Roivant Sciences Ltd.

speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 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.

Good morning and thank you for joining today's call to review Royvind's financial results for the first quarter and the June 30th, 2024 along with a business update. I'm Stephanie Lee with Royvind. Presenting today we have Mackline, CEO of Royvind. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at .royvind.com. We'll also be providing the current client 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 was filed with the SEC for more information regarding these forward-looking statements and related risks that are answered. And with that, I'll turn it over to Matt.

Great. Thanks, Stephanie. 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 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 slide five in the deck with a reminder just kind of 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 Brepsetna, where we'll be beginning our faith-through program at NIU shortly, where we have data coming in the middle of the lab, later this year in sarcoidosis, and so on. We're very much looking forward to it. We'll talk a little bit about VECAMA today, but the story for VECAMA for this year is really the expansion of the label AD and some acceleration of the crisis, certainly volumes and revenues over time. And then we continue to be hard at work expanding our pipeline, looking at mid to late stage programs. I know there's a lot of focus on that activity. We will be unveiling our much-discussed sort of so far-unscathed program just next month. So we'll 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. And one of the things that I struggle with sometimes, I get all these questions about VD, but every time I look at our pipeline, I'm like, well, we still have one of the best I&I pipelines, even without any VD. So excited about the breadth of opportunities there. In particular, excited about the next, call it 18 months, both in the FDSRN world, we've talked a lot more about today. And in BREP-SITMID, we'll have available data coming shortly. So the main updates for the quarter, serving on slide eight, one is on BREP-SITMID, which is that we've now completed enrollment in our phase three 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 two meeting with FDA on the NIU opportunity and are planning to begin a 52-week phase three study in the near future in NIU or phase two program. At Immunivant, we had announced, 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 and so we'll get data in the first quarter of next year, as we've previously discussed. And we remain on track for the initiation of a registration 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 two program, as I said, in September next month. Excited to do that. It will be the accommodation and 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 GenOvant in our IP litigation around the COVID-19 vaccines. Discovery continues. We requested a slightly amended case schedule so that we could get some more information from Moderna, which is proving that the trial will be just about a year from now, so in September of 2025. And then we achieved some important clinical regulatory milestones that resulted in cash coming in the door. We're going to get a $28 million milestone related to the Japanese approval of the Camel Brother. We got that in July, and we have received our portion of $110 million of the remaining proceeds for T-Lavent now that they've begun. They've hit the definition for that milestone, so that has been received this month. So pleased with that. Obviously, even at our $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 want to 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 Immunivant, around the NTF-CRN opportunity. 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 a portion of a small pie. When in fact, I think our view is that the biology for FCRN, the biology for T-cell immunology and beyond is very broad. And so I just wanted to highlight, 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 reminder of just why we are so excited about the program. So as a reminder on slide 11, we've said this in multiple places, we really do believe that IMBT-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 NTF-CRN 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 going to be able to launch, in all likelihood, IMBT-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 where, 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, we'll rewind back to 2020. There were eight total FCRN indications in development, with about 700,000 addressable patients. There are now 23 indications in development for NTF-CRN antibodies, with a current total addressable population of 4 million. And that number is growing often, and we expect to add some to it in the relative linear future as well. So just a huge area of biology 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 NTF-CRN 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 the Tokamab and Graves and the Tokamab and KED, some of which generated by others, such as in children'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, IG 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 been interesting to us only in the sense that it's so much earlier than FCRN, and FCRN has sort of elegantly cleared this bar that there's still a lot of work to do in some of these other mechanisms. You can see here, again, multiple approvals for our class in immunology, multiple positive phase three studies, multiple positive phase two 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 excited about that. These are the places we can take a pill. Again, we think many of these other classes are interesting. Watching them closely, we make investments in other areas. And so you can imagine we're watching these areas. 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. On slide 15, everyone wants to compare themselves to the biggest drugs. And so the behavior of comparison is maybe overdone. But I liked a couple of things about it here. One of the things I liked about it is 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. 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. 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 when the TNF class was able. And I think it's notable, apropos of the competitive point, the TNF class didn't achieve these obviously phenomenal results just on their own. By 20 years after launch, there were nine other approved MOAs 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 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 a big tent. ImmuneVent on slide 16 has an aggressive plan. We are excited about that plan. 1402 will be in four to five potential registration programs this fiscal year, moving up to 10 indications by next fiscal year. So 3IND is expected to be active by the end of this calendar year. Really excited at what we're doing with 1402, what we're going to generate for data in the coming months to validate that approach. So enough said on ImmuneVent, but wanted to revisit that topic. And a couple of other smaller things. One on slide 18, just a quick update on VTAMA. 18.4 million in product revenue for the quarter, relatively flat on GTN yield. Notably, script volumes are doing actually relatively well. We get frequently the question, it looks flat, it looks flat-ish. Script volumes are up 20% year over year relative to the same quarter last year. They're growing single digit percent quarter on quarter every quarter, and we continue to see that. That suggests we are continuing to slowly build into the psoriasis market, and we're happy with that. It suggests a willingness over time for this dock behavior to change. We remain the best selling from the volume perspective, novel topical in psoriasis. All that sets us up really well for, as we said before, the main event, which is the launch in 18 that will come after approval at the end of this year. I think on GTN quickly, because the GTN yield fluctuations have sort of obscured the overall positive trend in volume here. 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. That resulted in bolting some one time and also just like an overall reset of GTN. I expect to accrete from here. It'll continue to be a slow increase from here. Long term, I don't have a huge difference in my expectations, but I think this year it'll sort of build from here instead of building from what 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 to. 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 14.02 putting out detailed development plan information, as well as data from the BOTOCLONAP study in GRAVES coming this fall. We're pretty excited to put that data out there. We think GRAVES is a really exciting opportunity. In the middle of now, we're going to get top line data from that phase two trial. So I notice this 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. VECAMA, again, the big event, the atopic dermatitis label expansion hopefully coming at the end of this year. And then by the end of the fiscal year, data from BOTOCLONAP in my senior GRAVES, as we talked about, as well as data from the period one of the phase two B study in CIDP. And then by the end of the fiscal year, initiating four to five tensile retracerate programs in 14.02, all of which we together with the immunomantural support 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 income this year, this quarter of $57 million, net revenues of 55, including product revenues of 75.18, 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 Dermavent. And you can see Sharjah standing 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're frankly a pretty rich couple of months ahead between the unveil of the new program, I continue to work on the BD side and data coming from Tokamap and from Mutamap 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, 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.

Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. One moment. And our first question comes from Allison Bratzell of Piper Sandler. Your line is open.

Hey, good morning. Thanks for the update, Matt, and thanks for taking the question. Just one for me on PriVent. Now that you've met with FDA on BREPO and NIU, I guess what is left to be worked out or decided on the Phase 3 design? I think you've given some high-level guidance looking for 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, what would you view as an outcome that reinforces your view on the opportunity and new VITAS? Thanks.

Yeah, sure. Thanks. Zula, 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. And then I'd say basically none of the study design hinges on the 52-week data, although obviously we saw something surprising. We looked closely at it. And 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 flexibility data, we

certainly expect. Thanks, Alex. Thanks for the great question.

Thank

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

Hey, good morning, team. This is Craig on for Corrin. 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?

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 baseline characteristics or demographics right now, but I think we're perfectly happy with the patients that we've enrolled and we think it sets us up well. I guess the other comment I'll make with a shout out to the Privant team is PM 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 right way. We have what we needed. I'm very proud of the effort there. I'm proud of how quickly that study was able to get to fully enroll and looking forward to sharing that data with the other ones. So the largest shout out as I said earlier to the UGM. Thanks for the question on PM.

Of course, just one more if I may. Could you just remind us of what you're looking for in terms of a go or no go decision for the phase two and the middle map data coming relatively soon?

We haven't so thanks yet. 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 food 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, it's certainly worth progressing. You know,

as with

all phase two trials, we're going to evaluate the fatality of the data and we'll think about what else is on our plate. We're also looking for consistency across not just the primary but across a few secondaries as a bunch of different ways that people look at the treatment of sarcoidosis patients.

Thank

you. Got

it. Thank you guys.

Thank you.

Our next question comes from Brian Chang of JP Morgan. Your line is open.

Hey guys. Good morning. Thanks for taking out questions. Many sources with the recent sell off in the market. Just doesn't make it easier or harder for you to find a new asset. Does it change the way how you negotiate?

Thanks, Brian, for the great question. I

will hand it over to my you. But the short thing I'll say is we look, we work with a wide range of different perspective 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. What would you say to the question about the sell off?

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

Thanks, my dude. So Brian, I think the short answer, the other piece of this, 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. Okay.

Maybe just one question on 1402. I guess just overall I just want to 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 through the next fiscal year, and you talk a lot about the range of themes of 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 MGMITP. In other words, how do you intend to get credit to push 1402 into uncharted indications? And then maybe just one last one, more like a housekeeping one. What is the cadence of Calais flow in the fall? And because we're going to get phase two asset unveiling in September, grace plan also unveiling for immunovent and psychodosis data coming out. What's the cadence of data flow?

Thanks, Brian. All great questions. Look, on 1402, I think the anodyne answer that's also true is obviously the biggest factor that went into our picking and choosing indications are the quality of the biology, the size of the unmet need, where we can be competitively positioned, cost and risk kind of trade-offs. Those are obviously the main factors that go in.

I'd

say a couple things about 1402 that I find exciting or about the SRM landscape, and it seems like you may want to jump in also. One of the things that we've said over and over again about FCRN is that anyone's phase two study is everyone's phase two 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. 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. 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. As a reminder, we're generating a meaningful data set and MG with a total amount that will underscore and get to the more is better question just in the coming months. I think there's a lot to sort of focus on there, even for people who are myopically focused on the existing commercial indications.

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.

That's right. I think that's a great way to put it. In terms of cadence of catalyst flow, we have a busy call at six to seven months ahead here. I'd say September will be a busy month, and then the MilMap data comes later this fall. Then I think we've said MG will come early next year, and CIDP and TED probably a little bit thereafter. I think that's what the immediate flow looks like. Obviously, shortly on the hill to that, we'll be looking at the EM

and beyond. Thanks, guys. Great. Thanks, Brian.

Thank you.

Our next question comes from Dave Rissinger of Luring Partners. Your line is open.

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.

Yeah, sure. Thanks, Dave. Both great questions. 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 going to continue, we hope, for a few more months. We, together with Moderna and Arbutus and Genovin have asked for a moderate extension of that process to get answers to a few of the outstanding questions. So I think that's the sort of next thing here. And then that calendar, there's a call with the judges in the next few weeks to get that approved. If that calendar is approved, it would have summary judgment happening in the beginning portion of next year, followed by a trial a year from now. So a little bit later than the most recent version of the calendar, but for good reason instigated by our side. On external transaction prospects, I guess I'll hand it over to Mike to answer that question straight from the source.

Sure. Hi, Dave. Thanks for the question. So I think we have carefully avoided, I think, getting bucketed whenever asked. And I think that 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 going to be heterogeneity in any one deal. But I think overall, I think obviously our arc. So I 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.

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 multi-billion dollar public companies. I think we are stingy by nature and are looking for places where we can spend more of the dollars on political development. So we are never saying never company, but I think that's just that's just true about who we are. Thank

you, Dave. Thank you.

Thank you.

Our next question comes from Dennis Ding of Jeffries. Your line is open.

Hi, good morning. Thanks for taking our questions. Two for me. So maybe if we can revisit sarcoidosis briefly. Correct me if I'm wrong, but previously you may have characterized the phase two 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 two around OpEx, I mean, given amino ban 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.

Yes, thank you. That's a great set of questions. Look, we are on sarcoidosis. The truth is, it's a phase two study. It's 100 patients. It's certainly large enough to serve as at least a pivotal study if successful. And obviously, medication with high end that needs. 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 two 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 immunovent question, look, I think the short answer to the question on its face is given that immunovent 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 three program for an FCRN in general has ranged from, call it, $8,220 million. And so over the life of the program, those are like reasonable estimates plus overhead and personnel and stuff like that. So I'd expect them to go up there over time. Obviously, if you look at some of our competitors, I'd say like their R&D expenses may be useful, but a big piece of the cost to your ultimately winds up coming as you get closer to a commercial launch from a GNA perspective as well. And notably, immunovent is well capitalized right now for this program and we are

obviously excited to be a good part of that. Great. Thank you. Thanks, Rob. Thank you.

Thank you.

Our next question comes from Yaron Berber of TD Cowan. Your line is open.

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 two 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 GMG and CIDP will start phase three, let's say Q1 potentially with 1402. For the other three, is it sort of Graves, Chogrens and maybe TED? Is that sort of the order? Thank you.

Thanks, Yaron. On Minnesota's 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 with the same mechanism being studied by a big foreign company to different indications. We've said that publicly before. And other than that, 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, obviously the Graves data is coming shortly. And we expect both to communicate the top of that data as well as the development plan for that program. And then the FATO, MG data, and CIDP data are coming 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 in a minute we'll paint a full picture of that relatively soon. But my expectation to be clear is the phase three studies for some of those programs. Again, we expect that three INDs by the end of this year. All of those INDs will be for registration of phase two to three kind of programs. And so I expect that we've really studies to, in essence, have begun by the end of this year and

the other two in the first quarter. Thanks, Jerome.

Thank

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

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

On the first question, I'll say we are certainly aware of a once upon a time small biotech company that launched an NTF or an 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 going to do what maximizes the value of that opportunity for us. And beyond that, while things are on the table. On the FITAMA and AD, look, I think there's a couple of things. One is, and probably most importantly, looking for the prescribers who were not currently in front of allergists, pediatric allergists, pediatric dermatologists, really hitting hard in beads where we'll be alone at launch among novel topicals. So I think that's sort of that prep is important. And then looking, taking a hard look at our existing Salesforce targeting and making sure 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. I think the pediatric population is different. The safety, the tolerability profile, I should say, of the drug is even better in the AD data set. 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. And 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.

Thank

you. Our next question comes from Yatran Sunecha of Guggenheim. Your line is open.

Guys, thank you for taking my question. Maybe just one more on Vitama, 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 to 20 million range on a quarterly basis. And what does that imply about the world market opportunity? What can you do to sort of re-inflex sales in psoriasis? I understand you talked about that. I just could give a lift for just in psoriasis. Just curious, you know, how you view the market, what sort of peak sales you are assuming. Thanks.

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 Vitama, which is to say, industry 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 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 like noise around gross tonnets that we expect to climb out of from here. And volumes are actually building. As you know, people have been asking us about the supposed flattening of this curve for a while. We're up 20% for 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, the docs that like the product, the docs that write the product, will continue to write it more and more. So I do think psoriasis has the potential to be very meaningful over time. It's just been a little bit of a slower burn. And I think the thing about AD is it's got the potential to be an inflection of a different sort, which is a much larger patient population with a set of data that we can use through easier facially to see the differences versus our peers.

And so excited for that launch as well. Thank you very much.

Thank

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

Hi. 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 become more focused on looking at potentially acquiring companies?

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 an asset, I don't know if that's like dividing line for us versus what are we getting and is the value there and what do we think we can do something that matters with it. Matt, are you going to get into that? No, I think

we got it. 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. Great. Thank you.

Thank you.

Our next question comes from Andy Chenow-Wolf Research. Your line is open.

Good morning. Thank you for taking the question. One more question about VITAMA. Can you talk about specifically how you view competitive dynamics between you and your competition, such as our QLIS and Insights, 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 growths to net if they prefer your competition? Thank you.

Thanks, Andy. Those are good questions. 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. 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 Zorin versus Absaloro versus VITAMA and deciding on a -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. There are differences. In AD, for example, we would hope for a label all the way down to day two. I think our competitors don't have labels that cover anything like quite that young. So I think there are opportunities to address patient populations that are different there. 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 about like segmenting versus the other novel topicals per se. That's not sort of a major challenge mostly. And on the sort of PBM side, I think the short answer is commercially insured patients should have coverage for VITAMA 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. Thank you.

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

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 thanks to the Reuven team. Thanks to those folks at X-Tune and Drown. Thanks to all of the patients and investigators who trust us and work with us. And we will talk to you very soon. Have a great day.

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