Roivant Sciences Ltd.

Good day and thank you for standing by. Welcome to Roy Vann's first quarter 2026 earnings conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask questions during the session, you need to press star 1 and 1 on your telephone. Please be advised that today's call is being recorded. I would now like to hand the conference over to your first speaker today, Stephanie Lee. Thank you. Please go ahead.

Good morning, and thanks for joining today's call to review Roybant's financial results for the first quarter ended June 30th, 2026. I'm Stephanie Lee with Roybant. Presenting today, we have Mack Line, CEO of Roybant. 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.roybant.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 good morning everybody, and thank you for joining. This is a little bit of a calm before the storm moment for us, and so a pretty quiet quarter and maybe not the most interesting of our earnings calls in recent memory, but nonetheless a lot of great progress in the business, and certainly we're expecting a jam-packed second half, as I'll get to in a moment. So I'll be relatively brief in my remarks, and then we'll go to Q&A. I just want to start on slide four. This is a slide we took from our own prior deck. This is from the investor day that we did in December of last year, and this was a list of our priorities for the year. And we're sitting here a little bit more than halfway through the year, so just wanted to highlight that it's gone well for us, that we feel really good about the setup. And so on slide five, Looking across the list here, we've got brevacitinib expected to launch by the end of September. Obviously, we've got a priority review, and our PDUFA date, as we said, is this quarter. We had great data from 1402 in the DTCRA study that we presented on our last quarterly call. Probably the most notable update for today, the top center of this slide, is that we've now enrolled patients in the Phase III study in continuous sarcoidosis for brevacitinib. which follows on the positive results that we had in our Phase 2 data, which I think we announced on our first quarterly call this year, earlier in the calendar year. We've now received the initial payment from Moderna in the settlement, and the sort of second part of that, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case. And finally, earlier this year, we added LPP as a fourth representative indication, and as I'll remind people later today, that study is continuing to enroll really well. As I mentioned at the top of the call here on slide six, I'll just say this is a quiet quarter and this is a quiet day. I don't know exactly how the following statement could be true, but I think it is. The next six to 12 months are in many ways busier than the prior six to 12 months for us. And so we just have an enormous amount coming up. Starting, as I mentioned, with the upcoming potential brepcitinib launch in DM, which should happen imminently assuming everything goes as we hope and expect it will with FDA. We've got top line data in brepo from the NIU study, an indication that could easily be as large as dermatomyositis. That data is coming in the second half of this year. We also have top line data coming shortly in the second half. from Moseley, the phase two study in PHLD. I know that's being closely watched and we're looking forward to getting that data and presenting it. We will provide updates, further updates on the D2DRA program at Immunavant in the second half of this year, including hopefully a download on a conversation we hope to have with FDA about that program as well as the results from the second part of the study and a little bit more about our plans going forward. and then finally probably the smallest of these, we're expecting top line data from the POC study and CLE also in the second half this year. I'm looking forward to finding out what we've got there when that comes in as well. So just a jam-packed second half and even more coming in 2027 with the GRAVES data and beyond. So just a lot, a lot in those here. I'll just hit a couple of highlights in terms of pipeline updates in a little more detail here before, again, before going to Q&A. Starting on slide eight with a reminder, because it's been a few months since we've talked about it, the initiation of this cutaneous sarcoidosis phase three study is a pretty exciting event. It's a little bit ahead of schedule in terms of what we've been able to do here. And this is a disease that we're just privileged to be able to work in here. It's a high morbidity, very difficult disease with a high urgency to treat. You can see on slide eight some of the photos we've shared before, but these are patients who are really sick and have very few treatment options. You know, on slide nine, as a reminder of the data that we generated in our phase two study, we had set for ourselves a goal of a sort of five point benefit on the CSAMI scale for clinical meaningfulness. And in the study on the top left of this chart, we showed a greater than 20 point benefit compared to roughly nothing on placebo. So just a huge benefit to those patients in the phase two study and really excited to carry that forward. into the Pivotal Program. As a reminder on slide 10, we think this is a pretty decent-sized indication, again, with high unmet need, probably about 40,000 patients in the U.S., and reasonable overlap with some other organ systems, including optical sarcoidosis or eye sarcoidosis, where that overlaps with NIU. That is one of the types of NIU that we're studying, as well as pulmonary sarcoidosis, which is a big A big potential indication as well and where we hope to be able to treat some of those patients via either their ocular sarcoidosis or CS. The Phase 3 study that we've now begun, the design is laid out on slide 11. I know there were some questions after the Phase 2 about what exactly this study would look like. It is designed to take all of the learnings from the Phase 2 study that was successful. It is a 16-week study with the primary endpoint of Susami, greater than or equal to 50% response rate. It's a 140-patient study across about 70 sites, three to two randomized with patients either on 45 milligrams of brepsitinib or placebo and with a mandatory steroid taper going from week two to week eight down to zero, which is roughly consistent with what we did in the phase two and generally consistent with what we think is appropriate for patients in this indication. So that study, as I said, has already begun enrolling patients, and we expect top-line data in 2028, which just adds to the list of potential registrational indications for brevacitinib coming up. I'll reiterate on slide 12, the other ongoing registrational program is the brevacitinib study in lichen planipolaris LPP that we announced earlier this year. That study is enrolling, I'll say, extremely well. There's a lot of enthusiasm from physicians and patients for that. speaks to the high-end need on the indication, speaks to the quality of the work being done by Ben and the private event team. I'm looking forward to sharing more about that as soon as we've got it. So that's also moving along nicely. Look, finally, and I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it, hopefully with a potential approval and beyond. Obviously, one of the major events in the near term here is the launch, a potential launch of brepsitinib in dermatomyositis. Obviously, I think we're in a phenomenal position here in terms of what we've got and in terms of what we hope to be able to do. Starting with the quality of our clinical data, which as you know from the mobile times we've talked about it, from the publications, including in the New England Journal and so on, just phenomenal data, stats take across all 10 endpoints. and a lot of enthusiasm from the doc community. This is a really tough disease, a large addressable population, most of them on sort of polypharmacy trying a lot of different things and frankly most of them still dissatisfied with the available treatments. So we feel like we have an opportunity to do something big and different for this patient population. Our team has been out spending a lot of time with the physician and the patient communities on overall education and I think The enthusiasm for a new therapy is coming out loud and clear, including with all the academic presentations that have been done and so on. Commercial launches, there's not much to say today other than that it's on track. We're ready to launch on time, having received priority review. The sort of commercial and patient support teams are built out, trained, ready to deploy. We feel really great about the hires we've made there, really great about the organizations we've built there. We think we're doing this in a way that is both Capitalizing on all the learnings from successful launches at other companies in recent years and doing it in a really private way. There's nobody in the world that would be more excited to oversee this than the team we've got at PriEvent with Ben and Daniel and others, and I think we're going to be fully ready. Everything's on schedule, so we'll have much more to say about that with a potential approval and after, but looking forward to it. I'll say one more thing about the commercial franchise overall at PrepSitNew on slide 14. You know, we get a lot of enthusiastic questions from investors around pace of launch, and we've been pretty consistent that our answer to that question is sort of slow and steady is what we're looking to build there. And I think there's a bunch of reasons for that. Obviously, some of them are DM is a new indication and no one's launched novel therapy basically ever. Thank you for joining us. what work will need to be done to get everyone comfortable and excited and on drug, although I think we're fully prepared. But also, to me, it's because prepositive is a lot more than just dermatomyositis. And to me, what we're really doing here is not just trying to make that launch as fast as possible, we're trying to lay the groundwork for the overall opportunity, which goes beyond DM into first NIU and then CS and LPP with the data coming thereafter. And I think as you think about that layering, To me, it's much less about what week one or month one or quarter one look like and much more about making sure that the foundation around access, the foundation around patient support, the foundation around the institutional are all set up to deliver the maximum opportunity for Revisit across all of these indications. I think slow and steady isn't just about guidance. Slow and steady is about the approach that we're taking with the program to make sure we have maximum reach across everything that we're doing there, including indications that we're excited about beyond the ones we've already announced. A lot to come, as I said, on track for that launch. You all hear the same thing we do, which is a ton of enthusiasm from the patient and physician community for new options and all of these indications. I'm looking forward to sharing more when we know about it. But our guidance is going to continue to be slow and steady because that's what we think we're building. You know, final business update here is we got the upfront payment in the settlement with Moderna. That $950 million has come in, $770-ish of it. to Genevent and the rest to Arbutus. So that's done. There'll be progress in terms of return of capital, et cetera, of that by Arbutus and so on. The 1498 sort of appellate ruling is that that process is ongoing at the Federal Circuit. That'd be another $1.3 billion if we got a favorable outcome there. And then we continue to advance our litigation against Pfizer and BioNTech. We filed Three international lawsuits, notably in Canada and the UPC, in July, so just last month, and continue to progress that case as fast as we can. Obviously not all of it in our control, but equally enthusiastic about the potential there in terms of what we could get. I'll wrap up just with our usual financial update on slide 17. Look, I think overall, most importantly, we are spending in areas that we're excited to be spending. We're excited about all of our R&D programs, about $200 million of R&D expense for the quarter, just under $100 million of non-GAAP-adjusted G&A or 166 of GAAP G&A expense, and cash just under $4 billion, and that's before the receipt of the 772. Notably, pretty significant share repurchase activity, about $200 million in the quarter, a bit more than that when you include March. Obviously, what we did there was we accelerated our share repurchase program upon the announcement of the Moderna settlement so that we could get those shares in. And a reminder, the shares that we bought by kind of the first round of this, the $1.5 billion that we had bought back sort of up through mid-last year, we bought back at around $10 a share. I think the average price at which we've been able to buy back stock since we kicked off the second round of this in earnest in March has been in the High 20s. So, you know, feeling good overall about retiring those shares and getting that capital back to shareholders. I'm going to continue doing that according to our authorizations for now. And all of it ahead of, on slide 19, a really rich catalyst calendar ahead with a lot coming. So looking forward to all of that with just an incredibly busy, incredibly busy stretch ahead. You know, on slide 20, again, a little bit incredulous for the people around Roivant who are doing all of this work, or incredible for the people around Roivant who have to do this work. But by the end of calendar 2028, we'll have had hopefully three or more commercial launches, nine or more study readouts, four plus MDA or BLA filings, a number of proof of concept studies, just a ton coming up in the near term. So with that, I'm going to wrap up my prepared remarks for the day, and I will hand it back over to the operator for Q&A in just a moment. Thank you again for listening this morning and looking forward to taking your questions. Thank you. Operator, over to you.