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Cowen Health Care Conference

Mar 7, 2023

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Good morning, everyone. Geez, maybe we can Is this slide over? Is there interference from the speaker or? I guess it's just loud. All right. Well, again, good morning. Tyler Van Buren here, Senior Biotech Analyst at TD Cowen. Thanks again for coming to TD Cowen's 43rd Annual Healthcare Conference. For our next session, we're privileged to have a fireside chat with Gilead. From Gilead, we have Andy Dickinson, the Chief Financial Officer. Andy, thank you very much for being here.

Andrew Dickinson
CFO, Gilead Sciences

Thank you. We're thrilled to be here. Appreciate you having us.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Of course. If you guys have any questions, feel free to raise your hand and we'll do our best to get it asked. For an opening question, Andy, maybe you could just start with, you know, the earnings guidance for 2023, it assumes about a 5% year-over-year decline, but that's obscured by the unfavorable year-over-year impact from Veklury. Can you speak to Gilead's core earnings growth and what you expect for the next several years?

Andrew Dickinson
CFO, Gilead Sciences

Sure. Yeah, I'd be happy to. Maybe I'll just back up and start by. I think when you think kind of going forward, it's helpful to talk about 2022 just to frame where we are. We're still one of the companies that is in a unique, you know, situation of having a fantastic COVID-19 therapy, Veklury. I think we're at a point, and clearly in 2022, we got finally to the point where investors really look at our base business and then they look at Veklury separately. I think the vast majority of investors today focus on the growth in the base business. We saw a really strong growth in the base business last year.

It was the first year, really since 2015, where you saw strong growth in the base business, not only in our HIV business, but in the oncology business that we're building. It's a really exciting and really the first tangible evidence of all the work that we've been putting in over the last four or five years. We had a new CEO, Daniel O'Day, that joined four years ago, almost four years ago to the day, and we've made a lot of progress. The real focus is on the base business. There's less of a focus on the overall revenues.

I would say in 2022, the other interesting thing was, you know, our total sales were roughly on par with 2021 at $27 billion, despite the fact that we had a little bit less than a $2 billion decline in Veklury for COVID, meaning that the base business. You saw the extraordinary growth of the base business, again, both kind of equal contribution from the early and emerging oncology business and the HIV business. Your question on kind of where we are and where we're going forward, we're expecting, you know, that we're entering a new growth cycle and that this is just the beginning of it. We have a lot of confidence in where we are over the next decade.

It's clear from our perspective that our HIV business should continue to grow through at least the end of the decade and hopefully beyond. Then again, we have a great oncology business with both our cell therapy business and then Trodelvy as a product in a pipeline that are both growing beautifully, and we expect to continue to grow. It's a really exciting period. Then to your question specific on what does that mean for earnings growth, you know, the earnings growth, when you include Veklury, it will be a little bit variable given it's hard for us to forecast Veklury sales or the progression of the pandemic. You know, what is clear to us with Veklury is that there will, there's a continued demand. It's the absolute standard of care for hospitalized patients.

We're guiding to $2 billion of sales this year versus the roughly $4 billion in sales we saw last year for Veklury. A lot of that will just depend on the progression of the pandemic. There's a greater variability of that business which will impact our EPS. If you model out EPS excluding Veklury, again, it's not something that we can present as a company, but a lot of our investors look at it that way. We expect our EPS to grow over the coming years, year-over-year, and to really see continued acceleration in that growth given the leverage in our business, as we get additional momentum or carry forward the momentum that we have from 2022.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

You touched on the durability of the HIV franchise. Obviously, you guys had the settlement which pushed the LOEs into the early 2030s, but maybe you could just elaborate on how healthy the HIV business is coming out of the pandemic, and what do you expect revenue growth to look like over the next few years, and what are some of the pushes and pulls?

Andrew Dickinson
CFO, Gilead Sciences

Sure. Yeah, the HIV business is really healthy. I mean, I think that the pandemic had a greater impact on HIV treatment than we and I think others in the market would have expected. You've seen the market recover. Now in 2022, we are really back to that 2%-3% growth in the treatment market that we expected and that we're seeing going forward. There were some tailwinds in pricing, especially the government mix in 2022. The HIV business overall grew at 5% last year. Really strong growth. The, you know, the major pushes and pulls for the HIV business are relatively straightforward. We expect the treatment market to continue to grow. We don't have any major patent cliffs through the end of the decade or beyond.

The first major patent cliff for us is really 2032 or 2033 on some of the TAF patents in Biktarvy. We have new product launches that we're expecting. There's probably a handful, at least, of new treatment product launches, that would include once-daily product options, once-weekly oral product options, potentially, and every three or every six-month injectable options, preferably SubQ options. A number of new products that should come and drive additional market share gains for Gilead over that period of time, which we're excited about that would add on to the 2%-3% market growth. Separately, in the HIV prevention market, which is a really exciting opportunity, we launched our first prevention drug 10 years ago.

The efficacy of prevention once-daily pills is remarkable. We really expect that the prevention market will be a step function change in the size and ability to treat patients in prevention with a long-acting therapy, and in particular, Sunlenca, which is an every six-month subcutaneous injection. It's a product that's already approved for highly treatment-experienced HIV patients. A lot of times when we're talking to shareholders, they think of the every six-month subcutaneous product as something that's more theoretical. In fact, it's real. It's approved in both the United States and Europe for highly treatment-experienced patients. We're in the middle of our phase III studies for prevention. We should have data at the end of next year or early the following year, and that should be a real catalyst for continued growth in the HIV business as well.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Okay. Just to continue on Sunlenca, you mentioned the heavily treatment-experienced patient population, the approval, it's small PrEP could add. In terms of treatment and treatment combinations, what's the current strategy there, and when might we get data from those combinations?

Andrew Dickinson
CFO, Gilead Sciences

Sure. We're exploring a number of different combinations for lenacapavir. Again, lenacapavir is our novel HIV capsid inhibitor that is the generic name for Sunlenca. It's really an incredible molecule in terms of its potency and its ability to be formulated as a once-daily pill, a once-weekly pill or a subcutaneous long-acting injection for at least every six months and potentially longer. The key, as you know, in treatment, is finding another agent to pair with that. We today have seven programs in early stages of clinical development of potential partner programs. We have another three that we expect to be entering the clinic over the next 12-24 months. That gives you a total of 10 potential partner agents. Five of those are integrase inhibitors. One partner agent or set of partner agents are broadly neutralizing antibodies or bnAbs.

We have a novel NUC, a novel non-Nuc. There's a number of programs. The integrase inhibitors are the ones that, given where they are today in treatment and the efficacy and resistance profile that you see with the integrase inhibitors that are probably the most obvious partnering agents. We're really excited about all the programs. To your question of where are we, I mean, there will be a lot of data generated in all these long-acting potential partner agents over the next year or two years, and we'll have a much better sense of which programs we're gonna take forward and what their competitive profile looks like.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Got it. Okay. You touched on Veklury, and you guys have guided the $2 billion in sales for this year, and hopefully it's stabilized. I guess, can you talk about your level of confidence that maybe it has stabilized, that this could be a sustainable number as we look out over the next few years?

Andrew Dickinson
CFO, Gilead Sciences

Sure.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

How might the oral program contribute?

Andrew Dickinson
CFO, Gilead Sciences

Yeah. Veklury is unique in that, again, the data is exceptional. Maybe we should just start with the benefit for patients and the data. I think there are a lot of real-world data sets that have been coming out recently, not from Gilead, but from others that just reinforce how important and effective this treatment is for patients. Again, it's an infusion, so we're talking about an infusion in the hospital. It is approved for infusions outside of the hospital as well, but it's predominantly used in the hospital. You still see today that greater than in the U.S., greater than 50% of hospitalized patients get Veklury.

The challenge in forecasting Veklury is it's forecasting the progression of the pandemic, where again, if you look historically, we had $5.8 billion of sales in 2021. We had $3.9 billion in sales last year. We're forecasting $2 billion this year. It's not because the product's not being used. In fact, we're seeing increasing use in Europe and Japan and consistently strong use in the United States. It's that you see less in terms of surges from COVID-19 in the US as a result of both natural and acquired immunity. That could change over time.

To answer your question, we expect Veklury to have a much longer product life than the market would have expected when we launched the product three years ago, and it's still difficult for us and for you and others to forecast it. We'll have a much better sense of where we are in terms of We've pledged to shareholders that we'll provide updates throughout the year. When I look forward, I expect the cash flows and the revenues to be durable, but I also expect them to be dynamic year-over-year. The best analog, as many of you know, is another molecule that Gilead developed, which is Tamiflu, that we outlicensed years ago to Roche.

That's a great analog. It provided sales for Roche, benefit for patients for years, but it was highly variable, and I think it's a good, it's a good proxy for what you're likely to see with Veklury. It'll have a long product life. It'll generate a lot of cash flow for the company. It'll benefit a lot of patients, but it's going to be dynamic year-over-year. Hence why I think most of our investors focus on the base business and the growth of the base business, and then Veklury is the icing on the cake, so to speak.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Okay. With 5245, the oral, you've got the phase III BIRCH and OAKTREE trials ongoing. When could we see data from those programs or just a rough estimate of when it might be able to get to market if all goes well?

Andrew Dickinson
CFO, Gilead Sciences

Yeah. I'm sorry I didn't answer that question earlier. It's a great question. The both of the studies are running. Again, this is a no-novel COVID Nuc. It's a prodrug of the parent nucleotide of remdesivir, if I remember correctly. We have two studies running. One is in standard risk patients, which includes sites in the U.S. The other trial is in high-risk patients, where we're only doing the study outside of the U.S., given some of the regulatory feedback. Both of those studies are just getting underway, it's hard to give you a sense of the completion date. You know, it's all gonna depend on the progression of the pandemic and the ability to find patients in the U.S. or outside of the U.S. These could be trials that take a long time.

If we see a surge in the pandemic, we may be able to enroll them quickly, but it's just way too early for us to give you any sense. They're exciting opportunities for patients and for Gilead in the long run. It'll just take, certainly many more months, if not, you know, through the end of the year and until next year before we really have a sense of how the studies are gonna enroll and more specific timelines.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Let's move to oncology. For cell therapy, you guys have stated that Yescarta, still the majority of Yescarta growth is coming from the third line plus indication despite the ongoing second line launch. I guess, you know, my question is, when do you expect second line to become the majority of growth? What's the inertia, perhaps, that you're experiencing in the second line, and how can you overcome that?

Andrew Dickinson
CFO, Gilead Sciences

Yeah. Yescarta is our cell therapy product. It's approved, if I remember correctly, for two or three indications. We have two approved cell therapy products approved for five indications. Yescarta is a CD19 cell therapy, and the primary indication is DLBCL. We had some incredible data from the ZUMA-7 study, and then an approval last year that resulted in a significant increase in our cell therapy sales from the Q1 to the Q2 , and then we've grown sequentially kind of back at the more normal 5%-8% growth rate from there. What should you expect? It's a little bit different in the U.S. and Europe. We are seeing physicians change their treatment behaviors in Europe faster than the United States.

In third line plus DLBCL, the percentage of patients that get cell therapy in Europe is higher than it is in the United States. It's growing in the United States as well, but it's far below where you would expect it to be for a therapy that appears to be curative. Remember it, at five years, 43% of the patients, and these are patients that were third line plus from the ZUMA-1 study, 43% of the patients have no sign of disease or residual disease. It's too early to say, to call it a cure, but it appears to be curative. You still have kind of the low to mid-20 percentage points of patients in the United States that are getting cell therapy in the third line plus and less than that in the second line.

To your question of it is gonna grow, we expect more not only in the third line and the second line. Cell therapy for us, and I think for the competitors, is much more about the class usage increase than the individual market share of the companies. We expect that, and we did when we acquired the company five-plus years ago, that this is a slow, steady build over time. Your, you know, oncologists are getting used to, especially the community oncologists, sending their patients away, in some cases, to academic treatment centers, for treatment, and then understanding that some of those patients will come back. You're slowly changing the behaviors of physicians. Again, it's been a little bit slower in the U.S.

We think that over the next three to four years, five years certainly, you're gonna see substantial increase in both third line and second line usage for Yescarta. It's just gonna take time. It's a slow and steady build, which is fine.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Just out of curiosity, why is use significantly higher in Europe versus the U.S.?

Andrew Dickinson
CFO, Gilead Sciences

It's a great question. I mean, It's hard to say that there's one reason specifically. I think in the U.S., you know, there are many physicians are so used to sending patients off to stem cell transplant. You also have in the U.S., many of the physicians have an economic interest in the treatment centers that they have. Whether that has any impact, it's hard to say. In Europe, I think the data, they just really embrace the data, the curative, potentially curative nature of the therapy and have moved more quickly to adopt it broadly. I think that's gonna change. You'll see the U.S. catch up. The best proxy is stem cell transplant to some extent.

It took, as I understand it, decades for stem cell transplant to slowly really become the standard of care in second line. It didn't happen overnight. There is a good proxy for kind of the slow, consistent change in prescribing or treatment behaviors over time.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

What do you think is the likelihood that we see approvals or use in that first line or post first line setting and potentially even outpatient?

Andrew Dickinson
CFO, Gilead Sciences

Well, post first line setting, we're already there with the second line approval, with the spectacular data that, again, it was head-to-head against stem cell transplant, showing very substantial improvement in outcomes for patients versus stem cell transplant. In the first line setting, R-CHOP, as I understand it, I'm not a physician, works very well. It's a generic regimen, low cost. It's gonna be hard to overcome R-CHOP in the first line, with the exception of patients that are high-risk patients. Our study is focused in the first line on high-risk patients that have certain markers of disease or, you know, more explosive disease that suggests that they should go to cell therapy immediately.

I do think over time, not only in DLBCL, but other indications for the higher risk patients, we expect that you could see some cell therapy usage, but it's not gonna be in the majority of first line patients, at least not today in terms of how we see it.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Okay. Maybe we'll move to Trodelvy. I guess, do you believe that people are underappreciating the opportunity in the Trop-2 patient population, and, what's your outlook for that launch?

Andrew Dickinson
CFO, Gilead Sciences

The answer is, I think, simply yes. We think that the market's underappreciating the opportunity for Trodelvy and the importance of Trop-2-directed ADC and kind of the broad scope of the opportunity. It's up to us to demonstrate that over time. We have a number of studies underway, not only in breast cancer. Remember, let me just again step back for the people that are listening. Trodelvy is a antibody drug conjugate targeting Trop-2, which is an antigen that's broadly expressed across most solid tumors. The data from Trodelvy has been spectacular. We have three approvals in triple-negative breast cancer, a third line plus, if I remember correctly, bladder cancer, and now second line plus hormone receptor positive HER2 negative breast cancer.

Again, three very impressive data sets. We have studies running to move up in earlier lines of therapy. you know, there's some data from a phase I basket study that Immunomedics did before we acquired the company showing some activity in lung cancer. It's an obvious area to move in. We're in the middle of pivotal studies in lung cancer. There's another Trop-2-directed antibody called datopotamab deruxtecan from AstraZeneca and Daiichi Sankyo that will have lung cancer data that reads out quickly. Even though the ADCs target the same antigen, they have slightly different constructs, which we think could lead to benefits, especially in earlier line patients for us down the road in terms of side effect profile. It'll be interesting to see how the data develops over time. No, we're very excited about Trodelvy.

We see Trodelvy as a pipeline and a product, an absolute blockbuster, product. We had nearly, if I remember correctly off the top of my head, nearly $700 million in sales last year. Sales are still growing, you know, well north of 50%, and we think this is an important growth franchise for patients and for us over a very long period of time. It's early days, but it's pretty exciting. Made a lot of progress since we acquired the company.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

What's the longer-term vision for Trodelvy? Is it, combining it with, standard care and, various, solid tumors or agents within your own pipeline or both?

Andrew Dickinson
CFO, Gilead Sciences

Yeah, it's both. I mean, that's what's so exciting about Trodelvy for us is when we look at Trodelvy, it has the potential to replace older generations of chemotherapies in all the different lines of solid tumor treatment and in many solid tumors. The, you know, the real vision is that including in first first line non-small cell lung cancer for people that have lower PD-1 expression that you would see, you know, Trodelvy used with PD-1. Beyond that, we have a TIGIT program, I think as you know, we really expect that for high PD-1 expressers, you're likely to see the standard of care move over the coming years to TIGIT plus PD-1. For lower PD-1 expressers, the vision is that it would be PD-1 TIGIT plus Trodelvy. It's a really exciting time in lung cancer.

There's a number of exciting programs that we have in our pipeline and a lot of data that'll read out over the next two or three years. That's the vision. Again, it's not just restricted to lung cancer. The same thing's true for earlier lines of breast cancer and other solid tumors. We're doing exploratory work in a number of new solid tumors. The other obvious combination partner for Trodelvy is a PARP inhibitor, potentially. There are so many ways for us to take Trodelvy. It's a pretty exciting opportunity for us and our team and patients.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

On TIGIT or domvanalimab, maybe you could reflect on the data that was shown in December and what we should expect with the upcoming ASCO presentation, and if there might be anything new that we're not anticipating.

Andrew Dickinson
CFO, Gilead Sciences

Again, our TIGIT antibody, to provide some background, is partnered with Arcus. It's an important partner of ours in the Bay Area. They have a number of great programs, including the TIGIT program. The ARC-7 study, which is a phase II B3 study, in 150 patients, and this is in first-line non-small cell lung cancer, in combination with PD-1 versus PD-1 head-to-head. Reasonably big phase II study of 150 patients. The dataset, Roche had a dataset in a study, I believe it was SKYSCRAPER, if I remember, that people were really excited about.

That was like 50 patient study, they had, on a retrospective analysis, 28 patients that were PD-1 high that showed a very significant benefit in this similar patient population from a TIGIT antibody in addition to a PD-L1, I believe, in that case. Our study was significantly bigger. This is another interim analysis. The study has five interim analyses, I believe, or this is the fourth interim analysis. Really exciting data. It showed a meaningful hazard ratio in PFS at the interim. Again, it's a bigger study. It's well powered. The study was presented at the monthly ASCO plenary. You know, what it showed is that when you look at...

It was less about the response rates and more the really strong PFS data, gives us a lot of comfort that the TIGIT is showing additive efficacy benefit on top of PD-1 in these patients, PD-L1 high expressing patients. You're not seeing additive toxicity, which is really exciting. There will be an update of that data at ASCO this summer, which will just be more patients. I think of the 150 patients, like off the top of my head, I think it was maybe 130 were evaluable or a little bit more than that were evaluable. You'll have more patients this summer, and you'll have a longer data set. We'll get a sense of whether you see deepening and increasing responses over time. There is an overall survival endpoint for the study.

You wouldn't expect to hit it for this small of a study down the road. We'll keep following these patients over the long run. We've already started the phase III studies at risk together with Arcus. We are, you know, committed to TIGIT. We see a real opportunity here, and we're moving forward aggressively. It's a competitive landscape.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

How long might those phase III studies take or that phase III program?

Andrew Dickinson
CFO, Gilead Sciences

The phase III program, I don't know that we've said anything specifically. The studies are enrolling very quickly, as you might expect. I mean, there's a lot of enthusiasm across academic centers and globally, so I don't think we've, Tyler, we've provided any specific update. What I can say is the studies are enrolling very quickly. We're making great progress, and we're looking forward to sharing a much more comprehensive data set over the next two years.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Okay. On the business development front, what is Gilead's capacity to do deals? How large would you be willing to go?

Andrew Dickinson
CFO, Gilead Sciences

Yeah. We have a lot of capacity. I mean, that's not the focus. I think the key where I would take you is, you know, what we've done over the last five years, we've done over 100 deals, including some very large acquisitions. We've completely reset and rebuilt our pipeline. We believe that we have one of the most strongest pipelines in the industry. We have a diverse pipeline. We do need to add more programs in the early stage part of the pipeline. We've made some really good progress in 2022.

I think you'll see that going forward. When I think about corporate development going forward, what I would focus people is that what you saw in the last five years was needed and necessary to rebuild the pipeline, to diversify the company, and to drive the growth that you're starting to see. The benefits that you saw in our base business growth in 2022 are kind of a tangible evidence of the work that we've been putting in to really broaden our research focus and to invest more in R&D. Historically, Gilead substantially underinvested in R&D. I would say last year we reinvested 18% of our revenues in R&D. That's still well below the industry average. This year, our guidance suggests that we'll invest about 20% of revenues on R&D.

We're finally getting to what I view as a more healthy level that will sustain our growth ambitions going forward. What does that mean then for BD, to your question, is like the next five years are gonna look very different than the last five years going back. Maybe 2022 is a pretty good proxy for what you should see, but we're focused on ordinary course partnering small deals. A good example, like the MiroBio deal that we did last year. Miro is a small company in Oxford, in the U.K., that had four preclinical, one was moving into the clinic, immune agonist for immunology that we were excited about. That's a great example of the type of deals that we're focused on. From time to time, we will do a bolt-on acquisition.

I use our Forty Seven deal a couple of years ago as a good example of a bolt-on acquisition. When you saw us deploy over $50 billion of capital over the last five or six years in corporate development, the future, at least from my perspective, as I look down the road, is very different. We build a lot of cash. We'll continue to build cash that we can return to shareholders, but we're gonna, first of all, make sure that we have the pipeline right and the R&D spend right. Secondly, we're committed to our dividend and growing our dividend, and then we have flexibility on whether we wanna pay off some more debt. We're very comfortable with our gross debt and our net debt. We've paid off all the debt from the Immunomedics acquisition.

We can selectively return money to shareholders through, either one-time dividends in addition to our annual dividend growth or share repurchase, but we'll be flexible. I think you should expect that we'll continue to build the pipeline, but the amount of capital that's gonna be required going forward is very different than what we used over the last five years, from my perspective.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Yeah. I imagine you'll continue to be active in oncology, of course. The Arcellx deal was a great deal, but I guess on cell therapy in particular, do you anticipate that it'll be CD19 and BCMA for the foreseeable future, or do you plan to augment that with additional external deals?

Andrew Dickinson
CFO, Gilead Sciences

Well, we will definitely augment it with additional external deals. I can't tell you what those are now. I mean, there's so much happening in the cell therapy space that's really exciting. We expect that the cell therapy space, a number of these partner or potential partners will be looking to work with a company like Kite. I think Kite is clearly the partner of choice in the cell therapy space in terms of our expertise, not only on the commercial side and how we work with the hospitals and the treatment centers, but certainly on the manufacturing side and on research and development. I think there's gonna be a lot of opportunities, and we wanna broaden the cell therapy business beyond just CD19 and BCMA.

I mean, to be clear, the CD19 and BCMA CAR T markets are large, very attractive. We think, you know, we're gonna build a great business there. We already have in CD19. It'll continue to grow. In BCMA, we have a great partnership with Arcellx that you highlighted that we did at the end of last year, and we're moving into solid tumors. We think that people will make a lot of progress in solid tumors, companies will, and researchers over the next five to 10 years. It's exciting to see where that goes. Of course, there's always the potential of taking cell therapy into immunology or to virology over the long run. We will continue to do deals in Kite, not only next year in the next couple of years, but for the, you know, for the long run is my expectation.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Okay. A last business development question. You mentioned MiroBio, right? Which is, I guess, associated with the I&I space, which is becoming, you know, a very hot space. NASH is staging a comeback. Should we expect you guys to be active in those two areas as we look to the future?

Andrew Dickinson
CFO, Gilead Sciences

Yeah. I mean, the MiroBio deal is a great example. We're gonna be active in the I&I space. There are a couple of areas of primary interest and focus. You know, RA, UC, lupus are good examples. We have a couple of exciting internal programs that I think people are sleeping on that are all moving into phase II, or at least two of them are moving into phase II, and the other. So one is an oral alpha 4, beta 7 program. There's a small company in Boston called Morphic that has a competitive program, but we think we have a great program. It's moving into phase II-B. We have a TYK2 inhibitor that we're excited about. There were some new, kind of...

People are working out the, as I understand it, some of the TYK2 biology, and as a result, I think there's a lot of interest in our program there. Then we have an IRAK4 inhibitor that's moving out of phase I, hopefully, knock on wood, into phase II. Again, it's early days with all those programs, but we're probably doing more in I&I than people appreciate. MiroBio and that deal, we think is a great one in terms of building it out. We will do more in the long run, we will build that franchise. There's no urgency to go out and do a big deal in I&I.

I think that we're doing a great job of kind of building it slowly and thoughtfully, given where we are, but we're excited about the internal portfolio and some of the plans that we have for development there.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Got it. I take it... Terry? No. Tim.

Andrew Dickinson
CFO, Gilead Sciences

Yeah.

Speaker 3

Can you just remind us when Biktarvy would be subject to negotiation in your Medicare exposure?

Andrew Dickinson
CFO, Gilead Sciences

Sure. maybe to repeat the question. Thanks, Terry, for the question. On the first part of the question, sorry, was what? On the IRA. What's the second part?

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Yeah, IRA impact on your franchise overall. Then Biktarvy in particular.

Andrew Dickinson
CFO, Gilead Sciences

Yeah. On that, there was a first part, I'm sorry, Terry. I spoke Oh, right.

Speaker 3

Small molecules going in.

Andrew Dickinson
CFO, Gilead Sciences

Yeah, I'm sorry. Okay. Yes. The question is, will the IRA change how we do drug development in oncology? I don't think so. I mean, again, we're one of the few companies that has a focus across the entire therapeutic spectrum. We're a world's leader in small molecule drug development combinations. We obviously have been building over the last couple years our antibody bispecific and protein capability. Obviously, with the ADCs and cell therapy, we have that end of the spectrum. Scientifically, we will always take the approach of applying whatever mechanism of action we think makes the most sense, Terry, against a given target. We do, of course. It will impact how we value opportunities, both internally and externally, when we think about the IRA as it's currently constructed, and again, we'll see whether it changes over time.

In terms of the Biktarvy impact, again, we're one of the few companies that has a very novel and kind of new pipeline, so the IRA, in terms of the mandatory price negotiation, is expected to have. It'll have a potential impact on our business, but probably more modest than many companies. Biktarvy, which is our gold standard HIV treatment therapy, could conceivably be subject to price negotiations starting in 2028, we believe, at the earliest, based on the letter of the law, and I would say between now and then, a lot of things could change. The last part, Terry, of your question was Medicare. Across our HIV treatment, Medicare is about low 20 percentage point of the HIV treatment market in the United States.

I would also highlight that we already operate in HIV, as the same thing is true for our competitors, in a heavily discounted market. Remember, in the government segment, the ADAP, and the 340B segments, in addition to Medicaid, are already significantly discounted. You know, there could be an impact on our business, and it's manageable, and it doesn't change the overall growth profile of the business through the end of the decade and beyond, from our perspective.

Speaker 3

I mean, how exactly is there an ADAP to the whole entire IRA that negotiation?

Andrew Dickinson
CFO, Gilead Sciences

It's too early to say. I think. Terry's asking the question of could it have a knock-on effect of your other discounted seg-sectors. I don't know is the answer. I think we're still working through it. Whether the question is could it have effect on the commercial business or otherwise, we'll work through it. Again, our expectation is a lot could change over the next four or five years, and we'll all have a better sense of how it's gonna work out. Again, when we kinda step back and look at the big picture, even though it will impact our business, we expect to kinda grow through it, and we're excited, especially with the youth of our portfolio. We think the setup from here is really attractive for investors and for the company.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Yeah. When I did the work, I was surprised by how limited the impact was relative to the IRA. I think people don't appreciate that Medicare spend, as a proportion of Biktarvy and Epclusa sales, are actually lower than what some of the other products are.

Andrew Dickinson
CFO, Gilead Sciences

Right.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Anyways, we're well over time, and lunch is coming up, Andy.

Andrew Dickinson
CFO, Gilead Sciences

Thank you.

Tyler Van Buren
Senior Biotech Analyst, TD Cowen

Thank you very much.

Andrew Dickinson
CFO, Gilead Sciences

Thank you for having us. Thank you.

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