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spk12: Good day and thank you for standing by. Welcome to the Roy Bent Third Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 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.
spk02: Thank you. Good morning, and thank you for joining today's call to discuss Royvan's financial results for the quarter ended December 31, 2022. Presenting today, we have Matt Klein, our Chief Executive Officer. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing news results on our IR website at www.investor.rogan.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation that reflect our current views and expectations, including those related to our financial performance and the potential attributes of our products and product candidates. We strongly encourage you to review the information that we filed with SEC, including the earnings release and the Form 10Q file this month. For more information regarding these forward-looking statements and related risks and guarantees, we will begin with Matt Glines, who will review key business updates and provide a financial update. We will end the call with a Q&A session. And with that, I'll turn it over to Matt.
spk08: Thank you, Steph, and thank you, everybody, for joining this morning. I'm pleased to present our third fiscal quarter financial results for the quarter end of December 31st, 2022. Yeah, thank you. I'm excited to be able to get together. This will be a relatively shorter update because, frankly, we've had a very busy quarter, and so we've taken a few opportunities to get together. It's hard to believe, but actually it was after we last had a quarterly update call that we in-licensed and then published data for RBC 3101 as well. We pre-announced certain of our fiscal results last week when we did a financing update. or two weeks ago. So again, thank you, everybody, and looking forward to hearing some updates, and in particular, have some interesting updates to share around the commercial launch of the TAMO. So I'm going to start out just quickly on slide five, reminding everybody, because it's still early in 2023. We are very excited about this year. You know, the year started off strong for us with the announcement of our RBT30-101 data, the data for our NCPO1A antibody from the induction phase of our ongoing phase 2 study. We expect a number of really important updates from across the business, including we'll talk more literally today about continued reach and payer coverage of the CAMO, which we expect over time to translate over the course of this year into continuing to improve gross net yields and SRIPs. We can now say both the ADORING-1 and ADORING-2 atopic dermatitis studies are fully enrolled, and we expect to share top-line data from those studies from ADORING-2 in March of 2023 and ADORING-1 in May of 2023. important data from our AD program coming very soon, which is exciting because it opens up a market. We'll talk a little bit more about this, four times the size of the market where we're currently in psoriasis. We expect data in the first half, right closer to the middle of the year than the beginning, from RVG3101, our NGTO1A antibody, from the chronic dosing period of that trial, the 52-week data, which we think is important data. We think the first time anyone's reported meaningful 52-week data for an NGTO1A antibody. So we're looking forward to sharing that whole data set when it's available. In the middle of this year, as I know many are watching, we will have human data from our next generation anti-FCR and antibody IMGT-1402, which will, if successful, leave us with, we think, the best anti-FCR and franchise in the category, at least potentially the best with two drugs, both with maximal suppression of IgG, as well as with IMGT-1402, potentially no impact on albumin or LDL. And then finally, among the major announcements in the fourth quarter of this year, we expect to produce pivotal data from one of two potential pivotal studies in brevisitinib and SLE, our dual inhibitor PIK2 and JAK1, which we think has the potential to be some of the best data, as we talked about before, that the world has seen in SLE. So excited to share that data when we've got it. So with that, I'm going to start today with an update on the commercial launch of BCAMA, which we continue to be just incredibly excited for. And I'll start on seven with just a brief review of financial results. Some of this, as I mentioned, we disclosed last week. A near doubling of revenue for the quarter, with revenues now at $9.2 million in our second quarter of launch. And one thing I'm particularly happy to report, we've seen already early improvements in our gross net yield from 12% in our first quarter of launch up to 18% as the quarter just ended. And, you know, I think, and we'll talk about payer updates in a moment. I think with continued payer updates, we expect to see that number continue to improve over time here. We are really happy with the continued level of patient and physician demand for the product. We continue to get great feedback more or less across the board. And the demand's really had a, as you'll see, a positive impact on our ongoing payer conversation. So, yeah, really excited about how that launch is going and excited to continue to share updates as we get into, you know, the calendar year. You know, on slide eight, we continue to be the number one branded topical. We have been since our eighth week of launch. After a little bit of choppiness around the holidays, we're excited to see Scripps return to growth, and we are optimistic for the trajectory from here as we look forward. And, yeah, just really excited with what these Scripps volumes mean for patient and doc enthusiasm and payer enthusiasm. But perhaps equally, and I show this slide pretty often on slide nine because I think it's a great slide, This is really just the beginning for us, right? In the most recent disclosed IMF suite, we did about 3,800 scripts, which is a great number for this stage of our launch. But remember that even in psoriasis alone, there are 90,000 topical prescriptions every week, of which the vast majority are topical steroids. And once we get our atopic dermatitis data and have access to that patient population, there are well over 300,000 atopic dermatitis prescriptions every week. again, the vast majority of which are topical steroids. And in psoriasis, our data conclusively, in our view, establishes us as both more efficacious with a limited benefit than topical corticosteroids, as well as meaningfully safer and better tolerated. So we're looking forward to sharing that profile on atopic dermatitis and looking forward to, you know, continuing to push the dials and levers that will allow us to grow into those very, very large opportunities. a quarter of solid execution for the DERMAVAN team. As I mentioned before, both atopic dermatitis trials on slide 10 are fully enrolled. And again, with those readouts expected, the first one, adoring two, expected in March 2023, and adoring one expected in May. So important clinical data coming. And we continue to expand high-quality formulary access. And maybe I'll just provide an update on that on slides 11 and 12. First of all, I'm pleased to say at this point, we have 57% of commercial lives covered for VITAMA that's close to 95 million lives. That includes an addition of a national PBM formulary, two national health plans, a regional PBM formulary, eight Blue Cross Blue Shield plans, and one national PBM that actually lifted its new-to-market block ahead of a review so that we have good coverage across those lines. So these, in many cases, are decisions being led by the medical teams of these payers who are so enthusiastic about the medical profile of the TAMA and what it offers to patients that we're making really, really good progress on coverage. I have a couple of examples on slide 12 that I think sort of drive home the point around quality of coverage. And I'd say, look, multiple factors have driven this progress, including a ton of patient and physician demand Payer judgment, as I mentioned, in the medical teams on fundamental clinical value. Overall prescription volume is a lot of hard work from our team. Some representative examples, you know, one of the major PBMs lifted the new-to-market block and requires only a single step at it through a topical or a vitamin D. Another major PBM added us to formulary and requires a step from two, either a topical, steroid, vitamin D, or a combination. A regional PDM has added Vitamma with no restrictions, edits, or steps at all. So in effect, sort of on parity with generic steroids. Two national health plans cover Vitamma with a step through any one of, sorry, any two of the four most common tablet therapies. And many regional plans cover Vitamma as completely unrestricted or with a simple steroid look back. And I'll add, and this is a small plan, a small regional plan so far, but there's one small regional plan that actually covers us ahead of other recently launched branded topical competitors and has this as a preferred product. And the last thing I'll say about sort of how pleased we are around the payer discussions here is, you know, we're really, not only are we happy with the coverage overall, we are consistently covered at parity or better than our topical competitors. And that's important because you'll remember there was a fair amount of discussion early on around different pricing strategies and a question around which pricing strategy was going to drive better access. And we are now very happy to report that our pricing strategy and market access strategy has achieved really high quality coverage. And we are definitely plan by plan, PBM by PBM at no disadvantage, and in some cases are at an advantage overall. So really, really happy with the payer progress here. As far as how this progresses, some of our competitors have shown good progress in analogous indications from a GTN yield perspective over time. I expect to show the same. Candidly, the first quarter of the calendar year is sometimes a little bit more difficult because of deductible recess. So I think you'll start to see more progress coming, you know, second quarter and beyond. But really excited for those developments and think that we're going to head towards an attractive commercial P&L, as we've said before, and that can now back that up with broad coverage and an understanding of the economics of those contracts. So I'll stop there on the camera, but I'm sure I'll get some questions on in the Q&A and move on to clinical execution. First of all, just as a high-level sort of observation on slide 14, we are really excited about the inflammation immunology franchise we're building here. We didn't set out to build an INI company. And in fact, we have a number of interesting opportunities that go beyond INI. But at this point, we have multiple new approvals and 10, more than 10, phase two or three data readouts coming each year. multiple data readouts, including readouts, registrational readouts coming each year between now and 2025. So massive progress over the next couple of years. Obviously, we talked a lot about the 2023 data earlier. That leads from 2025 beyond to a wave of potential additional approvals across large I&I indications with high unmet need. And we think building towards an I&I franchise that has $15 billion or more in aggregate peak revenue potential. So just a huge opportunity for us. And remember, this spans FCRN and TL1A and our TIC2 JAK1 franchise as well as VCAMA and other programs behind that. So we think this is one of the most exciting biotech INI franchises, and we're excited to build this forward, and we're excited to see lots of interest from many different borders in what we're building here. You know, you can see the late-stage pipeline on slide 15. more familiar and have discussed many of these programs before. We talked about VTAMA earlier today. We'll talk about RBT 3101 as we review that data in a second. I'm not going to spend too much time beyond that in the portfolio today, but I will say we're excited for all of the updates coming this year and looking forward to sharing them as they come in. And it is really unprecedented, at least for Royvind, in terms of the amount of high-quality important clinical data coming in for us. What I am going to do briefly, and I know many of you have heard this before, but it's an area that's been closely watched and we're really proud of it. I'm just going to review the data for RVT3101, our anti-TL1A antibody, just because it's actually, it's hard to believe this, but we first put it out only a little bit over a month ago. And so it's still new to us and still new to our story. So as a reminder, RVT3101 is a phase three ready anti-TL1A antibody, which we are currently developing for ulcerative colitis and Crohn's disease and plan to develop in other indications. This class and our agent in specific has delivered some data that we are really excited about. It's extraordinary data. It's some of the highest-end efficacy in an all-commerce population that we were statistically meaningful with meaningful clinical benefit across all the doses we tested. We further were able to enrich response rates in a prospectively defined biomarker subset. Remember that Our partner Pfizer had run a phase two study that had explored different biomarkers and prospectively identified a specific biomarker, was able to use a lot of data to sort of optimize this choice of biomarker, which covers 60% of the UC patient population. And overall, we have a great safety and accountability profile as well. We think this should be the first in class agent potentially in large and well validated markets. This was one of the largest phase two B studies ever run in ulcerative colitis. We have 300 patients dosed between this phase 2B study and our phase 2A study. And we have an important near-term catalyst that I mentioned before, our phase 2B data coming in the first half of this year for the chronic dosing phase. You know, T01A on slide 17, as a reminder, is a really cool mechanism. It's got a pretty different mode of operation where it's sort of a signal amplifier for a whole bunch of different important pro-inflammatory and fibrotic cytokines. And so it's got a sort of multiple mechanism of action across that pipeline with impact on these different parts of the inflammatory pathway, which frankly both supports a little bit of the sort of quality of the clinical data and the unique quality of the clinical data we've seen as well as the safety profile. And given the quality of our data in UC, it encourages some real blue sky thinking with opportunities that are well beyond UC and Crohn's. It's a multiple inflammatory diseases as well as other fibrotic diseases, intestinal fibrosis, pulmonary fibrosis. liver fibrosis. And as a reminder, Pfizer, in their Phase IIa publications, showed a meaningful impact on fibrotic markers associated with the drug. So I'm just going to remind everyone of the data on slides 18 and 19, starting with just incredibly compelling activity, both for our agent and supported by data from a competitor across the class here. Again, some of the best gross efficacy seen and the best placebo-adjusted delta seen across any class. We showed a 31% gross clinical remission rate or 20% placebo-adjusted delta in all comers at our expected phase three dose, or a 40% gross efficacy with a 30% placebo-adjusted delta in that biomarker population. Great data on endoscopic improvements as well. And then one of the data sets that we are most excited about on slide 19 is that we were able to preserve that efficacy in the biologics-experienced patient population with our biomarker. which is always a very difficult population. Most other classes of drugs fall over or have significant degradation of efficacy. Once you get into that patient population, placebo populations no longer respond in second line. And this is, in many cases for patients with multiple second line therapies, this is a sick patient population. This data opens us up to some really extraordinary possibilities, including, given the breadth of our biomarker, an opportunity to become a real second line agent of choice. so we're going to develop the drug for all comers we're going to see nothing from a label perspective but we are excited for an opportunity to develop this uh to help uh patients with albino marco in second one basically and all of this couples on slide 20 uh with just a a really sort of remarkably clean safety profile with almost every category being uh frankly less than placebo or certainly placebo-like at both the pool and our expected phase three dose and so you can see to hear a lot of data. We've talked about it before, so I'm not going to talk about it now. We'll have to take questions on it. We continue to be confident about the fact that that profile will hold up, both based on the preliminary internal analysis and maintenance data we've seen, as well as looking at the relationship between immunogenicity and our safety and efficacy, and we've seen a relationship there. So with that, I'm going to end the clinical and business update portion of this. We're not going to talk more about other programs today. I'm just going to give a brief financial update, and then we'll open the line to Q&A. So we had a good quarter financially as we discussed. We had adjusted R&D expense non-GAAP of $117 million or GAAP R&D expense of $126 million. We had SG&A expense, again, adjusted of $116 million or GAAP of $168 million. And notably, the majority of that SG&A expense comes from government and associated with the launch of the TAMA. And then we have a very strong cash position that we continue to develop. We ended the quarter with balance sheet cash equivalents of $1.5 billion, or about $1.9 billion, giving effect to the financing we did two weeks ago, as well as expected to see the proceeds from the sale of the minorities who become a pharma, which we expect to complete this quarter. So that gives us, as we've discussed before, cash runway into the second half of 2025. We are producing a tremendous amount of important clinical data during that period across all of the programs I've just mentioned. The financing we did a couple weeks ago gives us the ability to run full speed at 3101, including across multiple clinical programs, and I'm confident we will produce some important data for 3101 along with the other programs during that window. So really looking forward to hearing those updates. I feel happy with the financial position that we're in, proud of all the work the employment team has done over the last quarter, and looking forward to taking your questions and continuing to provide, obviously, a bunch of updates between now and when we file our 10-K later this year. So thank you, everybody. Thanks for your time this morning. And with that, after that brief session, I'll turn it over to the operator to go to Q&A.
spk12: 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. Our first question comes from Brian Chang with JP Morgan. Your line is now open.
spk09: Hey, guys. Thanks for taking my question this morning. As we look into your drawing to read out next month, what should we expect there in terms of advocacy at top line? And what do you think that we'll need to see to be commercially viable?
spk08: Thanks, Brian. Appreciate the question. Appreciate your listening this morning. So thank you. what should we expect to see at top line? That's always a good question. We have not yet seen the data. Our phase 2B data was really compelling. As you may know, we showed 49% gross efficacy in an IGA responder rate at our eight-week endpoint. You know, I'd say there's a pretty wide range of what good could look like in that study. But I would say if we're in the, you know, if we're in the 40s from a gross efficacy perspective, that's a grand slam for us. And if we're in the mid to high 30s, I'd say it's a solid home run. And I'd say anything in the 30s up would be commercially sort of viable for products, given the quality of our data, the quality of our competitors' data, the quality of our safety data, et cetera. So, you know, I'd say stay tuned for what the actual data look like, but feeling excited about the opportunity and for a broad range of data that could be sort of commercially promising.
spk09: Great. And maybe just one on Retema. I think we talked previously about the potential for a DTC campaign. I'm just curious, what's your latest thought on the timing or the need to launch a DTC campaign here based on the trajectory that you see? And how important is it based on where you stand in terms of uptick? And are there any pockets of opportunities that you haven't fully tapped in yet for the Votama launch? Thank you.
spk08: Yes, thanks. That's a great question, and I'll give an answer and then interview Frank, see if there's anything to add. Look, I think, first of all, we have some DTC efforts ongoing already. They are highly targeted in specific markets or using social media. We are excited about what we've been able to show there, but it's really the earliest days in terms of DTC strategy, and we haven't pulled out anywhere near to the level of stops that we could to sort of make this a thing. For us, we've been relatively conservative here because, in our view, it makes sense to drive DTC volume only as payer coverage really ramps up so that the patients who are sort of finding out about the drug are eligible for coverage when they go to their doctors. So we're still planning for that. Obviously, our sort of patient model is different than some of the systemic therapies that advertise very aggressively, but I think you'll continue to see us being thoughtful and use targeted DTC to drive volume, and I think we have a lot of opportunity from here to make an impact. But, Frank, anything you would add to that? I think that's a nice summary, Matt.
spk12: All right.
spk08: Great. Thank you, Brian.
spk01: Great.
spk12: Thanks, Matt.
spk09: Thank you.
spk12: Please stand by for our next question. Our next question comes from Yaron Werber with Cohen. Your line is now open.
spk00: Hi, thank you. This is Joyce on for your own. So our understanding is that formularies are typically negotiated in the back half of the year, in the fall and winter for the following calendar year. So I guess our question, our first question is, are you sort of all set with your formulary additions for 2023 calendar year, or do you expect further additions? And then our second question is just on the Crohn's disease indication for F3101. I think on clinicaltrials.gov, the original start date for that was around mid-23. Is that when you plan to commence the study? Have you chosen the dose already? And are you potentially waiting for the chronic maintenance data from the UC study to select a dose? Thank you.
spk08: Okay, thanks. I will answer those questions in reverse order. So on the 3101 question on Crohn's, so there was a trial on cc.gov that Pfizer had put up that was a specific trial design. That is not the study that we intend to run, and Pfizer basically decided not to run that study around the time they got in serious discussion with us in order to allow us to design a study of our choosing. We are preparing to share information about our Crohn's plan shortly, and we'll share it when we're ready. And, you know, we'll continue to share updates on our clinical plans overall for 3101 over the course of this year, including partially after the maintenance data has read out and we've spoken to FDA about our Phase III plans and usage. So that's on that one. I'll hand it over to Frank to answer the formulary question, other than to say we are not done for the year. We have some other major formulary additions that we expect to make imminently that would have a meaningful impact on that number. But Frank, I'll hand it over to you.
spk01: Thanks, Matt. what what you said is while generally true about industry structure what we've seen with vtama and the exceptional job done by our team there at germavant is is the kind of remarkable patient and physician demand for the product has changed those cycles changed the negotiation timeline of those cycles and just generally led to a much higher degree of engagement across the board with you know those typical timelines largely not being the deciding factor for any of our access conversations. So we're really excited by that because I think it speaks to the fundamental value the product is bringing to patients and the community in dermatology.
spk08: Great, thank you. Great, thanks. And just to reiterate, I expect our sort of covered lives to increase significantly between now and the next update we provide.
spk05: Thank you very much for the question. Please stand by for our next question.
spk12: Our next question comes from Louise Chen with Cantor. Your line is now open.
spk04: Hi, thank you for taking my questions and congratulations on a productive quarter. So I had a few questions for you. First, what I wanted to ask you is that I know we're expecting some updates in the anti-FCRN space from some of your competitors, second quarter for CIDP, from J&J rheumatoid arthritis later in the year. How do you think those read-throughs will impact your thinking on your clinical development program?
spk08: Yeah, thanks, Louise. It's a great question. Maybe I'll hand it over to Mayuka if she's got thoughts after I say a couple words. Look, I think the really nice thing about FCRN as a target is that IgG has been a phenomenal biomarker for clinical efficacy. And so I think we will get a lot of information from any competitor readout that shows a relationship between IgG and clinical meaningful data. You know, I think we'll learn more about how nipicalumab's RA study was conducted and a little bit more about that when J&J chooses to share it. Obviously, the world is watching the organic study very closely. You know, one of the things that I think will be interesting for us in that study And the reason we're running a study of our own is because that study is not going to inform us on what the impact of a higher IgG suppression would be, simply because F-cortisomide can't suppress IgGs at the same level as our agents can. So we're excited to learn more about dose ranging from our own CIGP study. But obviously, there's a lot of interesting questions around the way FCRN works for that patient population that we'll learn from that study. At a high level, I think that data will be informative, and there's probably other data coming too. You know, there was a data from a competitor and a small indication just a couple weeks ago that was probably sort of new to the field and informative on yet another place in which FCRN appears to work. So that's sort of at a high level. Mike, anything you'd add there?
spk10: Not really, Matt. I mean, I think, as you said, really the home run scenario for our program and our franchise overall is to see that there is sort of validation and efficacy from these other programs but an efficacy picture that leaves room on the table for greater efficacy from our greater IgG suppression.
spk04: Okay, thank you. And then can I ask you about brevisitinib also in SLE? I know you have some data coming up, and just curious how it's performed versus some of its competitors, such as baricitinib and ducravacitinib, and what are you expecting, you know, would be considered a positive outcome for your studies?
spk08: Yeah, thanks, Louise. It's a great question. Look, obviously, we're excited to generate the data from BREPO and SLE. Obviously, SLE has been a challenging indication, and so we're approaching it with a healthy amount of respect for that challenge and understanding that Pfizer did a lot of the preliminary work and a lot of the execution on that study. That said, I think there's a lot of reason to be very optimistic here. For starters, you know, you mentioned a couple of competitors. Basically, you know, BREPO, as you know, is a dual inhibitor of TIK2 and JAK1. We have data about JAK1. You mentioned baricitinib in SLE, which was, I'd say, pretty good in phase two and okay in phase three from a top-line perspective. And then we have data from ducravacitinib, which is a little bit variable but also fairly impressive relative to the field in SLE. And then what we know is in cross-trial comparisons across other indications, and we have cross-trial data with either bari or DUPRA in each of psoriasis, psoriatic arthritis, ulcerative colitis, and alopecia, and in each of those indications, Brepo has produced sort of numerically superior data in cross-track comparison than either or both of the sort of standalone JAK1 or TIK2. This is kind of in line with how we think of Brepo, which is it's just a really big gun. It's a powerful drug that appears to produce sort of top-end efficacy, and we think SLE is the kind of population where that could make a big difference. Am I getting anything you'd add there?
spk10: No, not really. I mean, I think, look, you know, Benlisto, you know, was approved and showed efficacy, but with an SRI for Delta, you know, between 9% and 14% across all of its different studies, and in spite of that, you know, is a, you know, a blockbuster drug, I think, just showing kind of the, you know, unmet needs that is still remaining there, and we're looking forward to the results by this year.
spk08: As a reminder, that's a 52-week study. Fully enrolled as of August.
spk04: Okay, thank you. And then just one last really quick question. When do you expect to reach steady state for your growth to net for the comma?
spk08: Yes, so we haven't provided exact guidance on that. It depends a little bit on some of the final payer discussions. And then, as you've seen with top competitors of ours, it probably takes, you know, six plus months for GTN to sort of really flow through from a contracting process. So I'd say I expect to see meaningful sort of step function improvements over the course of this year, especially as you get into sort of middle and back half of the year. I'd say it's probably the case that those last couple of, like we'll see a meaningful set of improvements. At some point, it'll slow down a little bit in those last couple of percentage points of improvements, getting us to true steady state. We'll take a little bit of time beyond that. I think, you know, payer contracting gets you 80 to 90% of the way there. And then the last little bit is other things, things like distribution costs that are often sort of volume based in their contracts. So those take a little bit longer to hit.
spk12: Thank you. Please stand by for our next question. Our next question comes from Nina, the Trito Guard with Citi. Your line is now open.
spk03: Hey, guys. Thanks for taking my question. So on the anti-TL1A, I appreciate you providing some additional color on kind of next steps and additional indications, but can you just talk a little bit more about the breadth of indications that you see as applicable for an anti-TL1A agent? and when we could see some updates on that front. And then, just to follow up to the last question on the growth to net, I guess any updated thoughts on what we should expect in terms of the long-term growth to net for VITAMA? Thanks.
spk08: So, I'll take the second question first, and then I'll start on the first one, and probably will hand it over to Mike for his thoughts as well. You know, on the GTN question, We haven't given specific numerical guidance. That's been sort of a principled stance of ours because we are actively negotiating, as you can see, with probably literally dozens of payers and regional plans and some PBMs. And those discussions are all sort of active negotiations. That said, I will say it seems like the field was sort of settled on a standard answer to the question of what a biotech company steady state GTN looks like. And it seems like our various topical competitors, as well as even, you know, things like NERTEC at Biohaven or whatever, all have sort of settled on a similar answer. And so I would expect us to be kind of the same as everybody else at SteadyState is the honest answer to that question. So on CO1A in terms of breadth of indications, I think you can probably hear it from me that there's a lot of enthusiasm for where to go beyond I think in terms of timing, we will share thoughts on our clinical plan when we're ready. And because of the competitive nature of that space, we're probably going to be a little bit careful about disclosing exactly when and what we're doing from an indication perspective. But Mayuk, if you want to talk a little bit about the potential breadth there and how broad it could really go.
spk10: Yeah, look, I think we're excited. I think we've talked a bit about sort of the, you know, there's a wide range of indications for which I think at this point K1A is implicated. I think uniquely, again, both the, you know, anti-inflammatory as well as anti-fibrotic, you know, types of indications. And I think, you know, just as we've done with some of our other, you know, programs, I think you should expect us to, you know, go and strike a balance of indications that are already at this point clinically validated, as well as indications for which we, you know, will be first in class as well in novel indications.
spk08: The only thing I'd add to that is just remember, we ultimately expect to have a franchise of anti-TL1A antibodies. We have an option on the next generation compound that Pfizer has now disclosed as a bispecific antibody to TL1A and P40, which we think will have super interesting biology and potential applicability in different indications and in different settings. And so we're watching that closely, a little bit of a ways out. We're gonna get phase one data in 2025 there, but excited for the full breadth of what we should be able to do with that franchise.
spk03: Got it, thank you.
spk12: Thank you for the question. Please stand by for our next question. Our next question comes from Robin Karnowskis with Truist. Your line is now open.
spk13: Great, thanks. I just have a couple. Let me just first ask about the Thomas strips. So the nudibrand, if I'm looking at it correctly, they seem to be stabilizing. Maybe you can talk a little bit about what kind of trends you're seeing with patients. Are they seeing the remittive effects? Is this sort of a factor of of coverage or is it more about just like trends with patients and what do you expect to see going forward? And then this is sort of a question around 1402 and Immunovant. So you've got a lot of, you know, I've got a big data set coming up with 1402 and then potential RA data from Nipah-Calamab coming. And so there's a lot of questions we're getting around, you know, how much this opportunity could really expand and you'd have to maybe do a lot more trials once we see data in rheumatoid and with 1402, how does it work between you and Immunovant and deciding how broad you actually can expand the market for 1402 and the spend and, and how does it work? We get a lot of questions on MNA on whether or not, like, you know, if someone approaches you for Immunovant for that, that company, like how does it work as far as your, your factoring into whether or not that company could be acquired? Thank you.
spk08: Yes. Thanks Robin. Uh, it's a, uh, It's a couple of great questions. We appreciate it and good to hear from you. On the camera, the first thing I'll say is I don't think we believe that scripts are stabilizing. I think we think there's a little bit of chop in the last month or so, which was a combination of the holidays. And then we had winter Salesforce meetings. So we had a third of our Salesforce out of the field for each of sort of three consecutive weeks. And when we look at trends at the doc level, we are optimistic that we continue to grow in all of the important directions there. So I think You will continue to see scripts growing from here. I think the AD data, for what it's worth, has the potential to supercharge that, just in terms of drawing doc attention to what this drug is capable of broadly. But I think even without that, you should expect to see a real sort of growth focus in those script numbers. And obviously, the payer contracting progress, much of which is pretty recent, is helpful there. but also just sort of continued enthusiasm. We think we'll build script volumes from here. So again, appreciate that it looks a little choppy in the last month or so, but I think you'll see that looking better and better over time. On 1402, yeah, look, I think we agree that there's a lot of opportunity here. Our relationship with Immunavant is really tight. Frank's exec chair. We work incredibly closely with them on indication strategy. Obviously, their team is experienced and thoughtful and has a lot of great ideas. And we try and bring the best employment to the table as well so that we're bringing all the best ideas up for consideration. A lot of ideas for where that could go, obviously, both internally and externally. And so we learn a lot from the field. You know, as far as M&A is concerned, look, it's fantastic to be in a category with so much therapeutic relevance and to see that opportunities are growing frequently as our competitors and we show new data. You know, I think it's fair to say we are an economic actor as far as how we think about Immunivant and understand the great appeal that FCRN will have as a target for many big pharma companies. So, I think it's fair to say, while we would be involved in any discussions, that we will act thoughtfully and rationally as we hear anything.
spk13: And just to follow up there, and this is really a stupid question, but, like, can you stop it, for example, to say if someone approaches and they have a, you know, an offer for immune advance, they're interested, and I just ask, because I get this question a ton of times, like, you know, how does the relationship between Roivant and Univet work if that situation were to unfold? Sorry to follow up like that.
spk08: No, it's good. And I appreciate there's a lot of questions about this stuff. But the simple answer is that we are a majority shareholder, like any other majority shareholder. And so we have mechanical voting control. But as I said, we're an economically rational actor. And so I don't think the question of whether we could stop M&A winds up being a particularly relevant question to the way that we expect any situation to develop.
spk13: Great. And one last one. So you really have done a good job of talking about all your programs ongoing, a lot of catalyst-driven, but we go back to the original format of Roivant with having an engine that produces drugs. What are your thoughts on how we should view the cadence of new VAMPs coming out of the company this year when you have so much data coming out and there's so many big opportunities with the current VAMPs you have on the market? How do we think about the rest of the company as a whole?
spk08: Thank you. It's a great question. The first thing I'll say is we've been very mindful of the capital environment over the last, call it, 18 months. Obviously, that affects the bar for new programs and it affects the way that we think about opportunity. That said, the Look, I think there's approximately nobody out there who regrets the fact that we brought in our anti-TLNA antibody. That was something that was not on anybody's radar as a part of Royvan as recently as about three and a half months ago. So, you know, this is the thing we often do best. And, you know, what I think is the bar is high, but if we see more opportunities of the same quality as TLNA, you've got to imagine we're going to take them. And the same thing is true for external opportunities and for things that develop internally, whether it's clinical data or something sort of into a new phase of life. If the data are compelling, we will figure out a way to progress it.
spk05: Please stand by for our next question.
spk12: Our next question comes from Corrine Jenkins with Goldman Sachs. Your line is now open.
spk14: Yeah, good morning, everyone. Maybe just with additional time since the Vitamil launch, what can you share with respect to what you're seeing from patient behavior in terms of things like refills and what's the rate at which you're seeing any refills if you're seeing much of that?
spk08: Yeah, thanks, Corrine. It's a great question. Look, I think The first thing is the most important thing that's come out of the time since launch is just a lot of patient and doc enthusiasm for the product. We have a decent number of refills. You can see it in the approximations in the IMS script data around NRX versus TRX. You know, I think we will continue to see patients, many patients using multiple tubes a year. I think exactly how many tubes a year and parsing out that behavior. To be honest, I wish I had, I wish I could stop saying this, but I think it's still a little bit premature to fully know the answer to how many tubes a year. But the quote unquote good news is it remains true that steroids are generally kind of one to two tube a year products. And mostly, the opportunity that we're chasing is to replace steroid scripts with vitamin scripts. So I think there's upside from more scripts beyond that per year, more tubes beyond that per year. But that's plenty of opportunity for the near term. So prematurity gives sort of a quantification to tubes per year. But in general, we see a decent amount of refill activity, which we take as a sign of patient enthusiasm.
spk14: Helpful. Thanks. And then maybe on 3-101, just as you think about additional indication selection through the year, Can you help us understand which criteria you're using to assess which indications you're most interested in pursuing?
spk08: I'll hand it over to Mayuk for that question. Sorry, I missed the question. It's criteria to select new indications.
spk10: Yeah. I mean, I think, look, I think we look at it, I think, very holistically. I think, you know, it's a mix of, you know, strength of biological basis for it, I think mechanistic evidence in support of it. And then I think to a certain extent, it's also, you know, design and sort of structure of a clinical trial. In other words, is there a way in which we could kind of, you know, find an answer, see a signal, you know, without running a very large study as the next study?
spk08: TAB, Mark McIntyre, yeah I think the other thing was two other things, one is obviously we're focused on commercial opportunities or the size of the indication, the size of the opportunity. TAB, Mark McIntyre, And frankly, given the quality of the clinical data we've seen you see just a huge amount of. TAB, Mark McIntyre, of potential for the class, we want to make sure we're maximizing that opportunity and actually go back to another answer I gave, which is this is one of the areas where. TAB, Mark McIntyre, Over the long term, having a franchise with multiple approaches to to one a, as we will. between our sort of lead program and then the TL1A P4D-Bi-specific gives us an opportunity to think holistically about indication strategy over time. Now, obviously, right now, you can imagine we are doing the work on the biggest, fastest opportunities for where we can go with TL1A and have an impact that is, you know, IBD in size, and then we'll sort of branch out from there.
spk14: Great. Thank you.
spk12: Please stand by for our next question. Our next question comes from Dennis Dang with Jefferies. Your line is now open.
spk07: Hi, good morning. Thanks for taking my questions. I have three questions on PL1A. So number one, if you look at the industry maintenance data for UC, it does look a little bit noisy with some drugs showing remission going up, some showing it coming down. And for Roivand, it'll be the first time maintenance data will be reported for ATL1A antibody. And, you know, obviously, you've looked at some of the initial data already, and you said that the data has held up. So are you confident that when we get the chronic data in the first half, that remission wouldn't come down from the induction period? And then number two, I don't see anywhere on your slides, you know, about your phase three plans in UCN, given that TL1A is obviously a very competitive space. What additional things do you need to do before phase three starts? And are you confident that phase three would start this year? And then lastly, can you remind us and perhaps reiterate your confidence around the sub-Q reformulation that you'll be taking to phase three? Thank you.
spk08: Great. Thanks, Dennis. Those are all great questions. So on the first one, I'm not a superstitious person, but I find it hard to express confidence in clinical readouts that we, again, there's still real data to collect there. There's still patients that we don't know the data for and patients who are still being evaluated. So, but I think I agree with you that there are drugs that are all over the map from degradation to improvement in efficacy. I'll say that we start from a very favorable bar. Our sort of induction data was really strong. And so, you know, I think, you know, FLAT would create, fill some of the best 52-week data the world had ever seen. So I think, you know, from that perspective, in some ways, the question is a little bit less relevant to us than to some other classes where the induction data may be on the disappointing side. but then the maintenance data pulls it up into more interesting territory. I think for us, flat or even a little bit of degradation is probably commercially fine. Obviously, there's certainly the possibility with the antifibrotic effect and so on to see better, but we'll see that when we see the data. So, look, I think we feel good about where we are. We feel good about what we know based on the inner look, but we'll know for sure when we see the data, and we're excited to share it with everybody once we've got it. On Crohn's, I'll say, first of all, I agree with you. It's a competitive space. And I think one of the reasons that we're being a little bit careful with how we communicate about study start timelines, and that's frankly for both Crohn's and for UC, is that we're sort of focused on that competitive environment. We have, as you know, an incredibly robust phase 2B data set with full dose ranging. Our phase 2B study was run sub-Q. So you're asking about sub-Q into phase 3. We are the only PL1A antibody with actual patient data a clinical trial from any subcu formulation so you know i think we've got a lot of information in our hands that will aid with phase three design that will allow us to run a tight fast phase three program and so i think we're sort of holding a lot of that design question uh in reserve competitively as we think it's an advantage to when we get the product through and we'll share it kind of when we're when we're ready um look on uh on the subcu Look, the first thing I'll say is I'll just remind everybody. We are the only anti-TL1A antibody that has been studied in patients sub two. So our data gives us tremendous confidence around our ability to treat patients sub two and to deliver the kind of efficacy that you've seen. We are ready to take a more concentrated formulation than our phase two formulation into phase three. We're not going to comment right now on the specifics, but we are highly confident about that formulation. And that work was effectively already completed even before we took the program into Pfizer. So that's ready to go. And in short, we're not, we don't think there's going to be any issues with sub-Q formulation. And yeah, feel good about our sort of ability to carry the drug sub-Q into phase three, given the data we've already got from sub-Q in our phase two. There's no issues with our formulation whatsoever.
spk07: Got it. Thank you. That's very helpful.
spk05: Thanks, Dennis.
spk12: Please stand by for our next question. Our next question comes from Douglas Sal with HCW. Your line is now open.
spk11: Hi. Good morning. Thanks for taking the questions, and congrats on the progress, Matt. Maybe just touching on your emerging I&I franchise, just curious, Matt, because, you know, as a company, Voivant has had a history of monetizing assets. Obviously, to Robin's question, there's questions around the strategic value of Immunivant as well as other individual assets. So just curious, how essential do you think each of these are individually towards building an I&I franchise, or do you think, given the strength of the assets, that some individual ones could be potentially separated out and still have the franchise stand on its own? Thank you.
spk08: Yeah, look, it's a great question. I think the short answer is, we are fiercely economic actors in every way. And so on the one hand, we're very proud of the franchise that we've built and the opportunity for each of these things. And on the other hand, we've got the track record that you've observed. You know, the last thing I'll say is there's a lot of interest in individual I&I programs and targets out there, obviously, but also as a whole, there are many businesses that, MAY NEED TO EXPAND BY MULTIPLE OPPORTUNITIES AT THE SAME TIME, AND SO THE FRANCHISE IN AGGREGATE COULD ALSO PRESENT SOME UNIQUE OPPORTUNITIES, AND ACTUALLY AT LEAST ONE OF OUR PAST MONITORIZATIONS THAT YOU REFERRED TO INVOLVED A FRANCHISE WITH MULTIPLE PROGRAMS, AND I'D SAY NOTHING IS OFF THE TABLE.
spk11: So, Matt, at what point, just given the size of that category and when you look at many of the leading players, they have multiple assets. Do you think that you need to have multiple assets to be effective in I&I commercially? Or do you think that that is not an appropriate sort of interpretation and that given the strength of each of your assets, they can stand on their own?
spk08: As a practical matter, I think most of the things in our portfolio could mechanically stand on their own, just given the quality of the individual things that we've got. Certainly, one of our competitors in FCRN has shown that a single FCRN antibody can succeed on its own. I think our competitor in TL1A, it's such a unique target, talks about the fact that it could mechanically stand on its own. That said, there's clearly also synergistic opportunity in these things sort of coexisting and being next to each other. And certainly, if any of these things were to wind up in big pharma hands, there would be benefit to sort of being co-resident with other INI programs. So, look, I think these things can definitely stand alone, but I think there's also some value to having them together.
spk11: Okay, great. Thank you so much.
spk12: I am showing no further questions at this time. I would now like to turn the conference back to Matt Glein for closing remarks.
spk08: Thank you, Operator. Thank you, everybody, for listening this morning. We appreciate it. It's been an exciting quarter. We've had a lot of opportunity to talk about some updates. Looking forward to sharing more in the very near future. And looking forward to getting back together when we file our 10-K later this year as well. So we'll talk multiple times before then, and we'll speak again on a call like this closer to the middle of the year. Thank you, everybody, and have a great day.
spk12: This concludes today's conference call. Thank you for participating. You may now disconnect.
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