On Thursday, Immunovant (NASDAQ:IMVT) discussed first-quarter financial results during its earnings call. The full transcript is provided below.
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Summary
Immunovant reported a quiet first quarter but anticipates a busy second half with several major developments, including the potential launch of brepocitinib for dermatomyositis.
The company has initiated a phase 3 study for brepocitinib in cutaneous sarcoidosis and received a significant settlement payment from Moderna, with ongoing litigation against Pfizer and BioNTech.
Strategic focus is on a slow and steady commercial approach for brepocitinib, aiming to build a strong foundation for future expansions into other indications such as NIU and CLE.
Financials showed an R&D expense of $200 million and a cash reserve of just under $4 billion, with share repurchases accelerated following the Moderna settlement.
Management is optimistic about upcoming data readouts and potential approvals, emphasizing the unique position of their therapies in addressing unmet medical needs.
Full Transcript
OPERATOR
Good day, and thank you for standing by. Welcome to Immunovant's first quarter 2026 earnings conference call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask questions during the session, you need to press star, one-and-one on your telephone, please. We advise 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.
Stephanie Lee, Investor Relations
Good morning, and thanks for joining today's call to review Immunovant's financial results for the first quarter ended June 30, 2026. I'm Stephanie Lee with Immunovant, presenting. Today we have Matt Glein, CEO of Immunovant. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these updates, on our IR website at www.investor.immunovant.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.
Matt Gline, CEO
Thank you, Steph, and good morning, everybody, and thank you for joining. This is a little bit of a calm-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 jam-packed 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'd like 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. Just wanted to highlight that it's gone well for us, that we feel really good about the setup. And so on slide 5, you know, looking across the list here, we've got brepocitinib 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 in the D2RA study that we presented on our last quarterly call. Probably the most notable update for today, the top center of this slide, is that we've now enrolled patients in the phase 3 study in cutaneous sarcoidosis for brepocitinib, which follows on the positive results that we had in our phase 2 data, which I think we announced on our first quarterly call of this year, earlier in the calendar year.
We've now received additional payment from Moderna in the settlement, and the 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 pre-specified indication. And as I'll remind people later today, that study is continuing to enroll as 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 brepocitinib launch in DM, which should happen imminently assuming everything goes as we expect it will at FDA. We've got top-line data in brepocitinib 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 Moseley, the phase 2 study in PH. I know that's being closely watched and we're looking forward to getting that data and presenting it. We will provide further updates on the D3 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 in 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 this year. I'm looking forward to finding out what we've got there when that comes in as well. So just a jam-packed second half and even more coming in 2027 with the Graves data and beyond. So just a lot, 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 going to Q&A, starting on slide 8 with a reminder, because it's been a few months since we talked about it.
You know, the initiation of this cutaneous sarcoidosis phase 3 study is a pretty exciting event. It's a little bit ahead of, in terms of, what we're 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 a higher urgency to treat. You can see on slide 8 some of the photos we've shared before, but these are patients who are really sick and have very few treatment options.
On slide 9, as a reminder of the data that we generated in our phase 2 study, we have set for ourselves a goal of a sort of five-point benefit on this CSAMI scale for clinical meaningfulness. And in the study in 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 2 study and really excited to carry that forward into the pivotal program.
You know, as a reminder on slide 10, we think this is a pretty decent-sized indication given the high unmet need—probably about 40,000 patients in the US—and reasonable overlap with some other organ systems, including ocular 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 3 study that we've now begun—the design is laid out on slide 11. I know there were some questions after the phase 2 about what exactly this study would look like. And it is designed to take all of the learnings from the phase 2 study that was successful. It is a 16-week study with the primary endpoint of CSAMI greater than or equal to 50% response rate, 140-patient study across about 70 sites, 3:2 randomized, with patients either on 45 milligrams of brepocitinib or placebo, and with a mandatory steroid taper going from week two to week eight down to zero, which is roughly consistent with what we did in the phase 2 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 potential registration indications for brepocitinib coming up. I'll reiterate on slide 12. The other ongoing registration program is the brepocitinib study in lichen planopilaris (LPP) that we announced earlier this year. That study is enrolling, I would say, extremely well.
There's a lot of enthusiasm from physicians and patients for that. It speaks to the high unmet need in the indication and speaks to the quality of the work being done by VAN and the prior VAN team. I'm looking forward to sharing more about that as soon as we've got it. So that's also moving 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 potential approval and beyond—obviously one of the major events in the near term here is the potential launch of brepocitinib in dermatomyositis.
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 in the New England Journal and so on, just phenomenal data 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 dissatisfied 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 and patient communities on overall education, and I think the enthusiasm for new therapy is coming out loud and clear, including with all the academic presentations that have been done and so on. Commercial launch—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 organizations 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 relevant, private way. There's nobody in the world I'd be more excited to see oversee this than the team we've got at Priovant with Ben and Daniel and others.
And I think we're going to be fully ready. Everything's 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. At Priovant, 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 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 and on drug, although I think we're fully prepared. But also to me, it's because brepocitinib 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 one or month one or quarter one look like, and much more about making sure that the foundation around access, the foundation on 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 brepocitinib across all of these indications.
And so I think, you know, 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 the patient 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. You know, final business update here is we got the upfront payment in the settlement with Moderna—that $950 million has come in, $770-ish of it to Genevant and the rest to Arbutus. So that's done. There'll be progress in terms of, you know, return of capital, et cetera, of that and so on. The ’1498 ruling— that process is ongoing. The Federal Circuit: that'd 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 three 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 of it 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, just under $100 million of non-GAAP adjusted G&A, or $166 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—reminder—the shares that we bought by kind of the first round of this, the billion and a half that we 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. 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, incredibly busy stretch ahead. You know, on slide 20—again, a little bit incredulous for the people around Lloyd Grant who are doing all of this work. Incredible around whether or not to do this work. But by the end of calendar 2028, we'll have had hopefully three or more commercial launches, nine full-year pivotal study readouts, four-plus NDA or BLA filings, a number of proof-of-concept studies.
Just a ton, 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.
Stephanie Lee, Investor Relations
Thank you. The operator, over to you.
OPERATOR
Certainly. We will now begin the question and answer session. As a reminder to ask questions, please press star one and one on your telephone. If you'd like to cancel your request, you can also press star one and one again. Our first question comes from the line of Brian Ching of J.P. Morgan. Your line is open. Please go ahead.
Brian Ching, Analyst at J.P. Morgan
Hey guys, good morning. Thanks for taking our questions. Maybe just thinking through the DM launch pad, can you give us a quick sense of, you know, what metrics we could be receiving right out of the gate to help us better track the initial launch? And then secondly on PH-ILD, as we think about the baseline characteristics here in FOCUS, it seems that more patients are on nintedanib. We're curious if there's any implication in terms of the fibrosis versus emphysema ratio in the population and then further down the line whether there's any implication to what's the bar for success for both extended log and also PVR.
Matt Gline, CEO
Thank you. Yeah, perfect. Thanks. I appreciate both questions on the mic. A thing 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 plainly 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 approval, 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 for practical purposes, but, you know, we'll provide more guidance on that as it gets closer. In this year on PH-ILD, I guess first of all, we've obviously been watching, for example, the 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 we're 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 Moseli. Overall on 6-minute walk and PVR, I'm sure I'll get versions 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 at all active, we will. We don't expect to see very much with clarity on 6-minute walk.
The study's 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. Thanks, Brian.
OPERATOR
Thank you, Matt. Thank you for the questions. Next question comes from the line of Dave Risinger from Leerink Partners. Your line is open. Please go ahead.
Dave Risinger, Analyst at Leerink Partners
Thanks very much and thanks for all the updates, Matt. 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 Moseli, 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? That is, what would be relevant to the clinicians and to the patient? So that's my first question.
Matt Gline, CEO
Yeah, 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 2. The truth is that PH-ILD patients are really sick. There are not a lot of options for these patients. And as we saw in Group 1 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, from like 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, you know, 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 like correct scientifically to describe a specific numerical bar that matters versus just being able to get into therapy. And some of that's frankly because 6-minute walk in clinical settings is an artifice 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. 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.
Thanks, Dave.
Dave Risinger, Analyst at Leerink Partners
Great, that's very helpful. And then regarding the forthcoming Brepocitinib 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 six months after launch before putting drugs on formulary.
Matt Gline, CEO
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 expect us to have at this stage. And also I think this is a critical point about all of these launches. We are super focused on making sure that 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 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 exception procedures and other things that you can do to get patients covered. And we have a whole team of people built out at Priovant that's dedicated to making sure whether the formulary work has happened yet, whether the P&T 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.
Dave Risinger, Analyst at Leerink Partners
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?
Matt Gline, CEO
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 is 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 quite preparing to initiate programs to various degrees, depending on how busy those teams are today versus next month or the month after. But real progress. I think the answer is we are actively working on that, that 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.
Dave Risinger, Analyst at Leerink Partners
Excellent. Thanks so much.
OPERATOR
Thank you. Thank you for the questions. The next question comes from the line of Samantha Semenkow from Citi. Please go ahead.
Samantha Semenkow, Analyst at Citi
Hi, good morning. Thanks very much for taking the questions. I also have two, one on Moseli, one on Brepo. For Moseli, 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 Moseli data? And I have a follow-up.
Matt Gline, CEO
Yeah. 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 someplace. Again, the Phase 1 data, including in PAH patients, looks very good on a PVR basis. So one of the main, quote unquote, 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. 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 a PH-ILD patient, you get drug to the healthy lung tissue and it matters.
So that's what I'd like.
Samantha Semenkow, Analyst at Citi
Got it. Thank you. That's very helpful. And then just on Brepo and DM, in your conversations that you've been having with physicians for education, I'm wondering if you could talk about the reception to Brepo 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.
Thanks very much.
Matt Gline, CEO
Yeah, we've said a few times that, you know, 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 was to choose indications where the safety profile of JAKs was 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
Scott
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, 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 in themselves add meaningfully—in fact, in many cases much worse than JAK inhibitors—to those very same risks. So, you know, I think in general physicians are not going to spend a lot of time worrying about this, especially when reminded of the inherent risks of steroids and immunosuppressants that they're on anyway. And it's clear from our conversations with docs across different prescriber bases that they're very comfortable using these agents, including across prescriber bases, as we said, for patients with significantly less severe disease. You know, as a reminder, we fully expect that our label is going to look like the labels for other JAK inhibitors, that it's going to have four black box warnings. It's going to talk about experience with JAK inhibitors in 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 with, in many cases, significantly worse safety concerns.
OPERATOR
Questions. Our next questions will come from the line of Praka Agarwal from Cantor Fitzgerald. Your line is now open.
Praka Agarwal, Analyst at Cantor Fitzgerald
Hi, thank you so much for taking my questions and congrats on the continued execution. So maybe a couple of questions from my side as well. Firstly, on Brepo in 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 Brepo? If not, why is that the case? And secondly, for Brepo in NIU trial, what do you see as the biggest risk for Phase 3 given the Phase 2 was really strong, and is geographic variation—which has been a key risk for this drug—something which could drive some of the baseline variability? This has been flagged as one of the risk factors by some of the KOL checks that we have done. Thank you, really appreciate it.
Matt Gline, CEO
Great, thank you. So, you know, in terms of your first question on Brepo in DM—around who's on off-label JAKs and, you know, what does that look like—look, I think first of all there's just variability in physician practice and some physicians use more JAKs and some physicians use less JAKs. That has more to do, I think, with the docs in many cases than with any specific subcategory of patient. You know, I think what we've said publicly is a low single-digit percentage or mid single-digit percentage of myositis patients have experience with these things.
Yeah, some of the docs who are involved do use them, and some docs don't use off-label drugs full stop. I think some of the docs who use off-label JAKs 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 docs have different sort of ideals in mind for who their first patients might be.
And I think it just varies based on the patient experience and the physician. And so, you know, obviously we'll be able to have much more of these conversations pending a potential approval, but I think, medically, we'll see a wide variety of different phenotypes. On NIU, what is the biggest risk in Phase 3? It feels funny to call placebo a 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, 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 2 data was quite compelling and the level of drug activity seemed good, and so I'm pretty optimistic about the study. But certainly this is biotech, so you can lose sleep over anything. Is geography a risk? You know, 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. You know, I don't know that it's a risk in the sense that it's 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. Thank you.
OPERATOR
Thank you. Our next question comes from the line of Andy Chin of Wolfe Research. You may proceed.
Andy Chin, Analyst at Wolfe Research
Hey, thank you for taking the question. I don't think this has been talked about yet, but for the Brepo 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 Breville in DM? Thank you.
Matt Gline, CEO
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 quote-unquote analog in the sense that, you know, 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, you know, just 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 paces.
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, these patients—and, you know, the benefit and the cost of being a pioneer in an indication is that you don't get to look at others; you have to chart your own course. I don't have an analog to point to. Thanks, Andy.
OPERATOR
Thank you for the question. One moment. Next question. Our next question comes from Yaktin Suneja from Guggenheim. Please go ahead.
Yaktin Suneja, Analyst at Guggenheim
Hey guys, thank you for taking my questions. Just a quick one on difficult-to-treat random. Could you maybe talk about the strategy there? Would you need one more study, two 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?
OPERATOR
Thank you.
Matt Gline, CEO
Yeah, thanks, Scott. Great question. Look, on study designs—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 within 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. You know, I think we designed it to serve potentially as one of two, 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 on the randomized withdrawal section. So I think we've got to sort of see all that, take it in an 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 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's working on it hard. The data was obviously exciting. It has been noticed. We've got a lot of enthusiastic reception, including from the doc community on it, and we're excited to finalize those plans and bring them back to you later this year. Thank you.
OPERATOR
Thank you for the questions. Our next question comes from Jaron Werba from TD Cowen.
Jaron Werba, Analyst at TD Cowen
Great, thanks so much. I have a couple of questions. The first one: 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—it makes obviously a lot of sense. The primary endpoint is CSAMI more than a 50% response. Can you maybe translate the Phase 2 data into the same context? Because I think the Phase 2 looks at CSAMI 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.
OPERATOR
Thank you.
Matt Gline, CEO
Great. So on Moseli, 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.
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 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 a little bit of information about incremental efficacy just so that we could get a sense for inclusion criteria and management in the Phase 3, but I'm not sure it's going to be a super, super informative outcome.
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 placebo. So the delta was wide. And, you know, I think in the press release that may have gone out around the initiation of the CS study, it almost said well north of 50% of the patients in the treatment arm of the Phase 2 had a CSAMI response rate greater than 50%. I think it was too low on C dose.
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 2, but I think the point is it's well powered for probability of success given what we saw in the Phase 2.
Jaron Werba, Analyst at TD Cowen
And if I can just sneak in: the Phase 3 NIU—do you have a sense, is the percent Humira-experienced going to be the same as the Phase 2 given that the data looked pretty good overall? So it must have been pretty good in that segment too. Thank you.
Matt Gline, CEO
I don't think we've said what the percentage of patients in the Phase 3 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 3, which matters in terms of ability to go into all 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 2.
Thanks, Jerome.
OPERATOR
Our next question comes from Thomas Smith from Living Partners. Your line is now open.
Matt Gline, CEO
Yeah, perfect. Those are both really great questions. On the first one, I think what we said when 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 Part 2 data, the FDA conversation, maybe some further analysis of patient experience, movable periods in the RA study, all shared at the same time. Obviously, until we have the Part 2 data in hand, we can't 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 the full update later this year on everything all at once 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 options; the last time a novel therapy was developed in Graves disease was like the 1950s or 1960s.
There are so many patients who have need of novel therapy that it's not about outrunning a bear, it's not about beating some specific competitor. It's about changing doc behavior in an indication that badly needs new options. You know, 1402 will 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 Synthroid, or you know, there's lots of different approaches and 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 Graves—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, and 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 in the first place here. Thank you.
OPERATOR
Next question comes from Yasmin Rahimi of Piper Sandler. The line is now open.
Shannon, Analyst at Piper Sandler
Hi, this is Shannon on for Yasmin Rahimi. Congrats on a great quarter. Maybe just one more from us about clarity with the readout in second half ’26. Could you give us 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 FDA submission and what would be the cadence on that? Thanks.
Matt Gline, CEO
Thanks. Look, 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 cleaned. 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. 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 a numerical bar. Obviously, better data is better, and the more we look at phase 2, the happier I'll be about that. Our phase 2 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 in real-life patients we can reach. And I don't want to put Ben on the spot right now on exactly when that SMDA goes in.
But we got the DM1 in nice and quickly, and I know the team is enthusiastic for how to use the indication. So if that study's positive, you gotta believe that team's gonna be working really quickly to get that SMDA in as fast as possible. Thank you.
OPERATOR
Since our next question comes from Douglas Tao from HC Wainwright. Please go ahead. Douglas, your line is open. You can unmute locally. In that case, we'll move on to our next questions. One moment, please. The next question comes from Sam Slatsky from LifeSci Capital. Please go ahead.
Sam Slatsky, Analyst at LifeSci Capital
Hey, thanks for taking the questions. Two quick ones for me. 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. Thanks.
Matt Gline, CEO
Yeah, thanks. On CLE—and again, I think we've said before in other settings that bear mentioning—I think CLE is an interesting indication. This is a small study. It's really a fact-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, and data from a couple of patients that we have dosed was encouraging. We're really, 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 for 600 versus placebo, and then in period two, all patients go up to 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 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, those docs, those centers are an important part of the overall picture. But there are other important physicians as well. And I think Ben 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 medical publication strategy. Obviously the new journal 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. Thank you. Great questions.
OPERATOR
We will now take the last questions from Alex Thompson. Please go ahead.
Alex Thompson, Analyst
Great. Thanks for taking our question. Maybe two more on 1402. 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 ATD 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 where 1402 could fit within MG and CIDP as that landscape continues to evolve?
Matt Gline, CEO
Yes, thank you. Great questions, 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 meds, I think that the simple truth is placebo should be pretty manageable here. Without saying much more about exactly how the ATV hydration works and so on, and different 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, you know, overall I think this is something that is likely manageable. And then, you know, 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. You know, FcRns have been studied many times in MG at this point; 1402 really should work in MG.
The data that we generated in batoclimab, although I know there was plenty of debate over the deeper-is-better question, we think showed a real treatment benefit, especially on things like MSV and sort of clinical remission that other FcRn, 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 two 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 FcRns, 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 next-generation therapy.
I think Argenx may very well remain the class leader there and, you know, 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 kinds of administration and so on. So I think in MG we'll 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 end on other indications—I think in CIDP, you know, class leadership has been less concretely established at this point. It's a more recent launch and, you know, I think there's probably a little bit more room for improvement on, you know, treatment paradigm. And so, you know, I think what we showed with batoclimab 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 makes me tremendously excited about Graves and about DTGRA and the other indications where we are first in—that the first-mover advantage that Argenx has been able to develop in their indications are significant and I expect to over 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. These docs are going to follow the quality of the evidence. Thank you. Appreciate the question.
OPERATOR
Thank you for the questions. With that I'd like to hand the call back to Manishun for closing.
Matt Gline, CEO
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 Immunovant 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 then I want to thank the physicians and investigators and patients in our studies who trust us with their care and 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 losing sleep over them until we get there.
Thank you, everybody. Have a good day.
OPERATOR
That does conclude today's conference call. Thank you for your participation. You may now disconnect your lines, please.
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