Good day, and thank you for standing by. Welcome to Roivant’s Fourth Quarter and Fiscal Year 2021 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. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] 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 and business updates for the fourth quarter and fiscal year ended March 31, 2022. I'm Paul Davis, the Head of Communications at Roivant. On the call today, we have Matt Gline, our Chief Executive Officer; Richard Pulik, our Chief Financial Officer; Frank Torti, our Vant Chair; Eric Venker, our President and Chief Operating Officer; and Mayukh Sukhatme, our President and Chief Investment Officer. For those dialing in by phone, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll be providing the slide numbers as 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 and 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-K filed this morning for more information regarding these forward-looking statements and related risks and uncertainties. Matt Gline will review key business updates across Roivant in advance, including the commercial launch of VTAMA at Dermavant as well as Priovant and Aruvant today, and we'll provide a financial update. We will end the call with a Q&A session. Without further ado, I'll hand it over to Matt.

Thank you, Paul, and thank you, everybody, for joining this morning. It's an exciting call for us. It's our first 10-K as a public company. It's our third earnings call, so we appreciate everyone being here this morning. So I'll start just briefly on Slide 4 and talk a little bit about what's going on in the business. Starting with and I think everybody is familiar with this, but we have, as of this month, really the commercial launch ongoing of VTAMA Cream and we'll provide a brief update there, although it's still early days. Behind that, we have a really exciting differentiated pipeline of clinical programs, and we'll talk a little bit about some reprioritization we've made there in part to make room for Priovant, a new vant that we've announced this morning that's developing a drug that we'll spend a fair amount of time on today. We also have our Chip-to-Clinic discovery platform with our proprietary tools, including QUAISAR and VantAI working on a pipeline of preclinical programs against challenging targets. I'll talk a little bit about some collaborations during the quarter there. And there are a number of sources of asymmetric potential upside, including the Genevant IP portfolio and others, all backed by a strong capital position with as of 3/31 at $2.1 billion in cash and cash equivalents on our balance sheet and a significant portfolio of public equity stakes. So we won't spend a ton of time on Slide 5 on VTAMA today because we just provided the update call a few weeks ago on the approval, and it's too early to say much. I'll say, we see strong early prescriptions recorded to date. The IMS numbers are here. We’ve got some feedback from physicians on the label and really excited about what that looks…

Thank you. [Operator Instructions] Our first question comes from Dennis Ding with Jefferies. Your line is open.

Hi, good morning. Thanks for taking the questions and congratulations on the progress on the partnership with Pfizer. Two questions for me, one on Priovant. Can you just talk about the decision for Pfizer to out-license these assets? I think there's clearly a lot of interest in the class and these trials seem relatively late stage having enrolled already or close to fully enrolled. So perhaps why do you think these assets are in better hands with Priovant versus Pfizer whose cost of capital is presumably lower? And then my follow-up question is on VTAMA and script volumes and whether these have been tracking in line or better than your expectations thus far? And I guess, especially on pricing, if you can right-size the Street on personally that would be really helpful. Thank you very much.

Yeah. Thanks, Dennis. Appreciate the questions, appreciate your listening this morning. I'll probably take those in reverse order, and I'll take the VTAMA question first, and then I'll give some thoughts on the Priovant question, I also ask Mayukh to work closely on that collaboration to chime in. On VTAMA, in terms of script volumes, we haven't said exactly what our expectations were. I think what I'll say is we're pleased with the early demand. We're very pleased with the response from the docs that we're out talking to. It is very early days. And so it's hard to look at this and say that we're ready to draw any conclusions. We are excited to see where this goes, and we're looking forward to providing a more fulsome update. And then on gross to net, I guess I'll just go back to what we said on the launch call, which is we are focused very hard at this stage in the game on getting credible high-quality coverage, which includes the right formulary, which includes the rebating strategy and so on. I think until that happens, we're not providing specific guidance, but I would expect deep gross to net discounts just because of the way the market works. And then I expect that will normalize once we have credible coverage. And what we've said is that's going to be about 12 to 18 months. So that's kind of what I would say on VTAMA. On the Priovant and Pfizer question, the first thing I'll say is, yes, I think you can see it in the partnership terms. Pfizer remains excited about this program. They continue to invest in the Lupus trial alongside us. They own 25% of Priovant, they have economics flowing back to them. And they have a large portfolio of drugs in this general sort of area of the world. And so I think even companies like Pfizer need to pick and choose and make strategic decisions. And I think this was - if I had to guess a tough one for them to “let go”, and it has to do with the quality of our relationship that they thought it was in good hands with us and that it was going to generate good value for them in this construct. So that's sort of my high-level answer. Mayukh, I don't know if you would add anything to that in terms of how you think Pfizer was thinking about it.

Yeah, I think that's right. Thanks, Matt. So I mean, I think, as Matt mentioned, obviously, we view Pfizer is really the world leaders in this specific biology and has a number of other programs, both marketed and late-stage development in these areas. And I think we were looking at the data for Brepo that all had largely been developing in the sort of the broader market indications. And I think that they saw in our proposal sort of a way to develop it in a unique set of indications that, again, really plays the strength of this specific molecule. I think as you guys probably all appreciate, Pfizer has got a long history now of partnering assets with new codes. They've done it with Cerevel, with allergy and with SpringWorks, and we're really excited to move forward with this has been a great partnership. Thanks.

Thank you.

Thank you. Our next question comes from Yaron Werber with Cowen. Your line is open.

Yes, hi. Thanks for taking my questions and congrats also on this deal. So I also have a couple of questions on brepo. Number one, can - I guess I have three questions. One is the collaboration open-ended in terms of indications? Or are you sort of restricted to Lupus and dermatomyositi? They're retaining to develop any other TYK2 or JAK1 independent of view for any indications, including these two. And then finally, when we look at the prior data, kind of two things to jump to mind, you're right, the data you showed us pretty good. The atopic dermatitis data was a bit weak on efficacy. And then infection, there's obviously some infections, but nothing overly concerning on the safety to address those two as well? Thank you.

Yeah, thanks. So I'll let you have a couple of these things. First of all, the collaboration is definitely open ended with regard to indications. And I would say not only are we not limited to these two, but given the quality of the compound, I think you can imagine we are considering a whole range of things we might do with this. So definitely not limited. Maybe you can comment a little bit more on the specifics of what Pfizer might be limited to. But in short, I think you can imagine for a company like Pfizer with a portfolio like theirs, they don't have a lot of limitations on what they can do, but Mayukh can comment on the specifics there. And then on the safety side, and then I'll hand over to Mayukh to comment on any of these topics. I'd say, broadly, first of all, remember, this compound has been developed extensively. It's been exposed in to over 1,000 subjects and patients. And we've observed rates of, let's say, JAK-class specific adverse events that are in line with those observed in other programs. From a tolerability standpoint, has generally been well tolerated. I agree with you, things like reflection numbers are not particularly problematic. I think we feel like the safety profile is consistent as favorable for the development strategy we have in mind and it's something we're mindful of. I think, frankly, the focus on tolerability for JAK inhibitors is part of what has given us the opportunity to do something unique and different here. So Mayukh I don't know there anything you'd add on any of those points and specific if you want to comment on the AD data around any limitations that Pfizer has.

Yeah. Nothing really to add here. I mean I think as one might expect, I mean, I think that we were committed to these programs as our sort of expression of our interest in this particular biology. I think as Matt noted, we don't have limitations on what we can pursue. And I think, as one might expect, I think sort of some of these core indications that we've highlighted today, it was important to us to kind of have Priovant be the way in which Pfizer is expressing interest in these indications as well.

Just one comment on the [indiscernible]. I think you're referring to the published data- they published some data. The published data was in topical brepocitinib, so our lead compound here is the oral formulation. We have rights to the topical as well. We're sort of deciding what to do with it. And obviously, it's an area we have a fair amount of interest in. But I would say the activity data that we have that's most relevant to us is the data from the oral program.

Thank you so much.

Thank you. Our next question comes from Robyn Karnauskas with Truist Securities. Your line is open.

Hi. This is Alex on for Robyn. Congrats on the partnership. A quick question on Roivant, and I want to know if you could provide a little more color on what factors led to the wind down of the sickle cell program? And also how should we think about the approach to future resource allocation for existing events versus interest in additional initiation of subsidiaries?

Yes, thanks. Look, it's always a tough decision to wind down the program that you're potentially excited about. And so there were a lot of factors. I would say, chief among them from my perspective, others and a broad desire to be sort of careful about how we're allocating resources in the current environment is the clinical bar for curate therapy and sickle cell disease really is curative. And I think as you look at the development of that field with the other programs, we felt like that bar was really high, and we got nervous that we might not quite achieve this weekly clinical bar there. And look, these are these are patients with few options. But actually, the pipeline across biotech is pretty broad. It's obviously been a little bit of a challenged area, but we still feel good about the high likelihood that curative therapies using genetic medicine are going to make it to sickle cell patients. We're obviously disappointed to bow out, but we're incredibly appreciative of the patients that have worked with us and obviously, the investigators that have worked with us as well as our whole team, and it's something that we took a swing at. So yes, it's a tough decision. I think what it enables for us is to continue to be broad-minded in our portfolio. We have to make decisions like this and we have to make them quickly and decisively in order to be able to do things like this partnership with Pfizer opportunistically, and we think the current capital markets are going to give us even more opportunities of that kind. And so when we have the ability to make these decisions, it's just something we have to do quickly. So it's something that - it's always disappointing, as I said, but it's just the kind of decision we have to wait to make.

Got you. And you mentioned that you got some initial physician feedback on the [indiscernible] label. Can you elaborate on that a little bit?

Yes. I would say just generally, as we've been out to docs, as our field force has went out to docs are, our leadership team has been sort of out talking to the medical community. I think there's just a lot of excitement and enthusiasm for the label. We obviously were excited about it when we first saw it, but what you heard on the call a few weeks ago was really our in the Derma management team's first impressions of what seemed to be a very clean label. And I think as you get out there, just all the things that we would have hoped resonating are resonating with prescribers. And so yes, we're really excited to watch the progress there as that team gets out and does what it does best.

Great. Thanks so much.

Thank you. Our next question comes from Louise Chen with Fitzgerald. Your line is open.

Hi. Thank you for taking my questions here. So I wanted to ask you a few things. First one, if you could talk about the market opportunity for batoclimab in myasthenia gravis? And where do you think your drug would fit into the treatment landscape if it's approved? The second question I have for you is, how do you think about tapinarof or Dermavant [ph] and the potential opportunity in psoriasis and in atopic dermatitis? What gives you confidence in the positive data or positive data readout in 2023 in atopic dermatitis? And then can you talk about the pushes and pulls on your cash runway? Thank you.

Yes. Thank you. I will - I'll take those questions in some order here. I'll start with the VTAMA question with the [indiscernible] question. We're looking forward to that readout. We like the biology of AHR modulations are much. It's something you've heard us talk a fair amount about. And we think it's important to inflammatory skin disease generally. And then I would say the thing that gives us most confidence about our readout in the first half of next year is that we have compelling Phase II data in atopic dermatitis that has guided our development strategy, and we feel like we've designed the trial to maximize the opportunity there. In terms of the opportunity, look, we think it's really, really big. We think we have an opportunity for a blockbuster program in both indications or in each indication. And we're hopeful that our data next year is going to support it. So on Batoclimab in MG, we've talked a bit about this before, and I think the Immunovant will continue to talk about it as well. We view that market as large and interesting. We view the evidence for FcRn modulation being effective is obviously robust at this point across multiple programs. And we think that the specific trial design that Immunovant is employing there with induction and maintenance and rescue therapy. And with all the flexibility that comes from the subcutaneous administration from the trial design, allowing docs to move patients between doses at various times and randomizing across different doses is going to give us a really differentiated profile relative to any of the other FcRns in development. And obviously, the details of those programs, including the label on VivGuard [ph] is well known and frankly, doesn't have the same level of flexibility. So I think…

Thank you.

Thank you. Our next question comes from Neena Bitritto-Garg with Citi. Your line is open.

Hey, guys. Thanks for taking my questions. So for the Proteovant partnership with Pfizer, I believe there were actually two assets as part of that deal. Could you maybe talk a little bit about the second asset and kind of thoughts on that? And then on the updates on the LNP patent litigation, I guess, any update that you can give in terms of timing for when we could hear the court's decision on the motion of business would be great. Thanks.

Sure. So the other asset in the Pfizer partnership was a selective TYK2 with its own unique signature. We wanted to use this call to focus on repo, given the fact that the lead molecule is already in registrational studies. We don't have claims to shed right now for brepocitinib, which is that selective to TYK2. We're more focused on the combination. I'm sorry. And then on the IP question that you asked, I don't think we have a specific comment on the court's time line for response there. I think it's ultimately up to the court. I don't think there's a prescribed time line for it. So they have the discretion to decide when they want to. So we're watching for it in the coming months is what I would say.

Awesome. Thank you.

Thanks, Neena.

Thank you. Our next question comes from David Risinger with SVB Securities. Your line is open.

Yes. Thanks very much. And I wanted to add my congrats on the submarine Pfizer transaction. So my questions are as follows. First, could you talk about the expected payer access ramp for tapinarof? And then how we, as investors, should think about net sales in coming quarters since it's going to take a while for payer access to actually take hold. Then second, with respect to court action on the LNP litigation ahead, could you just talk about potential timing and how we should think about developments to watch? And third, I don't know if Richard is on the call, but would be helpful to understand how we should be thinking about cash flow in the upcoming fiscal year, specifically operating cash flow or operating cash burn, I mean? Thank you.

Thanks, Dave. Those are all great questions. I appreciate it. On tapinarof, payer ramp, I think we've commented a little bit in response to some of the other questions here. We've said our main focus is on high-quality coverage. What that means is we're prepared to do the work to get the covered claims through to get payers to pay attentions of the program, and that's what we're doing now. So we are most focused on, as I think we've said a few times, script volume during this period of initial launch and expect that to last for a little while here. And then what we said is that we expect to have that coverage online kind of in the 12 to 18 months time line, and that's when we would expect gross to net to - to ramp up and normalize. And I would say we'll be prepared to provide sort of better specific guidance on what we think normal gross to net will look like for us once we have a little more visibility into those contracts and so on. So I think stay tuned on that topic. Then on the LNP litigation, I think a similar answer to the prior question here. I think the District Court has discretion on when they respond. And sort of the next major action there is the District Court response to [indiscernible] motion to dismiss or had some discretion there. But in general, they tend to respond within months. So that's something to specifically watch out for. We think the acute to situation is of less direct interest, but that's obviously also ongoing, and we'll get some feedback from the court there. And then beyond that, I don't have a lot to comment on right now or on any other possible movement there, but those are the things we're watching most closely. And then Richard is on, so I can hand it over to him for any additional comments on operating cash flow. But I think while we haven't given a specific sort of cash flow statement metric guidance, I think you can look at where things have been and you can look at the sort of runway guidance that we're giving overall and back in a little bit to kind of what we think things are going to look like from an operating cash flow perspective. Richard, I don't know if there's anything you would add to that?

Thanks for the question. Look, we haven't provided guidance for the year specifically, but I'm very pleased with a lot of the reputation we've done this quarter. And as we think about the portfolio, I think we have a really high bar here as we move things forward, we'll have data emerging from us from competitors, and we'll put the same laser-focused lens on taking additional programs forward to data mergers from our programs and externally. And certainly, as we ramp up the VTAMA launch and the 80 data [ph] comes through, you can think about some of the additional spend for launch down the line. And then as we said, for Dermavant [ph] we have the additional Phase III trials that will be coming through that you'll see kind of by the end of the year and some of the other savings that we've talked about should confidently lend us the 2-plus year runway, but we're not providing 1 year guidance.

Thank you very much.

Thanks, Dave.

Our next question comes from Sal [ph] with H.C. Wainwright. Your line is open.

Hi, good morning. Thanks for taking the questions. Just Matt, maybe to start, I know you highlighted that you've gotten some positive feedback on Vitoma [ph] in the early days. I'm just curious, when we think about the sort of selling points that you've had for [indiscernible], is there anything in particular that is resonating with physicians or sort of really standing out to them in the early conversations?

Yes. So in the last couple of weeks, we've acted on speaker trainings. We've been out to sort of top thought leaders on psoriasis, I think in general, what are we getting. People were excited about the bit of data. Obviously, that's something we expected. I'd say the cosmetic elegance of the stream itself as the kind of thing that people can tell immediately on use. I say we've gotten good feedback on that and on tolerability right out of the gate. It mostly confirms the survey data that we've previously shared. And we're excited to see that patients want to use the end. And then the other, I'd say early indications from the field onset of action benefit - benefit. I think these are the kinds of things that we were expecting in early launch, but we're pretty encouraged by it.

Okay. Great. And then just as a follow-up, and I might have missed it. Could you just maybe talk a little bit about the origins of the brepo transaction with Pfizer. Was this an asset that you would identify and reached out to them? Or did they reach out to you to discuss it?

I will hand over the origin story to Mayukh.

Sure. Yeah, I mean, I think that you should assume that, look, I think we have a great working group with Pfizer. We have great work in life with all the pharma companies as well, and it's almost more of an ongoing dialogue than an outreach or a specific outreach in either direction. But this is obviously a striking, I think, really unique drug that I think we had seen their data evolve and emerge for a period of time. And we're excited that we're able to kind of have a win-win collaboration and we're just getting started.

And I guess just maybe Matt, final question on Beta when you think about sort of prioritization, obviously, you're starting in dermatitis and Lupus. I'm just curious how are you thinking that some of the bigger indications that we already have some proof of concept data on or sort of some early clinical data are those worth pursuing or something that you think about down the road?

Yes, thanks. It's a good question. And obviously, the data that we have are highly compelling across a range of indications. I think they highlight just how strong a molecule it is. I think right now, we're focused on the development strategy that we've laid out here, not just in these indications, but frankly, in other indications that Rhine [ph] with means, and we think there are many. And so I'd say that's our initial focus, and I think you can expect to sort of continue to pursue that line at we're walking the yield closely and looking forward to continuing to provide up group as we get going. We think we can - we can generate yes, that's perfect.

And I guess, Matt, is pain should we think about this as sort of an asset similar to what we've seen with batoclimab in terms of just the rollout of new indications? Or do you think that these two are going to be the ones that we should focus on for some amount of time?

I think you should focus on these two but you should expect us to continue to announce some further opportunities as they crystallize. Obviously, it's a competitive area. So like batoclimab, we're focused on making our decisions executing on them and talking about them in the right order. But I think you should expect us to continue to face - look, we think that they should work in indications - a variety of indications of high morbidity and mortality with few approved therapy therapies, and we're looking at areas where there's highly inflammatory pathobiologies where specifically do inhibition in TYK2 and JAK1would we expect to provide greater efficacy than either alone. And we think there's multiple to choose from in addition to the two that we've mentioned today.

Thank you.

Thank you. Our next question comes from Corinne Jenkins with Goldman Sachs. Your line is open.

Yeah, good morning. You highlighted at the end there that you have this increasingly broad immunology portfolio. And of course, these are across different bands. So I'm curious. Could you talk about any potential synergies across the set of bands, whether that's an area we should expect you to continue to focus on as you expand the portfolio?

Yes. Thanks. It's a good question. I appreciate you listening. I would say a couple of things. First of all, we continue to not want to pigeonhole ourselves through specific therapeutic areas. So I think you'll continue to see us taking opportunities more broadly than just immunology. There are obvious benefits to having a concentration or some elevated expertise in an area. I think we see it in our diligence. We see it in our track record in people's understanding of our ability to execute these kinds of deals and these kinds of programs. Ultimately, if there are overlaps in commercial sort of footprint, we have the ability to do interesting things through the family and working with management teams to maximize sort of synergistic value, but we also have the flexibility to treat the programs as separate. So I would say we get benefit from talent mobility. We get benefit from leadership. We get benefit from sharing ideas across the family. And I think down the line as we get closer to commercial in some of these programs, we have the ability to think creatively about collaborations and the flexibility to do what makes sense across the family. And I'll highlight one of the things in particular, which is talent mobility. We talked about deprioritizing some programs today. I think one of the great things about the Roivant model is that we have the ability to take - to offer top talent from - from [indiscernible] programs that we do prioritize opportunities in other places around the organization, and that's something that's always been core to our model, and it's something that a concentration in human therapeutic area makes it even easier. And so I think it's something we're excited to have.

Thank you.

Thank you.

Thank you. Thank you. And I'm currently showing any questions at this time. I would like to turn the call back to Matthew Gline for closing remarks.

Great. Well, thank you, operator, and thank you to all who are listening today. Appreciate all of the really good questions. Obviously, an exciting combination of announcements for us. So yeah, looking forward to continuing to provide updates over time. Thank you for listening. And have a good summer. We'll be back out on a call like this in a couple of months.

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