Q4 2025 Roivant Sciences Ltd Earnings Call

Unknown Executive: Good day and welcome to the Roivant 4th Quarter 2024 Earnings Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session.

Good day and welcome to the fourth quarter 2024 earnings call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session.

Unknown Executive: Instructions will be given at that time. As a reminder, this call may be recorded.

This will be given at that time.

Stephanie Lee: I would like to turn the call over to Stephanie Lee. Please go ahead.

Speaker Change: As a reminder, this call may be recorded I would like to turn the call over to Stephanie Lee. Please go ahead.

Stephanie Lee: Good morning, and thanks for joining today's call to review Roivant's financial results for the fourth quarter and fiscal year ended March 31st, 2025. I'm Stephanie Lee with Roivant.

Stephanie Lee: Good morning, and thanks for joining today's call to review <unk> financial results for the fourth quarter and fiscal year ended March 31st 2000.

Stephanie Lee: Presenting today, we have Matt Gline, CEO of Roivant. 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.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along.

Stephanie Reed: I'm, Stephanie Reed, but break presenting today, we have not lines at yellow rose.

Stephanie Reed: For those dialing in via conference call you can find it like being presented today as well as the press release announcing this on our IR website at Www Dot Investor got right.

Stephanie Reed: We'll also be providing the current slide number three for that to help you follow along 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 have filed with the SEC for more information regarding these forward looking statements and related risks and uncertainties.

Stephanie Lee: I'd like to remind you that we'll be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties.

Matthew Gline: And with that, I'll turn it over to Matt. Thank you, Steph, and thank you, everybody, for listening this morning for our fiscal year-end conference call. Good morning. So I'm going to I'm going to start in the deck here on slide five by saying it's hard to believe this actually not only has it been a very impactful fiscal year, but this is the reporting quarter in which, for example, we generated the data for Batocla MAB, MIT Grabs and CIEP. So it's been a very busy six months for us to start off at 2025. 2025 is just a really important year for our business, starting with the data we've already generated, which we think sets us up for a best in class potential franchise in the NTFCRN world with with IBT 1402.

Stephanie Reed: And with that I'll turn it over to Matt.

Matt: Thank you everybody for listening this morning for our fiscal year end conference call.

Matt: So I'm going to I'm going to start in the deck here on slide five.

Matt: It's hard to believe it's actually not only has it been a very impactful fiscal year, but this should be a reporting quarter, which for example, we generated.

The data for them to talk about it makes me grab since the AEP. So it's been a very busy six months for us to start off at 25 by 'twenty one.

Matt: It's just a really important year for our business starting with data we've already generated which we think sets us up for a best in class potential franchised.

Speaker Change: <unk> CRM world without diabetes, 14th two.

Speaker Change: First in class in a number of indications such as grapes that he is and potentially best in class we think anywhere.

Speaker Change: Wait.

Speaker Change: Coming in one of the most important events of the year.

Speaker Change: Second half is the Registrational data from our Ah potentially registrational data for Mercedes Bremen sitting here.

Speaker Change: And Grandma situs, which.

Speaker Change: AH study, we are super excited for its a patient population with high unmet need.

Speaker Change: We'd be the first novel oral B M drug I'm pretty long lead time over at really any other late stage programs and I look forward to sharing more about that both today and in the near future.

Speaker Change: And then finally this is a really pivotal year.

Speaker Change: Things for our LNP litigation, we'd been around with Pfizer beyond tax. We are currently in a narrowing in summary judgment phase of that trial and upon the completion of that phase, we expect to move to trial in the relatively near future. So incredibly important moment for that as well that's an interesting.

Matthew Gline: We are currently in a narrowing and summary judgment phase of that trial. And upon the completion of that phase, we expect to move to trial in the relatively near future. So an incredibly important moment for that as well. That's some of the terms. You know, on 5.6, we say this every time we get on the phone, but I am incredibly proud of our late-stage pipeline here. First, with brevacitinib, which obviously has the potential to be an on-market therapy as soon as within the next couple of years with this data coming into metamycitis, with IMD-1402 actively enrolling multiple potentially registrational studies across, or pivotal studies across multiple indications, where we either already know or strongly expect FCRN antibodies to matter quite a lot.

Speaker Change: You know on slide six we say this every time, we get on the phone, but I am incredibly proud of our late stage pipeline here.

Speaker Change: First with PREPA sitting there, which obviously has the potential to be.

Speaker Change: And on market therapy as soon as within the next couple of years at this data coming in from out of my status with IBD 14th to actively enrolling multiple potentially registrational studies across our four pivotal studies across multiple indications, where we either already now are strong we expect CRM bodies to matter quite a lot.

Matthew Gline: We also have Mosley-Szigot, our inhaled therapy for PHLD, with data expected to be coming next year. And obviously, for those who follow our story, ongoing BD with multiple possible pipeline expansion opportunities as well. On slide seven, we are in a period of just significant clinical execution and progress here in really all of our main clinical franchises with 1402 and additional cleared IND, five potentially registrational studies ongoing, one proof of concept study initiated in CLE, and in the next coming years, potential for, yes, six plus indications each with potential multi-blockbuster launches. Obviously, in Brevacitinib, among other things, in 2025, we initiated our study of cutaneous sarcoidosis.

Speaker Change: We also have most of the gigawatt hour inhaled therapies with DHL deal with data expected next year.

And obviously for those who follow our story.

Speaker Change: Ongoing BD with multiple passes by my expression that piece as well.

On slide seven we are in a period of significant clinical execution and progress you're.

Speaker Change: It really all of our main clinical franchises with 14 O two.

Speaker Change: Additional cleared IMT five potentially Registrational studies ongoing one proof of concept study initiating CLA.

Next coming years potential for six plus indications with each with a potential multi blockbuster launches.

Obviously, a breakfast sitting there.

Speaker Change: Among other things in 2025, we initiated a study to take sarcoidosis. We go later this year, we got the second study again with the potential in 'twenty and beyond.

Matthew Gline: We will later this year read out the Dermatomyositis study. And again, with the potential in 2026 and beyond for a multi-blockbuster orphan franchise anchored by launches in DM and NIU, more about that in a minute. And then, as I mentioned before, in Moseley, we've got the PHLD study enrolling nicely at this point, and we believe that that program could be positioned in frontline use for PHLD and potentially other respiratory disease. You know, on slide eight, and I don't want to say too much about this yet, because we haven't actually generated that amount of data yet.

Speaker Change: Our multi blockbuster orphan franchise anchored by Washington D M&A.

Speaker Change: And then as I mentioned before in mostly we've got the ph Lv study enrolling nicely at this point.

Speaker Change: And we believe that that program could be positioned in frontline use for ph ILD and potentially other respiratory diseases.

Speaker Change: Right.

Speaker Change: I don't want to say too much about this yet because we haven't actually generate a bit about las vegas data, yet, but but but but on a thematic point that I expect will talk more about if that data meets our hopes and expectations. This is really the beginning of a pretty stacked 36 months for us in terms of data and launches.

Matthew Gline: But on a thematic point that I expect we'll talk more about if that data meets our hopes and expectations, this is really the beginning of a pretty stacked 36 months for us in terms of data and launches, with multiple launches in potential blockbuster indications, first for RepositMib, and then for our FCRN franchise in a way that we think adds up to one of the most exciting commercial portfolios, potentially, in I&I over the next couple of years here. So really looking forward to that flow and excited for DM as the sort of first domino. Again, fingers crossed or knocking wood or whatever you do if you're superstitious, that that data does what we would like it to do.

Speaker Change: With multiple launches in potential blockbuster indications first for representing them and then for our MCR in franchise in a way that we think adds up to one of the most exciting commercial portfolios potentially.

Speaker Change: Ini.

Speaker Change: The next couple of years here, so really looking forward to that flow.

Speaker Change: Cited for DM is that the sort.

Speaker Change: The first Domino again fingers crossed or knocking wood or whatever you do with your superstitious that that data that does what we would like it to do.

Matthew Gline: You know, on slide nine, I guess, last overall framing point before I talk about some of the specific programs is, you know, I think one of the things that Roivant has been very focused on over the last couple of years, obviously, since the cash inflow from the sale of our NTTO and antibody has been thinking critically and carefully about capital allocation, and we feel very good about where we are right now. We are set up, as we've said before, to capitalize Roivant to profitability, again, with just under $5 billion in cash on the balance sheet today, supporting the current pipeline to profitability with about $2 billion still in reserve for pipeline expansion and deployment on VD opportunities.

Speaker Change: Yes.

Speaker Change: On slide nine I guess last overall framing point before I talk about some of the specific programs.

Speaker Change: I think one of these that Raymond has been very focused on over the last couple of years, obviously since the cash inflow from the sale of our engineered one antibody.

Speaker Change: <unk> been thinking critically and carefully you about capital allocation and we feel very good about where we are right. Now we are set up as we've said before to capitalize worthy to profitability again with just under $5 billion in cash on the balance sheet today supporting the current pipeline to profitability.

Speaker Change: About $2 billion still in reserve for pipeline expansion and deployment on BD opportunities and that's against the backdrop of having repurchased already $1 3 billion and our own stock as a 331 25, thats reduced our share count by not quite 15%.

Matthew Gline: And that's against the backdrop of having repurchased already $1.3 billion in our own stock as of 3-31-25. That's reduced our share count by not quite 15%, and that capital return continues on the existing share repurchase authorization, and we continue to think critically about what to do from a capital return perspective thereafter, given our balance sheet. So, again, really excited about what we've been able to do from a capital allocation perspective and excited for the capital position that we are in, particularly in what we acknowledge is a very challenging market for many of our peers and for the industry.

Speaker Change: And that can't work continues under the existing share repurchase authorization at the beginning to think critically about what to do from a cap worker perspective. There are thereafter, given our given our balance sheet. So again really excited about what we've been able to do from a capital allocation perspective.

Speaker Change: For the capital position that we're in particularly in what we acknowledged as a very challenging market for many of our peers for the industry.

Matthew Gline: Great. So with that, as Framing Commons, I just want to spend a little bit of time on a couple of the key events for this year, starting with BREP-CITNB, where I do mean a little for a reason that will become obvious in a moment. So on slide 11, just as a reminder, what we're really focused on for BREPO is indications with high end need that are tailored to our specific novel mechanism with Dual TIC-2 and JAK-1 Univision. The announced indications so far are DM with the readout that I've talked a lot about already, NIU, which is actively enrolling in our phase three program, in our pivotal phase three program, where we think there's a very high overall opportunity and very few other therapies approved, and then our proof of concept trial in cutaneous sarcoidosis.

Speaker Change: Yes.

Speaker Change: So with that framing comments I, just want to spend a little bit of time on a couple of the key events for this year starting with Brexit.

Speaker Change: I do mean, a little for a reason that we come out of this in a moment on slide 11, just as a reminder, what we're really focused on for Brent.

Speaker Change: Indications with high unmet need that are tailored to our specific novel mechanism with dual picture with JAK inhibition announced indications. So far are D. M will be read out, but ive talked a lot about already niu, which is actively enrolling in our phase III program in our pivotal phase III program.

Speaker Change: Where we think theres, a very high overall opportunity and very few other therapies approved and then our proof of concept trial and continuous sarcoidosis. We are as you might expect also investigated we're exploring other areas in which we might like to develop reps if.

Matthew Gline: We are, as you might expect, also investigating or exploring other areas in which we might like to develop BREP-CITNB, and you can potentially hear more about those in the coming month. We feel we've rapidly expanded on this opportunity from when we actually, we first initiated the DM trial in 2022, same time as proof of concept study in NIU, and since then we obviously read out that NIU study, initiated the pivotal program in NIU, got going in CS, and are now set up for the upcoming readouts, three of which, the pivotal in DM, the pivotal in NIU, and the proof of concept in CS are coming within the next, call it, 18 to 24 months.

Speaker Change: You can you can potentially hear more about those in the coming in the coming months, we feel we rapidly expanded on this opportunity from what we actually we first initiated the <unk> trial.

Speaker Change: 2022 at the same time as proof of concept study in Niu and since then we obviously read out that Niu study initiated the pivotal program in Niu got going in <unk> and are now set up for us.

Speaker Change: For the upcoming Readouts three.

Speaker Change: Three of which the pivotal and Vmware pivotal and Niu.

Speaker Change: And the proof of concept in CFS or coming out within the next call. It 18 to 24 months. So again, a really exciting year for reps hitting them. So much so that it is.

Matthew Gline: So, again, a really exciting year for BREP-CITNB.

Matthew Gline: So much so that, and there's details of this on the next slide, on Tuesday, June 17th, we're going to hold an investor event, a sort of mini R&D day, where the Royvon team, together with the Pryvant leadership team, Ben Zimmer, CEO of Pryvant, will get together and we're going to do a little bit of DM disease education and some details on the trial design for the ongoing trial, because we hope and expect that people will be watching for that data later this summer, and we want everyone to have a clear frame of reference for what to expect as it comes around.

Speaker Change: Details on this on the next slide on Tuesday June 17th we're going to hold an investor event that many R&D day.

Speaker Change: With the right team together with the private leadership team that is overseeing your private will get together and we're going to do a little bit of DM disease education, and some details on the trial design for the ongoing trial.

Speaker Change: Because we hope.

Speaker Change: Hope and expect that people will be watching for that.

Speaker Change: Later this summer and we want everyone to have a clear frame of reference for what to expect as it comes around and obviously, we've been exciting to watch general progress in that field in recent weeks months as well.

Matthew Gline: And obviously, we've been excited to watch general progress in that field in recent weeks and months as well, and are pleased with our positioning, both from a timing and structure perspective.

Speaker Change: Pleased with our positioning both from a timing and structure perspective.

Matthew Gline: So given that we're reserving time for BREFO in the future, that's all I'll say about it on this call, but stay tuned for more on that future call.

Speaker Change: So given that we're reserving time for breath will in the future. That's all I'll say about it on this call, but stay tuned for more on that on a future call.

Matthew Gline: Next, I'm going to talk a little bit about ImmuneVant and the recent developments in our anti-epithelial and antibody franchise.

Speaker Change: Next I want to talk a little bit about <unk> and the recent developments in our NDS hearing antibody franchise. As a reminder, this call also effectively services, we would event conference call for the quarter of the year as theyre not doing their own IR activities right now.

Matthew Gline: As a reminder, this call also effectively serves as the ImmuneVant conference call for the quarter of the year as they're not doing their own IR activities right now. So look, I think everyone is familiar with the overall sort of structure of this story right now, but on slide 14, we really think we have a tiger by the tail in IMD-1402. We think it's a potential drug that has an opportunity to be a first and best-in-class anti-FCRM across multiple indications. We think we get IgG lowering up to, call it, 80% or the low 80s in studies.

Speaker Change: So I think everyone is familiar with the overall <unk>.

Speaker Change: Structure of the story right now, but on slide 14, we really think we have a tiger by the tail in IMTT 14 are too.

Speaker Change: Thank you Sir.

Speaker Change: Potential drug that has appeared to be first and best in class.

Speaker Change: CRM.

Speaker Change: It's multiple indications, we think we get ITG lowering.

Speaker Change: Call it 80% of the low Eighty's in studies that is.

Matthew Gline: matched with or at the most robust IgG lowering observed not just, frankly, in ATFs and antibodies, but across the field of IgG lowering therapies with a favorable safety profile that we think gives us overall clean differentiation. We have a great community administration with a market-proven, friendly auto-injector device that will be used at launch. We have data that we think validates deeper IgG suppression mattering across multiple indications. Obviously, we felt strongly that the evidence generated in our MG and CIDP data studies were constructive to that end. And also, we've got data in Graves. We've got our own data from Phase II and TED.

Speaker Change: Last week or at the most robust ITT lowering observed not just frankly, you made yesterday antibodies, but across the field of actually lowering therapies.

Speaker Change: With a favorable safety profile.

Speaker Change: We think it gives us overall clean differentiation, we have a breakeven <unk> administration with a market proven friendly auto injector device that will be used at launch.

Speaker Change: We have data that we think validates deeper ITG suppression battering across multiple indications. Obviously, we felt strongly that the evidence generated in Mg and <unk> studies were constructed to that and also we've got data and graves, we've got our own data from phase II with Ted and we've seen it multiple other places that there is a clear clinical benefit for patients for whom.

Matthew Gline: And we've seen it in multiple other places that there's a clear clinical benefit for patients for whom you can get IgG reduction over 70 percent. And we hope and expect to continue showing that in our ongoing clinical programs. And then we just a lot of ongoing clinical progress across multiple indications, including the ones I've mentioned, as well as the ongoing studies in D2G, fourth-line rheumatoid arthritis, in Sjogren's, where we have programming expected to start this summer, and CLE indications that we've talked a lot about in recent months because we just announced them, actually, about five or six weeks ago.

Speaker Change: You can get IGT reduction over 70% and we hope and expect to continue showing that in our annual global programs.

Speaker Change: And then we just a lot of ongoing clinical progress across multiple indications, including the ones I've mentioned as well as the ongoing studies in <unk> arthritis.

Speaker Change: <unk>, where we have program expected to start this summer and see all the indications that we've talked a lot about in recent months because we just we just announced that actually published two weeks ago.

Matthew Gline: And then, as a reminder, the IPM 14-week group is out to 2043, so quite a long franchise as well. And that's not including any PTTs. So, a really good setup.

Speaker Change: And then as a reminder, the IP opportunity presents 2043, so quite a long franchise as well and that's not assuming any features so as already gets out.

Matthew Gline: Our indication strategy from prioritization perspective on slide 15 has been first and foremost indications where we feel confident we can be both first and potentially best in class. Obviously the most obvious example in that category is Graves' disease where we believe we've helped the field understand that that is an interesting market with a lot of or interesting opportunity with a lot of them that patient need. We think we are out in front there in terms of working with that field, working with those physicians, working with those sites and we that position of scientific leadership. And then we've also got our ongoing programs in DQTRA and cutaneous lupus where we feel like we are first in class in the FCRM field as well.

Speaker Change: Our indication was strategy from prioritization perspective on slide 15 has been first and foremost indications, where we feel confident we can be bought first and potentially best in class. Obviously, the most obvious example in that categories graves disease, where we believe helped the field understand that that is an interesting market with a lot of other interesting.

Speaker Change: Unity with a lot of unmet patient need we think we are out in front there in terms of working with that Youre working with those physicians working with those sites and we expect and are working hard to maintain that position of scientific leadership and then we've also got our ongoing programs in <unk> cutaneous lupus, where we feel like we are first in class in the year.

Matthew Gline: Then there's a category of indications where Sjogren's is probably the best example, which I call nearly first in class indications, where we believe with good execution we can minimize the time gap between us and our competitors while maintaining a potential for a differentiated clinical profile driven by best in class IGG reductions. And finally, there's the sort of tried and true known indication space like MG and CIDB, which we acknowledge are competitive, which are well-established, where Vivgar, for example, is a well-loved drug in MG, but where we feel like we have potential to differentiate on efficacy and clinical benefit.

Speaker Change: In the <unk> field as well then there's a category of indications where showrooms is probably the best example, which I called nearly first in class indications, where we believe with good execution, we can minimize the time gap between us and our competitors.

Speaker Change: Maintaining a potential for a differentiated clinical profile driven by best in class IGT reductions and finally, there is the sort of tried and true known indication space like <unk>, which we acknowledge our competitors, which are well established where they've got for example is a well loved drug in Mg, but where we feel like we have potential to differentiate on efficacy clinical benefit.

Matthew Gline: And I was pleased to see, for example, in the last few days that some of the myasthenia gravis patient organizations are encouraging physicians to think about deeper response measures like MSC as the future of treatment for those patients, and where we think we can take a leadership position given the profile of 1402. So tremendously excited about the way we're thinking about indication prioritization, and I think you can imagine if we're going to announce more programs over the time that it will roughly follow this sort of prioritization hierarchy.

Speaker Change: Pleased to see for example in the last few days, but some of the nice thing about this patient organizations are encouraging physicians to think about.

Speaker Change: Deeper response measures like MSC as the future of treatment for those patients where we think we can take a leadership position given the profile of 14 hotels. So tremendously excited about the way, we're thinking about indication prioritization and I think you can imagine if we're going to announce more programs over time that it will roughly follow this sort of prioritization hierarchy.

Matthew Gline: On slide 16, and we've ambitiously called this slide Settling the Deeper is Better Debate, I think in our minds we feel quite confident at this point that deeper IgG suppression across indications is going to yield meaningfully better clinical benefit. We've seen it on this sort of less than 70, greater than 70 IgG reduction cut point where we've divided our data in multiple indications. We have consistently seen deeper and better responses. That includes in our GRAVES Phase 2a data from the Tocumab where we had 60% of patients effectively off ATGs in the over 70% cohort compared with just over 20 off ATGs.

Speaker Change: On slide 16 mix.

Speaker Change: We are ambitious we call it the slide settling the diverse better debate I think in our minds, we feel quite confident at this point that deeper agg suppression across indications is going to yield meaningfully better clinical benefit that we have.

Speaker Change: <unk> seen it on the sort of less than 70 greater than 70, IGD reduction cut point, where we've divided our data in multiple indications we have consistently seen that.

Speaker Change: Deeper and better responses that includes.

Speaker Change: Great Phase Iia data for October that where we had 60% of patients effectively off <unk> in the over 70% cohort compared with just over 20 off Mtge's again. These are all patients who have normalized three in Q4.

Matthew Gline: Again, these are all patients who have normalized T3 and T4. And depending on IgG cut off, you know, we saw over 50% of patients with minimal sensory repression effectively with clinical remission in Myasthenia gravis in the over 70% cohort versus, you know, just under a third in the under 70% cohort. And likewise in CIDP on NCAT, we saw a significantly different responder rate in the deeper IgG responders bucket than in the lesser IgG responders bucket. So we really do feel like this is a consistently demonstrated hypothesis. And we think that high dose, the Tocumab and most importantly high dose NMD 1402 drive the vast, vast, vast majority of patients into that over 70% bucket.

Speaker Change: And that depending on agg cutoff.

Speaker Change: We saw.

Speaker Change: Over 50% of patients with <unk>.

Speaker Change: Minerals introgression effectively critical mission in myasthenia gravis.

Speaker Change: Over 70% cohort versus just under a third in the under 7% cohort and likewise in CDP on a cat that we saw a significantly different responder rate in the deeper IGT responders bucket then in the lesser IGT responders bucket. So we really do feel like this is a consistently demonstrated hypothesis and we think that high dose we're talking about.

Speaker Change: Most importantly, hydro is and will be working hard to.

Speaker Change: Drive the vast vast vast majority of patients into that over 70% bucket. So we think this is representative what we may be able to deliver.

Matthew Gline: So we think this is representative of what we may be able to deliver as a clinical benefit in those patient populations. So we feel very good about what we have in terms of the profile of the molecule given this data. On slide 17, we do feel like we've set some new benchmarks for efficacy in our MG and CIDP data, you know, in MG, both on an absolute MG ADL improvement, as well as on other measures, we think we've shown some of the best observed absolute improvement. And then, frankly, the best placebo-adjusted MG ADL improvements, on things like MSE, where we're putting patients against these sort of deeper, deeper, more durable response, response goals.

Speaker Change: As a clinical benefit in those patient populations. So we feel very good about that about what we have in terms of the profiled molecule given this data.

Speaker Change: On slide 17, we do feel like we've set some new benchmarks for efficacy.

Speaker Change: In our <unk> data in Mg both on an absolute Mg ADL improvement.

Speaker Change: As well as on other measures. We think we've shown some of the best observed absolute improvement.

Speaker Change: And then frankly, the best placebo adjusted Mg ADL improvements.

Speaker Change: On things like MSC.

Speaker Change: Where we're putting patients against the sort of deeper deeper more durable responses response goals and so we felt we feel really good about what we're going to be able to deliver LNG to 14 or too. We're really excited of what we're seeing in the available data.

Matthew Gline: And so we feel we feel really good about what we're going to be able to deliver in MG with 1402. We're really excited of what we've seen in the available data tool due to the ongoing study in CIDP. And then, you know, obviously, the Tokamak has been consistent with its prior studies in terms of overall power abilities. So, so, you know, a really strong position in terms of, in terms of what our data has put out here.

Speaker Change: Due to the ongoing study in <unk>.

Speaker Change: And then obviously the total demand.

Speaker Change: Consistent with its prior studies in terms of overall tolerability.

Speaker Change: Really strong position.

Speaker Change: In terms of entered and what our data is put out here.

Matthew Gline: You know, one point to make, and this is really sort of more specific to MG, and maybe some of the comments we've seen from patient groups recently as well, is we believe that the MG field is going to progress from here in a way that is similar to what we've seen in other, in other indications, particularly in immunology, where you go from sort of first generation prior, you know, early therapies that just look at overall response rates, improvement in a position global assessment in psoriasis, or, you know, relatively low relapse rates in MS, or MGADL response rates in MG.

Yes.

Speaker Change: Yes, one point to make and this is really sort of more specific mg and maybe some of the comments we've seen from patients, which recently as well is we believe that the Mg field is going to progress from here in a way that is similar to what we've seen in other.

Speaker Change: Their indications, particularly in immunology, where it <unk>.

Speaker Change: Go from sort of first generation prior.

Speaker Change: Early therapies that just look at overall response rates improvement and a physician global assessment.

Speaker Change: In psoriasis or.

Speaker Change: Relatively low relapse rates.

Speaker Change: Or Mg ADL response rates in Mg.

Matthew Gline: So, you know, once you get to the first generation of innovative compounds, people start talking about remission rates, PASI-75s and higher, you know, EDSS and MS, the higher ACR rates in RA. And in the case of MG, we think MSE is sort of the next generation here of what people are going to look at. And then, you know, as we get to the future here, people looking at PASI-100s and psoriasis for complete, effectively complete clinical correlates. You know, same thing in MS, no evidence of disease activity. And we think people are looking at deep and durable responses, you know, Many-week or many-month durability to MSC after therapy is the kind of thing that we think the field is going to move towards in MG, and we think we are in a privileged position to lead the FCRM category in those kinds of endpoints going forward.

Speaker Change: Once you get to the first generation of innovative compounds people start talking about remission rates, passing 70 fives and higher.

Speaker Change: S asset MFS, the higher ACR rates in R&D.

Speaker Change: And in case of MGE, We think MSC is sort of the next generation here of what people are going to look at and then yes, as we get to the future here people looking at past one hundreds in psoriasis for complete effectively complete global core rates.

Speaker Change: Same thing in EMS no evidence of disease activity and we think people are looking at deep and durable responses.

Speaker Change: Many weak for many months durability to MSC.

Speaker Change: After therapy.

Speaker Change: That we think the field is going to look towards in Mg and we think we are in a privileged position to lead the CRM category in those kinds of endpoints going forward you can see on slide 19 for example in the <unk> study.

Matthew Gline: You know, you can see on slide 19, for example, in the Batocumab MG study, you know, maintenance of minimal symptom expression for greater than or equal to six weeks. This is this chart on the bottom right-hand side of slide 19. You know, you can see at high-dose Batocumab, when we were getting those deep levels of IgG suppression, you had 75% of patients maintaining that status for six or more weeks, which we think is the kind of endpoint. By the way, 93% of patients achieved a clinical response. We think this is the kind of data that is going to move the market in terms of what patients are looking for in an MG treatment, and so we're excited to focus on those kinds of endpoints in the ongoing phase three program, or the ongoing clinical program in 1402.

Speaker Change: Maintenance of minimal system minimal symptom expression.

Speaker Change: For greater than or equal to six weeks. This is a chart on the bottom right hand side of slide 19, you can see a high dose pilgrim app will be we're getting those deep levels of IGT suppression U S, 75% of patients maintaining that status for six or more weeks, which we think of the kind of endpoint by over 93% of patients achieved a clinical response.

Speaker Change: We think this is the kind of data that is going to move the market in terms of what patients are looking for in an mg treatment and so we're excited to focus on those kinds of endpoints in the ongoing phase III program again to a pivotal program with Hino true.

Matthew Gline: On slide 20, just as a brief reminder, because we spent some time on this on the most recent call, we've now initiated programs in Sjogren's and in CLE, in the case of Sjogren's, an indication of what we think we have the potential to be, as I said before, nearly first and best in class in a large market with a large population and a high unmet medical need, with some good evidence of autoantibody-driven disease, and with clear dose response data from the CalMab showing that IgG suppression seems to matter. And then in CLE, again, with a fairly large market, obviously some good recent data from the field there, with 75,000 addressable patients uncontrolled on standard of care therapy, and with relatively well-identified CLE-specific IgG autoantibodies that are a part of the disease presentation.

Speaker Change: Okay.

Speaker Change: On slide 20, just as a brief reminder, because we spent some time on this on the most recent call. We've now initiated programs and programs at EMC early indications show brings an indication where we think we have potential to be as I said before nearly first and best in class in a large market with a large population and a high unmet medical need.

Speaker Change: Some.

Speaker Change: Some good evidence of auto antibody driven disease.

Speaker Change: Clear dose response data from <unk>, showing the deep Reds discretion seems to matter and then in cle again with a fairly large market. Obviously some some good recent data from the field there.

Speaker Change: 75000 addressable patients uncontrolled on standard of care therapy, and with relatively well identified specific <unk> antibodies that are part of the disease presentation. So we're excited about the data we're going to generate there next year and we obviously have that principal case study data, we werent shown for patients who were the first patients in any disease dose to the 90 the 14th.

Matthew Gline: So we're excited about the data we're going to generate there next year. And we obviously have that principal case study data we've already shown for patients who were the first patients in any disease dosed with IgG 1402 with data reported.

Speaker Change: <unk> data reported.

Matthew Gline: You know, finally, just two quick things on slides 21 and 22 here. One is, these will both be on clinicaltrials.gov in the near future. Slide 21 is the design of our potentially registrational trial in CIDP for 14.02, which is, you know, a different design than the first generation of studies that folks like our competitors have run or even that we ran for the DocuMab, but clearly sort of pretty much in line with where we see the field going and a study that we think gives us a real opportunity to put out some great data in a patient-friendly format and a design that we think investigators are pretty excited about enrolling patients into as well.

Speaker Change: Finally.

Speaker Change: Two quick things on slide 22 here. One is these are lumpy and globe trial back up on your future on Slide 21 is the design of our potentially Registrational trial in CIP for fortino too.

Speaker Change: Which is a different design than the first generation of studies that folks like our competitors and broader than that we ran for Brooklyn lab, but clearly sort of pretty much in line with where we see the field going in a study that we think gives us a real opportunity to put out some great data in a patient friendly format.

Speaker Change: We the investigators are pretty excited about going basis into as well.

Matthew Gline: And on slide 22, you can see the design for our second study in Graves' disease, which is now up and running, which we'll be enrolling patients quite soon. And so that design also is now public. You can see some of the features here. Notably, although it's not sort of hit you on the face obvious in the design, one of the things we hope you'll get from both of these studies at this point, based on our understanding of the patient population, is some clear information about the impact these drugs are having on proptosis and the progression into TED-like symptoms. And so looking forward to generating that data in these studies as well.

Speaker Change: On Slide 22, you can see the design for our second study and graves disease, which is now up and running which will be enrolling patients quite soon.

Speaker Change: And so that design also is now public you can see some of the features year, notably, although it's not sort of hits you on the face obvious and assigned one of things. We hope you will get from both of these studies at this point based on any of the patient population is so clear information about the impact of these drugs are having on proptosis on the progression into indicated like symptoms and so looking forward to generating that.

Speaker Change: Data in these studies as well.

Speaker Change: Slide 23, I will be here in great detail, but theres just rehashing, we feel really really great about the overall portfolio of indications that we're studying with our <unk> franchise, including just a very large overall potentially addressable U S patient population over 600000 patients with a pretty meaningful subset of those patients existing and graves disease.

Speaker Change: Which is our shorter lead indication would be great.

Speaker Change: To truly define that opportunity into it to be the first out there helping patients.

Matthew Gline: Absolutely jam-packed couple of years ahead, as I led with earlier on slide 24, in terms of data that we expect to generate. Obviously, including remission data that we're going to put out this year, engraved disease from the Tocomab study, the potentially registrational top-line data coming in TED and the Tocomab second half of this year, and then starting next year, a ton of data from 14.02, including open-label period one results from the DHTRA study, the CLE study next year, and then potentially registrational data in multiple indications, including Graves and Meissner-Gravis in 2027, and Sjogren's and CIDP beyond.

Speaker Change: Yes.

Speaker Change: Absolutely Jam packed couple years ahead as I led with earlier on slide 24.

Speaker Change: In terms of data that we expect to generate obviously.

Speaker Change: <unk> remission data, which I'm going to put out this year and graves disease from broken lab study.

Speaker Change: Registrational topline data coming at <unk> and the total amount of the second half of this year and then starting next year.

Speaker Change: Data from <unk>, including.

Speaker Change: The open label period, one results from good CRA studied UCLA study next year, and then potentially registrational data.

Speaker Change: Locations include ingredients in messenger gratis in 2027, and <unk> and beyond so really tremendous couple of years ahead.

Matthew Gline: So really tremendous couple of years ahead.

Matthew Gline: Eric is in his early days in the role at Immunevent, really excited about seeing what he's going to deliver there. I think the team over at Immunevent is just super energized to deliver a meaningful product. It's going to help patients a lot. Thank you.

Speaker Change: Eric This is early days in the role of immune to that.

Speaker Change: We're really excited about seeing what he's going to deliver there I think the team over to <unk> to super energized to deliver a meaningful product that can help our patients.

Speaker Change: Finally in terms of business updates on slide 26, just a reminder, that this is a really important period for our LNP litigation. We are effectively the summary judgment phase of the trial are part of that.

Speaker Change: <unk> was expected from the beginning is this is a narrow process alright, a normal process of narrowing the scope.

Speaker Change: Our claims and our and Madonna's defenses in the trial that process is ongoing and we've had some discussions with the judge about making sure everyone gets that right.

Speaker Change: Immediately following that summary judgment motion should be going in and then we'll be sort of.

Speaker Change: I had a pending U S jury trial. The data is at the moment TBD, but looking forward to all of us progressing in the near future and then finally, starting next year I will have the beginnings of our international trials and litigation that we filed just couple of months ago. The Pfizer case continues to be ongoing we are awaiting the markman ruling, which we think could come this year.

Speaker Change: In the case.

Speaker Change: So look forward to all of that.

Speaker Change: I will now wrap up quickly with a financial update I won't read all the numbers on slide 28, but a pretty normal solid quarter for us from a financial perspective, obviously, just under $5 billion in cash as I mentioned, we have no debt on our balance sheet as of <unk>. One we continue to reduce share count over time.

Speaker Change: Ed.

Speaker Change: Overall sort of net use of cash for the quarter, including everything in terms of both interest income and the sort of pull to par on our Treasury securities was about 150 or little more than $150 and 150 160.

Speaker Change: I think as a.

Speaker Change: As there is a quarter for the business thinking about the business on its own thats, probably like a pretty a pretty normal quarter.

Speaker Change: Obviously first quarter tends to be a little bigger for us and unfortunately, two starts to ramp up over the course of the year, but overall feeling good about what we're able to do in terms of the cash utilization and capital allocation framework as I mentioned earlier.

Speaker Change: I'll wrap up on slide 30, just by saying, we have an incredibly data rich year or two years three years ahead of us.

Speaker Change: Look there is nothing in our business like putting out data that matters facing so looking forward to all of our events and to talking to you all.

Speaker Change: So with that I'll wrap up my prepared remarks. Thank you again for listening and I will hand, it over to the operator for Q&A.

Unknown Executive: If you'd like to ask a question, please press star 1. If your question has been answered and you'd like to remove yourself.

Speaker Change: Thank you if you'd like to ask a question. Please press star one one is.

Speaker Change: Your question has been answered and you'd like to remove yourself from the queue. Please press star one again.

Brian Cheng: Our first question comes from Brian Cheng with J.P. Morgan, your line is open. Hi, Matt. Thanks for taking our call this morning.

Brian Chen: Our first question comes from Brian Chen with Jpmorgan. Your line is open.

Matthew Gline: First, on DiEM, I assume that you'll touch on this a little bit more at your event next month. How should we think through a win scenario in DiEM, in the back half? And can you tell us a little bit more on, you know, what we should focus on at your event, focusing on Tableau? Yeah, look, I think it's hard to comment on ongoing litigation, any specificity, but it is a normal part of patent cases that the number of claims gets narrowed before trial. These are jury trials, so ordinary people are on the other side of the court, and you want to make sure that you are presenting a case to them that is circumscribed in a way that everybody in the courtroom can get through in a reasonable amount of time.

Brian Chen: Thanks for taking our call.

Speaker Change: Good morning.

Speaker Change: Sure.

Speaker Change: I assume that you touch on that a little bit more.

Speaker Change: Next lines.

Speaker Change: How should we think so a win scenario.

Speaker Change: And.

Speaker Change: Can you tell us a little bit more on what we should focus on.

Speaker Change: Events focusing on Cabo.

Speaker Change: Yes, thanks, Brian by the way I pointed out I said later this summer and VM data what I meant was later this year I think we said second half of that data.

Speaker Change: It should be sometime early fall probably.

Speaker Change: I think in terms of.

Speaker Change: What we're looking for in the BMS study and we've been pretty consistent at this point I think what we need to win VM is a positive studies, we need statistically significant separation from placebo on tests.

Speaker Change: A P value.

Speaker Change: And the reason I say that is.

Speaker Change: First of all this is a patient population with very high unmet medical need the only real novel approved therapy is <unk>, which is a lot of liabilities associated with it.

Speaker Change: It's a patient population that is eager for new therapeutic options.

Speaker Change: Physician population that understands our mechanism is excited for what we can do.

Speaker Change: So we feel like we are prime for a successful study really beginning the goal in terms of what winning looks like.

Speaker Change: So I think thats.

Speaker Change: I think there's a lot of great properties of JAK <unk> inhibition speed of onset et cetera that we hope will show in the data, but I think success really here is about is about a positive study.

Speaker Change: And remember the safety and Tolerability profile JAK inhibitors as well understood. So I think we should be we should be coming in within expectations. There in terms of what to focus on on the event next month.

Speaker Change: I think the truth for US is because it has been such a busy 24 months in our business.

Speaker Change: I think the irony of it all is although this is a potentially registrational readout.

Speaker Change: It is in some ways flown under the radar a little data. So I think most of what we're hoping to do is to make sure everyone's on the same page about what dermatomyositis is about what the endpoints are in the study how we're measuring them how JAK inhibition works and how we see the commercial opportunity and to give the wall the chance to hear from Ben and his team who are actually running that study in advance of the data that.

Speaker Change: It comes later this year, so I think thats what were looking for.

Speaker Change: In the event I think again really in part in particular, focusing on just a high quantity of unmet medical need.

Speaker Change: In DM patients thanks, Brian for the question.

Speaker Change: And maybe just one quick follow up on that.

Speaker Change: <unk>.

Speaker Change: Our litigation against <unk>.

Speaker Change: Yes.

Speaker Change: I'll kind of update there.

Speaker Change: We laid out.

Speaker Change: Potentially narrowing decay.

Speaker Change: Based on our numbers.

Speaker Change: Thanks.

Speaker Change: Can you shed some light on that.

Speaker Change: Potentially putney.

Speaker Change: And what is the potential next milestone actually Neal.

Speaker Change: Regarding potential kind of narrowing.

Speaker Change: Any holiday can provide will be super helpful.

Speaker Change: Yes look I think.

Speaker Change: Hard to comment on ongoing litigation any specificity, but it is a normal part of patent cases.

Speaker Change: The number that the number of claims gets narrowed before trial or are these are jury trial. So ordinary people are on the outside of the court and you want to make sure that you are presenting our case to them that is circumscribed in a way that everybody in the courtroom get through in a reasonable amount of time and so that's the phase we're in the way. It works is that we discussed with our with Madonna and with the judge and we agree on what the narrowing of the cases.

Matthew Gline: And so that's the phase we're in. The way it works is that we discuss with Moderna and with the judge, and we agree on what the narrowing of the case is going to look like. And so I think, you know, the parameters of that will be evident in the relatively near future, but mostly, I think, there's nothing much that's, like, interesting or important coming out of that narrowing. And, you know, you can imagine we're focused on presenting our best possible case and presenting it in the cleanest and most straightforward Great. Thanks for taking our question.

Speaker Change: Look like and so I think the parameters of that will be evident in the relatively near future, but mostly I think there is.

Speaker Change: Theres nothing much that's like interesting or important coming out of that narrowing.

Speaker Change: You can imagine we're focused on presenting our best possible case and presenting it in the cleanest and most straightforward.

Speaker Change: Hi, Thanks for taking my question.

Unknown Executive: Thank you.

Brian: Thanks, Brian.

David Risinger: Our next question comes from David Risinger with Lyrinc Partners. Your line is open. Thanks very much. Good morning, Matt and team. So, congrats on the progress and updates. I have two questions.

Operator: Thank you. Our next question comes from David Risinger with Leerink Partners. Your line is open.

David Risinger: Thanks, very much good morning, Matt and team so.

David Risinger: Congrats on the progress and updates I have two questions first could you. Please comment on the pending.

Matthew Gline: First, could you please comment on the pending Pfizer LNP litigation Markman decision, which seems to be taking a little longer than expected? And then second, ahead of 1402 registrational trial results in 2027 and 2028, could you provide a framework for the two 1402 readouts in 2026, specifically the open-label difficult-to-treat RA trial and the Phase II CLE trial? Thanks very much. Yeah, great. Thank you. So on the pending Pfizer Markman decision, the truth of the matter is that the judge in that case, and in every case, has the discretion to issue the Markman opinion on a timeline of their choosing.

David Risinger: Pfizer LNP litigation, Markman decision, which seems to be taking a little longer than expected.

David Risinger: And then second.

David Risinger: Ahead of $14 two Registrational trial results in 2027% in 2028 could.

Speaker Change: Could you provide a framework for the 2014 O two readouts in 2006, specifically the open label difficult to treat our <unk> trial and the phase two <unk> trial, thanks very much.

Speaker Change: Yeah, great. Thank you so on the pending Pfizer Markman decision the truth of the matter is that the judge in that case in every case has the discretion to issue the markman opinion.

Speaker Change: On a timeline of their choosing as Youll remember.

Matthew Gline: As you'll remember, the Moderna opinion was issued in a couple of months on a timeline the judge had set for himself publicly at the outset. So we don't know when the judge will rule on the Markman decision. But given the issues at hand and so on, I think, again, we're hoping and thinking it may come later this year. And hopefully so. But again, it's not something we want to control over. I don't think there is any signal to take in the timing of that opinion. I don't think there's really any information coming in that.

David Risinger: Yes.

David Risinger: The majority opinion was issued in a couple of months on the timeline. The judge had set for himself publicly at the outset. So.

David Risinger: So we don't know when the judge will rule on the Markman decision.

David Risinger: But given the issues at hand, and so on I think again.

David Risinger: Hoping you can may come it may come later this year.

David Risinger: I hope, we ship, but again, it's not something we'd electro over I don't think there is any signal to take in the timing of that opinion I don't think there's really any inflammation.

Matthew Gline: On the other question, you know, look, I think I think both of those both of the readouts in 2026 are designed to be informative on what would cause us to carry the program forward. I think they're pretty different situations, right, in the sense that the CLE study will be the first time anyone's generated placebo-controlled CLE data in an FCRN. We obviously have a fair amount of information from competitors in the field. And so I think we will look at the balance of evidence, including the safety and convenience of FCRNs, the quality of that data, and what other people look to be generating in making a decision on whether to progress to a pivotal program with that data.

David Risinger: Coming in that.

David Risinger: On the other question.

David Risinger: Look I think.

David Risinger: I think both of those both of the Readouts in 2026 are designed to be informative on what would cause us to carry the program forward.

David Risinger: They are pretty different situations right in the sense that the CLI study will be the first time anyone's generated in placebo controlled data in CRM.

David Risinger: We have a fair amount of information from competitors in the field and so I think we will look at the balance of evidence, including the safety and convenience of SCR and the quality of that data and what other people look to be generating in making a decision on whether to progress to a pivotal program data I think were pretty normal. The <unk> data look that is an open label run in period to what would ultimately be.

Matthew Gline: I think pretty normal. The DGTRA data, look, that is an open-label run-in period to what would ultimately be, if we carried it forward, one of two potentially pivotal studies in the indication. And so I think, you know, on the one hand, it's a bigger study with more information in there, and there isn't a placebo. And so it's a little bit of a different setup. That said, you know, I think we're wide, wide open on what the RA market is, both for the good and for the challenges. And I think we're looking for data that gives us a clear signal on progression.

David Risinger: We know that forward one.

David Risinger: One two potentially pivotal studies in the indication and so I think on the one hand.

David Risinger: It's a bigger study with more information or if there isn't a placebo and so it was a little bit of a different setup that said I think we are.

David Risinger: Why is wide open on what the market is both for the good and for the challenges and I think we're looking for data that gives us a clear signal on progressing.

Matthew Gline: Thanks, Dave. Guys, thanks very much. Thank you.

David Risinger: Thanks, Dave got it thanks very much.

Dennis Ding: Our next question comes from Dennis Ding with Jeffries. Your line is open. Hey, guys. Good morning. Thanks for taking our questions. I just have two, mainly around DM. So, you know, how are you planning to position Breto if it's approved? If the goal there is to be pre or post-IVIG, you know, what types of patients do you consider to be the low-hanging fruit? And then as a follow up to that, can you also frame how often off-label JACs are used in DM? And if you expect any kind of pent-up demand, you know, there, given familiarity with the mechanism, if Breto is eventually approved.

Speaker Change: Thank you. Our next question comes from Dennis <unk> with Jefferies. Your line is open.

David Risinger: Thanks.

Speaker Change: Hey, guys. Good morning, Thanks for taking my questions.

Speaker Change: I just have two mainly around DM. So how are you planning to position breakfast.

Speaker Change: Farooq <unk>.

Speaker Change: Barriers to be clear post IPO.

Speaker Change: What types of patients do you consider to be the low hanging fruit.

Speaker Change: And then as a follow up to that here also frame, how often ask label jacks or use in <unk> and if you expect any kind of pent up demand.

Speaker Change: They are Kevin familiarity with the mechanism. If brookdale is eventually approved thank you.

Dennis Ding: Thank you. Yeah, perfect. Thanks.

Dennis Ding: And look, obviously, these are great questions, and I expect to, I'll give a brief answer now, but I expect to cover both of these issues on June 17th in detail. You know, in terms of how we're positioning REFO, I'll just say, I don't think we are particularly focused on a specific subset of the market. I think we view that entire market as addressable here. And I think, bluntly, many of the patients are low-hanging fruit, given the lack of options. Again, I think you'll hear more about that from Ben. And then there are hundreds, at this point, of case reports on the use of JACs in the in DM.

Speaker Change: Yeah, perfect. Thanks, and look obviously these are.

Speaker Change: Great questions.

Speaker Change: I expect I'll give a brief answer now, but I expect to cover both of these issues.

Speaker Change: On June 17th in detail.

Speaker Change: And how were positioning Remo I will just say I don't think we are particularly focused on a specific subset of the market I think we view that entire market as addressable here.

Speaker Change: And I think at one of the many of the patients are low hanging fruit given the lack of options again, I think you'll hear more about that from band and then there are hundreds at this point.

Speaker Change: Case reports.

Speaker Change: The use of of Jack's in that.

Dennis Ding: And so I don't know if I'd literally call that pent-up demand so much as really, really good physician familiarity. There's been now three investigator-initiated trials. There are 600 plus case reports under metamyositis.

Speaker Change: MDM and so.

Speaker Change: I don't know literally call that pent up demand. So much is really really good physician.

Speaker Change: Familiarity theres been now three investigator initiated trial of our 600 plus case reports.

Dennis Ding: Again, Ben will cover all of this in pretty great detail in a couple of weeks. So I'm really looking forward to that. There are over 30,000 patients currently being treated for the metamyositis. And so we think there's a ton of addressable opportunity. And by the way, broadly, we think the sort of safety and tolerability profile of JAK inhibitors should compare favorably to that of IVIG.

Ben: And my sense is again, Ben will cover all of this.

Speaker Change: Pretty great detail a couple of weeks I'm really looking forward to that there are over 30000 patients currently being treated for the metal by scientists and so we think there's a ton of addressable opportunity and by the way broadly we think the sort of safety and Tolerability profile JAK inhibitor should compare favorably to that of IAG. So more to come on that in just a few weeks here.

Dennis Ding: So anyway, with that, more to come on that in just a few weeks here. Thanks, Dennis.

Unknown Executive: Thank you.

Speaker Change: Thanks Dennis.

Speaker Change: Thank you.

Yaron Werber: Our next question comes from Yaron Werber with TD Cowan. Your line is open. Great. Thanks so much and congrats on the really nice progress. I have a couple of questions.

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

Yaron Werber: Great. Thanks, so much and congrats.

Speaker Change: Really nice progress.

Yaron Werber: Andbrepo, give us a little bit of a sense. What are you expecting? Our consultants and, you know, our work, and I know many people have done work here, are pretty positive on this asset. The question that we get from investors is what to expect from the placebo arm, just given there aren't a lot of, you know, historical randomized sort of small molecule studies. So number one, what do you expect from the placebo in this study?

Speaker Change: A couple of questions on <unk> give us a little bit of a sense, what do you expecting our consultants and our own.

Speaker Change: Work and I know many people have done work here are pretty positive on this asset.

Speaker Change: The question that we get from investors is what to expect from the placebo arm just given there aren't a lot of historical randomized sort of 12.

Speaker Change: Small molecule study sellable on what do you expect from the placebo and the study.

Matthew Gline: And then secondly, so you have about $200 million left under the stock buyback. Is that something you'll take care of pretty quickly? And is there contemplation to open another buyback? Thank you. Yeah, thanks, Yaron. Both good questions. On the buyback question, Richard, let me know if there's anything to add here. But, you know, I think you can imagine we're continuing to use that and happy to continue to use the existing authorization. I think once we conclude the existing authorization, we'll take a look at our overall capital picture in the market and make decisions on where to go from there.

Speaker Change: Secondly, so you have about $200 million left under the stock buyback is that something youll take care of it pretty quickly and is there a contemplation to open another buyback. Thank you.

Speaker Change: Yes, thanks Youre on both.

Speaker Change: Good questions.

Speaker Change: On the buyback question to Richard loans, you have anything to add here, but I think you can imagine we're continuing to use that.

Speaker Change: And happy to continue to use the existing authorization I think once we include the existing authorization, we will take a look at our overall capital picture in the market.

Richard Pulik: Anything to add, Richard? No, I think that's exactly right. Great.

Speaker Change: Surgeons on where to go from there anything you'd add Richard.

Matthew Gline: And then on the placebo arm and DM. Look, I agree that that is a reasonable question, and certainly in immunology studies in general, it's something that people have to focus on. Obviously, TIS as an endpoint has various properties that make it fair to ask the question. I'll point out two things. One is, well, really one thing, which is that we now have the published data in abstract form from the Vivgard-Mysitis study. Different patient population that's across multiple mysitis types. But, you know, at 24 weeks, they saw whatever, a 30, 35 point TIS. That's without serine taper that we have in our study.

Richard Loans: That's exactly right Greg.

Richard Loans: And then on the placebo arm in DM look.

Richard Loans: I agree that that is a reasonable question.

Richard Loans: Certainly in immunology studies in general.

Richard Loans: That people are focused on obviously tests as an endpoint.

Richard Loans: As various properties that make it make a fair fair to ask the question.

Richard Loans: I'll point out two things.

Richard Loans: One is.

Richard Loans: Really one thing which is that we now have the published data.

Richard Loans: In abstract form from the <unk> study different patient population thats across multiple by situs types.

Richard Loans: At 24 weeks, they saw whatever 30% 35 tests.

Matthew Gline: That's 24 weeks. Our study is 52. I think it was nice to see in that study a relatively well-behaved placebo, nice separation for the drug, and a nice low p-value. And so I think that's the sort of thing that is encouraging. But I'll bite my nail through the reed out, just like anyone would in our position. Thank you.

Richard Loans: Without steroid taper that we have in our study that's 24 weeks. Our 752 I think it was nice to see in that study a relatively well behaved placebo nice separation for the drug in a nice low P value and so I think thats the sort of thing that is encouraging but.

Richard Loans: But right now through the readout, just like anyone would be in our position.

Speaker Change: Thank you.

Sam Slutsky: Our next question comes from Sam Slutsky with LifeSci Capital. Your line is open. Hey, good morning, everyone. Thanks for taking the questions.

Speaker Change: Thank you. Our next question comes from Sam Slutsky with Roth Capital. Your line is open.

Sam Slutsky: Hey, good morning, everyone. Thanks for taking the questions.

Sam Slutsky: On the 1402, just looking at the treatment duration in your Registrational Graves Disease Studies, it looks like one has a 26-week treatment period and the other allows kind of up to 52 weeks before the off-treatment follow-up period. Just kind of curious on how you're thinking about the typical duration of treatment in the real world for graves. Would that be restricted or could some patients be treated kind of post-52 weeks possibly? Yeah, thanks, Sam. It's a great question. I think the first thing to say, well, a few things to say. One is, this is now a competitive field, and so I think we're focused on our competitive differentiation, and we have more data than anybody else does to inform the design of these studies, because we have the batoclinab phase two data.

Richard Loans: On the 14th so you're just looking at the treatment duration and your Registrational Grace disease studies. It looks like one has had 26 week treatment period and the other allows kind of up to 52 weeks before the off treatment follow up period, just kind of curious on how youre thinking about the typical duration of treatment in the real world for graves.

Richard Loans: That would be restricted or some patients be treated kind of post 52 weeks, possibly.

Richard Loans: Yes, Thanks, Tim.

Richard Loans: It's a great question.

Richard Loans: I think the first thing to say a few things. One is this is now a competitive deal.

Richard Loans: And so I think we're focused on our competitive differentiation and we have more data than anybody else does to inform the design of these studies because we have the.

Richard Loans: <unk>.

Matthew Gline: It's definitely the case that Graves' disease is chronically treated now, and that many patients are on long-duration methimazole. In fact, one of the things that is a focus for us is patients who are uncontrolled despite being on long-duration methimazole therapy, and so I think there is certainly a possibility for chronic therapy, as with many other autoimmune diseases. Obviously, one factor that goes into this is the possibility of clinical remission, which is something that happens in a subset of patients who are able to get controlled on methimazole. We are putting out data at some point later this year, or expecting to, on our own clinical remission from the batoclinab study, and so I think that'll be important.

Richard Loans: <unk> phase II data.

Richard Loans: It's definitely the case that.

Richard Loans: Graves disease is chronically treated now and that many patients are on long duration with Amazon in fact, one of the things that is a focus for US is patients who are uncontrolled despite being on long duration with Ingersoll therapy, and so I think there is certainly a possibility for chronic therapy as with many other autoimmune diseases. Obviously, one factor that goes into this is the path.

Richard Loans: Stability of clinical remission, which is something that happens in a subset of patients who are able to get control along with him. His all.

Richard Loans: We are putting out data at some point later this year or expecting to on our own clinical remission on the <unk> study and so I think that'll be that'll be important.

Matthew Gline: Obviously, until there are novel therapies in Graves' disease, the exact treatment paradigms are uncertain, but I think there's certainly an opportunity for chronic therapy, and I don't think anything about our study leaves us with an expectation of an unlabeled limitation of duration.

Richard Loans: Obviously until there are novel therapies and raise that he used the exact treatment paradigms are uncertain.

Richard Loans: But I think theres, certainly an opportunity for chronic therapy and I don't think anything about our study leaves us with an expectation of like an on label and limitation of duration.

Matthew Gline: Okay, and then just quickly too, obviously, some patients with uncontrolled Graves disease will have thyroid eye disease in the real world. You obviously have the Batoclimab phase three readout later this year, but kind of what makes the most sense commercially to optimize on this ability for STRNs to work in both diseases? Yeah, I think the studies that we are running in BRAVES are optimized to give us a lot of useful information and data to share in various forums, including potentially on label, depending on how we design the final staff plan and things like that, around proptosis, the development of proptosis in active BRAVES patients, the time to develop proptosis, the amount of proptosis people come into the study with, and how it sort of evolves over time.

Richard Loans: Okay, and then just quickly to obviously some patients with uncontrolled graves disease will have thyroid eye disease in the real world.

Richard Loans: You, obviously have the cocoa mab phase III readout later this year versus kind of what makes the most sense commercially to optimize on the Sidoti for SCR and <unk> diseases.

Richard Loans: Yes, I think the studies that we are running and grades are optimized to give us a lot of useful information and data to share in various forums, including potentially on label depending on how we design.

Richard Loans: The final fast line and things like that.

Richard Loans: Round Proptosis the development of Proptosis in active <unk> patients the time to develop proptosis the nonprofit group come into the study with <unk>.

Matthew Gline: And I think being able to go out to this patient population and talk about that, we think will be a helpful part of the overall treatment landscape. Awesome, thank you. Thank you.

Richard Loans: I'll turn evolves over time.

Richard Loans: And I think being able to go out to this patient population and talk about that we think will be helpful. Part of the overall treatment landscape.

Richard Loans: Awesome. Thank you.

Yatin Suneja: Our next question comes from Yatin Suneja with Guggenheim. Your line is open. Guys, thank you for taking my question. Just two for me as well. First one is on the TET study. I understand that is not sort of an indication that you might take forward, but you still describe that as a potential registrational study. So what are the expectations? What are the plans in TET? Could they change once we unblind those data? So that's one. And then if you can just help on the modeling side, how should we think about the spend in 2026? Thanks.

Richard Loans: Thank you and the next question.

Speaker Change: Our next question comes from yacht in Sarnia with Guggenheim. Your line is open.

Yacht: Okay. Thank you for taking my question.

Speaker Change: Two for me as well.

Speaker Change: First one is on the pet study I understand that is not sort of indication that you might take forward, but would you still describe that as a potentially registrational study. So what are the expectations what are the plans intact <unk>.

Speaker Change: To entry on blind dose data. So that's one and then if you can just help on the modeling side, how should we think about the spend.

Speaker Change: In two.

Yatin Suneja: Yeah, thanks. Yeah, and I appreciate the question.

Speaker Change: 2026, thank you.

Speaker Change: Yes, Thanks, and I appreciate the question.

Matthew Gline: Look, on TED, Roivant has always committed to being a data-driven organization. So we're going to make final decisions on Patokomab and TED once we see that data and the study is designed to be potentially registrational. Obviously, we are focusing an enormous amount of our effort on 14.02 given its clinical profile. I think that's kind of where we sit on TED and on Patokomab overall.

Speaker Change: Look on head.

Speaker Change: <unk> is always committed to being a data driven organization. So we're going to make final decisions on local lab and that once we see that data in the study is designed to be potentially registrational.

Speaker Change: Obviously, we are focusing an enormous amount of our effort on 14th June given its clinical profile I think that's kind of where we sit on Canada number telecom album overall.

Richard Pulik: In terms of Spend 2026, Richard, do you want to take that question? Yeah. So, look, I think we, as you heard from Matt, we had roughly 150 in cash used this quarter. That'll ramp up a little bit as 14.02 starts. And then depending on how the DM data looks like, assuming that's positive, you can then assume that we're going to put a little bit of power behind launch activities and pre-launch activities. So I think that's, you know, you'll see a little spend on the S&A side as that moves forward, but not significant changes beyond that.

Richard Loans: In terms of spending towards <unk>, Richard do you want to take that question, yes. So look I think we.

Richard Loans: In Europe, we had roughly 150 in.

Richard Loans: And cash used this quarter that will ramp up a little bit as well.

Richard Loans: To start and then depending on the.

Richard Loans: The DM data looks like.

Richard Loans: Assuming thats positive.

Richard Loans: And then assume that we're going to put a little bit.

Richard Loans: Power behind launch activities and prelaunch activities.

Richard Loans: Yeah.

Richard Loans: You'll see on the plant.

Richard Loans: And that moves forward.

Richard Loans: But not significant changes beyond that.

Richard Pulik: Thank you.

Speaker Change: Thanks, Jeff.

Douglas Tsao: Our next question comes from Douglas Tsao with HC Wainwright. Your line is open. Hi, good morning, thanks for taking the questions. I'm just curious, Matt, as you know, so far in the F2RN space, you've obviously seen companies sort of coalesce around sort of some core indications, MG, CIBP. As we potentially see other entrants and, you know, other companies looking at sort of IGG lowering strategies without CRNs or other modalities, we're starting to see more competition. And I'm just curious how you're thinking about pricing, because there will obviously be much greater variability in terms of the sort of size of indications, right?

Speaker Change: Our next question comes from Douglas Tsao with H C. Wainwright Your line is open.

Douglas Tsao: Hi, good morning, Thanks for taking my question.

Speaker Change: I'm just curious Matt as you know.

Douglas Tsao: So far in the CRM space with <unk>.

Richard Loans: Obviously, a company sort of KOL appstore out sort of some core indications and GE CIBC.

Richard Loans:

Richard Loans: As we potentially see other entrants and other companies looking at sort of ITG var strategies with SCR range, either modality, we're starting to see more competition.

Richard Loans: And I'm, just curious how youre thinking about pricing because there will obviously be much greater variability in terms of the.

Matthew Gline: You know, we had, you know, yesterday, you know, one of the, a competitor with the greater program sort of talked about pursuing graves.

Richard Loans: Sort of size of indications right we had yesterday.

Richard Loans: One of them.

Richard Loans: Got it.

Matthew Gline: And so I'm just curious how you're thinking that could influence pricing and your thought around sort of pursuing orphan indications versus more prevalent indications. Thank you. Yeah, thanks. Thanks for the thanks for your questions. I am.

Richard Loans: The greater program sort of talked about pursuing Craig.

Speaker Change: And so I'm, just curious how youre thinking that could influence pricing and your thought around sort of pursuing orphan indications versus more prevalent indications. Thank you.

Richard Loans: Yeah. Thanks, Thanks for the thanks for your questions.

Matthew Gline: I was tempted to go into a little vignette here of like, imagine it's 2005, and someone gets on the phone, and they're like, well, you know, obviously, so far in the TNF space, people have focused on a couple of indications, return arthritis, and, you know, maybe sciatica arthritis, and to point out that, look, I think we're really just at the beginning in terms of focus. And I think this is going to be quite a broad field across companies in the coming years. And I think that's sort of the point you're making in terms of the explosion of indications that is, that is ongoing.

Richard Loans: I was tempted to go into a little vignette here imagine it's 2005 when someone gets on the phone and they're like well, obviously, so far the TNF space people are focused on a couple of indications rheumatoid arthritis, and maybe start attic arthritis.

Richard Loans: As you pointed out, but what I think we're really just at the beginning in terms of focus and I think this is going to be quite a broad field across companies.

Richard Loans: In the coming years.

Richard Loans: And I think that's sort of the point youre, making in terms of the explosion of indications that is that is ongoing.

Matthew Gline: Look, I think we have a lot of flexibility around pricing strategy for multiple reasons. We obviously have the ability to deliver a couple of different doses. There's, on the one hand, variability around some of the size of these indications. On the other hand, a thing that a lot of FCRN indications have in common is this is a relatively new biology tent, and there have not been a lot of other therapies that can address these kinds of diseases. And frankly, in the cases where there have been, there's a pricing band that we think is, like, generally compatible with the FCRN pricing that's been currently set by our competitors.

Richard Loans: Look I think.

Richard Loans: We have a lot of flexibility around pricing strategy for multiple reasons, we obviously have the ability to deliver a couple of different doses.

Richard Loans: <unk>.

Richard Loans: On the one hand.

Richard Loans: Variability around some of the size of these indications on the other hand, our fingers in a lot of SCR and indications have in common is this is a relatively new biology and to there have not been a lot of other therapies that can address.

Richard Loans: These kinds of diseases.

Richard Loans: And frankly in the cases, where there have been theres a pricing band that we think is like generally compatible.

Richard Loans: The FCA are embracing this and currently set by our competitors. So I think there's a lot of opportunity obviously.

Matthew Gline: So I think there's a lot of opportunity. Obviously, final pricing decisions are going to depend on the exact order in which we launch indications, and on things like the quality of our remission data and grades and so on. But, you know, overall, I think we have a lot of flexibility. And I think, despite the apparent variability here, I think the concentration of indications and patients within that year fit pretty nicely together in terms of promotion.

Richard Loans: Final pricing decisions are going to depend on exact order of which we launched indications in on things like the quality of our emission data graves and so on but.

Richard Loans: Overall, I think we have a lot of flexibility and I think despite the apparent variability here I think the concentration of indications in patients with unmet need here.

Richard Loans: Nicely together in terms of the promotional model.

Matthew Gline: Okay, great, that's helpful. Thank you very much. Thank you.

Richard Loans: Okay, Great Thats helpful.

Richard Loans: Thank you very much.

Prakhar Agrawal: Our next question comes from Prakhar Agrawal with Cancer. Your line is Hi, thank you for taking my questions. So going back to DM and the placebo response, obviously there is variability on the test endpoint, and Matt, you've talked about the steroid tapering that can be done to mitigate that, but are the guidelines consistent across centers on tapering up and down? What exactly are the steroid tapering protocols and is there any subjectivity involved? And beyond just the steroid tapering, are there any other steps incorporated in the trial that can mitigate the placebo response? Thank you. Hey, thanks.

Speaker Change: Thank you. Our next question comes from for car Agora with Cantor Your line is open.

Speaker Change: Hi, Thank you for taking my questions, so going back to <unk>.

Speaker Change: And the placebo response, obviously, there is variability in the test and Brian and Matt you've talked about sterno tampering that can be done to mitigate that but other guidelines consistent across centers on deepening up and done what exactly are the steroid tapering vertical is there any subjectivity involved.

Speaker Change: And beyond just <unk>.

Speaker Change: Tampering our than any other steps and corporate in the trial.

Speaker Change: It can mitigate the placebo response, thank you.

Prakhar Agrawal: This is a great question.

Matthew Gline: We will cover a lot of detail on this question at the upcoming call in a couple of weeks. So far, I'd say stay tuned. Some of that information is in published papers and so on. But, you know, the thing I'll say is the steric paper is mandatory in the study and set out with a pretty clear protocol in the protocol. So, you know, I think we expect it is being relatively consistently applied here, given the way the study is designed. And I think the team's done a pretty careful job making sure of that.

Speaker Change: This is a.

Richard Loans: Great question, we will cover a lot of detail on this question at the upcoming call in a couple of weeks. So far I would say stay tuned some of that inflation and published papers and so on.

Richard Loans: Bye.

Richard Loans: Yes, let me I'll say the steroid taper is mandatory in the study and set out with a pretty good vertical.

Richard Loans: In the vertical.

Speaker Change: So I think we we expected as being relatively consistently applied here given the lead study is designed so yes, and I think the team has done a pretty careful job, making sure that again, Ben will talk more about it.

Matthew Gline: Again, Ben will talk more about it. And I think a lot of that, by the way, is just like boots on the ground, spending time with the doc community, which is helpful for enrollment, which is helpful for ultimately building those relationships with future prescribers, and which is helpful for making sure that people are adhering to the protocol as we've designed it. And then in terms of other steps to mitigate placebo, look, I think in general, there's a lot of things you do in a well-run study to make sure you're managing these risks in terms of how you think about discontinuations, in terms of how you think about measuring TIS and the time points and so on.

Speaker Change: And I think a lot of that by the way is just like boots.

Speaker Change: Boots on the ground spending time with the Doc Committee, which is helpful for enrollment which is helpful. For ultimately building those relationships. If you took drivers which is helpful.

Speaker Change: We're hearing from political as we've designed it.

Speaker Change: And then in terms of other steps to mitigate placebo, yes look I think in general there is a lot of things you do when a well run study to make sure you're managing these risks in terms of.

Speaker Change: How do you think about discontinuation in terms of how you think about.

Matthew Gline: And so I think there's a lot that went into the design in terms of that risk. Obviously, ultimately, as I said before, none of that stops the biting of nails. But it's nice to see other DM studies or other my study studies having relatively well-behaved placebo arms. Thank you.

Speaker Change: Measuring tests at the time points and so on and so on so I think I think there's a lot that went into the design in terms of that risk.

Speaker Change: Obviously, ultimately as I said before.

Speaker Change: None of that stops the stops debating males, but it's nice to see other <unk> studies urbanized satisfying having relatively well behaved placebo arms.

Speaker Change: Thank you.

Andy Chin: Thank you. Our next question comes from Andy Chin with Wolf Research. Your line is open. Hey, thank you for taking the question. So regarding BM again, my understanding is that this is modestly underdiagnosed. Just can you talk about what you believe to be the observable population in the US based on your claims analysis or otherwise, and how that compares to what you believe to be the prevalence in the US? And also a separate question that's related. Do you think off-label Zalgene is doing better on the market right now than Octogen based on physician feedback? Thank you.

Speaker Change: Thank you.

Speaker Change: Next question comes from Andy Chien with Wolfe Research Your line is open.

Andy Chien: Hey, Thank you for taking the question so regarding PM again, my understanding is that this is modestly underdiagnosed.

Speaker Change: Just can you talk about what you believe to be the observable population in the U S. Based on your claims analysis.

Speaker Change: Otherwise then how that compares to what you believe to be the prevalence.

Speaker Change: The U S and also a separate question that's related.

Speaker Change: Do you think off label Xeljanz is doing better on the market right. Now then hopped again based on physician feedback. Thank you.

Matthew Gline: Great questions. So thank you.

Matthew Gline: And again, we'll talk more about it in a couple weeks as a partial answer. Look, our view of the DM market has been, you know, 40-plus thousand or 40,000 patients. I think we said 37 based on one study, as I mentioned before, there's about 34,000 treated patients. I think that's like one measure of it. One of our competitors has indicated a 70,000 patient number based on their own work. You know, I think to your point, there is like a little bit of a range. I think that sort of 40 to 70,000 patients is probably the right way to think about the size and amount of myositis market for the moment.

Speaker Change: Great questions. So thank you and again, we'll talk.

Speaker Change: I will talk more about it in a couple of weeks there was a partial answer.

Speaker Change: Look.

Speaker Change: Our view of the <unk> market has been.

Speaker Change: 40, plus thousand or 40000 patients I think we said 37 based on one study as I mentioned before there are about 34000 treated patients.

Speaker Change: I think thats like one measure of it one of our competitors has indicated a 70000 patient number based on their own work.

Speaker Change: But to your point there is like a little bit of a range I think that sort of 40 to 70000 patients is probably the right way to think about the size of that amount <unk> market for the moment, but I agree with you that it could be modestly underdiagnosed.

Matthew Gline: But I agree with you that it could be modestly underdiagnosed and that I expect patients will emerge once a good treatment opportunity exists. When you say off-labeled Zelgens versus Octogam, I mean, obviously the direct comparability of like in terms of like like physician experience, what I can say is that physicians are very excited for an oral option that's on label. They're very excited for specifically for things that are in the JAK family, JAK1 and JAK2. I think we get a lot of enthusiasm from physicians around the program, which I think is in part informed by off-label use of Zelgens.

Speaker Change: I expect patients will emerge once the current treatment opportunity exists.

Speaker Change: When you say off label Xeljanz versus <unk>, I mean, obviously, the direct comparability of bike in terms of like physician experience. What I can say is that physicians are very excited for an oral option.

Speaker Change: It's on label, they're very excited for specifically for things that are in the Jack family, Jeff One thing too I think we get a lot of enthusiasm from physicians around the program, which I think is in part informed by off label use of Xeljanz is important for them, but the fact that these physicians are used to treating other conditions, where JAK inhibitors and similar mechanisms work well for them and as important formed by the.

Matthew Gline: It's in part informed by the fact that these physicians are used to treating other conditions where JAK inhibitors and similar mechanisms work well for them. And it's in part informed by the by just the overall complexity of dosing patients with IVIG. And then as a reminder, you know, relative to Zelgens, Brepro obviously does more than just JAK1 inhibition. And we think both JAK1 and JAK2 have the potential to be meaningful contributors to value here. We think that is something that physicians frankly already in the study understand and we think they will understand it better once we have more of an opportunity talking about the data.

Speaker Change: Bye bye.

Speaker Change: Overall complexity of dosing patients with.

Speaker Change: <unk>.

Speaker Change: <unk>.

Speaker Change: And then as a reminder, realm.

Speaker Change: Relative to Xeljanz breadth, obviously does more than just JAK, one inhibition that we think both JAK, one and two have the potential to be meaningful contributors to value here. We think that is something that physicians frankly already in the study understand or we think they will understand it better once we have more of an opportunity to talk more about the data.

Matthew Gline: Thanks Andy. Thank you.

Speaker Change: Thanks, Andy.

Speaker Change: Thank you.

Thomas Smith: Our next question comes from Thomas Smith with Learing Partners. Your line is open. Hey, guys. Good morning. Thanks for taking the questions.

Speaker Change: Thank you. Our next question comes from Thomas Smith with Leerink Partners. Your line is open.

Thomas Smith: Hey, guys. Good morning, Thanks for taking the questions just on <unk>.

Thomas Smith: Just on 1402 and the potentially registrational trial design for CIDP, you mentioned in the prepared remarks it's a bit of a different design relative to some of the other contemporary studies. You don't have the washout period, which I think should help drive enrollment, but you also won't be measuring response rates. Could you just elaborate a bit on why you chose this design and how you're going to optimize for patient selection, and then how you expect this data set will help position you commercially with 1402? Yeah, thanks. It's a great question. And actually, look, there are fundamentally three factors driving the overall change in the way CIDP studies work in the world.

Speaker Change: <unk> and the potentially Registrational trial design for CIBC.

Speaker Change: Mentioned in the prepared remarks, it's a bit of a different design relative to some of the other contemporary studies.

Speaker Change: Don't have to wash out period, which I think should help drive enrollment, but you're also lumpy measuring response rates could you just elaborate a bit on why you chose this design and how youre going to optimize for patient selection and how you expect this data set will help positioning commercially with 14 it Sir.

Speaker Change: Yes, it's a great question and I'd say look there are fundamentally three factors driving the overall change in the <unk> studies work in the world.

Matthew Gline: One is the FDA, who has made no secret about the fact that they do not like the previous set of designs for CIDP studies. And the agency cares very much about aspects of this design, principally, just sort of the direct placebo control versus the randomized with all piece. Then, and you mentioned this correctly, you know, studies are moving away from these washouts. The truth is that physicians and investigators hate the washouts because they suck for patients. and so you know I think therefore in a competitive environment for CIDP studies but also just in general it's gotten to be pretty important to offer a patient-friendly sort of setup here and then the third thing which I think enables all of it is the field broadly has figured out how to select the right patients for CIDP studies vastly vastly better than we knew a few years ago and so like in our BATO study for example we were able to select patients almost all of whom flared on withdrawal therapy during the washout period and so I think based on the quality of patients that we were able to select for in the BATO study I think we feel like the sort of top of the funnel inflow activities have gotten good enough here that we can offer a patient-friendly no washout solution and still have a good setup on the program and you know maybe at some point we'll the specific data but as I said I think the data from the washout period of the BATO study strongly suggests that we are getting the patient population that we want into the study.

Speaker Change: <unk>.

Speaker Change: One is the FDA.

Speaker Change: He has made no secret about the fact that you've got like a previous set of designs for CIP studies.

Speaker Change: And the agency cares very much about aspects of this design the.

Speaker Change: Principally as a sort of a direct placebo control versus the randomized withdrawal piece.

Speaker Change: And you mentioned this correctly.

Speaker Change: Studies are moving away from these washouts the truth is that.

Speaker Change: Physicians and investigators H, the washouts, because they suck for patients.

Speaker Change: And so I.

Speaker Change: I think therefore.

Speaker Change: In a competitive environment for <unk> studies, but also just in general it's gotten to be pretty important to offer a patient friendly sort of setup here and then the third thing, which I think enables all of it is the field broadly has figured out how to select the right patients for IDP studies vastly vastly better than we do a few <unk>.

Speaker Change: As ago and so like in our Shadow study for example, we were able to select patients almost all of whom flared odd withdrawal therapy during the washout period.

Speaker Change: Based on the quality of patients that we were able to select for in the <unk> study I think we feel like the sort of top of the funnel inflow activities have gotten good enough here that we can offer a patient friendly no washout solution.

Speaker Change: And still have a good setup on the program.

Speaker Change: Maybe at some point without the specific data, but as I said I think.

Speaker Change: Data from the washout period, but that are studying strongly suggests that we are getting the patient population that we want into the study.

Matthew Gline: Thanks very much. Thank you.

Speaker Change: Thanks very much.

Yasmeen Rahimi: Our next question comes from Yasmeen Rahimi with Piper Sandler Company. Your line is open. Hi, this is Dominic on for YAS. Thank you for taking our questions and congrats on a great quarter. So kind of I guess a follow-up to the CIDP study. Could you just remind us what the study was powered for key primary endpoint as well as the secondaries? And then on that, what was the rationale for selecting the 600 milligram dose in the study? Thank you. So I don't, we have not yet said what the study is powered for in terms of primary and secondary.

Speaker Change: Thank you. Our next question comes from Yasmin Rahimi with Piper Sandler Company. Your line is open.

Speaker Change: Alright. This is Dominic on for you guys. Thank you for taking our questions and congrats on a great quarter, so kind of a.

Speaker Change: I guess, a follow up to the <unk> study.

Speaker Change: Could you just remind us what the study was powered for key primary endpoint as well as the secondaries and then on that what was the rationale for selecting the 600 milligram dose in the study. Thank you.

Speaker Change: So I don't we have not yet said what the study is powered forward towards the primary and secondary.

Matthew Gline: You know, we have some time there, but maybe we'll share some more information about the specific sort of goals of that study in the coming month. And then, you know, in terms of why 600 milligrams, look, I think we put out this really clear data from the BATO study showing the under 70 versus over 70 IgG cut points. And we know that lower IgG suppression mattered a lot in the BATO data. Deeper IgG suppression mattered a lot in the BATO data. Frankly, this is a patient population where it's a severe disease, efficacy is paramount. And we're coming in in a competitive landscape where a competitor who does not suppress IgG as deeply, in our view, is already going to have been on market for a few years.

Speaker Change: We have some time there maybe if there's a more information.

Speaker Change: About the specific sort of goals of that study in the coming months.

Speaker Change: And then in terms of <unk> 600 milligrams.

Speaker Change: Look I think we put out this.

Speaker Change: Clear data from the <unk> study showing the under 70 versus over 70, ITG got points, and we know that lower IGT discretion mattered a lot in the battle data deep Reds discretion matter a lot in the battle data frankly, this is a patient population, where it's a severe disease efficacy is paramount and we're coming in and the competitive landscape.

Speaker Change: A competitor who does not suppress ITG is deeply in our view is already and has been on market for viewers. So I think for all those reasons the 600 milligram dose.

Matthew Gline: So I think for all of those reasons, the 600 milligram dose really sets us up for success. for Success. It's also the kind of thing where we think it will help with enrollment, as I think patients want to know they're getting the deepest energy suppression, the most potentially efficacious therapies. So, a lot of good reasons why that study is built around the 600 milligram dose. Again, this is a very sick patient population, especially if we're choosing the patients correctly. And remember, at the beginning of the study, these are many patients who are coming in, for example, controlled on IVIG, and they're being forced to wash out, and we want the patients who are going to work to really work.

Speaker Change: Really sets us up for.

Speaker Change: Sure.

Speaker Change: For success. It's also the kind of thing, where we think it will help with enrollment.

Speaker Change: I think patients want to know, they're getting the deepest agg suppression the most potentially efficacious.

Speaker Change: Therapies. So a lot of good reasons why that study is built around 600 milligram dose again. This is a very sick patient population, especially for choosing the patients correctly.

Speaker Change: I remember at the beginning of the study many patients who are coming in for example control of an IV and are being forced to wash out and we want the patients who are going to work to really work. Its also two to one randomized studies in most of these patients will be on drug.

Unknown Executive: It's also a two-to-one randomized study, so most of these patients will be out. Well, thanks, great question. Thank you.

Speaker Change: Thanks, Great question.

Matthew Gline: That's all the time we have for questions.

Matthew Gline: I'd like to turn the call back over to Matt Gline for closing remarks. Fantastic. Thank you, everyone, for listening. Thank you to all the teams of both Roivant and Immunoband who get all these filings together. Thank you to the investigators and patients who are working with us on our studies and trusting us with their care. And looking forward to a really exciting, important second half of the year ahead here. We're, I guess, three quarters of the year, although it feels like it's going fast. So I hope to be back on the phone with all of you soon, including the next couple of weeks for the Get Out of My Situs event.

Speaker Change: Thank you that's all the time.

Matt: We have for questions I'd like to turn the call back over to Matt <unk> for closing remarks.

Matt: Fantastic. Thank you everyone for listening thank you to all.

Matt: All the teams of both revenue, Nevada or get all the filings together. Thank you.

Speaker Change: Due to the investigators and patients who are working with us on our studies and trusting us with their care.

Speaker Change: Looking forward to a really exciting important second half of the year ahead here.

Speaker Change: Three quarters of the year, although it feels like it's growing fast so I hope to be back on the whole development, including in the next couple of weeks further to that on my side. This event.

Unknown Executive: Together with that, have a great day. Thank you for your participation. You may now disconnect. Everyone, have a great day. Thank you for watching!

Speaker Change: With that have a great day.

Speaker Change: Thank you for your participation you may now disconnect everyone have a great day.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Yes.