Roivant Sciences Ltd (ROIV) 2024 Q4 法說會逐字稿

Good day and welcome to the Roivant fourth-quarter 2024 earnings call. (Operator Instructions) As a reminder, this call may be recorded. I would like to turn the call over to Stephanie Lee. Please go ahead.

Good morning and thanks for joining today's call to review Roivant's financial results for the fourth quarter and fiscal year ended March 31, 2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant.

For those dialing in via conference calls, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers that we present to help you follow along.

I'd like to remind you that we'll 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 uncertainty.

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

Thank you and thank you, everybody, for listening this morning for our fiscal year-end conference call. Good morning.

So I'm going to start in the deck here on slide 5 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 Batoclimab MG and CIDP. So 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 registrational data from our -- 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 will be the first novel oral DM drug and pretty long lead time over, really, any other latest program. So looking forward to sharing more about that, both today and in the near future.

And then 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. And upon the completion of that phase, we expect to move to trial in the relatively near future, so an incredibly important moment for that, as well. That's the Moderna case.

On slide 6, 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 across or pivotal studies across multiple indications, where we either already know or strongly expect FcRn antibodies to matter quite a lot. We also have mostly mosliciguat, our inhale therapy for PH-ILD with data expected to be coming next year. And, obviously for those who follow our story, ongoing BD with multiple possible pipeline expansion opportunities as well.

On slide 7, we are in a period of just significant clinical execution and progress here. It 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. And in the next coming years potential for, yes, six plus indications each with potential multi-blockbuster launches.

Obviously in brepocitinib, among other things in 2025, we initiated our study cutaneous sarcoidosis. We will later this year read out the dermatomyositis study. And again with the potential in 2026 and beyond for a multi-blockbuster orphan franchise anchored by launches and DM and NIU. More about that in a minute.

And then as I mentioned before, Mosli, we've got the PH-ILD study enrolling nicely at this point. And we believe that that program could be positioned in frontline use for PH-ILD and potentially other respiratory diseases.

On slide 8 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 central 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 I&I over the next couple of years here.

So really looking forward to that flow and excited for DM as the 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 9, I guess last overall framing point before I talk about some of the specific programs is, I think one of things that Roivant has been very focused on over the last couple of years, obviously, since the cash inflow from the sale of our acetylcholine antibody has been thinking critically and carefully about capital allocation. And 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 BD opportunities. And that's against the backdrop of having repurchased already $1.3 billion in our own stock as of 3/31/25. That's reduced our share count by not quite 15%, and that capital return continues on the existing share purchase authorization and we continue to think critically about what to do from a capital perspective thereafter given our given our balance sheet.

So 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.

Yeah, great. So 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 become obvious in a moment.

So on slide 11, just as a reminder, what we're really focused on for brepo is indications with high-unmet needs that are tailored to our specific novel mechanism with Dual TYK2 and JAK1 Inhibition. The announced indications so far are DM with the read up. I've talked a lot of that already.

NIU, which is actively enrolling in our Phase 3 program, in our pivotal Phase 3 program, where we think there's a very high overall opportunity and very few other therapies approved. And 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. And you can potentially hear more about those in the coming in the coming months.

We feel like we've rapidly expanded on this opportunity from when we -- actually, we first initiated the DM trial in 2022, at the same time as a concept study in NIU. And since then we obviously read out that NIU study initiated the pivotal program at NIU got going in CS and are now set up for the upcoming readouts; three of which the pivotal in DM, pivotal in NIU and the group concept and CS are coming within the next, call it, 18 to 24 months. So again, a really exciting year for brepocitinib.

So much so that in the details of this on the next slide, on Tuesday, June 17, we're going to hold an investor event, a mini-R&D day, where the Roivant team together with the private leadership team, Ben Zimmer CEO of Priovant, we'll get together. And 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, and we want everyone to have a clear frame of reference for what to expect as it comes around.

'And 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 the timing and structure perspective. So given that we're reserving time for brepo in the future, that's all I'll say about it on this call, but let's 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.

So, look, I think everyone is familiar with the overall structure of this story right now. But 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 the 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 auto-injector 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 data studies were constructed to that end.

And also we've got data in Graves. We've got our own data from Phase 2 in [TED], and we've seen it in multiple other places that there's a clear clinical benefit for patients for whom you can get IgG reduction over 70%. And we hope and expect to continue showing that in our ongoing clinical programs.

And then with just 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 expect to start this summer. And CLE indications that we've talked a lot about in recent months because we just announced them actually about five or six weeks ago.

And then as a reminder, the IP unfortunately goes up to 2043, so quite a long franchise, as well. And that's not doing any PTP. So we get set up.

Our indication strategy from 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 interesting opportunity, with a lot of them that patients need.

We think we are out in front there in terms of working with that field, working with those physicians, working with those sites. And we expect and are working hard to maintain that position of scientific leadership.

And then we've also got our ongoing programs in D2T RA, cutaneous lupus, where we feel like we are first-in-class in the FcRn field as well. Then there's 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 the profile driven by best-in-class IgG reductions.

And finally, there's the tried and true known indication space like MG and CIDP, which we acknowledge are competitors, which are well established where [regor], for example, is a well-loved drug in MG, but where we feel like we have potential to differentiate on efficacy and clinical benefit. And I was pleased to see, for example, in the last few days that some of the IC patient organizations are encouraging physicians to think about deeper response measures like MSEs as the future of treatment for those patients and where we think we can take a leadership position given the profile of 1402.

So tremendously excited about the way we're thinking about indication prioritization. And I think you can imagine if we're going to announce more programs over the time that we'll roughly follow this sort of prioritization hierarchy.

On slide 16, and 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 the 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 2a data for batoclimab where we had 60% of patients effectively off ATD use in the over 70% cohort compared with just over 20% off ATDs. Again, these are all patients who have normalized T3 and T4.

And that depending on IgG cut off, we saw over 50% of patients with minimal (inaudible) repression effectively remission in myasthenia gravis, and the over 70% cohort versus just under a third in the under 70% cohort. And likewise in CIDP and aINCAT, we saw a significantly different responder rate in the deeper IgG responders bucket than in the lesser IgG responders' bucket. So we really do feel like this is a consistently demonstrated hypothesis.

And we think that high dose, and most importantly, high dose IMVT 1402, drives the vast majority of patients into that over 70% bucket. So we think this is representative of what we may be able to deliver as a clinical benefit in the patient populations. So 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, and then, frankly, the best placebo adjusted MG-ADL improvements on things like MSE, where we're putting patients against these deeper, more durable response goals.

And so we feel really good about what we're going to be able to deliver in MG and 1402. We're really excited about what we've seen in the data pool due to the ongoing study of CIDP. And then, obviously batoclimab has been consistent with its prior studies in terms of overall power abilities. So a really strong position in terms of what our data has put out here.

One point to make, and this is really 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 first-generation, prior, early therapies that just look at overall response rates; improvement in a position global assessment in psoriasis or relatively low relapse rates in MS, or MG-ADL response rates in MG.

So, once you get to the first-generation of innovative compounds, people start talking about remission rates. PASI 75 is in higher, EDSS and MS, the higher ACR rates in RA. And in the case of MG, we think MSE is the next generation here, what people are going to look at.

And then, yeah, as we get to the future here, people looking PASI 100s and psoriasis for complete, effectively complete clinical cure rates. Same thing in MS, no evidence of disease activity, and we think people are looking at deep and durable responses.

Many week or many months durability to MSC after therapy is the kind of thing that we think the field is going to move towards an MG. And 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 batoclimab 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 a high dose batoclimab where we're 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. And so we're excited to focus on those kinds of endpoints in the ongoing Phase 3 program, the ongoing program in 1402.

On slide 20, just as a brief reminder because we spent some time on this on the most recent call, we've now initiated programs in Sjogren's and in CLE. In the case of Sjogren's, an indication that 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 auto-antibody driven disease, and with clear dose response data from nipocalimab showing the deeper edge discretion seems to matter.

And then in CLE, again, with a with a fairly large market, obviously some good recent data from the field there with that 75,000 addressable patients uncontrolled on standard care therapy. And with relatively well identified CLE specific IgG autoantibodies that are part of the disease presentation. So we're excited about the data we're going to generate there next year and we obviously have that principal case study data we've 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 be on clinical trials that govern your future. Slide 21 is the design of our potential rational 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 batoclimab.

But clearly, pretty much line with where we see the field going and a study that we can gives us a real opportunity to put out some great data in a patient-friendly format. And the design that we think investigators are pretty excited about enrolling patients into as well.

And 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. And so that design also is now public, and you can see some of the features here.

Notably, although it's not hit you on the face, obvious in the sign. One of the things we hope you'll 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 [temp] like symptom. And so looking forward to generating that data in the studies as well.

On slide 23, I won't be in great detail, but this is just rehashing. We feel 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 indication where we feel like we are to truly define that opportunity and to be the first out there helping patients.

Absolutely jam-packed 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 batoclimab study, the potentially registrational top line data coming in TED in the batoclimab second half of this year.

And then starting next year, a ton of data from 1402, including Open-Label Period 1 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, yeah.

So 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. It'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 narrow process, sorry -- a normal process of narrowing the scope of our claims and Moderna's defenses in the trial.

That process is ongoing and we've had some discussions with the judge about making sure everyone gets that right. Immediately following that summary judgment motion should be going in and then we'll be at a pending US jury trial. The date is at the moment, TBD. But looking forward to all this progressing in the near future.

And then finally starting next year, we'll 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 ruling, which we think could come this year in the case. So looking forward to all that.

I will now just wrap up quickly with a financial update. I won't 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 3/31, and we continue to reduce churn count over time.

Overall net use of cash for the quarter, including everything in terms of both interest income and the pull-for-pull on our treasury securities is about $150 million, a little more than $150 million, between $150 million and $160 million. And so, I think as a quarter for the business, thinking about the business on its own, that's probably like a pretty normal quarter.

Obviously the 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 at what we're able to do in terms of the 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. And look, there's nothing in our business like putting out data that matters to patients, so looking forward to all of those things and to talking to you all as part of that.

So with that, I will wrap up my prepared remarks. Thank you again for listening and I will hand it over to the operator for Q&A.

(Operator Instructions) Brian Cheng, JPMorgan.

First, on DM, I assume that you'll touch on this a little bit more at your event next month. How do we think through a win scenario in DM in the back half and can you tell us a little bit more on what we should focus on at your event focusing on travel next month?

And 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 for that data, it should be 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 polling. I think what we need to win in DM is a positive study. We need statistically significant separation from placebo on tests and a p-value.

And 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 for 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.

And so we feel like we are primed for a successful study really being the goal in terms of what winning looks like. Yeah, so, I think that's it.

I think there's a lot of great properties of JAK and TYK2 Inhibition, speed of onset, et cetera, that we hope will show in the data. But I think success really here is about a positive study. And remember that the safety and tolerability profile of JAK Inhibitors is well understood. So I think we should be coming in within the expectations there.

In terms of what to focus on the event next month, I think that 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, that it has in some ways flown under the radar a little bit. And so 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 end points 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. So I think that's what we're looking for in the event. I think, again, really in part in particular focusing on just the high quantum of unmet medical need in the patients. Thanks, Brian, for the question.

And =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 land claims. Can you shed some light on what that potentially could mean and what is the potential next milestone actually regarding the potential cave narrowing? Any color they can provide would be super helpful.

Yeah, look, I think it's hard to comment on ongoing litigation any specificity, but it is a normal part of patent cases that the number of claims gets narrowed before trial. But these are jury trials, so 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.

And so that's the phase we're in. The way it works is that we discussed with Moderna and with the judge and we agree on what the narrowing of the case is going to look like. And so I think, the parameters of that will be evident in the relatively near future, but mostly I think that there's nothing much that's like interesting or important coming out of that narrowing. And you can imagine we're focused on presenting our best possible case and presenting it in the cleanest and most straightforward way.

Great. Thanks for taking my question.

David Reisinger, Leerink Partners.

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?

And then second, ahead of 1402 registration or trial results in 2027 and 2028, could you provide a framework for the two 1402 readouts in '26, specifically, the open-label difficult to treat RA trial and the Phase 2 CLE trial? Thanks very much.

So, on the pending Pfizer Markman decision, the truth of the matter is that the judge in that case and 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.

So we don't know when the judge will rule on the Markman decision, but given the issues at hand and so on, I think again we're hoping and thinking it may come later this year. And hopefully she'll, but again, it's not something we'd like to go over.

I don't think there is any signal to take in the timing of that opinion. I don't think there's really any information coming in that.

On the other question, look, I think both of the 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. And so I think we will look at the balance of evidence, including the safety and convenience of FcRn, the quality of that data, and what other people look to be generating in making a decision on whether to progress to (inaudible) data that I think pretty normal.

The D2T RA, look, that is an open-label run in period to what would ultimately be if we carried forward one of two potentially pivotal studies in the indication. And so I think, on the one hand, it's a bigger study with more information in there and there isn't a placebo and so it's a little bit of a different setup.

That said, I think we're wide open on what the RA market is both for the good and for the challenges. And I think we're looking for data that gives us a clear signal on progressing. Thanks, David.

Got it. Thanks very much.

Dennis Ding, Jefferies.

I just have two, mainly around DM. So, how are you planning to position breath those if it's approved? If the goal there is to be pre- or post-IVIG and what types of patients do you consider to be the low-hanging fruit?

And then as a follow up to that, can you also frame how often off-label JAKs are used in DM and if you expect any pent up demand there, given familiarity with the magnetism if brepo is eventually approved? Thank you.

And look, obviously these are great questions, and I expect to I'll give a brief answer now, but I expect to cover both of these issues on June 17 in detail. In terms of how we're positioning brepo, I'll just say I don't think we are particularly focused on a specific subset of the market.

I think we do that entire market as addressable here. And I think, many of the patients are low-hanging fruit, given the lack of options. Again, I think you'll hear more about that from them.

And then there are hundreds at this point of case reports on the use of JAKs in DM and so I don't know, I literally call that pent up demand so much as really good physician familiarity. There's been now three investigator-initiated trials. There are 600 plus case reports around my status.

Again, then we'll cover all of this in pretty great detail in a couple of weeks. I'm really looking forward to that. There are over 30,000 patients currently being treated for the dermatomyositis, and so we think there's a ton of addressable opportunity.

And by the way, broadly, we think the safety and tolerability profile of JAK Inhibitors should compare favorably to that of IVIG. So anyway, with that, more to come on that in just a few weeks here. Thanks, Dennis.

Thank you.

Yaron Werber, TD Cowen.

I have a couple of questions on brepo, 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 small molecule studies.

So number one, what do you expect from the placebo in this study? And then secondly, so you have about $200 million left under the stock buyback. Is that something you'll take care of pretty quickly? And is there contemplation to open another buyback? Thank you.

On the buyback question, Richard if you have anything to add here, but 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 you want to add, Richard?

No, I think that's exactly right.

Great. And then on the placebo arm in DM, look, I agree that that is a reasonable question, and certainly in immunology studies in general, it's something that people have to focus on. Obviously tests as an end point, 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 [dermatomyositis] study, different patient population that's across multiple [myositis] types, but at 24 weeks they saw whatever 30-to-35-point test.

That's without a steroid taper that we have in our study. That's 24 weeks. Our study's 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. And so I think that's the sort of thing that is encouraging, but I'll bite my nail through the readout just like anyone would in our position.

Thank you.

Sam Slutsky, LifeSci Capital.

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

I think the first thing to say, well, a few things to say. One is, this is now a competitive field, and so I think we're focused on our competitive differentiation, and we have more data than anybody else does to inform the design of these studies because we have the batoclimab Phase 2 data.

It's definitely the case that Graves' disease is chronically treated now and that many patients are on long duration of methimazole. In fact, one of the things that is a focus for us is patients who are uncontrolled despite being on long duration with methimazole therapy.

And so 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 control on the methimazole.

We are putting out data at some point later this year or expecting to on our own clinical remission from the (inaudible) lab study. And so I think that'll be important.

Obviously, until there are novel therapies in Graves' disease, the exact treatment paradigms are uncertain, but I think there's certainly an opportunity for chronic therapy. And I don't think anything about our study leaves us with an expectation of like an unlabeled limitation of duration.

Okay. And then just quickly too, obviously, some patients with uncontrolled Graves' disease will have thyroiditis disease in the real world. You obviously have the batoclimab Phase 3 readout later this year, but it's kind of what makes the most sense commercially to optimize on this ability for FcRns to work in both diseases?

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 fast 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 evolves over time. And 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.

Awesome. Thank you.

Yatin Suneja, Guggenheim.

Just two for me as well. First one is on the TED study. I understand that is not an indication that you might take forward, but you still describe that as a potential registrational study. So what are the expectations? What are the plans in TED? Could they change once we unbind those data? So that's one.

And then if you can just help on the modeling side, how should we think about the spend in 2026? Thank you.

Look, on TED, Roivant has always committed to being a data-driven organization so we're going to make final decisions on the batoclimab and TED once we see that data and the study is designed to be potentially registrational.

Obviously, we are focusing an enormous amount of our effort on 1402, given the clinical profile. I think that's where we sit on TED and on batoclimab overall.

In terms of spending 2026, Richard, do you want to take that question?

Yeah so look, I think we, as you heard from (technical difficulty) we had, roughly $150 million in cash uses 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. So I think that you'll see a little depend on the side as that moves forward, but not significant changes beyond that.

Thank you.

Douglas Tsao, HC Wainwright.

I'm just curious, Matt, as so far in the FcRn space, we've obviously seen companies coalesce around some core indications MG, CIDP. As we potentially see other entrants and other companies looking at sort of IgG lowering strategies for FcRns or other modalities, we're starting to see more competition.

And I'm just curious how you're thinking about pricing because there will obviously be much greater variability in terms of the size of indications, right? We had, yesterday, one of the competitor with the degrader program talked about pursuing grades. And so I'm just curious how you're thinking that could influence pricing and your thought around pursuing orphan indications versus more prevalent indications. Thank you.

I was tempted to go into a little vignette here of like, imagine it's 2005 and someone gets on the phone and they're like, well, obviously so far in the FcRn space people have focused on a couple of indications, rheumatoid arthritis and maybe psoriatic arthritis. And to point out that, look, I think we're really just at the beginning in terms of focus, and I think this is going to be quite a broad field across companies in the coming years. And I think that's 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, the 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.

And frankly, in the cases where there have been, there's a pricing band that we think is like generally compatible with the FcRn pricing that's been currently set by our competitors. So 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 emission data in Graves' and so on. But overall, I think we have a lot of flexibility, and I think despite the apparent variability here, I think the concentration of indications and patients with unmet need here fit pretty nicely together in terms of promotional models.

Okay, great. That's helpful.

Prakhar Agrawal, Cantor.

So going back to DM and the placebo response, obviously, there is variability on the test end point. And Matt, you have talked about the steroid tapering that can be done to mitigate that.

But are the guidelines consistent across centers on tapering up and down? What exactly are the steroid taping protocols and is there any subjectivity involved? And beyond just the steroid tapering, are there any other steps incorporated in the trial that can mitigate the placebo response? Thank you.

We will cover a lot of detail on this question at the upcoming call in a couple of weeks. So in part I'd say stay tuned. Some of that information is in published papers and so on.

But the thing I'll say is the steroid taper is mandatory in the study and set out with a pretty clear vertical, in the vertical. And so, I think we expect it is being relatively consistently applied here given the way the study is designed. So, yeah, and I think the team's done a pretty careful job making sure of that again, then we'll talk more about it.

And I think a lot of that, by the way, is just like boots on the ground, spending time with the doctor 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've designed it.

And then in terms of other steps to mitigate placebo, look, I think in general, there's a lot of things you do in a well-run study to make sure you're managing these risks in terms of how you think about discontinuations, in terms of how you think about measuring tests and the time points, and so on. And so I think there's 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. But it's nice to see other DM studies, or other myositis studies having relatively well-behaved placebo arms.

Thank you.

Andy Chen, Wolfe Research.

So 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 US based on your claims analysis or otherwise and how that compares to what you believe to be the prevalence in the US? And also a separate question that's related, do you think off-label Xeljanz is doing better on the market right now than Octagon based on physician feedback? Thank you.

And 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-plus 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. So I think that's like 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 like a little bit of a range. I think that's sort of 40,000 to 70,000 patients is probably the right way to think about the size and amount of myositis market for the moment. But I agree with you that it could be modestly underdiagnosed and that I expect patients will emerge once the treatment opportunity exists.

When you say off-labels Xeljanz versus Octagon, I mean, obviously the direct comparability of like in terms of like physician experience, what I can say is that physicians are very excited for an oral option that's on label. They're very excited for specifically for things that are in the JAK family, JAK1 and TYK2.

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 it's important informed by just the overall complexity of dosing patients with IVIG.

And then as a reminder, relative to Xeljanz, brepo obviously does more than just JAK1 Inhibition, and 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 and we think they will understand it better once we have more of an opportunity to talk to them about the data. Thanks, Andy.

Thank you.

Thomas Smith, Leerink Partners.

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 the 1402?

And 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, and the agency cares very much about aspects of this design, principally the direct placebo control versus the randomizing draw piece.

And then, and 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. And so, 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 setup here.

And then 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 better than we knew a few years ago. And so like in our shadow study, for example, we were able to select patients, almost all of whom flared on withdrawal therapy during the washout period.

And so I think based on the quality of patients that we were able to select for in the battle study, I think we feel like the 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 set up on the program. And maybe at some point, we'll put up the specific data, but as I said, I think the data from the washout period of the battle strongly suggests that we are getting the patient population that we want into the study.

Thank you very much.

Yasmine Rahimi, Piper Sandler Company.

Hi, this is [Dominic] on for Yasmine. Thank you for taking our questions and congrats on a great quarter. So 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? And then on that, what was the rationale for selecting the 600-milligram dose in the study? Thank you.

And so I don't -- we have not yet said what the study is powered for in terms of primary and secondary. We have some time there, maybe, share some more information about the specific goals of that study in the coming months.

And then, in terms of why 600 milligrams, look, I think we put out this really clear data from the battle study showing the under 70 versus over 70 IgG cut points, and we know that lower IgG suppression mattered a lot in the battle data; deeper IgG suppression mattered a lot in the battle data.

Frankly, this is a patient population where it's a severe disease, efficacy is paramount, and we're coming 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. So 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. So a lot of good reasons why that study is built around the 600-milligram dose.

So again, this is a very sick patient population, especially if we're choosing the patients correctly. And remember, at the beginning of the study, there are many patients who are coming in, for example, controlled on IVIG and they're being forced to wash out, and we want the patients who are going to work to really work. It's also a 2:1 randomized study, so most of these patients will be on drugs. Thanks, great question.

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.

Fantastic. Thank you everyone for listening. Thank you to all the teams of both Roivant and Immunovant who get all these filings together. Thank you to the investigators and patients who are working with us on our studies and trusting us with their care, and 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.

So 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.

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