Roivant Sciences Ltd.

Good day, and welcome to the Roy Vant Fourth Quarter 2024 Earnings Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would like to turn the call over to Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review Roy Vant's financial results for the fourth quarter and fiscal year ended March 31, 2025. I'm Stephanie Lee with Roydent. Presenting today, we have Matt Klein, CEO of Roydent. For those dialing in via 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.roydent.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 thank you, everybody, for listening this morning for our fiscal year-end conference call. Good morning. So I'm going to start in the deck here on slide five by saying it's hard to believe this, actually. Not only has it been a very impactful fiscal year, but this is the reporting quarter in which, for example, we generated the data for Botoclumab in my city of Grabs and CIUP. So it's been a very busy year. six months for us to start off at 2025. 2025 is just a really important year for our business, starting with the data we've already generated, which we think sets us up for a best-in-class potential franchise in the NTFCRN world with IMG 1402, first-in-class in a number of indications, such as Graves' disease, and potentially best-in-class, we think, anywhere that we're going to play. Upcoming and one of the most important events of the year in the second half is the potential registrational data from our study of brevacitinib in dermatomyositis, which is a study we are super excited for. It's a patient population with high unmet need. We would be the first novel oral DM drug and pretty long lead time over really any other late stage program. So looking forward to sharing more about that both today and in the near future. And then finally, this is a really pivotal year among other things for our LMP litigation with Moderna and with Pfizer-BioNTech. We are currently in a narrowing and summary judgment phase of that trial. And upon the completion of that phase, we expect to move to trial in the relatively near future. So an incredibly important moment for that as well. That's in the Moderna case. You know, on slide six, we say this every time we get on the phone, but I am incredibly proud of our late stage pipeline here. First, with brevacitinib, which obviously has the potential to be an on-market therapy as soon as within the next couple of years with this data coming into metamyositis, with IMDT-1402 actively enrolling multiple potentially registrational studies across or pivotal studies across multiple indications where we either already know or strongly expect FCR in antibodies to matter quite a lot. We also have our inhaled therapy for PHLD with data expected to be coming next year. And obviously for those who follow our story, ongoing VD with multiple possible pipeline expansion opportunities as well. On slide seven, we are in a period of just significant clinical execution and progress here. really all of our main clinical franchises with 1402 and additional cleared IND, five potentially registrational studies ongoing, one proof concept study initiated in CLE, and in the next coming years, potential for, yes, six plus indications with each with potential multi-blockbuster launches. Obviously, in brepacitinib, among other things, in 2025, we initiated our study of cutaneous sarcoidosis. We will later this year read out the dromedomyositis study. And again, with the potential in 2026 and beyond for a multi-blockbuster orphan franchise anchored by launches in DM and NIU. More about that in a minute. And then, as I mentioned before, in Moseley, we've got the PHLD study enrolling nicely at this point, and we believe that that program could be positioned in frontline use for PHLD and potentially other respiratory diseases. You know, on slide eight, and I don't want to say too much about this yet because we haven't actually generated the dramatically excited data yet, but on a thematic point that I expect we'll talk more about if that data meets our hopes and expectations, This is really the beginning of a pretty stacked 36 months for us in terms of data and launches, with multiple launches in potential blockbuster indications, first for Repositive and then for our FCRN franchise, in a way that we think adds up to one of the most exciting commercial portfolios potentially in I&I over the next couple of years here. So really looking forward to that flow and excited for DM as the the sort of first domino. Again, fingers crossed or knocking wood or whatever you do if you're superstitious that that data does what we would like it to do. You know, on slide nine, I guess last overall framing point before I talk about some of the specific programs is, you know, I think one of the things that Roivant has been very focused on over the last couple of years, obviously since the cash inflow from the sale of our NTTO and antibody has been thinking critically and carefully about capital allocation. And we feel very good about where we are right now We are set up, as we've said before, to capitalize to profitability, again, with just under $5 billion in cash on the balance sheet today, supporting the current pipeline to profitability with about $2 billion still in reserve for pipeline expansion and deployment on VD opportunities. And that's against the backdrop of having repurchased already $1.3 billion in our own stock as of 3-31-25. That's reduced our share count by not quite 15%. And that capital return continues on the existing shared purchase authorization, and we continue to think critically about what to do from a capital return perspective thereafter, given our balance sheet. So again, really excited about what we've been able to do from a capital allocation perspective, and excited for the capital position that we are in, particularly in what we acknowledge is a very challenging market for many of our peers and for the industry. Great. So with that, as Framley comments, I just want to spend a little bit of time on a couple of the key events for this year. starting with brepsitinib, where I do mean a little for a reason that will become obvious in a moment. So, on slide 11, just as a reminder, what we're really focused on for BREPO is indications with high NMET needs that are tailored to our specific novel mechanism with dual TIK2 and JAK1 inhibition. The announced indications so far are DM with the readout that I've talked a lot about already, NIU, which is actively enrolling in our Phase III program, in our pivotal phase three program where we think there's a very high overall opportunity and very few other therapies approved. And then our proof of concept trial in cutaneous sarcoidosis. We are, as you might expect, also investigating or exploring other areas in which we might like to develop Repcitinib. And you can potentially hear more about those in the coming month. We feel like we've rapidly expanded on this opportunity from when we've actually, we first initiated the DM trial in 2022, at the same time as the proof of concept study in NIU. And since then, we obviously read out that NIU study, initiated the pivotal program in NIU, got going in CS, and are now set up for the upcoming readouts, three of which, the pivotal in DM, the pivotal in NIU, and the proof of concept in CS are coming within the next, call it, 18 to 24 months. So, again, a really exciting year for RepSys, Ed. So much so that, and there's details of this on the next slide, on Tuesday, June 17th, we're going to hold an investor event, a sort of mini R&D day, where the Royvan team together with the private leadership team, Ben Zimmer, CEO of Priyavan, will get together and we're going to do a little bit of DM disease education and some details on the trial design for the ongoing trial, because we hope and expect that people will be watching for that data later this summer, and we want everyone to have a clear frame of reference for for what to expect as it comes around, and obviously we've been excited to watch general progress in that field in recent weeks and months as well, and are pleased with our positioning both from a timing and structure perspective. So, given that we're reserving time for BREPO in the future, that's all I'll say about it on this call, but stay tuned for more on that on that future call. Next, I'm going to talk a little bit about Immunovant and the recent developments in our anti-F-serum antibody franchise. As a reminder, This call also effectively serves as the Univant conference call for the quarter of the year as they're not doing their own IR activities right now. So, look, I think everyone is familiar with the overall sort of structure of this story right now, but on slide 14, we really think we have a tiger by the tail in IMBD-1402. We think it's a potential drug that has an opportunity to be a first and best in class anti-FCRN across multiple indications. We think we get IgG lowering, up to, call it, 80% or below 80s in studies that is matched with or at the most robust IgG lowering observed, not just, frankly, in anti-inflammatory antibodies, but across the field of IgG lowering therapies, with a favorable safety profile that we think gives us overall clean differentiation. We have a great, convenient administration with a market-proven, friendly auto-injector device that will be used at launch We have data that we think validates deeper IgG suppression mattering across multiple indications. Obviously, we felt strongly that the evidence generated in our MG and CIDP studies were constructive to that end. And also, we've got data in Graves. We've got our own data from Phase II and TED. And we've seen it in multiple other places that there's a clear clinical benefit for patients for whom you can get IgG reduction over 70%. And we hope and expect to continue showing that in our ongoing clinical programs. And then just a lot of ongoing clinical progress across multiple indications, including the ones I've mentioned, as well as the ongoing studies in DGT, fourth-line pneumothoracic arthritis, in Sjogren's, where we have a program expected to start this summer, and CLE indications that we've talked a lot about in recent months because we just announced them, actually, about five or six weeks ago. And then as a reminder, the IP on 14.2 goes out to 2043, so quite a long franchise as well, and that's not including any PTPs, so a really good setup. Our indication strategy from prioritization perspective on slide 15 has been, first and foremost, indications where we feel confident we can be both first and potentially best in class. Obviously, the most obvious example in that category is Graves' disease, where we believe we've helped the field understand that that is an interesting market or interesting opportunity with a lot of them that patient need. We think we are out in front there in terms of working with that field, working with those physicians, working with those sites, and we expect and are working hard to maintain that position of scientific leadership. And then we've also got our ongoing programs in DGT-RA and cutaneous lupus, where we feel like we are first in class in the FCRM field as well. Then there's a category of indications where Sjogren's is probably the best example, which I call nearly first-in-class indications, where we believe with good execution we can minimize the time gap between us and our competitors while maintaining a potential for a differentiated clinical profile driven by best-in-class IgG reductions. there's the sort of tried and true known indication space like MG and CIBP, which we acknowledge are competitive, which are well-established, where Vivgar, for example, is a well-loved drug in MG, but where we feel like we have potential to differentiate on efficacy and clinical benefit. And I was pleased to see, for example, in the last few days that some of the Nicene Gravis patient organizations are encouraging physicians to think about deeper response measures like MSC as the future treatment for those patients and where we think we can take a leadership position given the profile of 1402. So tremendously excited about the way we're thinking about indication prioritization. And I think you can imagine if we're going to announce more programs over time that it will roughly follow this sort of prioritization hierarchy. On slide 16, And we've ambitiously called this slide Settling the Deeper is Better Debate. I think in our minds, we feel quite confident at this point that deeper IgG suppression across indications is going to yield meaningfully better clinical benefit. We've seen it on this sort of less than 70, greater than 70 IgG reduction cut point where we've divided our data in multiple indications. We have consistently seen deeper and better responses. That includes in our Graves Phase IIa data for protoclomab where we had 60% of patients effectively off ATDs in the over 70% cohort compared with just over 20 off ATDs. Again, these are all patients who have normalized T3 and T4. And depending on IgG cutoff, you know, we saw over 50% of patients with minimal central depression effectively with clinical remission in myasthenia gravis in the over 70% cohort versus, you know, just under a third in the under 70% cohort. And likewise in CIDP on NCAT, we saw a significantly different responder rate in the deeper IgG responders bucket than in the lesser IgG responders bucket. So we really do feel like this is a consistently demonstrated hypothesis. And we think that high dose, the tokamab and most importantly high dose IMDT-1402 drive the vast, vast, vast majority of patients into that over 70% bucket. So we think this is representative of what we may be able to deliver as a clinical benefit in most patient populations. So, we feel very good about what we have in terms of the profile of the molecule given this data. On slide 17, we do feel like we've set some new benchmarks for efficacy in our MG and CIDP data, you know, in MG, both on an absolute MG ADL improvement as well as on other measures. We think we've shown some of the best observed absolute improvement, and then, frankly, the best placebo-adjusted MGADL improvements on things like MSE, where we're putting patients against these sort of deeper, more durable response goals. And so we feel really good about what we're going to be able to deliver in NG with 14.02. We're really excited about what we've seen in the available data pooled through the ongoing study in CIDP. And then, you know, obviously the Tokamak has been consistent with its prior studies in terms of overall power abilities. So, you know, a really strong position in terms of what our data has put out here. You know, one point to make, and this is really sort of more specific to MG and maybe some of the comments we've seen from patient groups recently as well, is we believe that the MG field is going to progress from here in a way that is similar to what we've seen in other indications, particularly in immunology, where you go from sort of first-generation prior, you know, early therapies that just look at overall response rates, improvement in a physician global assessment in psoriasis or, you know, relatively low relapse rates in MS or MGADL response rates in MG. So, you know, once you get to the first generation of innovative compounds, people start talking about remission rates. PASI 75 is in higher, you know, EDSS in MS, the higher ACR rates in RA. And in the case of MG, we think MSE is sort of the next generation here of what people are going to look at. And then, yeah, as we get to the future here, people looking at PASI-100s and psoriasis for complete, effectively complete clinical correlates, you know, same thing in MS, no evidence of disease activity. And we think people are looking at deep and durable responses, you know, many week or many month durability to MSC after therapy is the kind of thing that we think the field is going to move towards in MG. And we think we are in a privileged position to lead the FCRM category. in those kinds of endpoints going forward. You know, you can see on slide 19, for example, in the Pitocumab-MG study, you know, maintenance of minimal symptom expression for greater than or equal to six weeks. This is this chart on the bottom right-hand side of slide 19. You know, you can see at high-dose Pitocumab, where we were getting those deep levels of IGT suppression, you had 75% of patients maintaining that status for six or more weeks. which we think is the kind of endpoint. By the way, 93% of patients achieved a clinical response. We think this is the kind of data that is going to move the market in terms of what patients are looking for in an MG treatment. And so we're excited to focus on those kinds of endpoints in the ongoing phase three program, or the ongoing phase three program with Latino 2. On slide 20, just as a brief reminder, because we spent some time on this on the most recent call, We've now initiated programs in Sjogren's and in CLE in the case of Sjogren's, an indication where we think we have the potential to be, as I said before, nearly first investing class in a large market with a large population and a high unmet medical need with some good evidence of autoantibody-driven disease and with clear dose-response data from Nipicalimab showing that deeper antidepressant seems to matter. And then in CLE, Again, with a fairly large market, obviously some good recent data from the field there, with 75,000 addressable patients uncontrolled on standard of care therapy and with a relatively well-identified CLE-specific IgG autoantibodies that are part of the disease presentation. So we're excited about the data we're going to generate there next year. And we obviously have that principal case study data we've already shown for patients who were the first patients in any disease dosed with IMDT-1402 with data reported. You know, finally, just two quick things on slides 21 and 22 here. One is, these will both be on clinicaltrials.gov in the near future. Slide 21 is the design of our potential registrational trial in CIDP for 1402, which is, you know, a different design than the first generation of studies that folks like our competitors have run or even that we ran for the DOCLA lab, but clearly sort of pretty much in line with where we see the field going and a study that we think gives us a real opportunity to put out some great data in a patient-friendly format. and a design that we, the investigators, are pretty excited about enrolling patients into as well. And then on slide 22, you can see the design for our second study in Graves' disease, which is now up and running, which we'll be enrolling patients quite soon. And so that design also is now public. You can see some of the features here. Notably, although it's not sort of hit you on the face obvious in the design, one of the things we hope you'll get from both of these studies at this point, based on our understanding of the patient population, is some clear information about the impact these drugs are having on proptosis and the progression into TED-like symptoms, and so looking forward to generating that data in these studies as well. You know, on slide 23, I won't go through it in great detail, but this is just rehashing. We feel really, really great about the overall portfolio of indications that we are studying with our FCRN franchise, including just a very large overall potentially addressable U.S. patient population, over 600,000 patients, with a pretty meaningful subset of those patients existing in Graves' disease, which is our sort of lead indication to truly define that opportunity and to be the first out there helping patients. Absolutely jam-packed couple years ahead, as I led with earlier on slide 24, in terms of data that we expect to generate, obviously including remission data that we're going to put out this year in Graves' disease from the Proclamab study, the potential registrational top-line data coming in TED in the second half of this year, and then starting next year, a ton of data from 1402, including open-label period one results from the DGT-RA study, the CLE study next year, and then potentially registrational data in multiple indications, including Graves and Meissner-Gravis in 2027, and Schrodinger's and CIDP beyond. So really tremendous couple of years ahead. Eric is in his early days in the role of a new event, really excited about seeing what he's going to deliver there. I think the team over at Immune Events is just super energized to deliver a meaningful product. It's going to help patients a lot, I think. Finally, in terms of business updates on slide 26, just a reminder that this is a really important period for our L&P litigation. We are in, effectively, the summary judgment phase of the trial. Part of that, which was expected from the beginning, is this is a normal process of narrowing the scope of our claims and Moderna's defenses in the trial. That process is ongoing, and we've had some discussions with the judge about making sure everyone gets that right. Immediately following that, summary judgment motions should be going in, and then we'll be sort of at a pending U.S. jury trial. The date is at the moment TBD, but looking forward to all this progressing in the near future. And then finally, starting next year, we'll have the beginnings of our international trials and litigation that we filed just a couple of months ago. The Pfizer case continues to be ongoing. We are awaiting the Markman ruling, which we think could come this year in the case. So looking forward to all of that. I will now just wrap up quickly with a financial update. I won't read all the numbers on slide 28, but a pretty normal, solid quarter for us from a financial perspective. Obviously, just under $5 billion in cash, as I mentioned, with no debt on our balance sheet as of 3-31. We continue to reduce the share count over time. overall sort of net use of cash for the quarter, including everything in terms of both interest income and the sort of pull to par on our treasury securities is about 150, a little more than 150, between 150 and 160. And so, you know, I think as a quarter for the business, thinking about the business on its own, that's probably like a pretty normal quarter. You know, obviously, first quarter tends to be a little bigger for us, and then 1402 starts to ramp up over the course of the year. But overall, feeling good about what we're able to do in terms of the cash utilization and capital allocation framework, as I mentioned earlier. You know, I'll wrap up on slide 30 just by saying we have an incredibly data-rich year, two years, three years ahead of us. And look, there's nothing in our business like putting out data that matters to patients, so looking forward to all of those events and to talking to you all as part of that. So with that, I will wrap up my prepared remarks. Thank you again for listening, and I will hand it over to the operator for Q&A.