Good day, and thank you for standing by. Welcome to the LISRAYA Approval Call. At this time, all participants are on a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephanie Lee. Please go ahead.
Good morning, and thanks for joining today's call to review the FDA approval of LISRAYA. I am 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 will also be providing the current slide numbers as we present to help you follow along. I would like to remind you that we will 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. With that, I will 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 are really happy to be here. I reflected to a few people over the last couple of days a thought that I have had, which is that it is a deeply unsatisfying marathon when the prize for winning is that you get to start running another marathon immediately, and that is the moment that we are at now where we finally, as you all know, have gotten LISRAYA to the point of approval. Now we get to get it out to patients, and there is a ton of work associated with that. So we will talk a little bit today about what this means, about why we are excited about it. Ben is going to talk a little bit about the label and the process from here.
We will do a quick review of the clinical data we have for the drug because we think it is worth remembering, and then we will leave much time at the end for Q&A. So I am going to start just on slide three of the deck with the headline, which is that LISRAYA is now approved. It is a huge day. It is the first modern therapy approved for dermatomyositis patients, the first oral-targeted therapy approved for dermatomyositis patients. Just in general, there are so few options that a new option is a great thing here. Then also, there is just a bunch of other firsts associated with what this drug means. We are super excited about the opportunity to get it out to patients. We are super excited to get to deliver this kind of potential benefit to them. So it is a big opportunity.
It'll be available at a list price of $35,000 for a 30-day supply. Ben will talk a lot about this. Access is obviously a huge focus for us, and 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 on many people's mind. On slide four, 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. Actually, we thought they did a really nice job summing up just how exciting this moment is. I've just included on slide four the quote from the director of the Office of Immunology and Inflammation at CDER.
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. 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 five 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.
The first ever TYK2/ 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. We've mentioned this, but I'll say it again on slide six. 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. We've continued to see challenges in getting P values in DM studies until even more recently than that. 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.
As I said, we'll do a couple things to review the data, et cetera. Before I do that, I just want to hand it over to Ben. By the way, 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. 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. Although this morning I was doing what I suspect many people do every morning, which is talking to ChatGPT, in this case about the timelines here. 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 Civil Money Penalty 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 feed. 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. Thank you, Ben, and I'll hand it over to you to take over on slide seven.
Thanks so much. Obviously very exciting and meaningful day for me and all of us at Priovant and many others who have been working on this program for a number of years. It's exciting starting on slide seven, actually, not only because 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 one 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. 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 through that is access to insurance assistance and financial assistance programs from Priovant. We believe that many patients on this drug will have actually $0 of out-of-pocket costs. So very excited and committed to ensure that patients are able to get access to this therapy. 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 one of the next one.
Turning now to slide eight, I want to talk a bit about the label, which generally speaking, we're extremely pleased with how that turned out. I'll just spend a few minutes walking through in a little bit of detail 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 indication statement and restrictions of use. 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 synthetic DMARDs, or IVIG, which are the therapies that the vast majority of DM patients are on today.
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. 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 fits to be considered for therapy and really are quite pleased with the fact that the label supports and enables that. Now turning next to the efficacy section, I would say that for many drug launches, this is obviously where the heart of the label is and we couldn't be more thrilled with this.
I would also say it because it's a point that I mentioned to Matt a few times before we knew what the final label was 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 targets the underlying disease biology, that would be enough. We could have massive commercial success if that was the only claim we could make because this is a disease where the patients are really sick and they're managed on non-targeted therapies that are just not really consistent with modern therapeutics. It's important to understand LISRAYA coming to market in that context. But I'm thrilled to say that notwithstanding that fact, we 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 for claims and really brings to life the breadth and depth of the benefit of this 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. We are able to call out both many of the specific symptoms on which we've shown benefit as well as benefit on the TIS, which measures whatever aspects of the disease are most burdensome to an individual patient.
In a rare heterogeneous condition, the 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 focus promotional efforts. Patients, it really resonates with them to have proof points from how patients felt and functioned, not just how clinicians perceived their disease. Then, perhaps most importantly of all is the steroid-sparing benefit that is included on the label. And actually two aspects of steroid-sparing benefit, both absolute reductions in steroid use compared to placebo, those were quite dramatic in the trial as those familiar with the VALOR data already knew.
Then also the endpoints that measure the ability to simultaneously improve disease while reducing or eliminating steroid dependency. I think, Matt talked about the set of firsts that this approval represents, and 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. Then lastly, in terms of the safety information, in many ways, this was really the most predictable part of the label. We've known since we in-licensed brepocitinib in 2021 that we were going to have the JAK 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, and these therapies are now very widely used, including in diseases where there's many more alternative treatment options than there are in DM. And we're very confident that LISRAYA presents a compelling benefit-risk profile in this condition for HCPs and patients. 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 that treatment discontinuations due to adverse events occurred at nearly twice the rate on placebo as compared to LISRAYA in that trial.
Very low discontinuation rates due to AEs for LISRAYA, 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 nine, just want to bring to life with specifics some of the efficacy data that we were discussing before. And again, really hammer home, I think, two specific points. First starting on the left is the combination of the breadth and depth of response on the TIS. 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.
Again, I would emphasize, the TIS is obviously a composite endpoint, 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. In a condition like DM where you have skin disease, you have muscle disease, you have, in some patients, pulmonary disease or other various manifestations. The TIS is really a great way to capture overall whether patients are benefiting. We see really the vast majority of patients who are in this trial achieving meaningful improvement. Then finally, on the right side of the slide, really just repeating what I already said on the previous slide, the fact that we are able to achieve both very significant clinical improvement on disease activity and very meaningful steroid-sparing.
This is unprecedented in dermatomyositis, and I think is a really compelling part of the LISRAYA value proposition. More than half of patients on LISRAYA able to simultaneously achieve a TIS-40 improvement and bring their steroids down to minimal or no burden by the end of the study. As you can see on the right, this is for patients who started on 7.5 mg per day or more, nearly 2/3 of them getting to 2.5 mg or less, and nearly half coming off steroids altogether. Again, very meaningful clinical and disease benefit, very meaningful steroid-sparing benefit. We are really excited to bring LISRAYA to market. We are off to the races already, as I said before, and look forward to sharing updates as we charge ahead with the commercial launch. Thanks, and back to you, Matt.
Thank you, Ben. Appreciate it. Look, I am sure as you can hear from Ben's enthusiasm, we really feel like we have got everything we could possibly need on this label to help patients and physicians understand the benefit of LISRAYA, and Ben and the team are chomping at the bit, excited to be out there, finally sharing that message in an appropriate way. All the data Ben just described on slide nine is consistent with the FDA-approved prescribing information for LISRAYA. I think just a great reminder of just how much we have been able to get onto this label to share with the community. I am going to say a few words just as a reminder about the overall clinical data package for LISRAYA beyond just what is specifically on the label.
Starting with on slide 10, just a reminder, this VALOR was the largest phase III placebo-controlled study ever conducted in dermatomyositis. We have had tremendous success owing to the quality of that study and the quality of the data in getting it disseminated in the medical community, including with the publication this spring in The New England Journal of Medicine and the publication just this week, I think, in JAMA Dermatology of the skin-specific secondary endpoints. More to come there, but just an enormous wealth of new data in dermatomyositis owing to the size and scale of the study. There is a little bit more in here on slides 11, 12, and 13. I will maybe just point out on slide 12, as we have said before, this was a study that hit on the primary and every ranked secondary endpoint.
This is the data as was reported in The New England Journal publication. It just gets to the breadth of what brepocitinib was able to do in this trial, that it hit on skin and muscle activity, that it hit across the board on these endpoints. One that I keep coming back to is this HAQ-DI questionnaire that focuses on the actual disease burden in the daily lives of these patients. Things like, can you walk up five steps? Can you dress yourself? Can you feed yourself? We delivered a meaningful, statistically significant improvement on that questionnaire. 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 VALOR study as presented in the NEJM. Again, a table that highlights some of the risk-benefit associated with a drug like brepocitinib in a disease where things like malignancies and thrombotic events are both a feature of the disease itself, the underlying inflammation, as well as of things like high-dose steroids that these patients are using. So, excited overall with what the 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 breadth to this is a large indication affecting many people.
We are, again, excited that LISRAYA is now going to be an option for a variety of these patients and looking forward to getting out there. On slide 15, Ben hit a fair amount of this, as have I already, but again, this is a tough disease, and I think that's a point that bears mentioning on a day like today. These patients, 60% or more unable to climb a flight of stairs, half unable to walk more than a mile, a good percentage, 50% unable to bend, kneel, or stoop. 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 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.
These outcomes are compounded by the toxicities of, for example, high-dose chronic steroids. We've shown we can reduce that burden with brepocitinib. We are, and you heard this from Ben, fully ready here from a commercial perspective. We are out and about. Patients are at the center of this launch. Ben mentioned My Compass Support, which is the patient assistance program with a dedicated patient access liaison helping each patient through navigating the complicated U.S. health insurance system. Eligible patients will pay as little as $0 a month via the copay 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. 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. Excited to see that play forward. I mentioned earlier, 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. 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 a patient on a full year of therapy is probably in the low to mid $300,000s. 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, that our expectation is that it will be slow and steady, that 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. Looking forward to doing all 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, if you missed 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 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, will add another indication here. And then with ongoing registrational programs in each of cutaneous sarcoidosis and lichen planopilaris coming in the near future. 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.
I think there's a lot of opportunity to do so given what we've 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 PHLD program as well in the second half of this year in CLE for IMVT-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 adalimumab with imvt-IMVT-1402 reading out in Graves' disease and myasthenia gravis both. Gosh, 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.
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. Then, really first and foremost to the investigators and the patients involved in the VALOR study, who, without the patients and investigators in clinical trials, we wouldn't have new medicines. Today is really for and about them as much as about anything else. 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.
Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from the line of Dave Risinger with Leerink Partners. Your line is now open. Dave Risinger, your line is open. Please check your mute button.
Yes, thanks very much. So congrats, Matt and team. I've got a number of questions. Is it okay if I go one by one?
Sure. Thank you.
Great. 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. I am wondering if you could discuss the opportunity to convert off-label JAK users more broadly to LISRAYA, given its dual TYK2/JAK1 mechanism.
Thanks, Dave. It is 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. Certainly, we have heard also from KOLs about the possibility that off-label JAK inhibitor patients could benefit from switching to brepocitinib from a variety of different angles. We may very well see some of that behavior. Ben, anything you would add to that?
Yeah. 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. I think people understand that. They understand the way that this drug is different from the approved JAK inhibitors used off-label, the previously approved JAK inhibitors used off-label. This drug has different pharmacodynamic effects that derive 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. I think that that is certainly an area where we would see a lot of receptivity.
Excellent. 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. Could you tell us the WAC price, and then I'll pass it on to the next person to ask questions.
Yeah, thanks, Dave. Again, I think I mentioned this on the call, but the WAC price for the drug is $35,000 for a 30-day supply. What I said is my look, it's hard to translate that into practice without 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.
Got it. Thanks so much.
Thank you. Our next question comes from the line of Samantha Semenkow with Citi. Your line is now open.
Hi, this is Ben on for Sam. Thanks so much for taking the question. Given the lack of approved targeted competitors, do you anticipate prior auths primarily focused on diagnosis confirmation or step-edit requirements? I have a follow-up too, please.
Yeah. 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 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 auth, medical exceptions, to help people understand what's needed. 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.
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. Thanks, Ben.
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 over to Ben to answer that question.
I think it 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. Ultimately, I think each of them will kind of decide individually how they want to approach that.
Thanks, Ben. That is, in fact-
Thank you.
how I expect you to answer it.
Thank you. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.
Yes. Terrific. Congrats. Really great to see. A couple of questions. One is, I know many people have been talking to a lot of KOs 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? Then maybe secondly, a question that we get a lot from investors. We think the market is huge, and from our surveys, 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? Thank you. In terms of segmentation.
Yeah. On the first question, and mindful of [Keyur's] 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. It's about where we are at mile 20, not where we are at mile one is, I guess, what I'd say. But we'll see. 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 IIM, 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'll 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. 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. 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. So I think we will reap the same benefit that they have as more people come up. In terms of 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 their data ultimately looks like.
So it's hard to say, but I think brepocitinib has a super practical 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.
Thank you. Our next question comes from the line of Brian Cheng with JP Morgan. Your line is now open.
Hey, guys. 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? We have a quick follow-up. Thank you.
Yeah. I'll reiterate what Ben says and see if he has anything he wants to add to it. 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 patient phenotypes. 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. I think we are keen to support the DM 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?
Nope.
Great.
And what-
Thanks, Brian.
What kind of metrics could we get during the launch for LISRAYA? Will we be able to track the launch curve using some of the script service, like IQVIA or Symphony?
Yeah, 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. 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.
Great. Thanks, guys.
Thank you.
Thanks, Brian.
Our next question comes from the line of Prakhar Agrawal with Cantor. Your line is now open.
Hi. Thank you for taking my questions, and congratulations on the approval. Maybe just one clarification on the label. Seems like there were few new cases of thrombosis, MACE, and malignancy during the OLE period. 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 here? Second question, fully realizing that you do not want to raise expectations here and expect a slow and steady RAM, but are there any specific barriers in DM that we should be aware of on why should not this be the most rapid rare drug disease launch ever, given the unmet need and the strong efficacy data for brepocitinib? Thank you.
Thanks, Prakhar. I will 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 is 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 with resistance with dermatomyositis. Changing treatment paradigm takes time, and it will here, as it has in other orphan diseases. I do not think there is any sort of magic specific to DM thing that affects the pace of this.
But I think the truth is it is just hard to know when a novel disease state in a novel setting exactly what the future is going to look like. So that is why we are sort of thinking about slow and steady as the base case. The other thing I will just say is, as a reminder, dermatomyositis is just the beginning for brepocitinib, 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. We are excited to see that play forward as well. I turn it over. Ben, do you want to take the question on the OLE period, and overall on safety?
Yeah. Sure. Yeah, I think we will share the full efficacy and safety data from the OLE at a later point. I do not want to fully preempt that. I think your hypothesis is not entirely correct as worded. The one thing I would flag that is correct and is seen on the label is that there were MACE events in the OLE. This is to be expected. Dermatomyositis patients are very sick. They are at higher risk of these types of events due to underlying inflammation due to steroid burden, which contributes significantly to cardiovascular risk. Also, certainly these warnings are on JAK labels for a reason. All of these events have been seen across the brepocitinib development program. But consistent with other JAK inhibitors, they have occurred at rates that are rare and are uncommon.
Again, ultimately, as we have said before, it is a safety profile that physicians have become extremely comfortable with using JAK inhibitors very widely for patient populations with probably less need for aggressive therapy and more alternative modern options than we have in dermatomyositis.
Great. Thank you.
Thanks, Ben. I will just say one additional case of thrombosis in the OLE and no malignancies on treatment in the OLE. So also not a material change in the risk profile and just entirely consistent with the labeling and sort of considerations around the JAK class generally. As Ben said, I think overall, given the background risks for these patients and the therapies that they are on otherwise, it is a relative non-issue in dermatomyositis.
Thank you. Our next question comes from the line of Dennis Ding with Jefferies. Your line is now open.
Hi, this is Anthea on for Dennis. Thanks for taking our questions and congrats on the approval. Just two questions from us. Matt, you kind of mentioned quarterly net sales as a potential metric for the launch. I am curious how long you expect the lag to be between a patient being prescribed LISRAYA and that demand showing up in reported net sales, and how that should evolve over the next 6- 12 months, and if we should expect any other launch metrics, disclosures around patient start forms, new patient enrollments, payer coverage, et cetera. Then second, how should we think about conversion of patients who participated in the VALOR program in terms of how many patients remain on brepocitinib through the extension, and what proportion you expect to convert onto commercial drug over the coming quarters? Thank you.
Yeah. Thanks, Anthea. It's a helpful question. On the first question about launch metrics and timing and everything else, look, I think we could give best estimates on any of these things, but they would just be guesses on our part at the moment. I think we're just going to have to wait and see in the first months of launch how this process plays forward. I think we'll be able to provide a little more clarity on this as we have it, but right now I don't have much to guess in terms of the timing. I think on launch metrics, let's get a little bit further into it. I think in general, our view is we're playing for the long haul, and the sort of intrigue about the early numbers is less interesting than where we can get to over time.
But we're going to sort of look a little bit at how things go in the first innings, and then we'll get back to you. On the second question of conversions of patients from VALOR to commercial, I don't personally know the answer to that question. Ben, I don't know if you have an easy answer in terms of those conversions or if it's something we're working through.
Yeah, I think many patients from the VALOR trial are excited to get on LISRAYA. It's not something we're singularly focused on. We're focused on all the patients who could benefit from the medicine, which includes, but is not limited to those.
Great. Thanks, Ben.
Thank you.
Thank you, Anthea.
Thank you. Our next question comes from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.
Good morning, team. Congrats on your first approval and many more to come, so congrats. A few questions, maybe just some easy ones in terms of now with the launch under go, what is the size of the sales force that you have already put into place, and how do you envision growing that over the next 12 months? Then second one is, what do you think the time it takes from writing the script to being reimbursed now that everything's ready to go? Then also, how do you envision that three months from now, six months from now, a year from now? At what point during this launch will you feel really comfortable to give a little bit more color around the matrix and how things are going?
Obviously, today's day one, but what are the things that you need to see where you could come back and just because you guys are very numbers-driven, data-driven and do such a great job on guiding us. So at what point do you feel like you could provide some of these more granular matrixes? I know that you can't do that right now, but what do you need to learn to do that? Sorry, three-part question, so yes.
Sure. Perfect. Thank you, Yasmeen. Those are great questions. I feel pride bound to make one small correction to your question, which is you said it was our first approval. It's actually the ninth approval to come out of the Roivant apparatus. Obviously including one of the drugs that we commercialized ourselves for a while. But it's potentially the one that's most impactful for us, and we're obviously super excited about it. It's the first for Priovant, which will hopefully be the first of many for LISRAYA. On sort of field force in general, I'll say we have a phenomenal team in place. Ben and his team have been laser-focused on getting the right people into these seats, and they're people who are going to do a great job engaging with the medical community. We're really excited to see that play forward.
We've said before, this is a relatively concentrated field. I think one of the things we've said before is about half these patients are treated at 200 specialty referral centers. So I think from that perspective, we feel confident. We will probably continue to grow our field force over time. But for the moment, I think we're in a really great spot in terms of how many people we've got and what we're doing. I think overall, as far as this is a part of cost question, the guidance that we've given historically on cost structure is approximately the same as we give now. No significant change there from what we've said. On the next question, which is what do we need to see to come back with more metrics? Look, I think it's just too early now to say exactly.
My honest view is and I don't mean to be glib. I just think in the end, the commercial performance of the drug is what's going to eat everything else that's being used to make predictions. I think mostly we're just going to be focused on maximizing the breadth of usage and making sure that we're out there doing everything we can to make the lives of patients getting on drug easy and to help physicians understand what they can do here. Thank you.
Thank you.
Thank you. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.
Hi, good morning. Congratulations, and thanks for taking the questions. Matt, maybe if you could just talk a little bit about what the considerations were in terms of the list price that you set. Obviously, the DM is an orphan indication, and you're largely pursuing other ones, but how do you see that playing out? And how much did you consider the addition of other indications on label? And if you had sort of used any other sort of commercial analogs that might be helpful that sort of informed your thinking.
Yeah. Thanks, Doug. It's a great question, and obviously there's a lot of judgment and debate and thought that goes into how you do this in the U.S. healthcare system in 2026. So it's a complicated question. Obviously, we have a number of analogs out there that are in various ways launched in orphan diseases, and I think we've learned a lot from how those launches have gone and from our conversations with payers and other stakeholders. Obviously, the commercial cost and value of IVIG is one consideration that was relevant to us as we were thinking about where it made sense to price the product.
I think overall, we are confident in the decision we've made in terms of getting maximum access and the overall value proposition for the drug to patients, clinicians, and payers, including the long-term benefits from reduced steroid burden, which we think will be significant. In terms of the gist of other indications and the sort of relevance there, look, obviously, that's something we think about all the time in terms of what brepocitinib could become across a variety of indications. I think given the differences in dose and other things, we still have some flexibility to think creatively about that as the clinical profile of the molecule and these other indications and the breadth of indications becomes clear. But I think the price point here supports and is homologous with or in harmony with everything else that we're planning on doing for LISRAYA.
I think we feel really great about delivering on the full value proposition of LISRAYA in orphan and long-term.
Matt, if I have a follow-up, I appreciate your point that LISRAYA offers a lot of versatility and could be relevant for a wide range of DM patients. I'm just curious if you have in mind sort of an initial group of patients that you're going to have the field force really sort of hone in on in terms of the messaging with clinicians, in terms of who you want to sort of get onto drug to sort of have the real-world effect match what we saw in VALOR.
Thanks, Doug. It's a great question. I'm tempted because we've gotten this question in a few different forms to say something like, "Well, we're really focused on Fred, Joan, and Amy." But look, obviously, the short answer to this question is to repeat what I've said, which is that we think there's a pretty wide range of patients who could benefit from brepocitinib. In talking to the physician community, I think it's clear that enthusiastic physicians have a variety of different sort of early use cases in mind for their patients, and that we really do want to support all of those use cases.
And what I think in practice is there will be some docs for whom the early use case is converting JAK inhibitor patients and some docs for whom the early use case is patients on high steroid burden who are ineligible or don't want to use IVIG for various reasons, and some docs who have been struggling with other off-label therapies or struggling with the side effects of steroid immunosuppressants. I think our view is wherever these physicians want to go, we want to be there to support it. I think we have been specifically focused on not narrowing to a specific subset of patients, but rather helping the community meet us or helping meet the community wherever they want to be.
If I can, one final one. You said that you expected Matt?
Yeah, I'm here. Go ahead.
Oh, just one final. You said that you expected sort of low to mid $300,000s in terms of net to the company in addition to rebates and sort of free drug. I think you mentioned some compliance. If you could just give us everything that's going into that, just so we can. So is it sort of like net pricing, or were you just talking about net revenue to avoid that? Thank you.
Yep. Perfect. I think the short answer is, I think part of the reason we gave a range and part of the reason we caveated it as a rough estimate is there's a lot that goes into these assumptions around compliance, around GTN, around other things. I think it's fair to say while we obviously have some sense of how each of those components shake out, the error bars are sufficiently wide and the compounding across those different factors is sufficient. It's hard to say specifically, and there's even error bars around that range. I do not have a ton more to add to that. I will-
Do you have a target for coverage?
Sorry?
Do you have a target for coverage, sort of number of or percentage of lives and so forth?
Our hope and goal is that every patient who would benefit from brepocitinib will have access to it. Hopefully will have access to it in a way that works in terms of coverage and out-of-pocket expense and so on. That's really where we're focused. Sorry. Ben, I want to hand it back to you just to answer. I think I missed one of Doug's questions about the VALOR trial specifically.
Yeah. I just wanted to add, in terms of your question around, kind of patients where we would see the results of the VALOR trial maybe replicated in the real world. I thought that was a thoughtful question and just wanted to say, I think one of the things that's exciting about the VALOR trial, and I think exciting to physicians about it is really the breadth of patients who are enrolled. It enrolled a wide, real-world population, including patients with mild, moderate, and severe disease, patients on a wide variety of different background therapies, patients where skin disease was driving a lot of the disease burden, patients where muscle disease was driving a lot of disease burden, 20% of the patients had ILD.
Across this heterogeneous population, we saw very strong efficacy on both the total improvement score and, as we've discussed, other disease measurements across skin disease, muscle disease, physical functioning, and steroid sparing. I think that is what supported the broad label we have received and, I think, as a result, gives us the confidence that a kind of broad set of patients being evaluated for care in the real world will allow the benefit risk of the drug to shine through in that setting similarly.
Thanks, Doug. Appreciate all the questions.
Great. Thank you.
Thank you. Our next question comes from the line of Andy Chen with Wolfe Research. Your line is now open.
Hey, this is Brandon on for Andy, and thanks for taking the question. Matt, you mentioned barriers and challenges that you'd need to get through on the launch. What specifically there were you referring to? I think we're curious to know why this launch wouldn't be blasting out of the gates. Second question, on your internal assumptions, what are the key factors that would push net price to the lower end or the higher end of that low to mid $300, 000 annual expectation? Is this something within GTN, or is it compliance that would be the bigger swing factor?
Yeah, thanks. On challenges, I want to be clear, it's not that we're nervous about facing anything specific to dermatomyositis that is unusual relative to other orphan launches, just that orphan launches are hard. I'll give it to Ben to answer some of the specific things that we're working on preparing for.
Yeah. Look, I would say, I think it goes back a bit to the last question. I think the same thing that is the opportunity for this drug in the long term is what makes the early launch challenging in some ways. Which is, there has been no innovation here in decades, and prescribers have been treating patients in certain ways for decades because there hasn't been innovation, and obviously they need to change that behavior and, behavioral change takes time for human beings, even when there's a lot of intellectual enthusiasm around it. I think, there's, as we've discussed, not, "Okay, this is the singular group of patients who are going to get on drug initially at launch." Because in an area where you don't really have moderate approved therapies, every doctor manages their patients differently.
There's a lot of heterogeneity in terms of how patients are cared for today. Our approach is really to think about the medium to long-term outcome of, as Matt described before, meeting doctors where they are and presenting the breadth of our label and the breadth of data from the VALOR study for them to really consider all adults DM patients who could be a good fit for the drug and consistent with the label for therapy. We think that over time that's going to come through. But exactly how fast that adoption is going to vary a lot by prescriber and is pretty hard to predict with any degree of confidence. Then, I would say a similar approach applies to the reimbursement. We've been engaging with payers a lot. I'm very confident they appreciate the unmet need. They appreciate how sick these patients are.
But obviously until we get into it, we won't know a lot about the exact way that that's going. Again, very confident that over time we will be able to have access to patients, and we have a lot of support in place to ensure they're able to get that access. We're committed as Priovant to providing that to patients 100%. But what it means in terms of our commercial results and exactly how quickly those are achieved, we'll have to see.
Thanks, Ben. I want to take a moment to unify the community of everyone listening to this call, and we will all silently in our heads, but with the knowledge that everybody else is doing it at the same time, chant my other comment about this, which is that our expectation about the launch is that it will be altogether now slow and steady. However many hundreds of people are now repeating that in their heads. On the other question that you asked about the band of net price. Look, I think there's a lot of moving parts. You mentioned a few of them. I think the short answer is it'll come into sharper relief relatively early in the overall picture here. We'll be able to talk more about GTN, disclose it and so on when the time comes.
Thank you.
Thank you.
Thank you. Our next question comes from the line of Yatin Suneja with Guggenheim Securities. Your line is now open. Yatin, your line is open. Please check your mute button.
Hi, this is [Maignan] on behalf of Yatin Suneja. Thank you for taking my question. Congrats on approval. You described slightly earlier, but if you can add a little more about the step edit expectation, the early adapter, who can be, and how should we think about the launch cadence? Thank you.
Look, thanks for the question. I do not actually feel like I have a ton to add on this question. I think from a physician perspective, the early adopters. Look, there is a lot of enthusiasm in the physician community for a novel therapy and indication where there has not been a lot of innovation, and I think we have a lot of discussion with physicians who are excited to use the product. Obviously, Ben and the team did a great job running the clinical trial, and therefore, we have a lot of those relationships. I suspect some of the docs who are most familiar are probably also some of the practices from where the early scripts are coming.
On the patient side, I think we've answered already the question of what we think sort of segmentation looks like here, which is that we have a broad view of who the early patients are going to be. On launch cadence, we get to say it one more time, which is we get to say, look, our expectation for the launch will be slow and steady, and that we're building something big and important. It's not about where we are in a month or two months or six months. It's about where we are in a year and two years and six years, and that's how we're thinking about the long-term proposition here, both in dermatomyositis and beyond dermatomyositis.
Look, I think we have a unique opportunity as Roivant, and maybe this is a good place to wrap this up, to build a durable company that is benefiting patients across a variety of indications. I think the quality of the data in dermatomyositis speaks to what we're trying to do. I think we're hoping to replicate that in a bunch of places and to build something that matters. I hope we can continue to share data in the near future that supports that mission, as well as continuing to get this drug, starting and now focusing on getting this drug out to dermatomyositis physicians and patients. Thank you very much.
Thank you. That concludes the question and answer session. I'd like to hand it back over to Matthew Gline for any further closing remarks.
Great. Thank you. Look, thank you, everybody, for listening this morning. It is a privilege to be able to take a drug like this, generate data like this, and get it out to patients. It's something we have the honor and responsibility of doing well at this point, and I know that Ben and the team are super focused on it. You've heard a fair amount of commentary on this call about our long-term enthusiasm and about our focus on doing this the right way. I'm hopeful and confident that we're going to be able to do that. So I want to say thank you again to the enormous number of people who it takes to get to a milestone like this one and in advance to the enormous number of people who it's going to take to carry the baton through the next race here.
There's a ton of work coming. To the Roivant team, to Ben and the Priovant team who executed tirelessly on this program and will execute tirelessly on what's to come. Again, to the patients and investigators, it's hard to overstate the extent to which this carries meaning for some of them who have been suffering from this disease for a long time. So look, thank you again, everybody. We look forward to getting back in touch in the near future on a pretty exciting six and then 12 months ahead. I am sure we will have lots of opportunity to stay slow and steady on future calls as well. Thanks.
Thank you. This concludes today's conference. Thank you for your participation. You may now disconnect.