Roivant Sciences Ltd.

Good day, and thank you for standing by. Welcome to the Voivod 1Q 2022 earnings 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 the session, you will need to press star 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Paul Davis, Head of Communications. Please go ahead.

Good morning, and thank you for joining today's call to discuss Roivant's financial results for the quarter ended June 30, 2022. I'm Paul Davis, the Head of Communications at Roivant. Presenting today, we have Matt Klein, our Chief Executive Officer. For those dialing in by a conference call, you can find the slides being presented today, as well as the press release We'll also be providing the current slide numbers we present to help you follow along. I would like to remind you that we will be making certain forward-looking statements during today's presentation that reflect our current views and expectations, including those related to our financial performance and the potential attributes of our products and product candidates. We strongly encourage you to review the information that we have filed with the SEC, including the earnings release and Form 10-Q filed this morning for more information regarding these forward-looking statements and related risks and uncertainties. We'll begin with Matt Klein. We'll review key business updates across Roy Vance's advance and provide a financial update. We'll end the call with a Q&A session. And with that, I'll turn it over to Matt.

Thank you, Paul, and good morning, everybody, and thank you for joining our first quarter earnings call. Today's call will be a little bit shorter than usual because we last got together about six weeks ago when we presented our year-end results. So I'll begin on page four, and I'll take you through some of the key highlights of the business today, and then we'll make some time for Q&A. So, as a reminder, we're excited about where we are at the end of our first quarter this year, with obviously a number of important attributes, including the ongoing commercial launch of VITAMA, which we will spend a little bit of time on this morning. That is backed by a broad clinical stage pipeline, including multiple pivotal and registrational studies currently ongoing. Our tip-to-clinic discovery program, including our proprietary Quasar platform, that we are using to bolster that pipeline at the discovery stage. A number of sources of asymmetric potential upside, including our GenEvent IP portfolio, and all of that supported by what continues to be a strong capital position with $2 billion in cash and cash equivalents and restricted cash, which enables us to finance and develop all of our programs across our pipeline. I'll start on page five with a brief update on the vCAMBO launch. And I'll say, first of all, I'm incredibly pleased with the very early information here. Obviously, as we've said on a number of occasions, we are principally tracking prescriptions at this time, and we feel script volume has been robust in the early days of the launch. Obviously, it is still the early days. We're only a couple months in, but we feel the script volume and the early feedback from providers has been very, very strong. There are a few key updates in recent weeks around this launch. The first is that our LTE data, our long-term extension study data, has been published in JAD, and that highlights the 130-day remittive effect off therapy for patients achieving a PGA of zero on Vitamma. That's something that we've talked about a fair amount before, and it's something we think is an important differentiating attribute of the drug. We also have noted that our Japanese partner reported positive phase three data for dipenterof in atopic dermatitis, including statistically significant results in IGA and IAZI, with plans to file that for approval in Japan. And finally, our own phase three study in atopic dermatitis is expected in the first half of next year, which would expand our market to potentially 15 million annual topical prescriptions. And then this is from the data from We're excited to note that we've become the number one most prescribed branded topical for psoriasis as of eight weeks into our launch. So on page six, I'll note, again, from a script volume perspective, we are excited about how we are performing relative to other topical launches that we've seen in psoriasis. You can see a number of those launches in the solid lines here, and we feel proud of our early performance and think it's reflective of the enthusiasm around the CAMA. We also feel excited about the fact that we are approximately keeping pace with Opsalura. That's the dashed line on the slide, which is obviously in atopic dermatitis, a market about four times as large from a prescription perspective as psoriasis. So, again, early days, but an exciting indicator for us. And just as a reminder, we really are principally focused on prescription volume at this time. You know, the quarter here is only for the really one month or about a month of launch data for VITAMA. So the revenues are not significant, but we're focused on prescription data as we work through our coverage and contracting. And as we said, it'll be about 12 to 18 months before we expect those contracts to be in place. On page seven, I just want to remind people of a few key attributes around VTAM and sort of attributes that we think will support our blockbuster potential, both in psoriasis and potentially ultimately in atopic dermatitis. You know, we have the efficacy and durability that we need, and maybe most importantly, we have this off-treatment remitting benefit that we've talked about a fair amount. We have a broad target population with a label that permits use across the entire psoriasis disease spectrum from mild to moderate to severe. We have no warnings or precautions at all, nor do we have any restrictions or notes about concomitant medications on our label. We're labeled for use on all areas of the body, and notably that includes interpregnous areas. And something we've talked a little bit less about that I'll remind everyone on this call, we have statistically significant improvement in itch as early as week two in our study data. So on slide eight, I put that itch data in the presentation so that we can just look at it and remind us of the data. And you can see the data across the two studies here. And one thing I'd like to call your attention to is that we saw statistically significant separation from vehicle on impact on itch as early as week two. in our studies, and you can see those p-values on the slide. And notably, this comports with some of the early feedback we're getting from prescribers and patients, which is to say that overall, I would say one of the early attributes that we're hearing is that the drug is working faster than people expected, and we're obviously pleased to hear that from the field. So, I'll close on VTAMA on slide nine. just to update our differentiation profile versus the field for psoriasis. Obviously, one of the main updates here is that Zoriv was approved recently, and so we've updated this chart accordingly. And you can see we feel we have a truly differentiated profile. We are among the only topicals to have an on-label remittive benefit. We continue to be pleased with the fact that we have no duration limitations, no body surface limitations, including no limitation against endocrinogenous regions, We have no safety warnings or precaution section on our label. And then we have no labeled drug interactions and no contraindications as well, which is something that's differentiated versus some of our competitors. So with that, I'll move on from VTAM, although I'm sure we'll touch on it in the Q&A section as well. And I'll talk a little bit, if you jump forward to slide 11, about where we are from a clinical perspective with all the programs backing that up. We're showing here a subset of our pipeline. We're focusing on some of the most important and latest stage programs, notably including our VITAMA study in atopic dermatitis that I mentioned before. We also have now begun our phase three program in brepacitinib and dermatomyositis, and we have our ongoing program in brepacitinib and lupus that I'll talk about in a moment that's going to enroll its last patient any day now. And then at Batoclumab, there have been a number of updates to the event put out recently, including the fact that multiple of their pivotal trials are initiated and indications that we think could be blockbuster indications for Batoclumab. So looking forward to sharing more about that generally as those programs progress. You can see on slide 12, some of the sort of features of our current clinical positioning, including the fact that by the end of this year, we will have seven trials, including four pivotal trials ongoing. with multiple – with progress across multiple fronts. I won't talk about each of the individual studies here. And we expect three additional or more additional initiations of programs in 2022, notably including – we've already initiated, as I mentioned, the programs in mitoclomab and mycinogravus. We expect to be initiating a thyroiditis study imminently. The last thing I want to do on this call, before I turn it over to Q&A, is we went through the most recent addition to our pipeline, Prevacitinib at Prievant, last quarter at the year-end call earlier this summer. But I just want to reiterate some of the features of that program, because it's a program that we're very excited about in our late-stage portfolio, and because, as I mentioned before, we are expecting the final patients to enroll in our lupus study any day now, and we think that'll be an important catalyst for us next year. And so we wanted to continue to draw attention to that program. So brepacitinib overall, as a reminder, is a unique dual targeted first in class TIK2 and JAK1 inhibitor, which we're developing for a variety of specialty autoimmune diseases. We think that dual inhibition of TIK2 and JAK1 is scientifically important because we think it'll potentially provide greater efficacy than agents that inhibit either one alone in inflammatory autoimmune disease where both pathways are relevant and where the interaction between the pathways is relevant. We have extremely robust, as a reminder, this program, Wynn licensed it from Pfizer and announced it in the last call. We have extremely robust clinical data, statistically significant, clinically meaningful benefits in five placebo-controlled studies demonstrated to date in our oral formulation, including exposure of over 1,000 subjects with a safety profile consistent with approved JAK inhibitors. We have, we think, a distinctive strategy to develop the program, including development in a series of uncrowded orphan and specialty autoimmune diseases, where there's high morbidity and mortality, where there's high unmet need, and where we think the science of our drug, the dual inhibition of TIK2 and JAK1, will contribute directly to efficacy. We have two ongoing registrational programs, including a single registrational Phase III study in dermatomyositis that we've already initiated, as well as a large global Phase IIb study in lupus that's expected to complete enrollment this month, with data expected in the second half of next year. And that's designed to serve as one of two registrational studies in that indication. And then finally, we have strong intellectual property protection. So on slide 14, I don't think I need to remind people in great detail, but SLE is an important disease with obviously many, many patients, up to 300,000 people in the United States affected by it. And there's significant unmet need and obviously a disruptive and difficult clinical presentation. There are not very many approved therapies that work well, and those therapies are – are commercially successful and provide important benefit to patients, but with significant room beyond. So on page 15, a reminder of a little bit of the rationale that we have for why we think this drug will be exciting in SLE. And that's, first of all, there is data from a number of JAK1 or TIK2 inhibitors in SLE. And in both cases, we see signs of efficacy, but with significant room of improvement. So you can see on this slide the placebo-adjusted response week 24 on the left-hand side from a phase two study of baricitinib in SLE, and you can see a nice response there, as well as the phase two study on the right of ducravacitinib, a TIK2 inhibitor in SLE. And again, you can see a nice response there, but there's obviously significant room across both of these for improved overall efficacy. And again, we think that we have the opportunity with baricitinib to improve on both of them. One of the rationales for that, one of the reasons we think we may be able to do well on page 16, is there are a number of existing indications where we have data in both brepacitinib and either ducravacitinib, baricitinib, or both. And you can see that data shown here. We are not currently prosecuting any of these indications for brepacitinib, but they give you a sense of just how significant our efficacy has been across multiple studies with the drug. And that makes us excited for what we expect we might be able to see in this SLE study. So you can see on slide 17 the design of that study. As I said, we're expecting our last patient to enroll any day now, and it's a 52-week study with a couple of different dose arms. So you can see all of that on page 17. So with that, I'll wrap up on some of the specific updates. I'll note on the next slide, slide 18, we are having and we've announced our annual Roivin Investor Day. will be on Wednesday, September 28th at 11 a.m. So more details to come about that, and we're excited to hear from any of you then, and we're excited to share a number of key updates around the business, including R&D updates and others at that event. So I'll close, and obviously the market continues to gyrate, but even with some little green shoots, just to say we are extremely privileged from a capital position perspective. If you jump forward to page 20, I'll just point out some of the key financial items for the quarter. So we have R&D expense of 136 million or adjusted R&D non-GAAP of 123 million, SG&A of 149 million or adjusted non-GAAP of 88 million, for a total adjusted net loss of 354 million or an adjusted net loss of 211 million. Our cash and cash equivalents and restricted cash stayed at about $2 billion for the quarter, which we think is important for being able to support our activities. We have balance sheet debt of approximately $417 million, of which only $33 million is sort of a standard credit facility with a carrying value of $33. And then the remainder are milestone or fair value of royalty obligations related to VTAMA. And then we have $703,625,000 common shares issued and outstanding as of Friday. Okay. So finally, on slide 21, I'll just remind everybody, this is an incredibly catalyst-rich period for our business with obviously regular ongoing updates on the CAMA as well as new mid- and late-stage in-licensing that's ongoing currently that I'm excited to provide updates on. We'll continue to provide updates on our L&P patent litigation at Genovant as we have them. and continue to provide updates on Quasar on our greater discovery efforts as we have them as well. In addition to that, we'll be initiating multiple pivotal programs. I've mentioned some of these on this call. We'll get top-line data from a number of pivotal programs within the next 12 to 15, 18 months between Vitamma and brepacitinib. We expect potential data from RBT 2001 in our Phase I-II trial in lower-risk myelodysplastic syndrome next year. and we continue to work towards data on other programs as well. So it's an exciting period of execution for us. Looking forward to connecting with everybody on our investor day and looking forward to continue to track many of these things, including the Vitamil launch in the weeks and months to come. So with that, I'll conclude my remarks for the day, and I'll open the line for Q&A and hand it back to the operator.