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

All right. Good afternoon, everyone, from the virtual JPMorgan Healthcare Conference. My name is Cory Kasimov. I'm the senior large-cap biotech analyst, and it's my pleasure to introduce our next company, Gilead, and Chairman and CEO, Dan O'Day. Please note that following this presentation, we will have a Q&A session right here in the same Zoom room, and you're able to submit your own questions via the little blue ask-a-question button in the conference portal. So please do that throughout the presentation. We'll get to as many as we can after Dan is finished. So with that, Dan, thanks for being here today, and let me turn things over to you.

Great. Thanks, Cory and JPMorgan, for hosting us here. Really appreciate the opportunity to speak to you about Gilead. It is -- just 1 year ago, that was my first JPMorgan with Gilead, and a lot has happened in that year time, and I look forward to really walking you through that. It's been basically almost 2 years since I've been at the company. And I think, really, what I'd like to communicate today on behalf of the management team and the leadership is that we are now very clear about our next chapter and the clear road to near-, mid- and long-term growth. And I look forward to going over that with you. And of course, the team and I look forward to answering any questions, but it's been a terrific couple of years. I couldn't be more enthusiastic about the road that we have ahead. So I know all of you are moving your own slides. I'll start briefly on Slide 3 and kind of indicate where I'm going from here. But this is just a slide to reemphasize that a year ago was when we kind of launched our strategy about how to approach this next chapter. And I continue to be really amazed, the colleagues at Gilead, I think, I call it biotech at scale. The entrepreneurial spirit is alive at Gilead. The scale is such that we have the financial resources to make sure we're investing in transformational medicines. And that's what it's really all about, keeping with our scientific expertise and focusing on 3 therapeutic areas of virology, oncology and inflammation. If you advance the slide to the next slide, I mean, this is what the team and I are really proud of is that essentially, 2020, of course, is a year that none of us ever want to repeat again for a variety of reasons with the pandemic. Having said that, the organization did an amazing job at what I like to say is chewing gum and walking at the same time. I mean the ability to have made such a difference in the pandemic with remdesivir, and at the same time, executing on our strategy. And you can see that here. It's an all-time high for the number of product launches for the company with 5, but also the BD milestones that contributed to the shaping of our portfolio, which I'll, of course, get to, starting with Forty Seven at the beginning of the year, followed by a variety of interesting options and opt-ins with Arcus, Pioneer and Tizona. And then a transformational acquisition for us with Immunomedics, providing the cornerstone for our future oncology strategy with Trodelvy, and then finalizing the year with the MYR transaction, which is a really elegant bolt-on to our hepatitis business. And you can see in addition to executing on the BD, the pipeline has significantly increased, but it's not, of course, only about numbers, it's also about quality, and we'll get into that as well. And that was a result of also new governance, new expertise in the organization shaping that portfolio. And then finally, given our strength and expertise in virology, we made significant steps in creating kind of a terrific talent pool for oncology as well, and of course, our other therapeutic area of inflammation, which I'll get into as well. All that led to our announcement this morning, which was to update our guidance for the year for 2020. And you see it here on one slide. I'm sure you've seen our 8-K release this morning. The reason we did that this year is because there's a significant difference between our October guidance and where we are likely to end the year, still finalizing all the numbers that we'll announce the final year-end results in early February and, of course, the 2021 guidance. But we thought with the significant difference, particularly with remdesivir, Veklury, significantly above the top end of our range, that it was important to update you on that appropriately. And so you can see that here, good, strong underlying core business that we'll speak more about, particularly growth in Biktarvy continues to drive our HIV franchise, but also a significant increase in Veklury. And we've already indicated the expense associated with Veklury guidance in our previous guidance. But in addition to that, with some of the rearrangements in our agreement with -- on filgotinib, we also wanted to update you on the R&D expense and SG&A aligned accordingly. And of course, that all led to a superior performance in our last guidance on EPS. And this is really the story about the guidance change. I mean one thing that we've learned this year is don't try to predict the pandemic. It's challenging. And I think what's important to note is that hospitalizations increased by fourfold since October. And we, at Gilead, are proud that we're playing a role in that so much so that 1 in 2 patients that are hospitalized are now treated with Veklury in the United States. That's really significant, up from around 30% in October to around 50% to 60% now. I think it speaks volumes to the role that Veklury is playing during this pandemic. As you know, it has significant impacts upon reducing hospitalizations and helping people live longer, particularly if it's provided earlier in the hospital setting. And so all this is coming to work at the right time for the pandemic. And it's now been reflected obviously in our revenue as well, which is important because we have invested and continue to invest in Veklury moving forward. We continue to think Veklury will play an important role during this pandemic in the coming months and years, and we'll talk a little bit more about that as we get into guidance. But certainly, right now, it is really being utilized and correlates very well with hospitalization. The story for today, though, as I move to the next slide, which is Slide 7 in the deck, is to really talk about, excluding Veklury, our clear path to near- and long-term growth. So the remaining slides are really excluding Veklury. And that's where we've been able to do both things last year, progress on the pandemic and progress on our strategy. And that really has several components. It has the new growth drivers. In the short and medium term, you'll see in oncology, and longer term, in inflammation as well, the strength of our underlying antiviral business. And all of that comes together in our actions taken to diversify and create a sustainable portfolio, very different than the portfolio that I entered into a couple of years ago and attribute to the teams internally and externally, innovation that came in to driving that. So I want to dig into this now and be specific about what's going to be driving that growth over the near, mid and long term. And this kind of on the next slide, on Slide 8, really articulates the growth drivers. And you'll see some of them, of course, crossed the near, mid and long term such as Trodelvy. It's really a very long-term growth driver with us with a lot of potential. And the same with cell therapy, as you can see here accordingly. But you see Biktarvy, for instance, having a greater growth impact in the first half of this slide, whereas when you get into the second half, you also start to see lenacapavir coming in, in our HIV business. So this was really a slide that allows you to see which products are contributing to the growth in which time frames accordingly. And if we dig into the next slide, Slide 9, and then we can transition to Slide 10, I'd like to first talk about oncology. Having spent more than 3 decades with a world-leading oncology company, I have to say, when I look at what's been put together over the past year or 18 months, this is a real world-class oncology portfolio that we have now. It's characterized by a fundamental antibody drug conjugate that goes across multiple disease states, complemented by first best-in-class type mechanisms in immuno-oncology, cell therapy. And then it's also complemented by a variety of opt-ins that allow us to kind of de-risk some of this first-in-class, best-in-class I/O portfolio by allowing the data readout and part of our BD strategy and then opting in as we see the data accordingly. But you can see on the market today, very clearly and strongly, we have Trodelvy, we have Yescarta, and we have the second cell therapy and Tecartus as well. So a really strong portfolio that allows us to not only deliver solutions for patients, but also, it's also allowed us to significantly increase our internal expertise in oncology in the company. And I've spoken before about Trodelvy. It's a transformational medicine for Gilead. It's certainly a transformational medicine for our oncology portfolio. And here's the reason why. We see that in very late-stage, hard-to-treat triple-negative breast cancer, you see this kind of astonishing results in being able to double the survival rate for patients. Now clearly, there's much more to develop here. But we're focused right now in the short term, and we have, since the culmination of the acquisition, filed for a full approval for triple-negative breast cancer in the United States. We'll also be filing in Europe for triple-negative breast cancer. And we've also filed for accelerated approval for bladder cancer. All that's happened within the past weeks and couple of months since the transaction. There's one other important announcement around this that as we look to the many indications we'll be looking at, there was one trial in the hormone receptor positive that we continue to be very encouraged by because of the data that we've -- early data that we've seen here that, as we looked at that with our Immunomedics colleagues that have now joined Gilead, we determined to actually increase the size of that trial, so that we now have co-primary endpoints in both PFS and OS. And as a result of that, we then relooked at the interim that was originally set up under Immunomedics of overall response rate and decided that actually, the PFS data, given the rapidity and recruitment here, comes not too long after that interim would have been anyway. And we've decided to not do that interim, not spend the alpha, but rather look for a full readout in the second half of next year on the PFS data and be able to then, based upon those results, move to file quickly on that. So overall, we thought for the benefit of patients and also our ability to invest in this medicine that was the right decision. OS data would, of course, follow in 2023 as well. But on the next slide, on Slide 12, you see really the potential of this medicine. And certainly, this slide doesn't capture all of it, but it's how we think about these multi-tumor potential products. And Trodelvy, clearly, given the Trop-2 expression across many tumor types, has potential in many tumors. And we've seen Phase I data that are early indicators of this. And so obviously, moving up in lines of therapy, both as a monotherapy but also in combination will be important. And we also know with Trodelvy that the early data in combination with PD-1, PD-L1s and PARP inhibitors looks very encouraging accordingly. So you can see just some of the potential here. We're actually studying Trodelvy in 10 different tumor types. And not only with the agents that I mentioned, PD-1 and PD-L1 and PARP, but now we're putting together a robust portfolio of cancer immunotherapies with options like TIGIT and CD47 that all have combinability potential for our oncology franchise for the future. So a lot of progress in the past year to build up what I think is really a top-class oncology portfolio now. Now on top of that growth that can be delivered by oncology in the short, medium and long term, it's important that we continue our leadership in antivirals. And so as we look on Slide 14, you can see the history of Gilead. Gilead has always been focused on best-in-class and making sure that when we make an innovation, it's something that truly is going to move the needle from the current standard of care, and it's what patients and consumers out there are demanding. So the legacy is clear, of course, that led us to the current environment we have, where we have the current single-tablet regimen to Biktarvy in treatment and Descovy in prevention and still a tremendous amount of growth in both of those medicines. But we're not resting on that, of course, and we are really pleased that the data we're seeing in lenacapavir to move to longer-acting on our road to the cure. So as you see on the next slide, Slide 15. Biktarvy is in a tremendous growth mode right now and will continue in this growth mode going into 2021 and beyond so much so that the loss of exclusivity with Truvada can be overcome largely with the Biktarvy growth next year, which is extremely important. It's the #1 prescribed regimen in the U.S. and other regions. One out of every 2 patients in the United States are receiving Biktarvy for treatment. It has a long patent life out to 2033, with peak estimate potentials of more than $10 billion. So it's very clear that Biktarvy, as talked to some doctors, they say, until there's a cure, at least we have Biktarvy. And I think that, that's really going to be important to the -- to solidifying our leadership in HIV. And at the same time, we'll continue to, of course, grow Descovy, but lenacapavir, we believe, is a long-acting game changer, potential first-in-class HIV capsid inhibitor. Many of you have -- by now, you should have seen the data in highly treatment-experienced patients and the potency of this medicine, which gives us really good confidence in our ability to extend the dosing interval here. So you've seen some of the data we've already submitted the FDA -- or excuse me, we will be anticipating to submit the FDA submission in the second half of 2021 for the highly treatment-experienced patients, and it's already received FDA breakthrough therapy designation. I think what's important as we think about improving upon the convenience of a one daily oral for treatment or prevention that we really think about what's going to move the needle. And in market research we've done, I mean, clearly, getting to intervals, and this data is in prevention, of every 6 months in a subcutaneous injection could be very meaningful to patients. It doesn't mean, by the way, that the entire daily oral market would go away because some patients prefer that, but you can see that you really need to get to much less frequent dosing to encourage patients to change from the convenience of one daily oral. And that's really what drives our program on the next slide, Slide 17, that shows what lies ahead for lenacapavir. Obviously, on the treatment side, we'll have some additional data this year, and I'll get to a table with all the data you should expect from us about the 6-month data in treatment naive. And in addition, we are actively -- we have been actively exploring the combination partners in treatment for lenacapavir, which provides us for a potential flexible dosing profile, either with orals that could be as infrequent as once a week or to every 6-month subcutaneous. And we have a variety of options for that, both internally and externally for combinations. You'll be hearing more about that. But some of those potential combinations will be going into the clinic in the next 12 or 18 months. On the prevention side, we feel that monotherapy may very well be sufficient. And in the first half of 2021, we'll be starting a couple of prevention trials to begin to explore lenacapavir as a single agent monotherapy prevention with significantly less frequent dosing. So a real game changer, I think, for our HIV franchise. And beyond our HIV franchise, as you look at Slide 18, we've got growth in our antiviral business with HBV, with Vemlidy. You can see that we are confident about our ability to grow that to $1 billion medicine by 2022. And then the uniqueness of our presence in hepatitis and hepatitis B and a bolt-on acquisition that we're pursuing right now with MYR Pharmaceuticals with Hepcludex with hepatitis D, and you see some of the powerful data there in such a difficult-to-treat illness and the synergies, of course, associated with our HBV franchise. Now we hope to close the transaction with MYR in the very near future and bring Hepcludex to patients around the world as well. So as hepatitis C is largely now in a stable phase of its life cycle, HBV and HDV will be growing, and you'll continue to see robustness in our HIV business, both short, medium and long term. Now of course, all of this is only possible in our ability to execute on the portfolio. And if I move now to Slide 20, I want to talk about some of the aspects of what belies our confidence in the robustness of this new portfolio. As I mentioned, a couple of years ago at Gilead, I think we had a high reliance on a couple of shots on goal in our portfolio that were relatively high-risk and/or entering in a highly competitive area without necessarily significant differential advantages. You see a very different portfolio at Gilead today. And the growth drivers have high probability of success because of their on-market status like Trodelvy. So we've seen the data, and we've seen some of the early data in other disease areas beyond triple-negative breast cancer or compelling early data like we have with lenacapavir. We've also complemented that, as I mentioned, with smart deal structures that de-risk our investments, providing opt-ins. And all this has led to now the team and I having a larger portfolio, but higher quality, higher value portfolio, which really means the bar is high for things to get into our portfolio. We have lots of options, but we'll keep the bar very high. And in order, of course, to do that, you have to take consequential decisions on other programs that don't meet that bar. And so a robust portfolio is about making choices. And we just pointed out some of the choices. Some of them are data driven, some of them are regulatory driven, some of them are just not meeting the bar driven. But you can see the decisions we've taken relative to filgotinib or NASH, overall portfolio moving towards a Phase IIb and taking a look at that more carefully versus running into a Phase III and out-licensing of things that are either of higher risk or not within our sweet spots of development. We'll continue to make those decisions as we move forward and keep the bar high. I would say that our Galapagos collaboration has lots of innovative first-in-class opportunities within inflammatory disorders, particularly in the mid and longer term. We remain fully committed to that and look forward to working with that and our other partners to continue to complement our late-stage portfolio over time. Slide 21 is really the slide that we expect you to hold us accountable for. It's select 2021 milestones, it's not everything. And I want to highlight a couple of things here. But they're important milestones that you can judge our progress with this portfolio accordingly. And of course, lenacapavir is present here, magrolimab, Hepcludex. There are 2 that I really want to point your attention to that we think are quite meaningful in terms of needle-moving for us in the short term. And that is, of course, the Yescarta second-line DLBCL, so moving up in the lines of therapy for our cell therapy business. We'll be getting that data in the first half of this year. And in the second half of this year, we will be getting, as I described before, the Trodelvy hormone-receptor positive data, really the Phase III first of the co-primary endpoints results. Of course, there are a variety of other milestones that may not be present on this slide yet because they may be opt-ins that we could be provided with from our partners that will be added to this. And we'll continue to complement, for instance, our Trodelvy milestones as we further develop that program in other tumor types, the progression of the lung cancer program and the 10 total tumor types with Trodelvy. So more to come on this, but we'll be reporting out to you quarter-on-quarter with our progress on this, and you should continue to hold us accountable. On Slide 22, we did a tremendous amount of business development to build this portfolio. And of course, we continue to -- we will continue to do that, but probably not at the exact same pace as we've done in the past, 18 strategic partnerships and acquisitions in 2020. But our focus on BD will be to continue to focus on transformational science in the areas where we have expertise, executing on the options we have and pursuing bolt-ons with a very high bar to complement this portfolio that we have now that we're all very proud of. On Slide 23, I'll just reiterate, maybe give a little bit more color to our capital allocation strategy. The priorities remain the same for Andy and I and the team, and the order remains the same. But I just want to emphasize a couple of things here. Of course, we'll continue to emphasize -- to invest in our business and our R&D pipeline, but we have a keen focus on expense management and prioritization as well. And that's a discipline that is strengthening at Gilead and will continue to strengthen moving forward. We think that's extremely important. And that's a big focus of ours. Secondarily, we want to grow our dividend over time and pay down at least $4 billion in debt this year as a second priority. And third, we'll always be opportunistic about repurchasing shares. Of course, repurchasing the shares associated with stock-based employee compensation. But when appropriate, of course, as a third order of priority, look at repurchasing shares as well. I think it might be good for me just to pause here on the investment thesis when I think about Gilead at this time in 2021. I mean with the clear -- near and clear path for growth and the shape of the portfolio, in addition to that, I think you add to that, the attractive and growing dividend, certainly, industry-leading yields on the dividend, very strong cash flow generation and a strong balance sheet that allows us to continue to be opportunistic about bolt-on acquisitions. In no way do we have to do large M&A given the stage of our portfolio and the path ahead. But we do have the ability to do bolt-ons and to continue to supplement our business. So that in a nutshell is the way that I see Gilead as I sit here almost 2 years after I arrived in the investment thesis and our commitment to execute. And then finally, on the last slide, Slide 24, it's really a summary. And what I would say is, although we're not giving guidance right now for 2021, we'll be doing that in early February along with the full year results. We have said and we continue to remain confident in our ability to grow both the top and bottom line, excluding Veklury in 2021. We believe that we have an important new pillar of growth in oncology with Trodelvy as the cornerstone, strong antiviral foundation with continued path for leadership in HIV, a tangible path, data-driven and data produced. And our sustainable growth for the future will be driven by this internal portfolio and external innovation and our attention to financial discipline. So with that, thank you very much for your attention. I'm going to invite Cory back and look forward to entertaining your questions with the team. By the way, the team I have joining me is Andy, our CFO; Johanna, our Chief Commercial Officer; and Merdad, our Chief Medical Officer. So I welcome them to the screen, and over to you, Cory.

They even sequentially filed as their names were called, that was impressive.

We are really regimented.

Fine-tune machine. Hard to believe it's already been 2 years since you've been there, by the way.

Well, not exactly. I still have 2 months to my 2 years, but close.

I think March, right? I remember well. Well, thank you very much, Dan. And we have the Q&A portion now obviously.

We -- I see some questions coming in, but just a reminder to those out there listening, you do have the ability to ask questions and join in on this conversation by clicking that little blue ask-a-question feature. We have about 15 minutes to get to them. I wanted to start, though, you talked a lot about growth. You issued some guidance today. I just wanted to go into this a little bit more on how you're thinking about the growth outlook ex remdesivir kind of over the course of '21 and even beyond? And what the key aspects of it are in your opinion? And in shorter term to start, is it really more Biktarvy? Or does that traction come with Trodelvy in the relative near term, too?

Yes. Let's start with the short term because I think that's what people want. They want to feel granular about this ability to grow next year. So I think, look, there are a variety of growth drivers in 2021. And I'll ask Johanna to comment a little further, and let me just tee it up. But clearly, Biktarvy, Biktarvy, Biktarvy, and that's very important. Secondly, Trodelvy. I mean you've seen the third quarter sales. We'll update you on the fourth quarter sales and beyond. Vemlidy, is another key important growth driver for next year. And obviously, I mean, Veklury is, although unpredictable, I think, will clearly add growth accordingly. Johanna, please complement that a little bit from your perspective as well. And I should say before I turn it over to Johanna, cell therapy, of course, with the Yescarta continues on a growth trend. And particularly, based upon the ZUMA-7 results and the ability to move fairly quickly with the filing for that, that could be another important contributor as we head into 2021. But Johanna, excluding cell therapy, love to hear your comments.

Sure. Thanks, Dan. So maybe just to add a little bit more details behind what Dan said. So if I start with Biktarvy, which is absolutely still a very strong performer, continues to grow, is one that grows quarter-over-quarter. And despite what's going on with COVID-19 pandemic, we still continue to see share growth as well, #1 regimen across naive and Switch. And we expect that to continue as we go into 2021 and beyond. I do think that the profile of Biktarvy lends itself extremely well despite the pandemic actually because of the pandemic. So rapid start is something that is part of the guidelines for Biktarvy. And so, therefore, there's no HLA testing, there's no genotype testing, which just makes it a lot easier if patients need to switch off their medicines to Biktarvy. So both from a naive standpoint and a Switch standpoint, Biktarvy continues to stay strong. I think Trodelvy is an interesting one, and we've really seen a nice uptake of Trodelvy as we go into Q4. And as we come out of that for 2021, this is one that has not been impacted by the pandemic just because it's metastatic triple-negative breast cancer. You're looking at third-line patients. These are patients that cannot wait for treatment. And we've seen a really nice uptake. We've seen awareness, unaided awareness, go up to about 90% with academic centers, a little bit lower than that, about half of that in communities. So we still have some work to be done there. And this is despite a pandemic and doing everything virtually. So we're also tracking third-line share very closely and acceleration into third line from second line to third line to try -- as physicians are trying to get patients on Trodelvy faster. So I think exciting about that, and obviously, with an opportunity to grow out in different indications, as Dan mentioned in his presentation. Vemlidy, just to touch on that one a little bit. A lot of the growth that we've seen this year in 2020, I should say, has really been across a couple of markets, namely China and the U.S. And so we've seen a nice growth there, and we think we have a nice opportunity post close with Hepcludex to really join hands on that one and make sure that we bring an incredible product to a very high unmet medical need. So both of those pieces together are exciting for our HBV team. And so I think those are the major pieces in addition to the cell therapy piece with Yescarta that Dan mentioned.

Okay. Terrific. We're starting to get a lot of investor questions coming in here. So let me try to work through these as quick as I can. So first of all, probably for Merdad, is there a potential for an interim in the first half of 2021 for the TROPiCS-02 study?

Yes. Maybe it's good for me to set the context there. So Immunomedics has planned to do an interim analysis in the early part of the year, looking at ORR for that study. When we came on Board and we worked with the team, we realized that, that study was probably underpowered for OS. And so we actually upsized the scale of the trial to make sure we were powered properly for OS. So the sample size has gone up to about 520. And secondly, we looked at and realized that we would have the full PFS readout towards the end of the year because enrollments have gone so well. And we didn't want to spend the alpha for the ORR interim. So what we did is we removed that ORR interim, and we'll be seeing the PFS data towards the end of the year.

Okay. Next question, probably for Dan or Andy is, coming off a very active year on the M&A and business development front, how much of a priority does that remain for you guys going into 2021?

Andy, go ahead, please.

Sure. I'd be happy to take it. Cory, thanks for the question. It remains a priority. I mean I think it's going to be important for us to continue to do corporate development transactions in the ordinary course. What you're going to see is, you won't see the same level of activity that you saw in 2020, I would expect or we would expect. But you will, as Dan said, continue to see bolt-on transactions as well as ordinary course partnerships. So I think Gilead, going forward, will continue to do corporate development in order to supplement our pipeline over time and that will allow us to make a lot of these portfolio rationalization decisions that Dan talked about earlier.

Okay. Next question regarding remdesivir, Veklury, how that's doing outside of the U.S., the uptake in utilization there?

Johanna, please.

Sure. So as Dan mentioned, the 1 and 2 patients that are getting remdesivir right now are in the U.S. We've done a lot of good work in Europe, where we signed a joint procurement agreement so that all countries can have access to remdesivir as quickly as possible. So now all European countries have access to it. And it's a little bit mixed in the uptake. And it really depends -- it kind of follows the pandemic, just like we've seen in the U.S. as well and the hospitalizations associated to that pandemic. So for example, there are some uptakes that are a bit stronger in Spain and Italy and then some of the other countries, and obviously, the pandemic being a little bit slower in some of the other markets like Germany and whatnot. So the utilization goes hand-in-hand with that. Across the world, Japan is another important country for remdesivir, where they were the first approval actually for remdesivir earlier last summer. And although the pandemic has not -- which is a good thing, has not gotten to the levels that we've seen elsewhere in Europe as well as in the U.S., their use of remdesivir is actually very high as well. So it depends on the pockets, and it really depends on the evolution of this pandemic is what we see.

Okay. Next question we have here is, with Roche and Johnson & Johnson advancing their combo therapy for HBV, is HBV still a top target? And do you have all the assets you need either via partnership or in-house at this point?

Merdad, please.

Yes. It's a great question. We do believe and agree that it's a -- the way to get to cure is to use a combination approach. And as you know, we have a number of internal assets that we're looking at and doing combination trials. We certainly think there are opportunities for other agents that could be used as part of those combinations and are looking at sort of a holistic picture that we can approach the cure paradigm with. So we are open to bringing other agents into that mix.

Okay. A question regarding your relationship with Galapagos. And what that looks like going forward after returning the rights to filgotinib?

Yes. I'll start here, Cory, and others can add. But remember that when I came into the organization is when we did this kind of broad partnership with Galapagos, which is essentially a 13-year partnership. And that was designed not around filgotinib because that was already done. It was designed around some of the first-in-class screening programs that Galapagos has, our enthusiasm, scientists to scientists around how they approach that. So nothing has changed in that regard. If anything, that's a major part of our inflammation strategy that I spoke about that comes in kind of the, I would say, the midterm growth to the longer-term growth. And of course, we have the IPF medicine passing its interim this year and some of the later-stage programs, but also the early-stage program is quite complementary with what we're doing internally as well.

Okay. This is great rapid fire here.

Yes.

I'm trying to get all of them. We're really doing a good job of it.

Well, go ahead, Cory.

So your next one is back to the pipeline and the TIGIT compound. When do you expect to have the Phase II interim analysis? And could Gilead opt-in prior to that interim data?

Merdad, please.

We're working really closely with Arcus. We anticipate having the ability to make a decision in the second quarter. So I think we'll -- we're so close, we'll look at those data and make a decision one way or the other. That's the latest on the time lines.

Okay. Another one on COVID and remdesivir and the status of the inhaled formulation that you're working on?

Merdad, please.

Yes. We're -- we continue to work on the inhaled program. We've passed the single and multi-dose and are continuing to pursue that approach and other approaches potentially for remdesivir in the long run. So we believe that we have a number of shots on goal there to try to expand the reach of remdesivir if we can.

Okay. And then on the HIV front, how do you expect competition to evolve with GSK ViiV in the long-acting HIV space?

I don't know who wants to handle that, Johanna or Merdad or...?

I'm happy to start it. And Merdad, if you want to add anything, that's all right. So yes, obviously, we're always very conscious of what's going on competitively around us. We feel, thus far, with the competition that we've been able to maintain and actually continue to grow our leadership in this space. And as I was touching on Biktarvy's growth quarter-over-quarter share and year-over-year, it continues and that's the assumption going forward into 2021. The competition currently is that the latest competitor is single -- low single digit at this point in time. So I think we feel very strongly that we have a good path forward. As it comes to the long-actings, which is probably part of the second half of that question that we expect to hit the market, we also believe that it has to be the right long-actings. It has to have the right components. And that's why we're very focused on our long-acting strategy and making sure that it's the right mix of products to make sure that we are very patient-centric in our decision how we move forward. And that's why lenacapavir is really the cornerstone as we think of long-actings moving forward. Merdad, anything to add?

Yes, nothing to add. Let's get to other questions. But yes...

Okay. I probably have time for one more in, and it's back to remdesivir. And whether you're facing any supply constraints as you try to -- or given the ramp we're seeing, I presume, in cases of COVID?

Yes, Johanna?

So we've been -- the team has been doing incredible job. And obviously, we have a lot of partners across the world helping us with our supply chain. And we were really -- we did a lot of investment early at risk to ensure that we were ready for any type of surge, and we kind of used our max potential. And so therefore, no, absolutely no supply concerns. Supply is greatly over the demand, not just for the U.S. but globally. So we feel very confident that we can continue to meet that demand.

Excellent. Well, I wish we could work more in, but we are out of time. So thank you all very much for spending this time with us, and look forward to speaking to you again soon.

Thank you, Cory.

Thanks.

Thanks, team.

Thank you.