Good morning. Still morning, right? My name is Mohit Bansal. I'm one of the biopharma analysts here at Wells Fargo, and this is my third year hosting it, and I think-
Third year.
third year you being here. So, thank you, Andy, for joining us today.
Thank you for having us. I'm thrilled to be here. Appreciate the invitation.
Awesome. So, I mean, maybe, like, before we start in Q&A, so let's just talk a little bit about, I mean, what is going on in the company, and then-
Sure.
the company has seen some success with PrEP market, PrEP space as well. So just talk a little bit about
Sure, where Gilead is today.
Yeah. Yeah.
Yeah, so, again, thanks for having us. Happy to provide a little color. For those of you that don't know Gilead, Gilead is one of the world's largest biotech companies, biopharma companies. We focus in three areas: virology, oncology, and inflammation immunology. We have the world's largest HIV set of assets, both for HIV treatment and prevention. We have a large liver franchise with viral hepatitis products and a new launch in that area that's very exciting, that we'll talk about that turns that franchise into a growth franchise. Then we have a growing oncology franchise, including the world's leading cell therapy business. That's very exciting, so it's an exciting time for the company.
I think there have been, as you pointed out, some very promising data, especially in HIV prevention recently, that's exciting, that we can dig into, but it's a nice chapter for the company. I'd say the other big picture, you know, as we've been building the last five years with a new management team to diversify the business into these other areas, to build a much bigger portfolio, both research development and commercial, than we had historically, you know, you're seeing significant progress. That our base business grew 8% two years ago, 7% last year. First half of this year, we saw strong growth at 6% plus, and we have a number of product launches that we're either in the middle of or that come up in the next couple of years that should drive additional growth.
And then the final point, as you saw in the second quarter, the really strong financial leverage that we have in our model, with very strong growth in EPS, based on a beat on both the top line, a bigger beat on expense management, and a significant beat on the bottom line. So it's an exciting period at the company.
Got it. So this is very helpful. And then, so maybe let's just start with the PrEP space. So, I mean, we saw successful data with the PURPOSE 1 trial, and then PURPOSE 2 is also reading out. And when we chatted a couple of weeks ago, you talked a little bit about the background rates and how that could... that needs to be considered when we think about PURPOSE 2. So can you talk a little bit about that?
Sure. Yeah.
for the investors?
So HIV prevention, or PrEP, is a very large market opportunity that is still, even though HIV prevention has been available through primarily two, our two products, one of which is now generic, that are daily oral pills, the market has been available or the, the prevention medicines have been available for 10 years. And the market has grown substantially, and you're seeing an increase kind of in the growth over the last 5 years, certainly as awareness has increased and additional products have been brought to the market. We presented data, I think, 2 months ago now, with our every 6-month subcutaneous, injectable HIV capsid inhibitor that showed 100% efficacy in a very large study, done predominantly in women in sub-Saharan Africa, versus. And there were two comparisons, as you know, Mohit.
There was a comparison against the background rate of HIV infection and a comparison against the oral alternatives. You saw a meaningful improvement, both against the background rate of infection. Again, as I mentioned, the lenacapavir every six months showed 100% efficacy. There is a higher background, a significant background rate of infection in women that didn't get any therapy, and then those on oral PrEP, because people that don't have HIV don't tend to take the oral pills every day. You still saw a reasonably high rate of infection in women that had oral PrEP available to them. So really incredible landmark data that underscore an incredible opportunity to open up this market, not only further in the United States, but globally.
That study, called the Purpose 1 study, as compared to the second phase III study that she'll read out, likely later this year, or early next year. This study, the next study is being done in many major markets, including the United States, but predominantly in men having sex with men, and the background rate of infection there is lower. It's still, you know, we still have the utmost confidence that you're gonna see a meaningful difference between the background rate of infection in this patient population and the rate of infection with the drug on board. And then there's also an arm in the study where people in the study have the availability of oral prevention pills, and you should see a difference there, too.
So I think just maybe summarize it by saying, just with the data that we have in hand, it's clear to us that lenacapavir should be a game changer and open up an entirely new part of the HIV prevention market, both in the United States and globally.
Got it. I mean, one follow-up to that question is that, I mean, we have seen equivalance trial in terms of, you know, what control arm could look like and all that, but you are using a background rate. So how much should we read into the other trials for the cross-trial comparison and-
I-
Yeah.
Yeah. I mean, they're totally different trials. I mean, the nice thing about the trials that have been done historically-
Mm-hmm.
So start with the oral prevention trials. They've demonstrated that if people at risk of getting HIV take the oral pills every day, there's a very high-
Right
... degree of protection from the transmission of the virus. Probably not as high as the injectable that guarantees the adherence, but because of the adherence component of it. There is an injectable that's on the market, that it requires two intramuscular injections every month or every two months. Their studies were done head-to-head against the oral and demonstrated nicely that by guaranteeing the adherence through the long-acting injections, you get better outcomes than you do on the oral pills in the real world and in a real-world setting. And we don't expect that to change with this study. Again, the key difference in this study versus those studies is there's two ways to win.
One, the first comparison is against the background rate of infection, and then there's a separate comparison against the arm of people in the study that are on oral Truvada, and you can win either way. And as I said, the existing data for lenacapavir, both in HIV treatment but also in HIV prevention, is so strong that from our vantage point, there's a very clear path to both successful clinical study and then approval by the end of next year, and launch.
Got it. That's super helpful. And then let's just talk about the commercial side of it. And, I mean, as we understand, right now, PrEP market, from whatever the CDC, however, defines it, it's about one third or so. So, like, because lenacapavir is a major improvement versus what is out there-
Yes.
How do you see this market evolving? I mean, there are numbers out there, people think 50%, 60%, but how do you think about, one, opportunity to grow this market, and then two, I think the adherence and compliance could have inherent pricing benefit as well.
Absolutely.
Talk about that.
Yeah, I mean, there's a lot of different components here.
Right
... that we should talk about and, and kind of pull apart. So the, the first is that the, the market that's evolved over the last 10 years is really today only in the United States, and that will change over time. I'll come back to that. And it's predominantly in a pretty rigid category of people that the CDC defines as being at risk of getting HIV, and it's, it's mostly men having sex with men. So, and as, as you said, Mohit, the, the market is maybe a third of the way penetrated to date. So it's still early days, and you've seen significant growth of the PrEP market over the last three or four years as awareness has increased. There are a number of organizations out there that are building businesses around this, raising awareness, that are helping us build the market.
The easiest way to think about the market, in my mind, is when the first approved therapy, our drug, Truvada, went generic three years ago, our sales, and we had two drugs approved at the time, Truvada and Descovy. Our sales in the prevention market were approximately $2 billion a year. That was over three years ago. Since that time, the market has grown dramatically. We would estimate that if the market were branded today, it's a $3-$3.5 billion market. And as you mentioned, most of the people that are taking HIV prevention don't take the pills every day. They take them on demand or intermittently, so for purposes of illustration, it's hard to say what the compliance rate is.
If you just assume that the compliance rate is 60% or less, you know, with lenacapavir launching overnight, you know, you should, because of the level of innovation and the guaranteed adherence, you should convert. You know, our goal is to convert the majority of the market, including, patients on generic oral pills, to the long-acting, much better efficacy, insured compliance, and you get this, you know, significant lift from the compliance. So if the market is $3-$3.5 billion branded market today on the oral pills, directionally, you know, you get a step up in compliance, that grows the market substantially. Then think of the market as, you know, growing further in the United States, both in the at-risk CDC population. As I mentioned, the PURPOSE 1 study is in women.
There are women and people that have multiple sexual partners that are at risk of getting HIV. That should expand the market further, and then, of course, we expect the market to grow outside of the United States with this really incredible data.
Got it. That is super helpful, and then, like one thing you mentioned, I just want to follow up on that, was, you can share from Truvada as well. So,
Sure.
The data are definitely supporting it. So, I mean, like, how... Like, is it easy? Like, how should we think about it?
I don't think it's ever easy, but the level of innovation that you see-
Right
... in the clinical data is incredible.
Right.
It's profound.
Right.
I mean, this is a step function change. So the easiest way to think about it is when Descovy, which was, you know, arguably a better version, safer version of Truvada, was approved for prevention, we moved, you know, half of the market in the United States, roughly half of the market, in less than eighteen months, moved from Truvada to Descovy before Truvada went generic. The level of innovation between lenacapavir and the two approved orals is a step function change, an order of magnitude better in terms of the insured, compliance and as a result, the efficacy that you should see in the real world. So it's not unrealistic to expect that you... We will target moving both the branded market and the generic market over, and we will target doing that as quickly as reasonably possible.
Got it. And is there a bar in your mind that, I mean, the MSM trial need to look this good for you to have that kind of conversion as well?
I don't think so. Again, I think if you talk to, you know, one of the leading KOLs said to one of our shareholders a couple weeks ago that in her mind, it would be, you know, almost unethical to not give someone-
I heard that.
... given the clinical data. And that's not, from our perspective, an unreasonable way to think about it. So I don't, you know, you know, I think it will be raising awareness. This is, you know, a lot of the prevention market is raising awareness in a direct-to-consumer advertising campaign that our team will work through. So, you know, clearly, we believe that we have what is gonna become the gold standard for HIV treatment for years to come, and we will develop that market as quickly as we can.
Got it. That's super helpful. Maybe like, like sticking with HIV for a little bit, if I think about, so you have a really good longer-acting agent with lenacapavir, but, people are looking for the other stuff which can be combined, and then you can have a every three month or every six month kind of treatment. So where are you with that? And then when can we learn more about some kind of, you know, combination?
Yeah, we're making a lot of progress-
Right.
On all of our next generation HIV treatment regimens. Two of them are actually in phase three clinical development that I can talk about. One of them is in phase two, and then we have a number of phase one programs and programs coming into phase one that are partner agents for lenacapavir. So maybe just to step back, again, lenacapavir is such a unique molecule. It's the first HIV capsid inhibitor. We believe it's also best in class, first in class and best in class, an incredibly potent molecule that's been formulated as a once daily pill, a once weekly pill. It can be formulated as a once monthly pill.
Mm-hmm.
And then every three month, every six month, and maybe every twelve month subcutaneous injection. For treatment, the art is now, as you, you're highlighting, finding agents to pair with it. We have three of those in clinical studies today. So if you look at the phase three clinical studies, you know, there, there are two. One of them is a daily pill of two drugs, lenacapavir and Bictegravir, which is our integrase inhibitor that is the backbone in Biktarvy and is really another incredible molecule. That's probably an underappreciated opportunity in phase three, that even though it's not long acting-
Yeah
Gives patients another choice, if for any reason they want to switch off of Biktarvy. Most patients in the U.S. and outside of the U.S. start on Biktarvy. If they want to switch for any reason, this gives them a what we think will probably be the best alternative, and we look forward to seeing that data. There's a phase three program in partnership with Merck, with lenacapavir and islatravir. We'll have data out there as well. That's a once weekly oral that we'll have. Is in phase three. And then, you know, the most near term and probably largest opportunity for the long-acting for treatment is our wholly owned once weekly integrase inhibitor, which is a novel integrase inhibitor, long-acting oral integrase inhibitor, together with a prodrug of lenacapavir that is formulated for once weekly.
That's in phase two studies now and should progress rapidly into phase three and be available by the end of the decade as well. Then beyond that, there's a whole series to your question of when are you gonna see data of compounds that are in phase one or moving into phase one. Some of those could be monthly orals that we're very excited about. I think that maybe one of the most exciting things, as our scientists would say today, that monthly orals are much more of a possibility than we maybe would have expected a year ago. So we're excited about the progress that we're making internally there. And then the every three and every six month subcutaneous agents, we have a number of partnering agents, including integrase inhibitors.
Some of them are going through phase one testing, and we'll share more data later this year and next. So to your question on when are you gonna see data, we'll have an HIV day, we expect, later this year in the fourth quarter, and we'll share some updates at that time, and then we'll continue to share updates through next year and beyond.
Got it. I mean, so on your point on, this, the capsid plus bictegravir combination is underappreciated. We have seen that with, ViiV as well. We have seen that with some of your previous, prior generation molecules, where the products were not that different, but every time you launch a new product in the HIV market, it does gain some share because there is always some subset of patients.
That could use-
Do you think of it that way?
Yeah, I think, I think this is different because the HIV capsid is so unique and adds something completely different. Remember, I mean, this is a completely orthogonal, different treatment mechanism. There are patients that don't want to take some of the existing therapies or have developed resistance to them, whether it's they have side effects or they've developed resistance. So when you look at the daily doublet that we've talked about, I think, yes, you know, there are new agents that will, you know, that people may want to switch to over time. You've seen that in the market historically. It's really the agents like Biktarvy that are step function changes.
Right.
I mean, Biktarvy wasn't the first three-drug, single-pill combination, but it was by far the best, and it's become the absolute gold standard for HIV treatment. You know, 70% plus, if I remember correctly, of patients in the US start on Biktarvy.
Right.
Roughly half in Europe. Total market share is approaching 50%. I think our daily doublet brings, you know. And we'll see. We need to see the data, could bring that level of innovation and change. And by having this orthogonal treatment mechanism, may lead to even greater usage over time versus some of the other launches that you're referencing. It's definitely an exciting opportunity that we think is underappreciated, and then you layer on all of the long-acting launches that should be following it. You know, it speaks to the sustainability and durability of our HIV portfolio that we think people probably underappreciate broadly.
Awesome. Twenty minutes, almost twenty minutes on HIV. Yay. Good.
Sure.
Let's just talk about another launch. You are launching right now, seladelpar, the asset you acquired earlier this year. It seems like still under the radar a little bit. Part of it is because of the competitor, which is doing okay. But again, talk a little bit about your own expectations.
Sure
... for this drug and what are we missing?
Yeah, well, so to step back, we acquired Seladelpar from a company called CymaBay earlier this year. The drug is now approved. So recently-
Yeah
... it was approved. It's launched, incredibly exciting, great label. So this is from our perspective a best-in-class treatment for PBC. PBC is a liver disease that it's a large orphan disease, 130,000 patients in the U.S., roughly, probably an equal number or slightly smaller number in Europe. Probably underdiagnosed and undertreated, because there have not been good treatment alternatives available for patients. You know, we think it's a really big opportunity. We are the world's largest liver disease company with our hepatitis C and hepatitis B franchises. We have a large commercial organization. This is a perfect strategic synergistic fit. 80% of the physicians that treat PBC also treat viral hepatitis. So there are a lot of, you know, synergies in terms of slotting this into our organization.
They already have, you know, long-established relationships with the physicians that treat PBC. I'd say, and we think the market's really underestimating the potential for PBC, likely because there haven't been, you know, effective treatments available for patients, and you see that in numerous examples over the last couple decades. The best example, in my mind, and there's lots of them, is the pulmonary hypertension market. When Actelion launched Tracleer twenty years ago, people thought that Tracleer, you know, broadly, I'm generalizing, would be a $300-$400 million product. It turned out to be, you know, orders of magnitude bigger, and the pulmonary hypertension market is a $10-$15 billion market today. There's a lot of similarities, both in size, chronic nature of the disease, severity of the disease, pricing.
So I think PBC is an underappreciated opportunity, and Seladelpar is clearly, in our mind, and when you look at the label, we have a best-in-class opportunity. So we have the opportunity in front of us to shape the PBC market in the same way that Actelion and others did the PAH market, and it's really exciting to see what we can bring forward for patients. So more to come. I should say on the launch, you know, the first couple quarters of the launch will be. You'll see very modest sales. It's typical in ultra-orphan diseases, where you're working through formulary access, step edits, prior authorizations. You should really see the growth in Seladelpar. Livdelzy is the commercial name. I should call it Livdelzy. You'll see that really driving additional top-line growth next year and then beyond.
It's exciting. Maybe the big picture, as I alluded to earlier, but you know, our liver franchise will be growing again. I mean, the liver franchise, the hepatitis C, you know, incidence rate is you know, and the cure rates are roughly equal. You've seen kind of the viral hepatitis market. Our business has flattened after years of decline after curing hepatitis C. It you know. And now we have another leg of the stool that's gonna drive growth. You have the durability of our existing hepatitis C and hepatitis B franchises and the growth coming from PBC. It's an exciting time to see not only the HIV business growing, the oncology business growing, but the liver disease business unit growing again is our expectation.
So on that point, I mean, I want to bring in the 2025 somewhat in the mix, because you did talk about the challenges with the Part D redesign in the past that HIV business will face. But sorry, obviously, I don't want you to give the guidance there, this is too early. But how do you see qualitatively how 2025 could look like, given that you have oncology business growing and seladelpar as well?
Sure, yeah. I mean, we have given some guidance, and I'm happy to repeat it and put it in the proper context. The, you know, the Part D reform impacts all companies with Part D drugs, including Gilead. The vast majority of our Part D drugs today are HIV medicines, and in particular, Biktarvy, that we mentioned earlier, which is the gold standard for HIV treatment. What we've said is that the growth in our HIV business next year, which will be meaningful, will be offset in large part or entirely by the impact of Part D reform, you know, that really starts next year and then carries through. So it will...
The Part D reform will mask the growth of our business to some extent next year, but you still will see overall growth in the business, being driven not only by HIV, but also the oncology business and Seladelpar. The other thing that we should say is that when we give that guidance, we tend to take a very conservative approach. We are not assuming that with Part D reform, prescriptions that are left traditionally at the pharmacy counter, because patients can't afford the copay or they're moving through the donut hole, are then taken and that you see an uptick in actual prescriptions that are filled and paid for. So there's upside to our guidance. So, you know, we tend to be appropriately conservative in our expectations.
So, you know, it's an impact that will go beyond 2025, but you see it in 2025 because you have the step down. It's modest, but it's real. We've highlighted it, and we have plenty of growth in the business to, you know, kind of grow and then grow, you know, meaningfully from there. As I highlighted earlier, we have a number of launches, both underway with seladelpar and additional launches coming. So as we look at the coming years, we have obviously the HIV prevention launch that we're very excited about. We have a BCMA cell therapy that we're incredibly excited about, that's partnered with Arcellx, that should launch into the cell therapy BCMA market. That's an exciting opportunity. So there's a number of growth drivers that will be coming in the coming years that should drive additional top-line growth. So it's manageable.
We've talked about the impact. We'll provide, you know, more updates as we work through this next year, but it doesn't mean that our business is not growing or gonna continue to grow.
That's helpful. So since you mentioned BCMA, so next question on that. So, like, I mean, in terms of profile, I mean, obviously, Carvykti is out there already, but how do you see... I mean, the profile looks interesting. Obviously, it is comparable efficacy, and then safety is the benefit. How do you see it competing, given the lead time Carvykti has? That's the question we get. And also, how much does the, you know, the manufacturing time comes into play? Because it takes some time for Carvykti to-
Yeah. No, it's really important. So just to step back, we have the world's largest cell therapy business that we acquired through our acquisition of Kite. I think it was almost seven years ago now-
Right.
-which is hard to believe. We have two approved cell therapies, Yescarta and Tecartus. It's a $2 billion business and growing for us, and we have the world's best cell therapy manufacturing. We have three global cell therapy manufacturing plants that are up and running. They have significant expansion capacity. We're bringing the cost of manufacturing down year after year, making progress. And then we have this really exciting program partnered with Arcellx of a next, you know, what we think is probably, you know, has potential to be a best-in-class, BCMA cell therapy for multiple myeloma. There are two approved therapies, including the one, Mohit, that you mentioned. And we're excited to present together with Arcellx data at ASH later this year.
That will be the first larger set of data that is in kind of more of an apples-to-apples data set relative to the, I think it was called CARTITUDE-1, if I remember correctly.
Right.
The first study of Carvykti. So very excited to see that. You know, even if we have a similar profile, this is a big commercial opportunity for us, and part of that is our ability to serve the market. We have the 98, 90... I believe it's 96-98% manufacturing success rate in cell therapy, which is far greater than the other competitors in the cell therapy space, and we have a much shorter turnaround time, for a lot of these patients that have advanced aggressive disease, the turnaround time is pretty important and the reliability of the manufacturing. The thing that's interesting when there's discussion around the order of entry in cell therapies, that it may be less relevant, you know, our perspective.
'Cause remember, cell therapy is essentially a one-time, potentially curative treatment that is very different than standard small molecules and antibodies. So if you have to choose, you know, which treatment you have, you're gonna want the best. And so far, our data suggests that our BCMA cell therapy could be differentiated both in efficacy and safety, and we need to see more data to confirm that. But if that's the case, it's a relatively straightforward that, you know, if you're a patient and have an option, you're gonna wanna take the cell therapy that or you're gonna wanna be infused the cell therapy that has gives you the best chance for long-term benefit and survival.
So we'll see how it all plays out, but I think the order of entry may be less relevant in cell therapy than some of the debate suggests, and the profile that we have suggests that we could be best in class as well. So, it's an exciting time for... Anito-cel is the name of the product that's in development that, together with Arcellx. So it's an exciting one to watch, and again, the ASH data later this year should be another important inflection point for us.
Got it. And then maybe, like, staying with cell therapy, so how are you thinking about Yescarta and Tecartus franchise near term and long term? Because near term, there are some challenges you talked about, but how do you think about,
Yeah, there's some near-term headwinds in cell therapy. The business is growing beautifully outside of the United States, right?
Mm-hmm.
I mean, nothing has changed in terms of our long-term expectations for cell therapy. We think that cell therapy is gonna be an incredibly important treatment modality, not only in hematological cancers, but likely also in solid tumors, and in autoimmune and maybe neurology over time, and that the market will grow for decades, just like antibody therapies and protein therapies grew, and we're in the early innings of cell therapy. The clinical data for cell therapy, if you just look at whether it's our data in DLBCL, follicular lymphoma, or the data that's available today in multiple myeloma, is really incredible in terms of the level of efficacy that it delivers and the life-changing nature of it for many of these patients. That gives us a lot of confidence that the market is gonna continue to grow over the long run.
It's very hard to foresee biosimilars of cell therapy, so the durability of this business, I think, is probably underappreciated. In the short term, there are a couple of headwinds. One is, in the United States, cell therapies are not being used in as many patients as they should be used in. When you look at the level, the clinical data suggests that everyone should get this, and yet in DLBCL, second-line plus, only two out of ten patients are getting cell therapy, and it's up to us and the other competitors to continue to raise awareness. We saw a little bit of an increase in the second quarter, which is great.
But just to put it in context, you know, 15% of patients in the United States now roughly are getting it, 15 plus percent or minus, depending on the quarter, second line plus. In France, it's 40% plus of patients second line plus are getting it. So there's a big opportunity for us to take this $2 billion business and continue to grow it just by increasing the number of patients that get access to the medicines. The other headwind is, one of our competitors has released additional manufacturing availability, and you have some bispecifics that have launched.
Right.
All of these feel like more short-term headwinds to us. They're real, they're manageable. You know, again, we think that. You saw growth in the U.S. in the second quarter. From the first quarter, you saw greater growth outside of the U.S. But yes, we may continue to see those headwinds throughout the rest of this year, maybe into early next year. But overall, when we look at, you know, a multiyear period, and certainly over the long run, we expect our cell therapy business to continue to grow, both the approved products plus products like Anito-cel that we could be launching.
Got it. Super helpful. So since you are here, I have to ask about BD as well.
Sure.
How are you thinking about BD at this point? Seems like you have a lot going on right now, but at the same time,
... It's always good to have something when you don't need it versus-
Yeah
-when you need it. So how do you think about that?
That's a good question. I mean, first of all, we're gonna continue to be very active in business development.
Yeah.
But what that means over the next five years is very different than what it means over the last five or seven years.
Right
Where we needed to rebuild the pipeline and diversify the business in a really significant way. And you saw that in the number of deals that we did and the amount of capital that we allocated to BD. So we will continue to focus on ordinary course partnering and small acquisitions. You know, CymaBay is a good example of a great deal that's you know, late stage, de-risked, synergistic. We would like to do more of those deals over time. You should expect us to do a kind of a regular cadence of those deals. That typically means one of those every two to three years. Sometimes it might be faster, sometimes it might be slower.
We'll continue to look at it, but you should not expect us to allocate the quantum of capital necessarily, you know, over the next five years, that we did over the last five years. Because we have a much larger, diverse, you know, healthy portfolio, and a lot of programs internally, both internally and externally developed, that we'd like to allocate more capital to. So for instance, you know, we have a number of programs in autoimmune and inflammation, including an oral alpha-4 beta-7 and an oral TPL2 inhibitor. Both of those are in phase 2. We think those are really exciting programs. They're kind of under the radar.
Okay.
And if the data continues to look promising, we'll allocate more capital to those over time. So, we will balance internal and external innovation, but we really like where we are today, and the amount of capital we need to apply to that strategy is probably different going forward than it has been the last five years.
Got it. And then any thoughts on the oral GLP-1 you have internally?
Yeah, we have an oral GLP-1 small molecule that's moving into phase 1, phase 2 clinical studies. We'd be appropriately cautious. There's always high risk when something moves into phase 1. This is a program that we've been working on for years. Even when I arrived at the company eight years ago, I think it was already in the works. We have some of the world's best chemists. They've done an incredible job in HIV, viral hepatitis, and other areas. They worked on this program tirelessly. You know, it's interesting. We think it has... It appears to be very potent. We believe it crosses the blood-brain barrier, so it could be unique, but there's always risk in a phase 1 study. We're gonna do the phase 1, 2, phase 1a, 1b study this year and next in patients with obesity and metabolic disease.
We'll see what the results look like, and if we have something that we think is differentiated, then we'll decide how to move forward. That could be on our own. It could be with a, you know, in combination with a partner, or it could be an out-licensing to a company that has a large presence in the space. So it's definitely exciting, and it's early, and we'd be cautious about people getting out over their skis on it, but we'll provide updates when we can. That probably is next year at some point.
Awesome. Thank you very much, Andy. Really appreciate it.
Oh, thank you for having us again. I appreciate it. Thank you.