Roivant Sciences Q1 2026 Earnings Report

Roivant Sciences EPS Results

• Actual EPS: N/A
• Consensus EPS: -$0.23
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Roivant Sciences Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $6.92 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Roivant Sciences Announcement Details

• Quarter: Q1 2026
• Date: 8/11/2025
• Time: Before Market Opens
• Conference Call Date: Monday, August 11, 2025
• Conference Call Time: 8:00AM ET

Roivant Sciences (NASDAQ:ROIV), a commercial-stage biopharmaceutical company, engages in the development and commercialization of medicines for inflammation and immunology areas. The company provides Vants, a model to develop and commercialize its medicines and technologies focusing on biopharmaceutical businesses, discovery-stage companies, and health technology startups. It develops VTAMA, a novel topical for the treatment of psoriasis and atopic dermatitis; batoclimab and IMVT-1402, the fully human monoclonal antibodies targeting the neonatal Fc receptor across various IgG-mediated autoimmune indications; and RVT-3101, an anti-TL1A antibody for ulcerative colitis and Crohn's disease. The company was founded in 2014 and is based in London, the United Kingdom.

Roivant Sciences Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Dermatomyositis data approaching: The pivotal VALOR trial for brepcitinib is completing patient visits with top-line results expected in H2 2025, enabling a potential NDA filing in early 2026.
• Positive Sentiment: Robust FcRn antibody pipeline: IMVT-1402 (birtocimab successor) is advancing in five registrational trials across MG, CIDP, Graves’ disease and Sjögren’s, targeting best-in-class status.
• Positive Sentiment: Aggressive share repurchase: Completed a $1 billion buyback, reducing shares by 15% at $10 average and secured an additional $500 million authorization for opportunistic repurchases.
• Positive Sentiment: Strong financial position: Q1 cash of $4.5 billion with no debt and manageable R&D spend underpins upcoming clinical and regulatory milestones.
• Neutral Sentiment: LNP litigation update: Summary judgment motions in the Moderna case are due August 22, with a U.S. jury trial scheduled for March 2026 and patent hearings ongoing against Pfizer/BioNTech.

Presentation

[Operator]

Good day, and thank you for standing by. Welcome to the Royvant First Quarter twenty twenty five Earnings Call. At this time, participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.

[Operator]

I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

[Stephanie Lee Griffin, COO at Roivant Sciences]

Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended 06/30/2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Klein, 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.roybans.com. We'll also be providing the current slide numbers as we present to help you follow along.

[Stephanie Lee Griffin, COO at Roivant Sciences]

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.

[Matt Gline, CEO & Director at Roivant Sciences]

Thank you, Stephanie, and thank you, everybody, for joining this morning. I appreciate it. It is a relatively quiet quarter before promises to be a very busy fall, so look forward to sharing some updates and then taking some Q and 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.

[Matt Gline, CEO & Director at Roivant Sciences]

The first of those is the continued progress that we're making with IVT-fourteen oh two 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 birtocimab, our first generation drug in MG and CIDP. And now it's really a story of that team focused clinical execution, 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 brepcitinib, which we hope will set the stage for commercial launch of that drug in that indication. That pivotal trial is now less patient, less visit completed as of last month.

[Matt Gline, CEO & Director at Roivant Sciences]

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 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 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 operating with today. Obviously, first and foremost, with REPCIPIVA with that registrational data coming shortly and with multiple indications.

[Matt Gline, CEO & Director at Roivant Sciences]

With an enormous amount of clinical progress ongoing and with a bunch of registrational trials, five registrational trials with fourteen oh two currently ongoing. And then obviously also mostly single out our pulmonary hypertension program update on the second half of next year and ongoing BD 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 rempcitinib 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 brepcitinib and then across the FcRn portfolio.

[Matt Gline, CEO & Director at Roivant Sciences]

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 repurchase program. As I think you're all aware, we completed the 1,000,000,000 point dollars authorized share repurchase program from last year as of June 2025. We repurchased just under 150,000,000 shares at an average price of just over $10 a share.

[Matt Gline, CEO & Director at Roivant Sciences]

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 catalysts over the next thirty six months. As you likely saw, once we completed that program, the board authorized additional $500,000,000 repurchase program that 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.

[Matt Gline, CEO & Director at Roivant Sciences]

We continue to rapidly advance PrevSib and across indications. We'll talk more about PrevSib 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 IMTT-fourteen oh two, probably most importantly with enthusiasm around our Graves' disease study with a second registrational trial, a potential registrational trial has begun. Enrollment is picking up nicely there as well.

[Matt Gline, CEO & Director at Roivant Sciences]

And then we expect additional data from betokumab's Phase two trial in Graves' disease with the six month remission data to be presented at ATA next month. And we've initiated now our potentially registrational program in Sjogren'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 Brep O as we sort of stare down the barrel of this upcoming data, starting on slide 11.

[Matt Gline, CEO & Director at Roivant Sciences]

We're really proud of how brepcitinib reflects on the Roivin journey. We feel like we've rapidly expanded it into multiple orphan immunological conditions at this point in a drug now with a well established safety profile and 1,500 patients dosed. As a reminder, we in licensed this program in the 2021 when luckily the verdict on JAK inhibitors were still out and there were some impressions of what black box warning was going 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.

[Matt Gline, CEO & Director at Roivant Sciences]

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 affecting, in our analysis, forty thousand about US 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, don't work that well overall.

[Matt Gline, CEO & Director at Roivant Sciences]

Reppo is the only oral therapy in late stage development and will be the 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 we, as we announced on our call in June, have seen good success with our steroid caper, which should help us ensure strong differentiation from SIBO.

[Matt Gline, CEO & Director at Roivant Sciences]

The VAWOR study on slide 13, there's a schematic test two doses of Rebacitinib thirty milligrams and fifteen milligrams over a fifty two week period with a mandatory steroid taper as I mentioned. It requires both active skin and muscle disease And the primary endpoint is mean tests for placebo age 52. 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 on Priavant 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 myositis, the pro derm study of IVIG.

[Matt Gline, CEO & Director at Roivant Sciences]

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 tests as an endpoint. And again, this is all information we put out in June, but we had good success with ninety eight percent of patients achieving the mandatory CAPER, over forty percent fully eliminating optical, sorry, optical, oral corticosteroids and over sixty percent achieving a greater than seventy fifth percentile percent reduction from baseline. So really good progress on getting these patients off steroids, which should give rebasitinib 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.

[Matt Gline, CEO & Director at Roivant Sciences]

Obviously, there's multiple programs ongoing at this point. Dizucobart at Pfizer, efgartigimod, molecule we know well at ARGX and at Afroblumab 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 at 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 twenty twenty seven top line data in NIU and around the same time, a launch in the end, hopefully.

[Matt Gline, CEO & Director at Roivant Sciences]

And then following that on a regulatory following in the '27 for people within NIUs. So quite a lot coming there. The last deeper dive update I'm going to give on this call, and as I said, relatively brief call given the quiet report 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 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.

[Matt Gline, CEO & Director at Roivant Sciences]

The US jury trial is currently scheduled for March 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 inactive discovery. The Markman hearing was held in December and the ruling could come this year.

[Matt Gline, CEO & Director at Roivant Sciences]

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 US Moderna case. As a reminder, at this point we are asserting four patents, three related to lipid composition, the three fifty nine, four thirty five, and three seventy eight patents. That's which lipids make up the sort of balloon, the outside of the LNP inside of which the mRNA is capsulated. And then the six fifty one patent on mRNA LNP compositions that describes the encapsulation of mRNA within an LNP.

[Matt Gline, CEO & Director at Roivant Sciences]

We, a gentleman in Arbutus, filed three motions summary judgment 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 the six fifty one patent is valid on certain specific grounds. Moderna also filed three motions for summary judgment. Probably the most talked about is the motion of fourteen ninety eight, which is Moderna's attempts to defray liability to the US government under a World War I era patent statute. Secondly, claims around our ability to use the doctoral equivalence based on the prosecution history of the patents. And finally, they're asking for a summary judgment on claims of indefiniteness around the six fifty one patent.

[Matt Gline, CEO & Director at Roivant Sciences]

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 26. 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 and A, just a quick financial update.

[Matt Gline, CEO & Director at Roivant Sciences]

Relatively straightforward quarter On an adjusted basis, net loss of 170,000,000 cash utilization of about 200,000,000 outside of the share repurchase program and other throughout these onetime events. Balance sheet remains incredibly strong. We're privileged. We have $4,500,000,000 of cash as of June 30, no debt, and a significantly reduced share count thanks to share repurchase program. So that's where we are from a financial perspective.

[Matt Gline, CEO & Director at Roivant Sciences]

Hopefully, we'll be able to talk more about the upcoming year two and three in terms of upcoming catalysts once we have the bremsitinib data on 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. 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]

Thank you. Our first question comes from the line of Brian Chang with JPMorgan. Your line is now open.

[Brian Cheng, Senior Biotech Analyst at J.P. Morgan]

Hey, guys. Thanks for taking our questions this morning. Matt, just on VM, can you talk about 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.

[Matt Gline, CEO & Director at Roivant Sciences]

Yeah, 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 secondary reason, the major safety data to share approximately contemporaneously with the data. And beyond that, we'll see.

[Matt Gline, CEO & Director at Roivant Sciences]

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.

[Brian Cheng, Senior Biotech Analyst at J.P. Morgan]

John. 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 three hundred mg that you're testing. What's the rationale of testing a lower dose in that second GRAVES trial? Thank you.

[Matt Gline, CEO & Director at Roivant Sciences]

Yeah, thanks. It's a great question. And I appreciate your pointing out actually that we 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 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 a minimally efficacious dose with FDA in that process. Thank you.

[Operator]

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.

[Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group]

Hi, good morning. Thanks for taking our questions. Have two on the the first question is just around how is a flare defined in the trial? And how does a flare get treated on test? I think gives as much color as you can on how patients who require steroid rescue will be treated.

[Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group]

And then my second question, you you guys mentioned forty percent 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 tests between the two hours meaning if more patients are able to eliminate steroids in the breathable arm versus placebo arm, could that mask the potential test improvements on a placebo adjusted basis? Thank you.

[Matt Gline, CEO & Director at Roivant Sciences]

Yeah, thanks, Dennis. These are obviously good questions that get at what we've discussed is obviously a risk in the trial, is ensuring correct management of placebo patients. We haven't shared all of that detail, and I'm not sure we're gonna 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 thirty two week study.

[Matt Gline, CEO & Director at Roivant Sciences]

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 EM study ever run with a steroid taper. And a number of previous trials have been successful without a steroid taper.

[Matt Gline, CEO & Director at Roivant Sciences]

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 or the drug arm, that could result in better tests for the placebo arm. But as I said, I think all 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.

[Matt Gline, CEO & Director at Roivant Sciences]

But I think in general, we're managing these patients carefully to try and get the most benefit we can out of a steric taper. Those are great questions. Thank you.

[Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group]

Great. Thank you.

[Operator]

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

[Corinne Johnson, Vice President at Goldman Sachs]

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.

[Corinne Johnson, Vice President at Goldman Sachs]

You obviously have quite the balance sheet at your disposal, so how should we think about the outlook for BD from here and the type, size, or structure of deals you're most interested in? Thanks.

[Matt Gline, CEO & Director at Roivant Sciences]

Yeah, thanks, Shereen. 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. Mean, literally, we have docs telling us if even ten percent of these patients were able to go to remission. Remember, these are patients who couldn't adequately be controlled on ATDs.

[Matt Gline, CEO & Director at Roivant Sciences]

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 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.

[Matt Gline, CEO & Director at Roivant Sciences]

I don't know. Think obviously people care about it if it's in betokumab. 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.

[Matt Gline, CEO & Director at Roivant Sciences]

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 and L and restructuring.

[Matt Gline, CEO & Director at Roivant Sciences]

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, potentially transformational late stage opportunities in some cases. And we're looking forward to connecting those rackets to evolve. Thanks, Trent.

[Operator]

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

[Prakhar Agrawal, Managing Director at Cantor Fitzgerald]

Hi. Congrats on the quarter and thank you so much for taking my questions. I had two. First, a follow-up on the DM question around the flare up. So when the patient gets a flare up, what's a typical steroid dose that these patients get?

[Prakhar Agrawal, Managing Director at Cantor Fitzgerald]

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? Thank you.

[Matt Gline, CEO & Director at Roivant Sciences]

Yes, perfect. Thanks. Those both great questions. On the DM question, just to be clear, because the term flare has come up a couple times on this call, the trial design and SaaS 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.

[Matt Gline, CEO & Director at Roivant Sciences]

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'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.

[Matt Gline, CEO & Director at Roivant Sciences]

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 eighteen months. I expect we will continue to look there. There are things that are attractive. There are things that we are close to there.

[Matt Gline, CEO & Director at Roivant Sciences]

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 JAK1T2 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]

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

[Sam Slutsky, MD & Senior Research Analyst at LifeSci Capital, LLC]

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 and 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 when on the primary endpoint?

[Sam Slutsky, MD & Senior Research Analyst at LifeSci Capital, LLC]

And then second question is for betoclimab in TED. How might you leverage that data as positive, whether it's to help the positioning of FcRn in Graves' disease, or would you even consider a future program intent with 1402? Thanks.

[Matt Gline, CEO & Director at Roivant Sciences]

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 sig trial on tests is the bar for efficacy. And part of that, bluntly, is, as you said, docs are generally pretty exposed to the mechanism. But I think part of it also is that tests is an artifice of clinical trials as an endpoint.

[Matt Gline, CEO & Director at Roivant Sciences]

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. I think we've got frankly a variety of endpoints in the study that wonders for that. I think the answer is that the bar is pretty clearly a stat sick trial and not any specific number. For Batto 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.

[Matt Gline, CEO & Director at Roivant Sciences]

So we'll learn a lot that informs Graves'. As far as TED itself is concerned, we're going be informed by the data as we see it, and we'll make decisions on TED together with our partner Hanh All once we have that data at hand. Thank you.

[Operator]

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

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

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

[Matt Gline, CEO & Director at Roivant Sciences]

Sorry.

[Matt Gline, CEO & Director at Roivant Sciences]

Yes. So the question is, on the steroid taper, what's the goal for patients to get off steroids? In terms of timing. Yeah, the patient begins at week twelve. The taper begins at week twelve, and the mandatory taper concludes at week thirty six.

[Matt Gline, CEO & Director at Roivant Sciences]

So ninety eight percent of patients fractionally were below five at week thirty six. Obviously once you start tapering at week twelve, the goal in general is to get these patients as low as possible by week thirty six. And so that's of the 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, know, lot of the data for breakfast has been, or the positive data was with the thirty milligram dose, which is obviously included.

[Matt Gline, CEO & Director at Roivant Sciences]

Just curious if you have what your expectations are for fifteen milligram dose. Yes, on the one hand thanks for your question fifteen has been an active dose of brepcitinib in other programs and other indications. On the other hand, and we've said before, 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 fifteen looks like. And I think it's not sort of 100% obvious whether we expect to hit on fifteen or not.

[Matt Gline, CEO & Director at Roivant Sciences]

The primary is on 30. And I think we're really focused on generating the best possible data that we can at the 30.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

Okay, great. Thank

[Operator]

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

[Yatin Suneja, Senior MD & Biotechnology Analyst at Guggenheim Partners]

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 grades? And also, if you can comment on the spend rate, particularly as it relates to the immunohent piece? I saw a little bit of a bump up in R and D.

[Yatin Suneja, Senior MD & Biotechnology Analyst at Guggenheim Partners]

Just curious how it's going to shape up for both R and D and G and A as we go into later this year and next year. Thank you.

[Matt Gline, CEO & Director at Roivant Sciences]

Yes, thanks, John. Great question. I assume you mean on 1402 for the enrollment, obviously the 1401 trials are all fully enrolled at this point. For 1402, look, think we feel good about enrollment across all of the trials. Obviously Eric's now been on the ground since April.

[Matt Gline, CEO & Director at Roivant Sciences]

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.

[Matt Gline, CEO & Director at Roivant Sciences]

On spend, our guidance remains that we're comfortably set up here to hit GRAVE's data the current balance sheet. Obviously, you will see an uptick in R and 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 SP related stuff that obviously doesn't get to firms. So overall feeling good about those timelines and about our cash guide. Thank you.

[Operator]

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

[Analyst]

Hi, this is Dominic on 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?

[Analyst]

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. Thank you.

[Matt Gline, CEO & Director at Roivant Sciences]

Yeah, thanks. Great question. We are also looking forward to that data for sure. I think, look, what we're hoping to report, 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 going to be on lifelong medicine to remission.

[Matt Gline, CEO & Director at Roivant Sciences]

Which still 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, to treat these patients differently. So my hope is that any amount of remission showed is just patients who again have their lives really changed. Think even small levels of remission will be super meaningful to docs in that context. So I think that's really the goal.

[Matt Gline, CEO & Director at Roivant Sciences]

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.

[Matt Gline, CEO & Director at Roivant Sciences]

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, 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 really looking forward to it as a meaningful step. You.

[Operator]

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

[David Risinger, Senior Managing Director, Biopharma at Leerink Partners]

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

[Matt Gline, CEO & Director at Roivant Sciences]

Perfect. Thanks. Yes, we are super excited about REPO at 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.

[Matt Gline, CEO & Director at Roivant Sciences]

Our guidance remains data 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 would be a sNDA. So it's a shorter review timeline than the original NDA. So yeah, really looking forward to that.

[Matt Gline, CEO & Director at Roivant Sciences]

And I think that the hope there, again, with the 2027, we would be getting data in NIU right around the time that we were launching in DM. 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 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 good sense of who we need to talk to from a doc perspective.

[Matt Gline, CEO & Director at Roivant Sciences]

So we feel really good about both of those commercial opportunities. Thanks, Dave. Really appreciate the question.

[David Risinger, Senior Managing Director, Biopharma at Leerink Partners]

Thank you.

[Operator]

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

[Analyst]

Hi, good morning, guys. This is Sarah Kai on for Yaron. Just a quick question on brefacitinib. In the prior data with JAK1s on TIP, they've shown really impressive efficacy in the exploratory open label study. So how informative is that prior data for brecasitinib? Thank you.

[Matt Gline, CEO & Director at Roivant Sciences]

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.

[Matt Gline, CEO & Director at Roivant Sciences]

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, are not placebo controlled studies. There's lot of variability in tests.

[Matt Gline, CEO & Director at Roivant Sciences]

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 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 precedent studies is not sufficient to get a drug approved. So until we see the Phase III data, we'll be nervous.

[Matt Gline, CEO & Director at Roivant Sciences]

And you can all be nervous with us. Thank you.

[Analyst]

Thank you.

[Operator]

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

[Emma Gutstein, Equity Research Associate at Wolfe Research]

Hi, this is Emma on for Andy. Thanks for taking our question. 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.

[Emma Gutstein, Equity Research Associate at Wolfe Research]

Are there specific preparations or key milestones you're planning for in the next six to twelve months? Thank you.

[Matt Gline, CEO & Director at Roivant Sciences]

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.

[Matt Gline, CEO & Director at Roivant Sciences]

Obviously, 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 that would be a benefit of a 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.

[Matt Gline, CEO & Director at Roivant Sciences]

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 dosed with our molecule, we think we should be well set up with the stat community. In terms of preps for launch, look, there's only so much you can do before you have 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.

[Matt Gline, CEO & Director at Roivant Sciences]

I think one of the things that clearly matters is great engagement with the physician community, and the Prievent 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 expectation around what the drug can do and in the quality of the team that we have at Priavant. 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.

[Operator]

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

[Matt Gline, CEO & Director at Roivant Sciences]

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. And I hope to speak again soon.

[Matt Gline, CEO & Director at Roivant Sciences]

I want to say thank you again to obviously the Roivant and Vamp teams, ImmunoVamp, Priavant, Polivant, etcetera, 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.

[Operator]

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

Participants

Executives

• Stephanie Lee Griffin, COO
• Matt Gline, CEO & Director

Analysts

• Brian Cheng, Senior Biotech Analyst at J.P. Morgan
• Dennis Ding, VP - Equity Research Analyst at Jefferies Financial Group
• Corinne Johnson, Vice President at Goldman Sachs
• Prakhar Agrawal, Managing Director at Cantor Fitzgerald
• Sam Slutsky, MD & Senior Research Analyst at LifeSci Capital, LLC
• Douglas Tsao, Managing Director at H.C. Wainwright & Co.
• Yatin Suneja, Senior MD & Biotechnology Analyst at Guggenheim Partners
• Analyst
• David Risinger, Senior Managing Director, Biopharma at Leerink Partners
• Emma Gutstein, Equity Research Associate at Wolfe Research