Immunovant, Inc.

Good day, and thank you for standing by. Welcome to the ROY event first quarter 2025 earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review Royvan's financial results for the first quarter ended June 30th, 2025. I'm Stephanie Lee with Royvan. Presenting today, we have Matt Klein, CEO of Royvan. 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.royvan.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 will 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, Stephanie, and thank you, everybody, for joining this morning. I appreciate it. It is a relatively quiet quarter before what promises to be a very busy fall, so I look forward to sharing some updates and then taking some Q&A. I will start on page five, which is a reminder of sort of where we are for this year. So, you know, three main themes for calendar year 2025. The first of those is the continued progress that we're making with IVT-1402 and Immunovant, where we are developing what we hope will be the best-in-class anti-FCRN antibody. We put out data earlier this year in Botoclumab, our first-generation drug in MG and CIDP, and now it's really a story of that team-focused clinical execution of getting the GRAVE study enrolled and continuing to progress with other indications that we've announced there. The second major theme for the year, which is approximately imminent, is the registrational dermatomyositis data from brepsitinib, which we hope will set the stage for a commercial launch of that drug and that indication. That pivotal trial is now last patient, last visit completed as of last month, so that data will come, as we've guided before, in the second half pretty shortly. And then finally, the other ongoing major stream that we've been drawing attention to is the L&P litigation with Moderna, which is in the latest innings, at least of the first game here as we approach trial, now scheduled for March of 2026, as well as the ongoing trial with Pfizer and BioNTech. And we'll give a brief update there on this call. On slide six, just as a reminder, we are really proud of the pipeline that we are operating with today. Obviously, first and foremost, with that registrational data coming shortly and with multiple indications with an enormous amount of clinical progress ongoing and with a bunch of registrational trials, five registrational trials for 1402 currently ongoing. And then obviously also mostly CIGAWAT, our owner hypertension program, the update on the second half of next year and ongoing VD as well. You know, on slide seven, I'm not a superstitious person. I'm not going to spend that much time talking about the future beyond the brepcidnib data. But suffice it to say, our next few years ahead are really, really exciting, starting with this PIRL data DM and then with multiple potential registrational data sets and launches, first in brepcidnib and then across the FCRM portfolio. I feel like a few years from now, we could be on these calls describing a pretty different company with quite a large commercial footprint. So we're looking forward to getting started on that, hopefully shortly. Finally, on slide eight, a brief update on our share and purchase program. As I think you're all aware, we completed the $1.5 billion authorized share and purchase program from last year, as of June of 2025. We repurchased just under 150 million shares at an average price of just over $10 a share, so we reduced our share count by over 15%. In the same period, we had meaningfully expanded our pipeline And so we're excited to have increased our own exposure as shareholders and all of your exposure as shareholders to the upcoming catalyst over the next 36 months. As you likely saw, once we completed that program, the board authorized an additional $500 million repurchase program, which we plan to continue evaluating for opportunistic use, especially as the market remains a little bit up and down. You know, on slide nine, just a period of real progress across the entire pipeline. We continue to rapidly advance brepacitin in the press indications. We'll talk more about brepo in just a moment, but as we completed last patient last visit for Valor and DM and our enrolling patients in registrational trials in non-infectious uveitis at a good pace, as well as our proof concept study, tachinosarcoidosis. We are intensely focused on clinical execution for IMVT-1402, probably most importantly with enthusiasm around our Gravesy study with a second registrational trial, a potential registrational trial has begun. And enrollment is picking up nicely there as well. And then we expect additional data from Patoka-Myosin Phase II trial in Graves' disease with the six-month remission data that's presented at ATA next month. We've initiated now our potential registrational program in Sjogren's disease. And then finally, continued progress on our LMP litigation. We'll talk more about it in just a few slides. So I'm going to take just a very brief moment here to refresh everyone on BREPO as we sort of stare down the barrel of this upcoming data. Starting on slide 11, you know, we're really proud of how grepsitinib reflects on the Royvan journey. We feel like we've rapidly expanded it into multiple orphan immunological conditions with a, at this point, in a drug now with a well-established safety profile and over 1,500 patients' dose. You know, as a reminder, we unlicensed this program in the summer of 2021 when, bluntly, the verdict on JAK inhibitors was still out and there were some some questions about what Black Box Morning was going to be. As that field has evolved favorably, obviously some of our competitors are now selling literally many, many billions of dollars with the target. We have separately advanced in now two pivotal programs from the concept program, and we're super excited about some additional indications that we're still doing some work on. Brevacitinib on slide 12 with the Valor study could redefine the standard of care for patients specifically with dermatomyositis. So we've talked about this a fair amount in this forum, but DM is a truly debilitating disease with major unmet medical needs. In our analysis, 40,000 about U.S. adults, there's obviously some slightly higher numbers coming out of some of our competitors. It's a skin and muscle disease that is debilitating to patients' quality of life. They are currently heavily treated with high-dose chronic steroids and other immunosuppressants, which don't work that well overall. REPO is the only oral therapy in late-stage development. It will be the first advanced novel therapy of any modality for patients with DM apart from IVIG. And then the VALOR study is designed to truly establish our profile there. There's good pharmacological rationale for TIK2 and JAK1 inhibition. This is the largest interventional trial in DM ever conducted with a variety of useful endpoints for showing how we benefit quality of life for these patients. And we, as announced at our call in June, have seen good success with our steroid taper, which should help us ensure strong differentiation from SIBO. The Vower study on slide 13, there's a schematic test, two doses of Repcitinib, 30 milligrams and 15 milligrams over a 52-week period with a mandatory steroid taper, as I mentioned. It requires both active skin and muscle disease, and the primary endpoint is mean test for SIBO H52. On slide 14, You can see the baseline characteristics in the study. We put these out again at our representative-specific, DM-specific call in June, which, by the way, if you haven't watched, is a really nice team, the PRIOVAMP team, on the study and the indication. I think we're pretty happy on slide 14 with the baseline characteristics mapped to the other successful late-stage study run into metamyositis, the prognome study of IVIG. And so, again, we're looking forward to those results. One thing we've been quite focused on on slide 15 is the steroid taper here, which, again, is designed to help us manage some of the inherent variability in TIS as an endpoint. And, again, this is all information we put out in June. But we had good success with 98% of patients achieving the mandatory taper, over 40% fully eliminating oral corticosteroids, and over 60%, as you percentile percent reduction from baseline. So really good progress on getting these patients off steroids, which should give reposidinib a truly fair shot in the trial. On slide 16, since we began our DM program, I'd say DM has been increasingly recognized as a commercial opportunity and as a market with high-end that need. Obviously, there's multiple programs ongoing at this point. Dezucabart at Pfizer, F-Cortisumab, a molecule we know well, and Argenix, and Anafoamab at AstraZeneca. We are the only orals. We are the soonest of those readouts. And there's multiple phase two programs that have initiated since the beginning of the Valor study across a variety of mechanisms and companies. BREFO has an overall pretty busy couple of years ahead here, obviously starting with this DM data coming soon, and then following thereafter a regulatory filing for use in DM. We'll then next year get our proof of concept data in cutaneous sarcoidosis, as well as, you know, first half of 2027, top line data in NIU. and around the same time, a launch in the end, hopefully, and then following that, a regulatory filing in the second half of 27 for people in NIU. So quite a lot coming there. The last deeper dive update I'm going to give on this call, and as I said, a relatively brief call given the quiet report here, is on the L&P litigation. So on slide 19, as a reminder, we are in a pivotal period for our L&P litigation overall. In the Moderna cases, we are in a pretrial process to narrow the scope of claims and defenses with an ongoing what's called summary judgment phase, which I'll talk more about in a moment. The U.S. jury trial is currently scheduled for March of 2026, so we're obviously looking forward to that, and we also expect major international hearings in the first half of next year as well. The Pfizer case is ongoing and in active discovery. The Markman hearing was held in December of last year, and the ruling could come this year. So looking forward to that progress also. Probably the biggest update on the case in recent weeks has been on slide 20, the summary judgment motions that were filed in the U.S. Moderna case. As a reminder, at this point, we are asserting four patents, three related to lipid composition, the 359, 435, and 378 patents. That's which lipids make up the sort of balloon, the outside of the LMP inside of which the mRNA is encapsulated. And then the 651 patent on mRNA LNP compositions that describes the encapsulation of mRNA within an LNP. We, Genement and Arbutus, filed three motion summary judgments related to the relitigation of obviousness arguments that were resolved in the IPR process and appeal that we don't want Moderna to be able to assert certain invalidity arguments related to prior art. and that the 651 patent is valid on certain specific grounds. Moderna also filed three motions for summary judgment. Probably the most talked about is the motion of 1498, which is Moderna's attempt to defray liability to the U.S. government under a World War I era patent statute. Secondly, claims around our ability to use the doctoral equivalents based on the prosecution history of the patents. And finally, they're asking for a summary judgment on claims of indefiniteness around the 651 patent. So we look forward to all of those issues being resolved this fall in summary judgment. Some other developments, the case was assigned to a new judge in the same court with trial scheduled for March 26th. And upcoming opposition motions in the summary judgments are due August 22nd. And then there'll be a volley of replies back and forth in September before those summary judgment rulings are made by the judge. Finally, before we wrap up and go to Q&A, just a quick financial update. Relatively straightforward order, you know, on an adjusted basis, net loss of 170, cash utilization of about 200 outside of the shared purchase program and other obvious one-time events. Balance sheet remains incredibly strong. We're privileged. We have $4.5 billion of cash as of June 30th. no debt and a significantly reduced share count thanks to shared purchase program. So that's where we are from a financial perspective. Hopefully we'll be able to talk more about the upcoming year two and three in terms of upcoming catalysts once we have the data in hand. And I'm really excited for what that commercial franchise could look like, what that could mean for patients as an opportunity and what everything else coming beyond it could look like. But we'll wait to talk about that until we can talk more about what that data looks like once we've seen it. So in the meantime, I'll just say thank you again for listening to the prepared portion of this call, and I'm looking forward to taking questions. Operator, over to you.

Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Brian Chang with JPMorgan. Your line is now open.

Hey, guys, thanks for taking our questions this morning. Matt, just on DM, can you talk about just how much data we could get at the time of your top line? Assuming the data is positive, how far are you from filing for approval, and what are some of the remaining gating factors from filing? I have a follow-up. Thank you.

Yeah, perfect. Thank you. Great questions. Look, I think, obviously, we haven't seen the data yet, but my expectations will have top line, all the key secondaries and the major safety data to share approximately contemporaneously with the data. And beyond that, we'll see. But I think all of that obviously gets analyzed at roughly the same time. Assuming that, I think what we've guided to in terms of filing is maybe the very beginning of next year. And I think there's nothing sort of specific and unusual gating other than all of the normal NDA PREP activities, which are significant. Obviously, we've been doing as much of that in parallel as we can, and we'll be looking to hit the gas on that as much as we possibly can and get that filing as early as we can once we've got the data in hand.

Thanks. Got it. And then just on the GRAPES trial, the second trial, can you talk about the trial design that we saw posted here? in your latest deck. You know, we noticed that there is 300 mcg that you're testing. What's the rationale of testing a lower dose in that second Graves trial? Thank you.

Yeah, thanks. It's a great question, and I appreciate your pointing out, actually, that we had posted that Graves trial design. The short answer, along other things, is as Graves may be the first trial reading out in the first registration files or neck and neck with some of the others. We wanted to make sure we had a trial that would ensure FDA approval and they made sure to tell us it would work for them without issue with the lower dose. It's really about ensuring that we can advocate for a minimally efficacious dose with FDA in that process.

Thank you.

Our next question comes from the line of David Reisinger with Lee Ring Partners. Your line is now open. David Reisinger, your line is open.

Please check your mute button.

Our next question comes from the line of Dennis Ding with Jefferies. Your line is now open.

Hi, good morning. Thanks for taking our questions. I have two on the... The first question is just around how is a flare defined in a trial and how does a flare get treated on TIS? Can you give as much color as you can on how patients who require steroid rescue will be treated? And then my second question, you know, you guys mentioned 40% of patients had eliminated steroids. That's a blinded or pooled estimate, correct? And can you hypothesize on what impact, if any, could an imbalance have on the primary endpoint of TIS? between the two arms, meaning if more patients are able to eliminate steroids in the brepo arm versus the placebo arm, could that mask the potential TIS improvements on a placebo-adjusted basis? Thank you.

Yeah, thanks, Dennis. These are obviously good questions that get at what we've discussed is obviously a risk in the trial, which is ensuring correct management of placebo patients. We haven't shared all of that detail, and I'm not sure we're going to do it all now, but Look, I think obviously there's an active protocol for managing these patients as they progress in the trial. It's a two-week study. These patients worsen, they get better, and there are sort of allowances for the doctors to treat them as they come and go. There are sort of different definitions for rescue depending on whether the investigator calls it a rescue or whether they're simply treating the patient. And again, I think all of it is designed to make sure that we're really identifying patients who are flaring and worsening versus those who aren't. In terms of the potential impact of an imbalance, look, I think this is the first DM study ever run with a steroid taper. And a number of previous trials have been successful without a steroid taper. So it's not necessary that the steroid taper do anything, bluntly, in order to have a positive study. Again, you're correct that that is a blinded pooled number and that we've only seen any of this data on a blinded pooled basis. Obviously, if it turned out that steroid doses were much higher in the placebo arm than the drug arm, that could result in better TIS for the placebo arm. But as I said, I think all of this is called belt and suspenders to try and maximize the opportunity for the trial. And I think it goes sort of hand-in-glove with your first question on rescue therapy. But I think in general, we're managing these patients carefully to try and get the most benefit we can out of a steroid taper. These are great questions. Thank you. Great, thank you.

Our next question comes from the line of Corinne Johnson with Goldman Sachs. Your line is now open.

Good morning, guys. Thanks. Maybe could you provide some context around the upcoming GRAVES remission data? What does clinically meaningful outcomes look like there, and how does that fit into the broader clinical strategy in GRAVES? And then maybe one on just business development, you obviously have quite the balance sheet at your disposal. So how should we think about kind of the outlook for VD from here and the type, size, or structure of deals you're most interested in? Thanks.

Yeah, thanks for both really good questions. You know, on Graves, look, I think the short answer to that question is Graves patients and docs tell us that really any amount of meaningful remission would be practice changing for them. I mean, literally, We have docs telling us if even 10% of these patients were able to go into remission. Remember, these are patients who couldn't adequately be controlled on ATDs. So remission of these patients is a truly extraordinary outcome. These are patients who would have been likely potentially on lifelong ATD therapy. And instead, you're putting them here on a new drug and not only getting them off ATDs, but getting them off therapy altogether. So I think any amount of remission would be appealing to docs. So I think that's the answer in terms of the bar. And bluntly, I'm not actually sure how closely the street is following this data. I don't know. I think obviously people care about it. It's in the Tokamab. But I think if you talk to Graves' docs, I think they are very interested in this data. And I think good data here would be helpful for patient enthusiasm, doc enthusiasm, enrollment in the trials. So I think it's a pretty important readout for us. On the BD question, and thanks for asking it, look, I think this remains an attractive market for an asset hunter. The market's choppy. There's a lot of uncertainty. Big pharma companies are obviously going through it in terms of P&L and restructuring. And that creates a good opportunity for us. We have been opportunistic. We will continue to be opportunistic. And the things we see on our racket are really exciting opportunities. sort of potentially transformational late stage opportunities in some cases. And we're looking forward to connecting those brackets to evolve. Thanks, Trent.

Thanks. Our next question comes from the line of Prakhar Agarwal with Cantor. Your line is now open.

Hi, congrats on the quarter and thank you so much for taking my questions. I had to first follow up on the DM question or on the flare up. So when the patient gets a flare up, what's a typical steroid dose that these patients get? Is it close to their baseline or something even higher? And is the steroid dose on a disease flare up defined in the protocol or is it up to the investigator discretion? And secondly, a follow-up on BD. You've seen so many assets in autoimmune as well coming out of China, whether it's in licensing by pharma or formation of NUCO. Is the market an interest for your BD strategy, and what's your latest take on the China market as it relates to competition, the quality of assets, and the valuation these assets are commanding now? Thank you.

Yes, perfect. Thanks. Those are both great questions. On the DM question, just to be clear, because the term flair has come up a couple times on this call, The trial design and stats point stuff is less about the definition of a flare and more about what constitutes rescue therapy. And I think the answer is the physicians will treat these patients in a variety of ways depending on the patient's experience and on the practice. And what we are trying to make sure is that we treat rescue therapy consistently across different docs. So it's not like there's some magic number around which, you know, if the patient looks this way, they get this much incremental steroid dose. And obviously there are some patients who get treated at high doses, and there's some patients who just get bumped up a little bit. And I think what we're really trying to get at with the definitions is making sure that we're capturing patients who are worsening and getting steroids because they are worsening. And that's what all the definitions are designed to capture. On the BD question, look, we're agnostic hunters, so we look everywhere. We've done a fair amount of looking in China, Over the last 18 months, I expect we will continue to look there. There are things that are attractive. There are things that we are close to there. It's an interesting market, as you mentioned, in autoimmune and other areas as well. I think one thing that's super impressive about that market now is the lead among programs has significantly shortened because you get high-quality drugs coming out of China or high-quality drug candidates coming out of China very quickly, at least in certain targets. And so I think we're thinking broadly about it. mechanisms like the FCRN or JAK1, TIK2 mechanism where you can do a lot with the mechanism through creative clinical development, and we think that's going to be an important battlefield for the future across big pharma and biotech.

Thanks for the question.

Thank you. Our next question comes from the line of Sam Slutsky with LifeSci Capital. Your line is now open.

Hey, good morning, everyone. Thanks for the questions. Just two for me. I guess on brepo and DM, since physicians are overall comfortable with the efficacy of JAK inhibitors in the disease, do you get the sense from doctors that the bar is just to hit that figure here so that they have it at their disposal to use on label? Or is there a specific bar on what they would consider a win on the primary endpoint? And then second question is for bitoclumab and TED. How might you leverage that data as positive, whether it's to help the positioning of FCRNs in Graves' disease, or would you even consider a future program in TED with 1402? Thanks.

Yeah, thanks, Sam.

I appreciate both questions. Look, on DM, and we've said this before, but it's a great reminder, we think and we think docs think that a simple stat-seq trial on TIS is the bar for efficacy. And part of that, boldly, is, as you said, docs are generally predisposed to the mechanism. But I think part of it also is that TISS is an artifice of clinical trials as an endpoint. And so I think docs are just focused on good options for these patients that overall improve the way the patients feel and their quality of life. And I think we've got, frankly, a variety of endpoints in the study that will underscore that. So I think the answer is that the bar is pretty clearly a stat-safe trial and not any specific number. Look, for BADO and TED, obviously we will learn a lot in that TED study that informs patients our Graves disease development. There will be patients in the study that are Graves patients, so we'll learn a lot that informs Graves. As far as TED itself is concerned, we're going to be informed by the data as we see it, and we'll make decisions on TED together with our partner, HANALL, once we have that data at hand.

Thank you.

Thank you. Our next question comes from the line of Douglas Sao with HC Rainright. Your line is now open.

Hey, good morning. Thanks for taking the question. Just, Matt, on the DM study, I'm just curious in terms of the steroid taper, what's the goal for patients to get off steroids?

Sorry, yes. So the question is, on the steroid taper, what's the goal for patients to get off steroids? In terms of timing. Oh, in terms of timing. Yeah, how far... Yeah, the patient begins at week 12. The taper begins at week 12, and the mandatory taper concludes at week 36. So 98% of patients factually were below five at week 36. Obviously, once you start tapering at week 12, the goal in general is to get these patients as low as possible by week 36. So that's the sort of goal. And again, the point here is to make sure that the drug has its time to do its thing.

And I'm just curious, you know, a lot of the data for brepacitinib has been, or the positive data is with the 30 milligram dose, which is obviously included. I'm just curious what your expectations are for 15 milligram dose.

Yeah, so on the one hand, thanks for your question, 15 has been an active dose of brepacitinib in other programs and other indications. On the other hand, and we've said before, I think the main reason for the inclusion of 15 here was regulatory in nature, and I don't think we're particularly focused on what 15 looks like. And I think it's not sort of 100% obvious whether we expect to hit on 15 or not. The primary is on 30. And I think we're really focused on generating the best possible data that we can at the 30 milligram dose. Okay, great. Thank you so much.

Our next question comes from the line of Jatin Suneha with Guggenheim. Your line is now open.

Hey, guys. Thank you for taking my question. Two for me. On 1401, I mean, all these registration studies that you're running, would you please... give us an update on how the enrollment is shaping up for all these studies, whether it's the CIDP, myasthenia gravis, or the Graves. And also, if you can comment on the spend rate, particularly as it relates to the immunoend piece. I saw a little bit of a bump up in R&D. I'm just curious how it's going to shape up for both R&D and GNA as we go into later this year and next year. Thank you.

Yeah, thanks, John. Great question. I assume you mean on 1402 for the enrollment, but obviously the 1401 trials are all fully enrolled at this point. For 1402, yeah, look, I think we feel good about enrollment across all of the trials. Obviously, Eric's now been on the ground since April. I think that team is really humming. Obviously, there's a lot of enthusiasm across most of these indications for FCRMs, and I think we see that in the speed of site activation and the speed of enrollment, so I think we feel good. We're on track to hit all of our publicly stated timelines. So we're feeling good about enrollment altogether. You know, on spend, our guidance remains that we're comfortably set up here to hit Graves data on the current balance sheet. Obviously, you will see an uptick in R&D here because we now have so many ongoing registrational studies for 1402, but feeling good. Spend should be pretty stable, a little bit of an adverse working capital this quarter and some one-time SPC-related stuff that obviously doesn't get to Burns. So overall, feeling good about those timelines and about our cash guide. Thank you.

Thank you. Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.

Hi, this is Dom McDonald for Yasmeen Rahimi. Congrats on a great quarter, and thank you for taking our question. So, we just had a question on 1402. We are excited to see the additional data and six-month remission data from the Graves Disease Program will be presented at ATA in September. So, what do you hope to report at ATA? And could you walk us through how, I guess, you're thinking more about the importance of this? And then you talked a little bit about the doc and patient's perspective. Thank you.

Yeah, thanks. Great question. And we are also looking forward to that data for sure. You know, I think, look, what we're hoping to report, and we got it a little bit with the question of what the quote-unquote bar is earlier. is to highlight that this is a really paradigm-shifting opportunity for Graves patients, that this will help endos who treat these patients realize that this is not an incremental tool, that it's transformative and that it can get patients who are currently gonna be on lifelong medicine to remission. which still is possible for milder patients with ATDs, but has never really been possible for these more severe recalcitrant patients. And this is, you know, an ability then to avoid surgeries, to avoid radioactive iodine, to treat these patients differently. So my hope is that any amount of remission showed is just patients who, again, like have their lives really changed. And I think even small levels of remission will be super meaningful to docs in that context. So I think that's, That's really the goal. And I think the importance there, look, it's threefold at some level. It gets to the commercial opportunity and how enthusiastic we expect docs and patients will be when FCRNs are hopefully approved in Graves' disease. It gets to the enrollment of the study. That is, it gets to how excited patients are to get in the trial, how excited docs are to be pushing. And I think that'll be helpful as well. And then it just gets to the clinical profile of the drug. It gets to what we're able to do versus other classes, versus other mechanisms, versus the current standard of care in a way that I think, you know, insofar as the goal here is always to drive benefit for patients, it gives us an opportunity to point to what we're doing there.

So we're really looking forward to it as a meaningful step. Thank you.

Thank you. Our next question comes from the line of David Reisinger with LeadRink Partners. Your line is now open.

Yeah, thanks very much. Sorry about the background noise. Congrats on all the progress. My questions have been asked, so I'm curious just about GREPO and NIU, if you could give us a roadmap for the pivotal development and the potential filing year. Thanks very much.

Perfect. Thank you. Super excited about REPO and NIU. It's obviously an indication where we developed our own. We did generate our own phase two data last year, and it was quite good data that we were very proud of. So the enrollment of that trial is going extremely well. Our guidance remains data first half of 2027. We're certainly on track to hit those timelines, and we're hoping we can file an SMDA relatively shortly after we get that data. And this would be an SMDA, so it's a shorter review timeline than the original uh NDA so yeah really looking forward to that and I think that the hope there again with the first half of 2027 we would be getting data at NIU right around the time that we were launching uh in DM and so we get to kind of stack those indications uh in a way that should be additive overall and give us an opportunity to get our feet set in DM and then relatively quickly to to pivot into or to add the NIU patient population and doc population. And one of the nice things about both of these commercial opportunities is they're quite tractable. The patients are treated at a concentrated set of sites. We have a pretty clear sense of who we need to talk to from a doc perspective, so we feel really good about both of those commercial opportunities. Thanks, Dave. Really appreciate the question. Thank you.

Our next question comes from the line of Jerome Werber with TD Cowan. Your line is now open.

Hi, good morning, guys. This is Sarah Cai on For Your Own. Just a quick question on brecocitinib. In the prior data with JAK1s on TIF, they've shown really impressive efficacy in the exploratory open-label studies. So how informative is that prior data for brecocitinib? Thank you.

Thank you. Appreciate the question. Obviously, we hope the answer to that question is that it is highly informative. Look, I think you can learn a certain amount from open-label studies. And the fact that they're so consistent at this point is comforting. The fact that there's a bunch of case reports as well. The fact that, and this is a question we used to get more, but the number of case reports and the number of studies showing benefit on both muscle and skin has been significant. So I think that's all comforting. That said, these are not placebo-controlled studies. There's a lot of variability in TISS. And so ultimately, I will bite my nails and lose sleep until I see the placebo-controlled data just the same. We obviously also hope to see benefit sort of from both JAK1 and TIK2. And so hopefully that gives us some additional edge even relative to those studies. But again, comfort among docs and great open-label data from precedent studies is not sufficient to get a drug approved. So until we see the Phase III data, we'll We'll be nervous, and you can all be nervous with us.

Thank you. Thank you. Thank you. Our next question comes from the line of Emma Gutstein with Wolf Research. Your line is now open.

Hi, this is Emma on for Andy. Thanks for taking our question. Two questions from us. Just looking at slide 16, numerous companies are targeting DM. Can you elaborate on your approach for navigating this highly competitive market? And also in the press release, you mentioned preparations for potential launch and DM. Are there specific preparations or key milestones you're planning for in the next six to 12 months? Thank you.

Yeah, thank you. I appreciate the question. One thing I'll say is in highly competitive commercial markets, and I can't say this everywhere in our portfolio, but I can say it here, our view is that it helps to be first. And so I think the fact that we're in the lead of this pack is helpful. Obviously, we have... Look, I think JAK inhibitors, to your point, have shown impressive efficacy in other settings. I think we would hope to have a good, strong clinical benefit for these patients. I think that's obviously a part of the strategy, although given the high level of comfort these docs have, I think there would be a benefit of the doubt. We're obviously an oral therapy, which is different from all of these other mechanisms. And remember, these patients are often managed. If they're not on IVIG, they are managed on oral steroids, and so they're used to taking regular oral medication. So I think we should have a great profile in addition to being first. Obviously, given comfort with the class, given thousands of patients with our molecule, we think we should be well set up with the staff community. In terms of preps for launch, look, there's only so much you can do before you have the phase three data in hand, but there's a lot of, at this point, roadmap to follow from other highly successful commercial launches by biotech companies that we've gotten to watch. I think one of the things that clearly matters is great engagement with the physician community. And the Priyavan team has been out engaging in the context of the trial and otherwise with the physician community super actively. And I think we have a reputation with that community that I'm very proud of and I think has been hard won, both in terms of the sort of expectation around what the drug can do and in the quality of the team that we have at Priyavan. So I think those docs are super important. I think we will continue to engage with them. And once we have the data, we'll be able to do a bit more. Thank you.

Thank you. This concludes the Q&A session. I would now like to hand the call back over to Matt Glein for closing remarks.

Thank you again, everybody, for listening this morning. Again, a relatively quiet quarter, but a really exciting few months ahead for the business, so looking forward to getting back on the phone and talking about a number of updates as they come, and I hope to speak again soon. I want to say thank you again to, obviously, the Roivant and VAMP teams, Univant, Privant, Pullament, etc., who are working hard to get these studies enrolling, working hard to generate this clinical data. I want to thank, obviously, our shareholders, and I want to thank all the investigators and patients who trust us with their care. We're looking forward to sharing some of that patient data as soon as we get it. So thank you, everybody, and have a great Monday.

This concludes today's conference call. Thank you for your participation. You may now disconnect.