heavily treatment-experienced -
Okay
experienced patients as the benchmark as a comparator, if you like, for our pricing. We'll be using PrEP comparators for our pricing, for Len, for PrEP pricing. I think that's about what we can say right now at this stage.
Okay.
With a focus on access and expanding that population.
Right.
I mean, that's key.
Yep. Yep. What... I mean, how do you change that payer mindset? 'Cause again, I've been surprised that there's still generic Truvadas about half the market right now in prevention. So what is kind of the totality of the-
Sure
argument that you guys are bringing to the payers now, so that some of those barriers come down? 'Cause when we talk to some of the payers, they continue to think that, you know, generic Truvada is a good option, despite, you know, the adherence challenges. And so how do you convince those that are still, you know, prioritizing that as kind of like a, it's not really line of therapy, but as a, like, frontline option, and convince them that, like, you know-
Sure
... once every six months is the better one to go with, and-
Yeah, I-
- change that dynamic?
Yeah, it's a great question, and I think it's relatively straightforward. I mean, it's the clinical data. I mean, the PURPOSE 1 clinical data shows definitively, and you saw this in one of the competitor studies in long-acting PrEP also showed, that even though the orals work very well, if they're taken daily, they're not taken daily in the real world. In fact, they're taken 50%, in some patients, less of the time, some patients more, but you don't get the same benefit from an efficacy standpoint. So you have, you know, a great safety profile from lenacapavir. You have extraordinary efficacy, 100% efficacy, as Dan highlighted. You can't do better than that.
It gives us a very strong argument, and there's a strong pharmacoeconomic argument as a result of that as well, which not only we think will resonate in the US, but it should resonate outside of the US, where Dan said there's a real opportunity to bring HIV prevention to Europe and Asia and other markets. The best analog... Remember, I mean, if you go back when we launched Descovy, when Descovy was approved for prevention, I think it was roughly three and a half years ago, and Truvada went generic, you know, we had we maintained very high formulary access for Descovy over time. And the level of innovation, I mean, Descovy, the data, especially in long-term chronic treatment, there is a significant difference and benefit of Descovy in a certain smaller number of patients, with some of the side effects. The
But we were able to maintain formulary access with Descovy, with a level of innovation that what we're talking about was a little bit different. What we're talking about here is a step function change in innovation. One of our shareholders used the analog in treatment, moving from the multi-pill regimens to Atripla in two thousand and six or two thousand and seven. That was a complete game changer for the treatment market, and you saw that both in terms of the access, but also what it did to open up the market. And I think it's not a perfect analog, but it's a good analog for what we're talking about here.
But the simple answer is, you can't do better than the PURPOSE 1 data, and that should give us a very strong, you know, set of, you know, talking points with the payers, not only in the United States, but globally. I mean, maybe two quick add-ons-
Sure
... 'cause I agree with that. I mean, one is, remember, this is a community whose voice is heard strongly amongst payers, and it's a... And when you have this type of data that could potentially have, you know, complete prevention of HIV, I think that'll be taken into account. And so we don't expect that we're gonna have, you know, a lot of confrontation with payers over this. And the other thing I would say is, you know, outside the United States, where there really hasn't been a lot of appetite for reimbursing anything other than generic, you know, PrEP, and even there, there's been limited appetite. With the Purpose One data, we're starting to have conversations with other countries that say, "Oh, wait a minute. Now, this is, this is really different." And those are highly HTA, of course, driven countries.
You know, I think to Andy's point, the data will change the economic discussion in a way that I think will be very, very beneficial to countries around the world and people who could benefit from PrEP.
What does that ex-US market look like? I mean, you talked about 400,000 in the US, you know, expanding from there, but what's the theoretical relative size of kinda, you know, G7 or whatever, that you'd look to, to kinda build out?
I mean, probably the way to think about that, just in terms of how you might model this, is to first think just about in the United States, because of the 400,000 patients today... And if you were to think about that as a totally branded market, that'd be a $3 billion plus market today-
Yeah
... right? And then, if you were just low-hanging fruit, think about getting the adherence from 50% to greater, you know, penetrating that market further, you can, you know, that, that could go to a $4-$4.5 billion market at that stage. So I think the U.S. will continue to be a disproportionate size market for HIV PrEP, without a doubt. Back to your G7, I mean, you know, the populations, I think everybody understands there. It may be different country to country, so we'll see where that goes, and we'll see how that plays out. But I do think, you know, you have to think about this both in terms of expanding users, prescribers, and geographies to do the math completely. I don't know if you want to add?
Yeah, I mean, I would just add that the 400,000 plus patients or people that are taking these are people taking PrEP today, and we would, you know, both in it's in a very narrow population, and to Dan's point earlier, that's the starting point. So the way to think about the 400,000 patients or whether that's, you know, $3-$3.5 billion branded, then you add on the compliance, it's a $4-$4.5 billion dollar opportunity out of the gate to take people that are using PrEP today, to convert them as quickly as possible to a better long-acting option, and then you grow the market from there.
So your question on Europe, you know, the market in the United States should expand substantially, both in the traditional market of men having sex with men, but into women. Anyone at risk of, you know, that has multiple sexual partners is a target, is an opportunity to prevent HIV spread there as well, and then outside of the United States. So I mean, the starting point in the US is bigger because of the use of PrEP, but the size of the market, both in the US and outside of the US, is much, much larger than that number today. And we have years to kind of build that market over time. It will be a unique market to build, but there's a good starting point.
It will take years to build.
Yeah.
Okay. Okay, great. Maybe just one more before we go over to oncology is just, you know, Biktarvy. I think the patent in the US expires in twenty thirty-three. You guys are working on once-weekly oral regimens. You know, you talked about the innovation, going back all the way to the initial single tablet regimen that Gilead introduced. Is a once weekly oral another enough of a step function change to kind of continue to transition the market over? Or there-
Sure
... You have to get to a once every four month or something, the treatment-
Yeah
-side or six months.
It certainly, for some patients, is a step function change. Again, market research will suggest this. This is, you know, relatively straightforward, but, you know, a once monthly oral is probably more desirable than a once weekly oral. It all depends on the patients, but maybe the big picture that's important is we have line of sight now with our programs that are either in the clinic as potential partner agents for lenacapavir or agents that will be coming into the clinic. Remember, lenacapavir is unique, and it's so potent, and we've already formulated it as a once daily pill, a once weekly pill. We can formulate it as a once monthly pill, or a prodrug of it, every three months subcutaneous, every six months subcutaneous, and maybe every twelve months.
So then it's all about finding partner agents for treatment so that you have at least two different drugs on board. I would say today, you know, we are focused on all of those. We have two programs that are once weekly pills. One's in phase III in partnership with Merck. One is a wholly owned program in phase II. Both of those are exciting. Our wholly owned program includes our proprietary integrase inhibitor that we think is really exciting. That will be a meaningful step function change for some patients. We have, I'd say today, our scientists would say that we are much closer to a once monthly pill for treatment than we thought we'd be 12 months ago, which is exciting.
And then we have a number of agents in the clinic or coming into the clinic for the long-acting subcutaneous treatment. So all of those will be step function changes. The every six months injections, or, or every year, if you can get there, and the once monthly pill probably are the, the biggest opportunity for step function change, but all of it is additive to our business.
But along that journey, we've said we could have the len for PrEP approved as early as very late 2025.
Yeah.
Potentially alternatives for treatment, including the once daily BIK/LEN or the once weekly orals in 2027. Some of this is nearer term, some of this, but you know, the space moves quickly.
Right.
I guess my point is, you know, I think by the time we get to a patent expiry of Biktarvy in 2033, we will have reduced the concentration risk significantly on Biktarvy in the treatment population with a variety of different options.
Okay. Understood. Maybe moving on to oncology, just as we think about the forward outlook for Trodelvy, is that still the cornerstone of your strategy here in oncology?
Yeah, look, I think when you think about our oncology business today versus what it was three years ago, it's now a three billion run rate business when you look at both cell therapy and Trodelvy, and it's generating about half of our quarterly growth on that line. So you know, I think about the holistic nature of our oncology business. I think about the cell therapy opportunity at around two billion today. We're still in maybe the first or second inning of where we can go with Yescarta and Tecartus, because you know, it's still penetrated in a small percentage of patients who could benefit from this potentially curative therapy. I think about multiple myeloma as a potentially you know, near-term opportunity with our world-leading cell therapy business.
I think about Trodelvy in breast cancer and moving up in earlier lines of breast cancer and expanding into other tumor types, including potentially lung and also cancers like endometrial. I think also about the Arcus optionality with our silent TIGIT program and other oncology programs within our Arcus collaboration. I think about the holistic nature of an oncology business that is still developing, still very early, with lots of optionality as data readouts come.
Okay, great. Maybe just to drill in on the Trodelvy dynamics, here is, you know, obviously there's some competition from Enhertu. You have, you know, Dato-DXd potentially coming. So just confidence level in the breast cancer setting and continuing to kind of grow that opportunity. And then the kind of somewhat related question is lung cancer, you mentioned, Dan. This obviously second-line setting looks like not going forward. First line trial, ongoing confidence level in the first-line lung setting. So kind of two-part on Trodelvy.
Sure. So look, in breast cancer, and you've seen some of this data, but first I'll remind you, we're the only Trop-2 ADC approved in breast cancer, triple-negative breast cancer, hormone receptor-positive, HER2-negative. They have very different dynamics, those two indications in breast cancer. In triple-negative breast cancer, we see, you know, strong market share uptake in second line and beyond. We've got the data readout, or an update, I would say, on the first-line triple-negative breast cancer later this year. So we'll give you an update on that. And back to your point, I mean, that roughly doubles the patient population as you go from second line plus into first line with triple-negative breast cancer. We'll see how those results play out.
And we have the same type of, you know, desire to move up in lines of therapy and hormone receptor positive, HR-positive, HER2-negative. Thankfully, for patients, it is competitive. There's a lot of options, and currently with Trodelvy, we play in the IHC0 population there well or perhaps after other therapies in lines of therapies. But we think ... And that's IHC0 is around 30-35% of that HR-positive, HER2-negative. We have studies ongoing to see how we'll perform in earlier lines of therapy, particularly in the IHC0 population. So I think that's kind of the breast cancer opportunity.
Again, as you move up in lines of therapy, increasing the patient populations, and we still have a lot to work to do to, you know, change the, you know, the chemo preference kind of that's been developed over years in both these indications. But the OS data is a strong data to kind of change those patterns and those behaviors. Lung cancer, again, I believe that what you saw at ASCO this year on the EVOKE-02 data, which is the phase two program in second-line lung cancer, and in particular at ASCO, you saw the PD-L1 high expression population, where we combined Trodelvy with Keytruda in the first-line lung cancer, gives us a lot of confidence around the ongoing EVOKE-03 trial, which again, is in that PD-L1 high patient population.
You're gonna see a bit more data on the broader attribution of Trodelvy in non-small cell lung cancer at World Lung, coming up, different cohorts. But I would say one of our strongest potential opportunities is in that PD-L1 high with the ongoing EVOKE-03 trial. So we'll be data-driven around this. We continue to have a lot of confidence in Trodelvy, where we've seen its impact and effect in the OS data that we have in our hands, and we'll build upon that because Trodelvy as a medicine within our portfolio, could potentially be combined not only with PD-1, PD-L1, we'll see what happens with TIGIT, but there's possibilities for multiple different combinations with Trodelvy moving forward.
Okay, great. Maybe just in the last couple of minutes, because again, another focal pipeline asset, anito-c el in myeloma. Again, you referenced this in your opening remarks here. You know, remind us kind of the target profile that you're aiming for in this upcoming, you know, pivotal data set. And again, I think you guys have confirmed that will be at ASH, but maybe just remind us kind of how you're thinking about the profile.
Sure. Yeah, no, I'm happy to take it. This is a really exciting program, partnered with Arcellx. It's a what we believe looks like a next-generation BCMA cell therapy that's currently in fourth line plus study. We just started a second line plus study as well. At ASH this year, you're gonna see the first set of data that we believe will kind of as a more apples to apples data comparison against the CARTITUDE-1 study from one of the approved competitors. So it's very exciting. I mean, so far we are seeing really strong efficacy, including in the phase one study of roughly thirty-eight patients, I believe. Incredible efficacy and really difficult to treat patients, including those with a lot of extramedullary disease.
Most importantly, and we reiterated this on our second quarter earnings call, and Arcellx did as well, we have seen no neurotoxicity to date, and we've treated enough patients. You typically, as I understand it from our clinicians, see the development of neurotoxicity the first month or two after treatment. You know, we had the original phase one study. We're now well through kind of the second study. It's a much bigger study that we'll be presenting at ASH and have not seen any neurotoxicity to date. So there's a lot of excitement. I mean, what we've always said is it's a very big opportunity for us and Arcellx, even if we're just as good as the existing approved cell therapies.
If we're better on efficacy or safety, let alone both, which we think we have the possibility to be, you know, it's even a bigger opportunity. Order of entry, I said this recently in another forum. Order of entry is less important, I think, in cell therapy, given that this is a one-time bespoke treatment. And so if you have a best-in-class asset and one that you can manufacture quickly and reliably, which we, as you know, Kite has the world's best cell therapy manufacturing. It's really an incredible competitive advantage for us. Really gives us a lot of conviction around the size of the opportunity. So we're, you know, to be clear, very excited about it. Look forward to sharing data at ASH and think this could be another big growth driver for us in our oncology portfolio.
Great. Well, I think we're up against time, but.
Sure
... Thank you, Dan. Thank you, Andy. Really appreciate it.
Thank you.
Thank you for having me.
Thank you. Appreciate it. Thank you. Thanks, Andy.