Gilead Sciences, Inc. (NASDAQ:GILD) Q3 2023 Earnings Call Transcript

And as we kind of shared with you in Q2, we are seeing that normalize out for the second half of this year. And I think you should expect that not only for the next quarter, but then as we go into 2024. And therefore, because of all that, we believe that our HIV sales growth is closely mirroring now more of the market and the demand growth, where we’re seeing real strength, both from a market standpoint in treatment and prevention, we’re seeing about two points to three points growth in the market when you look at retail and non-retail market, and then, of course, 15% growth in the PrEP market. And then from a demand standpoint, I think obviously with BIKTARVY growing at 12 points year-on-year and DESCOVY continuing to hold on to a very strong share over 40% or so in a competitive market with generics and, of course, new formulations.

So more to come as we go into Q4, but hopefully that gives you a better picture of some of the mix of channels.

Jacquie Ross: Thank you. Maybe I have our next caller, please.

Operator: Our next question goes to Tim Anderson of Wolfe Research. Tim, please go ahead. Your line is open.

Unidentified Analyst: Hi. Thanks for taking our question. This is Adam on for Tim Anderson at Wolfe Research. Also on TROP2, just in light of competitor data, can you provide some more color on just latest thoughts on the competitive dynamics within the class? For example, if AstraZeneca gets a label for HR+ breast cancer in the second-line, and Trodelvy only has a label for the third-line, won’t that displace Trodelvy? Thanks.

Johanna Mercier: Yes, good question, Adam. So I’m assuming you’re referring to some of the data we saw at ESMO with data DXD. We don’t believe there is material impact for now anyway, or even in the future for Trodelvy. And the reason for that really has to do with the data itself and the lines of therapy, to your point, I think we’ve proven very clearly with Trodelvy in second-line TNBC and beyond around the overall survival data that we’ve shown. And then, of course, showing OS again in HR+/HER2-, although in later lines. I think what we’re seeing today in the marketplace is not only are we the leaders in TNBC, we’re also leading from an IHC 0 population. And then, of course, looking at sequencing of ADCs posts in HER2, as expected in the HR+/HER2- populations, so quite pleased with our positioning and we don’t believe the data that we’ve seen thus far is going to have a direct impact there.

Daniel O’Day: Yes, I would just add that we continue to expand our programs and continue to want to generate additional data for Trodelvy. So we are very comfortable with where we are. I think our ability to interact with our caregivers and patients now having been on the market for quite some time, is really helping us make sure that we get Trodelvy to as many patients who could benefit from it as possible.

Jacquie Ross: Nadia, may we have our next question, please?

Operator: Of course, our next question goes to Salveen Richter of Goldman Sachs. Salveen, please go ahead. Your line is open.

Salveen Richter: Good afternoon. Thanks for taking my question. Just a question here on the pipeline, just given two data releases that came out. So on the TIGIT gastric data that was presented today, how do we think – or how do you think about the terms, the opportunity, the competitiveness versus standard of care combos and next steps? And then with regard to the multiple myeloma for Arcellx that was presented, it looks to be tracking a Carvykti like profile in relapse refractory multiple myeloma. Could you just walk us through next steps path to market competitive positioning here? Thank you.

Daniel O’Day: Sure. Maybe I’ll start with TIGIT and I’ll hand it off to Cindy for the multiple myeloma discussion. Yes, I think, look, we find the data that we presented today at the ASCO plenary to really be promising for continued momentum for TIGIT. The data from an ORR standpoint, and I think importantly, the landmark PFS analysis are very promising. It’s early data, it’s single-arm data, and I think those are all caveats that are appropriate when looking at these. But when you think about the context around what the standard of care PFS and OS are, we think there’s certainly promising signals that we could do better than that. So, obviously, what we need to do next is allow these data to mature in ARC-21. And then, of course, we have the 221 study.

That is our Phase 3 study, where we will be comparing to standard of care in a randomized Phase 3 trial. We think the data shown today really will help us with momentum in accruing that trial and hopefully demonstrating the promise of TIGIT added onto standard of care, a standard of care like regimen with zim and FOLFOX. We’re excited about that Phase 3 outcome, and it really gives us the opportunity to be, we think ahead on that indication compared to the competition in TIGIT. And Cindy, do you want to.

Cindy Perettie: Yes. Happy to. Thank you. So, this is early days, obviously, for the ddBCMA molecule. We have 38 patients worth of data. If I compare it to Carvykti, the population looks more like the LEGEND-2 population. We have 34% extramedillary disease, which is a high risk prognosis patient. And if you look at the LEGEND-2 data, they had 30%. Our overall response rate to date in those 38 patients at 22 months is 100%, and in the LEGEND-2 data is 88% at 25 months. So I do think there is a potential to differentiate on efficacy. We’re seeing a differentiation as it relates to the safety profile around the Parkinson syndrome. We are not observing that in any of our patients to date. Obviously, we’re going to continue to watch that as we enroll the IMAGINE 1 study and move into our next studies as well.

Multiple myeloma is a large market. There is enough room in multiple myeloma to have multiple competitors. But we also feel like we will have a differentiated molecule with Arcellx. So we’re looking forward to generating more data and talking to folks about it at ASH.

Jacquie Ross: Thank you, Nadia. We’re ready for our next question.

Operator: Our next question goes to Tyler Van Buren of TD Cowen. Tyler, please go ahead. Your line is open.

Tyler Van Buren: Hey, guys, thanks for the presentation. I have another question, actually on the myeloma program. So assuming that Arcellx’s CAR-T ddBCMA data continue to look great at ASH, and the IMAGINE-1 trial does later next year and leads to approval, how prepared have you guys gotten on the manufacturing front in the past year? And do you expect the launch to have a similar trajectory to Yescarta in terms of supply or be significantly better.

Johanna Mercier: Hey there’s a number of things that we have learned over the course of the years with Yescarta and around manufacturing, all of which we’re applying that knowledge to the manufacturing of the ddBCMA CAR-T. So we plan to launch that out of our facilities at Kite and expect to have a strong launch again. We will be applying Yescarta learnings. So our goal is to be significantly better than we were at the launch of Yescarta.