Immunovant, Inc. Common Stock 2027 Q1 Earnings Call

Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2026. 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. 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. Nonetheless, a lot of great progress in the business. Certainly, we're expecting a jam-packed second half, as I'll get to in a moment. I'll be relatively brief in my remarks, and then we'll go to Q&A. I'd like 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. We're sitting here a little bit more than halfway through the year.

Just wanted to highlight that it's gone well for us, that we feel really good about the setup. On slide five, looking across the list here, we've got brexpiprazole expected to launch by the end of September. Obviously, we got priority review and our PDUFA date, as you said, is this quarter. We had great data from IMVT-1402 in D2T RA 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 cutaneous sarcoidosis for brexpiprazole, which follows on the positive results that we had in our phase II data, which I think we announced on our first quarterly call of this year or earlier in the calendar year.

We've now received the initial payment from Moderna in the settlement, the 1498 part of that case is progressing, and we filed international proceedings against Pfizer and BioNTech in that case. Finally, earlier this year, we added LPP as a fourth brexpiprazole indication, and as I'll remind people later today, that study is continuing to enroll as 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, we just have an enormous amount coming up.

Starting, as I mentioned, with the upcoming potential brexpiprazole 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 aromatase inhibitors. That data is coming in the second half of this year. We also have top-line data coming shortly in the second half from PHocus, the phase II study in PH-ILD. I know that's being closely watched and we're looking forward to getting that data and presenting it.

We will provide further updates on the D2T RA program at Immunovant 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. Finally, probably the smallest of these, we're expecting top-line data from the POC study in CLE also in the second half of this year, and looking forward to finding out what we've got there when that comes in as well. Just a jam-packed second half and even more coming in 2027 with the GRAPES data and beyond. Just a lot in the here. I'll just hit a couple of highlights in terms of pipeline updates in a little more detail here before, again, turning to our Q&A.

Starting on slide eight with a reminder because it's been a few months since we talked about it. The initiation of this cutaneous sarcoidosis phase III study is a pretty exciting event. It's a little bit ahead of schedule in terms of what we're able to do here. 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. On slide nine, as a reminder of the data that we generated in our phase II study, we had set for ourselves a goal of a sort of five-point benefit on the CSAMI scale for clinical meaningfulness.

In the study in the top left of this chart, we showed a greater than 20-point benefit compared to roughly nothing on placebo. Just a huge benefit to those patients in the phase II study and really excited to carry that forward into the pivotal program. 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 potential indication as well, and where we hope to be able to treat some of those patients via either tracheal sarcoidosis or OCS.

The phase III study that we've now begun, the design is laid out on slide 11. I know there were some questions after the phase II about what exactly this study would look like. It is designed to take all of the learnings from the phase II study that was successful. It is a 16-week study with the primary endpoint of CSAMI greater than or equal to 50% response rate. It's a 140-patient study across about 70 sites, 3:2 randomized with patients either on 45 milligrams of brexpiprazole 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 II, and generally consistent with what we think is appropriate for patients in this indication. 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 brexpiprazole coming up. I'll reiterate on slide 12, the other ongoing registrational program, is the brexpiprazole study in lichen planus or 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 unmet need in the indication. Speaks to the quality of the work being done by Ben and the Biovant team. I'm looking forward to sharing more about that as soon as we've got it. That's also moving along nicely. Finally, I'm sure there will be questions about this in Q&A and lots of opportunity to talk about it hopefully with regulatory approval and beyond. One of the major events in the near term here is the potential launch of brexpiprazole in dermatomyositis.

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 multiple times we've talked about it from the publications, including "The New England Journal of Medicine" and so on, just a phenomenal data set taken across all 10 endpoints, big clinical benefit, 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. 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, 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 base 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 Roivant private way.

There's nobody in the world that'd be more excited to oversee this than the team we've got at Roivant with Ben and Daniel and others, and I think we're going to be fully ready. Everything's on schedule. We'll have much more to say about that with the potential approval, and after, but looking forward to it. I'll say one more thing about the commercial franchise overall of brexpiprazole on slide 14. 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. I think there's a bunch of reasons for that. Some of them are DM is a new indication and no one's launched a novel therapy basically ever, or at least a targeted therapy, basically ever.