Gilead Sciences, Inc. (GILD) Morgan Stanley 22nd Annual Global Healthcare Conference (Transcript)

Gilead Sciences, Inc. (NASDAQ:GILD) Morgan Stanley 22nd Annual Global Healthcare Conference September 5, 2024 12:20 PM ET

Company Participants

Daniel O’Day – Charman & CEO
Andrew Dickinson – Chief Financial Officer

Conference Call Participants

Terence Flynn – Morgan Stanley

Terence Flynn

Thanks for joining us, everybody. I’m Terence Flynn, the U.S. 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.

Daniel O’Day

I really appreciate having us here.

Question-and-Answer Session

Q – Terence Flynn

Appreciate the time. maybe we’d start, I thought high level on kind of strategy. Obviously, 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? Like do you think you’ve made all the necessary investments? Or is there more work to do as you look at the next medium to longer term here?

Daniel O’Day

Yes, 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 we set — the team and I set it across a strategy to look at a more sustainable diversified Gilead for the future, right? That was our objective. And within that context, 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 — and to your point, Terence, I mean, we made key investments that have allowed us to kind of make really a lot of progress along that journey. And everything I’m going to speak about now as a result of those key investments. The first one is 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 in an alternative to a once-daily oral to once weekly oral to potentially 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 the 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 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, 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 near-term issues, we’ve got Trodelvy in 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. And then maybe the last thing I’ll say is on the portfolio, and then it’ll turn to kind of the commercial and near-term launches, is that we built up a Phase II portfolio in oncology 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, TPL2 and then an 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 in our base business, which is the way we kind of measure the durability of our business moving forward. And we’re really excited about the upcoming potential launches that we have on top of our strong base businesses 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 len 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 we’ll continue to invest in the business, we’re at a level now that you can see the leverage that’s coming through our model. So bottom line is, 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.

Terence Flynn

Okay. Great way to start it off and frame everything. I guess the one area is you have been active in business development, including 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 through what you’ve done and also your internal pipeline to kind of run at steady state from here?

Daniel O’Day

Yes. Let’s get to Andy’s…

Andrew Dickinson

Yes, I’m happy to jump in and start. Again, thanks for having us. I’d say that 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 will be different by definition. And part of it, 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 II. We have a TPL2 inhibitor. We have a number of programs that will require additional resources that we’re excited about that supplements our deep late-stage pipeline. So we will add to it over time, but it will 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 want to do, late-stage, derisk, 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 we had to build out the rest of the company.

But if you just step back today, we now have three growing franchises. We have a growing HIV business that’s going to see additional growth, both in PrEP and long-acting treatment. You have a liver disease portfolio with hepatitis and now seladelpar in 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 — 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.

Terence Flynn

Okay. Okay. Great. 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 tier you’re going to make a pretty important role.

Daniel O’Day

Yes, terrific. I want to thank Merdad. I think the first five years of the journey, his skill set around 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. We now have a very, very functional business outside of HIV, which was Gilead’s sweet spot in oncology and inflammation and all the disciplines we need to be successful, both clinically and commercially.

So as we think about kind of the baton handing off to the next CMO, it will be somebody who’s got a very strong experience in development, late-stage development across the therapeutic areas that we are focused on, somebody who can take 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 we’re looking for this transition sometime later this year or early next year. So stay tuned.

Terence Flynn

Okay. Great. Okay. I guess more on kind of the business side of things, probably a question 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 a lot of the ramp is going to happen. So it seems like any leverage would be driven by kind of top line growth, but would love your perspective here as we get closer to ’25.

Andrew Dickinson

Yes. I mean we do expect to have top line growth next year. Some of that will be masked by the Part D reform. And 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 percent, 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. And 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, 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 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 — 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.

Daniel O’Day

And this is always planned. I mean, Andy and I always have this plan. But in order to get to the sustainability and diversification, there was this period of time of somewhat overinvestment. And then now we’re in the optimization kind of leverage standpoint. So this is what we expected to be. Now we’re implementing and executing on that.

Terence Flynn

Does that — how does the dividend fit into that if you’re getting more leverage on the bottom line? For cash like how do you think about…

Andrew Dickinson

Yes, we’ve been entirely consistent with the dividend. We have a strong dividend. We expect to grow the dividend over time. You’ve seen that. And 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, been anywhere from $8 billion to $12 billion a year in the last five years, if I remember correctly.

Our cash builds back up quickly. You see that 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 we will do additional BD in corporate development, but our cash will build up so quickly, we may have opportunities to return additional cash to shareholders either through opportunistic onetime dividends or share repurchase, but all of that will be determined by kind of the borrow down the road. But there’s no doubt, we are very healthy from a financial perspective, and we see kind of with the accretive — strong growth profile going forward that should absolutely continue.

Terence Flynn

Okay. Great. Maybe moving on to lenacapavir. Obviously, very exciting data in the PrEP as you talked about, Dan. The second study of PURPOSE II 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 I trial and any differences we need to consider as we get ready for the next readout?

Daniel O’Day

Yes, absolutely. And look, I think when we designed 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 we led and started with perhaps where the need is greatest, Sub-Saharan Africa, amongst this gender women and seeing that 100% efficacy is 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 the PURPOSE programs and PURPOSE II, in particular, is designed similarly to PURPOSE I.

In other words, the objective is to show a difference between lenacapavir twice a year versus background HIV infection rate. I won’t get all the dynamics, but you’ve seen PURPOSE I, and you know that, that system works and that trial design works. Now while the background HIV incidence rate for PURPOSE II, we expect could be lower amongst this population, 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. Most experts that we talk to at IAS and elsewhere, say, 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 — 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 — and really a very small percentage of the population that could benefit. It’s large — it’s almost completely in the United States. It’s urban areas, it’s MSN 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 in the oral setting, but we know that goes — the adherence will go up significantly from where it is today to what we saw for instance in the PURPOSE I study. So there’s lots of ways to build out the concentric circles of how this PrEP market expands over the coming years.

Terence Flynn

Yes. 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 kind of segments, likely different 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?

Daniel O’Day

Right. So we haven’t discussed exactly obviously how we’re going to price len from PrEP yet. But what we have said is we’re not going to use the HT, the heavily treatment experienced patients 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. And with a focus on access and expanding that population. I mean that’s…

Terence Flynn

Yes. What — I mean how do you change that payer mindset? Because again, I’ve been surprised that there’s still generic Truvada about half the market right now in prevention. So what is kind of the totality of the argument that you guys are bringing to the payers now so that some of those barriers come down? Because when we talk to some of the payers, they continue to think that generic Truvada is a good option despite the adherence challenges. And so how do you convince those that are still prioritizing that as kind of like — it’s not really a line of therapy, but it’s a frontline option and convince them that like every six months is the better one to go with and change that dynamic.

Andrew Dickinson

Yes, it’s a great question. I think it’s relatively straightforward. I mean it’s the clinical data. I mean, the PURPOSE I 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 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 U.S., but it should resonate outside of the U.S. 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 3.5 years ago, and Truvada went generic, 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 use the analog of — in treatment moving from the multi-pill regimens to Atripla in 2006 or 2007, 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 I data, and that should give us a very strong set of talking points with the payers, not only in the United States but globally.

Daniel O’Day

I mean maybe two quick add-ons as I agree with it. I mean one is, remember, this is a community whose voice has heard strongly amongst payers. I mean — and when you have this type of data that could potentially have complete prevention of HIV. I think that will be taken into account. And so we don’t expect that we’re going to have a lot of conversation with payers over this. And the other thing I would say is outside the United States, where there really hasn’t been a lot of appetite for reimbursing anything other than generic PrEP and even there, there’s been limited appetite.

With the PURPOSE I data, we’re starting to have conversations with other countries and say, Oh, wait a minute. Now this is really different. And those are highly HTA, of course, driven countries. So I think to Andy’s point, the data will change the economic discussion in a way that I think could be very, very beneficial to countries around the world and people could benefit from PrEP.

Terence Flynn

What does that ex U.S. market look like? I mean you talked about the 400,000 in the U.S. expanding from there, but what’s the theoretical relative size of kind of G7 or whatever that you look to kind of build out?

Daniel O’Day

I mean, probably the way to think about that just in terms of how you might model this is the first thing 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 would be a $3 billion-plus market today, right? And then if you were just low-hanging fruit, think about getting the adherence from 50% to greater and penetrating that market further, you can — that could go to a $4 billion, $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. But back to your G7, I mean 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 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…

Andrew Dickinson

Yes. I mean, I would just add that the 400,000-plus people that are — these are people taking PrEP today. And we would — both — 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 $3 billion to $3.5 billion branded, then you add on the compliance. It’s a $4 billion to $4.5 billion 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, 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 that has multiple sexual partners as a target is an opportunity to prevent HIV spread there as well. And then outside of the United States. I mean the starting point in the U.S. is bigger because of the use of PrEP, but the size of the market, both in the U.S. and outside of the U.S. 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…

Daniel O’Day

And it will take years to build.

Terence Flynn

Okay. Great. Maybe just one more before we go over to oncology is just Biktarvy. I think the patent in the U.S. expires in 2033. You guys are working on once-weekly oral regimens. 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 is you have to get to a once every four months or something in the treatment side or six months?

Andrew Dickinson

It’s certainly for some patients is a step function change. So — and again, market research will suggest that this is relatively straightforward, but a once-monthly oral is probably more desirable than once weekly, 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 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 month subcutaneous and maybe every 12 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, 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. The — 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 are coming into the clinic for the long-acting subcutaneous treatment. So all of those will be step function changes that every 6-month injections or every year, if you can get there and the once monthly pill probably are the biggest opportunity for step function change, but all of it is additive to our business.

Daniel O’Day

And along that journey, we’ve said we could have the len for PrEP approved as early as very late 2025. And potentially alternatives for treatment, including the once-daily bic/len or the once weekly orals in 2027. So some of this is near term, some of this — but the space moves quickly. I guess my point is, 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.

Terence Flynn

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?

Daniel O’Day

Yes. Look, I think when you think about our oncology business today versus what it was three years ago, it’s now a $3 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 I think about the holistic nature of our oncology business. I think about the cell therapy opportunity at around $2 billion today, we’re still in maybe the first or second inning of where we can go with Yescarta and Tecartus because of — it’s still penetrated in a small percentage of patients could benefit from this potentially curative therapy.

I think about multiple myeloma is a potentially 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. And then I think also about the Arcus optionality with our Silent TIGIT program and other oncology programs within our Arcus collaboration. So 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.

Terence Flynn

Okay. Great. Maybe just to drill in on the Trodelvy dynamics years. Obviously, there’s some competition from in HER2, you have Dato-DX potentially coming. So just confidence level in the breast cancer setting and continuing to kind of grow that opportunity and then the 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.

Daniel O’Day

Yes. So look, in breast cancer, and you’ve seen some of this data. But first, I’ll remind you, we’re the only TROP2 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 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 desire to move up in lines of therapy and hormone receptor positive HER2 negative. Thankfully, for patients, it is competitive. There’s a lot of options. And currently with Trodelvy, we play in the IHC-0 population there well or perhaps after other therapies in lines of therapies.

But we think — and that IHC-0 is around 30%, 35% of the HR-positive, HER2-negative. We have studies ongoing to see how we’ll perform in earlier lines of therapy, particularly in the IHC-0 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 of work to do to change 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 II program in second-line lung cancer. And in particular, at ASCO, you saw the PD-L1 high-expression population, where we combine 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 going to 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.

Terence Flynn

Okay. Great. Maybe just in the last couple of minutes because again, another focal pipeline assets that need to sell in myeloma. Again, you referenced this in your opening remarks here, remind us kind of the target profile that you’re aiming for in this upcoming 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 profile.

Daniel O’Day

(indiscernible).

Andrew Dickinson

Sure. Yes. No, I’m happy to take it. This is a really exciting program partnered with Arcellx. It’s 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 going to see the first set of data that we believe will kind of as a more apples-to-apples data comparison against the CARTITUDE I 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 I study of roughly 38 patients, I believe, incredible efficacy and really difficult to treat patients, including those with a lot of extramedullary disease.

Most importantly, we reiterated this on our second quarter earnings call in Arcellx 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 neurotox in the first month or two after treatment. We had the original Phase I study. We’re now well through kind of the second study, it’s much bigger study that we’ll be presenting at ASH and have not seen any neurotox 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 in 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, it’s even a bigger opportunity.

Order of entry, I said this recently in another form, order of entry is less important, I think, in cell therapy, given that this is a onetime bespoke treatment. And so if you have a best-in-class asset and one that you can manufacture quickly and reliably, which 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, 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.

Terence Flynn

Great. Well, I think we’re up against time. But thank you, Dan. Thank you, Andy. Really appreciate it.

Andrew Dickinson

Thank you for having us.

Daniel O’Day

Thank you. Appreciate it.