Roivant Sciences Ltd.

Good day, and thank you for standing by. Welcome to the ROY event first quarter 2025 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. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review Royvan's financial results for the first quarter ended June 30th, 2025. I'm Stephanie Lee with Royvan. Presenting today, we have Matt Klein, CEO of Royvan. 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.royvan.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 will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt.

Thank you, Stephanie, and thank you, everybody, for joining this morning. I appreciate it. It is a relatively quiet quarter before what promises to be a very busy fall, so I look forward to sharing some updates and then taking some Q&A. I will start on page five, which is a reminder of sort of where we are for this year. So, you know, three main themes for calendar year 2025. The first of those is the continued progress that we're making with IVG-1402 and Immunovant, where we are developing what we hope will be the best-in-class anti-FCR antibody. We put out data earlier this year in Botoclumab, our first-generation drug in MG and CIDP, and now it's really a story of that team-focused clinical execution getting the GRAVE study enrolled and continuing to progress with other indications that we've announced there. The second major theme for the year, which is approximately imminent, is the registrational dermatomyositis data from brepcitinib, which we hope will set the stage for a commercial launch of that drug and that indication. That pivotal trial is now last patient, last visit completed as of last month, so that data will come as we've guided before in the second half pretty shortly. And then finally, the other ongoing major stream that we've been drawing attention to is the L&P litigation with Moderna, which is in the latest innings, at least of the first game here as we approach trial, and that's scheduled for March of 2026, as well as the ongoing trial with Pfizer and BioNTech, and we'll give a brief update there on this call. On slide six, just as a reminder, we are really proud of the pipeline that we are operating with today. Obviously, first and foremost, with that registrational data coming shortly and with multiple indications with an enormous amount of clinical progress ongoing and with a bunch of registrational trials, five registrational trials for 1402 currently ongoing. And then obviously also mostly CIGAWAT, our owner hypertension program, that will update on the second half of next year and ongoing VD as well. You know, on slide seven, I'm not a superstitious person. I'm not going to spend that much time talking about the future beyond the brepsydnib data, but suffice it to say, our next few years ahead are really, really exciting, starting with this pill data DM and then with multiple potential registrational data sets and launches, first in brepsydnib and then across the FCRM portfolio. I feel like a few years from now, we could be on these calls describing a pretty different company with quite a large commercial footprint, so we're looking forward to getting started on that hopefully shortly. Finally, on slide eight, a brief update on our share and purchase program. As I think you're all aware, we completed the $1.5 billion authorized share and purchase program from last year as of June of 2025. We repurchased just under 150 million shares at an average price of just over $10 a share, so we reduced our share count by over 15%. In the same period, we have meaningfully expanded our pipeline, and so we're excited to have increased our own exposure as shareholders and all of your exposure as shareholders to the upcoming catalyst over the next 36 months. As you likely saw, once we completed that program, the board authorized an additional $500 million repurchase program, which we plan to continue evaluating for opportunistic use, especially as the market remains a little bit up and down. You know, on slide 9, Just a period of real progress across the entire pipeline. We continue to rapidly advance prep sit-in and press indications. We'll talk more about BREPO in just a moment, but obviously completed last patient last visit for Valor and DM and our enrolling patients in registrational trials in non-infectious uveitis at a good pace, as well as our proof of concept study, cutaneous sarcoidosis. We are intensely focused on clinical execution for IMDT-1402. Probably most importantly with enthusiasm around our Graves' disease study with a second registration trial, a potential registration trial has begun. And enrollment is picking up nicely there as well. And then we expect additional data from Patoka-Meyo's phase two trial in Graves' disease with the six-month permission data presented at ATA next month. We've initiated now our potential registration program in Sjogren's disease. And then finally, continued progress on our LMP litigation. We'll talk more about it in just a few slides. So I'm going to take just a very brief moment here to refresh everyone on Brepo as we sort of stare down the barrel of this upcoming data, starting on slide 11. You know, we're really proud of how brepsitinib reflects on the Royvan journey. We feel like we've rapidly expanded it into multiple orphan immunological conditions with a, at this point, in a drug now with a well-established safety profile and over 1,500 patients' doses. As a reminder, we unlicensed this program in the summer of 2021 when, luckily, the verdict on JAK inhibitors was still out and there were some questions about what the Black Box warning was going to be. As that field has evolved favorably, obviously, some of our competitors are now selling literally many, many billions of dollars with the target. We have separately advanced in now two filter programs from the concept program, and we're super excited about some additional indications that we're still doing some work on. Brevacitinib on slide 12 with the VALOR study could redefine the standard of care for patients specifically with dermatomyositis. So we've talked about this a fair amount in this forum, but DM is a truly debilitating disease with major unmet medical needs. In our analysis, 40,000 about U.S. adults. There's obviously some slightly higher numbers coming out of some of our competitors. It's a skin and muscle disease that is debilitating to patients' quality of life. They are currently heavily treated with high-dose chronic steroids and other immunosuppressants, which don't work that well overall. REPO is the only oral therapy in late-stage development. It will be the first advanced novel therapy of any modality for patients with DM apart from IVIG. And then the VALOR study is designed to truly establish our profile there. There's good pharmacological rationale for TIK2 and JAK1 inhibition. This is the largest interventional trial in DM ever conducted. with a variety of useful endpoints for showing how we benefit quality of life for these patients. And we, as announced at our call in June, have seen good success with our steroid taper, which should help us ensure strong differentiation from SIBO. The Vower study on slide 13, there's a schematic test, two doses of Repcitinib, 30 milligrams and 15 milligrams over a 52-week period with a mandatory steroid taper, as I mentioned. It requires both active skin and muscle disease, and the primary endpoint is mean TIS for placebo H52. On slide 14, you can see the baseline characteristics in the study. We put these out again at our representative-specific, DM-specific call in June, which, by the way, if you haven't watched, is a really nice team, the Priyavanth team, on the study and the indication. I think we're pretty happy on slide 14 with the baseline characteristics mapped to the other successful late-stage study run intrametabysitis, the proderm study of IVIG. And so, again, we're looking forward to those results. One thing we've been quite focused on on slide 15 is the steroid taper here, which, again, is designed to help us manage some of the inherent variability in TIS as an endpoint. And again, this is all information we put out in June, but we had good success with 98% of patients achieving the mandatory taper, over 40% fully eliminating optical, sorry, optical, oral corticosteroids, and over 60% achieving a greater than 75th percentile, percent reduction from baseline. So really good progress on getting these patients off steroids, which should give reposidinib a truly fair shot in the trial. On slide 16, you know, since we began our DM program, I'd say DM has been increasingly recognized as a commercial opportunity and as a market with high-end that need. Obviously, there's multiple programs ongoing at this point, at Pfizer, at CartesianMod, a molecule we know well, and at AstraZeneca. We are the only oral, we are the soonest of those readouts, and there's multiple phase two programs that have initiated since the beginning of the Bower study across a variety of mechanisms and companies. BREFO has an overall pretty busy couple of years ahead here, obviously starting with this DM data coming soon, and then following there after a regulatory filing for use in DM. We'll then next year get our proof of concept data in cutaneous sarcoidosis, as well as, you know, first half of 2027, top line data in NIU, and around the same time, a launch in DN, hopefully, and then following that, regulatory filing in the second half of 2027 for people in NIU. So quite a lot coming there. The last deeper dive update I'm going to give on this column, as I said, a relatively brief call given the client report here, is on the L&P litigation. So on slide 19, as a reminder, we are in a pivotal period for our L&P litigation overall. In the Moderna cases, we are in a pretrial process to narrow the scope of claims and defenses with an ongoing what's called summary judgment phase, which I'll talk more about in a moment. The U.S. jury trial is currently scheduled for March of 2026. So we're obviously looking forward to that. And we also expect major international hearings in the first half of next year as well. The Pfizer case is ongoing and in active discovery. The Markman hearing was held in December of last year, and the ruling could come this year. So looking forward to that progress also. Probably the biggest update on the case in recent weeks has been on slide 20, the summary judgment motions that were filed in the U.S. Moderna case. As a reminder, at this point, we are asserting four patents, three related to lipid composition, the 359, 435, and 378 patents. That's which lipids make up the sort of balloon, the outside of the LMP inside of which the MRNA is encapsulated, and then the 651 patent on MRNA LMP compositions that describes the encapsulation of MRNA within an LMP. We, gentlemen in Arbutus, filed three motion summary judgments related to the relitigation of obviousness arguments that were resolved in the IPR process and appeal that that we don't want Moderna to be able to assert certain invalidity arguments related to prior art, and that the 651 patent is valid on certain specific grounds. Moderna also filed three motions for summary judgment. Probably the most talked about is the motion of 1498, which is Moderna's attempt to defray liability to the US government under a World War I era patent statute. Secondly, claims around our ability to use the doctoral equivalents based on the prosecution history of the patents. And finally, they're asking for a summary judgment on claims of indefiniteness around the 651 patent. So we look forward to all of those issues being resolved this fall in summary judgment. Some other developments, the case was assigned to a new judge in the same court with trial scheduled for March 26. and upcoming opposition motions in the summary judgments are due August 22nd, and then there'll be a volley of replies back and forth in September before those summary judgment rulings are made by the judge. Finally, before we wrap up and go to Q&A, just a quick financial update. Relatively straightforward order, you know, on an adjusted basis, net loss of $170, cash utilization of about $200 outside of the shared purchase program and other throughout these one-time events. Balance sheet remains incredibly strong. We're privileged. We have $4.5 billion of cash as of June 30th, no debt, and a significantly reduced share count, thanks to the Shared Purchase Program. So that's where we are from a financial perspective. Hopefully, we'll be able to talk more about the upcoming year two and three in terms of upcoming catalysts once we have the data in hand. And I'm really excited for what that commercial franchise could look like, what that could mean for patients as an opportunity, and what everything else coming beyond it could look like. But we'll wait to talk about that until we can talk more about what that data looks like once we've seen it. So in the meantime, I'll just say thank you again for listening to the prepared portion of this call, and I'm looking forward to taking questions. Operator, over to you.