Gilead Sciences, Inc. (GILD) Earnings Call Transcript & Summary

Good afternoon, everyone. Thank you so much for being here. Well, I guess it's not quite afternoon yet, but almost lunch time. So hang in there. I'm Brian Skorney. I'm one of Baird's senior biotech analysts. Really, really excited to have with us as the next fireside chat, Cindy Perettie. She's the CEO of Kite, a subsidiary of Gilead that works on cell therapy. Very interesting acquisition that the company made going almost a decade now ago, but it's a big part of the story, and there's a lot of exciting data coming from a number of the late-stage programs. And certainly, the commercial has exceeded expectations for Yescarta.

So Cindy, you've been at Kite now for a little more than 2 years. How have you sort of seen the business of cell therapy evolve over that time?

Yes. No, it's been an exciting 2 years. And I'd say even before that, you highlighted Gilead's investment and acquisition of Kite, which has been fantastic because Gilead has strategically invested in Kite over the last decade, and it's allowed us to build out global manufacturing and a number of different things, and they'll continue to do that as part of the diversification of the portfolio. So we're excited to bring a lot of oncology assets and autoimmune, hopefully, in the future. The things that I've seen change, obviously, having Yescarta and Tecartus on the market, we've really made a push in the last couple of years to say, how do we get out of just the academic-only centers and how do we make this treatment more viable for patients closer to where they live. So we've had a strong effort really moving into the community in the outpatient setting over the last 2 years. We're also improving our manufacturing. We know that tightening the timelines and the turnaround is important to patients. We know that getting our cost of goods down are important to everybody. So improving on that. We are bringing forward our next product to market in 2026 potentially, which will be anito-cel. So we're really looking forward to moving out of just leukemia and lymphoma and into the multiple myeloma space. And are very excited about what we're seeing with that product, both safety and efficacy. And everything we've done with Yescarta and Tecartus, we will use as we bring anito-cel to the market. We have a series of next-gen products that we'll be sharing full data set on all 3 at the end of this year for lymphoma and leukemia, and we're really excited about that. We've done some work in solid tumors. And then recently, we've made an acquisition about 2 weeks ago of an in vivo company called Interius and remain very interested in that area. We've all been watching allo. We've been watching TILs, NKT cells, and we just haven't seen the depth of efficacy and sort of the persistence that we were looking for that autologous provides for patients. And the early in vivo therapy looks like this is possible.

Yes. So I think that's a great segue. You've had many recent developments, but you recently acquired a private company called Interius BioTherapeutics, I think for $350 million. Notably, that brings in an in vivo platform. Given that your leadership in sort of autologous CAR T for a long time, can you sort of discuss what you're seeing in in vivo CAR T to drive your confidence to invest further on this side?

Yes. So the early data came out probably -- I think it's 3 to 4 months ago now in The Lancet. So there's early data that came out of China that's really exciting for us. It's the first time, as I said, we're seeing data with that depth of response and potentially the persistence that we've seen with autologous. The pieces about in vivo where there's 2 approaches. One is Interius, the company that we bought is a viral vector. So it's an integrating approach. And a viral vector, we have production for viral vector today within the Kite family. It's a modular vector. You can insert different binders. There's components of it that we think are very important to getting this to T cells, getting the cell expansion. And so the IP that Interius had has been very important to us. We also think Kite brings a couple of things to the table. So you'll see that modular format, we'll be putting a few things into. The thing about integrating technologies for in vivo is it's the manufacturing, the cost of goods go down substantially. You're just making a vector. I don't want to say just, it's a modular vector. The second piece is that it's off the shelf so that it can be delivered almost anywhere, which makes it much more viable for meeting patients where they are. The third is that you don't have to use lymphodepletion. So the data that we're seeing, the early data is that lymphodepletion is not required. So you can imagine being able to use this in both the hematology setting as well as the autoimmune setting. And you can obviously manufacture this at a much lower cost of goods. So we're excited about what's possible here and what we can do with Interius together with Kite and really bringing these options for autoimmune and hematology to more patients globally.

Great. Maybe refocusing back on sort of the commercial portfolio with Yescarta and Tecartus. While you're working on moving further into the community setting, I know you recently showed data at ASCO showing similar outcomes in the inpatient and outpatient setting. Can you give us some color on why you believe these data can support confidence in physicians operating beyond sort of traditional inpatient basis? And what sort of commercial opportunity that potentially opens up?

Sure. So we shared about 238 patients worth of data looking at patients that were treated in an inpatient setting, and this is through a registry, so it's retrospective and then patients that were treated outpatient. And a couple of things that the data shared. So the data showed that there's no difference in the outcomes, whether it's efficacy or management of safety, whether they were inpatient or outpatient. It also provided some color as to how patients were treated outpatient. What does it look like in certain centers. That's important. It's giving HCPs confidence. It's giving them a road map for how they might use our products in an outpatient setting. Today, we've seen a lot of the major academic centers move to outpatient as their volumes have gone up. But what we want to do is instill confidence in that next level of centers that they would be able to also treat an outpatient as well as in the community and regional setting. So we have a lot of centers. I'll use Penn as an example, where they have satellite hospitals, well Memorial Sloan Kettering right up the street, satellite hospitals. And so the ability to be able to deliver that in the outpatient setting is what we wanted to show effectively there. And we think that this is going to open up the market. It's going to open up the market for those satellite centers with major hospitals, but more importantly, with the large integrated community practices.

Great. So it seems like the FDA is fairly aligned with your efforts to expand utilization as in June, they removed the REMS requirement for CD19-directed autologous CAR T. Can you discuss how the removal of this requirement can support further setting expansion and uptake on your commercial portfolio?

This is really a game changer for patients. This is something that we have been working on since I arrived. We have the largest data set. We have 25,000 patients worth of data when we spoke with the FDA, and coming together to show that what we've seen over the last 7 to 8 years is that patient safety subsides within 12 to 14 days. So you no longer see the safety events that require you to be hospitalized. Today's REMS or yesterday's REMS program required you to be within proximity of the hospital for 30 days, you and your caregiver. That puts tremendous burden on the patients. It puts tremendous burden on the HCPs as well as the caregivers. And so changing that to 2 weeks, which is where we sort of see the change in safety where there aren't the safety events that you'd be worried about. The second component is around driving. Patients were precluded from driving for 8 weeks, so for 2 months. So after -- if you look at cell therapy, most patients feel better at 2 weeks. They're ready to go home and resume their life, but weren't able to drive for another 2 months is really put a lot on the caregivers as well as the patients. So now that has also moved to 2 weeks. So we think having this allows patients to return to home faster, ensure that their local physician can take care of them and actually drive to those doctors' appointments themselves.

Great. So maybe turning to the pipeline. Certainly, I get -- I think, probably most investors ask about the anito-cel program. You did a partnership with Arcellx to in-license that program a couple of years ago. Now -- and you have a registrational program in fourth line plus relapsed/refractory multiple myeloma. You're saying you could potentially target launch maybe next year. Can you just give us some background on the existing data? And what's driving your confidence around differentiation here relative to the approved...

Therapy? Yes. So what we've been able to share in the last data cut we shared was at EHA this year, we're able to show really comparable and somewhat better efficacy for the construct that we put forward for anito-cel. And that we've shared 15-month -- or sorry, 18-month PFS and OS recently. So it's not totally mature, but our 15-month PFS is at 66% -- sorry, 18-month OS is at 66% and -- I'm messing this up. Our PFS is at 66%, our OS is at 99% -- 90%. And so what we've been looking at is we've got really strong efficacy with this construct. But more importantly, we have a differentiated safety profile. So we have not observed any of the delayed neurotoxicities that exist in the current constructs, whether it's Guillain-Barre, cranial nerve palsies, Parkinsonism, we haven't observed any of that. We also have not observed enterocolitis. And enterocolitis is something that can result in fatalities. And certainly, the regulators are very interested in that. So we haven't observed that to date with anito-cel. Couple that with Kite's manufacturing, we have a global manufacturing presence. We've now brought anito-cel into our manufacturing at our Maryland facility and have been able to produce it for our clinical trials since June of last year. The production today looks like our current products on the market with Yescarta and Tecartus with the same turnaround time, that reliability. Certainly, we'll continue measuring that over time. But we're excited at the opportunity to put Kite manufacturing, this very differentiated construct together and bring it to patients in the near future.

Great. So speaking about bringing it to patients, can you give us an update on the regulatory strategy with the FDA. Obviously, the approved product, CARVYKTI sort of did a similar study. Do you expect to file on pivotal data before the end of the year for 2026 launch? And I mean, is there any change in what the FDA hurdle is for approval?

Yes. So we're not communicating the filing strategy or timing to date. We are communicating our potential launch in 2026. But I will say the following. We have continued to have the same review team. We're continuing to have really constructive conversations with the FDA. And so I look forward to continuing those, but we haven't observed sort of bumps or breaks in the road at this point and looking forward to getting this filed and getting it out to patients.

Great. So we have a little bit of an insight from the CARVYKTI launch in terms of the market opportunity. But maybe you could just review what you perceive as what the initial label fourth-line market opportunity would look like and then over time, as it moves forward.

Yes. So today, there's 100,000 patients diagnosed annually with multiple myeloma around the globe. And different than lymphomas, lymphomas, you see about 50% to 60% of those patients cured in the front line. For myeloma, all of those patients progress through multiple lines of therapy. So again, we expect that to be about double the size of the lymphoma population receiving fourth-line therapy. And we will start with our launches, obviously, in the U.S. and as I said, come out with our manufacturing. So as I think about the opportunity here, there's a couple of things. One is not just the differentiated safety, but couple that with reliable short turnaround times, and we don't have capacity constraints in that respect. In 2026, I think we've communicated we will -- we have the ability to manufacture across our portfolio up to 24,000 therapies a year. So we plan to come out very strong with our production. And we think there's a huge opportunity and an unmet need here in the fourth line plus. With that said, we have started our second-line study called iMMagine-3, and that's ongoing right now, second through fourth line. We're excited about that because it looks at daru exposed. It also looks at len exposed. And so it's a broader population than what we've seen with some of the competitors on the market today. And we have begun our safety run-in for our frontline study as well. So we're making progress.

Great. Very exciting on the anito-cel front. Maybe looking at some of the earlier-stage programs, you have numerous next-gen CAR Ts moving down the pipeline. I know you selected 363, the bicistronic CAR targeting CD19 and 20. And for go forward in autoimmune settings. Can you talk generally about why you think this asset can be a particular benefit for autoimmune indications and where you think the first steps will be taken and what the general enthusiasm is for CAR T and autoimmune?

Sure. So this is a space where the CD19s have been playing, and we've been sort of closely watching, but we made a conscious decision to come forward with dual antigens. We have CD19, CD20. We also have dual co-stimulatory domains, which is a 4-1BB and a CD28. That's important, and we think it's going to be very important in this disease because it allows for the immediate killing of cells, but it also allows for the persistence that you see with 4-1BB and the safety profile. So having dual antigens and dual costimulatory domains, we think, is important. We've also married that with our standard manufacturing to go into rheumatology and neurology. Today, in rheumatology, we're looking at lupus, lupus nephritis, myositis and scleroderma. And as you think about -- I'll use lupus as an example, CD20 has been studied there. Rituxan has been used for lupus patients. We know CD20 has activity. We're seeing for the Schultz data, CD19 has activity. So we're excited to marry both dual antigens in those disease types. And that study is up and going today. We also got approval recently for a neurology study where we're going to be looking at myasthenia gravis, MS in the progressive forms as well as CIDP, which is chronic inflammatory demyelinating polyneuropathy, if you can get all that down. It's an indication that's demyelinating very similar to MS. The population is quite substantial. It's about the size of multiple myeloma market. And we know CD20 plays an important role there as we do in MS, where you see therapies like OCREVUS, where anti-CD20 antibodies. So we're excited to see what comes out of the Phase I studies and make a determination of where we go from there for pivotals.

Great. And you also noted that you plan to select go-forward CAR T for lymphomas in the second half of the year, 363 as well as CD19 and other bicistronic-753 both of which I think implement FitCAR or fast-in-time technology. Can you talk a little bit about the attributes of these different assets and what key factors are driving selection criteria?

So we have the 3 products that we're studying today in lymphomas. And the first is CD19, so it's Yescarta with a 3-day manufacturing. The interesting thing about that is you end up with more naive or juvenile cells, which are very potent. So we can dose at about 1/10, 1/20 the dose of what you see with Yescarta, still have the level of efficacy. But obviously, your safety profile looks really different when you have that lower dose. For the bicistronics, we've done something similar. So we've created the CD19, CD20, as I said, with the dual costimulatory domains. 363 is our standard manufacturing and 753 is a 3-day manufacturing. So where, again, we can bring the dose down to that 120 or 110. We're going to share all 3 constructs worth of data at a congress later this year. We're looking forward to it. All I can say is that we're very excited about the data, the efficacy that we're seeing in a Phase I population, which is usually your sickest population, looks really profound. But more importantly, even at the low doses with that 3-day manufacturing, you're seeing a safety profile that lends itself beautifully to an outpatient therapy.

Great. Before I let everyone run off for lunch, I guess, just given all we've spoken about today, is there anything that we didn't really talk about that you'd like to address that you think is particularly important on the Kite story?

Yes. I think there's a couple of things. One is we have the autologous franchise. We're very excited about our current products on market and bringing anito-cel to market. We talked a little bit about our next-generation therapies. The one piece we didn't talk about is we shared data earlier this year at ASCO in the GBM setting in a collaboration from the Tmunity acquisition with Penn, where we've been able to show that for GBM patients in the absence of lymphodepletion and direct delivery through the Ommaya port, we saw about 70% of those patients have a response. That does not happen in GBM. So we learned a lot from that Phase I study. We're continuing to move it now into earlier lines, but we're also reengineering our construct so that it will hang around in the brain a little bit longer. So moving into the solid tumor space is an area we haven't talked a lot about, but it's a place that we're going. I think with the in vivo acquisition and we look at sort of where is the space evolving to, we're excited with Interius about what's possible, and how we can bring more of these therapies without lymphodepletion in an off-the-shelf format to more patients globally. So at Kite, we've got a robust portfolio. We're excited about the products on the market and looking forward to sharing some of that data.

Great. Yes, exciting story, and I as well, I'm looking forward to some of that data. Appreciate the time today, Cindy.

Great. Thank you. Thanks a lot.

Thanks, everyone.