Roivant Sciences Ltd. Q2 FY2024 Earnings Call

Good day and thank you for standing by. Welcome to the Roivant Second Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.

Good morning, and thanks for joining today's call to review Roivant's financial results for the second quarter ended September 30, 2024. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant; and Ben Zimmer, CEO of Priovant. For those dialing in via conference call, you can find the slides being presented today, as well as a press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I'll turn it over to Matt.

Thank you, Stephanie. Thank you to the operator, and thank you everyone for dialing in this morning. We actually have a relatively full update, so I'm excited to share, and there's at least one major new thing we're going to talk about, which is the 52-week data from our NIU study, which I'm pretty excited about. So starting on slide five, look, I think there's really two major areas of focus for us right now. And the first is clinical trial execution. We have a lot of ongoing trials, all of which are important and are going to generate interesting data coming in the near future here. Obviously, today, we're talking about the 52-week data for brepocitinib in NIU in the Phase 2 study, where also the Phase 3 study is ongoing with the first patients enrolled and with fast-track designations having been granted. We presented this quarter batoclimab in Graves' disease. We are now getting our programs up and running for IMVT-1402 in both Graves' disease and with difficult-to-treat rheumatoid arthritis as well as a number of other programs to be starting soon. We have initiated our Phase 2 study of mosli in PH-ILD. And then we have clinical data coming, including namilumab in sarcoidosis by the end of this quarter, batoclimab data coming next year in MG, CIDP, and TED, and brepocitinib in dermatomyositis top-line data coming in the middle of next year as well. So that should be all exciting updates in the near future, all focused on clinical execution. On slide 6, the evolution of the business continues in some other ways as well with the Dermavant deal having closed just a week or so ago, allowing us to refocus on clinical execution while maintaining a large share of potential upside from VTAMA. We talked about that not long ago. We've made some progress with our LNP litigation with a Markman hearing in the Pfizer/BioNTech case in December with a trial less than a year from now in the Moderna case currently scheduled. We've continued our plan of returning capital to shareholders. We've so far repurchased an aggregate of $754 million worth of stock as of 9/30, including $106 million in the quarter reporting today with an ongoing commitment to be prudent and thoughtful in deploying this capital. And then, of course, and I know this will be a topic of discussion, we have ongoing business development activity and multiple negotiations for potential in-licensing of new programs that we are really excited about. This really does remain one of the most exciting environments for that activity that we've ever been in. So as we've been saying for a little while here on slide seven, the next chapter for us is really anchored by our late-stage pipeline that includes IMVT-1402 and batoclimab, together our FcRn franchise that includes brepocitinib, which we'll be talking about a fair amount today, our TYK2 and JAK1 dual inhibitor that includes namilumab and mosli and a number of other programs that we expect to hope and bring in, in the near future. Altogether, on slide eight, we think that really does give us one of the most exciting development-stage clinical pipelines out there with a path to a $10 billion-plus peak sales portfolio spanning multiple therapeutic areas, obviously including I&I and pulmonary hypertension as well as others with the first approvals potentially coming in the next couple of years, along with many Phase 2 and Phase 3 data readouts and a significant wave of approvals across new indications in the ‘26 to '30 timeframe. So really looking forward to the next handful of years here as our portfolio has time to mature and to develop. So with that as the 30,000-foot overview, what I want to do next is make sure we give due time to the most significant of our updates for today, which is the 52-week data from our NIU Phase 2 study. And so I'm going to give just a really brief introduction here and then I'm going to hand it over to Ben Zimmer, who's going to take you through the updates on that program in more detail. So, look, on slide 10, I'm going to steal only a tiny bit of Ben's thunder. So basically, as you'll recall, in the spring, we presented the 24-week data and it looked to be, both, like it supported the potential best-in-indication efficacy profile, data of a kind that the NIU field bluntly had not seen before. And the hope really was just to maintain that level of efficacy through 52 weeks. And I could say we've definitely hit that bar. We really only had one additional subject in each dose arm with a treatment failure and we had sustained improvement from baseline on important metrics like retinal vascular leakage, CST, and macular edema. So really, really exciting data. No new safety or tolerability signals. The safety database at this point, as you'll know, comprises 1,400 exposed subjects and patients and is consistent with approved and widely prescribed JAK inhibitors. And we've got fast track designation from FDA and NIU with patients currently enrolling. So that's the 30,000-foot overview, but the data is pretty exciting. So I want to hand it over to Ben Zimmer, as I said, the CEO of Priovant, who's going to take you through the next slides here. Ben, takeaway.

Thank you, Matt. Before discussing the 52-week data, I’d like to point out two positive trends in I&I related to the brepo Phase 3 programs in NIU and dermatomyositis, as detailed on slide 11. First, JAK inhibitors as a category have nearly doubled in both treated patients and revenue since 2020. This reflects a well-established benefit-risk profile for these treatments among physicians and patients, even in indications with much lower morbidity than those Priovant is targeting. In areas where Priovant is focused, specifically orphan diseases with high morbidity, we’ve recently witnessed several product launches that validate this category as a significant source of blockbuster revenue, achievable in a short period due to disease prevalence, high morbidity, unmet need, and a concentrated prescriber base with orphan pricing. Moving to slide 12, NIU aligns perfectly with this profile, with around 70,000 to 100,000 patients, very high morbidity, ranking as the fourth leading cause of blindness among the working-age population in developed countries, along with limited treatment options and a concentrated prescriber base. On slide 13, our claims analysis with IQVIA further confirms a significant number of patients receiving biologic and particularly TNF therapy, with around 40,000 patients with NIU on TNF inhibitors, including Humira and off-label options, a number that is growing rapidly. Data indicates that Humira only works for fewer than 50% of NIU patients. This highlights both the substantial commercial opportunity in the TNF-refractory population and the urgency from patients and physicians to explore alternative effective treatments. We believe this points to great potential for brepocitinib in the broader non-anterior NIU population. Now, turning to the data itself, on slide 14, I'll briefly remind you of the Phase 2 NEPTUNE study design, which enrolled patients with active non-anterior NIU and randomized them 2:1 to either brepo 45 milligrams or 15 milligrams, consistent with previous studies, including those for Humira. Given the critical condition of these patients, all received a two-week steroid burst, quickly tapered off. The primary endpoint focuses on preventing treatment failure. Notably, the taper in the NEPTUNE study was over six weeks, compared to 13 weeks in earlier studies like the Humira VISUAL 1 study, raising the bar for brepocitinib’s efficacy demonstration. Given this context, we are very pleased with the results. On slide 15, we present the primary endpoint from the NEPTUNE study. The left side displays the primary endpoint—the 24-week treatment failure rate—as shared previously, while the right side shows updated 52-week data, measured against historical placebo rates from the VISUAL 1 study. As Matt mentioned, only one additional patient met the treatment failure criteria in each arm, indicating excellent data sustained beyond 52 weeks. Humira’s failure rate at week 24 exceeded 50%, with a higher discontinuation rate, while their one-year failure rate based on published data significantly surpassed 70%. On slide 16, we compare the NEPTUNE study's one-year data against the pre-specified primary endpoint from the VISUAL 1 study: median time to treatment failure. In the VISUAL 1 study, the placebo arm had a median time of three months, and the active arm 5.6 months, indicating that more than half of patients failed to achieve benefit by the six-month mark. In contrast, the brepo low-dose arm had a median time to treatment failure at 9.3 months, and in the high-dose arm, we did not reach a 50% treatment failure rate even after one year, suggesting promising results. On slide 17, we support this clinical data with biomarker results for ocular inflammation, using wide-field fluorescein angiography to measure retinal vascular leakage. The left data represents the high-dose brepo 45 mg arm, while the right reflects the low-dose 15 mg arm. The top row shows data from week 24, previously presented at the EURETINA conference, and the bottom row features new 52-week data. We observe excellent outcomes, especially for the high-dose arm, with no worsening and overall improvement over time. On slide 18, I want to provide an update on our macular edema data. The significance of the 52-week data is evident, as macular edema can develop in uveitis patients as a medium- to long-term result of inflammation. From our previous week 24 data, we noted that none of the 10 patients without macular edema at baseline developed it, and three of seven who had it showed resolution. I am pleased to report that this positive trend has continued into the one-year mark. Moreover, this outcome is in stark contrast to Humira, as evidenced by VISUAL 1 data where a significant proportion of initial patients experienced the onset of macular edema. On slide 19, we emphasize the robustness of our findings by looking at mean CST over time. The data indicates a strong response from the 45 mg arm, along with a clear dose response from the 15 mg arm, showing a rapid effect onset in the initial weeks, even during the steroid taper. We are highly encouraged by the Phase 2 data and, with the completion of six months, our excitement has only intensified following the one-year mark. At Priovant, we are fully focused on the Phase 3 studies, which are already underway, as mentioned by Matt. On slide 20, we lay out the study schematic, closely modeled after the Phase 2 protocol. We are advancing only the 45 mg dose into Phase 3, randomizing patients 1:1 against a placebo. This is a single protocol study, consisting of two identical sub-studies labeled CLARITY 1 and CLARITY 2, with a total of 300 subjects. The primary endpoint remains time to treatment failure, mirroring the VISUAL 1 study design, with secondary endpoints covering all measurements from the NEPTUNE study. We will maintain the rapid steroid taper used in NEPTUNE based on the encouraging data, aiming to establish a new standard in uveitis clinical trials. Following a productive meeting with the FDA, our design incorporates their feedback. We are confident that successful results will support an NDA filing. In summary, there is considerable excitement surrounding NIU and the potential of brepocitinib. Before handing it back to Matt, I want to mention that, while we look forward to the Phase 3 NIU program, we simultaneously anticipate the readout of the fully enrolled Phase 3 dermatomyositis program scheduled for next year. On slide 21, similarly to NIU, this condition showcases rapid blockbuster revenue potential with approximately 40,000 adults in the U.S. actively seeking treatment options. This is a high morbidity indication with very few modern therapies available, primarily relying on steroids and IVIG. Our analysis suggests that about half of these patients are treated at a limited number of centers of excellence. On slide 22, we provide further detail on current treatment patterns for these patients. In 2022, around 35 patients were actively treated with late-stage therapies for dermatomyositis. We highlight that all mentioned steroids are either oral or injectable, without counting topical treatments. Over 50% received polypharmacy, indicating the severity of their conditions and the limitations of available treatments. On the right side, we show that patients on steroid-sparing therapies like ISTs, biologics, and IVIG are often not achieving that goal, with many still on high doses of oral steroids chronically. We are excited about the upcoming DM data readout and believe that brepo’s approval could lead to a significant demand surge early in the launch phase. To conclude my section on slide 23, we have focused on development execution over the past few years at Priovant, positioning us for major value inflection starting next year with the upcoming Phase 3 data for DM, followed closely by the NIU study. We also plan to initiate studies for additional orphan indications in 2025, all while navigating a favorable commercial landscape. We are truly excited about what lies ahead. Now, I’ll pass it back to Matt.

Thank you, Ben. I'm really excited about that data as well and appreciate all the efforts from the Priovant team. I'm looking forward to what's coming next. I want to go over a couple of updates highlighting events from the past few months that we're thrilled about, starting with our anti-FcRn franchise. On slide 25, while I know everyone is familiar with this data, we're very pleased with it. We've released strong proof-of-concept data in Graves' disease, which we believe positions IMVT-1402 as potentially best-in-class and first-in-class in that area. As you'll recall, we achieved over a 75% response rate in patients who were uncontrolled on ATDs, with more than 50% of those patients becoming ATD-free, successfully titrating their ATD dose, and reaching normal T3 and T4 levels within 12 weeks. We maintain that deeper IgG reduction is significant, particularly with our 680 milligram dose, as it leads to considerably higher response rates, reinforcing our belief in IMVT-1402 as a potential best-in-class treatment. This is especially relevant given the significant unmet needs, where 25% to 30% of Graves’ patients are uncontrolled or intolerant to ATDs with virtually no pharmacologic alternatives available. Furthermore, we have received FDA clearance for the IMVT-1402 IND, allowing us to transition straight to pivotal trials. While I won't detail the data again, we plan to replicate it in '26, '27, and '28, and it's truly exciting data for a condition that lacks options for this patient population. Moving on to slide 29, we announced a new indication for IMVT-1402 in difficult-to-treat rheumatoid arthritis. This group includes 5% to 20% of the RA patient population who have not responded to at least three therapies. Data from another FcRn program, nipocalimab, indicates that particularly in ACPA-positive RA patients, we see severe disease and poor outcomes. The in-class data from nipocalimab shows that patients respond to FcRn therapy, even with lower IgG suppression compared to what we expect IMVT-1402 to achieve. Our study is designed for quick readout with an open-label entry and randomized withdrawal, which should facilitate straightforward patient enrollment and provide rapid data, which we view as valuable for the overall IMVT-1402 program. We anticipate that our deeper IgG suppression will significantly enhance results based on previous observations. On slide 30, it's worth noting that this patient population is substantial. When considering the 1.5 million U.S. RA patients, there is a significant subset who are struggling to find effective treatment despite trying multiple therapies. Our focus is on the ACPA positive patients within this group, who are severely affected and in need of better options. I won’t delve into all details, as the Immunovant team recently held a successful call with a key opinion leader on this matter. On slide 31, we've announced two indications for IMVT-1402: Graves' disease, where we expect to be first-in-class, and RA, where we see clear potential to be best-in-class. We have several other indications in the pipeline, with five INDs submitted to the FDA. We are enthusiastic about discussing these additional indications in the coming weeks and months. Lastly, I want to touch on our clinical developments without going into detail, as we covered it earlier this fall. This quarter, we introduced mosliciguat, our Phase 2 inhaled sGC activator for pulmonary hypertension patients with interstitial lung disease. We're eager about the program's potential, especially in a market validated by the successful launch of Tyvaso. As a reminder, on slide 34, mosli has demonstrated remarkable reductions in pulmonary vascular resistance, which encourages us about potential overall improvements in PH-ILD patients. We believe we haven't even seen the best data yet, as shown on slide 35, where PVRs continue to improve at measured time points. Our dosing profile is appealing with one pump once a day, and importantly, as an inhaled sGC activator, we don’t see systemic vasodilation. We are confident in this, supported by systemic exposure data we’ve discussed. Additionally, slide 36 presents findings from a different Phase 1 study of mosli, demonstrating that we do not observe significant changes in systemic systolic blood pressure with increasing doses, reinforcing our confidence that there is no systemic impact from this drug. Now, looking towards the future on slide 38, I shared my excitement in August about our positioned growth over the next 18 months. We have several high-value opportunities, including upcoming Phase 3 data for namilumab in sarcoidosis, which presents a higher risk but could lead to substantial reward, along with multiple late-stage readouts. Ben mentioned brepocitinib and DM, and we foresee important data from batoclimab and Immunovant. There are also essential updates on our LNP litigation, and by the second half of 2026, we expect Phase 2 data from mosli. This period is packed with catalysts and opportunities, even without considering business development efforts. Speaking of which, we are excited about the current business development environment. Although it may take longer than anticipated, we're eager to share our ongoing initiatives. I believe you'll find them very exciting. A brief financial update on slide 40 reveals that we are diligently managing our burn rate. With the exit of Dermavant, we anticipate reduced figures in the coming quarters. This quarter, R&D expenses were $143 million, or adjusted non-GAAP at $132 million; G&A totaled $203 million, non-GAAP at $142 million, including some notable one-time costs. Our overall loss for continuing operations reached $237 million, or adjusted at $219 million. We ended the quarter with a robust cash position of $5.4 billion, largely due to expenditures in share repurchases, with no debt following the Dermavant transaction's closure. The credit facility was repaid at closing, and Roivant acquired all remaining debt, while our share count continues to decrease as we repurchase shares. I’ll conclude by referencing slide 42, which outlines our catalyst timeline. Thank you for joining us this morning, and I will now turn it over to the operator for questions.

Thank you. Our first question is from Louise Chen with Cantor. Your line is open. Please go ahead.

Hi. Congratulations on all the progress and the data today. Thanks for taking my questions. So I had two on brepocitinib. I wanted to ask you what set of efficacy you'd like to see in your Phase 3 NIU trial? And then also for brepo and HS, where do you stand and what's the latest update there? Thank you.

Yes, so I'll let Ben take both those questions other than I'll say what I hope I will say is we're very happy with the efficacy we've seen in Phase 2, and I think it gives us a pretty wide margin relative to the competitor programs like Humira, but Ben take it away.

Yes, I would agree with that. I think anything that even approximates the Phase 2 would be terrific. And I think even if there's standard drop-off in efficacy that one often sees between Phase 2 and Phase 3, this is a space where there's very little available for patients. TNF inhibitors are widely used in spite of their quite limited efficacy. And so I think anything that gets the drug approved would support widespread adoption and certainly, anything that supports a potential better product profile than Humira would support widespread adoption potentially even in the first-line setting.

Yes. And then on HS and Ben, you can jump in if you have any comments as well. But I guess what I'd say is, I can say this from the outside, I've been really happy with the work that the Priovant team has done on indication expansion, and we have some other ideas. HS is a great indication. We have very good Phase 2 data in it. It's a competitive field with a lot of other mechanisms, and there are some great places to take brepocitinib that may be less competitive, but we're continuing to consider a wide variety of indications and certainly, HS remains on our radar.

Yes, don't really have much to add to that.

Thank you, Louis. Thanks for the questions. Really appreciate it.

Thank you. Our next question comes from Brian Cheng with JPMorgan. Your line is open. Please go ahead.

Hey, guys. Thanks for taking our question this morning. Maybe just a question on CLARITY design. Are you requiring patients to have a certain steroid dose for entry? And are there any certification strategies that we should make note of? And also on the sub-studies between CLARITY 1 and 2, what is the difference here? Is there a geographical location difference?

Great. I'll let Ben take all of those.

Yes. So in terms of steroids, there's no specific requirement. Patients are allowed on any background steroid dose of up to 40 milligrams per day or no steroids at all. And again, with the notion that because there's the two-week burst at the start of the study, that kind of neutralizes whatever the background regimen was before. In terms of stratification, no particular stratification of material note. And in terms of the two sub-studies, sites will be assigned to one or the other in some geographies like the United States and certain other larger geographies will have sites in both sub-studies and then there are certain countries that will only be in one or the other.

Thanks for that. Appreciate it.

Absolutely.

Thank you. Our next question is from Yaron Werber with TD Cowen. Your line is open. Please go ahead.

Hey, good morning, guys. This is Joyce on for Yaron. Thanks for taking our question. Can you talk about your thoughts around pricing for brepocitinib, of course, orphan price point here, but how should we think about pricing by indication? Thank you.

Thanks. Look, appreciate the question. Thank you for asking. Look, it's obviously premature to have a firm view on pricing for a program at this stage. We're focused on orphan disease with high unmet need. So we think a pretty wide range of prices is supportable. What I would say, and I'll give it to Ben to answer as well, is that the only thing I'd say is other competitors in dermatomyositis have talked about net pricing in current sort of the high $100,000 range. And I think that's a useful benchmark for us as we think about the range of possibilities in that indication. But other than that, I think a pretty wide range if possible.

Yes, just to echo what Matt said, if you examine benchmarks for recent orphan launches, including both biologics and small molecules at similar price points, that's the kind of range we will be considering, but we don't have any firm decisions or plans at this time.

Thank you.

Thank you.

Thank you. Our next question is from Andy Chen with Wolfe Research. Your line is open. Please go ahead.

Hey, good morning. Thank you for taking the question. On uveitis Phase 3, can you talk about what placebo response you're assuming? So in the Humira trial, I think they saw 13 weeks or three months. But in your trial, you have a more stringent tapering. So your tapering is eight weeks versus the Humira trial, which was, I think, 15 weeks. So in other words, are you assuming 13 weeks? Is that going to be the placebo response on the primary endpoint? Is it going to be less than 13 weeks? Or should we be assuming that's going to be less than 13 weeks? Thank you.

That's a great question. Ben?

Yes. I mean, I think as the base case, our assumption was a similar placebo rate to what was seen in VISUAL I. We think there is opportunity potentially for it to be even higher for the reasons you said with the taper, but we didn't want to assume that. In general, the study is actually overpowered. So even if the placebo rate ends up being significantly higher or the failure rate significantly lower in the placebo group than we expected and we saw in VISUAL 1, we'd still have an opportunity to detect a difference just being humble about the fact that this is an area where there's really just one precedent study; we wanted to err on the side of being conservative, and that's why we're running as large a program as we are.

And one thing that's patient-friendly about the study, as a reminder, is that it's an event-driven study and as people fail, they'll move right over to brepo, which some of your patients will like about the study. Thanks, Andy. That was a great question.

Thank you. Our next question comes from Douglas Tsao with H.C. Wainwright. Your line is open. Please go ahead.

Hi, good morning. Thanks for taking the questions. Matt, just on that last one, do patients automatically switch to brepo if they have treatment failure or do they have the option to switch? And is there a sort of alternative protocol that they could pursue?

They automatically switch to brepo. Obviously, they can drop out of the study if they wish and do not have to take brepocitinib. But if they want to stay in the study, the first rescue medication in the event of failure is brepocitinib along with some other different options that the investigators have to deploy along with that. And then if the patient then fails for a second time in the open-label period, then there is an even wider array of options that the physician has available, and then at that point, the patient can choose whether or not they want to stay on drug and can still remain in the study.

Okay. Great. Thanks. And just as a follow-up for Matt. From a business development standpoint, obviously, with mosli and the creation of namilumab, we have sort of gone beyond what has been a short-term focus on I&I. I'm just curious how you're thinking about Roivant from a therapeutic category standpoint right now? And does this move respiratory like a big focus for adding additional assets or are you just going to continue to be, as you put it, sort of the economics and pick out the best opportunities as you identify? Thank you.

Yes, thanks, Doug. It's a great question. It's one you've been focused on and rightly so. I think we are pretty ruthlessly focused on doing the best things we can. The analogy that I've been using that you might have heard lately is that we exist in the excess dough outside of other people's cookie cutters. And so we're not the snowman; we're not the Christmas tree. We're the dough in between the two, and that means we've got to be flexible in terms of therapeutic area, but we think there's a lot of really great cookie to bake out of that dough as well.

Thank you. Our next question comes from Dennis Ding with Jefferies. Your line is open. Please go ahead.

Good morning. This is Anthea on for Dennis. Thanks for taking our questions. Two on DM. Could you talk about your plan to share the full lupus data and if you see any overlaps between lupus and DM? And then also, what's the willingness from doctors to prescribe JAKs in DM and how much off-label use is there currently, if any? Thank you.

Yes, thanks. That's a great question. I'll address part of it and then pass it on to Ben. Regarding lupus, I want to remind everyone about two things. One is that Pfizer designed and conducted the lupus study, which was one of the final studies in their original brepocitinib program. On the point about overlap, and I'm sure Ben will echo this, we have extensive data on brepocitinib across diverse indications, and any individual study in one indication is not as revealing as the overall body of data demonstrating the drug's efficacy. Therefore, I don't think we see much specific commonality between SLE and DM or any predictive relationship from SLE to DM. But Ben, do you want to address that and also the question about off-label JAKs?

Yes, I don't see a ton of read-through there. I mean, I think one lesson from these sort of rheumatic diseases in general and our lupus data was an example of that is you have to be very focused on managing placebo response, and that's something I can't say that in the DM study, where we've designed it and are running it ourselves, we've been extremely focused on that, including with the mandatory steroid taper in the study and a very high operational focus from our team on ensuring adherence to that taper among other kind of study execution-related steps we're doing. As far as JAKs and DM, yes, they're used pretty extensively. There was a recent publication that was kind of a literature review of case reports and there were 600 published case reports roughly in that across DM and juvenile DM in that. And I think if you talk to KOLs and other prescribers and other DM treaters, you'll see that they do use JAK inhibitors. So I think there's certainly an area of a lot of comfort. Most of the treating physicians here will be rheumatologists and dermatologists, a few neurologists as well. But both rheum and derms are also obviously very comfortable with JAK inhibitors from other indications as well. And as I mentioned before, both rheumatic and derm indications with less morbidity than DM, JAK inhibitors that are on-label for those indications are widely prescribed at this point. And so I think there's a lot of excitement in the physician community about JAK inhibition. I think there's a lot of excitement about a TYK2/JAK1 inhibitor in particular given the alignment of that particular mechanism to the pathobiology of DM and really just the prospect of having a once-daily oral approved therapy that's efficacious and targets the underlying disease that would be a new and important development for the field.

Great. Thank you.

Thank you. Our next question comes from Corinne Johnson with Goldman Sachs. Your line is open. Please go ahead.

Hey, good morning. This is Craig on for Corinne. So the first question here is, given the emergence of Humira biosimilars, how do you expect brepo could be positioned if it potentially gains approval? And then from there, will you recruit or target patients that are refractory to anti-TNF type medicines within CLARITY?

Yes, Ben, you want to take first Craig at both of those?

Yes. So on the first one, look, I think our base case kind of view of the market here is to be used predominantly in the TNF refractory population. And I think we're going into this with a lot of excitement about brepo's potential in NIU, even if that is the only population into which we're launching, I think, as I mentioned before, Humira's failure rate is high and its use is high. And I think the biosimilars available, we'd expect the use to be at least as high and the failure rate to be at least as high. And so I think that will only lead to an expansion of the TNF refractory market. I also think that this is a rare disease, very high unmet need, one of the leading causes of blindness in the United States. If our data is actually differentiated from Humira, there is going to be a very significant outcry from patients and physicians to use this drug first line because people don't want to go blind, and they want to use whatever the best available treatment is to prevent that.

And then does the study...

Okay. And then no. So there's no particular stratification or requirement in that regard, that's something we discussed with FDA. It's not something they are focused on in the study. I think our expectation is that we will be enrolling a number of patients who have been on prior TNF therapy, just given the extent to which these drugs are used, and we'll be tracking that and be able to analyze those subgroups, but it's not something that we're in any way, stratifying for pre-specifying.

Yes. And I would just reiterate, tolerance for ocular inflammation is very low. And I think if brepocitinib improves as the Phase 2 data suggests may to be a best-in-class agent with a pretty wide margin, there's just going to be a lot of demand to use it in the earliest setting as people can get comfortable because that's how you treat this disease most effectively. So we'll see. It's going to be a conversation with FDA and so on, but we feel confident given the profile of Phase 2 data that we have a good shot at a bigger population, even than the refractory population, acknowledging also refractory population is very large. Great. Thank you very much.

Thank you. I would now like to hand the conference back over to Matthew Gline for any further remarks.

Great. Thank you, operator. Thanks, everyone, for listening this morning. Thanks, obviously, to Ben and the Priovant team for the Phase 2 study in NIU. We're getting the Phase 3 going, thanks to all the patients and investigators. Thanks to the entire Roivant team who gets these results together and then moves us forward every quarter. Looking forward to a little bit of a busy end of the year with the namilumab data coming and then a very busy 2025. So we'll talk to you all very soon. Thank you. Have a good day.

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