Q3 2024 Roivant Sciences Ltd Earnings Call
Ladies and gentlemen, thank you for standing by. Welcome to Roybent's second quarter 2024 earnings call. At this time, all participants are in the 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 to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.
To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded I would like now to turn the conference over to Stephanie Lee. Miss Lee, please go ahead
Stephanie Lee: Hi, thanks. Good morning. We're actually reviewing the third quarter and December thirty one twenty twenty four for ribbon. I'm definitely for event for the new day.
Stephanie Lee: We have Mack Lyons, CEO of Royvance. 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.royvance.com.
Stephanie Lee: We'll also be providing the current slide numbers as we present to help you follow along. I'd like to remind you that we'll be making certain forward-looking statements during today's presentation.
Stephanie Lee: We strongly encourage you to review the information that we have filed with the SEC for more information regarding these boards of new statements and related risks and uncertainties.
Stephanie Lee: and with that I'll turn it over to Matt. Thank you chef and thank you everybody for listening. Good morning. I'm going to start on slide five and thank you again for joining our third quarter results call. So, um, look, I wanted to just
Matt: Start by setting the stage. This is our first quarterly call in 2025.
Matt: It is, so we talked a little bit about this at the conference in January, but yeah.
Matt: We think 2025 is just a pretty incredible year for us in terms of the setup and the opportunity. Obviously that starts this quarter with an opportunity to validate our NTSC-RM franchise as a potentially best-in-class franchise with data coming in NMG and CIGP in the coming weeks.
Unknown Speaker 00.00.00.
Matt: It continues in the middle of this year with a registrational, central registrational readout in Dermatomyositis, which would set the stage.
Unknown Executive, Matthew Gline . .
Speaker Change: many of which we planted the seeds for years ago at this point and so we're excited to see to see those results.
Speaker Change: Look, all of this ultimately on slide six comes down to our pipeline, which we think is one of the most exciting pipelines.
Speaker Change: in late-stage biotech, obviously anchored by FCRN and Brevis-Citnib, but with a number of other programs, including Leslie Ciguat, which we unveiled last year, and also Ongoing BD, which we'll talk a little more about later in this call.
I'm
This year, really, on slide seven,
is anchored around clinical execution, right? Obviously,
Speaker Change: In some sense, the die has been cast for the MG and the CIDP data, which will be imminent. But there's an enormous amount of work ongoing. We've now cleared six INDs in advance. Those trials are all beginning now or have begun and are looking to initiate a number more by March of 2026.
Speaker Change: So just a ton of clinical work happening at Immunovant. Obviously, continuing to conduct the Brev-Sitnev-DM study that we'll read out later this year, as well as the NIU data, the NIU study, which is ongoing. And then we've initiated our trial in Mosley and PHLD.
Speaker Change: So between the data that we have coming and the work that we have to do, it's really a year around clinical execution to drive to drive that value. And then, you know, we have obviously a lot of exciting data coming this year when we look at how we're sort of stacked for the future.
Even beyond 2025.
Speaker Change: In Immunomat, we have the potential for 10-plus indications with multi-blockbuster launches. In BRAFO, we have a potential multi-blockbuster franchise in orphan immunology anchored by DM, and hopefully DM that's subsequent to NIU, a proven concept study in sarcoid adding to that.
and then in Mosley by next year, by 2026.
Speaker Change: We hope to have, by the end of next year, data on our Phase II study, which we hope sets us up for frontline use in PHLD and other respiratory disease.
Speaker Change: And all of that on slide nine is anchored by what continues to be a major strength of ours, which is which is our cash balance. We have 5.2 billion in cash and marketable securities as of 1231. That includes 500 million authorized for about additional for additional share buybacks was bought back about a billion dollars in stock.
Speaker Change: so far as of the end of 2024. We closed the sale of Dermavan to Organon, which is about $259 million.
Speaker Change: and removed all of our debt and meaningful retirement obligations while keeping a lot of upside in milestones and royalties, we talked about that last year. And then this continues to be among the most fruitful or the most fruitful regroup in Auburn environments we've ever seen, and I very much hope and expect that we'll be adding to that pipeline in months to come.
Speaker Change: So I want to now turn to talk about a new opportunity for us, something that's probably
Speaker Change: A little bit further out, but something we're we're trying to get going on. It'll be public and the trials back up soon. Etcetera.
Speaker Change: which is we have now initiated a new program for brevacitinib, our third indication. This is a proof of concept study in a disease called cutaneous sarcoidosis. So if you turn to slide 11,
This is a
Speaker Change: It fits really well, I'll talk about this again in a second, into our strategy of pride advancement, developing and indications.
Speaker Change: with high-end that need that are specifically tailored to our dual-tick-two-jack-one mechanism. First of all, in terms of sort of scope of disease, it's pretty similar bluntly to the other diseases that we are studying with Greco. There's somewhere between 30 and 50,000 cutaneous sarcoidosis patients.
Speaker Change: with no approved therapies, and the uncontrolled disease can result in severe disfigurement. It's very tough for these patients. There is proof of concept data from about 20 JAK-treated patients.
Speaker Change: So not so different from what we've seen in some of the other indications we're studying. And then we think, and we'll talk more about this, dual TIK2 and JAK1 inhibition is particularly well suited to the Th1 immunofenotype of sarcoidosis.
Speaker Change: So we'll get to talk a little more about that. And then it's aligned with DM and NIU in terms of a prescriber-based concentration that overlaps with DM in terms of a potential working price point. So we think it makes a lot of sense as a place for us to go from here.
Speaker Change: As a reminder, on slide 12 of the overall strategy in BREPO, we're really focused on indications with very high unmet need tailored to our unique mechanism, where we think any viability to the JAK class will be far outweighed by our ability to deliver meaningful benefit to these patients.
Speaker Change: Obviously, DM and NIU both, in our view, met that, and CS lovely looks pretty similar. It's got well-suited biology, a large unmet medical need, a similar patient prevalence.
Speaker Change: There is some proof of concept with JAK1 patients, and there's been nothing approved in the last 60 years.
Speaker Change: So we're really excited to add this add this to our portfolio
Speaker Change: There is, on slide 13, a little bit of proof-of-concept data. There was an investigator-initiated trial at Yale providing proof-of-concept for JAK inhibition and cutaneous sarcoid. That was an open-label study of tofacitinib in 10 patients with long-standing CS.
Speaker Change: and considering that study it was about 10 patients with CS and the mean CSAMI is going to wind up being what we talked about here a lot.
Speaker Change: of 37. And patients on five milligrams twice a day of TOFA for six months, all of them achieved clinical meaningful reduction in CSAMI, and six of them achieved complete resolution of disease. So pretty remarkable data from that study, again, with all the caveats of
of Open Label Studies.
Speaker Change: for pretty sick patients a big improvement. So that gives us a bit of comfort going into this proof-of-concept study. And then, you know,
On slide 14, just from a sort of pathophysiology perspective.
Speaker Change: Th1 type immunity is the main polarization, the predominant polarization in sarcoidosis skin and lung tissue.
Speaker Change: and we know that the more upregulation of TTH1 cytokines like type 2 interferon and alfalfa, which we think gives us potentially exactly the right profile with dual inhibition of TIK2 and JAK1, which are both obviously important in mediating that collection of cytokines. So we feel really good about coming at this with a uniquely
with a uniquely big gun.
Speaker Change: Repo has generated on slide 15, particularly strong data in inflammatory skin disease. So these are all cross-drop comparisons with whichever other jack inhibitors have reasonable data available.
Speaker Change: But, you know, you can see in alopecia, NHS, and flaxoriasis, we have, we have among the best in class or the best in class data and across our comparison that's that's been seen. So we feel we feel pretty good as well about sort of entering into an inflammatory skin disease area where we have good data coming at a broad set.
Speaker Change: The study design is lated on 16. It's a 16 week study, testing two doses of brevibook 45 and brevibook 15, as well as a placebo. And yeah, we hope to hope to get data in the second half of next year. So more to come.
as that study starts enrolling.
Speaker Change: Cool. I'm going to move on now to just a reminder of what's upcoming and what's sort of happened recently in our NTF CRM franchise at ImmuneVamp, starting on slide 18.
Our confidence collectively, including your confidence.
Speaker Change: the deeper IgG reduction results in better clinical outcomes. We've obviously now seen this
Speaker Change: across many clinical trials across four different NTFs and antibody museums.
in seven different indications.
Speaker Change: but we're going to get another 500 patients worth of data out of these protocol map studies.
Speaker Change: that we think will help us show how much better we can do with deeper IgG suppression across different indications for which patients.
Speaker Change: and by which metrics. So we're looking forward to generating that data, which by the way, just as a reminder, nobody at Roivindor-Munivant has seen any of this data. So any interpretation of my tone of voice should be no different from my tone of voice in the last six months.
Um,
Speaker Change: The upcoming data on slide 19 in MD, this is just a reminder of that trial design. It's a trial that we think is well suited to treating these patients where they're at. It is a 12-week induction study with two doses, high and low, followed by a re-randomization into a 12-week maintenance period with either a sort of low dose from the first phase or an every-other-week version of that. And we think this will give us, hopefully, a clear picture of potential dose response in that first period, as well as an understanding of what chronic treatment of these patients look like with the possibility of rescue therapy and so on.
Unknown Speaker So feeling good about the trial design.
Speaker Change: We also have our upcoming battle phase 2B readout from period one of the CIP study. That design is shown on page 20. I think you're all very familiar with these designs at this point. These are pretty complicated designs. But we're looking forward as well to the possibility after that period one, which is the highlighted in red piece here, to being able to answer some questions about possible dose response and treatment and response rates.
in the 12-week randomized period.
Speaker Change: 1402 on slide 21 continues, in our view, to have a combination of potentially best-in-class attributes that we don't see in other programs. We have a deep IUG wall ring. Our Phase I data suggests we're going to continue to be able to reach about 80%
Speaker Change: IGG suppression or thereabouts with continued dosing of 600 milligrams delivered by a simple subcube injection. 1402 does not in our phase one data appear to impact albumin or LDLs, so no minimal effect there.
Speaker Change: We have convenient administration, we will be delivered by a market-proving, user-friendly auto injector that we will be launching with, we'll highlight that again in a second. And as a reminder, we have IP out to 2043.
Speaker Change: not including extensions. So a really long runway with a drug that we think could be best in class.
Speaker Change: My slide 22, as a reminder, we will be starting our pivotal trials or are starting our pivotal trials with a standard auto injector.
Speaker Change: It's the only FCRM we've ever developed as a true subcube injector from inception. It's a pretty well proven technology. It'll be a 2 ml injection volume.
Speaker Change: and this is a picture of the device. Needless to say, it looks like all the other sort of widely successful auto injectors and we think this is a real benefit. It's also less than 10 seconds in at-home administration. We thank OROHP administration. So looking forward to continuing to address that form factor.
Speaker Change: And then, you know, on slide 23, look, the main event to me in the long run here is getting 1402 into indications that really matter. We are tremendously excited about Graves' disease where we have
Speaker Change: We think first-in-class and best-in-class potential communication with extremely high unmet need where we have run our own phase two study that shows that we lower autoantibody levels and that we have a high response rate with a good dose response.
that sets us up well for success.
Speaker Change: We think both from Immunovamp and from the world, you're going to be hearing a lot more about Graves' disease in the months and years to come. And we are excited to be at the front of that pack with an agent that we think is maximally positioned to deliver benefit to those patients.
Speaker Change: And then we've also announced that we're running a study in difficult to treat rheumatoid arthritis. We talked about that late last year. We are excited for that trial. We think it sets us up for a
Speaker Change: quick answer on how much we can do for these patients who have not a lot of other options once you get into that corner of the RA landscape. As we said, there are six IMDs approved and this is only two of them. We've also talked about MG and CIP, but that leaves
Unknown Executive, Matthew Gline
Finally, in terms of major upcoming
Speaker Change: Milestones in 2025. We talked only a little bit over time on these calls about the gentleman LMP litigation.
We are.
Speaker Change: Hoping for the decision from the Pfizer-BioNTech-Markman Markman hearing in the first half of this year, so that could be upcoming. Obviously not on any fixed calendar, so it could in theory come any time.
and then in the
Speaker Change: Second quarter, third quarter of this year, we will have the important summary judgment phase of the Moderna trial.
Speaker Change: where we will learn from the board important features of how that trial will progress, followed by the jury trial scheduled for September and the second half of this year. So a year where we will really learn a significant piece of the answer to the at least maternal puzzle here. So looking forward to that playing out as well.
Speaker Change: So I'll wrap up quickly with a financial update on slide 27 and then open up the Q&A. So relatively straightforward quarter from a financial perspective.
R&D of expensive 142 or adjusted of 131.
Speaker Change: uh GNA of 142 or just 71 uh in uh you know end of the quarter as we said with 5.2 billion in cash which excludes
Speaker Change: The $75 million milestone from the approval of atypical dermatitis from January, as well as $113 million of external capital, which was raised alongside Royden's investment in the January private placement there.
Speaker Change: and no debt on a balance sheet following the close of the Organon transaction, and so that...
That's about that on the finance side.
Speaker Change: Looking at slide 29, we feel like we have a quite rich cattle's calendar coming.
Speaker Change: with a bunch of important milestones, some of which we've talked about for this year, some of which sort of stacking the year beyond, and again continue to be excited about adding to our pipeline hopefully in the near future with some really exciting things we have on our racket.
Speaker Change: So, with that, I will end my prepared remarks and turn it back over to the operator for Q&A.
Speaker Change: Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.
Speaker Change: Great, thanks very much. So congrats on all the progress, Matt.
Speaker Change: I have two questions, please. First, could you review the Batoclimab efficacy bars for success?
Speaker Change: ahead of the release of results in coming weeks. And then second, could you also discuss the additional batoclimab GD data, the six month treatment free remission results that are coming this summer, including what you're hoping to see. Thanks so much.
Speaker Change: Thanks Dave. I appreciate the question. I confess we anticipated that it would be among the earlier questions asked this morning. Look, we have had a lot to say on this over the past months and obviously insofar as
Speaker Change: All of these questions get to sort of pre data positioning. I think we finished our pre data positioning the $330 million sack that we bought in January. So I don't have a ton to add.
Speaker Change: Unknown Speaker Obviously our view is that deeper is better has been pretty well established in our own GRAVES trial and our own TED study, in J&J's Sjogren's study, in UCB's ITP study, and even at the individual patient level in our own and other people's.
M.G. studies.
Speaker Change: So, you know, I've said over and over again, in some ways, I think this data is a little bit less interesting to us than it seems to be to other people, because it mostly
Speaker Change: is a referendum in my mind on what an MG study is able to show that said, I think what we're looking for is a nice clear dose response between the two doses. I think if we saw that it would give us confidence that an MG study is able to differentiate in a way that sets us up well for best in class. And I think we're looking.
Speaker Change: across the evidence for other things that can help us structure our 1402 MG program for maximal success.
I'm glad you asked about the six month remission data.
Speaker Change: for Univant. Obviously in graves coming later this year. What we are
Speaker Change: Excited about the greatest data we generated in phase two. I think it already offers a completely novel option with significant potential efficacy for patient population that's had nothing. Obviously, the dream here is that not only can we get these patients under control, but that we can get at least some of the patients who are under control to stay controlled off therapy.
And so my hope is that we see.
Speaker Change: I don't know exactly what the number is, but some reasonable rate, some percentage of the patients who got controlled in the initial study, stay controlled off drug for a period of time after the study ended. And that's something that we think will be helpful for patients who want to know that there's a path of therapy, and then also obviously for payers and others.
who I think will look at that data with interest.
Thank you, Dave. Thank you.
Speaker Change: And the next question will come from Dennis Dean with Jeffries. Your line is open.
Dennis Dean: Hi, good morning. Thanks for taking our question. We had a question around the LMP litigation and the upcoming summary judgment.
Can you help us understand the range of outcomes?
as it relates to 1498.
Dennis Dean: Meaning, will the judge rule that, you know, either Moderna or the U.S. government will be liable for all the patent infringement liabilities?
Dennis Dean: or could there be a middle scenario based on terms within the contract where Moderna would only be liable for damages for, I don't know, like 25, 50, 75% of the doses?
Thank you.
Dennis Dean: Yes, thanks Dennis. I appreciate the question. A couple things. First of all, it's obviously a little bit difficult to comment on an ongoing litigation, so my answers will be couched.
Dennis Dean: Unknown Speaker in that, or with that predicate. Second of all, just as a reminder for those who are a little bit less close to it on 1498 what 1498 represents.
Speaker Change: is a World War I-era section of the U.S. Patent Code that is designed for government contractors.
Speaker Change: who have been asked by the government to manufacture an infringing product for the government to allow the government to take on infringement liability. For example, if you were manufacturing like patented jet engines for U.S. Air Force planes in World War II or something like that. So Moderna has asked
Speaker Change: for the court to acknowledge that they can use that defense for at least some of the of the vaccine that they have sold. They have attempted twice
Speaker Change: to get claims removed on that basis. First, in an initial motion to dismiss.
Speaker Change: and then the US government filed a statement of interest in the case.
Speaker Change: early in 2023. And in both cases, the court declined their request.
Unknown Speaker
So I think that is one.
Speaker Change: That is one piece of evidence in the statement of interest moment.
Speaker Change: One thing that happened is so 1498 has two prongs to it. There's a for the government prong and there's a with authorization and consent of the government prong.
Speaker Change: and in the statement of interest from the DOJ in early 2023, the government pointed out that of the two contracts they had signed with Moderna, only one of them included express reference.
Speaker Change: Therefore, it seemed to them that perhaps that one was not made with authorization and consent. Anyway, we'll learn more about that in the summary judgment phase. But suffice it to say, therefore, the answer is there could be a range of outcomes on that point.
Great. Thank you so much.
Speaker Change: And our next question will come from Yaron Werber with TV Co and your lines open.
Speaker Change: Great. Good morning. Thanks for taking Matt. I got a couple of questions.
Speaker Change: Maybe just the first one on cutaneous sarcoidosis. This looks like a really interesting opportunity. So as you were, thanks for that slide showing us the Beacon trial design. So this is a study that's
got three to three to two randomization
Speaker Change: Can you give us a little bit of a sense sort of how do you power it?
Speaker Change: What do you want to see in terms of Delta over placebo? And then secondly, just for the Graves disease in terms of remittive ability, what would be good data from your KOL checks in terms of remissions that takes at six months? Thank you.
Speaker Change: Yes. Thanks, Yaron. Those are both great questions. I appreciate them both.
I'm Cutaneous Charcoid.
Speaker Change: You know, I think the short answer is this is a proof of concept study. This is less about sort of powering for some specific statistic outcome.
Speaker Change: and more bluntly, again, there has not been and there have been some studies run in zircoid where CSAMI was measured.
Speaker Change: but there's not been a lot of research into the indication, so we're really trying to get a sense for what the placebo bar looks like.
Speaker Change: In the IIT study was encouraging, but there was no placebo in that study. And so I think we're trying to get a sense for.
Speaker Change: What these response rates look like overall, and I think the benefit of the placebo arm here is to give us something to shoot for in a larger phase three study later. Once we understand kind of what that what that patient population looks like.
Speaker Change: So I think that's really what it is. And the reason we're so heavily randomized in favor of drugs, first of all, is we have two doses, but second of all, is because we're looking for the study to enroll pretty quickly so that we can get this information and get on with a with a bigger later stage study.
Speaker Change: On graves, you know, look, we've had quite a lot of conversations.
Speaker Change: with KOL's about Graves' disease. And we think there's a lot of enthusiasm for a new treatment option. The truth is there's a lot of enthusiasm for a new treatment option among prescribers, even if it does not bring about remission.
Speaker Change: But I think patients would be excited to see a limit of benefits.
Look, I think, you know, therefore.
Speaker Change: Any meaningful amount of remission, I think, would be encouraging to see here and would set us up well to detect a signal in the phase three study that we've got designed with a similar outcome in mind. I don't know that we've set a numeric bar at this point. Maybe we'll talk a little bit more about that as we get closer, but.
Speaker Change: My guess is even if a couple of patients who got off therapy managed to stay in the mission We'd be pretty happy with that
Thank you.
Brian Ching: And our next question will come from Brian Ching with J.P. Morgan. Your line is open.
Hey guys, thanks for taking our questions this morning
Brian Ching: We have two. First on immune events, there are certainly a lot of investor questions on how the high dose Patokomab is going to look compared to the low dose.
Speaker Change: But just curious, you know, if you can tell us the level of your commitment you are, you have today to advance 1402 specifically into MG and CIDP, regardless of what the data show. Will you still proceed in both indication with both pivotal studies?
Thanks for the question. I appreciate it.
Look, I think like any.
Speaker Change: reasonable people, we're going to look at that data and take signal from it in terms of what we think of MG and CIDB and how to develop there.
Speaker Change: MGMCIDP are huge markets where there is a lot of unmet need, and we bring unique things to the table literally no matter what this data shows in terms of form factor, in terms of dosing schedule relative to some of the other trials. So I don't think this data alone is going to inform that question.
Speaker Change: how likely we think we are to be able to differentiate in these studies on efficacy.
Speaker Change: One reminder, obviously we think 340 and 680 are pretty much exactly the same.
Speaker Change: from an IGG suppression perspective at 300, 600, 1402. And we think 340 will suppress IGG, you know, in the mid 60s. And if it does, that'll be pretty similar to what our competitors do. So we think this study will give us a relatively decent lead on what an MG study is capable of showing, for example.
Okay, and then on the neocycloidosis indication for Prevo.
Speaker Change: The Phase II beacons seem to be a relatively small study.
Speaker Change: So can you give us a sense of the trials powering on the CSAMI score?
Speaker Change: How do you assume the placebo will perform in a target population?
Speaker Change: And just wondering if the choice of psychodosis here for Preble here today has anything to do with, you know, the infrastructure they already built with Canavan. Thanks.
Speaker Change: Yeah, perfect, Brad. Thanks for that question. We are really excited about changing the Starcoil. With the study small here, I think for starters, again, the
Matthew Griffin, Unknown Executive, Matthew Gline
The eye study. The eye study.
had a very large effect size.
Speaker Change: And so I think if it's going to look anything like that, powering is not going to be a question. This is not, though I said this before, not really about like powering for stats saved on CSAMI, although I hope we get it obviously. This is really about signal finding. It's really about understanding the range of parameters and giving us some information about dose ranging that we can use to design a phase three that serves for registration purposes.
Speaker Change: So, you know, I think there's not a lot of studies done historically on CSAMI, so there's not a ton of information, but docs mostly believe placebo response is going to be pretty low, which sort of makes sense when you think about what the disease looks like and how it presents. So, you know, I think that's the hope, but we'll see in the study, obviously.
Okay, thank you. Thanks, Brian.
Speaker Change: And our next question will come from Yatin Senajal with Guggenheim. Your line is open.
Speaker Change: And then if part of the question is that the valuation is attractive, you made the investment now, why not bring the whole asset in-house and sort of take advantage of the dislocation in pricing?
Speaker Change: Yes, thank you. Yeah, it's a great set of questions. Obviously.
Speaker Change: We made the investment because we thought it was attractive. We thought the opportunity was attractive. We thought
Speaker Change: We thought there was a good possibility that it would be validated with the data that we're going to generate and so we were excited to
to be able to put that in place.
Speaker Change: You know, I think we also felt that in the hopeful event that the MG data is clean and successful, that we'd like for Minivant to be able to message to the market that the company is funded through Graves data, if we choose to run it that way. And we think that's
Speaker Change: That's a pretty powerful statement to be able to make, especially given just how excited we are about graves and what we think that could mean as an opportunity.
Speaker Change: So I think there's there was a lot a lot attractive to us about the timing and the setup of that investment
Speaker Change: Look, we participated super pro rata in the financing because we liked the opportunity and wanted to own more of it.
I think that's clear.
Speaker Change: It would be a large investment for us to own the entire thing. Now, it would require either billions of dollars of cash or billions of dollars of stock and our stock is not currently valued at a place where we're that excited to issue.
Speaker Change: A ton of it. We've been buying it back. So I think, you know, steps in a direction that we care about and continue to be incredibly enthusiastic about what our FCR franchise could be.
Speaker Change: One more question, if I may, and this is regarding the data, the ImmunoVan data that's coming out. I think there is increasing focus in terms of, you know, the relative better efficacy or a little bit more efficacy that you have to show versus other FCRN. It is our understanding that in many different classes
Speaker Change: a drug with similar efficacy and maybe some differentiation can still get significant share. So, do you really need to produce?
Speaker Change: More efficacy than other FCRN player. I'm just curious like how you are benching benchmarking the
The data relative to the others.
Speaker Change: Yeah, well, thanks. I appreciate that question. I think, first of all, to be clear, if your question is, what is the bar for an immune event to have a commercially valuable important therapy across indications, I think there is basically nothing that could come out of this MG study that could take us off that trajectory given the quality of the molecule we have, the depth of IgG suppression, the form factor. I don't think this data is a referendum on the commercial viability of 1402 at all.
Speaker Change: In MG, where it is more of a referendum. I completely agree with what you just said. I think that if this if the drug look, we have other competitors in the FCR and space, but have showed.
Speaker Change: bluntly less good data than F Carthaginibod and are still expecting to launch those drugs. Those companies expect to launch those drugs. I think those drugs are expected to be commercial successes with pretty meaningful sales, either because they bring a form factor benefit or a dosing regimen benefit, or just because MG is a large market with a lot of different entrants.
and there's a
There's an opportunity for multiple therapies.
Speaker Change: we bring a lot to the table that has nothing to do with generating an efficacy differential. We bring, we talked about the autoinjector, we bring a simple subq autoinjector, we bring chronic dosing in our study.
Speaker Change: So there's a whole bunch of things that I think we bring to the table that mean that we don't in my opinion for commercial viability
Speaker Change: Need to show a delta. Obviously, the bigger delta we show an efficacy, the more share I expect we will ultimately take in the class. That's sort of tautological. And I hope
Speaker Change: We show a meaningful delta that everyone can understand, and I hope that means we're going to be a leader in the class in MG, but I completely agree with the point that you've made that in order to be commercially successful, we don't need that.
Speaker Change: My impression, to be blunt, when everybody has been asking me about the bar for the MG data has not been that they were asking me, what do you think the bar is for a commercially successful drug? The question that I think they've been asking me is, what do I think the bar is for?
Near-term market reaction and my answer mostly has been that
Unknown Speaker
Speaker Change: But I think the people asking me that question are supposed to be better at it than I am.
Speaker Change: So anyway, but totally agree with the point you're asking about. Yeah. Thank you
Thank you.
Emma Gutsing: And our next question will come from Emma Gutsing with Wolf Research. Your line is open.
Emma Gutsing: Hi, good morning. This is Emma on for Andy. Thanks for taking our question. Just one question from us with the top line DM readout expected in the second half of 2025 with potential registration on the table, and with also Argenix's recent success in DM. I guess, what are your expectations for the Brepo Phase 3 readout and the future just competitive landscape if Argenix successfully completes its Phase 3? Thank you.
Speaker Change: Yeah, thanks. It's a great question. And we're obviously really excited for about my status. You know, we are
and we are, if the data are successful and the
Speaker Change: and the drug is approved years ahead of any competitor that we are aware of in dermatomyositis at this point. So I think we get to we get to describe that market basically, in terms of how it comes together and how it gets positioned.
Speaker Change: Regardless of the comparative efficacy, I think we have a four-factor differentiation that's going to matter. There's tons of unmet need, and honestly, I think there's room for multiple additional new mechanisms in neuromyositis.
if it comes to it.
Speaker Change: So, you know, I think from that perspective, it's all a good setup, but I think the trial really needs to do.
is just succeed.
Speaker Change: and I think with that, we will have a big opportunity that said, because I can't quite help myself.
Speaker Change: and I think we have a real shot of delivering meaningful efficacy for these patients, and the JAK inhibition has the potential to be, or especially JAK inhibition combined with TIK2 inhibition, has the potential to be a best overall mechanism, at least among the things currently being studied, but obviously we won't know the answer to that for years and years.
Speaker Change: as those other mechanisms stay there. Thank you. Great. Great. Appreciate the results.
Speaker Change: And our next question will come from Douglas Sow with HCW. Your line is open.
Speaker Change: Hi, good morning. Thanks for taking the questions. And Matt, I guess, just maybe starting with representative, and obviously now have another indication.
I'm just curious if you have thoughts on sort of.
Speaker Change: The page that you would potentially roll out additional indications with breakfast that note just given the fact that it seems to be an asset that could have fairly broad applicability across a range of orphan indications, which I know sort of has been your initial focus. Thank you.
Speaker Change: Can I have a follow-up? Yeah, sure. No, that's a great question. Thank you. Look, we're obviously excited about continuous starcoids that we've unveiled today, and what I can say is that we are actively evaluating a number of other indications that we think would fit well into the paradigm for BREPO, and I think we're...
Unknown Speaker
We're not unveiling them at some predetermined pace based on
Speaker Change: a goal or expectation. We're unveiling them as we get primed, ready and good to go with each successive new indication. And so I think my hope is that you can expect more in the in the period to come here, but let's let's see what we get.
Speaker Change: I mean, I guess Matt is a follow up. I mean, it's like, you know, immune event has talked about sort of 10 studies over a certain amount of period.
Speaker Change: and I get you don't want to necessarily commit to that similar timing, but do you think that that's a fair number of opportunities that that provoke could ultimately be relevant to?
Speaker Change: Sure, I think the answer is there is probably a very long list of opportunities that Brepo could be.
Speaker Change: You can ask CHAT GPT with deep reasoning for a list of inflammatory orphan indications with tens to low hundreds of thousands of patients. There's a long list of them and I think we are spoiled for choice in terms of places where patients might benefit and so I think what we're doing is spending our time picking our spots.
Speaker Change: figuring out which indications have the right set of competitive dynamics, the right sort of leaning into both Jack one and take two, which is something that creates a competitive vote for us. Things that have
Speaker Change: a patient population that is sized for our competitive landscape and price point.
and then, frankly, making sure that we.
Speaker Change: scale operationally to match the sort of level of activity ongoing in private.
Speaker Change: so that we continue to run good studies and generate good data. And obviously we're really happy with the job that team has done is doing and are excited to keep investing in them.
Speaker Change: So, look, I think there are a lot of possible places to go. I'm not sort of given a number today, but I think we're choosing our spots and moving at Reuven's pace, which is to say, hopefully, quickly.
Okay, great. Thank you.
Thank you very much.
Speaker Change: I show no further questions in the queue at this time. I would now like to turn the call back over to Matt Gline for closing remarks.
Speaker Change: Great. Well, thank you, everybody, for listening this morning. Thank you to.
Speaker Change: The Roivint team, the Mid-Event team, the Pri-Event team, all of the event teams at Roivint.
Speaker Change: whether hard work, the patients and investigators who helped us progress.
Speaker Change: and looking forward to the year 2025 and excited to get back on the phone and talk about more updates.
probably pretty soon.
So thanks, everybody. Have a good day.
Speaker Change: This concludes today's conference call. Thank you for participating. You may now disconnect.
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