Q1 2024 Roivant Sciences Ltd Earnings Call

Unknown Executive: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the War Events First Quarter Twenty-23 Earnings Conference Call. At this time, all participants are in the LIS in Nonny Mode.

Speaker 2: Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the Royal Events First Quarter 2023 Earnings Conference Call. At this time, all participants are on the list in 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. Thanks for staying by.

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Unknown Executive: you need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference to a guest today. Stephanie Lee, please go ahead.

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Stephanie Lee Griffin: Good morning, and thanks for joining today's call to review Royvans' financial results from the company's first quarter ended June 30, 2020. I'm Stephanie Lane. Presenting today are Matt Klein, CEO of Roiven, and Mayucus Akhan, President and Chief Investment Officer of Royden. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing these updates, on our IOR website at www. Invester.orgment.com.

Speaker 3: Good morning and thanks for joining today's call to review Royvan's financial results from the company's first quarter at June 30, 2023. I'm Stephanie Lave with Royvan. Presenting today, we have Matt Klein, CEO of Royvan, and Mayuk Sukhatme, President and Chief Investment Officer of Royvan. For those dialing in via conference call, you can find the slides being presented today as well as the press release.

Stephanie Lee Griffin: We'll also be providing the current slide numbers as we present them to help you follow along a lot. I'd like to remind you that we'll be making certain forward-looking statements during today's meeting. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward-looking statements and related risks on the With that, I'll turn it over to you.

Speaker 3: I'd like to remind you that we'll be making certain forward-looking statements during today's presentation.

Speaker 3: We strongly encourage you to review the information that we filed with the FCC for more information regarding these board-level statements and related risks and uncertainties.

Matthew Gline: Thank you, Stephanie, and thank you, everybody, for joining us this morning and for listening. It's only been a short, actually, six weeks since our last call because our last call was for the K. So comparatively, a little bit fewer updates, but certainly an exciting quarter ended June 30th and a lot to talk about today. I'm going to give just a brief sort of update on the state of the business as well as an update on the quarter in Vitamac sales.

Speaker 3: And with that, I'll turn it over to Matt.

Speaker 4: Thank you Stephanie, and thank you everybody for joining us morning and for listening. It's only been a short, actually six weeks since our last call, because our last call is for the K. So comparatively a little bit fewer updates, but certainly an exciting quarter end to June 30th and a lot to talk about today. I'm gonna give just a brief.

Matthew Gline: And then actually, what we're going to spend the bulk of our time on today is, we've been getting more questions about repisitinib, and we've actually got some new data there for Crohn's disease, so we're going to share that and talk through again a reminder of sort of how we're thinking about that program as we approach the lupus data in the back half of the year and more beyond. So with that, I'm going to get started, just starting on page five.

Speaker 4: a brief sort of update on the state of the business as well as an update on the corridor in Vitamis sales. And then actually what we're going to spend the bulk of time on today is we've been getting more questions about rep sit-nib and we've actually got some new data there in Crohn's disease. So we're going to share that and talk through again a reminder of sort of how we're thinking about that program.

Matthew Gline: You know, as an overall reminder, we continue to be pleased with the progress we've made in the business. During the 630 quarter, we completed our 10th consecutive positive phase-through trial. That was the adoring two, sorry, during one study, the second study of Econa-topic dermatitis, which we continue to be proud of that track record, which has now led to six FDA-approved products across Roevin and the Sumitomo collaboration. As of 630, we had just under a billion and a half dollars in cash on the balance sheet, which, as we've guided before, comfortably funds us into the second half of 2025, with a lot of clinical data both generated recently and even more coming in the near future.

Speaker 4: As an overall reminder, we continue to be pleased with the progress we've made in the business. During the 6-30 quarter, we completed our 10th consecutive positive phase 3 trial. That was the adoring one study, the second study of vitamins A topic dermatitis.

Speaker 4: which we continue to be proud of that track record, which has now led to six FDA-approved products across Roivin, Dendef, and the Sumitomo collaboration. As of 6-30, we had just under a billion and a half dollars in cash on the balance sheet, which as we've guided before, comfortably funds us into the second half of 2025.

Matthew Gline: And we're very proud of our pipeline at this point. We have what we think is among the strongest I&I pipelines, with, by our estimate, over $15 billion in peak sales potential supported by Vitamma, but also on. a number of critical first and best in class programs behind it. You know, on slide six, and it's funny because this is a relatively, as I said, quiet moment, but 2022 has been, and I expect it will continue to be, an extraordinary year for us as a business. You know, as a reminder, up till now.

Speaker 4: with a lot of clinical data both generated recently and even more coming in the near future. And we're very proud of our pipeline at this point. We have what we think is among the strongest I&I pipelines with, by our estimate, over $15 billion in peak sales potential supported by VTAMA, but also a number of critical...

Speaker 4: first and best in class programs behind it. You know, on slide six, and it's funny because this is a relatively, as I said, quiet moment, but 2022 has been, and I expect will continue to be an extraordinary year for us as a business. And as a reminder, up till now, we're going to be back.

Matthew Gline: In addition to continuing progress on the Vitama commercial launch, and we'll come to that second, we've generated positive data from now both large randomized controlled studies, phase three studies, and atopic dermatitis for Vitamah, which, as we've said before, will support our filing for additional indications there at the beginning of next year, and hopefully, approval, hopefully next year as well. And then we've also now put out two important data sets, one in January and one in June, demonstrating the efficacy and our overall enthusiasm for RBT3101, our TLNA antibody, which has obviously gotten a lot of discussion.

Speaker 4: In addition to continued progress on the VITAMA commercial launch, and we'll come to that in a second, we've generated positive data in now both large randomized controlled studies, phase three studies, and atopic dermatitis for VITAMA, which as we've said before will support our filing for additional indication there at the beginning of next year of approval.

Speaker 4: hopefully next year as well. And then we've also now put out two important data sets, one in January and one in June , demonstrating the efficacy and our overall enthusiasm for RBT3101, our anti-T1A antibody, which obviously has gotten.

Matthew Gline: That program is obviously one of the most important in our pipeline. Now we are currently underway with our phase two crone study and in the midst of preparations for our phase three study and ulcerative colitis, which we will share more detail on in the near future. Also, still coming for the year are two pretty important events.

Speaker 4: a lot of discussion. That program is absolutely one of the most important in our pipeline now. We are currently underway with our phase two Crohn's study and in the midst of preparations for our phase three study in ulcerative colitis, which we will share more detail on in the near future.

Matthew Gline: One, which I expect we'll get some questions on, and I know MUNivant has spoken a lot about recently, is the upcoming single-ascending dose and multiple-sending dose data for IMBT-402, our next generation anti-FCR antibody at Immunivant. Obviously, that data, we think, has the potential to show that we have a best-in-class program there, and we're really looking forward to putting it out. There are a number of other data sets in our FCRN franchise and, sure, more broadly, in the FCR Enfield coming in the near future as well.

Speaker 4: Still coming for the year are two pretty important events. One, which I expect we'll get some questions on, I know immunovans has spoken a lot about recently, is the upcoming single sending dose and multiple sending dose data for IMBT1402, our next generation anti-FCR and antibodies at immunovans. Obviously that data, we think, has the potential to show that we have a...

Speaker 4: best-in-class program there and we're really looking forward to putting it out. There's a number of other data sets in our FCRN franchise and more broadly in the FCRN field coming in the near future as well. And then as I mentioned the topic on which we'll spend the most time this morning is brepositinib. We had that's our dual inhibitor of TIC2 and JAK1 at Pride Event. That program has its what would be one of two registrational studies.

Matthew Gline: And then, as I mentioned, the topic on which we'll spend the most time this morning is prefaceitinib. We had, that's our dual inhibitor of tick two and Jack 1 at Priivant. That program has its, what would be one of two registrational studies in SLE, a phase 2B study, reading out in the fourth quarter of this year, and actually just a lot going on generally there as well. And it's a program that I think is, you're just starting to get some attention, but it's really sort of earlier on people's radar.

Speaker 4: in SLE, a Phase IIB study reading out in the fourth quarter of this year. And actually just a lot going on generally there as well. And it's a program that I think is just starting to get some attention, but is really sort of earlier on people's radar.

Matthew Gline: So all of that is on slide seven in our late-stage pipeline, which, again, we are very excited about in terms of its breadth and in terms of the importance of many of the mechanisms we're working on. And again, there remain programs in that pipeline, like Milanab and RVT 2001, that are earlier stage, higher-stue opportunities that we'll share more about as we get data, which will happen sort of starting at the end of this year with 2001 and beyond within Milanab.

Speaker 4: So all of that situates on slide seven in our late-stage pipeline, which again we are very excited about in terms of its breadth and in terms of the importance of many of the mechanisms we're working on. And again, the remaining programs in that pipeline like Namila Mab in RVG 2001.

Speaker 4: that are earlier stage higher skew opportunities that we'll share more about as we get data which will happen sort of starting at the end of this year with 2001 and beyond within the milanab.

Matthew Gline: So with that, I'm just going to go into a brief update on where we are on GICMA, starting on slide nine. So look, we continue to be very excited about the progress that we are making here. We continue to see monthly scripts increase. We continue to see docs excited. We continue to hear a lot of enthusiasm for our AD data. We continue to make payer progress, as I'll talk about in a moment, and continue to see. improvements in revenue, which is ultimately the bottom line at the moment.

Speaker 4: So with that I'm just going to go into a brief update on where we are on Jitamma starting on slide 9. So look, we continue to be bluntly very excited about the progress that we are making here. We continue to see

Speaker 4: monthly scripts increase, we continue to see docs enthusiastic, we continue to hear a lot of enthusiasm for our AD data, we continue to make payer progress as I'll talk about in a moment and continue to see improvements in revenue, which is ultimately the bottom line at the moment. So we're just very pleased with the growth there. We've got now over 11,500 indie prescribers who have written over 200,000 scripts.

Matthew Gline: So we're just very pleased with the growth there. We now have over 11,500 unique prescribers who have written over 200,000 scripts, which is pretty extraordinary for just over a year on the market. It's a really strong start from our perspective. Um, you know, on slide 10, I just wanted to give a sort of payer update. So we're up to about 130 million lives covered, just a tick under 80% of commercial lives, plus 87 million government lives.

Speaker 4: which is pretty extraordinary for just over a year on the market. It's a really strong start from our perspective.

Speaker 4: You know on slide 10, I just wanted to give a payer update. So we're up to about 130 million lives covered Just a tick under 80% of commercial lives plus 87 million government lives. This is a

Matthew Gline: This is the kind of coverage we dreamed of having maybe 18 months after our launch. This is really exactly where we need to be from a coverage perspective. We are on formulary with all three of the major PDMs.

Speaker 4: The kind of coverage we dreamed of having maybe 18 months after our launch, this is really exactly where we need to be from a covered perspective. We are on formulary with all three of the major PVMs.

Matthew Gline: So we're in good shape from a major PBM perspective. We have four additional National Health Plan formularies. We have made a lot of progress across some of the regional and smaller plans. We are in a great place from a recovery perspective.

Speaker 4: So we're in good shape from major PVM perspective. We have four additional national health plan formularies. We have a bunch of progress across some of the regional and smaller plans. We are in a great place from a coverage perspective. And the other thing I'll say is the significant majority of this coverage obviously has no prior off. That's a little bit of a red herring.

Matthew Gline: And the other thing I'll say is the significant majority of this coverage obviously has no prior history. That's a little bit of a red herring in dermatology where very few drugs are true priors. But most importantly, the majority of it is single step through a steroid with a very easy process for that step to be achieved. And so we feel really good about the strength of our coverage.

Matthew Gline: And we think it's underpinning a successful commercial model. You can see a little bit more about that on slide 11. We did 16.7 million in net revenues for the quarter, which continues to be a solid progression in growth quarter on quarter. I feel good about that growth and expect to continue to see it accelerate with both volume and gross margin improvements in the future. Gross to net was a hair better, with a 26% yield over last quarter.

Speaker 4: for that step to be achieved. And so we feel really good about the strength of our coverage. And we think it's underpinning a successful commercial model. You can see a little bit more about that on slide 11. We did 16.7 million in that revenues for the quarter, which continues to be a solid progression in growth quarter on quarter.

Speaker 4: That's good about that growth and expect to continue to accelerate with both volume and growth and improvements in the future. Growth and that was a hair better 26% yield over the last quarter. We had pulled, as we said on the prior call, some of the GTN improvements from this quarter to the June 30th quarter back into the 331 quarter with some earlier formulary addition. So.

Matthew Gline: We had polled, as we said on the prior call, some of the GTN improvements from this quarter, the June 30th quarter, back into the 331 quarter with some earlier formulary additions. So, you know, I expect GTN to progress sort of linearly on the trend line over the course of the year. And I expect to end this fiscal year, call it in the mid to high 30s from a yield perspective and still believe very comfortably that it will be on a trajectory to get to that 50% yield that we and others have guided to as we progress.

Speaker 4: I expect the CGTN to progress sort of linearly on the trend line over the course of the year and I expect to end this fiscal year call it in the mid to high 30s from a yield perspective and still believe very comfortably we'll be on a trajectory to get to that 50% yield that we and others have guided to as we progress so the contracting

Matthew Gline: So the contracting and sort of other payer progression is all moving exactly in the direction we need it to, and we think we're in, yeah, we're in good shape from a GTN perspective. So that's about it on VTAMA for now. I'm sure we'll get some more questions.

Speaker 4: from a GTN perspective.

Speaker 4: So that's about it on the camera for now. I'm sure we'll get some more questions. Look, I think the...

Matthew Gline: Look, I think the continued progress there is exciting for us, and we're excited about all the feedback we're getting. We believe script volumes will continue to increase over the course of this year, especially as our now live DTC campaigns begin to have an impact on volumes. And, you know, we're really looking forward to getting going in AD next year, which is, as you may remember, a about four times larger market opportunity where we have some truly exciting and highly differentiated data.

Speaker 4: The continued progress there is exciting to us and we're excited about all the feedback we're getting. We believe script volumes will continue to increase over the course of this year, especially as our now live DTC campaigns begin to have an impact on volumes. And we're really also looking forward to getting going in AD.

Speaker 4: next year, which is as we may remember, about four times larger market up. Can you do where we have some truly exciting and highly differentiated data? So with that, I'm going to turn it over in just a moment to my youth. We're going to do a relatively deep dive here on Brexit and IB, our dual inhibitor pick 2 and Jack 1. And I think it's a program that we, that has been high on our minds, but a little bit below the line for others just because of everything else going on our pipeline. But it's a really exciting program.

Matthew Gline: So with that, I'm going to turn it over in just a moment to Mayyuk, who's going to do a relatively deep dive here on Brepositinib, our dual inhibitor pick two and Jack 1. And I think it's a program that has been high on our minds but a little bit below the line for others just because of everything else going on in our pipeline.

Matthew Gline: That's a really exciting program, a very potent agent, which continues to demonstrate strong clinical efficacy. And one of the many reasons we're highlighting it today, which many people talk about, is that we've generated some data. Pfizer had an ongoing study in Crohn's disease that's read out, and once again, the agent has shown great promise in another clinical study. We are unlikely, as you know, to progress this in Crohn's disease, but nonetheless, really excited about the data there and what it means for what we're going to do in some of these other places. So with that, I'll hand it over to Mayu to take it away, starting on slide 13. Yeah, thanks, Matt.

Speaker 4: Pfizer had an ongoing study in Crohn's disease.

Speaker 4: Let's read out them once again, the agent has shown.

Speaker 4: great promise in another clinical study. We are unlikely as you know to progress it in clinical crises, but nonetheless, really excited about the data there and what it means for what we're gonna do in some of these other places. So with that, let me hand it over to my youth to take it away, starting on slide.

Mayukh Sukhatme: Yeah, so, please, turn to slide 13. So, as Matt said, I want to take the opportunity today to talk a little bit about one of, I think, what I consider one of the sleeping giants within our portfolio. To the extent that that's representation has begun to get some notice for investors, I think it's mostly through the lens of being a pivotal study catalyst for Royvint by the end of this year. And while that is true, we do have the Lupus data later this year. I think the lupus story is just a small part of what we're trying to build with Bresitinib. And so I want to go through that story of a fresh few here today.

Speaker 5: 13. Yeah, thanks Matt.

Speaker 5: Yeah, so yeah, please turn to slide 13. So as Matt said, I want to take the opportunity to talk a little bit about one of, I think, what I consider one of the sleeping giants within our portfolio. To extent that the requisite members are going to get some notice from investors, I think it's mostly through the lens.

Speaker 5: of being a pivotal study catalyst for revenue by the end of this year. And while that is true, we do have the loop of data later this year. The loop of story is just a small part of what we're trying to build with prophesytinib. And so I want to go through that story of fresh to you here today. The punchline from my perspective is don't tweak on prophesytinibs.

Mayukh Sukhatme: The punchline from my perspective is, "Don't sleep on Brepacitinib." So put simply, Brepacitinib is a unique, highly, highly active dual inhibitor of both PIC2 and Jack 1 that has already shown spectacular efficacy in a broad range of autoimmune diseases. So, as Matt said, we were reporting here for the first time, the sixth consecutive positive phase two study for Brepacitinib, this time in Crohn's disease, which is a study that is being run by Pfizer and Pfizer-Fexpend.

Speaker 5: So, but simply, representin' it is a unique, highly, highly active duelant if there are a book, Kick-Q, and Jack one.

Speaker 5: that has already shown spectacular efficacy in a broad range of auto-mechanical diseases.

Speaker 5: So as Matt said, we're reporting here for the first time, the sixth consecutive positive phase two study for prophesied nerve, this time in Crohn's disease, which is study that is being run by Pfizer and Pfizer to extend.

Mayukh Sukhatme: And that adds to the string of positive phase two studies already reported, now covering as you see here on the slide, psoriasis, alopecia, psoracarphritis, ulcercholitis, hydraditis, supratidivia, and now clinicalitis, We'll go to the rest of the material on this slide in greater detail later, but we think that we really have the potential to become the leading oral therapy in loops, given the dual inhibition of TIC II and Jack 1 should provide greater efficacy than inhibition of either one alone. That is a large global study that is designed to serve as one of two registrational studies.

Speaker 5: And that adds to the string of positive phase two studies already reported. Now covering, as you can see here on the slide, psoriasis, alopecia, psoric arthritis, ulcerative colitis, hydrodinitis, superativa, and now chronic disease.

Speaker 5: We'll go through the rest of the material on this slide in greater detail later, but we think that we really have the potential to become the leading oral therapy. And we've given the dual inhibition of TIC-2 and JAS-1 should provide greater efficacy than inhibition of either one alone.

Mayukh Sukhatme: And importantly, it is a 52-week study with a 52-week primary endpoint, which is the registrational endpoint that has historically been the most predictive of future studies. Our ongoing single phase three study in dermatomyocitis, which will serve as the basis of an NDA filing shortly after data, is coming up to the extent that it now seems a little far off. I think as we round out the year and are sitting in the first half of 2024, it will come into focus as a near-term catalyst. And that's just the beginning for this program.

Speaker 5: That is a large global study that is designed to serve as one of two Registration studies. And importantly, it is a 52 week study with a 52 week primary end point, which is the Registration end point that has historically been the most predictive of future studies.

Speaker 5: Our ongoing single-face research study in the Metamise SIDIS, which will serve as the basis of an NDA filing shortly after data, is coming up to the extent that it now seems a little far off, I think, as we round out the year and are sitting in the first half of 2024, it will come into focus as a near-term catalyst service.

Mayukh Sukhatme: So we think that the unique dual mechanism and high demonstrated efficacy of Repositinib really creates a pipeline and a product approach where we can own a series, especially in Rheumatology, each of which has high-end need and blockbuster revenue potential for representativeness. And we'll show that in the coming slides. And then finally, we have a long IP runway here with protection for at least 20, 30 minutes. Please turn the slide forward.

Speaker 5: And that's just the beginning for this program. So we think that that unique dual mechanism and high demonstrated efficacy of REPA-CITN have really created the pipeline and a product approach where we can own a series, especially roomatology indications, each of which has high end need and blockbuster revenue potential for REPA-CITN.

Speaker 5: and we'll show that in the coming slides. And then finally, we have a long IP run right here with protection to at least 2039. And we'll show that in the coming slides.

Speaker 5: show that in the coming slides. And then finally, we have a long IP run right here with protection to at least 2039. Please turn to slide board.

Mayukh Sukhatme: So, as many of you know, the Jack family consists of four Is: Jack 1, Jack 2. Jack 3, and tick 2. The Jack's family inhibition has proven over the past several years to be an enormously powerful mechanism for treating a wide spectrum of autoimmunity. While the field has accumulated approvals, starting in rheumatology, moving on to a, and then IBD, as you see across the top, the underlying biology often remains complex and stubbornly irreducible. Sown here is a simplified schematic detailing a number of key satokines that have been shown to drive pathobiology of autoimmune disease, along with the key jack isoforms responsible for mediating those signaling

Speaker 5: So as many of you know, the Jack family consists of four I support.

Speaker 5: Jack one, Jack two.

Speaker 5: Jack III and Tick Tick. The Jack family inhibition has proven over the past several years to be an enormously powerful mechanism for treating a wide spectrum of autoimmune disease.

Speaker 5: While the field has accumulated approvals starting in rheumatology and moving on to immunodermatology and then IBD, as you see across the top, the underlying biology often remains complex and stubbornly irreducible.

Speaker 5: Shown here is a simplified schematic detailing a number of key cytokines that have been shown to drive pathobiology of autoimmune disease.

Mayukh Sukhatme: While early jack inhibitors were relatively non-selective, more recently the field has trended towards more specific inhibitors, with Jack 1 having the broadest applicability and, therefore, unsurprisingly, the first to be explored. You can see here the dark blue band across the middle where Jack 1 inhibitors, such as Rinvold, and the cytokines that are most directly impacted. Notably, selective Jack 1 inhibitors are able to suppress signaling of IL6 and interferon gamma, two important cytokines linked to autoimmunity that are not suppressed in selective TIC2. Now, two selective inhibitors, such as Siktu, are now coming out of the scene in a particular set of indications.

Speaker 5: Along with the key jack isopharm is responsible for mediating the signaling pathway.

Speaker 5: While early Jack and Hebrews were relatively non-slack, more recently, they've sealed us trended towards more specific in-hidlers, with Jack one having the broadest applicability, and therefore unsurprisingly, the first to be explored.

Speaker 5: You can see here in the dark blue band across the middle where jack one and hevers, such as rim build, and the static lines that are most directly in-zapped.

Speaker 5: Notably, selective jack 1 inhibitors are able to press signaling of IL-6 in interferon gamma. Two important cytokines link to auto-unity have been are not suppressed and selected to an emission.

Speaker 5: Now, took two selective inhibitors, such as the TIC-2, are now coming out of the scene in a particular set of indications.

Mayukh Sukhatme: They cover a different set of cytokines, which you can see in the light blue on the right. Key among these are IL12 and 23, the latter of which drives the differentiation and activation of TH17 cells in downstream IL-17 production, a key pathogenic driver of many autoimmune diseases. Now, both Jack 1 and Tick2 approaches are accumulating a track record of meaningful clinical benefits and commercial success across the range of diseases. Rinvoke is already approaching $1 billion in net revenue per quarter, and SIFT, too, is also projected to be a multi-billion dollar product.

Speaker 5: They cover a different set of cytokines, which you could see in the light blue on the right. Key among these are I-12 and 23, the latter of which drives the differentiation in activation of TH17 cells and downstream I-70 production.

Speaker 5: a key pathogenic driver of many auto-immune diseases.

Speaker 5: Now both Jack 1 and TIG 2 approaches are accumulating a track record of meaningful clinical benefit and commercial success across a range of disease.

Speaker 5: RINVOF is already approaching $1 billion from net revenue per quarter, and so TITQ is also projected to be a multi-dillion dollar product.

Mayukh Sukhatme: But in spite of their many successes, both of these medicines also have their limitations. Saticu, for instance, failed outright in both ulcerative collides and crones, while Rindvote has produced lackluster phase two data in both lupus and NHS. We see this at least in part connected to the underlying biofinding.

Speaker 5: But in spite of their many successes, both of these medicines also have their limitations.

Speaker 5: Setictu, for instance, fails outright in both ulcerative collides and Crocs, while Rinbo has produced lock plus for phase 2 data in both lupus and NHF.

Mayukh Sukhatme: While some diseases may be well treatable by selective Jack 1 or pick 2 in additional loans, many others involve multiple inflammatory pathways and may require intervention across multiple orthogonal lax to see maximum effect, or maybe even to see a meaningful effect at all. The latter is especially true for heterogeneous, highly inflammatory diseases, which have high patient burdens, so that clinically meaningful efficacy has to be beets and limited. So that's what drove our original hypothesis at Royvint, that the field in its current state may not be fully maximizing the power of Jack inhibition, that efficacy might be getting left on the table in certain indications with highly specific pick two or Jack 1 inhibitors. So in our search for the right molecule to prove out this hypothesis, we unsurprisingly ended up partnering with FISA, probably the company with the longest history and deepest experience with Jacks in

Speaker 5: We see this at least in part connected to the underlying biode. While some disease may be well treated as one of the selected JAPS-1 or TIC-2 inhibition alone, many others involve multiple inflammatory pathways and may require intervention across multiple orthogonal activities. See maximum effect.

Speaker 5: or maybe even the same info attack at all.

Speaker 5: The latter is especially true for heterogeneous highly inflammatory diseases, which have high patient burden.

Speaker 5: for clinically meaningful advocacy has to date and limit.

Speaker 5: So that's what drove our original hypothesis at Roivin, that the field in its current state may not be fully maximizing the power of Jack inhibition, that efficacy might be getting left on the table in certain indications with highly specific PIC-2 or JAK-1 inhibitors.

Speaker 5: So when I search for the right molecule to prove out this hypothesis.

Speaker 5: We unsurprisingly ended up partnering with Pfizer.

Mayukh Sukhatme: In Brethosidinib, we found a highly active, safe, and well-characterized molecules with a novel mechanism perfectly suited for what we were looking to do. Simultaneous inhibition of both tick two and Jack 1, which we can uniquely accomplish with prepositeness, creates two distinct opportunities to deliver differentiated up, For diseases driven largely by type 1 interference signaling, that is to say, interferon alpha and beta, a dual hit on both sides of the heterodimer shown in the bottom in pink, second from the right and schematic on the slide, may allow for greater suppression and thus potentially greater efficacy as compared to hitting tick two or jack one alone.

Speaker 5: Probably the company with the longest history and deepest experience with jacks in the industry.

Speaker 5: In Bremel's Sydney, we found a highly active, safe, and well-characterized molecule with a novel mechanism perfectly suited for what we were looking to do.

Speaker 5: Bammalaneous inhibition of both TIC-2 and JAP-1, which we can uniquely accomplish with purpose-cittness, creates two distinct opportunities to deliver different heated episodes.

Speaker 5: For diseases driven largely by type 1 interferon signaling, that is to say interferon alpha and beta, a dual hit on both sides of the heterodimer shown in the bottom in pink, second from the right and schematic on the slide, may allow for greater suppression and thus potentially greater efficacy as compared to hitting tick 2 or JAK 1 alone.

Mayukh Sukhatme: And second, diseases with broad statokine involvement that include, for instance, both IL6 and B-cell pathways on the one hand, and IL1223 and the IL 17 TH17 pathway on the other, may actually be treatable with repositinib in a way that would not be possible with either Jack 1 or tick 2 in a bison alone. So that's the core hypothesis stated in the bottom line. Replicitinib will deliver best-in-class efficacy in indications mediated by the Tick2 Jack 1 dimer and in diseases requiring broad cytokine coverage. Please turn the slide.

Speaker 5: And second, diseases with broad cytokine involvement that include, for instance, both IL-6 and B cell pathways on one hand and IL-1223 and the IL-17-TH axis on the other may actually be treatable through draposinib in a way that would not be possible to either JAK1 or JAK2 inhibition alone. As is testified in the main

Speaker 5: So that's the core hypothesis stated in the bottom line. Repuscitated and will deliver metacinthalacificacy in indications mediated by the TIC-2-JAC-1 diver and in diseases required for requiring broad cytokine coverage.

Mayukh Sukhatme: So what concretely drove our excitement about our Brepacinum? So to start, when we looked at a series of standard satakine inhibition assays, we saw exactly what we had hoped to see. So shown here are the results of studies run internally at BISTA. The left panel looks at type 1 interference signal, a key driver across multiple autoimmune diseases, and one where tick two and Jack 1 inhibition would be expected to have an effect. That's exactly what you see experimentally.

Speaker 5: Please turn to slide 15.

Speaker 5: So what concretely drove our excitement of our breath of sitting? So to start, when we looked at a series of standard cytokine inhibition acids, we saw exactly what we hoped to see. So shown here are the results of studies run internally at five. The left panel looks at type 1 interference signal.

Speaker 5: a key driver across multiple autoimmune diseases and one where both TIC-2 and JAK-1 inhibition would be expected to have an effect. That's exactly what you see experimentally. The NICE inhibition by the leading TIC-1 inhibitor and NICE inhibition by the leading TIC-2 inhibitor.

Mayukh Sukhatme: The nice inhibition by the leading pure Jack 1 inhibitor and nice inhibition by the leading peer to Q&A. And then importantly, Pfizer's experimental data showed that Brepacinidin is able to suppress Type 1 interferon signaling as well as, or potentially even better than either RINVOT or Scycine. This is exactly what would have been predicted in the prior slide.

Speaker 5: And then importantly, Pfizer's experimental data showed that brepositinib is able to suppress type 1 interferon signaling as well as, or potentially even better than, either RINVOT or CITIC-2.

Mayukh Sukhatme: We were benefiting from the double hit and thus achieving a greater inhibition of Type 1 interfered signal. On the right, we show two other critical cytokine drivers. So on the top right, you see type 2 interferon, interferon gamma, which is mediated by Jack 1, but not by TIC2. So the pattern of inhibition is, again, what you'd expect.

Speaker 5: This is exactly what would have been predicted in the prior slide. We are benefiting from the double hit and thus achieving a greater inhibition of type 1 interferon signal. We are also benefiting from the double hit and thus achieving a greater inhibition of

Speaker 5: On the right, we showed two other critical cytokine drivers. So on the top right, if you type two interferon, interferon gamma, which is mediated by a jack one, but not by tick two. So the pattern of inhibition is, again, what you'd expect. You see that rainbow can represent it, which both inhibit jack one, have a relatively higher degree of inhibition than of interferon gamma.

Mayukh Sukhatme: You see that RINVOKE and RepositNM, which both inhibit Jack 1, have a relatively higher degree of inhibition than interferon gamma compared to a selective tick 2 specific inhibitor. And then, on the bottom right, you see the opposite performance of the single isoform drugs on a cytokine inhibition assay for IL12 and 23, both of which are Tick2 and not Jack 1 mediated. So here you see a nice inhibition by Satic2, the Ticuosecccuh, while the action of Rindv is much more modest. Again, that's exactly as you'd expect based on the schematic shown in the prior slide.

Speaker 5: compared to selective TIC-2 specific inhibitor, TIC-2. And then on the bottom right, you see the opposite performance from the single-licer form drugs on a cytokine inhibition assay for IL-12 and 23, both of which are TIC-2 and not Jack-1 mediate. So here you see a nice inhibition by TIC-2, the TIC-2 specific inhibitor.

Speaker 5: while the action of RINVOQ is much more modest. Again, that's exactly what we expect based on this format we showed in the Farah slide. And again, you see that the proper sit-in name is a very, very good and...

Mayukh Sukhatme: And again, you see that Bratocitinib is a very, very good mediated satokine, hot-performing to pick two in this aspect. The conclusions here are listed at the bottom. On the left, you can see that Brepositinib should achieve greater type 1 interference suppression than is possible by targeting either tick 2 or jack 1 alone, by virtue of the dual hit. And on the right, Brepositinib can revert in a single molecule to cytokine suppression profiles of both the leading tick 2 agents and the leading Jack 1A. Please turn to the next slide.

Speaker 5: to be a set of kinds, outperforming to take two in this aspect. The conclusions here are listed at the bottom. On the left, you can see the purpose and it should achieve greater type 1 interference suppression and as possible by targeting either take two or jack one alone by virtue of the dual hit.

Speaker 5: And on the right, breathicinib can re-puffitulate in a single molecule, the cytokine suppression profile, of both the leading pick two agents and the leading jack one agent.

Mayukh Sukhatme: That stratokinibetian experimental data has translated well into a string of phase two data readouts today. As you can see, oral brepricidinidin has demonstrated an extremely consistent pattern of meaningful clinical efficacy in every single indication tested. Efficacy results for alopecia, psoraccharitis, ulceratitis, psoriasis, and aHS were all statistically significant and consistent with being as good or better than any other small module inhibitor.

Speaker 5: Please turn to slide 16.

Speaker 5: That cytokine inhibition experimental data has translated well into a string of phase 2 data readouts today. As you can see, oral breast acid name has demonstrated an extremely consistent pattern of meaningful clinical efficacy in every single indication tested. After the results for alopecia, psoracostritis, ulcer colitis, psoriasis, and HS.

Mayukh Sukhatme: The HS data, which I'll cover later with relatively recent readouts, heard subsequent to R taking over the drug from five. We're also excited to be reporting today the induction results of a large global phase two crone study run by FISA. So I'll provide some additional details in the following slide. Finally, we have another major benefit in the clinical package for Brea Cidney. We know what we have on safety as well.

Speaker 5: for all statistically significant and consistent with as good or better than any other small module inhibitor. The HS data, which I'll cover later, was a relatively recent readout that occurred subsequent to our taking over the drugs from Pfizer.

Speaker 5: We're also excited to be reporting today the induction results of a large global phase two prone study run by Pfizer. So I'll provide some additional detail in the following slide. Finally, we have another major benefit in the Center for Practice for Breville Sydney. We know what we have on safety as well. We know that stacking both tick two and a vision.

Mayukh Sukhatme: So we know that stacking both TIC2 inhibition and Jack 1 inhibition does not appear to lead to a safety profile that undercuts the efficacy advantages that we hope to show. Our extensive safety database now consists of over 1,400 patients exposed across 20 different phase one and phase two clinical studies for up to 64 weeks. And what we've seen as a well-characterized safety profile in line with Jack's family and hip. Please turn to slide seven.

Speaker 5: And Jack one inhibition does not apparently lead to a safety profile that undercuts the efficacy advantages that we hope to show. Our extensive safety database now consists of over 1400 patients exposed across 20 different phase one phase two clinical studies for up to 64 weeks.

Speaker 5: And what we've seen is a well-tired thread safety profile in line with approved Jack family inhibits.

Mayukh Sukhatme: So we're placed to report today the top line results from the induction portion of a phase two study with reposidum and chromosome. This is a 151 patient global phase two study. The primary endpoint was the SES CD-50, and the key secondary endpoint was a clinical remission rate at week 12, defined as a proportion of patients who achieved the CDAI of less than 150, both endpoints were highly statistically, We think that actually the true efficacy might have been understated on the SES CD-50 in this study, as there ended up being a slight imbalance in baseline severity between the arms, which made it harder to achieve that end point for the drug arm.

Speaker 5: Please turn to slide 17.

Speaker 5: So our place to report today the top line results from the induction portion of a phase 2 study with A

Speaker 5: This is 151 patient, global Phase II study. The primary endpoint was the SES CD50, and the key secondary endpoint was the clinical remission rate at week 12. Defined is a proportion of patients who achieved the CDAI of less than 150.

Speaker 5: Both endpoints were highly significant.

Speaker 5: We think that actually the true efficacy might have been understated on the SES, the 50 in the study, as they're ended up being a slight imbalance in baseline severity between the arms, which made it harder to achieve that end point for the drug arm. That imbalance would not have an impact on the secondary end point, since the way that that end point is calculated only takes into account patients.

Mayukh Sukhatme: That imbalance would not have an impact on the secondary endpoint since the way that that endpoint is calculated only takes into account patients who start with a baseline CDI of greater than or equal to 220. The punchline here is that this is a trial that I'm sure wasn't on any investors' radar and yet has delivered really strong results. In fact, that 33.5% placebo-adjusted Delta on clinical remission, which is used as a co-primary endpoint in registrational studies and is particularly important for prescribers, is, in fact, the highest seen in a late-state study from any drug, oral or biologic Please turn to slide age.

Speaker 5: to start with a baseline CBAI of greater than or equal to 220. The punchline here is that this is a trial that I'm sure wasn't on any investor's radar and yet has delivered really strong efficacy.

Speaker 5: In fact, that 33.5% placebo adjusted Delta on clinical remission, which is used as a co-prime re-end point in Registrational Studies, and is particularly important for prescribers, is in fact the highest seen in the late stage study from any drug or all of biologic to date.

Mayukh Sukhatme: We find ourselves in an enviable position. We have a highly efficacious molecule that has strong biologic and clinical translation and a variety of large market indications. There are lots of things that we could do with them, but our vision with representative from the start was to really focus on those indications where we could deliver step function improvement and outcomes for patients, generating maximum impact for patients and maximum return for our investment.

Speaker 5: Please turn to slide 18. So we find 1000 and end-viewable positions. So we have a highly efficacious module with a strong biological and clinical translation and a variety of large market indications.

Speaker 5: There are lots of things that we could do with Rappers' name. But our vision with Rappers' name from the start was to really focus on those indications where we could deliver a step-function improvement in outcome for patients.

Mayukh Sukhatme: To that end, we asked ourselves, what are the disease indications where the unique properties of Brepositinib really surprised us. For us, that came down to a few simple considerations laid out on the left side of the slide. So, in light blue, and moving clockwise.

Speaker 5: generating maximum impact per patients and maximum return for our investors.

Speaker 5: To that end, we asked ourselves, what are the disease indications where the unique properties of brepisitinib were really shining? For us, that came down to a few simple considerations laid out on the left side of the slide.

Mayukh Sukhatme: So first, where is inhibition of both tick two and Jack 1 required for maximum levels? Here, we looked for a biological rationale for dual pick two jack-won inhibition and corresponding clinical validation. Second, in dark flu, which indications have extremely high morbidity or mortality, creating a need for novel therapies that provide a meaningful efficacy benefit. And third, in pink, the indication has few available treatments, including no approved oral therapy. And finally, of course, we need to be confident that we could run an efficient experiment, minimizing development and regulations.

Speaker 5: So in the light blue and moving clockwise, first, where is inhibition of both kick two and jack one required for maximum left-fitting?

Speaker 5: Here we looked for biologic rationale for dual PIC2 JAK1 inhibition and corresponding clinical validation. Here we looked for biologic rationale for dual PIC2 JAK1 inhibition and corresponding

Speaker 5: Second, in dark flu, which indications have extremely high morbidity and mortality?

Speaker 5: creating a need for novel therapies that provide a meaningful efficacy benefit.

Speaker 5: And third in pink, the indication has few available treatments, including no approved oral therapies.

Mayukh Sukhatme: Put those together, and we think that there's an opportunity for Bruptersonib to become a leading treatment option in a series of large and uncharted markets. The next two slides will go into more detail on the premium business, but remember, that's just the beginning. Please turn to slide 19.

Speaker 5: And finally, of course, we need to be confident that we could run an efficient experiment, minimizing development and regulatory risk.

Speaker 5: Let those together and we think that there's an opportunity for representative to become a leading treatment option in a series of large and uncrowded markets.

Speaker 5: The next two sides will go into more detail in the human movements. But remember, that's just the beginning.

Mayukh Sukhatme: Dermatomycytis is a large orphan indication with a very similar profile to indications like PAH and cystic fibrosis, where oral small molecules have become a billion-dollar-plus product. Over the past 30 years, dermatomyocytics have become much better understood and characterized in the medical community. An increasing disease awareness and diagnosis has led to higher incidence and prevalence estimates over time. We've done our own analysis with claims data from 2016 to 2020 and estimated that U.S. adult turbulence sits at 37,000 patients, consistent with recently published estimates as well.

Speaker 5: Please turn to slide 19.

Speaker 5: Dermadomyositis is a large orphan indication with a very similar profile to indications like PAH and cystic fibrosis, where oral small molecules have become billion-dollar-plus products.

Speaker 5: Over the past 30 years, Dramatic Myosatic has become much better understood and characterized in the medical community.

Speaker 5: An increasing disease awareness of diagnosis has led to higher incidence and prevalent estimates over time. We've done our own analysis with claims data from 2016 to 2020 and estimated the US adult prevalence fits at 37,000 patients consistent with recently published estimates as well.

Mayukh Sukhatme: So we're looking at a patient population that is already clearly in the large orphan category. This is not an ultra-rare indication. And as awareness and diagnosis of the disease continues to increase, we expect the number of patients to grow over time. For an autoimmune disease impacting this many patients, Tremadis presents the strikingly high disease birth rate. There is high mortality, with some estimates of up to 40% at five years.

Speaker 5: So we're looking at a patient population that is already clearly in the large orphan category. This is not an ultra rare indication.

Speaker 5: And as awareness and diagnosis of the disease continue to increase, we expect a number of patients to grow over time.

Speaker 5: For an autoimmune disease impacting this many patients, Mr. Madhama A. Marthadev presents the strikingly high disease burden.

Mayukh Sukhatme: The characteristic skin rashes, shown on the right, cover large percentages of the body and lead to significant pain in addition to disfigurement. The vast majority of patients also suffer from proximal muscle weakness, which can severely impact daily living. Many patients end up needing walkers or wheelchairs. Finally, a meaningful proportion of patients suffer from interstitial lung disease. In sum, this is a high-mortality, highly inflammatory disease that affects multiple organ systems and will evolve into a large commercial market.

Speaker 5: There is high mortality with some estimates of up to 40% in five years.

Speaker 5: The characteristic skin rashes shown on the right.

Speaker 5: cover large percentages of the body and lead to significant pain in addition to this figure.

Speaker 5: The vast majority of patients also suffer from proximal muscle weakness, which can severely impact daily living activities.

Speaker 5: Many patients end up needing walkers or wheel tears.

Speaker 5: Finally, a meaningful proportion of patients suffer from interstitial lung disease.

Speaker 5: In some, this is a high mortality, highly inflammatory disease, which covers multiple organ systems, and will evolve into a large commercial market.

Mayukh Sukhatme: On top of that, there have been no NCE approved in the past 60 years, and there are no oral therapies in industry-sponsored late-stage development. Steroids, ISTs, and IVIG have been used for many years, with the latter recently gaining formal approval. But again, there's not a single modern drug approved for the indication, and the current treatment options present high safety and convenience in addition to limited benefits. IVIG, for instance, requires multi-hour infusions for three or more days every month, and is associated with side effects including quite a high rate of sombotic events.

Speaker 5: On top of that, there have been no NCEs approved in the past 60 years, and there are no oral therapies in industry sponsored late phase development.

Speaker 5: Paradise I.C. is an NI-??.

Speaker 5: For many years, with the latter recently gaining formal approval. But again, there's not a single modern drug approved for the indication, and the current treatment options present high safety and convenience burdens in addition to limited benefits.

Speaker 5: IVIG, for instance, requires multi-hour infusions for three or more days every month, and is associated with side effects, including quite a high rate of symbolic event.

Mayukh Sukhatme: So we really see DM as one of the major unmet needs in all autoimmune diseases and an opportunity for a modern targeted therapy, particularly oral ones, to enter the market and rapidly become a blockbuster. And while a number of companies are exploring small proof of concept studies, there are very few drugs in late-stage development and no oral therapies in phase three other than Brea-Sytenis. So looking ahead to a product launch of Brepo in this market in just three years, we think this has the potential to become a material commercial driver for Roevin as we think about the overall sales across our pipeline over the next five plus years. Please turn this slide.

Speaker 5: So we really see DM as one of the major unmanned needs and all of autoimmune disease, and an opportunity for a Marta targeted therapy, particularly in ORL1, to enter the market and rapidly become a Blastbuster Pros.

Speaker 5: And while a number of companies are exploring small groups of concept cities, there are very few drugs and late stage developments, and no-world therapies and phase three, other than breath of Sydney.

Speaker 5: So looking ahead to a product launch of Brepo in this market in just three years, we think this has the potential to become a material commercial driver for Royben as we think about the overall sales across our pipeline over the next five plus years.

Speaker 5: on to Brepo in this market in just three years. We think this is the potential to become a material commercial driver for Reuben as we think about the overall sales across the pipeline over the next five years. Please turn to slide 20.

Mayukh Sukhatme: We also see this as an indication that the success rate for Brethle is very high. With no modern medicines approved for DM, physicians often experiment with various different therapies to add on to protopaceres. As a result, based on investigator-initiated studies in an extensive body of case reports, there is meaningful clinical validation for Jack 1 in Abition and DM. This aligns with the pathobiology of the disease, which is driven in large part by type 1 and type G. Given no other Jack 1 inhibitors are approved or an industry-sponsored development for DM, even if Rep would just match this level of efficacy, that would set up well for clear commercial success.

Speaker 5: We also see this as an indication where the probability of success for breathable is very high.

Speaker 5: With no modern medicines approved for DM, physicians often experiment with various different therapies to add on to corticosteroids. As a result, through investigator-initiated studies and an extensive body of case reports, the patient is able to see the patient's face and the patient's face.

Speaker 5: There is meaningful clinical validation for Jack 1 and Abyssin in DM. This aligns with the pathobiology of the disease, which is driven in large parts by type 1 and type 2 in a pre-on signal.

Speaker 5: Given no other JAK1 inhibitors are approved or an industry sponsored development for DM, even if REPA would just match this level of efficacy, that would set up well for clear commercial success. But there's also reason to believe that the addition of TIC-2 inhibition can further add to the benefit the PREPA-SIT unit will provide.

Mayukh Sukhatme: But there is also reason to believe that the addition of Pick 2 inhibition can further add to the benefit that Repositinib will provide, both to enhance the potency of type 1 interferon suppression, as well as through suppression of IL12 and 23, which are also involved in DM pathobiology. Please rotate the slide.

Speaker 5: Both who enhance potency of type 1 interference suppression, as well as through suppression of I-12 and 23, which are also involved in DM pathobiology.

Speaker 5: to see if type 1 interference suppression, as well as through suppression of I-12 and 23, which are also involved in DM pathobiology. Please turn to slide 20.

Mayukh Sukhatme: Given the high-end need and our high-confidence system of success, we took the bold step of moving directly into a phase three program that involves a single registrational study. Our expectation is that this study, if successful, would support an NDA filing for preface with NDABN. The single phase three study is already well underway, tracking to complete enrollment in 2024, with data and a potential NDA filing in 2025. This timeline has us clearly positioned to be the first in the world to market by potentially several years, and likely also ahead of a few biologics in later stage development. One idiosyncratic consequence of our decision to move directly into phase three is that it means that our next catalyst in DM won't be

Speaker 5: Given the high-on need in our high-compensational success, we took the bold step of moving directly into a phase-through program that involves a single, registration of study. Our expectation is that this study, if successful, would support an NDF filing for proper suit-nade in the end.

Speaker 5: The single-phase-free study is already well underway, tracking the complete enrollment in 2024 with data and a potential NDA filing in 2025. This timeline has a clearly positioned to be the first oral to market by potentially several years, and likely also ahead of the few biologic and later stage development.

Speaker 5: One idiosyncratic consequence of our decision to move directly into phase three is it means that our next catalyst EDM won't be coming until 2025. But that catalyst could be a major inflection point for RoiVent as a business, with a potential billion-dollar-plus product launch immediately to follow. And given this launch would be an orphan indication with a specialized subscriber base.

Mayukh Sukhatme: But that catalyst could be a major inflection point for Reuven as a business, with a potential billion-dollar-plus product launch immediately to follow. And given this launch would be in an orphan indication with a specialized descriptionr base, we would expect the revenue ramp to be significant and steeper than for a volume product like the Kama. So as you think about modeling RU&L in the next five years and beyond, we think this is a major first conditional value that investors right now may be underappreciating. Please turn to slide 22.

Speaker 5: We would expect the revenue ramp to be significant and steeper than for a volume product like the TAMA. So as you think about modeling the NL of the next five years and beyond, we think this is a major source of additional value that investors right now may be under appreciating.

Mayukh Sukhatme: EM is the first of many orphan indications where we see a similar opportunity for Brevacitinibna. I'll talk about a few more of those in a bit. But first, I want to talk about the other indication where we have an ongoing pivotal study and where we do have a major catalyst coming up later this year. And that's moot.

Speaker 5: Please turn to slide 22. GM is the first of many orphan indications where we see a similar opportunity for brevacitinib and I'll talk about a few more of those in a bit. But first I want to talk to the other indication where we have an ongoing pivotal study and where we do have a major catalyst coming up later this year, and that's colupus. Colupus is a disease that everyone knows well and is one that's gotten an increase in

Mayukh Sukhatme: So lupus is a disease that everyone knows well, and it's one that's gotten an increasing amount of attention from industry in recent years. Hundreds of thousands of patients suffer from lupus in the U.S., many with serious and debilitating conditions. Only two therapies have been approved in the past 20 years, both injectors. It's a sign of how desperate the field is for efficacy. Ben List is doing greater than $1.4 billion in U.S. revenue despite very modest efficacy, at between 9 to 14% placebo-adjusted SRI4.

Mayukh Sukhatme: And Cessnelo, which launched recently, is projected to be a billion-dollar-plus product despite mixed phase 3 data. One study didn't show physical significance, while the other showed about 18% placebo-adjusted SRI4. Please turn to slide to. The limited options reflect an unfortunate reality everyone knows well.

Mayukh Sukhatme: Lupus is simply a very challenging disease to treat. It's highly heterogeneous, with multiple interconnected inflammatory pathways acting on T cells, B cells, and interferon signaling, and multiple impacted organ systems. To date, most attempts to treat Lucas involve a molecule acting predominantly across one of those reactions. Benlisted, for example, depletes B cells, while Cepnelo suppresses interferon signaling.

Mayukh Sukhatme: Both have generated meaningful but ultimately somewhat modest effects. And, of course, there's a long history of failed attempts at individual cytokine inhibition, indicating broader cytokine suppression is needed as Through dual, pick two, and Jack 1 interpicion, Repositnib is distinctively optimized to address all three axes simultaneously. The T-2 arm modulates T-cell activities with IL-12 and the IL-17-P-817 axis for I-L-23.

Mayukh Sukhatme: The Jack-1 arm modulates B-cell activity through I-L-6, I-L-7, and IL-21, and both arms work together to maximally suppress pathogenic type 1 interference. Please turn to slide 20. Over the past 18 months, we've had data from three jack inhibitors and lupus, including phase 3 data from aluminum, a jack 1-2 inhibitor, phase 2 data from Linvoke, a jack-1 inhibitor, and phase 2 data from sotik-2 inhibitor. These data provide clinical evidence for the therapeutic relevance of each of Jack 1 and tick 2, respect, in Lupus and, as such, have increased our confidence and represent a public success

Mayukh Sukhatme: At the same time, none of these molecules have demonstrated particularly compelling benefits, with the high water marks so far being specific to, if you blooded across and roughly the mid-teens, plus you will adjust it as for I-4.

Mayukh Sukhatme: This is what we might expect, given that unlike Replicitin, none of these molecules directly targets all three inflammatory axes and leopi. So we are cautiously optimistic that through dual tick two and jack one inhibitions, Preface and NIP can deliver greater efficacy benefits than we've seen from these other oral therapies and become the leading oral therapy for patients and physicians. Please turn this slide 25.

Mayukh Sukhatme: We continue to expect top-line results from our ongoing study of Brepacit and Evin Lupus in the fourth quarter of this year. As we've stated in previous earnings calls, this is a large global study using the registration of 52 weeks primary influence, and as such, is assigned to serve as one of the two registrations. In the event of a positive outcome, we would expect to rapidly initiate a second confirmatory registrational study.

Mayukh Sukhatme: I do want to emphasize that while we're cautiously optimistic that repositinic can deliver data that will position it as a leading world therapy in lupus, our confidence in the problem of success here is not as high as in dermatomycide. We feel rock solid that we are hitting the pathways that matter, but we as an industry have had mixed success in proving out efficacy and regulatory endpoints such as SRI4. Lupus is just a challenging indication in that respect, and it was not the core bet that we underwrote when we looked at license repositories.

Mayukh Sukhatme: That bet, rather, is the opportunity in dermatomyosate, isn't a string of other large orphan indications to potentially follow. And given the six successful phase two placebo control studies you've had to date, our enthusiasm about Brepacitnib and these other indications will remain irrespective of our results in the loop. Please turn to slide 20. Turning now to these other indications, I just want to highlight two, in addition to deomatomyocitis, where we have a rapid potential path to market with launches that could follow closely behind DMs.

Mayukh Sukhatme: A couple to highlight here are non-infectious or NIAU, and H.S. Please turn. NIA, like Dermata mysitis, is a large orphan indication with a very high disease burden, with approximately 3,000 cases of legal blindness attributable to NIA each year.

Mayukh Sukhatme: Unlike DM, there is one approved targeted therapy, Humira, which has generated over a half billion dollars per year in sales despite limited efficacy and almost no indication-specific promotion. The development stage competitive landscape in IU is even more wide open than in DM, with no ongoing phase three studies at this time for any oral or biologic therapy. An efficacious oral therapy could easily match Humerus peak sales and this indication, and with sufficiently compelling data, we could potentially do so significantly better. Please turn to slide 21.

Mayukh Sukhatme: As with CM, we also have clinical validation of Jack 1 inhibition in NIH. Before Zilgatenov development was discontinued in the U.S., and it generated phase two data in NIU suggesting Jack 1 inhibition in ambition may be more efficacious than TNF alpha suppression by Humira. However, the extent and robustness of clinical validation of Jack 1 inhibition in NIU are not quite as great as in DM.

Mayukh Sukhatme: And so in this indication, rather than moving straight to phase three, we are conducting a quick proof of concept. This study also includes dose ranging that would make a potential pivotal study even more efficient. We're excited to report that this study is now fully enrolled, with top-line data expected in the first quarter of 2024. Please turn to slide 21.

Mayukh Sukhatme: H.S. follows a similar pattern to DM and NIU, a highly debilitating disease with a large orphan prevalence increasing over time through increased diagnosis and awareness. Here, too, Humira is the only approved targeted therapy with indication-specific sales of approximately $3 billion per year. Again, despite limited efficacy and limited indication-specific promotion. Please turn to slide 30.

Mayukh Sukhatme: Unlike DM and NIU, HS does have other oral therapies in later stage development, specifically two Jack 1 inhibitors. So, as you can see on this slide, the phase 2 data recently generated by prefaceitis is greater, both in terms of absolute and placebo-adjusted benefit than that seems from either of these molecules. Reficitinib's benefit observed in phase two also surpasses with 42% gross and 16% placebo-adjusted benefit seen in Sumer's phase three program. Notably, Preficitness Benefit was robust and caused both TNF naive and TNF refractory patients and was generated despite the study being heavily impacted by COVID-related discontinuation.

Mayukh Sukhatme: In fact, the placebo-adjusted benefit among completers was actually 27%, suggesting an opportunity to potentially demonstrate even greater benefit in phase three than in phase. This is further supported by H.S. Pathobiology, which involves not only Jack 1 mediated inflammatory pathways but also the clinically validated I.L. 23-1817 access, which is suppressed by TIC2 inhibitions, but not Jack 1 inhibitions.

Mayukh Sukhatme: Please turn to slide 31. So I hope I've been able to convey in some small part how excited we are about the potential for Brea Sitman. It's a highly active molecule with a unique mechanism of action and a long patent line that sets us up to potentially create the leading oral specialty autoimmune franchise in the pharmaceutical industry. Here on this slide, you see how this pipeline and this product will build in the coming year.

Mayukh Sukhatme: The successful Lupus readout later this year clearly teases up a multi-billion-dollar commercial opportunity in Lupus alone. But even without lupus, we have a rapid de-risk path to a billion-dollar-plus commercial launch in DM, with full enrollment in our pivotal study coming next year, data in 2025, and a potential product launch in 2026. And then there's a rapid pipeline of other large orphan indications to follow, each with blockbuster potential. A pivotal program in H.S., N.I.U. or Both could be initiated in 2024.

Mayukh Sukhatme: And we have other large orphan indications to follow with potential proof of concept studies planned for 2025. With that, I'd like to thank Ben Zimmer and the rest of the private team for all their work on Breposit so far. And, of course, to our colleagues at Pfizer for both partnering with us on this program and, of course, for all their work in discovering the compound and generating this really rich data set. And I'd also like to thank all the investigators, site personnel, and importantly, the patients who participate in these trials as well. With that, I'll turn back over to Matt.

Matthew Gline: Thanks, Mayuk. I appreciate it. And, obviously, thank you for that deep dive into the program. I suspect there will be some questions about it, but also just want to set people up for the months and, frankly, years ahead with it. So looking forward to more there. I'm going to go very quickly through the rest here and then open up Q&A in just a minute or two. Starting with slides 34 and 35, while we're not going to spend any time today on the TL1A data, it occurred to me as we were finalizing this presentation. The June 30th quarter was the quarter in which we had generated the 56-week maintenance data, and it felt weird not to at least nod to that extraordinary data.

Matthew Gline: So we've had a couple of calls on that topic so far. The TL1A program is an incredibly exciting opportunity, and we continue to look at this data and find new things to like about it, including the continued improvement into 56 weeks and some of the things that set us up really well for the phase three programs. So more on that to come.

Matthew Gline: As a reminder, on slide 36, we are now underway, including the first patient dose, with our phase two study in Crohn's. The goal here is to get, as I've said before, dose ranging, quote, quote, out of the way prior to beginning phase three in a way where when we look at all of these timelines and stack them together, we think we still have an opportunity to be effectively first in class in Crohn's disease by going quickly from this study into a phase three study in Crohn's.

Matthew Gline: So we're very excited about the opportunity for T01A in Crohn's in addition to UC and look forward to sharing more data next year when this study concludes. And then lastly, on the late-state portfolio on slide 37. I talked about this a little bit at the beginning. Obviously, we, collectively, likely led by Immunivance, are going to have an opportunity to get back together in the next couple of months to talk about updates on our FCR in franchise.

Matthew Gline: Most notably, we are expecting imminently within the next, you know, I think Immunivant has said September for the single-sending dose data and October and November for the multiple-centing dose data, data that we think will validate the best in class potential for IMP-202, our next generation anti-FCRN. As a reminder, the hope there is to show that we can continue to suppress IGG to a best-in-class level while also avoiding the impacts on Albumin and LDL that have been seen with Toklab.

Matthew Gline: It's been a busy year for the FCRN field, and the other thing I'll point out is that we just recently saw data from a competitor, F-Gartijimod, in CIDP, which was really great data that both continued to underpin and validate the FCRN mechanism. It's now working basically everywhere it's been studied and shows potential in a new market, including one where we have an ongoing phase 2B study of a relatively similar design.

Matthew Gline: Theogenics one that I just read out will have some top-line data from that study next year. And then the last thing I wanted to briefly shine a spotlight on on slide 38 is just how we continue to make progress on our various discoveries and efforts.

Speaker 4: I've got a slide here on Vant AI, which is a rapidly progressing effort that we have to use certain advanced machine learning techniques, specifically on induced proximity and protein degradation. One note here, we had previously had a number of efforts in this area, including one at Proteivance. We've now effectively collapsed the Proteivance induced proximity effort into Vant AI and have sold the balance of our Proteivance shares to our partner SK. And so Vant AI is now the instantiation of our principal bed at Roivant on induced proximity and protein degradation. And we are really excited with the early progress there, including some great hirings. Notably, we've now got Michael Bronstein as Vant AI's chief scientist. He's one of the lions in the field of molecular modeling using machine learning. And so we're really excited to have him on board. And some other great hires there as well that we'll talk more about soon. Real progress coming. And we'll get back on the phone as we've got data to share. But keep an eye on this space, as it were. So I'll wrap up very quickly on slide 40 with a brief.

Matthew Gline: I've got a slide here on Vantei, which is a rapidly progressing effort that we have to use certain advanced machine learning techniques, specifically for induced proximity and protein degradation. One note here; we have previously had a number of efforts in this area, including one at Proteovance. We've now effectively collapsed the Proteovant, induced proximity effort into Vantei, and have sold the balance of our Proteovant. shares to our partner SK. And so Ventei is now the sort of instantiation of our principal bed at Roevent on use proximity and protein degradation.

Matthew Gline: And we are really excited about the early progress there, including some great hiring. Notably, we've now got Michael Bronstein as a science scientist. He's one of the really lions in the field of molecular modeling using machine learning. And so we're really excited to have him on board and some other great hires there as well, but we'll talk more about that soon. Real progress is coming, and we'll get back on the phone as we've got data to share, but keep an eye on this space, as it were.

Matthew Gline: So I'll wrap up very quickly on slide 40 with a brief financial update. The financial picture continues to evolve as we'd expected, you know, revenues and so on. talked about, you know, cash most notably good into the second half of 2025, as we had discussed before, and continuing to keep an eye on that and on managing it across our portfolio with various opportunities coming soon. So with that, I will, I'll stop. Slide 42 is the catalyst map.

Speaker 4: Financial update, financial picture continues to evolve as we'd expected, revenues and so on we've talked about. Cash most notably good into the second half of 2025 as we had discussed before, and continuing to keep an eye on that and on managing it across our portfolio with various opportunities coming soon. So with that, I'll stop. Slide 42 is the catalyst map. We've talked about some, all these things coming and just an exciting balance to 2022 ahead.

Matthew Gline: We've talked about some, but not all of these things coming. And just an exciting balance to 2022 ahead. Sorry, 2023 ahead. So I'll say, Thank you to Mike, to the team, and to everybody, including patients and investigators who helped make this quarter what it was. And I will turn it over to the operator to open the line for Q&A. Thank you, everybody.

Speaker 4: Sorry, I'm 23 ahead. So I'll say thank you to my youth, to the team, and to everybody, including patients and investigators who helped make this quarter what it was. And I will turn it over to the operator to open the line for Q&A. Thank you, everybody.

Unknown Executive: Thank you, Lisa and gentlemen. To ask a question, you will need to press 1-1 on your Touchdown Telephone. To withdraw your question, press on.

Speaker 2: Thank you, Lisa and gentlemen. To ask a question, you will need to press star 11 on your touch tone telephone. To withdraw your question, press star 11 again. Please stand by while we compile the Q&A roster.

Unknown Executive: your touchstone telephone To withdraw your question, press R11 again please stand back, we'll compile the Q&A roster

Louise Alesandra Chen: Now, the first question coming from the line of Brian Chen with JP Morgan. Your line is open. Hey guys.

Speaker 2: And our first question coming from the line of Brian Chang with JP Morgan, your line is open. I'm finally available.

Matthew Gline: Hey guys, thanks for taking my question this morning and for the walkthrough on Prebo. Maybe first on Prebo, given what we saw from other Jacks in SLE specifically, how confident are you that Preble can perform better than Ducra specifically in SLE?

Speaker 6: Hey guys, thanks for taking my question this morning in the walkthrough on PREVO. Maybe first on PREVO, given what we saw from other JACs in SLE specifically, how confident are you that PREVO can perform better than Drukra specifically in SLE? Is there anything that you would want to flag from the baseline characteristics in the ongoing suspense of this Participant Page? Unless...

Matthew Gline: Is there anything that you would want to flag from the baseline characteristics in the ongoing phase two design to ensure that you can show the differentiation and also make sure the placebo rate is low? Then I have a follow-up question. Thank you. Yes, thanks, Brian. And maybe I'll take one second to that question, then also hand it over to see if he's got further comments. Look, I think in terms of confidence in SLE, and I think you heard Mayuq say it, on the one hand, I think there's a strong biological rationale that hitting both tick two and Jack 1 should provide a meaningful benefit.

Speaker 6: way is slow. Then I have a follow up. Thank you.

Speaker 4: Yes, thanks, Brian . And maybe I'll take one second to that question, then also hand it over to Mayuk to see if he's got further comments. Look, I think in terms of the confidence in SLE, and I think you heard Mayuk say it, on the one hand, I think there's strong biological rationale that hitting both TIC-2 and JAK-1 should provide a meaningful benefit. But I think there's a lot of confidence in SLE, and I think there's strong biological rationale that hitting both TIC-2 and JAK-1 should provide a meaningful benefit.

Matthew Gline: And so I think that's an important point. And then I think the second important point is understanding the bar correctly. And I think if you look closely at the Dukra data, look, I'm not going to say Duker is not an impressive agent.

Speaker 4: And so I think that's an important point. And then I think the second important point is understanding the bar correctly. And I think if you look closely at the DUCRA data, look, I'm not gonna say DUCRA is not an impressive agent, but really I think the way to read that data is probably sort of mid-teens blended efficacy.

Matthew Gline: But really, I think the way to read that data is probably sort of mid-teens blended efficacy. And I think if you look at the three milligram dose where they showed something more impressive than that, I think there was a pretty significant sort of patient population imbalance that suggests to us that that mid-teens is really the bar to beat. You know, as far as the baseline characteristics are concerned, I think, first of all, as a reminder, this is a study that Pfizer designed and ran.

Speaker 4: And I think if you look at the three milligram dose where they showed something more impressive than that, I think there was a pretty significant patient population imbalance that suggests to us that mid-teens is really the bar to beat.

Matthew Gline: We think it's a pretty well-designed study, and we've been watching it closely. There were certain things that we didn't control, and as Mayyuk mentioned, look, lupus is a scary indication for trial execution, but we feel overall pretty good. And, you know, I think that our study design, for example, was designed to try and flag some more severe baseline criteria, which are historically correlated with success, but we'll obviously see how that plays out later this fall. Mike, anything you'd add to that? No, not really actually, Matt.

Speaker 4: As far as the baseline characteristics, you know, I think first of all as a reminder, this is a study that Pfizer designed and ran. We think it's a pretty well designed study and we've been watching it closely. There were certain things that we didn't control and as Mayuk mentioned, lupus is a scary indication for trial execution, but we feel overall pretty good.

Speaker 4: You know, I think that our study design, for example, was designed to try and flag some more severe baseline criteria, which is historically correlated with success, but we'll obviously see how that plays out later this fall. Mike, anything you'd add to that?

Matthew Gline: I think you nailed all the points that would have made. Great. Thanks. And maybe just one more follow-up on UMinovans 1402 data coming up next month. Just to prep us for the Top Line coming up, can you walk us through how we should gauge the profile at Topline in terms of 1 IGG suppression compared to Patocl Map and FGR? And more importantly, the impact on album and LDL, given the potential variability in the LDL aspect?

Matthew Gline: Yeah, thanks, Brian. Great question, obviously, when we're getting a lot right now, and I'm sure Immunabance is getting a lot too. I think Immunovans spoke a fair amount on this point publicly. I think the short answer is: on IGG suppression, look, we believe we have an equivalently potent molecule here, and we'd like to see equivalently deep IGG suppression. Remember, comparing apples to apples versus as close as we've got to equivalent time points and things like that.

Matthew Gline: But in general, I think we'd like to see it really have the same level of deep IGG suppression and certainly we'd like to feel like we're going to be able to suppress ITG comfortably deeper than FGARTIGMOD can. So that's on the IGD suppression points.

Matthew Gline: You know, on Album and LDL, obviously, there's a lot of speculation and discussion on this point. The facts are that the variability of the Albuman assay is about 5%, and the variability of the LDL assay is, you know, 10 plus percent. And so I think within first approximation with relatively small studies, you want to be comfortably within both of those. Smaller is generally better.

Matthew Gline: And my sense is that, Bye, you know, if the albumin impact in the sad is relatively modest, that the LDL will follow, and that because of the variability in the LDL, it'll be easier to see if you've got a few weeks of compounding data after multiple objections. So I'm mostly looking at the albumin in the sad data. I haven't seen really any of this yet, so I can't say what it's going to look like, but that's what I'm keeping my eye out for. Thanks, Matt. Thanks, Matt. Thank you. One moment for our next question, and our next question coming from the line of David Riesinger with Lerinkillan is open. Good morning.

David Reed Risinger: Thanks very much, Matt and team, for all the updates. So I have questions for both Matt and Mayuk. Matt, could you provide an update on the evaluation of potential monetization of assets? And also provide an update on the pursuit of new product acquisition opportunities. And then I'll pause and follow up with a question or two for my youth. Thank you, Dave.

Matthew Gline: I appreciate it, and I figured we would get some version of that first question. Look, I think we are in a privileged moment in terms of the amount of clinical data we have generated and will generate soon. That data is both deeply informative about our own strategic future and also exciting to potential partners, acquirers, and so on. And it's, you know, flattering to be the focus of attention. It's made me wonder a little bit how exactly public speculation happens. But anyway, it's flattering.

Matthew Gline: Look, I think the short answer is on the monetization side, we're value-oriented, and we're going to have to make these decisions carefully, knowing that a number of our late-stage programs are really rare opportunities. with huge potential. And so we don't take any decision on them in either direction lightly, with the dollar sums at hand being very large and the opportunity for patients being very large. Certainly, I wouldn't expect us to make any decisions of substance on this point until we've started to get some of the immunovant data in, just because that's a pretty important strategic catalyst for us as we think about what the future of Roitman could look like across the breadth of our portfolio.

Matthew Gline: You know, on the new opportunity side, I will hand that over to Mayuq, actually, but I guess the one thing I'll say is this has been a phenomenal asset sourcing opportunity and environment for us. Obviously, a year ago today, we would not have been talking about T1A. We also wouldn't have been talking about 14-02.

Matthew Gline: We hope we've proven that we see some pretty interesting and unique things and that we can bring them in. And I'll say, we've got things on our radar right now that are just as exciting to me bluntly as anything in our late-stage portfolio. And I hope we can convert some of those, and the next year, we'll be talking about them as well.

Mayukh Sukhatme: But, Mayyuk, anything you'd add to that? Not really, Dave, as Matt said, this is kind of, you know, our sort of normal course of business to be out there looking for new and hot value things. I think that work is ongoing. I feel really good about, you know, as Matt said, things in our racket.

Not really yeah, Dave I mean look I think that this is as Matt said it was got it.

Our sort of normal course of business that would be out there looking for new and high value things I think that work is ongoing I feel really good about.

As Matt said things that are racket.

Mayukh Sukhatme: And then just to follow up, so Ayyuk, thanks for providing the comprehensive vision for Brepacitinib. Could you discuss the decision not to pursue a number of indications despite compelling results, including Crohn's. And then if you could also discuss TIC2's inverse dose response in SLE and whether there are any potential implications for BREPO in SLE or not. Thanks very much.

Stay tuned.

Cool. Thank you everybody I appreciate the question. Thank you and then just a follow up so thanks for providing the comprehensive vision for breath of Sydney.

Could you discuss the decision not to pursue a number of indications despite compelling results, including Crohn's.

And then if you could also discuss so TIK twos inverse dose response in SLE and whether there are any potential implications for breath Po.

In SLE or no thanks very much.

David Reed Risinger: Sorry, I missed just the last part of that question, Dave. So yeah, so on the last part, the slide shows an inverse dose response for SOTIC2 in SLE. So as the dosing went up for SOTIC2, the efficacy went down. Just wanted to see if you had any comments on that and whether there may or may not be implications for Repo as a dual agent in SLE as it's dosed up. And as I understand it, you're testing 1530 in 45 milligram doses. That's right, Matt. Do you want to take the indication question? Yeah, sure.

Sorry, I missed the last part of that question Nick.

So yes, so on the last part the slide shows an inverse dose response force so check to unnecessarily. So is the dosing went up four so tick to the efficacy when town just wanted to see if you had any comment on that and whether there may or may not be implications.

For <unk> as a dual agent and SLE as it's dosed up.

And as I understand that you're testing 15, 30, and 45 milligram doses.

That's right, Matt do you want to take the <unk>.

Indication question.

Matthew Gline: I mean, look, I think, David, it comes down to, And this was sort of the inherent thesis in Brepo as well. I think at the moment that we acquired Brepo from Pfizer, it was sort of just in the thick of the sort of turning point on jack inhibitors because of labeling. And I think our view has been, in the face of very compelling data, as you point out, in Crohn's and a number of these other indications, that the competitive landscape there is such that the Jack labeling may be a disadvantage difficult to develop through.

Yes, sure I mean look I think Dave it comes down to.

And this was sort of the inherent thesis and <unk> as well.

At the moment that we acquired breath from Pfizer It was sort of just in the pick of the sort of <unk>.

The point on JAK inhibitors because of labeling.

And I think our view has been.

The face of very compelling data as you pointed out in Crohn's and in a number of these other indications that the.

The competitive landscape there is such that the JAK labeling maybe.

Yes.

Disadvantage difficult to develop through I think if you take Crohn's for example, and I think that's an interesting question in the sense that clearly.

Matthew Gline: You know, I think if you take Crohn's, for example, you know, I think that's an interesting question in the sense that clearly, as we continue to study Renvoke in IBD pretty aggressively, and also the Alistarctic twos have struggled a little bit there. So I think we'll get some more data on that later. I think we'll continue to reevaluate those questions. That said, I'd say the other thing about our view is, I think, with the data that, frankly, the TL1A class is putting out. And also, ABD.

We continue to see steadier invoke in IBD pretty aggressively.

Alright.

And also the Alastair kicked twos have struggled a little bit there. So I think we'll get some more data on that later.

I think we'll continue to reevaluate those questions that said I'd say the other thing about our view is I think with the data that frankly, the Tijuana a class is putting out in IBD.

Matthew Gline: We're not sure, exactly where a jack will fit in the future treatment paradigm, understanding the obvious benefits of being oral. But anyway, look, I think the affirmative bet we're making here is that orphan indications where the jack liabilities won't be a problem with the unmet need is highest, is sort of the place where it makes the most sense for us to pursue, for us to pursue Brapo. Yeah, I mean, I think just that, just adds that, look, I think we were always, always going to be, I think, kind of dynamic in our evaluation and really sort of, you know, this sort of comes down to in a certain sense, an embarrassment of riches in terms of just the clinical data set and the breadth of potential indications we could go after, I think as Matt said and articulated on the call, you know, a sort of primary thrust as it were is in these, you know, orphan indications for which I think we feel like our ability to separate versus other options is great as the competitive intensity is the least, et cetera, and that sort of really allows us to kind of have this and own that area for ourselves.

We're not sure.

Exactly where.

Jack will fit in the future treatment paradigm.

And the obvious benefits of being an oral but anyway look I think the affirmative bet. We're making here is that orphan indications, where the Jack liabilities won't be a problem with the unmet need is highest is sort of a place where it makes the most sense for us to pursue.

To pursue Bravo.

Yeah, Yeah, I think just that and just to add to that look I think we were all we always going to be I think kind of dynamic in our evaluation and really sort of this sort.

Comes down to you in a certain sense.

An embarrassment of riches in terms of just the clinical data set and the breadth of potential indications to go after I think as Matt said and articulated on the call.

I sort of primary thrust is it worse.

Yes.

Orphan indications for which I think we feel like.

Our ability to separate versus other options as great as the competitive intensity is as beliefs et cetera, and that sort of early allows us to kind of have been especially with intelligence.

And on that area for ourselves.

Matthew Gline: And so, you know, I think we've got a lot of different options here and then, I think, over the next couple of, you know, data systems that we get in both Lupus and IU and then the DM coming right. And tell me your question about Svictu.

And.

And so.

I think we got a lot of different different options here and I think in part.

Over the next couple of data centers get and both lupus Niv Roman MDM coming right.

And tell me a question on <unk>.

So look I mean, I think obviously this is sort of the b.

Mayukh Sukhatme: So look, I mean, obviously, this is sort of the inherent sort of uncertainty around just, you know, relatively small end point estimates, as well as, as well as this sort of, you know, lupus clinical trial readouts generally. I think that our own view is that there's not, you know, not really likely to be, the truth is not an inverted dose response in that specificity study.

You know.

Yes.

It sort of be an inherent sort of uncertainty in Iraq, just relatively small end point estimates.

As well as well as just sort of lupus clinical trial Readouts generally I think that our own view is that there is not you know not really likely.

Truth is not an inverted dose response in that setting.

Mayukh Sukhatme: I think there are reasons to believe that, you know, in essence, this could be like a little bit of a reflection of just a slight imbalance, imbalances, you know, between the various dose arms. So, for example, you know, we think that, you know, the three milligrams BID arm, the one that produced the sort of highest print had, you know, more subjects receiving sort of triple combination standard of care, baseline, compared to other arms, and then that the 12 milligrams once Daly Arm had higher dropout rates, et cetera.

Study I think there are reasons to believe.

That.

In essence, this could be like a little bit of our flex fan.

Like flight imbalances.

Imbalances between the various dose arm. So so for example.

We think that that the three milligram tid arm, though.

Sort of highest brand Ted more subjects, receiving sort of triple combination standard of care baseline.

Back to other arms, and then that the 12 milligram.

Once daily arm had higher dropout rates et cetera, and ultimately I think what through.

Mayukh Sukhatme: And ultimately, I think you can look through, sort of, sick to just generally, seems like they're quite close to saturation, you know, at the three makes. There's not really kind of like a true reason to believe that there's sort of more, more juice in there at the higher makes. And then finally, it seems like, you know, mid-teens, it's kind of blended across these three values.

So take two.

Generally.

It seems like they're quite close to saturation.

<unk> does not really kind of like a true reason to believe that there is sort of more more juice in there at the higher doses.

And then finally it seems like you know.

Mid teens kind of blended across these three values.

Mayukh Sukhatme: It seems to be consistent with how Bristol themselves seem to be car-on their face. Got it. Thanks very much. Thanks, Dave. Appreciate the question. Thank you. And our next question, coming from the line of Robin Karnakas with Truth Security, Ceylon is open.

It seems to be consistent with how Bristol themselves.

Three as well.

Got it thanks very much.

Thanks, Dave I appreciate the questions.

Thank you and our next question coming from the line of Robyn <unk> with <unk> Securities. Your line is open.

Robyn Kay Shelton Karnauskas: Hi guys, and thanks Mayuk for doing all the work for me on Lupus and Brepbo. It's a fantastic presentation.

Hi, guys and thanks for getting all the work for me on Lupus and breath, though it's fantastic presentation.

Matthew Gline: Question on capital allocation. First, just on Brepbo, when you think about how, you know, whether it's been more on these orphan drug indications, can you just remind us of the Pfizer agreement and how much, if there's anything, they contribute? And then, bigger picture, you talked about making capital decisions after seeing at least initially some of the data from 1402, and you've got so many moving parts just this year and next year with many drugs and decisions you'll have to make.

A question on capital allocation first just unproper when you when you think about how you know whether it's spend more on these orphan.

Orphan drug indications can you just remind us of the Pfizer agreement in and.

How much if.

If they if theres anything to contribute and then bigger picture you talked about making capital decisions after.

Seeing at least initially some of the data from <unk> and you've got so many moving parts just this year and next year with many drugs and decisions you'll have to make like can you just walk us through how you're going to think about that would you start thinking about that you know after side and how long might it take you to come up with a game plan for what Youre going to do for rate at four.

Matthew Gline: Like, he just walks us through how you're going to think about that. Would you start thinking about that, you know, after sad, and how long might it take you to come up with a game plan for what you're going to do for the way event for spend? Thanks. Yeah.

Matthew Gline: Yeah, on the first question on Repo specifically, the answer is that the lupus study itself was very heavily subsidized by Pfizer. So our cost there was a fraction of the total study cost, and that obviously made it an attractive setup for us. The rest of the costs associated with other indications are ours to bear; Pfizer does not contribute.

Thanks.

Yeah on the first question on repo specifically.

The answer is the lupus study itself was very heavily subsidized by Pfizer. So our costs. There was a fraction of the total study cost.

And that obviously made it an attractive set up for us.

The rest of the costs associated with other indications or orange to Bayer Pfizer does not contribute they are protected from dilution of their 25% stake.

Mayukh Sukhatme: They are protected from dilution at their 25% stake up to a dollar cap, relatively, to the mechanism at Pilevant with the G1A program. So in terms of other orphan indications, NIU, DM is all our cost, et cetera. Those capital allocations aren't for us the same as any others, but SLE in particular has been highly subsidized through the end of this current study. If we decided to run another study, that would also be ours to fund. More generally, I guess I probably, insofar as I said, we wouldn't think about it until we saw the Univant data. That was probably an oversight.

Up to a dollar cap frankly relatively similar to the.

Mechanism at Q event.

You know when a program so in terms of other orphan indications Niu DM as all our cost et cetera, those are capital allocation decisions for us the same as any other.

<unk> in particular has been highly subsidized through the end of this current study if we decided to run another study that would also be ours to fund.

More generally I guess I, probably insofar as I said, we wouldn't think about it until we saw the data that was probably an overstatement obviously.

Matthew Gline: Obviously, we have spent a lot of time thinking about capital and capital decision-making as we explore the opportunity said, and I agree there's a lot of moving pieces coming. You know, I think the sad data will be informative. I think the mad data will be informative. I think we're going to learn other things from the FCRN field, including some RA data from Jane J and from our own. grade study, et cetera, through the balance of this year.

I've spent a lot of time thinking about.

GAAP capital and capital decision, making as we explore the opportunity set and I agree there's a lot of moving pieces coming I think.

Because that data will be informative I think the mad data will be informative.

I think we're going to learn other things from the <unk> field, including some already data from J&J from our own grave study et cetera through the balance of this year.

Matthew Gline: You know, I don't know that there's going to be like a single, tipping point obvious moment where before which we can't make any decision and after which we can. I think it's more of, you know, taking the facts as we have them and trying to understand in which direction things swing over the coming months. That said, we have the best version of this problem, I think, in the sense that we just have lots of different options for capitalizing the business going forward. And so I think we're just, we're frankly picking among good choices at this point.

There's going to be like a single.

Tipping point obvious moments, where before which we can't make any decision and after which we can I think it's more of.

Taking the factors, we have them and trying to understand in which direction things swing over the coming months.

That said we.

We have the best version of this problem I think in the sense that we just have lots of different options.

Capitalizing that business going forward and so I think we're just.

We're frankly picking among good choices at this point.

Robyn Kay Shelton Karnauskas: Okay, great. Thank you. Thanks, Rob. I appreciate the question. Thank you. And our next question comes from the line for Louis Chan with Cancer, Yonis Offen. Hi, thanks for taking my questions here. And congratulations on all the progress this quarter. So I wanted to ask you about Brepacitnib, one thing people have been asking,

Okay, great. Thank you.

Thanks, Rob I appreciate the question.

Thank you and our next question coming from the line of Louise Chen with Cantor. Your line is open.

Hi, Thanks for taking my questions here and congratulations on all the progress this quarter. So I wanted to ask you about this thing and one thing people have been asking us how you think about pricing if the drug is approved and I know, it's a little bit earlier, if you can't talk about specifics maybe you could tell us the book ends and how you're thinking about it and what you might cockpit too.

Corinne Jenkins: is how you think about pricing if the drug is approved. And I know it's a little bit early, so if you can't talk about specifics, maybe you could tell us the bookends and how

Matthew Gline: you're thinking about it and what you might comp it to. And then on VTama, the reimbursement work,

And then on the Palmer the reimbursed not work you did on psoriasis, how much can that be leveraged to the atopic dermatitis opportunity. So that you can lose quickly on uptake on that one and then one more here on breakfast fitness can you be a little bit more specific on when this year, we'll see the data is it early mid early.

Matthew Gline: Did on psorias, how much?

Matthew Gline: Can that be leveraged for the atopic dermatitis opportunity so that you can move quickly on uptake on that one? And then, uh,

Matthew Gline: And then one more here on Breficitnib. Can you be a little bit more specific on when this year? We'll see the data. Is it early, mid, or late fourth quarter? Thank you.

Fourth quarter. Thank you.

Matthew Gline: Yeah, thanks, Louise. On the two Brepo questions about timing, I think it's safe to assume mid to late, mid to late fourth quarter is probably the way to think about that.

Yes, Thanks Louise.

On the two breath or questions on the timing I think it's safe to assume.

Mid to late mid to late fourth quarter is probably the way to think about that.

Matthew Gline: On pricing, I mean, I'll hand it to my UK, but I think my short answer to that question is at this point, there's a pretty wide breadth of possible indication spaces between SLE and DM and so on, so it's probably premature, but But I'll hand it over to my youth. Yeah, I think the punchline is, we're thinking about this principally as sort of a, you know, call it an orphan drug pricing ban, you know, given the sort of indication set and sort of what makes sense, you know, independent, um, you know, potentially compatible with pricing and leopis as well, as a, And then on the Metama access question, I think the short answer is yes, that is a lot of that work can be heavily leveraged, and I would expect the sort of process with payers to be significantly streamlined, given that we're all on formulary.

Uh huh.

On pricing I mean, I'll hand, it to you, but I think my short answer to that question is at this point, there's a pretty pretty wide breadth of possible indication spaces between SLE and.

And so on so it's probably premature but.

But I'll hand over to you.

Yeah, I think I think the punch line is.

We're thinking about this principally as sort of.

Call it an orphan drug pricing band.

Given the sort of indication set and sort of what what makes sense.

Yes.

With.

That is.

Potentially compatible with with pricing in lupus as well.

Efficacy data is really strong.

And then on the <unk> question I think the short answer is yes.

Yes that is a lot of that work can be heavily leveraged and I would expect the sort of process with payers to be significantly streamline given that we're all on formulary. Obviously there is still work to do it's not like it's.

Matthew Gline: Obviously, there is still work to do. It's not like it's instantaneous and automatic, but I would expect it to be a faster, more straightforward, and, frankly, much more predictable process where I have, look, I think there were some real unknowns about how coverage was going to materialize prior to this, uh, prior to our launch. And I think at this point, we are pretty confident that we are going to get comfortably covered with reasonable rebates by the payers.

Containing some automatic but I would expect it could be a faster and more straightforward and frankly much more predictable process, where I have.

Look I think there were some real unknowns about how coverage was going to materialize.

Prior to this prior to our launch and I think at this point, we are pretty confident that we're going to get comfortably covered with reasonable rebates.

Matthew Gline: Thanks, Louise. Thank you. And our next question, coming from the line of Dennis Sting with Jeffries, Yon is open. Hi, good morning. Thanks for taking our questions. I just had one on AminoVant.

By the payers.

Thanks Louise.

Yes.

Thank you and our next question coming from the line of Dennis Yang with Jefferies. Your line is open.

Hi, good morning, Thanks for taking our questions I just had one on immuno van so on the upcoming <unk> two data can you just.

Dennis Sting: So on the upcoming 1402 data, can you just remind us the study design and how long the follow-up for Sat and Matt is? And interestingly, you know, how often albumin is being measured? And as a follow-up, you know, maybe given your comments around the assay variability and that, you know, there could be different time points at which albumin is measured, and it's also appreciating the fact that albumin reductions can go up and be down at some points and others.

Minus the study design and how long is the follow up for stat, and Matt and interesting.

Often is albumin being measured.

And as a follow up you know maybe given your comments around the assay variability in that.

There could be different time points at which albumin as measured in.

Just also appreciate the fact that albumin reductions can go up and be down at some point and others and I was just wondering what are some what's a good outcome for you guys.

Dennis Sting: And I was just wondering, what are some, you know, what's a good outcome for you guys in sad and mad on the album front? Thank you. Yes, thanks, Dennis. I appreciate these questions, and obviously it's an area of a lot of focus, so it makes sense.

Sad and demand on the albumin front. Thank you.

Yes, Thanks, guys I appreciate these questions and obviously its scenarios.

A lot of focus so it makes sense.

Matthew Gline: Look, I think about study design. There's a fair amount about this in the Immunivant Corporate deck and in ours as well. You know, in the sad study, it's 61402 plus two placebo patients. I forget exactly how far out it's measured, but it's at least a few weeks.

I think on study design, there's a fair amount about this in the.

Corporate deck and in ours as well.

On the Sad study at 614 or two plus two placebo patients.

I forget exactly how far it it's measured but it's at least a few weeks.

Matthew Gline: And then in the mad study, it's 10, 14, or two and two placebo patients, and it's weekly dosing for four weeks. And again, with a several week tail at the end. And we've got pretty frequent data points, I'd say, as a reasonable benchmark, if you went and looked at some of the Patoklomab data we've put out, I'd say, like, the measuring points are pretty similar. And so, you know, early, yeah, in fact, we follow these patients out for a lot more than a few weeks, and there's sort of a number of measurements within So, again, there's a fair amount of data in the Menn back on this point. In terms of what good looks like on Albumin and the SAD and the MAD, against the backdrop of smaller is better.

And then on the Mad study, it's 10 to 14, 2% and two placebo patients.

Weekly dosing for four weeks and again with a with a several week tail at the end, we've got pretty frequent data points I'd say as a reasonable benchmark. If you went and looked at like some of the <unk> data, we've put out I'd say like the measurement points are pretty similar.

And so you know.

Early yes in fact, we follow these patients out sorry, a lot a lot more than a few weeks.

A number of measurements within 10 days and then it starts to get a little bit more spaced out.

In the Sad study so yeah, again, theres, a fair amount of data.

Back on this point in terms of what good looks like on albumin in the sad and Mad.

Against the backdrop of smaller is better I think you know again with a 5% variability on the assay I think we'd hope to be comfortably within 5% and I'd say any of the agents frankly that show, a 5% or less impact on albumin seem to be pretty well set up from an LDL perspective.

Matthew Gline: I think, you know, again, with a 5% variability in the assay, I think we hope to be comfortably within 5%, and I'd say any of the agents, frankly, that show a 5% or less impact than Albumen seem to be pretty well set up from an LVL perspective. So I think, you know, it's hard to say exactly how things would sort of compound from the sad study to the mad study, but in general, you know, I'd say lower is better within that 5% bar is probably what I'm looking for. I got it. Thank you. Thanks, Dennis.

I think it's.

Hard to say exactly how things would sort of compound from the sad study to the Mad study, but in general.

I would say lower is better within that 5% bar is probably what I'm, what I'm looking for.

Got it thank you.

Dennis Sting: I appreciate the question. Thank you. And our next question coming from the line of Corinne Jenkins with Goldman Sachs, Yelan is open. Good morning. This is Craig on behalf of Corinne.

Thanks, Dan I appreciate the question.

Thank you and our next question coming from the line of Corn Jenkins with Goldman Sachs. Your line is open.

Good morning. This is Craig on for <unk>. So as you referenced earlier in the call that this can be a pretty tricky indication. So on that what do you view as the bar to support continued study of new indications.

Corinne Jenkins: So, as you referenced earlier in the call, this can be a pretty tricky indication. So on that, what do you view as the bar to support continued study in the indication? In actuality, you said, "yeah."

Initially you said yeah yeah.

Matthew Gline: Yes, that's right. Yeah, look, I think the way we are currently thinking about the program, understanding that it's kind of a balance of the factors is Dukra is the bar to beat, given that they have the cleaner tick number two. This would count as one of two pivotal studies, we believe, if successful. So the data from here would already make it onto the label.

Yes, that's right.

Yeah look I think the way. We're currently thinking about the program understanding that it's kind of a balance of the factors is Duke raised the bar to beat given that they have the the.

Back clean Arctic two this would count as one of two pivotal studies, we believe if successful so the data from here or would already make it onto the label.

Matthew Gline: It's a 52-week study, so it should be relatively predictive of a future study as well, given the way that it is. So I think we have the best possible setup, understanding that there has been some complexity in SLE trials before. You know, in terms of the bar, I think it's a balance of the factors, but I think, you know, you've heard us say that we think Sotiktu is a mid-team drug, and you've heard us say that we'd like to be better than Sotiktu.

Its 52 week study.

So it should be relatively predictive of a future study as well.

Given the way that it set up so I think we have the best possible setup.

Understanding that there has been some complexity nationally trials before.

In terms of the bar.

It's a balance of the factors, but I think you've heard us say that we think <unk> is a mid teens drugs.

And you've heard us say that wed like to be better.

Matthew Gline: So I think that gives you sort of some indication of where our heads are at, but we're going to have to look at, you know, there are multiple endpoints in and things like that. So, you know, I'd say, you know, mid to high teams, sort of, and whatever that trend is into across the other places to luck. Got it, that's helpful, and maybe just a quick one. You highlighted for the first time that you've achieved payer coverage with government-covered lives. I guess, how should we think of the, I guess, doctor adoption of these patients following this update? Is it going to be a similar timing?

So take too so I think that gives you sort of some indication for where our head yet, but we're going to have to look at there is multiple.

Multiple end points and things like that so.

Okay.

Mid to high teens.

And whatever that trend was into.

Across the other places don't watch.

Got it that's helpful and maybe just a quick one you highlighted for the first time that you've achieved payer coverage with the government covered lives I guess, how should we think of the I guess doctor adoption.

These are patients.

Following this update is it going to be a similar timing the commercial covered lives you've kind of highlighted around six months in the past.

Matthew Gline: as the commercial covered lives. You've kind of highlighted it's around six months in the past. Yeah.

Matthew Gline: Yeah, look, the truth is that the psoriasis market is sort of 80%ish commercial anyway. So even though we've got a lot of covered lives there, it's a smaller chunk of the patient population. And so, you know, I think now that we've got coverage, they're government patients, and they'll sort of accrue over time to better GTN yields and so on. You know, I think, in general, I just expect to see steady improvements in GTN from here.

Yeah look the truth is that the psoriasis market is 80% ish commercial anyway. So even though we've got a lot of covered lives. There. It's a smaller chunk of the patient population.

And so I think now that we've got coverage their government patients.

Sort of accrue over time test.

Better GT and yields and so on.

I think in general I, usually expect to see steady improvements in <unk> from here on out as we get closer and closer to that 50% bogey over the next.

Matthew Gline: on out as we get closer and closer to that 50% bogeyman over the next 12 months and beyond. And I think the government lives will contribute to that, but I don't think it's sort of going to be like there's some kind of step function specifically associated with the government license.

12 months and beyond.

And I think the government lives will contribute to that but I don't think its.

Sure it's going to be like there is some kind of step function specifically associated with the government lives.

Corinne Jenkins: Thank you very much. No problem. Thank you. Thank you. And our next question coming from the line of Ron Weber with Colin Yelan is, "Is Elan Is Elphine." Great, thanks for taking it. I have a couple of questions on Brepositnib.

Got it thank you very much.

No problem. Thank you.

Yeah.

Thank you and our next question coming from the line of Euro.

Huron Weber with Cowen Your line is open.

Great. Thanks for taking the I have a couple of question.

Breakfast, Sydney, and just remind us a a alopecia reorder.

Ron Weber: Just remind us, AA, Lepicia Ariata, what are your plans sort of with that indication? And then, secondly, for H.S., can you just conduct one pivotal? Is that sort of sufficient, or do you think you need two?

What are your plans with that indication.

And then secondly for Hs can you file can you just conduct one pivotal is that sort of sufficient or do you think you need to and then I guess finally, what point can you present or as far as is it going to present the data.

Matthew Gline: And then, I guess, finally, what point can you present or how far you're going to present the data from the studies? I mean, the studies are positive, obviously. I'm talking about Crohn's and H.S., but just so we can also understand the overall profile safety-wise.

From the studies. The studies are positive, obviously, I'm talking about Crohn's and Hs, but just so we can also understand the overall profile safety wise I mean, there's obviously a lot of data out there, but just so we see the full data. Thank you yep perfect.

Matthew Gline: I mean, there's obviously a lot of data out there, but just so we see the full data. Thank you. Yeah, perfect. Look, I think, um, the first answer is alopecia. We have no current plans to progress in alopecia.

Look I think.

The first answer is.

On our P chef.

Have no current plans to progressing alopecia, it's an interesting indication of our data looks promising.

Matthew Gline: That's an interesting indication. Our data looks promising, but our view was sort of the same as for the other slightly larger indications. So, you know, I think not sort of on our near-term roadmap, but obviously, with the quality of the data we have, we'll be watching everything. You know, on the other questions, you know, first of all, on H.S. specifically, look, I think it's, it's, uh, it's premature. We haven't sort of discussed it with FDA in detail or anything like that. We don't have a concrete plan there.

But our view was sort of the same as for the other slightly larger.

Indications.

So I think not not sort of on our near term roadmap, but obviously with the quality of data we have will be watching everything.

On the other questions.

First of all on Hs, specifically look I think it's.

It's premature we haven't sort of discussed it with FDA in detail or anything like that we don't have a concrete plan there.

Matthew Gline: So I'd probably rather not box this in on a particular study design. That's probably what I'd say there. Might you have anything else you'd say in terms of, you may be sort of slightly closer than I am to the Pfizer publication timelines. Um, yeah, so I think, um, not too much more to add. I think, um, you know, that, uh, the Cone study in particular, um, you know, uh, still has a maintenance portion to couple of wrong with. I look forward to seeing more at a future medical meeting. And then the ACHS study actually has been published at this point. So we, And Pfizer's got discretion on the publication on Chrome. Thanks, Sharon. I appreciate it.

I'd, probably rather not boxes in a particular study design.

Yeah.

Probably what I would say there isn't anything else you would say in terms of.

The other points or you might be sort of a slightly closer than I am to the Pfizer publication timelines.

Yeah sure so I think.

Not too much to add I think.

That current study in particular.

So a lot of the maintenance portion of that coupled along with it.

We look forward.

Look forward to seeing more of that at a future medical meeting.

The Hs study is actually Hasnt been published at this point, so we think that that.

Pfizer's got discretion on the publication microbes.

Okay.

Yes.

Mayukh Sukhatme: Thank you. Our next question comes from the line of Douglas Sawitz-HC Winwright. The line is open. Hey, Doug, you might be on mute. Can you hear me now, Matt? Sorry about that.

Thanks, John I appreciate it.

Thank you and our next question coming from the line of Douglas Tsao with H C. Wainwright. Your line is now open.

Hey, Doug you might be on mute.

Can you hear me now, Matt sorry about that yes perfect.

Starting with the kana.

Douglas Dylan Tsao: Yeah, perfect. Okay, um. Starting with the camera, I'm just curious, as you have successfully added to the coverage for the product. Do you anticipate making any changes to the sort of co-pay card or the sort of access program, consumer access program as it is now, or do you anticipate waiting until getting approval in AD before making any changes? Yeah, thanks, Doug. That's a great question. Look, I think for the moment we have no immediate plans to change the co-pay card.

I'm just curious as you have you successfully added.

Two the coverage.

For the product do you anticipate making any changes to the sort of copay card or the sort of access program consumer access program as it is now or do you anticipate waiting until getting approval in <unk> before before making any changes.

Yeah. Thanks, Doug that's a great question look I think for the moment, we have no immediate plans to change that.

To change the copay card.

Matthew Gline: Sort of set up in a way as I'm very appreciated to work well for us as people migrate from uncovered to covered. And, you know, unlike some of the other cards that were set up initially, some of our competitor programs or other new topicals had like, you know, $10, $10 programs or whatever, where the uncovered side of the card was low in order to attract scripts at a time when coverage was spotty. You know, we always had a slightly higher copay on the uncovered side.

Sort of set up in a way as I'm sure you appreciate to work well for us as people migrate from uncovered the covered.

And unlike some of the other cards that were set up initially some of our competitor programs or the new topical would have like.

$10 $10 programs or whatever the uncovered side of the card was low in order to attract trips at a time when coverage was spotty or you know, we always had a slightly higher co pay on the uncovered side. It was frankly set up to carry us into the <unk> launch and beyond.

Matthew Gline: It was frankly set up to carry us into the AD launch and beyond. You know, we evaluate this stuff constantly, and our focus right now is, the high prescribing doctors feel really great about the product, and what we're really focused on is taking the doctors who are writing two scripts a month and turning them into five and ten scripts a month doctors. And I think the sort of goal of whatever changes we make would be to sort of keep that process in motion. But the short answer is that I think the copay card actually works reasonably well.

We evaluate this stuff constantly.

And our focus right now is the high prescribing docs feel really great about the product and what we're really focused on is taking the actual rate in two scripts per month and turning them into five <unk> docs and I think the sort of goal of whatever changes, we make would be to sort of keep that process in motion, but the short answer is I think the copay card actually works reasonably.

Matthew Gline: To be honest, if there's something I think we're sort of working on, it's, I think at this point, the actual quality of coverage is better than the perception of coverage. I think these docs have been burned a fair amount historically on challenging coverage in Durham, and we actually have quite good coverage. It's easy to obtain many, many of their patients, as you can see from the presentation, will be covered.

Well.

Honestly, if there is something I think we're sort of working on it I think at this point the actual quality of coverage is better than the perception of coverage I think these docs have been burned a fair amount of historically challenging coverage in them.

And we actually have quite good coverage, it's easy to obtain many many of their patients as you can see from the presentation. We will be covered I think many dermis frankly have not caught up with that reality and so a lot of the educational work. We're doing is just trying to make sure.

Matthew Gline: I think many people have not, frankly, caught up with that reality yet. And so a lot of the educational work we're doing is just trying to make sure people understand that picture as well as we can possibly help them understand it. Matt, you sort of touch on another point.

People understand that picture as well as well as we can possibly help them understand it.

Okay.

That you sort of touched on another point I'm, just curious your perspectives and how do you.

Matthew Gline: I'm just curious about your perspectives, and how do you, or what's the plan right now to sort of help accelerate the writing from sort of your low prescribers, right? I mean, because it sounds like, you know, your script base is fairly concentrated, and obviously, to sort of take it to the next level, you're going to need to increase that depth. What are the things that you're able to do to get people to go beyond just writing that first initial script and are used in a way? What is keeping them from only writing just a couple of scripts, right?

What's the plan right now just sort of help accelerate.

The writing from some sort of a good low prescribers right I mean, because it sounds like.

Your your script basis fairly concentrated in obviously to sort of take it to the next level youre going to need.

To increase net debt what are the things that you're able to do to get people to go beyond just writing that first initial script and.

Aware of what is keeping them from only right and just a couple of scripts right now. Thank you, yes. Thanks, Doug.

Matthew Gline: Yeah, thanks, Doug. Look, it's a great question. It's quite literally a billion-dollar question, so we spend a lot of time thinking about it. You know, I think the short answer is we've already taken certain steps. We have DTC now. DTC was something we were pretty conservative about up until we got to this sort of good payer coverage position.

Look it's a great question.

It's quite literally 1 billion dollar question. So we spend a lot of time thinking about it.

I think the short answer is we've already taken certain steps. We've got now DTC was something we were pretty conservative about up until we got to the sort of good payer coverage position so within the last month or two.

Matthew Gline: So within the last month or two, we've really sort of started to ramp up the DTC campaign, and that should take months more to really fully sort of make it into the script volumes, but it's something that we are watching. to drive volumes that way

We really should have started to ramp up the DTC campaign and that should take months more to really fully sort of make it into the script volumes, but it's something that we're watching to drive volumes that way.

Matthew Gline: There's other things too. There are some. You know, one property of these patients is that they don't go to the doctor very often. And so, frankly, if you were a hypertriving dermatologist, you'd have been waiting for the VTAMA launch for many years. If you were a low-prescribing dermatologist and just sort of showed up, maybe you wrote a few test scripts or you wrote a few test scripts every month, but you actually haven't seen very many patients back in your office who you put on VTAMA a year ago.

There's other things too.

You know.

One property is these patients don't go to the Doctor very often and so frankly, if you were a.

If you were a hydrocracking dermatologist you've been waiting for the <unk> launch for many years. If you were a little bit driving dermatologists sort of showed up maybe he wrote a few test scripts are you're right. A few test scripts every month, but you actually haven't seen very many patients back into your office, who you've put out and became a year ago.

Matthew Gline: And so, you know, I think one thing that works in our favor is just time, docs sort of seeing repeat visits from patients who they put on, you know, earlier in the launch. And I think that will cause a compounding effect for us. And then we continue to sort of keep our ear to the ground and work on, you know, whatever the questions are. As I mentioned, the coverage question is probably one of the most important messaging questions that we're working on right now.

You know I think one thing that works in our favor is just time is just docks through we're seeing repeat visits from patients who they put on.

Earlier in the launch and I think that will cause a compounding effect for US and then we continue to sort of keep our ear to the ground and work on whatever the question as I mentioned the coverage question is probably one of the most important messaging questions that we're working on right. Now is just helping docs understand that this isn't like other topical but it is going to make a difference for their patients who is going to be easy for them to use.

Matthew Gline: It's just helping doctors understand that this isn't like other topicals, but it's going to make a difference for their patients and it's going to be easy for them to use in a way that some of the other historical launches have been more challenging. And so I think that's, um, That's where a lot of our focus is. I'd say in the doctor hall that I've been closest to, frankly, the number one point is this payer coverage point: docs are a little gun shy about where things are on the payer side.

Some of the other historical launches have been more challenging and so I think that some.

That's where a lot of our focus is.

Hey.

In the dark hole, but I'd been closest to frankly the number one point is this payer coverage point just your stocks are a little gun shy about where things are on the payer side, but we hear other other things that we continue to work on and in General I think Dr. We're familiar with the product we're pretty happy to be using it. So we're just trying to get.

Matthew Gline: But we hear other things that we continue to work on. And in general, I think doctors who are familiar with the product are pretty happy to be using it. So we're just trying to get everybody else to build some muscle memory. Remember, these doctors write cortic steroids in their sleep.

Get everybody else to build some to build some experience in muscle memory remember these stocks right corticosteroids in their sleep. So it just takes it takes some time.

Matthew Gline: So it just takes, it takes some time, but we'd love to see it faster. Okay, great. Thank you so much. Thanks, Doug. Thank you. And I'm not showing any further questions in the Q&A at this time. I will not turn the call back over to Mr. Matt Glein for any closing remarks.

But we'd love to see faster.

Okay, great. Thank you so much.

Thanks, Doug.

Thank you.

And I'm not showing any further questions mechanic you at this time I will now turn the call back over to Mr. Matt Klein for any closing remarks.

Unknown Executive: Great. Well, look, I just want to say thank you to everybody for listening this morning. Thank you to our team for all the work this quarter and beyond. I'm really looking forward to the next couple of months here. We're going to have some important opportunities to get back together. And, yeah, thanks to all. And have a great rest of your summer. And we'll be back here soon to talk about some more exciting updates. So thank you, operator. Thank you, everyone, for listening. And we'll talk again soon. Ladies and gentlemen, that I'm having a conference for today. Thank you for your participation. You may now disconnect.

Great well look I just want to say thank you to everybody for listening. This morning. Thank you to our team for all the work this quarter and beyond I'm really looking forward to the next couple of months here I think we're going to have some important opportunities to get back together.

Yeah, Thanks, all and have a great rest of your summer.

We'll be back here soon to talk about some more trading update so thank you operator. Thank you everyone for listening and we'll talk again soon.

Ladies and gentlemen that does conclude our conference for today. Thank you for your participation you may now disconnect.

Okay.

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