Roivant Sciences Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to a Royvent second quarter 2024 earnings 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 a question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Stephanie Lee. Ms. Lee, please go ahead.

Hi, thanks. Good morning. We're actually reviewing the third quarter ended December 31, 2024 for Roybent. 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.coordinates.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 uncertainty. And with that, I'll turn it over to Matt.

Thank you, Chef, and thank you, everybody, for listening. Good morning. I'm going to start on slide five, and thank you again for joining our third quarter results call. So, look, I wanted to just start by setting the stage. This is our first quarterly call in 2025. It is, we talked a little bit about this at the conference in January, but we think 2025 is just a pretty incredible year for us in terms of the setup and the opportunity. Obviously, that starts this quarter. with an opportunity to validate our NTF-CRN franchise as a potentially best-in-class franchise with data coming in MG and CIDP in the coming weeks. It continues in the middle of this year with a central registrational readout in dermatomyositis, which would set the stage for approval for commercial launch of brevacitinib. And so we're really excited about that program and excited also to talk today about a new indication for brevacitinib, in which we'll be starting a trial this year as well. And it's also a big year for our L&P litigation with Moderna and Pfizer-BioNTech with a jury trial currently scheduled for September and the summary judgment phase to take place in the second to third quarter of this year. So just a big year with a lot of important milestones, many of which we planted the seeds for years ago at this point, and so we're excited to see those results. Look, all of this ultimately on slide six comes down to our pipeline, which we think is one of the most exciting pipelines in late-stage biotech, obviously anchored by FCRN and brevisitinib, but with a number of other programs, including Lesley-Sigawat, which we unveiled last year, and also ongoing BD, which we'll talk a little more about later in this call. This year, really, on slide seven, is anchored around clinical execution, right? Obviously, in some sense, the dye has been cast for the MG and the CIDP data, which will be imminent. But there's an enormous amount of work ongoing to, we've now cleared six INDs and Immunovant. Those trials are all beginning now or have begun and are looking to initiate a number more by March of 2026. So just a ton of clinical work happening in Immunovant. Obviously, continuing to conduct the brepsytinib-DM study that we'll read out later this year, as well as the NIU data, the NIU study, which is ongoing, and then we've initiated our trial in Mosley and PHLD. So, between the data that we have coming and the work that we have to do, it's really a year-round clinical execution to drive that value. And then, you know, we have, obviously, a lot of exciting data coming this year. When we look at how we're sort of stacked for the future, Even beyond 2025, we have the potential for 10 plus indications with multi-blockbuster launches. In BRACO, we have a potential multi-blockbuster franchise in orphan immunology anchored by DM and hopefully subsequent to that, or hopefully DM and then subsequent to NIU. Approved concept study in sarcoid adding to that. And then in mostly by next year, by 2026, we hope to have by the end of next year, data on our phase two study which should, we hope, set us up for frontline use in PHLD and other respiratory disease. And all of that on slide nine is angered by what continues to be a major strength of ours, which is our cash balance. We have $5.2 billion in cash and marketable securities as of 12-31. That includes $500 million authorized for additional share buybacks. We've bought back about $1 billion in stock so far as of the end of 2024. We closed the sale of Dermavant to Organon, which is about $259 million. and removed all of our debt and meaningful retirement obligations while keeping a lot of upside in milestones. And we talked about that last year. And then this continues to be among the most fruitful or the most fruitful development environments we've ever seen. And I very much hope and expect that we'll be adding to that pipeline in the months to come. So I want to now turn to talk about a new opportunity for us, something that's probably a little bit further out, but something we're excited to get going on. It'll be public on clinicaltrials.gov soon, et cetera, et cetera. which is we have now initiated a new program for brepacitinib, our third indication. This is a proof-of-concept study in a disease called cutaneous sarcoidosis. So if you turn to slide 11, this is a, it fits really well, and I'll talk about this again in a second, into our strategy of prior advance for developing an indication with high-end that need that are specifically tailored to our dual TIK2JAK1 mechanism. First of all, in terms of sort of scope of disease, it's pretty similar, bluntly, to the other diseases that we are studying with brepo. There's somewhere between 30 and 50,000 cutaneous sarcoidosis patients with no approved therapies, and the uncontrolled disease can result in severe disfigurement. It's very tough for these patients. There is proof-of-concept data from about 20 JAK-treated patients, so not so different from what we've seen in some of the other indications we're studying. And then we think, and we'll talk more about this, dual TIK2 and JAK1 inhibition is particularly well-suited to the Th1 immunophenotype of sarcoidosis. So, we'll get to talk a little more about that. And then it's aligned with DM and NIU in terms of a prescriber-based concentration that overlaps with DM in terms of potential work and price point. So, we think it makes a lot of sense as a place for us to go from here. As a reminder on slide 12 of the overall strategy in BREPO, we're really focused on indications with very high unmet need tailored to our unique mechanism, where we think any liabilities under the JAK class will be far outweighed by our ability to deliver meaningful benefit to these patients. Obviously, DM and NIU both, in our view, met that. And CS looks pretty similar. It's got well-suited biology, a large unmet medical need, a similar patient prevalence. There is some proof of concept with JAK1 patients, and there's been nothing approved in the last 60 years. So, we're really excited to add this to our portfolio. There is, on slide 13, a little bit of proof of concept data. There was an investigator-initiated trial at Yale. providing proof of concept for JAK inhibition and cutaneous sarcoid. That was an open-label study of tofacitinib in 10 patients with long-standing CS. And considering that study, it was about 10 patients with CS, and the mean CSAMI is going to wind up being the endpoint we talk about here a lot, of 37. And patients on 5 milligrams twice an day of TOFA for six months, all of them achieved clinical immunopore reduction in CSAMI. and six of them achieved complete resolution of disease. So pretty remarkable data from that study. Again, with all the caveats of open-label studies. But for pretty sick patients, a big improvement. So that gives us a bit of comfort going into this proof-of-concept study. And then, you know, on slide 14, just from a sort of pathophysiology perspective, Th1 type immunity is the main polarization, the predominant polarization in sarcoidosis skin and lung tissue. And we know that there's more regulation of TTH1 cytokines like type 2 interferonol 12, which we think gives us potentially exactly the right profile with dual inhibition of TIK2 and JAK1, which are both obviously important in mediating that collection of cytokines. So, we feel really good about coming at this with a uniquely big gun. Breadbone has generated on slide 15 particularly strong data. in inflammatory skin disease. So, these are all cross-track comparisons with whichever other JAK inhibitors have reasonable data available. But, you know, you can see in alopecia, NHS, and plaque psoriasis, we have among the best-in-class or the best-in-class data in a cross-track comparison that's been seen. So, we feel pretty good as well about sort of entering into an inflammatory skin disease area where we have, again, good data coming out of RevCit. The study design is laid out on 16. It's a 16-week study testing two doses, BREP45 and BREP15, as well as a placebo. And, yeah, we hope to get data in the second half of next year. So more to come as that study starts enrolling. Cool. I'm going to move on now to just a reminder of what's upcoming and what's sort of happened recently in our NTFCRN franchise at Immunovans, starting on slide 18. So we have, as you all know, quite a bit of data coming this year, starting out with NG and CIDP this quarter, that we hope can bolster our confidence collectively, including your confidence, that deeper IgG reduction results in better clinical outcomes. We've obviously now seen this across many clinical trials, across four different anti-ester and antibodies in seven different indications. But we're going to get another 500 patients' worth of data out of these Botoclumab studies that we think will help us show how much better we can do with deeper IgG suppression across different indications for which patients and by which metrics. So, we're looking forward to generating that data, which, by the way, just as a reminder, nobody at Roivind or Mutavant has seen any of this data. So, any interpretation of my tone of voice should be no different from my tone of voice in the last six months. The upcoming data on slide 19 in MZ, this is just a reminder of that trial design. It's a trial that we think is well-suited to treating these patients where they're at. It is a 12-week induction study with two doses, high and low, followed by a re-randomization into a 12-week maintenance period with either the sort of low dose from the first phase or an every-other-week version of that. And we think this will give us, hopefully, a clear picture of potential dose response in that first period, as well as an understanding of what chronic treatment of these patients look like with the possibility of rescue therapy and so on. So feeling good about the trial design. We also have our upcoming battle phase 2b readout from period one of the CIGP study. That design is shown on page 20. I think you're all very familiar with these designs at this point. These are pretty complicated designs, but we're looking forward as well to the possibility after that period one, which is the highlighted in red piece here, to be able to answer some questions about possible dose response and treatment and response rates in the 12-week randomized period. Look, 1402 on slide 21 continues, in our view, to have a combination of potentially best-in-class attributes that we don't see in other programs. We have deep IgG lowering. Our Phase I data suggests we're going to continue to be able to reach about 80% IgG suppression or thereabouts with continued dosing of 600 milligrams delivered by a simple sub-Q injection. 1402 does not, in our Phase I data, appear to impact albumin or LDLs, so no minimal effect there. We have convenient administration. We will be delivered by a market-proving, user-friendly auto-injector that we will be launching with. We'll highlight that again in a second. And as a reminder, we have IP out to 2043, not including extensions, so a really long runway with a drug that we think could be best in class. By slide 22, as a reminder, we will be starting our pivotal trials or are starting our pivotal trials with a standard auto-injector. It's the only FCRM we think ever developed as a true sub-Q injector from inception. It leverages a pretty well-proven technology. It'll be a 2 mL injection volume, and this is a picture of the device, needless to say. It looks like all of the others are widely successful auto injectors, and we think this is a real benefit. It's also less than 10 seconds in at-home administration, we think, or HCP administration. So looking forward to continuing to press that form factor. And then, you know, on slide 23, look, the main event to me in the long run here is getting 1402 into indications that really matter. We are tremendously excited about Graves' disease, where we have, we think, first in class and best in class potential in an indication with extremely high unmet need, where we have run our own phase two study that shows that we lower autoantibody levels and that we have a high response rate with a good dose response. that sets us up well for success. We think both from Immunovant and from the world, you're going to be hearing a lot more about Graves' disease in the months and years to come, and we are excited to be at the front of that pack with an agent that we think is maximally positioned to deliver benefit to those patients. And then we've also announced at Immunovant that we're running a study in difficult to treat rheumatoid arthritis. We talked about that late last year. We are excited for that trial. We think it sets us up for a quick answer on how much we can do for these patients who have not a lot of other options once you get into that corner of the RA landscape. As we said, there are six IMDs approved, and this is only two of them. We've also talked about MG and CIUP, but that leaves two unannounced, but nonetheless, IMD clear indications, and we're looking forward to talking about those soon. Obviously, a lot of news coming in the near term in advance, so I'm sure we'll be in touch collectively in the near future. Finally, in terms of major upcoming milestones in 2025. We've talked only a little bit over time on these calls about the Genovant LMP litigation. We are hoping for the decision from the Pfizer-BioNTech Markman hearing in the first half of this year, so that could be upcoming. Obviously not on any fixed calendar, so it could, in theory, come any time. And then in the second quarter, third quarter of this year, we will have the important summary judgment phase in the Moderna trial. where we will learn from the important features of how that trial will progress, followed by the jury trial scheduled for September and the second half of this year. So a year where we will really learn a significant piece of the answer to the, at least in the journal puzzle here. So looking forward to that playing out as well. So I'll wrap up quickly with a financial update on slide 27 and then open up the Q&A. So relatively straightforward quarter from a financial perspective. R&D expense of 142 or adjusted of 131, G&A of 142 or adjusted of 71. And, you know, end of the quarter, as we said, with $5.2 billion in cash, which excludes the $75 million milestone from the approval of HOP dermatitis from January, as well as $113 million of external capital, which was raised alongside Roy's investment in January private placement there. And no debt on a balance sheet following the close of the Organon transaction. And so that's about that on the finance side. Look, on slide 29, we feel like we have a quite rich catalyst calendar coming with a bunch of important milestones, some of which we've talked about for this year, some of which sort of stacking the year beyond. And again, continue to be excited about adding to our pipeline, hopefully in the near future with some really exciting things we have on our racket. So with that, I will end my prepared remarks and turn it back over to the operator for Q&A. Thank you again for listening.