Roivant Sciences Ltd.

Good day and thank you for standing by. Welcome to the Roy Vant second quarter 2024 earnings conference 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 this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 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 Roybent's financial results for the second quarter ended September 30, 2014. I'm Stephanie Lee with Roybent. Presenting today, we have MacLyne, CEO of Roybent, and Ben Zimmer, CEO of Private. For those that are in the end of the 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.roybent.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 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, Stephanie. Thank you to the operator, and thank you, everyone, for dialing in this morning. We actually have a relatively full update. So I'm excited to share, and there's at least one major new thing we're going to talk about, which is the 52-week data from our NIU study, which I'm pretty excited about. So starting on slide five, look, I think there's really two major areas of focus for us right now. And the first is clinical trial execution. We have a lot of ongoing trials. all of which are important and are going to generate interesting data coming in the near future here. Obviously, today we're talking about the 52-week data for brepacitinib and NIU in the Phase II study. We're also, the Phase III study is ongoing with the first patients enrolled and with fast track designations having been granted. We presented this quarter betoclonab in Graves' disease. We are now getting our programs up and running for IMVT-1402 in both Graves' disease and in difficult to treat rheumatoid arthritis, as well as a number of other programs to be starting soon. We have initiated our phase two study of Moseley and PHILD. And then we have clinical data coming, including nabilumab and sarcoidosis by the end of this quarter. Botocumab data coming next year in MG, CIDP, and TED. And brepacitinib and dermatomyositis top line data coming in the middle of next year at Wells. So that should be all exciting updates in the near future, all focused on clinical execution. On slide six, the evolution of the business continues in some other ways as well. With the Dermavent deal having closed just a week or so ago, now allowing us to refocus on clinical exclusions I just mentioned, while maintaining a large share of potential upside from VTAMO. We talked about that not long ago. We've made some progress with our LMP litigation with a Markman hearing in the Pfizer-BioNTech case in September, with a trial less than a year from now in the Moderna case currently scheduled. We've continued our plan of returning capital to shareholders. We've so far repurchased an aggregate of $754 million worth of stock as of 9-30, including $106 million in the quarter reporting today, with an ongoing commitment to be prudent and thoughtful in deploying this capital. And then, of course, and I know this will be a topic of discussion, we have ongoing business development activities and multiple negotiations for potential and licensing of new programs that we are really excited about. This really does remain one of the most exciting environments for that activity that we've ever been in. You know, As we've been saying for a little while here on slide seven, the next chapter for us is really anchored by our late-stage pipeline. That includes IMFG-1402 and Batoclumab together, our FCR enfranchised. That includes brepacitinib, which we'll be talking about a fair amount today, our TIK2 and JAK1 dual inhibitor. That includes Nimilamab and Mosley and a number of other programs that we expect and hope to be bringing in in the near future. All together on slide eight, we think that really does give us one of the most exciting development stage clinical pipelines out there with a path to a $10 billion plus peak sales portfolio spanning multiple therapeutic areas, obviously including INI and pulmonary hypertension as well as others, with the first approvals potentially coming in the next couple of years, as well as many phase two and phase three data readouts and a significant wave of approvals across new indications in the 26 to 30 timeframe. So really looking forward to the next handful of years here as our portfolio has time to mature and develop. So with that as the 30,000-foot overview, what I want to do next is make sure we give due time to the most significant of our updates for today, which is the 52-week data from our NIU Phase II study. And so I'm going to give just a really brief introduction here, and then I'm going to hand it over to Ben Zimmer, who's going to take you through the updates on that program in more detail. But on slide 10, I'm going to steal only a tiny bit of Ben's thunder. Basically, as you'll recall, in the spring, we presented the 24-week data, and it looked, to be blunt, like it supported a potential best-in-indication efficacy profile, data of a kind that the NIU field, bluntly, had not seen before. And the hope, really, was just to maintain that level of efficacy through 52 weeks, and I can say we've definitely hit that bar. We really only had one additional subject in each dose on with the treatment failure, and we had sustained improvement from baseline on important metrics like retinal-vascular leakage, CST, and macular edema. So really, really exciting data. No new safety or tolerability signals. The safety database at this point, as you'll know, comprises 1,400 exposed subjects and patients and is consistent with approved and widely tried JAK inhibitors. And we've got best-tracked designations from FDA and NIU with patients currently enrolled. So that's the 30,000-bit overview, but the data is pretty exciting. So I want to hand it over to Ben Zimmer, as I said, the CEO of Priyavant, who's going to take you through the next slides here and walk through the actual data. Ben, take it away.