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

Excellent. Listen guys, thank you so much for joining us. It's a huge pleasure to have a broad representation from the Gilead management join us, from the R&D side, the commercial side, the Investor Relations side. Thank you guys so much for joining us.

Thrilled to be here. Thanks, Um.

Fantastic.

Thank you.

So just as we get started, I thought given the way this year evolved, maybe we should start off on COVID, if that's okay, but perhaps not get too bogged down there and really go beyond that if that's okay.

Absolutely.

Yes. Sounds good.

Fantastic. So I want to start perhaps on remdesivir. Interestingly, more on the commercial side for a change. And Johanna, the question really is, how are you thinking about expectations on the need for remdesivir? So I don't want to use the word sales, but the need for remdesivir beyond summer next year.

Beyond summer next year. Umer, I have to tell you, this is a really unpredictable market. And so if you're asking me in the next month, I could probably give you a better understanding. I think if we're saying next year, it's going to be a little bit more challenging. What we've been doing is really tracking both the incidents, of course, as well as the total hospitalizations. And as you all know, those have been increasing over the last few weeks quite dramatically. And obviously, not just in the U.S., but beyond the U.S. and Europe as well. And so we're just tracking that very closely to make sure that we better understand kind of the need for remdesivir forward. In most hospitals in the U.S., it has become standard of care. And so we're tracking that as well. We do appreciate, and I think that's where your question is going, that there are new treatments, and we look forward to them. I think we need more, including the vaccines that we're hearing a lot about of late. But we still believe that there's going to be a need for remdesivir because despite the strong accuracy these vaccines are currently showing, not everybody's going to get vaccinated, number one, and there's still going to be need for treatment for remdesivir. So hopefully, this pandemic slows down as we go into 2021 and the vaccines really help that slowdown, but I think there will always be a need for an antiviral as well for treatment, and so that's what we're going to track. And obviously, can't really predict what it's going to look like in late '21, but I'm hoping by that point, we have a lot more options to play with from a therapeutic standpoint.

Got it. Got it. Got it. I know there's a lot of orals coming as well. Inevitably, those will probably have a bigger role on the nonhospitalized side, perhaps. But I think on the hospitalized side, given the experience there might be on remdesivir, it may continue to be standard of care. But the one question I do have, which is -- which I've found completely confusing for the last several weeks is how -- WHO, which may not even have a lot of clinical trial expertise, has gone out of the way to characterize remdesivir's clinical profile in a very public way, almost to the point where they've effectively created an aura around it, which I personally don't agree with, but I'm curious, Merdad, if you could characterize the limitations of that SOLIDARITY trial.

Sure, and I don't want to be -- look, I think we're at a time where everybody's generating data as quickly as they can and doing the best they can, and I don't want to be in the position around -- denigrating other people's work. So I think it's probably more important to think about the differences between sort of the body of evidence that we have generated ourselves and then with the NIAID compared with the WHO trial, and I think a lot of people end up focusing on the fact that the WHO trial is so big and sort of being somehow more impactful. The trials we've done, they've been randomized. They've been -- while we've had some open label trials, the main study that has been the basis for the approval and that we continue to reference is randomized double-blind, placebo-controlled, multicenter experienced clinical trial sites and measured the appropriate things, everything from monitoring the sites to auditing the results to looking at the specific endpoints that were in that trial. If you look at the New England Journal paper, there's a lot of detail there that was captured with the caveat that we still haven't gotten the data from the WHO, so we haven't had a chance to look at it despite the fact that was our agreement with them. Our understanding is that they didn't collect that level of data, right? They have sort of this rough estimation of mortality. It's not clear what they captured and what they didn't capture even on the mortality endpoint, much less things like detailed patient demographic data at baseline. For example, if you look at our New England Journal data -- I shouldn't say ours -- they're NIH -- New England Journal Paper, there's a breakdown of low flow oxygen and high flow oxygen. And if you look at that, in that breakdown, those patients behave differently. The WHO data, there's no such breakdown. So there's a lot of aggregation of patients that makes it really difficult to understand...

Time from initiation.

Time from initiation, all these different variables that we haven't even seen, much less to try to be able to explain.

Got it.

We've also -- we also know they have a lot of missing data. They've done the studies at places where they're not used to doing trials. We understand that some of the study's investigators weren't critical care or ID docs. One of the investigators -- actually, a group of investigators from Iran just published a letter to the editor, saying that the data from Iran, which apparently makes up over 30% of the data should be excluded because the investigators there didn't know what they were -- weren't experienced folks. So I think there's just a lot of questions we have that we aren't able to answer. And so when I step back from it, if you look at the body of data, right, you have this negative trial and you have a bunch of other positive studies, you have to ask yourself, is there -- is the SOLIDARY trial a false negative? Or is the NIH trial false positive? And I just have a hard time believing that NIH and all of our data are false positive data and that somehow that SOLIDARITY trial represents truth.

Got it.

I kind of believe we do in signs all the time, right? You look at all the aggregate data, all the different studies you have and decide what's the strength of the data.

Sure, sure.

That's the conclusion we come to for sure.

Got it.

Maybe just to add to that, Umer, I would just add what we're seeing in hospitals...

Right.

With physician usage. And I think anybody -- any physicians who have had experience with remdesivir are seeing real value to the product in hospital and really truly seeing that reduction in hospitalization, patients getting back on their feet much faster and then clearing beds for others, right, because of the overwhelming hospitalization rates right now. And so I think that the practice is really showing the value of remdesivir, which I also think is an important piece of the puzzle.

Right.

Yes.

Got it. Got it. And Johanna, what's the time from symptom onset you're seeing commercially?

From the symptom -- I'm sorry?

The time of remdesivir initiation versus symptom onset in the real world.

In the real world. So it's hard -- it's a little bit hard to tackle, but we're seeing it within less than 7 days.

Okay.

And I think people more and more now are not waiting. They understand that the earlier you treat, the better. So I think that's also why you're seeing the pressures on the hospital.

Got it. Fantastic. My last quick one really on this topic before we start to move on is, did you guys ever look at viral load benefit in seronegatives only? I think that was one cut of the data, which could have really start to explain the clinical profile.

Yes. We don't have a lot of our load data, right? Because when we did most of our trials, the viral load, the PCRs weren't available, right? So with NIH trial, we didn't have viral load data. We should start seeing some viral load data from the data we're generating now, and we'll have to look at that as we get those data.

Okay. Bo?

Yes, thanks. So maybe pivot a little bit to the inhaled formulation of remdesivir. Could you remind us the dose versus the IV dose and also the lung exposure, please?

Yes. So what we're targeting is we're -- you obviously have to model with inhaled drugs. But what we're doing based on our preclinical experiments and -- is we're modeling, basically getting the same level of triphosphate in the lung as we do -- with inhaled formulation as we do with the IV formulation. So that's our target. We're actually going to try to go above that to see if there's any benefit to that. So we are in the Phase I study. There is some dose ranging that we'll be doing to sort of look for evidence. But we're certainly targeting at least as much exposure as we get with IV in the lung and hope maybe even a little bit higher than that.

Got it. If I may step in then and perhaps one for Monica and Johanna on a combined basis if -- maybe. When I personally look at Gilead going forward, sure, there's a 2021 -- and I'm talking on a bigger picture now. 2021, you've got certain patent exclusivities happening, and that's well understood. But as we start to go past that, not only is there some residual contribution from remdesivir, there's going to be new contribution from capsid kicking in. Trodelvy is already on the market, and certain call options remain, TIGIT as well as CD47 and beyond. Do you see Gilead as a growth company going forward? Have you guys thought about a certain minimal growth potential that the company could have? And I ask that, by the way, because one of the questions I get from growth managers is, is Gilead a growth company or a value company? And that's a big question for them because they can't own it in certain portfolios.

Understood, and we've heard that before. I have to tell you, the growth is on everybody's line at Gilead because that's exactly why we've done everything we've done. So if you think about all the new acquisitions, collaborations, work that we've done over the last 12 to 18 months are really aligned to get to -- back to a growth company and despite the LOEs, the loss of exclusivities that you were referring to, right? And so the Truvada loss of exclusivity obviously impacts us in 2021. But then after that, we're good for another good 4 or 5 years before the next loss of exclusivity with Descovy. And I think by then, we'll have kind of replaced all of Descovy with Biktarvy in treatment as well as the fact that in prevention, there's going to be other options, including lenacapavir as you were referring to earlier. So I think we're in really good shape to make sure that we prepare for that as well. From a growth standpoint, I think Trodelvy is a big play on that growth if you think about it not just in metastatic triple-negative breast cancer, which is currently on the market, and we're seeing very strong results on that. I think the team has been doing an incredible job launching, and I think integration has gone as smoothly as you could have imagined. So really thrilled to say that. And I think it really sets us up very well for 2021 and beyond, specifically in breast and obviously in bladder as we add that in and then setting us up for the future. So I think all of those pieces that I've just described and that you offered up earlier are really what's going to get us back to the growth in addition to that core business being so solid with Biktarvy. So yes, I think that is absolutely the intent. We'll obviously give guidance for '21 as we go into February and not before then, but I do think that all things are heading in that direction.

Got it. Monica, is there a consideration for -- in the finance organization? And by the way, there may not be a final decision on this yet, but is there a consideration to start to put out a long-term growth target, some sort of a floor growth target for the next 10 years just to start to crystallize that for the ease of these generalist investors?

So Umer, this is something that I know that a lot of companies think about, but at this time, there is not a consideration of putting a long-term target. Like Johanna said, in February, we'll provide guidance for 2021 and show how the story is going to play out, but not providing guidance beyond that.

Okay. Fair enough. Fair enough. So on that note, then, perhaps let's turn to some specific catalysts, which, in our opinion, could really juice the growth potential that exists. Let me first turn it over to Bo. On the company, we both cover in, and you guys are partnered up with Bo.

Yes. So Merdad, you are on the Board of Arcus after the collaboration. Could you share with us your expectation of the triplet arm in the ARC-7? That's PD-1 plus TIGIT plus the adenosine. And what's your thoughts on lack of monotherapy activity for TIGIT?

Sure. I think we're -- look, we're really excited about this collaboration first off. And the number of shots on goal, especially, as you know, with multiple data readouts, I think, coming in the near term has us excited, not only for the TIGIT antibody, to your point, but also for the other programs. So we are going to be looking for that triplet arm. I think it's a really interesting experiment they brought in. I think Bill has done a really nice job of designing that trial. So we'll get a sense of both what the doublet does and what the triplet does, and I think those are going to be both interesting. I think we'll just have to see what the data -- how the data read out. I don't have any previews on what the data is going to look like. I think we're going to be waiting just like you are. Sorry, the second part of your question?

Monotherapy activity.

Oh, lack of monotherapy. Yes. Look, I think that it's -- the Roche molecule also doesn't have monotherapy activity. I think that TIGIT in and of itself is generally, if you look in preclinical models, there's not really a great monotherapy signal. So I'm not surprised. I think that's to be expected. And honestly, it's one of the things that we've often thought is, in a sense, I would call it a benefit in this regard that it means you don't get any added toxicity when you add it on to the checkpoint inhibitors, right? So you're getting a fairly -- a very clean profile when you add to the checkpoint inhibitors. And so you get additional efficacy without operating a lot of toxicity along with you. But that doesn't bother me. I think that's consistent with what we would expect from the biology.

Got it. Merdad, perhaps switching to Trodelvy for a quick second. Oh, actually, sorry, before we do, Merdad, the one thing we haven't seen is -- or maybe I haven't seen, have we seen or confirm that the PD-1 from Arcus is active? Because the scenario I want to avoid is that TIGIT does what it's supposed to do but PD-1 was a little less than what I was supposed to be.

Yes. I think that's -- it's ongoing. But certainly, the data that we've seen, it looks very strong to me. I think when we look at everything on the [ CAD 67 ] signals, for example, that we see in same patients. So I don't think it's -- I don't think we've hit like metaphysical certainty at this point, but I think the data is all heading in the right direction. We're pretty comfortable with it.

Got it. And do you intend to develop that PD-1 stand-alone as well? Or would it be too late?

It's a good question. We're really not looking at it as a stand-alone opportunity to go and launch. We see it as something that we -- that is really valuable to us in part for trials and various things like that. But at this time, I think we're not really looking at it that way.

Got it. Okay. As we go past the Arcus collaboration, and there's tons of other programs there as in trials, so we'll all be in touch there. When I think about Trodelvy, the one question I have thought about, which was an obvious question for any ABC is the possibility of the indication -- and again, now it's no longer a smid biotech, so we can talk about it without a pushback. The possibility for the indication truly being in Trop-2 high expressors and not necessarily all comers. The only challenge being the Trop-2 expression levels are super high in many, many different indications. But is that something you guys have explored? Is there a case to be made for a higher efficacy on a certain threshold even within Trop-2 positives? Because that could change the conversation.

It could. It's a great question, and I think it's just too early to tell right now, right? As you know, with biomarkers and looking for markers of activity, you have to generate a fair bit of data to understand, especially with exactly what you said, which is the cut point for difference in activity. So there's been some limited work so far. And exactly right, we are limited by the fact that the Trop-2 expression is relatively high across the board. So we may be seeing consistent activity because everybody's got Trop-2 expression. I think over time, we'll continue to look at that. We're making the diagnostic more robust, and we'll be looking at that. Right now, we're not going to prescreen, we're not going to preselect for Trop-2 expression. But we'll be following it, and we'll be exploring whether this a correlation perhaps with these.

And Merdad, do you know why Trodelvy was developed in a more fractionated way, like week 1, week 2 dosing, day 0, day 7 dosing and not every 21 days?

I think the initial intent was to manage toxicity and to get enough of the chemo on board, basically load up as much as quickly as you could without getting too much toxicities early on and almost like a loading dose kind of approach.

Johanna, do you find that to ever be a commercial issue or not so much in oncology?

It's interesting because when we first started looking at it in our due diligence, that was definitely one of the questions we wanted to dig into. And as we've spoken to physicians, breast cancer specialists around the country, that hasn't come up as an issue at all. And I think it has a lot to do, of course, with the benefits that they're seeing with the patients, right, with Trodelvy. So I think that goes hand-in-hand. But they're so used to -- with the different treatment options that they have, they're so used to different regimens that they've been able to manage this extremely well.

Got it. Okay. That makes sense. And then the other big one for me, commercially, a competitive dynamic would be the Daiichi HER2 program, and it looks very active in HER2 lows. And there starts to be -- given how we just discussed Trop-2 expression is so high, there will inevitably be a very meaningful overlap. How are you thinking about how big is that overlap as a percentage of -- so if Trop-2 is 80% of most tumors, for example, what fraction of that is HER2 lows? And how do you guys think about your data versus your expectations for where Daiichi trials shake out within the next year or so?

Yes. I think our thinking is that, to your point, the fact that Trop-2 is so broadly expressed, that gives us sort of a broader footprint, if you will, with our antibody Trodelvy as we were just talking about. That remains to be seen, but I think that's as opposed to being really having to look for HER2 even if it's HER2 low, right? I think the -- it's just a different footprint. And we think they're just going to be distinct, right? To your point, there'll be some overlap, but there'll be some [indiscernible]. I think the issue we see, at least early on in their data is the ILD issue that they're seeing, and we think that's less about HER2 and Trop-2 than it is about payload. I think we have to see how that plays out. We haven't seen that sort of ILD happen with Trodelvy, and I think that's going to be the -- probably the bigger differentiator, I believe, unless we find populations where Trodelvy doesn't work and HER2 does work. People may be more willing to take that risk. But where there is overlap, we can get efficacy. I think the safety profile is going to be really important here.

Yes. I would just add to that, what we're seeing right now, even in TNBC -- later lines of metastatic TNBC is interesting because there is a lot -- there is starting to see off-label usage as well in HR-positive HER2. So it's been an interesting dynamic to kind of watch how physicians are kind of playing out. And I think we're all used to this in oncology, but I do think that also gives Trodelvy a little bit of a leg up prior to any competitors coming into the marketplace because they're going to have first-hand experience with Trodelvy.

Got it.

And what we're hearing is people are pretty comfortable with neutropenia and the diarrhea, right? I think those -- these are -- they're used to it, they're manageable. So it's not being -- that hasn't really been a barrier to adoption.

Yes, it's more of a predictable safety profile.

Yes.

Got it. Okay. Makes sense. And then as I think about the urothelial indication, that's a very important trial for you guys. And one of the questions I've had is, in the Phase I data that was shown in that setting for Trodelvy, usage was not broken out, how the OS looks for patients with or without prior I-O. Meanwhile, in a lot of comparisons that were done by Immunomedics, they would suggest that, look, our Phase I tracks at -- I forget the exact number. Our Phase I tracks at about 16 months, and then these prior trials suggest the competitor arm should track around 7 months. The problem is the prior trials that were referenced did not have prior I-O. So my -- I wonder is the median OS materially more for the comparator arm than the expectation? So where -- how do you guys expect that to shake out?

Yes. It's a good question and a good observation, Umer. I think that -- first of all, I would say, it's really difficult to do sort of a lot across trial looking -- we expect that most of the patients who are in third-line plus will have seen some I-O at some point in these studies. So I think that's a fairly common. And so we think the more prior treatment somebody has had, that they're less likely to be responding to a new treatment. And so we do expect that the duration will be shorter with those people who've had fewer treatments. So I think it's difficult to say really what the response rate will be and how short it will be in that slightly different patient population. So to your point, I think we're just going to have to see how the data play out. I think it's difficult to extrapolate. I think it's dangerous to extrapolate too much, and I think you're absolutely right.

Got it. I want to turn to the next pipeline program with Bo. But just before that, there's a -- I'm going to summarize a couple of investor questions. One was a question on future of Gilead stock. I think we'll spare that one. But there were a couple of additional questions on a specific pipeline program that you all really like but doesn't get brought up very much by The Street. And then the other one is, it was for Johanna, if you think the remdesivir expectations should have increased given the acceleration of pandemic.

So sorry, was there any specific...

Any pipeline program that doesn't get...

Oh, look, you haven't talked about it. Well, it's interesting. I think magrolimab has sort of -- it was sort of very big for us early on and when the acquisition happened. And with Trodelvy, I think that's kind of crowded out, growing that a little bit. I think we're still pretty excited about that. The only one that I think we're really excited about is lenacapavir. I think that those are probably the 2 really big ones that, I would say, in addition to...

Those are our next 2 topics.

Well, good, then so I think we haven't missed them. I think those are probably the most exciting. Look, I think there are a lot of other things in the pipeline, especially externally. We talked about the TIGIT molecule and we talked about the Arcus pipeline. I think we have a lot of shots on goal both internally and externally that we're going to be waiting on data for. And I think next year and the year after, we should start seeing a lot of those data that will tell us how excited to be about those programs. They're relatively early, but we're really excited about the pipeline we built up across indications. I think it's really -- we're pretty excited about it.

Bo?

And Johanna, about the Trodelvy...

Remdesivir?

Veklury, yes. Do you want to talk about that?

Yes. So yes, specific to Veklury, listen, we had modeled out, obviously, that there would be a surge in cases in Q4 like everybody was predicting. I think that you'll appreciate the fact that the surge is probably higher than -- unfortunately than everybody was thinking. So we're just tracking very closely to the hospitalization rates. But honestly, not just the rates of the total hospitalizations that are really important for us to track. And so we've been tracking that, and we've obviously seen a rise through October into November. And the expectation is, unfortunately, because of Thanksgiving get togethers that probably in the next 2 weeks, we could see a continued rise into December. Hopefully, with the holidays, people will probably take care and be safer if they see these numbers kind of jump out. But I think what we're preparing for is the next 2 months kind of being really ready. From an expectation standpoint or number standpoint, to your question, Umer, obviously, we'll talk more about that as we go into February for the earnings call as we close out Q4 and think through remdesivir. But we're kind of obviously just managing it day by day, month by -- week by week, to be honest, as we're going forward.

Got it. Okay.

Yes. Great. So maybe we can pivot to the CD47 program, as Merdad highlighted. First, do you think that you can file for the MDS based on the Phase Ib cohort? And when should we expect the data? Is that by EHA? And also, how comfortable are you with the anemia profile given the priming dose adjustments?

Yes. So we are -- our plan is to explore the -- an accelerated approval pathway for MDS as we've discussed before. I think that's something that I would expect and were planning on, and so that work is certainly something that we think is a big potential for us. And we have started our Phase III study with that as well for [indiscernible]. So I think that will -- for the confirmatory approval, I think that's ongoing. So I think we'll -- the single-arm study will continue, and we'll keep looking at that, and it will really depend on the data availability and the discussion around the ability to do and accelerate approval there, will really depend on that regulatory discussions we're having right now. And as we have those, we'll obviously share that -- the feedback we're getting from the regulators around our ability to do that. So give us some time to flesh that out with the regulators and as the data mature, and we'll come back with you on that. In terms of anemia, look, I think it's been really great. I mean, I think the dosing regimen that -- especially with the priming dose, it really mitigates this anemia issue that I think people would have. You've seen it -- if you look at the MDS studies, you look at the AML studies, we see most of those patients are anemic at baseline. We don't restrict based on anemia baseline for enrollment. And when we see -- when we do that, we see a minimal drop in hemoglobin in those patients after they're approved, right? It's less than a gram per deciliter. And additionally, when you look at the need for transfusions in the -- like in the AML and MDS patients, more than half of patients become independent from transfusions. So we think we've got the anemia issue dosing -- with the dosing paradigm, really pretty well covered there. And I think that's going to be really the implant, right? It's kind of readout for -- especially in the MDS population. So I think it's going well. Those data, there should be -- there's an oral presentation for magro at ASH, and so we will be providing some additional data at that presentation that hopefully will be of interest to folks.

Got it. Got it. Got it. Merdad, sorry, I might have just missed it during your answer. So you guys do think there's a path for filing on Phase Ib?

We do. Yes, we do. We're -- it's -- I mean we hope so. I mean we're talking to the regulators. We believe there's a path. We think the data should get us there, but we have to get confirmation from the regulators and get that all squared away.

Got it. I want to spend the last several minutes, maybe up to 10 minutes, I think we have, on the capsid inhibitor, partially because I don't think this gets much time and partially because we wonder, there might be a possibility that capsid becomes the next Biktarvy of sorts. Johanna, do you disagree with that?

I think it depends how you look at it, right? I think Biktarvy will always have a place to play in the oral market and once a day because I think it offers so much to patients. So I think Biktarvy is here to stay. I would say that lenacapavir has incredible opportunities just because of the potential for twice-a-year type dosing. I think is super exciting in many areas. Prevention, for sure and obviously in treatment as well. We -- especially in the harder for compliance reasons, adherence seasons in some patient populations. But I think in that setting, you're going to need to find a partner, and we're looking for a partner, obviously, both internally, we have a lot of assets that we're looking at with lenacapavir, but also externally. And we're open to either/or because I do think it will make a difference for patients, and it will make a difference to ending this epidemic, which I think is the goal of many governments around the world. So I think you're right, lenacapavir can play a really important role here, but I wouldn't dismiss Biktarvy too quickly.

Got it. So if you were to have that partner to pair up the capsid with, you may then potentially be more open to this new regimen being a standard of care as a Biktarvy-like regimen in terms of the size as they go to oral?

Not oral, right? It would be the subcu injections. Is that what you're referring to?

Oh, no, sorry, I meant the oral plus oral purposes and then subcu for injectable perspective.

Yes, on a daily basis, my answer would be no. I think Biktarvy already addresses all the patient and physician needs that are currently in play. I think on a long acting and offer something very different for patients than I do for the long acting, whether it's every week, every month or every 6 months, I think those are all options that, yes, absolutely would be an incredible benefit to the marketplace.

Is the weekly oral, the...

Yes. Just would like to clarify, yes, like a weekly oral or a weekly potentially oral...

Monthly.

Monthly. Or so subcu, yes, or subcu every 6 months. I think those are all the different barriers.

To define long acting, I would just split out in versus not.

Makes sense. Makes sense. So maybe getting a little more specific then. There's some evidence from your -- and Merdad, I'm going to get a little specific on this one now just because these things will matter from a clinical perspective. The in vitro data on the capsid suggests gag cleavage site mutations could alter the capsid activity. I didn't quite see that play out in Phase II. I don't even know to what extent gag cleavage site mutation showed up in Phase II. But can you speak to that?

Yes. I think you're right. I think it's probably too early to say, right, from a clinical standpoint, the exposure right now that we have in the CAPELLA trial, right, with the highly treatment-experienced patients. So I think we have to wait to see if that in vitro translates into the clinic, which I think time will tell. Having said that, I think the reality is that the data from the CAPELLA trial, those certifications are pretty impressive, and we're pretty excited about those data. So it certainly suggests that we're having a pretty important impact on that, really important patient population, right? It's a relatively small proportion of HIV-infected patients, but it's a really important population who are running out of treatment options and the fact that the capsid is a new modality of therapy, right, a new mechanism of action and the fact that we've seen what we've seen with the CAPELLA trial that you know about. We're pretty excited that that's going to provide an option for those patients and potentially even a potential early filing for us in that HTE population as a sort of along the path to that, the broader indications that we were talking about earlier about the craft for the long-acting approach.

Got it. Okay. The other one is, Merdad, I looked at your in vitro activity against major resistant mutants in HIV, which would be highly relevant considering the role for capsid as a highest barrier to resistant regimen. One thing I found interesting was when I dig into super resistant integrase mutations, which you've shown activity for, I haven't quite seen -- or maybe I just haven't found it yet. I haven't seen data on the specific resistant mutations that popped up on dolutegravir or bictegravir, for example, L74, Q95, V151. Has that data been generated? I know you've shown it on some integrase resistant mutations. But what about the ones which have popped up because of dolutegravir or bictegravir?

Yes. We have not -- to my knowledge, I don't think we have done -- I have to go back and look over on that specific question around dolutegravir sequencing on that. That would be -- I mean I have to say I don't think we're going to have too much of those data except for the patients who are coming into trials who may be coming off of dolutegravir. And you'd have to assume that those are associated with dolutegravir. I'm not sure we're going to have that much robust data on that. As we enroll more patients, right, who may have these resistance patterns, we'll get more sequence data and we'll get more of these mutations accumulated, along with the history of what they may have been on in the past. And I think maybe we can give you a more robust answer at that point. But I think it's just -- right now, in the field, our experience is just too limited to be able to answer that question to...

Got it. Johanna, do you -- how -- what's the commercial relevance of the recent CAPELLA trial? I don't think there's got much airtime at all. It sounds like it's the next key launch for Gilead on the HIV side. But even for the overall company, how commercially significant is it? And I think it'll stack on with time with more indications.

I think you're right. I think, really, if you think about HTE, it's such an important patient population. But if you think about the sizing of it, it's about 2% of your HIV population, right? So it's a smaller piece of the puzzle, but obviously, one that needs options that don't have options today. So I think that's where lenacapavir can play a role. The way I see it commercially, though, is actually -- this is a fast-to-market strategy. So we get lenacapavir in the market. It gets physician experience with lenacapavir early on so that we can build on that as we look at prevention and treatment in the future. So for me, that's the way I see it. So it's a first step to moving forward with lenacapavir...

Got it. So the CAPELLA trial in the uber resistant patients is not necessarily a blockbuster opportunity?

On its own? No. Right. I think it's really what you referred to, is it's a step approach, but it is the best way for us to get experience with physicians early on and to meet an unmet medical need today in that population. But from a financial standpoint, if that's what you're referring to, not at this point in time. I think it becomes as you move into prevention and treatment with a partner.

It's much more important to me. I think I just want to emphasize that, right? I think this is -- when you look at pockets of really need in HIV, this is a huge [indiscernible] make sure we start treating patients.

Got it. And then perhaps stepping out of -- to a bigger picture again. Is there still, Johanna, on your end, a commercial build ahead of -- on the autoimmune side ongoing? Does the commitment remain high to the Galapagos collaboration on filgotinib specifically?

Yes. So I think overall, absolutely. And filgotinib as well, we still believe in filgotinib. We just launched in Germany. We've also just launched in Japan, and we're looking to prepare for launches in other European markets at this point in time. So I think the commitment is absolutely still there. We still believe that this is an option for patients where the unmet medical need, unfortunately, is still very high just because the type of disease that it is, right? So within RA, and we're looking at filings in UC as well. So I think that's all moving forward. And I think in the U.S., obviously, Merdad can speak to this better, but from a regulatory standpoint, that's kind of the next step for us to decide kind of how do we move forward here.

Yes. I mean the Type A meeting is the next key event for us on the U.S. side. And that's, as we said, in the fourth quarter, which is -- means imminently, and we'll get back to you on that and go from there.

Excellent. And just as we wrap up, nothing surprising on HIV side from a pricing perspective or anything we should keep in mind, right, Johanna? Nothing that we're aware of?

I think the only dynamic that's going on is, obviously, the payer dynamic, which is because of COVID-19 in this pandemic, where your government channels are increasing versus your commercial channels, right? But I think you're probably seeing that across the board with all medicines.

Fantastic. Bo, any last-minute investor questions? If not, we will go ahead and be very respectful of the management's time.

No. We have a last question from [indiscernible]. Will Immunomedics remain a separate company like -- a separate entity like Kite?

No. We are in the middle of getting that then integrated. We're really excited about it. It's a great team, but they will be part of Gilead and they'll be pulling great.

Sounds great. Fantastic. Excellent. Well, listen, I'll be super respectful of your time. Thank you all so much for joining us. I know this was a long year for many reasons, but really looking forward to being in touch and talking nonremdesivir next time.

I love it. Thank you both.

Thank you so much.

Thank you guys. Thank you, Doug.

Bye.