Roivant Sciences Ltd.

presentation there will be a question and answer session to ask a question during the session you will need to press star 1 1 on your telephone you will then hear an automated message advising 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 first quarter ended June 30th, 2024, along with a business update. I'm Stephanie Lee with Roybent. Presenting today, we have Matt Klein, CEO of Roybent. 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.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 was 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.

Great. Thanks, Steph, and thanks, everybody, for joining. It's always a pleasure to get on these calls. We, in truth, we saved all of our fun updates for this fall. So today is a relatively straightforward set of updates, but a couple of really meaningful clinical execution points and a couple of other things that I'm happy to be talking about. So thank you again. I'll start just quickly on slide five in the deck with a reminder just kind of where we are this year, which is that this is a year of growth and expansion for us. So we're focused very much on delivering clinical data across multiple of our franchises, the anti-FCR enfranchised, where we have some meaningful data sets coming as soon as the near, near future, as well as over the next, call it, six months. We have continued clinical development beyond that in our pipeline, including in brepsitinib, where we'll be beginning our phase-through program at NIU shortly, where we have data coming into Milimab, later this year in sarcoidosis, and so on. We're very much looking forward to it. We'll talk a little bit about Vecama today, but the story for Vecama for this year is really the expansion of the label IDAID, And some acceleration of the crisis, certainly volumes and revenues over time. And then we continue to be hard at work expanding our pipeline, looking at mid to late stage programs. I know there's a lot of focus on that activity. We will be unveiling our much discussed sort of so far unsposed program just next month. So we'll hold on for a few more weeks there. And then continuing to work on prioritizing capital allocation, including thinking aggressively around the use of capital to continue to buy back shares and so on. We are super proud on slide six of the pipeline as it currently stands. And one of the things that I struggle with sometimes, I get all these questions about BD, but, you know, every time I look at our pipeline, I'm like, well, we still have one of the best I&I pipelines even without any BD. So, you know, excited about the breadth of opportunities there. In particular, excited about the next, call it, 18 months, both in the FDSRM world, we'll talk a lot more about today, and to prep a sit-in, we have a little data coming shortly. So the main updates for the quarter, starting on slide eight, one is on brepsitinib, which is that we've now completed enrollment in our phase three study in dermatomyositis. It's 241 subjects across 90 sites. It is the largest interventional DM study ever conducted, and we can now say with confidence we expect top-line data in the second half of next year. That study completed enrollment a few weeks back. And we've completed our end of phase two meeting with FDA on the NIU opportunity and are planning to begin a 52-week phase three study in the near future in NIU or phase three program. At Immunovant, you know, we had announced that, as you may recall, a slight delay last quarter for the MG study. We can now say that that study has completed enrollment, only a little bit behind the original schedule, and so we'll get data back. in the first quarter of next year, as we previously discussed. And we remain on track for the initiation of a registrational program in MG for next year, as well as multiple other programs. We'll talk more about that in a minute. We will unveil our upcoming phase two program, as I said, in September next month. Excited to do that. It will be a combination of a presentation of some data. We will likely do a phone call like this one. So looking forward to getting together at that time. And then a couple of other updates on slide nine. One is just to say we continue to be pleased with the progress we're making at GenEvant in our IP litigation around the COVID-19 vaccines. Discovery continues, and you may have seen we requested a slightly amended case schedule so that we could get some more information from Moderna, which if approved, we think that the trial will be just about a year from now, so in September of 2025. And then we achieved some important clinical regulatory milestones that resulted in cash coming in the door. We're going to get a $28 million milestone related to the Japanese approval of the Camel Brother. We got that in July and we have received our portion of $110 million of the remaining proceeds for T-Levant now that they've begun, they've hit the definition for that milestone. So that has been received this month. So please with that and obviously even $110 million, still a multiple, even in this milestone of the capital that we originally invested in the program. So those are the main updates for the quarter. I want to spend a couple of minutes on some things in particular. One of them, just to review where we are and our level of enthusiasm around Immunovant, around the NTF CRN opportunity. We've been having some conversations over the last few months And it occurs to me that I have a little bit of regret, only that we've been drawn into, as a field I'd say, a conversation about apportionment of a small pie, when in fact I think our view is that the biology for FCRN, the biology for B-cell immunology and beyond is very broad. And so I just wanted to highlight, you know, again, where we think we are, the amount of data that's been generated here that supports the breadth of the opportunity. And a little bit of a reminder of just why we are so excited about the program. So as a reminder on slide 11, look, we've said this in multiple places. We really do believe that IMBD-1402 has a potentially best-in-class profile here. That comes, obviously, first and foremost from our ability to suppress IgG as deeply or deeper than any of the other anti-FCR and antibodies, in our view, without any impacts on things like albumin and LDL, which obviously was something that affected our first-generation program. And then I think it's worth remembering, we are also going to be able to launch, in all likelihood, IMDb 1402 in an auto-injector. It'll be a simple subcutaneous injection that should enable self-administration at home, subject to FDA being okay with that. And we think that'll be a really compelling format for patients and a differentiated option versus where, certainly where the field is right now, and our sense is potentially differentiated relative to even where the field will be in a couple of years. There has been, on slide 12, just absolutely explosive growth over the past couple of years in the breadth of what FCRN has demonstrated. Rewind back to 2020, there were eight total FCRN indications in development with about 700,000 addressable patients. There are now 23 indications in development for anti-FCRN antibodies with a current total addressable population of 4 million, and that number is growing often. And we expect to add some to it in the relatively near future as well. So just a huge area of biology and a patient population that prior to this moment had a ton of unmet need. You know, on slide 13, you can see there have now been across 22 positive late-stage studies in nine indications, four different anti-MGF antibodies have been studied in about 2,000 patients. There's a tremendous amount of data about this mechanism, some of which generated by us, such as the Tokamab and Graves and the Tokamab and KED, some of which generated by others, such as in Sjogren's recently. But overall, just a really compelling picture of a well-tolerated class that shows meaningful efficacy and clinical benefit in a pretty wide range at this point of diseases. So we are really excited about that. You know, the other piece, and I don't want to spend too much time dwelling on this, on slide 14, is there's been a lot of interest, let's say, in competitive mechanisms, IG degradation or some of the CAR-T or B-cell biology, T-cell engagers for autoimmune disease. I want to say nothing on this slide is meant to suggest that we are not enthusiastic about much of that biology. We think it's really great biology. But I think it's... It's been interesting to us only in the sense that it's so much earlier than FCRN, and FCRN has sort of elegantly cleared this bar that there's still a lot of work to do in some of these other mechanisms. You can see here, again, multiple approvals for our class in immunology, multiple positive phase three studies, multiple positive phase two studies, and thousands of patients. It just sets up a different picture in terms of the level of validation and the proximity of the opportunity. And so we're excited about that vis-a-vis our place in the competitive field. Again, we think many of these other classes are interesting. Watching them closely, we make investments in other areas. And so you can imagine we're watching these areas. We like the biology, but we feel really good about where FCRN is positioned competitively and just how different it looks in terms of stage of opportunity. You know, on 515, everyone wants to compare themselves to the biggest drugs, and so the humoric comparison is maybe overdone, but I liked a couple of things about it here. But one of the things I liked about it is, you know, if you try and stack up where FCRN is versus where the TNF class was at various points in history, It just feels exciting to be at this stage in the biology, right? We are in a much larger set of indications than TNFs were being studied in at the time and growing. FCRNs have sold extremely well on a time-adjusted basis. You know, the first FCRN approved reported about $1.2 billion in net sales in its first year post-launch. And if you look at our forecast, you look at street forecasts, I think there's a chance this class will build, especially given the breadth of early development, meaningfully quicker over time than the TNF class was able. And I think it's notable, apropos the competitive point, the TNF class didn't achieve these obviously phenomenal results just on their own. There were, by 20 years after launch, there were nine other approved MOAs sort of directly competing with TNFs in many of their indications, and yet TNFs being a foundational class, being novel biology, being well-tolerated, we're able to carve out a really meaningful portion of that. So I think as we look at, and there's many other examples we could have picked, but as we look at these other spaces, I think our view is the opportunity here is big, it's broad. Notably, these are not just many indications. Many of these indications are very large indications, and so we feel like even success in a handful of them for any given program can make a big impact. And indications that are big enough, as with many of the TNF indications, to accommodate multiple programs, multiple mechanisms. This is It is a big tent. On slide 16 has an aggressive plan. We are excited about that plan. 1402 will be in four to five potential registrational programs this fiscal year, moving up to 10 indications by next fiscal year. So three INDs expected to be active by the end of this calendar year. Really excited at what we're doing with 1402, what we're going to generate for data in the coming months to validate that approach. Enough said on Immunovant, but wanted to revisit that topic. A couple of other smaller things. One on slide 18, just a quick update on Vitama. $18.4 million in product revenue for the quarter. Relatively flat on GTN yield. Notably, script volumes are doing actually relatively well. We get frequently the question, it looks flat, it looks flattish. Script volumes are up 20% year over year relative to the same quarter last year. They're growing, you know, single-digit percent quarter-on-quarter every quarter, and we continue to see that. So that suggests we are continuing to slowly build into the psoriasis market, and we're happy with that, and it suggests a willingness over time for this doc behavior to change. We remain the best-selling from the volume perspective, novel topical in psoriasis, and all that sets us up really well for, as we said before, the main event, which is the launch in AD that will come after approval at the end of this year. Yeah, I think on GTN quickly because the GTN yield fluctuations have sort of obscured the overall positive trend in volume here. I'll just say we had one payer contract that had a reset effectively earlier this year that we were not getting a rebate on last year that we are rebating now. So that resulted in both some one-time and also just like an overall reset of GTN. I expect to accrete from here. It'll continue to be sort of slow accretion from here. Long-term, I don't have a huge difference in my expectations, but I think, you know, this year it'll sort of build from here instead of building, you know, we hoped might have been a higher level. Notably, net price continues to increase over time outside of that one contract, so we continue to see everything trending in the direction that we want it to. Key upcoming catalysts on slide 20. First of all, not on this slide, but we'll be presenting this undisclosed program including some clinical data in September. Also upcoming here, we've got 1402 putting out detailed development plan information as well as data from the Botoclumab study in Graves coming this fall. We're pretty excited to put that data out there. We think Graves is a really exciting opportunity. Namilamab, we're going to get top-line data from that Phase II trial, and sarcoidosis, again, not an area of great sort of external focus right now, but if that data are positive, those data are positive, we're excited about what that will mean. Vecama, again, the big event, the atopic dermatitis label expansion hopefully coming at the end of this year. And then, you know, by the end of the fiscal year, data from Batoclumab in myosinia gravis, as we've talked about, as well as data from the Period 1 of the Phase IIb study in CIDP. And then by the end of this fiscal year, initiating four or five potential registration programs in 1402, all of which we, together with the MUNA Managerial Looking Board, are speaking more about in the near future. So finally, before I wrap up this relatively quick update on slide 22, just a financial update, I think overall a pretty normal quarter for us from a finance perspective. We actually had net income this year, this quarter, of $57 million, net revenues of $55, including product revenues of $7.18, expenses sort of within our historical bounds. We ended the quarter with $5.7 billion in cash and cash equivalents. That sort of reflects the Sumitomo repurchase that we had made in April, I want to say, of last quarter. And then the carrying value of our debt has come down a bit thanks to the renegotiation that we have done at Dermavent. And you can see shares outstanding on the slide as well, about $7.9 million. So with that, I'll wrap up the presentation portion of this on slide 24. You can see that we have a pretty exciting catalyst calendar coming up with, frankly, a pretty rich couple of months ahead between the unveil of the new program, continued work on the BD side, data coming from Tokamab and from Mutamab generally in the coming months. So really looking forward to getting together, what I'm sure will be multiple times in the next few months, talking about those updates and to continue to see this all develop. And with that, I will wrap up the presentation for the morning. Thank you again for listening, and I'll hand it back to the operator for Q&A.