Good day, and thank you for standing by. Welcome to the Roivant Third Quarter 2022 Earnings Call. [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, Stephanie Lee. Please go ahead.

Thank you. Good morning, and thank you for joining today's call to discuss Roivant's financial results for the quarter ended December 31, 2022. Presenting today, we have Matt Gline, our Chief Executive Officer. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these results 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'd 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 the Form 10-Q filed this morning for more information regarding these forward-looking statements and risks -- and related risks and uncertainties. We will begin with Matt Gline, who will review key business updates and provide a financial update. We will end the call with a Q&A session. And with that, I'll turn it over to Matt.

Thank you, [ Steph ], and thank you, everybody, for joining this morning. I'm pleased to present our third fiscal quarter financial results for quarter ended December 31, 2022. Yes, thank you, I'm excited to go to get together. This will be a relatively shorter update because, frankly, we've had a very busy quarter. And so we've taken a few opportunities to get together. It's hard to believe, but actually, it was after we last had a quarterly update call that we in-licensed and then published data for RVT-3101 as well. We've preannounced certain of our fiscal results last week when we did a financing, or 2 weeks ago. So again, thank you, everybody, and looking forward to sharing some updates and in particular, have some interesting updates to share around the commercial launch of VTAMA. So I'm going to start out just quickly on Slide 5, reminding everybody because it's still early in 2023. We are very excited about this year. The year started off strong for us [ in ] the announcement of our RVT-3101 data, the data for our anti-TL1A antibody from the induction phase of our ongoing Phase IIb study. We expect a number of really important updates from across the business, including -- we'll talk more literally today about continued reach and payor coverage of VTAMA, which we expect over time to translate, over the course of this year, and to continue to improve gross net yields and scripts. We can now say both the ADORING 1 and ADORING 2 atopic dermatitis studies are fully enrolled, and we expect to share top line data from those studies from ADORING 2 in March of 2023 and ADORING 1 in May of 2023. So important data from our AD program coming very soon, which is [ exciting…

[Operator Instructions] Our first question comes from Brian Cheng with JPMorgan.

As we look into you're going to read out next month, what should we expect there in terms of efficacy at top line? And what do you think that we'll need to see to be commercially viable?

Thanks, Brian. I appreciate the question. I appreciate your listening this morning. So thank you. What should we expect to see at top line? That's always a good question. We have not yet seen the data. Our Phase IIb data was really compelling. As you may know, we showed 49% gross efficacy on an IGA responder rate at our 8-week endpoint. I'd say there's a pretty wide range of what, good, could look like in that study. What I would say if we're in the 40s from a gross efficacy perspective, that's a grand slam for us. And if we're in the mid- to high 30s, I'd say it's a solid home run. And I'd say, anything in the 30s up would be commercially sort of viable for products given the quality of our data, the quality of our competitors' data, the quality of our safety data, et cetera. So I'd say stay tuned for what the actual data look like. But feeling excited about the opportunity and for a broad range of data that could be sort of commercially promising.

Great. And maybe just 1 on VTAMA. I think we talked previously about the potential for our DTC campaign. I'm just curious what's your latest thought on the timing or the need to launch a DTC campaign here based on the trajectory that you see? And how important is it based on where you stand in terms of uptick? And are there any pockets of opportunities that you haven't fully tapped in yet for the VTAMA launch?

Yes. Thanks. It's a great question. And I'll give an answer and then over to Frank to see if there is anything to add. Look, I think, first of all, we have some DTC efforts ongoing already. They are highly targeted in specific markets. They're using social media. We are excited about what we've been able to show there, but it's really the earliest days in terms of DTC strategy, and we haven't pulled out anywhere near to the level of stops that we could to sort of make this a thing. For us, we've been relatively conservative here because, in our view, it makes sense to drive DTC volume only as payer coverage really ramps up. So the patients who are sort of finding out about the drug are eligible for coverage when they go to their doctors. So we're still planning for that. Obviously, our sort of patient model is different than some of the systemic therapies that advertise very aggressively. But I think you'll continue to see us being thoughtful and use targeted DTC to drive volume. And I think we have a lot of opportunity from here to make an impact. But Frank, anything you would add to that?

I think that's a nice summary, Matt.

Our next question comes from Yaron Werber with Cowen.

This is Joyce on for Yaron. So our understanding about formularies are typically negotiated in the back half of the year and the fall and winter for the following calendar year. So I guess my question -- first question is, are you sort of all set with your formulary additions for 2023 calendar year or do you expect further additions? And then my second question is just on the Crohn's disease indication for 3101. I think on clinicaltrials.gov, the original start date for that was around mid-'23. Is that when you plan to commence the study? Have you chosen the dose already? And are you potentially waiting for the chronic maintenance data from the UC study to select a dose?

I will answer those questions in reverse order. So on the 3101 question on Crohn's, so there was a trial on ct.gov, that Pfizer had put up. That was a specific trial design that is not the study that we intend to run. And Pfizer basically decided not to run that study around the time they got a serious discussion with us in order to allow us to design a study of our choosing. We are preparing to share information about our Crohn's plan shortly, and we'll share it when we're ready. And we'll continue to share updates on our clinical plans overall for 3101 over the course of this year, including partially after the maintenance data has read out, and we've spoken to FDA about our Phase III plans in usage. So that's on that one. I'll hand it over to Frank to answer the formulary question, other than to say, we are not done for the year, and we have some other major formulary additions that we expect to make imminently that would have a meaningful impact on that number. But Frank, I'll hand it over to you.

Thanks, Matt. I think the -- what you said is, while generally true about industry structure, what we've seen with VTAMA, and the exceptional job done by our team there at Dermavant is the kind of remarkable patient and physician demand for the product has changed those cycles, changed the negotiation time line of those cycles and just generally led to a much higher degree of engagement across the board with those typical time lines largely not being a deciding factor for any of our access conversations. So we're really excited by that because I think it speaks to the fundamental value of the product bringing to patients and the community in dermatology.

And just to read, I expect our covered lives to increase significantly between now and the next update we provide. Thank you very much for the question.

[Operator Instructions] Our next question comes from Louise Chen with Cantor.

Congratulations on a productive quarter. So I had a few questions for you. First, what I wanted to ask you is that I know we're expecting some updates in the anti-FcRn space, from some of your competitors, second quarter for CIDP from J&J, rheumatoid arthritis later in the year. How do you think those read-throughs will impact your thinking on your clinical development program?

Yes. Thanks, Louise. It's a great question. Maybe I'll hand over to Mayukh if he's got a bunch after I say a couple of words. Look, I think, the really nice thing about FcRn as a target is that IgG has been a phenomenal biomarker for clinical efficacy. And so I think we will get a lot of information from any competitor readout that shows a relationship between IgG and clinically meaningful data. I think we'll learn more about how Nipocalimab's RA study was conducted and a little more about that when J&J choose to share it. Obviously, the world is watching the organic study very closely. One of the things, I think, would be interesting for us in that study, and the reason we're running a study of our own is because they'll -- that study is not going to inform us on what the impact of a higher IgG suppression would be simply because Efgartigimod can't suppress IgG at the same level as our agents can. So we're excited to learn more about dose ranging from our own CIDP study. But obviously, there's a lot of interesting questions around the way FcRn works for that patient population, that we will learn from that study. So, at a high level, I think that data will be informative and there's probably other data coming, too. There was a data from a competitor and a small indication just a couple of weeks ago that was probably sort of new to the field and informative on yet another place which FcRn appears to work. So that's sort of at a high level. Mayukh, anything you would add there?

Not really, Matt. I mean, I think as you said it, really the home run scenario for our program and our franchise overall is to see that there is sort of validation and efficacy from these other programs, but an efficacy picture that leaves room on the table for greater efficacy from our greater IgG suppression.

Okay. And then can I ask you about Brepocitinib also on SLE. I know you have some data coming up. And just curious how it's performed versus some of its competitors such as baricitinib and Deucravacitinib? And what are you expecting would be considered a positive outcome for your studies?

Yes. Thanks, Louise. It's a great question. Look, obviously, we're excited to generate the data from Brepo and SLE. Obviously, SLE has been a challenging indication. And so we're approaching it with a healthy amount of respect for that challenge understanding that Pfizer did a lot of the preliminary work and a lot of the execution on that study. That said, I think there's a lot of reason to be very optimistic here. For starters, you mentioned a couple of competitors, basically Brepo, as you know, is a dual inhibitor, TYK2 and JAK1. We have data about JAK1, you mentioned baricitinib in SLE, which was, I think, pretty good in Phase II and okay in Phase III from a top line perspective. And then we have data from Deucravacitinib, which is a little bit variable, but also fairly impressive relative to the field in SLE. And then what we know is in cross-shop comparisons across other indications, and we have cross trial data with either bari or Deucra in each of psoriasis, psoriatic arthritis, ulcerative colitis and alopecia. And in each of those indications, Brepo has produced sort of numerically superior data across our comparison than either or both of the sort of stand-alone JAK1 or TYK2. This is kind of in line with how we think of Brepo, which is it's just a really big gun. It's a powerful drug that appears to produce sort of top end efficacy. And we think SLE is the kind of population where that could make a big difference. Mayukh, anything you'd add there?

No, not really. I mean I think, look, BENLYSTA was approved in efficacy, but with an SRI-4 delta between 9% and 14% across all of its different studies. And in spite of that, it is a blockbuster drug, I think, just showing kind of the unmet need that is still remaining there, and we're looking forward to the results by this year.

As a reminder, that's a 22-week study fully enrolled as of August.

Okay. And then just 1 last really quick question. When do you expect to reach steady state for your gross to net for VTAMA?

Yes. So we haven't provided exact guidance on that. It depends a little bit on some of the final payer discussions? And then as you've seen with competitors of ours, it probably takes 6 plus months for GTN to sort of really flow through from a contracting process. So I'd say I expect to see meaningful sort of step function improvements over the course of this year, especially as you get into sort of the middle and back half of the year. I'd say, it's probably the case that those last couple of -- like we'll see a meaningful set of movements. At some point, it will slow down a little bit in those last couple of percentage points of improvements getting us to true steady state, or it will take a little bit of time beyond that. I think payer contracting gets you 80% to 90% of the way there. And then the last little bit is other things, things like distribution costs. They're often sort of volume-based in their contracts. So those take a little bit longer to hit.

[Operator Instructions] Our next question comes from Neena Bitritto-Garg with Citi.

So on the anti-TL1A, I appreciate you providing some additional color on kind of next steps and additional indications. But maybe can you just talk a little bit more about the breadth of indications that you see applicable for an anti-TL1A agent? And when we could see some updates on that front? And then just a follow-up to the last question on the gross to net. I guess any updated thoughts on what we should expect in terms of the long-term gross to net for VTAMA?

So I'll take the second question first and then I'll start on the first 1 and probably hand it over to Mayukh for his thoughts as well. On the GTN question, we haven't given specific numerical guidance. That's been sort of a principal stance of ours because we are actively negotiating as you can see, with probably literally dozens of payers and regional plans and some PBMs and those discussions are all sort of active negotiations. That said, I will say, it seems like the field was sort of settled on a standard answer to the question of what a biotech company steady-state GTN looks like. And it seems like our various topical competitors as well as even things like Nurtec at Biohaven or whatever, all have sort of settled on a similar answer. And so I would expect us to be kind of the same as everybody else of steady state, is the honest answer to that question. So TL1A in terms of breadth of indications, I think you can probably hear it from me, there's a lot of enthusiasm for where to go beyond UC and Crohn's. I think in terms of timing, look, we will share thoughts on our clinical plan when we're ready. And because of the competitive nature of that space, we're probably going to be a little bit careful about disclosing exactly when and what we're doing from an indication perspective. But, Mayukh, if you want to talk a little bit about the potential breadth there and how broad it could really go.

Yes. Look, I think we're excited. I think we've talked a bit about sort of the -- there's a wide range of indications for which I think, at this point, TL1A is implicated, I think uniquely, again, both the anti-inflammatory as well as anti-fibrotic types of indications. And I think just as we've done with some of our other programs, I think you should expect us to go and strike a balance of indications that are already at this point clinically validated as well as indications for which we will be first-in-class as well in novel indications.

The only thing I'd add to that is just remember, we ultimately expect to have a franchise in anti-TL1A antibodies. We have an option on next-generation compounds that Pfizer has now disclosed as a bispecific antibody to TL1A and P40, which we think will have super interesting biology and potential applicability in different indications and in different settings. And so we're watching that closely. A little bit of ways out, we're going to get Phase I data in 2025 there. But excited for the full breadth of what we should be able to do with that franchise.

[Operator Instructions] Our next question comes from Robyn Karnauskas with Truist.

I just had a couple. Let me just first ask about the [ Thomas ] scripts. So the new to brand, if I'm looking at it correctly, it seemed to be stabilizing. Maybe you could talk a little bit about what kind of trends you're seeing with patients? Are they seeing [indiscernible]? Is this sort of a factor of coverage? Or is it more about just like trends with patients? And what do you expect to see going forward? And then just a sort of a question around 1402 and Immunovant. So you've got a lot of -- you have got a big data set coming up with 1402 and then potential RA data from nipocalimab committing. And so there's a lot of questions we're getting around how much this opportunity could really expand. And you'd have to maybe do a lot more trials once we see data in rheumatoid and with 1402. How does it work between you and Immunovant and deciding how broad you actually can expand the market for 1402, I understand? And how does it work because we get a lot of questions on M&A on whether or not like if someone approaches you for Immunovant for that company, like how does it work as far as you're factoring into whether or not that company could be acquired?

Yes. Thanks, Robyn. It's a couple of great questions. I appreciate it, and good to hear from you. The first thing I'll say is, I don't think we believe that scripts are stabilizing. I think -- we think there's a little bit of chop in the last month or so, which was a combination of the holidays. And then we had winter sales force meetings, so we had 1/3 of our sales force out of the field for each of sort of 3 consecutive weeks. And when we look at trends at the doc level, we are optimistic that we continue to grow in all of the important directions there. So I think you will continue to see scripts growing from here. I think the AV data for what it's worth has the potential to supercharge that just in terms of drawing doc attention to what this drug is capable of broadly. But I think, even without that, you should expect to see a real sort of growth focus in those group numbers. And obviously, the payer contracting progress, which -- much of which is pretty recent is helpful there, but also just sort of continued enthusiasm, we think we'll build script volumes from here. So again, I appreciate that it looks a little choppy in the last month or so. But I think you'll see that looking better and better over time. On 1402, yes, look, I think we agree that there's a lot of opportunity here. Our relationship with Immunovant is really tight. Frank's exact Chair. We work incredibly closely with them on indication strategy. Obviously, their team is experienced and thoughtful and has a lot of great ideas. And we try and bring the best deployment to the table as well so that we're bringing all the best ideas up for consideration. A lot of ideas for where that could go, obviously, both internally and externally. And so we learn a lot from the field. As far as M&A is concerned, look, it's fantastic to be in a category with so much therapeutic relevance and to see that opportunities are growing frequently as our competitors, and we show new data. I think it's fair to say we are an economic actor as far as how we think about Immunovant, and understand the great appeal that FcRn will have as a target for many big pharma companies. So I think it's fair to say, while we would be involved in any discussions, that we will act thoughtfully and rationally as we as we hear anything.

And just a follow-up there, and this is really a [ typical ] question, but like can you stop it, for example, to say if someone approaches and they have an offer for Immunovant that are interested? And I just ask because I get this question a ton of times, but how does the relationship between Roivant and Immunovant work if that situation were to unfold? Sorry to follow up like that.

No, it's good. And I appreciate there's a lot of questions about the stuff. Look, the simple answer is that we are a majority shareholder, like any other majority shareholder. And so we have mechanical voting control. But as I said, we're an economically rational actor. And so I don't think the question of whether we could stop M&A and winds up being a particularly relevant question to the way that we expect any situation to develop.

Great. And 1 last one. So you really have done a good job of talking about all your programs ongoing, a lot of catalyst driven. When we go back to the original format of Roivant of having an engine that produces drugs, like what are your thoughts on how we should view the cadence of new vants coming out of the company this year when you have so much data coming out and there's so many big opportunities with the current vant you have on the market. How do we think about the rest of the company as a whole?

It's a great question. Look, the first thing I'll say is, we've been very mindful of the capital environment over the last, call it, 18 months. And obviously, that affects the bar for new programs and it affects the way that we think about opportunity. That said, look, I think there's approximately nobody out there who regress the fact that we brought in our anti-TL1A antibody that was something that was not on anybody's radar as a part of Roivant as recently as about 3.5 months ago. So this is the thing we often do best. And what I think is, the bar is high, but if we see more opportunities of the same quality as TL1A, you've got to imagine we're going to take them. And the same thing is true for external opportunities and for things that develop internally, whether it's clinical data or something sort of bring to a new phase of life. If the data are compelling, we will figure out a way to progress it.

[Operator Instructions] Our next question comes from Corinne Jenkins with Goldman Sachs.

Maybe just with additional time since the VTAMA launch. What -- can you share with respect to what you're seeing from patient behavior in terms of things like refills? And what's the rate at what you're seeing in refills if you're seeing much of that?

Yes. Thanks, Corinne. It's a great question. Look, I think, the first thing is the most important thing that's come out of the time since launch is for a lot of patients and doc enthusiasm for the product. We have a decent number of refills, you can see it in the -- approximations in the IMS script data around NRx versus TRx. I think we will continue to see patients -- many patients using multiple tubes a year. I think exactly how many tubes a year on parsing out that behavior. To be honest, I would say -- start saying, I think it's still a little bit premature to fully know the answer to how many tubes a year. But the "good" news is it remains true that steroids are generally kind of 1 to 2 tube a year products. And mostly the opportunity that we're casing is to replace steroid scripts with the VTAMA scripts. So I think there's upside from more scripts beyond that for a year or more tubes beyond that for a year, but that's plenty of opportunity for the near term. So prematurity to give sort of a quantification to tubes per year. But in general, we see a decent amount of refill activity, which we take as a sign of patient enthusiasm.

Helpful. And then maybe on 3101, just as you think about additional indication selection through the year, can you help us understand which criteria you're using to assess which indications you're interested in pursuing?

I'll hand it over to Mayukh for that question.

Sorry, I missed the question.

It's criteria to select new indications.

Yes. I mean I think -- look -- I think we look at it, I think, very holistically, I think it's a mix of strength of biological basis for it, I think mechanistic evidence to support of it. And then I think to a certain extent, it's also designed and sort of structure of a clinical trial. In other words, is there a way in which we could kind of find an answer, see a signal without running a very large study as the next study?

Yes. I think the other thing -- there is 2 other things. One is, obviously, we're focused on commercial opportunities, sort of the size and indication of the size of the opportunity. And frankly, given the quality of the clinical data we've seen in UC, just a huge amount of potential for the class. We want to make sure we're maximizing that opportunity. And then actually, I'll go back to another answer I gave, which this is one of the areas where, over the long term, having a franchise with multiple approaches to TL1A as we will between our sort of lead program and then the TL1A P40 bi-specific gives us an opportunity to think holistically about indication strategy over time. And obviously, right now, you can imagine we are doing the work on the biggest, fastest opportunities for where we can go with TL1A and have it impacted in IBD in size, and then we'll sort of branch out from there.

[Operator Instructions] Our next question comes from Dennis Ding with Jefferies.

I have 3 questions on TL1A, so #1, if you look at the industry maintenance data for UC, this looked a little bit noisy with some drugs showing remission going up, some showing it coming down. And for Roivant will be the first time maintenance data will be reported for anti-TL1A antibody. And obviously, you've looked at some of the initial data already, and you said that the data has held up. So are you confident that when we get the chronic data in the first half, that remission wouldn't come down from the induction period? And then #2, I don't see anywhere on your slides about your Phase III plant in UC. And given TL1A is obviously a very competitive space, what additional things do you need to do before Phase III starts? And are you confident that Phase III would start this year? And then lastly, can you remind us and perhaps reiterate your confidence around the subcu reformulation that you'll be taking into Phase III?

Thanks, Dennis. Those are all great questions. So on the first one, I'm not a superstitious person, but I find it hard to express confidence in clinical realty, but again there's still real data to collect there. There's still patients that we don't have the data for and patients who are still being evaluated. So -- but I think -- I agree with you that there are drugs that are all over the map from degradation to improvement in efficacy. I'll say that we start from a very favorable bar. Our sort of induction data was really strong. And so I think flat would create still some of the best 52-week data the world had ever seen. So I think, from that perspective, in some ways, the question is a little bit less relevant to us than to some other classes where the induction data may be on the disappointing side but then maintenance data pulls it up into a more interesting territory. I think, for us, flat or even a little bit of degradation is probably commercially fine. Obviously, there's certainly the possibility with the anti-fibrotic effect and so on to see better, but we'll see that when we see the data. So look, I think we feel good about where we are. We feel good about what we know based on the interim look, but we'll know for sure when we see the data, and we're checking to share it with everybody once we've got it. On Crohn's, I'll say, first of all, I agree with you it's a competitive space. And I think one of the reasons that we're being a little bit careful with how we communicate about study start time lines, and that's frankly for both Crohn's and for UC, is that we're sort of…

[Operator Instructions] Our next question comes from Douglas Tsao with HCW.

Congrats on the progress, Matt. So maybe just touching on your emerging I&I franchise. Just curious, Matt, because as a company, Roivant has had a history of monetizing assets. Obviously, to Robyn's question, there's questions around strategic value of [ Immunovant ] as well as other individual assets. So just curious how essential do you think each of these are individually towards building an I&I franchise or do you think given the strength of the assets that some individual ones can be -- could be potentially separated out and still have the franchise stand on its own?

Look, it's a great question. I think the short answer is, we are fiercely economic actors in every way. And so on the one hand, we're very proud of the franchise that we've built and the opportunity for each of these things. And on the other hand, we got the track record that you've observed. The last thing I'll say is, there is a lot of interest in individual I&I programs and targets out there, obviously. But also as a whole, there are many businesses that may need to expand by multiple opportunities at the same time. And so the franchise, in aggregate, could also present some unique opportunities. And actually, at least one of our past monetizations that you referred to involved a franchise with multiple programs, and I'd say nothing is off the table.

But I guess -- so Matt, do you -- at what point, just given the size of that category and when you look at many of the leading players, they have multiple assets. Do you think that you need to have multiple assets to be effective in I&I commercially? Or do you think that, that is not appropriate sort of interpretation? And that given the strength of each of your assets, they can stand on their own?

As a practical matter, I think most of the things in our portfolio could mechanically stand on their own, just given the quality of the individual things that we've got, right? Certainly, one of our competitors in FcRn has shown that a single FcRn antibody can succeed on its own. I think our competitor in TL1A, it's such a unique target, talks about the fact that it could mechanically stand on its own. That's it. There's purely also a synergistic opportunity in these things sort of coexisting and being next to each other. And certainly, if any of these things were to wind up in big pharma hands, there would be benefit to sort of being co-resident with other I&I programs. So look, I think these things can definitely stand alone, but I think there's also some value to having them together.

I am showing no further questions at this time. I would now like to turn the conference back to Matt Gline for closing remarks.

Thank you, operator. Thank you, everybody, for listening this morning. We appreciate it. It's been an exciting quarter. We've had a lot of opportunity to talk about some updates, looking forward to sharing more in the very near future and look forward to getting back together when we file our 10-K later this year as well. So we'll talk multiple times before then, and we'll speak again on a call like this closer to the middle of the year. Thank you, everybody, and have a great day.

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