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

Good day, and thank you for standing by. Welcome to the LISRAYA approval call. [Operator Instructions] 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 the FDA approval of LISRAYA. 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 the 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 have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. And with that, I'll turn it over to Matt.

Thank you, Steph, and thank you, everyone, for dialing in this morning. Obviously, an exciting update from us. So we're really happy to be here. I've reflected to a few people over the last couple of days, the thought that I've had, which is that it's a deeply unsatisfying marathon when the prize for winning is that you get to start running another marathon immediately. And that's the moment that we're at now where we finally, as you all know, have gotten LISRAYA to the point of approval and now we get to get it out to patients, and there's a ton of work associated with that. So we'll talk a little bit today about what this means, about why we're excited about it. Ben is going to talk a little bit about the label and the process from here. We'll do a quick review of the clinical data we have for the drug because we think it's worth remembering. And then we'll leave much time at the end for Q&A. So I'm going to start just on Slide 3 of the deck with the headline, which is that LISRAYA is now approved. This is -- it's a huge day. It is the first modern therapy approved for dermatomyositis patients, the first oral targeted therapy approved for dermatomyositis patients. And just in general, there are so few options that a new option is a great thing here. And then also, there's just a bunch of other firsts associated with what this drug means. We're super excited about the opportunity to get it out to patients. We're super excited to get to deliver this kind of potential benefit to them. So it's a big opportunity. It will be available at a list price of $35,000 for a 30-day supply, but -- and Ben will talk a lot about this. Access is obviously a huge, huge focus for us, and we're incredibly -- we're working incredibly hard to make sure that every patient who needs it has access to it at a reasonable out-of-pocket price. I know that was a question that many people mind. On Slide 4, it's -- FDA put out a press release on the approval of LISRAYA yesterday. Obviously, we put out one, too. But we didn't prompt anything in the FDA press release. And actually, we thought they did a really, really nice job summing up just how exciting this moment is. And so I've just included on Slide 4 the quote from the Director of the Office of Immunology and Inflammation at CEDAR. And I think it just sums up what we feel too, which is that it's been far too long where patients with dermatomyositis have had a significant unmet need. And today is really the first time that there's something targeted approved oral studied specifically in dermatomyositis to help them manage what is a really difficult disease. I hit some of the points on Slide 5 earlier, but this is the first ever targeted therapy approved for DM, the first once-daily oral therapy ever approved for DM. It is the first therapy ever approved specifically for a steroid-sparing benefit in DM alongside, obviously, a disease improvement. It's the first therapy ever approved for DM to show statistical significance in a 52-week DM-specific trial and the first ever TYK2 and JAK1 inhibitor approved for any indication, a novel first-in-class approval for what we think is a unique mechanism that has a lot of potential from here. And we've mentioned this, but I'll say it again on Slide 6. That's not for lack of trying. There have been a lot of attempts in history to bring some of the greatest drugs in immunology, rituximab, REMICADE Enbrel, many others across the finish line in dermatomyositis. And none of those have been successful in DM-specific studies, and we've continued to see challenges in getting p-values in DM studies until even more recently than that. So it's just really exciting that we've been able to deliver this kind of opportunity. And I think the DM patient and physician community have been waiting for a moment like this. So as I said, we'll do a couple of things to review the data set. Before I do that, I just want to hand it over to Ben, by the way, and I'll say this at the end as well. One of the things about these approval calls is they're an important moment to thank a ton of people who are involved in bringing these drugs forward. Obviously, among the most important there are the patients and investigators who trusted us in the execution of the clinical trial, who trusted us with their care, and we're forever indebted. This approval is forever indebted to them. There's also just an enormous number of people at Roivant and at Priovant. And I want to give a special note of thanks to Ben and the Priovant team before handing it over to him for the speed, rigor, quality of execution and patient focus of this program. And I'll note this morning, I was doing what I suspect many people do every morning, which is talking to ChatGPT. In this case, about the time lines here because the truth is I looked through the drugs that came to my mind and with the exception of drugs that have benefited from the new CNPV program, vanishingly few drugs have gone as quickly as we were able to go here from the necessary Phase III data package to an approval. We got together to talk about the data for brepocitinib in dermatomyositis less than a year ago in mid-September of 2025. And it's just a huge privilege to be here now with this speed. And I think Ben and his team deserve a ton of credit for a lot of things. But one of the things they deserve credit for is that they acted with urgency for a population that needed it. So thank you, Ben, and I'll hand it over to you to take over on Slide 7.

Obviously, very exciting and meaningful day for me and all of us at private and many others who have been working on the program for a number of years. And exciting starting on Slide 7, actually, not only because today marks the -- or yesterday marks the approval of LISRAYA, but yesterday also marked the commercial launch of LISRAYA. About a month ahead of when we had initially planned, again, speaking to the urgency that Matt spoke about in terms of our enthusiasm to make this drug available to patients and bring it to market for them. Ultimately, that's really what drives us and drives the sense of urgency, DM patients deserve better treatment options. We're excited to finally have 1 for them, and we want them to be able to access it as quickly as possible prescribing is open as of yesterday. We actually have already received our first prescriptions for LISRAYA. And importantly, we also have our first patients consented into the My Compass support program. This is a critical service that we're offering to patients. Among many other things that will be provided to that is access to insurance assistance and financial assistance programs from Priovant. And we are -- believe that many patients on this drug will have actually 0 out of pocket costs. So very excited and committed to ensure that patients are able to get access this therapy, and we're really excited to have the launch underway. As Matt said, we celebrated the completion of the first marathon very quickly, and we've started charging ahead with mile 1 of the next one. Turning now to Slide 8. I want to talk a bit about the label which generally speaking, we're extremely pleased with how that turned out, and I'll just spend a few minutes walking through in a little bit of detail on my own personal perspective on it. I think the first thing I would say that in my view, the most important part of the label is the statement and restrictions of use. And we're really quite pleased with how that turned out. Broad indication statement for adults with dermatomyositis with no restrictions based on clinical presentation, disease severity or prior treatment history. And also no restrictions on concomitant use with steroids, conventional DMARDs or IVIg, which are the therapies that the vast majority of DM patients are on today. And importantly, that gives physicians a lot of flexibility to use LISRAYA in a lot of different ways and different combinations. It can be used as an alternative therapy to what patients are managed on today or in many cases, as an add-on therapy. And we think that's going to be very important, combined with the broad indication statement, because we feel really that the vast majority of DM patients are good fit to be considered for and really quite pleased with the fact that the label supports and enables that. Turning next to the efficacy section. I would say that from drug launches, this is obviously where the heart of the label is, and we couldn't be more thrilled with this. But I would also say it because -- but I mentioned about a few times before we do it the final label is going to be if the only thing we could say about LISRAYA is that it is an oral once-daily therapy specifically approved by FDA for dermatomyositis that specifically charts the underlying disease biology. That would be enough. We could have massive commercial success if that was the only claim we can make because this is a disease where the patients are really fit and they're managed on nontargeted therapies that are just kind of not really consistent with modern therapeutics. And it's important to understand that are coming to market in that context. But I'm thrilled to say that notwithstanding that fact, we kind of got the icing on the cake too, and got a lot of icing. I think really the efficacy section of the label provides an extremely deep and robust set of support claims and really brings to life the breadth and depth of the benefit of the therapy for DM patients we have claims to support improvements in skin disease, muscle strength and physical function as well as overall disease burden, which is important in a heterogeneous disease like dermatomyositis where different patients experience the disease in different ways and we are able to call out both many of the specific symptoms on which we've shown benefit as well as benefit on the test, which measures whatever aspects of the disease are most burdensome to an individual patient. So in a rare heterogeneous condition. TIS is actually a quite important and meaningful commercial endpoint, not just a regulatory one, in terms of bringing to life how the drug can help a wide variety of patients. And importantly, we have on the label, both physician reported and patient-reported outcomes. The latter, we think, is very important for our patient-focused promotional efforts. Patients really resonates with them. to have proof points from how patients felt and function, not just how clinicians perceive their disease. And then perhaps most importantly of all, is the steroid sparing benefit that is included on the label and actually 2 aspects of star-sparing benefit, both absolute reductions in steroid use compared to placebo that those were quite dramatic in the trial as those familiar with the VALOR data already new? And then also the endpoints that measure the ability to simultaneously improve disease while reducing or eliminating steroid dependency and think Matt talked about the set of first that this approval represents. I think one of the ones that I'm most excited about is to have the first and only medicine for DM that can deliver both benefit on disease activity as well as steroid sparing benefit simultaneously. And then lastly, in terms of the safety information. In many ways, this is really the most predictable part of the label. We've known since we in-licensed repacitinib in 2021 that we were going to have the Jack class safety warnings we did not make an effort to not have those warnings and they came in really as expected and consistent with other approved JAK inhibitors. This is a safety profile that physicians understand and are very comfortable with the piece now very widely used, including in diseases where there's many more alternatives treatment options and there are in India. And we're very confident that Lycra presents a compelling benefit risk profile in this condition for HCPs and patients. And I would also note that the VALOR trial specific data really reinforced this benefit risk profile both with the efficacy data that we saw in that trial, but also with the safety data in that trial. And particularly notable, this is actually cited in the FDA's press release is the treatment discontinuation due to adverse events occurred at nearly twice the rate on placebo as compared to LISRAYA in that trial. So very low discinuation rate due to AEs LISRAYA very higher in placebo. And I think really nothing speaks better to the benefit risk than that in terms of the patients voting with their feet as it were. Turning lastly to Slide 9. I just want to kind of bring to life with specific, some of the efficacy data that we were discussing before. And again, really hammer home, I think 2 specific points. First, starting on the left is the combination of the breadth and depth of response on the test, Nearly 70% of patients achieving moderate response nearly 50%, achieving a major response, which is a very high and difficult bar to achieve in a DM study. And again, I would emphasize the TIS is obviously a cost end point serves regulatory purpose, but I think is very resonant to patients because it captures things like the patient's global assessment, the physician's global assessment, things that kind of overall capture whatever matters most to a particular patient about their disease. And in a condition like DM where you have skin disease, you have muscle disease, you have in some patient's pulmonary disease or other various manifestations, the TIS is really a great way to kind of capture overall, whether patients are benefiting, and we see really the vast majority of patients who are in this trial achieving meaningful improvement. And then finally, on the right side of the slide, really just repeating what I already said on the previous slide, the fact that we're able to achieve both very significant clinical improvement on disease activity and very meaningful staid sparing. This is unprecedented and dermatomyositis and I think is a really compelling part of the atria value proposition. More than half of patients on LISRAYA are able to simultaneously achieve a TIS 40 improvement and bring their steroids that to minimal or no burden by the end of the study. As you can see on the right, for patients who started on 7.5 milligrams per day or more nearly 2/3 of them getting to 2.5 milligrams to last to nearly half coming off steroids altogether. So again, very meaningful clinical and disease benefit, very meaningful steroid sparing benefit and we're really excited to bring LISRAYA to market. We're off to the races already, as I said before, and look forward to sharing updates as we charge ahead with the commercial launch. So thanks, and back you, Matt.

Thank you, Ben. Appreciate it. And look, I'm sure, as you can hear from Ben's enthusiasm, we really feel like we got we've got everything we could possibly need on this label to help patients and physicians understand the benefit of LISRAYA and our chopping it a bit excited to be out there of finally sharing that message appropriate way. All the data bends described on Slide 9 is consistent with the FDA-approved prescribing information for LISRAYA. I think just like a great reminder of just how much we've been able to get on to this label to share with the community. I just say a few words, just as a reminder about the overall clinical data package for LISRAYA beyond just what specifically on the label. So starting with -- on Slide 10, just a reminder, this valor was the largest Phase III placebo-controlled study ever conducted in doradomysitis. We have had tremendous success owing to the quality of that study and the quality of the data and getting it to seminate community, including with the publication this spring the Reglan Journal of Medicine in the publication just this week, I think, in Jamandermatology of the skin-specific secondary endpoint, more to come there, but just an enormous wealth of new data in dermatomyositis owing to the side-scale study. A little bit more in here on Slide 11, 12 and 13. I'll maybe just point out on Slide 12, as we've said before, this was a study that hit on the primary and every rent secondary endpoint. This is the data as it was reported in the England Journal publication. And it just gets to the breadth of what previsitinib was able to do in this trial to hit on skin and muscle activity that it hit -- across the board on these endpoints. One that I keep coming back to is hacktiquestionnaire. The focus is on the actual disease burden in the daily lives of these patients, things like can you walk up 5 steps can you address yourself, can you feed yourself and we delivered a meaningful, statistically significant improvement on that question here. So just a tremendous and broad benefit to patients from the study. We've also reproduced on Slide 13 the safety data from specifically within the VAR study as presented in the Again, a table that highlights some of the risk benefit associated with the drug like brepocitinib in a disease where things like malignancies and thrombotic events are both the feature of the disease itself, the underlying inflammation as well as the things like high dose steroids that these patients are using. So excited overall, we look study was able to show and obviously tremendously excited as Ben highlighted with the data that's on label that's available now for use in this practice. On Slide 14, we won't go through this again today. But just a reminder that while there's some breath to this, this is a large indication affecting many people, and we are, again, excited that LISRAYA is not going to be an option for a variety of these patients and looking forward to getting out there. On Slide 15, and then a fair amount of LISRAYA already. But again, this is just -- this is a tough disease. And I think that's a point that Ben has is mentioning on a day like today. These patients, 60% are more unable to climb a flight of stairs, half unable to walk more than a mile, a good percentage, 50% unable to bend meal or stop. They rely on mobility aids. They are heavily treated with polypharmacy, including very high dose corticosteroids, if you've ever been on something like high-dose corticosteroids. If you've ever been on something like high-dose prednisone, you can imagine the burden of being on that chronically is challenging. They are unhappy with existing options. They frequently switch. They have continued symptoms, flares, a lot of pain despite treatment. And these outcomes are compounded by the toxicities of, for example, high-dose chronic steroids, which we've shown we can reduce that burden with brevocitinib. We are -- and you heard this from Ben, fully ready here from a commercial perspective. We are out in about -- patients are at the center of this launch. Ben mentioned byicompass Support, which is the patient assistance program with a dedicated patient access liaise on helping each patient through the -- navigating the complicated U.S. health insurance system and eligible patients will pay as little as $0 a month via the co-pay support program. We have a limited network of specialty pharmacies that are offering the kind of white glove high-touch support that rare disease patients have come to benefit from across other launches, and we're just excited to see all of that play forward. On Slide 17, look, I'll just say we're ready here. All of this is in place. And as Ben said, prescriptions are already coming in. So excited to see that play forward. I mentioned earlier, again, the list price will be $35,000 for a 30-day supply. It's complicated and there's a lot of judgment in translating that to actual meaning in the end. But I think it's reasonable with compliance and other assumptions, and we're not prepared to break them out specifically yet. I think the net value to us or net price to us associated with the patient on a full year of therapy is probably in the low to mid- $300,000. But again, there's a lot that goes into that estimate. And frankly, because no one's ever launched a novel therapy in this disease before, we'll know much more about that as we get into it. The other thing I'll say is I know Ben used the phrase massive commercial success in his presentation. I'll just remind everybody that what we've said about this launch is that our expectation is that it will be slow and steady. This is the first time anyone's gotten a novel therapy out to these patients and that we are excited to do that, but obviously also know that there will be barriers and challenges that we'll have to clear through to be successful, and we're going to have to get behavior to change in an area that's been stagnant from a therapeutic development perspective for a very long time. So looking forward to doing all of that, looking forward to coming back with further updates. I will move to Q&A in just a moment here. But before I do that, I'd be remiss on Slide 18 if I didn't say, for LISRAYA, this is really just the beginning. This is the first brick in what we hope is going to be a large wall of patient benefit that we're able to build or yes, a large wall of patient benefit that we're able to build across indications. Obviously, DM with tens of thousands of patients now approved, but coming up very soon in the windshield is the non-infectious uveitis data, which, if successful, we'll add another indication here and then with ongoing registrational programs in each of cutaneous sarcoidosis and liplantpolaris coming in the near future. So just tremendously excited about what we've already built and are working on, tremendously excited about what's coming soon. And as it says here on the slide, we couldn't be more excited to add even more indications for LISRAYA, think there's a lot of opportunity to do so given what we found so far in clinical practice. And then as a final reminder on Slide 19, brepocitinib LISRAYA is just the beginning. We have data coming in the near term in our PH-ILD program as well in the second half of this year in CLE for 1402. We have further updates to our RA program all before the end of this year. And 2027 is an incredibly impactful year across the board, including specifically at Immunovant with 1402 reading out in Graves and myasthenia gravis, both. So gosh, we're just -- we're spoiled and privileged with the amount of clinical data and the opportunity we have for reaching patients in the coming couple of years here and looking forward to hopefully many positive updates, and I'm sure some negative ones, too, coming in the next months and years. So with that, I just want to say again, a tremendous debt of gratitude to everyone who has supported this journey from Ben and the Priovant team to Frank and the other members of the Roivant management team and the entire team at Roivant who has worked tirelessly to make this successful. And then really, first and foremost, to the investigators and the patients involved in the VALOR study who without the patients and the investigators in clinical trials, we wouldn't have new medicines. And today is really forward about them as much as about anything else. So I just want to say thank you to all of them. I'll stop there. I will open the line up to Q&A, and I'll pass it back to the operator. Thank you, everybody, for listening this morning.

[Operator Instructions] Our first question comes from the line of Dave Risinger with Leerink Partners.

So congrats to Matt and the team. I've got a number of questions. Is it okay if I go one by one?

Sure. Thank you.

Great. So I guess let me start with the first one, which is we spoke with a leading KOL last year who said that they would convert all of their off-label JAK patients to brepocitinib after approval. So I'm wondering if you could discuss the opportunity to convert off-label JAK users more broadly to LISRAYA given its dual JAK TYK2 mechanism.

Thanks, David. It's a great question. Look, I think the short answer, unless Ben has more to say is I think we believe a very broad set of dermatomyositis patients are potentially eligible, including patients on a variety of other therapies on and off-label. And certainly, we have heard also from KOLs about the possibility that off-label JAK inhibitor patients could benefit from switching to brepxitinib from a variety of different angles, and we may very well see some of that behavior. Ben, anything you'd add to that?

Yes. I would add that I think many of those patients will switch. But I think also the ultimate eligible population goes well beyond that. I would also add, I think physicians do really understand and appreciate the distinctive value of TYK2/JAK1 inhibition. TYK2 contributes in real way to suppressing the cytokine signaling that drives dermatomyositis. And I think people understand that. They understand the way that this drug is different from other -- from the approved JAK inhibitors used off-label, the previously approved JAK inhibitors used off-label. This drug has different pharmacodynamic effects that derived from TYK2/JAK1 inhibition, and that has implications for DM patients. Not to mention there is the most massive DM data set ever generated for a therapeutic behind it. So I think that, that's certainly an area where we would see a lot of receptivity.

Excellent. And then could you comment on anticipated payer access, including the pace of achieving reimbursed prescriptions over the next several months?

Thanks, Dave. It's a good question. I'm sure it's on other people's minds, too. I'll just say, look, I think in general, one of the great things about this moment is that we've been able to follow and learn from many other launches in large orphan indications around access, around helping patients and physicians navigate that dynamic to the greatest extent possible. I think we're following all of those best practices. And I think we will be there to help patients in every way that we're able. I expect that we will be able to get patients on drug and benefiting from the therapy quickly and that we'll be able to navigate the system. It may take some time to get to full coverage and reimbursement across the board, but I'm confident we have the right systems in place.

Excellent. And then could you tell us the WAC price? And then I'll pass it on to the next person to ask questions.

Yes. Thanks, Dave. Again, I think I mentioned this on the call, but the WACC price for the drug is $35,000 for a 30-day supply. And what I said is my -- look, it's hard to translate that into practice without sort of knowing what the real-world use is going to look like. But for a patient on a year of drug adjusting for compliance and with a pretty wide range of possibilities around GTN and other things, I think that probably translates after adjustments to somewhere in the low to mid- $300,000 on a net basis, but we'll see.

Our next question comes from the line of Samantha Seminkko with Citi.

This is Ben on for Sam. Given the lack of approved targeted competitors, do you anticipate prior offs primarily focused on diagnosis confirmation or step edit requirements? And then I have a follow-up, too, please.

Yes. I'll -- look, obviously, to the extent that we're able, we've had conversations, Ben and the team have had conversations with the payer community. We've had lots of conversations with the physician community. I think it's hard to say specifically how this plays out in terms of like which specific things need to happen. The thing that I'm most confident of is that we -- as I mentioned in the prior answer, just have all the systems in place to manage and work through prior offs, medical exceptions to help people understand what's needed. And my belief is that the level of enthusiasm and the level of unmet medical need is going to carry the day there sort of regardless of what that looks like. And I also think that will just evolve over time as the physician community, the patient community and payers get used to brepocitinib and LISRAYA and get used to using it in practice.

And then a follow-up, if I may. You highlighted no restrictions based on disease severity presentation or prior therapy. Based on your physician interactions, where do you expect uptake to occur earliest?

I think I know how I'll answer that question, but I'm going to hand it over to Ben to answer that question.

I think that varies by doctor is the short answer. I think what's exciting to me is that as I was saying, there's a wide variety of patients who are eligible for this medicine and a lot of different ways that doctors can use it. And ultimately, I think each of them will kind of decide individually how they want to approach that.

That is exactly what I expect you to answer.

Our next question comes from the line of Yaron Werber with TD Cowen.

Yes. Terrific. Congrats. Really, really great to see. A couple of questions. One is we've -- I know many people have been talking to a lot of KOLs and running surveys. We're hearing, number one, that some practices are already warehousing patients and have a high degree of potentially switching from other JAK1s. The key is going to be, can they get reimbursement? And does that make sense to do? What are your thoughts on that? And then maybe secondly, a question that we get a lot from investors. We think the market is huge. And from our service, it's pretty clear that VYVGART, if approved, would probably be positioned more as an IVIg switch and LISRAYA could really get used in everybody. Sort of what are you anticipating in terms of segmentation.

On the first question and mindful of payers appropriately watchful eye. I'll just remind people that our expectation for the launch here is slow and steady. Look, we obviously also talk to the physician community. We know there's a lot of enthusiasm out there. We are confident in the tools and supports we have in place to help patients navigate access. But how physician practice evolves in the coming weeks and months is something we're just going to have to wait and see, and we're here for the long run and here to build something big in the dermatomyositis community, not. It's about where we are at MILE20, not where we are at MILE-1 is, I guess, what I'd say. But we'll see. And again, we hear some of the same messages that you do, obviously, from talking to physicians. On VYVGART Look, obviously, we watched the data set earlier this month with interest and thought it was impressive, especially in IM, where there's a tremendous amount of unmet need and where we're excited to see a therapy. In DM, it was a small study. I think it will be interesting to see. They've expressed enthusiasm for getting regulatory approval in DM, and we're watching that. Most of all, I'll say, there's an enormous amount, as you highlighted, of unmet need in dermatomyositis. And I have said repeatedly that if argenx or anyone else joins us in the space, I think it's a net positive for us in terms of increasing the level of attention paid to these physicians and the level of enthusiasm in the community for new therapies, as I think you've seen in indications like myasthenia gravis, where the more therapies come to market, the bigger that opportunity appears to be. And I think as argenx has benefited from being the first sort of significant novel approved therapy in myasthenia gravis in terms of physician enthusiasm, I think we have the same benefit in terms of being first in dermatomyositis. And so I think we will reap the same benefit that they have as more people come up. In terms of like how specifically VYVGART get used, I think the answer to that question depends enormously on the path they take from here from a regulatory perspective and what the data ultimately looks like. And so it's just hard to it's hard to say, but I think revocitinib has a super attractive profile. And you mentioned some important dynamics, including being on the market first, probably being comparatively attractively priced and being a once-daily oral. Thanks, Yaron.

Our next question comes from the line of Brian Chen with JPMorgan.

Congrats on the approval here this morning. well, yesterday. First, it seems that some doctors are using JAK off-label more among patients with skin manifestation first. Do you expect the initial wave of LISRAYA usage to be driven more from that segment first? And then we have a quick follow-up.

Yes. I'll reiterate what Ben says and see if he has anything he wants to add to it. But I think the practical truth is that the early brepocitinib use is going to come from a variety of different sources and a variety of different sort of patient phenotypes. And I think one of the things that's so exciting to us is that there's a lot of different patients potentially eligible for brepocitinib and a lot of different use cases. And I think we are keen to support the DAC community in figuring out what works best for them and what works best for these patients. I think we'll see a lot of different kinds of experimentation in the early innings and support it. Ben, anything you'd add to that?

No.

Great. And what kind of metrics could we get during the launch for LISRAYA? nd will we be able to track the launch curve using some of the script service like IQVIA or Symphony?

Yes. Look, the truth is that the way these orphan disease launches work for reasons that have nothing to do with investor management, it can be relatively difficult to see that data. And so I think we will be roughly consistent with that. I think quarterly net sales will be a useful metric ultimately on which to judge us. And we'll see what else we're able to provide as we get further into it.

Our next question comes from the line of Prakhar Agrawal with Cantor.

Congratulations on the approval. Maybe just one clarification on the label. It seems like there were a few new cases of thrombosis, MACE and malignancy during the OLE period. So if you can provide more details about this, whether the open-label extension period had flexibility on management of their background treatment? And what are the commercial implications there? And second question, fully realizing that you don't want to raise expectations here and expect a slow and steady ramp, but are there any specific barriers in DM that we should be aware of on why shouldn't this be the most rapid rare drug disease launch ever given the unmet need and the strong efficacy data for Breo?

Thanks. I'll take the second question first and then hand it over to Ben for the first one. On the second question, I will respectfully reiterate what we have said, which is that our expectation is slow and steady. Look, I think actually, it's important to note on the one hand, at some level, faster is better. But mostly, I think what we are optimizing for is getting this drug out to patients and making it a sustainable, valuable option for patients and physicians with dermatomyositis and changing treatment paradigm takes time, and it will here as it has in other orphan diseases. So I don't have any -- I don't think there's any sort of magic specific to DM thing that affects the pace of this. But I think the truth is it's just hard to know in a novel disease state in a novel setting exactly what the future is going to look like. So that's why we're sort of thinking about slow and steady as the base case. The other thing I'll just say is as a reminder, dermatomyositis is just the beginning for brevocitinib, and we want to set up a franchise that is not just sustainable to grow over time within DM, but is able to support all the other indications that are coming, and we're excited to see that play forward as well. I'll turn it over to Ben, do you want to take the question on the OL period and overall on safety?