Roivant Sciences Ltd

F:87S

Q1-2026 Earnings Call

[Operator]

Good day, and thank you for standing by. Welcome to the Roivant First Quarter 2025 Earnings Call. [Operator Instructions] 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.

[Stephanie Lee Griffin, executive]

Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2025. 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 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.

Now with that, I'll turn it over to Matt.

[Matthew Gline, executive]

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 5, which is a reminder of sort of where we are for this year. So three main themes for calendar year 2025.

The first of those is the continued progress that we're making with IMVT-1402 in 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 batoclimab, our first-generation drug in MG & CIDP. And now it's really a story of that team focused clinical execution, getting the Graves 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 brepocitinib, which we hope will set the stage for a commercial launch of that drug in that indication. That pivotal trial is now with last patient's 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 LNP 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 6, just as a reminder, we are really proud of the pipeline that we are operating with today. Obviously, first and foremost, with brepocitinib, 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 Mosliciguat, our pulmonary hypertension program, that we will have data in the second half of next year and ongoing BD as well.

On Slide 7, I'm not a superstitious person, I'm not going to spend that much time talking about the future beyond the brepocitinib data. But suffice it to say, our next few years ahead are really, really exciting, starting with this pivotal data in DM and then with multiple potential registrational data sets and launches first in brepocitinib and then across the FcRn 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 8, a brief update on our share repurchase program. As I think you're all aware, we completed the $1.5 billion authorized share repurchase 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 have meaningfully expanded our pipeline and so we're excited to have increased our own exposure to our shareholders and all of your exposure to shareholders to be upcoming catalysts 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.

On Slide 9, just a period of real progress across the entire pipeline. We continue to rapidly advance brepocitinib across indications. We'll talk more about brepo in just a moment. But obviously completed last patient last visit for VALOR and DM and are enrolling patients in registrational trials in non-infectious uveitis at a good pace as well as our proof-of-concept study, cutaneous sarcoidosis.

We are intensely focused on clinical execution for IMVT-1402, probably most importantly, with enthusiasm around our Graves' disease study with the second registrational trial, potentially registrational trial has begun and enrollment is picking up nicely there as well.

And then we expect additional data from batoclimab Phase II trial in Graves' disease with the 6-month remission data to be presented at ATA next month. We've initiated now our potential registrational program in Sjögren's disease.

And then finally, continued progress on our LNP 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 sit down with arrow this upcoming data, starting on Slide 11. We're really proud of how brepocitinib reflects the Roivant journey. We feel like we've rapidly expanded it into multiple orphan immunological conditions with -- at this point, in a drug now with a well-established safety profile in over 1,500 patients dosed.

As a reminder, we in-licensed this program in the summer of 2021, when -- but the verdict on JAK inhibitors was still out and there were some questions about what black box warning 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, proof-of-concept program, and we're super excited about some additional indications that we're still doing some work on.

Brepocitinib on Slide 12 with the VALOR study could redefine the standard of care for patients specifically with dermatomyositis. So we talked about this a fair amount in this forum, but DM is a truly debilitating disease with major unmet medical need, affecting 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, but don't work that well overall.

Brepo is the only oral therapy in late-stage development that will be first advanced novel therapy of any modality for patients with DM or from IVIG. And then the VALOR study is designed to truly establish our profile there. There's good pharmacological rationale for TYK2 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 as we announced a call in June, have seen good success with our steroid taper, which should help us ensure a strong differentiation from placebo.

The VALOR study on Slide 13, there's a schematic test, 2 doses of brepocitinib, 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 TIS for placebo age 52.

On Slide 14, you can see the baseline characteristics in the study. We put these out again at our brepocitinib specific, DM specific call in June, which by the way, if you haven't watched, is a really nice team, the Roivant 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 in dermatomyositis, the ProDERM 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 end point. 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 -- sorry, oral corticosteroids and over 60% achieving a greater than 75th percentile -- 75% reduction from baseline. So really good progress on getting these patients off steroids, which should give brepocitinib 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 unmet need. Obviously, there's multiple programs ongoing at this point. Dazukibart at Pfizer; Efgartigimod, a molecule we know well, at Argenx; and Anifrolumab at AstraZeneca. We are the only oral. We are the soonest of those readouts, and there's multiple Phase II programs that have initiated since the beginning of the VALOR study across a variety of mechanisms and companies.

Brepo 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 first half 2027 top line data in NIU, and around the same time, a launch in DM, hopefully. And then following that, a regulatory filing, in the second half of '27, of brepo for use 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 quieter quarter here is on the LNP Litigation.

So on Slide 19, as a reminder, we are in a pivotal period for our LNP Litigation overall. In the Moderna cases, we are in a pre-trial 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 in inactive discovery. The Markman hearing was held in December of last year and the ruling could come in this year. So looking forward to that, 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 which lipids make up, sort of, balloon the outside of the LNP, inside of which the mRNA is encapsulated. And then the '651 patent on mRNA LNP compositions that describes the encapsulation of mRNA within in LNP.

We, Genevant and Arbutus filed three motions for summary judgment related to the relitigation of obviousness arguments that were resolved in the IPR process and appeal that, that we don't want Moderna to be able to assert certain invalidity arguments related to a 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 attempts to defray liability to the U.S. government under a World War 1 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 2026. And upcoming opposition motions in the summary judgments are due August 22, 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 quarter on an adjusted basis, net loss of $170 million, cash utilization of about $200 million outside of the share repurchase program and other throughout these onetime events.

Our balance sheet remains incredibly strong. We're privileged we have $4.5 billion of cash as of June 30, no debt and a significantly reduced share count. Thanks to share purchase program. So that's where we are from a financial perspective.

Look, hopefully, we'll be able to talk more about the upcoming year 2 and 3 in terms of upcoming catalysts once we have the brepocitinib data in hand. And I'm really excited for what that commercial franchise could look like, what that could mean for patients is an opportunity of what everything else coming beyond it can 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.

[Operator]

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

[Lut Ming Cheng, analyst]

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 filings? I have a follow-up.

[Matthew Gline, executive]

Yes. Perfect. Thank you. Great questions. Look, I think obviously, we haven't seen the data yet, but my expectation is we'll 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 roughly at 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.

[Lut Ming Cheng, analyst]

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

[Matthew Gline, executive]

Yes. Thanks. It's a great question. And I appreciate you pointing out actually that we have posted that Graves' trial design. The short answer among other things is, as Graves may be the first trial -- now in the first registration we filed sort of neck and neck with some of the others. We wanted to make sure we had a trial that would ensure FDA approval, and they make 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 minimally efficacious dose with FDA in that process.

[Operator]

Our next question comes from the line of David Risinger with Leerink Partners. Our next question comes from the line of Dennis Ding with Jefferies.

[Yuchen Ding, analyst]

I have two on DM. The first question is just around how is a flare defined in the trial? And how does the flare get treated on TIF? And 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 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 TIF 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?

[Matthew Gline, executive]

Yes. 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 52-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 steroid taper do anything bluntly in order to have a positive study. Again, you're correct that, that is a blinded pool number and that we've only seen any of this data on a blinded pool 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 kits for the placebo arm. But as I said, I think all of this is -- all of this is, call it, 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 the steroid taper.

These are great questions. Thank you.

[Operator]

Our next question comes from the line of Corinne Johnson with Goldman Sachs.

[Corinne Jenkins, analyst]

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 BD from here and the type size or structure of deals you're most interested in?

[Matthew Gline, executive]

Yes. Thanks, Corinne, both really good questions. 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 in 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 batoclimab. 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 trial. 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 is 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 sort of potentially transformational late-stage opportunities in some cases. And we're looking forward to connecting those rackets to evolve.

[Operator]

Our next question comes from the line of Prakhar Agrawal with Cantor.

[Prakhar Agrawal, analyst]

I had two. First, a 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. We've seen so many assets in autoimmune as well coming out of China, whether it's in-licensing by pharma or formation of NewCo. 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?

[Matthew Gline, executive]

Yes. Perfect. Those are both great questions. On the DM question, just to be clear, because the term flare has come up a couple of times on this call. The trial is -- sort of trial design in staff point stuff is less about sort of 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 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 are 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 hunter, 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, high-quality drug candidates coming out of China very quickly, at least in certain targets. And so, I think we're thinking broadly about mechanisms like the FcRn or JAK1/TYK2 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.

[Operator]

Our next question comes from the line of Sam Slutsky with LifeSci Capital.

[Samuel Slutsky, analyst]

Just two for me. I guess on Brepo and DM, since physicians are overall comfortable with the efficacy of JAK inhibitors and the disease, do you get the sense from doctors that the bar is just to hit stat sig here, so that they have it at their disposal to use on label? Or is there a specific bar on what they would consider when on the primary end point?

And then second question is for batoclimab in TED. How might you leverage that data if 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?

[Matthew Gline, executive]

Thanks, Sam. I appreciate both questions. Look, on DM, and we said this before, but it's a great reminder. We think and we think docs think that a simple statistic trial on TIS is the bar for efficacy. And part of that, partly is, as you said, docs are generally pretty exposed to the mechanism. But I think part of it also is that TIS is an artificial 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 sig trail and not any specific number. Look, for Bato and TED, obviously, we will learn a lot in that TED study that informs 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.

[Operator]

Our next question comes from the line of Douglas Tsao with H.C. Wainwright.

[Douglas Tsao, analyst]

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?

[Matthew Gline, executive]

Sorry. Yes. So the question is on steroid taper, what's the goal for patients to get off steroids. In terms of timing. Yes, the patient begins at week 12. The taper begins at week 12 and the mandatory taper concludes at week 36. So 98% of patients actually were -- were below 5 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.

[Douglas Tsao, analyst]

And I'm just curious, a lot of the data for brepocitinib has been -- or positive data with the 30-milligram dose, which is obviously included. Just curious if you have -- what your expectations are at the 15-milligram dose?

[Matthew Gline, executive]

Yes. So on the one hand, thanks to your question. 15-milligram has been an active dose of brepocitinib 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-milligram here was regulatory in nature. And I don't think we're particularly focused on what 15-milligram looks like, and I think it's not sort of 100% obvious, whether it's we expect to hit on 15-milligram or not. The primary is on 30-milligram. And I think we're really focused on generating the best possible data that we can at the 30-milligram dose.

[Operator]

Our next question comes from the line of Yatin Suneja with Guggenheim.

[Yatin Suneja, analyst]

Two for me. One 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 Immunovant piece? I saw a little bit of a bump up in R&D. Just curious how it's going to shape up for both R&D and G&A as we go into later this year and next year.

[Matthew Gline, executive]

Yes. Thanks, Yatin. Great question. I assume you mean our 1402 for the enrollment. But obviously, the 1401 trials are all fully enrolled at this point. For 1402, look, I think we feel good about enrollment across all of the trials. Obviously, Eric has 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 FcRn. 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. On spend, our guidance remains that we're comfortably set up here to hit Graves' data on the current balance sheet. Obviously, we 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 onetime SPC-related stuff that obviously doesn't get burned. So overall, feeling good about those timelines and about our cash guidance.

[Operator]

Our next question comes from the line of Yasmeen Rahimi with Piper Sandler.

[Unknown Analyst]

This is Dominic on for Yasmeen Rahimi. So we just had a question on 1402. We are excited to see the additional data and 6-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? I know you talked a little bit about the doc and patient's perspective?

[Matthew Gline, executive]

Yes, thanks. Great question. We are also looking forward to that data for sure. I think, look, what we're hoping to report, and we got it a little bit with the question of what the "bar" is earlier, is to highlight that this is a really paradigm shifting opportunity for Graves' patients, that this will help and those who treat these patients realize that this is not an incremental tool, but it's transformative and that can get patients who are currently going to be on lifelong medicine to remission, which something is possible for milder patients with ATDs, but has never really been possible for these more severe recalcitrant patients. And this is an ability then to avoid surgeries to avoid radioactive iodine and 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 exciting patients are to get in the trial, how excited docs are to be pushing. And I think that will 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, as far 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 that as a meaningful step.

[Operator]

Our next question comes from the line of David Risinger with Leerink Partners.

[David Risinger, analyst]

Congrats on all the progress. My questions have been asked. So I'm curious just about brepo and NIU. If you could give us a road map for the pivotal development and the potential filing here.

[Matthew Gline, executive]

Perfect. We are super excited about brepo and NIU. It's obviously an indication where we developed our -- we generated our own Phase II 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 sNDA relatively shortly after we get that data, and this will be an sNDA. So it's a shorter review timeline than the original NDA.

So we are really looking forward to that. And I think the hope there, again, with the first half of 2027, we would be getting data in NIU right around the time that we were launching in DM. And so we get to kind of stack those indications 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 pivot into or add the NIU patient population, a doc population.

And one of the nice things about both of these commercial opportunities is, they're quite tractable. The patients are treated in a concentrate set of sites. We have a pretty good sense of who we need to talk to from that perspective. So we feel really good about both of those commercial opportunities.

Thanks, Dave. I really appreciate the question.

[Operator]

Our next question comes from the line of Yaron Werber with TD Cowen.

[Unknown Analyst]

This is Sara on for Yaron. Quick question on brepocitinib in the prior data with JAK1 on TIS. They've shown really impressive efficacy in the exploratory open-label study. So how informative is that prior data for brepocitinib?

[Matthew Gline, executive]

Thank you. Appreciate the question. Obviously, we hope the answer to that question is, if 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 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.

Next, these are not placebo-controlled studies. There's a lot of variability in TIS. 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 TYK2. 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 baricitinib studies is not faced to get a drug approved. So until we see the Phase III data, we'll be nervous and you could all be nervous with us.

[Operator]

Our next question comes from the line of Emma Gutstein with Wolfe Research.

[Emma Gutstein, analyst]

This is Emma on for Andy. Two questions from us. Just looking at Slide 16 and 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 in DM. Are there specific preparations or key milestones you're planning for in the next 6 to 12 months?

[Matthew Gline, executive]

Yes. Thank you. I appreciate the question. One thing I'll say is in a 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 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 will be a benefit of a doubt. We're obviously an oral therapy, which is different from all of these other mechanisms.

Remember, these patients are often managed. If they're not on IVIG, they are managed on oral steroids. And so they are 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 dosed with our molecule, we think we should be well set up with this doc community. In terms of preps for launch, look, there's only so much you can do before you have the Phase III data in hand, but there's a lot of -- there's a lot of, at this point, a road map to follow from other highly successful commercial launches by biotech companies that we've got to watch.

I think one of the things that clearly matters is great engagement with the physician community and the Priovant 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 Priovant. 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.

[Operator]

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

[Matthew Gline, executive]

Yes. 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. I hope to speak again soon. I want to say thank you again to obviously, the Roivant and Vant Teams, Immunovant, Priovant, Pulmovant, et cetera, who are working hard to get these studies enrolled in working hard to generate 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. And 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.

[Operator]

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