Good day, thank you for standing by. Welcome to the Roivant Q3 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 one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.
Thank you. Good morning, and thank you for joining today's call to discuss Roivant financial results for the quarter ended December 31st, 2022. Presenting today, we have Matt Gline, our Chief Executive Officer. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these results on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation 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 10-Q filed this morning for more information regarding these forward-looking statements and risks, and related risks and uncertainties. We will begin with Matt Gline, who will review key business updates and provide a financial update. We will end the call with a Q&A session. With that, I'll turn it over to Matt.
Thank you, Steph, and thank you everybody for joining this morning. I'm pleased to present our Q3 fiscal financial results for the quarter ended 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 that actually it was after we last had a quarterly update call that we in-licensed and then published data for RVT-3101. As well, we pre-announced certain of our fiscal results last week when we did a financing, or two weeks ago. Again, thank you everybody and looking forward to sharing some updates and in particular have some interesting updates to share around the commercial launch of VTAMA.
I'm going to start out, just quickly on slide 5, reminding everybody 'cause 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 RVT-3101 data, the data for our Anti-TL1A antibody from the induction phase of our ongoing phase IIB study. We expect a number of really important updates from across the business, including we'll talk more literally today, about continued reach and, and payer coverage of VTAMA, which we expect over time to translate over the course of this year into continued improved, gross net yields and scripts.
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 'cause it opens up a market, we'll talk a little bit more about this, 4x the size of the market where we're currently in psoriasis. We expect data in the H1, probably closer to the middle of the year than the beginning, from RVT-3101, our Anti-TL1A antibody from the chronic dosing period of that trial, the 52-week data, which we think is important data. It will be the first time anyone's reported meaningful 52-week data for an Anti-TL1A antibody.
We're looking forward to sharing that full data set when it's available. In the middle of this year, as I know many, many are watching, we will have human data from our next generation anti-FcRn antibody, IMVT-1402, which will, if successful, leave us with we think the best anti-FcRn franchise in the category, at least potentially the best with two drugs, both with maximal suppression of IgG, as well as with IMVT-1402 potentially no impact on albumin or LDL.
Finally, among the major announcements in the Q4 of this year, we expect to produce pivotal data from one of two potential pivotal studies in brepocitinib and SLE, our dual inhibitor TYK2 and JAK1, which we think has the potential to be some of the best data, as we've talked about before, the world has seen in SLE. Excited to share that data when we've got it. With that, I'm going to start today with an update on the commercial launch of VTAMA, which we continue to be just incredibly excited for. I'll start on 7 with just a brief review of the financial results. Some of this, as I mentioned, we disclosed last week.
You know, a near doubling of revenue for the quarter with revenues now at $9.2 million in our Q2 of launch. One thing I'm particularly happy to report, we've seen already, early improvements in our gross net yield from 12% in our Q1 of launch up to 18% in the quarter just ended. 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 patients and physician demand for the product. We continue to get great feedback, more or less across the board. The demand's really had a, as you'll see, a positive impact on our ongoing payer conversation.
Yeah, really, excited about how that launch is going and excited to continue to share updates as we get into, the calendar year. You know, on slide 8, we continue to be the number 1 branded topical. We have been since our 8th week of launch. After a little bit of choppiness around the holidays, we're excited to see scripts return to growth, and we are optimistic for the trajectory from here as we look forward. Yeah, just really excited with what these script volumes mean for, patients and doc enthusiasm and payer enthusiasm. Perhaps equally, and I show this slide pretty often on slide 9 just 'cause I think it's a great slide. This is really just the beginning for us, right?
In the most Recent disclosed IMS week, we did about 3,800 scripts, which is, you know, a great number for this stage of our launch. Remember that even in psoriasis alone, there are 90,000 topical prescriptions every week, of which the vast majority are topical steroids. 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. In psoriasis, our data conclusively, in our view, establishes us as both more efficacious with a limited benefit than topical corticosteroid, as well as meaningfully safer and better tolerated.
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. It's been a quarter of solid execution for the Dermavant team. As I mentioned before, both atopic dermatitis trials in month like ten are fully enrolled. And again, with those readouts expected, the first one, ADORING 2, expected in March 2023, and ADORING 1 expected in May. Important clinical data come in. We continue to expand high quality formulary access. Maybe I'll just provide an update on that on slide 11 and 12. You know, first of all, I'm pleased to say at this point, we have 57% of commercial lives covered for VTAMA.
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 listed its new-to-market block ahead of a review so that we have good coverage across those lines. These, in many cases, are decisions being led by the medical teams of these payers who are so enthusiastic about the medical profile of VTAMA and what it offers to patients that we're making, you know, really, really good progress on coverage. I have a couple of examples that on slide 12, I think drive home the point around quality of coverage.
I'd say, look, multiple factors have driven this progress, including a ton of statement physician demand, payer judgment, as I mentioned in the medical teams on fundamental clinical value, overall prescription value and volume, just a lot of hard work from our team. You know, so some representative examples. You know, one of the major PBMs lifted the new-to-market block and requires only a single step edit to a topical or a vitamin D. Another major PBM added us to formulary and requires a step through 2, either a topical steroid, vitamin D, or a combination. A regional PBM has added VTAMA with no restrictions, edits, or steps at all. So in effect, on parity with generic steroids.
Two national health plans cover VTAMA with a step through any one of, sorry, any two of the foremost common topical therapies, and many regional plans cover VTAMA as completely unrestricted or with a simple steroid look back. 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 us as a preferred product. The last thing I'll say about how pleased we are around the payer discussions here is, you know, not only are we happy with the coverage overall, we are consistently covered at parity or better than our topical competitors.
That's important because you'll remember there was a fair amount of discussion early on around different pricing strategies and the question around which pricing strategy was going to drive better access. We are now very happy to report that our pricing strategy and market access strategy has achieved really high-quality coverage. We are definitely plan by plan, PBM by PBM, at no disadvantage, and in some cases are at an advantage overall. Really, really happy with the payer progress here. You know, as far as how this progresses, some of our competitors have shown good progress in analogous indications from a DT and yield perspective over time. I expect to show the same. Candidly, the Q1 of the calendar year is sometimes a little bit more difficult because of deductible resets.
I think you'll start to see more progress coming, you know, Q2 and beyond. 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 I can now back that up with, you know, broad coverage and an understanding of the economics of those contracts. I'll stop there on VTAMA, but I'm sure I'll get some questions on it in the Q&A, and move on to clinical execution. First of all, just as a high level 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 I&I company, and in fact, we have a number of interesting opportunities that go beyond I&I.
At this point, we have multiple new approvals and 10 -- more than 10 phase II or III data readouts coming each year. Multiple data readouts, including registrational readouts coming each year between now and 2025. 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. We think building towards an I&I franchise that has $15 billion or more in aggregate peak revenue potential. Just a huge opportunity for us. Remember, this spans FcRn and TL1A and our TYK2/JAK1 franchise as well as VTAMA and other programs behind that.
We think this is one of the most exciting biotech I&I franchises, and we're excited to build this forward, and we're excited to see lots of interest from many different quarters in what we're building here. You know, you can see the late-stage pipeline on slide 15. We're familiar and have discussed many of these programs before. We talked about VTAMA earlier today. We'll talk about RVT-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.
It is really unprecedented, at least for Roivant, in terms of the amount of high-quality important clinical data coming immediately 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 close to Washington. We're really proud of it. I'm just going to review the data for RVT-3101, 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, so it's still new to us and still new to our story. As a reminder, RVT-3101 is a phase III-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 agents 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-comers population that we were statistically meaningful with meaningful clinical benefit, clinically meaningful 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 II study that had explored different biomarkers and prospectively identified a specific biomarker, was able to use a lot of data to optimize this choice of biomarker, which covers 60% of the UC patient population. Overall we have a great safety and tolerability profile as well.
We think this should be the first in class agent potentially in large and well-validated markets. This is one of the largest phase IIB studies ever run in ulcerative colitis. We have 300 patients dosed between this phase IIB study and our phase IIA study. We have an important near-term catalyst that I mentioned before, our phase IIB data coming in the H1 of this year for the chronic dosing phase. You know, TL1A on slide 17 as a reminder is a really cool mechanism that's got a pretty different mode of operation where it's a signal amplifier for a whole bunch of different important pro-inflammatory and fibrotic cytokines.
It's got a 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 quality of the clinical data and the unique quality of the clinical data we've seen as well as the safety profile. Given the quality of our data in UC encourages some real blue sky thinking with opportunities well beyond UC and Crohn's into multiple inflammatory diseases as well as other fibrotic diseases, intestinal fibrosis, pulmonary fibrosis, liver fibrosis. As a reminder, Pfizer in their phase IIA publications showed a meaningful impact on fibrotic markers associated with the drug.
I'm just going to remind everyone of the data on slides 18 and 19, starting with, look, just incredibly compelling activity both for our agent and supported by data from a competitor across the class here with, again, some of the best gross efficacy seen and the best placebo-adjusted delta seen across any class. We showed 31% gross clinical remission rate or a 20% placebo-adjusted delta in all comers at our expected phase III dose, or a 40% gross efficacy with a 30% placebo-adjusted delta in that biomarker population. Great data on endoscopic improvement as well. 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 population is no longer responding in second-line. 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. We're going to develop the drug for all comers. We're going to cede nothing from a label perspective, but we are excited for an opportunity to develop this to help patients with our biomarker in second-line therapy.
All of this coupled on slide 20, with just a really remarkably clean safety profile with almost every category being, frankly less than placebo or certainly placebo-like, at both the pooled and our expected phase III dose. You can see here a lot of data. We've talked about it before, I'm not going to talk about it now, although I'm happy to take questions on it. We continue to be confident about the fact that that profile will hold up both based on the preliminary interim analysis and maintenance data we've seen, as well as looking at the relationship between immunogenicity and our safety and efficacy and we see no relationship there. 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. 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 of adjusted of $116 million or GAAP of $168 million. Notably a majority of that SG&A expense comes from Dermavant and associated with the launch of VTAMA. Then we have a very strong cash position that we continue to develop.
We ended the quarter with balancing cash and cash equivalents of $1.5 billion or about $1.9 billion, giving effects to the financing we did 2 weeks ago, as well as expected to see the proceeds from the sale of the MiMed minority Sumitomo Pharma, which we expect to complete this quarter. With that gives us, as we've discussed before, cash runway into the H2 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 makes us gives us the ability to run full speed at RVT-3101, including across multiple clinical programs.
I'm confident we will produce some important data for 3101 along with the other programs during that window. Really looking forward to sharing those updates. Feel happy with the financial position that we're in. Proud of all the work the Roivant team has done over the last quarter. 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. Thank you, everybody. Thanks for your time this morning. With that, after that brief session, I'll turn it over to the operator as I go to Q&A.
As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Brian Cheng with JP Morgan. Your line is now open.
Hey, guys. Thanks for taking my question this morning. As we look into your ADORING 2 readout, next month, what should we expect there in terms of efficacy at top line? What do you think that we'll need to see, to be commercially viable?
Thanks, Brian. Appreciate the question. Appreciate your listening this morning. Thank you. You know, what should we expect to see at top line? That's always a good question. We have not yet seen the data. Our phase IIb data was really compelling. As you may know, we showed 49% gross efficacy on 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.
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. If we're in the mid to high 30s, I'd say it's a solid home run. I'd say anything in the thirties up would be commercially viable for products, given the quality of our data, the quality of our competitors' data, the quality of our safety data, et cetera. 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 commercially promising.
Great. Maybe just one on VTAMA. I think we talked previously about, you know, 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? How important is it, you know, based on what, where you stand in terms of uptick? Are there any pockets of opportunities that you haven't fully tapped in yet for the VTAMA launch? Thank you.
Yeah. Thanks. That's a great question. I'll give an answer and then hand over to Frank, see if there's anything to add. You know, look, I think first of all, we have some DTC efforts ongoing already. They are highly targeted in specific markets. They're 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 make this a thing.
You know, 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 finding out about the drug are eligible for coverage when they go to their doctors. You know, we're still planning for that. Obviously, our patient model is different than some of the systemic therapies that advertise very aggressively. 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. Frank, anything you would add to that?
I think that's a nice summary, Matt.
Fine. Great. Thank you, Brian.
Great. Thanks, Matt. Thank you.
Please stand by for our next question. Our next question comes from Yaron Werber with Cowen. Your line is now open.
Hi. Thank you. This is Joyce on for Yaron. Our understanding about formularies are typically negotiated in the back half of the year, in the fall and winter for the following calendar year. I guess our question, our first question is, are you all set with your formulary additions for 2023 calendar year, or do you expect further additions? Our second question is just on the Crohn's disease indication for RVT-3101. I think on ClinicalTrials.gov, the original start date for that was around mid-2023. Is that when you plan to commence the study? Have you chosen the dose already? Are you potentially waiting for the chronic maintenance data from the UC study to select a dose? Thank you.
Yeah, thanks. I will answer those questions in reverse order. On the 3101 question on Crohn's, 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. 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 more information about our Crohn's plan shortly, and we'll share it when we're ready.
You know, we'll continue to share updates on our clinical plans overall for RVT-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 in usage. 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, and we have some other major formulary additions that we expect to make imminently that would have a meaningful impact on that number. Frank, I'll hand it over to you.
Yeah. Thanks, Matt. I think what you've said is, while generally true about industry structure and what we've seen with VTAMA and the exceptional job done by our team there at Dermavant is the 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, you know, not being the deciding factor for any of our access conversations. 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.
Great. Thank you.
Great. Thanks. Just to reiterate, I expect our covered lives to increase significantly between now and the next update we provide. Thank you very much for the question.
Please stand by for our next question. Our next question comes from Louise Chen with Cantor. Your line is now open.
Hi. Thank you for taking my questions, and congratulations on a productive quarter. I had a few questions for you. First one I wanted to ask you is that I know we're expecting some updates in the anti-FcRn space from some of your competitors, Q2 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?
Yeah. Thanks, Louise. It's a great question, maybe I'll hand over to Mayukh if he'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. I think we will get a lot of information from any competitive readout that shows a relationship between IgG and clinical meaningful data. You know, I think we'll learn more about how nipocalimab'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's not going to inform us on what the impact of a higher IDP suppression would be simply because efgartigimod can't suppress IgGs at the same level as our agents can. We're excited to learn more about dose ranging from our own CIDP 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 in a small indication just a couple weeks ago that was probably new to the field and informative on yet another place in which FCRN appears to work. That's at a high level. Mayukh, anything you'd add there?
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 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.
Okay. Thank you. Then can I ask you about brepocitinib also on 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 deucravacitinib. What are you expecting, you know, would be considered a positive outcome for your studies?
Yes. 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, 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 TYK2 and JAK1. We have data about JAK1, you mentioned baricitinib and SLE, which was, I'd say, pretty good in phase II and okay in phase III from a top-line perspective.
Then we have data from the deucravacitinib, which is a little bit variable but also fairly impressive relative to the field in SLE. 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. In each of those indications, Brepo has produced numerically superior data in cross-trial comparison than either or both of the standalone JAK1 or TYK2. This is 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 top-end efficacy, and we think SLE is the population where that could make a big difference. Mayuk, anything you'd add there?
No, not really. I mean, I think look, you know, Benlysta, you know, was approved and showed efficacy, but, with an SRI-4 delta of, you know, between 9% and 14% across all of its different studies. In spite of that, you know, it was a blockbuster drug, I think just showing the unmet need that is still remaining there. We're looking forward to the results later this year.
Just a reminder, that's a 52-week study, fully enrolled as of August.
Okay. Thank you. Just one last really quick question. When do you expect to reach steady state for your growth net for VTAMA?
Yes. 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 competitors of ours, it probably takes, you know, 6-plus months for GTN to really flow through from a contracting process. I'd say I expect to see meaningful step function improvements over the course of this year, especially as you get into 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, will take a little bit of time beyond that. I think, you know, payer contracting gets you 80%- 90% of the way there, and then the last little bit is other things like distribution costs that are often volume-based in their contracts, so those take a little bit longer to hit.
Thank you.
Please stand by for our next question. Our next question comes from Neena Bitritto-Garg with Citi. Your line is now open.
Hey, guys. Thanks for taking my question. So on the anti-TL1A, I'd appreciate you providing some additional color on next steps and additional indications. But maybe 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? Just a 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 VTAMA? Thanks.
I'll take the second question first, and then I'll start on the first one, probably hand it over to Mayukh for his thoughts as well. You know, on the GTN question, you know, we haven't given specific numerical guidance. That's been 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 active negotiations. That said, I will say it seems like the field was settled on a standard answer to the question of what a biotech company steady-state GTN looks like. It seems like our various topical competitors, as well as even, you know, things like Nurtec at Biohaven or whatever, all have settled on a similar answer.
I would expect us to be the same as everybody else at steady state, is the honest answer to that question. On TL1A, in terms of breadth of indications, I think you should probably hear it from me that there's a lot of enthusiasm for where to go beyond UC and Crohn's. I think in terms of timing, look, we will share thoughts on our clinical plan when we're ready. Because of the competitive nature of that space, probably going to be a little bit careful about disclosing exactly when and what we're doing from an indication perspective. Mayuk, if you want to talk a little bit about the potential breadth there and how broad it could really go.
Yeah, look, I think we're excited. I think we've talked a bit about the, you know... There's a wide range of indications for which I think at this point TL1A is implicated, I think uniquely again, both the, you know, anti-inflammatory as well as anti-fibrotic, you know, types of indications. 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.
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 next generation compounds, 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. We're watching that closely a little bit of a ways out. We're going to get phase I data in 2025 there, but excited for the full breadth of what we should be able to do with that franchise.
Got it. Thank you.
Thank you for the question.
Please stand by for our next question. Our next question comes from Robyn Karnauskas with Truist. Your line is now open.
Great. Thanks. I just had a couple. Let me just first ask about the VTAMA scripts. The new brand, if I'm looking at it correctly, it seemed to be stabilizing. Maybe you could talk a little bit about what trends you're seeing with patients. You know, are they seeing your minim effect? Is this a a factor of coverage, or is it more about just like trends with patients and what do you expect to see going forward? Just a a question around 1402 and Immunovant. You've got a lot of, you know, got a big data set coming out with 1402 and then potential RA data from nipocalimab coming.
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 fourteen oh two. How does it work between you and Immunovant in deciding how broad you actually can expand the market for fourteen oh two and the spend? How does it work? We get a lot of questions on M&A, on whether or not, like, you know, if someone approaches you for Immunovant for that company, like, how does it work as far as your factoring into whether or not that company could be acquired? Thank you.
Yes. Thanks, Robyn. It's a couple of great questions, so appreciate it and good to hear from you. You know, on VTAMA, 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. Then we had winter sales force meetings, so we had a third of our sales force out of the field for each of three consecutive weeks. When we look at trends at the doc level, we are optimistic that we continue to grow in all of the important directions there. I think you will continue to see scripts growing from here.
I think the AB 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. I think even without that, you should expect to see a real growth focus in those script numbers. Obviously the payer contracting progress, which much of which is pretty recent, is helpful there. Also just continued enthusiasm, we think we'll build script volumes from here. 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 Immunovant 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 of Roivant to the table as well, so that we're bringing all the best ideas up for consideration. Lot of ideas for where that could go, obviously, both internally, and externally. 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 opportunity growing frequently as our competitors and we show new data.
Y ou know, I think it's fair to say we are an economic actor as far as how we think about Immunovant, and understand the great appeal that FcRn will have as a target for many big pharma companies. I think it's fair to say while we would be involved in any discussions, but we will act thoughtfully and rationally as we hear anything.
Just to follow up there, and this is really a stupid question, but like, can you stop it, for example, so say if someone approaches and they have a, you know, an offer for Immunovant, 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 Immunovant work if that situation were to unfold? Sorry to follow up like that.
No, no, it's good. I appreciate there's a lot of questions about this stuff. Look, the simple answer is that we are a majority shareholder like any other majority shareholder. We have mechanical voting control. As I said, we're an economically rational actor. 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.
Great. One last one. You really have done a good job of talking about all your programs ongoing and a lot of catalyst-driven. We go back to the original format of Roivant with having, you know, an engine that produces drugs. What are your thoughts on how we should view the cadence of, you know, new vants 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 vants you have on the market? How do we think about the rest of the company as a whole? That's it.
Yeah. Thank you. It's a great question. Look, 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, look, I think, there's approximately nobody out there who regrets the fact that we brought in our anti-TL1A antibody. That was something that was not on anybody's radar as a part of Roivant as recently as about 3.5 months ago.
You know, this is the thing we often do best. You know, what I think is the bar is high, but if we see more opportunities of the same quality as TL1A, you got to imagine we're going to take them. The same thing is true for external opportunities and for things that develop internally, whether it's clinical data or something into a new phase of life. If the data are compelling, we will figure out a way to progress it.
Please stand by for our next question. Our next question comes from Corinne Jenkins with Goldman Sachs. Your line is now open.
Good morning, everyone. Maybe just with additional time since the VTAMA launch, what can you share with respect to what you're seeing from patient behavior in terms of things like refills and, you know, what's the rate at which you're seeing any refills if you're seeing much of that?
Thanks, Corinne. It's a great question. 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, you know, 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 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.
The "G ood news is, it remains true that steroids are generally 1 to 2 tube a year products." Mostly the opportunity that we're chasing is to replace steroid scripts with VTAMA scripts. I think there's upside from more scripts beyond that per year or more tubes beyond that per year. That is plenty of opportunity for the near term. Premature to give a quantification to tubes per year. In general, we see a decent amount of refill activity, which we take as a sign of patient enthusiasm.
Helpful. Thanks. Maybe on 3101, just as you think about additional indication selection through the year, can you help us understand which criteria you're most interested in pursuing?
You know what? Maybe I'll hand it over to Mayukh for that question.
Sorry, I missed the question.
It's criteria to select new indications.
Yeah. I mean, I think, look, I think, we look at it, I think, very holistically. I think, you know, it's a, it's a mix of, a mix of, strength of biological basis for it. I think mechanistic evidence in support of it. I think, to a certain extent it's also, you know, design and structure of a clinical trial. In other words, is there a way in which we could , you know, find an answer or see a signal, you know, with, without running a very large study, as the next study?
Yeah. I think the other thing, well, two other things. One is obviously we're focused on commercial opportunity, the size of the indication, the size of the opportunity. Frankly, given the quality of the clinical data we've seen in UC, just a huge amount of potential for the class. We want to make sure we're maximizing that opportunity.
Actually I'll go back to another answer I gave, which is this is one of the areas where over the long term, having a franchise with multiple approaches to TL1A as we will between our lead program and then the TL1A p40 bispecific, gives us an opportunity to think holistically about indication strategy over time. 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 branch out from there.
Great. Thank you.
Thanks, Mayukh.
Please stand by for our next question. Our next question comes from Dennis Ding with Jefferies. Your line is now open.
Hi. Good morning. Thanks for taking my questions. I have three questions, all on TL1A. Number 1, you know, 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. For Roivant, it'll be the first time maintenance data will be reported for a TL1A antibody. You know, obviously you've looked at some of the initial data already and you said that the data has held up. Are you confident that when we get the chronic data in the H1, that remission wouldn't come down from the induction period?
Number 2, I don't see anywhere on your slides, you know, about your phase III plans in UC. Given TL1A is obviously a very competitive space, what additional things do you need to do before phase III starts, and are you confident that phase III would start this year? Lastly, can you remind us and perhaps reiterate your confidence around the SubQ reformulation that you'll be taking to phase III? Thank you.
Great. Thanks, Dennis. Those are all great questions. On the first one, I'm not a superstitious person, but I find it hard to express confidence in clinical readouts that 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, they're still being evaluated. 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 induction data was really strong. You know, I think, you know, flat would create still some of the best 52-week data the world had ever seen.
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. Look, I think, I think we feel good about where we are. We feel good about what we know based on the interim 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.
You know, 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 focused on that competitive environment. We have, as you know, an incredibly robust phase IIB data set with full dose ranging. Our phase IIB study was run SubQ. You're asking about SubQ into phase III. For what it's worth, we are the only TL1A antibody with actual patient data in a clinical trial from any SubQ formulation.
You know, I think we've got a lot of information in our hands that will aid with phase III design that will allow us to run a tight, fast phase III program. I think we're holding a lot of that design question in reserve competitively as we think it's an advantage to when we get the product approved. We'll share it when we're ready. Look, on the SubQ opportunity, look, the first thing I'll say is I'll just remind everybody, we are the only TL1A anti-TL1A antibody that has been studied in patients . Our data gives us tremendous confidence around our ability to treat patients SubQ and to deliver the efficacy that we've seen.
We are ready to take a more concentrated formulation than our phase IIB formulation into phase III. 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. That's ready to go. In short, we don't think there's going to be any issues with SubQ formulation. And yeah, feel good about our ability to carry the drug SubQ into phase III given the data we've already got from SubQ in our phase II. There's no issues with our formulation whatsoever.
Thank you. That's very helpful.
Thanks, Dennis.
Please stand by for our next question. Our next question comes from Douglas Tsao with HCW. Your line is now open.
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, Roivant has had a history of monetizing assets. Obviously, to Robyn's question, there's questions around the strategic value of Immunovant as well as other individual assets. 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 can be potentially separated out and still have the franchise stand on its own? Thank you.
Yeah, look, it's a great question. I think the short answer is, we are fiercely economic actors in every way. On the one hand we're very proud of the franchise that we've built and the opportunity for each of these things. On the other hand, we've got the track record that you observe. 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. The franchise in aggregate could also present some unique opportunities. Actually at least one of our past monetizations that you referred to involved a franchise with multiple programs. I'd say nothing is off the table.
I guess Matt, do you 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 interpretation and that given the strength of each of your assets they can stand on their own?
As a fraction of the 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, right. Certainly one of our competitors in FCRN has shown that a single FCRN antibody can succeed on its own. You know, I think our competitor in TL1A, it's such a unique target. It talks about the fact that it could mechanically stand on its own. That said, there's clearly also synergistic opportunity in these things coexisting and being next to each other. Certainly if any of these things were to wind up in big pharma hands, there would be benefit to being co-resident with other I&I programs. Look, I think these things can definitely stand alone, but I think there's also some value to having them together.
Okay, great. Thank you so much.
I am showing no further questions at this time. I would now like to turn the conference back to Matt Gline for closing remarks.
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. Look forward to getting back together when we file our 10-K later this year as well. 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.
This concludes today's conference call. Thank you for participating. You may now disconnect.