Good day, and thank you for standing by. Welcome to the Roivant Sciences Fourth Quarter and Fiscal Year 2022 Earnings Call. At this time, all participants are in listen on the 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. I would now like to hand the conference over to your speaker today, Stephanie Lee with Roivant. Your line is open.

Good morning, and thank you for joining today's call to review Roivant's financial results from the company's fourth quarter and fiscal year ended March 31, 2023. I'm Stephanie Lee with Roivant Sciences. Presenting today, we have Matt Gline, CEO of Rogan. For those dialing in via conference call, you can find the slides being presented today as well as the press release and now can be updated on our IR website at www.investor.agan.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 SEC 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, Steph, and thank you, everybody, for listening this morning. It's great to be back. It's -- I was talking to the team this morning saying it feels like a slightly anti-connected call because we were obviously just together last week to talk about the really exciting data from the chronic period of our RVT3101 study. But actually, an enormous amount has happened for us, both in this fiscal year generally as well as specifically in recent quarters. So looking forward to providing updates on those topics. We'll talk a little bit about where we are through the course of our year. We'll give some great updates on the progress that we're making with the ongoing launch of VTAMA as well as a reminder of our atopic dermatitis results. We'll do a quick refresh of the data we put out last week on RG311, A quick update on our FcRn program, a financial update, and then we'll turn the line over to Q&A. Starting on Slide 5. Just kind of as a reminder or a level setting, look, we're really proud of the continued progress that we've made here. We celebrated this quarter with a dooring, the 10th consecutive positive Phase III study that we have run. That's the most recent 10 studies that we've run have been successful. We now have 6 products that we've gotten approved by FDA out of our model. We reported $1.7 billion in cash as of March 31, which supports our cash runway to the second half of 2025 before which we'll have a tremendous amount of data to share. And then we are incredibly proud of what we now believe is an industry-leading pipeline, especially in late-stage I&I with over $15 billion of sales potential supported by the ongoing launch of VTAMA…

[Operator Instructions] Our first question comes from Robyn Karnauskas from Truist Securities.

Just going back, Matt, on your comments around like the bar for 1402, do you think, given the properties of the molecule that we should look at the graphs that you've shown for the SAD and IgG data and it will look similar? Like is -- are the properties of the molecule similar enough that we should expect the curves to look similar? That's my first question, then I have a follow-up.

So I'll also invite Frank, if he has any comments there. Obviously, Immunovant team talks about this often. I see like overall, in terms of the broad properties, I think the answer is we would expect them to look generally similar. Obviously, with the notable difference that 1402 has been engineered to avoid the almond binding, and so the albumin interferon steric hindrance. And so I would not expect to see an impact on Aluminide. Frank, anything you'd add to that?

I think that's well said. The only thing I'd add is, they are not identical antibodies, obviously. So they have slightly different properties and they are similar. I would encourage the investment community to kind of look at the albumin data as probably the most robust and reproducible assay among the assays we're going to be presenting in the future, but I do think that the curve should be directly similar.

And for IgG as well. That's what I was really asking. And then a question on VTAMA. So congratulations on doing a great job selling so much drug this quarter. I was just curious, can you give us some trends on what you're seeing in feedback from the remittance effect. At what point might you expect to see patients not taking the drug or pausing the drug and not -- and then waiting for the disease to come back a little bit. I know it's early in the launch. So I just wanted to see if you're seeing anything there in that thing.

Thanks, Robyn. It's a great question. I'll say broadly, first of all, physician and patient feedback on the remitted benefit is great. I think it's something that patients experience very quickly on drug, right? People go on. They use it for a while, they go off, they see the effect preserve, and we get a lot of feedback from docs and from patients that they are excited about it. I suspect that, that is embedded in the renewal rate for the product already. That is like the rate at which patients are renewing, the number of tubes that they're using is a function of that already. It's obviously a little bit too early to tell how that shakes out versus the overall growth in demand. But in general, it's not like I would expect to see some sort of significant change in the future because of that effect. And I think it's a selling point for the drug. I think it's something that physicians are happy to tell the patients that they can go off drug and continue to see a benefit. In terms of tubes, I guess like I'm not sure that exactly your question, but our view has always been that in order to be successful, we need to be a steroid replacement. And the steroid sort of just over a 2 year, maybe a 2.25 a year. It already looks from our data like we are in excess of that. It's hard to tell how much in excess of that, given how early it is, but my expectation is that we will have more to per euro than steroids, mostly given the lack of duration limit on the drug.

We have a question from David Risinger from SVB Securities.

So congrats to you, Matt and your team for all the nice updates and the corporate progress. So with respect to my questions, I guess I'll start with VTAMA. So the trends are obviously moving in the right direction. But on Slide 9, it does show that the TRx peaked and I know that there are sometimes anomalies in the data, but the TRx peaked for a few weeks, close to 5,000 and they're not back at that level yet. So could you just talk about the trajectory ahead and the commercial drivers for the continued ramp of the product. And then second, with respect to the approval clock for AD, once you file it in the first quarter of '24, how many months after filing would you expect approval? And then finally, a higher-level question, could you talk about second half '23 transaction opportunities. So should we expect a potential acquisition of additional external assets? Is it possible for Roivant to monetize an undervalued asset, any framework for thinking about potential external transaction activities would be helpful.

Thanks for listening, David. Thanks for those are all great questions. I will take them in order. First of all, on the script trends, thanks for asking the question. Look, I think, first of all, there's clearly just like week-on-week variability in the strips, and that's been true for all of the topical launches. It's not just ours. And so I think a little bit of the sort of "choppiness" noise, and I expect we will continue to break through the ceilings that we set for a set for ourselves over time. It may not be linear. The particular peak that you pointed out was just on the back of AD. And I think there were some docs who were maybe trying the product out on the back of that first atopic dermatitis data. And I guess my hope and expectation is that that's a preview of what's to come when the AD approval comes in, in terms of the level of enthusiasm around that data. But obviously, the product is currently not approved in that indication. In terms of time lines, so it's an sNDA, we expect a 10-month approval clock is the short answer after filing. And then in terms of transactions in the second half of the year, look, I think it is clear from our history that we are not great at sitting still. It's a pretty exciting market in a lot of different directions. Obviously, some of the targets that we are in are targets that are closely watched. They're targets that big pharma companies clearly care about. So you can imagine those are discussions that we're thinking through economically and trying to make sure we do the right thing for patients and the right thing for each program in turn. And then in the other direction, it remains a very fertile opportunity for new programs. Big pharma companies are constantly making portfolio prioritization decisions. obviously, the patent flip dynamics and other things facing the industry that have provided us opportunity in the past still can. And I think you can expect that we are looking actively at lots of things. And I hope to be able to share some of them with you over the course of the rest of the year.

Our next question comes from Neena Bitritto-Garg with Citi.

Sorry, if you can hear me. I just wanted to ask a follow-up question to Robyn's question earlier about what you're looking to see with 1402. Just in terms of the albumin reduction since it sounds like that is the most reliable sort of assay to look at. How should we think about what an acceptable albumin reduction looks like. I believe with the lower dose of batoclimab or the, I think, the 340 mg dose, you saw about a 30% reduction, which corresponded to about a 40% increase in LDL. So I guess, is there a benchmark on albumin reduction that we should be thinking about in terms of translatability to that kind of 10% or less LDL increase?

Yes. Thanks, Neena. And I'll ask Frank if you had any comments as well. Look, I think the short answer is lower is clearly better. And our expectation is it will be categorically different than what we saw with batoclimab and much lower. I think the sensitivity of these assays is in the kind of mid-single-digit range. And so I would say anything within that range should be completely acceptable as noise and will, in our view, lead to very low LDL in any reasonable patient acylation. So that's probably how I answer that question. Frank, anything to add to that?

No, I think that's…

Perfect.

We have a question from Corinne Jenkins with Goldman Sachs.

Maybe a couple of questions from us. First, what can you share with respect to like fill rate and the time from prescription to fill for VTAMA? And it sounds like it's early, but whatever other color you could provide on refill rate at this point would be helpful. Maybe I'll start there and ask my second one as a follow-up.

Thanks, Corinne. Appreciate the question. And I'll -- again, I'll ask Frank had anything to add here. I think our general view is patients getting scripts filled has not been a significant challenge at this stage. Early in our launch of specialty, we were heavily seeing fills through specialty retail derm pharmacies, which are a direct channel that the dermatologists work with all the time that we're very knowledgeable about VTAMA, knowledgeable about our copay card program and so on. So I think that was helpful at this point with our insurance coverage, frankly, many patients who show up at the pharmacy or just cover that the pharmacy. And so again, I feel it was as easy as any other product of Walgreens or CVS and so on. So I think we're not seeing much in terms of challenges getting scripts filled. On refill rate, look, I think we've been happy to see growth in NRx as well as good growth in TRx. And I think we're seeing a good number of refills. That's, in our view, a measure of the fact that patients on drug are happy to be on drug and continue to use it. And again, we don't have that duration limit. So I don't know how much to add beyond the data that say, I think it's clear from our current refill rate, as I said before, that we will be in excess of steroids in terms of tunes per year. Frank, anything you'd say on either of those points?

I think the only thing to add is, as you know, our coverage has been increasing meaningfully over time, and that is -- there's a little bit of a lagging effect, obviously, and how that coverage comes into play and plans its way into downstream plans. And so I think you'll see our -- the ease of prescriptions at the point of sale only continue to get better as that coverage has come and continues to come into place.

Okay. Helpful. And then as you think about, I think you referenced direct-to-consumer campaigns and spend, just how do you think about balancing that spend versus the coverage and yield rates you're working with today? And how can that change over the course of the year?

Yes, thanks. Look, it's a great question. And obviously, I think we've talked about this in various forms for early in the launch, when we didn't have the kind of payer coverage that we do now, DTC is a real balancing act because you can definitely drive volume through DTC. But if you're not getting coverage, you're driving volume that is not sort of commercially helpful volume per se, and it does cut against GTM. But where we are now with 76% commercial coverage, I'd say in general, demand generation is going to be helpful. And so we've increased sort of the picture around DTC. The Derm team has put together a great campaign. It's out there now, and we're sort of still in the early days of it figuring out exactly the right targeting plans and sort of getting real-time feedback from the marketplace. -- but feel good about what that's going to mean. I would expect to see that take some time to filter into the strip trajectory. It takes a number of impressions before patients respond to you can see and come into the office and so on. So that's something to watch for kind of through the end of this year and beyond. But in general, I think it will matter. And then in terms of spend, I'll just say it's included in the various guidance that we've given in terms of where we expect it to be. And I'd say in the grand scheme of things, it will be well worth it for the demand that we generate on the back of it.

We have a question from Dennis Ding with Jefferies.

Just 2 for me on TL1A. For your Crohn's program, thanks for timing your deck. Can you comment on if you will use similar doses as you did in UC? Or could you explore higher doses? And maybe talk a little bit more about the biomarkers is this the same biomarker from UC. And then number 2, I saw in your 10-K that for TL1A, 20% of patients who are biomarker positive did not give consent. Can you confirm that's true? And maybe give a little bit more color as to why and perhaps the commercial interpatient there.

Perfect. Thanks. So on the dose question, I'd say we're pulling from a similar range of doses in the Crohn's study as in UC. So I think that's the answer on dose. And on biomarker, we are using the same biomarker algorithm in Crohn's as we used in UC. And our expectation is that the patient population should be similar in the size of the patient population. And our belief based on our understanding of our biomarker algorithm is that it should obtain equally chrome, obviously, we're excited to see that data from the study. On your question about the 20% consent. So this is something we had shared at the time of the induction data. Basically, the biomarker samples were gathered from all patients in the study but the analysis of those samples required a separate consent and the sponsor of the study did not obtain consent for 20% of the patients in the study for those samples to be analyzed because of local IRB and site policies. So basically, all of our biomarker data, biomarker-positive and biomarker-negative effectively reflects on 80% of the study population. Where all comers include even those 20% of patients for which the biomarker data was not gathered. We have no reason to believe there's any relationship between those consents and severity or anything else. The data are robust. There's plenty of end, but that's just the way the study was conducted.

Great. And maybe as a quick follow-up around the LNP patent litigation. What's going on there? And when can we get the next update? Are we still waiting for that claims construction order maybe in 2024?

Yes. Thanks. So those cases, and there are several of them at this point are ongoing, and we continue to be pleased with the overall progress now that we're actually in the medium the case. We are in the discovery process in the Moderna case now. And so you can imagine new information will be forthcoming that will affect the progression of the case. But most importantly, we're gearing up for that same think construction hearing and claim construction order that will come at the beginning of next year. That will probably be the biggest, most publicly visible next step, although plenty will be happening behind the scenes over the course of the fall.

We have a question from Yaron Werber from TD Cowen.

This is Julius on for Yaron. Maybe just a follow-up on the question before about 101 in Crohn's. Is there a hypothesis here that it might work better in Crohn's just given that the fibrotic component is a bit more involved in this disease versus UC. And then you obviously show really great data on endoscopic remission in the FDIC study. Can you just maybe comment on what you're hoping to see there in Crohn's disease? And maybe what other studies have shown in the past on this endpoint?

Yes. Perfect. Thank you. These are great questions. Look, obviously, the study will show what it will show. Certainly, the line of pression you're asking is one that we thought to that Crohn's is an even more -- fibrosis is even more involved in Crohn's ease than it is in UC. And when we look at things like the specific markers of fibrosis that were identified in Pfizer's Phase II(a) study as well as the anomic remission and the clean endoscopy that we saw in our own Phase II(b) in the chronic period. I think there's certainly reason to believe that we could potentially be even more differentially efficacious MCD. And look, agents typically that work in one typically work for the other. So I think that's the other the other sort of generally historically true fact. And certainly, a biology of TL1A suggests the same would be true here. And then look, our biomarker, as I just said, also we think should carry through into CD. It should give us an opportunity for differential efficacy in a large subset of CD patients as well. In terms of endoscopic remission specifically, it's a good question. I don't have a super specific answer. I think Crohn's patients may have more tissue involvement than UC patients. So that may be a slightly tougher endpoint in that patient population. But on the other hand, we're delivering an antifibrotic benefit that could matter. And I would say it certainly seems plausible that we would see benefit in endoscopic remission as well.

And our next question comes from Brian Cheng with JPMorgan.

Maybe just first one on TL1A related to your Phase II trial design that you have ongoing for Crohn's. I'm just curious if you can provide a bit more color on the dosing that you have selected, specifically in the chronic period. It seems that you will be only be evaluating one specific maintenance dose based on Slide 23. Just curious if you already have a sense of what the dose will be for the chronic portion? If not, what would be the deciding factors for the chronic portion? And I have a follow-up.

Yes. Thanks, Brian. Look, I appreciate the question. We believe we got a fair amount of information from the dose ranging in our UC study that has been helpful in making a prediction here, a pretty robust understanding from our dose response there. That's given us a good deal of confidence in Crohn's dosing. And we are pretty confident that we know what our chronic period dose will be in the Crohn's study. So there's no -- there's not really any ambiguity for us in that. We are -- for the same reason that we have not shared specific dosing information in UC. We're not going to share our choice of doses at this stage for the CD study, we will be happy to share those around the same time we're willing to share dose ranging data in use next year. But in general, dose response that has been identified USC is generally predictive across IPD. And so we feel pretty confident in our selection of doses there. As a reminder, we have very robust dose-ranging data at this point for 3.

Okay. I guess related to hemavant, which I don't think a lot of investors have looked at yet. Just curious, one is, how should we think about the timing for this update given that you will have immunovant data spread through the fall and also you have brepocitinib data in the fourth quarter. So one is how should we think about the timing from the Phase I/II? And then also, what do we think about -- what should we think about the expectation for the lower risk MDS data? How do you think about the bar there for you to move forward to the next stage?

Yes. Perfect. Thanks, Brian. That is -- it's a great question. You're absolutely right. We don't get it very often. So the study for 2001 is an open-label study, and we've had good progress on enrollment. So we're going to have a decent number of patients worth of data. We will provide the update probably pretty late this year, frankly, because the longer we wait, the more data we have, and I think we want to provide an update on the load comprehensive set of that data. I think in terms of the bar, as I think we've said before, in the earlier patients -- in the earlier study in AI -- or the early report of the study at AI conducted, there were about 20 patients or a little bit less than 20 patients that had the sort of profile that we are looking for here that were sort of low-risk transfusion-dependent MDS patients. And we saw sort of a little bit higher than 30% transfusion independence rate. But I think what we're looking for here as we move into earlier line patients is something that would be sort of obviously competitive with or superior to luspatercept, which as I'm sure you know, is in kind of the mid-40s in patients without privalienomide exposure. So I think that's probably the first thing. The second thing we're looking for is we are hoping that a decent number of these patients will have this biomarker Abertamon14C transcripts, where we saw a very high response rate in the earlier patients. And if that's true, we should be able to provide some update on how we are doing in that patient population and whether that opens up for precision icono strategy. So that's broadly what we're looking for here. We will share that update, as I said, very late this year, almost certainly after the other.

We have a question from Louise Chen from Cantor.

Congratulations on the quarter. So I wanted to ask you, if you're approved for atopic dermatitis, is all the work or the payer work that you went -- or that went into beta for psoriasis, can that be leveraged? And then secondly, are rheumatoid arthritis, is that a potential opportunity for Immunovant? And if so, what do you think your go-forward plan would be there? And then lastly, just wanted to ask you for brepocitinib, big data readout coming at the end of the year. What do you think you need to see to move forward with this opportunity? And why do you think you'll be successful when others have failed here?

Yes. Thanks, Louise. Those are all good questions that span the portfolio. So I'll take them in turn, but thanks for asking and thanks for listening, as always. So on the first one, the short answer to that question is it's definitely yes. That is all of the payer contracting work in psoriasis is extremely helpful in atopic dermatitis. Obviously, at some level, there is an additional sort of formulary positioning question that needs to be answered because the cascade of therapies at AD is slightly different. But the contracting work, all of the commercial work in psoriasis will translate and be very helpful in getting quickly on to formulary NAD. In terms of 1402, look, the sky is the limit from an indication perspective. And I think, especially now that we think we have really the only true at-home Easy subcu, any indication is eligible. RA, it's an interesting question biologically. It's probably not something that we were initially very focused on. JJ has this ongoing study that they've talked a bit about, and they've said they are going to show that data later this year. You can imagine in autoantibody RA patients that there could be an opportunity. And I'd say if the JJ RA data looks good, we could be very quickly in, frankly, a pivotal study if we needed to and compete with them, probably, again, sort of the more severe patient population. And I think that could be a really, really exciting opportunity for 1402. And given 1402 profile, a simple subcu, what we believe will be the cleanliness in Albian LDL and the depth of ITT suppression. We think that's an example of an indication where if JJ's data is good, we think we ought clearly to be the best-in-class agent and frankly, it could be neck and neck for first-in-class at that time as well. So really exciting possibility. On brepocitinib and SLE, we talked a little bit about this. It's not a simple numerical bar. Look, I think it's about building on the data that we've already seen, including data on baricitinib as a JAK1, more recent data in baricitinib is a DAC1 and then the data that we've seen in deucravacitinib as ATCI, combined with the knowledge that brepocitinib, which has now been in well over 1,000 patients, has outperformed the cross-trial comparisons, both JAK1 and TYK2s across many, many, many studies. Remember, it's been running 5 large late-stage sort of Phase II studies at this point. And so look, I think that combination gives us optimism that the agent could perform very well in SLE. The other factor with SLE always is you mentioned some of the challenges. So there's a base these studies are difficult to conduct. Pfizer has the conduct of the study, although we've had a lot of input. And I think we're doing everything we can to ensure including the study learned from many of the prior designs to optimize for the possibility for success there.

Our next question comes from Douglas Tsao with H.C Wainwright.

Sorry, I was on mute. Can you hear me now?

Yes.

Congrats on the progress. Just given what we saw from Tuscany, obviously, with 3101, you're starting the study in Crohn's. I'm just curious how much more broad how are you thinking about the opportunity with that asset outside of IBD. So obviously, Crohn's is a natural sort of first step, but are you thinking about other indications in I&I with that asset?

Yes. Thanks. Look, the short answer is yes. We are thinking about opportunities that go broader to other inflammatory disease to other fibrotic diseases. I think the plan -- given the quality of the data in IBD, the playing field is very large. And so we're thinking about ways right now to narrow it down a little bit and figure out what our best lines are. And we're looking forward to sharing more of that color as soon as we can look, there's just a lot of biology to support indication expansion here. And frankly, TNA knocks down so many different targets along the inflammatory and fibrotic axis, but you can look at like we have an impact on IL-6. You can go where the 6s are. We have an impact on T&F if you look at all of the many places the TNF sander. So there's just a lot of different places to go. And I think our goal is to be smart about it to find things that benefit from the full access to find things that fit from a commercial perspective together with where we're starting and to try and learn as much as we can from small studies to guide our decisions. So that's all sort of to come soon.

And I guess, Matt, as a follow-up, within the portfolio, I&I has certainly become a clear focus from a business development standpoint, obviously, bringing in 3101, you bought brepocitinib. I'm just curious at this point with the portfolio, how are you thinking about the balance between bringing in new additional assets as they potentially might become available versus pursuing some of the natural expansion opportunities or sort of just running new studies in different indications than the initial targets.

Yes. Look, I think on the one hand, we are very pleased with the coherence of our late-stage portfolio and of the fact that we've built and I&I pipeline that we think is among the best out there. So I think we're proud of that. And we think insofar as opportunity begets opportunity, we will continue to get calls and look at lots of different things within I&I. That said, when we started talking about the TO18 program with Pfizer, 1402 hasn't yet presented itself, and we obviously didn't have TL1A yet, and we still had -- I think at the time, we still had our sickle cell program, and we weren't obviously an I&I company. And I think if we had said that we're something else company, we might not have had the opportunity to work on TL1A. So I guess what I'd say is the next TL1A, if it is outside of I&I, but that attractive, it's still something we will work on. So look, I think we see lots of opportunity in lots of places. We like the concentration but not so much that it would stop us from working on something else great in another area. And we see plenty of exciting things inside and outside of I&I.

Thank you. I would now like to turn the conference back to Mr. Matthew Gline for any closing remarks.

Yes. Thank you, operator, and thank you, everybody, for dialing in this morning and for listening. I know we made you do 2 calls in the space of a week. So we appreciate it. We have a lot more to share over the course of this year and look forward to getting back together later in the summer. So thank you again, and have a great day.

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