Good day, and welcome to the Roivant Fourth Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, this call maybe recorded. I would now 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 call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as 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 uncertainties. And with that, I'll turn it over to Matt.

Thank you, Steph, 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 in Myasthenia Gravis 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 anti-FcRn world with IMVT-1402, first-in-class and a number of indications such as Graves’ disease and potentially best-in-class. We think anywhere that we are 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 would be the first novel oral DM drug and have pretty long lead time over really any other late stage 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 and 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 another Moderna case. On Slide 6, we say this every time we get…

Thank you. [Operator Instructions] Our first question comes from Brian Cheng with JPMorgan. Your line is open.

Hi, Matt. Thanks for taking our call this morning. First, on DM, I assume that you touched 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? And can you tell us a little bit more on what we should focus on at your events focusing on [indiscernible] next month?

Yes. Thanks, Brian. 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 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 on this point. I think what we need to win DM is a positive study. We need statistically significant separation from placebo on TIS 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 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 and so we feel like we are primed for a successful study really being the goal in terms of what winning looks like. 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 sort of coming in within expectations there. In terms of what to focus 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 that it is in some ways, flown under the radar a little bit. And so I think most of what we're hoping to do just to make sure everyone is on the same page about what dermatomyositis is about what the end points are in the study, how 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 events. I think, again, really in part, in particular focusing on just the high quantum of unmet medical needs in DM 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 patent claims. Can you shed some light on what that potentially could mean and what is the potential next milestone actually regarding the potential case narrowing? Any color that you can provide would be super helpful.

Yes. 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. Remember 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 discuss 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 our question.

Thanks, Brian.

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

Thanks very much. Good morning, Matt and team. So 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? And then 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 II CLE trial? Thanks very much.

Yes. Great. Thank you. 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's 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 sort of hoping and thinking it may come, it may come later this year and hopefully soon, but again, it's not something we want to control 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 in placebo controlled CLE data in 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 FcRns, the quality of that data, and what other people look to be generating in making decision on whether to progress to pivotal program and 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. And so I think, on the one hand it's a bigger study with more information. 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, Dave.

Got it. Thanks very much.

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

Hey guys, good morning. Thanks for taking our questions. I just had two, mainly around DM. So how are you planning to position brepo if it’s approved? If the goal there is to be pre or post IVIg, 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 using DM. And if you expect any kind of pent-up demand, they are given familiarity with the mechanism if brepo is eventually approved? Thank you.

Yes. Perfect. Thanks. 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 17th 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 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. And then there are hundreds at this point of case reports, on the use of JAKs in DM. And so I don't know if I'd literally call that pent-up demand. So much is really, really good physician familiarity. There's been now three investigator initiated trials. There are 600 plus case reports under dermatomyositis. Again, Ben, we will cover all of this in pretty great detail in a couple of weeks. So I'm really looking forward to that. There are over 30,000 patients currently being treated for dermatomyositis. And so we think there's a ton of addressable opportunity. And by the way, broadly, we think the sort of safety and tolerability profile in 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.

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

Great. Thanks so much and congrats on the really nice progress. I have a couple of questions on brepo. Give us a little bit of a sense, what are you expecting our consultants and all 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 in the placebo arm, just given there aren't a lot of historical randomized sort of small molecule studies. So number one, what do you expect from the placebo in the study? And then secondly, so you have about $200 million left under the stock buyback. Is that something you'll take care of quickly? And is there contemplation to open another buyback? Thank you.

Yes. Thanks, Yaron. Both good questions. On the buyback question, Richard is going 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 on the market and make decisions on where to go from there. Anything you'd add, Richard?

No, I think that's exactly right.

Great. And then on the placebo arm and 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 TIS as an endpoint has various properties that make it fair, 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. But at 24 weeks they saw whatever, a 30 to 35 point TIS 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 in 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.

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

Hey. Good morning, everyone. Thanks for taking the questions. On the 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?

Yes. 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 deal. 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 II 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. 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 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. 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 on-label limitation of duration.

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

Yes, 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 test point of 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 develop and how it sort of 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.

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

Guys, thank you for taking my question. Just two for me as well. First one is on the TED study. I understand that is not sort of a indication that you might take forward, but you still describe that as a potentially registrational study. So what are the expectations, what are the plans in TED? Could they change once we unblind 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.

Thanks. Yes, and I appreciate the question. 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 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?

Yes. So look, I think we – as you heard from now, we had roughly 150 in cash used 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's – you'll see a little bit of spend on the SG&A side as that moves forward, but not significant changes beyond that.

Thanks, Yatin.

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

Hi, good morning. Thanks for taking the questions. I'm just curious, Matt, so far in the FcRn space, you'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. And 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? Yesterday, one of the competitor with the greater program sort of talked about pursuing Graves. And so 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.

Yes. Thanks for good questions. 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, you know, obviously so far the TNF 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 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. On the one hand variability around some of the size of these indications. On the other hand, I think 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 ban 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 and 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 in patients with unmet need here fit pretty nicely together in terms of promotional models.

Okay, great. That's helpful.

Thank you very much.

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

Hi. Thank you for taking my questions. So going back to DM and the placebo response, obviously there is variability on the test endpoint, 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 tapering 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.

Hey, 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. So in part, I'd say stay tuned. Some of that information's 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 protocol – in the protocol. And so I think we expect it is being relatively consistently applied here, given the way the study is designed. So yes – and I think the team's done a pretty careful job making sure of that. Again, Ben will 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 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'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 TIS 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.

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

Hey, thank you for taking the question. 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 U.S. based on your claims analysis or otherwise, and how that compares to what you believe to be the problems in the U.S. And 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.

Great questions. So 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 plus thousand or 40,000 patients. I think we said 37 based on one study that, 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 range. I think that sort of 40,000 to 70,000 patients is probably the right way to think about the size of the amount of dermatomyositis market for the moment. But I agree with you that it could be modestly underdiagnosed and that I expect patients will emerge once a good treatment opportunity exists. When you say off-label Xeljanz versus Octagam 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 is important informed by 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. And 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.

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

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?

Yes. Thanks. It is a great question. And I'd say, 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 sort of the direct placebo control versus the randomized withdrawal piece. And then 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 sort of 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, 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 bato study, I think 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. And maybe at some point we'll put out the specific data, but as I said, I think the data from the washout period of the bato study strongly suggests that we are getting the patient population that we want into the study. Thanks very much.

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

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

So we have not yet said what the study is powered for in terms of primary and secondaries. We have some time there. Maybe just share some more information about the specific sort goals of that study in the coming month. And then in terms of why 600 milligrams, look, I think we put out this really clear data from the bato study showing the under 70 versus over 70 IgG cut points. And we know that lower IgG suppression mattered a lot in the bato data. Deeper IgG suppression mattered a lot in the bato data. And 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 be on 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. Again, this is a very sick patient population, especially if we're choosing the patients correctly. And remember at the beginning of the study, because many patients who are coming in for example, controlled on IVIg and they're being forced to washout and 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 drug. Well, 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. 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 you soon, including in the next couple of weeks for the Priovant myositis event, together with that. Have a great day.

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