Roivant Sciences Q4 2025 Earnings Call Transcript

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May 29, 2025
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Operator

Good day, and welcome to the Worrevant Fourth Quarter twenty twenty four Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded.

Operator

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

Stephanie Lee Griffin
Stephanie Lee Griffin
COO at Roivant Sciences

Good morning, and thanks for joining today's call to review Roivant's financial results for the fourth quarter and fiscal year ended 03/31/2025. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Klein, 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.roydent.com. We'll also be providing the current slide numbers as we present to help you follow along.

Stephanie Lee Griffin
Stephanie Lee Griffin
COO at Roivant Sciences

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

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 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 birtoclimab in myCD graphs and CIEP. It's been a very busy six months for us to start off at 2025. '20 '20 '5 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 IMT1402.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

First in class in a number of indications such as Graves' disease and potentially best in class, we think anywhere that we're going play. Upcoming and one of the most important events of the year in the second half is the registrational data from our study of brevacitinib in dermatomyositis, which is a study we are super excited for. It's a patient population with high unmet need. We would be the first novel oral DM drug and pretty long lead time over really any other late stage program. So looking forward to sharing more about that both today and in the near future.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And then finally, is a really pivotal year among other things for our LNP litigation with Moderna and with Pfizer BioNTech. 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 an incredibly important moment for that as well. That's in the Moderna case. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 myotomyositis, with IMG1402 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. We also have mozlizumab, our inhaled therapy for VHLD with data expected to be coming next year. And obviously for those who follow our story, VD 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 fourteen oh two 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 with each with potential multi blockbuster launches. Obviously in brepfacitinib among other things in 2025 we initiated our study in cutaneous sarcoidosis.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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, mostly 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 diseases. On slide eight, and I don't want to say too much about this yet because we haven't actually generated the dermatomyositis data yet.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 thirty six months for us in terms of data and launches, with multiple launches in potential blockbuster indications, first for rapacitinib 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 and I over the next couple of years here. Really looking forward to that flow and excited for DM as the sort of first domino. Again, fingers crossed or knocking the door, whatever you do if you're superstitious, that that data does what we would like it to do. On slide nine, guess last overall framing point before I talk about some of the specific programs is I think one of these that Royvint has been very focused on over the last couple of years, obviously, since the cash inflow from the sale of our anti TK1 antibody, has been thinking critically and carefully about capital allocation. And we feel very good about where we are right now.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

We are set up, as we've said before, to capitalize Roivant to profitability, again, with just under $5,000,000,000 of cash on the balance sheet today, supporting the current pipeline to profitability with about $2,000,000,000 still in reserve for pipeline expansion and deployment on BD opportunities. And that's against the backdrop of having repurchased already $1,300,000,000 in our own stock as of threethirty onetwenty five. That's reduced our share count by not quite 15%. And that capital return continues on the existing share repurchase authorization. We continue to think critically about what to do from a capital return perspective thereafter given our balance sheet.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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. Great. So with that as framing comments I just want to spend a little bit of time on a couple of the key events for this year starting with brepcitinib 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 unmet needs that are tailored to our specific novel mechanism with dual TYK2 and JAK1 inhibition. The announced indications so far are DM with the readout that I've talked a lot about already.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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. We are, as you might expect, also investigating or exploring other areas in which we might like to develop repicitinib, and you can potentially hear more about those in the coming months. We feel like we've rapidly expanded on this opportunity from when we actually we first initiated the DM trial in 2022 at the same time through the concept study in NIU. And since then, we obviously read out that NIU study, initiated the pivotal program at 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 eighteen to twenty four months.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

So again, a really exciting year for reps. Much so that the details of this on the next slide on Tuesday, June 17, we're going to hold an investor event, a sort of mini R and D day, where the Royven team together with the private leadership team, Ben Zimmer, CEO of Priavant, we'll 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. 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. So given that we're reserving time for breath hold in the future, that's all I'll say about it on this call, but stay tuned for more on that future call. Next I want to talk a little bit about Immunovant and the recent developments in our anti FcRn antibody franchise.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

As a reminder, this call also effectively serves as the Immunovant 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 IMG1402. We think it's potential drug that has an opportunity to be a first and best in class anti FcRn across multiple indications. We think we get IgG lowering up to, call it, 80% or the low 80s in studies that is matched with or at the most robust IgG lowering observed, not just frankly in antihistorine antibodies, but across the field of IgG lowering therapies with a favorable safety profile that we think gives us overall clean differentiation.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 studies were constructed to that end. And also we've got data in GRAVES, we've got our own data from phase two with TED, 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%. And we hope and expect to continue showing that in our ongoing clinical programs.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And then we just have a lot of ongoing clinical progress across multiple indications, including the ones I've mentioned as well as the ongoing studies in DTT fourth line rheumatoid arthritis in Sjogren's where we have program expect to start this summer and clearly indications that we've talked a lot about in recent months because we just announced them actually about five or six weeks ago. And then as a reminder, the IPF fourteen oh two goes out to 02/1943, so quite a long franchise as well. And that's not including any PTG. So it's a really good setup. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 or interesting opportunity with a lot of unmet 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 expect and are working hard to maintain that position of scientific leadership. And then we've also got our ongoing programs in DGT RA and cutaneous lupus where we feel like we are first in class in the FcRn field as well. 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 CIDP, which we acknowledge are competitors, are well established where Viipgar, for example, is a well loved drug in MG, but where we feel like we have potential to differentiate on efficacy and clinical benefit.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And I was pleased to see, for example, in the last few days that some of the nicely established 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 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 will roughly follow this sort of prioritization hierarchy. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 two a data for birtoplimab where we had sixty percent of patients effectively off ATDs in the over seventy percent cohort compared with just over twenty off ATDs. Again, are all patients who have normalized T3 and T4. And depending on IgG cut off, we saw over fifty percent of patients with minimal ceftriopression effectively with clinical remission in myasthenia gravis in the over seventy percent cohort versus just under a third in the under seventy percent cohort. And likewise in CIDP on NCAT, we saw a significantly different responder rate in the deeper IgG responders bucket than in the lesser IgE responders bucket.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

So we really do feel like this is a consistently demonstrated hypothesis. And we think that high dose vadokumab and most importantly high dose IVD1402 drive the vast, vast, vast majority of patients into that over seventy percent bucket. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 MSC where we're putting patients against these sort of deeper, more durable response goals. So we feel really good about what we're going to be able to deliver in MG fourteen oh two. We're really excited about what we've seen in the available data pooled through the ongoing study in CIDP.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And then obviously the topoman has been consistent with its prior studies in terms of overall tolerability. A really strong position in terms of what our data has put out here. 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 indications particularly in immunology where you go from sort of first generation prior early therapies that just look at overall response rates, improvement in a physician global assessment in psoriasis or relatively low relapse rates in MS or MG ADL response rates in MG. So once you get to the first generation of innovative compounds, people start talking about remission rates. PASI75s and higher EDSS and MS, the higher ACR rates in RA.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And in the case of MG, we think MSC is sort of the next generation here of what people are going to look at. And then as we get to the future here, people looking at PASI 100s and psoriasis for effectively complete clinical co rates. Same thing in MS, no evidence of disease activity. And we think people are looking at deep and durable responses. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And we think we are in a privileged position to lead the FcRn category in those kinds of endpoints going forward. Know you can see on slide 19 for example in the metoclimab MG study you know maintenance of minimal system 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 a high dose birtocimab where we were getting those deep levels of IgG suppression. You had seventy five percent of patients maintaining that status for six or more weeks, which we think is the kind of endpoint by the way ninety three percent of patients achieved a clinical response.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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. 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 indication of Sjogren's 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 with some good evidence of autoantibody driven disease and with clear dose response data from nipocalimab showing that deeper IgE expression seems to matter. And then in CLE, again with a fairly large market, obviously some good recent data from the field there, with seventy five thousand addressable patients uncontrolled on standard of care therapy, and with relatively well identified CLE specific IgG antibodies that are a part of the disease presentation. So we're excited about the data we're going to generate there next year.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 IVD1402 with data reported. Finally, just two quick things on slides twenty one and twenty two here. One is these are both the unequivocetrials.gov in near future. Slide 21 is the design of our potential registrational trial in CIDP for 1402, which is a different design than the first generation of studies that folks like our competitors have run or even that we ran for betoclimab, 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. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And so that design also is now public and 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 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. On slide 23 I won't go into great detail but this is just rehashing. We feel really, really great about the overall portfolio of indications that we are studying with our FcRn franchise including just a very large overall intensely addressable US patient population over 600,000 patients with a pretty meaningful subset of those patients existing in Graves' disease, which is our sort of lead indication where we feel like we need to truly define that opportunity and be the first out there helping patients.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Absolutely jam packed couple 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 generally want to put out this year in Graves' disease from the tokamav study, the potentially registrational top line data coming in TED and metoclimab second half of this year. And then starting next year a ton of data from 1402 including open label period one results from the DPRA study, the CLE study next year. And then potentially registrational data in multiple indications including Graves and Meisner Gravis in 2027 and Sjogren's and CIDP beyond. So really tremendous couple of years ahead. Eric is in his early days in the role of Immunovant, really excited about seeing what he's going to deliver there.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

I think the team over at Immunovant is just super energized to deliver a meaningful product that's going help patients a lot I think. 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 in effectively the summary judgment phase of the trial. Part of that, which was expected from the beginning, this is a narrow process, sorry, a normal process of narrowing the scope of our claims and and Moderna'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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Immediately following that, summary judgment motions should be going in and then we'll be sort of at a pending U. S. Jury trial. The date is at the moment TBD, but looking forward to all this progressing in the near future. And then finally starting next year, we'll have the beginnings of our international trials and litigation that we filed just a couple of months ago.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

The Pfizer case continues to be ongoing. We are awaiting the Markham ruling, which we think could come this year in the case. So looking forward to all that. I will now just 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Obviously just under $5,000,000,000 in cash. As I mentioned, we've no debt on our balance sheet as of threethirty one. And we continue to reduce share count over time. 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 is about 150 a little more than 150 between 150 and 160. And so I think a quarter for the business thinking about the business on its own that's probably like a pretty normal quarter.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Obviously first quarter tends to be a little bigger for us and then $14.00 2 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. 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 and look there's nothing in our business like putting out data that matters to patients so looking forward to all of those events and to talking to you all as part of that. So with that I will wrap up my prepared remarks. Thank you again for listening and I will hand it over to the operator for Q and A.

Operator

Thank you. Our first question comes from Brian Chang with JPMorgan. Your line is open.

Brian Cheng
Brian Cheng
Senior Biotech Analyst at J.P. Morgan

Hi, Matt. Thanks for taking our call this morning. First on DM, I assume that you touch on this a little bit more at your event next month. How should we think through a win scenario in DM in the back half? And can you tell us a little bit more on what we should focus on at your events focusing on travel next month?

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yes. Thanks, Brian. And by the way, I pointed out I said later this summer on DM data. What I meant was later this year. I think we said second half of that data.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

It should be sort of sometime early fall probably. Know, look, I think in terms of what we're looking for in the DM study, and we've been pretty consistent in this point. I think what we need to win DM is a positive study. We need statistically significant separation from placebo on tests and a p value. And the reason I say that is, look, first of all, this is a patient population with very high unmet medical need.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

The only real novel approved therapy is IVIG, which has a lot of liabilities associated with it. It's a patient population that is eager for new therapeutic options. It's a physician population that understands our mechanism and is excited for what we can do. And so we feel like we are primed for a successful study really meeting the goal in terms of what winning looks like. So I think that's it.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

I think there's a lot of great properties of JAK and TYK2 inhibition, speed of onset, etcetera, that we hope will show in the data. But I think success really here is about a positive study. And remember that the safety and tolerability profile of JAK inhibitors is well understood. So I think we should be sort of coming in within expectations there. In terms of what to focus on the event next month, I think the truth for us is because it has been such a busy twenty four months in our business, I think the irony of it all is although this is a potentially registrational readout, it has in some ways flown under the radar a little bit.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And so I think most of what we're hoping to do 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, how we see the commercial opportunity, and to give the world a chance to hear from Ben and his team who are actually running that study in advance of the data that comes later this year. So I think that's what we're looking for in the event. I think again, in particular focusing on just the high quantum of unmet medical need in DM patients. Thanks Brian for the question.

Brian Cheng
Brian Cheng
Senior Biotech Analyst at J.P. Morgan

And maybe just one quick follow-up on the LNP litigation against Moderna. A recent docket update there is an update related to potentially narrowing the case based on a number of end claims. Can you shed some light on what that potentially could mean? And what is a potential next milestone actually regarding the potential cave narrowing? Any color they can provide would be super helpful.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yeah, look, I think it's hard to comment on ongoing litigation in 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. 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 the parameters of that will be evident in the relatively near future.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

But mostly I think that there's nothing much that's interesting or important coming out of that narrowing. And you can imagine we're focused on presenting our best possible case and presenting it in the cleanest and most straightforward way.

Brian Cheng
Brian Cheng
Senior Biotech Analyst at J.P. Morgan

Great. Thanks for taking our question.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Thanks, Brett.

Operator

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

David Risinger
Senior Managing Director, Biopharma at Leerink Partners

Thanks very much. Good morning, Matt and team. So, congrats on the progress and updates. I have two questions. First, could you please comment on the pending Pfizer LNP litigation Markman decision, which seems to be taking a little longer than expected?

David Risinger
Senior Managing Director, Biopharma at Leerink Partners

And then second, ahead of fourteen oh two registrational trial results in 2027 and 2028, could you provide a framework for the 02/1402 readouts in 'twenty six, specifically the open label difficult to treat RA trial and the phase two CLE trial? Thanks very much.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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. As you'll remember the Moderna issue 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, think again we're sort of hoping and thinking it may later this year and hopefully soon, but again it's not something we'd like to draw over.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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. On the other question, look, I think both of the readouts in twenty twenty six are designed to be informative on what would cause us to carry the program forward. I think they're pretty different situations 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 for that data. Think pretty normal. The D2TRA 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 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

That said, I think we're eyes 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 progressing. Thanks, Dave.

David Risinger
Senior Managing Director, Biopharma at Leerink Partners

Got it. Thanks very much.

Operator

Thank you. Our next question comes from Dennis Ding with Jefferies. Your line is open.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Hey, guys. Good morning. Thanks for taking our questions. I just have two, mainly around VM. How are you planning to position Breppo if it's approved?

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

If the goal there is to be pre or post IVIG and 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 JAKs are using DN? And if you expect any kind of pent up demand there given familiarity with the mechanism if Breppo is eventually approved? Thank you.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yeah, perfect.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Thanks. 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 17 in detail. In terms of how we're positioning repo, I'll just say I don't think we are particularly focused on a specific subset of the market. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And then there are hundreds at this point of case reports on the use of JAKs in DM. And so I don't 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 myositis. Again, Ben will cover all of this in pretty great detail in a couple of weeks.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

So I'm really looking forward to that. There are over 30,000 patients currently being treated for the metomyositis 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. So anyway, with that, more to come on that in just a few weeks here. Thanks Dennis.

Dennis Ding
Dennis Ding
Vice President - Equity Research Analyst at Jefferies Financial Group

Thank you.

Operator

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

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

Great. Thanks so much and congrats on the really nice progress. I have a couple of questions on Brepo. Give us a little bit of a sense, what are you expecting Our consultants and 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 historical randomized sort of small molecule studies.

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

Number one, what do you expect from the placebo in this study? And then secondly, so you have about $200,000,000 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yeah, thanks, Yaron. Both great questions. On the buyback question, Richard, don't know if got anything to add here. But I think you can imagine we're continuing to use that and happy to continue to use the existing authorization. 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. Anything you'd add, Richard?

Richard Pulik
Richard Pulik
Chief Financial Officer at Roivant Sciences

No, I think that's exactly right.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Great. 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 Vidgard mycitis study. Different patient population that's across multiple mycitis types. But at twenty four weeks they saw whatever, thirty, thirty five point tests. That's without a steroid taper that we have in our study.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

That's twenty four 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 re out just like anyone would in our position. Thank you.

Operator

Thank you. Our next question comes from Sam Slutsky with LifeSci Capital. Your line is open.

Sam Slutsky
Senior Research Analyst at LifeSci Capital, LLC

Hey, good morning, everyone. Thanks for taking the questions. On the 1402, just looking at the treatment duration in your registrational Graves' disease studies, looks like one has a twenty six week treatment period and the other allows kind of up to fifty two 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?

Sam Slutsky
Senior Research Analyst at LifeSci Capital, LLC

Or could some patients be treated kind of post fifty two weeks possibly?

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yeah, thanks, Sam. It's a great question. I think the first thing to say, well, 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 botoclimab phase two data.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

It's definitely the case that Graves' disease is chronically treated now and that many patients are on long duration with imozol. In fact, of the things that is a focus for us is patients who are uncontrolled despite being on long duration with imozol 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 the pimozole. We are putting out data at some point later this year or expecting to on our own clinical remission from the toco lab study

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 like an on label limitation of duration.

Sam Slutsky
Senior Research Analyst at LifeSci Capital, LLC

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 birtoclimab Phase three readout later this year, but just kind of what makes the most sense commercially to optimize on this ability for FcRn to work in both diseases?

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yeah, I think the studies that we are running in brains 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 status point and things like that, around proptosis, the development of proptosis in active Graves patients, the time to develop proptosis, the amount of proptosis that people come into the study with and how it sort of evolves over time. 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.

Sam Slutsky
Senior Research Analyst at LifeSci Capital, LLC

Awesome. Thank you.

Operator

Thank you. Our question comes from Yatin Suneja with Guggenheim. Your line is open.

Yatin Suneja
Senior Managing Director, Biotechnology Analyst at Guggenheim Partners

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 potentially registrational study. So what are the expectations?

Yatin Suneja
Senior Managing Director, Biotechnology Analyst at Guggenheim Partners

What are the plans in Intact? 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? Thank you.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yeah, thanks. Yeah, and I appreciate the question. Look, on TED, Revan has always committed to being a data driven organization. So we're going to make final decisions on the local level of TED once we see that data. And the study is designed to be potentially registrational.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Obviously, are focusing an enormous amount of our effort on 1402 given the clinical profile. I think that's kind of where we sit on TED and on betoclimab overall. In terms of spend 2026, Richard, do you want to take that question?

Richard Pulik
Richard Pulik
Chief Financial Officer at Roivant Sciences

Yeah, so look, I think we, as you heard from out, we had roughly 150 in cash use this quarter. That'll ramp up a little bit as 1402 starts.

Richard Pulik
Richard Pulik
Chief Financial Officer at Roivant Sciences

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 prelaunch activities. So I think that's, you know, you'll see a little bit spend on the SG and A side as that moves forward, but not significant changes beyond that.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Thanks, Jeff.

Operator

Thank you.

Operator

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

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Hi, good morning. Thanks for taking the questions. I'm just curious, Matt, as so far in the FcRn space, we've obviously seen companies sort of coalesce around sort of some core indications, MG, CIDP. As we potentially see other entrants and other companies looking at sort of IgG lowering strategies with FcRn 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, We had yesterday, one of the competitor with the greater program sort of talked about pursuing GRAVE.

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Yeah, thanks for the good questions. I was tempted to go into a little vignette here of like, imagine it's 02/2005 and someone gets on the phone and they're like, well, obviously so far in the TNF space, people have focused on a couple of indications, rheumatoid arthritis and maybe psoriatic 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 ongoing. Look, I think we have a lot of flexibility around pricing strategy for multiple reasons.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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, I think 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 generally compatible with the FcRn pricing that's been currently set by our competitors. So I think there's a lot of opportunity.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Obviously, final pricing decisions are going depend on the exact order in which we launch indications and on things like the quality of our emission data and graves and so on. But 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 fit pretty nicely together in terms of promotional models.

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Okay, great. That's helpful.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Thank you very much.

Operator

Thank you. Our next question comes from Prakhar Agarwal with Cantor. Your line is open.

Prakhar Agrawal
Managing Director at Cantor Fitzgerald

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 steroid tapering that can be done to mitigate that. But are the guidelines consistent across centers on tapering up and down? What exactly are those steroid tapering protocols, and is there any subjectivity involved? And beyond just steroid tapering, are there any other steps incorporated in the trial that can mitigate the placebo response? Thank you.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

This is a great question. We will cover a lot of detail on this question at the upcoming call in a couple of weeks. So in part I'd say stay tuned. Some of that information is in published papers and so on. But the thing I'll say is the steroid taper is mandatory in the study and set out with a pretty clear protocol in the protocol.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And so 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. 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 submitting a placebo, look I think in general there's a lot of things you do in a low run study to make sure you're managing these risks in terms of how you think about discontinuations, terms of how you think about measuring tests and the time points and so on.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 bites of nails, but it's nice to see other DM studies or other my side of studies having relatively well behaved placebo arms. Thank you.

Operator

Thank you. Our next question comes from Andy Chen with Wolfe Research. Your line is open.

Andy Chen
Director, Senior Equity Research Analyst at Wolfe Research

Hey, thank you for taking the question. So regarding PM again, my understanding is that this is modestly under diagnosed. 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 US? And also a separate question that's related. Do you think off label Xeljanz is doing better on the market right now than Octagon based on physician feedback? Thank you.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Great questions. So thank you. And again, we'll talk more about it in a couple of weeks with a partial answer. Look, our view of the DM market has been 40 plus thousand or 40,000 patients. I think we said 30 seven based on one study.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

As I mentioned before, there's about 34,000 treated patients. So 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. Think to your point, there is like a little bit of a range. I think that sort of 40,000 to 70,000 patients is probably the right way to think about the size of the dermatomyositis market for the moment.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 label Xeljanz versus Octagam, I mean obviously the direct comparability of like in terms of 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 cell exams, is 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 is in part informed by just the overall complexity of dosing patients with IVIG. And then as a reminder relative to Xeljanz, REPL does more than just JAK1 inhibition.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And we think both JAK1 and TYK2 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 to talk more about the data. Thanks Andy.

Andy Chen
Director, Senior Equity Research Analyst at Wolfe Research

Thank you.

Operator

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

Thomas J. Smith
Senior Managing Director, Immunology and Metabolism at Leerink Partners

Hey guys, good morning. Thanks for taking the questions. Just on fourteen oh two 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?

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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. 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 the sort of the direct placebo control versus the randomized withdrawal piece.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And you mentioned this correctly, studies are moving away from these washouts. The truth is that physicians and investigators hate the washouts because they suck for patients. And so 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 in our shadow study, for example, we were able to select patients, almost all of whom flared on withdrawal therapy during the washout period.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And so I think based on the quality of patients that we were able to select for in the VADTO 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. Maybe at some point we'll put out the specific data. But as I said, I think the data from the washout period of the Batto study strongly suggests that we are getting the patient population that we want into the study. Thanks very much.

Operator

Thank you. Our next question comes from Yasmeen Rahimi with Piper Sandler Company. Your line is open.

Analyst

Hi, this is Dominic on for Yaz. 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 six hundred milligram dose in the study? Thank you.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

So I don't we have not yet said what the study is powered for in terms of primary and secondary. You know, we have some time there, but maybe we share some more information about the specific sort of goals of that study in the coming months. And then, you know, in terms of why six hundred milligrams, look, I think we put out this really clear data from the Batto study showing the under 70 versus over 70 IgG cut points. And we know that lower IgD expression mattered a lot in the Batto data. Deeper IgD expression mattered a lot in the Batto data.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And 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. So I think for all of those reasons, the six hundred milligram dose really sets us up 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 IgG suppression, the most potentially efficacious therapies. So a lot of good reasons why that study is built around the six hundred milligram dose. Again this is a very sick patient population, especially if we're choosing the patients correctly.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

And remember at the beginning of the study, were many patients who were 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. It's also a two to one randomized study, so most of these patients will be on drug. Thanks. Great question.

Operator

Thank you. That's all the time we have for questions. I'd like to turn the call back over to Matt Gline for closing remarks.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

Fantastic. Thank you everyone for listening. Thank you to all the teams of both Revan and Immunovan 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.

Matt Gline
Matt Gline
CEO & Director at Roivant Sciences

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 Devanomycitis event together with them. Have a great day.

Operator

Thank you for your participation. You may now disconnect. Everyone, have a great day.

Executives
    • Stephanie Lee Griffin
      Stephanie Lee Griffin
      COO
    • Matt Gline
      Matt Gline
      CEO & Director
    • Richard Pulik
      Richard Pulik
      Chief Financial Officer
Analysts
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Key Takeaways

  • Upcoming registrational data for brevacitinib in dermatomyositis are expected in the second half of 2025, potentially delivering the first novel oral therapy for a high-unmet-need patient population.
  • The IMT1402 FcRn antibody franchise is advancing across multiple indications—including Graves’ disease, myasthenia gravis, CIDP, Sjögren’s and CLE—with deep IgG lowering and potential best-in-class profiles supporting multi-blockbuster opportunity.
  • Roivant’s strong capital position—approximately $5 billion in cash, no debt, $1.3 billion in share repurchases (reducing shares by ~15%) and $2 billion earmarked for pipeline expansion—underpins its path to profitability.
  • The company’s LNP patent litigation against Moderna and Pfizer BioNTech is in a summary-judgment narrowing phase, with a U.S. jury trial date yet to be determined and outcomes remaining uncertain.
  • Roivant’s data-rich pipeline features five potential registrational studies, IND clearance for IMT1402, proof-of-concept trials in CLE and cutaneous sarcoidosis, and inhaled mozlizumab data due next year, promising a steady flow of catalysts over the next 36 months.
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Earnings Conference Call
Roivant Sciences Q4 2025
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