All right. We are just about time, so we can get started with our next session. My name is Asad Haider. I'm the Co-head of the Healthcare Business Unit here at Goldman Sachs and the U.S. Pharma Analyst. I'm very excited to be joined by Tom Cavanaugh, Company Group Chairman of North American Innovative Medicine over at J&J. Tom, thank you for being with us.
Thank you, Asad, for having me again.
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. 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.
Oh, absolutely. Look, first and foremost, as we said last year and over the last year, STELARA was a thing of the past. We're going to grow through the loss of exclusivity of STELARA, something that many companies have not been able to do, their biggest asset, and really look at that 5%- 7% compound annual growth rate over the next five years. 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 you exclude STELARA, it's 17% growth operationally, and in the U.S., 22%. We're really excited about the momentum that we have coming into 2026. It was described as last year as a catapult year, but this year we've said 2026 is going to be better than 2025, and 2017 is going to be better than 2026. We're well on the way to do just that. I think first and foremost, we had 10 products over double-digits growth in Q1, and some exciting product launches, which I know we'll get into. I'll maybe leave it to you to ask some questions, and we can go from there.
Well, let's go right into some of the exciting-
Right.
...product launches, starting with TREMFYA. It grew 64% in Q1 with leadership in new patient starts in IBD. We look at weekly scripts, the momentum seems to be continuing. 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?
Yes. First and foremost, with TREMFYA, it's the only dual-acting IL-23, so hits 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. We are seeing that. 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 growing class in IBD, both in UC and CD. I would say it's barely penetrated, so it's about 20%-25% penetration. 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, we are now what we call the induction share leader in IBD with TREMFYA, we're just about one year into full launch with both CD and UC. I can tell you the excitement is really profound, the team is executing across all measures. I would say we're seeing the differentiation from our customers and from the uptake. A lot of it is that 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. Just recently coming out of DDW, we're really excited about this new data with the FUZION trial. It's basically perianal fistulizing Crohn's disease.
Represents around 25% of the population, 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. This is the first time product TREMFYA has shown to differentiate in this population, similar to the way REMICADE did, which we're quite familiar with. Also leads to the differentiation why we're so excited and feel confident we're going to be over $10 billion.
The last thing I would just say is, as we think about psoriatic diseases, we'll get to it, I'm sure, with ICOTYDE, as the tides rise, we're seeing significant growth also now and acceleration of psoriasis and psoriatic arthritis. A lot of it is off the APEX data that's showing that TREMFYA is the only IL-23 that shows to inhibit structural damage. That 30% of the population in psoriasis that have underlying joint disease.
Before we get into ICOTYDE, because that is my next question, 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. How do you think from a competitive dynamic perspective things could change there?
Yeah, I think we need to understand both in UC and CD, if there's any differences there with dose and efficacy and, I would say, longer-term results. Look, they're a formidable competitor. We feel very confident. We have broad access. We have significant momentum. We have a molecular differentiated product, we're here to compete to win for patients.
Fantastic. All right. Well, let's go right to the ICOTYDE launch. This is obviously something that's very much in focus. It's probably one of your most in-focus new launches. On the mid-April earnings call, you provided some really helpful early metrics on the launch. I think you said 1,500 patients with prescriptions have been written, over 1,000 unique prescribers shortly after the approval. I guess any updated thoughts on how the launch is tracking? It seems like IQVIA may not be capturing all the channels right now. Any new metrics to share in terms of how things are going would be helpful.
I would say some of the new metrics, we're going to have to wait for earnings call to release those.
Okay.
I will share-
I tried.
...with you some qualitative and some early insights that we have in the launch. I think it's important because I do think we're, one, incredibly excited about the launch of ICOTYDE. You heard from the earnings call some of the early indicators. I can tell you we have roughly 4,500 prescribers now. The data that you quoted is our hub services. We have a fully dedicated hub services that we're able to get this information in. 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.
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, is this product what's right for them. It is really the sweet spot. We're hearing it from our customers. I've been able to engage with many of the providers at either an AAD or a conference, CCD, that was down in Florida just recently. The insights, what we're hearing, intent to prescribe and awareness in just two months has jumped 20 points.
You're seeing intent to prescribe and 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 a DTC campaign. There's still huge opportunities ahead of us once we engage the patient and create awareness there. The provider base is, 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, obviously dermatologists. 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. Last but not least, that became quite exciting for many of the providers, no mandatory TB testing.
When does the DTC campaign start?
Soon.
Okay. What can you tell us about the patient profile? Treatment naive versus existing oral JAKs. Is there any impact on the current injectable biologics? Where are the patients coming from?
I say roughly I would say 60/40.
Okay.
60% predominantly what we call systemic naive, and about 25% sourcing from the orals.
I guess, how should we think about ICOTYDE's opportunity in IBD in the context of rapidly evolving market combinations, emerging orals, atacicept, et c? How are you thinking about that?
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 for those that are moderate to severe that may not be receiving treatment or subtherapeutic treatment. Again, similar to psoriasis as an opportunity. In future, there's definitely combinations. We are the first ones to look at combinations in IBD with J&J-4804. I'm sure you probably have some questions around that.
Next question.
I'd say that absolutely in select populations, the ultimate goal here is remission. That is truly what we need to do in IBD, is really get to the highest levels of remission. Most of that will be in combinations in the future. ICOTYDE's a wonderful product to be able to combine with because of everything I just said.
I guess, when you make the statement, and Joaquin's made the statement that this could be one of your biggest drugs ever, 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?
Yeah. I think our current development plan will get us there.
Okay.
A lot of it is, kind of I alluded to, if you think about a population, let's take psoriasis. You have roughly 3 million- 5 million patients suffering from moderate to severe psoriasis. 75% of them are cycling through therapies or are not on advanced systemic treatment. 25% are. If you just think about the total size of the marketplace, that 25% is the ones that we're competing in today, with TREMFYA and the likes.
This true untapped marketplace is that first-line systemic treatment. That just opens up a large opportunity. 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. I do think the systemic treatment of an IL-23, such as ICOTYDE, truly will unlock that opportunity. Sky's the limit.
When can we expect to see the data for ICOTYDE head-to-head versus STELARA?
It should be getting the data in this year and then reading out at an upcoming congress.
Okay. Let's move to J&J-4804. You set me up for that. 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've cycled through treatments. How should we be thinking about this program and the size of the opportunity in the context of, I think Joaquin's framed this as a third blockbuster in your immunology stack on top of the dual powerhouse of TREMFYA and ICOTYDE. Maybe just, with that framing, talk to us about this program a little bit.
No, absolutely. We're very excited about J&J-4804. Really a co-antibody targeted to both IL-23 and TNF. You mentioned the data, it's really important to do this trial so that we can understand the data in the populations by which it is the most effective. This is what we found. 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. Right there, it's close to 1 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 patient population, high unmet need. The data supports really that market opportunity. That allows us to also, as you think about the marketplace. Typically, eventually, longer term, I do believe it's going to be like oncology, use the best first and get the highest remission. 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. If they're not getting the treatment they want, they might move on to another one. Then probably go more aggressive. That's where a lot of the KOLs are doing it. Sometimes I would say off-label, they're looking at combinations therapies already in the clinic. I think that's where JNJ-4804 is beautifully positioned. Looking at this co-antibody therapy in that line 2+ in a heavily refractory population. I do think that value recognition will be there globally as well.
Let's unpack that a little bit. First, just in terms of just the long-term coexistence of this compound with TREMFYA and ICOTYDE . Where does this live?
I think if you just think kind of how I described 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, could be ICOTYDE , it could be TREMFYA. If they're not getting the results they need, they might cycle to another alternative mechanism of action. Then maybe. Or not maybe, that is beautifully positioned then where JNJ-4804 will be.
All right, let's talk about nipocalimab. 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 wAIHA, you recently presented very good data in lupus, numerous readouts in 2027. Help us frame the opportunity for this compound unfolding and from which indications you see the largest contributions.
Yeah, I think, ICOTYDE , as we've highlighted before, we do believe it to be molecularly different. We do have the fastest and the deepest IgG, IgA reduction. 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, wAIHA, Sjögren's disease, lupus, MG, if you look at maternal fetal, highly differentiated. It's basically from a safety perspective. 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. We're well on the way there. wAIHA 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, we're quite excited about the priority review and the recognition from the agency on just the high medical need, also shows differentiation. I do believe, really some of these rheum diseases where it's going to really unlock the potential and why we do believe it's a $5 billion+ asset.
If you think about lupus, roughly 500,000 patients in the U.S. Really nothing is available there. It could be the first FcRn antibody to show demonstrated an effect in lupus in the data that you just saw at EULAR, is pretty amazing. You take that as an opportunity. I believe we have fast track designation for lupus. We look at Sjögren's disease as well, the most prevalent. If you think about that's breakthrough therapy designation that we have already, the excitement is there.
We do believe the data will play out, that's just untaps a huge opportunity for us as we think about just in those diseases. Highly prevalent diseases of women of childbearing potential. That's why I brought up the females or the, I would say, maternal fetal approaches that we have in HDFN, it just truly differentiates the product and the safety side of things as well as the efficacy, across the other indications.
Okay, terrific. Looking forward to seeing that program progress. I want to move to oncology. 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. Oncology. I guess, first just starting with RYBREVANT. Joaquin called this out as one of the products that still remains underappreciated. You had some good data at ASCO recently. Consensus numbers still have this regimen, RYBREVANT from LAZCLUZE doing about $4.4 billion in 2030, peaking at about $5 billion and change. Where do you see the disconnect there?
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. In the U.S., we received approval for FASPRO, our subcutaneous formulation, at the end of last year. We should receive permanent J-code July 1. If you think through that from a reimbursement perspective. As well as we've come to understand and have the data now to support, and ASCO was part of that. I was really looking at the long-term survival that we see in exon 20, which really differentiate in RYBREVANT in a population that's undertreated and really there's not much for those patients.
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 RYBREVANT LAZCLUZE in that setting. 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. Also the absolute necessity of using RYBREVANT. 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. That is something that I think is differentiated. We can't just say use chemo or not.
No, RYBREVANT should be essential for the treatment of EGFR non-small cell lung cancer. It's in combination with LAZCLUZE in the frontline setting because you have to use your most effective. Really look at change the course of the disease. That's when you can look at it as a RYBREVANT LAZCLUZE combination in that frontline setting. I bring up just recently, we presented the data for head and neck. Have submitted already and received priority review from the agency for line 2+ for head and neck cancer.
I'll tell you the feedback that we had from the providers especially, they have not seen anything like this as a single agent showing a 42% response rate, 1/3 of them being complete remission. I do believe, and if you've talked to some of them, they see it, the tumor essentially melts very quickly. Highly effective in head and neck as well as in colorectal cancer. Two high unmet medical needs from an oncology perspective and a cancer perspective. 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. I do believe, with the totality of all that combined, $5 billion+ easily.
Okay. Let's maybe talk about ERLEADA that had another very promising plenary session at ASCO, the discussant called the data practice-changing. Congratulations on another successful trial there. I guess, what does this mean in terms of the revenue opportunity for ERLEADA? How do you see the ramp from here? How can J&J make the most of the opportunity given the composition of Madix buys in 2030?
Yeah. A couple things. I think first and foremost, we'll take the PROTEUS data that you're highlighting aside. Currently with ERLEADA, we're showing double-digit growth already, and some of it is based on most recent real-world data that we have, showing that ERLEADA either combined to the other ARPIs, showing overall survival irrespective of which ARPI that you're comparing to. 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 ERLEADA."
We're seeing an uptake there in the current indications. You now have PROTEUS, which was in high-risk, localized disease, those who are looking to intending to receive radical prostatectomy, so before and after surgery. This is where it's shown, it was the plenary session highlighted at ASCO, the number one abstract. They do believe this to be practice change. It's the first time in an earlier-line setting if you use ERLEADA 12 months before surgery and then 12 months after, you're showing a magnitude of effect of a 20% risk reduction, which has not been shown to date.
I do believe that'll have a halo approach across the brand overall, but also really change practice, and that's why we do these studies. A lot of the feedback, it was the belle 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 want to allude to loss of exclusivity assumptions, but we do foresee there's still a lot of runway left with ERLEADA.
Let's move to INLEXZO. This is another product that is getting a lot of attention. It's a very in-focus product launch in oncology. It was highlighted on the sell-side call that was done last week. I'm not going to press you on quantitative metrics because I know the answer to that, but qualitatively, give us a sense of how the trajectory is going on the back of the April 1st J-code. 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?
Very nicely. Just to remind everybody, launching INLEXZO, 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. It's a fairly niche population, high-risk non-muscle invasive bladder cancer with carcinoma in situ. It's roughly 3,000 patients in the U.S. If you just think about it, that smaller niche introduced into 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, especially with the urology provider base, they were waiting for the J-code, a lot of them were. Post J-code, you saw a 50% increase in providers utilizing it. There's almost like a 90% increase in insertions.
Yep.
There was a little bit of a wait for it, and it'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 INLEXZO, and we can get to Erda-iDRS, which is our erdafitinib intravesical drug release system. With INLEXZO, you have SR-5, 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. That will be spontaneous until we get the approval for SunRISe-5 or the data reads out. You have SunRISe-3, which is a much broader population.
This is the first time anybody's ever gone head-to-head against BCG in bladder cancer. This is a population around 40,000- 50,000. Those are two-step change that I think there is the disconnect with the Street with regards to the greater opportunity for INLEXZO being $5 billion+. You add in Erda-iDRS, which is erdafitinib in this drug release system. That is looking at it in non-muscle invasive bladder cancer for intermediate risk with the FGFR expression. Roughly 70% of the population has FGFR, targeted using FGFR. 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+.
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- Also the MoonRISe trials, maybe give us a quick update on that.
Yeah. They're fully accrued, we're just awaiting the results on two of them, I think. I do believe that 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, targeted to FGFR alterations, that's where you'll see the differentiation. Erda-iDRS is also every three months, it's four times a year.
Okay.
A little less frequent insertions.
Okay. All right. Let's talk about TECVAYLI. You had some data at ASCO just showing continued support to use as early second line. 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, CARVYKTI and TECVAYLI?
Yeah. I think we remain committed to search for the cure. Our development program, our investment, will all be put around that. 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 TECVAYLI data, DARZALEX 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 in multiple myeloma. What you saw in the combination with TECVAYLI, truly unprecedented results. I've been in myeloma for quite some time. I've never seen anything with a hazard ratio of 0.17 and the flat-lining of the Kaplan-Meier curve. That's what we're hearing back from 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 CARVYKTI or TECVAYLI. That is the mindset. Right now, where the setting is, line two is available. You do the quad in line one, you might have transplant or non-transplant, then if they're progressing, you either, based on patient preference or site of care, availability, things like that, you either go to a CARVYKTI or a TECVAYLI/DARA. That sometimes becomes that, I would say, that shared decision-making with the patient and the provider. Right then and there, you have two incredible choices.
Then post that, you'll see at EHA, we have the TAL/DARA data that will be presented at the plenary session at EHA. That's TALVEY in combination with daratumumab, so DARZALEX. That allows us then, you have that position to bring in BCMA up front, hit the best immunotherapy. If once they progress or if they progress, then you can go on to additional therapies. That's our whole commitment. In each line of therapy, we want to be along a step of the way.
What about your tri-specific program? Maybe give us an update on how that's going, and then also your involvement in vivo CAR T. It's been a topic.
Yes. Tri-specific ramantamig, we're very excited about. Different molecule, engineered by our scientists. I'll tell you, it's one of the benefits of being in myeloma so long with the team. We have the insights, we have the science, and we have the expertise and the external engagement to help shape this. You guys have followed us as well. You know all along, step-up dosing, what's required for co-administration with either TECVAYLI or TALVEY, needs some education and I would say practice. What we understood also from a community to get expanded and really get the patient population, how do you make a community-friendly targeted treatment that can be administered in the community by the community with less AEs? That's what we did when we engineered ramantamig.
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. Really looking at that cure to 10. It's a different CD3 binder also, CRS is looking a little different, as well as the GPRC toxicities. We're being able to dial those down. Really taking it and saying, all right, we've built very incredible combinations, how do we improve even more so? That's the ability that we're able to do with ramantamig. We're going to be looking aggressively in line 2+ and bringing that in the front line as well.
Okay.
You mentioned.
Oh, in vivo.
Obviously-
Yes.
...in vivo CAR Ts, we obviously have some programs in-house, and we have a partner product with Kelonia, but we haven't disclosed any of the targets. I'll just leave it at that. 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.
Okay. Looking forward to that. I'm going to take another pause there. Any questions on oncology before we pivot? Okay. Tom, let's pivot to milvexian. You've got this AFib trial coming up from the milvexian program at the end of the year. You guys are running that trial along with your partners, Bristol Myers. Maybe give us your latest update and framing of your level of confidence on the success of that trial, is it still expected at the end of the year, I believe? Yeah.
It's an event-driven time, anticipating around that time.
Okay.
It could be before or after, it's on an event-driven timeline. I would tell you, we're very excited, and we do believe milvexian will be another $5 billion+ asset for us. In working with our partner BMS on this one, I do believe there's a significant unmet need still when you think about claudication and either being not treated or undertreated. 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 II and really helped us inform on the phase III. It's where we feel confident. Really looking at similar efficacy to, say, an ELIQUIS or apixaban, superior safety profile. 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.
On the bleeding side, what's the expected magnitude of bleeding superiority that you think would be needed to drive a meaningful displacement of ELIQUIS?
I think from the research that we have from our providers, 30%-40% risk reduction is absolutely significant.
How should we think about addressable subpopulations, elderly, renal, et c?
I think when we get the data, we're going to need to identify that and see if there's enrichment strategies or subpopulations that might benefit versus others.
Okay. Then maybe just on launch and access and pricing, anything you can share in terms of just color on how you're thinking about those metrics, the commercial opportunity, and really in the world of generic apixaban?
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, XARELTO, as well as our partner ELIQUIS, when those products came into the marketplace, you were dealing with generic warfarin. We found a significant unmet need, and we're able to identify the value and ensure access and success.
Okay. Terrific. Let's move to neuroscience. This is an area that Joaquin has talked about an ambition to be number one in that segment. Do you feel that J&J is positioned to achieve that with the current portfolio?
Absolutely. I think what's helped us reinforce that was the acquisition for CAPLYTA, Intra-Cellular. I do think not only for CAPLYTA, actually Intra-Cellular in totality. CAPLYTA, obviously, we're well underway of the biggest indication for adjunctive major depressive disorder. We're seeing significant uptake already. New-to-brand shares surpass REXULTI. We're well on our way to look to become the number one atypical antipsychotic for branded.
We just recently have data that two studies, network meta-analysis that shows CAPLYTA is the most effective treatment across all branded atypical antipsychotics. You have CAPLYTA, the momentum that we have there. We also got ITI-1284 through the acquisition. We're looking at generalized anxiety disorder as well as agitation with dementia.
ITI-1284 is?
It's another compound. It's a derivative CAPLYTA, essentially.
Okay.
It's unique. 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, opening up treatment centers and having utilization productivity at treatment centers. We still see significant runway with SPRAVATO.
Our INVEGA baseline business, as well as what I would say is seltorexant that we are looking to have read out this year, looking at major depressive disorder with those with underlying insomnia. I think in totality of that, we are and will be the number one neuropsychiatry company. We're going to continue to look as we think about neurodegeneration. Obviously, we have [posdinemab], but we continue to look there in other spaces.
On the orexin 2 agonist that you mentioned. You said it's going to have phase III data later this year, I believe.
Yes.
What level set us on what we should be looking for there?
A positive trial.
What would define a positive trial?
Significant improvement in MADRS, of course, and in some of the sub-endpoints that we're looking at with regards to insomnia.
Okay. Questions? All right. 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?
Yeah. I think a couple I would say. You touched on ERLEADA-
Okay.
...I would say our prostate cancer pipeline. We just recently did the acquisition of Halda Therapeutics 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 CoStim. There'll be data that's going to be presented at ESMO that's looking at our KLK CD3 plus CoStim in prostate cancer.
We have the ability to really target prostate cancer across all lines of therapy in different modalities, really looking at curative intent. I do believe what you're hearing, like the KLK2 data, is pretty remarkable. 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 CoStim into there and really showing 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. I do believe, as we think about our prostate cancer portfolio, we have significant opportunities to really help with the curative intent there. That RIPTAC technology is not just prostate cancer, it's a platform that we can look across all other tumor types as well.
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.
Significant growth.
Okay. Well, I think that's a great place to leave it. Thank you very much.
Thank you.
We covered a lot. Appreciate it.