Roivant Sciences Ltd.

Good day. Thank you for standing by. Welcome to the Roy Vance Second Quarter 2025 earnings call. At this time, all participants are in a 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. Please note that today's conference is being recorded. I will now hand the conference over to your first speaker, Stephanie Lee. You may begin.

Good morning, and thanks for joining today's call to review Royvan's financial results for the second quarter ended September 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 the 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 filed with the FPC 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, Steph, and good morning, everybody, and thank you for listening. I appreciate all your dialing in. say, not at all a quiet quarter for us in that we put out both the Graves data and obviously the Phase 3 data for Brebsit, Niven, and DM. So just a tremendous moment of transformation for the business, but a relatively quiet earnings call as we're looking forward to getting everybody together in December for a more fulsome telling of where we are as a business, more about the future on our investor day on December 11th. That registration link is live on our website. So look forward to seeing you all there. Today will be more of a review of what's happened in the recent quarter, and then we'll talk much more about the future when we get together in December. So looking forward to that. I want to start out on slide five just by taking a short victory lap because it's been a pretty wild year for us. Obviously, starting with, and probably most notably, the Valor data for prep, sit, and DM, which hit on all 10 ranked endpoints and just a phenomenal data set that we think is going to transform the lives of DM patients. So that NDA filing remains on track, planned for the first half of next year, and it'll be the first novel oral therapeutic in DM if approved. We also put out data in this quarter from the durable remission sort of portion of the Graves' disease trial for Botoclumab, which sets us up for... for the future there in our 1402 Graves program. You know, that demonstrated disease-modifying potential for 1402. And then we think earlier this year, we put out some data in MG and CIDP that we can do a pretty nice job of validating the deeper is better idea for FCRNs. from an IgG suppression perspective. We also have initiated at ImmuneVant this year potentially registrational trials in Graves, Meissen, DeGravis, CIDP, DL3RA, and Sjogren's, as well as a POC trial in CLE, so some really exciting progress there with IMDT 1402, which we hope will take us to a first-in-class in many cases and best-in-class in, we hope all, in all indications potential. We got a favorable market ruling this quarter for Genevant in the Pfizer case and just overall continued progress in the LNP litigation with the jury trial on the Moderna case scheduled for March of 2026. And our capital position remains very strong with $4.4 billion of cash-to-cash equivalents, which will get our current pipeline to profitability and support pipeline expansion and potential additional capital return, including the $500 million that we have currently authorized. On slide six, and we've been showing this slide for a while, but it feels realer and realer with each passing quarter, a late-stage pipeline that we are really excited about with 11 potentially registrational trials and indications with blockbuster potential. Obviously, the first, though, with dermatomyositis now behind us, but many more to come. setting us up for a slide that we've been showing since June on slide seven, which is just a stacked 36 months ahead of us between multiple registrational data sets, first DM and NIU and BREPO, and then the beginnings of a long list of them in 1402, lining up for a series of launches, again, first DM and BREPO, and then NIU and BREPO, and then very shortly thereafter, 1402, across multiple blockbuster indications, including Graves. So, look, as I said, a moment of real change and transformation for the business. I think we recognize that. We're excited to talk more about it when we get together in December. It's something that the team internally is excited about. It's exciting to hear from investigators, certainly, and patients and docs in the DM landscape and from investors as well. So, looking forward to the next leg of our journey here. I'm going to do just a brief recap of the two major data sets from the quarter. So, I won't spend a ton of time on either of these because we've talked about all of them in this setting before, but they bear re-mentioning just because of how exciting both of them are, starting with the representative VAUR data, you know, on page nine. Again, we've gone through this all before, but VAUR succeeded with really highly significant, robust, and consistent data across the primary and all key secondary endpoints. with a nice clear dose response that sets us up for 30 milligrams to be the optimal dose here. Responses were rapid, deep, broad, and clinically meaningful. Across the board, a statistically meaningful and clinically important delta to placebo on mean TIF with deep responses occurring quickly and across a range of endpoints, including muscle and skin. And as a reminder on slide 10, This is a patient population with very significant unmet need and this is a story that has been underscored over and over again as our team has been out talking to physicians in the field after this data. This is a patient population that is significantly underserved by therapeutic options. 75% of these patients are on only either steroids or ISTs and are struggling to get well controlled. And many of them are requiring high doses of oral prednisone in order to be treated appropriately and are all looking for options, or many of them are looking for options. Only a relatively small percentage, only a quarter of the market is currently on other therapies at all. And of the ones that are, some of them are on very demanding IVIG regimens, multiple days a month spent entirely in the infusion centers. and others are on a series of off-label therapies, many or most of which have failed DM programs before but are used simply because there are no better options. So we're getting a predictably enthusiastic response from all of the physicians we've engaged with on this data already and are obviously looking forward to continuing that as we go through the registration process in the coming year. You know, looking at slide 11, again, a recap from before, but this is the primary endpoint. This is mean TIS. And, you know, this is a textbook picture from my perspective of positive clinical data, statistically significant at the high dose starting at the earliest time point, nice clear separation, nice clear dose response. And one thing it bears mentioning, and we said this when we put the data out originally, you know, we had originally been focused on the steroid taper as a risk mitigant in order to make sure we saw a clear benefit from the drug against the background of not really placebo, but actually actively managed background therapy. And we did that, but the other thing we were able to show is a real dose response on steroid reduction. We were able to get a significantly greater portion of patients to lower steroid doses or off steroids on high-dose prepacitinib than on placebo, and I think that actually with the doc community has been an enormously resonant finding. It's something that the docs are really, really focused on in DM, getting these patients off high-dose steroids, and we are very excited that we were able to show this in the study, including as a part of at least one of the key secondary endpoints. You know, on slide 12, more than a third, and this is the key secondary where we were able to really hit both the TIS improvement, or the TIS, I should say, and a minimal or no steroid burden. More than a third of BREPA30 patients were able to get to both major TIS responses and minimal or no steroid burden at week 52. So that's just a really exciting finding across the board. And more than half of patients were able to achieve a TIS40, a moderate TIS response with very low dose of oral steroids at the same time. So just a phenomenal outcome there on the combination. of endpoints. You know, on slide 12, again, without going through them all, just a statistically robust data set, I'll say, with really low p-values across every secondary we tested, benefit on muscle, benefit on skin, benefit on patient-reported outcomes, like the HAC-B questionnaire on disability, just a terrific across-the-board outcome here. In terms of what's next here, I think everyone's clear. You know, the NDA submission, we're moving as fast as we can. The only real gating item here was drafting, and it's ongoing right now. We expect to get a file in the first half. Data readout from that proof concept study in CS that we have ongoing will be next year. And the NIU study, which is enrolling very nicely, is currently anticipated to read out or say guide into the first half 27 around the same time as potential registration of BREPO and launch in DM. And then, you know, we'd submit the SMDA for NIU shortly thereafter with potential further indications and so on to come. So, that's preface it. And I'm sure we'll get some questions about it. And like I said, we'll talk more about that program and what it could represent commercially on the 11th. But suffice it to say, a tremendous quarter and something we're really excited to carry forward from here. Next up, I'll just recap the grave disease remission data that we put out earlier this quarter as well. Starting on slide 16, just a reminder, This is a very large patient population with a significant unmet need. And there's been, I think this is an important point as people are doing their work here, a shift away from ablation over time as patients don't want to go through the surgical procedure or the radioactive iodine, but really a lack of new medical therapies that's left something like a quarter to 30% of grave disease patients who are relapsed, uncontrolled on, or intolerant to ATDs. Just a very high proportion of patients who are unable to get well controlled. As a reminder, on slide 17, this is a bad disease. These patients are at much higher risk of cardiovascular events, much higher risk of preeclampsia, four times higher risk of preeclampsia, and a seven times higher risk of thyroid cancer than the general population. So these patients are really sick or at a high risk of developing severe comorbidities. They often go on to develop thyroid eye disease. About 40% of patients go on to develop these eye symptoms, some of which get optic neuropathy and other issues that can be pretty significant for vision. And then there's a bunch of other complications here. You know, 16% are diagnosed with thyroid storm, which has a, in patients with hospitalized for great disease, 16% are diagnosed with thyroid storm, which has a 20% mortality rate. So again, potentially sort of very sick patients and again, a relatively high risk of thyroid cancer, including a high risk of progressive thyroid cancer. So a disease that makes people quite sick. Again, more to come on the 11th, but just wanted to highlight that fact. And then, you know, on page 18, In addition to being a severe disease, it's a disease affecting a lot of people. And so you've got, you know, every year, call it 65,000 newly diagnosed patients of which, you know, 20,000 of those wind up in that sort of refractory bucket. And then there's 880,000 diagnosed U.S. patients of which 330,000 in the prevalent population are walking around in that intolerant or unable to get well-controlled buckets. So they're just a huge patient population with a significant unmet medical need. What we showed earlier this year in the Pitocumab study is a pretty interesting result. We showed real disease-modifying benefit in these patients. Of the 25 patients who came in at baseline, as a reminder of the way the study worked, patients were treated for 12 weeks of high-dose Pitocumab followed by another 12 weeks of low-dose Pitocumab and were then followed for another 24 weeks off-drug entirely. And what we saw is, you know, after that first 12 weeks, 20 out of 25 of those patients were responders to therapy. After dropping to low dose after another 12 weeks, 18 out of 25 of those patients were responders. And truly, remarkably, after being off-drug for a further six months, 17 out of the 21 patients we were able to follow up with at week 48 were responders to therapy. So these are patients who were uncontrolled on standard of care at the beginning of the study, and 17 out of the 21 of them that we were able to follow up with remained responders to therapy, having been off-drug for six months. So a pretty remarkable disease-modifying benefit. Of the off-drug responders on page on slide 20, nearly half of them were fully off ATDs, and over 75% of them were on only the lowest doses of ATDs or off ATDs. So, not only were we able to deliver a disease-modifying benefit for patients who were uncontrolled on ATDs before, we were able to significantly reduce or eliminate ATD need for those patients. This was underscored on slide 21, not just by the sort of clinical data on T3 and T4 and so on, which is obviously in some ways what's most important to the patients, but you can also see it in the T-REB reductions on slide 21. And as you can see, as you'd expect for FCRN therapy, these patients showed a rapid decline both in general IgG and in T-REB levels, especially on high-dose patients. The IgG levels came back a little bit, as you'd expect, during the lower-dose period. And then what is maybe unique to Graves' disease, or at least unusual among FCRN indications, is while IgG bounces right back when you come off therapy, and the only time points on this graph are week 24 and week 48, but by week 48, these patients were effectively back at baseline from IgG, the vast majority of these patients still had basically sort of reduced or no T-REBS, and that is a pretty remarkable finding around the durability of the benefit here. On slide 22, the next period is absolutely stacked for us in 1402, with data coming in a variety of indications, DGT-RA and CLE next year, the second part of the DGT-RA study, as well as Graves and MG in 2027, and then Sjogren's and CIDP after. One small update, just a flag for today. The TED study remains on track to conclude this year. Last patient, last visit is a very close to today, but we're going to hold off reporting the top-line data from that first study in all likelihood until we see the top-line data for the second study in the first half of next year. The evolving competitive landscape in TED and especially in Graves' disease has led us to take a more prudent path there, and so we're going to collect that data together and report it when we have it all. Moving on briefly to just a reminder of where we are on the L&P litigation, which I know some people are following. In the Moderna case, we are in a pretrial process around the narrowing claims and defenses and around summary judgment, which is happening now. The judge is reviewing summary judgment briefings in this sort of a calendar on the docket that we're hoping will take us through trial in March. The trial is scheduled for March, and the first international proceedings are also expected in the first half of 2026. The Pfizer case is ongoing in discovery, and there was a favorable Markman ruling issued in September that certainly sets us up nicely for what we think we need to do from there. So I'll conclude before we go to Q&A with a brief financial update. Overall, a straightforward quarter from a financial perspective, loss from tendering operations, net attacks of 166, and cash-to-cash equivalents of $4.4 billion with no debt on the balance sheet, and obviously a share count reflective of the significant share buybacks we've done over the last 18 months. So a strong position overall that, as I said, is expected to carry us through profitability. We've got more of our financials in here and the catalyst sort of roadmap on slide 28. But again, just a really exciting six months or 12 months behind us and a really exciting 12 months or 36 months ahead of us. So feeling great about where the business is, feeling great about the significant transformation in our profile that we've been through in the recent months and looking forward to carrying that forward from here. Once again, as a reminder, we have an investor day in New York City. For those that can make it in person on December 11, 2025, that registration link is live. It's in the presentation we put up as well as on our website. I hope to see many of you there to round out the year and talk about the future. So with that, I'll say thank you again for listening. Again, a relatively quiet earnings call, but not at all a quiet quarter. And I will pass it back over to the operator for Q&A. Thank you, everybody.