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spk05: Good day and thank you for standing by. Welcome to the Roivant Q2 2023 Earnings Conference 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 that session, you will need to press star 1-1 on your phone. 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. And I would now like to hand the conference over to your speaker today, Ms. Stephanie Lee. Please go ahead.
spk00: Good morning, and thanks for joining today's call to review Royvent's financial results for the second quarter ended September 30th, 2023, along with a business update. I'm Stephanie Lee with Royvent. Presenting today, we have Matt Klein, CEO of Royvent. 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 www.investor.royvent.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 FCC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt.
spk09: Thank you, Stephanie, and good morning, everybody. Thank you for joining us on this call this morning. It has been a highly eventful quarter But comparatively, an uneventful call, given that most of the major updates, including the Immunovant data from September and the sale of Telovant to Roche, have already been discussed. But I'm looking forward to giving everyone our normal business update and taking questions and answers. The plan here is to talk a little bit about where we are as a business. I'm going to remind everybody of the parameters of the sale of Telovant. We're going to give a brief overview of the data that Immunovant presented back in September. a little bit about the VTAMR launch, a brief reminder of the upcoming representative data, and then we'll wrap up with financials and Q&A. So I'm going to start on slide six in the presentation, which is a slide that's fun to put up. So we're sitting here in November of 2023, and I keep saying on these calls, but it's true, it's been a pretty wild year. We said this was going to be our biggest year yet. And at this point, it has surpassed certainly my expectations. We've delivered some really great phase three data for VTAMA in atopic dermatitis, as well as continued progress on that commercial launch. We'll talk more about that a little later on this call, but those, believe it or not, were the first clinical data sets this year. We delivered some extraordinary clinical data for RVT3101, our anti-TL1A antibody in ulcerative colitis, both at the beginning of the year in the induction phase and in June in the maintenance phase. Obviously, we announced the culmination of that journey a couple of weeks ago with the planned sale of that program to Roche. We announced the first cut of the IMT-1402 Healthy Volunteers SAD and MAD data in September and showed a profile that we believe sets us up to have a potentially best-in-class anti-FCR antibody with betoclumab-like IgG suppression, and at least in the cohort shown so far, no impact on LDL or albumin. And that's all sort of up until now. And believe it or not, there's still more data coming through the rest of this year, including the final 600 milligram multiple sending dose cohort from Immunovant, the SLE data for the Phase IIb study of brepacitinib, we'll talk a little bit more about, and the GRAVES data at Immunovant also coming this year. So just a year really chock full of clinical data, and I could not be more proud of how it has gone so far. and of the Roche and Levant teams for delivering on it. So on the next slide, I just want to talk a little bit about the acquisition here that we've already messaged, which is that the plan here is for us to sell T-Levant, our NTTL1A antibody program, to Roche. We previously discussed that a couple weeks ago. The sale is for $7.1 billion up front with $150 million milestone. As a reminder, Roivant owns about 75% of that business, so our cash proceeds will be about $5.2 billion on close, as well as $110 million from that milestone, which we expect next year. At the close of this transaction, including the proceeds from that transaction, as well as the unit of follow-on offering, we expect cash and cash equivalents consolidated for Roivant of $7 billion. which is an extraordinary capital position. We will talk a little bit more on this call and a lot more in the future about what we plan to do with that capital. And, you know, Pfizer will keep commercial rights to the program outside of the U.S. and Japan and will continue to partner with Roche on the program. As a little bit of a reminder of the why on slide seven, you know, first of all, we think for the program, Roche will continue to do great things. Obviously, we were proud of the work that we had done and would have been excited to continue developing the program, but Roche certainly adds the resources and expertise of a large global pharma company to maximize access for patients across indications. For us, this is tremendous near-term value generation with proper value to a large opportunity and with a lot of capital efficiency relative to the modest amount that we had so far invested in the program. And this is a transformational capital opportunity for us. We, as we've said on the previous call, are going to be patient and thoughtful. I know, and I've heard it from a lot of investors, people are looking for a sense of what we're going to do with the capital. I'll just remind people, we have a phenomenal pipeline already between Immunivant and our FCRM program and a number of others. We're excited to put some of the capital to work there. We see transaction opportunities in the relatively near term that are as large and exciting as anything we've ever done before, TL1A included. We expect to continue to be capital efficient in those business development transactions, and while I'd never rule anything out, I think it is more likely that the deals that we do will continue to look like the ones we've done before with relatively smaller upfront components. But again, we're taking stock of the full opportunity side, and it is a great opportunity. And we have the potential to return capital to shareholders above and beyond that, given the significant sum. So we'll talk more about all three of those things in the near future and over time. As a reminder on slide eight, one of the questions I've gotten frequently from investors is, what does the catalyst roadmap look like now that this deal has happened? And my answer is, well, it looks much the same as it did before. And, in fact, the TL1A program, with the exception of the Crohn's data at the end of that year, didn't have an interim catalyst. Our pipeline is tremendously rich today, with VITAMA, obviously, a commercial program with a significant amount of data coming at both prepositinib and especially in our NTFCR enfranchise in the next 12 months. And we look forward to continuing to generate important clinical data from those and other programs in the months to come. So, with that, I'm going to do a brief review. of where we are at Immunovant and some of the other programs. And I'll just start on slide 10 with a reminder. We are very proud of the NTF-CRN franchise that we have. We believe we have two great programs, both of which are capable, as best we can tell from the data we have available, of suppressing IgG as deeply or deeper than anybody else. And, you know, one of them, Botoclumab, we've generated a lot of data and are continuing to generate mid-stage clinical data in indications that matter, where we think we're going to be able to prove out that deeper is better IgG hypothesis. And the other one, IMVT-1402, coming close behind, now looking like it delivers that same IgG suppression, but without an impact on LDL and albumin. So a really exciting opportunity for a franchise of these programs. As a reminder on slide 11, 1402 is in the late innings of this single ascending and multiple ascending dose healthy volunteer study that was designed to to reveal the clinical profile of that program. It had both multiple single ascending dose cohorts that were IV, from 100 milligrams all the way up to 1,200 milligrams IV. It had subcutaneous single ascending dose cohorts at 300 and 600, and then multiple ascending dose cohorts at 300 and 600 sub-Q. And at this point, we've delivered all other than that higher dose 600 milligram multiple ascending dose sub-Q cohort, which, as a reminder, immune advantage signals they expect this month and that is fully on track um i'm not going to share all of the data here obviously everything we believe that we shared in september was fully consistent and painted a pristine picture as far as we were concerned of what this drug could do on slides 12 and beyond i just have the multiple ascending dose data which as a reminder shows uh On slide 12, very much the toclamab-like IgG suppression with 300 of 1402 suppressing IgG by a very similar amount to 340 milligrams of the toclamab. Sorry, 1402 similar to the toclamab 340. And then on slide 13, you can see that that's achieved with really no time course impact on albumin at all. Albumin wound up at the end slightly above... baseline and slightly above placebo. Remember, down is the direction to be concerned about. Unlike betoclumab, which in the multiple sending dose data showed a clear dose-dependent, time-course-dependent impact on albumin. And then you can see in the LDL data, which unfortunately we don't have in the same study for betoclumab, but you can see, again, really no time-course impact of note on LDL, with LDL in this case winding up slightly below baseline. So as a reminder, there was variability in these data. We always said we expected variability in LDL to the plus or minus 10% tune, but we believe the consistency of it across all of this suggests that we have a strong profile, and we're looking forward to sharing the 600 milligram MED data once we have it. And then as a sort of final reminder on slide 15, just to note, This is an incredibly broad target. Even since September, when we shared our data, we've continued to see developments in this field, including the full J&J CalMEB RA data. We've continued to make progress on our own studies, Graves data coming later this year. Graves is an indication that I think is significantly underappreciated for the commercial potential and the number of patients that we can help. And it's just a really broad target. with at this point great clinical validation across multiple indications that FCRN is active and that it matters clinically in a number of these diseases as well. So really excited about what's to come there. A very, very data rich set of months and really a full year ahead. Excited to generate that data to continue to evaluate strategic options that I believe will present themselves and to continue to communicate about where we are as that plays forward. So, next up, I'm going to provide a brief update on the camera launch, starting on slide 17. So, I'd say, overall, we continue to be pleased with how this launch is going. It continues to, you know, script line continues to grow at a steady clip, probably not a quite as fast as we would like at this stage, but we're overall pleased with the reaction from physicians and the reactions from patients. And we see continued uptake of the product, so we're hopeful that we're going to be able to continue to bend the curve and generate more volume in psoriasis. This remains the best launching topical in history. And we're in particular excited for the atopic dermatitis launch in the second half of next year, where we have terrific data and with a significantly larger patient population. On slide 18, we just got the financials here. Revenues continue to build. We did about $18.4 million for the quarter. GTN yield accreted, I'd say, modestly up to $27.6. We're sort of through the contracting process at this point, so I would expect GTN yield to continue to improve modestly and at a steady clip over time as we approach the steady state of which we think long-term will get to the 50% that we've talked about and will take some time to build up to there as we've communicated. Finally, just a couple of notes about where we are from a data perspective. There's actually been some additional data generated or published in this program in the last month or two, including on slide 19, One of the things that at least one of our competitors has talked aggressively about is efficacy in interterigenous psoriasis. This is psoriasis inside the skin fold, inside the elbow and the groin, etc., where psoriasis is pernicious and where some of the other, especially the most potent steroids, are not permitted. And you can see we have really phenomenal data in interterigenous psoriasis. as good in our view on a cross-trial comparison as anybody else here, so we feel very good about what we deliver in endocrinitis psoriasis. We also put out some additional data, which is super important in the atopic dermatitis area, which is the speed of onset for itch. As you can see on slide 20, we had a statistically significant separation from placebo as early as week one, and just a clear, visible separation really within 24 hours and a meaningful reduction in itch within 24 hours. So we feel very good about the speed of onset, and that's something that matters quite a lot to atopic dermatitis patients. So it's data we're excited to continue to put out there as we get closer to that NDA filing and eventual launch. And then as a reminder on slide 21, we just couldn't be more excited for the clinical profile of this agent in ADE. with some really phenomenal data when you look across mechanisms. This is, we just picked one endpoint, EG75, we've published before. But across mechanisms, some of the best data that's ever been shown with safety profile that is about as good as any. In fact, an efficacy profile that looks numerically differentiated from even some of the systemic therapies. So really exciting and looking forward to that. Progression as a reminder, expect that SMDA to go in early next year and expect the launch sort of later next year. Finally, on the program side, I just want to give a reminder of the upcoming data in brepacitinib. So brepacitinib is a really exciting drug to me. In some ways, it had been sort of sitting in the shadow of, I'd say, the TO1A and FCRN programs, but it's an incredibly effective agent. We have now six positive phase two studies with some of the best data that's been shown across the JAK or TIC2 classes. I think we have the single best numerical remission rate in Crohn's disease, for example, that we talked about on the last call. So just a very potent, kind of a big gun agent for inflammatory disease. We are really excited about what our plans are for the program, which include the sort of main program for which we set up here, which was the registrational study that we're running from MISitis at REIT in 2025. But more importantly, near term, we also have this phase 2B study that would be one of two pivotal in SLE. Reading out this quarter, you know, we've talked a lot about some of the challenges in SLE, and that's not the sort of main or at least the sole focus of the program. But if it works and if it generates what we think it should be capable of as an agent, That's an indication that is in need of highly effective therapies, and we think if we can beat the sort of the equivalent bar that we've set for ourselves, we will have a really big opportunity to benefit patients. So, we're looking forward to it. There's obviously potential beyond that, including another data set. We have a proof concept study in non-infectious uveitis reading out in the first quarter of next year, as well as the possibility to run a study in hydrodentita suppletiva, which is an area that's attracted a lot of attention recently. So really excited for Brexit. On slide 24 and 25, we just have a reminder of the study designs in each of SLE and the NIU study reading at the beginning of next year, both of which we're really looking forward to seeing that data and sharing it with the world. So I will wrap up here as a relatively quick update. Just a reminder of the financials on slide 27. I won't read all of the numbers on here, but You know, relatively straightforward quarter and excited again for that $7 billion consolidated cash balance, giving effect to the closing of the deal, which would put us in a very strong position to do lots of great things in this next phase of our life. So I won't go through the full catalyst roadmap again on slide 29. other than to say 2023 was a huge year for us. It will be hard to top in 2024, but we are definitely going to try. And we're excited for quite a lot of data that's coming our way to help us out. So with that, I will say thank you to everybody. Thank you to the entire team at Roivant, to our investors, to everybody who helped make this quarter possible in this year of date. And I will hand it back over to the operator for Q&A.
spk05: Thank you. As a reminder, to ask a question, please press star one one on your phone and wait for your name to be announced. To withdraw your question, please press star one one again. Stand by as we compile the Q&A roster. One moment please for our first question. Our first question will come from David Reisinger of Lyric Partners. Your line is open.
spk07: Yes, thanks very much. Good morning, Matt and team. So I have a few questions. First, obviously the TAMA scripts have flattened for many months now. Could you talk about prospects ahead and whether we should really assume flattish scripts in calendar 24 or do you think there might be drivers for prescriptions to grow ahead of the addition of ad to the label at the end of calendar 24 and then second clearly management has shown an exceptional ability to acquire highly compelling assets and create tremendous shareholder value. But now the company will have a huge amount of money to work with and probably faces undue pressure to, you know, put that money to work quickly. So could you just talk a little bit about, I guess, you know, how the company can, you know, effectively time putting money to work in exceptional business deal making in short order, i.e., you know, it's really not up to Roivant when great assets are up for sale and when Roivant can acquire them. And so how are you balancing considering transactions with what may be you know, pressure to put cash to work. Thanks so much.
spk09: Thanks, Dave. Those are both great questions and appreciate your listening this morning. You know, on the camera, and this is in truth, in all of my conversations, investors have not been a significant investor focus of late. But obviously, we agree that scripts have been growing, as I said earlier, slower than we would have hoped. You know, we continue to see growth in demand. I think if you look quarter over quarter, it's growing every quarter. I would expect that to be at least steady over the coming quarters. We have some ideas about how to create some inflection. One of the main pieces of feedback that we continue to get from prescribers is concerns about coverage and the patient experience, especially at some of the larger pharmacies like the Walgreens, where the middle of the distribution docs who are writing fewer scripts tend to send patients. In fact, our coverage position is very good now. It is at least as good as really any other topical, and we think patients who show up at the pharmacy are very likely to have a good experience. So, you know, I think there's a little bit of a perception gap there that we are working to close, and we're continuing to experiment with other demand generation tools, including DTC. So I'd expect, you know, as a base case, I would expect sort of continued progression at about this pace until the AD launch, but there's certainly the possibility for better, and we're working on it. You know, I'd say two other things. One is Navy Launch is a really big opportunity. Obviously, the patient size is much larger. I think the program is on a path to being a source of non-dilutive financing, if that's what we'd like for it, and that's through either as it ramps to profitability, which we think it will continue to do, or through other means, partnership, et cetera. And the only other thing I'd say is I think in the spirit of your second question, I think one of the reasons we say we're going to be patient here is we don't want to make the mistake of having a lot of capital and therefore spending it kind of by default or by fiat. And so we are evaluating every dollar that goes into every one of our programs, including the camera critically and making sure that we're spending those dollars in a place where they're going to be most, uh, most valuable. That said, again, I think as the camera ramps profitability, uh, it'll be quite as useful, uh, a useful baseline for the business. So, you know, that's on the, on the first question, uh, on the second question, uh, I expect I'm going to say this a few times today, but we really believe that patience is an asset. We believe the ability to be patient is important. We think that is what's going to get us the best opportunities. We think it's what's going to put us in the strongest position to take advantage of, as you said, we don't control exactly when the great assets become available, and we don't want to be in a position where we miss something because we do something else that's not quite as good. As you know, we're being very thoughtful about what we see. The truth is that we see some really great opportunities. As I said, we see some opportunities that are, in my opinion, every bit as exciting as the TL1A or a number of our other programs. So there's certainly the possibility for near-term deployment of capital on something like that, but I think you will see us be patient because we think it is a huge advantage, especially in the current market with so much available, to be patient. You know, I think that's as many times as I can say the word patient in one sentence, but we feel good about that. That said, we're not going to go into a dark period. We're going to continue to update the street regularly on where we're at. We'll continue to talk about our plans. We'll continue to talk about capital deployment as we see the SLE data, as we see some more of the FCRN data, as we get some transactions done. So I would expect continued updates. We're not asking people to trust us in silence. We're just asking to come along with us on our capital deployment process.
spk07: Great. Thank you.
spk05: Thanks, Dave. Thank you. And one moment, please, for our next question. Our next question will come from Brian Chang of JP Morgan. Your line is open.
spk01: Morning, guys. Thanks for taking my questions. First, on Prevost-Sinniff's upcoming Phase II data in SLE, Matt, you talked about the difference of sort-theroid tapering between the study compared to Ducras Phase II. Can you talk about just how might that impact the readout? And given SLE is a heterogeneous indication, are there other variables that we should also consider that could impact the outcome ahead of the readout? And then I have a follow-up. Thank you.
spk09: Yes. Thanks, Brian. We're obviously tremendously excited about REPO, and those are some of the right questions. You know, SLE is an important disease. It's a tough indication historically for a variety of reasons. A lot of, as you say, A heterogeneity in a patient population is a lot of variability in things like placebo response rates. You know, we're generally happy with the study design. It was designed that Pfizer put in place that's been only slightly modified since we took the program on, and Pfizer has been executing the study. I would think it's a good design. As you noted, there are some modest differences in the mandatory steroid taper between our study and the gravisitinib study, but they will have mandatory steroid tapers. So, in many ways, they're more similar than different. That said, there is a lot of variability in general, both in placebo response rates and in studies across the board. And so for that reason, I think we're just being appropriately measured in what we signal here. But, you know, in short, I'd say the agent looks to us as good biologically as any agent in SLE could at this moment, at least as a small molecule. And the study design is a solid study design, so sort of in the hands of SLE states. at the present moment. Mayuk, anything you'd add?
spk12: Yes, sure. I mean, I think you hit most of it, Matt. I think what Brian has well appreciated. It's a heterogeneous disease, and there's a lot of different subtleties and nuances to, you know, really every trial. And You know, you asked about steroid paper. I think a couple other factors, you know, might be, for example, just to give you a sense of things that are different or slightly different in a trial. And each of these sort of contribute in their own different ways. But, you know, severity of disease at baseline, so baseline flea dye or things like baseline steroids, you know, all sort of contribute to the best.
spk01: And also just on Graves' readout later this quarter, Can you help us set the expectations there? How does success look like to you? And, you know, given it's a single-arm trial and the first FCRN program in graves, how do you think of the success rate? You know, how do you think of the read-through coming from efficacy of FCRN showing in other indications?
spk09: Yeah, thanks. This is a great question. We're tremendously excited about what graves could be I'll take it, and then, Frank, I'll hand it over to you if you've got it again. The Immune Event team has spoken about this. You know, Graves is pretty straightforward biologically here in that it's relatively well understood to be autoantibody mediated, and there's a clear biomarker in thyroid hormone levels that you're looking to normalize. So I think the data will tell us what we've got. I think we'll have a clear sense of what we've got. I think what we're looking for is relatively high rates of normalization of thyroid hormone levels, and we're also tracking people's ability to get off oral antithyroid drugs. And I think we will have a pretty clear answer to that question from this data. Frank, anything you'd add to that?
spk11: I would say as a bar, as we've talked to KOLs, they've said, look, if you can get patients, you know, about 50% of the patients to normalize thyroid levels, that would be very clinically meaningful to them. And so that's a bar we look to as, you know, a level of importance.
spk01: Great. Thank you so much. Thanks.
spk05: Thanks, Brian. Thank you. And one moment for our next question. Our next question will come from Yaron Werber of TD Cohen. Your line is open.
spk10: Great. Thanks for taking my question. So I also have a couple, one on breatho and then another on just an immune event. So for breakfast, maybe just to Follow-up, for lupus and definitely for noninfectious uveitis, that's definitely more, a little bit less competitive. Where's the bar for you in lupus? Is it, we sort of have a good sense already what the safety profile of Brepo is. So is it mostly on the efficacy side as you're looking to differentiate? And for noninfectious uveitis, sort of what do you want to see to continue forward and then have a quick follow-up?
spk09: Yeah, I'll take the SLE question. Mayuk, maybe I'll hand it over to you for the NIU question. You know, on SLEM, I think we've said this before, we think the safety profile of REPOs is, as you've said, well understood. We've been in well over 1,000 patients. We have a lot of data. It is, you know, effectively JAK-like from a safety profile perspective, and we expect the FDA to treat it like a JAK inhibitor so it will have the appropriate labels and so on. So, you know, I think that's pretty well characterized. I think for us it's about efficacy. I think we feel the bar has been set by the Ducra studies, which are the current sort of best oral data in a large late-stage program that we've seen. Our view of the bar that Ducra sets, adjusting for some pretty significant imbalances in their dosing arms, is like a mid-teens SRI-4 placebo-adjusted delta, and so we'd like to do kind of better than that in order to feel confident about progressing the program, but it'll be a balance of the factors. We'll look at multiple endpoints and so on. You know, on... On NIU, I'll hand it to Mayuk. I think we sort of laid this out on the last call, but Mayuk, please go ahead.
spk12: Sure, sure. So I think, you know, we'll make an overall assessment. This is, you know, kind of a signal-finding study here, really. We're looking for a treatment failure rate of no greater than 70 percent. The treatment failure rate is quite high. and not on treatment, and so that's a good bar. And overall, I think really the bet here across these indications fundamentally is on efficacy, and so that's the thing that we're really looking to hit robustly.
spk10: And just to clarify, the NIU study you're running, right? It's not Pfizer. That's right. That's right. That's our study. Okay, great. Yep. Okay, and we've gotten a lot of questions, and I know you have as well. When you guys announced appeal when they deal with Roche, I think the word you used was ruthlessly monetized, the immune offense take. Can you just help us understand kind of philosophically or conceptually how you're thinking about that? Thank you.
spk09: Sorry, I apologize. You cut out literally, as you said, what word we can use, something monetized?
spk10: I think it was ruthlessly monetized, the immune offense take.
spk09: I think we said it would be ruthlessly economic about the unit of end state, is what I think I said, although we can go back and look at the transcript, but I think that's true. The way that we have always thought about this is we're going to do what maximizes value. We think the FCRN program is as good a program as biotech has to offer at this point. It has true best-in-class potential, numerically evident best-in-class potential in an area where IGG has been a phenomenal biomarker for clinical efficacy and where we have really exciting IGG suppression with a clean safety picture as what we can tell so far. So, you know, I think that program in our hands without monetizing it could be the basis for, yeah, one of the great I&I biotech companies of the next generation. And we are excited and fully resourced to progress that program that way. But along the way, as we've shown historically, we're going to evaluate options and we're going to make sure we understand the competitive landscape and understand the strategic options available to us. And we're going to be ruthlessly economic in assessing that position. And that's just who we are. Thank you, Ron.
spk05: Thank you. And one moment please for our next question. Our next question will come from Corrine Jenkins of Goldman Sachs. Your line is open.
spk03: Yeah, good morning. Maybe a couple from us. First, you mentioned the commercial potential you see with Graves' disease. Could you just step us through how you're thinking about the market opportunity there? And in particular, which patients within Graves' disease do you think are candidates for new therapeutic agents?
spk09: Yeah, perfect. Thanks. And I'll ask Frank to add anything if he's got anything after I give a first cut here. But look, this is a large indication. It has hundreds of thousands of patients. And our study is on patients who are uncontrolled by ATDs. That's the existing study. There's a pretty significant percentage of patients. By some accounts, 40% to 50% of patients on ATDs do not wind up fully controlled. So there's hundreds of thousands of uncontrolled patients. You know, surgery and radiation are effective, but surgery and radiation are complicated and not everyone wants to sign up for that. So uncontrolled patients currently don't have a great therapeutic option. There has not been real novel drug development in grades for a long time. So we think this is a, it's one of these indications where there's just a very large patient population that has unmet need. And if you talk to these patients, they're clear about that. Frankly, some of the patients who are controlled on ATDs still feel like they have symptoms, although we're obviously going to start with the uncontrolled patients. So we think this has the potential to be just a really, really large market that people are not appreciating because it's been a while since you've been developing. The only thing I'll add to that before handing over to Frank is, you know, there's sort of an interesting dynamic here where we've been severing this data, and in some ways, the better the data is, the more closely we may need to keep some of it to the vest because You know, we've said before, anyone's face to study is everyone's face to study, and that works in our favor in many other indications, but it's just something we need to be thoughtful about here. But in short, we think the commercial potential is really, really large. Frank, anything you'd add there?
spk11: I think you've covered most of the important parts. I mean, just to restate it, you know, there is a substantial opportunity in patients who are antithyroid medicine refractory patients. And there is a very large, both incident and prevalent population of patients who are just not getting enough benefit. This is a category of medicines that hasn't seen meaningful innovation in the disease state in decades. And so there's a ripe opportunity to come into something that really matters and disrupt that. And we'll look forward to talking about it in more detail soon.
spk03: Great things. And then And you mentioned anyone's Phase II programs, everyone's Phase II programs, and maybe that's a good segue to the data over the weekend in rheumatoid arthritis from J&J, I guess. What were your takeaways from those results, and how are you thinking about the read-across to your own program and plans in rheumatic disease?
spk09: Yeah, perfect. So, in good event, we'll obviously speak more to this consistently over time as we can as we lay out our study plans and get everything geared up. I continue to feel about the J&J RA data the way that I felt when we had first seen the abstract, which is it's tremendously exciting to see an FCRN show signs of activity in an immune complex disease, and it opens a large envelope of what could be possible. You know, I'd say like this data in and of itself needs some work to better understand and characterize, and J&J is doing some of that work. You know, I think encouraging signs include that, you know, the response rates look pretty solid, specifically in patients who have the autoantibody measured. And the sort of efficacy is well correlated with autoantibody suppression. And as we would have talked about before, you know, I think one of the things that's interesting about nipicalumab in this study is it was, it seemed to us somewhat underdosed. And so they really only got to, I think it was about a 58%. present suppression of IgG, and I think lower than that on the autoantibody. And so I think it's sort of possible to understand that there is room for better efficacy at higher IgG suppression. You know, I think it is not very likely, although this is for Minivant to ultimately announce, that we're going to immediately begin a large phase three program in RA. But I think it's certainly really informative data for how how we see the FCRN class developing, and it suggests activity in an even broader set of indications than one might have originally imagined. So, I think that's kind of how we think about it. Great.
spk05: Thank you.
spk09: Thank you.
spk05: Thank you. And one moment for our next question. Our next question will come from the line of Robin Konoskas of Truist Securities. Your line is open.
spk02: Hi, guys. Thanks for taking my question. And I love the word ruthless economic. I think that's a great, great term for a company to use. So I have three. So first, you just mentioned grays. I may have to keep some of that data close to your vest. How much data would you release or would you just say the results were positive and you're moving forward? A second question is really about the other comment you made about but Thomas may shape up to be an opportunity for dilutive financing. And given that you've sold assets before, how do you think about running the company and thinking about, or you can be just a, um, like a breeding ground where you get drugs developed and then you sell them and then you have some that you keep and how do you figure that out? And then the last question is on the Tama. Um, you've mentioned gross margins of 20% are relatively flat, hoping to go see over time. How, you know, what's influencing the gross margins? Are you still sampling? Is that still influencing that? How do we model those? How do you help us model gross margins over the next, say, 18 months?
spk09: Thanks. Yeah. Thanks, Robin. I appreciate you're listening. I appreciate all of the great questions. You know, the first question I'll say, having not yet seen the GRAVES data, it's hard to say exactly what we would disclose about it, and it probably depends a little bit on the data and exactly what we see and the contours of the outcome. But, you know, I think the full range is on the table in terms of when and how we share that data, other than we expect to get the main thrust of it in the relatively near future, and so we'll be able to say something, I'm confident, that'll be helpful. You know, on the other two questions, I guess I'll take the bigger strategic one first, and then I'll come back to sort of the TAMA GTN progression. We are here to build a – great, durable, long-lasting, important biopharma company that delivers medicines to patients. As we did with Vitama, that will mean that we commercialize products. As we did with the T01A, that will mean sometimes we partner or monetize them. And, you know, you use the phrase again, you know, we're going to be ruthlessly economic in deciding which of those. Again, just to be clear, we meant non-diluted financing in terms of Vitama. And I think the nice thing about Vitama is that In the event that we monetize it or partner geographies or whatever, that's one source of non-dilutive financing. In the event that we don't and build it into profitability, that's a steady stream of free cash flow out into the late 2030s. There's a different source of non-dilutive financing. And on top of that, we've learned a tremendous amount about commercialization. We've built some infrastructure. We've got distribution agreements and things like that that should be leverageable if we add additional products. And so I think overall the launch of Ecamm has been an important formative experience for us. We are excited to continue to see it play out. We're excited to get the AD launch up and running. And I am confident we will commercialize many products in our long life from here. On sort of GTN trajectories, I think we're largely through contracting. And so the things that are going to drive GTN from here It's not sampling per se. We've never had a sampling program that meaningfully affected our yields. You know, it's getting patients onto the right side of the copay card, and it's getting more patients into a covered position at pharmacies like Walgreens and CVS and so on, which is all groundwork at some level. It's just getting out there and talking to docs and working through the issues to make sure the patients are getting on drugs. So I would model, you know, steady improvement in GTN yield over time, you know, maybe at around or a slightly faster clip than the one that we've had in recent quarters. And I would expect that to sort of continue to build up to, you know, that's kind of 40 plus and getting to 50 eventually, sort of steady state that products seem to get to. You know, I think some of the dynamics of the past couple of quarters with new contracts signed have created a little bit of volatility in the progression, but I expect it to be pretty steady from here.
spk02: And one follow-up is just on 1402, using the word ruthless. It seems like with so many different indications you can go after and how aggressive your competitors are spending money toward all these indications, how do you compete with them? Like, how do you compete if you just go into indications where they're not going? It seems like it's just such a competitive space. Even though you have a best-in-class, we can argue that you have best-in-class drug, you know, how... Do you expect to run, like, 20 trials? I mean, how do we think about your plans for 1402, given the clinical landscape?
spk09: Perfect. I mean, I think the first thing we do to compete is monetize an anti-TL1 antibody and generate quite a lot of capital, which puts us in a strong position if we ultimately need to run 20 trials to be able to do that. So I think we're in a really good spot from that perspective. You know, again, I think we're going to be – capital efficient as we always try to be, I think we're going to be thoughtful about where we go. In terms of exactly which indications and how we compete, I think we have to be aggressive, and I think we're positioned to be aggressive, and I think it's a huge opportunity if we are aggressive. I think first and foremost, we have some clear white space in front of us with Graves' disease and some others like it that we'll carve out as ours. And I think that will give us a real foothold. And then I think the second thing is to really line up all of the other Phase II studies that anybody is doing and decide which of those we want to use as guidance for our own pivotal programs so that we stay close to the front of the line everywhere that matters. So I think that's sort of how we're thinking about it more generally. But there's multiple first-in-class opportunities, and we have the capital to deliver on it.
spk02: Great. Congrats, and thanks for the questions.
spk05: Thank you. Thank you. One moment, please, for our next question. Our next question will come from Louise Chen of Kantor. Your line is open.
spk04: Hi. Thanks for taking my questions. So I wanted to ask you, as you look to grow the company, what therapeutic areas do you see the most unmet need in? And then what areas do you think might be a little bit too crowded? And then secondly, on the HS indication for FREPO, have you decided if you're going to move forward with it? And if you have, when do you think you'll start those studies? And then just lastly, on 1402, just curious how you're thinking about the first indication you're going to go after. Thank you.
spk09: Yes. So I'll go in reverse order there. So, you know, the first indication that we've disclosed as a 1402 indication has been grades. So our plan, if that data is successful, is to progress in Graves, although we're working on lots of other things that we just haven't talked about yet, so I'll leave it to Univant to give specific updates at their cadence. On Bravo for ATS, I think we have not made a final decision yet, and so there's no specific plan, study start timeline. We're in a pretty close to ready position in terms of the basics, but we need to actually start a study if we're going to start a study. I think the SLE data will be informative. in terms of thinking about what pairs with what and just how to develop the franchise. So I think we'll probably come back with a little bit more of an update on that after either the SLE or the SLE and NIU data. And then in terms of therapeutic areas where we see the most unmet need, we've always been therapeutic area agnostic. We continue to be therapeutic area agnostic. There is unmet need for patients in every therapeutic area. That's clear. Some areas are more competitive than others. Obviously, this is going to deal with a lot of activity in I&I, although it's It's also proven to be a year where some mechanisms have had an easier go of it than others in INI. So, but we're looking across their precarious landscape and are really open to anything.
spk04: Thank you.
spk05: Thank you. Thank you. And one moment please for our next question. Our next question will come from Douglas Soto of HC Wainwright. Your line is open.
spk06: Hi, good morning. Thanks for taking the questions. Just maybe as a starting point, Matt, if you could provide some color on the time. I know you sort of indicated physicians were having some questions or sort of misperceptions around the coverage. I'm just curious what feedback you've gotten from a clinical standpoint, both the positive and negative, and what sort of things you might need to correct. within the physician community to perhaps sort of jumpstart growth within psoriasis. Thank you.
spk09: Yeah, perfect. So, on the fair side, you covered it well. On the clinical side, we really have a little bit of a tale of two cities where we have docs who use it quite a lot in their practice and love the drug, report constantly positive both patient feedback and their own feedback in terms of how it helps them to have a real steroid alternative with this level of safety and efficacy. And then we have docs who are writing, you know, I'd say like six or fewer scripts a month. We bucket them in a couple of different ways. And, you know, I think those docs are still sort of experimenting. And so we get different feedback. I'd say like we're not getting a lot of like specific negative perceptions that we need to counteract. I'd say the main thing is these are docs who, because they've only used the product a little bit, have not sort of figured out how they want to think about it vis-a-vis steroids. And so if anything, the feedback is, yeah, this is a great product, but steroids are pretty good too. And so I think that's what we're sort of most actively working on is how to help those docs sort of see the benefits versus start to see the remittive benefit, see the tolerability benefit. You know, the intertrigenous data that we just put out here is potentially helpful to support our position, although we've always had good data there. So, you know, I think those are the kinds of messages that matter. And it's really about working on continued strategies to convert those docs into to the kinds who write it more. So, you know, as I said, we're hopeful about the work that we're doing there, but I want to be measured given what we've seen over the past, call it, five or six months.
spk06: And that maybe as a follow-up, and I know you touched on it a little bit on the Televac call, but just given, you know, your sort of what your capital position will be, does that change the sort of opportunities that you look at and sort of the commitment that those would take be it either from a development standpoint or as well as ultimately a commercial standpoint in terms of the infrastructure needed to support them? Thank you.
spk09: Yeah, I think the short answer is it just puts us in an incredibly strong position to do anything. And so commercialized drugs, developed drugs, we feel like we have the capital to pursue the biggest opportunities aggressively. I think we are still frugal by nature, and so I think it's still hard for us to stomach large upfront capital commitments generally. And so I think that's probably the one thing where if we do it, it'll be for something really special. But other than that, I'd say the main way I think about the capital is it just lets us do more. And I think I've said this in a couple of places now, but in hindsight, it doesn't seem like it should have been. But the decision to pursue the TL&A program a year ago was not a totally easy decision. at least not for our entire team, because those would have been expensive phase three studies. And we were doing it at a time where everyone's access to capital and their own access to capital were somewhat limited. And I think I don't want to be in the position next time of tiptoeing around an opportunity that is that good. So, you know, I think having this capital base and being able to put it to work really gives us strength in those kinds of discussions.
spk06: And that may be just one follow-up, final follow-up for me. You know, over the last couple of years, we've seen sort of a progressive de-emphasis on some of the internal drug discovery efforts by the company. Does that, do some of those come back into focus a little bit more, just given your cash needs or cash position is so much stronger? Thank you.
spk09: Yeah, I think the evolution of that exercise in general for us has been a positive one. You know, it's been challenging at times, but I think we've got some bets on right now at Vantai, at CoVant, that we are excited about. And one of the things we like about it is I think we found very capital efficient ways for that work to be funded through partnership or by outside capital. It's just that we have a lot of optionality on success, but it's always been a pretty small piece of our burn. And I'd say it's gotten significantly smaller over the past couple of years as our late stage pipeline has come into sharper relief. I don't candidly expect that to change significantly in the near term, just because I think we're pretty well set on how those businesses are running, and we like the way it's set up.
spk06: Okay, great. Thank you.
spk05: Thanks, Doug. Thank you. And one moment, please, for our next question. Our next question will come from the line of Yatin Sineja. of Guggenheim Securities. Your line is open.
spk08: Evan Sadio- Hey, team. Good morning. This is Evan Sadio on for Jotun. Thanks for taking our questions. Two for us. First is on Brepo, and then I have another one kind of on broader strategy. On Brepo, how would your POS change for dermatomyositis, you know, if you didn't meet the bar, the Ducra bar in SLE? And then from a strategic standpoint, you know, when you're thinking about the potential progression of Royvent to a $20 to $30 billion company, what proportion of the growth comes from the existing pipeline that you already have versus an external, you know, BD opportunity? So, in other words, you know, do you have to bring in an asset or two to reach that future valuation?
spk09: Yeah. So, I'll start with the BD. with the first one of that, which is I don't think our view of the POS and DM would change at all, depending on the outcome in SLE. The biology of BREPO is very clear. We have six positive, large, well-run phase two studies, and SLE is known to be a fickle place. So I think overall, there would be no change in our view of BREPO's likelihood of success in DM as a function of any kind of outcome in SLE. Honestly, in either direction. If DREPO works great, necessarily, I'm not sure it will materially affect our view of probability in DM. At this point, DREPO has presented itself as an agent, and it's just a question of finding the right therapeutic application for its profile. So, that's on that question. On the general strategy, and I can't say this clearly enough, If we never do another VD deal, and that is not us, we are definitely going to do more VD deals, but if we never do another VD deal, we are sitting on, we think today, the most exciting late-stage INI portfolio between FCRN and Breppo and Vitama and others. And there is no question in my mind that, frankly, I mean, we know this from our competitor, FCRN alone can support that kind of value creation. let alone a drug like prepacitinib, which certainly, again, pursuing a different strategy, but RINVOC is on track to do fantastically well. And I think we have an agent that has some real competitive advantages versus RINVOC with the two activities. So I think there is no question to me that we don't need to do BD for the next major leg of growth for us. That said, practically speaking, if you're asking me what I expect, I expect to see significant value creation outside of our late-stage pipeline as well, in new opportunities, just because we've always been active, because the opportunity set is literally as rich now as it has ever been in terms of the quality of things that we see, and we expect to take full advantage of that given our current capital position.
spk08: Thank you very much. Appreciate it.
spk05: My pleasure. Thank you. And this will end the Q&A portion of the conference. I would now like to turn the conference back to Matt Glein for closing remarks.
spk09: Yes, thank you. I just want to say thank you again to everybody, to the Roivant ADVANCE teams, to all of our investors, to the patients and investigators in our studies, to our partners. It's been a phenomenal year. This is probably not the last time we'll get on the phone together, given the amount of data coming. But just want to thank everybody for following along on what has felt like a really exciting moment for us. So if we don't talk before Thanksgiving, and I guess, again, it's possible that we will, but if we don't talk before Thanksgiving, have a great holiday for those who celebrate it, and I'm looking forward to getting on the phone again soon. Thank you very much.
spk05: This concludes today's conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.
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