Daniel O’Day: Mohit, maybe I’ll start and then have others add. First of all, I think just stepping back and thinking about the portfolio that we’ve built over the past four years now more than doubling the size of the portfolio and with significant advances in our HIV portfolio and oncology and with outside of cell therapy. So as we think about growth moving forward, I mean, first of all, I would say on the HIV side of the business, we had to constantly remind ourselves and others that in addition to the treatment market and the potential for long-acting treatment that we have a very robust program on, and we’ll update you a little bit more on towards the second half of this year with an analyst event, we’ve got the prep market that is just kind of the dimensionalized.
And that is I think that provides significant growth opportunity when you think about your time frame, which you mentioned, which is until the end of the decade. So I think it allows us to think about accelerated HIV total growth prevention and treatment as we head towards the second half of the decade. That — on top of that, then we have the entirety of the oncology portfolio. So both cell therapy within the large B-cell lymphoma area as well as potentially the multiple myeloma entry with Anito-cel and then on top of that, a very robust oncology portfolio that has both Trodelvy and other novel agents that will read out over the course of this decade. And I’ll just remind you, again, we’ve got close to 20 readouts this year, of which three of those are in Phase 3, including lenacapavir for perhaps in the second half of this year to Trodelvy Phase 3 readouts.
And then importantly, we’ve added seladelpar to the mix with a PDUFA date in August. And then finally, just the opportunity to update you on Anito-cel at the end of the year as well. So we’ll be providing more guidance as we continue to look at the entirety of our portfolio, but we really think we have within the company today, by the way, I’ll just mention in addition to complementing where needed from the outside. But within the company today, we have what it takes to drive a substantial growth in our business over the course of the next decade with focus on expense management as well to produce good returns for investors.
Operator: Our next question comes from Simon Baker at Redburn Atlantic. Go ahead, Simon, your line is open.
Simon Baker: Thanks for taking my question. One on seladelpar, if I may. And a question really around the competitive dynamics at launch. If all goes according to plan, your launch in August and Ipsen will launch out of elafibranor in June. So I was just wondering if that really makes any difference. You’ve obviously got far greater infrastructure than Ipsen. Is it too early for them to stay in March? Or paradoxically thus having somebody else on the market promoting PBC actually raise disease awareness and help the situation. So any color around the dynamics that launch would be very helpful. Thank you.
Johanna Mercier: Thanks, Simon. It’s Johanna. Let me take that one. And I think you’re absolutely right. I think the fact that there is more than one competitor hitting the market is great for patients namely around increasing disease awareness around PDC and the fact that there are true options available. Having said that, I also feel incredibly confident that seladelpar is well differentiated to potentially be best in disease when you think about the significant impact and clinically meaningful impact we have with the ALP normalization in the clinical jet Phase 3 clinical trial we’ve seen as well as the improvement in pruritus which is a key symptom of the disease. And today, there really is no effective anti-pruritic option for PDC patients.
And so all of that put together, in addition to the fact that we believe our footprint, both commercial and medical is incredibly well established when it comes to liver disease. It already covers about 80% of all U.S. PBC prescribers. And with that strong differentiated profile we were just referring to, I don’t think those three months make a difference. I think really it’s about best-in-class launch and that potential with seladelpar that we look forward for our PDUFA date.
Operator: Our next question comes from Brian Skorney of Baird. Brian, go ahead. Your line is open.
Charles Moore: Hi, thanks for taking the question. This is Charlie on for Brian. So again, to ask something about seladelpar. Just wondering if you have any ambitions for potentially looking at a label for first line in the future, considering there’s a lot of unmet need with pruritus there as well as any potential synergies you may be considering with the remainder of your liver portfolio? Thank you.
Merdad Parsey: Thanks, Charlie. This is Merdad. Frontline is a challenge given the — what is currently the background standard-of-care. But as you know, we think that seladelpar is going to bring a lot of benefit to a lot of patients, especially given the pruritus and the potential for getting to patients earlier in their course will be really important for us. And so we have to see how the market starts to respond to the presence of seladelpar in the second line. And recall, I think the other thing to recall or think about is the how long people actually get frontline therapy before moving on to second-line therapy, given the efficacy profile of the frontline therapies and the fact that there haven’t been any options, one could anticipate that patients are moved to second-line therapy relatively early in their treatment course and making moving up formally for registrational trials to the frontline potentially superfluous.
So I think we’ll see how that plays out in the market. And once we see our label and all those sorts of things. So we’ll be able to update more after that.
Operator: Our next question comes from Brian Abrahams at RBC Capital Markets. Brian, go ahead. Your line is open.
Brian Abrahams: Hi, good afternoon. Thanks so much for taking my question. PURPOSE 1 is obviously an upcoming readout. So I wanted to clarify some elements of its unique design, specifically what’s the sensitivity of assessing when HIV infection occurred to accurately project the control infection rate? And then — how do you control for potential intrinsic differences in risk behavior that the screened out group serving as the control may have versus individuals who make it into the trial. Thanks.
Merdad Parsey: Brian, thanks, it’s Merdad again. And I could talk about this for a long time. Let me — I’ll try to give a very concise answer. The recency assay that’s been developed for HIV, it has been studied very thoroughly, and we can, based on the diagnosis at the time of screening, create a profile for anyone who’s potentially HIV infected at that time as to how recently they were infected. And I think that’s a key part. And that relates to the second part of your question in that the — we don’t, in a sense, need to compare risk behaviors before and after randomization in that we’ll be looking at the overall incidence of HIV at the time of screening and then comparing in this counterfactual design, with what happens after people start therapy.
So I think between those two elements and all the discussions we’ve had with the regulators and the experts in the field, we’re confident in that the design will provide the information necessary to get us to approval and for adoption.
Operator: Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead. Your line is open.
Terence Flynn: Great. Thanks for taking the question. Just had two parts on the CAR-T franchise. So just was wondering, high level, your commitment to Anito-cel if it proves there is parkinsonism, so meaning it’s less differentiated. And then the second part is, curious where your progress stands with respect to developing the CAR-T for immunology. Obviously, a lot of focus here amongst a number of other companies in the industry. So just curious on Gilead’s thoughts on the forward. Thank you.
Johanna Mercier: Thanks, Terence, for the question. So on the commitment to Anito-cel, we’re — as it relates to Parkinson’s we absolutely feel that we’re differentiated potentially on both safety and efficacy. As we noted earlier, we have not observed the neurotox that some of the other constructs have observed, and we’ll continue to monitor it, but we feel great about the profile right now. And then the efficacy profile, early signals are we think we will be equivalent or could best-in-class. So we’re 100% behind the Anito-cel and we’re looking forward to bringing those data soon. The second question around autoimmune space. So we continue to monitor the autoimmune space. And as you’ve heard from Andy and others before, we will play in that space. We are taking time to take a look at what’s in the space versus what we have in our portfolio, and we’ll be — I don’t have any updates further than that today.
Operator: Our last question comes from Carter Gould at Barclays. Carter, go ahead. Your line is open.
Carter Gould: Great. Good afternoon. Thanks for squeezing me in. Maybe just to round things out on cell therapy, you flagged the same dynamics that have been kind of persisting in the U.S. as far as some of the constraints of the ATCs. I also saw the Tennessee oncology reference. But I guess putting that all together, just your level of confidence you’ll sort of hit that return to more meaningful growth in the second half of the year. I didn’t hear that mentioned and clearly, that’s a point of focus. Any commentary there would be appreciated.
Cindy Perettie: Yes. No, we feel very confident that we’re going to return to growth in the second half of the year, as we stated. I think just as a reminder, we had shared in quarter four our guidance was that we’d be flat to slightly down in quarter one. And part of that is due to the restructure. So we are putting our strategy into play. We feel very confident about the approach we’re taking in the U.S. And we now are looking at having almost a fully [staffed] (ph) sales team back out and working hard. I think a piece that we need to talk about as well is the market dynamics. So the things we’re observing. We’re observing out-of-class competition with the bispecifics, the ATC constraints that we’ve spoken about in the past based on multiple myeloma constructs coming in. But what we’re seeing is a lot of the hospitals and ATCs are working through those constraints, and we feel really confident about the second half of this year.
Daniel O’Day: Thank you, Cindy. This is Dan. So I appreciate all of you joining. Maybe just a bit of a summary statement. I want you all to know where we at Gilead are very focused on the near-term execution and the long-term plans. We’ll continue to stay disciplined and agile in our approach. And just as highlights, we’ve got 54 active clinical programs, no major patent expiries through the end of the decade, a variety of opportunities for growth and a lot more to deliver. On top of that, we are on track to provide updates from 3 Phase 3 clinical trials for trodelvy, lenacapavir. We’ve got the seladelpar PDUFA date in August, and the update on the Anito-cel Phase 2 update with the management one at the end of the year. So rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I’ll hand over to Jacquie for closing comments.
Jacquie Ross: Thank you, Dan. To close, just 1 housekeeping item. I can share that we are tentatively planning to release our second quarter 2024 earnings results on Thursday August 8. Please note that this date is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of the second quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter. With that, we’ll close our call for today. Thank you.
