Roivant Sciences - Earnings Call - Q4 2025

Executive Summary

• Q4 FY2025 delivered minimal revenue ($7.57M) and a larger GAAP continuing EPS loss (-$0.29), while non-GAAP opex stayed comparatively stable; R&D rose on anti-FcRn and mosliciguat program spend, and G&A rose on share-based comp tied to the 2024 program.
• Versus S&P Global consensus, revenue and EPS were mixed: Q4 revenue missed materially, while Q3 EPS was a modest beat and Q2 EPS was slightly worse than estimates (see Estimates Context). The company emphasized its development-stage profile and pipeline-driven cash utilization.
• Cash, cash equivalents, restricted cash, and marketable securities were $4.9B at March 31, 2025, and Roivant had repurchased $1.3B of shares, reducing outstanding shares by 14% YoY—supporting runway “into profitability” and ongoing capital return.
• Near-term catalysts are predominantly clinical: brepocitinib dermatomyositis Phase 3 topline in H2 2025, TED topline for batoclimab in H2 2025, and multiple IMVT‑1402 programs initiating or enrolling; management hosted/announced investor education and maintained timelines, with litigation milestones (Moderna/Pfizer) progressing.

What Went Well and What Went Wrong

What Went Well

• “I am incredibly proud of the progress we reported... Continued broad development of brepocitinib, positive data from our myasthenia gravis study, and expansion of IMVT‑1402 into new indications...” (CEO).
• Strong capital position and disciplined allocation: “Set up... to capitalize Roivant to profitability... just under $5 billion in cash... already repurchased $1.3 billion... reduced share count by not quite 15%”.
• Clinical execution and pipeline breadth: five potentially registrational studies for IMVT‑1402, ongoing brepocitinib programs in DM/NIU/CS, and mosliciguat PH-ILD Phase 2 enrolling.

What Went Wrong

• Higher GAAP opex and deeper loss: R&D +$37.7M YoY to $145.2M; G&A +$39.0M YoY to $147.1M—driven by program costs, personnel, and share-based compensation; Loss from continuing operations widened to $(252.4)M in Q4.
• Minimal revenue ($7.57M) amid development-stage portfolio, limiting margin optics and creating headline misses versus consensus revenue in Q4.
• Ongoing litigation timing uncertainty: case narrowing and summary judgment phases continue; court indicated timing updates for Moderna case (trial dates subject to change).

Transcript

Operator (participant)

Good day, and welcome to the Roivant Fourth Quarter 2024 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. Instructions will be given at that time. As a reminder, this call may be recorded. I would like to turn the call over to Stephanie Lee. Please go ahead.

Stephanie Lee (COO)

Good morning, and thanks for joining today's call to review Roivant's financial results for the fourth quarter and fiscal year ended March 31st 2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these updates on our IR website at www.investor.roivant.com. We will 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 will turn it over to Matt.

Matt Gline (CEO)

Thank you, Steph. Thank you, everybody, for listening this morning for our fiscal year-end conference call. Good morning. I'm going to start in the deck here on slide five by saying it's hard to believe this actually. Not only has it been a very impactful fiscal year, but this is the reporting quarter in which, for example, we generated the data for the token lab in my citagrab and CIDP. It's been a very busy six months for us to start off at 2025. 2025 is just a really important year for our business, starting with the data we've already generated, which we think sets us up for a best-in-class potential franchise in the anti-FcRn world with IMVT-1402, first in class in a number of indications such as Graves' disease and potentially best in class. We think anywhere that we're going to play.

Upcoming, and one of the most important events of the year in the second half, is the potentially registrational data from our study of brepocitinib in dermatomyositis, which is a study we are super excited for. It's a patient population with high unmet need. We would be the first novel oral DM drug and have pretty long lead time over really any other late-stage program. Looking forward to sharing more about that both today and in the near future. Finally, this is a really pivotal year, among other things, for our LNP litigation with Moderna with Pfizer-BioNTech. We are currently in a narrowing and summary judgment phase of that trial. Upon the completion of that phase, we expect to move to trial in the relatively near future. An incredibly important moment for that as well. That's in the Moderna case.

On slide six, we say this every time we get on the phone, but I am incredibly proud of our late-stage pipeline here. First, with brepocitinib, which obviously has the potential to be an on-market therapy as soon as within the next couple of years with this data coming in dermatomyositis, with IMVT-1402 actively enrolling multiple potentially registrational studies or pivotal studies across multiple indications where we either already know or strongly expect FcRn antibodies to matter quite a lot. We also have mosliciguat, our inhaled therapy for PH-ILD with data expected to be coming next year. Obviously, for those who follow our story, ongoing BD with multiple possible pipeline expansion opportunities as well.

On slide seven, we are in a period of just significant clinical execution and progress here in really all of our main clinical franchises with 1402 and additional cleared IND, five potentially registrational studies ongoing, one proof of concept study initiated in CLE. In the next coming years, potential for, yes, six-plus indications with each with potential multi-blockbuster launches. Obviously, in brepocitinib, among other things, in 2025, we initiated our study of cutaneous sarcoidosis. We will later this year read out the dermatomyositis study. Again, with the potential in 2026 and beyond for a multi-blockbuster orphan franchise anchored by launches in DM and NIU. More about that in a minute. As I mentioned before, in mosliciguat, we have got the PHLD study enrolling nicely at this point. We believe that that program could be positioned in frontline use for PHLD and potentially other respiratory diseases.

On slide eight, and I don't want to say too much about this yet because we haven't actually generated the dermatomyositis data yet, but on a thematic point that I expect we'll talk more about if that data meets our hopes and expectations, this is really the beginning of a pretty stacked 36 months for us in terms of data and launches with multiple launches in potential blockbuster indications, first for brepocitinib and then for our FcRn franchise in a way that we think adds up to one of the most exciting commercial portfolios potentially in INI over the next couple of years here. Really looking forward to that flow and excited for DM as the sort of first domino. Again, fingers crossed or knocking wood or whatever you do if you're superstitious that that data does what we would like it to do.

On slide nine, I guess last overall framing point before I talk about some of the specific programs is I think one of the things that Roivant has been very focused on over the last couple of years, obviously since the cash inflow from the sale of our NTTL antibody, has been thinking critically and carefully about capital allocation. We feel very good about where we are right now. We are set up, as we've said before, to capitalize Roivant to profitability, again, with just under $5 billion in cash on the balance sheet today, supporting the current pipeline to profitability with about $2 billion still in reserve for pipeline expansion and deployment on VD opportunities. That's against a backdrop of having repurchased already $1.3 billion in our own stock as of 3/31/2025. That's reduced our share count by not quite 15%.

That capital return continues on the existing share repurchase authorization that we continue to think critically about what to do from a capital return perspective thereafter given our balance sheet. Again, really excited about what we've been able to do from a capital allocation perspective and excited for the capital position that we are in, particularly in what we acknowledge is a very challenging market for many of our peers and for the industry. Great. With that as framing comments, I just want to spend a little bit of time on a couple of the key events for this year, starting with brepocitinib, where I do mean a little for a reason that will become obvious in a moment.

On slide 11, just as a reminder, what we're really focused on for brepocitinib is indications with high unmet need that are tailored to our specific novel mechanism with dual TYK2 and JAK1 inhibition. The announced indications so far are DM with the readout that I've talked a lot about already, NIU, which is actively enrolling in our phase three program, in our pivotal phase three program where we think there's a very high overall opportunity and very few other therapies approved. Then our proof of concept trial in cutaneous sarcoidosis. We are, as you might expect, also investigating or exploring other areas in which we might like to develop brepocitinib. You can potentially hear more about those in the coming months.

We feel like we've rapidly expanded on this opportunity from when we actually first initiated the DM trial in 2022 at the same time as proof of concept study in NIU. Since then, we obviously read out that NIU study, initiated the pivotal program in NIU, got going in CS, and are now set up for the upcoming readouts, three of which, the pivotal in DM, the pivotal in NIU, and the proof of concept in CS, are coming within the next, call it, 18-24 months. Again, a really exciting year for brepocitinib. So much so that, and there are details of this on the next slide. On Tuesday, June 17, we're going to hold an investor event, a sort of mini R&D day where the Roivant team together with the Priovant leadership team, Ben Zimmer, CEO of Priovant, will get together.

We're going to do a little bit of DM disease education and some details on the trial design for the ongoing trial because we hope and expect that people will be watching for that data later this summer. We want everyone to have a clear frame of reference for what to expect as it comes around. Obviously, we've been excited to watch general progress in that field in recent weeks and months as well and are pleased with our positioning both from a timing and structure perspective. Given that we're reserving time for brepocitinib in the future, that's all I'll say about it on this call. Stay tuned for more on that future call. Next, I'm going to talk a little bit about Immunovant and the recent developments in our anti-FcRn antibody franchise.

As a reminder, this call also effectively serves as the Immunovant conference call for the quarter of the year as they're not doing their own IR activities right now. I think everyone is familiar with the overall sort of structure of this story right now. On slide 14, we really think we have a tiger by the tail in IMVT-1402. We think it's a potential drug that has an opportunity to be a first and best in class anti-FcRn across multiple indications. We think we get IgG lowering up to, call it, 80% or the low 80s in studies that is matched with or at the most robust IgG lowering observed, not just, frankly, in anti-FcRn antibodies, but across the field of IgG lowering therapies with a favorable safety profile that we think gives us overall clean differentiation.

We have a great convenient administration with a market-proven friendly autoinjector device that will be used at launch. We have data that we think validates deeper IgG suppression mattering across multiple indications. Obviously, we felt strongly that the evidence generated in our MG and CIDP studies were constructed to that end. We have got data in Graves. We have got our own data from phase two and TED. We have seen it in multiple other places that there is a clear clinical benefit for patients for whom you can get IgG reduction over 70%. We hope and expect to continue showing that in our ongoing clinical programs.

We just have a lot of ongoing clinical progress across multiple indications, including the ones I've mentioned, as well as the ongoing studies in D2T, fourth-line rheumatoid arthritis, in Sjogren's, where we have a program expected to start this summer in CLE indications that we've talked a lot about in recent months because we just announced them actually about five or six weeks ago. As a reminder, the IMVT-1402 goes out to 2043. Quite a long franchise as well. That is not including any PTEs. Really good setup. Our indication strategy from a prioritization perspective on slide 15 has been first and foremost indications where we feel confident we can be both first and potentially best in class.

Obviously, the most obvious example in that category is Graves' disease, where we believe we've helped the field understand that that is an interesting market with a lot of or interesting opportunity with a lot of unmet patient need. We think we are out in front there in terms of working with that field, working with those physicians, working with those sites. We expect and are working hard to maintain that position of scientific leadership. We have also got our ongoing programs in D2T RA and cutaneous lupus, where we feel like we are first in class in the FcRn field as well.

There is a category of indications where Sjogren's is probably the best example, which I call nearly first-in-class indications, where we believe with good execution, we can minimize the time gap between us and our competitors while maintaining a potential for a differentiated clinical profile driven by best-in-class IgG reductions. Finally, there is the sort of tried-and-true known indication space like MG and CIDP, which we acknowledge our competitors, which are well-established, where Vyvgart, for example, is a well-loved drug in MG, but where we feel like we have potential to differentiate on efficacy and clinical benefit.

I was pleased to see, for example, in the last few days that some of the myasthenia gravis patient organizations are encouraging physicians to think about deeper response measures like MSE as the future of treatment for those patients and where we think we can take a leadership position given the profile of 1402. I am tremendously excited about the way we're thinking about indication prioritization. I think you can imagine if we're going to announce more programs over time that will roughly follow this sort of prioritization hierarchy. On slide 16, we've ambitiously called this slide settling the deeper is better debate. I think in our minds, we feel quite confident at this point that deeper IgG suppression across indications is going to yield meaningfully better clinical benefit.

We've seen it on this sort of less than 70%, greater than 70% IgG reduction cut point where we've divided our data in multiple indications. We have consistently seen deeper and better responses. That includes in our Graves phase IIa data for protocol now, where we had 60% of patients effectively off ATDs in the over 70% cohort compared with just over 20% off ATDs. Again, these are all patients who have normalized T3 and T4. Depending on IgG cutoff, we saw over 50% of patients with minimal symptom expression effectively with clinical remission in myasthenia gravis in the over 70% cohort versus just under a third in the under 70% cohort. Likewise, in CIDP on INCAT, we saw a significantly different responder rate in the deeper IgG responders bucket than in the lesser IgG responders bucket.

We really do feel like this is a consistently demonstrated hypothesis. We think that high-dose metoclopramide and, most importantly, high-dose IMVT-1402 drive the vast, vast, vast majority of patients into that over 70% bucket. We think this is representative of what we may be able to deliver as a clinical benefit in those patient populations. We feel very good about what we have in terms of the profile of the molecule given this data. On slide 17, we do feel like we've set some new benchmarks for efficacy in our MG and CIDP data. In MG, both on an absolute MG-ADL improvement as well as on other measures, we think we've shown some of the best observed absolute improvement.

Frankly, the best placebo-adjusted MG-ADL improvements on things like MSE, where we're putting patients against these sort of deeper, more durable response goals. We feel really good about what we're going to be able to deliver in MG with 1402. We're really excited about what we've seen in the available data pooled due to the ongoing study in CIDP. Obviously, the protocol has been consistent with its prior studies in terms of overall tolerability. A really strong position in terms of what our data has put out here.

One point to make, and this is really sort of more specific to MG and maybe some of the comments we've seen from patient groups recently as well, is we believe that the MG field is going to progress from here in a way that is similar to what we've seen in other indications, particularly in immunology, where you go from sort of first-generation early therapies that just look at overall response rates, improvement in a physician global assessment in psoriasis or relatively low relapse rates in MS or MG ADL response rates in MG to once you get to the first generation of innovative compounds, people start talking about remission rates, PASI 75s and higher, EDSS in MS, the higher ACR rates in RA. In the case of MG, we think MSE is sort of the next generation here of what people are going to look at.

As we get to the future here, people looking at PASI 100s in psoriasis for effectively complete clinical cure rates, same thing in MS, no evidence of disease activity. We think people will be looking at deep and durable responses, many-week or many-month durability to MSE after therapy is the kind of thing that we think the field is going to lead towards in MG. We think we are in a privileged position to lead the FcRn category in those kinds of endpoints going forward. You can see on slide 19, for example, in the protocol MG study, maintenance of minimal symptom expression for greater than or equal to six weeks. This is this chart on the bottom right-hand side of slide 19.

You can see at high-dose protocol where we were getting those deep levels of IgG suppression, you had 75% of patients maintaining that status for six or more weeks, which we think is the kind of endpoint. By the way, 93% of patients achieved a clinical response. We think this is the kind of data that is going to move the market in terms of what patients are looking for in an MG treatment. We are excited to focus on those kinds of endpoints in the ongoing phase three program or the ongoing clinical program in 1402. On slide 20, just as a brief reminder, because we spent some time on this on the most recent call, we have now initiated programs in Sjogren's and in CLE.

In the case of Sjogren's, an indication where we think we have the potential to be, as I said before, nearly first and best in class in a large market with a large population and a high unmet medical need, with some good evidence of autoantibody-driven disease and with clear dose response data from Nipocalimab showing that deeper IgG suppression seems to matter. In CLE, again, with a fairly large market, obviously some good recent data from the field there with 75,000 addressable patients uncontrolled on standard of care therapy and with relatively well-identified CLE-specific IgG autoantibodies that are a part of the disease presentation. We are excited about the data we are going to generate there next year. We obviously have that principal case study data we have already shown for patients who were the first patients in any disease dosed with IMVT-1402 with data reported.

Finally, just two quick things on slides 21 and 22 here. One is these will both be on clinicaltrials.gov in the near future. Slide 21 is the design of our potential registrational trial in CIDP for 1402, which is a different design than the first generation of studies that folks like our competitors have run or even that we ran for protocol lab, but clearly sort of pretty much in line with where we see the field going and a study that we think gives us a real opportunity to put out some great data in a patient-friendly format and a design that we think investigators are pretty excited about enrolling patients into as well. On slide 22, you can see the design for our second study in Graves' disease, which is now up and running, which will be enrolling patients quite soon.

That design also is now public. You can see some of the features here. Notably, although it is not sort of hit you on the face obvious in the design, one of the things we hope we will get from both of these studies at this point, based on our understanding of the patient population, is some clear information about the impact these drugs are having on proptosis and the progression into TED-like symptoms. Looking forward to generating that data in these studies as well. On slide 23, I will not go through it in great detail, but this is just rehashing.

We feel really, really great about the overall portfolio of indications that we are studying with our FcRn franchise, including just a very large overall potentially addressable US patient population, over 600,000 patients, with a pretty meaningful subset of those patients existing in Graves' disease, which is our sort of lead indication where we feel like we are about to truly define that opportunity and to be the first out there helping patients. Absolutely jam-packed a couple of years ahead, as I led with earlier on slide 24, in terms of data that we expect to generate, obviously including remission data that we said we're going to put out this year in Graves' disease from the protocol map study, the potentially registrational top-line data coming in TED and batoclimab second half of this year.

Then starting next year, a ton of data from 1402, including the open label period one results from the D2T RA study, the CLE study next year, and then potentially registrational data in multiple indications, including Graves' and myasthenia gravis in 2027, and Sjogren's and CIDP beyond. Really tremendous couple of years ahead. Eric is in his early days in the role of Immunovant. Really excited about seeing what he's going to deliver there. I think the team over at Immunovant is just super energized to deliver a meaningful product that's going to help patients a lot, I think. Finally, in terms of business updates on slide 26, just a reminder that this is a really important period for our LNP litigation. We are in effectively the summary judgment phase of the trial.

Part of that, which was expected from the beginning, is this is a normal process of narrowing the scope of our claims and Moderna's defenses in the trial. That process is ongoing. We have had some discussions with the judge about making sure everyone gets that right. Immediately following that, summary judgment motions should be going in. We will be sort of at a pending U.S. jury trial. The date is at the moment TBD, but looking forward to all this progressing in the near future. Finally, starting next year, we will have the beginnings of our international trials and litigation that we filed just a couple of months ago. The Pfizer case continues to be ongoing. We are awaiting the Markman ruling, which we think could come this year in the case. Looking forward to all of that.

I will now just wrap up quickly with a financial update. I will not read all the numbers on slide 28, but a pretty normal solid quarter for us from a financial perspective, obviously just under $5 billion in cash, as I mentioned, with no debt on our balance sheet as of March 31, 2024. We continue to reduce the share count over time. Overall, sort of net use of cash for the quarter, including everything in terms of both interest income and the sort of pull to par on our treasury securities, is about $150 million, a little more than $150 million, between $150 million and $160 million. I think as a quarter for the business, thinking about the business on its own, that is probably like a pretty normal quarter.

Obviously, first quarter tends to be a little bigger for us, and then 1402 starts to ramp up over the course of the year, but overall feeling good about what we're able to do in terms of cash utilization and capital allocation framework, as I mentioned earlier. I'll wrap up on slide 30 just by saying we have an incredibly data-rich year, two years, three years ahead of us. Look, there's nothing in our business like putting out data that matters to patients. Looking forward to all of the events and to talking to you all as part of that. With that, I will wrap up my prepared remarks. Thank you again for listening. I will hand it over to the operator for Q&A.

Operator (participant)

Thank you. If you'd like to ask a question, please press star one one. If your question has been answered and you'd like to remove yourself from the queue, please press star one one again. Our first question comes from Brian Cheng with JPMorgan. Your line is open.

Brian Cheng (Biotech Analyst)

Hi, Matt. Thanks for taking our call this morning. First, on DM. I assume that you'll touch on this a little bit more at your event next month. How should we think through a win scenario in DM in the back half? Can you tell us a little bit more on what we should focus on at your event, focusing on travel next month?

Matt Gline (CEO)

Yeah. Thanks, Brian. By the way, I pointed out I said later this summer on DM data, what I meant was later this year. I think we said second half of that data. It should be sort of sometime early fall, probably. Look, I think in terms of what we're looking for in the DM study, and we've been pretty consistent in this point, I think what we need to win in DM is a positive study. We need statistically significant separation from placebo on TISS and a p-value. The reason I say that is, look, first of all, this is a patient population with very high unmet medical need. The only real novel approved therapy is IVIG, which has a lot of liabilities associated with it. It's a patient population that is eager for new therapeutic options.

It's a physician population that understands our mechanism and is excited for what we can do. We feel like we are primed for a successful study, really being the goal in terms of what winning looks like. I think that's it. I think there's a lot of great properties of JAK and TYK2 inhibition, speed of onset, etc., that we hope will show in the data. I think success really here is about a positive study. Remember that the safety and tolerability profile of JAK inhibitors is well understood. I think we should be sort of coming in within expectations there.

In terms of what to focus on on the event next month, I think the truth for us is because it has been such a busy 24 months in our business, I think the irony of it all is, although this is a potentially registrational readout, it has in some ways flown under the radar a little bit. I think most of what we're hoping to do is to make sure everyone's on the same page about what dermatomyositis is, about what the endpoints are in the study, how we're measuring them, how JAK inhibition works, and how we see the commercial opportunity, and to give the world a chance to hear from Ben and his team who are actually running that study in advance of the data that comes later this year. I think that's what we're looking for in the event.

I think, again, really in particular focusing on just the high quantum of unmet medical need in DM patients. Thanks, Brian, for the question.

Brian Cheng (Biotech Analyst)

Maybe just one quick follow-up on the LNP litigation against Moderna. In a recent docket update, there is an update related to potentially narrowing the case based on a number of planned claims. Can you shed some light on what that potentially could mean? What is a potential next milestone actually regarding the potential case narrowing? Any color they can provide would be super helpful.

Matt Gline (CEO)

Yeah. Look, I think it's hard to comment on ongoing litigation and any specificity, but it is a normal part of patent cases that the number of claims gets narrowed before trial. Remember, these are jury trials. Ordinary people are on the other side of the court, and you want to make sure that you are presenting a case to them that is circumscribed in a way that everybody in the courtroom can get through in a reasonable amount of time. That is the phase we're in. The way it works is that we discuss with Moderna and with the judge, and we agree on what the narrowing of the case is going to look like. I think the parameters of that will be evident in the relatively near future. Mostly, I think there's nothing much that's interesting or important coming out of that narrowing.

You can imagine we're focused on presenting our best possible case and presenting it in the cleanest and most straightforward way.

Brian Cheng (Biotech Analyst)

Great. Thanks for taking our question.

Matt Gline (CEO)

Thanks, Brian.

Operator (participant)

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

David Risinger (Senior Managing Director and Senior Research Analyst)

Thanks very much. Good morning, Matt and team. Congrats on the progress and updates. I have two questions. First, could you please comment on the pending Pfizer LNP litigation Markman decision, which seems to be taking a little longer than expected? Second, ahead of 1402 registrational trial results in 2027 and 2028, could you provide a framework for the two 1402 readouts in 2026, specifically the open label difficult-to-treat RA trial and the phase two CLE trial? Thanks very much.

Matt Gline (CEO)

Yeah. Great. Thank you. On the pending Pfizer Markman decision, the truth of the matter is that the judge in that case, in every case, has the discretion to issue the Markman opinion on a timeline of their choosing. As you'll remember, the Moderna opinion was issued in a couple of months on a timeline the judge had set for himself publicly at the outset. We do not know when the judge will rule on the Markman decision. Given the issues at hand and so on, I think, again, we're sort of hoping and thinking it may come later this year. Hopefully soon. Again, it's not something we have a lot of control over. I do not think there is any signal to take in the timing of that opinion. I do not think there's really any information coming in that.

On the other question, look, I think both of those readouts in 2026 are designed to be informative on what would cause us to carry the program forward. I think they're pretty different situations, right, in the sense that the CLE study will be the first time anyone's generated placebo-controlled CLE data in an FcRn. We obviously have a fair amount of information from competitors in the field. I think we will look at the balance of evidence, including the safety and convenience of FcRns, the quality of that data, and what other people look to be generating in making a decision on whether to progress to a pivotal program after that data. I think pretty normal. The D2T RA data, look, that is an open label run-in period to what would ultimately be, if we carried it forward, one of two potentially pivotal studies in the indication.

I think on the one hand, it's a bigger study with more information. On the other hand, there isn't a placebo, and so it's a little bit of a different setup. That said, I think we're eyes wide open on what the RA market is, both for the good and for the challenges. I think we're looking for data that gives us a clear signal on progressing. Thanks, Dave.

David Risinger (Senior Managing Director and Senior Research Analyst)

Thanks very much.

Operator (participant)

Thank you. Our next question comes from Dennis Ding with Jefferies. Your line is open.

Dennis Ding (SMID Cap Biotech Equity Research Analyst)

Hey, guys. Good morning. Thanks for taking our questions. I just have two, mainly around DM. How are you planning to position brepocitinib if it's approved? Is the goal there to be pre or post IVIG, and what types of patients do you consider to be low hanging fruit? As a follow-up to that, can you also frame how often off-label JAKs are used in DM? Do you expect any kind of pent-up demand there, given familiarity with the mechanism if brepocitinib is eventually approved? Thank you.

Matt Gline (CEO)

Yeah. Perfect. Thanks. Look, obviously, these are great questions. I'll give a brief answer now, but I expect to cover both of these issues on June 17th in detail. In terms of how we're positioning brepocitinib, I'll just say I don't think we are particularly focused on a specific subset of the market. I think we view that entire market as addressable here. I think, bluntly, many of the patients are low-hanging fruit given the lack of options. Again, I think you'll hear more about that from Ben. There are hundreds at this point of case reports on the use of JAKs in DM. I don't know if I'd literally call that pent-up demand so much as really, really good physician familiarity. There's been now three investigator-initiated trials. There are 600-plus case reports in dermatomyositis.

Again, Ben will cover all of this in pretty great detail in a couple of weeks. I am really looking forward to that. There are over 30,000 patients currently being treated for dermatomyositis. We think there is a ton of addressable opportunity. By the way, broadly, we think the sort of safety and tolerability profile of JAK inhibitors should compare favorably to that of IVIG. Anyway, more to come on that in just a few weeks here. Thanks, Dennis.

Dennis Ding (SMID Cap Biotech Equity Research Analyst)

Thank you.

Operator (participant)

Thank you. Our next question comes from Yaron Weber with TD Cowen. Your line is open.

Yaron Werber (Managing Director and Senior Biotechnology Analyst)

Great. Thanks so much. Congrats on the really nice progress. I have a couple of questions on brepocitinib. Give us a little bit of a sense. What are you expecting? Our consultants and our work, and I know many people have done work here, are pretty positive on this asset. The question that we get from investors is what to expect from the placebo arm, just given there aren't a lot of historical randomized sort of small molecule studies. Number one, what do you expect from the placebo in this study? Secondly, you have about $200 million left under the stock buyback. Is that something you'll take care of pretty quickly? Is there contemplation to open another buyback? Thank you.

Matt Gline (CEO)

Yeah. Thanks, Jerome. Both good questions. On the buyback question, Richard will know if there's anything to add here. I think you can imagine we're continuing to use that and happy to continue to use the existing authorization. I think once we conclude the existing authorization, we'll take a look at our overall capital picture in the market and make decisions on where to go from there. Anything to add, Richard?

Richard Pulik (CFO)

No, I think that's exactly right.

Matt Gline (CEO)

Great. On the placebo arm in DM, look, I agree that that is a reasonable question. Certainly in immunology studies in general, it's something that people have to focus on. Obviously, TISS as an endpoint has various properties that make it fair to ask the question. I'll point out two things. One is, well, really one thing, which is that we now have the published data in abstract form from the Vyvgart myositis study. Different patient population that's across multiple myositis types. At 24 weeks, they saw whatever, 30 and 35-point TISS. That's without a steroid taper that we have in our study. That's 24 weeks. Our study is 52. I think it was nice to see in that study a relatively well-behaved placebo, nice separation for the drug, and a nice low p-value.

I think that's the sort of thing that is encouraging. I'll bite my nails through the readout just like anyone would in our position. Thank you.

Operator (participant)

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

Sam Slutsky (Senior Research Analyst)

Hey, good morning, everyone. Thanks for taking the questions. On 1402, just looking at the treatment duration in your registrational Graves' disease studies, looks like one has a 26-week treatment period and the other allows kind of up to 52 weeks before the off-treatment follow-up period. Just kind of curious on how you're thinking about the typical duration of treatment in the real world for Graves. Would that be restricted, or could some patients be treated kind of post 52 weeks possibly?

Matt Gline (CEO)

Yeah. Thanks, Sam. It's a great question. I think the first thing to say, well, a few things to say. One is this is now a competitive field. I think we're focused on our competitive differentiation. We have more data than anybody else does to inform the design of these studies because we have the batoclimab phase two data. It's definitely the case that Graves' disease is chronically treated now and that many patients are on long-duration methimazole. In fact, one of the things that is a focus for us is patients who are uncontrolled despite being on long-duration methimazole therapy. I think there is certainly a possibility for chronic therapy as with many other autoimmune diseases.

Obviously, one factor that goes into this is the possibility of clinical remission, which is something that happens in a subset of patients who are able to get controlled on methimazole. We are putting out data at some point later this year or expecting to on our own clinical remission from the batoclimab study. I think that'll be important. Obviously, until there are novel therapies in Graves' disease, the exact treatment paradigms are uncertain. I think there's certainly an opportunity for chronic therapy. I don't think anything about our study leaves us with an expectation of an on-label limitation of duration.

Sam Slutsky (Senior Research Analyst)

Okay. And then just quickly too, obviously, some patients with uncontrolled Graves' disease will have thyroiditis in the real world. You obviously have the batoclimab phase three readout later this year. What makes the most sense commercially to optimize on this ability for FcRNs to work in both diseases?

Matt Gline (CEO)

Yeah. I think the studies that we are running in Graves are optimized to give us a lot of useful information and data to share in various forums, including potentially on-label, depending on how we design the final stats plan and things like that, around proptosis, the development of proptosis in active Graves' patients, the time to develop proptosis, the amount of proptosis that people come into the study with, and how it sort of evolves over time. I think being able to go out to this patient population and talk about that, we think will be a helpful part of the overall treatment landscape.

Sam Slutsky (Senior Research Analyst)

Awesome. Thank you.

Operator (participant)

Thank you. Our next question comes from Yatin Suneja with Guggenheim. Your line is open.

Yatin Suneja (Biotechnology Research Analyst)

Guys, thank you for taking my question. Just two for me as well. First one is on the TET study. I understand that is not sort of an indication that you might take forward, but you still describe that as a potentially registrational study. What are the expectations? What are the plans in TET? Could they change once we unblind those data? That is one. If you can just help on the modeling side, how should we think about the spend in 2026? Thank you.

Matt Gline (CEO)

Yeah. Thanks. Yeah. I appreciate the question. Look, on TED, Roivant has always committed to being a data-driven organization. We are going to make final decisions on batoclimab and TED once we see that data. The study is designed to be potentially registrational. Obviously, we are focusing an enormous amount of our effort on 1402 given its clinical profile. I think that's kind of where we sit on TED and on batoclimab overall. In terms of spend in 2026, Richard, do you want to take that question?

Richard Pulik (CFO)

Yeah. So look, I think as you heard from Matt, we had roughly $150 million in cash use this quarter. That'll ramp up a little bit as 1402 starts. And then depending on how the DM data looks like, assuming that's positive, you can then assume that we're going to put a little bit of power behind launch activities and pre-launch activities. I think you'll see a little bit of spend on the SG&A side as that moves forward, but not significant changes beyond that.

Matt Gline (CEO)

Thanks, yeah.

Operator (participant)

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

Douglas Tsao (Senior Analyst for Biopharmaceuticals)

Hi. Good morning. Thanks for taking the questions. I'm just curious, Matt, as so far in the FcRn space, we've obviously seen companies sort of coalesce around sort of some core indications, MG, CIDP. As we potentially see other entrants and other companies looking at sort of IgG lowering strategies with FcRns or other modalities, we're starting to see more competition. I'm just curious how you're thinking about pricing because there will obviously be much greater variability in terms of the sort of size of indications, right? We had yesterday one of the competitors with the Greater program sort of talked about pursuing Graves. I'm just curious how you're thinking that could influence pricing and your thought around sort of pursuing orphan indications versus more prevalent indications. Thank you.

Matt Gline (CEO)

Yeah. Thanks for the good questions. I was tempted to go into a little vignette here of imagine it's 2005 and someone gets on the phone and they're like, "Well, obviously so far in the TNF space, people have focused on a couple of indications, rheumatoid arthritis and maybe psoriatic arthritis." To point out that, look, I think we're really just at the beginning in terms of focus. I think this is going to be quite a broad field across companies in the coming years. I think that's sort of the point you're making in terms of the explosion of indications that is ongoing. Look, I think we have a lot of flexibility around pricing strategy for multiple reasons. We obviously have the ability to deliver a couple of different doses. There's, on the one hand, variability around some of the size of these indications.

On the other hand, a thing that a lot of FcRn indications have in common is this is a relatively new biology tent, and there have not been a lot of other therapies that can address these kinds of diseases. Frankly, in the cases where there have been, there's a pricing band that we think is generally compatible with the FcRn pricing that's been currently set by our competitors. I think there's a lot of opportunity. Obviously, final pricing decisions are going to depend on the exact order in which we launch indications and on things like the quality of our remission data in Graves and so on. Overall, I think we have a lot of flexibility. I think despite the apparent variability here, the concentration of indications in patients with unmet need here fit pretty nicely together in terms of the promotional models.

Douglas Tsao (Senior Analyst for Biopharmaceuticals)

Okay. Great. That's helpful.

Matt Gline (CEO)

Thank you very much.

Operator (participant)

Thank you. Our next question comes from Prakhar Agrawal with Cantor. Your line is open.

Prakhar Agrawal (Senior Biotech Analyst)

Hi. Thank you for taking my questions. Going back to DM and the placebo response, obviously, there is variability on the TISS endpoint. Matt, you've talked about the steroid tapering that can be done to mitigate that. Are the guidelines consistent across centers on tapering up and down? What exactly are the steroid tapering protocols, and is there any subjectivity involved? Beyond just the steroid tapering, are there any other steps incorporated in the trial that can mitigate the placebo response? Thank you.

Matt Gline (CEO)

Yeah. Thanks. This is a great question. We will cover a lot of detail on this question at the upcoming call in a couple of weeks. In part, I'd say stay tuned. Some of that information is in published papers and so on. The thing I'll say is the steroid taper is mandatory in the study and set out with a pretty clear protocol in the protocol. I think we expect it as being relatively consistently applied here given the way the study is designed. I think the team's done a pretty careful job making sure of that. Again, Ben will talk more about it.

I think a lot of that, by the way, is just boots on the ground, spending time with the doc community, which is helpful for enrollment, which is helpful for ultimately building those relationships with future prescribers, and which is helpful for making sure that people are adhering to the protocol as we have designed it. In terms of other steps to mitigate placebo, look, I think in general, there are a lot of things you do in a well-run study to make sure you are managing these risks in terms of how you think about discontinuations, in terms of how you think about measuring TISS and the time points and so on. I think there is a lot that went into the design in terms of that risk. Obviously, ultimately, as I said before, none of that stops the biting of nails.

It is nice to see other DM studies or other myositis studies having relatively well-behaved placebo arms. Thank you.

Operator (participant)

Thank you. Our next question comes from Andy Chen with Wolfe Research. Your line is open.

Andy Chen (Senior Analyst)

Hey, thank you for taking the question. Regarding DM, again, my understanding is that this is modestly underdiagnosed. Just can you talk about what you believe to be the observable population in the U.S. based on your claims analysis or otherwise, and how that compares to what you believe to be the prevalence in the U.S.? Also, a separate question that's related. Do you think off-label Xeljanz is doing better on the market right now than Octagam based on physician feedback? Thank you.

Matt Gline (CEO)

Great questions. Thank you. Again, we'll talk more about it in a couple of weeks as a partial answer. Look, our view of the DM market has been 40,000+ or 40,000 patients. I think we said 37,000 based on one study. As I mentioned before, there's about 34,000 treated patients. I think that's one measure of it. One of our competitors has indicated a 70,000 patient number based on their own work. I think to your point, there is a little bit of a range. I think that sort of 40,000-70,000 patients is probably the right way to think about the size of the dermatomyositis market for the moment. I agree with you that it could be modestly underdiagnosed and that I expect patients will emerge once a clear treatment opportunity exists.

When you say off-label Xeljanz versus Octagam, I mean, obviously, the direct comparability of in terms of physician experience, what I can say is that physicians are very excited for an oral option that's on label. They're very excited specifically for things that are in the JAK family, JAK1 and JAK2. I think we get a lot of enthusiasm from physicians around the program, which I think is in part informed by off-label use of Xeljanz, is in part informed by the fact that these physicians are used to treating other conditions where JAK inhibitors and similar mechanisms work well for them, and is in part informed by just the overall complexity of dosing patients with IVIG. As a reminder, relative to Xeljanz, brepocitinib obviously does more than just JAK1 inhibition. We think both JAK1 and TYK2 have the potential to be meaningful contributors to value here.

We think that is something that physicians, frankly, already in the study understand. We think they will understand it better once we have more of an opportunity to talk more about the data. Thanks, Andy.

Andy Chen (Senior Analyst)

Thank you.

Operator (participant)

Thank you. Our next question comes from Thomas Smith with Leerink Partners. Your line is open.

Thomas Smith (Senior Managing Director and Biotechnology Analyst)

Hey, guys. Good morning. Thanks for taking the questions. Just on 1402 and the potentially registrational trial design for CIDP, you mentioned in the prepared remarks, it's a bit of a different design relative to some of the other contemporary studies. You don't have the washout period, which I think should help drive enrollment, but you also won't be measuring response rates. Could you just elaborate a bit on why you chose this design and how you're going to optimize for patient selection and then how you expect this data set will help position you commercially with 1402?

Matt Gline (CEO)

Yeah. Thanks. It's a great question. Actually, look, there are fundamentally three factors driving the overall change in the way CIDP studies work in the world. One is the FDA, who has made no secret about the fact that they do not like the previous set of designs for CIDP studies. The agency cares very much about aspects of this design, principally just sort of the direct placebo control versus the randomized withdrawal piece. You mentioned this correctly. Studies are moving away from these washouts. The truth is that physicians and investigators hate the washouts because they suck for patients. I think, therefore, in a competitive environment for CIDP studies, but also just in general, it's gotten to be pretty important to offer a patient-friendly sort of setup here.

The third thing, which I think enables all of it, is the field broadly has figured out how to select the right patients for CIDP studies vastly, vastly better than we knew a few years ago. In our shadow study, for example, we were able to select patients, almost all of whom flared on withdrawal therapy during the washout period. I think based on the quality of patients that we were able to select for in the batoclimab study, we feel like the sort of top of the funnel inflow activities have gotten good enough here that we can offer a patient-friendly, no washout solution and still have a good setup on the program. Maybe at some point we'll put out the specific data.

As I said, I think the data from the washout period of the batoclimab study strongly suggests that we are getting the patient population that we want into the study. Thanks very much.

Operator (participant)

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

Dominic Risso-Gil (Managing Director)

Hi. This is Dominic on for Yasmeen. Thank you for taking our questions and congrats on a great quarter. Kind of, I guess, a follow-up to the CIDP study. Could you just remind us what the study was powered for, key primary endpoint as well as the secondaries? On that, what was the rationale for selecting the 600 milligram dose in the study? Thank you.

Matt Gline (CEO)

We have not yet said what the study is powered for in terms of primary and secondaries. We have some time there, but maybe we'll share some more information about the specific sort of goals of that study in the coming months. In terms of why 600 milligrams, look, I think we put out this really clear data from the batoclimab study showing the under 70 versus over 70 IgG cut points. We know that lower IgG suppression mattered a lot in the batoclimab data. Deeper IgG suppression mattered a lot in the batoclimab data. Frankly, this is a patient population where it's a severe disease. Efficacy is paramount. We're coming in in a competitive landscape where a competitor who does not suppress IgG as deeply, in our view, is already going to have been on the market for a few years.

I think for all of those reasons, the 600 milligram dose really sets us up for success. It's also the kind of thing where we think it will help with enrollment, as I think patients want to know they're getting the deepest IgG suppression, the most potentially efficacious therapy. A lot of good reasons why that study is built around the 600 milligram dose. Again, this is a very sick patient population, especially if we're choosing the patients correctly. Remember, at the beginning of the study, there were many patients who were coming in, for example, controlled on IVIG, and they're being forced to wash out. We want the patients who are going to work to really work. It's also a two-to-one randomized study, so most of these patients will be on the drug. Thanks. Great question.

Operator (participant)

Thank you. That's all the time we have for questions. I'd like to turn the call back over to Matt Gline for closing remarks.

Matt Gline (CEO)

Fantastic. Thank you, everyone, for listening. Thank you to all the teams at both Roivant and Immunovant who get all of these filings together. Thank you to the investigators and patients who are working with us on our studies and entrusting us with their care. I am looking forward to a really exciting, important second half of the year ahead here, or I guess three-quarters of the year, although it feels like it's going fast. I hope to be back on the phone with all of you soon, including in the next couple of weeks for the dermatomyositis event together with them. Have a great day.

Operator (participant)

Thank you for your participation. You may now disconnect. Everyone, have a great day.