Q1 2025 Roivant Sciences Earnings Call

Speaker #2: Good day, and thank you for standing by. Welcome to the Roivant first quarter 2025 earnings call. At this time, all participants are in a listen-only mode.

Speaker #2: 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 *11 on your telephone.

Speaker #2: You will then hear an automated message advising your hand is raised. To withdraw your question, please press *11 again. Please be advised that today's conference is being recorded.

Speaker #2: I would now like to turn the conference over to your speaker today, Stephanie Lee. Please go ahead.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: We'll also be providing the current slide numbers as presented to help you follow along. I'd like to remind you that we will be making certain board meeting statements during today's presentation.

Speaker #3: We strongly encourage you to review the information that we have filed with the SEC for more information regarding these board meeting statements and related risks and uncertainties.

Speaker #3: And with that, I'll turn it over to Matt.

Speaker #4: Thank you, Stephanie. And thank you, everybody, for joining this morning. I appreciate it. It is a relatively quiet quarter, but it promises to be a very busy fall.

Speaker #4: I look forward to sharing some updates and then taking some Q&A. I will start on page 5, which is a kind of overview of where we are for this year.

Speaker #4: So, you know, three main themes for calendar year 2025. The first of those is the continued progress that we're making with IBT-1402 and Immunovant.

Speaker #4: We are developing what we hope will be the best-in-class anti-FCRN antibody. We put out data earlier this year in botulinum ab, our first-generation drug, in MG and CIDP.

Speaker #4: And now it's really a story of that team on focused clinical execution, getting the GRAFE study enrolled and continuing to progress with other indications that we've announced there.

Speaker #4: The second major theme for the year, which is approximately imminent, is the registrational dermatomyositis data from Brevicitinib. We hope this will set the stage for a commercial launch of that drug and that indication.

Speaker #4: That pivotal trial is now completed, with the last patient’s last visit having occurred as of last month. So, that data will come, as we've guided before, in the second half—pretty shortly.

Speaker #4: 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, and that's scheduled for March of 2026.

Speaker #4: As well as the ongoing collaboration with Pfizer and BioNTech. I'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.

Speaker #4: Obviously, first and foremost, with Brevicitinib and that registrational data coming shortly, combined with multiple indications and an enormous amount of clinical progress ongoing, we have a series of registrational trials—five registrational trials for 1402 currently ongoing.

Speaker #4: And then obviously also mostly SIGILOT, our pulmonary hypertension program, that we'll have data in the second half of next year and ongoing ED as well.

Speaker #4: You know, on slide 7, I'm not a superstitious person. I'm not going to spend that much time talking about the future beyond the Brevicitinib data.

Speaker #4: But suffice to say, our next few years ahead are really, really exciting. Starting with this pivotal data DM, and then with multiple potential registrational data sets and launches—first in Brevicitinib and then across the FCRN portfolio.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: As of June 2025, we repurchased just under $150 million shares at an average price of just over $10 per share. So, we reduced our share count by over 15%.

Speaker #4: In the same period, we have meaningfully expanded our pipeline, and we're excited to have increased our own exposure as shareholders, along with all of your exposure as shareholders, to the upcoming catalysts over the next 36 months.

Speaker #4: 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.

Speaker #4: You know, on slide 9, there's a period of real progress across the entire pipeline. We continue to rapidly advance Brevicitinib across indications. We'll talk more about BREPO in just a moment, but obviously, we completed the last patient last visit for VALOR and DM.

Speaker #4: And we're enrolling patients in registrational trials in non-infectious uveitis at a good pace, as well as our proof-of-concept study in cutaneous sarcoidosis.

Speaker #4: We are intensely focused on clinical execution for IMPT-1402. Probably the most important thing to highlight is the enthusiasm around our GRAFE ase study, with a second potentially registrational trial that has begun.

Speaker #4: And enrollments are picking up nicely there as well. We expect additional data from the botulinum antibody's phase two trial in GRAFE disease, along with the six-month remission data that we will present at ATA next month.

Speaker #4: And we've initiated now our initial registrational program in children's disease. And then finally, continued progress on our LNP litigation. We'll talk more about it in just a few slides.

Speaker #4: So, I'm going to take just a very brief moment here to refresh everyone on BREPO as we sort of stare down the barrel of upcoming data.

Speaker #4: Starting on slide 11, you know, we're really proud of how Brevicitinib reflects on the Roivant journey. We feel like we've rapidly expanded it into multiple orphan immunological conditions.

Speaker #4: With, at this point, a drug now with a well-established safety profile on over 1,500 patients' doses. You know, as a reminder, we unlicensed the program in the summer of 2021.

Speaker #4: When roughly the verdict on JAK inhibitors was still out and there were some questions about 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.

Speaker #4: We have separately advanced in now two pivotal proof of concept programs, and we're super excited about some additional indications that we're still doing some work on.

Speaker #4: Brevicitinib, on slide 12 with the Valor study, could redefine the standard of care for patients specifically with dermatomyositis. We have talked about this a fair amount in this forum, but DM is a truly debilitating disease with major unmet medical needs.

Speaker #4: Affecting in our analysis, about 40,000 U.S. adults. There are obviously some slightly higher numbers coming out of some of our investors. It's a skin and muscle disease that is debilitating to patients' quality of life.

Speaker #4: They are currently heavily treated with high-dose chronic steroids and other immunosuppressants, which don't work that well overall. BREPO is the only oral therapy in late-stage development, and we're being advanced as the first novel therapy of any modality for patients with DM apart from IVIG.

Speaker #4: And then the VALOR study is designed to truly establish our profile there. There's good pharmacological rationale for TIC2 and JAK1 inhibition. This is the largest interventional trial in DM ever conducted.

Speaker #4: With a variety of useful endpoints for showing how we benefit the quality of life for these patients. As we announced at our call in June, we have seen good success with our steroid taper, which should help us ensure strong differentiation from SIGILOT.

Speaker #4: The Valor study on slide 13 features a schematic. It tests two doses of Brevicitinib: 30 milligrams and 15 milligrams over a 52-week period, with a mandatory steroid taper, as I mentioned.

Speaker #4: It requires both active skin and muscle disease, and the primary endpoint is mean tests for SIGILOT age 52. On slide 14, you can see the baseline characteristics in the study.

Speaker #4: We put these out again at our Brevicitinib-specific DM-specific call in June. By the way, if you haven't watched, it is a really nice team from Bryovant on the study and the indication.

Speaker #4: I think we're pretty happy on slide 14 with the baseline characteristics mapped to the other successful late-stage study run in myositis, the prodrome study of IVIG.

Speaker #4: 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.

Speaker #4: 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 eliminated oral corticosteroids, and over 60% achieved a greater than 75th percentile reduction from baseline.

Speaker #4: So, really good progress on getting these patients off steroids, which should give Brevicitinib 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.

Speaker #4: Obviously, there are multiple programs ongoing at this point. Dizucavart at Pfizer and Cartesimod, a molecule we know well in our genetics, and at a formal lab at AstraZeneca.

Speaker #4: We are the only orals. We are the soonest of the Ose readouts. And there are multiple Phase 2 programs that initiated since the beginning of the Valor study across a variety of mechanisms and companies.

Speaker #4: BREPO has an overall pretty busy couple of years ahead. Obviously, starting this DM data coming soon, and then, following thereafter, a regulatory filing for use in DM. We will then, next year, get our proof of concept data in cutaneous sarcoidosis.

Speaker #4: As well as the first half of 2027, top line data in NIU. Around the same time, a launch in DM, hopefully. And then, following that, a regulatory filing in the second half of '27 for Google in NIU.

Speaker #4: 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.

Speaker #4: 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 bit.

Speaker #4: The U.S. jury trial is currently scheduled for March of 2026, so we're obviously looking forward to that. We also expect major international hearings in the first half of next year as well.

Speaker #4: The Pfizer case is ongoing and in active discovery. The Markman hearing was held in December of last year, and the ruling could come this year.

Speaker #4: So looking forward to that progress also. Probably the biggest update on the case in recent weeks has been on slide 20, the summary judgment motions that were filed in the U.S. Moderna case.

Speaker #4: As a reminder, at this point, we are asserting four patents: three related to lipid composition, the 359, 435, and 378 patents. That's which lipids make up the sort of balloon on the outside of the LNP, inside of which the mRNA is encapsulated.

Speaker #4: And then the 651 patent on mRNA LNP compositions that describes the encapsulation of mRNA within an LNP. We, gentlemen at Arbutus, filed three motions for summary judgment.

Speaker #4: Related to the relitigation of obviousness arguments that were resolved in the IPR process and appeal, we don't want Moderna to be able to assert certain invalidity arguments related to prior art.

Speaker #4: And that the 651 patent is now the uncertain specific grounds. Moderna also filed three motions for summary judgment. Probably the most talked about is the motion on 1498.

Speaker #4: Which 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.

Speaker #4: 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.

Speaker #4: In summary judgment, some other developments included the case being assigned to a new judge in the same court, with trial scheduled for March 2026.

Speaker #4: And the upcoming opposition motions in the summary judgments are due August 22nd. Then there will be a volley of replies back and forth in September before those summary judgment rulings.

Speaker #4: As made by the judge. Finally, before we wrap up and go to Q&A, just a quick financial update. Relatively straightforward quarter. You know, on an adjusted basis, net loss of $170 million, cash utilization of about $200 million outside of the share purchase program and other sort of obvious one-time events.

Speaker #4: The balance sheet remains incredibly strong. We're privileged to have $4.5 billion in cash as of June 30th, no debt, and a significantly reduced share count, thanks to the share purchase program.

Speaker #4: So that's where we are from a financial perspective. Hopefully, we'll be able to talk more about the upcoming Year 2 and Year 3, as well as upcoming catalysts.

Speaker #4: Once we have the Brevicitinib data in hand, I'm really excited about what that commercial franchise could look like and what that could mean for patients as an opportunity.

Speaker #4: And what everything else coming beyond it could look like. But we'll wait to talk about that until we can discuss more about what that data looks like once we've seen it.

Speaker #4: So in the meantime, I'll just say thank you again for listening to the prepared portion of this call. I'm looking forward to taking questions. Operator, over to you.

Speaker #2: Thank you. As a reminder, to ask a question, please press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again.

Speaker #2: 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.

Speaker #5: Hey, guys. Thanks for taking our questions this morning. Matt, just on DM, can you talk about how much data we could get at the time of your top line?

Speaker #5: And assuming the data is positive, how far are you from filing for approval? And what are some of the remaining gaining factors from filing?

Speaker #5: I a follow-up. Thank you.

Speaker #4: 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 results, all the key secondaries, and the major safety data to share approximately contemporaneously with the data.

Speaker #4: And beyond that, we'll see. But I think all of that obviously gets now analyzed at roughly the same time. You know, assuming that I think what we've guided to in terms of filing is maybe the very beginning of next year.

Speaker #4: And you know, I think there's nothing sort of specific and unusual gaining other than all of the normal NDA prep activities, which are significant.

Speaker #4: 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.

Speaker #4: Once we have the data in hand. Thanks.

Speaker #5: Got it. And then just on the GRAFE trial, the second trial, can you talk about the trial design that we saw posted here? In your latest deck, I noticed that there is 300 mcg that you're testing.

Speaker #5: What's the rationale for testing a lower dose in that second GRAFE trial? Thank you.

Speaker #4: Yeah, thanks. It's a great question, and I appreciate you pointing out that we had posted that GRAFE trial design. The short answer, among other things, is that GRAFE may be the first trial reading out and the first registration we file, sort of neck and neck with some of the others.

Speaker #4: We wanted to make sure we had a trial that would ensure FDA approval, and they'd make sure to tell us it would work for them without issue.

Speaker #4: With the lower dose, it's really about ensuring that we can advocate for a minimally efficacious dose with the FDA. In that process, thank you.

Speaker #5: Thank you.

Speaker #2: Our next question comes from the line of David Reisinger with Levering Partners. Your line is now open. David Reisinger, please check your mute button.

Speaker #2: Our next question comes from the line of Dennis Ding with Jefferies. Your line is now open.

Speaker #6: Hi, good morning. Thanks for taking our questions. I have two on DM. The first question is just around how a flare is defined in a trial?

Speaker #6: And how does a flare get treated on tests? And can you give as much color as you can on how patients who require steroid rescue will be treated?

Speaker #6: And then my second question, you know, you guys mentioned 40% of patients had eliminated steroids. That's a blinded or pooled estimate, correct? And can you hypothesize on what impact, if any, could an imbalance have on the primary endpoint of tests between the two arms?

Speaker #6: Meaning if more patients are able to eliminate steroids in the BREPO arm versus the placebo arm, could that mask the potential test improvements on a placebo-adjusted basis?

Speaker #6: Thank you.

Speaker #4: Yeah, thanks, Dennis. These are obviously good questions that get at what we've discussed is obviously a risk in the trial, which is ensuring correct management of placebo patients.

Speaker #4: We haven't shared all of that detail, and I'm not sure we're going to share it all now. But look, I think obviously there's an active protocol for managing these patients as they progress in the trial.

Speaker #4: It's a 32-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.

Speaker #4: 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.

Speaker #4: In terms of the potential impact of an imbalance, look, I think this is the first DM study ever run with a steroid taper.

Speaker #4: And a number of previous trials have been successful without a steroid taper. So it's not necessary that the steroid taper do anything bluntly in order to have a positive study.

Speaker #4: Again, you're correct that that is a blinded pooled analysis, 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 in the drug arm, that could result in better test results for the placebo arm.

Speaker #4: But as I said, I think all of this is called a belt and suspenders to try and maximize the opportunity for the trial.

Speaker #4: 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 to get the most benefit we can out of a steroid taper.

Speaker #4: It's a great question. Thank you.

Speaker #6: Great. Thank ou.

Speaker #2: Our next question comes from the line of Corinne Johnson with Goldman Sachs. Your line is now open.

Speaker #7: Hey, good morning, guys. Thanks. Maybe you could provide some context around the upcoming GRAFE remission data? What do clinically meaningful outcomes look like there?

Speaker #7: And how does that fit into the broader clinical strategy in GRAFE? And then maybe one on just business development. You know, obviously have quite the balance sheet at your disposal.

Speaker #7: 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?

Speaker #7: Thanks.

Speaker #4: Yeah, thanks for both really good questions. You know, on GRAFE, look, I think the short answer to that question is GRAFE's patients and docs tell us that really any amount of meaningful remission would be practice-changing for them.

Speaker #4: 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.

Speaker #4: So, remission of these patients is a truly extraordinary outcome. These are patients who would have been likely to be on lifelong ATD therapy. And instead, you're putting them here on a new drug.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: I don't know. I think obviously people care about it. It's in botulinum ab. But I think if you talk to GRAFE's docs, they are very interested in this data.

Speaker #4: And I think good data here would be helpful for patient enthusiasm, doctor enthusiasm, and enrollment in the trial. So I think that's a pretty important readout for us.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: We will continue to be opportunistic. And the things we see on our radar are really exciting—sort of potentially transformational late-stage opportunities in some cases.

Speaker #4: And we're looking forward to connecting those rackets to the Revolve. Thanks, Corinne.

Speaker #7: Thanks.

Speaker #2: Our next question comes from the line of Prakhar Agarwal with Cantor. Your line is now open.

Speaker #8: Hi, good morning from the quarter. And thank you very much for taking my questions. I had two. First, a follow-up on the DM question or on the flare-up.

Speaker #8: 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?

Speaker #8: And is the steroid dose on a disease flare-up defined in the protocol, or is it up to the investigator's discretion? And secondly, a follow-up on BD.

Speaker #8: We've seen so many assets and autoimmune as well coming out of China. Whether it's unlicensed by pharma or formation of muco. Is the market and 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?

Speaker #8: Thank you.

Speaker #4: Yeah, perfect. Thanks. Those both great estions. 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 the sort of trial design and status point stuff is less about sort of the definition of a flare.

Speaker #4: And more about what constitutes rescue therapy. I think the answer is that physicians will treat these patients in a variety of ways, depending on the patient's experience and on the practice.

Speaker #4: And what we are trying to make sure is that we treat rescue therapy consistently across different docs. So it's not like there's some magic number around which, you know, if the patient looks this way, they get this much incremental steroid dose.

Speaker #4: 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. I think what we're really trying to get at with the definitions is making sure that we're turning patients who are worsening and getting steroids because they are worsening.

Speaker #4: And that's what all the definitions are designed to illustrate. On the BD question, look, we're agnostic hunters. So we look everywhere. We've done a fair amount of looking in China.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: At least in certain targets. And so I think we're thinking broadly about mechanisms like the FCRN or JAK1-TIC2 mechanism where you can do a lot with the mechanism through creative clinical development.

Speaker #4: And we think that's going to be an important battlefield for the future across big pharma and biotech. Thanks for the question.

Speaker #2: Thank you. Our next question comes from the line of Sam Slutsky with Lifecycle Capital. Your line is now open.

Speaker #9: Hey, good morning, Yone. Thanks for the question. 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?

Speaker #9: Or is there a specific bar on what they would consider when on the primary endpoint? And then the second question is for botulinum antibody in TED.

Speaker #9: How might you leverage that data as positive, whether it's to help the positioning of FCRNs in GRAFE? Or would you even consider a future program in TED with 1402?

Speaker #9: Thanks.

Speaker #4: 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 static trial on tests is the bar for efficacy.

Speaker #4: And part of that, bluntly, is you said docs are generally predisposed to the mechanism. But I think part of it also is that tests are an artifice of clinical trials as an endpoint.

Speaker #4: And so I think docs just focused on good options for these patients that overall improve the way the patients feel and their quality of life.

Speaker #4: And I think we frankly have a variety of endpoints in the study that we'll underscore that. So I think the answer is the bar is pretty clearly a static trial.

Speaker #4: And not any specific number. Look, for BATO and TED, obviously we will learn a lot in that TED study that informs our GRAFE disease development.

Speaker #4: There will be patients in the study that are GRAFE patients, so we'll learn a lot that informs GRAFE. As far as TED itself is concerned, we're going to be guided by the data as we see it.

Speaker #4: And we will make a decision on TED together with our partner, Han All, once we have that data in hand. Thank you.

Speaker #2: Thank you. Our next question comes from the line of Douglas Sal with HC Ringwright. Your line is now open.

Speaker #10: Hey, good morning. Thanks for taking the question. Just Matt, on the DM study, I'm just curious in terms of the steroid taper. What's the goal for patients to get off steroids?

Speaker #4: Sorry, just yes. So, the question is on the steroid taper: what's the goal for patients to get off steroids? The mandatory taper? In terms of timing.

Speaker #4: Yeah. The patient begins at week 12. The taper begins at week 12, and the mandatory taper concludes at week 36.

Speaker #4: So, 98% of patients fractionally 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.

Speaker #4: And 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.

Speaker #10: And I'm just curious, you know, a lot of the data for BREPO has been 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.

Speaker #4: Yeah, so on the one hand, thanks for a good question. 15 has been an active dose of BREPO and other programs and other indications. On the other hand, and we've said before, I think the main reason for the inclusion of 15 here was regulatory in nature.

Speaker #4: And I don't think we're particularly focused on what 15 looks like. And I think it's not sort of 100% obvious whether we expect to hit on 15 or not.

Speaker #4: The primary is on 30, and I think we're really focused on generating the best possible data that we can at the 30 milligram dose.

Speaker #10: Okay, great. Thank you so much.

Speaker #2: Our next question comes from the line of Yatten Sineha with Guggenheim. Your line is now open.

Speaker #11: 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?

Speaker #11: Whether it's CIDP, myasthenia gravis, or GRAFE, I would like to comment on the spend rate, particularly as it relates to the immuno piece.

Speaker #11: 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.

Speaker #11: Thank ou.

Speaker #4: Yeah, thanks, John. Great question. I assume you mean our 1402 for the enrollment. But obviously, the 1401 trials are all fully enrolled at this point.

Speaker #4: 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.

Speaker #4: I think that the team is really humming. Obviously, 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.

Speaker #4: So think we feel good. We're on track to hit all of our publicly stated timelines. So we're feeling od about enrollment altogether. You know, on spend, our guidance remains that we're comfortably set up here to hit GRAFE data.

Speaker #4: On the current balance sheet, obviously, you will see an uptick in R&D here because we now have so many ongoing registrational studies for 1402.

Speaker #4: But feeling good. Spend should be pretty stable. A little bit of an adverse working capital this quarter and some one-time SPC-related stuff that obviously doesn't get to burns.

Speaker #4: So, overall, I’m feeling good about those timelines and about our cash guidance. Thank you.

Speaker #2: Thank you. Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.

Speaker #12: 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.

Speaker #12: We are excited to see the additional data in six-month remission data from the GRAFE disease program. Will be presented at ATA in September. So what do you ope to report at ATA?

Speaker #12: 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.

Speaker #12: Thank ou.

Speaker #4: Yeah, thanks. Great question. And we are also looking forward to that data, for sure. You know, I think, look, what we're hoping to report—and we got it a little bit with the question of what the quote-unquote bar is earlier.

Speaker #4: Is to highlight that this is a really paradigm-shifting opportunity for GRAFE patients. That this will help and those who treat these patients realize that this is not an incremental tool, that it's transformative and that can get that it can get patients who are currently going to be on lifelong medicine to remission.

Speaker #4: Which is something that is possible for milder patients with ATDs, but has never really been possible for these more severe recalcitrant patients. And this is, you know, an ability then to avoid surgeries, to avoid radioactive iodine, to treat these patients differently.

Speaker #4: So my hope is that any amount of remission shown 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.

Speaker #4: So I think 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 GRAFE disease.

Speaker #4: It gets to the enrollment of the study. That is, it gets to how excited patients are to get in trial, how excited docs are to be pushing.

Speaker #4: And I think that'll be helpful as well. And then 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.

Speaker #4: In a way that I ink, you know, insofar as the goal here is always to drive benefit for patients, it gives us an opportunity to point to at we're doing there.

Speaker #4: So we're really oking forward to it as a meaningful step. Thank ou.

Speaker #2: Thank you. Our next question comes from the line of David Reisinger with Levering Partners. Your line is now open.

Speaker #13: Yeah, thanks very much. Sorry about the background noise. Congrats on all the progress. My questions have been asked. So I'm curious just about BREPO and NIU.

Speaker #13: If you could provide us with a roadmap for the pivotal development and the potential filing year. Thanks very much.

Speaker #4: Perfect. Thanks. Yeah, we are super excited about BREPO and NIU, which is obviously an indication of where we developed our own. We generated our Phase 2 data last year.

Speaker #4: It was quite good data, and we were very proud of it. The enrollment of that trial is going extremely well, and our guidance remains for the first half of 2027.

Speaker #4: We're certainly on track to hit those timelines. And we're hoping we file an SMDA relatively shortly after we get that data. And this would be a, yeah, an SMDA.

Speaker #4: So it's a shorter review timeline than the original NDA. So yeah, I'm really looking forward to that. I think the hope there is that for the first half of 2027, we would be getting data in NIU.

Speaker #4: Right around the time that we were launching in DM. And so we get to kind stack those indications in a way that should be editable overall and give us an opportunity to get our feet set in DM.

Speaker #4: And then relatively quickly to pivot into or add the NIU patient population and doc population. And one of the nice things about both of these commercial opportunities is they're quite ctable.

Speaker #4: 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.

Speaker #4: So we feel really good about both of those commercial opportunities. Thanks, Dave. Really appreciate the question.

Speaker #13: Thank you.

Speaker #2: Our next question comes from the line of your own worker with TD Cowan. Your line is now open.

Speaker #14: Hi, good morning, guys. This is Sarah Kai on for your line. Just a quick question on BREPO and NIB. In the prior data with JAK1s on tests, they've shown really impressive efficacy in this exploratory open-label study.

Speaker #14: So how informative is that prior data for BREPO and NIB? Thank ou.

Speaker #4: 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.

Speaker #4: And the fact 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.

Speaker #4: So I think that's all comforting. That said, these are not super controlled studies. There's a lot of variability in tests, and so ultimately, I will bite my nails and lose sleep until I see the super controlled data just the same.

Speaker #4: We obviously also hope to see benefit sort of from both JAK1 and TIC2. And so hopefully that gives us some additional edge even relative to those studies.

Speaker #4: 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 three data, we'll be nervous and you could all be nervous with us.

Speaker #4: Thank you.

Speaker #14: Thank you.

Speaker #2: Thank you. Our next question comes from the line of Emma Gutsing with Wolf Research. Your line is now open.

Speaker #15: Hi, this is Emma on for Andy. Thanks for taking our estion. Two questions from us just looking at slide 16 and numerous companies are targeting DM.

Speaker #15: Can you elaborate on your approach for navigating this highly competitive market? Also, in the press release, you mentioned preparations for a potential launch in DM.

Speaker #15: Are there specific preparations or key milestones you're aiming for in the next 6 to 12 months? Thank you.

Speaker #4: Yeah, thank you. I appreciate the question. One thing I'll say is that in the 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.

Speaker #4: And so I think the fact that we're in the lead of this pack is helpful. Obviously, we have look, I think JAK hibitors, to your point, have shown impressive efficacy in other settings.

Speaker #4: 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 they would be given the benefit of the doubt.

Speaker #4: We're viously 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.

Speaker #4: And so they're used to taking regular oral medications. So I think we should have a great profile in addition to being first. Obviously, given comfort with the class and given thousands of patients dosed with our molecule, we think we should be well set up with this doc community.

Speaker #4: In terms of preps for launch, look, there's only so much you can do before you have the Phase 3 data in hand. But there's a lot, at this point, roadmap to follow from other highly successful commercial launches by biotech companies that I've gotten to watch.

Speaker #4: I think one of the things that clearly matters is great engagement with the physician community. The private team has been out engaging in the context of the trial and otherwise with the physician community super actively.

Speaker #4: And I think we have a reputation with that community that I'm very proud of. And I think has been part one both in terms of the sort of expectation around what the drug can do and in the sort of ity of the team that we have in private s.

Speaker #4: So I think those docs are super important, and I think we would continue to engage with them. Once we have the data, we'll be able to do a bit more.

Speaker #4: Thank you.

Speaker #2: Thank you. This concludes the Q&A session. I would now like to hand the call back over to Matt Glenn for closing remarks.

Speaker #4: Yeah, 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.

Speaker #4: As they come, I hope to speak again soon. I want to say thank you again to obviously the Roivant and VAMP teams, Immunovant, Priovant, Pulmavant, and others.

Speaker #4: 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.

Speaker #4: We're looking forward to sharing some of that patient data as soon as we get it. So thank you, ybody. And have a great Monday.