Q1 2025 Roivant Sciences Ltd Earnings Call

Good day and thank you for standing by.

Speaker Change: Welcome to the Roivant First Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode.

Speaker Change: After this speaker's presentation, there will be a question and answer session.

Speaker Change: To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.

Speaker Change: 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.

Stephanie Lee: Good morning and thanks for joining today's call to review Roivant's financial results for the first quarter and the June 30, 2024, along with a business update.

Stephanie Lee: I'm Stephanie Leigh with Roivant.

Stephanie Lee: Presenting today we have Matt Gline, CEO of Roivant. For those dialing in via a conference call, you can find the slides being presented today as well as a press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along.

Stephanie Lee: 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 was 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. Great. Thanks, Steph, and thanks, everybody, for joining. It's always a pleasure to get on these calls.

Speaker Change: We, in truth, we saved all of our fun updates for this fall.

Matt: So today is a relatively straightforward set of updates, but a couple of really meaningful execution points and a couple of other things that I'm happy to be talking about. So thank you again. I'll start just quickly on slide five in the deck with a reminder

Matt: Just kind of where we are this year, which is that this is a year of growth and expansion for us. So we're focused very much

Matt: on delivering clinical data across multiple of our franchises, the anti-FCRN franchise, where we have some meaningful data sets coming as soon as the near, near future, as well as over the next, call it, six months.

Matt: We have

Matt: Continued clinical development beyond that in our pipeline, including in PrEP-Cytinib, where we'll be beginning our phase three program at NIU shortly, where we have data coming into Milumab, later in sarcoidosis.

Matt: and so on.

Speaker Change: We're very much looking forward to it. We'll talk a little bit about BCAMA today, but the story for BCAMA for this year is really the expansion of the label AD.

Speaker Change: And some acceleration of the crisis, certainly volumes and revenues over time. And then we continue to be hard at work expanding our pipeline, looking at Middle East stage programs. I know there's a lot of focus on that activity. We will be unveiling our much-discussed sort of

Speaker Change: So far, I'm supposed to program just next month, so we'll hold on for a few more weeks there, and then continuing to work on prioritizing capital allocation, including thinking aggressively around the use of capital to buy back shares and so on.

Speaker Change: We are super proud, on slide six, of the pipeline as it currently stands. One of the things that I struggle with sometimes, I get all these questions about BDs.

Speaker Change: But but, you know, every time I look at our pipeline, we still have one of the best INI pipelines without any BD. So yeah, excited about the breadth of opportunities there. In particular, excited about the next call it 18 months both in the FDF and we'll talk a lot more about today.

Unknown Executive: So, the main updates for the quarter, starting on slide eight, one is on rep SIDMID, which is that we've now completed enrollment in our phase three study in dermatomyositis with 241 subjects across 90 sites.

The main updates for the quarter, starting on slide 8, one is on-prep SIDMIB, which is that we've now completed enrollment in our Phase 3 study in dermatomyositis with 241 subjects across 90 sites.

Nibret Sitnoe: and Debra Sittner, who we have available data coming shortly.

Nibret Sitnoe: So, the main updates for the quarter, starting on slide 8.

Nibret Sitnoe: One is on-rep SIDMIB, which is that we've now completed enrollment in our Phase 3 study in Dermatomyositis.

Matthew Gline: It is the largest interventional DM study ever conducted, and we can now say with confidence we expect top-line data in the second half of next year from that study, which completed enrollment a few weeks ago. And we've completed our end-of-Phase 2 meeting with FDA on the NIU opportunity and are planning to begin 52-week Phase 3 studies in the near future in NIU or a Phase 3 program. At a mute event, you know, we had announced, as you may recall, a slight delay last quarter for the MG study.

Unknown Executive: It is the largest interventional DM study ever conducted, and we can now say with confidence we expect top-line data in the second half of next year from that study, which completed enrollment a few weeks ago. And we've completed our end of phase two meeting with FDA on the NIU opportunity and are planning to begin a 52-week study. At a minute event, you know, we had announced, as you may recall, a slight delay last quarter for the MG study.

Nibret Sitnoe: It's 241 subjects across 90 sites.

Nibret Sitnoe: It is the largest interventional DM study ever conducted, and we can now say with confidence we expect top-line data in the second half of next year, that study completed enrollment a few weeks back.

Nibret Sitnoe: And we've completed our End of Phase II meeting with FDA on the NIU opportunity and are planning to begin a 52-week

Matthew Gline: We can now say that that study has completed enrollment, only a little bit behind the original schedule. And so we'll get data in the first quarter of next year, as we previously discussed. And we remain on track for the initiation of the Registrational Program in MG for next year, as well as multiple other programs. We'll talk more about that in a minute. We will unveil our upcoming Phase 2 program, as I said, in September next month. I'm excited to do that.

Nibret Sitnoe: Phase III studies in the near future in NIU or Phase III program.

Nibret Sitnoe: At a mute event, we had announced, as you may recall, a slight delay last quarter for the MG study. We can now say that that study has completed enrollment.

Unknown Executive: We can now say that that study has completed enrollment, only a little bit behind the original schedule, and so we'll get data in the first quarter of next year, as we previously discussed, and we remain on track for the initiation of the Registrational Program in MG for next year, as well as multiple other programs. We'll talk more about that in a minute.

Nibret Sitnoe: only a little bit behind the original schedule. And so we'll get data in the first quarter of next year, as we previously discussed. And we remain on track for the initiation of

Unknown Executive: We will unveil our upcoming Phase 2 program, as I said, in September next month. I'm excited to do that. It will be a combination of the presentation of some data. We will likely do a phone call like this one.

Nibret Sitnoe: Registrational Program in MG. I'd prefer next year as well as multiple other programs. We'll talk more about that in a minute.

Unknown Executive: So I'm looking forward to getting together at that time. And then there are a couple of other updates on slide 9. One is just to say we continue to be pleased with the progress we're making at GenEvent in our IP litigation around the COVID-19 vaccines. Discovery continues, and you may have seen, we requested a slightly amended case schedule so that we could get some more information from Moderna, which, if approved, would mean that the trial would be just about a year from now, so in September of 2025.

Nibret Sitnoe: We will unveil our upcoming Phase 2 program, as I said, in September next month, excited to do that.

Matthew Gline: It will be a combination of a presentation of some data and a phone call like this one. So I'm looking forward to getting together at that time. And then I have a couple of other updates on slide nine. One is just to say we continue to be pleased with the progress we're making at GenEvent in our IP litigation around the COVID-19 vaccines. Discovery continues, and you may have seen, we requested a slightly amended case schedule so that we could get some more information from Moderna, which, if approved, would mean that the trial would be just about a year from now. So in September of 2025,

Nibret Sitnoe: accommodation and presentation of some data we will likely do a phone call like this one so looking forward to getting together at that time.

Nibret Sitnoe: And then a couple of other updates on slide nine.

Nibret Sitnoe: One is just to say we continue to be pleased with the progress we're making at GenEvent in our IP litigation around the COVID-19 vaccines. Discovery continues, and you may have seen, we requested a slightly amended case schedule so that we could get some more information from Moderna.

Matthew Gline: And then we achieved some important clinical regulatory milestones that resulted in cash coming in. We're going to get a $28 million milestone related to the Japanese approval of Camel Brother in July.

Nibret Sitnoe: which if approved will mean that the trial will be just about a year from now, so in September of 2025.

Matthew Gline: And we have received our portion of $110 million of the remaining proceeds for Keylevant now that they've begun. They've hit the definition for that milestone, so that has been received this month. I'm so pleased with that.

Unknown Executive: And then we achieved some important clinical and regulatory milestones that resulted in cash coming in the door. We're going to get a $28 million milestone related to the Japanese approval of Bicam, whether we got that in July, and we have received our portion of $110 million of the remaining proceeds for TLAVANT now that they've begun. They've hit the definition for that milestone, so that has been received this month. I am so pleased with that.

Speaker Change: And then we achieved some important clinical regulatory milestones that resulted in cash coming to the door. We were going to get a $28 million milestone related to the Japanese approval of BKM, whether we got that in July . And we have received our portion of $110 million of the remaining proceeds for T. levant.

Unknown Executive: And obviously, even $110 million is still a multiple of the capital that we originally invested in the program by others, such as in Sjogren's recently. But overall, just a really compelling picture of a well tolerated class that shows meaningful efficacy and clinical benefit in a pretty wide range of diseases. So we are really excited about that. But I think it's been interesting to us only in the sense that it's so much earlier than FCRN.

Speaker Change: Now that they've begun, they've hit the definition for that milestone, so that has been received this month. So feel pleased with that, and obviously, even at $110 million, still a multiple, even in this milestone of the capital that we originally invested in the program.

Matthew Gline: And obviously, even at $110 million, still a multiple of the capital that we originally invested in the program. So those are the main updates for the quarter. I want to spend a couple of minutes on some things in particular.

Nibret Sitnoe: So those are the main updates for the quarter. I want to spend a couple of minutes on some things in particular. One of them, just

Matthew Gline: One of them, just, to review where we are and our level of enthusiasm around Immune Event and the NTF-CRN opportunity. You know, we've been having some conversations over the last few months, and it occurs to me that I have a little bit of regret, only that we've been drawn into, as a field, I'd say, a conversation about the apportionment of a small pie when, in fact, I think our view is that the biology of FCRN, the biology of B-cell immunology and beyond is very broad.

Speaker Change: to review where we are and our level of enthusiasm around ImmuneVant, around the NTF-CRN opportunity. You know, we've been having some conversations over the last few months.

Speaker Change: And it occurs to me that I have a little bit of regret, only that we've been drawn into, as a field I'd say, a conversation about apportionment of a small pie, when in fact I think our view is that the

Matthew Gline: And so I just wanted to highlight, you know, again, where we think we are, the amount of data that's been generated here that supports the breadth of the opportunity, and a little bit of a reminder of just why we are so excited about the program. So as a reminder, on slide 11, we've said this in multiple places, we really do believe that IMD-1402 has a potentially best-in-class profile here. That comes, obviously, first and foremost from our ability to suppress IgG as deeply or deeper than any of the other NTFs here and antibodies, in our view, without any impact on things like albumin and LDL, which obviously was something that affected our first-generation program.

Speaker Change: Biology for FCRN, the biology for B-cell immunology and beyond is very broad. And so I just wanted to highlight, you know, again, where we think we are, the amount of data that's been generated here that supports the breadth of the opportunity, and a little bit of reminder of just why we are.

Speaker Change: So excited about the program

Speaker Change: So, as a reminder on slide 11, look, we've said this in multiple places, we really do believe that IMBT 1402 has a potentially best-in-class profile here.

Speaker Change: That comes, obviously, first and foremost from our ability to suppress IgG as deeply or deeper than any of the other NTF-serine antibodies, in our view, without any impacts on things like albumin and LDL, which obviously was something that affected our first-generation program. And then I think it's worth remembering...

Matthew Gline: And then I think it's worth remembering that we are also going to be able to launch, in all likelihood, IMD-1402 in an auto-injector. It'll be a simple, subcutaneous injection that should enable self-administration at home, subject to FDA being okay with that.

Speaker Change: We are also going to be able to launch, in all likelihood, IMD-1402 in an auto-injector. It'll be a simple, subcutaneous injection that should enable...

Matthew Gline: And we think that'll be a really compelling format for patients and a differentiated option versus where the field is right now, and our sense is potentially differentiated relative to even where the field will be in a couple of years. There has been, on slide 12, just absolutely explosive growth over the past couple of years in the breadth of what FCRN has demonstrated. You know, rewind back to 2020, and there were eight total FCRN indications in development with about 700,000 addressable patients.

Speaker Change: Self-administration at home, subject to FDA being okay with that. And we think that'll be a really compelling format for patients, and a differentiated option versus where, certainly where the field is right now, and our sense is potentially differentiated relative to even where the field will be in a couple of years.

Speaker Change: There has been, on slide 12, just absolutely explosive growth over the past couple of years in the breadth of what FCRN has demonstrated. You know, relying back to 2020, there were eight total FCRN indications in development with about 700,000 addressable patients.

Matthew Gline: There are now 23 indications in development for anti-epsteroid antibodies with a current total addressable population of 4 million, and that number is growing frequently, and we expect to add some to it in the relatively near future as well.

Speaker Change: There are now 23 indications in development for anti-epstein antibodies, with a current total addressable population of 4 million, and that number is growing often.

Matthew Gline: So, just a huge area of biology and a patient population that, prior to this moment, kind of toned it down. You know, on slide 13, you can see there have now been, across 22 positive late-stage studies and nine indications, four different anti-anti-epsteroid antibodies have been studied in about 2,000 patients. There's a tremendous amount of data about this mechanism, some of which generated by us, such as Patokomab and Graves and Patokomab and KED, some of which generated by others, such as in Sjogren's recently.

Speaker Change: and we expect to add some to it in the relatively near future as well. So, just a huge area of biology and a patient population that prior to this moment had a ton of unmet need. You know, on slide 13, you can see there have now been across 22 positive late-stage studies and 9 indications.

Speaker Change: Four different anti-inflammatory antibodies have been studied in about 2,000 patients. There's a tremendous amount of data about this mechanism, some of which generated by us, such as patoclomab and RAVES and patoclomab and TED, some of which generated by

Matthew Gline: But overall, just a really compelling picture of a well tolerated class that shows meaningful efficacy and clinical benefit in a pretty wide range of diseases at this point. So we are really excited about, You know, the other piece, and I don't want to spend too much time dwelling on this, on slide 14, is that there's been a lot of interest, let's say, in competitive mechanisms, IgG degradation, or some of the CAR T or B cell biology, T cell engagers for autoimmune disease. I want to say nothing on this slide is meant to suggest that we are not enthusiastic about much of that biology. We think it's really great biology.

Speaker Change: by others, such as in Sjogren's recently, but overall just a really compelling picture of a well-tolerated class that shows meaningful efficacy and clinical benefit, you know, in a pretty wide range at this point of diseases. So we are, we are really excited about that.

Speaker Change: You know, the other piece, and I don't want to spend too much time dwelling on this, on slide 14.

Speaker Change: There's been a lot of interest, let's say, in competitive mechanisms.

Speaker Change: I want to say, nothing on this slide is meant to suggest that we are not enthusiastic about much of that biology. We think it's really great biology.

Matthew Gline: But I think it's been interesting to us only in the sense that it's so much earlier than FCRN, and FCRN has sort of elegantly cleared the bar that there's still a lot of work to do on some of these other mechanisms. You can see here, again, multiple approvals for our class in immunology, multiple positive phase 3 studies, multiple positive phase 2 studies, and thousands of patients. It just sets up a different picture in terms of the level of validation and the proximity of the opportunity.

Speaker Change: But I think it's...

Unknown Executive: And FCRN has sort of elegantly cleared this bar that there's still a lot of work to do on some of these other mechanisms. You can see here, again, multiple approvals for our class in immunology, multiple positive phase three studies, multiple positive phase two studies, and thousands of patients. It just sets up a different picture in terms of the level of validation and the proximity of the opportunity. And so we're excited about that vis-a-vis our place in the competitive field.

Speaker Change: It's been interesting to us only in the sense that it's so much earlier than FCRN, and FCRN has sort of elegantly cleared this bar that there's still a lot of work to do on some of these other mechanisms. You can see here, again, multiple approvals for our class in immunology, multiple positive phase 3 studies, multiple positive phase 2 studies.

Speaker Change: and thousands of patients. It just sets up a different picture in terms of the level of validation and the proximity of the opportunity. And so we're excited about that.

Matthew Gline: And so we're excited about that vis-a-vis our place in the competitive field. Again, we think many of these other classes are interesting. Watching them closely, we make investments in other areas. And so you can imagine we're watching these areas. We like the biology, but we feel really good about where FCRN is positioned competitively and just how different it looks in terms of stage of opportunity. You know, I'm 5'15.

Unknown Executive: Again, we think many of these other classes are interesting. Watching them closely, we make investments in other areas. And so you can imagine we're watching these areas, and we like the biology, but we feel really good about where FCRN is positioned competitively and just how different it looks in terms of stage of opportunity. It sold extremely well on a time-adjusted basis. You know, the first FCRN approved reported about $1.2 billion in net sales in its first year post-launch. And if you look at our forecasts, you look at street forecasts,

Speaker Change: These will be our place in the competitive field. Again, we think many of these other classes are interesting.

Speaker Change: Watching them closely, we make investments in other areas, and so you can imagine, we're watching these areas. We like the biology, but we feel really good about where FCRN is positioned competitively, and just how different it looks in terms of stage of opportunity.

Matthew Gline: Everyone wants to compare themselves to the biggest drugs, and so the HMRA comparison is maybe overdone, but I liked a couple of things about it here. But one of the things I liked about it is, you know, if you try and stack up where FCRN is versus where the TNF class was at various points in history, it just feels exciting to be at this stage in biology, right? We are in a much larger set of indications than TNFs were being studied in at the time and growing.

Speaker Change: You know, on slide 15...

Speaker Change: Everyone wants to compare themselves to the biggest drugs, and so the Humira comparison is maybe overdone, but I liked a couple of things about it here.

Speaker Change: But one of the things I liked about it is, you know, if you try and stack up where FCRN is versus where the TNF class was at various points in history,

Speaker Change: It just feels exciting to be at this stage in the biology, right? We are in a much larger set of indications than TNFs were being studied in at the time, and growing. FCRNs have

Matthew Gline: FGRNCHAD, Yaron Werber, David Risinger, Andrew Baum, Louise Chen, Douglas Tsao, Allison Bratzel, Yuhchen Gangba, Yuchen Ding, Matthew Gline, Roivant Sciences. I think there's a chance this class will build, especially given the breadth of early development, meaningfully quicker over time than the TNF class was able to. And I think it's notable.

Speaker Change: sold extremely well on a time-adjusted basis. The first FGRN approved reported about a 1.2 billion dollars in net sales in its first year post-launch.

Speaker Change: And if you look at our forecast, you look at street forecasts, I think there's a chance this class will build, especially given the breadth of early development, meaningfully quicker over time than the TNF class was able, and I think it's notable

Matthew Gline: There were, by 20 years after launch, there were nine other approved MLAs sort of directly competing with TNFs in many of their indications. And yet, TNFs, being a foundational class, being novel biology, being well tolerated, were able to carve out a really meaningful portion of that. So I think as we look at, and there are many other examples we could have picked, but as we look at these other spaces, I think our view is that the opportunity here is big and broad.

Speaker Change: I propose a competitive point. The TNF class didn't achieve these obviously phenomenal results.

Speaker Change: Just on their own, there were, by 20 years after launch, there were nine other approved MOAs sort of directly competing with PNFs in many of their indications.

Speaker Change: And yet TNFs being a foundational class, being novel biology, being well tolerated, were able to carve out a really meaningful portion of that. So I think as we look at, and there's many other examples we could have picked, but as we look at these other spaces,

Matthew Gline: Notably, these are not just many indications. Many of these indications are very large indications, and so we feel like even success in a handful of them for any given program can make a big impact. And indications that are big enough, as with many of the TNF indications, to accommodate multiple programs, multiple mechanisms.

Speaker Change: i think our view is the opportunity here is big it's broad notab these are not just many indications many of these indications are very large indications and so

Speaker Change: We've got even success in a handful of them for any given program that can make a big impact. And indications that are big enough, as with many of the TNF indications, to accommodate multiple programs, multiple mechanisms. This is a big tent.

Matthew Gline: This is a big event, and Slide 16 has an aggressive plan. We are excited about that plan. 14.02 will be in four to five potential registrational programs this fiscal year, moving up to 10 indications by next fiscal year.

Speaker Change: Immune event on slide 16 has an aggressive plan. We are excited about that plan. 14.02 will be in four to five potential registrational programs this fiscal year, moving up to 10 indications by next fiscal year. So three INDs expected to be active by the end of this calendar year. Really excited at what we're doing with 14.02, what we're gonna generate for data in the coming months.

Matthew Gline: So three IMDs expected to be active by the end of this calendar year. Really excited at what we're doing with 14.02 and what we're going to generate for data in the coming months to validate that approach. So enough said on Immune Evamp, but wanted to revisit that topic.

Matthew Gline: And a couple of other smaller things, one on slide 18, just a quick update on Vitama, $18.4 million in product revenue for the quarter, relatively flat on GTN yield. Notably, script volumes are doing actually relatively well. We get the question frequently: "It looks flat, it looks flattish."

Speaker Change: to validate that approach.

Speaker Change: So, enough said on the moon event, but why don't you revisit that topic.

Speaker Change: Thank you.

Speaker Change: and a couple of other smaller things one on slide eightteen justlike a quick update on cama

Speaker Change: 18.4 million in product revenue for the quarter, relatively flat on GTN yield.

Speaker Change: Notably, script volumes are doing actually relatively well for, you know, we get frequently the question, it looks flat, it looks flattish, you know, script volumes are up 20% year over year relative to the same quarter last year. They're growing, you know, single digit percent, quarter on quarter, every quarter, and we continue to see that. So that suggests

Matthew Gline: Script volumes are up 20% year over year relative to the same quarter last year. They're growing single-digit percent quarter on quarter every quarter. And we continue to see that. So that suggests we are continuing to slowly build into the psoriasis market. And we're happy with that. And it suggests a willingness over time for this doctor behavior to change. We remain the best selling novel topical in psoriasis.

Speaker Change: we are continuingating just loan building into this r market and we're happy to that and suggest willingness over time for this

Speaker Change: do behavior to change we remain the best the best selling from the volume perspective novel topical the wer i is andall thatsets us up really well for as we said for the main event which is the launching d that will come after approval at the end of this year i think on gtm quickly because the gt n yield fluctuations have sort of

Matthew Gline: And all that sets us up really well for, as we said before, the main event, which is the launch in A.D. that will come after approval at the end of this year. I think on GTN quickly because the GTN yield fluctuations have sort of obscured the overall positive trend in volume here. I'll just say we had one payer contract that had a reset effectively earlier this year that we were not getting a rebate on last year that we are rebating now. So that resulted in both some one-time savings and also just like an overall reset of GTN.

Speaker Change: obscured the overall positive trening volme here i' just saying we had one payer contracts that

Speaker Change: that had a reset effectively earlier this year that we were not getting a rebate on last year that we are rebating now. So that resulted in both some one-time and also just like an overall reset of GTN. I expect to accrete from here. It'll continue to be sort of slow accretion from here. Long term, I don't have a huge difference in my expectations, but I think, you know, this year it'll sort of build from here instead of going, you know, remote.

Matthew Gline: I expect to accrete from here. It'll continue to be sort of slow accretion from here. Long term, I don't have a huge difference in my expectations, but I think, you know, this year it'll sort of build from here instead of building, you know, we both might have been higher levels. Notably, net price continues to increase over time outside of that one contract.

Matthew Gline: So we continue to see everything trending in the direction that we want it to. Hello, my name is Yain Chen. Key Upcoming Catalysts on slide 20. First of all, not on this slide, but we'll be presenting this undisclosed program, including some clinical data, in September. Also coming up, we've got 1402 putting out detailed development plan information, as well as data from the Botoclomab study in Graves coming this fall. We're pretty excited to put that data out there. We think Graves is a really exciting opportunity.

Speaker Change: been higher level notonlyally that price continues increase overthe time outside of that one contracts so we continue to see everything trending in the direction that we wanted to

Speaker Change: Key upcoming catalysts on slide 20. First of all, not on this slide, but we'll be presenting this undisclosed program, including some clinical data in September . Also upcoming here, we've got 1402, putting out

Speaker Change: detailed development plan information as well as data firm with the token best study and graes

Matthew Gline: You know, in the middle of now, we're going to get top-line data from that phase two trial on sarcoidosis. Again, not an area of great sort of external focus right now, but if that data are positive, those data are positive, we're excited about what that will mean. Vekama, again, the big event, the atopic dermatitis label expansion, hopefully coming at the end of this year.

Speaker Change: Coming this fall, we're pretty excited to put that data out there. We think Greaves is a really exciting opportunity.

Speaker Change: You know, in the middle of NAB, we're going to get top-line data from that phase 2 trial. And so acidosis, again, not an area of great sort of external focus right now, but if that data are positive, those data are positive, we're excited about what that will mean. The CAMA, again, the big event, the atopic dermatitis label expansion, hopefully coming at the end of this year.

Matthew Gline: And then, you know, by the end of this fiscal year, data from Botoclomab in mycinic Graves, as we talked about, as well as data from the period one of the phase two study in CIDP. And then, by the end of this fiscal year, initiating four or five potential registration programs in 1402, all of which we, together with Mutivant, are speaking more about in the near future. So, finally, before I wrap up this relatively quick update on slide 22, just a financial update, you know, I think overall, a pretty normal quarter for us from a finance perspective.

Speaker Change: And then, you know, by the end of the fiscal year, data from Patokomab in Mycenae Gravis, as we talked about, as well as data from the period one of the Phase 2B study in CIDP. And then by the end of this fiscal year,

Speaker Change: Initiating 4 or 5 potential registrational programs in 1402, all of which we, together with MUNIMAN, are looking forward to speaking more about in the near future.

Speaker Change: So finally, before I wrap up this relatively quick update on slide 22, just a financial update, I think overall a pretty normal quarter for us from a finance perspective.

Matthew Gline: We actually had net net income this year, this quarter of $57 million, net revenues of $55, including product revenues of $7.18, and expenses sort of within our historical bounds. We ended the quarter with $5.7 billion in cash and cash equivalents.

Speaker Change: We actually had net income this year, this quarter, of $57 million.

Matthew Gline: That sort of reflects the Sumitomo repurchase that we had made in April of last quarter. And then the carrying value of our debt has come down a bit thanks to the renegotiation that we have done at Dermavent. And you can see shares outstanding on the slide as well, about $7.9 million.

Speaker Change: net revenues of fifty-five including product revenues every by eighteen expenses sortted within with ourhistorical downs we ended we end the quarter with five point seven billion cash and cash quivalence

Speaker Change: That sort of reflects the Sumitomo repurchase that we had made in April , I want to say, of last quarter.

Speaker Change: And then the carrying value of our debt has come down a bit thanks to the renegotiation that we have done at DERMAVENT. And you can see shares outstanding on the slide as well, about 7.9 million.

Matthew Gline: So with that, I'll wrap up the presentation portion of this on slide 24. You can see that we have a pretty exciting catalyst calendar coming up with, frankly, a pretty rich couple of months ahead between the unveiling of the new program, I continue to work on the BD side, and data coming from Toclomav and from Univent generally in the coming months. So really looking forward to getting together, what I'm sure will be multiple times in the next few months, talking about those updates, and continuing to see this all develop. And with that, I will wrap up my presentation for the morning. Thank you again for listening, and I'll hand it back to the operator for Q&A. As a reminder,

Speaker Change: So with that I will wrap up the presentation portion of this on slide 24. You can see that we have a pretty exciting catalyst.

Speaker Change: calendar coming up with frankly a pretty rich couple of months ahead between the unveil of the new program. I continue to work on the beauty side and

Speaker Change: Data coming from ToclNav and from Univant generally in the coming months. So really looking forward to getting together, what I'm sure will be multiple times in the next few months, to talk about those updates and to continue to see this all.

Speaker Change: And with that I will wrap up the presentation for the morning. Thank you again for listening and I'll hand it back to the operator for Q&A.

Operator: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. One moment. And our first question comes from Allison Bratzel on Piper Sandler. Your line is open.

Speaker Change: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. One moment.

Unknown Executive: And our first question comes from Allison Bratzel of Piper Sandler. Your line is open.

Speaker Change: And our first question comes from Allison Bratzel of Piper Sandler. Your line is open.

Allison Bratzel: Hey, good morning. Thanks for the update, Matt, and thanks for taking the question. Just one for me on PriVant. You know, now that you've met with FDA on Brepo and NIU, I guess what is left to be worked out or decided on the Phase III design? I think you've given some high-level guidance. I'm looking for 300 to 350-ish patients and a protocol basically as close to Neptune as possible. I guess it was just a high level, is that still the case?

Allison Bratzel: Hey, good morning. Thanks for the update, Matt, and thanks for taking the question. Just one for me on Pryvan. You know, now that you've met with FDA on Brepo and NIU, I guess what is left to be worked out or decided on the Phase 3 design? I think you'd given some high-level guidance.

Speaker Change: I'm looking for 300 to 350-ish patients and a protocol basically as close to Neptune as possible.

Allison Bratzel: And is any of this protocol design dependent on the 52-week readout later this year? And then just, I guess, on that longer-term follow-up, you know, what would you view as an outcome that reinforces your view on the opportunity in uveitis? Thanks.

Speaker Change: I guess just high level, is that still the case? And is any of this protocol design dependent on the 52 week?

Speaker Change: read out later this year. And then just I guess on that longer term follow up, you know, what what would you view as an outcome that that reinforces your your view on the the opportunity and in uveitis? Thanks.

Matthew Gline: Yeah, sure. Thanks.

Matthew Gline: So, first of all, extremely constructive interaction with FDA. I think they are really excited to see a new opportunity in NIU, which is a disease that really needs to be studied. I think we feel good about where that's headed. I'd say the previous guidance we gave was largely in line with what we expect to see. And I think we got just about everything we really feel like we needed to make that program a success.

Speaker Change: Yeah, sure. Thanks. So first of all, extremely constructive interaction with FDA. I think they are really excited to see a new opportunity in NIU, which is a disease that really needs to be studied. I think we feel

Speaker Change: I think we feel good about where that's headed. I'd say the previous guidance we gave was largely in line with what we expect to see, and I think we got just about everything we really feel like we needed to make that program a success.

Matthew Gline: So, really, at this point, small tweaks, but just getting the study up and running, and we'll be able to provide a full description of it pretty soon here, honestly. And then I'd say basically none of the study design hinges on the 52-week date.

Speaker Change: So really at this point, small tweaks, but just getting the study up and running and we'll be able to provide a full description of it.

Speaker Change: appretysume here honestly and then i think basically non of the sudden design hinges on the fifty two data though viously we saw something przing we look close we add it and i think

Matthew Gline: We saw something surprising, we looked closely at it, and I don't think there's anything in particular.

Operator: for Earnings Call. At this time, all participants are in a listen only mode. After this speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again.

Matthew Gline: And I don't think there's anything in particular we're looking for in 52 weeks to reinforce the program other than continued strong benefits to patients, which given the quality of the data, we certainly expect. Thanks, Alec. Thanks for the great questions.

Speaker Change: I don't think there's anything in particular we're looking for in 52 weeks to reinforce the program other than continued strong benefits to patients, which, given the quality of the 2020 data, we certainly expect.

Speaker Change: Thanks, Alec. Thanks for the great questions.

Operator: Please be advised that today's conference is being recorded.

Corin Johnson: Our next question comes from Corin Johnson of Goldman Sachs. Your line is open.

Alec: Thank you.

Speaker Change: 's sent

Stephanie Lee: I would now like to hand the conference over to you, speakers today, Stephanie Lee, please go ahead. Good morning and thanks for joining today's call to review Roivant's financial results for the first quarter and the June 30th, 2024, along with a business update. I'm Stephanie Lee with Roivant.

Speaker Change: Our next question comes from Corinne Johnson of Goldman Sachs. Your line is open.

Craig McLean: Hey, good morning team. This is Craig on behalf of Corinne. So following the completion of enrollment in the Valor study, can you kind of outline how the final enrollment compares to your original expectations and maybe walk us through some powering of some

Speaker Change: Hey, good morning, team. This is Craig on for Corinne. So,

Speaker Change: Following the completion of enrollment of the VALOR study,

Stephanie Lee: Presenting today, we have Matt Klein, CEO of Roivant. For those of you who have been on the conference call, you can find the slides being presented today, as well as a press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along.

Craig: Can you kind of outline how the final enrollment compares to your original expectations and maybe walk us through some powering assumptions there?

Matthew Gline: Yeah, sure. A couple of things. One is that the actual number of patients we enrolled, at 241, was a little bit higher than our original plan for the study. Originally, it had been 225.

Speaker Change: Yeah, sure. A couple of things.

Speaker Change: One is the actual number of days to be enrolled at 241 was a little bit higher than our original plan for the study. Originally it had been 225, so we feel extremely well powered.

Stephanie Lee: I'd like to remind you that we'll be making certain forwards of these statements during this presentation. Strongly encourage you to review the information that we filed with the SEC for more information regarding these 14 statements and related risks that answered.

Matthew Gline: So we feel extremely well powered. I don't have a lot to say about baseline characteristics or demographics right now other than to say I think we're perfectly happy with the patients that we've enrolled and we think it sets us up well. You know, I guess the other comment I'll make with a shout out to the private team is DM is an incredibly difficult indication in which to develop drugs, because these patients are hard to find.

Speaker Change: I don't have a lot to say on my baseline characteristics or demographics right now, other than to say I think we're...

Matt Klein: And with that, I'll turn it over to Matt. Great. Thanks, Stephanie. Thanks everybody for joining. It's always a pleasure to get on these calls. We, in truth, we saved all of our fun updates for this fall. So today is a relatively short forward, straightforward set of updates, but a couple of really meaningful execution points and a couple of things that I'm happy to be talking to us. So thank you again.

Craig: I'm perfectly happy with the patients that we've enrolled and we think it sets us up well.

Speaker Change: You know, I guess the other comment I'll make, with a shout out to the PrioVant team, is DM is an incredibly difficult indication in which to develop drugs. These patients are hard to find, and frankly, our experience is that the key is a lot of legwork with the sites.

Matthew Gline: And frankly, our experience is that the key is a lot of legwork with the sites. So we spend a lot of time talking to investigators and trying to get out there in the field to make sure that we, Yeah, we have what we need. So yeah, I'm very proud of the effort there. I'm proud of how quickly that study was able to get fully enrolled. I'm looking forward to sharing that data with you all. Thanks for the question; I'm done.

Matt Klein: I'll start just quickly on on slide 5 in the deck with a reminder, it's going to where we are this year, which is this is a year of growth and expansion for us. So we're focused very much on delivering clinical data across multiple of our franchise, the anti-FCR and franchise where we have some meaningful data sets coming as soon as the near future, as well as over the next call it six months.

Craig: So we spend a lot of time out and about talking to investigators, trying to get out there in the field to make sure that we

Speaker Change: We have what we needed. So, yeah, I'm very proud of the effort there. I'm proud of how quickly that study was able to get to fully enrolled. I'm looking forward to sharing that data when it's available.

Unknown Executive: Of course, just one more question, if I may, could you just remind us of what you're looking for in terms of a go, no-go decision for phase two and the middle map data coming relatively soon?

Matthew Gline: Of course, just one more, if I may, could you just remind us of what you're looking for in terms of a go, no-go decision for phase two and the middle map data coming relatively soon? Ah, we haven't, so thanks, yeah, look, I.

Speaker Change: So the larger side, as I said earlier, so what does the UGM say? Thanks for the question on the MDM.

Matt Klein: We have continued clinical development beyond that in our pipeline, including in brepsitment, where we'll be beginning our faith through program and I you shortly, where we have data coming into the mill map, ladies, you and Sarkoidosis, and so on. We're very much looking forward to talk a little bit about the camera today, but the story for the camera for this year is really the expansion of the label of the day. And so the acceleration of the stresses certainly volumes and rathers are over time. And then we can continue to be hard at work, expanding our pipeline, looking at mid to late stage programs. I know there's a lot of focus on that activity.

Speaker Change: Of course, just one more, if I may. Could you just remind us of what you're looking for in terms of a go, no-go decision for the phase two and the middle map data coming relatively soon?

Matthew Gline: Ah, we haven't, so thanks. Yeah, look, I think we haven't articulated it like a simple, straightforward bar. And I think the truth is that sarcoidosis is one of these diseases where there's not a lot of other food mechanisms. There's not a lot of There's not a lot of, there's not a lot of options for patients who are sick with the disease.

Speaker Change: We haven't, so thanks, yeah, look, I think we haven't articulated like a simple straightforward bar and I think the truth is that sarcoidosis is one of these diseases where there's not a lot of other food mechanisms, there's not a lot of

Matthew Gline: So I don't think the bar is meaningful. I think the bar is that if the study works, it's certainly worth progressing. You know, as with all phase two trials, we're going to evaluate the totality of the data. And, you know, we'll think about what else is on our plate. We're also looking for consistency across not just the primary care but across a few secondary care. There are a bunch of different ways that people look at the treatment of sarcoid patients.

Craig: There's not a lot of...

Speaker Change: There's not a lot of options for patients who are sick with the disease, so I don't think the, I think the bar is meaningful. I think the bar is, if the study works, it's certainly worth progressing.

Matt Klein: We will be unveiling our much discussed sort of so far on close program just next month. So we'll hold on for a few more weeks there. And then continuing to work on prioritizing capital allocation, including thinking aggressively around the use capital to buy back shares, so on. So we are super proud on slide six of the pipeline is currently stands. One of the things that I sure was sometimes I get all these questions about BD, but, but, you know, I every time I look at our pipeline, but we still have one of the best I and I pipelines even without any BD.

Speaker Change: You know, as with all pastry trials, we're going to evaluate the quality of the data.

Speaker Change: and you know we'll think about what else is on our plate. We're also looking for consistency across not just the primary but across a few secondaries. There's a bunch of different ways that people look at the treatment of sarcoid patients.

Speaker Change: Thank you. Got it. Thank you guys. Thank you.

Unknown Executive: Our next question comes from Brian Cheng of J.P. Morgan. Your line is open.

Brian Cheng: Our next question comes from Brian Cheng of J.P. Morgan. Your line is open.

Matt Klein: So, you know, excited about the breadth of opportunities there, in particular, excited about the next call 18 months, both in the idea for a lot more about today. And the brepsitment will be a little data coming shortly.

Speaker Change: Our next question comes from Brian Cheng of J.P. Morgan. Your line is open.

Brian Cheng: Hey, guys. Good morning. Thanks for taking our questions. Many sources. With the recent sell-off in the market, does it make it easier or harder for you to find a new asset? Does it change the way you negotiate?

Unknown Executive: Many sources. With the recent sell-off in the market, does it make it easier or harder for you to find a new asset? Does it change the way you negotiate?

Brian Cheng: Hey guys, good morning. Thanks for taking our questions. Many sources, with the recent sell-off in the market, does it make it easier or harder for you to find a new asset? Does it change the way how you negotiate?

Matt Klein: So the main updates for the quarter serving on slide eight. One is on brepsitment, which is that we've now completed enrollment in our phase three study in demand of my site is 21 subjects across 90 sites. It is the largest interventional DM study ever conducted. And we can now say with confidence we expect top line data and say I have an x year that study completed enrollment. A few weeks back. And we've completed our end of phase two meeting with FDA on the NIU opportunity and are planning to begin a 52 week.

Matthew Gline: Thanks, Brian, for the great question. I will hand it over to Mayukh.

Mayukh: Thanks, Brian , for the great question. I will hand it over to Mayukh, but the short thing I'll say is we, look, we work with a wide range of different prospective partners.

Speaker Change: They are affected by varying degrees to the financial markets, but mostly we're focused on getting great opportunities at prices that we're excited about. But Mayukh, what would you say to the question about the sell-offs?

Mayukh Sukhatme: But the short thing I'll say is, look, we work with a wide range of different potential partners. They are affected to varying degrees by the financial markets. But mostly, we're focused on getting great opportunities at prices that we're excited about. But Mayukh, what would you say to that question about the size of the market?

Matt Klein: [inaudible] in any near future, in any near future, in any near future in any near future, in any near future, in any near future,[inaudible] by others such as in showrooms recently. But overall, just a really compelling picture of a well-tolerated class that showed meaningful efficacy and clinical benefit in a pretty wide range at this point of diseases. So we are really excited about that. The other piece, I don't want to spend too much time dwelling on this, on slide 14, is there's been a lot of interest, let's say, in competitive mechanisms, IG degradation or some of the Cartier or V-cell biology, T-cell engages for autoimmune diseases.

Mayukh: Yeah, look, I think...

Mayukh: The short answer is it depends, but I think I don't have too much more to add to what Matt said.

Mayukh Sukhatme: Yeah, look, I think... The short answer is it depends. But I think I don't have too much more to add to what Mayukh and Brian said. The other piece of this that's sort of the question behind the question is we remain really excited about what we see in the world, and we're looking forward to doing the right deal at the right time.

Brian Cheng: Thanks Mayukh. So look, Brian , I think the short answer, the other piece of this that's sort of the question behind the question is we remain really excited with what we see in the world and we're looking forward to doing the right deal at the right time.

Brian Cheng: Okay, maybe just, you know, one question on 1402. I guess, you know, just overall, I just want to get a better sense of how you're thinking around this asset. As we think through the 10 indications that you're lining up for, you know, through the next fiscal year, and you talk a lot about the range of themes of opportunities that you have laid out in your slide deck today, how do you pick and choose the different areas?

Unknown Executive: Okay, maybe just, you know, one question on 1402. I guess, you know, just overall, I just want to get a better sense of how you're thinking around this asset. As we think through the 10 indications that you're lining up for, you know, through the next fiscal year, and you talk a lot about the range of themes and opportunities that you have laid out in your slide deck today, how do you pick and choose the different areas?

Speaker Change: Okay, maybe just, you know, one question on 1402. I guess, you know, just overall, I just want to get a better sense of how you're thinking around this asset.

Speaker Change: As we think through the 10 indications that you are lining up for, you know, for the next fiscal year,

Speaker Change: And you talk a lot about the range of themes of opportunities that you have laid out in your slide deck today. So how do you pick and choose the different areas?

Unknown Executive: And I think most importantly, it's how you get credit for it in front of investors, because it seems that investors today are very fixated on MGNCIDP. So in other words, how do you intend to get credit to push 1402 into uncharted indications?

Brian Cheng: And I think most importantly, how you get credit for it in front of investors. Because it seems that investors today are very fixated on AMG and CIDP. So in other words, how do you intend to get credit for pushing 1402 into uncharted territories? And then maybe just one last one, you know, more like a housekeeping one.

Speaker Change: And I think most importantly is how you get credit for it in front of investors because it seems that investors today are very fixated on AMG and CIDP. So in other words, how do you intend to get credit for to push 1402 into uncharted indications?

Matthew Gline: What is the data? You know, what is the cadence of callus flow in the fall? And because, you know, we're going to get phase two asset unveiling in September, Grace's plan also unveiling for immunogen and cyclodosis data coming out. So what's the data cadence? Thanks.

Speaker Change: And then maybe just one last one, you know, more like a housekeeping one.

Speaker Change: What is the cadence of CALIS flow in the fall, because we're going to get...

Speaker Change: Phase II Asset Unveiling in September , Grace Plan also unveiling for immunogen and psychodosis data coming out. So what's the cadence of data flow? Thanks.

Unknown Executive: Thanks, Brian. All great questions.

Matthew Gline: Thanks, Brian. All great questions.

Speaker Change: Thanks, Brian . All great questions.

Matthew Gline: Look, on 1402, I think the anodyne answer that's also true is obviously the biggest factors that go into our pick and choosing indications are the quality of the biology, the size of the unmet need, where we can be competitively positioned, you know, cost and risk kind of trade-offs. Like, those are obviously the main factors that go in. I'd say a couple things about 1402 that I find exciting, or about the FCRN landscape, and it seems like you may want to jump in also.

Speaker Change: Look, I'm 1402. I think the...

Speaker Change: The anodyne answer that's also true is obviously the biggest factor that goes into our pick and choosing indications are the quality of the biology, the size of the unmet need.

Speaker Change: where we can be competitively positioned.

Unknown Executive: Look, at 14.02, I think the anodyne answer that's also true is obviously the biggest factors that go into our pick and choosing indications are the quality of the biology, the size of the unmet need, where we can be competitively positioned, you know, cost and risk kind of trade-offs. Like, those are obviously the main factors that go in. And I'd say a couple things about 14.02 that I find exciting, or about the FCRN landscape, and it seems like you may want to jump in also. You know, on, you know, one of the things that we've said over and over again about FCRN is that anyone's face-to-face, everyone's face-to-study. That goes both ways.

Speaker Change: You know, cost and risk kind of trade-offs, like those are obviously like the main factors that go in.

Speaker Change: I'd say a couple things about a 1402 that I find exciting, or about the S&M landscape, and it seems like you might want to jump in also.

Matthew Gline: You know, on, you know, one of the things that we've said over and over again about FCRN is that anyone's phase two study is everyone's phase two study. That goes both ways. It means that we need to be careful about when we put our data out, but it means that once you know what the depth of IgG suppression does in a patient population, you can really be in the front of the pack. And so I think we're looking at indications where we can be in the front of the pack, where we can get out there commercially and sort of be neck and neck with our defenders, hopefully with deeper IgG suppression.

Speaker Change: On, you know, one of the things that we've said over and over again about FCRN is that anyone's phase 2 study is everyone's phase 2 study. That goes both ways. It means that we need to be careful about when we put our data out, but it means that once you know what the depth and IgG suppression does in a patient population, you can really be front of the pack. And so I think we're looking at indications where we can be

Unknown Executive: It means that we need to be careful about when we put our data out, but it means that once you know what the depth of IgG suppression does in a patient population, you can really be in front of the pack. And so I think we're looking at indications where we can be in the front of the pack, where we can get out there commercially and be sort of neck and neck with our defenders, hopefully with deeper IgG suppression.

Matthew Gline: So I think that's obviously a factor. But for what it's worth, we also think MG is a really big opportunity. We also think CIDP is a big opportunity. And as a reminder, we're generating a meaningful data set in MG with Tokumab that will underscore and get to the more is better question in the coming months. So I think there's a lot to sort of focus on there, even for people who are myopically focused on the existing commercial implications.

Speaker Change: In the front of the pack where we can get out there commercially and sort of be neck and neck with our competitors, hopefully with deeper IDG suppression. So I think that's

Unknown Executive: So I think that's obviously a factor. But for what it's worth, we also think Mg is a really big opportunity. We also think CIDP is a big opportunity. And as a reminder, we're generating a meaningful data set in Mg with Tocomab that will underscore and get to the more is better question in the coming months. So I think there's a lot to sort of focus on there, even for people who are myopically focused on the existing commercial indications.

Speaker Change: Obviously, A factor. For what it's worth, we also think MG is a really big opportunity. We also think CIDP is a big opportunity. And as a reminder, we're generating a meaningful data set in MG with TocLinAb that will...

Matt Gline: underscore and get to the more is better question just in the coming months. So I think there's a lot to sort of focus on there, even more myopically focused on the existing commercial indications. Yeah, I think you hit most of the point, Matt. I just like the way, Brian , that you framed the question, which is...

Matthew Gline: Yeah, I think you hit most of the points, Matt. I just like the way, Brian, that you framed the question, which is, all right, people are focused on them, GNC, NEP, and everything else basically is upside down. That's right. Yeah, I think that's a great way to put it.

Matthew Gline: And in terms of the cadence of catalyst flow, look, we have a busy, call it six to seven months ahead here. I'd say September will be a busy month, and then the MilMAP data comes later this fall, and then I think we've said MG will come early next year, and CIDP and TED kind of will come a little bit thereafter. So I think that's what the sort of immediate flow looks like, and then, obviously, shortly on the heels of that, we'll be looking at DM and beyond.

Speaker Change: All right, people are focused on MG and TADP and everything else basically is upside. That's right. Yeah, I think that's a great way to put it. And in terms of cadence of catalyst flow, look, we have a busy, call it six to seven months ahead here.

Speaker Change: I'd say...

Speaker Change: September will be a busy month, and then the MilMet data comes later.

Speaker Change: later this fall. And then I think we've said MG will come early next year, and CIDP and TED kind of a little bit thereafter. So I think that's, that's what the sort of immediate flow looks like. And obviously, shortly on the heels of that, we'll be looking at DM and beyond.

Speaker Change: Thanks guys. Great, thanks Brian . Thank you.

Dave Risinger: Our next question comes from Dave Risinger of Lyrinc Partners. Your line is open.

Speaker Change: Our next question comes from Dave Risinger of Lyrinc Partners. Your line is open.

Dave Risinger: Thanks very much. And thanks for all the updates.

Matthew Gline: So I have two questions, please. First, could you provide more color on the LNP litigation, including the event path ahead. And then second, could you discuss external transaction prospects, including the size potential of deals that you're looking at?

Dave Risinger: Thanks very much and thanks for all the updates. So I have two questions, please.

Dave Risinger: First, could you provide more color on...

Dave Risinger: The LNP litigation, including the event path ahead, and then second, could you discuss external transaction prospects, including the size potential of deals that you're looking at? Thanks very much.

Matthew Gline: Thanks very much.

Matthew Gline: Yeah, sure. Thanks, Dave. Both great questions.

Matthew Gline: So, on the L&P litigation, again, there's not that much that we're generally able to say about an ongoing litigation, but in terms of what's coming, so we're in discovery now. And as I mentioned on the call, that process is going to continue for a few more months. We, together with Moderna, Arbutus, and Genovant, have asked for a moderate extension of that process to get answers to a few of the outstanding questions.

Speaker Change: Yeah, sure. Thanks, Dave. Both great questions. So,

Speaker Change: ok

Speaker Change: On the L&P litigation, again, there's not that much that we're generally able to say about an ongoing litigation, but in terms of what's coming,

Unknown Executive: That process is going to continue for a few more months. We, together with Moderna, Arbutus, and Genovant, have asked for a moderate extension of that process to get answers to a few of the outstanding questions. So, you know, I think that's the sort of next thing here. And then that calendar, there's a call to the judge in the next few weeks to get that approved. But if that calendar is approved, it would have summary judgment happening kind of in the beginning portion of next year, followed by a trial a year from now. So a little bit later than the most recent version of the calendar, but for good reason, instigated by our side.

Speaker Change: So we're in discovery now. And as I mentioned on the call,

Speaker Change: that process is going to continue we hope for a few more months we together with mirder on our views in gennevand to ask for a moderate extion of process to get answers to approve the outstanding questions

Matthew Gline: So, you know, I think that's the sort of next thing here. And then that calendar, there's a call to the judge in the next few weeks to get that approved. If that calendar is approved, it would have summary judgment happening kind of in the beginning portion of next year, followed by a trial a year from now. So a little bit later than the sort of most recent version of the calendar, but for good reason, instigated by our side.

Speaker Change: So, you know, I think that's the sort of next thing here. And then that calendar, there's a, there's a, they're apologizing the next few weeks to get that approved. But if that calendar is approved, it would have.

Speaker Change: Summary judgment happening kind of in the beginning portion of next year, followed by a trial a year from now. So a little bit later than the most recent version of the calendar, but for good reason instigated by our side.

Matt Klein: And I want to say, nothing on this slide is meant to suggest that we are not enthusiastic about much of that biology. We think it's really great biology. But I think it's been interesting to us, only in the sense that it's so much earlier than FCRN. And FCRN is sort of elegantly clear to this bar that there's still a lot of work to do with some of these other mechanisms. So you can see here, again, multiple approvals for our class in immunology, multiple positive-based researches, multiple positive-based two studies and thousands of patients.

Matthew Gline: On external transaction price prospects, I guess I'll hand over to Mike to answer that question straight from the source. Sure. Hi Dave.

Unknown Executive: On external transaction price prospects, I guess I'll hand over to Mike to answer that question straight from the source. Sure. Hi Dave. Thanks for the question.

Speaker Change: On external transaction price prospects, I guess I'll hand over to Mike to answer that question straight from the source. Sure, hi Dave, thanks for the question.

Unknown Executive: Hi Dave, thanks for the question. So I think we have carefully avoided, I think, getting bucketed whenever sort of sort of asked. I think that that continues.

Matthew Gline: Thanks for the question. So I think we have carefully avoided, I think, getting bucketed whenever we are sort of asked, and I think that that continues. So I would think about the size of the, size of, you know, opportunity and things that we're looking at. We're really thinking about this, I think, as you know, Dave, as a portfolio. And so there's going to be heterogeneity in any one deal. But I think, you know, overall, I think, obviously, our arc, so we think about things kind of on a deal by deal basis, really, through that investment lens, it's a good investment.

Mike: I think we have carefully avoided, I think, getting bucketed whenever asked, and I think that that continues.

Matthew Gline: But then, over sort of the surface area of all those deals, we're looking to move the needle on our enterprise overall. The only thing I'd add is, because we get the question sometimes, and I'm always surprised when I get it, I think we are a very unlikely buyer of multi-billion dollar public companies. I think we are stingy by nature and are looking for places where we can spend more of the dollars on clinical development. So we are a never-say-never company, but I think that's just what's true about who we are.

Speaker Change: So...

Matt Klein: It just sets up a different picture in terms of the level of validation and the proximity of the opportunity. And so what we're excited about that is the our place in the competitive field. Again, we think many of these other classes are interesting and we're watching them closely. We make investments in other areas. And so you can imagine, we're watching these areas. And we like the biology. But we feel really good about where FCRN is positioned competitively and just have different looks in terms of stage of opportunity.

Mike: I would think about size of opportunity and things that we're looking at.

Speaker Change: We really think about this, I think as you know, Dave, as a portfolio and so there's going to be heterogeneity in any one deal, but I think, you know, overall, I think obviously our arc, so we think about things kind of on a deal by deal basis, really through that investment lens, it's a good investment.

Speaker Change: But then over sort of the surface area of all those deals, we're looking to move the needle on our enterprise overall. The other thing I'd add is, because we get the question sometimes, and I'm always surprised when I get it, I think we are a very unlikely buyer of multi-billion dollar public companies.

Unknown Executive: The only thing I'd add is, because we get the question sometimes, and I'm always surprised when I get it, I think we are a very unlikely buyer of multi-billion dollar public funds.

Matt Klein: You know, on 515, everyone wants to compare themselves to the biggest drugs. And so the hemorrhoid comparison is maybe overdone. But I'd like to couple of things about it here. But one things I liked about it is, you know, if you try and stack up where FCRN is versus where the TNF class was at various points in history, it just feels exciting to be at this stage of the biology, right? We are in a much larger set of indications than TNF were being studied in at the time and growing.

Speaker Change: I think we are stingy by nature, and are looking for places where we can spend more of the dollars on clinical development. So we are a never say never company, but I think that's just true about who we are.

Speaker Change: mayday thank you

Dennis Sting: Our next question comes from Dennis Sting of Jeffrey's, "Your Line is Open."

Speaker Change: Thank you.

Speaker Change: Our next question comes from Dennis Sting of Jeffries. Your line is open.

Dennis Sting: Hi, good morning. Thanks for taking our questions. Two for me.

Matthew Gline: So maybe if we can revisit sarcoidosis briefly, correct me if I'm wrong, but previously you may have characterized phase two as potentially registrational. Can you reiterate that and see if and confirm if that's true? And maybe talk a little bit about the path forward if that data is positive. And then, number two, around OpEx. I mean, given ImmunoVan will start a bunch of new trials over the next few years, how do you think your OpEx will evolve during that time? Thank you.

Matt Klein: FCRN had sold extremely well on a time adjusted basis. You know, the first FCRN approved reported about $1.2 billion in that sales and it's first year post launch. And if you look at our forecast, you look at street forecasts, I think there's a chance this class will build, especially given the breadth of early development, meaningfully quicker over time when the TNF class was able. And I think it's notable, I prefer the competitive point.

Dennis Sting: Hi, good morning. Thanks for taking our questions. Two from me. So maybe if we can revisit sarcoidosis briefly.

Dennis Sting: Correct me if I'm wrong, but...

Speaker Change: previously you may have characterizede the face has potentially registrational can you reiterate that see and confir that's true maybe possible a bitof the path for that data is positive and then number two around obacks i mean

Speaker Change: Given ImmunoVan will start a bunch of new trials in the next few years, how do you think your op-ecs will evolve during that time? Thank you.

Matthew Gline: Thank you. That's a great set of questions.

Matt Klein: The TNF class didn't achieve these obviously phenomenal results. Just on their own, there were by 20 years after launch, there were nine other approved MLAs sort of directly competing with DNFs in many of their indications and yet TNFs being a foundation of class, being novel biology, being well tolerated, were able to carve out a really meaningful portion of that. So I think as we look at many other examples, we could have picked those, we look at these other spaces, I think our view is the opportunity here is big, it's broad.

Matthew Gline: But we are on sarcoidosis. The truth is, it's a phase two study. It's 100 patients. It's certainly large enough to serve as at least a pivotal study, if successful, and obviously communication with high-end that need. So depending on the quality of the data, there's always a chance.

Speaker Change: Yeah, thank you. That's a great set of questions. Look, we are, on sarcoidosis...

Unknown Executive: The truth is, it's a phase two study. It's 100 patients. It's certainly large enough to serve as at least a pivotal study, if successful, and obviously communication with high-end that need. So depending on the quality of the data, there's always

Speaker Change: The truth is, it's a Phase II study. It's 100 patients.

Dennis Sting: It's certainly large enough to serve as at least a pivotal study.

Unknown Executive: I think our expectation is that it's a phase 2 study and that we would have a program behind it in basically all scenarios, and we're just excited to be developing the disease. There are no approved agents outside of steroids, so the unmet need is really significant.

Mayukh Sukhatme: Mayukh Sukhatme

Matthew Gline: and the regulators. But then, I think our expectation is that if they do a phase two study and that we would have a program behind it, it can basically all...

Matt Klein: Notably these are not just many indications, many of these indications are very large indications. And so even success in a handful of them for any given program can make a big impact. And indications that are big enough, as with many TNF indications, to accommodate multiple programs, multiple mechanisms. This is, it isn't big, and Kent.

Matthew Gline: in basically all scenarios, and we're just excited to be developing the disease. There are no approved agents outside of steroids, so the unmet need is really significant.

Speaker Change: All scenarios, and we're just excited to be developing the disease. There are no approved agents outside of steroids, so the unmet need is really significant.

Matthew Gline: Um, on the Immunevent question, look, I think the short answer to the question on its face is, given that Immunevent is starting a number of federal studies, I would expect their offsets to increase. I don't have super specific financial guidance right now to offer. The cost of a Phase III program for an FCRN, in general, has ranged from, call it, $80 to $120 million. And so, you know, over the life of those programs, I think those are, like, reasonable estimates plus overhead and personnel and stuff like that. So, you know, I'd expect BIRM to go up there over time.

Matt Klein: Immunivant on slide 16 has an aggressive plan. We are excited about that plan. 14 or 2 will be in 4 to 5 potential registration programs this fiscal year, moving up to 10 indications by an next fiscal year.

Speaker Change: I'll leave you to make questions.

Speaker Change: Look, I think the short answer to the question on its face is, given that Immunevent is starting a number of pivotal studies,

Speaker Change: I would expect their affects to increase.

Speaker Change: i don't have super-specific financial guidance right now to offer the cost of a p three program for an fcrr end of general has red from call it eighty hundred twenty milliondollars

Matt Klein: So 3IND is expected to be active by by the end of this calendar year. Really excited at what we're doing with 14 or 2, what we're going to generate for data in the coming months to validate that approach.

Matthew Gline: Obviously, you know, if you look at some of our competitors, I'd say their R&D expenses may be useful, but a big piece of the cost here ultimately winds up coming as you get closer to a commercial launch from a G&A perspective as well. And notably, Immunevent is well capitalized right now for this program, and we are obviously excited to be a good part of it. Great. Thank you. Thanks, Rob

Mayukh Sukhatme: And so, you know, over the life of those programs, I think those are like reasonable estimates plus overhead and personnel and stuff like that. So, you know, I'd expect BIRM to go up, go up there over time. Obviously, you know, if you look at some of our competitors, I'd say like

Matt Klein: So enough said on Immunivant, but wanted to revisit that topic. And a couple of other smaller things, one on slide 18, just a quick update on the camera, 18.4 million in product revenue for the corner, for the quarter, relatively flat on GTN yield. Notably, script volumes are doing actually relatively well for, you know, we get frequently the question, it looks flat, it looks flatish. You know, script volumes are up 20% year over year relative to the same quarter last year.

Speaker Change: there are the expenses maybe useful but a big piece ofthe costitut ultimatelyeveryoneones that coming get closer to a commercial launch ferogen and a perspective as well

Speaker Change: And notably, Immunevent is well-capitalized right now for this program, and we are obviously excited to be a good partner for them.

Unknown Executive: Great, thank you. Thanks for having us.

Matthew Gline: Great, thank you. Thanks, Rob.

Matt Klein: They're growing, you know, single digit percent quarter on quarter every quarter, and we continue to see that. So that suggests we are continuing to slowly build into this rise, market, and we're happy with that, and it suggests a willingness over time for this dot behavior to change.

Speaker Change: Great, thank you. Thanks, Rob. Thank you.

Yaron Werber: Our next question comes from Yaron Werber of TD Cowan. Your line is open.

Yaron Werber: Great. Thanks for taking my question. I have a couple.

Unknown Executive: Great, thanks for taking my question. I have a couple, or maybe just the first one.

Matthew Gline: Maybe just the first one. We started getting questions, and I think you've highlighted now that you're planning on unveiling your recently licensed Phase II program in September. Is there anything you can unveil a little bit today?

Speaker Change: Our next question comes from Yaron Werber of TD Cowen. Your line is open.

Matt Klein: We remain the best selling from the volume perspective, novel top of all. I think in surrises and all that sets us up really well for as we said before the main event, which is the launch in AD that will come after approval at the end of this year.

Unknown Executive: We started getting questions, and I think you highlighted now that you're planning on unveiling your recently licensed phase two program in September. Is there anything you can unveil a little bit today? Just an indication, or how big is the study? Is it a randomized study? Is it just an open-label study? Has there been other studies with this mechanism in whatever indication you're examining? And then maybe just secondly, so it sounds like GMG and CIDP will start phase three, let's say Q1 potentially with 1402. For the other three, is it sort of Graves, Sjogren's, and maybe TED? Is that sort of the order? Thank you.

Yaron Werber: Great, thanks for taking my question. I have a couple.

Yaron Werber: Maybe just the first one, we started getting questions, and I think you highlighted now that you're planning on unveiling your

Matthew Gline: Just indication, or how big is the study? Is it a randomized study? Is it just an open-label study? Has there been other studies with this mechanism in whatever indication you're examining?

Yaron Werber: Recently licensed phase two program in September . Is there anything you can unveil a little bit today? Just indication or how big is the study? Is it a randomized study? Is it just an open label study? Has there been other studies with this mechanism in whatever indication you're examining?

Matt Klein: I think on GTN, quickly, because the GTN yield fluctuations have sort of obscured the overall positive trend in volume here. I'll just say we had one payer contract that had a reset effectively earlier this year that we were not getting a rebate on last year that we are rebating now. So that resulted in both in some one time and also just like an overall reset of GTN. I expect to accrete from here.

Matthew Gline: And then maybe just secondly, so it sounds like GMG and CIDP will start Phase III, let's say Q1, potentially with 1402. For the other three, is it sort of Graves, Sjogren's, and maybe TED? Is that sort of the order? Thank you. Thanks, Yaron. On Minnesota Asset, we're...

Speaker Change: And then maybe just secondly, so it sounds like GMG and CIDP will start phase 3, let's say Q1 potentially with 1402. For the other three, is it sort of Graves, Sjogren's, and maybe TED, is that sort of the order? Thank you.

Matt Klein: It'll continue to be surrised while accreted from here. A long term, I don't have a huge difference in my expectations, but I think this year it'll sort of build from here instead of going to be both might have been higher level. Notably net price continues to increase over time, outside of that one contract. So we continue to see everything trending in the direction that we want to.

Matthew Gline: Thanks, Yaron. On Minnesota Asset, we're weeks away, so I think I'm going to mostly reserve comment, other than to reiterate some things we've already said. Basically, first of all, obviously, we're excited about the program. We have clinical data to share when we release the program. That clinical data, I think, is useful, and people will find it informative. And there is a competitor program. There's another program of the same mechanism being studied by a big pharma company for a different indication. We've said that publicly before.

Speaker Change: Thanks, Yaron.

Speaker Change: a' notle in thatasset

Speaker Change: We're weeks away, so I think I'm going to mostly reserve comment, other than to reiterate some things we've already said. Mainly, first of all, obviously we're excited about the program. There is clinical data to share when we release the program. That clinical data, I think, is useful and people will find it informative.

Matt Klein: The key upcoming catalysts on slide 20. First of all, not on this slide, but we'll be presenting this on this program, including some clinical data in September. Also upcoming here, we've got 14 or two putting out detailed development plan information, as well as data from the total amount of study in graves. Coming this fall, we're pretty excited because that data out there we think raises a really exciting opportunity. You know, in the middle of now, we're going to get top line data from that face to trial. And so it goes this again, not an area of great sort of external focus right now, but if that data are positive, those data are positive, we're excited about what that will mean.

Speaker Change: and there is a competitor program there's another program with the same mechanism being studied about big f company to different indication which said that publicly for and other than that other than networkres orve comment unt kills

Matthew Gline: And other than that, we'll reserve comment until we unveil the rest in September, but I'm looking forward to it. Of the programs that we've sort of described, you know, I would say the Graves data is coming shortly. We expect both to communicate the Ptolemaic data as well as the development plan for that program. And then the BATO-MG data and CIDP data are coming at the beginning of next year. And we've said clearly and affirmatively that we plan to study in MG. We haven't said exactly what the other indications are yet.

Speaker Change: Until we unveil the rest in September , but looking forward to it.

Speaker Change: of the programs that we've sort of described i was the grave data is coming shortly and

Unknown Executive: We expect both to communicate the Ptolemaic data as well as the development plan for that program. And then the BATO-MG data and CIDP data are coming at the beginning of next year. And we've said clearly and affirmatively that we plan to study it in MG. We haven't said exactly what the other indications are yet, but I think Immunovamp will paint a fulsome picture of that relatively soon. But my expectation, to be clear, is for phase three studies for some of those programs.

Matt Klein: If you come again, the big event, the atopic limititis label expansion, hopefully coming at the end of this year. And then, you know, by the end of the fiscal year data from the total map, in my graphic, as we talked about, as well as data from the period one of the face to be study in CIDP. And then by the end of especially your initiating 405 cancer or transfer program that's important or two, all of which we together with the National Report, speaking more about in the near future.

Speaker Change: we expect both to communicate the to of that dataas well as it developed plan for for that program and then the battle mg data begat coming next year and we' said clearly affirmly that we've study j

Matthew Gline: I think, in the event, we'll paint a fulsome picture of that relatively soon. But my expectation, to be clear, is the phase three studies for some of those programs. Again, we expect at least three INDs by the end of this year; all of those INDs will be for registrational sort of phase two to three kind of programs. And so I would expect at least three of these studies to, in essence, have begun by the end of this year and the other two in the first quarter.

Speaker Change: We haven't said exactly what the other indications are yet. I think we'll paint a fulsome picture of that relatively soon. But my expectation, to be clear, is...

Unknown Executive: Again, we expect that three IMDs by the end of this year; all of those IMDs will be for registrational sort of phase two to three kind of programs. And so I would expect at least three of these studies to have begun by the end of this year and the other two in the first quarter. Thanks, Yaron.

Matt Klein: So finally, before I wrap up, this relatively quick update on slide 22, just a financial update. I think overall a pretty normal order for us from a finance perspective. We actually had that income this year, this quarter of $57 million, that revenue is of $55, including product revenues is set up by 18 expenses sort of within our circle bounds. We ended, we ended a quarter with $5.7 billion cash and cash equivalence, that sort of reflects the, that reflects the sum become what we purchased that we have made in April, I want to say, of less quarter. And then the carrying value or debt has come down a bit, thanks to the re-association that we have done at Durant, and you can see shares outstanding on the slide as well about $7.9 million.

Speaker Change: The phase three studies for some of those programs, again we expect at three IMDs by the end of this year, all of those IMDs will be for registrational phase two to three kind of programs, and so I would expect at least three of these studies to in essence have begun by the end of this year, and the other two in the first quarter.

Speaker Change: that

Speaker Change: bl

Louise Chen: Our next question comes from Louise Chen of Canter. Your line is open.

Speaker Change: Thank you.

Louise Chen: Hi, thank you for taking my questions here. I just had two for you. The first one I wanted to ask you is, if the launch of FCRM is a possibility just for Roivant to do on its own, is that on the table? And then, secondly, just curious about the market opportunity for Futama and AD and how you're preparing for the launch of this product at the end of this year. Thank you.

Speaker Change: Our next question comes from Louise Chen of Canter, your line is open.

Louise Chen: Hi, thank you for taking my questions here. I just had two for you. The first one I wanted to ask you is,

Louise Chen: If the launch of FCRN is a possibility just for Roivant to do on its own, is that on the table? And then secondly, just curious on the market opportunity for Futama and AD and how you're preparing for the launch of this product coming at the end of this year. Thank you.

Matt Klein: So with that, I will wrap up the presentation board for this on slide 24, you can see that we have a pretty exciting catalyst calendar coming up with, frankly, a pretty rich couple of months ahead between the unveil of the new program, I continue work on the BD side and data coming from total math and from the event generally in the coming months. So really looking forward to getting together, when I'm sure we'll be multiple times in the next few months, talk about those updates and to continue to see this all.

Matthew Gline: On the first question, I'll say we are certainly aware of Once Upon a Time, a small biotech company that launched an NTF-stern engine body on its own and met some success doing so. And so it certainly seems possible to do that ourselves. And look, I think that has been an exciting outcome. I think as the class presents itself, the breadth of the opportunity is wide. And so I think we're going to do what maximizes the value of that opportunity for us. And beyond that, all things are on the table.

Louise Chen: yeah

Unknown Executive: Once upon a time, a small biotech company launched an NTFs or an antibody on its own and met some success doing so. And so it certainly seems possible to do that ourselves. And look, I think that has been an exciting outcome. I think as the class presents itself, the breadth of the opportunity is wide. And so I think we're going to do what maximizes the value of that opportunity for us. And beyond that, all things are on the table. Thank you. Those are both great questions. I appreciate it.

Speaker Change: On the first question, I'll say we are certainly aware of a

Speaker Change: Once upon a time, a small biotech company that launched an NTF-stern engine body on its own and met some success in doing so.

Speaker Change: And so it certainly seems possible to do that ourselves, and look, I think that has been an exciting outcome. I think as the class presents itself, the breadth of the opportunity is large, and so I think we're going to do what maximizes the value of that opportunity.

Operator: And with that, I will wrap up the presentation for the morning. Thank you again for listening, and I'll hand it back to the operator for Q&A. Thank you, as a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again.

Speaker Change: for us. And beyond that, all things are on the table.

Matthew Gline: On the camera and AD, look, I think there's a couple of things. One is, and probably most importantly, looking for prescribers who are not currently in front of them. Allergists, pediatric allergists, pediatric dermatologists are really hitting hard in peds, where we'll be alone at launch among novel topicals. So I think that's certain that that prep is important. And then looking, taking a hard look at our existing Salesforce targeting and making sure that we're covering all the right docs for the opportunity and getting our messaging exactly right to those docs, especially, frankly, because, look, I think the story in AD is a little bit different than the story they're used to seeing in psoriasis, right? I think the pediatric population is different.

Speaker Change: on the camera on a look i think there's a couple of things one is very most importantly

Operator: Please stand by while we compile the Q&A roster one moment.

Speaker Change: Looking for the prescribers who we're not currently in front of. Allergists, pediatric allergists, pediatric dermatologists really hitting hard in PEDS where we'll be alone at launch among novel topicals, so I think that's

Allison Bratzel: And our first question comes from Allison Brett Cell of Piper Sandler, you're lying is open.

Matt Klein: Hey, good morning. Thanks for the update, Matt, and thanks for taking the question. Just one for me on private, now that you've met with FDA on BREPO and NIU, I guess what has left to be worked out or decided on the phase 3 design? I think you've given some high level guidance looking for 300 to 350-ish patients in a protocol, basically as close to an opportunist possible. I guess just high level, is that still the case?

Speaker Change: I'm sure that that prep is important. And then looking, taking a hard look at our existing salesforce targeting and making sure that we're

Speaker Change: Covering all the right docs for the opportunity and...

Unknown Executive: and getting our messaging exactly right to those docs, especially, frankly, because

Matthew Gline: The safety, the tolerability profile, I should say, of the drug is even better in the AD data set. I think the quality of our data in AD is differentiated to an even greater degree relative to some of the other novel topicals than it is in psoriasis. And so I think we need to, you know, we need to get that across. Itch, for example, is a major symptom in AD. It's acute. Our itch data is very, very good.

Unknown Executive: Look, I think the story in AD is a little bit different.

Speaker Change: Than the story they're used to seeing in psoriasis. I think the pediatric population is different. The tolerability profile, I should say of the drug,

Speaker Change: even better in the agen data set i think the quality of our data in a is

Matt Klein: And is any of this protocol design dependent on the 52-week readout later this year? And then just I guess on that longer term follow-up, what would you view as an outcome that reinforces your view on the opportunity and UVIS? Thanks. Yeah, sure. Thanks.

Unknown Executive: differentiated to an even greater degree relative to some of the other novel topicals.

Speaker Change: then it is in seriaassistandso i think we need to going to get that pro for example isas a major sympimtoity it's a cute data is very very good and think we will be making sure to highlight that so i think itre trying to get med with all that right make we talking to theright to make sure we're pecially vering the duct or not

Matthew Gline: And I think we'll be making sure to highlight that. So I think really trying to get messaging with all doctors right, make sure we're talking to the right doctors, and make sure we're especially covering the doctors who are not kind of overlapping with the psoriasis doctors, so we're sort of ready to get out in front of those as soon as we get the nod from FDA. Thank you. Those are both great questions. I appreciate it.

Matt Klein: So, first of all, extremely constructive interaction with FDA. I think they are really excited to see a new opportunity in NIU, which is a disease that really needs to be studied. I think we feel, I think we feel good about what I've had it. I'd say the previous guidance we gave was largely in line with what we expect to see. And I think we got just about everything really needed to make that program a success.

Speaker Change: kind of overlapping with the psoriasis docs that we're ready to get out in front of those as soon as we get the nod from FDA.

Unknown Executive: Thank you. Those are both great questions. Appreciate it.

Unknown Executive: Thank you.

Yatin Suneja: Our next question comes from Yatin Suneja of Guggenheim. Your line is open.

Yatin Suneja: Yeah, thank you for taking my question. Maybe just one more on Vitama, specifically on the psoriasis side. I mean, if you look at the past, I would say four, five quarters, you are in that, you know, 18 to 20 million range on a quarterly basis. What does that imply about the overall market opportunity? What can you do to sort of re-inflect sales in psoriasis? I understand atopic dermatitis could give a lift, but just in psoriasis, I was just curious, you know, how you view the market, and what sort of peak sales you are assuming? Thanks.

Speaker Change: our next question comes from yach' nature of googenham your line is open

Matt Klein: So really at this point, small tweaks, but just get me study up and running and we'll be able to provide a whole description of it pretty soon here, honestly. And then I think basically none of the sudden design hinges on the 52-week data, although obviously we saw something surprising. We were closely at it. And I think I don't think there's anything in particular we're looking for 52 weeks to reinforce the program other than continuing strong benefit patients, which given the quality of the totally data we certainly expect. Thank you. Thanks for the great question. Thank you.

Speaker Change: Thank you for taking my question. Maybe just one more on Vitama, specifically on the psoriasis side. If you look at the past, I would say four or five quarters, you are in that 18 to 20 million range on a quarterly basis.

Speaker Change: What does that imply about the world market opportunity? What can we do to sort of re-inflect sales in psoriasis? I understand atopic dermatitis could give a lift, but just in psoriasis, just curious.

Matthew Gline: Yeah, so thanks. It's a good question.

Speaker Change: You know how you view the market, what sort of peak sales you are assuming. Thanks.

Speaker Change: yeah so thanks it's a good question first of all say i continue to be pleased with how how we're set up on became o is to say things cre gives us no credit for it so i thinkit' all upside fromhere which is always nice anice place to be like i think on the

Corinne Jenkins: Our next question comes from Corinne Johnson of Goldman Tax, your line is open. Hey, good morning, team. This is Craig on for Corinne.

Matt Klein: So, following the completion of Enrollment of the Valor Study, can you kind of outline how the final enrollment compares to your original expectations and maybe walk us through some powering assumptions there? Yeah, sure. A couple of things. One is the actual number base to be enrolled at 241 was a little bit higher than our original plans for the study originally it had been 225. So, we feel extremely well-powered. I don't have a lot to say on like baseline characteristics of dental graphics right now.

Matthew Gline: First of all, I'll say, I continue to be pleased with how we're set up on decamo, which is to say, the industry gives us no credit for it. So I think it's all upside from here, which is always a nice, nice place to be. Look, I think on the sort of tracking the progress as it were, as I said in my prepared remarks, I think the sort of mechanical sales number probably understates the progression in the sense that we've had a little bit of, just like, noise around gross to net that we expect to climb out of from here.

Unknown Executive: on the sort of tracking the progress, as it were, as I said in my prepared remarks. I think the.

Unknown Executive: The sort of mechanical sales number probably understates the progression in the sense that we've had a little bit of, like, noise around gross to net that we expect to climb out of from here. And volumes are actually building, as you know, people have been asking us about the supposed flattening of this curve for a while. We're up 20% for volumes versus the same quarter last year and continuing to grow every quarter.

Unknown Executive: The sort of mechanical sales number probably understates

Unknown Executive: the progression in the sense that we've had a little bit of like

Unknown Executive: did

Matthew Gline: And volumes are actually building. You know, people have been asking us about the supposed flattening of this curve for a while. We're up 20% from a volumes perspective versus the same quarter last year and continuing to grow every quarter. You know, I think as GTN climbs, as GTN normalizes, that sort of base that we've been building month in, month out, quarter in, and quarter out from a volume perspective will continue to work for us.

Unknown Executive: they

Unknown Executive: Noise or ungrossed net that we expect to climb out of from here and volumes are actually building You know, people have been asking us about the supposed flattening of this curve for a while

Unknown Executive: You know, I think as GTN climbs and as GTN normalizes, that sort of base that we've been building month in, month out, quarter in, a quarter out from a volume perspective will continue to work for us. And I still have hope that over time, there will be some real compounding effects there that doctors that like the product, the doctors that write the product, will continue to write it more and more. So I do think psoriasis has the potential to be very meaningful over time, but it's been a little bit of a slower burn.

Unknown Executive: We're up 20% from a volumes perspective versus the same quarter last year and continuing to grow every quarter. You know, I think as GTN climbs, as GTN normalizes, that sort of base that we've been building month in, month out, quarter in and quarter out from a volume perspective will continue to work for us.

Matt Klein: I think we're perfectly happy with the patients that we've enrolled and we think it sets us up well. You know, I guess the other comment I'll make with a shout out to the private team is, the end is an incredibly difficult indication in which to develop drugs. These patients are hard to find and frankly are experiences that the the key is a lot of work with the sites. So, we spend a lot of time out about talking to investigators trying to get out there in the field to make sure that we have we have what we needed.

Matthew Gline: And I still have hope that over time, there will be some real compounding effects there. The doctors that like the product, the doctors that write about the product, will continue to write about it more and more. So I do think psoriasis has the potential to be very meaningful over time. It's just been a little bit of a slower burn. And I think that the thing about AD is it's got the potential to be a like an inflection of a different sort, which is a much larger patient population with a set of data that we can use easier facially to see the differences versus our peers. And I'm so excited for that launch. Thank you very much.

Unknown Executive: And I still have hope that over time, there will be some real compounding effects there, the docs that like the product, the docs that write the product.

Unknown Executive: We'll continue to write it more and more. So I do think...

Unknown Executive: And I think that the thing about AD is, it's got the potential to be a like an inflection of a different sort where there is a much larger patient population with a set of data that we can use easier facially to see the differences versus our peers. And I'm so excited for that one.

Unknown Executive: psoriasis has the potential to be very meaningful over time. It's just been a little bit of a slower burn. And I think that the thing about AD is...

Speaker Change: it's got the potential of the a like the inflection of a different sort which' a much larger patient population with a set of data that we can dothis through easier faciility to see the differences versus our peers and so excited for that launch as well

Matt Klein: And so, yeah, I'm very proud of the effort there. I'm proud of how quickly that study was able to get to fully enrolled and looking forward to sharing that data with the elderly. So, largest data, as I said earlier, to the MDM state. Thanks for the question on the end.

Unknown Executive: Thank you very much.

Douglas Tsao: Our next question comes from Douglas Tsao of H.C. Wainwright. Your line is open. Douglas, your line is open.

Matt Klein: Of course, just one more if I may. Could you just remind us of what you're looking for in terms of a go and no go decision for the phase two in the middle map data coming relatively soon? We haven't so thanks yet. Look, I think we haven't articulated like a simple straightforward bar. And I think the truth is that circuitosis is one of these diseases where there's not a lot of other food mechanisms.

Unknown Executive: Our next question comes from Douglas Tsao of H.C. Wainwright. Your line is open.

Unknown Executive: Douglas, your line is open. Hi, good morning. Thanks for taking the questions. Matt, you know, I think from a business development standpoint, you have largely focused on

Matt Klein: There's where it's sick with the disease. So, I don't think the the I think the bar is meaningful. I think the bar is if the study works, certainly worth progressing, you know, as with all phase two trials, we're going to know with the quality of the data and know what we'll think about what else is on our plate. We're also looking for yet consistency across not just the primary, but across a few second. There is a bunch of different ways that people look at the treatment of chocolate patients. Thank you. Got it. Thank you guys. Thank you.

Speaker Change: Pulling individual assets out just given the sort of ongoing status and biotech Does it ever change that you become more focused on looking at potentially acquiring companies?

Matthew Gline: We are back. Generally, just agnostic to the form in which great programs come our way. And so I think. Whether it's a company, whether it's an asset, I don't know that that's like the dividing line for us versus what are we getting, and is there value there?

Unknown Executive: We are back, generally just agnostic to the form in which great programs come our way. And so I think I think a lot of what we are focused on right now. I'd say the vast majority of what we're focused on right now is stuff that's in clinical development. And so when we talk about companies versus assets, I don't think it matters so much whether it's a company or an asset, but we're mostly going to be looking at companies that have clinical stage or development stage programs. Thank you. Great

Unknown Executive: four

Unknown Executive: we are by

Unknown Executive: generally just agnostic to the form in which great programs come our way and so I think

Matthew Gline: And what do we think we can do something that matters? But that's why you're going to need to get into that. I think you've got it. Yes. So I think the answer to that question is, we've always sort of been indifferent to that. I think there's I guess the only thing I'll say is, I think a lot of what we are focused on right now. I'd say the vast majority of what we're focused on right now is stuff that's in clinical development.

Unknown Executive: Whether it's a company, whether it's an asset, I don't know that that's like the dividing line for us versus what are we getting and is the value there? And what do we think we can do something that matters with it?

Unknown Executive: Yes, so I think the answer to that question is, we've always sort of been indifferent to that. I think there's, I guess the only thing I'll say is like,

Brian Chen: Our next question comes from Brian Chen of JP Morgan. Your line is open. Hey guys. Good morning. Thanks for taking out questions. Many sources with the reason so often the market just doesn't make it easier or harder for you to find a new asset. Does it change the way how you negotiate? Thanks. Thanks Brian for the great question. I will hand over to my you but the short thing I'll say is we look we work with a wide range of different perspective partners.

Unknown Executive: I think...

Unknown Executive: a lot of what we are focused on right now i say the vast majority but we're foc on right now you stuff ' in phinitical development and so when we talk about companies versus assets i it matter so much whether it's company asset but but 're also going to be looking at company that global age course development saage programce

Matthew Gline: And so when we talk about companies versus assets, I don't think it matters so much whether it's a company or an asset, but we're mostly going to be looking at companies that have clinical stage or development stage programs.

Brian Chen: They are affected by varying degrees to the financial markets, but mostly we're focused on getting great opportunities at prices that we're excited about, but may look what would you say to the question about the sell-off. Yeah, look, I think the short answer depends, but I think I don't have too much more to add to what matters in. Thanks, my dear. So, Brian, I think the short answer, the other piece of this that sort of the question behind the question is, Will you really excited with what we see in the world and will look forward to doing the right deal with the right time?

Matthew Gline: Development Stage Program

Unknown Executive: Development Stage Programs

Matthew Gline: Thank you, Patrick. Great.

Unknown Executive: Thank you, everybody.

Unknown Executive: Our next question comes from Andy Chen of Wolf Research. Your line is open.

Andy Chen: Our next question comes from Andy Chen of Wolf Research. Your line is open.

Speaker Change: Our next question comes from Andy Chen of Wolf Research. Your line is open.

Andy Chen: Good morning. Thank you for taking the question. One more question about Vitama. Can you talk about specifically how you view competitive dynamics between you and your competition, such as Arcutis and Insight? Which patients do you think are going to prefer which product? And then, on a related note, in your pre-approval engagement work with PBMs, do you foresee getting hit on gross to net if they prefer your competition? Thank you.

Andy Chen: good morning thank you for taking the question one more question about gua

Speaker Change: Can you talk about specifically how you view competitive dynamics between you and your competition?

Speaker Change: Such as our Q and A's and insights. Which patients do you think is going to prefer which product?

Speaker Change: and then on a related note and your preapproval engagement work with pbm to you foresee getting h on gross the net if they prefer your competition thank you

Matthew Gline: Thanks, Andy, those are good questions. And I want to give you special thanks because I think the analysts who come late in the rotation on these calls have a lot of work to do. So I appreciate the thoughtful question late in the morning.

Unknown Executive: that

Andy: Thanks, Andy. Those are good questions and I want to give you a special thanks because I think the analysts who come late in the rotation on these calls have a lot of work to do. So appreciate the thoughtful question late in the morning. Look, on the first question...

Matt Klein: Okay, maybe just, you know, one question on Volcano 2, I guess, you know, just a while, I just want to get a better sense of how you're thinking around this aspect. As we think through the ten indications that you're lining up for, you know, through the next fiscal year. And, and you talk about a lot about the range of themes that upwards up opportunities that you have laid out in your slides actually.

Matthew Gline: Look, on the first question. The key thing about these markets, which we've said from the beginning, is the competition is not other novel agents; the competition is steroids. There are many, many, many steroid scripts written. And the challenge is in changing well-ingrained doctor behavior. I don't think in general, it's like for the median psoriasis or the median AD patient. It's like, oh, some doctor is sitting there and carefully thinking about the attributes of Zorin versus Absalora versus Vitama and deciding on a patient by patient basis to give one or the other.

Speaker Change: The key thing about these markets, which we've said from the beginning, is the competition is not other novel agents. The competition is steroids. There are many, many, many steroid scripts written.

Matt Klein: So how do you pick and choose the different areas? And I think most importantly is how you get credits for it in front of investors. Because it seems that investors today are very fixated on MG and ZITP. So in other words, how do you intend to get credits for the push 1402 into uncharted indications?

Speaker Change: and challenge is in changing well and brain do behavior

Speaker Change: I don't think, in general, it's like for the median psoriasis or the median AD patient, it's like, oh, some doc is sitting there and carefully thinking about the attributes of Zori versus Apsaloro versus Vitama and deciding on a patient-by-patient basis to give one or the other.

Matt Klein: And then maybe just one last one, you know, more like a housekeeping one. What is the data? You know, what is the cadence of call as flow in the fall? Because, you know, we're going to get face to asset unveiling in September, Grace Plan also unveiling for human awareness cycle doses data coming out. So what's the cadence of data flow? Thanks. Thanks, Brian. All of great questions. Well, the 1402, I think the, the anodine answer that's also true is, obviously, the biggest factor of the philanthropic and choosing indications of the quality of the biology, the size of the unmet need.

Matthew Gline: I think the key point is getting doctors comfortable that they have things to reach for. You know, there are differences. In AD, for example, we would hope for a label all the way down to AD2. I think our competitors don't have labels that cover that.

Speaker Change: I think the key point is getting docs comfortable that they have things to reach for. You know, there are differences. In AD, for example, we would hope for a label all the way down to A2. I think our competitors don't have labels that cover

Unknown Executive: Unknown Speaker Anything like quite that young, you know, so I think there are opportunities to address patient populations that are different there. You know, I think the once-a-day application and AD are probably helpful, the consistency of formulation, the fact that it's a single concentration, whereas at least one of our competitors has a couple of different concentrations going to be on the market. I think those things are all helpful.

Matthew Gline: David Risinger, Andrew Baum, Louise Chen, Douglas Tsao, Allison Bratzel, Mayukh Sukhatme, Richard Pulik, Gao Chen, Craig McLean, Roivant Sciences

Unknown Executive: And if you like quite that young, you know, so I think there are opportunities to address patient populations that are different there. You know, I think the once a day application in AD is probably helpful. The consistency of formulation, the fact that it's a single concentration, whereas at least one of our competitors has a couple of different concentrations going to be on the market. I think those things are all helpful.

Speaker Change: but it's not

Matt Klein: Where we can be competitively positioned, you know, cost and risk kind of trade-offs. Like those are actually like the main factors that go in. I say a couple of things about a 1402 that I find exciting, or about the S&L landscape, and I just may want to jump in also. You know, on that, on, you know, one of the things that we've said over and over again about FCRM is that anyone's face to study is everyone's face to study.

Unknown Executive: But it's not about segmenting versus the other novel topicals, per se. That's not sort of a major challenge, mostly. And on the sort of...

Speaker Change: PDM side, I think the short answer is commercially insured patients should have coverage for VITAMA under our current managed care agreements. So I don't expect any super significant changes in the GTN or commercial dynamics on AD approval, which is a great question. Thank you.

Matt Klein: That goes both ways. It means that we need to be careful about what we put our data out. But it means that once you know what the depth of life, each expression does, in a patient population, you really be front of the pack. And so I think we're looking at indications where we can be in the front of the pack, where we can get out there commercially and, and sort of be neck and neck with them.

Unknown Executive: Thank you. Thank you. This concludes the question and answer session. I would like to turn it back to Matt Gline for closing remarks.

Speaker Change: Thank you everybody. Thank you to all of our analysts for the great questions. Thank you everyone for dialing in for a relatively quiet quarterly update. I'm looking forward to getting back on the phone in the coming weeks with some other things to share. And thanks to the Roivant team, thanks to those folks actually doing this fellow trial, thanks to all the patients and investigators who trust us and work with us, and we will talk to you very soon. Have a great day.

Matt Klein: And hopefully with deeper IGG suppression, so I think that's obviously a factor. But what it's worth, we also think MG is a really big opportunity. We also think the IGP is a big opportunity. And as a reminder, we're generating a minimal data set, an MG with a total amount, that will underscore and get to the most better question just in the coming months. So I think there's, there's a lot to sort of focus on there even before my topic.

Speaker Change: This concludes today's conference call. Thank you for participating and you may now disconnect.

Matt Klein: We focus on existing commercial indications. And yeah, that you hit most of the point, Matt. I just like the way brand that you bring the question, which is, all right, people are focusing on the MG and TADP and everything else basically is upside. That's right. Yeah, I think that's really what it put up.

Matt Klein: And in terms of cadence of catalyst flow, what we have a busy call in six to seven months ahead here. I say, September will be a busy month. And then the moment that data comes later, later this fall. And then I think we've said MG will come kind of early next year. And GPP and TADP kind of will put probably a little bit there after. So I guess that's what the sort of really important looks like. I think that obviously, shortly, I'm going to know that. We're looking at the, and beyond. Thank God. Great. Thanks, Brian.

Matt Klein: Thank you.

Dave Risinger: Our next question comes from Dave Risinger of Learing Partners. Your line is open. Thanks very much and thanks for all the updates. So I have two questions please. First, could you provide more color on the LNP litigation, including the event path ahead? And then second, could you discuss external transaction prospects, including the size potential of deals that you're looking at? Thanks very much. Yeah, sure. Thanks Dave. Both great questions.

Matt Klein: So on the LNP litigation, again, there's not that much that we're generally able to say about an ongoing litigation but in terms of what's coming. So we're in discovery now. And as I mentioned on the call, that process is going to continue. We hope for a few more months. We together with modern on our view this in Genevieve and asked for a moderate extension of that process to get answers to a few of the outstanding questions.

Matt Klein: So I think that's the sort of next thing here and then that calendar, there's a call of the judge in the next few weeks to get that approved. But if that calendar is approved, it would have summary judgment happening kind of in the beginning portion of next year followed by a trial a year from now. So a little bit later than the most recent version of the calendar, but for good reason, instigated by our side.

Unknown Executive: On external transaction projects, I guess I'll hand over my to answer that question straight from the source. Sure.

Unknown Executive: Hi, Dave. Thanks for the question. So I think we have we have carefully avoided, I think getting bucketed whenever sort of sort of asked, I think that that continues, I think. So I would think about size of size of opportunity, I think that we're looking at. We really think about this, I think you know Dave, as a portfolio, and so there's going to be 180 in any one deal, but I think, you know, overall, I think obviously our arc.

Unknown Executive: So I think about things kind of on a deal by deal basis, really through that investment, that's a good investment. But then over sort of the surface area of all those deals, we're looking to move the needle on on our enterprise overall. The only idea is because we get the question sometimes, and I'm always surprised when I get it, I think we are a very unlikely buyer of multi billion dollar public companies.

Unknown Executive: I think we are stingy by nature and are looking for places where we can spend more than dollars and funnable development. So we are never saying ever company, but I think that's just true about who we are.

Dave Risinger: Thanks Dave. Thank you.

Dennis Ding: Our next question comes from Dennis Ding of Jeffries, your line is open. Like a morning, thanks for taking our questions to from me. So maybe if we can revisit sarcoid doses briefly, correct me if I'm wrong, but previously you may have characterized the face to a potentially registration. Can you reiterate that and see if and the confirmed that's true? And maybe talk a little bit about the path for that data is positive.

Dennis Ding: And then number two around off backs. I mean, given him you know, we'll start a bunch of new trials in the next few years. How do you think your effects will evolve during that time? Thank you.

Matt Klein: That's a great set of questions. Look, we are on circuitosis. The truth is, it's a phase two study. It's 100 patients. It's certainly large enough to serve as at least a pivotal study if successful. And obviously, medication with high on that need. So depending on the quality of the data, there's always a conversation to have with the regulators. But then I think our expectation is that it's a phase two study and we even have a program behind it in basically all scenarios. And we're just excited to be developing in the disease. There are no approved agents outside of steroids. So the only thing that is really significant.

Matt Klein: And the next question. Look, I think the short answer to the question on its face is given the movement to starting a number of fiddle studies, I would expect their ethics to increase. I don't have super specific financial guidance right now to offer the cost of a phase three program for next year. Our end of general has ranged from call it $820 million dollars. And so, you know, over the life of those programs, I think those are like reasonable estimates, plus overhead and personnel and stuff like that.

Matt Klein: So you know, I'd expect burn to go up, go up there over time. Obviously, you know, if you look at some of our competitors, I'd say like there are any expenses, maybe useful, but, but a big piece of the cost to your ultimately ones that come in as you get closer to a commercial launch. Technology and a perspective as well. And notably, I mean, that is well capitalized right now for the program and we are obviously excited to be a good part of that.

Matt Klein: Great. Thank you.

Yaron Werber: Our next question comes from year and rubber of TD Cal and your lawn is open. Great. Thanks for taking my question. I have a couple. Maybe just the first one. We started getting questions and I think you highlighted now that you're planning on unveiling your recently in license phase two program in September. Is there anything you can unveil a little bit today? Just indication or how big is the study? Is it a randomized study?

Yaron Werber: Is it just an open label study? Is there been other studies with this mechanism in whatever indication you're examining? And then maybe just secondly, so it sounds like GMG and CIDP will start phase three, let's say Q1 potentially with 1402. For the other three, is it sort of Graves, Schoengrins and maybe Ted? Is that sort of the order? Thank you.

Matt Klein: Thank you, Ron. On the other side of that, we're weeks away. So I think I'm going to mostly reserve comment other than to reiterate some things we've already said. I mean, first of all, obviously we're excited about the program. There is clinical data to share when we release the program that clinical data. I think it is useful and people will find it informative. And there is a competitor program. There's another program of the same mechanism being studied by a big foreign company to different indication, we've said that publicly before.

Matt Klein: And other than that, other than that, reserve comment until until we unveil the rest of September, but looking forward to it, of the programs that we've sort of described. You know, I was going to say the Graves data is coming shortly. And we expect both the communicator to talk about data as well as a development plan for that program. And then the battle MG data and see how to pick it or come into the next year and we've said clearly in a firm that we've studied in MG. We haven't said exactly what the other indications are yet.

Matt Klein: I think a bit of that. We'll paint a closer picture of that relatively soon. But my expectation to be clear is the phase three studies for some of those programs. Again, we expect a three IMDs by the end of this year. All of those IMDs will be for registrational sort of phase two to three kind of programs. And so I would expect that we three of the studies to in essence have begun by the end of this year and the other two in the first quarter. Thank you.

Louise Chen: Our next question comes from Louise Chen of Cantor. Your line is open. Hi, thank you for taking my questions here. It's had two for you. So the first one I wanted to ask you is if the launch of FCRN is a possibility just for Royal Man to do on its own. Is that on the table. And then secondly, just curious on the market opportunity for vitamin AD and how you're preparing for the launch of this product coming at the end of the year. Thank you.

Matt Klein: On the first question, I'll say we are certainly aware of a once one time small biotech company that launched an empty of certain antibody on its own and that some success is doing so. And so it certainly seems possible to do that ourselves. And look, I think that has been an exciting outcome. I think as the class presents itself, the breadth of the opportunity is large. I think we're going to do what maximizes the value of that opportunity for us. And beyond that, all things are on the table.

Matt Klein: On the camera and AD look, I think there's a couple of things. One is, and probably most importantly, looking for the prescribers who were not currently in front of. [inaudible] I think the story in AD is a little bit different than the story they're used to seeing in psoriasis, right? I think like the pediatric population is different. The safety, the tower ability profile, say, and the drug is even better in the AD data set.

Matt Klein: I think the quality of our data in AD is differentiated to an even greater degree relative to some of the other novel topicals than it is in psoriasis. I think we need to get that across. The age, for example, is a major symptom in AD. It's acute. Our age data is very, very good. And I think we'll be making sure the highlight that so I think you're really trying to get messaging with all docs, right?

Matt Klein: Make sure we're talking to the right docs and make sure we're especially covering the doc to or not. Kind of overlapping with the psoriasis docs that we're sure ready to get out in front of those soon as we get the amount from FDA. Thank you. There's a lot of great questions for you. Thank you.

Yatin Suneja: Our next question comes from Yatin Suneja of Guggenheim. Your line is open. Yeah, thank you for taking my question. Maybe just one more on the Tama, specifically on the Sarisit side. I mean, if you look at the past, I will say four, five quarters. You are in that, you know, 18 to 20 million range on a quarterly basis. And what does that imply about the overall market opportunity? What can you do to sort of re-influx sales in Sarisit?

Yatin Suneja: I understand a top dermatitis could give a lift, but just in Sarisit, just curious, you know, how you read the market, what sort of peak sales you are assuming. Thanks. Yeah, so thanks. It's a good question.

Matt Klein: First of all, I'll say, I continue to be pleased with how, how we're set up on the Tama, which is to say, I think the street gives us no credit for it, so I think it's all upside from here, which is always a nice place to be. Look, I think on the, on the sort of tracking the progress, as it were, as I said in my spare remarks, I think the sort of mechanical sales number probably understates the progression in the sense that we've had a little bit of like noise around gross tenets that we expect to climb out of from here.

Matt Klein: And volumes are actually building. You know, and people have been asking us about the supposed flattening of this curve for a while, we're up 20% for volume perspective versus the same quarter last year and continuing to grow every quarter. You know, I think as GTN climbs as GTN normalizes that sort of base that we've been building month in, month out, quarter in, quarter out from a volume perspective, we'll continue to work for us.

Matt Klein: And I still have hope that over time there will be some real compounding effects there, the docs that like the product, the docs that write the product, we'll continue to write it more and more. So I do think psoriasis has potential to be very meaningful over time. It's been a little bit of a slower burn. And I think the thing about AD is it's got the potential for VA, like the inflection of a different sort, which is a much larger patient population with a set of data that becomes easier facial to see the differences versus our peers. And so excited for that launch as well.

Matt Klein: Thank you very much. Thank you.

Douglas Fowl: Our next question comes from Douglas Fowl of HC Wainwright. Your line is open. I want to thank you for taking the questions.

Matt Klein: Matt, you know, I think through business development standpoint, you have largely focused on pulling individual assets out, just given the sort of ongoing status and biotech, does it ever change that you become more focused on looking at potentially acquiring companies? We are generally just agnostic to the form in which great programs come our way. And so I think whether it's a company, whether it's an asset, I don't know, that's like the dividing line for us versus what are we getting and is the value there and we think we can do something that matters, but that's what you're getting into that.

Matt Klein: So I think the answer that question is, we've always sort of been indifferent to that. I think there's, I guess, the only I think a lot of what we are focused on right now, I say the vast majority of what we're focused on right now is stuff that's in clinical development. So when you talk about companies versus assets, I want to get matter so much whether it's company or asset, but what's going to be looking at companies that have clinical stage development stage programs. Thank you very.

Matt Klein: Great.

Matt Klein: Thank you.

Andy Tannep Wolf: Our next question comes from Andy Tannep Wolf, research. Your line is open. Good morning. Thank you for taking the question. One more question about Vitaama.

Matt Klein: Can you talk about specifically how you view competitive dynamics between you and your competition, such as archaeologists and insights, which patients do you think is going to prefer which product. And then on a related note and your pre-approval engagement work with PVMs, do you foresee getting hit on growth in that if they prefer your competition? Thank you. Thanks Andy. Those are good questions and I want to give you a special thanks because I think the animals to come late in the rotation on these calls have a lot of work to do.

Matt Klein: So appreciate the thoughtful question late in the morning. On the first question, the key thing about these markets, which we've said from the beginning is the competition is not other novel agents, the competition is steroids. There are many, many, many steroids scripts written and challenge is in changing well and bring back behavior. I don't think in general, it's like for the median psoriasis or the median A.D, patient. It's like, oh, some doc is sitting there and carefully thinking about the attributes of Zorae versus Abselora versus Vitaama and deciding on a patient vacation basis to give one or the other.

Matt Klein: I think the key point is getting docs comfortable that they have things to reach for. But you know, there are differences in A.D, for example, we would hope for a label all the way down to A.2. I think that we don't have label that cover anything like quite that young, you know, striving to opportunities to address patient populations that are different there. You know, I think that the once a day application in A.D, is probably helpful, the consistency of formulation.

Matt Klein: The fact that it's a single concentration, whereas at least one of our competitors has a couple of different concentrations to be on the market. I think those things are all helpful. But it's not, but it's not it's not about like segmenting versus the other novel top of goals per day. That's not certain major challenge mostly. And I'm a sort of PDM side. I think the short answer is commercial insert patient should have covered for Vitaama under our current match here. So I don't expect any super significant changes in the GTN or commercial dynamics on A.D, approval, which is great question. Thank you. This concludes the question and the answer session.

Matt Klein: I would like to turn it back to Matt Glign for closing remarks. Well, yeah, thank you, everybody. Thank you to all of our analysts for the great questions. Thank you everyone for dialing in for a relative. We quite orderly update. I'm looking forward to getting back on the phone in the coming weeks. We've some some other things to share. And yeah, thanks. Thanks to the working team. Thanks to those sorts of activities. Go drown. Thanks to all the patients and investigators who trust us and work with us. And we will talk to you very soon. Have a great day.

Operator: This concludes today's conference call. Thank you for participating and you may now disconnect.