Johnson & Johnson (JNJ) Earnings Call Transcript & Summary

We're just right about at time, so let's get started. Tail end of day 3 of our conference, saving the best for last. Very welcome to Tom Cavanaugh, group -- Company Group Chairman, North American Innovative Medicines for Johnson & Johnson. Tom, welcome. It's great to have you with us.

Thank you. Pleased to be here.

So we have about 35 minutes and a lot of topics to cover. And maybe just to kick off, just a high-level question, just to sort of tick the box because we've been asking all of our companies just on the external environment in the context of all of this uncertainty on drug pricing and MFN. Any -- just any updates on sort of like the vibe in DC, and what you're hearing, and what might -- how that might emerge in the range of outcomes that you're thinking through for the Innovative Medicines business?

Yes, I would say as probably with many of our peers, there's ongoing discussions with the administration. There's -- obviously, we take it very serious. Not literal all the time. At times, we want to make sure for understanding what ultimately we want to have. And I think we all share the same goals and that is really to reduce health care costs for patients in America. And we are front and center, wanting to work with the administration, And there's areas that I would say organizationally and from an industry perspective, I think we could have a substantial impact. And some of it, we're encouraged by the administration recognizes some of the middleman, focused on the PBM reform, 340B reform, areas where we can bring the cost and drive it down to the patient so they actually see at the pharmacy counter. So those are areas I think we want to continue to work with the administration on on fixing, and that's where I think we stand today. But those -- the discussions are going weekly, as you probably know.

Yes, certainly. All right. Well, maybe we can just dive right in, then, again, sort of staying big picture. Tom, talk us through the strategy in the Innovative Medicines business, unpack for us some of the drivers behind this growth trajectory framing of 5% to 7% growth? And what are some of the major catalysts that we should be watching?

Yes, yes, and I'll be happy to. I think as you probably remember, in 2023, we had our enterprise business review at the end of the year. And we laid out a strategy in innovative medicine really to focus on 3 pillars: immunology, oncology and neuroscience with some other select disease area strongholds. And we also said we were going to hit $57 billion by 2025. I will say, as you look back, we did that in 2024 and are on track to continue that momentum into 2025, as you saw in the first quarter. I think if we stick with the strategy, as we think about in oncology, substantial growth in oncology still on the backbone of many of our assets, whether it be DARZALEX, ERLEADA, some of the new entrants that we're launching, RYBREVANT FASPRO and RYBREVANT LAZCLUZE is one area that I would say, of significant growth opportunity for us. We've declared that a $5 billion-plus asset, our combination asset. And we're well on track to achieve that. I think based on -- if you just talk about that product, or the combination of those products, really substantial impact in eGFR, non-small cell lung cancer, really displacing the standard of care. As you think about the overall survival advantage that we highlighted at ELCC really showing at least a 1-year advantage of survival over osimertinib. That is an area of truly transformation. There has not been an innovation over 10 years in this area that has demonstrated that. We developed that product and that combination fairly quickly, and we learned along the way. We learned that we also need to look at some of the AE management. So we did additional trials there to mitigate some of the AEs associated with the combination and have released that data as well. So if you think about survival advantage, the AE mitigation as well as some of the other areas in which we can expand into, we definitely see substantial opportunity in growth. Immunology as well and neuroscience, just with the acquisition of Intra-Cellular that we did not know at the EBR, this gives more confidence to be able to deliver that 5% to 7% growth. And in Q1, you'd look at it, we had 4.2% operational growth. That's despite LOE with STELARA, basically about 810 basis points of headwinds from an LOE perspective. If we take that aside and move that aside, you're looking at underlying operational growth of roughly 12%. So significant momentum, 11 products growing double digits. So we're very confident in delivering that 5% to 7% growth.

Perfect, perfect framing. Let's start double clicking on some of the things you said there, you said a lot. So I want to start with immunology, just maybe just to just STELARA, I guess it's been a few months now since the biosimilar launches. How is that erosion curve playing out? And I'd be interested in hearing about what you're seeing in terms of switches to TREMFYA, if any at all, as a compound compresses?

Absolutely, absolutely. Look, I would say we were quite pleased and proud of the progress that we did and the impact STELARA has had on many patients worldwide. We reached peak year sales of roughly $11 billion. And as you highlighted, we lose an exclusivity of STELARA, biosimilar entrants have taken place within the first quarter of this year, many of them in February. So you didn't really see a significant impact. You'll probably see a little bit of acceleration. But I would say, we still believe year 2 of HUMIRA is a good proxy as we think about the erosion curves for STELARA with obviously a little bit of the Part D on top of that from an impact perspective. If we think about STELARA though in TREMFYA now is what we really believe TREMFYA is going to overcome that LOE and really displace STELARA. Not only have we proven head-to-head superiority in psoriasis, that was communicated years ago. But most recently, we demonstrated within the CD trials for our Galaxy that STELARA was inferior, TREMFYA was superior to STELARA in many endoscopic remission endpoints. So that's one area that we do believe it's going to displace. We're quite excited about the launch of TREMFYA in IBD most recently. We launched first in ulcerative colitis. And with that launch, we do believe we have one of the best in disease assets. based on the efficacy, one of the highest rates of endoscopic remission as well as the sustained remission that you see there. And what we saw is significant uptake. It's quite impressive to see, you talked about STELARA, but IL-23 is the fastest-growing class in ulcerative colitis. And now within the first 6 months, we've seen that we're -- TREMFYA has actually taken about 50% of that new share from an induction perspective. So we're off to the -- I would say, the races with the UC indication. And then now just recently, we got the approval in the U.S. for CD. That's the head-to-head data that we showed against STELARA. And with CD Also, the one thing that was different, that is really a game changer we're hearing from the providers is the subcutaneous formulation for induction, the only IL-23 that has a subcutaneous formulation and ease in administration and use in a simple procedure at home, it's really a game changer, and we're hearing that from a lot of the early reception from many of the providers. So STELARA, I mentioned had $11 million -- $11 billion, sorry, peak year sales. 75% of it was IBD. So if you just think about TREMFYA, we delivered about $4 billion in net trade sales off of the psoriatic indications. Now with IBD, there's no reason why you don't see it to exceed what we saw with STELARA.

And that launch, like you said, it certainly does seem to be paring ahead. I mean you beat first quarter consensus by about 6%. And like you said, Crohn's just got approval at the end of the first quarter. So I'd just be curious and just high-level framing on what you're seeing on the ground, particularly as it relates to receptivity between UC and Crohn's disease?

Absolutely. I think we do market research, obviously, and we have the voice of the customer. I think some of the things that we think about from leading indicators intent to prescribe, unaided awareness, how we're getting in the marketplace. And we are really hitting all the parameters and all the metrics, exceeding what we see from a competition standpoint, the other IL-23s in the marketplace on UC, and we're already seeing that on a CD perspective. As I highlighted some of the early feedback, whether it be the subcutaneous formulation and administration for CD. We're anxiously awaiting the approval of that for UC, which we do believe will have another inflection point and see a rapid uptake. One of the other things that we did was invest heavily into the fulfillment. So how can patients be helped along the process to get the product post prescription. And we invested heavily there. And I would tell you the fulfillment journey in some of our patient services, many of our customers are saying it's best in the industry now. And that's something we're quite proud of. Now that we have the ability to deliver the product at home, if a patient has commercial insurance as an adult, they can basically receive this treatment within 24 hours. So these are some of the things that I would say are leading indicators, but also receptivity from the customer that they see truly differentiating.

That's perfect. Very helpful. Let's just maybe stay within that and talk a little bit about the oral IL-23, Icotrokinra.

It's a test.

It's all of the test. And I'm going to have to just keep practicing and saying it over and over.

Icotrokinra.

Thank you. How about Ico? Going to be filing soon for plaque psoriasis. And I believe this is the first time that an oral pill is going to have the efficacy and tolerability of a biologic and you have framed a tremendous amount of enthusiasm for this opportunity, which we share to some extent. So maybe just high level, start framing the opportunity for us? And then also talk about how you see this fitting in with the injectables like TREMFYA, and why wouldn't there be -- why wouldn't it potentially cannibalize some of the TREMFYA opportunity along its launch and ramp?

Yes. So we are incredibly excited by Icotokinra, our first targeted oral peptide, targeting IL-23 pathway. One, we obviously released the data in psoriasis against placebo, truly looking at the perfect combination that you see our perfect product, if you think about just complete skin clearance, safety and the convenience of once-a-day oral administration. As you think about it, we have about 125 million patients suffering from autoimmune diseases. Just in IBD and psoriatic diseases, roughly 5 million patients should be on an advanced therapy or a biologic that are not on. So there's significant opportunity from just a market expansion. You talk about positioning, there is this group of patients that may not want to go on to a biologic but need to receive treatment, whether it be in psoriasis or in inflammatory bowel disease. So if you think about the market opportunity, that's there. And then within the space where those that want a treatment, 75% of patients believe they would like to switch to an oral therapy that are already on a biologic. So you have some that may be on a biologic, they may want to go on to an oral therapy. We don't believe it just to be a convenience play though. We do believe the safety profile, and we soon will be releasing head-to-head data against deucra later this year. We do believe this will be the first-line systemic treatment for patients with autoimmune diseases.

And then would you -- I know you haven't commented it, but just sort of high-level framing in the context of where we started MFN, drug pricing. Just any early thoughts on how you would think about sort of the pricing strategy for this compound?

Yes. We don't talk about future pricing strategies for any of our investigational drugs. I would just tell you, we know the marketplace very well. We know the innovation that it's bringing. We're going to continue down our pricing principles of how we deliver that to the market.

Let's segue to multiple myeloma, a little bit more complicated in some than immunology. I think there's some debates on the margin on a few different things that I want to talk to you about. Number one, just on DARZALEX, I guess, that has been the subject of some debate around IRA price negotiation inclusion. Just maybe talk about J&J's position regarding when it could be potentially up for negotiation? And sort of what gives you the confidence that if it's not up for negotiation by the -- what gives you that confidence?

Yes, yes. So I think first and foremost, DARZALEX, what a remarkable product.

Absolutely.

And such a significant innovation that has taken place within multiple myeloma. We're quite proud of the progress we've made. We're not satisfied until we reach cure across all patients from a J&J perspective. We've delivered now half of the 11 products that are approved in multiple myeloma. So we know the space very well. Getting to your point with regards to IRA or the draft guidance for interpretation and under comment for you right now, looking at fixed dose combinations or different subcutaneous formulations, we do believe based on the current draft guidance and our interpretation of that, our stance remains the same. We do not foresee to have an impact from negotiations any sooner than 2034 because DARZALEX is an innovative fixed-dose combination that delivers clinically meaningful benefits to patients versus the IV, a significant reduction in IRRs and AEs associated with the subcutaneous versus the IV formulation. So based even on the draft guidance, we feel very confident that we will be up for negotiation prior to 2034.

So that's truly clinically different what you're saying in terms of different moieties.

Yes.

And when does that patent expire? When is it...

We were looking for -- we -- based on the current guidance of IRA, we wouldn't look for negotiations until 2034.

2034. Negotiations in 2034. Okay. Let's talk about anything else on DARZALEX that you'd want to.

Look, I would tell you, DARZALEX had significant growth year-over-year. As you know, quarter 1, roughly 24%, 23% or 24% growth. We still see significant growth in the future. I think -- if you think about it, we're awaiting in the U.S., the additional quad indication for the transplant ineligible population. And we believe DARZALEX is the foundational treatment in multiple myeloma. So there's significant opportunity in many markets to continue to grow share in the front line. Duration of response or duration of therapy also growing as you go into earlier lines, but also being the foundational backbone of all investigational drugs, even our own that are coming into marketplace are in combination with DARZALEX in so that is a standard of care. So we see significant opportunities ahead of us still with DARZALEX. And then obviously, our portfolio of products in multiple myeloma.

Perfect segue into CARVYKTI then. Continues to throw some pretty remarkable data on the efficacy side. I mean coming out of ASCO these CARTITUDE-1 data that you saw, the 5-year data that was suggestive of a cure in -- potential cure in a subset of patients, it's really remarkable efficacy. But within that, there's also the subtext of this lingering debate with respect to Parkinsonism and neurotox and whether this could actually impact J&J's position in an increasingly crowded landscape where everyone is battling to go into earlier lines of treatment. So just speak to the pushes and pulls on the growth trajectory for CARVYKTI in this backdrop.

Absolutely. You touched on it already upfront. I mean we are quite impressed as well as the community out there and hopefully, patients, the opportunity or hope for cure. In the CARTITUDE-1 data that was released at ASCO and then actually the most downloaded publication in JCO, showing that really 1/3 of the patients or 33% of the patients are disease-free after 5 years. And those are patients that have blown through 5 lines of therapy. So truly transformative. You take the CARTITUDE-1 data and we went in CARTITUDE-4 and released that data and showed a substantial survival advantage over standard of care in lines 1 through 4, so prior line therapy. If you take that, that's really where you got to start with. Overall survival is key and cure even key. So that's a relative benefit risk ratio that you need to look at. Right there, you're saying overall survival advantage. So we do believe CARVYKTI is going to be a mainstay, especially as you go in earlier lines of therapy. In fact, half of our utilization is in earlier lines now as we think about the utilization. So there's already adoption and receptivity. You touched on potential AEs, neurotoxicity. Yes, we did see some of that in the later lines. As we're thinking about and seeing in the earlier line setting, it's less than 1% as you go into earlier lines. So that relative risk-benefit ratio is already leaning towards benefit. And we learned a lot through the development as with other products in our portfolio, as with any other company in oncology, you start with a single-arm trial and you go to Phase III trials, you start to characterize the profile of the product and understand from a safety standpoint, how you can mitigate that. Many of the sites have already looked at that, bridging therapies, we understand a little bit better and educate around the proper bridging therapies as well as looking at ALC count. So there is mitigation factors to even delay the neurotox further if it is. So we feel very confident in our ability to deliver CARVYKTI and being a $5 billion-plus asset as well. And the totality of our multiple myeloma profile, we feel very confident as we said at EBR of $25 billion by 2030.

Very clear. Thank you for that. Let's stay within oncology, let's talk about bladder cancer and the TAR-200 program. Your team has made some comments about how you want to make bladder cancer the next multiple myeloma, so sort of a good segue into maybe unpacking this opportunity. And that's a big statement in terms of like what we just discussed on DARZALEX and even CARVYKTI. And when I look at the landscape thus far, bladder cancer is still sort of commercially unproven in some respects. So walk us through your thinking on how you're getting to these sort of numbers that are getting framed?

Absolutely. I think first and foremost, bladder cancer still is a high unmet medical need. I mean, roughly 1 million patients globally, whether it be early diagnosis to recurrent disease. So significant unmet need still exists in the marketplace. We have the ability to deliver 2 products. TAR-200 is the first product that I'll get to. TAR-210 is another one. TAR-200 has gemcitabine into the intravascular drug delivery system and erdafitinib is the product for TAR-210. I'll talk about the difference of those 2 products. But if you think TAR-200 right now is under review with the FDA in the real-time oncology review, which we did receive priority review for that, and we do anticipate that approval later this fall. And that is in high-risk non-muscle invasive BCG unresponsive bladder cancer. So a pocket of non-muscle invasive bladder cancer. And then the data that we shared at AUA, it showed over an 82% CR rate where half those patients are disease-free after a year. So truly differentiated, true innovation. And this is in a device or a drug delivery system that it's a simple procedure in a practice, in a urology practice. It was made by a urologist for urologists. So locally administered AEs, minimal AEs when it's locally administered and every 3 weeks, go to an administration to have it removed and then inserted back in. So substantial opportunity ahead of us. Easy -- the supply chain as well as you think about storage, easily supplied within the urology office. So we do see that to be transformative. And as we go into further indications or expansion in the marketplace, going head-to-head against BCG as well as we're looking at in muscle invasive bladder cancer. So across all of bladder cancer, we do believe it to be a $5 billion-plus opportunity. TAR-210 is now targeted towards FGFR. So FGFR has a higher expression in earlier-stage bladder cancer, 40% to 60% expression. So you now have a targeted approach in a similar device or a delivery system with similar AE profile. So again, you have 2 combinations, 2 products that you can look at the targeted approach and then another depending on the patient population. So significant opportunity as you think about a portfolio play.

And how are you thinking about the -- like the competition from CG Oncology? Just maybe just talk to us about the competitive landscape, the emerging competitive landscape.

Yes, yes. We do believe that we have what we believe to be a best-in-disease product. Let's just talk TAR-210. With TAR-210, not only in the indication that we're initially seeking, but also as we think about in the future indications. One of the things that we are going head-to-head against and nobody else has is BCG. So BCG is an old therapy, a toxic therapy as well, hard to administer. If you talk to patients, they believe it's like a tiger clawing at your bladder. We're going head-to-head to displace BCG. Many of the others are combining with BCG. So if you just think from a patient perspective, here, you now are able to remove a therapy that they do not want to have administered to them and the complexity of administration is even more so. To go into a urology practice and have inserted in your bladder TAR-200 and deliver the CR rates with the durability of CR rates is truly going to be differentiating. So we do believe in the future, we'll be looking at TAR-200.

And Tom, you mentioned timelines. I still get the sense that there's some investor debate about whether this actually will get approved this year. And you said you seem pretty confident by the fall, we'll see approval. I know you have priority review, like you mentioned, I believe you also have a brand name now that's been thrown out, so which is obviously very encouraging. So just maybe zone in on the -- what's giving you confidence that you'll get timeline approval by the fall?

Yes. I think you touched on it. I think we obviously are in frequent discussions with the FDA through our real-time oncology review. We have the appropriate data that they're looking for, and they have provided us priority review. So we anticipate fall approval.

And how should we be just high level thinking about the early launch out of the gates?

Yes. I think we know the space very well. We've been in urology for prostate cancer. We know the buy-and-bill practice as well in the U.S. We do believe we're going to be able to quickly penetrate the marketplace. And then obviously, with many other buy-and-bill products, J-code comes a little bit later. And then you'll see an inflection with the J-code as well.

Okay. All right. Let's talk about RYBREVANT LAZCLUZE. You talked about this in your opening remarks already. I do want to drill in a little bit further and magnify and double-click on some of the comments that you made. So consensus estimates for '27, '28 are about $2 billion. And I think you guys have said it could be twice that in that time frame. So $4 billion-ish by 2028. In the first quarter, you did $140 million. So the ramp that, that sort of opportunity is assuming is pretty steep. So help us understand how you're getting to those numbers?

Yes. I think if you just focus on EGFR, non-small cell lung cancer. First and foremost, we're approved frontline, second line, exon 20, so 3 indications. We currently in the U.S., ex U.S., we don't have -- we have the subcu formulation available. In the U.S., we're anticipating that later this fall as well. So currently, in the U.S., as you think about the IV formulation, so not only do we have those 3 indications, we also have, and I highlighted earlier, an overall survival advantage versus osimertinib. So that is critical. I mean survival trumps everything. When we were doing market research with many of our physicians, they said what would be substantially different and differentiated would be a 6-month advantage. What we have highlighted and already communicated at least a 12-month projected advantage over OC. So right there, you have the opportunities now, truly high efficacy. Patients on average live 3 years in this disease setting, you can give them another year. That's truly substantial. We also developed this product pretty quickly, and we had to understand the safety profile of it as well, the administration, the burdens of the administration. So if you think through that, we also did 2 other trials, what we call COCOON and SKIPPirr. COCOON data was released that we were able through a simple prophylactic regimen to reduce dermatologic AEs by 50%. SKIPPirr as well reduced IRRs substantially. Now we also did the PALOMA trial, which showed subcu versus IV, significant reduction in IRRs, which we were anticipating, but we weren't anticipating was this overall survival advantage and durability of response that we saw in the trial. So if you just think about EGFR non-small cell lung cancer, you have a frontline overall survival advantage with a subcutaneous formulation that demonstrates that response and that ability to have impact on patients. And then if they're already on a treatment, they're able to get RYBREVANT in combination with chemotherapy. So you have immediate play on all lines of therapy. We are also doing a trial. So we didn't just rest there. We're doing a trial called COPERNICUS. So this is a trial in the frontline setting. Our MARIPOSA-1 data, the frontline data was with IV. Now you're bringing in the subcutaneous formulation with all the benefits that we just demonstrated with PALOMA with Q4-week dosing. So ensuring that the patient as well as the provider have a seamless experience. So we do believe that's going to be the regimen of choice as we've learned a lot about the compound. The other thing that I'd like to highlight that we've shared data already, and we're going to share a little data later this year. For RYBREVANT, we also have colorectal cancer, significant unmet need, a high number of patients -- innovation has not happened in colorectal for some time now. Head and neck is another area that we're going to release some data. So not only are we looking at EGFR non-small cell lung cancer, we also have colorectal and head and neck, 2 huge tumor types with significant unmet medical need.

Yes. Very clear. Maybe just sticking with lung, I do want to ask you just on your views on the PD-1 measured bispecifics, just given all of the activity and excitement about this modality as a potential disruptor in large oncology indications. So what is J&J's appetite to participate in this opportunity?

Yes. We obviously consult with our R&D colleagues who are following the space quite closely as well. And some of this is drug development. I touched on the magnitude of benefit that RYBREVANT LAZCLUZE has provided patients with overall survival advantage. What you saw in some of these trials that you just highlighted was you saw a PFS advantage, but also not a survival advantage. So we need to really understand the biology of the disease and why that's the case. As you know, you're going to really need survival data to really make an impact. So we continue to monitor it. We do believe we might have some other immunotherapies in our pipeline that we're more excited about and want to invest in and many of our R&D colleagues.

Colleagues?

Someone we released, I would say, maybe not in lung cancer. In prostate cancer, we had at ASCO. We had our KLK2 CD3 redirector in prostate cancer or metastatic castrate-resistant prostate cancer, really showing early signs of efficacy, but also a safety profile really for the community urologists to be -- oncologists to be able to administer. So we do believe that's an exciting one, and we have some other ones that will be disclosed, I'm sure, at other times.

Keep an eye on it. Let's talk about nipocalimab. Just maybe just color on how is that launch going?

It's early. It's early. We're definitely excited finally to bring IMAAVY to the marketplace, nipocalimab. It's the first and only FcRn blocker for a broad population of both pediatric as well as adult and ACR positive anti-MuSK positive patients. So it's early in myasthenia gravis, but we do believe the profile of the product, the safety profile as well as the dosing and efficacy is truly differentiated. We're already hearing early signals, I would say, anecdotal from many of our customers that are excited about it. Some of them are switching from previous FcRn blockers and some are just naive to it. So that's our first entrance into autoantibody-driven diseases. Then obviously, we look at rare autoimmune diseases as well, autoantibody diseases. maternal fetal, which we do believe is truly differentiated as well as rheumatic diseases such as Sjögren's and lupus. And many of these diseases, if you think about the safety profile of the compound where we're studying it, if you just think maternal fetal, so female of child-bearing potential, really demonstrating truly a safe product in these patient populations, there's a high prevalence of females in Sjögren's, lupus and some of these other autoantibody-driven diseases. So truly having a differentiated safety profile and a sustained efficacy. And that's one of the things through our dosing and knowing the biology is what we're showing, it's going to be differentiated.

What do you think is going to lead to the inflection in that?

Yes. I think, obviously, how we're going to launch in myasthenia gravis, but then the secondary indications that I would say are going to -- that are untapped, that it's going to be a major inflection point.

Okay. Let's maybe move to neuroscience, SPRAVATO. That's also early-ish, but it's been a very exciting launch and certainly doing better than expectations. So give us sort of updating framing of that opportunity.

Yes. I would say taking a step back in neuroscience, it's one of our 3 core pillars for development from end-to-end as we think about our resources and investment. We're focused on neuropsychiatry and neurodegeneration. In neuropsychiatry, we have SPRAVATO on the marketplace today, truly innovative for treatment-resistant depression. The only one that got priority review for both the adjunctive as well as the monotherapy that we just received approval this year for truly showing a differentiated profile. I mean you have complete significant reduction of depression symptoms within 24 hours as well as the safety AEs resolving within 24 hours. So something that's truly differentiated to any of the antipsychotics in the marketplace. We have seen rapid advancements in acceleration of treatment centers. So where they can administer the product, it has to be administered under the observations of a health care provider. But we're seeing -- as you've seen highlighted, it's already a blockbuster. We foresee this to be a $1 billion to $5 billion asset, really penetrating into earlier lines. Right now, many of the usage for SPRAVATO is in like fifth and sixth line. We think if you can bring it up into earlier line, maybe third, fourth, you're going to see a significant inflection point and continued growth and momentum. And that's where our strategy is to do just that. I also have to highlight our recent acquisition for Intra-Cellular.

I was going to go there but please go ahead.

You think about neuroscience. We do think -- if you think about multiple myeloma, we now have -- we're just excited to welcome Intra-Cellular to the organization. It's truly what we do believe is the best-in-disease product for depression. CAPLYTA already approved for bipolar I and II, the only one approved for bipolar I and II depression as well as schizophrenia. And we have a pending sNDA with the FDA for AMDD. And if you think about the data for AMDD, it's truly a best-in-the-disease asset. The consistency between 2 trials and the reduction of the MADRS scores, 2x what you see on the marketplace today. So -- and with a profile that can be delivered, no necessarily change in weight gain, EPS and some of the safety signals and baggage, I would say, that you see with some of the other antipsychotics. Absolutely believe this to be a $5 billion-plus asset. So if you think about line of therapy, you have CAPLYTA, earlier lines of major depressive disorder and then for treatment-resistant depression, you have SPRAVATO. In the pipeline, we have seltorexant and [indiscernible] .

How is the integration of the ITCI acquisition going?

It's going really well. Yes. Yes. I would tell you, the more and more we look behind the curtain, the more excited we are. I have to highlight also the pipeline, 1284 that we acquired from them, also a highly differentiated asset in GAD and Alzheimer's disease. So we have a portfolio of products that we're able to play with. And at the end of the day, it's truly going to be important because significant unmet need in depression and neuropsychiatry.

We have a couple of minutes left, and there's 2 more things I want to talk about. Number one, is there anything else in terms of pipeline opportunities, Tom, that we have not touched on?

Wow, I mean, you could talk -- I talked about neurodegeneration. We have their tau programs for Alzheimer's disease. And then in oncology, I touched a little bit on prostate cancer. I will tell you, we have a pipeline of other products. In myeloma, we just released data, our trispecific antibody. So I would say as we're leaders in multiple myeloma, I do believe we're also leaders in bispecific antibodies. We've learned a lot about the chemistry and the biology. The engineering of our R&D organization and early discovery, I mean, really, we believe might have made a best-in-class asset with this trispecific. Early data is out there, but truly can be transformative. So we are leaders. We're going to shoot for that cure, and we're just excited and reaffirm our commitment to be able to deliver well above the 5% to 7% that we've said.

Okay. And I guess maybe just to wrap then in the last couple of minutes, where do you, from where you sit, Tom, see opportunity to build out the portfolio within innovative medicines? And I guess what I'm asking is that where would you -- where do you think you're still subscale and there could be an opportunity to lean in?

Yes. I would say they're still within the 3 therapeutic areas. We didn't touch on it. We've done some BD deals as we think about atopic dermatitis, another area in autoimmune diseases, maybe some other cancers within oncology. As we highlighted the EBR, we believe we're going to achieve $50 billion in oncology alone, non-risk adjusted. We could do well beyond that by our expertise as well as our commercialization.

Okay. All right. Well, any questions from the audience? Nick?

[indiscernible]

Yes. We continue, as you've seen, continue to see growth across both assets, OPSUMIT, UPTRAVI as well as the recently launched OPSYNVI. And we are anxiously awaiting one of the other studies that we have ongoing. It's our Maci-75 program that's comparing Maci-75 to Maci-75 in PAH. We anticipate a readout that eventually soon. And if that hits, that's going to be another growth opportunity for us from a PAH perspective. Outside of that, we'll continue to explore any other BD opportunities, but we want to maintain laser focus on the 3 core areas that we've highlighted.

All right. Well, we're just about at time. Tom, thank you very much for that discussion. It was very helpful. It was great to have you here, and I think that's a good place to wrap.

Glad to be here, Asad. Thank you.

Thank you.