Roivant Sciences Ltd. (ROIV) Earnings Call Transcript & Summary

Good day, and welcome to the NIU Phase II top line results call. At this time, all participants are in listen-only mode. After the speaker's remarks, there will be a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Jeffrey Kalmus. Please go ahead.

Good morning, and thank you for joining today's call to review the results from our Phase II study evaluating brepocitnib in non interior non-infection Uveitis. We will also discuss updates on our capital allocation and new share repurchase program. I'm Jeffrey Kalmus with Roivant Sciences. Presenting today, we have Matt Gline, CEO of Roivant; and Benjamin Zimmer, CEO of Priovant. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at 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 starting 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. We will begin with Matt Gline, who will do the opening remarks. And with that, I'll turn it over to Matt.

Thank you, Jeff, and thank you, everybody, for joining today on short notice as with the data call sometimes. I -- always excited to get on a phone and talk about some exciting data and I'll start to provide some clarity that I know people have been waiting for on capital allocation and capital return strategy. I just want to start quickly with a couple of framing remarks before Ben is going to do -- Ben is CEO of Priovant, is going to do most of the presentation on the NIU data, which is really setting data. But before that, just on Slide 4, and as a reminder of where we're at. We have said all along that 2024 was about -- was about sort of expansion clarification about building for the future for us. And I think the two really important milestones today against that backdrop. One, which I'll talk about in a second is I think some real progress on clarifying and advancing our capital allocation and capital return strategy, in particular, very happy we've been able to make some progress in providing some liquidity to a shareholder that really needs it and giving us the flexibility for the future. And then -- we got a lot of questions over the past few months about what the future of our pipeline looks like, and one of the things I've said is, well, part of the future of our pipeline looks like the present of our pipeline, we have some really, really great programs high on that list brepocitnib, and I think the data that we're going to talk about today in a lot of detail underscores just how amazing that opportunity can be for patients and frankly, just how potent and active a compound it is. So I'm really excited to share all of that soon. First, to get out of the way on Slide 5. So what's going on from a capital return perspective. So we announced this morning really 2 things. One is that we've got a board authorization to buy back the current board authorization is up for $1.5 billion in stock. I'll all put that number in context in just a second. And the other is that we've reached agreement with Sumitomo to repurchase their entire stake for $9.10 a share, $648 million in aggregate. So that first purchase from Sumitomo will reduce our share count by about 9%, and then the remainder of that $1.5 billion just gives us great flexibility at the current moment right? The way that we think about it is we're incredibly privileged to have the cash balance that we do. We've said all along that we intend to be disciplined that we intend to be ruthlessly economic and thoughtful about how we use that capital and that we thought it was virtually certain that we'd be able to return a meaningful portion of it to shareholders. When we think about the $1.5 billion really what I think about is flexibility. I think it gives us the ability now if we see opportunities in the market, if we see dislocations in the share price to really go out and use a lot of firepower. And if we use it up, we certainly have the ability on our balance sheet to re-up the authorization to do more in the future. But also, it gives us the flexibility. We see some truly incredible opportunities for capital deployment on new programs. We've talked a lot about how promising the environment is. I'm every bit as excited today as I was on our last quarterly call or more. And so as those opportunities come into relief, we have the flexibility to think very carefully about our capital. But now we're sort of here. We have the tools in our toolkit to do what we need to do yesterday, today and tomorrow. If there is mentioning, disposition -- our capital position is unchanged by this in the sense that we still have -- even if we use the entirety of this $1.5 billion and more, plenty of capital to fund our existing programs and profitability plenty of capital to expand our pipeline with some of big [indiscernible] just alluded to and plenty of capital continue to return capital to shareholders. So I hope this answers some of the questions that we've been getting around how to think about the large concentration in shareholder base. I hope it answers some of the questions about our ability and plans to return capital just really looking forward to being able to clarify that and move back on to the important work, which is generally a good thing to pay out. Against that backdrop, I'm going to let Ben speak by and large, to the brepocitnib data and NIU itself. But if you look at Slide 6, just as a reminder, kind of what the pipeline today looks like. I think we remain incredibly proud of our late-stage pipeline. We still have a concentration in I&I, although we're looking in other areas as well. And brepocitinib is one of these molecules, and we've talked about this before, that they come along infrequently. It's an incredibly capable compound with [indiscernible] data. As a reminder, we have before today, 6 positive Phase II studies over 1,400 patients worth of exposures, and then today, though, is kind of a special day for us with the program and that today is really the beginning of kind of the Roivant Priovant brepocitinib era, right? Prior to today, the 6 positive study that I mentioned were all sort of run by Pfizer, largely in advance of us acquiring the program and even SLE study that read out last year was a study run by Pfizer that we thought might have fit into our overall picture but it wasn't a part of our defined strategy. Our defined strategy began with the initiation of our dermatomyositis study when we first brought the program in, and that data is coming next year. But this is the first time we've kind of read out data from a study that we conceived out that the Priovant team, Ben who you'll hear from and his team designed and executed. And it's great when you're in that position of the data is just as extraordinary as the data that we're about to talk about. So look, I think this is a drug that matters or at least should be drug that matters. And I think this is a disease population that has, as you'll hear very few other options, and this is some of the -- really not some of, really the best data that we think has ever been seen in the NIU field. So I could be more excited to share that data with you and to hear more about it from Ben. So I'm going to hand it over to Ben now, and he'll take us through it starting on [indiscernible].

Perfect. Thanks, Matt. Great. into to tee this up. And if you turn to Slide 8, I'm really excited to share the results of our Phase II study evaluating REPO in NIU. As you see on the slide, and I'll walk through in detail later, the study generated the strongest data that's been generated to date in any study on the registrational endpoint in NIU and we also had great results on a number of important secondary endpoints, particularly certain measurements related to the prevention and treatment of macular edema and we achieved these results in spite of an aggressive 6-week steroid taper, which involves pulling patients off 60 milligrams per day of steroids, point that of that completely off prednisone more than twice as quickly as in precedent studies. So really great data against a very high bar for efficacy that I'm excited to walk through in more detail. But first, if you turn to Slide 9, I wanted to take a brief step back and provide a bit of additional context on brepocitinib and NIU for those of you who haven't been following me as closely or aren't that familiar with the indication. Brepocitinib is a dual inhibitor of TYK2 in JAK1. That's really a unique isoform selectivity termination among JAK inhibitors, what they had the approved in late stage pipeline, there's very little other therapies that are able to achieve what we do through that dual inhibition in terms of being able to hit type 1 interferon, type 2 interferon, IL-6, IL-12 and IL-23, all with a single targeted agents. As Matt walked through before a great background of clinical data in terms of both safety and efficacy across many different studies and indications and there's a lot of different directions that we could have taken this and as Matt walked through, the Roivant, Priovant strategy was really about developing brepocitinib is a large orphan franchise across multiple high-morbidity indications. These indications have tremendous commercial opportunity that's largely or in some cases, entirely untapped by both biologics and other JAK inhibitors. And we think that because of that mechanism I walked through before, brepocitinib is well positioned not only to be one of the first therapies to market, but also is well positioned to really generate best in indication data that stands the test of time, even as other drugs may in the future enter the development pipeline. And this is because we're able to hit so many of the pathogenic cytokines involved in these diseases through a single asset. And so I think the data we're sharing today from my perspective, is really cause for excitement first and foremost, as it relates to brepocitinib's potential in NIU, but I think it also really validate and bring to life this strategy for the drug more generally and increases our excitement for it across multiple other indications as well. Now turning now to Slide 10, just a bit of background on NIU. This is one of the leading causes of blindness in the United States, tremendous unmet need, the only non-steroidal therapy approved is HUMIRA, which has limited efficacy in the indication. And as you can imagine, given the risk of blindness and other very severe symptoms, physicians have a very high sense of urgency to treat. And for that reason, given the limited efficacy of HUMIRA, a large number of patients are prescribed off-label therapies as part of a general and a kitchen sink approach to treatments. And in our opinion, this unmet need is one of the most appreciated commercial opportunities in autoimmune disease, and to elaborate a bit on that, at least half of NIU cases as I know, slide occur in the context of other autoimmune conditions and really, the current diagnosis and treatment patterns related to that have only developed and really concretized over the past 2 decades. And for this reason, pharmacy claims analysis of HUMIRA prescription in NIU in our view, most likely significantly under assess the current market size capturing only the idiopathic cases, which is less than 50% of the total and only patients on HUMIRA without looking at the large number of off-label biologics, also use -- our own claims analysis has found about 30,000 patients receiving a biologic therapy for NIU and prescription rates appear to be growing rapidly. Both is ophthalmologists, increasingly embrace the criticality of systemic immunosuppression for treating ocular inflammation and also as other specialists in rheumatology, GI and otherwise develop greater awareness about the indication, helping to further drive diagnosis rates and treatment rates. And so brepocitinib, of course, to enter this market [indiscernible] I'll walk through momentarily, a potentially highly differentiated efficacy profile along with very limited competition and orphan pricing, we see clear potential for a multi-billion dollar peak sales opportunity in this indication alone. And Slide 11, I'll just briefly go through to reinforce this point, which is that the prevalence and morbidity rates in NIU are very much in line, or in some cases, exceed those in other recognized blockbuster orphan indication. And unlike some of those other indications, we have much less competition here. And so I think as you think about NIU as a market, I think one way to think about it is really having many features in common with rare indications like HS, TED and MG were several years ago, and we're excited to be bringing forward a molecule that has the potential both to be the next improved drug of any modality, first oral therapy, and that has generated data to support a highly differentiated product profile. So this brings us now to the NEPTUNE study itself on Slide 12. The study enrolled 26 patients who were randomized 2:1 to brepocitinib 45 milligrams per day and 15 milligrams per day. This is a study in active NIU. So patients all had active disease at baseline, consistent with the treatment paradigm, patients were given a 60-milligram per day steroid burst for 2 weeks. And then per protocol, there was a force taper completely off-prednisone by week 8. So a 6-week taper. And then the primary endpoint is the treatment failure rate, which is a composite endpoint of several measures of ocular inflammation and visual acuity and that is evaluated after week 52 as the primary endpoint at week 24. And we base the study very closely on Visual I which was the active uveitis registrational study for placebo. That study and a number of others of similar design that have established that followed to have established a pretty clear placebo rate of around 70% to 80% and so this is an indication where we don't see particularly high risk of placebo response, the measures of treatment failure are all currently objective assessments and so looking at Visual I is a great way to contextualize this data just as background, there is a second HUMIRA study Visual II that was done an inactive patients, which are patients who are basically quiescent at the time they enter. And so that's a very different [indiscernible] characteristics and not really quite as relevant comparison point. On Slide 13, I want to go a bit more in depth on the steroid taper, which is really the one and only material design change we did have from Visual I and as I mentioned before, this was to have a steroid taper that was more than twice as rapid as these other studies. And we did this to actually make it considerably harder for brepocitinib to prevent treatment failure and demonstrate efficacy benefit. The drug needed to have a very rapid onset of action with highly efficacious steroid-sparing benefit, to prevent flares while tapering patients from 60 milligrams per day to 0 milligrams per day in just 6 weeks, any physician will tell you that absent having a very efficacious steroid-sparing therapy being used that's going to lead to a flare. And then also notably brepocitinib to meet the primary endpoint needed to sustain steroid-free benefit for over 50% longer than HUMIRA did in Visual I to prevent treatment failure 5-6 month endpoints. And I emphasize this really just to reinforce that although this was a small study, it was not a small study designed to detect any signal benefit from the drug. To the contrary, it was a study setup to fail in any world where brepocitinib did not deliver overwhelming evidence of benefit, and it was really designed related to that to ensure that there were no false positives, and so against that backdrop, we're really expected by the results. And of course, it was important for other features of the study design to be in line with Visual I and as you'll see on Slide 14, endpoint definition and i.e. criteria were consistent and on Slide 15, baseline criteria were consistent. So now moving to Slide 16. I'll walk through the actual data itself, and again, contextualizing our results in the context of Visual I to provide a bit more meaning to kind of how to process these numbers. As included here 2 different cusps of the data, if you look on the left-hand slide, this was our prespecified of primary endpoint in which discontinuations were imputed treatment failure and the comparison to Visual I on the apples-to-apples methodology there. And then on the right-hand side of the chart, we see the way that the HUMIRA data from Visual I is presented on the HUMIRA website. There's multiple different ways that the HUMIRA data is described in certain different formats, but this was one of the most HUMIRA favorable description and was done in a way where their methodology was made pretty clear. And so we were able to do what we think is the apples-to-apples comparison there. And do you see across either one of these approaches, you have the brepocitinib 45 milligrams doing more than 3x better than the placebo arm and more than twice as good as the HUMIRA treatment arm. So really quite striking data. And you also see brepocitinib 15 milligrams doing quite well with a clear dose response. And if you turn to Slide 17, I'll contextualize that a bit, that good data from the 15-milligram arm is something we expected. By way of context, brepocitinib 10-milligram who's been studied in placebo-controlled studies in UC and psoriatic arthritis generated data that was roughly in line with HUMIRA there, so we would expect on the basis of that 15 milligrams, which is 50% stronger dose than 10 milligrams to also do equally or as we see here better than HUMIRA. And then also just looking in general at normalized dose response data across all the indications where brepocitinib has been studied over 1,400 patients dosed across many different indications. And we see brepo 15 milligrams at roughly 60% of maximum efficacy and over 90% at 45 milligrams. So again, that ratio of benefit from brepo 45 to brepo 15 milligrams, is consistent with what we've seen otherwise and the relative performance to HUMIRA consistent with what we have see otherwise. So we think that, that context certainly adds to the robustness of the data on Slide 16. Turning now to Slide 18. Starting to go through some of the secondary endpoints to add even further to the robustness and our excitement about the potential product profile that we're looking at in the event of approval. What we see on Slide 18 is the secondary end points on each of the 4 individual components that make up treatment failure and you see some great data here as well from brepocitinib. No new inflammatory lesions in either eye. [indiscernible] phase, which is one of the important markers of inflammation. We actually see brepocitinib getting the brepocitnib 45-milligram dose arm, the mean improving even after the best date achieved during steroid taper. So while tapering from 60 milligrams to 0 over 6 weeks, we're not only maintaining benefit, we're actually improving benefit on that endpoint and then just looking holistically across these you see both dose arms clearly outperforming the placebo from Visual I, brepo 45 milligrams clearly outperforming the HUMIRA treatment arm. Here, I think on the secondary endpoints, you see an even clearer dose response arguably than on the primary, which makes sense since these are, generally speaking, more continuous variable on our binary outcomes. And so we think again both some exciting data here in terms of the potential future product profile and then also really add to the robustness of the replicability of the primary endpoint data looking ahead to a Phase III study. And then turning to Slide 19 and 20, I also want to talk about an important end point outside of treatment failure, which is macular thickness and macular edema. This is an important long-term consequence of NIU. It is a very severe as anyone follows ophthalmology, is a very severe problem. One of the leading cause of blindness in uveitis patients. And you see on Slide 19, our data on macular thickness being quite excellent. And on Slide 20, we can look at macular edema itself, and you see in the brepocitinib 45-milligram arm of the 10 patients who did not have macular edema at baseline, none had developed it by week 24 and by comparison in the Visual I study at the 6-month time point, half of patients in the placebo arm, who did not have macular edema, had developed it after 6 months. So we think this is really a quite striking results in terms of the potential for brepocitinib to prevent the onset of macular edema and then similar for patients who did enter with macular edema at baseline, there were 7 of those with the 45-milligram arm. And we had a resolution rate of 43%, which again, is in line with data from leading current and potential UME treatments. And Yes. I think the treatment paradigm in general, can often view treatment of NIU itself and treatment of UME as different physicians often will use 2 different drugs for those. And I think one very exciting feature of this data is we have a drug that is being developed for the broader non-interior NIU population, but that has the potential as part of that to potentially not only resolve but prevent the development of macular edema in the first place, and I think that could be really transformative for the field in a very exciting way. Next, turning to the safety data. All in all, we're very pleased with what we saw from a safety consecutive on the study. So if you turn to Slide 21, I'll briefly walk through that. Most notably, no deaths, MACE, malignancy or ATE events in either treatment arm. There was one SAE in the 15-milligram arm. That was a Grade 2 hypersensitivity case that dissolved following discontinuation of study drug and administration of Benadryl. Notably hypersensitivity is on the label for approved JAK inhibitors and we've seen rates in other molecules, other JAK inhibitors that are approved in low to single-digit percent and the [ brepo ] program today, this is not the first type of sensitivity that we've had not all that much. And the rate we've seen to date is less than 0.5%. So considerably less actually than what we've seen from other JAK inhibitors. So this is really not something that gives us any cause for concern. And across the AEs in general, we had no Grade 3 events, except for one, uveitis related flare, in the 15 milligram arm and case of costochondritis in the 45-milligram arm, which is a benign sternum pan. So again, all in all, we're very pleased with what we see from a safety perspective. Group of safety database, all in all is very much in line with those have approved and widely prescribed the JAK inhibitors, including widely prescribed in indications where the morbidity is not always even as great as it is in NIU and for what sort of safety data and the rates here are also very much in line with what we saw in terms of rates in the HUMIRA treatment arm and Visual I study. So turning to Slide 22 and really tying all this together, we're very excited about this data, both again in terms of its robustness for replicability in Phase III, but also in terms of what it says about brepocitinib's potential product profile here. As I mentioned upfront, this is an indication where physicians are focused on treating aggressively with high risk of blindness even for patients who don't go all the way to legal blindness. It's a very severe disease, bosses in visual acuity, pain, blurriness, floaters and the treatment paradigm is really to not mess around given that very aggressive steroid birth and then just to try to find a different steroid experience therapies that allow you -- allow doctors to taper as quickly and sustainably as possible off of those bursts without causing treatment failure. And given the data we've seen in this study, low treatment failure rates, even with the rapid taper sustained over time, potential benefit, not only on inflammation, but also on macular edema, we think there's great potential for the drug to be used early in this paradigm. And again, as you kind of come back to where I started talking about the indication given the large number of patients on biologics and the limited efficacy of those, including many that are not even approved for NIU, we think even in the biologic refractory population alone, there's very significant commercial opportunity. And so finally, on Slide 23, I just want to talk a bit about this data in the context of looking ahead. And I think that, again, to kind of come back to the overall strategy for brepocitinib in these large orphan indication, it really derives from the fact that these diseases are so severe because there's many different inflammatory cytokines, multiple distinct inflammatory pathways involved and to generate maximum efficacy, you need a drug that can get many of those. And as you see in this chart, brepocitinib really does that distinctively and if we think about current or potential future competitors, we don't see them being able to do that in the same way. Starting with IL-17, IL-17 inhibitors have generated mixed data in NIU and that's not just because a specific molecule is impeding IL-17 hard enough. There is only hitting IL-17A rather than [ AFS ] rather because the TH17 pathway is only one inflammatory access in NIU and it's relevant, but it's only one access and an IL-17 inhibitor is going to have no impact on the TH1 pathway and also no impact on IL-6, which is involved in TH17 signaling, but also has other relevance in NIU too particularly for vascular permeability that contribute to macular edema. So we really see that as being a mechanism that's not likely to generate as much efficacy benefit as we see from brepo. I think turning next to selective TYK2 inhibitors, our view is really -- obviously, we're enthusiastic about TYK2, brepocitinib itself is a potent inhibitor of TYK2. But I think the kind of [indiscernible] of allosteric TYK2 inhibition specifically, so those mechanisms can be very beneficial and appropriate in certain indications. I think [indiscernible] as a sort of single solution for all autoimmune diseases worn off quite a bit lately. We've seen brepocitinib fail in IVD. We've seen Ventyx fail to meet expectations in psoriasis, and we think NIU is definitely an indication where JAK1 is adding a lot to what we see in terms of efficacy being able to hit IL-6, which TYK2 does not also being able to hit interferon gamma, which is very important in TH1 signaling and so we really think this is an area where JAK1 is doing a lot of the work. And that dual inhibition is particularly valuable. And of course, that logic also holds up a few look at other mechanisms like a selective JAK1 inhibitor or selective IL-6 inhibitor, each of these 2 important things are only going to be hitting certain inflammatory axes and we think that there's really a type of [indiscernible] here between the great data I just walked through and what brepocitinib is doing mechanistically and that further contributes to our confidence that this is great data, not only by the standards of studies that have read out so far, but also that it is highly likely to stand the test of time. So turning to Slide 24 and wrapping up. We're really excited about this and really excited about the potential for what it means for brepo, NIU and other indications. We're excited to be moving ahead with the Phase III program, which we expect to initiate later this year. And also, as Matt mentioned in his opening, we're very excited by the progress in dermatomyositis, our Phase III study there, which is underway. It's actually the largest interventional study ever conducted in dermatomyositis that's enrolling very well. We expect to have full enrollment there in the third calendar quarter of this year, and we're on track to have that readout in 2025. And this is another very exciting large-orphan indication that I think meets many of the same opportunity traits that I want through earlier for NIU. And so Slide 25, I won't belabor these points since we've already gone through them. But again, great data, really excited about its implications both for Phase III and a potential product profile as well as for other indications. Thanks so much.

Thanks, Ben. Appreciate it. And obviously, again, tremendously exciting data that we are really pleased to put out today and excited to see the progress in the program and looking forward to that Phase III study starting -- our Phase II study starting later this year. So with that, I'll say thank you, everybody, for joining. We're, again, excited about the progress with capital allocation and excited, most of all, to deliver clinical data that will matter to patients. And I'm looking forward to taking your questions. So I will hand it back over to the operator to begin that.

[Operator Instructions] Our first questions from Brian Cheng with JPMorgan.

Congrats on the buyback and the NIU data. First, a housekeeping question. What is the latest fully diluted share count after the repurchase of the Sumitomo block?

Thanks, Brian. Thanks for listening, and thanks for the great questions as always. On acquisition of Sumitomo block based on the 12/31 number, I'd say, either a basic share outstanding number, I think about $733 million, I'd say, on a treasury [indiscernible] dilution, about $790 million is probably the way to think about that share count.

Okay. And going back to one of your slides, you talked about further repurchase using a potential combination of open market tender offers and private transactions. After the Sumitomo block, there's still about $900 million or so still open to a combination of those. How are you allocating those 3 Matt? And is there a strategy to looping investors that have been keen on your story for some time? And I have a quick follow-up.

Yes. Perfect, Brian. Thank you. Look, I think first of all, as I said in this part of the discussion, we're just excited to have the flexibility to take advantage of whatever comes our way. So I think we don't have a sort of programmatic plan to -- it's going to be 1/3, 1/3, 1/3 something like that. I think our view is -- as Sumitomo, large shareholders looking for concentrated liquidity at an effective price, that's a conversation that we continue to have on a regular basis with those shareholders. I think uniquely now that we have the program in place, we can and will be out there any time that there's a dislocation in our value that we think doesn't reflect the value of the business to take advantage of it on behalf of the shareholders who are with us long term so I think that's a change, something we've always said we would do once we got ready for it and now we're positioned. So I think that's something we'll be out there in the market when that happens, taking advantage of it. And then I think like more generally, we're going to be opportunistic about how much of that to deploy, when to deploy and whether to go above and beyond what we even currently have authorization for. So I'd say stay tuned. And in terms of continuing to sort of cycle the shareholder base, look, I think we are really pleased with a lot of the progress we've made in bringing new folks into the story. And I think there were at least some people who were kind of waiting to see clarity on this point because some people were waiting to see clarity on our pipeline strategy, and I expect those things to come into relief some of it today, some of it in near future and look forward to continue to talking to those people and continue to try and place [indiscernible] stock with folks who want to be one of the holders for a long time.

Just one last one on the NIU piece. So fairly good data there. But it's interesting that the NEPTUNE study has a more aggressive steroid tapering that we saw compared to [indiscernible] Phase II and also the Phase III Visual I for HUMIRA. So how are you thinking about your Phase III? Is that going to be a similar approach of NEPTUNE where you are deploying a more aggressive steroid tapering, or does it not matter at all or more just a traditional steroid tapering. What's your latest thought on it.

I'll give a quick thought and I'll hand it over to Ben as he's got sort of more to say. Look, I think first of all, I think the design and Ben hit this in his comments, the design of steroid taper in the Phase II was in part designed to make sure that we did not see false positives in the study by being very assertive. Now the data we showed was extraordinary. And so I think it makes us sort of think carefully about what we want to do with Phase III. Mostly, I think we'll comment on Phase III design once we've had discussion with FDA. But Ben, anything you can say about your general principles.

Yes. I would echo kind of have more final thoughts after FDA engagement. I would say there's 2 unique values of the steroid taper. The first is in the context of this Phase II data having a very high bar to clear as they walk through. But the other is thinking about, from a physician perspective, the value of being able to have evidence that a drug can work in this way and to get patients off steroids faster, I think that is something that will be of high value to physicians, I think physicians are going to be very excited by what they see here and its potential. And I think that again, I think that steroid-sparing benefit and to getting patients off steroids faster is of very high value. So I think we set this very high bar for ourselves given we've cleared it. I think our default is not going to be back down from that. but move forward with, again, what we hope will be a product profile that is highly differentiated for this, among other reasons.

Our next question comes from David Risinger with Leerink Partners.

[Technical Difficulty] On the announcements, Slide 11 in the presentation today. And I have a number of questions. Let me just go one by one, if that's okay. First, for the planned NIU trial, the Phase III, are you considering including a HUMIRA arm in order to show superiority and forced payer coverage? That's my first one.

Yes. Thanks, Dave. Thanks for listening. Thanks for questions. Your audio is breaking up a tiny bit, just FYI, but I think I've got where you're coming from. Look, I think on the one hand, our data here is striking. And I think we know what we've got as it were. This is a -- it's a phenomenal data set. I think that cuts both ways from a trial design perspective in the sense that like to be honest with data this striking, I'm just not sure -- I'm not sure what data is striking for disease with this level of morbidity. I'm not sure we're that worry to be honest about payer coverage, but it's a thought for the future. I think it is relatively unlikely that we would have a HUMIRA arm in the Phase III trial design. But to begin those discussions are still in the future with FDA, and we're still sort of partnering ourselves out. So I think that's kind of where we're at.

Okay. And then just looking ahead regarding brepo in dermatomyositis, could the FDA issue accelerated approval on a single Phase III trial if the results are highly compelling, or will a second successful Phase III trial be required before approval?

So just to clear, I think we said this before, but just to be very clear about it. Our expectation is that the ongoing dermatomyositis Phase III program is registrational that is this is the last study wanting to run.

Yes. I think that's the key point is that our study was designed and powered to serve as a single Phase III study, and we've had engagement with FDA on that point. And obviously, as with any single Phase III study, we'll need to generate really excellent data to meet the standards, but this is orphan indication, dermatomyositis, no modern targeted therapies approved at all. And so we think that certainly with great data, there's going to be a lot of excitement to have this drug on the market as quickly as possible.

Got it. And then finally, how are you thinking about pursuing additional potential indications for brepo beyond dermatomyositis and NIU?

I'll say simply, we have a lot of ideas and Ben and the Priovant team come up with new ones on a very regular basis. So I think stay tuned. And every time we read out positive data with this compound and then look at it, it makes us feel like we should be doing more with us. So I think absolutely on the table.

Our next question comes from Yaron Werber with TD Cowen.

Congrats on the data. So I have one for NIU and then one on dermatomyositis. For NIU, are you contemplating also doing a study in nonactive NIU as well just to round out the label. And then secondly, for DM, it sounds like we should think that the data -- that problem is getting a lot of attention from KOLs, which is good to see. It sounds like it's going to be a 52-week endpoint. So I'm thinking sort of data in second half next year. Am I thinking about this correctly?

Thanks. I'll hand it to Ben to answer both the questions.

Yes. So first on NIU. I think that in general, I would say that the kind of treatment paradigm and way physicians think about active versus inactive NIU has been evolving. And these are not 2 separate patient populations an inactive patient is just an NIU patient where their disease is under control at that time. That's what -- An inactive patient is an active patient whose disease is under control at a given point in time. So again, I think that we'll kind of have final details on what our Phase III program looks like after we engage with FDA, but as a general matter, our perspective and I think the KOL perspective is that the active patient population is really what matters and mirrors how they're engaging in the real world. And important to note, the HUMIRA label itself does not distinguish between active and inactive NIU. And then on dermatomyositis, I think your inferences are reasonable. It is indeed a 52-week primary endpoint. And yes, we're looking at Q3 roughly for completion of enrollment. And so I think that can kind of do the math on the back of that, but your inferences seem correct to me.

Can I maybe just throw up a couple of follow-ons. So on both DM and NIU, is this a market that you guys would want to commercialize yourself? And do you have a preference to commercializing sort of U.S. and what to do ex U.S.? And then maybe just secondly, the remaining $850 million of the buyback, is there any chance that you'll try to do, as you said, I guess I'm trying to get a sense with SoftBank. I don't know how much you can share with us and some of the dialogue there.

Yes, I'll take those in reverse order. Look, on the remaining $850 million, again, we're going to be opportunistic. We talk to our large shareholders regularly. The question of what SoftBank would or wouldn't do as mostly a better question for them than for us. They continue to be as best as we can tell, we're excited about the story, but also a liquidity over time. So we'll see. But we certainly have the flexibility to have a conversation with them or to be in the market at any moment of dislocation. On the commercial question, look, I think the short answer to your question is, yes, look, I think these are indications we would be excited to commercialize. They are indications of time morbidity, their orphan diseases with relatively concentrated prescriber bases. One of the nice things about NIU is many of these patients are treated at specialty uveitis sort of focused centers. So we know who the backs are, the docs are incredibly excited about new therapies that using a lot in the pipeline and not a lot has been delivered. So I think it's absolutely the kind of market where we could do ourselves. The only caveat I'll give is the same caveat I give whatever I get any of these questions, which is that we are ruthlessly economic in thinking through these things, but it's a big opportunity. And the one thing -- I guess, the one thing I'd say a plug for it is you had called out or maybe David called out Slide 11. I think some say our view that NIU is a significantly underappreciated market in terms of the size of the opportunity right now. And it looks even a little bit of scratch to surface inspection, a lot like some of these other markets like HS or TED or myasthenia gravis, where until new therapies enter that until patients and doctors really started thinking about what things could look like. People just undercounted the opportunity. And I think we expect to prove out something similar in NIU. And so it could absolutely be an opportunity for commercializing ourselves. It gives us a chance to see that play out.

Our next question comes from the Yatin Suneja with Guggenheim.

Two questions for me. First one is on brepo indication expansion. Obviously, you're doing NIU and DM in the [ watch ]. How should we think about indication expansion? And then does this open up broader ophthalmology opportunity? And are there indications in the ophthalmology space that you can pursue. So that's one. The second one is maybe just a little bit more about the capital deployment, like how would you rate, let's say, buyback versus BD versus returning cash via dividends. Just if you can opine on that and the type of BD, the size and scope that you are considering?

Yes. I'll take these in reverse order again. On the capital allocation question, I think one of the things I like about the way we're set up here is even in the context of the existing buyback authorization, we have a lot of flexibility over the coming weeks and months to make decisions on a daily basis. And I think there are prices and situations where it's 100% going to make sense for us to buy that stack. And there are BD opportunities where it's 100% going to make sense for [indiscernible] capital there, and we're fortunate to be in or didn't really either or -- and to be honest, I don't -- I wouldn't view us either as committed to using the whole $1.5 billion if media opportunities come up that make us want to do something else instead nor would I view us as limited by the $1.5 billion in a world where we see dislocations that we can take advantage of that go beyond that size. It's just a conversation with our board. On indication expansion for brepocitinib, I'll hand it Ben to see if he's got things stay well. But look, I think when you have data this good and frankly, this consistent with supporting the sort of [indiscernible] of the molecule itself, it makes you want to think other things. I think you can imagine we're looking at any severe high-morbidity orphan disease where inflammation is the driver. And for example, where HUMIRA is used off-label or whatever, whether there is a lot to do in optho versus other places, I don't have a sort of a -- there's certainly a lot through other places. There may be additional opportunities in optho now that we have a sense that we're going to have [indiscernible] Ben what else would you say?

Yes. I would echo all of that. And I would just add that we'll definitely think about commercial synergies as we think about indication expansion. I think one thing to bear in mind for these for an indication is -- and that will alluding to this earlier in response to the last question, you have quite concentrated prescriber bases in tertiary centers of excellence. This high overlap between the KOL community and the investigator community and the eventual prescriber base. And so I think that there's actually a sort of different kind of commercial synergy that one gets even across different specialties by kind of having this really exclusive focus on these different large orphan indications. So I think that's another factor that we're going to bear in mind as we think about synergies as well as specialty overlap.

Our next question comes from Corinne Jenkins with Goldman Sachs.

Congratulations on the good data here. This is Craig on for Corinne. So to start us off here, do you see any read-through based on efficacy or safety that this study in NIU may have on the Phase III study in dermatomyositis.

Thanks, Craig. Thanks for listening, and thanks for pretty good question. Look, I think 2 things. One is -- and at that level, we're not -- I'm not a superstitious person [indiscernible] you're not surprised by great data. But remember, we already had 6 phenomenal studies in brepo and other indications. And so we knew it was a highly active compound, and we had good reason to believe that this mechanism would work well in NIU. I think this data certainly reinforces just how sort of the compound can be or how big a gun it is. And so I think in that sense, it adds to our confidence. And then look, I think it's also nice to see, for example, the level of activity on the 15-milligram dose in this study that probably gives us some additional confidence there. Anything else Ben you have had?

I would just say that I think we have high confidence in the dermatomyositis study given the totality of data we have on brepo, and I think NIU only adds to that. And I do think one feature that NIU and DM having common is they are both selected by and Priovant on the basis of really carefully looking at the alignment of the pathobiology of the disease to the mechanism of brepo and to the distinctive attributes of dual TYK2, JAK1 inhibition. And so I think seeing that kind of mechanistic alignment in NIU has played through to not only our 7 successful indication, but an indication where we have some of the best data, I think, can kind of give us confidence that the mechanistic alignment with pathobiology can really flow through into the clinic. And I think that, in combination with the totality of other reasons to have confidence around brepo and dermatomyositis make us only even more confident.

Got it. That's helpful. And maybe just one more, but -- can you provide a little bit more color on how you're thinking about pricing the agent?

It's premature until we see the data in all of the indications or at least some of the indications in Phase III we're going to carry forward. But look, I think these are orphan indications with high morbidity and this is great data, and so we think we're delivering a lot of value. I guess that's how I'll do for now. But stay tuned as we get a little bit of the clear picture of what we look like.

Our next question comes from Andy Chen with Wolfe Research.

Congrats on the data. Two from me. So first of all, can you talk about why you view this is not a competitive indication. I hear you on the 30,000 claims data receiving off-label biologics, but we've also seen pharma companies getting good data here and they choose to not go into uveitis. Just like can you talk about your confidence behind uveitis as an indication? And also a second question, just going forward, can you talk about the possibility of a combination therapy in uveitis, like are you going to allow HUMIRA background patients because now we're in the post HUMIRA biosimilar world. There might be like biosimilars might be just much cheaper in the future. Are you thinking about that as a potential segment of the patient population.

Yes, thanks. Both great questions. And thanks, Andy, for listening, and welcome to the call. Look, on competition, I guess what I'd say is I can't think of a lot of examples of pharma companies who have run successful NIU studies with good data and then decided not to pursue it. There have been other studies in the past. Some of those have been underwhelming. There was a study in filgotinib, which looked interesting. But as I'm sure you're aware, that drug wasn't pursued for other reasons unrelated to this. There was a study in IL-17 a while ago that was again interesting but not extraordinary. And we'll get some more IL-17 data, I think, later this year, in a Phase II. But again, based on what we've seen, I think, so far, obviously they're going to be able to look at this kind of benefit. So I say why isn't a competitive indication? I think the answer is even HUMIRA, which is really the only improved therapy of a recent generation, has treatment failure rates of 50% or higher, depending on how you count them in many contexts. And I think it's just been a tough bar. It's been a disease that has resisted successful development of agents with anything like this efficacy profile. So I think we feel really good about sort of where we'll fall out there. And to be honest, 3, 4 years ago, HS was also not that competitive an indication. And I think as people have come to appreciate the market dynamic there, it's gotten more competitive. I guess it seems possible to be something similar will happen here. But I think we're just early in the curve of what sort of potent drugs can -- seeing what really potent drugs can do in NIU. As far as for background therapy is concerned, I guess I'll let Ben answer as well. But what I'll say is just like given the high treatment failure rate of HUMIRA and every other biologic has shown, I think it's less -- I don't know that I would have a problem necessarily with patients who will fully put on background HUMIRA. But I think like the real point is that it's not a good enough therapy. It still leaves a lot of room on the table. And remember, these patients are acute, their risk of development risk of blindness, patients are just going to want to be on the thing that works best. But Ben, anything you'd add there?

No. I think again, we'll kind of have the final study designed to share after the Phase II meeting with FDA. But as a general matter, I think that this is final Phase III study design after meeting with FDA. But I think as a general matter, the Phase II study this generated great data. And I think basic principle of drug development is that we have great data in Phase II to base the Phase III on that. And so I think that kind of the first principle we'll be approaching going forward.

Our next question comes from Louise Chen with Cantor.

And congratulations on all the progress today. So first question I wanted to ask you, if you could give more color on this multibillion-dollar peak sales opportunity for brepo, how do you get there? And what gives you confidence that you can get there, especially if you're going to launch on your own? The other question I wanted to ask is when we'll hear an update on the undisclosed assets that you've been working on? And last question is just when will you have an update on potential business development deals? Is it something we hear in the second half of the year or first half of the year possible?

Yes, thanks. So I'll start with the last of those questions, which is, look, I think we continue to feel every day blessed to be in the position that we're in, in this market for opportunities. We have never seen a better opportunity set than the one we see right now. We don't have perfect control over when those opportunities materialize. So I can't say for sure whether it's next month or a few months from now or 6 months from now. But just suffice to say, we are sprinting in a lot of directions at once. On the -- update on the undisclosed asset, the short answer is, it's a -- unlike NIU, it's a particularly competitive area where there's another drug with a similar mechanism. And so our view is to get our Phase II started before we provide full color. We are going to share that update in due course, probably a little later this year, and it will come sort of around the same time as our Phase II starts. And then sorry, your first question was how we get to $1 billion peak sales in NIU. Look, I think there's a few ways to cut that question. One is -- and sorry, I said brepo generally, it's easy to get to $1 billion peak sales of brepo generally. But even in the context of NIU, I think there's a few ways to cut that question. One is if you just look at the patient population, the morbidity and the level of efficacy of existing therapies. And the truth is, I think it would be hard-pressed to name an indication that have a patient population and morbidity of this level that had a new therapy come in with data that was this much better than the standard of care, and it didn't, frankly, find itself on a path to being a $1 billion market. HUMIRA is growing solidly double digits a year and NIU is doing at least hundreds of millions of dollars today having been on the market not that long and again, growing at a pretty good clip. And HUMIRA is a different animal here. It's much less efficacious. It's priced for different indications, et cetera. So it's a pretty different story. And I think on top of that, NIU -- and this is an important point that we're going to do work on and also just publish over time, more work that we've done on it. NIU is an indication where the claims data definitely underestimates the rate of prescriptions for NIU for a drug like HUMIRA because about half of these patients have significant comorbidities, and it could be hard to tell, right? A patient gets an RA diagnosis, then they get an NIU diagnosis and they go on HUMIRA. A lot of the existing claims databases would look at that patient and assume that, that was an RA script. One, in fact, like we think it's pretty clear once you look more closely at these data, a lot of those scripts are NIU scripts. So even in the existing data on NIU, there's actually suggestion that blockers possibly with a less efficacious therapy. Once you get beyond NIU, even in -- even dermatomyositis, these are large orphan markets with high unmet need that support orphan pricing. It just doesn't take that many patients to get to a really big opportunity. And with data like the data we're generating, we just feel bigly confident.

Yes. I don't just echo that last point is I think in each of these alone, let alone across multiple of them, the percentage of -- if you think about overall prevalence of 70,000 or more patients with non interior NIU, 40,000 adults with dermatomyositis, at orphan pricing the absolute number of these needed to kind of get to a blockbuster level is not that high penetration rates and with the data that we've generated in NIU and hope to generate in DM, we actually think we can get high penetration rates into these populations and then in terms of the question commercializing ourselves, which I know is part of your question as well, kind of come back to some of what we're saying earlier, but I think that these orphan indications are really, in some ways, optimally suited for obviously, Roivant overall is a commercial stage company. Priovant is not. But for kind of looking just at the Priovant level at a kind of first time commercial launch, given that you're looking at a very concentrated prescriber base with high overlap with the KOLs and clinical trial sites. And I think there's a lot of precedent in orphan disease for biotech companies making the transition to commercial and launching therapies very successfully there.

Our next question comes from Douglas Tsao with H.C. Wainwright.

Congrats on the data. I guess 2 questions for me. First, in terms of NIU? I heard -- I understand your point in terms of physicians not necessarily discriminating between active and nonactive disease. I'm just curious if there could be a dynamic similar to what we've seen in the TED market where the FDA did not care, but payers did sort of -- sort of impose restrictions based on what the clinical trial data was in terms of what they were willing to reimburse. And then just a second question in terms of capital allocation. Obviously, you're going to still have a significant cash balance, which I understand you will use to sort of fund ongoing R&D. But just curious if you could provide some thoughts about how you're thinking about deals. I know you're still excited, but give perspective on size of deals that you're now looking at? Has that changed versus what you've done in the past?

Yes. Thanks, Doug. Those are both great questions. So I appreciate it. I'll take them backwards order. On capital allocation, I think the short answer is no change from our previous discussion on this topic. We are in a rich, rich, rich opportunity set. The [indiscernible] with Roivant has always been that stingy with upfront dollars and everything that comes with that. So we're not always a great M&A buyer, although never say never. And what we prefer to do is partners often with larger pharma companies who are less focused on upfront cash and more focused on risk sharing and an opportunity to do great if we do great. I think you're going to continue to see us looking at those kinds of opportunities first and foremost. But again, in the grand scheme of things, I think everything is on the table. And in terms of opportunity size, certainly nothing about today's announcement changes our appetite at all. I think we're still looking for programs where, frankly, where our capital is a competitive advantage among others, and we can go out and in some cases, run large Phase III programs that many competitors wouldn't be able to readily fund because we had more [indiscernible] capital to do so. On the active versus passive question on the payer point. Look, I think the short answer to that question is, first of all, we are going to have a long-dated follow-up that will give us a clearer sense of continued efficacy in these patients who are well beyond the acute early presentation of the disease. And I think it's important to understand, the biggest patient need here is at that moment of active disease where they're at risk of significant progression, at risk of blindness, et cetera. And I think we want to make sure we're focused specifically on that opportunity, first and foremost. And I think if we can deliver data to anything like the data we've shown today in that population. I am not concerned about the commercial lending.

Our next question comes from Neena Bitritto-Garg with Deutsche Bank.

I apologize if you have already been asked if it was missed the first bit of the call. But I guess first question is just how do the results today impact your desire to do additional deals in the ophthalmology space? I know that's not a space that you've prioritized previously. But I guess any thoughts on that would be helpful. And then second, anything -- any thoughts that you can provide on what a placebo response or treatment failure rate may have looked like given the study design, I know you -- we have the placebo group from the Visual I study. But just given the faster steroid taper, I guess any thoughts on what the placebo treatment failure rate may have looked like in a study like this.

Yes. Thanks, Neena. Great questions. On the first one, we've never been sort of indication first. We've always been opportunity first in the way that we look at opportunities. So I don't know that there's like a big change in how we think about therapeutic focus based on this data. I think the short answer is if and when we're launching brepo in NIU and we're out talking to these centers. If there are additional ways to make use of that commercial spend, we'll certainly think about it. And as Ben mentioned, there are synergies that go beyond us, though. On -- Sorry, on the question of placebo response rate, I think we hit on this. And if you look at Slide 16 in the deck, I think in the VISUAL I study, on an apples-to-apples basis to how we looked at our data, they had an 82% prudent failure rate in the placebo arm. That's with a lower bar that is with longer steroid therapy. So I think our expectation is that the placebo response rate would have been worse than that or a higher treatment failure rate. And I think, to be honest, I think we were a little bit worried about a situation in which our data looked facially comparable with something like HUMIRA we thought that indicated a better drug because of a more aggressive steroid taper. I think the fact that the data was so clear makes this an easier discussion. Ben, anything you'd add to that?

No. I mean, I would say, yes, the kind of in VISUAL I and looking at the few other studies that have had kind of similar design to this, we really see that 70% to 80% of placebo rate quite consistently. And with our much more aggressive steroid taper, as Matt said, we would expect something that would be even higher than that, again, in this case, higher being worse. That said, I think one of the nice things about this data is even if we're wrong about that and what the placebo rate would have been is more like 70% to 80%, it's still as these be on Slide 16, fantastic data against that bar.

Our next question comes from Robyn Kay Karnauskas with Truist Securities.

Congrats on the data. I just had if you drill down into the market. So just trying to figure out what the real opportunity is. So a couple of questions. Number one, like what percentage of patients do you think are actually well controlled and stable on HUMIRA? And the second question would be if there's comorbidities and someone has RA and obviously, HUMIRA might address those a little bit, maybe not as much. Going back to the combo question that was asked earlier, how do you see the drug being used? Do you think the safety studies need for docs to be comfortable combining the two, given their immunosuppressants? And then I have a follow-up.

Yes, sure. On the first question, Look, I think the easiest answer to that question is at the 6-month time point where these studies are at the week 25 time point of the study ran out, on our stat analysis, had a 62% treatment failure rate, and that includes either people that have discontinued or people that had effectively worsening of disease in various axes as we talked about earlier. I think like at a bare minimum, when you think of the limited group of patients on HUMIRA, 62% of them are not well controlled by virtue of either treatment failure or discontinuation. And my suspicion is the number is actually greater than that. But because those failure rates are what they are. First of all, as a lot of patients aren't going on HUMIRA because it's efficacious, but not that efficacious as it were. And also, there's a lot of patients who just like never make it quite to that point the treatment paradigm for various reasons. So we think it's a big opportunity. That's on the -- on how well controlled these patients. Ben, anything you'd add to that?

No, I think that's right, is that they're not that well controlled in the patients on off-label therapies, there is no evidence that the therapy is necessarily work beyond anecdotal evidence. And so we see the failure rate fair and then being even higher.

And then on the comorbidities point, I think the answer is, Ben, you can take this. Go ahead.

Yes. I was just going to say I think that there's generally a recognition for these patients or the etiology is in the context of other diseases, the treatment of the eye needs to lead. I think that's something that physicians across specialties would agree with when you're talking about risk of blindness and again, even when a short of blindness very severe visual problems. I think that this is something that obviously ophthalmologists, but I think also rheumatologists and others would have a very acute awareness of. Rheumatologist, obviously, are have a lot of experience thinking about systemic autoimmune diseases across multiple organ systems and thinking about which organ systems need to lead, the ophthalmologists, of course, they're going to be particularly focus on the eyes. And so we really think that that's kind of for these patients, what leads the treatment paradigm and then the treatment of the other perhaps less severe symptoms and other organ systems follows.

And look, in this Phase II study, look, the patient we have to treat where they are. We don't have the Phase III conversation with FDA. So I can't say exactly what we're going to do in Phase III. But in the Phase II study, patients were allowed to be on stable ISCTs, for example, because that's just what the patient population is. And so I think you'll see probably something similar in our Phase III study with [indiscernible].

That's helpful. And then last question is you talked about 30,000 of biologics with 5,000 to 10,000 that are not on therapy and seeing these trials, so many people have been diagnosed with uveitis, but not treated for many, many, many months, which I assume would open up the opportunity if there was a real potent drug out there that works. So why are patients not on therapy? And to give a sense -- I know it's probably early with your market research, like would a doctor prescribe the sooner what do they need to see in Phase III or duration of safety to get more comfortable with treating people on the spot?

I think there's sort of 2 separate questions here. One is taking the sort of acute active patients who need immediate therapy. Look, I think if you show up to the doctor's office and you're having a flare up or maybe it's your first presentation of NIU, what are you going to want against the backdrop of the disease that could cause blindness, you're going to want the biggest gun now. And so I think like one thing is -- the water is a little bit muddy in the current world, but like what that is, frankly, HUMIRA is a great drug, but like docs like doing steroid injections and other things, depending on where the disease presentation is and so on, like I think this data -- at least this data is clarifying, right? This is very good data. And I think if you're an acute patient, certainly, you're going to want a therapy of this kind. I think as you talk about sort of moving into the sort of broader treating paradigm, I guess there's a few things. One is, look, not to miss the point. It's a once-daily oral therapy. It's a med like any other. If your patient has never been on an injectable therapy and not sure what that's like, this is just like any other pill that you take. So I think there's a change in sort of treatable paradigm just based on lot of administration. And I think the other thing that will matter is seeing the kind of efficacy benefit out to 24 weeks, 52 weeks in a vigor study. For example, Ben reference to sort of macular swelling data. I think if something like that for 6 out of 12 months, and you're seeing patients on other therapies, developing recurrence, developing swelling, developing things that could lead to blindness over time, I think docs are going to want people well controlled on brepo for a long time, if that's what we see in that data.

Yes. And I think broadly speaking, kind of what you see in NIU is that steroids worked reasonably well, they don't always work but they work reasonably well and the biologics don't work very well. So you have docs kind of constantly trying to get patients off steroids, off the biologics, but the biologics not always doing what they need to do. And so that's why you kind of see a lot of that cycling, but a lot of those patients are maintained to some degree on steroids, including frequent bursts or even just medium to high doses administered chronically, and I think that important its own side effect for systemic steroids, those are obviously well known. Also important to note that steroid injections, which are used for NIU particularly as a treatment for macular edema, carry even worse side effects than systemic, including very high risk of glaucoma. So yes, I think to kind of echo Matt's point, I think the biggest problem in NIU is that there's just not drugs that work well enough and our hope is that brepocitinib can be that.

Thanks, Rob. Those are great questions. And we're going to continue to do work to try and focus people on the size of the opportunity here because again, it's just not one of these indications where a lot of that work has been done today. So stay tuned for more of our fringe analysis and so on.

There are no further questions. I'd like to turn the call back over to Matt Gline for closing remarks.

Yes. Thanks. Thank you, everybody, for listening again on such a short notice. We have great covering all. We appreciate it. I want to thank, obviously, Ben and the entire Priovant team who worked with on study. I want to thank Pfizer as our partners. And then I want to thank all of the investigators, and frankly, most of all the patients in the program who have entrusted us with their care. It's an exciting day we'll put out payout this quality. It's exciting to be able to say at the same time that we've seen at least sort of some of the overhang from our existing shareholders and that we have the firepower to continue to work on that problem. And I just couldn't be more excited for many other opportunities on the phone together in the coming months. Thank you all, and have a great day.

Thank you for your participation. This does conclude the program, and you may now disconnect. Good day.