Roivant Sciences Ltd.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Rory Vance First Quarter 2023 Earnings Conference Call. At this time, all participants are on 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. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host today, Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review Roybent's financial results from the company's first quarter at the June 30th, 2023. I'm Stephanie Lane with Roybent. Presenting today, we have Matt Klein, CEO of Roybent, and Mayuk Sukopny, President and Chief Investment Officer 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 we filed with the FCC 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, Stephanie, and thank you, everybody, for joining this morning and for listening. It's only been a short, actually six weeks since our last call, because our last call was for the K. so comparatively a little bit fewer updates, but certainly an exciting quarter end of June 30th and a lot to talk about today. I'm going to give just a brief sort of update on the state of the business as well as an update on the quarter end of the Tama sales. And then actually what we're going to spend the bulk of time on today is we've been getting more questions about Repcitinib, and we've actually got some new data there in Crohn's disease, so we're going to We're going to share that and talk through again a reminder of sort of how we're thinking about that program as we approach the lupus data in the back half of the year and more beyond. And so with that, I'm going to get started just starting on page five. You know, as an overall reminder, we continue to be pleased with the progress we've made in the business. During the 630 quarter, we completed our 10th consecutive positive phase three trial. That was the during two, sorry, during one study, the second study. of V-town and atopic dermatitis, which we continue to be proud of that track record, which has now led to six FDA-approved products across Roivant and the Sumitomo collaboration. As of 6-30, we had just under a billion and a half dollars in cash on the balance sheet, which, as we've guided before, comfortably funds us into the second half of 2025, with a lot of clinical data both generated recently and even more coming in the near future. And we're very proud of our pipeline at this point. We have what we think is among the strongest I&I pipelines with, by our estimate, over $15 billion in peak sales potential supported by VTAMA, but also a number of critical first and best-in-class programs behind it. On slide six, and it's funny because this is a relatively, as I said, quiet moment, but 2022 has been, and I expect will continue to be, an extraordinary year for us as a business. As a reminder, Up till now, in addition to continued progress on the VTAMA commercial launch, and we'll come to that in a second, we've generated positive data in now both large randomized controlled studies, phase three studies, and atopic dermatitis for VTAMA, which, as we've said before, will support our filing for additional indication there at the beginning of next year and approval hopefully next year as well. And then we've also now put out two important data sets, one in January and one in June, demonstrating the efficacy and our overall enthusiasm for RBT3101, our T1A antibody, which obviously has gotten a lot of discussion. That program is obviously one of the most important in our pipeline now. We are currently underway with our Phase II Crohn's study. and in the midst of preparations for our phase three study in ulcerative colitis, which we will share more detail on in the near future. Still coming for the year are two pretty important events. One, which I expect we'll get some questions on, I know Immunivant has spoken a lot about recently, is the upcoming single ascending dose and multiple ascending dose data for IMVT-1402, our next generation anti-FCR and antibody at Immunivant. Obviously, that data, we think, has the potential to show that we have a a best-in-class program there, and we're really looking forward to putting it out. There's a number of other data sets in our FCRN franchise and more broadly in the FCRN field coming in the near future as well. And then, as I mentioned, the topic on which we'll spend the most time this morning is brepacitinib. That's our dual inhibitor of TIK2 and JAK1 at PridaVant. That program has its what would be one of two registrational studies in SLE, a Phase IIb study reading out in the fourth quarter of this year. and actually just a lot going on generally there as well. And it's a program that I think is just starting to get some attention, but it's really sort of earlier on people's radar. So all of that situates on slide seven in our late stage pipeline, which again, we are very excited about in terms of its breadth and in terms of the importance of many of the mechanisms we're working on. And again, there remain programs in that pipeline, like in the Milimab and RVT2001, that are earlier stage, higher skew opportunities that we'll share more about as we get data, which will happen sort of starting at the end of this year with 2001 and beyond with the Milimab. So with that, I'm just going to go into a brief update on where we are on VITAMA, starting on slide nine. So look, we continue to be bluntly very excited about the progress that we are making here. We continue to see Monthly scripts increase. We continue to see docs enthusiastic. We continue to hear a lot of enthusiasm for our AD data. We continue to make payer progress, as I'll talk about in a moment, and continue to see improvements in revenue, which is ultimately the bottom line at the moment. So we're just very pleased with the growth there. We've got now over 11,500 unique prescribers who have written over 200,000 scripts, which is pretty extraordinary for just over a year on the market. It's a really strong start from our perspective. You know, on slide 10, I just wanted to give a sort of payer update. So we're up to about 130 million lives covered, just a tick under 80% of commercial lives, plus 87 million government lives. This is the kind of coverage we dreamed of having maybe 18 months after our launch. This is really exactly where we need to be from a coverage perspective. We are on formulary With all three of the major PBMs, so we're in good shape from a major PBM perspective. We have four additional national health plan formularies. We have a bunch of progress across some of the regional and smaller plans. We are in a great place from a coverage perspective. And the other thing I'll say is the significant majority of this coverage obviously has no prior auth. That's a little bit of a red herring in dermatology where very few drugs are true prior auth, but Most importantly, the majority of it is single step through a steroid with very easy process for that step to be achieved. And so we feel really good about the strength of our coverage, and we think it's underpinning a successful commercial model. You can see a little bit more about that on slide 11. We did $16.7 million in net revenues for the quarter, which continues to be a solid progression in growth quarter on quarter. I feel good about that growth and expect to continue to see it to accelerate with both volume and gross net improvements in the future. Gross-to-net was a hair better, 26% yield over the last quarter. We had pulled, as we said on the prior call, some of the GTN improvements from this quarter, the June 30th quarter, back into the 331 quarter with some earlier formulary additions. So I expect to see GTN to progress sort of linearly on the trend line over the course of the year, and I expect to end this fiscal year, call it in the mid to high 30s from a yield perspective, and still believe very comfortably in we'll be on a trajectory to get to that 50% yield that we and others have guided to as we progress. So the contracting and sort of other payer progression is all sort of moving exactly in the direction we need it to, and we think we're in, yeah, we're in a good shape from a GTN perspective. So that's about it on Vitama for now. I'm sure we'll get some more questions. Look, I think the continued progress there is, is exciting to us and we're excited about all the feedback we're getting. We believe script volumes will continue to increase over the course of this year, especially as our now live DTC campaigns begin to have an impact on volumes. And we're really also looking forward to getting going in AD next year, which is, as you may remember, a about four times larger market opportunity where we have some truly exciting and highly differentiated data. So with that, I'm going to turn it over in just a moment to Mayuk. who's going to do a relatively deep dive here on brepacitinib, our dual inhibitor PIK2 and JAK1. And I think it's a program that has been high on our minds, but a little bit below the line for others just because of everything else going on in our pipeline. But it's a really exciting program. It's a very potent agent, which continues to demonstrate strong clinical efficacy. And one of the many reasons we're highlighting it today, which maybe we'll talk about, is we've generated some data Pfizer had an ongoing study in Crohn's disease that's read out, and once again, the agent has shown great promise in another clinical study. We are unlikely, as you know, to progress it in Crohn's disease, but nonetheless, really excited about the data there and what it means for what we're going to do in some of these other places. So with that, let me hand it over to Mayuk to take it away, starting on slide 13.