Roivant Sciences - Earnings Call - Q1 2026

Executive Summary

• Q1 2026 was operationally “quiet” with focus on clinical execution and near-term catalysts; GAAP revenue was $2.17M, GAAP diluted EPS from continuing operations was -$0.33, and adjusted loss from continuing operations was $170.1M.
• Management reiterated imminent Phase 3 dermatomyositis (DM) topline for brepocitinib in 2H 2025 and strong progress across the FcRn (IMVT-1402) franchise (Graves’, Sjögren’s, MG, CIDP), positioning for multiple potential launches over the next 24–36 months.
• Balance sheet remains robust: $4.5B in consolidated cash, equivalents, restricted cash and marketable securities; completed $1.5B buyback (including $208M in Q1) and authorized an additional $500M repurchase program.
• Near-term stock catalysts: DM Phase 3 readout (2H 2025), Graves’ remission data from batoclimab (ATA, September), and LNP litigation summary judgment decisions in fall ahead of a U.S. jury trial scheduled for March 2026.

What Went Well and What Went Wrong

What Went Well

• Continued clinical execution: brepocitinib DM VALOR reached last patient, last visit in July; NIU Phase 3 and cutaneous sarcoidosis (CS) PoC are enrolling toward 2026–2027 readouts.
• FcRn portfolio expansion: initiated potentially registrational IMVT-1402 trials in Graves’ and Sjögren’s in June; all six indications remain on track.
• Capital allocation: completed $1.5B buyback, reduced share count >15% since Mar 31, 2024; board approved new $500M program. “We repurchased just under 150,000,000 shares at an average price of just over $10”.

What Went Wrong

• GAAP revenue declined to $2.17M and GAAP diluted EPS from continuing operations was -$0.33; loss from continuing operations was $273.9M, reflecting higher R&D and G&A (share-based comp) versus prior year.
• R&D increased to $152.9M (non-GAAP $141.0M), driven by anti-FcRn and mosliciguat program costs; G&A rose to $134.0M (non-GAAP $62.6M) primarily from higher share-based comp tied to 2024 executive awards.
• LNP litigation remains an overhang; summary judgment motions filed and case reassigned to a new judge; timeline extends to March 2026 jury trial, adding legal uncertainty into 2026.

Transcript

Speaker 6

Okay. Thank you for standing by. Welcome to the Roivant Sciences 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 one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one 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.

Speaker 0

Good morning, and thanks for joining today's call to review Roivant Sciences' financial results for the first quarter ended June 30, 2025. I'm Stephanie Lee with Roivant Sciences. Presenting today, we have Matt Gline, CEO of Roivant Sciences. 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.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I would 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. With that, I'll turn it over to Matt.

Speaker 5

Thank you, Stephanie, and thank you, everybody, for joining this morning. I appreciate it. It is a relatively quiet quarter before it promises to be a very busy fall. 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. Three main themes for calendar year 2025. The first of those is the continued progress that we're making with IMVT-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 batoclimab, our first-generation drug, in imaging at CIGP. Now it's really a story of that team on 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, what, last patient last visit completed as of last month. That data will come as we've said for in the second half pretty shortly. 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. 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 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 with IMVT-1402 currently ongoing. Obviously also mosliciguat, our pulmonary hypertension program, the data in the second half of next year and ongoing PD as well. On slide seven, I'm not a superstitious person. I'm not going to spend that much time talking about the future beyond the brepocitinib data. Suffice it to say, our next few years ahead are really, really exciting, starting with this pivotal data in dermatomyositis 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.

We're looking forward to getting started on that, hopefully shortly. Finally, on slide eight, a brief update on our share purchase program. As I think you're all aware, we completed the $1.5 billion authorized share purchase program from last year. As of June 2025, we repurchased just under 150 million shares at an average price of just over $10 a share. We reduced our share count by over 15%. In the same period, we have meaningfully expanded our pipeline, and we're excited to have increased our own exposure as shareholders and all of your exposure as shareholders to the 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 nine, just a period of real progress across the entire pipeline. We continue to rapidly advance Brepocitinib across indications. We'll talk more about Brepocitinib in just a moment, but obviously completed last patient last visit for VALOR and dermatomyositis and are enrolling patients in registrational trials in non-infectious uveitis at a good pace, as well as our proof of concept study in cutaneous sarcoidosis. We are intensely focused on clinical execution for IMVT-1402, probably most importantly, with enthusiasm around our Graves’ disease study with a second registrational trial, a potential registrational trial has begun, and it's picking up nicely there as well. We expect additional data from the anti-FcRn antibody therapies space to try on 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. Finally, continued progress on our LNP litigation.

We'll talk more about it in just a few slides. I'm going to take just a very brief moment here to refresh everyone on Brepocitinib as we sort of stare down the barrel of this upcoming data. Starting on slide 11, we're really proud of how Brepocitinib reflects on the Roivant journey. We feel like we've rapidly expanded it into multiple orphan immunological conditions, with at this point a drug now with a well-established safety profile on over 1,500 patients dosed. You know, as a reminder, we in-licensed this program in the summer of 2021 when broadly the verdict on JAK inhibitors was still out, and there were some impressions of what the 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 from the 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. We've 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, about 40,000 U.S. adults. There are 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 that don't work that well overall. Brepocitinib is the only oral therapy in late-stage development, and we're being the first advanced novel therapy of any modality for patients with DM apart from IVIG.

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. As we announced on our call in June, we have seen good success with our steroid taper, which should help us ensure strong differentiation from placebo. The VALOR study on slide 13, there's a schematic that tests two 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 MMT-8 at week 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 by the Priovant 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. We're looking forward to those results. One thing we've been quite focused on on slide 15 is the steroid taper here, which is designed to help us manage some of the inherent variability in tests as an endpoint. 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% achieving a greater than 75% reduction from baseline.

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 dermatomyositis (DM) program, I'd say DM has been increasingly recognized as a commercial opportunity and as a market with high unmet need. There are multiple programs ongoing at this point: Dazucumab, Adviser, and Eftirtizumab, a molecule we know well in argenx, and then a fluvimab at AstraZeneca. We are the only oral. We are the soonest of those readouts. There are multiple phase two 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, starting with this DM data coming soon and then following thereafter a regulatory filing for JUICE and DM.

Next year we will get our proof of concept data in cutaneous sarcoidosis, as well as, in the first half of 2027, top line data in non-infectious uveitis (NIU). Around the same time, a launch in DM, hopefully. Following that, a regulatory filing in the second half of 2027 will be in NIU. 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. 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 pretrial process to narrow the scope of claims and defenses with an ongoing summary judgment phase, which I'll talk more about in a moment. The U.S. jury trial is currently scheduled for March of 2026.

We're looking forward to that. 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 the summer of last year, and the ruling could come this year. 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, which lipids make up the sort of balloon of the outside of the LNP and inside of which the mRNA is encapsulated. Then the 651 patent on mRNA LNP compositions that describes the encapsulation of mRNA within an LNP.

We, joined with 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 on 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 doctrine of equivalence based on the prosecution history of the patents. Finally, they're asking for a summary judgment on claims of indefiniteness around the 651 patent. 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 the trial scheduled for March 2026. Upcoming opposition motions in the summary judgments are due August 22. There will 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 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 30, no debt, and a significantly reduced share count thanks to the share purchase program. 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 Brepocitinib data in hand. I am 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. We will wait to talk about that until we can talk more about what that data looks like once we have seen it. In the meantime, I will just say thank you again for listening to the prepared portion of this call. I am looking forward to taking questions. Operator, over to you.

Speaker 6

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

Speaker 5

Yeah, perfect. Thank you. Great, 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. Beyond that, we'll see. I think all of that obviously gets now 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. 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. We'll be looking to hit the gas on that as much as we possibly can to get that filing as early as we can once we've got the data in hand.

Got it. 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? 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, among other things, is as Graves may be the first trial reading out and the first registration we file, sort of neck and neck with some of the others, we wanted to make sure we had a trial that would ensure FDA approval. 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.

Thank you.

Speaker 6

Our next question comes from the line of David Risinger with Leerink Partners. Your line is now open. David Risinger, 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 DM. The first question is just around how is a flare defined in a trial, and how does a flare get treated on TIF? Can you give as much color as you can on how patients who require steroid rescue will be treated? My second question, you know, you guys mentioned 40% of patients had eliminated steroids. That's a blinded or pooled estimate, correct? 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 Brepocitinib arm versus a placebo arm, could that mask the potential TIF improvements on a placebo-adjusted basis? Thank you.

Speaker 5

Yeah, thanks, Dennis. These are obviously good questions that get at what we've discussed. There's 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. Look, I think obviously there's an active protocol for managing these patients as they progress in the trial of 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 different definitions for rescue depending on whether the investigator calls it a rescue or whether they're simply treating the patient. 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, I think this is the first dermatomyositis (DM) study ever run with a steroid taper. A number of previous trials have been successful without a steroid taper. 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 TIFs for the placebo arm. As I said, I think all of this is called belt and suspenders to try and maximize the opportunity for the trial. I think it goes hand in glove with your first question on rescue therapy.

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.

Speaker 6

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

Thanks. 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? Maybe one on just business development. You obviously have quite the balance sheet at your disposal. 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? Thanks.

Speaker 5

Yeah, 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 into remission. Remember, these are patients who couldn't adequately be controlled on ATDs. Remission in these patients is a truly extraordinary outcome. These are patients who would have been likely potentially on lifelong ATD therapy. Instead, you're putting them here on a new drug and not only getting them off ATDs, but getting them off therapy altogether. I think any amount of remission would be appealing to docs. I think that's the answer in terms of the bar. 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 Tocamab. If you talk to Graves docs, I think they are very interested in this data. I think good data here would be helpful for patient enthusiasm, doc enthusiasm, enrollment in the trials. 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. That creates a good opportunity for us. We have been opportunistic. We will continue to be opportunistic. The things we see on our racket are really exciting, sort of potentially transformational late-stage opportunities in some cases. We're looking forward to connecting those rackets to the ball. Thanks, Corinne.

Thanks.

Speaker 6

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

Hi. Coming out from the quadrant. Thank you so much for taking my questions. I had two. First, a follow-up on the DM question or on the flare-up. 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? Is the steroid dose on a disease flare-up defined in the protocol, or is it up to the investigator discretion? Secondly, a follow-up on BD. We've seen so many assets and autoimmune as well coming out of China, whether it's in licensing by pharma or formation of newco. Is the market in 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.

Speaker 5

Yeah, perfect. Thanks. 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 sort of trial design and stats point stuff is less about the definition of a flare and more about what constitutes rescue therapy. 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. What we are trying to make sure is that we treat rescue therapy consistently across different docs. 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. Obviously, there are some patients who get treated at high doses, and there's some patients who just get bumped up a little bit.

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. 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.

I think we're thinking broadly about mechanisms like the FcRn or JAK1 TIK2 mechanism, where you can do a lot with the mechanism through creative clinical development. We think that's going to be an important battlefield for the future across big pharma and biotech. Thanks for the question.

Speaker 6

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 Brepocitinib and dermatomyositis, 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 statement 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 endpoint? The second question is for batoclimab and TED. How might you leverage that data as positive, whether it's to help the positioning of anti-FcRn antibody therapies in Graves’ disease, or would you even consider a future program in TED with IMVT-1402? Thanks.

Speaker 5

Yeah, thanks, Sam. I appreciate both questions. Look, on dermatomyositis, and we've said this before, but it's a great reminder. We think, and we think docs think that a simple stat-significant trial on TIFs is the bar for efficacy. Part of that, frankly, is, as you said, docs are generally predisposed to the mechanism. I think part of it also is that TIFs is an artifice of clinical trials as an endpoint. 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. I think we've got, frankly, a variety of endpoints in the study that will underscore that. I think the answer is that the bar is pretty clearly a stat-significant trial and not any specific number.

Look, for brepocitinib 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. 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. We'll make decisions on TED together with our partner, Hanal, once we have that data at hand. Thank you.

Speaker 6

Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.

Hey, good morning. Thanks for taking the question. 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?

Speaker 5

Yes, the question is, on the steroid taper, what's the goal for patients to get off steroids?

The mandatory taper.

Oh, in terms of timing, yes.

Yeah, how it begins at week.

Yeah. The patient begins at week 12. The taper begins at week 12, and the mandatory taper concludes at week 36. 98% of patients factually were below five at week 36. Once you start tapering at week 12, the goal in general is to get these patients as low as possible by week 36. That's the sort of goal. The point here is to make sure that the drug has its time to do its thing.

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

Yeah. On the one hand, thanks. It's a good question. 15 has been an active dose of Brepocitinib in other programs and other indications. On the other hand, we've said it before, I think the main reason for the inclusion of 15 here was regulatory in nature. I don't think we're particularly focused on what 15 looks like. I think it's not sort of 100% obvious whether we expect to hit on 15 or not. The primary is on 30. 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.

Speaker 6

Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.

Hey, guys. Thank you for taking my question. Two for me. On 1401, I mean, all these registrational 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? 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. I'm 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. Thank you.

Speaker 5

Yeah, thanks, Yatn. 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. There's a lot of enthusiasm across most of these indications for FcRNs. I think we see that in the speed of site activation and the speed of enrollment. I think we feel good. We're on track to hit all of our publicly stated timelines. 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. You will see an uptick in R&D here because we now have so many ongoing registrational studies for 1402.

Feeling good. Spend should be pretty stable. A little bit of an adverse working capital this quarter and some one-time STT-related stuff that doesn't get to burn. Overall, feeling good about those timelines and about our cash guides. Thank you.

Speaker 6

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

Hi. This is Dominic Gom for Yasmine Rahimi. Congrats on a great quarter, and thank you for taking our question. 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. What do you hope to report at ATA, and could you walk us through how you're thinking more about the importance of this? I know you talked a little bit about the doc and patient's perspective. Thank you.

Speaker 5

Yeah, thanks. Great question. We are also looking forward to that data for sure. What we're hoping to report, and we got in 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 end those 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 going to be on lifelong medicine to remission, which is something that is possible for milder patients with ATDs, but has never really been possible for these more severe recalcitrant patients. This is an ability then to avoid surgeries, to avoid radioactive iodine, to treat these patients differently. My hope is that any amount of remission showed is just patients who, again, have their lives really changed.

I think even small levels of remission will be super meaningful to docs in that context. I think that's really the goal. The importance there, 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. I think that'll be helpful as well. 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, 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.

We're really looking forward to it as a meaningful stat. Thank you.

Speaker 6

Thank you. Our next question comes from the line of David Risinger with Leerink 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. I'm curious just about Brepocitinib and non-infectious uveitis, if you could give us a roadmap for the pivotal development and the potential filing year. Thanks very much.

Speaker 5

Perfect. Thanks. Yeah, we are super excited about Brepocitinib and NIU. It's obviously an indication where we developed our own, we generated our own phase two data last year, and it was quite good data that we were very proud of. 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. This would be a, yeah, an sNDA. It's a shorter review timeline than the original NDA. Really looking forward to that. I think that 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.

We get to kind of stack those indications in a way that should be editable 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, doc population. 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 good sense of who we need to talk to from a doc perspective. We feel really good about both of those commercial opportunities. Thanks, Dave. Really appreciate the question.

Thank you.

Speaker 6

Our next question comes from the line of YourOwnRiver with TD Cowen. Your line is now open.

Hi. Good morning, guys. Good to see you guys on for Roivant. Just a quick question on Brepocitinib. In the prior data with JAK1 on TIF, they've shown really impressive efficacy in the exploratory open-label study. How informative is that prior data for Brepocitinib? Thank you.

Speaker 5

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. 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. I think that's all comforting. That said, these are not placebo-controlled studies. There's a lot of variability in TIFs. 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 TIF2. Hopefully, that gives us some additional edge even relative to those studies.

Again, comfort among docs and great open-label data from precedent studies. It's not sufficient to get a drug approved. Until we see the phase three data, we'll be nervous. You can all be nervous with us. Thank you.

Thank you.

Speaker 6

Thank you. Our next question comes from the line of Emma Gutstein with Wolfe 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? 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? Thank you.

Speaker 5

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. 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. 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. I think we should have a great profile in addition to being first. Obviously, given comfort with the class, given thousands of patients dosed for that molecule, we think we should be well set up with this doc community. In terms of preps for launch, there's only so much you can do before you have phase three data in hand. 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. The Priovant team has been out engaging in the context of the trial and otherwise with the physician community super actively.

I think we have a reputation with that community that I'm very proud of. I think it 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. Those docs are super important. I think we would continue to engage with them, and once we have the data, we'll be able to do a bit more. Thank you.

Speaker 6

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

Speaker 5

Thank you again to everybody for listening this morning. A relatively quiet quarter, but a really exciting few months ahead for the business. 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, etc., who are working hard to get these studies enrolling, working hard to generate this clinical data. I want to thank, obviously, our shareholders. 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. Thank you, everybody, and have a great Monday.

Speaker 6

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