Immunovant, Inc. (IMVT) Q1 2027 Earnings Report, Transcript and Summary

Good day, and thank you for standing by. Welcome to Roivant's First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead.

Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt.

Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a time before the storm moment for us. And so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory. But nonetheless, a lot of great progress in the business. And certainly, we're expecting a Genpact second half, as I'll get to in a moment. So I'll be relatively brief in my remarks, and then we'll go to Q&A. I want to start on Slide 4. This is a slide we took from our own prior deck. This is from the Investor Day that we did in December of last year, and this was a list of our priorities for the year. And we're sitting here a little bit more than halfway through the year. So just wanted to highlight that it's gone well for us, but we feel really good about the setup. And so on Slide 5, looking across the list here, we've got brexpiprazole expected to launch by the end of September. Obviously, we got priority review and our PDUFA date, as you said, is this quarter. We had great data from 1402 and DCRA study that we presented on our last quarterly call. Probably the most notable update for today in the top center of this slide is that we've now enrolled patients in the Phase III study in cutaneous sarcoidosis for brexpiprazole, which follows on the positive results that we had in our Phase II data, which I think we announced on our first quarterly call of this year, earlier in the calendar year. We've now received the initial payment from Moderna in the settlement and that -- the sort of second part of that, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case. And finally, earlier this year, we added LPP as a fourth brexpiprazole indication. And as I'll remind people later today, that study is continuing to enroll really well. As I mentioned at the top of the call here on Slide 6, I'll just say this is a quiet quarter, and this is a quiet day. I don't know exactly how the following statement could be true, but I think it is. The next 6 to 12 months are, in many ways, busier than the prior 6 to 12 months for us. And so we just have an enormous amount coming up, starting, as I mentioned, with the upcoming potential brexpiprazole launch in DM, which should happen imminently assuming everything goes as we hope and expect it will with FDA. We've got top line data in brexpiprazole from the NIU study, an indication that could easily be as large as dermatomyositis. That data is coming in the second half of this year. We also have top line data coming shortly in the second half from mostly, the Phase III study in PH-ILD. I know that's being closely watched, and we're looking forward to getting that data and presenting it. We will provide updates -- further updates on the DroTRA program at Immunovant in the second half of this year, including hopefully a download on a conversation we hope to have with FDA about that program as well as the results the second part of the study and a little bit more about our plans going forward. And then finally, probably the smallest of these, we're expecting top line data from the POC study in CLE also in the second half of this year and looking forward to finding out what we've got there when that comes in as well. So just a jampacked second half and even more coming in 2027 with the GRA data and beyond. So just a lot in the I'll just hit a couple of highlights in terms of the pipeline updates in a little more detail here before we get to Q&A. Starting on Slide 8 with a reminder because it's been a few months since we've talked about it. The initiation of the cutaneous sarcoidosis Phase III study is a pretty exciting event. It's a little bit ahead of schedule in terms of what we've been able to do here. And this is a disease that we're just privileged to be able to work in here. It's a high morbidity, very difficult disease with high urgency to treat. You can see on Slide 8, some of the photos we've shared before, but these are patients who are really can have very few treatment options. On Slide 9, as a reminder of the data that we generated in our Phase II study, we have set for ourselves a goal of a sort of 5-point benefit on the CSAMI scale for clinical meaningfulness. And in the study on the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo. So just a huge benefit to those patients in the Phase II study and really excited to carry that forward into the pivotal program. As a reminder on Slide 10, we think this is a pretty decent sized indication given high unmet need, probably about 40,000 patients in the U.S. and reasonable overlap with some other organ systems, including topical sarcoidosis or eye sarcoidosis where that overlaps with NIU that is one of the types of NIU that we're studying as well as pulmonary sarcoidosis, which is a big potential indication as well and where we hope to be able to treat some of those patients via either their ocular sarcoidosis or CS. The Phase III study that we've now begun, the design is laid out on Slide 11. I know there were some questions after the Phase II about what exactly this study would look like. It is designed to take all of the learnings from the Phase II study that was successful. It is a 16-week study with the primary endpoint of CSAMI greater than equal to 50% response rate. It's 140-patient study across about 70 sites, 3 to 2 randomized with patients either on 45 milligrams of brexpiprazole or placebo and with a mandatory -- sorry, mandatory steroid taper going from week 2 to week 8 down to 0, which is consistent with -- roughly consistent with what we did in the Phase II and generally consistent with what we think is appropriate for patients in this indication. So that study, as I said, has already begun enrolling patients, and we expect top line data in 2028, which just adds to the list of registrational -- potential registrational indications for brexpiprazole coming up. I'll reiterate on Slide 12, the other ongoing registrational program is the brexpiprazole study in lien RS LPP that we announced earlier this year. That study is enrolling, I'd say, extremely well. There's a lot of enthusiasm from physicians and patients for that, speaks to the high unmet need in the indication, speaks to the quality of the work being done by Ben and the Biovant team and looking forward to sharing more about that as soon as we've got it. So that's also move along nicely. Look, finally, and I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it, hopefully, with a potential approval and beyond. Obviously, one of the major events in the near term here is the launch -- potential launch of brexpiprazole in dermatomyositis. Obviously, I think we're in a phenomenal position here in terms of what we've got in terms of what we hope to be able to do, starting with the quality of our clinical data, which, as you know, from the multiple times we've talked about it from the publications, including a New England Journal and so on, just phenomenal data, static across all 10 endpoints big clinical benefit, a lot of enthusiasm from the doc community. This is a really tough disease, a large addressable population, most of them on sort of polypharmacy, trying a lot of different things. And frankly, most of them still is satisfied with the available treatments. So we feel like we have an opportunity to do something big and different for this patient population. Our team has been out spending a lot of time with the physician, the patient communities on overall education. And I think the enthusiasm for a new therapy is coming out loud and clear, including with all the academic presentations that have been done and so on. Commercial launches, there's not much to say today other than that it's on track. We're ready to launch on time, having received priority review. The sort of commercial and patient support teams are built out, trained, ready to deploy. We feel really great about the hires we've made there, really great about the organization we've built there. We think we're doing this in a way that is both capitalizing on all the learnings from successful launches at other companies in recent years and doing it in a Roivant way. There's nobody in the world that will be more excited to see oversee this than the team we've got at Roivant with Ben and Daniel and others. And I think we're going to be fully ready. Everything is on schedule. So we'll have much more to say about that with the potential approval and after, but looking forward to it. I'll say one more thing about the commercial franchise overall of brexpiprazole on Slide 14. We get a lot of enthusiastic questions from investors around pace of launch. And we've been pretty consistent that our answer to that question is sort of slow and steady is what we're looking to build there. And I think there's a bunch of reasons for that. Obviously, some of them are DM is a new indication and no one's launched a novel therapy basically ever or at least a targeted therapy basically ever. And so it's just hard to know exactly what work will need to be done to get everyone comfortable and excited on drug, although I think we're fully prepared. But also, to me, it's because brexpiprazole is a lot more than just dermatomyositis. And to me, what we're really doing here is not just trying to make that launch as fast as possible, we're trying to lay the groundwork for the overall opportunity, which goes beyond DM into first NIU and then CS and LPP with the data coming thereafter. And I think as you think about that layering, to me, it's much less about what week 1 or month 1 or quarter 1 look like and much more about making sure that the foundation around access, the foundation around patient support, the foundation around the institutional activities, the foundation around our communication with the scientific and physician community and our communication with patients are all set up to deliver the maximum opportunity for brexpiprazole across all of these indications. And so I think slow and steady isn't just about sort of guidance. Slow and steady is about the approach that we're taking with the program to make sure we have maximum reach across everything that we're doing there, including indications that we're excited about beyond the ones we've already announced. So a lot to come, as I said, on track for that launch. You all hear the same thing we do, which is a ton of enthusiasm from patients and physician community for new options in all of these indications and looking forward to sharing more when we know about it. But our guidance is going to continue to be slow and steady because that's what we think we're building. Final business update here is we got the upfront payment in the settlement with Moderna, that $950 million has come in, $770-ish million of it to Genevant and the rest to Arbutus. So that's done. will be progress in terms of return of capital, et cetera, of that by our business and so on. The '498 sort of appellate ruling is that, that process is ongoing in the Federal Circuit. That would be another $1.3 billion if we got a favorable outcome there. And then we continue to advance our litigation against Pfizer and BioNTech. We filed 3 international lawsuits, notably in Canada and the UPC in July, so just last month and continue to progress that case as fast as we can. Obviously, not all in our control, but equally enthusiastic about the potential there in terms of what we could get. I'll wrap up just with our usual financial update on Slide 17. Look, I think overall, most importantly, we are spending in areas that we're excited to be spending. We're excited about all of our R&D programs, about $200 million of R&D expense for the quarter. of just under $100 million of non-GAAP adjusted G&A or $166 million of GAAP G&A expense and cash just under $4 billion, and that's before the receipt of the $772 million. Notably, pretty significant share repurchase activity, about $200 million in the quarter, a bit more than that when you include March. Obviously, what we did there was we accelerated our share repurchase program upon the announcement of the Moderna settlement so that we could get those shares in and the shares that -- and remember, the shares we bought back kind of the first round of this, the $1.5 billion that we have bought back sort of up through mid last year, we bought back at around $10 a share. I think the average price at which we've been able to buy back stock since we kicked off the second round of this in earnest in March has been in the high 20s. So feeling good overall about retiring those shares and getting that capital back to shareholders. I'm going to continue doing that according to our authorizations for now. And all of it ahead of on Slide 19, a really rich catalyst calendar ahead with a lot coming. So looking forward to all of that. with just an incredibly busy stretch ahead. On Slide 20, again, a little bit incredulous for the people around -- rents who are doing all of this work, incredible people to do this work. But by the end of calendar 2028, we'll have had hopefully 3 or more commercial launches, 9 study readouts, 4-plus NDA or BLA filings and a number of proof-of-concept studies, a ton coming up in the near term. So with that, I'm going to wrap up my prepared remarks for the day, and I will hand it back over to the operator for Q&A in just a moment. Thank you again for listening this morning and looking forward to taking your questions. Operator, over to you.

[Operator Instructions] Our first question comes from the line of Brian Chen of JPMorgan.

Good morning. Thanks for taking our question. Maybe just thinking through the DM launch map, can you give us a quick sense of what metrics we could be receiving way out of the gate to help us better track the initial launch? Secondly, on PH-ILD, as we think about the baseline characteristics here in PHocus, it seems that more patients are on sotatercept. We're curious if there's any implication in terms of the fibrosis versus erythema ratio in the populations, and then further down the line, whether there's any implication towards the bar for success for both six-minute walk and also PVR. Thank you.

Yes. Perfect. Thanks. I appreciate both questions. I think I've gotten fond of saying as I've watched other companies with commercial launches is that you all don't serve our guidance, which isn't quite fair. But look, I think other than sort of a slow and steady launch and obviously, the sort of top line metrics will be clearly visible in our financials each quarter. I don't know that we're going to provide a ton of detail in the early days. I think it's important for us mostly to spend our time focused on understanding those dynamics ourselves, getting out, talking to patients, talking to physicians, doing the work we need to do. We'll give a little more color on what that's going to look like on a call with potential approvals, and then we'll start to flesh out the package that we share with each successive quarter. But I don't have a lot to say right now about metrics. I'll say, I think typical with these launches, I'm not sure a ton is going to be visible in the early days, just given how the commercial apparatus is set up practical purposes, but we'll provide more guidance on that as it gets closer end here. On PH-ILD, I guess, first of all, we've obviously been watching, for example, the Treprostinil data in IPF and trying to understand a little bit better what's been going on with these PH-ILD patients in treatment of PH-ILD for fibrosis and for lung disease. It's been a view of ours for a while that one of the things to look out for in treatment of PH-ILD with vasodilators is emphysema. And so the study was designed with care around the amount of emphysema allowed in the study overall, and that was an important part of the guiding philosophy of the study to make sure that we could serve the patient population broadly, but also maximizing the potential benefit of the therapy. So that was considered from the beginning. So those are, I think, things we're keeping an eye on. I know there is a local cohort that believes that Treprostinil has antifibrotic benefit. Look, I think our view is if you treat PH-ILD patients well for their pulmonary hypertension, you may well deliver a benefit overall on their lung disease. And I think our view is probably that vasodilation is driving a lot of the activity there. But we also have some evidence from nonclinical models of antifibrotic activity for. Overall, on 6-minute walk and PVR, I'm sure I'll get version of this question more today. Look, I think it's consistent with what we said before. We're hoping to see a clear signal on PVR. We expect if the drug is all active, we will. We don't expect to see very much with clarity on 6-minute walk. The study is not powered for 6-minute walk. It would be nice to see some separation, but I don't think that's essential for our sort of go/no-go decision from here. And we'll just -- we'll know what we've got once we get a closer look at it, including the full balance of that data.

Next question comes from the line of Dave Risinger from Leerink Partners.

So I have three questions, but rather than rattling them all off right now, maybe if it's okay, I'll go one by one. So first, on Mosely, you commented just now on 6-minute walk distance. But if you were to run a large trial, what type of 6-minute walk distance would you be hoping for, i.e., what would be relevant to the clinicians and to the patients? So that's my first question.

Yes. Thanks, Dave. Look, I think obviously, we'll have a slightly better answer to these questions overall once we have a sense of what we saw in Phase II. The truth is the PH-ILD patients are really sick. There are not a lot of options for these patients. And as we saw in Group 1 in PAH, when you have more treatment options, first of all, patients go on multiple options, multiple lines of therapy. And second of all, most importantly, like the actual -- not from a clinical trial perspective, but from a real-world evidence perspective, like survival and mortality rates go down as new classes of drugs are introduced in PAH over time. And I think it's like less about a number on 6-minute walk and more about having an approvable therapy. Remember, these are patients that are trying to walk to the car. They're trying to walk to the bathroom. They're trying to like live their daily lives. So I don't know that I think it's like correct scientifically to describe a specific numerical bar that matters versus just being able to get a new therapy. And some of that's, frankly, because 6-minute walk in clinical settings is an art that is complicated and noisy and like a little bit difficult to translate into daily lives, whereas if these drugs really effectively vasodilate and improve lung function and improve PVR, I think you wind up seeing a lot of benefit for these patients. So I don't know that we're going to articulate or have a specific numerical bar versus a successful study. Obviously, we will be judged, especially by the investor community based on competitor data, but I don't think we even need to be per se better than any other mechanism in order to have a big benefit to patients.

Great. That's very helpful. And then regarding the forthcoming Brepocitinib DM launch, could you discuss the cadence of formulary reviews for rare disease drugs? I ask because for mass market drugs, P&T committees often wait until 6 months after launch before putting drugs on formulary.

Yes. Thanks. Look, I don't have a ton to say about that right now other than we're having all of the normal engagement with the payer community that you'd expect us to have at this stage. And also, and I think this is a critical point about all of these launches. we are super focused on making sure that patients -- the physicians who want to write this drug and patients who want to get on this drug are going to have access. I think that's going to be really important for our engagement with the community for access generally. I think in terms of like literal formulary, it's probably like not so different. It's not like there's a separate committee for different kinds of diseases, but there's lots of medical acceptance procedures and other things that you can do to get patients covered. And we have a whole team of people built out of Priovance dedicated to making sure whether the formulary -- the formulary work has happened yet, whether the PSC committee has happened yet is not something that our patients and physicians have to spend a lot of time thinking about as they're deciding how to use the drug.

Excellent. That's really helpful context. And then finally, beyond the list of programs on Slide 19, could you remind us about pipeline and product opportunities for your portfolio, including specific products that you could announce initiation of new studies for over the next year or so?

I think every single one of the programs that the world is aware of in our pipeline as well as potentially ones that the world does not yet aware of in our pipeline. In all of those cases, we could announce new trials, new indications in the next year. I think every one of those are eligible and all of our molecules could be put into indications beyond the ones we've talked about. And I think it's fair to say, in each case, we have specific ideas of indications we're excited about. We've done active work and are, in fact, like preparing to initiate programs to that degree, depending on how busy those teams are today versus next month or the month after, but real progress. So I think the answer is -- we are actively working on that, but all of our products are, as you call them, pipeline of products and that we're excited to share more indications as we start those studies.

Our next question comes from the line of Samantha Semenkow from Citi.

I also have two, one on Mosley, one on Brepocitinib. For mostly, I'm wondering if you could just talk about the translatability of PVR reductions in patients with PAH to those with the PH-ILD population that you enrolled in focus. Are there any aspects of either disease that could influence the magnitude of PVR that you could see in the mostly data? And I have a follow-up.

Yes. So look, I think -- thanks for the question. I appreciate it. I think the translation from PAH to PH-ILD is the fundamental question being answered by our study. And so the first unfortunate answer to that question is we're just going to have to see what we see. And it is the risk of the program at some level that we find something -- again, the Phase I data, including in PAH patients looks very good on a PVR basis. So one of the main "risks" of this program is that there's something, I would call it, unexpected in the PH-ILD translation. And obviously, I use the word unexpected because I think scientifically, it seems relatively straightforward that inhaled vasodilation is an effective mechanism in PH-ILD, but we'll find out. Obviously, the lungs of PH-ILD patients are different. than the lungs of PAH patients. And so you might expect some difference in sort of the pharmacodynamics of the drug in those patients. But overall, it seems pretty clear that when you take an inhaled vasodilator in PH-ILD patient, you get drug to the healthy lung tissue and it matters. So that's what I think.

Got it. That's very helpful. And then just on Brepocitinib and DM, in your conversations that you've been having with physicians for education, I'm wondering if you could just talk about the reception to Brepocitinib given the JAK class safety concerns. Obviously, the safety profile of VALOR was quite favorable. But from a class perspective, it would just be helpful to hear how the physicians are thinking about safety, particularly since DM patients already tend to have a higher underlying risk for cancer.

Yes. We've said a few times that when we first in-licensed brepocitinib, we didn't exactly know what the reception to JAK inhibitors was going to be following the addition of black box warnings and our whole view is to choose indications where the safety profile of JAKs is going to be much less of a focus. I think dermatomyositis is a poster child for this in that while JAK inhibitors are at this point, extremely widely used in diseases with much less morbidity, many more alternative therapies. In dermatomyositis, there's really no other options available. And I don't think physicians, therefore, are going to be particularly focused on this question. Remember, these patients are often -- first of all, and I think you sort of alluded to the profile in the trial. Dermatomyositis patients are inherently at risk of many of these concerns, malignancies, cardiometabolic events and treating them well makes them healthier and reduces those risks. And then on top of that, the therapies that they are currently on for dermatomyositis are things like high-dose steroids, which themselves add meaningfully, in fact, in many cases, much worse than JAK inhibitors to those very same risks. So I think in general, physicians are not going to spend a lot of time worrying about this, especially when reminded of the inherent risk of steroids and immunosuppressants that they're on anyway. And it's clear from our conversations with docs across different prescriber bases, they're just very comfortable using these agents, including prescriber basis, as we said, for patients with significantly less severe disease. As a reminder, we fully expect that our label is going to look like the labels for other JAK inhibitors that's going to have the black box warnings that's going to talk about experience with JAK inhibitors and other indications. And like I said, I think docs expect that and I think are not going to be too concerned about it because these patients are, a, very sick and b on other drugs, in many cases, significantly worse safety concerns.

Our next questions will come from the line of Prakhar Agrawal from Cantor Fitzgerald.

Congrats on the continued execution. So maybe a couple of questions from my side as well. Firstly, on brepocitinib and DM, could you remind us what percentage of DM patients are on off-label JAKs based on your latest primary or secondary research? And would you expect rapid switches from these patients who are on off-label JAKs to brepocitinib? If not, why is that the case? And secondly, for brepocitinib in NIU trial, what do you see as the biggest risk for Phase III, given the Phase II was really strong? And is this geographic variation, which has been a key risk for this trial, which could drive some of the baseline variability that has been flagged as one of the risk factors by some of the KOL checks that we have done. appreciate.

Great. Thank you. So I -- in terms of your first question on brepocitinib and DM around who's on off-label JAKs and what does that look like? Look, I think, first of all, there's just like variability in physician practice and some physicians use more JAKs and some physicians use less JAKs. And that has more to do, I think, with the docs in many cases than with any specific subcategory of patients. I think what we've said publicly is a low single-digit percentage or mid-single-digit percentage of randomization patients have experience with these things. Some of the docs who are involved who do use -- and some of that -- some docs don't use off-label drugs full stop. I think some of the docs who use off-label docs have said they expect to switch patients over, and I hope they do. And obviously, we'll be working to help them where that's appropriate, facilitate those switches. I think it's just going to be down to the preference and practice of each individual doc. I think one of the things that our team is finding in talking to physicians is that different patients have different docs have different sort of ideals in mind for who their sort of first patients might be. And I think it just varies based on the patient experience with the physician. And so obviously, we'll be able to have much more of these conversations pending potential approval. But I think medically, we'll see a wide variety of different phenotypes. On what is the biggest risk in Phase III? It feels funny to call placebo risk in these trials and that's not quite exactly what I mean, but I think the variability in placebo response rates in immunology trials is significant. If you're asking me what keeps me up at night, it's that we don't know exactly what placebo response rates will be in that study. And that just makes it hard to know exactly what the trial is going to look like on outcome. Obviously, the Phase II data was quite compelling and the level of drug activity seems good. And so I'm pretty optimistic about the study, but there's certainly -- this is biotech, you can lose sleep over anything. Is geography a risk I think there may be geographic variation just as there is in many other indications, and some of that's literally driven by geography and some of it's driven by physician practice and some of it's just noise. I don't know that it's a risk in the sense that it's like unanticipated or whatever. It's just a feature of running immunology studies. But overall, I think the team is doing a great job with the study, and I hope it's going to come out well.

Our next question comes from the line of Andy Chen of Wolfe Research.

I don't think this has been talked about yet. But for the Brepocitinib launch, can you maybe talk about a few launch analogs that you're assessing right now, either patient curve or market share curve? What are the historical products with the most resemblance to Brepocitinib in DM.

Well, thanks. It's a good question. The truth is there has never been a launch of a targeted therapy in dermatomyositis before. And so there is no good "analog" in the sense that you can point to lots of other launches of lots of other kinds and some have been faster and some have been slower and some have been slow and steady and some have been like different versions of different things. And I think it's hard to say, and there have been successful products with all kinds of different launch phases. So I think the short answer is I don't have a specific analog for another drug that we're watching as like evidence of our own penetration. I think what we're really focused on here is the dermatomyositis opportunity itself, these docs and these patients and the benefit and the cost of being a pioneer in indication is that you don't get to look at others, you have to try your own course. I don't have an analog to point to.

Our next question comes from Yatin Suneja from Guggenheim.

Just a quick one on difficult-to-treat RA. Could you maybe talk about the strategy there? Would you need one more study, 2 more studies? How are you thinking about that? What should be our expectations for the randomized withdrawal phase that we're going to get data on?

Yes. Thanks. Great question. Look, on study design, so we're going to come back later this year with a full update on that program, and that includes -- we don't yet have the randomized withdrawal period data yet, so I can't speak to what in it or how it will or will not inform strategy from here. And I think at some level, the results of that study may inform whether it is usable or not as one of our pivotal studies, et cetera. I think we designed it to serve potentially as 1 or 2. But obviously, it's got to hit for that to work. And as we said, when we announced the data, the quality of the response rates in the open-label period have set a somewhat higher bar for hitting a p-value of randomized withdrawal section. So I think we've got to sort of see all that taken in aggregate, look at the patient level data, understand what's going on. And we are planning for an FDA conversation this fall that will inform both the exact design of that study as well as help us answer those questions. I don't have a specific guidance to give on exactly what those studies are going to look like now because we don't know, but I'll say the team is working on it hard. The data was obviously exciting. It has got noticed. We've got a lot of enthusiastic reception, including from the doctor community on it, and we're excited to finalize those plans and bring them back to you later this year.

Our next question comes from Yaron Werber from TD Cowen.

I have a couple of questions. The first one was mostly, once you release the data this year, would you release both the mono and the combo data at the same time? And then secondly, for CS, the trial design is super interesting and makes obviously a lot of sense. The primary endpoint is CSAMI more than a 50% response -- can you maybe translate the Phase II data into the same context? Because I think the Phase II looked at C70 over 10 points and the change from baseline. So I'm just trying to get a sense of apples-to-apples kind of what to expect.

Great. So on mostly, I think the short answer to your question is we will not release the monotherapy data and the combo data at the same time because the combo study started much later and is enrolling now, whereas the monotherapy study, obviously, will read out pretty soon in the second half. So I think the answer is they won't come out at the same time, and we'll put out the combo data when we've got it. The combo study, remember, it's an open-label study. It was designed -- the truth is, I think a lot of the information that we could want will come out of the monotherapy study anyway, since the combo study like won't provide that much incremental. I think it was designed in part to give us really good safety experience in the combination as well as like a little bit of information about incremental efficacy just so that we can get a sense for like inclusion criteria and management in the Phase III. But I'm not sure it's going to be like a super, super informative outcome. Yes. So that's what I'll say on mostly. I think data are going to come at separate times. On CS, I don't have to give right now the exact delta, but I'll say we saw meaningfully higher rates of greater than 50% CSAMI in the treatment arm than in the placebo. So the delta was wide. And I think in the press release that may have gone out around the initiation of the CS study, it will have said well north of 50% of the patients in the treatment arm of the Phase II had a Card response rate greater than 50%, I think the 0 on placebo. So it should be a good bar to set for us in terms of the endpoint. I don't know that we're going to replicate exactly what we saw in the Phase II, but I think the point is it's well powered for probability success given what we saw in the Phase II.

Right. And if I can may just sneak in the Phase III NIU, do you have a sense, is the percent Humira experience going to be the same as the Phase II, given that the data look pretty good overall. So it must have been pretty good in that segment, too.

I don't think we've said -- thank you what the percentage of patients in the Phase III have HUMIRA experience. I don't have that number on the top of my head, so I'll have to check into it. But I think the answer is there's no reason to expect it to be very different than what we've seen. There are a meaningful number of HUMIRA experienced patients in the Phase III, which matters in terms of ability to go into all of those patients. But I think the short answer to your question is I wouldn't expect it to be a major driver, and I wouldn't expect anything markedly different about the patient population from the Phase II.

Our next question comes from Thomas Smith from Leerink Partners.

On the 1402 difficult-to-treat RA program, I just wanted to clarify how you're approaching the disclosure in the second half of the year. Should we expect to see the Part 2 randomized withdrawal data prior to your meeting with FDA? Are you planning to share the data and the regulatory feedback and next steps simultaneously? And then on Graves, just wanted to get your thoughts on the competitive landscape. Obviously, you're the first advanced therapy there with really stellar Phase II data and you'll have the first pivotal readout next year with 1402. But there are a number of different approaches targeting various segments of the Graves patient population. Just wondering if you could comment on the competitive landscape. And as you see some of the approaches some of these competitors are taking with respect to the patient population, wondering how you're thinking about potential future studies for 1402 and Graves.

Yes, perfect. Those are both really great questions. On the first one, I think what we said we put the data out still holds. I think my dream, our dream for the second half of this year is that we can come back with everything tied as nicely into a bow as possible, which is to say the period 2 data, the FDA conversation, maybe some further analysis of patient experience, period in the RA study, all shared at the same time. Obviously, until we have the Part 2 data in hand, we can't sort of specifically know whether there's anything in there that requires earlier disclosure. But in general, I think the answer is our hope and expectation would be to give a fulsome update later this year on everything all at once for D2GRA. On Graves, look, I think, first of all, I cannot say enough times that discussion of competition in Graves disease among therapeutic categories is just misplaced in the sense that you've got so many patients with unmet need that have had no -- the last time a novel therapy was developed in Graves disease was like the 1950s or 1960s. There's so many patients who have need of novel therapy that it's not about outrunning there. It's not about beating some specific competitor. It's about changing doc behavior in an indication that badly needs new options. 1402 have been studied in lots of patients. It's a safe and well-tolerated drug. Graves is going to have room for lots of mechanisms and lots of products. Among the other mechanisms, some will have specific either safety liabilities or they'll mimic a thyroidectomy and they'll require treatment with steroid or there's like lots of different approaches and most patients may be appropriate -- those drugs may be appropriate for later-line patients or a different subset of the patient population. And over time, I'm sure that segmenting will occur. But first of all, we're going to be first out in the marketplace there long before anybody else. And so we're going to get to have some influence over the treatment paradigms and also just get an option out to patients and physicians before some of those other choices are available. And second of all, I think it's mostly about building the market, not about any specific alternative and so on. So look, we're tremendously excited to be in our position in grades to be first to be able to offer hopefully a new option here. The only other thing I will say is -- you learn a lot running these studies. You learn a lot engaging with this physician community. And I do think there is nuance to the patient population. I think there is nuance to the prescriber behavior. I think there's a lot of heterogeneity in terms of how these patients are managed around the world and around the U.S. And I think one of the things that we're going to be able to do is to take advantage of those learnings in future studies, in these studies, in commercial prep. And I think that will be a big benefit to us being in the first place here.

Our next question comes from Yasmeen Rahimi of Piper Sandler.

This is Shannon on for Yasmeen Rahimi. Congrats on the great quarter. Maybe just one more from us about clarity with the readout in second half '26. Could you give us just maybe what you might be thinking about narrowing guidance if you expect to do that? And then sort of how you're thinking about the bar for success? And then timing post data, would you expect to file an sNDA and sort of what would be the cadence on that?

Thanks. Look, I think I doubt that we're going to provide more specific timing guidance at this point than we have. We announced, I think, when the study was fully enrolled, and I think we're just going to read the study out when it's done and we have the data clean. The truth is NIU is another one of these diseases where there's a lot of unmet need. Humira leaves a lot of room on the table. And frankly, a lot of patients aren't even getting it. And so I think the truth is that the bar for success is successful studies that would support registration. And I think if we get that, we will have a big opportunity to help patients who need it. So I don't think there's like a numerical bar. Obviously, better data is better. And the more we look at Phase II, the happier I'll be about that. Our Phase II was really, really great data. But overall, I think as long as we have a successful clinical trial, a successful outcome, we're going to get what we need and we have a lot of patients we can reach. And I don't want to put Ben on the spot right now on exactly when that sNDA goes in, but we got the DM1 in nice and quickly. And I know the team is enthusiastic for indications if that study is positive. You got to believe that team is going to be working really quickly to get that sNDA in as fast as possible.

Our next question comes from Douglas Tsao from H.C. Wainwright. The next question comes from Sam Slutsky from LifeSci Capital.

Two quick ones for me. I guess for the proof-of-concept readout in CLE, there's a few parts to that study. So just remind me what we'll be getting in that initial release this year. And then for the initial launch in dermatomyositis, remind me how many clinics you're targeting and the concentration of patients at those clinics?

Yes, thanks. On CLA, and again, I think we've said before in other settings that B was mentioning, I think CLE is an interesting indication. This is a small study. It's really a back finding proof-of-concept study. We've been watching the competitive landscape in CLE closely. There's a lot of other exciting therapies in development as well. Our early data from a couple of patients that we have dosed was encouraging. We're really sort of overall just looking to understand what our treatment benefit looks like, how we could conceptually stack up in the future treatment landscape. And I think that will all be super informative to what we do from here and whether we go forward. I think the primary, as a reminder, is 12 weeks, 600 versus placebo. And then in period 2, all patients collapse 600 at 52 weeks. The thing that we'll be reporting first is that 12 weeks for 600 versus placebo. So that's what we'll see. And then obviously, a bunch of other data beyond just the specific primary endpoint. On the DM launch, I'm not going to share today exactly what our sort of targeting strategy is. But as a reminder, there's about 200 myositis referral centers that treat approximately half of the U.S. patient population. And so obviously, those clinics are -- those docs, those centers are an important part of the overall picture, but there are other important physicians as well. And I think that and the team have done a really great job overall engaging with the physician community. So I'm excited about what we've done there, excited about the sort of medical publication strategy, obviously internal publication was a great outcome. So feeling good overall about that plan. And we're going to talk to as many docs and get out there as much as we can pending potential approval. So thank you. Great questions.

We will now take the last question from Alex Thompson of Stifel.

Maybe two more on '402. Going back to the questions around placebo responses, how are you thinking about managing placebo response in the Graves studies, particularly in the backdrop of ATP down titration and the potential for waxing and waning of disease in that context over longer periods of time? And then secondly, what's your current thinking on sort of where 1402 could fit within MG and CIDP as that landscape continues to evolve? Yes.

Thank you. Great questions. I appreciate it. Look, on Graves, I think the short answer to this question is, if you set the bar high enough on the endpoints, these are just not patients who are spontaneously remitting. And so if you're looking at patients who are getting to proper thyroid hormone levels and off ATDs, I think the simple truth is placebo should be pretty manageable here without saying much more about exactly how the AT titration works and so on and different of the studies being run by different companies are taking slightly different approaches there. So I'm not going to say too much about exactly what we're up to. But overall, I think this is something that is likely manageable. And then I think as far as MG and CIDP are concerned, and I'll say First of all, it's pretty rare that you have a great drug where you can run a clinical trial and be just like very confident that the trial is going to work. FcRns have been studied many times in MG at this point. '402 really should work in MG. The data that we generated in Battle, although I know there was plenty of debate over the deeper better question, we think showed a real treatment benefit, especially on things like MSD and sort of clinical remission that other FcRns in our view, have not been quite as compelling on. So I think we have an opportunity to deliver really great data, and I think that data will translate to adoption. I'll say 2 other things. One is that the MG market has just shown itself to be extremely large. There's room for lots of different classes. There's room for multiple FcRn. There's a little bit of cycling going on. There's differences in dosing paradigm and so on. So I think like no matter what share we take, even a relatively modest share of a market that size is a big opportunity. I think argenx has done a really great job establishing that market, establishing themselves in that market, becoming the drug of choice that people reach to for a next-generation therapy. I think they may very well remain the class leader there. And I think we will find lots of operating room around them with hopefully incremental meaningful benefit to patients beyond what they can deliver and just with another option with different route of administration and so on. So I think in MG, we will be out there. I think we'll have a big opportunity just given the size of the overall market and then exactly what our share is and where we fit in will depend on the clinical data that we generate in the study. CIDP -- my one comment is I think there is -- I think the -- on other indications. I think in CIDP, class leadership has been less concretely established at this point. It's a more recent launch. And I think there's probably a little bit more room for improvement on treatment paradigm. And so I think what we showed with Bato in the CIDP study was pretty encouraging, and I hope we're able to do something similar with 1402. And I think there will be a lot of enthusiasm if we can for our role there. So I think we have an opportunity to be a major driver in that market. Overall, I think the level of success that argenx has had with things like MG and CIDP make me tremendously excited about Graves and about DutragRA and the other indications where we are first in that the first-mover advantage that argenx is able to develop in their indications are significant, and I expect to build a similar moat for ourselves. Look, I think ultimately, these docs are going to be sensitive to clinical data, focused on clinical data. And I think if our data is phenomenal, we'll be able to lead in every indication where we have that kind of data. Big docs are going to follow the quality of the evidence.

With that, I would like to hand the call back to management for closing.

Great. Okay. Well, look, thank you, everybody, again. Thank you for the thoughtful questions. I appreciate how much work it is to come up with good questions in a quiet quarter. I promise there'll be lots coming in the coming weeks and months to give you more substrate in the future. But in the meantime, we appreciate it. We appreciate everyone for listening. As always, I'm super appreciative of everybody who works for in advance who are working just super hard on all of these programs to move them forward. I've been very proud of our execution and pleased with the quality progress we made. And I want to thank the physicians and investigators and patients in our studies who trust us with their care. And I couldn't be more excited for the 12 months ahead. This is the last -- one way or another, this is the last boring quarter we're going to have for a while. So looking forward to the more exciting ones ahead and moving sleep over them until we get there. Thank you, everybody. Have a good day.

That does conclude today's conference call. Thank you for your participation. You may now disconnect your lines.