Good day, and thank you for standing by. Welcome to the Roivant 1Q 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] 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 Communication. 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, Head of Communications at Roivant. Presenting today, we have Matt Gline, our Chief Executive Officer. For those dialing in via conference call you can find the slide being presented today as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we'll 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 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 Gline, who will review key business updates across Roivant in advance, and provide a financial update. We'll end the call with a Q&A session. 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 4 and I'll take you through some of the key highlights of the business today and then we'll make some time 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 VTAMA, 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 study is currently ongoing. Our chip-to-clinic discovery program, including our proprietary QUAISAR platform that we are using to bolster that pipeline at the discovery stage, a number of sources of asymmetric potential upside, including our Genevant 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. So I'll start on Page 5 with a brief update on the VTAMA 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…

[Operator Instructions] Our first question comes from David Risinger with SVB Securities. Your line is now open.

Great. Thank you very much and thank you for the updates. So I have a few questions. First, could you talk about the expected ramp of VTAMA going forward, particularly in the face of competitive dynamics? Second, could you discuss how you're thinking about gross to net over the next couple of years, particularly relative to Street expectations and what you're seeing from the sell-side? And then third, could you comment on the cash burn in the quarter and remind us about your cash runway? Thank you very much.

Thanks, Dave. Thank you for all those questions, they're all good questions and I'm happy to take them. So I appreciate it. I'll start with VTAMA question, which is, early in the launch to make long term projections on a ramp. We are pleased with the early prescription data and we think it sets us up well. We're pleased with the engagement we had with patients and physicians and with some of the early feedback we're getting on the drug. So all of that reads well. You asked about competitive dynamics, the first thing I'll say, which I think is an important point that we're just going to reiterate over and over again is, we don't view this as a competitive market versus other novel agents first and foremost. We view it as a competitive market versus corticosteroids, where there are literally millions of people on corticosteroids for psoriasis or literally millions of prescriptions for corticosteroids and psoriasis. And we think we have better efficacy and better tolerability that should allow us to take significant share from that whole category of agents, which is currently the standard of care mainline therapies. So that's the first thing I'd say. As far as the competitive landscape is concerned, yeah, I think there's a -- we obviously have a new topical competitor now on the market in ZORYVE. It's a drug that has some nice attributes. We think we are differentiated meaningfully between our remittive benefit and our overall more simple safety picture without contraindications or restrictions on concomitant meds. That's why we also think more voice share in novel topicals for psoriasis is helpful. We think there will be a little bit of a rising tide effect overall. So I would say given the population that we're going after, I'm excited about…

Great. Thank you.

[Operator Instructions] Our next question comes from Dennis Ng with Jefferies. Your line is now open.

Hi, guys. Thanks for taking the questions. Two for me. First on VTAMA (ph), can you please give some more granularity on the launch, in terms of who and where it's being prescribed? Are you seeing it from mild and moderate? And maybe talk about how penetrated are those accounts that you guys are currently in? And then secondly, perhaps on Proteovant, you guys mentioned that you had an AR [Technical Difficulty] that is and when can we expect the mix? Thank you very much.

Yes. Thank you, Dennis. That's both good questions. So I'll start on the VITAMA question. We've seen, I think, we mentioned in the Slide 6, 3,000 people write VTAMA prescriptions. We've been focused early on the sort of highest prescribing docs, the docs who write a significant percentage of topical prescriptions and who are the general thought leaders on novel topical agents. We've seen multiple -- many docs have written multiple prescriptions and obviously there's some concentration there. And then there's a whole population of doctors even in that high prescribing population that we're still getting out to and still getting our best readout too. So I think there's a lot of room to run there. We have not sort of focused on a specific severity band within those docs. And so we don't have a specific strategy as far as these severity or sub-setting the patient population. I would say, we get reports in the field from a variety of different patient populations, including mild patients who didn't like being on steroids, but also including reports from severe psoriasis patients who, for example, were on the cusp of using a systemic agent and have been pleased with their VTAMA experience in ways that may forestall (ph) that for them. So it's been a pretty broad, a pretty broad patient population and a lot of interest in the drug from across the spectrum. Again, we're pleased with both the number of prescriptions and the number of unique prescribers. And then your second question was around the androgen receptor degrader. I think we're still looking at that program both our data that we're sort of getting the final wisps of, in our competitor data and to be honest, it's the kind of program that we're watching closely in the context of the recent drug pricing legislation. So I would say, the bar for that is high and we're still sort of evaluating our options there and we'll provide an update when we've got one. But I appreciate the question. Thank you, Dennis.

Thanks.

[Operator Instructions] Our next question comes from Neena Bitritto-Garg with Citi. Your line is now open.

Hey, guys. Thanks for taking my question. I was just wondering, if you could talk a little bit more, Matt you just mentioned that you are seeing some docs write multiple prescriptions. If you could talk a little bit more about just the general prescriber behavior you're seeing. Are you seeing docs generally prescribed to maybe one to two patients first, see how things go with those patients and then kind of opening up their broader population of patients? And then also any initial kind of feedback or anything you're hearing on folliculitis? That'd be great. Thanks.

Yeah. Thanks, Neena. So those are both -- it's a great question overall and both parts that are good. I don't -- we don't have specific data to share right now on whether docs are kind of dribbling out or not. I would say anecdotally, we have a pretty wide variety of prescriber behaviors from fruit believers who -- we’re shooting out of the gate and continuing to shoot to facts who have become more and more enthusiastic about the drug as they've had positive patients experience. I think I mentioned we continue to get lots of positive reports from vaccine patients in the field. I would say one attribute that's coming back that we saw in our data, but think it's been exciting to hear in the real world has been the onset of efficacy. I think patients are pleased with how fast they're seeing results and then another set of reports that we're seeing, which I mentioned are from patients who were sort of on their last guess as far as tacticals were concerned and we're sort of evaluating progression to systemic agents. And I think it's been a real breath of fresh air for that patient population. So we've heard positive reports from docs and patients about that from both. On folliculitis, I'll just say, I think it's as we predicted, we have not heard any significant rumblings about it. It's not something that we think is meaningfully affecting the way docs use the drug or meaningfully affecting the patient experience given that it's transient and on target for the drug. So nothing new or significant around folliculitis that we think is affecting commercial behavior. Thank you, Neena. Thanks for listening.

Thank you.

Please standby for our next question. Our next question comes from Louise Chen with Cantor. Your line is now open.

Hi. Thanks for taking my question. So I have a few for you. First one I wanted to ask about was Brepocitinib and the SLE market landscape and how you think about that for your product? And also why you chose this one in dermatomyositis as the first two indications? And then secondly, on the Japan Tobacco, congratulations on that news. If you could be more specific on the feedback or the read through to your AD study, that would be very helpful? Thank you. And then last one, I wanted to ask you was broadly what is the physician feedback on VTAMA and how they view it as an addition to the market here with one of the first topicals being approved, novel topicals in a long time. Thank you.

Great. Thank you, Louise. All really good questions and appreciate them all. So thanks for listening. On the first on Brepocitinib with SLE. SLE, as you know from covering the field is that littered with lots of people who've tried lots of things. The competitive landscape is really there's two approved biologics with lots of unresponsive patients and many others who experience a partial response. So it's a disease that has been historically stymied (ph) by a combination of agents that haven't worked as well as they could other than just for development execution. So we see a huge opportunity for a novel agent. And we talked about this a little bit on our annual call and maybe some of the slides there are useful to refer to as you're looking back on it. But I think there's good scientific rationale for the combination of TYK2 and JAK1 being important in lupus. And we've seen the recent data from the Brepocitinib (ph) on the Phase 2 side, which Baricitinib on the deck one side, we'll put that data in this deck. So we think we have a real opportunity there. And as we mentioned last time, this is a study that we're running together with Pfizer and it's going to a capital efficient program for us with a readout next year. So we see it as an opportunity. As far as why, we've chosen these indications. I'd say one of these are both diseases with a high morbidity and mortality with no approved oral therapies at all. As I said in the case, lupus the approved therapies of biologics. And so no approved oral therapy side of getting mortality. And then maybe most importantly, from a scientific perspective, we're looking at diseases where we think the biology of both TYK2…

Thank you.

Thank you, Louise.

Please standby for our next question. The next question comes from Douglas Tsao with H.C. Wainwright. Your line is now open.

Hi. Good morning. Thanks for taking the questions. Just Matt, maybe just as a quick follow-up to Louise question on the VTAMA readout. In Japan just to confirm, the -- those two studies have the -- or that study had the same primary endpoint as the study that you were -- that you're currently running an atopic dermatitis, correct?

Yes. Primary and key secondary were IGA and EASI, which are also important endpoints for us, exactly. That's correct.

Yes. I just wanted to confirm because that sort of obviously highlights read-through, should be very strong. And then also just when you think about the progress and just curious in terms of the early phase feedback that you've been getting from payers in terms of getting contracts into place and how they're thinking about sort of prior authorizations and where they see this being put into the treatment paradigm? Because obviously to your point, it could represent an attractive opportunities and off ramp for more expensive biologics.

Yes. Thanks, Doug. Appreciate that question. It's a good one. Obviously, those are all active discussions. It's hard to comment on specifics of where they are. But I think the point you highlighted is obviously an important point to everybody and hadn't been lost on anybody that it's important to have an off rent before biologics. And I think we've said before our view on the treatment landscape is that we should be mainstay of therapy, which is important so not just a sort of a pre biologics option, but really as the baseline of care and that's just sort of where we think the drug deserves to be positioned. But we think obviously the factors around biologics will help us in getting the positioning we want. The second thing, I just remind people of is remember that the main things that insurance companies care about, the payers care about in determining coverage is demand. Obviously, the scientific attributes of the product is something they look at carefully in the FX per panels, but the way that sort of gets realized is around commercial demand. And so the early script volume that we're seeing here is incredibly important we think ensuring that we have the kind of credible broad coverage that we want. And then we talked a fair amount in the approval call about our pricing strategy and about making sure that we had both the price points that will be attractive to list price sensitive payers, but also importantly a price that offered us the opportunity to offer significant rebates to those PBMs that are rebate sensitive. So I think all of those dynamics are important and we think they're going to matter. And you're actually right, the biologics are really big pain points for payers right now. So they're all going to be very focused on defraying that spend over time.

And then just one quick follow-up. I mean, how do you envision obviously getting contracts in place for psoriasis? How long do you think it will take when you look to add the atopic dermatitis indication. Should -- do you think that should be come in place fairly quickly soon after that approval?

Yeah. I think once the AD indication is approved, we should see adoption in AD relatively quickly. In terms of the specifics around payer contracting and payer dynamics, I think once we have the psoriasis payer contracts in place and once we have the AD data, we'll be able to comment more specifically on that timeline. But I think it's fair to say that we expect uptake in AD to be relatively quick on approval.

Okay, great. Thank you so much, Matt. Congrats on the progress.

Thank you.

Please standby for our next question. Our next question comes from Corinne Jenkins with Goldman Sachs. Your line is now open.

Good morning. Two for me. First on the folliculitis (ph), you mentioned that you're not seeing much of an impact, but is that something you're having to educate physicians bond or is that some people seem to kind of understand from the get go? And then with respect to the script accelerate, what are you seeing there? And how do you think that $75 patient copay or responsibility is impacting this still right?

Yes. So Thanks, Corinne. Those are both good and important questions. Yes. On folliculitis, dermatologists are very familiar with folliculitis as condition. And that's all dermatologists are pretty familiar with the folliculitis conditions. So there's not a lot of education need to sort of explain what it is. I think it's important that they have the heads up about it. To be honest, we're just not hearing a lot about it in the field, which I think is exactly what we want. It's something that I think the docs are comfortable with, but also the patient experience of it is my old, it's transient. I suspect that we'll be hearing more about it as many patients were asking their doctors about it after experiencing it. So I think in general, it's just not having much read through on patient or prescriber behavior is sort of, how I understand the current situation to be based on the feedback that we do have. And then, so we're not sharing specific fill rates, but I think we're extremely pleased with the overall rate of that fill prescriptions. And I think that reflects the attributes of the product, it reflects the sales and marketing strategy and it obviously reflects the impact of the copay card program in all of its features in terms of getting patients on drug. And we talked a little bit about how the way that our copay card disruption is also designed to help us in the coverage process and so we're continuing to follow that as well.

Great. Thank you.

Thanks, Corinne.

Please standby for our next question. Our next question comes from Yaron Werber with Cowen. Your line is now open.

Hi, guys. This is Brendan on for Yaron. Thanks for taking the question. First on VTAMA, I just wanted to ask about the Japanese AD study. I guess looking at the baseline demographics there and maybe the enrollment criteria, would you say that's fairly reflective of the U.S. study and maybe what you can expect to there? And then on Brepocitinib, kind of building off one of the earlier questions. Can you maybe just tell us where you see the bar is for you on the Phase 2 study for next year given some of the competition? I know and you also mentioned that your drugs you think would be potentially better than even dual administration of separate inhibitors. Could you maybe elaborate a bit on why that would be the case? Thanks very much.

Perfect. So on VTAMA, the answer is, the studies criteria are similar. Patient populations are different only in the sense that the study in Japan was obviously exclusively Japanese patients. I think the read through is positive and then just a reminder that study is significantly smaller. I think overall that study is smaller than either of our individual Phase 3 studies in AD. So I think that's an important part of that read through there. And then I think your second question was on sort of Brepo and what do we think is the bar, we've talked a little bit about what the unmet need looks like there. I think candidly the bar has to be pretty high. We want to see superior SRI-4 to the approved therapies and then good data on secondary endpoints. So I think the bar for efficacy is reasonably high for the program. It would be sort of one of the only oral agents, actually they'll currently approve oral agents. So we think we have a pretty good opportunity there. Thank you.

Please standby for our next question. Our next question comes from Nishant Gandhi with Truist Securities. Your line is now open.

Hi. This is Alex on Truist Securities. Going back to the conversations with payers on formulary position, have the discussions been challenged at all of the launches ZORYVE and the price point that the competitor has chosen that modified the ongoing negotiations at all with the payers that you're seeing. And then also can you remind us, are you monitoring for how many tubes per month that patients use for VTAMA in real world practice? And if you do, are you going to present this data to investors and what time and future might that be? Thanks.

Yes, thanks. Those are both good questions about VTAMA launch. Thank you. Appreciate them. Yes, on the [indiscernible] price point. I guess a couple of comments. One is we're not going to comment on active discussions with payers and our tubes was just approved a couple of weeks ago. So I don't think there's a real kind of update on the impact anyway. I think we've talked a fair amount in our approval meeting about why we were pricing, where we were pricing. And our tube (ph) has been guiding to their pricing strategy for some time. I think for us it was about threading the needle between a low enough list price to appeal to those plans that we're going to focus on list price, but also high enough list price to be able to offer the kinds of rebates to the PBMs where so much of the commercial volume lies. And I think we feel good about our pricing strategy considering everything that went into it. So, I won't -- again, comes from an acute pricing strategy directly, but I feel good about ours. I also think we just have a differentiated product from ZORYVE. And I think the attributes of our product into these. And third, we have a remittive benefit that that we've talked a fair amount about. Their label has some features that we don't, including they have drug interactions listed with chip-384 (ph) metabolized drugs that's not a small thing. That's like Atorvastatin and Simvastatin and most contraceptives are included in their drug interaction profiles. So I think that's something that will potentially matter in practice. And so I think there's various differentiating features that will also impact payer conversations that will also impact, we will also impact, -- where we are. And I think as I'd say, refills in general, maybe I'll say on the question about tubes per month, we don't currently provide guidance on that. It's super early obviously with many of our patients who just received the first prescription. I think refills are good indicators of happy patients and we're seeing already refills, some number of refills just a couple months in, which looks great to sign at least some patients are going to use multiple tubes, who's going to be happy on the drug. So I think you should actually be able to track to some degrees at tube utilization from watching the NRx or CRx rate. I think we're happy with that. We continue to see good engagement in the [indiscernible] program as well. So I think overall it's too early to comparing long term conclusions on the refill rate or the number of tubes. But I think the early data is promising to us.

Thanks for taking the question and congrats on the progress.

Thank you.

At this time, I am showing no other questions in the queue. I would now like to turn the conference back to Matt Gline for closing remarks.

Great. Thank you, operator. Thank you for everyone for your questions. Thank you everyone for listening this morning. As I said, it was a short call for the last one was just six weeks ago. We're looking forward to getting together in September for our Investor Day and continue to provide updates on VTAMA and on many other exciting things within our business over the months to come. So thank you everybody and we'll talk again soon.

This concludes today's conference call. Thank you for participating. You may now (ph) disconnect.