Roivant Sciences - Q1 2025

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to the Roivant First Quarter 2024 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. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. 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.

Stephanie Lee (SVP, Corporate Affairs (Head of Investor Relations))

Good morning, and thanks for joining today's call to review Roivant's financial results for the first quarter ended June 30, 2024, along with a business update. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing in via phone conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.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. 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. With that, I'll turn it over to Matt.

Matt Gline (CEO)

Great. Thanks, Steph, and thanks, everybody, for joining. It's always a pleasure to get on these calls. We, in truth, we saved all of our fun updates for this fall, so today is a relatively straightforward, straightforward set of updates, but, a couple of really, meaningful clinical execution points and a couple of other things that I'm happy to be talking about. So thank you again. I'll start just quickly on, on slide five in the deck, with a reminder, just kinda where we are this year, which is that this is a year of growth and expansion for us.

So we're focused very much on delivering clinical data across multiple of our franchises, the anti-FcRn franchise, where we have some meaningful data sets coming as soon as the near, near future, as well as over the next, call it, six months. We have continued clinical development beyond that in our pipeline, including in brepocitinib, where we'll be beginning our phase III program at NIU shortly, where we have data coming in the namilumab related to sarcoidosis, and so on. We're very much looking forward to it. We'll talk a little bit about VTAMA today, but the story for VTAMA for this year is really the expansion of the label into AD and some acceleration of the psoriasis certainly volumes and revenues over time.

And then we continue to be hard at work, expanding our pipeline, looking at middle-late stage programs. I know there's a lot of focus on that activity. We will be unveiling our much-discussed, sorta so far undisclosed program, just next month, so we'll ask you to hold on for a few more weeks there. And then continuing to work on prioritizing capital allocation, including thinking aggressively around the use of capital to continue to buy back shares and so on. We are super proud, on slide six, of the pipeline as it currently stands.

One of the things that I struggle with sometimes, I get all these questions about BD, but you know, every time I look at our pipeline, I'm like, "Well, we still have one of the best I and I pipelines without any BD." So, you know, excited about the breadth of opportunities there. In particular, excited about the next, call it 18 months, both in the FcRn, we'll talk a lot more about today, and in brepocitinib, where we have available data coming shortly. So the main updates for the quarter, starting on slide 8. One is on brepocitinib, which is that we've now completed enrollment in our phase III study in dermatomyositis. It's 241 subjects across 90 sites.

It is the largest interventional DM study ever conducted, and we can now say with confidence we expect top-line data in the second half of next year. That study completed enrollment a few weeks back. And we've completed our end-of-phase II meeting with FDA on the NIU opportunity and are planning to begin a 52-week phase III study in the near future in NIU or phase III program. In at Immunovant, you know, we had announced that, as you may recall, a slight delay last quarter for the MG study. We can now say that that study has completed enrollment only a little bit behind the original schedule, and so we'll get data in the first quarter of next year as we previously discussed.

And we remain on track for the initiation of, registrational program in MG, for next year, as well as multiple other programs. We'll talk more about that in a minute. We will unveil our upcoming phase II program, as I said, in September next month. Excited to do that. It will be, a combination of the presentation of some data. We will likely do a phone call like this one, so looking forward to getting together, at that time. And then a couple of other updates on slide nine. One is just to say, we continue to be pleased with the progress we're making, at Genevant in our IP litigation around the COVID-19 vaccines. Discovery continues.

You may have seen, we requested a slightly amended case schedule so that we could get some more information from Moderna, which, if approved, would mean that the trial will be just about a year from now, so in September of 2025. We achieved some important clinical and regulatory milestones that resulted in cash coming in the door. We're gonna get a $28 million milestone related to the Japanese approval of batoclimab. We got that in July, and we have received our portion of $110 million of the remaining royalty proceeds from Telavant, now that they've hit the definition for that milestone. So pleased with that.

Obviously, even $110 million, still a multiple, even in this milestone, of the capital that we originally invested in the program. So those are the main updates for the quarter. I wanna spend a couple of minutes on some things in particular. One of them, just to review, where we are and our level of enthusiasm around Immunovant, around the anti-FcRN opportunity. You know, we've been having some conversations over the last few months, and it occurs to me that I have a little bit of regret, only that we've been drawn into, as a field, I'd say, a conversation about apportionment of a small pie, when in fact, I think our view is that the biology for FcRN, the biology for B-cell immunology and beyond, is very broad.

And so I just wanted to highlight, you know, again, where we think we are, the amount of data that's been generated here that supports the breadth of the opportunity, and a little bit of a reminder of just why we are so excited about the program. So as a reminder, on slide 11, look, we've said this in multiple places. We really do believe that IMVT-1402 has a potentially best-in-class profile here. That comes obviously, first and foremost, from our ability to suppress IgG as deeply or deeper than any of the other anti-FcRn antibodies, in our view, without any impacts on things like albumin and LDL, which obviously was something that affected our first-generation program. And then I think it's worth remembering, we are also gonna be able to launch, in all likelihood, IMVT-1402 in an auto-injector.

It'll be a simple subcutaneous injection that should enable self-administration at home, subject to FDA being okay with that. And we think that'll be a really compelling format for patients and a differentiated option versus certainly where the field is right now, and our sense is potentially differentiated relative to even where the field will be, in a couple of years. There has been, on slide 12, just absolutely explosive growth over the past couple of years in the breadth of what FcRN has demonstrated. You know, rewinding back to 2020, there were 8 total FcRN indications in development with about 700,000 addressable patients.

There are now 23 indications in development for anti-FcRn antibodies, with a current total addressable population of four million, and that number is growing often, and we expect to add some to it in the relatively near future as well. So just, just a huge, a huge area of biology and a, and a, and a patient population that, prior to this moment, had a ton of unmet need. You know, on slide 13, you can see there have now been across 22 positive late-stage studies in nine indications, four different anti-FcRn antibodies have been studied in about 2,000 patients. There's a tremendous amount of data about this mechanism, some of which generated by us, such as rituximab and Graves and rituximab and TED. Some of which generated by others, such as in Sjögren's recently.

But overall, just a really compelling picture of a well-tolerated class that shows meaningful efficacy and clinical benefit in a pretty wide range at this point, of diseases. So we are really excited about that. You know, the other piece, and I don't want to spend too much time dwelling on this, on slide 14, is there's been a lot of interest, let's say, in competitive mechanisms, IgG degradation or some of the CAR T or B-cell biology, T-cell engagers for autoimmune disease. I want to say, nothing on this slide is meant to suggest that we are not enthusiastic about much of that biology. We think it's really great biology.

But I think it's, it's been interesting to us only in the sense that it's so much earlier than FcRN, and FcRN has sort of elegantly cleared this, this bar that, that, that there's still a lot of work to do in some of these other mechanisms. You can see here, again, multiple approvals for, for our class in immunology, multiple positive phase III studies, multiple positive phase II studies, and thousands of patients. It just sets up a different picture in terms of the level of validation and the proximity of the opportunity. And so we're, look, we're excited about that. These are our place in the competitive field. Again, I... We think many of these other classes are interesting. We're watching them closely. We make investments in other areas, and so you can imagine we're, we're watching these areas, and we like the biology.

But we feel really good about where FcRN is positioned competitively and just how different it looks in terms of stage of opportunity. You know, on slide 15, everyone wants to compare themselves to the biggest drugs, and so the Humira comparison is maybe overdone, but I liked a couple of things about it here. But one of the things I liked about it is, you know, if you try and stack up where FcRN is versus where the TNF class was at various points in history, it just feels exciting to be at this stage in the biology, right? We are in a much larger set of indications than TNFs were being studied in at the time and growing. FcRNs have sold extremely well on a time-adjusted basis.

You know, the first FcRn-approved reported about $1.2 billion in net sales in its first year post-launch. And if you look at our forecast, you look at street forecasts, I think there's a chance this class will build, especially given the breadth of early development, meaningfully quicker over time than the TNF class was able. And I think it's notable, apropos to competitive point, the TNF class didn't achieve these obviously phenomenal results just on their own. There were... By 20 years after launch, there were 9 other approved MOAs sort of directly competing with TNFs in many of their indications. And yet, TNFs, being a foundational class, being novel biology, being well-tolerated, were able to carve out a really meaningful portion of that.

So I think as we look at, and there's many other examples we could have picked, but as we look at these other spaces, I think our view is the opportunity here is big, it's broad. Notably, these are not just many indications. Many of these indications are very large indications, and so, we feel like even success in a handful of them for any given program can, can make a big impact. And, indications that are big enough, as with many of the TNF indications, to accommodate multiple programs, multiple mechanisms. This is, it is a big tent. Immunovant on slide 16 has an aggressive plan. We are excited about that plan. 1402 will be in 4-5 potential registrational programs this fiscal year, moving up to 10 indications by next fiscal year.

So, three INDs expected to be active by the end of this calendar year. Really excited at what we're doing with 1402 and what we're going to generate for data in the coming months to validate that approach. So, enough said on Immunovant, but wanted to revisit that topic. Couple of other smaller things. One on slide 18, just a quick update on VTAMA. $18.4 million in product revenue for the quarter, you know, relatively flat on GTN yield. Notably, script volumes are doing actually relatively well. You know, we get frequently the question, it looks flat, it looks flattish. You know, script volumes are up 20% year-over-year relative to the same quarter last year.

They're growing, you know, single-digit%, quarter-over-quarter, every quarter, and we continue to see that. So that suggests we are continuing to slowly build into this psoriasis market, and we're, we're happy with that, and it suggests a willingness over time for this, doc behavior to change. We remain the, the best, the best selling from the volume perspective, novel, topical, in psoriasis, and all that sets us up really well for, as we said before, the main event, which is the launch in AD, that'll come after approval, at the end of this year. You know, I think on, on GTN quickly, because the, the GTN yield fluctuations have sort of obscured the overall positive trend in volume here.

I'll just say, we had one payer contract that had a reset effectively earlier this year, that we were not getting a rebate on last year that we are rebating now. So that resulted in both some one-time and also just like an overall reset of GTN. I expect to accrete from here. It'll continue to be sort of slow increase from here. Long term, I don't have a huge difference in my expectations, but I think, you know, this year it'll sort of build from here instead of building, you know, we hoped might have been a higher level. Notably, net price continues to increase over time outside of that one contract, so we continue to see everything trending in the direction that we want it. So, key upcoming catalysts on slide 20.

First of all, not on this slide, but we'll be presenting this undisclosed program, including some clinical data in September. Also upcoming here, we've got 14 oh 2, putting out detailed development plan information, as well as data from the tocilizumab study in Graves coming this fall. We're pretty excited to put that data out there. We think Graves is a really exciting opportunity. You know, nemolizumab, we're going to get top line data from that phase II trial in sarcoidosis. Again, not an area of great sort of external focus right now, but if that data are positive, those data are positive, we're excited about what that will mean. VTAMA, again, the big event, the atopic dermatitis label expansion, hopefully coming at the end of this year.

And then, you know, by the end of the fiscal year, data from tocilizumab in myasthenia gravis, as we've talked about, as well as data from period one of the phase II-B study in CIDP. And then by the end of this fiscal year, initiating 4-5 potential registrational programs in 1402, all of which, we, together with Immunovant, are looking forward to speaking more about, in the near future. So finally, before I wrap up this, relatively quick update on slide 22, just a financial update. You know, I think, overall, a pretty normal quarter for us from a finance perspective. We actually had, net, net income this quarter of $57 million.

Net revenues of $55 million, including product revenues, as I said, of about $18 million. Expenses sort of within our historical bounds. We ended the quarter with $5.7 billion in cash and cash equivalents. That sort of reflects the Sumitomo repurchase that we had made in April, I want to say, of last quarter. And then, the carrying value of our debt has come down a bit, thanks to the renegotiation that we had done at Dermavant, and you can see shares outstanding on the slide as well, about 7.9 million. So with that, I'll wrap up the presentation portion of this. On slide 24, you can see that we have a pretty exciting catalyst calendar coming up.

We've frankly a pretty rich couple of months ahead between the unveil of the new program, continuing work on the BD side, and data coming from tocilizumab and from Immunovant generally in the coming months. So really looking forward to getting together what I'm sure will be multiple times in the next few months to talk about those updates and to continue to see this all develop. And with that, I will wrap up the presentation for the morning. Thank you again for listening, and I'll hand it back to the operator for Q&A.

Operator (participant)

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. One moment. And our first question comes from Allison Bratzel of Piper Sandler. Your line is open.

Allison Bratzel (VP and Senior Research Analyst)

Hey, good morning. Thanks for the update, Matt, and thanks for taking the question. Just one for me on Priovant. You know, now that you've met with FDA on Breppo and NIU, just I guess, what is left to be worked out or decided on the phase III design? I think you'd given some high-level guidance, looking for 300-350-ish patients and a protocol basically as close to Neptune as possible. I guess, just high level, is that still the case? And is any of this protocol design dependent on the 52-week readout later this year? And then just, I guess, on that longer-term follow-up, you know, what would you view as an outcome that reinforces your view on the opportunity in uveitis? Thanks.

Matt Gline (CEO)

Yeah, sure. Thanks. So look, first of all, extremely constructive interaction with FDA. I think they are really excited to see a new opportunity in NIU, which is a disease that really needs to be studied. I think we feel good about where that's headed. I'd say the previous guidance we gave was largely in line with what we expect to see. And I think we got just about everything we really feel like we needed to make that program a success. So really, at this point, small tweaks, but just getting the study up and running, and we'll be able to provide a full description of it pretty soon here, honestly.

I'd say basically none of the study design hinges on the 52-week data, although obviously, if we saw something surprising, we'd look closely at it. I think, I don't think there's anything in particular we're looking for in 52 weeks to reinforce the program other than continued strong benefit to patients, which, given the quality of the 24-week data, we certainly expect. Thanks, Alex. Thanks for the great question.

Operator (participant)

Thank you. Our next question comes from Corinne Johnson of Goldman Sachs. Your line is open.

Speaker 13

Hey, good morning, team. This is Craig on for Corinne. So following the completion of enrollment of the VALOR study, can you kind of outline how the final enrollment compares to your original expectations, and maybe walk us through some powering assumptions there?

Matt Gline (CEO)

Yeah, sure. A couple of things. One is the actual number of patients we enrolled at 241 was a little bit higher than our original plan for the study. Originally, it had been 225, so we feel extremely well-powered. I don't have a lot to say on, like, baseline characteristics or demographics right now, other than to say, I think we're perfectly happy with the patients that we've enrolled, and we think it sets us up well. You know, I guess the other comment I'll make with a shout-out to the Priovant team is, DM is an incredibly difficult indication in which to develop drugs. These patients are hard to find, and frankly, our experience is that the key is a lot of legwork with the sites.

So we spend a lot of time out and about, talking to investigators, trying to get out there in the field to make sure that we had what we needed. And so, yeah, I'm very proud of the effort there. I'm proud of how quickly that study was able to get to fully enrolled, and looking forward to sharing that data once available. It's the largest study, as I said earlier, in MG today. Thanks for the question on MG.

Speaker 13

Of course. Just one more, if I may. Could you just remind us of what you're looking for in terms of a go, no-go decision for the phase II nemolizumab data coming relatively soon?

Matt Gline (CEO)

We haven't. So thanks. Yeah, look, I think we haven't articulated like a simple, straightforward bar, and I think the truth is that Sarcoidosis is one of these diseases where there's not a lot of other approved mechanisms. There's not a lot of options for patients who are sick with the disease, so I don't think the bar is meaningful. I think the bar is if the study works, certainly worth progressing. You know, as with all phase II trials, we're going to evaluate the totality of the data, and you know, we'll think about what else is on our plate. We're also looking for, yeah, consistency across not just the primary, but across a few secondaries.

There's a bunch of different ways that people look at the treatment of sarcoid patients. Thank you.

Speaker 13

Got it.

Operator (participant)

Thanks.

Allison Bratzel (VP and Senior Research Analyst)

Thank you, guys.

Operator (participant)

Thank you. Our next question comes from Brian Cheng of JPMorgan. Your line is open.

Brian Cheng (VP and Equity Research Analyst)

Hey, guys, good morning, and thanks for taking our questions. Maybe start this with the recent sell-off in the market, just, does it make it easier or harder for you to find a new asset? Does it change the way how you negotiate?

Matt Gline (CEO)

Thanks, thanks, Brian, for the great question. I will hand it over to Mayukh, but the short thing I'll say is we work with a wide range of different prospective partners. They are affected by varying degrees to the financial markets, but mostly we're focused on getting great opportunities at prices that we're excited about. But Mayukh, what would you say to the question about the sell-off?

Mayukh Sukhatme (Co-President and Chief Investment Officer)

Yeah, look, I think the short answer is it depends. But I think I don't have too much more to add to what Matt said.

Matt Gline (CEO)

Thanks, Mayukh. So look, Brian, I think, the short answer, the other piece of this, the sort of the question behind the question is, we remain really excited with what we see in the world, and we're looking forward to doing the right deal at the right time.

Brian Cheng (VP and Equity Research Analyst)

Okay. Maybe just, you know, one question on 1402. I guess, you know, just overall, I just wanna get a better sense of how you're thinking around this asset. As we think through the 10 indications that you're lining up for, you know, through the next fiscal year, and you talk about a lot about the range of themes and opportunities that you have laid out in your slide deck today. So how do you pick and choose the different areas? And I think most importantly is how you get credits for it in front of investors, because it seems that investors today are very fixated on AMGN CIDP. So in other words, how do you intend to get credits for, to push 1402 into uncharted indications?

Maybe just one last one, you know, more like a housekeeping one. What is the data, you know, what is the cadence of data flow in the fall? Because, you know, we're going to get phase II asset unveiling in September. Graves' plan also unveiling for Immunovant and sarcoidosis data coming out. So what's the cadence of data flow? Thanks.

Matt Gline (CEO)

.Thanks, Brian. All great questions. Look, unfortunately, too, I think the anodyne answer that's also true is obviously the biggest factor that go into our pick and choosing indications are the quality of the biology, the size of the unmet need, where we can be competitively positioned, you know, cost and risk kind of trade-offs. Like, those are obviously, like, the main factors that go in. I'd say a couple things about fourteen oh two that I find exciting or about the SCM landscape, and you may wanna jump in also. You know, on, you know, one of the things that we've said over and over again about FcRn is that anyone's phase II studies, everyone's phase II study, that goes both ways.

It means that we need to be careful about when we put our data out, but it means that once you know what the depth of IgG suppression does in a patient population, you can really be front of the pack. And so I think we're looking at indications where we can be in the front of the pack, where we can get out there commercially and sort of be neck and neck with our competitors, hopefully with deeper IgG suppression. So I think that's obviously a factor. For what it's worth, we also think MG is a really big opportunity. We also think CIDP is a big opportunity, and as a reminder, we're generating a meaningful data set in MG with tocilizumab that will underscore and get to the more is better question, just in the coming months.

So I think there's a lot to sort of focus on there, even for people who are myopically focused on the existing commercial indications.

Mayukh Sukhatme (Co-President and Chief Investment Officer)

Yeah, I think you hit most of the point, Matt. I just like the way, Brian, that you framed the question, which is, all right, people are focused on MG and CIDP, and everything else basically is upside.

Matt Gline (CEO)

That's right. Yeah, I think that's, that's a great way to put it. And in terms of cadence of catalyst flow, look, we have a busy, call it 6-7 months ahead here. I'd say September will be a busy month, and, and then the batoclimab data comes later, later this fall, and then I think we've said MG will come kind of early next year, and CIDP and TED kind of probably a little bit thereafter. So I think that's, that's what the sort of immediate flow looks like. And then obviously shortly on the heels of that, we'll be looking at BD, and beyond.

Brian Cheng (VP and Equity Research Analyst)

Thanks, guys.

Matt Gline (CEO)

Great. Thanks, Brian.

Operator (participant)

Thank you. Our next question comes from Dave Risinger of Leerink Partners. Your line is open.

Dave Risinger (Senior Managing Director and Senior Research Analyst)

Thanks very much, and thanks for all the updates. So I have two questions, please. First, could you provide more color on the LNP litigation, including the event path ahead? And then second, could you discuss external transaction prospects, including the size potential of deals that you're looking at? Thanks very much.

Matt Gline (CEO)

Yeah, sure. Thanks, Dave. Both great questions. So, on the LNP litigation, again, there's not that much that we're generally able to say about an ongoing litigation, but in terms of what's coming, so we're in discovery now, and as I mentioned on the call, that process is gonna continue, we hope for a few more months. We, together with Moderna, Arbutus, and Genevant, have asked for a moderate extension of that process to get answers to a few of the outstanding questions.

So, you know, I think that's the sort of next thing here, and then that calendar, there's a call with the judge in the next few weeks to get that approved, but if that calendar is approved, it would have summary judgment happening kind of in the beginning portion of next year, followed by a trial a year from now. So a little bit later than the sort of most recent version of the calendar, but for good reason, instigated by our side. On external transaction price prospects, I guess I'll hand over to Mike to answer that question straight from the source.

Speaker 14

Sure. Hi, Dave. Thanks for the question. So, I think we have carefully avoided, I think, getting bucketed whenever sort of asked, and I think that continues. I think, so I would think about size of opportunity and things that we're looking at. We really think about this, I think, as you know, Dave, as a portfolio, and so there's gonna be heterogeneity in any one deal. But I think, you know, overall, I think obviously our—so we think about things kind of on a deal-by-deal basis, really through that investment lens, it's a good investment. But then over sort of the surface area of all those deals, we're looking to move the needle on our enterprise overall.

Matt Gline (CEO)

The only thing I'd add is, because we get the question sometimes, and I'm always surprised when I get it: I think we are a very unlikely buyer of multibillion-dollar public companies. I think we are stingy by nature and are looking for places where we can spend more of the dollars on clinical development. So we are never saying ever company, but I think that's just, that's just true about who we are. Thanks, Dave.

Dave Risinger (Senior Managing Director and Senior Research Analyst)

Thank you.

Operator (participant)

Thank you. Our next question comes from Dennis Ding of Jefferies. Your line is open.

Dennis Ding (VP and Equity Research Analyst)

Hi, good morning. Thanks for taking our questions. Two from me. So maybe if we can revisit sarcoidosis briefly. Correct me if I'm wrong, but previously, you may have characterized the phase II as potentially registrational. Can you reiterate that and see if and confirm if that's true? And maybe talk a little bit about the path forward if that data is positive. And then number 2, around OpEx, I mean, given Immunovant will start a bunch of new trials over the next few years, how do you think your OpEx will evolve during that time? Thank you.

Matt Gline (CEO)

Yeah, thank you. That's a great set of questions. Look, we are on sarcoidosis, the truth is it's a phase II study. It's 100 patients. It's certainly large enough to serve as at least a pivotal study, if successful, and obviously communication with high unmet need. So depending on the quality of the data, there's always a conversation to have with the regulators. But then I think our expectation is that it's a phase II study and that we would have a program behind it, in basically all scenarios. And we're just excited to be developing the disease. There are no approved agents outside of steroids, so the unmet need is really significant.

On the Immunovant question, look, I think the short answer to the question on its face is, given that Immunovant is starting a number of pivotal studies, I would expect their OpEx to increase. I don't have super specific financial guidance, right now to offer. The cost of a phase III program for an FcRn, in general, has ranged from, call it, $80-$120 million. And so, you know, over the life of those programs, I think those are like reasonable estimates plus overhead and personnel and stuff like that. So, you know, I'd expect them to go up, go up there over time.

Obviously, you know, if you look at some of our competitors, I'd say, like, their R&D expenses may be useful, but, but a big piece of the cost here ultimately winds up coming as you get closer to a commercial launch, from a GMA perspective as well. Notably, Immunovant is well capitalized right now for this program, and, we are, obviously excited to be a good partner for them.

Allison Bratzel (VP and Senior Research Analyst)

Great. Thank you.

Matt Gline (CEO)

Thanks, Ron. Thank you.

Operator (participant)

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

Yaron Werber (Managing Director and Senior Biotechnology Analyst)

Great, thanks for taking my question. I have a couple. Maybe just the first one, we started getting questions, and I think you highlighted now that you're planning on unveiling your recently in-licensed phase II program in September. Is there anything you can unveil a little bit today? Just indication or how big is the study? Is it a randomized study? Is it just an open label study? Has there been other studies with this mechanism in whatever indication you're examining? And then maybe just secondly, so it sounds like MG and CIDP will start phase III, let's say Q1, potentially with 14-02. For the other three, is it sort of Graves', Sjögren's, and maybe TED? Is that sort of the order? Thank you.

Matt Gline (CEO)

Thanks, Yaron. On this asset, we're weeks away, so I think I'm going to mostly reserve comment other than to reiterate some things we've already said. Mainly, first of all, obviously, we're excited about the program. There is clinical data to share when we release the program. That clinical data, I think, is useful, and people will find it informative. And there is a competitor program. There's another program of the same mechanism being studied by a big pharma company; it's a different indication. We've said that publicly before. And other than that, we'll reserve comment until we unveil the rest in September, but looking forward to it.

Of the programs that we've sort of described, you know, obviously, the Graves' data is coming shortly, and we expect both to communicate the total amount of data as well as the development plan for that program. And then the batoclimab MG data and CIDP data are coming at the beginning of next year, and we've said clearly and affirmatively that we plan to study in MG. We haven't said exactly what the other indications are yet. I think Immunovant will paint a fulsome picture of that, relatively soon. But my expectation, to be clear, is the Phase III studies for some of those programs. Again, we expect to have three INDs by the end of this year. All of those INDs will be for registrational, sort of phase II/III kind of programs.

And so I would expect at least three of these studies to, in essence, have begun by the end of this year and the other two in the first quarter. Thanks, Yaron.

Operator (participant)

Thank you. Our next question comes from Louise Chen of Cantor. Your line is open.

Louise Chen (Managing Director)

Hi, thank you for taking my questions here. I just had two for you. The first one I wanted to ask you is, if the launch of FcRn is a possibility just for Roivant to do on its own, is that on the table? And then secondly, just curious on the market opportunity for VTAMA and AD, and how you're preparing for the launch of this product coming at the end of this year. Thank you.

Matt Gline (CEO)

On the first question, I'll say, we are certainly aware of a once upon a time, small biotech company that launched an FcRn antibody on its own and met some success doing so. And so it certainly seems possible to do that ourselves. And look, I think that has been an exciting outcome. I think as the class presents itself, the breadth of the opportunity is large, so I think we're gonna do what maximizes the value of that opportunity for us and beyond that, all things are on the table. On VTAMA and AD, look, I think, there's a couple of things.

One is, and probably most importantly, looking for the prescribers who we're not currently in front of, allergists, pediatric allergists, pediatric dermatologists, really hitting hard in Peds, where we'll be alone at launch among novel topicals. So I think that's sure that prep is important. And then looking, taking a hard look at our existing sales force targeting and making sure that we're covering all the right docs for the opportunity and getting our messaging exactly right to those docs, especially frankly, because, look, I think the story in AD is a little bit different than the story they're used to seeing in psoriasis, right? I think, like, the pediatric population is different. The safety, the tolerability profile, I should say, of the drug is even better in the AD dataset.

I think the quality of our data in AD is differentiated to an even greater degree relative to some of the other novel topicals than it is in psoriasis. And so I think we need to be able to get that across. Itch, for example, is a major symptom in AD. It's acute. Our itch data is very, very good. It, and you know, I think we'll be making sure to highlight that. So I think, really trying to get messaging with all docs right, make sure we're talking to the right docs, and make sure we're especially covering the docs who are not kind of overlapping with the psoriasis docs, that we're so ready to get out in front of those as soon as we get the nod from FDA. Thank you. Those are both great questions. Appreciate it.

Operator (participant)

Thank you. Our next question comes from Yatin Suneja of Guggenheim. Your line is open.

Yatin Suneja (Senior Managing Director and Biotechnology Analyst)

Yeah, thank you for taking my question. Maybe just one more on VTAMA, specifically on the psoriasis side. I mean, if you look at the past, I would say four or five quarters, you are in that, you know, $18-$20 million range on a quarterly basis. I mean, what does that imply about the overall market opportunity? What can you do to sort of re-inflect sales in psoriasis? I understand atopic dermatitis could give a lift, but just in psoriasis, just curious, you know, how you view the market, what sort of peak sales you are assuming? Thanks.

Matt Gline (CEO)

Yeah. So thanks. It's a good question. First of all, I'll say, I continue to be pleased with how we're set up on VTAMA, which is to say, I think the street gives us no credit for it, so I think it's all upside from here, which is always a nice place to be. Look, I think on the sort of tracking the progress, as it were, as I said in my prepared remarks, I think the sort of mechanical sales number probably understates the progression in the sense that we've had a little bit of, like, just noise around gross to net that we expect to climb out of from here. And volumes are actually building. As I...

You know, and people have been asking us about the supposed flattening of this curve for a while. We're up 20% from a volumes perspective versus the same quarter last year and continuing to grow every quarter. You know, I think as GTN climbs, as GTN normalizes, that sort of base that we've been building month in, month out, quarter in and quarter out from a volume perspective, will continue to work for us. And I still have hope that over time, there will be some real compounding effects there, that docs that like the product, that docs that write the product will, will continue to write it more and more. So, so I, I do think psoriasis has the potential to be very meaningful over time. It's just been a little bit of a slower burn.

I think the thing about AD is it's got the potential to be a, like, inflection of a different sort, where it's a much larger patient population with a set of data that we can just sort of easier facially to see the differences versus our peers. And so, excited for that launch as well. Thank you very much.

Operator (participant)

Thank you. Our next question comes from Douglas Tsao of HC Wainwright. Your line is open. Douglas, your line is open.

Douglas Tsao (Managing Director of Equity Research)

Hi, good morning. Thanks for taking the questions. Matt, you know, I think from a business development standpoint, you have largely focused on pulling individual assets out. Just given the sort of ongoing status in biotech, does it ever change that you've become more focused on looking at potentially acquiring companies?

Matt Gline (CEO)

We are generally just agnostic to the form in which great programs come our way. And so I think, whether it's a company, whether it's a, an asset, I don't know that that's, like, the dividing line for us versus what are we getting and is the value there, and do we think we can do something that matters with it? Mayukh, you got anything to add to that?

Mayukh Sukhatme (Co-President and Chief Investment Officer)

No, I think you got it.

Matt Gline (CEO)

Yes. So I think the answer to that question is, we've always sort of been indifferent to that. I think there's... I guess the only thing I'll say is, like, I think a lot of what we are focused on right now, I'd say the vast majority of what we're focused on right now, is stuff that's in clinical development. And so when we talk about companies versus assets, I don't think it matters so much whether it's company or asset, but we're mostly going to be looking at companies that have clinical stage or sort of development stage programs. Thank you, Doug.

Douglas Tsao (Managing Director of Equity Research)

Great. Thank you.

Operator (participant)

Thank you. Our next question comes from Andy Chen of Wolfe Research. Your line is open.

Andy Chen (Director and Senior Analyst)

Good morning. Thank you for taking the question. One more question about VTAMA. Can you talk about, specifically how you view competitive dynamics between you and your competition, such as Arcutis and Incyte? Which patients do you think is going to prefer which product? And then on a related note, in your pre-approval engagement work with PBMs, do you foresee getting hit on gross-to-net if they prefer your competition? Thank you.

Matt Gline (CEO)

Thanks, Andy. Those are good questions, and I want to give you a special thanks because I think the analysts who come late in the rotation on these calls have a lot of work to do. So appreciate the thoughtful question late in the morning. Look, on the first question, the key thing about these markets, which we've said from the beginning, is the competition is not other novel agents. The competition is steroids. There are many, many, many steroid scripts written, and the challenge is in changing well-ingrained doc behavior. I don't think in general, it's like for the median psoriasis or the median AD patient, it's like, oh, some doc is sitting there and carefully thinking about the attributes of Zoryve versus Opzelura versus VTAMA and deciding on a patient-by-patient basis to give one or the other.

I think the key point is getting docs comfortable that they have things to reach for. You know, there are differences. In AD, for example, we would hope for a label all the way down to age two. I think our competitors don't have labels that cover anything like quite that young. You know, so I think there are opportunities to address patient populations that are different there. You know, I think the once-a-day application in AD is probably helpful, the consistency of formulation, the fact that it's a single concentration, whereas at least one of our competitors has a couple of different concentrations going to be on the market. I think those things are all helpful, but it's not, it's not about like segmenting versus the other novel topicals per se.

That's not sort of the major challenge, mostly. And then on the sort of PBM side, I think the short answer is commercially insured patients should have coverage for VTAMA under our current managed care agreements. So I don't expect any super significant changes in the GTN or commercial dynamics on AD approval. Which is a great question. Thank you.

Andy Chen (Director and Senior Analyst)

Thank you.

Operator (participant)

Thank you. This concludes the question and answer session. I would like to turn it back to Matt Gline for closing remarks.

Matt Gline (CEO)

Look, yeah, thank you, everybody. Thank you to all of our analysts for the great questions. Thank you, everyone, for dialing in for a relatively quiet quarterly update. I'm looking forward to getting back on the phone in the coming weeks with some other things to share. And, yeah, thanks, thanks to the Roivant team. Thanks to those folks exceeding us below ground. Thanks to all the patients and investigators who trust us and work with us, and we will talk to you very soon. Have a great day.

Operator (participant)

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