Roivant Sciences Ltd.

Good day, and thank you for standing by. Welcome to the Roy Vance Science's fourth quarter and fiscal year 2022 earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during this session, you'll need to press star 11 on your telephone. You will then hear an automated message advising you 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 now like to hand the conference over to your speaker today, Stephanie Lee with Roivant. Your line is open.

Good morning, and thank you for joining today's call to review Roivant's financial results from the company's fourth quarter and fiscal year ended March 31, 2023. I'm Stephanie Lee with Roivant Sciences. Presenting today, we have Matt Klein, 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.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 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. It's great to be back. I was talking to the team this morning and saying it feels like a slightly anticlimactic call because we were obviously just together last week to talk about the really exciting data from the chronic period of our RVT3101 study. But actually, an enormous amount has happened for us, both in this fiscal year generally as well as specifically in recent quarters. So looking forward to writing updates on those topics. You know, we'll talk a little bit about where we are through the course of our year. We'll give some great updates on the progress that we're making with the ongoing launch of VTAMA, as well as a reminder of our atopic dermatitis results. We'll do a quick refresh of the data we put out last week on RBT 3101, a quick update on our FCRN program, a financial update, and then we'll turn the line over to Q&A. You know, starting on slide five, just kind of as a reminder or a level setting, look, we're really proud of the continued progress that we've made here. We celebrated this quarter with adorning one, the 10th consecutive positive phase three study that we have run. That's the most recent 10 studies that we've run have been successful. We now have six products that we've gotten approved by FDA out of our model. We reported 1.7 billion in cash as of March 31st, which supports our cash run late second half of 2025 before which we'll have a tremendous amount of data to share. And then we are incredibly proud of what we now believe is an industry-leading pipeline, especially in late-stage I&I, with over $15 billion of sales potential, supported by the ongoing launch of VITAMA, and with a number of potential best or first-in-class programs. You know, we've said all along on slide six that 2023 was going to be our biggest year. We are right at the midway point, both in terms of the year and in terms of the data that we've been looking forward to sharing. We've continued to provide updates on VTAMA, as we will do today, and this has been another great quarter of progress for that launch. We've now shared data for both of our Phase III studies in atopic dermatitis for VTAMA, data that we think is really, really exciting and will support an important product in that class pending potential FDA approval next year. We've now supported data from both the induction and chronic periods, of our study of RBT3101, our anti-TL1A antibody in ulcerative colitis, which again is phenomenal data. We think sort of really top-end efficacy that has the potential to really matter for patients and to be an important new option. So we'll continue to provide updates on that program. Still coming, and obviously closely watched, are a number of updates from our anti-FCRN franchise, including the Healthy Volunteer Study for IMBT1402, which we hope and believe will establish that program as a best-in-class anti-FCRN antibody. as well as a number of ongoing trials in the toclamab to show continued efficacy of that agent in the class in multiple indications. And then finally, at the fourth quarter of this year, and we'll talk more about this before it comes, we have our readout of brevacitinib, our TIK2JAK1. It's a potentially pivotal one of two studies in SLE, which we think has the potential to be, again, transformational top-level efficacy in that patient population. And on slide seven, just as a reminder, We are just very proud of our portfolio, of our pipeline overall here, with a number of late-stage agents that we think matter in some of the biggest classes, certainly in immunology. And, you know, we will continue to add to this pipeline as opportunities present themselves. Obviously, we made some really important additions within the last 12 months with IBT 1402 and RBT 3101. And I hope we can find more just like those two to bring on in the coming year. So I will start in the next section here with an update on the commercial launch of Vitamma. You know, on slide nine, I'll say we are very excited about the way that demand continues to evolve for Vitamma. We are the best launching novel topical we believe in psoriasis history. We are obviously the best selling branded topical in psoriasis and have been since very shortly after our launch. We continue to like the way that the demand has grown. And we expect to see it continue to build through the end of this year as various things, including coverage and our DTC efforts build. On slide 10, some really great progress here in the early launch that we just wanted to make sure we hit. First of all, we did $13.7 million in net product revenue for the March 31st quarter, which is up a pretty good degree from $9 million or $9.2 million in the prior quarter. It's obviously happy with the sales number. maybe, frankly, even happier with the progress that we made during the quarter in gross net yield up from 18% to 25%, which is a reflection of the breadth of coverage that we added, frankly, faster than expected in the first quarter of this year. And we've continued to add coverage since. So we're really happy with that. In some ways, I think we managed to pull forward gross to net improvements earlier this year, and we continue to feel good about our trajectory through the year. We'll talk more about that over time. You know, from a coverage perspective, on slide 11, we're now up to 76% of commercial lives covered within a year of launch. This is better by a meaningful margin than our expectation at the time we launched the product. This includes the addition of two major, two national PBM formularies, two national health plan formularies during this period, an important regional PBM formulary with 18 PCVS plans, so just really great coverage. And as a reminder, the significant majority of that coverage is single step through steroids, which is exactly where we want it to be when we launch the product, which gives us access to the patient population that matters most to us. As a reminder, there are almost 400,000 topical corticosteroid scripts every week between psoriasis and atopic dermatitis. And we're currently doing about 4,000 or a little bit more than 4,000 scripts a week. So we have a a ton of room to grow into that opportunity, and we're really excited to do that both in psoriasis today and pending FDA approval in atopic dermatitis as well. Speaking of atopic dermatitis, on slide 12 here, just a little reminder, we've talked a lot about this data. We got together to talk about the ADORING-2 data on a call in March. We put out the ADORING-1 data as well, which was extremely consistent. You know, this is just, it's great data. We are really excited about this. It's data that know is is really it's terrific on viga response rates really really good easy 75s and i'm i'm very happy with the quality of the itch data here uh the reported data was in adults it looked very good in children as well uh and about equivalent and you know we feel like In AD, which is really a disease marked by itch, these data are going to make a really big difference for patients. And as a reminder, this study went all the way down to pediatric patients at age two, which is great because the pediatric patient population in AD is large and the unmet need there is significant. Across all patients, and especially in pediatric patients on slide 13, one thing that you really care about with a topical agent is safety. And I think it's clear from our data that the tolerability of this agent in atopic dermatitis is very, very good. Frankly, even a little bit better than we saw in psoriasis with very low rates of contact dermatitis, very low rates of follicular events. Just a clean profile that gives us exactly the profile as a product we think will matter to physicians and patients. So really excited about this data from a safety perspective as well. I won't spend too much time on the Crestron comparison on slide 14. This is data in a moderate to severe patient population that looks competitive, whether better, even a number of systemic agents, and certainly in the same ballpark or better than anything else that is atopical in atopic dermatitis. So more updates to share on Dermavent over the course of the year. Looking forward to continued coverage. Looking forward to progress in the franchise. Looking forward to providing updates on the SMDA filing for for vitamin AD, which we expect to be at the very beginning of next calendar year. Looking forward to sharing those on quarters to come. So I'm going to pivot now and give a brief reminder. This is data that we put out just last week, so we won't spend a lot of time on it, with RBT 3101. On slide 16, we really believe this program is in a class of its own, right? NTTO and antibodies, at this point, between our program and one of our competitors that also reported data earlier this year, This is a remarkable class of drugs that has shown incredible efficacy, and we are very proud to be the first agent to show sort of real, sort of proper blinded 52-week data last week. And it's great data. We showed substantial improvements between week 14 and week 56 across basically all of the endpoints that are go-forward dosed. We are the only NTTO1A antibody at this point with validating long-term efficacy data, and we have over 200 patients of such data. We have a biomarker that we've talked a bit about that is relevant to 60% of the UC population with meaningful improvement in efficacy even relative to the all-comers population. And then safety has been very good for the agent in the study so far, and we've seen no impact of immunogenicity on the program, which we know was a question that people were hoping to get that. to get run to ground in this trial. So we're now full speed ahead here with a plan to run a simple phase three program with a single subcutaneous dose in the near future, and we'll provide updates on that just after our discussion with FDA, which is coming this summer. As a reminder of the data, and I'll go quickly on this on slide 17, we saw modified myoclinical remission. This is in our phase three dose. go from 29% at 14 weeks to 36% at 56 weeks, a remarkable 50% at week 56 in endoscopic improvement. And then endoscopic remission, this is an endoscopy sort of zero, is something that, frankly, very few agents hit, and so we don't typically see it reported. And we were really excited with what we saw there with 21% of patients in the all-comers population on the phase three dose achieving a clear endoscopy. Once you overlay the biomarker on slide 18, that data looks even better. It gets up to, yeah, 43% clinical remission in the phase 3 dose at week 56, 64% of patients meeting the bar for endoscopic improvement, and again, a really exciting 36% of patients in endoscopic remission by week 56, which, you know, look, we didn't measure specific antifibrotic markers here, but personally, I look at this data as suggestive that we are having a potential disease-modifying impact on these patients, so really exciting. You know, another topic, and this is also data that we shared, but just as a reminder, in a large patient population here, really the whole study in patients who are biologic experienced with our biomarker, we saw, frankly, just phenomenal data at 56 weeks, 34% clinical remission for biologic experienced patients, 45% endoscopic improvement. This is some of the best data that's been shown in biologic experienced patients, which are generally recalcitrant and hard to treat. And as a reminder, this includes patients on doses other than our optimally chosen dose. So we expect when we generate large end data in our phase three studies that there's room for improvement even over these really great numbers. So very excited about the potential for efficacy in the biologic experience population. I think any way that we look at our data where there's sufficient end to reach a judgment, we feel very confident that this is going to be a great agent in later lines of therapy. Obviously, all that has to be backed up by a good safety profile. And one of the really exciting things about the TL1A class, and you can see our safety data on slide 20, is because of the way TL1A works as a mechanism, because it is really only sort of present in diseased inflamed tissue, it's sort of a signal amplifier, you don't get some of the infection and other things that you see in other anti-inflammatory classes. And so we had no severe infections observed and no infections observed at greater than or equal to 5% rate in the chronic period. And just generally, we saw a really good safety profile through week 56, well-tolerated at all doses, and serious A's were sporadic and determined by the sponsor not to be related to drugs. So very, very clean safety profile that we think is going to help the utility of the drug going forward. And then finally, on the data on slide 21, as a reminder, one of the questions that we got a lot going into the maintenance period was whether immunogenicity was going to matter. We were reasonably confident that it was not. What you can see on this slide in the chart in the middle, this is across the data pool across all nine arms of the study. Patients with ADAs, by and large, had somewhat better clinical remission than patients without ADAs. And it was uncorrelated with the quartile of ADA titer. We don't think this is a real effect, obviously. We just think this is noise. We think the ADAs are having no impact on safety or efficacy across all the arms of the study. And we had said we expected our neutralizing antibody rate to be flat to down. I'm proud to say it was zero at week 56 in the expected phase three dose. So we had no patients neutralizing antibodies at week 56 on that arm. On slide 22, without belaboring the point too much, we feel really great about the amount of data that we have here. And it is quite differentiated relative to the field here. We have over 400 subjects dosed, including 250 patients dosed across an IV in three subcutaneous doses, 200 patients dosed across three subcutaneous doses out to a year of dosing, just hundreds of patients dosed no matter how you cut it. We are the only agent here with subcutaneous data, the only agent here with anything like this quantum of long-term data. Our biomarker, which was prospectively specified, has obviously been tested in many patients, and we expect a commercial form factor that is a once-monthly sub-Q auto-injector. So we really feel great about our profile versus the other agents in this class, which also have what we expect will show promising data given the quality of the target. Finally, on slide 22, I wanted to highlight we have initiated, as we mentioned last week, a phase two study in Crohn's disease. It's just over 100 patients. It is two doses subcutaneous monthly, similar in that sense to the Phase IIb study that we just ran in UC. There'll be 12 weeks of dosing followed by a 40-week chronic period, again, with a similar set of endpoints, which you can see on slide 22. This was a study that we wanted to start very quickly because we realized as we took a step back that we felt like we could run a proper dose-ranging study in Crohn's patients without giving up any ground on the opportunity to be first in class in Crohn's, and that would allow us to run, just as we are doing in UC, a straightforward, simple, single-dose Phase III study that will be optimal for patients. One question I expect we'll get is why no placebo arm in this study. The basic answer to that is we want to get the dose-ranging study done as quickly as we possibly could, and so we wanted to make this a really attractive study for patients to enroll in starting now, and so we're trying to have that study up and running. so overall as a reminder on slide 14 or sorry slide 24 i just really excited about this program think it is a major anchor in our late stage pipeline uh we think it will be the first in class anti-tl1a antibody uh with an efficient well-validated path to approval on a single a single a single dose carried forward to phase three uh we think we are uniquely positioned to overcome some of the limitations of ibd therapies including efficacy in later line therapy with sustained clinical remission and endoscopic improvements among the highest ever reported. We think our biomarker further differentiates this class and our agent versus other treatment options for IBD patients and gives us an opportunity to select for patients with an even higher clinical remission rate, although notably we think our data clearly supports a study in an all-comers population irrespective of biomarker status or line of therapy, and our expectation is that that is the patient population that we would be targeting for for approval. And then finally, many opportunities for additional growth, including the Crohn's study I just mentioned, as well as the dual targeting of both inflammatory and fibrotic pathways, opening up a range of large markets and high-end that need indications that go well beyond IBD, and we're looking forward to sharing more on that as soon as we're underway with additional studies. Finally, I want to spend a few minutes on IMBD-1402, and our anti-FCRN franchise. Obviously, Immunovan has spoken about this program, and there's no new updates in this section, but just wanted to remind everybody of what was coming, given how excited we are about this program. So slide 26 is a reminder. We have a proper franchise of anti-FCRN antibodies with our first-generation impotoclomab currently in multiple pivotal studies across MG, TED, and CIDP, with data coming over the next couple of years in those studies, as well as others. And then we have our next-generation antibody, IMBT1402, which we believe will have the same best-in-class suppression of IgG as Pitocumab, while showing minimal impact on albumin and LDL, and therefore being useful for chronic dosing and diseases with an even larger population. We have data coming from that program in August, September for single-sending dose data and October, November for multiple-sending dose data, and we think that has the potential to establish that agent is best-in-class. As a reminder, both of these agents are proper classic sub-qs uh they are subcutaneously administered they are simple uh sub-q injections they uh will be at home administered we believe and sort of very straightforward comparable to other sub-q programs on the market uh which we think is also at this point something differentiated and something we do not believe any of the other agents in the class have today um our phase one study that's ongoing in imbc 1402 has as i said single ascending and multiple ascending dose cohorts. That study is underway, and we are looking forward to sharing that data later this year, as I mentioned. And we believe that the data that we have in hand is likely, we have NHP data that we've shared on these calls and other forums. And based on our data for metoclomab, both on albumin and on IgG, we think the SAD data, which we will be putting out, as I said, at the end of the summer, maybe usefully predictive of MAD data. You know, I get a fair number of questions on the bar for success. And I guess the one thing I'd like to say is, you know, look, we believe based on the NHP data and based on the way these programs are engineered, that we should be clean on albumin and LDL. Remember that the LDL assay has about a 10% variability and the albumin assay is a little bit more specific than that, but has some variability. And frankly, although we have seen to be clear, none of this data today. So I have no information about what this will show. and our expectation from the NHP data is that it ought to be clean. Our advisors tell us that even up to, for example, a 10% excursion LDL would not be clinically meaningful. So looking forward to sharing that data, optimistic given the way that drug was engineered as well as the NHP data that we should have a good result there. And looking forward to getting back together with the Immunovant team later this year to go through it. Finally, I'll give a brief financial update on slide 21, and then we'll open the line for Q&A. So, you know, we showed net revenue of 27 million, including net product revenue of 14 million for the quarter ending March 31st, or net revenue of about 60 million and net product revenue of about 28 million for the fiscal year. For the quarter, we had R&D expense of $130 million or adjusted R&D expense of about $126 million. NSG&A was 126 or adjusted about 100. So, you know, it consisted with prior quarters from a spend and burn perspective. And notably, we ended the fiscal year with $1.7 billion in cash equivalents, which we feel good about as far as carrying us into that second half of 2025 guidance and giving us lots of opportunity to turn over data cards. So look, I won't go through all of the catalysts on slide 33. I'll just say we've talked about some of them here, but there is a long list to come of important developments, including in programs we've talked very little about, frankly. And so we're looking forward to sharing that data, looking forward to getting back together. It's been a tremendous fiscal year for us. It's hard to believe this is only the second 10K we filed. I want to thank all of our patients and the team at Roivant, as well as those listening on this call for being with us. And with that, I will pause and turn the line over to Q&A. Thank you, everybody.