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

Thank you, guys, for joining us. Pleasure to have the management team from Gilead with us. I always joke about it, but the last in-person event I hosted with any company -- well, actually I just did one with Lilly recently on the road in Boston and New York. But the one prior to that, pre-pandemic, was with Merdad in San Francisco. And I remember this was late February 2020, so I guess we've built up a lot of T cells during that.

We can only hope, right?

That's right. Well, listen, thank you guys for being here. Let me first turn it over to you, perhaps, Andy, to kick things off. Maybe lay the top priorities you have on your mind, and we'll jump right in.

Sure. No, I'm happy to. Thanks for having us, Umer. Great to reconnect. We've had a really strong 2021. So we're proud of the progress that we've made as a company in terms of diversifying the portfolio, in particular the progress that we've made in building out our oncology franchise. We feel really good about where Trodelvy is, both in launch and the plans that we have to develop Trodelvy further. And obviously, we've made a lot of progress in our cell therapy business. The ZUMA-7 data, we believe, is transformational and opens up a completely different set of opportunities for us as cell therapy becomes more mainstream and standard of care over the coming years and the coming decades, we believe. We're excited about what we're doing with magrolimab. And then of course, more recently, Umer, the opt-in to -- the broad opt-in to the Arcus programs in oncology is really exciting. In the virology business, again, our business continues to perform very well despite the pandemic. We saw growth in the HIV business over the last 2 quarters. We've seen a more pronounced rebound in PrEP but also a strong rebound in the HIV treatment market, and our market shares are holding really strong across the HIV business. And then, of course, in the next-generation HIV therapies, we're really excited about the potential approval of lenacapavir, its first approval in 2022, as well as the studies that we've started in PrEP and the studies that are underway or will be underway over the next year or 2 for -- in combination with other agents for long-acting treatment options for patients. So it's a great time to be at Gilead as an employee. We're excited about what we're doing for patients and really excited about the future of the company. So with that, let's jump into it.

Outstanding. Andy, Merdad, there's obviously a lot of important products and a lot of things to dig into, and we'll do them very sequentially. But I feel like, often, as we go down that track, and I seem to find that this happens on a lot of Gilead's earnings calls as well, is we end up with a bit of a focus away from sort of the bigger picture, if I may. So perhaps Andy, can I first start by asking you? As you think about the top line of Gilead, where it stands currently, mid-20s billion of dollars, how do you see the -- sort of the underlying growth trends in terms of the base business? But also characterize for us the big LOEs that we should or shouldn't think about between now and 2030.

Yes. There's a lot in that question, of course. But look, when you step back and look at the big picture, I think that we believe that we have -- and we said this a year ago. We believe it today and probably have even greater conviction behind our belief that the company is poised for growth in the short term, medium term and long term and that we have all of the puzzle pieces, Umer, that we need to drive growth and diversification of the business. So when you start with the base business, the HIV business, which is the lion's share of our revenues today, that business is very strong. The pandemic did have an impact on the business. We're coming out of that. We now expect -- I think we have a better sense of how to manage the pandemic with the business commercially as well, of course, like other companies. And we expect to see continued growth in the HIV business, and then we expect to have a transformation in the HIV business as we -- with lenacapavir, in particular, move into long-acting treatments in the '24, '25 time frame for PrEP and for treatment. And again, there's a very large unmet market in PrEP and a large opportunity in long-acting treatment. And we think that lenacapavir, as a small molecule that could be administered in a subcutaneous injection probably every 6 months, is the perfect molecule, both for PrEP individually and then to pair with other agents. So we're really excited about the base of the business. And I think when we think about the base of the business, Umer, we think that the base of the business will grow and is sustainable through the 2030s when you talk about the Biktarvy patent cliff in 2033 at the earliest. Then when you think of that base of the business, think of the oncology business and the inflammation business as a significant growth engine on top of that. Obviously, you see the growth that we're starting to see in the oncology portfolio with cell therapy and Trodelvy. And again, we're going to add to that, we believe, in the coming years additional indications for Trodelvy, additional combination partners with Trodelvy and potentially magrolimab. Magrolimab approval, we would expect in MDS and potentially other indications, both hematological indications and solid tumors. And then, of course, the Arcus programs as well as other programs that we have coming into our -- into the clinic, whether it's the Tizona antibodies, the Pionyr antibody, the CCR8 antibody that we in-licensed last year. There's a lot to be excited about in the pipeline, a lot of -- which will drive significant growth, we believe, on top of the base business through 2030. In terms of the patent cliffs, I mean, I think the patent cliffs that are coming are really no different than the patent cliffs that we've lived through. So if you look at the TDF patent cliff, really the 2 drugs, Atripla and Truvada, that went generic last year is about $1.5 billion of revenue that we lost. Our HIV business has largely grown through that now. In the next couple of quarters, we will completely have grown through that. We will see another patent cliff in '26, '27 on the TAF, tenofovir molecule, which will have a similar impact in our business. But we think, again, with all the growth drivers that we have, we can grow through that, Umer. And the same thing is true of the patent cliffs from some other agents towards the end of the decade, especially dolutegravir patents in HIV in '28 and '29. Again, we think that we will have significant growth drivers. Even though that will have some impact on our business, we don't expect it to be that material, and we do expect that we can grow through those. So let me just pause there, Umer, and see if I answered your question.

Yes. No, no, no. That was very helpful. But I think, Andy, embedded in your answer somewhere in there was for the $25 billion or so -- and I'm talking rough numbers. I don't want to get sort of specific if it's exactly $26 billion, et cetera. But mid-20s billions in sales but -- which consensus sort of has saying roughly sort of flattish basically through the end of the decade. It's $25 billion to $26 billion in sales model then -- sort of at surface. And that's kind of what a lot of investors look at, and they say, "Okay, well, if that's what it is, so they're technically not a growth company." But then if you factor into that the current base, the current $26 billion base includes over $4 billion worth of onetime, or if I may, remdesivir, which will certainly be there to some extent, but I don't know if it repeats at that $4 billion to $5 billion run rate. I guess how do you sort of disaggregate the current sales breakup? And is it fair to say that the underlying $20 billion base business through the balance of the decade should continue to grow, and it's basically offsetting some of the Veklury losses?

Yes. And, Umer, that's a really important point. I should have been very clear. When we talk about growth, we're talking about the base business. Veklury, we believe, has legs well beyond '21 and '22. We'll continue to generate revenue from Veklury sales, but it's going to be unpredictable. And then there will be a lot of volatility in the sales, depending on the progression of the pandemic and the progression of the development of other therapies to treat patients, presumably including some of those that may come out of our portfolio. So that's tough for us to forecast. When we talk about the growth of the business, we're talking about the base business, excluding Veklury, which is still a very sizable $20 billion-plus business that should grow substantially over the next 10 years plus, to the point I was making earlier. When you talk about analyst consensus estimates, the key to remember is that a lot of the portfolio products that we've pulled together over the last couple of years are not fully in analyst consensus numbers now. So whether it's Trodelvy indications beyond the 2 approved indications; whether it's additional lines of therapy for Trodelvy; whether it's magrolimab, which is not in a lot of the analyst models; long-acting lenacapavir or lenacapavir plus islatravir potentially, it was not in a lot of models. So -- and the Arcus programs aren't in a lot of models. So when we look at our -- kind of the expectation and we look at the entire portfolio that we've built, there's a lot that we're excited about that we expect to contribute growth. We think that has a very high probability of success, and a lot of that's not in analyst consensus numbers today. We do expect, Umer -- the last thing I'll say is I think that's changing, and we expect it to continue to change over the coming year and plus as we have additional clinical data and we share more information on where we're going with these programs and the studies that we're both running and planning on running. So I think that in terms of understanding our perspective, we need to do a better job of helping investors and Wall Street understand what we have and where we're going. And we expect to make a lot of progress in '22 in terms of opening the lens for people to see what we're both doing and what we're planning to do.

And Andy, just maybe the last one on this broader topic. Broad strokes, HIV business is $16 billion, growing. AFC is another $2 billion. So that makes it $18 billion. And then Veklury somehow can manage to do $5 billion or whatever the range is in that ballpark. So I guess as I think about the non-antiviral business, so again, this won't -- this will technically take out lenacapavir. But as I think about the non-antiviral business, which is, give or take, a couple of billion dollars or so, do you think there's a path for expansion to -- up to $10 billion in sales for the non-antiviral business?

Yes. I think we'll provide greater clarity. I mean, I want to be careful that I don't provide long-term guidance and get out ahead of us, especially in terms of updating the market on where we see the business, going around JPMorgan and next year. We expect substantial growth in that business that you're referring to, and we'll try to give you additional color and as much specificity as we can, Umer, in terms of what we mean about that specifically. But yes, we expect it to be a very substantial growth engine on top of the base business over the next 10 to 15 years. And again, we'll -- I think we'll provide a little more specificity in terms of what we're thinking over the coming months and the coming year.

Outstanding. So let's go through that then, and I'm going to start with the antiviral first. And perhaps the most important thing that's caught everybody's eye is obviously the recent updates with Merck islatravir program. And I felt like, in many ways, that, coupled with your once-weekly capsid, just formed the basis for the next regimen for many years to come. And I felt like -- Merdad, I felt like, in many ways, it was very prudent to just take that risk off the table to the extent regulators come in and end up requiring monitoring across your capsid as well. So I guess where do we stand now? Is -- do you need to find a better combination partner? Or is this still TBD? Or is there a path where that nuc from Merck is only decent in a once-daily setting at a 0.75 dose and nothing above that?

I think I would characterize it slightly differently, which is the and, which is how we've been looking at it long term. We've always thought about a potential combination between islatravir and lenacapavir as one of many shots on goal in the long-acting space, and we never intended for that to be the only approach we take. So while we work through understanding the data for islatravir and the combination data that we have with islatravir and lenacapavir, it's important to remember that we do have a pipeline of molecules that are early. But we do have a pipeline of molecules intended to be other partners -- other combination partners for lenacapavir in the long run. So I would -- we've never seen it as an or. It's an and. In terms of where we are right now with Merck and lenacapavir, we need to understand the data. So I think there's still -- we're in early days of understanding, both getting data from Merck in terms of islatravir alone and the combination of studies they've done, but more importantly, the combination studies that we initiated for islatravir and lenacapavir. As we understand those data, I think we'll have a better understanding of what the potential path will be.

Got it. Merdad, to my knowledge, that was really the nuc out there that had this type of potential. Is there anything -- there's nothing in clinical stage on the Gilead pipeline, any nuc that I'm aware of. Is that accurate?

Yes. We're -- like I said, they're early, and you should start seeing them pop up in our pipeline in the near term. So we have a number of molecules that we're advancing through. They're late preclinical molecules, and we'll start to get them into the clinic.

Got it. And...

One of which is a nuc and one -- at least another that we expect to enter the clinic next year would be as an integrase inhibitor, Umer.

Very interesting. And is it fair to say that your focus behind these programs is to come up with a profile that's obviously high barrier to resistance but also potential for doing once-weekly pill or not necessarily?

Yes. Our bar has been -- what we're really aiming for in the oral front is once-weekly oral, if not less frequent than that, if we can get to even longer durability. And then on the injectable side, we're looking for something that gets us to 3 months dosing, 2, 3 months dosing, if not longer. With lenacapavir, the potential to do that infrequent dosing is there. The real question then becomes whether the partner molecule can have the same sort of durability of efficacy as we get with lenacapavir and how long we can stretch that doublet.

Got it. Okay, makes sense. Anything also antiviral that we didn't ask that we should be asking you before we move on from the antiviral topic?

Well, I think Hepcludex is an important long-term opportunity for us as well. That is another growth driver. I don't want to overstate it, but it's launched. It's a commercial product in Europe. It's going to be a steady and slow build, we believe, Umer, as physicians globally start testing more frequently for hepatitis delta, especially in the United States. But don't forget, Hepcludex is an important treatment option for patients in hep D. We expect to have approval in the United States in the coming year as well. So that's another franchise that we're excited about in the long run, in addition to what we're already doing in HIV or the existing hepatitis B and hepatitis C portfolios.

Got it. Okay, makes a lot of sense. Excellent. Maybe turning to oncology then. I want to start with Trodelvy. Obviously, huge readout coming up in first quarter for you, guys. There's been a lot of questions around whether there has been an interim or not, and I think you guys are pretty definitive there has not been an interim. But I think there were also questions around why haven't -- why is there a bit of a delay on the scans coming in? And I feel like some of these questions originate with this understanding that the trial conduct at the Immunomedics time was perhaps not world class, and there were FDA observations made on some of their trial sites as well. So I guess, in general, investors are very curious in trying to understand is there -- is the delays in scans coming in, some of this like a residual effect of how Immunomedics was running things? And where do we stand now and the delay on scans?

Sure. No, it's a great question, Umer. I think what -- I think a lot of people forget is that when we -- after we acquired Immunomedics, this particular study was amended while it was ongoing. And the initial primary endpoint was ORR. And you may recall earlier in this year, we amended the protocol to change the primary endpoint to PFS and to power the study for OS. And so, as a consequence, you can imagine there were a lot of scans from those patients who were initially enrolled that had not been collected, in addition to then the logistics of getting the additional -- the newer -- the newly enrolled patients in getting their scans in. So I wouldn't say it's really a conduct issue. I'm not -- I don't think there's anything there particularly. It's just an issue of we changed the endpoint. We need to make sure we get all the scans in and that they're overread properly. That's the other really important thing is a large number of scans that just need to be overread at the CRO. So that's where we are now. We want to make sure we take care to make sure that we've got the scans in substantially and that there -- that we have a high integrity in terms of our data before we do the analysis. And so that's where we are.

Got it. Sitting here today, Merdad, I guess based on feedback you've heard from clinicians but also based on your prior work in your prior organization as well, what would be the minimum PFS benefit and number of months that would be clinically meaningful from this trial?

Yes, it's a good question and one we get commonly. And as you probably know, the range of that clinically meaningful bar varies depending on who you speak to. For us, I think we're looking at that roughly 2-month period, give or take a little bit, as sort of the -- our base case for clinical significance. Of course, that's a discussion to be had with regulators and with patients and others. But from our standpoint, that's certainly our base case. Certainly, we're hoping for greater than that to be able to get to a PFS benefit that's larger, but we are powered for PFS benefit certainly, even less than 2 months. It's also important to remember that we are going to be looking for OS in this trial. And so in addition to the PFS endpoint, we will be getting an OS readout. And once we get the OS readout, that should complement our PFS look in terms of helping establish clinical relevance and -- clinical meaningfulness, I should say.

Got it. Merdad, I feel like one question -- I mean, there's -- every time folks have thought about upcoming readout in HR positive, you look at sort of the CDK4 experience subgroup where the median PFS was less. I think that conversation happened enough over the last year. So I want to approach it a little differently and ask it this way. Based on the number of prior lines that -- the median prior lines in the ASCENT triple-negative study versus number of prior lines in HR positive, how is that different? But also, to what extent have the triple-negative patients not experienced this type of chemo in Trodelvy versus to what extent in HR positive there's been any experience on a similar or related chemo? Because I think that would influence the type of PFS benefit we should expect in the first place.

Yes. Very complicated question, so let me -- I'll do my best to answer, and please follow up if I miss a point. In terms of the demographics of the patients that are enrolled in this study, we -- since we haven't unblinded the study, I can't tell you with certainty exactly how we're going to land in terms of prior lines of therapy. But we do expect that the patients in the HR-positive study that we'll be reading out will be earlier in their treatment course, right? They will have fewer prior lines of therapy than the ones in the ASCENT study. The ASCENT study was third line and second line, and so we had patients who were a little bit later on. In that trial, we did have some patients who had seen CDK4/6 inhibitors prior to receiving Trodelvy. Those are relatively small number of patients, as you can imagine, in triple negative. Some of those are patients who may have had initially low HR-positive disease that then became triple-negative down the road. And so I don't think there's a real way to compare really an apples-to-oranges sort of comparison in terms of the patient population. And then, finally, for the patients who are coming into the TROPICS-02 study, of course, everyone is required to have gotten CDK4/6 as first-line therapy. So all the patients will have gotten CDK4/6 inhibitors, and we'll be stratifying the data based on duration of that prior CDK4/6 therapy. So -- and the cut point is 6 months. So less than 6 months or greater than 6 months will be the strata that we evaluate in terms of the prior CDK4/6 therapy.

Sorry, Merdad, I just want to make sure I have it right. Primary endpoint is PFS, but -- so the endpoint will be all-comers for the primary analysis, correct?

That's right. Yes.

But will also stratify by this -- less than -- greater than 6 months, obviously.

That's right. We'll look at the strata as -- in terms of seeing if there's a difference between those 2 strata in terms of their responsiveness. You can imagine that the patients with less than 6 months and greater than 6 months might be different in terms of their -- the progressive nature of their disease, how stable they are and how much they're progressing or how many -- how much therapy they may have seen before. So that's one of the things that we'll be looking at, just to ensure that we don't have a difference in terms of how those patients respond.

And this was there all along? Or is this a more recent analysis?

It was part of the amendment that we put together, yes. It was part of the amendment that went into -- to look at the change -- when we changed the primary -- yes.

And from a stat hierarchy perspective, all the alpha allocated to PFS. And then if it's positive, some of the alpha preserved for this less than 6-month and greater than 6-month analysis?

Yes. We'll look at -- that's right. That would be a secondary analysis.

Okay. Outstanding. Makes sense. Okay. And maybe one last quick one on this is commercially -- and from sort of clinical feedback perspective, how do you guys think about -- and HER2 and HER2 lows? Because that will be a mutation-specific patient coming in, competing with Trodelvy because there might be a 60% or so overlap.

Yes. It's difficult to tell. Obviously, it's hard to know until we get out there. I think that partly that's going to depend on the quality of the data that each of us generate, right, ultimately, in terms of what gets -- what the magnitude of the clinical benefit is. I do think there's the other element of the testing that we're hoping we won't have to do in advance of therapy, and I think that might be a bit of an advantage for us in terms of the -- where we go within HER2. But it's so difficult to predict right now given where we are in terms of data generation.

Okay, makes sense. Jessica, did you want to lead on CD47?

Yes. Just one main question regarding magrolimab. Since pushing back the readout for the MDS trial, has the FDA since then provided any clarity? Or has the data matured enough in the study to decide whether the filing requirements will need to be changed since Takeda's NAE inhibitor, azacitidine, didn't meet their EFS primary endpoint?

Yes. Our expectation, and I think our -- what I would direct everyone to think about is the base case should be that the Phase III data are what's required for approval -- full approval in MDS, right? And that study is going really well and enrolling very well. So we're -- that should be the -- our base case. We view any possibility of an accelerated approval based on Ib data as being, I think, really upside. And to your point, Jessica, I think there's risk in that, and I would say fairly substantive risk in that given what's happened recently. So we're -- our feeling is that we should be anchored to the Phase III study as our primary outcome for MDS.

When is the soonest? Could you walk us through, Merdad, any interims in that Phase III [indiscernible] as soon as we could get any data? I know the trial was initiated in fall last year. My sense is we could have data next year, no?

In terms of timing, it's difficult to say, only because of how enrollment goes. It might go faster than it's been going. It's been going fairly well. Yes, I would think we should certainly by '23 have those data in hand, and if things go well, potentially a little bit earlier.

Right. And from at least per clean trials, it looks like the Phase III has an endpoint of complete remission or OS. So theoretically, the CR endpoint could form the basis of an early positive hit at some point in 2022, no?

We would hope so, yes.

Got it. And theoretically, once you have that, coupled with this Phase Ib data, that should suffice for a basis of filing. So it might only be off by 6 months or so, tops.

That would be -- I would characterize as potential upside there. The major question here, I think, that we're all going to need to get comfort around is what the azacitidine response rates are, CR rates with azacitadine. I think that's going to be the question that we'll all have to look to. And so if we look at data from the Phase III study, that will be a key data point. And honestly, given how quickly that study is enrolling, the amount of time savings doing an interim may not be valuable enough to do. We may just wait until the primary endpoint until we get to the end of the study, if you follow my meaning. When a study enrolls very quickly, the value of an interim analysis drops dramatically because then you're -- the faster it enrolls, the closer your full analysis is to your interim analysis.

Makes sense. Makes a lot of sense. Okay, makes total sense. Turning next to Arcus programs, I know you guys opted in. You've probably seen -- I know both of you guys have seen what our take is, so I'm going to take our biases out of it. I just want to hear what is it that you guys saw now in the second interim that wasn't there on the first interim, outside of more patients?

Well, I think it's more patients and more durability, right? I think we saw more duration of therapy, more patients enrolled. But again, I think it would -- it's important to note that it's around the totality, right? The reason we went after and partnered with them around all of the agents that we opted into was the data we were seeing across trials and across indications that got us interested and enthusiastic about doing a partnership. It's very important for us as we look forward and one of the things that we were -- that drove this was the ability for us to do combination trials, as you can imagine, not only within the Arcus portfolio, but also with our portfolio. And this enables us to take really promising molecules and promising combinations and do those experiments early on with the goal of really developing differentiated combinations that really move the needle in terms of efficacy. So that's what we're excited about is really the totality of the opportunity that we have.

Got it. Anything -- any comment, Merdad, on sort of how you would set the expectations on incremental efficacy to expect on the TIGIT combo arms but also your expectations on the adenosine? Because, in some ways, investors would certainly look forward to some of the randomized data sets there in mid- next year around ASCO as whenever you guys do present. How you'd be setting the expectations there? Because the opt-in is being assumed to mean that there's some very large signal that you guys saw, but...

I think what Arcus has said and we've said, I think this coming year, we expect to have -- to really share data from 4 of the ongoing Arcus studies during the year -- during the course of the year, including the ARC-8 data. We haven't said exactly which meeting will be what study. But certainly, in '22, you guys should expect to see data from those trials.

Got it. Andy, can I ask you -- one of the questions I had was had you guys not opted into the adenosine and CD73, you would have had to pay the option -- the access fee to have the opt-in later anyways. Was that a part of the consideration to just opt in now, just to have it, instead of having to pay half the price and not opting in technically, just to have the access fee?

Not really. I mean, to be honest, the opt-in was driven by the quality of the data that we were seeing across the programs and our excitement to have a more active role in working with Arcus to take those programs forward. So as Merdad said, the data will continue to mature, both in the ARC-7 study, the ARC-8 study and obviously all the other studies that they have underway. But the broad opt-in was driven by the fact that we saw encouraging signs of activity across these programs and the studies that were underway. And recognizing, of course, that it's early, the data will mature. We should see additional patients as well as additional data -- durability data over the coming months and into next year before the data is shared publicly. But there's just a lot to be excited about. I think both parties recognize, Umer, that it made sense strategically for us to opt in so that we could move forward in a more comprehensive fashion. We could get better alignment amongst the 2 companies. We could start exploring combinations with other agents, including Trodelvy, maybe magrolimab and cell therapy down the line. And then the final piece is I think both parties recognize that because we weren't waiting to have additional data on the 2 adenosine programs, in particular, that, by definition, we are taking a little more risk in that there were some minor adjustments to the contract terms that would be appropriate to reflect that we were taking additional risk and to reflect the fact that it was best for both companies that we do the broad opt-in now. So I wouldn't read too much into it in terms of the access payment next year, which we would have been happy to pay in any event given the quality of science that we see underway at Arcus.

Makes sense. Maybe my last one. Did you guys have any look into ongoing ARC-8, for example, or no?

Yes, yes. I mean, that was part of it. To be clear, I think it was both looking at ARC-7 data and an update on the ARC-8 data that helped inform kind of the broad opt-in. So yes.

Got it. Okay. So you guys are familiar with that data as it stands right now. Okay. Got it. Okay, excellent. Oral remdesivir, where are we with that? Is that a realistic possibility as we think about it?

We've continued to progress our oral antiviral programs through the late preclinical and now into the -- we're moving into the clinic hopefully next year with our oral program. It's early days, but so far, so good. We've got a program that I think we're excited about. That should be in patients -- well, at least in Phase I next year, I hope.

Got it. And is it literally an oral remdesivir? Or is it a more synthetic version of something similar?

Yes. I'd describe it as it's -- another -- it's a broad-spectrum antiviral prodrug approach that we're taking.

I see. I see. And, Merdad, any one-liner on what happened on the inhaled program there?

We didn't get the distribution we wanted. We -- inhaled drugs are really difficult, especially that they dissolve in the saline well enough, and they aerosolize well enough and then deposit in the lung well enough, importantly. And so we weren't satisfied that we were going to get enough drug deposited broadly enough in the lung to maximize our chances of bringing benefit to patients. So I think that it's really that simple.

Got it. Okay, makes sense, makes sense, makes sense. And maybe since we're on this topic, I guess it will also be interesting to hear your take broadly on how you guys think about -- I guess why or why not potentially be in the vaccine business? And I feel like there's so many upstart vaccine players now. Has that ever been a consideration from a broader Gilead perspective, just given the presence in antiviral space?

Yes. We have not really thought about being a vaccine player broadly speaking. We do have some efforts on vaccines that are part of our -- for example, our HIV and HPV cure programs, but those are with partners. Right now, strategically, that's -- pursuing a straight vaccine approach is not something that we're considering as part of our strategy.

Got it. Okay, makes sense. And maybe just to wrap up the pipeline section, cell therapy, anything specific we should look -- most look forward to? I know -- I remember speaking a couple of years ago to your precedent management team, and it looked like there was early hints that look forward to the stuff we're going to do on the allogeneic side, but we kind of never heard a whole lot there and then the progress on Allogene. I guess I was just not sure what's the next sort of big things on the cell therapy side we should most look forward to.

Sure. Do you want...

I'm happy to start. I mean look, next week at ASH, I think you should look forward to the 5-year data from Yescarta and all the other data presentations that we have. So we're really excited to share the updated 5-year data. I think there's a whole set of data from the Kite team that it will be a pretty exciting rumor for people to get their arms around next week. And obviously then beyond that, the launch in second line that we expect in the first half of next year, we think, is really exciting and then more broadly when we look at -- you see the growth in the business. But when you look at the cell therapy business overall, having another competitor enter the market, we think, is a good thing. Overall, patients that should be getting cell therapy are not getting cell therapy. Only 2 in 10 were actually receiving cell therapy despite the fact that they have no other therapeutic options, and most of them are at kind of end stages of their disease, especially in our approved indications. So there's a significant opportunity over the coming years to increase the class usage in cell therapy and then to displace stem cell transplant in the second line, which won't happen overnight. It's going to take a long time. It took a long time for stem cell transplant to become the standard of care. There are a lot of reasons why hospitals and some providers are used to that approach, and it will take a while to change clinical practice, but we think you'll get there. So those are the things that are really exciting. But then when you step back and look at our pipeline, we still have the allogeneic programs we've been working on for a number of years with the Sangamo gene editing constructs. We had a couple of new partnerships that we entered into this year in iPSC and NK cell deals with Shoreline and Appia that we're excited about. Those things are just going to take a while. We've always had the view, Umer, that allogeneic cell therapies are going to take much longer to develop than many people were expecting. I think that view is broadly shared, and you see that with some of the updates in the market now. So the key is that the autologous cell therapies, in our mind, will have a much longer life. We are working on next-generation versions of Yescarta, for instance. You see some of those in the clinic now if you look at ClinicalTrials.gov with bicistronic constructs that we're excited about. Beyond that, we have allogeneic. And then beyond that, we'll have the -- some of the NK cell therapies and maybe iPSC. The final thing I'll say is we're pretty excited about the long-term potential of in vivo cell therapy. That's more than a decade away. That may be 15 or 20 years away. But you look at the investment we made in a private company called Orna that has circular self-amplifying mRNA constructs that could potentially be used in cell therapy. If you can get through some kind of lipid formulation, if you could get that selectively to T cells, that could be really interesting. So that's where it is broadly. Again, we have a long-term vision for cell therapy. It was true when we did the deal 4 years ago, and it continues to be true today. And the business is really moving in the right direction.

Got it.

Would you add anything?

No, I think the point -- just to emphasize a point on the second-line data with ZUMA-7, I think the improvement in outcomes for patients who receive cell therapy compared with stem cell transplant. I think that those are -- when you look at those data, I think it's really going to be important and impactful.

Got it. My last one, really just around M&A and broader strategic considerations, Andy. I guess the first one is -- and I'll ask it more directly because people ask me this, and I don't know if they asked you this. But the question I get a lot is Gilead valuation paid on some of the deals like Immunomedics, et cetera, they're on the rich side. And I guess how do you think about that question in the context of some of the competitive areas you guys have tried to do these deals?

Yes. Well, it's too early to have a real sense of whether they're rich, right? History will tell us 5 and 10 years down the road whether that's the case. We don't believe that's the case. I mean, I think when you look at both the Kite deal or the Immunomedics deal, which are the 2 that people tend to focus on, Umer, we believe down the line using -- and you can use countless other deals as good examples, whether it's the -- and maybe the most important being Gilead was criticized for overpaying with Pharmasset historically. And obviously in hindsight, it was one of the best deals of all time. The same thing was said -- can be said for a number of other deals and in our sector that have been great over time. So we're -- we see a lot of potential in Trodelvy over time and not just over the short run but in the long run as an antibody drug conjugate, and we believe that our investors are going to see a substantial return from that deal. The same thing is true from the Kite deal. It's just these things take a while to develop. So I think we'll be able to look back and make an appropriate judgment 5 years from now, 10 years from now. Where we sit right now, everything has gone as well or better than we expected. The Immunomedics deal, we have 2 approvals with broader labels than anyone, including us, could have reasonably expected. We've done the deal, and we're excited to share some data later this year. So -- and then in terms of where we go, Umer, which I think is kind of where you are going to go next, look, we have a lot in our hands for execution right now. So you're not going to see the same level of business development activity in '22 and maybe beyond '22 that you saw historically. We have a lot of execution that we need to get done and get it done correctly. That doesn't mean that we won't do ordinary course partnerships because we will. We may do some small acquisitions, but it's very unlikely that we would do any midsize or large acquisitions in the foreseeable future. So ...

Excellent, excellent, excellent. That's all we had on our end. Anything notable that you want to talk about and which didn't come up, Andy, Merdad?

I mean, I think the other thing that's important to highlight is we made a ton of progress in '21 in terms of building out our oncology organization overall. So I think when we're -- maybe I'd end by when we look at where we've been since Dan joined the company over 2 years ago, the amount of work that we put in, the progress that we've made, we have a very clear line of sight to where we think we're going. And again, repeating what I've said a couple of times, but we now have all the programs we need to grow the company, to diversify the company and to appropriately honor our leadership in HIV and to continue to develop the best programs and options for people living with HIV or people that are at risk of getting HIV infection. So we're pretty excited about where we are. And again, when you look at the teams that we've put in place, it's really remarkable, Umer, in terms of what we've been able to do, especially living -- the fact that we've been living through a pandemic. I mean it's -- so I'm excited. I don't know if there's anything that you would add.

I was going to say the same thing, though, that what we've managed to do in the past couple of years is to build our -- we've had this world-class virology HIV team that is second to none. And really during the pandemic, we've really been able to build a world-class oncology team and a world-class immunology and inflammation team. We have the leadership in place and the -- I think the right team members in place. We have work to do, but I'm really excited about having the right people around the table to get us where we need to go.

Maybe one last thing, Umer. Don't write off Galapagos, right? I think that the Galapagos is an important partner. You're going to see some important developments at Galapagos, I expect in 2022 if not earlier in terms of the new CEO and a new head of research. We have a long runway to make that partnership productive for both of our shareholders, and I'm still optimistic that we can develop 1 or 2 programs there that could be transformational for patients and for both sets of shareholders. So again, you have to have a long-term perspective. But Galapagos is something that I think people will start to build better appreciation for again in 2022. And I don't want to -- again, it's going to take a while for the company to rebuild the pipeline with our help hopefully, but it's another important potential source of diversification and growth for us over time. And we're really excited about getting some senior scientific leadership there that can help steer the direction of the company going forward.

Got it. So you're not necessarily pointing to a specific trial that's coming up in the next year or 2. So you're saying it will be...

No, of course. Just where we think the company can go with the new leadership that the company has announced and the specifics of the leadership transformation in terms of the people that will be coming in, I would hope would be finalized in the next 2 or 3 months. And I think it's an important pivot point for Galapagos as a company and an important partner of ours. So it tends to get lost in the shuffle these days And I understand why given some of the developments in 2021. But that is still a partnership and a company that can generate a lot of value for patients and for our shareholders over time with the right leadership team in place.

Outstanding. Andy, Merdad, always fun catching up with you guys. So thank you for making time. And hopefully, there'll be a JPMorgan soon or we can that and have breakfast again. But not anytime soon. All right. See you, guys.

Likewise. Good to see you. Thanks a lot.

Good to see you.

Thank you.