Roivant Sciences Q1 2024 Earnings Call Transcript

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Provided by Quartr
August 14, 2023

There are 11 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the RoyVanc First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please note that today's conference is being recorded. I will now hand the conference over to your speaker host today, Stephanie Li.

Operator

Please go ahead.

Speaker 1

Good morning, and thanks for joining today's call to review RoyVest Financial Results from the company's Q1 ended June 30, 2023. I'm Stephanie Lee with RoyVanc. Presenting today, we have Mac Lyne, CEO of RoyVanc and Mayib Sukhatni, President and Chief Investment Officer of RoyVanc. For those dialing in via conference call, you can find the slides being presented today as well as the press release announcing these updates on our IR website at www.investor.royVanc.com. We'll also be providing the current slide numbers as we present to help you follow along.

Speaker 1

I'd like to remind you that we'll be making certain forward looking statements during today's presentation. We strongly encourage you to review the information that we filed with the SEC for more information regarding these forward looking statements and related risks and uncertainties. With that, I'll turn it over to Matt.

Speaker 2

Thank you, Stephanie, and thank you everybody for joining this morning and for listening. It's only been a short actually 6 weeks since our last call because our last call is for the K. So comparatively a little bit short Certainly an exciting quarter ended June 30 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 VITAMA sales. And then actually what we're going to spend the bulk of time on today is We've been getting more questions about repitinib, and we've actually got some new data there in Crohn's disease.

Speaker 2

So we're 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 5. 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 enduring 2 sorry, during one study, the second study of VEKALIN atopic dermatitis, which we continue to be proud of that track record, which has now led to 6 FDA approved products across Roivent and and Sumitomo collaboration.

Speaker 2

As of six thirty, we had just under $1,500,000,000 in cash on the balance sheet, which as we've guided Comfortably funds us into the second half of twenty twenty five 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 and I pipelines With by our estimate over $15,000,000,000 in peak sales potential supported by VITAMMA, but also a number of critical first and best in class programs behind it. On Slide 6, and it's funny because this is a relatively, as I said, quiet moment, The 2022 has been and I expect will continue to be an extraordinary year for us as a business. As a reminder, up till now, In addition to continued progress on the VITAMMA commercial launch, and we'll come to that in a second, we've generated positive data in now both large Randomized controlled studies, Phase 3 studies in atopic dermatitis for vitama, which as we've said before, will support our filing for additional indication there beginning of next year approval, hopefully next year as well.

Speaker 2

And then we've also now put out Two important data sets, 1 in January and 1 in June, demonstrating the efficacy and our overall enthusiasm for RVT-three thousand one hundred and one, our TLNA antibody, which obviously has gotten a lot of discussion. That program is actually one of the most important in our pipeline now. We are currently underway with our Phase 2 Crohn study and in the midst of preparations Our Phase 3 study in ulcerative colitis, which we will share more detail on in the near future. Still coming for the year are 2 pretty important events. One which I expect we'll get some questions on, I know Immunovant has spoken a lot about recently, is the upcoming single ascending dose and multiple ascending dose data for IMVK-fourteen oh two, Our next generation anti FcRn antibody, at Immunovant.

Speaker 2

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's a number of other data sets in our FcRn franchise and sort of 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 brepacitinib. We have that's our dual inhibitor of TYK2 and JAK1 That program has its what would be 1 of 2 registrational studies in SLE, a Phase 2b study reading out in the Q4 of this year. And actually just a lot going on generally there as well.

Speaker 2

And it's a program that I think is just starting to get some attention, but it's really sort of early around people's radar. So all of that situates on Slide 7 in our late stage pipeline, which 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 nimilumab RBT 2001 that are earlier stage higher SKU opportunities that we'll share more about as we get data, which will happen sort of starting at the end of this year with 2,001 and beyond with nimilimab. So with that, I'm just going to go into a brief update on where we are on Tecama, Starting on Slide 9. So look, we continue to be bluntly very excited about the progress that we are making here.

Speaker 2

We continue to see 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 prescribers who have written over 200,000 scripts, which is pretty extraordinary for just over a year on the market.

Speaker 2

It's a really strong start from our perspective. On Slide 10, I just wanted to give a sort of payer update. So we're up to about 130,000,000 lives covered, Just a tick under 80 percent of commercial lives, plus 87,000,000 government lives. 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 covered perspective. We are on formulary With all 3 of the major PBMs, so we're in good shape from a major PBM perspective.

Speaker 2

We have 4 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 and recovery perspective. And the other thing I'll say is the significant majority of this coverage obviously has no prior auth. That's a little bit of a red herring In dermatology, we're very few drugs are true prior auth, but most importantly, the majority of it is single step through a steroid with very easy It's a process 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.

Speaker 2

We did $16,700,000 in net revenues for the quarter, which It continues to be a solid progression in growth quarter on quarter. I feel good about that growth and expect to continue to see it to accelerate with both volume and gross to net improvements in the future. Gross to net was a hair better, 26% yield over last 3.31 quarter with some earlier formulary additions. So I expect CGTN to progress sort of We're nearly 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 As other payer progression is all, we're moving exactly in the direction we needed to and we think we're in a good shape from a GTN perspective.

Speaker 2

So that's about it on VITAMA for now. I'm sure we'll get some more questions. Look, I think the continued progress there It's 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 yes, we're really also looking forward to getting going in AD next year, which is as you may remember, about 4 times larger market opportunity where we have some truly excited and highly differentiated data.

Speaker 2

So with that, I'm going to

Speaker 3

turn it over in just

Speaker 2

a moment to Mayank, who's going to do a relatively deep dive here on brepcitinib, 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. That's a really exciting program. It's a Very potent agent, which continues to demonstrate strong clinical efficacy. And one of the main reasons we're highlighting it today, which maybe we'll talk about is we generated some data Pfizer had an ongoing study in Crohn's disease. It's readout and once again the agent has shown Great promise in another clinical study.

Speaker 2

We are unlikely as you know to progress it 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, let me hand it over to Mayuk to take it away, starting on Slide 13.

Speaker 4

Yes. Thanks, Matt. Yes. So, yes, please turn to Slide 13. So, As Matt said, I wanted 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.

Speaker 4

To the extent that represent and we've begun to get some notice from investors, I think it's mostly through the lens of being a pivotal study catalyst for Roivent 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 rafasitinib. So I want to go through that story of fresh new year today. The punch line from my perspective is don't sleep on brepacitinib.

Speaker 4

So put simply, brepacitinib is a unique, highly, highly active dual inhibitor of both PIK2 and JAK1 that has already shown spectacular efficacy in a broad range of audit with feasas. So as Matt said, we're reporting here for the first time The 6th consecutive positive Phase 2 study for bracositinib, this time in Crohn's disease, which is a study that is being run by Pfizer and done at Pfizer's extent. And that adds to the string of positive Phase 2 studies already reported, now covering, as you can see here on the slide, Psoriasis, alopecia, psoriatic arthritis, ulcerative colitis, hidradenitis, suppurativa and now Crohn's disease. 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 TYK2 and JAK1 should provide greater efficacy than inhibition of either one alone.

Speaker 4

That is a large global study that is designed to Our ongoing single Phase 3 study in dermatomyositis, which will serve as the basis of an NDA filing shortly It's 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 twenty twenty four, It will come into focus as a near term catalyst to everyone. And that's just the beginning for this program. So we think that, that unique dual mechanism And high demonstrated efficacy of brepacitinib really creates a pipeline and a product approach where we can own a series of specialty rheumatology indications, each of which has high end need and blockbuster revenue potential for brefacitinib, and we'll show that in the coming slides. And then finally, We have a long IP runway here with protection to at least 2,039.

Speaker 4

Please turn to Slide 14. As many of you know, the JAK family consists of 4 isoforms, JAK1, JAK2, JAK3 and TIK2. The JAK family inhibition has proven over the past several years to be an enormously powerful mechanism for treating a wide spectrum of autoimmune disease. 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. Shown here is a simplified schematic detailing a number of Key cytokines that have been shown to drive pathobiology of autoimmune disease along with the key JAK isoforms responsible for mediating those signaling pathways.

Speaker 4

While early JAK inhibitors were relatively non selective, more recently in the field has trended towards more specific inhibitors with JAK1 having the broadest applicability and therefore unsurprisingly the first to be explored. You can see here in the dark blue band across the middle where JAK1 inhibitors such as RINVIL impact and the cytokines that are most directly impacted. Notably, selective JAK1 inhibitors are able to suppress signaling of IL-six and interferon gamma, 2 important cytokines linked to autoimmunity that are not suppressed through selective TYK2 inhibition. Now TYK2 Selective inhibitors such as CITIC-two are now coming out of the scene in a particular set of indications. They cover a different set of cytokines, which you can Now both JAK1 and TIK2 approaches are accumulating a track record of meaningful clinical benefit and commercial success across a range of disease.

Speaker 4

RINVOC is already approaching $1,000,000,000 Net revenue per quarter and Sotyqtu is also projected to be a multibillion dollar product. But in spite of their many successes, Both of these medicines also have their limitations. STATIKTU, for instance, failed outright in both ulcerative colitis and Crohn's, While RINVOC has produced lackluster Phase 2 data in both lupus and H. A. We see this At least in part connected to the underlying biology.

Speaker 4

While some of these may be well treatable by selective JAK1 or TIK2 inhibition alone, Many others involve multiple inflammatory pathways and may require intervention across multiple orthogonal lackeys 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 burden, where clinically meaningful efficacy has to date been limited. So that's what drove our original hypothesis at Roivent That the field in its current state may not be fully maximized in the power of JAK inhibition, that efficacy might be getting left on the table and certain indications with highly specific TYK2 or JAK1 inhibitors. So in our search for the right molecule to prove out this hypothesis, We unsurprisingly ended up partnering with Pfizer, probably the company with the longest history and deepest experience with JAKs in the industry. In replacitinib, we found a highly active, safe and well characterized molecule with a novel mechanism perfectly suited for what we are looking to do.

Speaker 4

Simultaneous inhibition of both TYK2 and JAK1, which we can uniquely accomplish with replacitinib, creates Two distinct opportunities to deliver differentiated efficacy. 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 TYK2 or JAK1 alone. And second, diseases with broad cytokine involvement that include, for instance, both IL-six and B cell pathways on one hand So that's the core hypothesis stated in the bottom right. Replacitinib will deliver Please turn to Slide 15. So what concretely drove our excitement about brefacitinib?

Speaker 4

So to start, When we looked at a series of standard cytokine inhibition assays, we saw exactly what we hoped to see. So shown here are the results of studies run internally at Pfizer. The left panel looks at type 1 Interference Signaling, a key driver across multiple autoimmune diseases and one where both TYK2 and JAK1 inhibition That's exactly what you see experimentally, the nICE inhibition by the leading KURJAK1 inhibitor and nice inhibition by the leading TRY-two inhibitor. And then importantly, Pfizer's experimental data showed that brepacitanib is able to suppress We are benefiting from the double hit and thus achieving a greater inhibition of Type 1 interferon signal. On the right, we show 2 other critical So on the top right, you see type II interferon interferon gamma, which is mediated by JAK1, but not by TYK2.

Speaker 4

The pattern of inhibition is again what you'd expect. You see that RINVOK and repacitinib, which both inhibit JAK1, have a relatively higher degree of inhibition than of interferon gamma compared to the selective TYK2 specific inhibitor, CEDICTI. And then on the bottom right, you see the opposite performance from the single isoform drugs on a cytokine inhibition assay for IL-twelve and twenty three. So here you see a nice inhibition by Cetiktu, the Cetiktu specific inhibitor, while the action of RINVOC is much more modest. Again, that's exactly as we'd expect based on the schematics we showed in the prior slide.

Speaker 4

And again, you see that bracositinib is a very, very good and strong TIK2 mediated cytokine, outperforming the TYK2 in this assay. The conclusions here are listed at the bottom. On the left, you can see that brepacitinib should achieve greater type 1 interference suppression And it's possible by targeting either TYK2 or JAK1 alone by virtue of the dual hit. And on the right, brepacitinib can resuspiculate in a single molecule That cytokine inhibition experimental data has translated well into a string of Phase 2 data readouts to date. As you can see, oral brepacitinib has demonstrated an extremely consistent pattern of meaningful clinical efficacy in every single indication tested.

Speaker 4

Advocacy results for alopecia, psoriatic arthritis, ulcerative colitis, psoriasis and HF were all statistically significant and consistent with As good or better than any other small molecule inhibitor, the ATS data, which I'll cover later, was a relatively recent readout that occurred subsequent to our taking over the drug from Pfizer. We're also excited to be reporting today the induction results of the large global Phase 2 Crohn study run by Pfizer. So I'll provide some additional details in the following slides. Finally, we have another major benefit in the clinical package for reprocitinib. We know what we have on safety as well.

Speaker 4

We know that stacking both TYK2 inhibition and JAK1 inhibition does not apparently lead to a safety profile that undercuts the Our extensive safety database now consists of over 1400 patients exposed across 20 different Phase 1 and Phase 2 clinical studies for up to 64 weeks. And what we've seen is a well characterized safety profile in line with approved JAK Family Inhibitors. Please turn to Slide 17. So we're pleased to report today the top line results from the induction portion We have a Phase 2 study with brepacitinib Crohn's disease. This is 151 patient global Phase 2 study.

Speaker 4

The primary endpoint was the SES CD50 and the key secondary endpoint was the clinical remission rate at week 12, Defined as a proportion of patients who achieved a CDAI of less than 150, both endpoints were highly significant. We think that actually the TRU F-fifty might have been understated on the FESC-fifty in this study as there ended up being a slight imbalance in baseline severity between the arms, which made it harder to achieve that endpoint for the drug arm. That imbalance would not have an impact on the secondary end Since the way that that endpoint is calculated only takes into account patients who start with a baseline CDAI of greater than or equal to 220. The punch line here is that this is a trial that I'm sure it wasn't on any investors' radar and yet has delivered really strong efficacy. In fact, that 33.5 is in fact the highest seen in the late stage study from any drug, oral or biologics to date.

Speaker 4

Please turn to Slide 18. So we find ourselves in an enviable position. So we have a highly efficacious molecule that has strong biologic and clinical translation in a variety of large market indications. There are lots of things that we could do with represidinib, but our vision with represidinib from the start was to really focus on those indications where we could deliver a To that end, we asked ourselves what are the disease indications where the unique properties of bracitinib really shine. For us, that came down to a few simple considerations laid out on the left side of the slide.

Speaker 4

So in the light blue and moving clockwise, the first, Where is inhibition of both TYK2 and JAK1 required for maximal efficacy? Here we look for biologic rationale for dual TYK2 JAK1 inhibition and corresponding clinical validation. 2nd, IndarFlu, which indications have extremely high morbidity and mortality, Creating a need for novel therapies that provide a meaningful efficacy benefit. And 3rd, in pink, there's the indication has few available treatments, including no approved oral therapies. And finally, of course, we need to be confident that we could run an efficient experiment minimizing development and regulatory risk.

Speaker 4

Put those together and we think that there's an opportunity for brefacinib to become a leading treatment option in a series of large and unproduct markets. The next two sides will go into more detail on Corvea Malignis, but remember that's just the beginning. Please turn to Slide 19. Dermatomyositis is a large orphan indication with a very similar profile to indications like PAH and cystic fibrosis, And the reason for the medical community is that an increase in 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 estimate that the U.

Speaker 4

S. Adult prevalence fits at 37,000 patients, consistent with recently published estimates as well. So we're looking at a patient population that is already clearly in the large 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 affecting this many patients, germanium arsenidec presents a strikingly high disease There is high mortality with some estimates of up to 40% at 5 years.

Speaker 4

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 activity. 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, which covers multiple organ systems and will evolve into a large commercial market.

Speaker 4

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 stage development. Steroids, ISTs and IVIG For many years, with the latter recently gaining formal approval. But again, there is 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. IVIG, for instance, So we really see DM as one of the major unmet needs in all of autoimmune disease and an opportunity for a modern targeted therapy, particularly in oral 1, to enter the market and rapidly become a blockbuster product. 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 3 other than brepacitanib.

Speaker 4

So looking ahead to Product launch of BREFO in this market in just 3 years, we think this has the potential to become a material commercial driver for Roivent as we think about the overall sales across our pipeline over the next 5 plus years. Please turn to Slide 20. We also see this as an indication where the positive success for Breville is very high. With no modern medicines approved for DM, Physicians often experiment with various different therapies to add on to corticosteroids. As a result, 2 investigator initiated studies and an extensive body of case report, There is meaningful clinical validation for JAK1 inhibition in DM.

Speaker 4

This aligns with the pathobiology of the disease, which is driven in large part by Type 1 and Type 2 Given no other JAK1 inhibitors are approved or an industry sponsored development for DM, even if BREPRO just matched this level of efficacy, You can further add to the benefit that brepacitinib will provide both to enhance potency of type 1 interferon suppression as well as through suppression of IL-twelve and IL-twenty three, which are also involved in DN Path of Biology. Please turn to Slide 21. Given the high unmet need and our high confidence system for success, We took the bold step of moving directly into a Phase 3 program that involves a single registrational study. Our expectation is that this study, if successful, would support an NDA filing for pravacitinib and DM. The single Phase 3 study is already well underway, tracking to complete enrollment in 2024 with data and a potential NDA filing in 2025.

Speaker 4

This timeline has us clearly positioned to be the 1st oral to market by potentially several years And likely also ahead of the few biologics in later stage development. One idiosyncratic consequence of our decision to move directly into Phase 3 is it means that our next catalyst in DM Won't be coming until 2025, but that catalyst could be a major inflection point for Roivent as a business with a potential $1,000,000,000 plus product launch immediately to follow. And given this launch would be an orphan indication with a specialized subscriber base, we would expect the revenue ramp to be significant and steeper than for a volume product like Tecama. So as you think about modeling RoyVanc's P and L over the next 5 years and beyond, we think this is a major first conditional value that investors right now may be under appreciating. Please turn to Slide 22.

Speaker 4

DM is the first of many orphan indications where we see a similar opportunity for brevacitinib and I'll talk about a 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 lupus. Lupus is a disease that everyone knows well and is 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 disease. Only 2 therapies have been approved in the past 20 years, both injectables.

Speaker 4

And as a sign of how desperate the field is for efficacy, Benlysta is doing greater than a $1,400,000,000 in U. S. Revenue despite very modest efficacy at between 9% to 14% placebo adjusted SRI 4. Ensifnalo, which launched recently, is projected to be a $1,000,000,000 plus product despite mixed Phase 3 data. One study didn't show statistical significance, while the other showed about 18% placebo adjusted SRI 4.

Speaker 4

Please turn to Slide 23. The limited options reflect an unfortunate reality everyone Well, lupus is simply a very challenging disease to treat. It's highly heterogeneous with multiple interconnected inflammatory pathways that can be T cells, This involves a molecule acting predominantly across 1 of those reactions. Enliste, for example, depletes B cells, while cephalelo suppresses interferon signal. Both have generated meaningful, but ultimately somewhat modest efficacy.

Speaker 4

And of course, there's a long history of failed attempts at individual cytokine inhibition, indicating broadest cytokine suppression is needed as well. Through dual TYK2 and JAK1 inhibition, pravacitinib is distinctively optimized To address all three axes simultaneously, the FIC II arm modulates T cell activities with IL-twelve and the IL-seventeen T-eight seventeen axis through IL-twenty three. The JAK1 arm modulates B cell activity to IL-six, IL-seven and IL-twenty one, and both are in force together to maximally suppress Please turn to Slide 24. Over the past 18 months, We've had readouts from 3 JAK inhibitors of lupus, including Phase 3 data from Olumiant, a JAK1two inhibitor Phase 2 data from Linbrook, a JAK1 inhibitor and Phase 2 data from SYDYK2, a TYK2 inhibitor. These data provide clinical evidence for the therapeutic relevance of each of JAK1 and TYK2, respectively, in lupus and as such increased our confidence in brefacitinib's positive success.

Speaker 4

At the same time, none of these molecules have demonstrated particularly compelling benefit With the high watermark so far being specific to, if you blended across in the roughly the mid teens placebo adjusted SRI 4. This is what we might expect given that unlike represetinib, none of these molecules directly targets all 3 inflammatory axes and lupus. So we are cautiously optimistic that through dual SYK2 and JAK1 inhibition, prapacitinib can deliver greater efficacy benefit that we've seen from these other oral therapies and become the leading oral therapies for patients and physicians. Please turn to Slide 25. We continue to expect top line results from our ongoing study of brefacitinib in lupus in the Q4 of this year.

Speaker 4

As we've stated in previous earnings calls, this is a large global study using the registrational 52 week primary endpoint and as such In the event of a positive outcome, we would expect to rapidly initiate a second confirmatory registrational study. I do want to emphasize that while we're cautiously optimistic that brefacitinib can deliver data that will position us as the leading oral therapy in lupus, Our confidence in the product success here is not as high as in dermatomyositis. We feel rock solid that we are hitting the pathways that matter, But we as an industry have had mixed success improving out efficacy on regulatory endpoints such as SRI IV. Lupus is just a challenging indication And given the 6 successful Phase 2 placebo controlled studies we've had to date, Our enthusiasm about representib in these other indications will remain irrespective of our results in lupus. Please turn to Slide 26.

Speaker 4

Turning now to these other indications, I just want to highlight 2 in addition to dermatomyositis where we have a rapid potential path to market with launches that could follow closely behind DN's. Coupled to highlight here are non infectious uveitis or NIU and HS. Please turn to Slide 27. NIU, like dermatomyositis, is a large orphan indication with a very high disease burden with approximately 30,000 cases of legal blindness attributable to NIU each year. Unlike DM, there is one approved targeted therapy, HUMIRA, which has generated over $500,000,000 per year in sales despite limited efficacy and almost no indication specific promotion.

Speaker 4

The development stage competitive landscape in NIU is even more wide open than in DM with no ongoing Phase 3 studies at this time for any oral or biologic. An efficacious oral therapy could easily match Humira's peak sales in this indication and with sufficiently compelling data, we could potentially do significantly more. Please turn to Slide 28. As with Centimeters, we also have clinical validation of JAK1 inhibition in NIU. Before filgotinib development was discontinued in the U.

Speaker 4

S, it has generated Phase 2 data in NIU suggesting JAK1 inhibition may be more efficacious than TNF alpha suppression by Humira. However, the extent and robustness of clinical validation of JAK1 inhibition in NIU It's not quite as great as NDM. And so in this indication, rather than moving straight to Phase 3, we are conducting a quick proof of concept study. 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 Q1 of 2024.

Speaker 4

Please turn to Slide 29. HS follows a similar pattern to DM in 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 $3,000,000,000 per year, Again, despite limited efficacy and limited indication specific promotion. Please turn to Slide 30. Unlike DM and NIU, HS does have other oral therapies in later stage development, specifically to JAK1 inhibitors.

Speaker 4

As you can see on this slide, the Phase 2 data recently generated by prepacitinib is greater, both in terms of absolute and placebo adjusted benefit Notably, brefacitinib's benefit was robust across both TNF naive and TNF refractory patients and was generated despite the study being heavily impacted by COVID related discontinuation. In fact, the placebo adjusted benefit among the completers was actually 27%, suggesting an opportunity to potentially demonstrate even greater benefit in Phase 3 than Phase This is further supported by HS Pathobiology, which involves not only JAK1 mediated inflammatory pathways, but also the clinically validated IL-twenty three-thirteen axis, which is suppressed by a TYK2 inhibition, but not JAK1 inhibition. 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 brepacitinib. It's a highly active molecule with a unique mechanism of action and long patent line that sets us up to potentially create the leading oral Specialty Autoimmune Franchise in the Pharmaceutical Industry.

Speaker 4

Here on this slide, you see how this pipeline and the product will build in the coming years. We have a rapid derisk pass to $1,000,000,000 plus commercial launch in DM with full enrollment of 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 HS, NIU or both could be initiated in 2024. We have other large orphan indications to follow with potential proof of concept studies planned for 2024.

Speaker 4

With that, I'd like to thank Ben Zimmer and the rest of 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 it back over to Matt.

Speaker 2

Thanks, Mig. Appreciate it. And obviously, thank you for that deep dive into the program. Some questions about it, but I also just want to set people up for the months and frankly years ahead with it. So looking forward to more there.

Speaker 2

I'm going to go very quickly through the rest here and then open up for Q and A in just a minute or 2. Starting with on Slides 3435, While we're not going to spend any time today on the CL1A 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 that it felt weird not to at least nod to that extraordinary data set. 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 the 56 weeks and some of the things that set us up really well for the Phase 3 programs. So More on that to come.

Speaker 2

As a reminder on Slide 36, we are now underway including first patient dose with our Phase 2 study in Crohn's. The goal here is to get, as I've said it before, dose ranging out of the way prior to beginning Phase 3 In a way where when we look at all of these timelines just acting together, we think we still have an opportunity to be effectively 1st in class in Crohn's disease by going quickly from this study into a Phase 3 study in Crohn's. So we're very excited about the opportunity for TO1a 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 stage portfolio on Slide 37, I talked about this a little bit at the beginning. Obviously, we collectively, like with Immunovance, are going to have an opportunity to get back together in the next Couple of months to talk about updates on our FcRn franchise.

Speaker 2

Most notably, we are expecting imminently Within the next I think, I mean, I mean, you said September for the single ascending dose data and October November for the multiple ascending dose data, data that we think will validate The best in class potential for IMBT-fourteen oh two, 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 botoqimab. 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 Escargitiamod in CIDP, which was really great data that both continue to underpin and validate the FCR mechanism. It's now worked Basically everywhere it's been studied and showed a potential in a new market, including one where we have an ongoing Phase 2b study of And then the last thing I wanted to briefly shine a spotlight on to on Slide 38 is just we continue to make progress on our various discovery efforts.

Speaker 2

I've got a slide here on VentAI, 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 Proteavant. We've now effectively collapsed The Protevant induced proximity effort into Vant AI and have sold the balance of our Protevant shares to our partner SK. And so event AI is now the sort of instantiation of our principal bed at RoyVent on used proximity and protein degradation and we are really excited With the early progress there, including some great hiring, notably, we've now got Michael Braunstein as an AI Chief Scientist. He's one of the Really the lions in the field of molecular modeling using machine learning.

Speaker 2

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. We'll get back on the phone as we've got to take the share, but keep an eye on this space as it were. So I'll wrap up very quickly on Slide 40 with a brief Financial update. Financial picture continues to evolve as we'd expected.

Speaker 2

Revenues and so on, we've talked about. Cash most notably, good into the second half of twenty twenty five 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. We've talked about some, but not all of these things coming.

Speaker 2

And just an exciting balance to 2022 ahead Sorry, 2023 ahead. So I'll say thank you to Mayuk, 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 and A. Thank you, everybody.

Operator

And our first question coming from the line of Brian Chiang with JPMorgan. Your line is open.

Speaker 4

Hey, guys. Thanks for taking my question this morning and a walk through on prebo. Maybe first on prebo, given what we saw from other JAKs in SLE specifically, How confident are you that preclinical can perform better than Dupra, specifically in SLE? Is there anything that you want to flag From the baseline characteristics in the ongoing Phase 2 design to ensure that you can show the differentiation and also make sure the placebo rate is low? Then I have a follow-up.

Speaker 4

Thank you.

Speaker 2

Yes. Thanks, Brian. And maybe I'll take one second to that question, then I'll 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 TIK2 and JAK1 That's an important point.

Speaker 2

And then I think the second important point is understanding the bar correctly. And I think if you look closely at the Duker data, Look, I'm not going to say DUKOR is not an impressive agent, 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 3 milligram dose where they showed something more impressive than that, I think there was a pretty significant patient population imbalance that It suggests to us that mid teens is really the bar to beat. As far as the baseline characteristics, 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.

Speaker 2

There were certain things that we didn't control and as Mayuk mentioned, Look, lupus is a scary indication for trial execution, but we feel overall pretty good. And 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, We'll obviously see how that plays out later this fall. Mayank, anything you'd add to that?

Speaker 4

No, not really answering that. I think you nailed all the points I would have made.

Speaker 2

Great. Thanks.

Speaker 4

And maybe just one more follow-up on ImmunoVance 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 top line in terms of 1 IgG suppression compared to botoqomab and eschar and more importantly, the impact on albumin and LDL given the potential variability in the LDL assay.

Speaker 2

Yes. Thanks, Brian. Great question. Obviously, one we're getting a lot right now, and I'm sure Immunovance is getting a lot too. But I think ImmuneVant has spoken a fair amount on this point publicly.

Speaker 2

I think on IgG suppression, look, we We have an equivalently potent molecule here and we'd like to see equivalently deep IgG suppression is the short answer. Remember comparing apples to apples versus as close as we've got to equivalent time points and things like that. But in general, I think we'd like to see really the same level of deep IGG suppression. And certainly, we'd like to I'd like to feel like we're going to be able to suppress IgG comfortably deeper than efgartigimod can. So that's on the IgG suppression points.

Speaker 2

On albumin and LDL, Obviously, there's a lot of speculation and discussion on this point. The facts are that the variability of the albumin assay is about 5 And the variability of the LDL assay is 10 plus percent. And so I think within first fractionation with relatively small studies, You want to be comfortably within both of those. Smaller is generally better. And my sense is that If the albumin impact in the SAD is relatively modest that the LDL will follow And because of the variability in the LDL, it will be easier to see if you've got a few weeks of compounding data after multiple injections.

Speaker 2

So I'm mostly looking to the albumin in the SAD data. I haven't seen really any of this yet, so I can't say

Operator

Thank you. One moment for our next question. And our next question coming from the line of David Risinger with Leerink. Your line is open.

Speaker 3

Good morning. 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

Speaker 2

Thanks, Dave. 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 to our own strategic future and also Exciting to potential partners, acquirers and so on.

Speaker 2

And it's 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. Look, I think the short answer 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 in 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 ImmunoVent data in just because that's a pretty important strategic catalyst for us as we think through what the future of RoyVent could look like across the breadth of our portfolio.

Speaker 2

On the new opportunity side, I will hand that over to Mayuk, Actually, but I guess the one thing I'll say is this has been a phenomenal asset sourcing opportunity environment for us. Obviously, a year ago today, we would not have been talking about TL1A. We also wouldn't have been talking about 1402. We hope we've proven We see some pretty interesting and unique things and that we can bring them in. And I'll say that we've got things on our racket right now that are just as exciting to me bluntly as anything in our late stage portfolio.

Speaker 2

And I hope we can convert some of those and The next year we'll be talking about them as well. But Mayuk, anything you'd add to that?

Speaker 4

Not really, Dave. I mean, look, I think that this is, as Matt said, this is kind of our sort of normal course of business to 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 in our racket. Stay tuned.

Speaker 2

Thanks, Dave. Appreciate the question.

Speaker 3

Thank you. And then just a follow-up. So, Ayuk, 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 SotyK2's inverse dose response in SLE and whether there are any Potential implications for Brepo in SLE or no? Thanks very much.

Speaker 4

Sorry, I missed just the last part of that question, Dave.

Speaker 3

So, yes. So, on the last part, the slide shows an inverse dose So as the dosing went up for so tick to 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

Speaker 4

That's right. Matt, do you want to take the indication question?

Speaker 2

Yes, sure, Hirsch. I mean, look, I think, Dave, it comes down to and this was sort of the inherent thesis in Brepo as well. I think at the moment that we acquired Breckle from Pfizer, it was sort of just in the thick of the sort of Turning point on JAK 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 in A number of these other indications that the competitive landscape there is such that the JAK labeling may be a Disadvantaged, difficult to develop through. I think if you take Crohn's, for example, I think that's an interesting question in the sense that clearly AbbVie continues to study RINVOC in IBD pretty aggressively and also the Allosteric TIC-2s have struggled a little bit there.

Speaker 2

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 in IBD, we're not sure Exactly where a JAK will fit in the future treatment paradigm, understanding 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 JAK liabilities won't be a problem and where the unmet need is highest It's sort of the place where it makes the most sense for us to pursue BREPO.

Speaker 4

Yes. I mean, I think just to add to that, look, I think we're always going to be, I think, kind of dynamic in our I think as Matt said and articulated on the call, a sort of primary thrust as it were is in these The competition is greatest, the competitive intensity is the least, etcetera. That certainly allows us to kind of have this specialty room talking about And own that area for ourselves. And so I think we've got a lot of Different options here. And then I think in part that we decontentialize over the next couple of data sets that we get in both lupus and IU and then the DM coming right In terms of your question on Sotek II, so look, I mean, I think obviously this is sort of The sort of the inherent sort of uncertainties around this Relatively small endpoint estimates as well as just sort of lupus clinical trial readouts generally.

Speaker 4

I think that Our own view is that there's not really likely a the truth is not an inverted dose response in that specific 2 study. I think there are reasons to believe That, in essence, this could be like a little bit of reflection of just like slight Imbalances between the various dose arms. So for example, we think that The 3 milligram PID arm that produced sort of highest front head, the more subjects sort of triple combination standard of care baseline compared to other arms and that the 12 milligram Once daily arm had higher dropout rates, etcetera. And ultimately, I think if you look through sort of So, take to just generally, it seems like they're quite close to saturation at the 3 mgs. There's not really kind of like a True reason to believe that there's sort of more juice in there at the higher basis.

Speaker 4

And then finally, it seems like Mid teens and blended across these three values, it seems to be consistent with how Bristol themselves seem to

Operator

Thank you. And our next question coming from the line of Robyn Karnauskas with Jefferies. Your line is open.

Speaker 5

Hi, guys, and thanks, Mayook, for doing all the work for me on lupus and BREPO. It's a fantastic presentation. A question on capital allocation. First, just on Grepco. When you think about how whether it's spend more on these Orphan Drug Indications, can you just remind us of the Pfizer agreement and how much if there's anything they contribute?

Speaker 5

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. Can you just walk us through how you're going to think about that when you start thinking about that At Versat, how long would it take you to come up with a game plan for what you're going to do for Ryvat for spend? Thanks.

Speaker 2

Yes. On the first question on REPO specifically, the answer is 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 large to bear. Pfizer does not contribute.

Speaker 2

They are protected from dilution at their 25% stake Up to a dollar cap, frankly relatively similar to the mechanism at Telavant with GLNA program. So In terms of other orphan indications, NIU, DM is all our costs, etcetera. Those are capital allocation decisions for us the same as any other. 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.

Speaker 2

More generally, I guess I probably insofar as I said, we wouldn't think about it until we saw the Univent data that was probably an overstatement. Obviously, we I've spent a lot of time thinking about capital and capital decision making as we explore the opportunity set. And I agree there's a lot of moving pieces coming. I think the SAD data will be informative. I think the MAD data will be informative.

Speaker 2

I think we're going to learn other things from the FcRn field, including some RA data from J and J, from our home grade study, etcetera, through the balance of this year. I don't know that 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 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.

Operator

Louise Chen with Cantor, your line is open.

Speaker 6

Hi, thanks for taking my questions here and congratulations on all the progress this quarter. So I wanted to ask you on brepacitinib, one thing people have been asking us 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 bookings and how you're thinking about it and what you might comp it to? And then on VITAMA, the reimbursement work you did on psoriasis, how much can that be leveraged to the atopic dermatitis opportunity so that you can move quickly on uptake on that one. And then one more here on brepacitinib.

Speaker 6

Can you be a little bit more specific on when this year we'll see the data? Is it early, mid or late Q4? Thank you.

Speaker 2

Yes. Thanks, Louise. On the 2 Brepo questions on the timing, I think it's safe to assume mid to late 4th quarter is probably the way to think about that. On pricing, I mean, I'll hand it to Mayuk, 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 I'll hand over to Mayuk.

Speaker 4

Yes. I think the punch line is, we're thinking about this principally as sort of a, call it, an orphan Drug pricing ban, given the sort of indication set and sort of what makes sense in the thesis. I think that that is potentially compatible with pricing in lupus as well. It's efficacy data is growing strong.

Speaker 2

And then on the Nutanixis 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 significant Streamline given that we're all on formulary. 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 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. Thanks, Louise.

Operator

Dennis Ding with Jefferies. Your line is open.

Speaker 7

Hi, good morning. Thanks for taking our questions. I just had one On Immuno Ensign, so on the upcoming 1402 data, can you just remind us the study design and how long is the follow-up for stat and met and Interestingly, how often is albumin being measured? And as a follow-up, maybe given your comments around the Assay variability and that there could be different time points at which albumin is measured and just also appreciating I was just wondering what are some what's a good outcome for you guys in SAD and the MAD on the albumin front. Thank you.

Speaker 2

Yes. Thanks, Dennis. I appreciate these questions. And obviously, it's an area I have a lot of focus, so it makes sense. Look, I think on study design, there's a fair amount about this in the ImmunoVent corporate deck and in ours as well.

Speaker 2

On the SAD study, it's 6,1402 plus 2 placebo patients. I forget exactly how far it is measured, but it's at least a few weeks. And then on the MAD study, it's 10, 1402 in 2 placebo patients, and it's Weekly dosing for 4 weeks and again 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 Some of the pedomab data we've put out, I'd say like the measuring points are pretty similar.

Speaker 2

And so Early yes, in fact, we follow these patients out, sorry, a lot more than a few weeks and there's sort of a number of measurements within 10 days and then it starts to get a little bit more spaced out in the SAD study. So, again, there's a fair amount of data in the minivan deck on this point. In terms of what good looks like on albumin in the SAD and the MAD, Against the backdrop of smaller is better, I think, again, with a 5% variability on 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 on albumin seem to be pretty well set up from an LDL perspective. So 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,

Operator

Corin Jenkins with Goldman Sachs. Your line is open.

Speaker 8

Good morning. This is Craig on for Corin. 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?

Speaker 2

In SLA, you said, yes?

Speaker 8

Yes, that's right.

Speaker 2

Yes, look, I think the way we are currently thinking about program understanding that it's kind of a balance of the factors is DUKRA is the bar to beat, given that they have the This would count as 1 of 2 pivotal studies, we believe if successful. So the data from here would already make it onto the label. It's 52 week study. So it should be relatively predictive of a future study as well, given the way that it's set up. So I think we have the best possible setup Understanding that there has been some complexity in SLE trials before, in terms of the bar, I think it's a balance of the factors, but I think you've heard us say that we think Sotek 2 is a mid teens drug And you've heard us say that we'd like to be better than Sotektu.

Speaker 2

So I think that gives you sort of some indication for where our head is at, but we're going to have to look at there's Multiple endpoints and things like that. So I'd say mid to high teens sort of and whatever that trend looks into across the other places to look at.

Speaker 8

Got it. That's helpful. And maybe just a quick one. You highlighted for the first 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 as the commercial coverage wise?

Speaker 8

You've kind of highlighted it's around

Speaker 2

Yes. 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 in DAS. So I think now that we've got coverage, there are government patients that they'll sort of accrue over time to better GTN yields and so I think in general, I just expect to see steady improvements in GTN from here on out as we get closer and closer to that 50% bogey over the next It's 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 lives.

Speaker 8

Got it. Thank you very much.

Speaker 2

No problem. Thank you.

Operator

Thank you.

Speaker 9

What are your plans sort of with that indication? And then secondly, for HS, can you file can you Conduct one pivotal, is that sort of sufficient or do you think you need to? And then I guess finally, at what point can you present or is Pfizer going to present the data From the studies, I mean, 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 There's obviously a lot of data out there, but just so we see the full data.

Speaker 9

Thank you.

Speaker 2

Yes, perfect. Look, I think The first answer is on alopecia. We Have no like current plans to progress in alopecia. It's an interesting indication. Our data looks promising, but our view is sort of the same as for the other slightly larger indications.

Speaker 2

So I think not sort of on our near term roadmap, but obviously On the other questions, first of all, on HS specifically, look, I think 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. So I'd probably rather not box us in on a particular study design. That's probably what I'd say there. Mike, anything else you'd say in terms of Drew, is there other points or you may be slightly closer than I am to the Pfizer publication timelines?

Speaker 4

Yes. So I think not too much more to add. I think that cone study in particular Phil has a maintenance portion to come along with it, but look forward to seeing more at a future medical meeting. And then The EHS study is actually has been published at this point. So we can send that to you, Yaron.

Operator

Doug Lissau with H. C. Wainwright, your line is open.

Speaker 2

Hey, Doug, you might be on mute. Can you

Speaker 10

hear me now, Matt? Sorry about that.

Speaker 4

Yes, perfect.

Speaker 10

Starting with Vitama, 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?

Speaker 2

Yes. Thanks, Doug. It's a great question. Look, I think for the moment, we have no immediate plans To change the copay card, it sort of set up in a way, as I'm sure you appreciate, to work well for us as people migrate from uncovered to covered. Dollars 10 programs or whatever, the uncovered side of the card was low in order to attract trips at a time when coverage was Spotty here, we always had a slightly higher co pay on the uncovered side.

Speaker 2

It was frankly set up to carry us into the AD launch and beyond. 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 docs we're writing 2 scripts a month and turning them into 5 and 10 scripts a month docs. And I think the sort of goal of whatever changes we make would be to sort To keep that process in motion, but the short answer is I think the copay card actually works reasonably well. To be honest, if there's something I think we're sort of working on, I think at this point, the actual quality of coverage is better than the perception of coverage. I think these dots have been burned a fair amount historically On challenging coverage in derm, we actually have quite good coverage.

Speaker 2

It's easy to obtain many, many of their patients, as you can see from the presentation, will be covered. I think many derms frankly have not like 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.

Speaker 4

And Matt, you sort of touched on another point.

Speaker 10

I'm just curious your perspective. 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 your script pace 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 And are you aware of what is keeping them from only writing just a couple of scripts right now?

Speaker 10

Thank you.

Speaker 2

Yes. Thanks, Doug. Look, it's a great question. It's It's quite literally a $1,000,000,000 question, so we spend a lot of time thinking about it. I think the short answer is we've already taken certain steps.

Speaker 2

We've got now DTC was something we were pretty conservative about up until we got to this sort of good payer coverage position. So within the last month or 2, 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 strip volumes, But it's something that we are watching to drive volumes that way. There's other things too. There's One property is these patients don't go to the doctor very often. And so frankly, if you were a If you are hyper driving dermatologists, you've been waiting for the Vitamil launch for many years.

Speaker 2

If you are a local driving dermatologist, it just sort of showed up, Maybe you wrote a few test scripts or you write a few test scripts every month, but you actually haven't seen very many patients back in your office You put on the Vkama a year ago. And so I think one thing that works in our favor is just time. It's just docs through seeing repeat visits from patients who they put Earlier in the launch, 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 Whatever the questions I mentioned, the coverage question is probably one of the most important messaging questions that we're working on right now. It's just helping docs understand that This isn't like other topical, 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.

Speaker 2

And so I think That's where a lot of our focus is. I'd say in the doc call that I've been closest to, frankly, the number one point is this payer coverage point, is just docs are a little gun shy about Where things are on the payer side, but we hear other things that we continue to work on. And in general, I think docs 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 experience in muscle memory. Remember these docs write corticosteroids in their sleep, so it just takes some time.

Operator

And I'm not showing any further questions in the Q and A Q at this time. I will now turn the call back over to Mr. Mathline for any closing remarks.

Speaker 2

Great. 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 Some important opportunities to get back together.

Speaker 2

And yes, thanks all and have a great rest of your summer. And we'll be back here soon to Talked about some more exciting updates. So thank you, operator. Thank you everyone for listening and we'll talk again soon.

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Earnings Conference Call
Roivant Sciences Q1 2024
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