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Conference · 2026-09-15
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Great. Good morning, everybody. Thanks for joining us. I'm Terrence Flynn, Morgan Stanley's U.S. biopharma analyst. For important disclosures, please see Morgan Stanley's research disclosure website at www.morganstanding.com backslash research disclosures.
If you have any questions, please reach out to your Morgan Stanley sales representative. I'm very pleased to be hosting Gilead this morning. Joining us from the company, we have Dan O'Day, the company's chairman and CEO, and Joanna Mercier, who's the company's chief commercial and corporate affairs officer. Thank you both so much for flying out here to the East Coast and taking time on your schedule.
Thank you for having me.
Looking forward to it. Maybe, Dan, I'll just turn it over to you to make some opening remarks, and then we can go into the Q&A.
Thank you, Terrence, for having us. Delighted to be here with Joanna. it. Look, first of all, maybe just to kind of set the table for Gilead, we are at, I think, a really important point in our journey. We, I think, are at another inflection point in value. And let me just kind of explain why I believe that. I mean, first of all, we have the most robust portfolio, I think, in our history, certainly since I've been here in the past seven and a half years. And this cadence of launches that we have right now is really going across all therapeutic areas, and we'll talk about that a bit. But the setup is such that, you know, we're a bit unique in the sector in that we don't have any significant major patent expiries until 2036, with a very strong plan on how to handle that patent expiry in 2036. But let me just break it down into a couple of components. I mean, I think about, you know, our portfolio from strength, but also diversification. And I think there's two different ways to look at diversification. One is the diversification that we're going through right now within our core business, our HIV business, which is, you know, in the past and currently still largely based on BICTARB. But we're in the middle of kind of transitioning the entirety of our HIV franchise across both treatment and prevention. I know we'll talk a lot about both of those and particularly prevention. But it's important to note on the treatment side, you know, we just recently launched a new daily oral called BixLenbo. I'm so used to call it BixLenbo. I know it's so close to the other name. I should be a little bit better at that. Which is an important, you know, addition to the treatment landscape, in particular the fact that it allows us to participate in the switch market, which, you know, in the past we haven't been as participative. And about 20% of patients on HIV treatment do do switches a year. And then we have, you know, an expected launch of the first weekly oral treatment in ISTLEN next year as well. And beyond that, and we'll continue to update you, a really robust portfolio of weekly orals, sorry, weekly and monthly orals, and once every six-month injection rules, including, you know, atlanticapavir is the backbone, a really strong capsid inhibitor, you know, the first capsid inhibitor, combined with a variety of different medicines, including 3242, which is an interesting INSTI that we are currently in the clinic on for every four months. And PK data suggests we may be able to take that to six months, so stay tuned for that because that trial is ongoing. So there's just a tremendous optionality within the treatment landscape. that will evolve that whole treatment landscape over the course of the coming years. Secondarily, PrEP is now almost – the number of users on PrEP has more than doubled since 2022, so in the past four years, driven by Estugo, now Descovy, but also with Linosite towards two new launches in the next couple of years, weekly oral PrEP first quarter of next year, and then in 2028, a one-year injectable version of Yes2Go. So, you know, just we think about diversification across that broad spectrum of HIV in both treatment and prevention for a growing durable business well into the end of the next decade. And then combined upon that strength, the work we're doing, you know, on oncology and INI. Just briefly on oncology, we'll get back into this, but InidoCell, is the most eminent launch in oncology of a new molecular entity in fourth-line-plus multiple myeloma. We're really excited about that being a best-in-disease profile, a one-and-done type of opportunity for people with multiple myeloma. We are fully enrolled in the second-line-plus study. Expect that data to read out next year. So moving that up in line to therapy, allowing people to achieve treatment-free durations is really what we're focused on in multiple bioloma. And then a broader cell therapy approach with bisestronics and lymphoma in vivo constructs and autoimmune. Combine that with the work we're doing in ADCs, both with Trevelby and first-line triple-legative breast cancer, as well as the acquisition of Tubulus, which we really are excited about as a novel ADC platform, starting first in platinum-resistant ovarian cancer, but then many indications with that platform as well. And then, so that's our oncology base, which is really just beginning to kind of shape and form and grow. And then INI at an earlier stage, you're going to hear more on that later this year, but I'd just point your attention to what our chemists have been working on for the past six or seven years. There's a couple of small molecules that we intend to read out phase two results later this year with alpha-4, beta-7, and a RAC-4. We also have a STAT-6 program, as well as an acquisition we did earlier this year on a BCMA T-cell engager for B-cell depletion. So all this to say that this is a special time at Gilead. I think we're in a unique position to drive value and growth, and not all against an operating model that we're committed to, which includes top industry quartile margins, strong cash flows, and ability to deliver to shareholders and to patients.
A lot to talk about, obviously. So I guess the first one, just, again, high level, I've been asking most of your peers this just seems like we're in a different place this year versus last year on the policy front, which I think is a good thing. But just anything that's on the company's radar as we head into midterms that, you know, we need to think about coming out of D.C.
Look, you know, Joanne and I and the team work constantly on policy. So I think it's just part of, you know, the integrated fabric of what we're doing. I'd say a couple of things on that front. First of all, I think the best defense is a good offense. So the more innovative your portfolio, the more differentiated your portfolio in any country around the world. So it just gets back to what I said before. I think we're really in a unique position of having this very, very robust portfolio that's highly differentiated as we approach any policy environment. But two things I would say. Look, we've been spending a lot of time in Washington, D.C. I think, you know, there will always be pressures on pricing in pharma. and the conversation is broader today than it was five years ago. In other words, people understand better the complexity of the health care system, where dollars go in the health care system, and I think we made real progress on making sure that people not only focused on pharma pricing but also focused on health care pricing, in particular insurance and PBMs and 340B, which I think we made some progress on and more to be made there. So we'll continue to focus on that in a bipartisan way. you know I think the conversations in Washington are always about you know how do you improve the health of Americans keep a strong American industrial strategy and I think on that point everybody can agree on the details of course we need to get into the details and then finally what I'd say on our front is we spend a lot of time focused on the diseases that we're in and I can say that regardless of the administration we've been able to draw attention because of this incredible innovation to the importance of funding HIV, public funding for HIV in this country, the work we do with the State Department in countries where HIV is more rampant and higher, and I think we always get an important audience on that, and we'll continue to stand for those patients there and patients with severe diseases like oncology.
Okay, great. I guess going to the recently launched product, Yes2Go, obviously front and center, I know it's a huge focus for you, Joanna, and the rest of the company. So maybe just talk to us about kind of the transition that's been going on in the marketplace from orals to injectables. Any other points of friction as we think about kind of the forward outlook here? And then we'll come to, you know, broader prep market growth, which I think was one of the bigger takeaways for me from your second quarter earnings was being able to deliver again to kind of, you know, teens market growth off an even larger base. And so I guess the first part of the question is just kind of Yes2Go latest dynamics and what you're most focused on in terms of driving, continuing to drive that growth.
Yeah, sure. Thanks, Terrence. Good morning, everyone. I really think the Yes2Go launch is an incredible success thus far, and it really has a lot to do with the preparation of the marketplace, but also the work that we've done for the last 10, 12 years in prevention and really understanding the market, the consumers for PrEP. We really have grown Yes2Go. We're now expecting our guidance is at $1 billion for its first full year of launch. And that's not by chance. That's obviously a lot of increased awareness, education of physicians, and, of course, consumers. I do think it's exciting to see that the market continues to grow. And one of the things that we always knew as we were launching Yes2Go, our focus and the scripts would come really from switch patients, switch prep people. But what we're seeing is actually a quite nice mix of both naive coming into prep on Yes2Go Q6 as well as the switch. And so you're seeing a nice balance there. We also know that it was important to grow the market. The growth of the market happens in different ways. But one of the ways that we've done it in the past is always just with new options on the marketplace, it kind of picks up the market and makes noise, increases awareness. Purpose 1 and 2 trials were such powerful trials for Yes2Go that it really helped everybody kind of, you know, sit up and pay attention to what prevention could be. The research that we've done with consumers is very clear that longer is better. And so the Q6 monthly is really an option that people were waiting for. And so that's why we're seeing not only switch from daily orals and from other long-actings to a Q6, but also even seeing naive people come in to prep for the first time. And so we're seeing that nice balance. One of the things around the market itself is it's growing at about 14%, 15% or so, to your point, on a larger base. And, again, not by chance, right? This is a lot of work that we do to increase awareness that our competitors do to make sure people understand the why, make sure people feel empowered to own their sexual health, making sure it's very targeted in who we speak to, where we speak to them, meet them where they are. And so we've really advanced the work that we do, and AI helps us do this, of course, even better than we've done in the past. And so that has also helped all the boats rise. So it's not only helped Yes2Go, but it's also helped DiscoV. And so you've seen really nice upside on DiscoV as well. And the total prevention portfolio is now, you know, over a billion dollars for the quarter. So that looks like an annual run rate of about $4 billion just for the prep business. So a lot of work behind it and a lot more to go. And one of the probably the signals that I'm most excited about is for us, whether it comes from a specialty pharmacy, whether Yes2Go goes through specialty pharmacy or through buying bill, it doesn't matter to us. But what's been interesting is to see the uptake in both segments, but actually buy-in bill is growing faster than we thought. What that means for me is a signal to future volume, right? If people are setting up their clinics, their setups to include buy-in bill, which is actually administratively takes a little bit of time and energy and resourcing, then basically that is very clear that they're thinking about increased volumes in the Q6. We also have a lot more options coming around the corner, I think Dan mentioned, not only do we have a Q-weekly oral early next year in February to do the date, but we also have the potential of Q-12 monthly by 2028, and so we also think that continues to expand the market. Two things. Expansion of the market happens with more options. It happens, of course, with the data that's provided by those options, but it also happens by making sure we're educating different people, so not just the HCPs that have always prescribed PrEP, but actually HCPs that have never prescribed PrEP and people that have never been on PrEP as well need to enter this marketplace. And that's what we're starting to see slowly but surely. So we think there's a lot of runway here and a lot more work to do.
Great. And maybe just, I think you said recently the current kind of user base is 550,000 roughly in the U.S. What are the kind of upper brackets as you think about that like addressable opportunity?
Yeah. So the CDC defines the addressable opportunity at about 2.2 million people in the U.S., the way they define that is really leveraging their estimates of men having sex with men. And so we believe that number is actually much higher than that. If you just look at STD diagnosis in the U.S., there's about 13 million a year. These are the people you would want to have a PrEP conversation with. Having said that, even if you just take the CDC estimate, you're only at about 25% or so penetration of the total PrEP estimate that the CDC's laid out. And so we believe there's a lot of space to grow, and we think that the opportunities are with options like Q6 or even the Q12. We can really make a difference here.
Okay, great. Maybe, you know, you mentioned Q, you know, the oral formulation of Yaz2Go coming next year, I guess one question that comes up is, what's your anticipation for the source of business for that formulation? Again, is this switch dynamic? Is it new? Like, how do you think about that, given what you've seen for Yaz2Go Q6 monthly?
Yeah, I would say I would start with Q6, because as much as the QWeekly is coming out, we still believe Q6 is actually really going to be the target. And what is preferred, just because of the six-month frequency really helps. It just meets them where they are. It's much easier to fit in their lifestyle. Having said that, we do think the Q Weekly is going to be a nice option for folks that don't like injections or folks that don't want to take a daily oral pill and wanted to stay on an oral long-acting. This is going to be the first oral long-acting available and a real opportunity to go once a week, maybe every Sunday or every Monday morning, you take your pill. So we think that's going to source from Discovy as well as the generic Chubatas that are in the marketplace. Different from the Q6 that actually sources from all, right? It sources from new, it sources from the Q2 current competitor, as well as the daily orals, both Discovy and generic. So a little bit of broader base for the Q6 than the QWeekly.
Okay, makes sense. And I guess the other question, which, again, I mean, you know, kind of waxes and wanes is just what you see for second-shot frequency with Yes2Go. It sounds like you guys also have, you know, a more recent campaign to kind of even improve that further. So maybe just talk about where we stand right now and then some of the steps you're doing to kind of continue on that second-shot journey.
Yeah, so obviously it took us a little bit of a while to have the right data, right? We've been following the claims longitudinally to ensure that we understood what the persistency was at that second injection. On our Q2 call, we shared that it was over 70%, which is well beyond anything we've seen from any of our competitors. That has a lot to do, again, with the profile of this medicine and what it offers to consumers of PrEP. So we're excited about that. We also believe that it's important to continue to surround Soundit. And what I mean by that is we know that specialty pharmacies right now are obviously calling back people to make sure they come back in for their injection at the right time. We know that the clinics, the doctor's clinics, are also doing that to make sure that they get within the window. We believe it's important to just make sure we just add a little bit of color to that. And so through a digital app, it's actually a program called Ready to Go, kind of playing on Yes to Go. And it's really about SMS, texting, alerts, things like that. It's all on digital, but it also has, you know, people, as much as AI is fabulous, people also want to talk to real people. And so there's also an opportunity to have an inbound, outbound nurse call center, which I think is actually proving to be very useful to manage anything along the way, but also to remind them that it's important to make your appointment to go back for that second, third, fourth injection.
Okay, great. Maybe just on the rest-of-world opportunity, where are we right now in terms of some of those conversations? I know that's an area that you guys have been working on and felt like, you know, there were some hesitancy with a once-daily oral to maybe embrace that, and we haven't seen much of a rest-of-world prep market. But maybe now with a, you know, every six-month option or even a once-yearly, maybe some of those governments are going to be more willing to kind of lean in. So where do we stand on those efforts?
Yeah, so a lot of work going on, and I would say I would kind of – there's three areas, I would say. The U.S., obviously, we've been talking about. We've also done incredible work in low-biddle-income countries, and, of course, that's no profit to the company, but work in sub-Saharan Africa where, you know, diagnostic rates are one out of four, one out of five in certain countries, which is just – in certain areas, which is just horrible. So anything we can do to help there, and we've been partnering with Global Fund as well as the State Department, to do just that. And then you have the other countries, which I think is what you're referring to, which are the first world countries. And it really depends. We've been working to ensure that lenacapavir has been a drug that we have been working on for 17 years prior to its launch. It is incredibly transformational versus what is currently available. And it is one that we want to ensure that that value gets recognized across the different countries around the world. And so So we are making sure we're educating and the value, the persistency, all of the benefits. And it's not for everyone. That's the whole point of optionality. But there is an opportunity in certain countries where you have a government that actually really wants to leave a legacy of ending new incidents of HIV. And they see lenacaphyde as the solution. And those are the governments we're working super closely with and for very specific populations. You have populations, great examples in Canada, where in some of the northern provinces in the west of Canada, you have very high rates, similar to sub-Saharan Africa, which is crazy. And so there's real opportunities to do something, and that's where lenacathivir can really make a difference. So we're working through it. But I will tell you, many markets have an HTA process that compare to a daily oral generic, and that's a tough comparison when you're bringing this kind of innovation to the market.
Okay, great. Maybe we'll just pivot over to the HIV treatment side. Dan, you mentioned a lot of the similar efforts to kind of transition the portfolio here as well, have some new launches on the switch market but also working on the long-acting. So I guess the first question is just on a current kind of market state. Again, you guys, you know, had a dip in growth in 2Q, but you expressed confidence getting back to kind of that 2% to 3%, which we've seen historically. So maybe just is that still, should that still be our expectation there? And what are you seeing, you know, as we kind of come into the end of the third quarter?
Yeah, what you're referring to is the market growth, right? The market growth for HIV, we did see a little bit of a dip. We think it has to do with a little bit more of an ACA impact than we had originally expected. Obviously, this is HIV. People will find their path and find a channel for them to get reimbursement in the right way. If not, the disease progresses. So we're not concerned. It was just a little bit of a Q2 play. We also did update our guidance for HIV in the Q2 setting in addition to this additional impact of ACA. and we actually moved it from 8% to 9% to 10% growth for HIV for Gilead. So I think overall we believe that we can more than cover that. We do think the market will get back to the two to three points that we've seen in the past and it will normalize within the next couple of quarters.
And that's what you're seeing right now or still too early to call that recovery?
Still too early a little bit, but what we are seeing is definitely that people need to find their path. And we've seen it even, you know, in the second quarter, we also had a little bit of a bump because of Florida ADAP, and we've seen that reset right away. So I do think that since Florida ADAP then reinstated Vic Tarvey on its formulary in July, I think that's been a great opportunity for patients to get back on their Vic Tarvey.
Okay, great. Maybe just to go to the new product launches. So Vic Len, again, I won't try to pronounce the name, was approved. so congratulations there. And then you have Lenacapreviris, Latreviris, the once weekly oral, you know, coming on the forward. So again, just remind us, this is all for the switch market. And so again, we get some of these questions where, oh, what's the impact of these next-gen regimens on BICTARVY? But again, these are going to be positioned primarily in the switch markets. So maybe just talk to us that kind of interplay. And then my understanding is Devato is kind of one of the leading switch regimens, and that's about a $3, $4 billion drug. So is that the right kind of dollar opportunity that we should think about, roughly? I know you're not going to give exact numbers, but again, there's an approved drug out there, and we know what the sales are. So just talk to us kind of how all that plays out.
Yeah, so let's start with Big Tarvey. Big Tarvey is the leading agent today globally, and so with over 50% share with Big Tarvey, It really is quite differentiated, and especially as you think about in the naive setting, the rapid starts, the HPV co-infections. I mean, it has so many indications that others do not, and it's why it leads in its naive share. So it has more than two-thirds of the market in the naive setting. And so, therefore, as you think about switch, we are also leaders in switch, but that has to do more with legacy medicines from the past and switching to BICTARVI. As we think about the future, if people want to switch, it's hard to switch from BICTARVI back to BICTARVI, right? So we do think it's really nice to have something like BICS Lenvo to enter the marketplace to bring one more asset into the mix, let alone Lennis Latrevere next year, to really have more competitive plays in the switch market, which is about, I think Dan mentioned, And about 20% of your total dynamic market, your 20% is dynamic. And so I think that's the opportunity. With Bix-Lenzel specifically, the launch is really focused around, we have two indications. One is virally suppressed patients, which is really your typical switch in that 20% that I just mentioned. But then we also have the indication for VSCR, which is your complex regimen patients. And those represent about 5%, 6% of your total HIV patient population today. And those are the ones really at launch that as you're navigating access, as you're ramping up access, those are the people that we've focused on. Because these are folks that are taking probably five, six, eight, ten pills a day. And they could actually potentially switch it to one pill a day with Big Sunfo. And so that's a huge opportunity. And that's something that obviously physicians are willing to kind of work through the paperwork until access kind of plays out. As that access ramps up, then obviously then the opportunity lies in the virally suppressed, which is a bigger population, let alone the fact that we have actually really unique data in the over 50-year-old population, more so than any other molecule, to really show the benefit, and that's really the population that are switching at this point, that have been on medicines for quite some time. So we think that's a great opportunity to expand our switch leadership, let alone with Lenazlachivir next year with the weekly oral, which I also think is going to be a nice new option for patients in the treatment switch market. And last but not least is we do believe that there is opportunity for us to have longer actings in the HIV treatment market as well. And Q6 would be the ideal scenario, and that's what we're working towards. towards, I think, Dan, you touched on the 3-2-4-2 molecule where we saw data at CROI and in phase one for PK data at four months. It looks like it could be longer than four months. We're waiting for that phase one data for six months to come through. We've already started our phase two program. This includes one arm with the Q4 regimen. And obviously, as soon as the phase one data comes through, we would, you know, assuming positive, then we would add a Q6 on to the same trial. So that's kind of what we're looking at, let alone the BNAPs that we also have in play. So we have a lot going on optionality-wise so that we can really continue to drive that leadership in the HIV treatment market.
Okay, great. And similar question as asked on Yes2Go, when you, you know, have new options, new formulations, is it safe to assume that this is, when you blend it all together, that it's additive rather than just a switching dynamic to your HIV treatment franchise?
Because of that market expansion play that we talked about earlier, I think depending on the option that we're referring to, but as a totality, most of them are all additive to the current market today for a couple of reasons. One is just execution on the market, increased awareness, and two is sometimes different populations that are coming through let alone the compliance that you're going to get with the longer acting.
Okay. Okay, great. Maybe just one strategy one for you, Dan, is just, you know, you mentioned immunology and a lot of the efforts you guys have on these oral, you know, drugs you're bringing to the market or in development. So as you think about, you know, Gilead has a history here in immunology and has been working for time to kind of scale up. Maybe just for us, like, what's the tipping point to make you guys a big player in immunology? immunology? Is it having a cornerstone asset? Is it having like scale portfolio? Like what's it going to take to kind of make you guys one of the bigger players in that space?
Yeah, I think both. And by the way, you know, we're eyes wide open here in terms of, you know, the competition on the one hand. On the other hand, we're also eyes wide open on the opportunity. I mean, I think just as what has been done in cancer, I think we're in an era of I&I scientific knowledge, and in particularly the ability to have new modalities that might be combinable, because part of what's, I think, you know, held us back in I&I is the ability to get to truly differentiated efficacy points at a tolerability profile. And that's where, you know, seven years ago when Joanna and I and the team, you know, we sat down with our strategy and said, where can we differentiate? And part of that, at least one aspect of that, was taking our small molecule chemistry expertise that has been put to work on everything that Joanna just spoke about on the HIV side towards targets in immunology. And that's what you're seeing play out now with the phase two readouts that you'll see later this year. I mean, those all come from Gilead chemistry, which is the alpha-4, beta-7, Iraq-4, again, stat-6, and others. And so to your point, I think it is both portfolio and anchor assets. And, you know, once you see the data that we'll present later this year, phase two data, to be clear, we'll be able to articulate more comprehensively with that data set but kind of how we anticipate moving ahead in INI. We absolutely understand that we have to have, you know, very differentiated efficacy moving forward, either alone or in combination. And I think we'll pick our disease states well within INI to make sure that we understand where we're moving. One example of that is the oral acquisition at the beginning of this year, which is a BCMA T-cell targeted therapy called Gengaritamig. I think I said that right. where we're looking at, you know, four kind of more, you know, rare diseases within INI where a B cell depletion strategy could really make a difference. So, you know, I think, you know, our INI strategy will follow the science, but it will also be very pragmatic about how we approach it. And that is combined to a very robust cell therapy and ADC strategy oncology and then the backdrop of this kind of strong durability in HIV.
And how do you think about, you know, solo versus collaboration? I mean, you guys were an innovator here in HIV, where we saw you do these cross-company collaborations, Johnson & Johnson, Bristol, Merck now. And so is that a playbook that you could use in immunology, or is this something that you think is kind of more ROI positive to go it alone?
Oh, definitely. Look, I think in the most recent one that we're getting ready to launch this year is the collaboration we had with Merck around in Slateria and Lena Capovir. So I think we've always been, our scientists have always been, And we've always been looking at when we have a single asset that's highly differentiated. Of course, we want to develop other single assets within our own portfolio, but we can't have patients waiting to do that. So we always look for optimal combos, and I think we would certainly look at that as a potential strategy in INI as well.
Okay, great. Maybe just in the last few minutes, I know oncology has been another focal effort, and you mentioned a lot of the efforts going on in your prepared remarks. AnitaCell is the most near-term asset that is coming. So maybe just, again, high-level kind of positioning here in the marketplace. And then, again, launch readiness maybe for Joanna.
Yeah, we'll tag team on this one. So I'll just set the table. And because Joanna's team and Cindy's team have been working really closely together, we are now in a very robust launch phase right now, and so we're sharing experiences on the launch side. But, again, I've spent a lot of time going around and speaking to folks within the multiple myeloma segment. You know, the profile of an endocel is really highly differentiated. We think it's best in disease. Starting in fourth line plus, it's very important to get the first launch right, and so the team is spending a lot of time on that, and Joanna can talk a little bit about some of the strategies there. But bottom line is that our approach with InidoCell is multifold. Of course, it's getting the fourth line launch right. It's moving up in lines of therapy because that's really, you want to use a CAR-T directed therapy when your immune system is strongest. This gives you the best opportunity for a long, durable response, potentially a cure, like we've seen in lymphomas from a curative intent. So it's rapidly moving up in lines of therapy, including the second-line trial that I mentioned was completed and beginning what we intend to launch a newly diagnosed multiple myeloma play as well. But then, you know, not to stop there, to use this same technology, this D-domain binder, which is present in a needle cell in potential in vivo constructs in the future, both for multiple myeloma but also other diseases, including cancers and autoimmune diseases. But let me turn it over to Joanna on some of the other profiles of AnitaCell that her and her team collaborated.
You know, you asked about launch readiness. We've been doing a lot of interchange, as Dan was referring to, between the kite team and the Gilead team because obviously we've had a few launches lately. And, I mean, they are absolutely ready. It's really impressive. They have right now about just under 180 or so authorized treatment centers. They think they're going to be at about 200 by the time we get the PDUFA in December. That means, you know, basically four times more than when the competitor launched from a setting standpoint of our authorized treatment center. So very well established. We've been having pre-informed on our medical, with our medical team on the data, making sure we get to our payers, our plans, make sure that everything's set up so that once you have the label, it's just plug and play so that you can kind of pull it through in the first quarter of next year and get those patients that really need something like an EdoCell as quickly as possible. The intent, obviously, is to really penetrate the fourth-line market quickly, about a $3.5 billion market opportunity in multiple myeloma. We think the profile, we talked about best, we believe best in disease, but so do our physicians especially, our KOLs are seeing it as well, and really an opportunity to differentiate there so then you move up lines of therapy as the data comes through. So excited about the opportunity. And also I do think the profile lends itself incredibly well for the outpatient setting, which is going to be even more important as you move up lines of therapy. The profile is thus far incredibly safe, right? We haven't seen any of the neurotoxicities we've seen with others. We're not seeing any of the enterocolitis. And so from an outpatient setting, that's important because in multiple myeloma, most of your patients you're going to actually see in the community versus academia. So as much as academia is important at launch, the bulk of the volume of patients is actually in the community where outpatient setting makes the difference. And that's where I think a native cell can really win.
Great. Well, thank you both so much. Thank you, Terry. I really appreciate the time and insights, and thank you. Thank you.
0:15 to 34:53 · One card per analyst, follow-ups included. Each plays from its start, and the one being answered is marked.
If you have any questions, please reach out to your Morgan Stanley sales representative. I'm very pleased to be hosting Gilead this morning. Joining us from the company, we have Dan O'Day, the company's chairman and CEO, and Joanna Mercier, who's the company's chief commercial and corporate affairs officer. Thank you…
Speaker 1: Thank you for having me.
Also speaking: Johanna Mercier