Daiichi Sankyo and Merck report phase 2 trial results for lung cancer drug
On Thursday, 04 September 2025, Gilead Sciences Inc. (NASDAQ:GILD) presented at the Wells Fargo 20th Annual Healthcare Conference 2025. The company showcased robust second-quarter results and an optimistic outlook, driven by strong product launches and strategic business development. However, Gilead also acknowledged potential macroeconomic headwinds and market exclusivity challenges.
Key Takeaways
- Gilead reported strong growth across all business units, raising financial guidance for the year.
- The launch of YES2Go for HIV prevention has been transformative, with unprecedented awareness levels.
- The HIV treatment business, led by Biktarvy, continues to grow despite market challenges.
- Gilead is optimistic about its oncology pipeline, focusing on AnetoCel and Trodelvy.
- The company remains committed to strategic business development and R&D investments.
Financial Results
- Gilead’s second-quarter performance was strong, with increased top-line and bottom-line guidance.
- The HIV prevention business saw notable growth, while the treatment segment grew 3% despite a $900 million impact from Part D headwinds.
- Excluding Part D effects, the HIV business would have grown by 7%.
Operational Updates
- YES2Go achieved 73% unaided and 95% aided awareness, with Descovy sales up 37% quarter-over-quarter.
- Gilead is on track to achieve 75% U.S. coverage by year-end and 90% by the end of the first year, supported by early wins with commercial and Medicaid payers.
- In oncology, AnetoCel’s Phase III data is anticipated later this year, and Trodelvy has shown promise in triple-negative breast cancer.
Future Outlook
- Gilead is focused on transitioning patients to YES2Go and expanding the HIV prevention market.
- The company has seven programs in clinical development for HIV treatment, exploring long-acting therapies.
- Business development will prioritize late-stage, de-risked assets, with a focus on diversifying the portfolio.
Q&A Highlights
- Gilead is confident in achieving YES2Go coverage goals, emphasizing the importance of clinical data in payer decisions.
- Biktarvy is considered the "gold standard" for HIV treatment, with a strong market position.
- The company is monitoring potential macroeconomic changes, such as MFN and Medicaid adjustments, but remains well-positioned.
For more detailed insights, readers are encouraged to refer to the full transcript of the conference call.
Full transcript - Wells Fargo 20th Annual Healthcare Conference 2025:
Mohit Bansal, Biopharma Analyst: Thank you very much for joining us today. My name is Mohit Bansal. I’m one of the biopharma analysts, and I’m very happy to have fourth year in a
Andrew Dickinson, CFO, Gilead: row with
Mohit Bansal, Biopharma Analyst: us Andrew Dickinson, the CFO of Gilead. Thank you, Andrew, for joining us today. And I’ll give the floor to you for opening remarks and exciting times ahead of Gilead.
Andrew Dickinson, CFO, Gilead: Thank you. Thanks for having us. It’s our pleasure to be here again. It’s a great conference. It is exciting times for Gilead.
I think we you saw we had an incredible second quarter, strong performance across all of our business units, increased our guidance for the year, both kind of on the top line, the bottom line, saw really strong growth in our HIV prevention business, among others, and obviously have launched what we think is a transformational therapy for HIV prevention and YES2Go. So it’s a great quarter for Gilead. It’s been a strong year for us and on the heels of a number of strong years. So it’s an exciting time in the company, and we’re really pleased with where we are.
Mohit Bansal, Biopharma Analyst: Awesome. So let’s just talk about the transformative launch. I’m sure you were not expecting those questions on yesterday. I don’t know. But, yeah, like, I think the question basically, like, you the the comments from the call were second quarter call were really positive.
So you have seen some early response, which was quite positive. So can you talk a little bit about that? Sure. And yes, mean, what you are seeing in the marketplace right now?
Andrew Dickinson, CFO, Gilead: Sure. Yes. No, it has it’s been a strong launch. When you think of kind of execution, we have a very experienced commercial team, both from Gilead and from people that had worked at other companies. When we look at the launch, not just with respect to other HIV launches, but launches overall, the comment was it’s the strongest execution that they’ve seen in a launch.
Mean there’s an extraordinary amount of planning that goes into a launch this size, especially for a therapy with this incredible clinical data and with a relatively new opportunity that we’ll continue to build over many years. So we realize the importance of the launch, and we’re happy that we’re off to a strong start. A couple of things to highlight that we highlighted on the call. The awareness of lenacapabir or YES TUGO is incredibly high at this point. So 73% unaided awareness, which is probably double what you would typically expect for a good launch, 95% aided awareness, which is extraordinary, even for drugs that have been on the market for many, many years, as you know.
So the anticipation and awareness of this therapy is really unprecedented. And you see that in the performance of the HIV the prevention business with Descovy sales up 37% quarter over quarter in the second quarter. So the awareness of a new option for HIV prevention has driven more people to HIV prevention, and you see that kind of in the business. So it’s an exciting start for us in terms of where we are today.
Mohit Bansal, Biopharma Analyst: Got it. So I mean, it’s great that you say that because you when you launched Descovy, that was an incredible launch. I mean, you converted fifty percent in year one. So, I mean, there are some challenges with this particular one, because you have, as a Gilead in HIV, you have only launched pills so far, so there are some logistical challenges as well. So how you are seeing those challenges in the marketplace?
And despite that, why do you think it has been great?
Andrew Dickinson, CFO, Gilead: Yeah. Well, it’s a different model, to your point. It’s an injectable. There are two ways that patients can access it. One is or physicians can buy and bill through the physician office for certain treatment centers, or the drug can be dispensed to patients through what we call white bagging, where the order is placed, the pharmacy ships the drug either to the patient or to the physician.
So it requires a different commercial build and a different commercial plan. I think that the execution, again, going like what we’ve seen in terms of not only the awareness, but then our ability to execute to work with a specialty pharma to get the drug to patients that have a prescription to work through the prior authorization process has been really strong. And we’re off to a good start. The other metric, obviously, that the market is looking at and that we’re looking at is coverage. And we’re we are well on our way to reaching our coverage goals.
So we had said a year ago that our goal was to have 75% coverage in The U. S. After six months, which would be roughly at the end of this year. We are well on track to hitting that. We’ve had a number of early wins with commercial payers and with Medicaid payers.
So two of the largest two of the four largest Medicaid states, California and Florida, put the YES2Go on formulary immediately with no restrictions. As I said with the commercial payers, we’ve had a number of significant wins out of the gate. So we’re well on track to hitting our goals, only at the end of the year, but the 90% by the end of year one, which is really important. The other thing that we’ve highlighted is the J code, which is the reimbursement code for this specific drug, was granted earlier than expected. That will be effective on October 1.
And that’s really important, especially for the practices that do buy and bill. Many of those practices have been burned historically where they will prescribe and dispense a drug that doesn’t yet have a J code and it’s difficult for them to get reimbursement. So having the J code and having it come at least a couple months earlier than we may have otherwise expected is going be important for the launch as well. So it’s all of those things taken together that we’re looking at that gives us a lot of confidence in terms of where we are and the progression of the launch so far.
Mohit Bansal, Biopharma Analyst: Got it. And there was some chatter probably in the late August about the CVS comments there. So can you comment on that? What are you seeing there? Not just CVS.
I mean, you actually, from Gilead, there was an email after that saying that, I mean, we still are on track to So achieve the goals how are you thinking about all those things?
Andrew Dickinson, CFO, Gilead: Yeah. I mean, we’re in the middle of hundreds of payer conversations and negotiations. So, typically, when you launch a drug and you’re dealing with commercial payers, it’s not unusual for some payers to not even consider putting a new drug on formulary until six months, twelve months or eighteen months after the launch. In many cases, companies talk about kind of where they’re going to be with commercial coverage at year two. We’re focused on six months and twelve months.
So as I highlighted earlier, I think the and we don’t comment on our discussions with any specific payer, as you can imagine. I do think that the early data, there are a number of wins that we’ll share more over time that are really important with significant with payers that are sophisticated payers who take the same view that we take, that this drug has incredible clinical efficacy and they’re happy to put the drug on formulary with unrestricted access. Some of that may be driven by The U. S. PFTF preventative mandate.
I think a lot of it is just driven by the clinical data and the pharmacoeconomic benefit that this drug clearly provides. So we have a lot of confidence that not only are we going to hit our goals, but we’re going to get there over time. The other thing that I’ve said here that’s important is we’ve taken an appropriately firm stance on commercial discounts on our HIV therapies over time. And yes, Tougo is no different. Mean, this is a drug that, again, under the mandate, should have broad, unrestricted access.
We believe that that’s warranted not only kind of statutorily, but again, given the clinical data. And have discussions where some payers will negotiate more than others. But at the end of the day, we’re confident that we’ll have broad coverage and that we’re well on track.
Mohit Bansal, Biopharma Analyst: So we spoke to another big payer on the same day this news came out. And that payer basically said that there is some effort being made to make these drugs being administered by pharmacists, not just a health care provider. Do you, like, where are, like, do you think it is realistic in near term, or this is probably a long way to go?
Andrew Dickinson, CFO, Gilead: I think it’s more of a longer term thing, would guess. I think in the near term, the drug’s going be administered by either a physician or in the physician’s office by a nurse. Typically, theoretically, could the drug be administered in a pharmacy like the COVID vaccines, of course, but that’s more of a long term thing, I think. Got it. Got it.
Very helpful.
Mohit Bansal, Biopharma Analyst: And then let’s talk about USPSTF as well. Like how significant like if there are any potential changes, like how significant are they? I mean, the product was growing even without that until October.
Andrew Dickinson, CFO, Gilead: So Right.
Mohit Bansal, Biopharma Analyst: Would love to understand.
Andrew Dickinson, CFO, Gilead: Yeah. I mean, think the mandate’s been in place for a while, but it wasn’t fully recognized by payers until more recently, to your point. So when you look at our HIV prevention business and incredible growth over the last ten years, but in particular, you look at the last six to nine months, a lot of that is being driven by kind of the broad recognition by payers that the preventative therapies, including the HIV prevention therapies, need to be offered on an unrestricted basis with no co pays. And that’s been a tailwind for us. But to your point, prior to that being recognized by many payers, you saw very strong growth in the PrEP market, and we don’t expect that to change if there’s any change to the coverage mandate.
And we’re not going to speculate. I think, again, the efficacy and clinical data of these therapies, but in particularly, yes, two go really speaks for itself. The pharmacoeconomic benefit is strong. So I think the discussions around what could happen if The U. S.
PFTF mandate is reversed, it’s a fair question, and it may be missing the point that the efficacy is so strong, the pharmacoeconomic benefit is strong. I think that’s the biggest driver of why many of the payers are coming to the table and very quickly putting the drug on formulary. So more to come. I also think the administration if you look at many of the recent comments from the administration emphasized the importance of focusing on infectious disease. And so it gives us a lot of confidence that the growth that we’re, we in the market are expecting should be realized over time.
It’s a really incredible therapy.
Mohit Bansal, Biopharma Analyst: Got it. Very, very helpful. Thank you for that. The other topic I wanted to touch upon is that, you know, like there are different buckets in these markets. I mean, first of all, HIV prevention is still underpenetrated a lot.
Like, I mean, what, fifty thousand to four hundred thousand patients on the drug, which should be one point two to three million. So how do you see market evolving? Like, there is aptitude, which is like an injectable, so could that be the first to go? Then Descovy, then Truvada, plus naive patients. Like how do you think about the market evolving towards just to go ahead.
Andrew Dickinson, CFO, Gilead: The HIV prevention market. Yeah. I think the what we’ve always said is the first area of focus are people that are already on HIV prevention today. And the most obvious are people that are on other inject another injectable option. We believe this is a more convenient injectable option with the best, you know, with unparalleled clinical data.
And you should see over time a significant move of patients that are on other HIV prevention therapies, including the injectables, over to YES2Go. And as you said, the market is only maybe a quarter to one third penetrated today in terms of using a pretty narrow definition of people that should be on HIV prevention therapy. So we think that there’s a significant opportunity for very significant market growth, only in The U. S. But outside of The U.
S. As well, we should highlight. But in The U. S, within the narrow definition that the CDC is focused on, people at risk of getting HIV, you have a long way to go. And then if you think more broadly of people that could be at risk, we’ve highlighted the fact that there are about ten times more people that get that are diagnosed with a sexually transmitted disease in The United States every year then are captured by the CDC definition of people that are at risk of getting HIV or at high risk.
So you could see the market evolving over time where you have a much broader set of people that are at risk of either STDs or HIV being candidates for HIV prevention, including college age people, first responders, etcetera. So this is a market that is, in the first couple of innings would be the analogy of development, and there are many, many years ahead of us for to develop and build out this market. And then to your point, again, I think in terms of order of priority, it’s less order of priority. It’s just all of the people that are on HIV prevention today should move over to something like YES-two Go over time, given the guaranteed adherence and the significant clinical benefit relative to the orals that are available today that you see in the clinical data.
Mohit Bansal, Biopharma Analyst: Got it. Very helpful. Thank you. So the other question, like, again, I mean, like, so obviously, this is an important product for you. Expectations have been rising on this.
So I mean, when you look at the street expectation, I know you cannot guide for anything, but do you think like, how do you think about the Street’s expectations? And then are they in the right place at this time or not?
Andrew Dickinson, CFO, Gilead: Yeah. I mean, we don’t we won’t comment on the Street expectations or give guidance beyond the high level guidance that we’ve given. I think about this first of all, it’s a again, it’s it’s an important launch for us. It’s an important launch for the industry. All of the early execution and metrics are are are promising.
And and, you know, we think about this both in terms of the short run, the medium term and the long run, and have a lot of confidence in all of those areas. So while I can’t comment on kind of Street expectations, specifically, we have a lot of confidence that in each of those phases, you should see a strong launch, and that this is a really important therapy for patients and for us in the development of our HIV business and our business overall.
Mohit Bansal, Biopharma Analyst: Got it. Helpful. Maybe let’s just talk about HIV treatment. I mean, again, it doesn’t get talked about a lot, but I mean, you raised the guidance, and actually, like, were expecting this to be a flat year, but again, you are growing despite the Part D headwinds, you’re growing at 3% at this point. So can you talk a little bit about the trends there?
You have had a tailwind of pricing as well for quite some time now. So how is this market evolving? And is there some kind of inflection in patient growth as well here?
Andrew Dickinson, CFO, Gilead: Yeah, it’s interesting. I mean, there’s no the HIV treatment business is doing really well, to So your to just kind of step back, we had expected with the Part D reform this year that kicked in for the HIV business to be flat year over year. The Part D headwind was about a $1,100,000,000 headwind for us overall in terms of revenue, dollars 900,000,000 specific to the HIV business. And in the middle of the year, we updated our guidance to say that we expect, as you said, the business the HIV business to grow three percent. And if you exclude the Part D impact, that would be 7% growth.
The important thing is that the vast majority of that is demand led growth, right? So we are seeing strong demand led growth. The HIV market is still growing 2% to 3% in The U. S. And Biktarvy continues to take market share.
And all of that kind of leads to the strong demand led volume growth. There has been a tailwind in pricing, to your point. It’s not it’s been a smaller piece of the equation, but one that’s important. And that’s driven largely by as the Medicare redetermination process kicked in more recently at the end of the national emergency related to the pandemic, where you could reevaluate Medicare coverage. Many of the patients that lost Medicare coverage moved to commercial plans, whether it’s and you’ve also seen a strong unemployment rate, more people returning to work with more commercial coverage.
Some of that is the government health care exchange plans. But it’s all driven more favorable pricing mix for us in HIV, where you have more commercial coverage than expected and less Medicare coverage less Medicare claims than expected, leading to a positive mix. But I would highlight again, most of the growth is demand led. The vast majority of it is demand led. There has been a pricing tailwind, which has also helped.
But the business, to your point, the HIV treatment business is probably underappreciated and is doing really, really well. The growth in the HIV prevention business has been so extraordinary, in particular the last two quarters, but certainly over the even over the last kind of nine to ten years, that it overshadows it a little bit. But the HIV treatment business, and Biktarvy in particular, is doing really well. Got it.
Mohit Bansal, Biopharma Analyst: This is very, very helpful. We get a lot of questions around the the, like, I mean, obviously, macro headwinds are there, or, I mean, the chatter is there. So there are two it comes in two flavors. So, like, before we get to macro, like, the one topic I want to discuss is the there are some questions around, as we get into late 2030s, 2020s, Victarvi has a longer patent life, but your competitor is losing patent. So do you see that as a risk at all, or or it’s manageable?
Andrew Dickinson, CFO, Gilead: It’s manageable. I mean, there’s so the answer is largely no. I mean, I think that Biktarvy is the gold standard for a whole for many, many reasons. I mean, it is by far, when you look at kind of efficacy, safety, the ability to put patients on therapy immediately without genotyping, the lack of resistance, I mean, it’s absolutely the gold standard in HIV treatment, and we don’t expect that to change. So the and you know, again, you highlighted earlier, know it’s HIV prevention, not HIV treatment, but you see what we were able to do with Descovy in HIV prevention relative to Truvada.
When Truvada went generic, it just reinforces that in the HIV market, patients and physicians tend to want to be on the best therapy, the safest, the most efficacious therapy, and we don’t think that’s going to change. There will always be discussions with payers, there are every year, in terms of the payer dynamics. We have very modest rebates on our HIV products generally, given the strength of the data and the strength of the portfolio. And we’ll continue to focus on that to make sure that we’re receiving kind of fair value for what we’re bringing to the market. But no, I don’t think it’s all included in our end markets assumptions, but it should not have a significant impact on the business.
Mohit Bansal, Biopharma Analyst: Got it. And this market is on like 50 class of agents at this point, right? A lot of
Andrew Dickinson, CFO, Gilead: Yes. And the other thing to remember there, should highlight, is there are a number of new launches coming, right? I mean there’s not only in the coming years, we’ll have a new we would expect switch option in a daily oral doublet of lenacapavir and bictegravir, which we think is a really exciting additional treatment option for certain patients. And then we have the broadly neutralizing antibodies with lenacapavir as well as all of our long acting therapies that should be coming to market. All of those should help us take additional market share and blunt the impact of any kind of generic launches.
Maybe the last thing that I just you saw this in prevention, and we’ve highlighted this historically. Even in treatment, the long acting therapies should provide an efficacy advantage. Because with the daily orals, patients that have HIV, even though these are lifesaving therapies that are incredible, they don’t always take their pills And every sometimes people will go off therapy. The long actings, just like you see in the data for prevention, should lead to better efficacy in HIV treatment. It won’t be the same degree of benefit in terms of the magnitude relative to each other that you see in prevention, where people are really not adherent to the daily orals, but you could and should see an uplift in terms of efficacy from the long acting HIV treatment therapies as well that will go into kind of how people think about the therapies that they’re prescribed and that they take in the future.
Mohit Bansal, Biopharma Analyst: Got it. No, that’s very helpful. And I talk about the pipeline. I do want to talk about the pipeline here. So I mean, you’d like me, you hosted a massive presentation last December, which was very helpful.
How are you thinking about, you know, timelines of the HIV treatment, longer acting HIV treatments here? And I think your own market research suggested that injectables are probably going to be very good if they are quarterly or every six months. So how far are we from getting to those?
Andrew Dickinson, CFO, Gilead: Yeah. Well, I think we’ve said we have seven programs in clinical development, others coming, the relatively high degree of probability that many of those will hit the market between now and the Biktarvy loss of exclusivity in the middle of the 2030s. So I think we’re in a great spot. I do think, to your point, the two therapies in the future that are likely to have the greatest impact and the greatest adoption would be a monthly oral and an every six month injectable for treatment again. And we think both of those are possible, and we have multiple programs that are exploring those.
So it’s too early to specifically give any specific guidance on kind of approval timelines beyond the therapies that are already in late stage studies in Phase II and Phase III. But we’re we have an incredible team that’s bringing those forward quickly, number of programs, multiple shots on goals, give us a lot of confidence that we will get there. So and again, to step back, I mean, I think it’s likely that at some point we have multiple weekly orals available, a monthly oral available for treatment, and then an every three month or every six month or both injectable option. But the ones that have the potential to be the biggest are the every six month injectable and the monthly oral.
Mohit Bansal, Biopharma Analyst: No. In some ways, it reminds me of the era between Atripla and Biktarvy. You had, like, multiple drugs launched, and then they all sold a lot. So Right. It could be, like, that kind of situation before you get to this every six month month?
Andrew Dickinson, CFO, Gilead: Yeah. I think that’s a it’s a you’re spot on. I think that’s likely the lock they were I would expect that you’ll see multiple launches. It’s hard to say today which therapies would be the biggest, the most attractive. We have to see the clinical data at the end of the day.
Different patients and different physicians have different needs or desires that you’ll see. But you could see a number of launches with drugs like the Genvoya equivalents or the ODEF C equivalents. Bucifla back in the Right, that are important for a period of time and that as you launch additional therapies, they may be cannibalized. And that’s Okay. I mean, our goal is to give physicians and people with HIV as many different treatment options as possible that really work best for them.
The other thing that we don’t always talk about that’s important, if you look at the HIV market, the percentage of people in The United States that have HIV that are, one, that are not aware that they have HIV is much higher than you’d expect. The percentage of people that are diagnosed with HIV but are not drug treated is shockingly high. And then of the people that are drug treated, those that are not under control or undetectable is high. When you kind of put it all together, I think roughly fifty percent of the people in The United States that have HIV are either not diagnosed, diagnosed but not drug treated, or not undetectable levels, meaning that they can still they can still you know, transmit HIV to others, which all of which means there really is a need for additional treatment options that help us reach all of those people and and reduce that number significantly. So, you know, even though it’s a really well developed market overall, there’s still a lot of potential and need for new treatment options in HIV treatment in The U.
S. Awesome. And globally. Thank you.
Mohit Bansal, Biopharma Analyst: So let’s touch upon the topic of, you know, macro headwinds from, one from the MFN to Medicaid side, and also Medicaid, potential funding cuts which could come. So I mean, how as a company you are thinking about these, and do you see them as a manageable risk? Or like, how do you prepare for all that?
Andrew Dickinson, CFO, Gilead: Well, like all companies, we’re looking at a lot of scenarios and preparing. We spend a lot of time in DC having discussions not only with the administration, but with the representatives and senators, helping them understand kind of the drug pricing in The U. S. And why the system is the way that it is, the value of the innovation that we’re bringing. It you know, I’m not going to speculate in terms of what’s going to happen with any potential MFN or Medicaid changes.
We do think it’s manageable if there are changes, and we think that the clinical profile of our drugs across our entire portfolio is so strong that it gives us a a really strong position to help people understand the benefit that we’re bringing to patients. So there’s a lot going on, but at the end of the day, we’re having positive discussions. It’s hard to say exactly where it’s going go, but we do think that there’s a growing recognition of the importance of both the healthcare sector, the drugs that we’re developing. There’s also been some comments from the administration recently in terms of the focus and importance of really focusing on infectious disease, which I think is encouraging, and as you know, is a huge piece of our business. So we kind of put it all together.
We think it’s manageable, and we’ll look at we’ll continue to monitor a number of different scenarios.
Mohit Bansal, Biopharma Analyst: Awesome. So let’s just talk about the oncology pipeline, where we are seeing also, like, I mean, kind of, like, you know, were excited, then they are not excited, and now, like, you are seeing some interesting data here as well. So RCELEX, first of all, I mean, you have some interesting data coming up and filing coming up next year So your partner has talked about big numbers, that it could be a big opportunity in fourth line, how Gilead is thinking about it internally in terms of opportunity. And you have a differentiated safety profile.
So how do you see that? Yeah.
Andrew Dickinson, CFO, Gilead: So you’re referencing a nido cel, which is a BCMA cell therapy for multiple myeloma that’s in late stage clinical You’ll see the full kind of phase III data set, fileable data set later this year. We haven’t said where, but it will be later this year. The filing, I think you said this time next year, meant the approval, directionally. The approval, sorry. Yes, not the filing.
And we haven’t guided specifically the kind of specific filing or approval dates. Our partner has said that they expect to file by the end of the year, which is a reasonable assumption. And then the other thing that you highlighted is our partner has said that they think it’s a really large commercial opportunity, and they’ve given kind of specific guidance on the size of the fourth line plus opportunity. We won’t give specific guidance, but what we will say is that we share their view that it’s a very large opportunity that’s underserved. There is another CAR T available in multiple actually, CAR Ts available in multiple myeloma today, one, though, that is the significant kind of market leader.
We believe, based on the data that we’ve seen historically and shared publicly, that we have a CAR T that is likely to provide better efficacy and safety advantages. And so it’s a big opportunity. I mean, we absolutely share their enthusiasm for having what we believe is likely to be a best in class CAR T in this area. It’s a really big opportunity, as you know. Multiple myeloma is significantly larger than the other hematological conditions that our existing cell therapies are approved for.
And even the fourth line, to your point, is a really big opportunity. And then of course, we’re also underway with the studies that would allow us hopefully to move into earlier lines of treatment, both second line plus and then ultimately first line for certain patients.
Mohit Bansal, Biopharma Analyst: Got it. Very helpful. And similarly for seladelpar, the initial launch uptake has been pretty good actually.
Andrew Dickinson, CFO, Gilead: Yeah.
Mohit Bansal, Biopharma Analyst: And so your expects I mean, I think Street was below your expectations in the beginning. So your internal expectations for this product, has it changed, or is it still it has always been high?
Andrew Dickinson, CFO, Gilead: Yeah. That was some we’ve always had a lot of and by the I want to come back to oncology to make sure I answer your question on Trodelvy and talk about the full oncology we can talk about that for you. But on seladelpar, this is a drug that we acquired from a company called Simabay last year. It was approved and launched. The launch has gone incredibly well.
Second quarter sales almost doubled Wall Street expectations. So the launch is off to a really strong start. It’s a competitive market. There’s another therapy that was launched just before this by another company. We think we have the best in class therapy.
I think you see that in the commercial progress so far. So to your point, we’ve always been bullish on it. I mean we think that the CinnaBay acquisition is one that, in the long run, is going to provide a really nice return to our shareholders. And it’s just one of the many pieces that we’ve put together over the last six to eight years to diversify our business and to grow our base business. And so we’re encouraged by it.
I mean there are four launches that are either in progress or underway, and nidocel will be the next one, but you have the seladelpar launch. You have additional launches with label expansions on Trodelvy, which I’ll talk about in a second, in breast cancer. And then, of course, the HIV prevention launch with YES TUGO, all of which are significant growth drivers for us. It’s a pretty unique position in the industry today in terms of having four very exciting launches. I think there are four of the five or six most watched launches in pharma that are either underway or soon underway at Gilead that will drive growth.
And then circling back to your question on oncology more broadly, AnetoCel is really exciting. Cell therapy is incredibly exciting overall in terms of the progress that we’ve made in the last decade and the benefit that cell therapies are bringing to patients. Mean, I our Trodelvy data we released earlier this year, data in earlier lines of triple negative breast cancer for both PD-one positive and PD-one negative, really incredible data with Trodelvy, which is poised to become the clear standard of care in triple negative breast cancer. It is now in later lines, but this brings us into kind of the first line setting. And that’s going to be, we believe, a significant inflection point for Trodelvy, which is a billion dollar plus drug today, but should grow substantially.
So the market in first line triple negative breast cancer is twice as big as the later lines that we’re in today. But the most important thing is the treatment duration for patients is much, much longer in the first line as you’d expect. And you see that in our clinical data. You see that with other therapies. So when you put it all together, we expect just in triple negative breast cancer alone significant growth from Trodelvy.
And then you have other opportunities with Trodelvy in hormone receptor positive breast cancer, lung cancer, etcetera. So I think that that’s another one that we’re really excited about, the potential growth for Trodelvy over time and the totality of what we’re doing in oncology.
Mohit Bansal, Biopharma Analyst: Awesome. Thank you for that. So this is very helpful. And then like one last question before we conclude. I mean, so now you have a lot going on.
You have new launches, pipeline progression as well. But at the same time, like, I have to ask about the BD as well. So when you like, how are you thinking about BD at this point? If you do something, would it be more like a Sambae or, I mean, or maybe even earlier at this point? Yeah.
Andrew Dickinson, CFO, Gilead: Well, we I mean, first of all, there’s gonna be a steady state of what I call ordinary course business development. We in the last six to eight years, we’ve done hundreds of deals to really build out our portfolio. So I’ll talk about BD, and then we should just talk about kind of the build out of our internal research and and the strength of our portfolio overall. But on the BD side, we will continue to do late stage deals. We love the Simbae deal.
We’ve said that’s kind of the template for late stage derisked assets that fit in our existing commercial infrastructure where you have significant synergies. Now that we’ve built that out in oncology, both at Kite and at Gilead, we can think about acquisitions there differently. So you should expect that we will add to our late stage portfolio on a regular basis over time. And we generate an extraordinary amount of free cash flow that allows us to reinvest in our internal portfolio, our external portfolio and then return a lot of that to shareholders as well. So I think the Cimabay deal is a good one.
I mean we’re never we’re kind of focused on what we call smaller M and A, but we always say that we could do kind of a medium sized deal. So but deals in that Simbae was a $4,000,000,000 deal, are very comfortable for us. We can do larger deals than that given our cash position, but we will focus on diversifying the portfolio. And then the final piece is we have we’ve made substantial investments in internal research and development since I joined the company nine years ago, and in particular, when our CEO, Dan O’Dea, joined the company six years ago. We were underinvesting in internal R and D.
We’ve made the investments that are required. We’re now investing at what I believe is a much healthier level, and our portfolio in terms of the quality, breadth and depth has never been stronger. You hear that from our new CMO, Dietmar Berger, who’s been a great addition to the team. And I think you’ll see more of that over the coming years. So it’s a pretty exciting time, both in terms of the launches that are underway, the size and quality of the portfolio and where we are, and then what we can add to it in the future, to your point.
Mohit Bansal, Biopharma Analyst: On that high note, thank you very much, Andy.
Andrew Dickinson, CFO, Gilead: Thank you.
Mohit Bansal, Biopharma Analyst: Thanks for having us.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.