Conference Transcript - JNJ 2026-06-09

Asad Header, Analyst — Goldman Sachs

All right. We are just at about time so we can get started with our next session. My name is Asad Header. I'm the co-head of the Healthcare Business Unit here at Goldman Sachs and the U.S. Farm Analyst. I'm very excited to be joined by Tom Kavanagh, Group Company Chairman of North American Innovative Medicine over at J&J. Tom, thank you for being with us. Thank you, Asad, for having me again. So, you know, just maybe just to kick off very exciting times for J&J. You have multiple new products sprouting across the innovative medicines business. Joaquin made some comments last week saying again that the street is continuing to underappreciate a number of these new products, both on the immunology side as well as in oncology. So before we start to unpack some of the specific products on which I have a number of questions I'm going to hit you with, maybe just make some high-level comments on what you've been most excited about.

Tom Kavanagh, Chairman

Oh, absolutely. Absolutely. First and foremost, as we said last year and over the last year, you know, Stellara was a thing of the past. We're going to grow through the loss of exclusivity of Stellara, something that many companies have not been able to do, you know, their biggest asset, and really look at that five to seven compound annual growth rate over the next five years. And we're well on track to really go for that upper end of that, I would say. Just looking at our Q1 results, we delivered $15.4 billion. It's our fourth quarter in a row, delivering over $15 billion. We have 7% growth in the U.S. We had roughly 10% growth, and the Excludes Dolar is 17% growth operationally, and in the U.S., 22%. So we're really excited about the momentum that we have coming into 2026. You know, it was described as last year as a catapult year, but this year we said 26 is going to be better than 25, and 27 is going to be better than 26. And we're all on the way to do just that. I think first and foremost, we had 10 products over double-digit growth in Q1 and some exciting product launches, which I know we'll get into. So I'll maybe leave it to you to ask some questions, and we can go from there.

Asad Header, Analyst — Goldman Sachs

Well, let's go right into some of the exciting product launches. Starting with, you know, Trimfire, it grew 64% in Q1 with leadership in new patient staff and IBD. You know, we look at weekly scripts. The momentum seems to be continuing. So just give us an update on what you're seeing, broadly speaking, in terms of overall market dynamics and really where the share gains are coming from.

Tom Kavanagh, Chairman

Yes, yes. First and foremost, with Tromphia, it's the only dual-acting IL-23, so it's CD64 and IL-23. CD64 is the source of inflammation. Why I say that's very important. We like to say tissue is the issue. If you can penetrate that tissue and hit at that target, you're going to see differentiated results, and we are seeing that. But if we just take a step back and we just think about IBD, we're just in the early phases of that launch. In IBD, the IL-23 class is the fastest-going class in IBD, both in UC and CD. and I would say it's barely penetrated, so it's about 20% to 25% penetration, so significant opportunity ahead of us in IBD and in psoriatic diseases, whether it be psoriasis, psoriatic arthritis, a little bit more penetration, but still the fastest-growing class. In IBD, we're the fastest-growing product in IBD, and we are now what we call the induction-share leader in IBD with Tromphia, and we're just about a year into launch, you know, full launch with both CD and UC. And I can tell you the excitement is really profound, and the team is executing across all measures. But I would say we're seeing the differentiation from our customers and from the uptake. A lot of it, as we talked about in the highlight, a little bit of the molecular structure showing that results. It's the only with subcutaneous induction, both in UC and CD. Highest endoscopic remissions in UC. And then just recently coming out of DDW, we're really excited about this new data with the fusion trial. It's basically perianal fistulizing Crohn's disease. It represents around 25% of the population, and it's a population that really is not getting treated by IL-23s. It's typically being treated by Remicade, because Remicade was the only product 20 years ago that was demonstrated success in this population. So this is the first time product Tromphia has shown to differentiate in this population, similar to the way Remicade did, which we're quite familiar with. So we're really excited about that opportunity. It really can untap there. It also leads to the differentiation, why we're so excited and feel confident we're going to be over $10 billion. And the last thing I would just say is, you know, as we think about psoriatic diseases, we'll get to it, I'm sure, with icotide, but I say tides rise, and we're seeing significant growth also now in acceleration of psoriasis and psoriatic arthritis, and a lot of it is off the APEX data showing that Trump-5 is the only IL-23s that shows they inhibit structural damage, that 30% of the population in psoriasis that have underlying joint disease.

Asad Header, Analyst — Goldman Sachs

Before we get into Iketide, because that is my next question, maybe just, you know, you talked about the sub-Q. AbbVie is going to be on the market at some point in the next several months with the sub-Q version. Just, you know, how do you think from a competitive dynamic perspective things could change there?

Tom Kavanagh, Chairman

Yeah, I think we need to understand both in UC and CD if there's any differences there with dose and efficacy in, I would say, longer-term results. But, look, they're a formidable competitor. We feel very confident. We have broad access. We have significant momentum. We have a molecular differentiated product, and we're here to compete to win for patients.

Asad Header, Analyst — Goldman Sachs

All right, well, let's go right to the Icotide launch. This is obviously something that's very much in focus. It's probably one of your most in-focus new launches. And on the mid-April earnings call, you provided some really helpful early metrics on the launch. You know, I think you said 1,500 patients with prescriptions have been written, over 1,000 unique prescribers shortly after the approval. So I guess any updated thoughts on how the launch is tracking? It seems like IQVR may not be capturing all the channels right now, so any new metrics to share in terms of how things are going would be helpful.

Tom Kavanagh, Chairman

I would say some of the new metrics, we're going to have to wait for earnings call to release those, but I will share with you some qualitative and some early insights that we have in the launch. I think it's important because I do think we are, one, incredibly excited about the launch of Iketide. You heard from the earnings call, some of the early indicators. I can tell you we have roughly 4,500 prescribers now, and the data that you quoted is our hub services. So we have a fully dedicated hub services that we're able to get this information in. And quite honestly, if the patient has commercial insurance, some sort of commercial insurance is diagnosed with it and is of age, they can get the product in 24 hours. So they can get it through our hub services, and then there's samples obviously available as well. I bring this up because ease of access is very important, and that's where they're getting the trial and able to understand, you know, is this product what's right for them? And it is really the sweet spot. I could tie, you know, and we're hearing it from our customers. I've been able to engage with many of the providers at either AAD or a conference, CCD that was down in Florida just recently. And the insights, what we're hearing, intent to prescribe an awareness in just two months has jumped 20 points. So you're seeing intent to prescribe an unaided awareness similar to what you see with current market products. We're fully focused from a commercial perspective, obviously from a sales and marketing perspective. That's without even, you know, a DTC campaign. So there's still huge opportunities ahead of us once we engage the patient and create awareness there. The provider base is, you know, typically what we're seeing is some of those that are treating it in the earlier diseases. First-line systemic is where it's beautifully positioned, but advanced practitioner providers, some primary care, and I would say, you know, obviously dermatologists. And a lot of that is because, one, there's the ease of access, complete skin clearance. Safety is fundamental when they're looking to switch from, say, a topical to a systemic treatment, placebo-like AEs. And then last but not least, that became quite exciting for many of the providers, no mandatory TB testing.

Asad Header, Analyst — Goldman Sachs

When does the DTC campaign start? Okay. And what can you tell us about the patient profile? I mean, treatment naive versus existing, you know, oral tick-toos. Is there any sort of, you know, impact on the current injectable biologics, like where are the patients coming from?

Tom Kavanagh, Chairman

Yeah, I would say, roughly I would say 60-40. 60% predominantly what we call systemic naive, and about 25% of that sourcing probably from, 25% sourcing from the orals.

Asad Header, Analyst — Goldman Sachs

And I guess, how should we think about Iketide's opportunity in IBD in the context of, you know, rapidly involving market combinations, emerging orals, AbbVivax, et cetera. Like, how are you thinking about that?

Tom Kavanagh, Chairman

Yeah, so we're obviously aggressively looking to accrue the trials in both UC and Crohn's disease. Coming off our Phase II data, we feel very confident about the target, the product, as well as the dose that we're going to be delivering, and see truly being a unique opportunity for us, the first really targeted oral therapy that has the trifecta efficacy, safety, and convenience that I do believe is going to hit an untapped marketplace right now. Those that are moderate to severe that may not be receiving treatment or subtherapeutic treatment, again, similar to psoriasis is an opportunity. And in future, there's definitely combinations. I mean, we are the first ones to look at combinations in IBD with 4804. I'm sure you probably have some questions around that. But I'd say that absolutely in select populations, you know, the ultimate goal here is remission, you know, and that is truly what we need to do in IBD is really get to the highest levels of remission. And most of that will be in combinations in the future. I guess it's a wonderful product to be able to combine with because of everything I just said.

Asad Header, Analyst — Goldman Sachs

And I guess, you know, when you make the statement, and Joaquin's made the statement, that this could be one of your biggest drugs ever, you know, any high-level quantitative framing on either the math on how to get there, or is that purely based on PSO and PSA? Does it require additional indication expansion into the IBD indications?

Tom Kavanagh, Chairman

Yeah, I think our current development plan will get us there. and a lot of it is kind of I alluded to if you think about a population let's take psoriasis you have roughly 3 to 5 million patients suffering from moderate to severe psoriasis 75% of them are cycling through therapies or not on advanced systemic treatment 25% are so if you just think about the total size of the marketplace that 25% is the ones that we're competing in today you know with trophias and the likes this true untapped marketplace is that first line systemic treatment. So that just opens up, you know, a large opportunity. And you take that same mentality or approach in IBD. In IBD, they're a little bit more aggressive. They are really trying to treat and really hit that underlying disease. But I do think the systemic treatment of an IL-23, such as icotide, truly will unlock that opportunity. So sky's the limit.

Asad Header, Analyst — Goldman Sachs

And when can we expect to see the data for icotide head-to-head versus telara?

Tom Kavanagh, Chairman

It should be getting the data in this year and then reading it at an upcoming Congress.

Asad Header, Analyst — Goldman Sachs

Let's move to 4.8.4. You set me up for that. So you had the results of these recently presented duet trials. I guess they fell short in the overall treatment population, but there was a pronounced effect in the subpopulation of highly refractory patients who cycled through treatment. So how should we be thinking about this program and the size of the opportunity in the context of, you know, I think Joaquin framed this as a third blockbuster in your immunology stack on top of the dual powerhouse of Tramphia and Iketide. So maybe just, you know, with that framing, talk to us about this program a little bit.

Tom Kavanagh, Chairman

We're very excited about 4804. Really, co-antibody targeted is both IL-23 and TNF. And you mentioned the data. Like, it's really important to do this trial so that we can understand the data in the population by which it is the most effective. And this is what we found. You know, I think if you think about it, the population, let's call it refractory IBD. This is a patient population that roughly at this time, there's roughly 20% of the patients have seen two lines of therapy already if you just take the market today. So right there, it's close to a million patients of an opportunity. If you think about it, truly high unmet need, where they really need to have high endoscopic remissions or high response rates, that's patient population, high unmet need, and then the data supports really that market opportunity. And that allows us also, as you think about the marketplace, Typically, eventually, you know, longer term, I do believe it's going to be like oncology, use the best first and get the highest remission. But in these chronic diseases, I do think you're going to start with a product, see if that product works, they're going to cycle through it, and if they're not getting the treatment they want, they might move on to another one, and then probably go more aggressive. And that's where a lot of the KOLs are doing it. You know, sometimes I would say off-label. They're looking at combinations therapies already in the clinic. I think that's where 484 is beautifully positioned, Look at this co-antibody therapy in that line 2 plus in a heavily refractory population. I do think that value recognition will be there globally as well.

Asad Header, Analyst — Goldman Sachs

So let's unpack that a little bit first, just, you know, in terms of just the long-term coexistence of this compound with Trimphi and nicotide. You know, where does this live?

Tom Kavanagh, Chairman

Yeah, I think if you just think kind of how I described, like, the patient journey, patients diagnosed with IBD, CD, or UC, they're coming in, they're probably going to get, depending on when they get diagnosed, It could be IcoTide. It could be Trimfaya. If they're not getting the results they need, they might cycle through another alternative mechanism of action. And then maybe then, or not maybe, that is beautifully positioned in where 4804 will be.

Asad Header, Analyst — Goldman Sachs

Let's talk about Nipocalumab. That's another potential new product cycle that we certainly are very excited about. You've had the launch in MG. You had a priority review in Weha. You recently presented very good data in Lupus, numerous readouts in 2027. So, you know, help us frame the opportunity for this compound unfolding and from which indications you see the largest contributions.

Tom Kavanagh, Chairman

Yeah, I think, you know, Igatide, as we've highlighted before, we do believe it to be molecularly different. We do have the fastest and the deepest IgA reduction. And why I bring that up is that's why I do think it's translating into many of these other diseases that we're looking at, whether it be, as you just highlighted, warm hemolytic anemia, Sjogren's disease, lupus, MG, and then if you look at maternal-fetal, highly differentiated. It's basically from a safety perspective. So if you think about MG, we're well on the way to launch. We just received full J-code at the beginning of the year. We're seeing definitely uptakes, the fastest-growing biologic in MG. So we're well on the way there. WEHA is a unique opportunity. Nothing has been proven or approved in that population. It's roughly 7,000 patients in the U.S. It's a highly unique population, and we're quite excited about the priority review and the recognition from the agency on just the high medical need. It also shows differentiation. I do believe some of these room diseases where it's going to really unlock the potential and why we do believe it's a $5 billion plus asset. If you think about lupus, lupus, roughly 500,000 patients in the U.S., really nothing is available there. It could be the first FCRN antibody to demonstrate an effect in lupus in the data that you just saw at ULAR. It's pretty amazing. You take that as an opportunity. We have, I believe, a fast-track designation for lupus. We then look at Sjogren's disease as well, the most prevalent. If you think about that, that's breakthrough therapy designation that we have already, so the excitement is there. We do believe the data will play out. That just on top is a huge opportunity for us as we think about just in those diseases. Highly prevalent diseases of women of childbearing potential. So that's why I brought up the females or the, I would say, maternal-fetal approaches that we have in HDFM, and it just truly differentiates the product and the safety side of things as well as the efficacy across the other indications.

Asad Header, Analyst — Goldman Sachs

Okay, terrific. Looking forward to seeing that program progress. I want to move to oncology, but before we do that, I just want to take a pause and see if there are any questions on the immunology side. All right, let's keep moving.

Tom Kavanagh, Chairman

So oncology.

Asad Header, Analyst — Goldman Sachs

I guess, you know, first just starting with VibroVant, Joaquin called this out as one of the products that still remains underappreciated. You had some good data at ASCO. Recently, you know, consensus numbers still have this regimen. VibroVant from Los Clues doing about $4.4 billion in 2030, peaking at about $5 and change. So, you know, where do you see the disconnect there?

Tom Kavanagh, Chairman

Yeah, I think a couple things. I think first if we just think about lung cancer, we're still in the early phases of the launch. And in the U.S., I mean, we're literally, you know, we received approval for FAST-PRO or subcutaneous formulation at the end of last year. So we should receive permanent J-code July 1. So if you think through that from a reimbursement perspective. And as well as we've come to understand and have the data now to support. And ASCO was part of that. It was really looking at, you know, the long-term survival that we see in Exxon 20, which is really differentiated in ribavent in a population that's undertreated and really there's not much for those patients. And then in a common EGFR, we're looking at significant uptake in share growth that we're seeing already globally and then in the U.S. as well. One in four patients are seeing a ribavent and less clues in that setting. So really now we're anticipating the five-year survival next year. That will be differentiated as well, we do believe, to support where we're seeing it. But also the absolute necessity of using ribavent. I think that is actually coming across with our provider base, especially, and I'll get to it, some of these follow-on indications, really looking at changing the underlying biology of disease. And that is something that I think is differentiated. We can't just say use chemo or not. No, it's, ribavent should be essential for the treatment of EGFR non-small cell lung cancer. And it's in combination with Las Clues in the front line setting because you have to use your most effective and really look at change the course of the disease. And that's when you can look at it as a ribavent Las Clues combination in that front line setting. Now I bring up just recently we presented the data for head and neck and have submitted already and received priority review from the agency for line 2 plus for head and neck cancer. And I'll tell you, the feedback that we have from the providers especially, I mean, they have not seen anything like this as a single agent showing a 42% response rate, a third of them being complete remission. So I do believe, and if you've talked to some of them, they see it, the tumor essentially melts, you know, very quickly. So highly effective in head and neck, as well as in colorectal cancer, two high medical needs from an oncology perspective and cancer perspective. And then we have already started and are well underway to the frontline trials on both of those and are aggressively pursuing those and accruing to those. So I do believe, you know, with the totality of all that combined, $5 billion plus easily.

Asad Header, Analyst — Goldman Sachs

Let's maybe talk about Alida that had, you know, another very promising plenary session at ASCO, the discussion called the data practice changing. Congratulations on another successful trial there. So I guess what does this mean in terms of the revenue opportunity for Alida? And how do you see the ramp from here? How can, you know, J&J make the most of the opportunity given the composition of MATA expires in 2030?

Tom Kavanagh, Chairman

Yeah, so a couple of things. I think first and foremost, we'll take the Proteus data that you're highlighting aside. Currently with Erlita, we're showing double-digit growth already, and some of it is based on most recent real-world data that we have, showing that Erlita either combined to the other ARPIs showing overall survival, irrespective of which ARPI that you're comparing to. And I do think that is really resonating in the community and with the practitioners saying, all right, this is different, and I need to use Orlita. So we're seeing an uptake there in the current indications. Then you now have Proteus, which was in high-risk, localized disease, those who look into intending to receive radical prosectomy, so before and after surgery. And this is where it's shown. It was the plenary session highlighted at ASCO, the number one abstract. And they do believe this to be practice change. It's the first time in an earlier line setting. If you use Orlita 12 months before surgery and then 12 months after, you're showing a magnitude of effect of 20% risk reduction, which has not been shown to date. I do believe I'll have a halo approach across the brand overall, but also really change practice, and that's why we do these studies. And it was, you know, a lot of the feedback, it was the bell of the ball. It was great to see. It was a long time coming, and we're quite excited that we were able to demonstrate that. I don't allude to lots of exclusivity assumptions, but we do foresee there's still a lot of runway left with Herlita.

Asad Header, Analyst — Goldman Sachs

Let's move to Inlexo. This is another product that, you know, is getting a lot of attention. It's a very in-focus product launch in oncology. It was highlighted on the cell site call that was done last week. I'm not going to press you on quantitative metrics because I know the answer to that, but, you know, qualitatively give us some, you know, give us some sense of how the trajectory is going on the back of the April 1st J-code. You know, you provided some metrics on the first quarter call, but just high-level, how are things progressing in terms of the overall launch and the feedback?

Tom Kavanagh, Chairman

Yeah, very nicely. You know, just to remind everybody, launching Alexo, it truly is transformative. 82% complete remission rates. Half of those patients still out after a year on therapy in a very high-risk population, fairly niche population, high-risk, non-muscle invasive bladder cancer with carcinoma in situ. It's roughly 3,000 patients in the U.S. So if you just think about it, that smaller niche, introducing the marketplace, and the receptivity has been pretty profound. The intent to prescribe, unaided awareness, highest ever in bladder cancer. The other things I would say is there is, you know, I would say especially with the urology provider base, they're waiting for the J-code, a lot of them are. Post-J-code, you saw a 50% increase in providers utilizing it. There's almost like a 90% increase in insertions. So there is a little bit of a wait for it, and there's still a smaller niche population. We just recently received NCCN guidelines, Category 2A, for papillary disease. Papillary disease, just to remind you, we have a robust program for NLEXO, and we can get to ERDA-RIS, which is our erdifitinib, intravascular drug release system. But with NLEXO, you have SR5, which is the papillary, Sunrise 5 trial, which is the papillary, so BCG exposed, roughly 15,000 patients in that population, so much greater opportunity there. That's that NCCN guideline. So that will be spontaneous until we get the approval for Sunrise 5 or the data reach out. Then you have Sunrise 3, which is a much broader population. This is the first time anybody has ever gone head-to-head against BCG in bladder cancer. And this is a population around 40,000 to 50,000. So those are two-step chains. I think there is the disconnect with the street with regards to the greater opportunity for an Alexa, it would be in 5 billion plus. And then you add in Erdoriz, which is Erdifitinib, in this drug release system. and that is looking at it in non-muscle invasive bladder cancer for intermediate risk with the FGFR expression. So roughly 70% of the population has FGFR. So targeted using FGFR, so I can tell you there's significant opportunities ahead there and co-positioned quite nicely that the totality of that is going to be well above $5 billion plus.

Asad Header, Analyst — Goldman Sachs

So I guess it sounds like, Tom, as we think about how quickly this product can sail, these additional population expansions from the Sunrise trials that you mentioned, But also the Moonrise trials, maybe give us a quick update on that.

Tom Kavanagh, Chairman

Yeah, so they're fully accrued, and we're just awaiting the results on two of them, I think. But I do believe that's the intermediate risk population, two of them, different types of intermediate risk, and then one that goes a little bit over into the high-risk population, but targeted to FGFR alterations. So that's where you'll see the differentiation. So ERDA-RIS is also every three months. So it's four times a year. So a little less frequent insertions.

Asad Header, Analyst — Goldman Sachs

Okay. All right, let's talk about Tecvaili. You had some data at ASCO just showing continued support to use as early second line. You know, maybe just zooming out from a big-picture perspective, can you just frame how J&J is thinking about the broader treatment paradigm in multiple myeloma and specifically the coexistence of your BCMA targeting agents, Carvicti and Tecvaili?

Tom Kavanagh, Chairman

Yeah. I think, you know, we remain committed to search for the cure. And our development program, our investment will always be put around that. And I do think the patients will ultimately win with regards to that. I think first and foremost is what you're seeing, and even with the Tecveli data, Darzelex is absolutely the foundational treatment and backbone therapy throughout the continuum, from the very beginning all the way through the end. It's one of the best combination immunotherapies on the marketplace of multiple myeloma. And what you saw in the combination with Tecveli, truly unprecedented results. I mean, I've been in myeloma for quite some time. I've never seen anything with a hazard ratio of 0.17 and the flatlining of the Kaplan-Meier curve. And that's what we're hearing back for the feedback from our providers. What is also said is that data is in earlier lines of BCMA. Absolutely need to bring BCMA earlier in the treatment, whether it be Carvicti or Tecveli. And that is the mindset. Right now where the setting is, line two is available. So you do the quad in line one. You might have transplant or non-transplant. And then if they're progressing, then either based on patient preference, or site of care, availability, things like that, you either go to a CARVICTI or a TECVAILI-DARA. And that sometimes becomes that, you know, I would say that shared decision-making with the patient and the provider. But right then and there, you have two incredible choices. And then post that, you'll see at EHA, we have the TAL-DARA data that will be presented. It's a plenary session at EHA. So that's TAL-V in combination with DARA-2-Mib, Darzilex. So that allows us then, you have that position, bring in BCMA up for it, hit the best immunotherapy, therapy, if once they progress or if they progress, then you can go on to additional therapies. And that's our whole commitment. In each line of therapy, we want to be along the step of the way.

Asad Header, Analyst — Goldman Sachs

What about your tri-specific program? Maybe give us an update on, you know, how that's going and then also your involvement in VivoCarty for the topic.

Tom Kavanagh, Chairman

Yes, yes. So it's tri-specific or mandomeg. We're very excited about. Different molecule engineered by our scientists. I'll tell you, you know, it's one of the benefits of being a myeloma so long with the team. You know, we have the insights, we have the science, we have the expertise and the external engagement to help shape this. You know, you guys have followed us as well. You know all along, step-up dosing, what's required for co-administration with either Tech Valley or Talve, need some education, and I would say practice. What we understood also from a community to get expanded and really get the patient population, is how do you make a community-friendly targeted treatment that can be administered in the community by the community with less AEs? And that's what we did when we engineered Romantimig. And also, as we think about either antigen expression or release, the availability of having this tri-specific targeting both GPRC5D and BCMA could prevent even further relapses and really looking at that cure-to-tent. It's a different CD3 binder also, so CRS is looking a little different, as well as the GPRC toxicities we're being able to dial those down. So really taking it and saying, all right, we've built very incredible combinations, but how do we improve it even more? And that's the ability that we're able to do with Romantamig. So we're going to be looking aggressively in line 2+, and bringing that in front line as well. You mentioned, so obviously in Viva Cartese, we obviously have some programs in-house, and we have a partner of products with Colonia, but we haven't disclosed any of the targets. So I'll just leave it at that. But we're quite excited about following that science as well, and we're looking across all modalities, anywhere where we can look for a cure in cancer to become the number one oncology company.

Asad Header, Analyst — Goldman Sachs

Okay, looking forward to that. I'm going to take another pause there. Any questions on oncology before we pivot? Tom, let's pivot to Milvexian. You've got this AF trial coming up from the Librexia program at the end of the year. You guys are running that trial along with your partners, Bristol Myers. Just maybe give us your latest update and framing of your level of confidence on the success of that trial, and is it still expected at the end of the year, I believe?

Tom Kavanagh, Chairman

It's an event-driven time, but we're anticipating around that time. It could be before or after, but it's on an event-driven timeline. But I would tell you, we're very excited, and we do believe Movaxin will be another $5 billion-plus asset for us, and working with our partner, BMS, on this one, I do believe there's a significant unmet need still when you think about claudication and Are they being not treated or undertreated? So I do believe AFib, obviously a significant opportunity ahead of us. We do believe the molecule and the dose we got right. We had modeled it appropriately. We've taken the data from the phase two and really helped us inform on the phase three. It's where we feel confident.

Asad Header, Analyst — Goldman Sachs

Really looking at similar efficacy to, say, an Eliquis or a Pixivan, but superior safety profile.

Tom Kavanagh, Chairman

And if you can reduce the risk of bleeding, we do believe that's going to untap a significant opportunity, both in AFib and, obviously, secondary stroke, which actually, from a proof of concept, have already been established.

Asad Header, Analyst — Goldman Sachs

On the bleeding side, what's the expected magnitude of bleeding superiority that you think would be needed to drive a meaningful displacement of aliquos?

Tom Kavanagh, Chairman

I think from the research that we have from our providers, 30% to 40% risk reduction is absolutely significant.

Asad Header, Analyst — Goldman Sachs

And how should we think about addressable subpopulations, you know, elderly, renal, et cetera?

Tom Kavanagh, Chairman

Yeah, I think when we get the data, we're going to need to identify that and see if there's, you know, enrichment strategies or subpopulations that might benefit versus others.

Asad Header, Analyst — Goldman Sachs

Okay. And then maybe just on launch and access and pricing, anything you can share in terms of just, you know, color on how you're thinking about those metrics, the commercial opportunity, and really in a world of generic Apixaban.

Tom Kavanagh, Chairman

Yeah, so I'd say, obviously, we're going to be working close partnership with BMS. We won't disclose our strategies, but I would tell you, If you think about both ourselves, Zeralto, as well as our partner, Eloquist, when those products came into the marketplace, you were dealing with generic warfarin. And we found a significant unmet need and were able to identify the value and ensure, you know, access and success. Okay. Terrific.

Asad Header, Analyst — Goldman Sachs

Let's move to neuroscience. You know, this is an area that Joaquin has talked about, an ambition to be number one in that segment. Do you feel that J&J's position to achieve that with the current portfolio?

Tom Kavanagh, Chairman

Absolutely. I think what helped us reinforce that was the acquisition for caplida, intracellular, and I do think it's not only for caplida, actually intracellular in totality. I think caplida, obviously, we're well underway of the biggest indication for adjunctive major depressive disorder. We're seeing significant uptake already, new to brand shares to pass regalty. We're well underway to look to become the number one atypical antipsychotic for branded. we just recently have data that tube studies network meta-analysis that shows capillitis the most effective treatment across all branded atypical antipsychotics so you have capillitis the momentum that we have there we also got 1284 through the acquisition we're looking at general anxiety disorder as well as agitation with dementia it's another compound it's a derogated capillitis essentially so it's unique And then coming back to our current portfolio, Spravato, we're seeing significant growth, over 45% growth, still very little penetration in treatment-resistant depression, significant unmet need, opened up treatment centers and having utilization productivity in treatment centers, so we still see significant runway with Spravato. our Envega baseline business, as well as what I would say is Celterexin that we are looking to have readout this year, looking at major depressive disorder with those with underlying insomnia. So I think in totality of that, we are and will be the number one neuropsychiatry company. And then we're continuing to look as we think about neurodegeneration. Obviously, we have Imave, but we continue to look there in other spaces.

Asad Header, Analyst — Goldman Sachs

On the Erexin II agonist that you mentioned, that you said is going to have phase three data later this year, I believe. What level set us on what we should be looking for there?

Tom Kavanagh, Chairman

Positive trial. What would define a positive trial? Significant improvement in Madras, of course. And then some of the sub-endpoints that we're looking at with regards to insomnia.

Asad Header, Analyst — Goldman Sachs

Questions? Maybe just in the last couple of minutes, Tom, we've covered a lot across the enterprise, across your portfolio. What haven't we talked about? Anything else you want us to be double-clicking on?

Tom Kavanagh, Chairman

Yeah, I think a couple I would say, you touched on Erlita, but I would say our prostate cancer pipeline, we just recently did the acquisition of HALDA at the end of last year with RIPTAC. We have a portfolio of products. I like to compare it now to our myeloma portfolio and how we're looking at myeloma. I think we have the ability, we have the science and the expertise. We have the only KLK CD3 redirector targeting KLK. We have the ADC KLK. We have COSTEM, so there will be data that's going to be presented at ESMO that's looking at our KLK CD3 plus COSTEM in prostate cancer. So we have the ability to really target prostate cancer across all lines of therapy in different modalities, really looking at curative intent. And I do believe what you're hearing, like the KLK 2 data, is pretty remarkable. I mean, think about it. It fits right nicely with the urology practice, oncology practice. you don't necessarily have the step-up dosing and things that you have from bispecifics, that if you can bring COSTEM into there and really show an even greater efficacy and forget about it when you bring in RIPTAC, we do believe that's really going to transform the treatment of prostate cancer. So I do believe, you know, as we think about our prostate cancer portfolio, we have significant opportunities to really help to look to curative intent there. And then that RIPTAC technology is not just prostate cancer, it's a platform that we can look across all other tumor types as well.

Asad Header, Analyst — Goldman Sachs

And at the end of this year, You guys are going to be hosting an enterprise business review day after a few years. Maybe in the last 30 seconds, give us a little bit of a preview on what we should be looking for from your enterprise.

Tom Kavanagh, Chairman

Significant growth. Well, I think that's a great place to leave it.

Asad Header, Analyst — Goldman Sachs

Thank you very much for being with us. We covered a lot. Appreciate it.