Q2 2025 Roivant Sciences Ltd Earnings Call
Good day, and thank you for standing by welcome to that.
Really that second quarter 2024 earnings conference call. At this time, all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need a press star one on your telephone you will then hear an automated message for fighting New your hand, just raised to withdraw your question.
Please press Star one again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, Stephanie Lee. Please go ahead.
Stephanie Lee: Good morning, and thanks for joining today's call are you worried that financial results for the second quarter ended September 30.
Stephanie Lee: Definitely.
Speaker Change: But anything that you'd be at Metlife.
Speaker Change: And that number quite yet.
So does that have to be at the conference call you can find the slides today.
But that's the only thing that we need.
Speaker Change: On our IR website.
Speaker Change: W Dot investors operating and dotcom.
Speaker Change: I'll also be providing the cross buy number could be for that.
Speaker Change: Help you follow along I'd like to remind you that we'll be making certain board.
Speaker Change: Okay.
Speaker Change: We strongly encourage you to review the information that we get.
Speaker Change: More information about it.
With that I'll turn it over to Matt. Thank you Stephanie. Thank you operator, and thank you everyone for dialing in this morning.
Speaker Change: We actually have a relatively full update.
Speaker Change: So I'm excited to share with us at least one major thing we can talk about which is the 52 week data from Orion IU study, which is pretty I'm pretty excited about.
Speaker Change: So starting on slide five.
Speaker Change: I think there's really two major areas of focus for us right now.
Speaker Change: First is clinical trial execution, we have a lot of ongoing trials all of which are important that are going to generate interesting data coming in the near future here. Obviously today, we're talking about the 52 week data for Brexit.
The phase II study, where also the phase III studies ongoing into the first patients enrolled and with fast track designation or haven't been granted.
Speaker Change: He presented this quarter.
Speaker Change: Local Nab and graves diseases, where you are now getting our programs up and running for IBD to with both grades that you use and the difficult to treat rheumatoid arthritis as well as a number of other programs to be starting soon.
Speaker Change: We have initiated our phase II study of mostly in ph ILD.
Speaker Change: We have clinical data coming in putting the mill a lab in sarcoidosis by the end of this quarter.
Speaker Change: The telco map data coming next year MVC IDP impairment.
Speaker Change: Representing them in Dermatomyositis top line data coming in the middle of next year at wells. So.
Speaker Change: That should be all exciting updates in the near future all focused on clinical execution.
Speaker Change: On slide six the evolution of the business continues in some other ways as well.
Speaker Change: With the terms of that deal having closed.
Speaker Change: Just a couple just a week or so ago now, allowing us to refocus them kind of excuse me as I just mentioned, while maintaining a large share of potential upside from became what we talked about that not long ago.
Speaker Change: We've made some progress with our LNP litigation with a markman hearing in the Pfizer biotech case in December with the trial West a year from now with Madonna case currently schedule.
Speaker Change: Continued our plan of returning capital to shareholders and so far our repurchase an aggregate et cetera at $54 million worth of stock as of 930, I believe of $106 million in the quarter reporting today with an ongoing commitment to be thoughtful in deploying this capital and then of course I notice will be filed with the discussions we have ongoing business development activity multiple negotiations for potential in licensing of new probe.
Speaker Change: Grams that we are really excited about this really does remain one of the most exciting environments for that activity that we've ever been in.
And we've been saying for a little while here on slide seven the next chapter for US is really anchored by our late stage pipeline that includes IBD working documents together, our SCR and franchise that includes sitting there, but we'll be talking about a fair amount today Arctic two and JAK one inhibitor that includes <unk>.
Speaker Change: And Mosley and a number of other programs that we expect and hope to bring again in the near future.
Speaker Change: All together on slide eight.
Speaker Change: That really does give us one of the most exciting development stage clinical pipeline out there with a path to a $10 billion plus peak sales portfolio spanning multiple therapeutic areas, obviously, including ini in pulmonary hypertension as well as others with the first approvals potentially coming in the next couple of years.
Speaker Change: As well as <unk>.
Speaker Change: <unk> phase II and phase III data readouts.
Speaker Change: Difficult wave approvals across new indications in the 26% to 30 timeframe. So really looking forward to that chemical of years here as our portfolio of his time to mature and develop.
<unk>.
Speaker Change: That is the 30000 foot overview, what I wanted to make sure we give new time too the most significant of our updates for today, which is the 52 week data from our Niu phase II study and so I'm going to give it just a really brief introduction here and then I'm going to hand, it over to Ben Zimmer, who can take you through.
Speaker Change: Just on that program in more detail. So on slide 10, I'm going to steal only a tiny bit of best under.
Ben Zimmer: Basically as Youll recall in the spring, we presented the 24 week data and it looked.
Ben Zimmer: To be bought like supporting the potential best indication efficacy profile data over kind of Athena you feel but we have not seen before.
The whole really was just to maintain that level of efficacy through 52 weeks and I can say, we've definitely hit that bar, we really only had one additional subjects in each dose arm and the treatment failure and we have sustained improvement from baseline on important metrics like retinal vascular liquid <unk> macular edema.
Ben Zimmer: So really really exciting data noticed safety tolerability signals the safety database at this point because youll know comprises 1400 expose subjects and patients.
Ben Zimmer: And it's consistent with the approved and widely tracked JAK inhibitors, and we got fast track designation from FDA in Niu with patients currently enrolling so thats. The first 30 days, but overview, but the data is pretty exciting so I want to hand, it over to Bert Zimbra as I said, the CEO of <unk> is going to take you through the next slides here and walk through the actual data been takeaway great. Thanks, Matt before going into the 52 week data I just wanted to be.
We highlight two tailwind in ini that we have.
Bert Zimbra: Really excited about as it relates to the Embraco phase III programs.
Bert Zimbra: As well as in Dermatomyositis.
Bert Zimbra: As outlined on slide 11, the first on the left hand side, you can see that if the category JAK inhibitors have roughly doubled since 2020 in terms of the treated patients and revenue.
Bert Zimbra: This really speaks to the fact that the benefit risk profile of these agents and physicians and patients comfort with that benefit risk profile is quite established at this point and that even include indications with significantly less morbidity.
Speaker Change: And which is.
Speaker Change: It's operating.
Speaker Change: And then in terms of those indications or private is operating these orphan diseases with high morbidity. We've also seen over the last few years several launches the notes, including the ones laid out on the right hand side of this slide it really validated this category of indication as a source not only a blockbuster revenue.
Speaker Change: Best of revenue that can be achieved in a very quick timeframe given.
Speaker Change: The disease high morbidity high unmet need and concentrated prescriber base with orphan pricing and so if you turn to slide 12, you'll see that Niu really fit.
Speaker Change: Phenotype.
Speaker Change: Quite on the money around 70 to 100000 patients in terms of travel and very high morbidity fourth leading cause of blindness in the developed world. The working age population very little little available for patients and concentrated prescriber base. Most of these patients are seen.
Speaker Change: Dedicated specialty centers.
Speaker Change: Turning to slide 13.
Speaker Change: Supporting our new claims analysis that we did with UBS.
Speaker Change: <unk> confirmed once again, a large number of patients receiving biologic therapy and TNF therapy.
Taylor I: Taylor I in 2022.
Taylor I: 40000 patients with Niu, receiving a TNF inhibitor, including Humira and off label TNF inhibitors at that number as you can see is growing quite significantly and includes between off label TNF and other biologics a large number of off label therapy, and we know both.
Taylor I: Real world experience in clinical trials that Humira is only it back.
Taylor I: Fewer than 50% of patients.
Taylor I: So I think that really speaks to both the large commercial opportunity in the TNF refractory population, but also with all of these off label therapy is that.
Taylor I: The urgency that physicians and patients feel to find something that does work and their willingness to try that and try to aggressively and we think that speaks to the additional opportunity for breakfast at Nab.
Taylor I: Our data potentially in the broader non anterior niu population.
Speaker Change: So with that context, I'll turn to the data itself. Just a brief reminder, on slide 14 of the design of the phase II <unk> study enrolled patients with active non interior Niu randomized two to wanted to wrap up 45 milligrams 15 milligrams.
Speaker Change: <unk> with past studies, including a Registrational study for Humira in the treatment paradigm.
Given that these patients are in dire need of it.
Speaker Change: Immediate therapy to avoid the risk of buying NES all patients in both arms received a two week 60 milligram per day steroid burst and then rapidly tapered off.
Right.
Speaker Change: The primary goal of the study that is to prevent treatment failure.
Speaker Change: Notably as a reminder.
Speaker Change: <unk> study the taper occurred over six weeks to two week eight while unprecedented studies, including the Humira visual one study it occurred over 13 weeks. So the study was designed.
Speaker Change: Actually a higher bar for PREPA sitting them make it more difficult for it to demonstrate efficacy.
Speaker Change: And so against that backdrop, we're very excited with the results that we're generating.
Speaker Change: Turning now to slide 15 to walk through that we start with the primary endpoints from the study.
Speaker Change: Ken.
Ken: Slide you see the what was the primary end point is the 24 week treatment failure rate, which we've shared previously and then on the right side. We have the updated data at week 52 in both cases measured here against the historical placebo rate from the visual one study as Matt mentioned only one additional.
Ken: Patient, Matt treatment failure criteria in each arm, so excellent data sustained out to week 52.
Regard the call that Humira is failure rate at week 24 was over 50% using this analysis that includes discontinuation, but 62% and although we did not specifically report of one year failure rate.
Ken: Their rate based on the data that was published.
Ken: Well in excess of 70% under this analysis and probably the most effective way to compare to Humira now, which we do on slide 16, now that we have one year data from the <unk> study is again. So it was the Prespecified primary endpoint individual one study, which was the median time to treatment failure.
Ken: And you'll see that on slide 16, with three months for the placebo arm and visual 156 months for the act environment. So again reinforcing that the median patient fails before six months, so more than half of patients even if that the six month mark quite a lot of the one year mark are not able to receive.
Ken: <unk> benefit and then you see in contrast, and breadth of the low dose arm median time to treatment failure nine three months and in the high dose arm as we did not get to a 50% treatment failures, even at one year.
Speaker Change: Not estimable.
Speaker Change: <unk> over 12 months.
Speaker Change: So very exciting data on treatment failure and on slide 17, we also see that clinical data supported by what is really the gold standard biomarker for measuring ocular inflammation, which is wide field for athene and geography measurements.
Speaker Change: Retinal vascular leak edge and you see here on the left side data for the high dose arm 45 milligram and the right side, the low dose arm tobacco 15 milligram.
Speaker Change: The top row as the week 24 data, which we presented at your Retina Conference. This fall and then the bottom is the new 52 week data today and you see.
Speaker Change: Really great data, particularly from the high dose arm no patients were spinning.
Speaker Change: Most of the patients improving and that improvement from week, 24, which was already quite significant not only being sustained at 252 weeks, but actually even increasing slightly and then you see at both time points very clear dose response as it relates to the 15 milligram data so very exciting data.
Speaker Change: Yes.
Speaker Change: I think resonate quite a bit with the ophthalmology community in.
Speaker Change: In particular.
Speaker Change: Turning to slide 18 wanted to share an update as well on our macular edema data.
Speaker Change: This is one where the 52 week data is particularly important because macular edema.
Speaker Change: <unk> patients really develops over time as the medium to longer term consequence of inflammation. So even if inflammation can be gotten under control to the point that it's not impairing visual acuity in the in the short term low levels of inflammation over time can lead to macular swelling and.
Speaker Change: And nobody macular edema, which of course is one of the causes of blindness in uveitis patients.
Speaker Change: Inefficiently impaired vision, otherwise and so we have 24 as Youll recall, we had quite a quite exciting data in the 45 milligram arm patients who did not have macular edema at baseline non develop that and of the seven patients.
Speaker Change: Who had a baseline three out of those seven had resolution, but at the time, we were very eager to see the extent to which that held up in one year and very excited to share that has held up as you can see here quite well with no.
Speaker Change: No new patients developing macular edema in the freight you had resolution.
Speaker Change: Maintaining that resolution.
Speaker Change: Again this compares quite favorably to Humira, which is generally viewed by physicians in the railroad is not being super effective at.
Speaker Change: Preventing the onset of macular edema, and you see that is actually supported by data from the visual one study where at one year patients who did not have macular edema baseline half of them had developed at one year and in the placebo group that was six months. So again, a small number of patients were <unk>.
Speaker Change: Cited to see what the fee.
Speaker Change: His III data looks like but certainly.
Speaker Change: Very promising in terms of the potential of <unk> and then just very briefly on slide nine wanted to further reinforce the robustness of best buy.
Speaker Change: That means the ft over time and you see here and in addition to the great data in the 45 milligram arm a clear dose response with the 15 milligram arm.
It's great to see as all the time course data that is consistent with what you'd hope to see particularly looking at the 45 milligram arm very rapid onset of effect in the first few weeks EBIT steroid taper has already begun at week two and then that is clearly sustained over time.
Speaker Change: Year.
Speaker Change: So very excited about about the phase two data in.
Speaker Change: We're already excited after six months, even more excited now after one year and.
Speaker Change: <unk>.
Speaker Change: Alrighty really focused now on the phase III the phase III.
Speaker Change: Excited to share as Matt mentioned, and as we announced a few months ago that enrollment of that study is underway and off to a great start you see on slide 20 here the schematic.
Speaker Change: The study very closely Modelled on.
Speaker Change: On the phase II as you would suggest as one would imagine.
Speaker Change: We are advancing only the 45 milligram dose into phase III with patients randomized one to one 445 against placebo.
This study is that a thing.
Speaker Change: <unk> protocol, so technically one study, but with two identical sub studies. So it will be reported out is two studies clarity one and clarity to 150 subjects per sub study. So 300 subjects total and the primary endpoint will be time to treatment failure. So the primary endpoint as the.
Speaker Change: As the visual one study.
Speaker Change: Yes.
Speaker Change: Will it be over period, one which is one year placebo control data and secondary endpoints will include all sustained measurements.
Speaker Change: As the napkin study and notably as well we are maintaining the rapid steroid taper that we've seen.
Speaker Change: And the Neptune study based on the data we had in spite of that taper. We saw no need to change that and are excited to be bringing that forward and really hopefully setting a new standard for for uveitis clinical trials in terms of the suits what therapy is should we expect it to to.
Speaker Change: And we did have a productive meeting with FDA over the summer.
Speaker Change: This design incorporates their input and we're confident that if we're able to deliver successful results. It will all support an NDA filing.
Speaker Change: So so all in all really a lot of excitement around niu around the Niu program and propose potential there.
Speaker Change: To highlight.
Speaker Change: Briefly before handing it back to Matt.
Speaker Change: As Matt mentioned actually although we're very excited about the phase III Niu program, even before that we're going to have a readout of the phase III Dermatomyositis program, which is fully enrolled and we'll be reading out next year.
Speaker Change: Just wanted to highlight on slide 21 that similar to Niu, that's again really meets that criteria.
Speaker Change: The attributes that we've seen being conducive to a <unk>.
Speaker Change: Very rapid blockbuster revenue potential indication.
Speaker Change: Again prevalence of around 40000 adults in the U S.
Speaker Change: The high percentage of these patients are in the active treatment funnel as I walked through on the next slide this is a very.
Speaker Change: Hi, morbidity indication west, but really nothing available for patients in terms of modern therapies.
Speaker Change: Mostly just steroids in the Ibs D and again concentrated prescriber base. Our claims analysis suggests that about half of these patients are treated at a few hundred tertiary centers of excellence.
Speaker Change: And on Slide 22. This provides just a bit more color on kind.
Speaker Change: Kind of what these patients are currently being treated on and where they stand as you see on the bacteria. It's mentioned for around 35 patients in 2020 to act.
Speaker Change: Actively treated with late stage therapies for <unk> side us, notably all of the steroids referenced here, our oral or injectable and no cases, typically count topical steroids.
Speaker Change: And you can see on the left hand side of the slide that over 50% of these patients are treated with polypharmacy. So I think it really goes to how.
Speaker Change: How sick they are and how women at the efficacy up to currently available treatments are and then you see on the right hand side a different cut at the same data, which looks set for any patients on each of these supposedly.
Speaker Change: Supposedly sparing therapy is in terms of ISG is biologics and IV Iga that theyre, not really achieving that goal intensive steroid sparing with over 50% of patients are some groups roughly 50% receiving greater than 10 milligrams per day.
Speaker Change: Oral steroids chronically.
We're really excited about the data.
Speaker Change: Data read out and we think that if PREPA has proved this claims analysis really supports.
A large bolus of potential demand for for.
Speaker Change: For rapid adoption early in the launch.
Speaker Change: Before handing it back to Matt really just to wrap up my section on slide 23.
Speaker Change: We've been working on really just as Matt mentioned development execution over the last few years and then I think starting next year that really Tees us up perhaps a major value inflection with the upcoming phase III data in DM Niu study to follow soon behind that we are also <unk>.
Speaker Change: Turning to start studies in additional orphan indication in 2025, and as I mentioned at the beginning doing all of this into an environment out west.
Ben Zimmer: Quite a few commercial tailwind so really excited about what's ahead and with that I'll hand, it back to Matt. Thank you Ben and as I said really excited about that data as well so.
Speaker Change: In other words pregnant team has done there and looking forward to what's coming so I am going to now bring it through a couple of other updates that are <unk>.
Matt: Rehashing, some things that have happened over the past several months, but we are excited about.
Matt: Starting with a reminder of what's going on in R&D of CRM franchise.
Matt: On slide 25, I know everyone's familiar with this data.
We're thrilled with it.
Matt: Put out some really really good.
Matt: David Graves disease, which we think positions language of working out to be a potentially best in class and first in class program in that indication as Youll remember we had.
Matt: And over 75% response rate in patients who are uncontrolled on <unk> with over 50% of patients becoming free.
Being able to completely titrate that Richard you dose and getting to normal Q3 in Q4 levels by 12 weeks, we continue to support our premise that deeper agg reduction.
Matt: As important with our 680 dose with deeper IGD reductions driving meaningfully higher response rates, which.
Matt: Gives us.
Speaker Change: Our position, Brian really fortunate to be potentially best in class and that's against the backdrop of a very high unmet need.
Speaker Change: With 25, 30% of <unk> patients uncontrolled or intolerant to <unk> and really with no pharmacologic options.
Speaker Change: And now.
It hasn't been invented announced support to ISC has been cleared by FDA, enabling straight to pivotal transition.
Speaker Change: Go through the data again in great detail, but on 26 and 27.
Speaker Change: Eight we repeat that data.
Speaker Change: It's really exciting data for disease really no other options for this portion of the population.
Speaker Change: The other announcement from immuno ramp on slide 29 is the first of several new indications now that have been.
Speaker Change: Wanted to get started in which is in difficult to treat rheumatoid arthritis, and so this is a subsidy DRA populations between 5% to 20% of the patient population that has failed at least three therapies and what we've seen from another CRM program for <unk> is it specifically in <unk> positive patients.
Speaker Change: Actually there was severe disease and poor outcomes.
Speaker Change: The inquest data from <unk> suggests that both patients respond, yes, yaron therapy, even when it delivers comparatively lower atg suppression and then we will be fortunate to be able to the liberal deliver the study design is built to readout quickly with a quick answer. It's got an open label will begin with a randomized withdrawal design that means that all of these pages are going to get on therapy.
Speaker Change: We think enrollment should be relatively straightforward proposition that will get data quickly, which is something we think is valuable for the overall program and again, we think our deeper agg suppression is going to help meaningfully.
Speaker Change: Given the data that we've observed from from from others.
Speaker Change: If you look at Slide 30, a reminder, on that patient population. This is this is a big population of patients.
Speaker Change: People think about already they think about sort of the full bolus of familiar with USAA patients, but for a subset of those patients. They just can't get treatment.
Speaker Change: Try multiple lines of therapy.
Just not working.
Speaker Change: We're focused specifically on both patients who are at the auto antibody positive.
Speaker Change: This is <unk>.
Speaker Change: This is a subset of patients that is quite sick.
Speaker Change: And really lacks for good options.
Speaker Change: So again I don't know what all the detail here.
Speaker Change: <unk> great.
Speaker Change: Called the Kols just last week on this but on slide 31 as a reminder, the two indications we have announced so far for 14 or to a greater seasonal array.
Speaker Change: <unk> is where we ought to be first in class in R&D, where we think we have clear potential to be best in class. We have a number of other indications coming even team has indicated that <unk> have been cleared by FDA.
Speaker Change: So we're excited to talk about more of those indications some of which are known to the public and some of which are not yet known to the public.
Speaker Change: Weeks or months to come.
Speaker Change: As or more excited for some of those today in Brazil, and what we've already announced so stay tuned but excited to see that program developing.
Speaker Change: And then finally on the clinical side and again I won't go through it in great detail, because we spent a fair amount of it on the call earlier. This fall as you recall this quarter, we unveiled monthly cigarette.
Speaker Change: She is our phase III inhaled STC activator for pulmonary hypertension patients with interstitial lung disease really excited with the potential of that program and talk to many folks about it since we unveiled it.
Speaker Change: I think it could be a really great program for these patients again with few treatment options.
Speaker Change: In a market that's now been validated by the very strong continued launch uptake there. So as a reminder, on slide 34, mostly as shown among the highest PBR reductions ever seen either a single or repeat dose setting.
Speaker Change: In a way that makes us excited for the possible translation of that to overall improvement.
Speaker Change: Ph ILD patients.
Speaker Change: And we're not totally sure even though we've seen the best of that PPR data on slide 36.
Speaker Change: <unk> continues to improve at the time point, where they will measure.
Speaker Change: And we've got and this is maybe one to move forward. This isn't just one piece of new data I'll share in a moment here.
Speaker Change: A really great dosing profile and formulations with sort of one pump once a day dosing for these patients.
Speaker Change: And.
One of the things that we think is really important here is that as an inhaled STC activator, we don't have systemic vasodilator.
Speaker Change: We've gotten some questions as we've been out talking about the program, but how we are confident that obviously the systemic exposure data that we've talked about it was very helpful. We do not see meaningful levels of systemic exposure and assays, but the other evidence we have that this is the first time, we put this out on slide 36. This.
Speaker Change: This is from a different phase one study of mostly this is from a multiple ascending dose study in healthy volunteers and what you would expect if you were getting systemic visit ablation as an impact on systemic.
Speaker Change: Systolic blood pressure and you can see on slide 36.
Speaker Change: Got a couple of dose arms of the study did not go all the way up to four milligrams, but Scott about half milligram, one milligram and two milligrams and you can see there's really no discernible pattern and in fact, you would expect if we had just done with disclosure reductions in systolic blood pressure and in fact, the lowest dose arm here is placebo. So we this gives us additional confidence that this drug is not is not having a system.
Speaker Change: Quick impact.
Speaker Change: So with that I'm, just going to turn a little bit to the future and then in just a minute we'll open the lineup for questions. So on slide 38.
Ben Zimmer: I talked about this in August, but I am just super excited for where we are right now in the next 18 months or dislike was at 24. We just have we have a number of really exciting large value creation opportunities, including things like the near term data middle of in sarcoidosis, which as we said, it's a little bit higher risk would be a huge opportunity as successful as well as multiple late stage Readouts Ben.
Ben Zimmer: Talked about <unk>, we have a number of really important we think highly value creative readouts from the Coke lab at MIT events.
Ben Zimmer: Important updates on our LNP litigation.
Ben Zimmer: Under this period of the second half of 'twenty 'twenty six we get that phase II data proposal. So this is a period, even with our existing pipeline without thinking about business development that is stacked with catalyst demand as I've said, a few times, we just could not be more excited for the business development environment, We're in and although everything takes a little longer than you want it to.
Ben Zimmer: Chomping at the bit waiting to share some of the things we're working on some soaps.
Ben Zimmer: So we continue to give us a minute and we'll be ready to share that I think you'll agree it's up it's pretty exciting.
Speaker Change: A brief financial update on slide 14, just to say.
Speaker Change: You need to be careful on managing burden.
Speaker Change: Youll see especially with <unk> now out of the picture of these numbers will come down in the coming quarters.
Speaker Change: And with some onetime expenses behind us.
Speaker Change: R&D expense of 143 or adjusted R&D non-GAAP of 132, G&A of two or three non-GAAP of $1 42, and that includes some pretty significant one time expenses and overall loss from continuing operations was 237 or adjusted of <unk> 19.
Speaker Change: We ended the quarter at a very strong cash position with $5 4 billion of cash again most of the dollars. We spent in the recent months have been on the share repurchase including US are we talking $1.
Speaker Change: Hi.
Speaker Change: No debt on our balance sheet. Following the close of <unk> transaction that credit facility was repaid at closing and Oregon are required all the remaining debt and a share count that continues to come down overtime as we repurchase shares.
Speaker Change: So with that I'll just end by one of your slide 42, which lays out the timeline for our upcoming catalysts and.
I will end there I will say thank you again to everybody is listening this morning, and I'll hand, it over to the operator to begin Q&A.
Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment, while we compile our Q&A roster.
Speaker Change: Okay.
Speaker Change: Our first question is going to come from the line of Louise Chen with Cantor. Your line is open. Please go ahead.
Speaker Change: Hi, congratulations on all the progress in the data today. Thanks for taking my questions I had two I brought the sitting there, but I wanted to ask you. What's the efficacy you would like to see in your phase III trial, and then also for <unk> and Hs, where do you stand there what's the latest update there. Thank you.
Ben Zimmer: Yes, I'll, let I'll, let Ben take both those questions other than I'll say, what I hope I Hope I will say is we're very happy with the efficacy received in phase II. We think it gives us a pretty wide margin relative to the competitive programs like humira, but been taken away yeah, I would agree with that I think.
Speaker Change: Thing that.
Ben Zimmer: Approximates the phase II would be terrific and I think even if there is some.
Ben Zimmer: Standard drop off in efficacy when occupancies between phase II and phase III.
Ben Zimmer: Okay.
Ben Zimmer: Space, where there is very little available for patients TNF inhibitors are widely used in spite of bear quite limited efficacy and so I think anything that gets the drug approved which support widespread adoption and certainly anything that supports.
Ben Zimmer: Ensure better product profile than that Humira, which support widespread adoption potentially even in the first line setting.
Ben Zimmer: Okay.
Ben Zimmer: And then on the Jessica and Ben you can jump in if you have any comments as well, but I guess, what I'd say is I can say is yes, I've been really happy with the work that the private team has done an indication expansion and we have some other ideas Hs is a great indication that we have very good phase two data in it it's a competitive field with a lot of other mechanisms. There are some great places to take representative that may be less competitive but we're.
Ben Zimmer: Would you consider a wide variety of indications and certainly Hs remains on our radar.
Don't really have much greater that thank you Louise thanks for the question is really really appreciate it.
Speaker Change: Thank you one moment as we move on to our next question.
Our next question comes from the line of Brian Chen with Jpmorgan. Your line is open. Please go ahead.
Speaker Change: Hey, guys. Thanks for taking our question. This morning, maybe just a question on clarity design.
Speaker Change: Requiring patients to have a certain steroid dose for entry and are there any stratification strategy that we should make note of and and also on the subsidies between clarity one and two what is the difference here is there a geographical location different.
Ben Zimmer: Great I'll, let Ben take all of those yeah. So in terms of steroids.
Ben Zimmer: No specific requirement patients are allowed on any background steroid dose of up to 40 milligrams per day or no steroids at all and again with the notion that because theres. The two week burst at the start of the study that kind of neutralizes whatever that the background regimen was before.
Ben Zimmer: In terms of stratification.
Ben Zimmer: Particular stratification.
Ben Zimmer: Material no.
Ben Zimmer: Terms of the two sub studies sites will be assigned to one or the other in some geographies like the United States and certain other larger geographies lots of sites.
Ben Zimmer: Both sub study is and then there are certain countries that will only be in one or the other.
Brad: Thanks, Brad I appreciate it.
Ben Zimmer: Yes.
Ben Zimmer: Thanks for listening.
Ben Zimmer: One moment for our next question.
Speaker Change: Our next question comes from the line of yarn, Robert with TD Cowen. Your line is open. Please go ahead.
Speaker Change: Hey, Good morning, guys. This is James on for Brian. Thanks for taking my question.
Speaker Change: Can you talk about your thoughts around pricing for purpose. It is of course a orphan.
Speaker Change: But how should we think about pricing by indication. Thank you.
Speaker Change: Thanks look I appreciate the question. Thank you for asking.
Speaker Change: It's obviously premature to have a firm view on pricing for a program at this stage. We are focused on orphan disease with high unmet need. So we think a pretty wide range of prices is supportable.
Speaker Change: I would say and I'll give it to them to answer as well.
Speaker Change: The only thing I'd say is.
Speaker Change: Yes.
Speaker Change: Other competitors in dermatomyositis I've talked about net pricing.
Incurred in sort of the high $100000 range I think thats, a useful benchmark for us as we think about the range of possibilities in that indication, but other than that I think.
Speaker Change: So a pretty wide range of possible but.
Speaker Change: Yes.
Speaker Change: Just to Echo what Matt said I think if you look at bench.
Speaker Change: Benchmarks for recent orphan launches, including both biologics and small molecules that have been a similar price points, that's obvious way that kind of abandoned range won't be looking at.
Speaker Change: Don't have any sort of firm decisions or plans at this point in time.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question is going to come from the line of Dan Andy Chin with Wolfe Research. Your line is open. Please go ahead.
Speaker Change: Hey, good morning, and thank you for taking the question.
Speaker Change: <unk> uveitis phase III.
Speaker Change: Can you talk about what placebo response youre, assuming so in the Humira the trial and I think they saw 13 weeks or three months, but in your trial you have a more stringent tapering. So you would say.
Speaker Change: Bring is eight weeks versus your mirror trial, which was I think 15 weeks. So in other words are you assuming 13 weeks is that going to be the placebo response on the primary endpoint is it going to be less than 13, 13 weeks or should we be assuming that it's going to be less than 13 weeks. Thank you.
Speaker Change: That's a great question, Ben Yes, I mean, I think as a base case, our assumption was similar placebo rate to what was seen in visual one we think there is opportunity potentially for it to be even higher for the reasons you said with the taper, but we didn't want to assume that in general the study is actually overpowered.
Speaker Change: Even if the placebo rate ends up being significantly.
Speaker Change: Higher failure rate significantly lower in the placebo group than we expected and we saw in visual one we still have an opportunity to to detach.
Speaker Change: I detect a difference just being.
Speaker Change: Humble about the fact that this is a scenario where there's really just one precedent study we wanted to err on the side of being conservative and Thats why were running as flagship program as we are.
Speaker Change: And one thing thats patient friendly about the study.
Speaker Change: As a reminder is that it's an event driven study and as people fail they'll move right over the Bravo.
Speaker Change: Sure.
Speaker Change: Some of your patients will like about the study thanks, Andy that was a great question.
Speaker Change: Thank you and our next question.
Speaker Change: Our next question comes from the line of Douglas Tsao with H C. Wainwright. Your line is open. Please go ahead.
Speaker Change: Hi, good morning, Thanks for taking the questions, Matt just on that last one.
When do patients automatically switched to Grupo they have treatment.
Speaker Change: The option to switch.
Speaker Change: Is there a sort of alternative protocol I think your first sale.
Speaker Change: They automatically switched to breath, obviously, they can drop out of the study if they wish and did not have to take that.
Speaker Change: But if they wanted to stay in the study.
Speaker Change: The kind of first phase.
Honestly, we don't know whether patients are on placebo or driver neither to the investigators. So the first rescue medication in the event.
Speaker Change: Failure is.
Speaker Change: Is PREPA fit with us.
Speaker Change: There are different options that investigators have to deploy along with that and then if the patient has been famous for a second time in the open label period, then there is an even wider array.
Speaker Change: Of options that the physician has available and then at that point, the patient can choose whether or not they wanted to stay on drug and can still remain in the study.
Speaker Change: Okay, great. Thanks, and just as a follow up.
Speaker Change: A business development standpoint, obviously with <unk>.
Mosley.
Speaker Change: And the creation of funnel that we have.
Speaker Change: Sort of gone beyond what has been a short term focus on high alert.
Speaker Change: I'm just curious how youre thinking.
Speaker Change: About.
Speaker Change: There are no therapeutic category standpoint, right now.
Speaker Change: And does it.
Speaker Change: The respiratory if I can say focus for adding additional.
Speaker Change: Assets before.
Speaker Change: Youre just going to continue to be as you put it.
Speaker Change: Now I'd like to seek out the best operator.
Speaker Change: Thank you.
Speaker Change: Yeah. Thanks, Doug It's a great question, it's one you've been focused on.
Speaker Change: Rightly so.
Speaker Change: I think we are pretty ruthlessly focused on doing the.
Speaker Change: The best thing, we can now would be that I've been using that you might've heard lately.
Speaker Change: We exist in the excess DAU outside of other People's Cookie cutters.
Speaker Change: We're not there's no matter what the Christmas tree.
Speaker Change: Where the delta between the two and that means we've kind of got to be flexible in terms of therapeutic area, but we think theres a lot of really great a lot of.
Speaker Change: A really great cookie debate out of that though as well.
Speaker Change: Okay.
Speaker Change: Okay, great. Thank you.
Speaker Change: Thank you and one moment for our next question.
Speaker Change: Our next question comes from the line of Dennis Yang with Jefferies. Your line is open. Please go ahead.
Speaker Change: Good morning. This is anthea on for Dennis Thanks for taking our questions.
Speaker Change: On DM could.
Speaker Change: Could you talk about your plan to share the full lupus data and if you see any overlaps between Lucas.
And then also what's the willingness from doctors to prescribe Jack's MTN how much off label use is there currently if any thank you.
Speaker Change: Yes. Thanks, that's a great question al I'll take a part of an inhibitor to then look on lupus my only reminders about two things one as a reminder.
Speaker Change: Pfizer designed it around the <unk> study.
Speaker Change: Sorry, the lupus study. Thank you it was one of the last ones.
Speaker Change: From their original reps hitting the program.
Speaker Change: Yes.
Speaker Change: Overlap point Durbin will say something similar we have so much data and Brexit and a across such a breadth of indications at this point that any one study in any one indication is really not not as informative as the overall boats. They don't how efficacious. The drug is so I'm not sure we see a lot of specific commonality in <unk> predictions from solely related to DM, but the thing you want to take that as well.
Speaker Change: As the off with Jackie's question, Yes, Don don't see.
Speaker Change: Yes.
Speaker Change: On a read through there I mean, I think one lesson from the us.
Speaker Change: Rheumatic diseases in general and our with this data as an example of that is you have to be very focused on managing placebo response, and thats something I can say that in the DM study, where we've designed it in a running it ourselves we have been extremely focused on that including.
Speaker Change: With the mandatory steroid taper in the study in a very high operational focus from our team on ensuring adherence to that paper.
Speaker Change: Among other kind of steady execution related steps we are doing.
Speaker Change: As far as far as Jackson DM, yes, they're used pretty extensively there was a recent.
Speaker Change: A recent publication that was kind of a literature review of case reports and there were 600 published case reports roughly in that across.
Speaker Change: GM and juvenile DM and that and I think if you talk to Kols and other prescribers and other DM treaters Youll see that.
Speaker Change: They do use JAK inhibitor, so I think it's certainly.
Speaker Change: Area of a lot of comfort, yes, most of the treating physicians here will be rheumatologists and dermatologists are few neurologists as well, but both through the vendors there also.
Speaker Change: Obviously very comfortable with JAK inhibitors from from other indications as well and as I mentioned before both through <unk> and derm indications with less morbidity than DM.
Speaker Change: Yes, JAK inhibitors that are on label for those indications are widely prescribed at this point and so I think there's a lot of excitement.
Speaker Change: And the physician community about.
Speaker Change: About JAK inhibition, I think theres a lot of excitement about it take two JAK one inhibitor in particular given the alignment.
Speaker Change: Of that particular mechanism to the path of biology of DIAM and really just the prospect of having once daily oral approved therapy that efficacious and targets the underlying disease.
Speaker Change: That would be.
Speaker Change: New and important development for the field.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you and one moment our next question.
Speaker Change: Our next question comes from the line of carbon Johnson with Goldman Sachs. Your line is open. Please go ahead.
Speaker Change: Hey, Good morning. This is Greg on for Karen. So the first question here is given the emergence of Humira Biosimilars. How do you expect <unk> could be positioned potentially gains approval and then from there will you recruit or target patients that are refractory to anti TNF type.
Speaker Change: Medicines within clarity.
Speaker Change: Yes, Ben do you want to do what they prefer to book those yeah.
Speaker Change: What was the first question was just how do we try to position breath relative to Humira Biosimilar, yes.
Speaker Change: And then the second one.
Speaker Change: Yeah. So on the first one.
Speaker Change: Look I think our.
Speaker Change: Base case.
Speaker Change: And the view of the market here is to be used.
Speaker Change: Used predominantly in the TNF refractory population and I think we're going into that with a lot of excitement about <unk> potential and niu, even if that is the only population.
Speaker Change: Which we're launching I think as I mentioned before Humira is.
Speaker Change: Failure rate is high and its uses high and I think the Biosimilar with Biosimilar is available we would expect to be used to be at least as high and the failure rate to be at least as high and so I think that will only lead to an expansion of the TNF refractory market. I also think that this is a rare disease.
Speaker Change: These very high unmet need and one of the leading causes of blindness in the United States. If our data is actually differentiated from Humira, there is going to be a very significant.
Speaker Change: Cry from patients and physicians to use this drug first line because people don't want to go blind and they want to use whatever the best available treatment is to prevent that.
Speaker Change: And then the study Okay and then so there is no. There is no particular stratification or requirement in that regard that's something we discussed with FDA, if not something ne.
Speaker Change: They are focused on and in the study I think our expectation is that we will be.
Speaker Change: Enrolling a number of patients who have been on prior TNF therapy, just given the extent to which these drugs are used it will be be tracking that and be able to analyze those subgroups, but it's not something that we're in any way satisfying for our pre specifying yes.
Speaker Change: Just reiterate tolerance for ocular inflammation is very low and I think if represented improves as the phase two data suggests may to be a best in class agent with a pretty wide margin theres just going to be a lot of demand to use it earlier setting as people can get comfortable.
Speaker Change: Because that's how you treat this disease most effectively so we'll see it's going to be a conversation with FDA and so on but.
Speaker Change: We feel that we feel confident given the profile of the phase II data that we have a good shot.
I had a bigger population, even though more breakthrough population.
Speaker Change: <unk> also refractory population is very large.
Speaker Change: Great.
Speaker Change: Thank you very much.
Speaker Change: Thank you I would now like the conference back over to Matthew Klein for any further remarks.
Great. Thank you operator, thanks, everyone for listening this morning.
Speaker Change: Obviously to date on the fragrant team for.
Speaker Change: The phase III study in a year or two.
Speaker Change: Getting the phase III going thanks to all the patients and investigators thanks.
Speaker Change: Thanks to the entire <unk> team, who gets it gets these results together that moves forward every quarter.
Speaker Change: Looking forward to.
Speaker Change: A little bit of a busy end of the year with no map data coming and been a very busy 2025.
Speaker Change: We'll talk to you all very soon thank you and have a good day.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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