Roivant Sciences Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2024

There are 13 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the Roizen First Quarter 2024 Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to speaker today, Stephanie Lee.

Operator

Please go ahead. Good morning, and thanks

Speaker 1

for joining today's call to review Royan's financial results for the Q1 ended June 30, 2024 along with the business update. I'm Stephanie Lee with Royvant. Presenting today, we have Matt Klein, CEO of Royvant. For those dialing in via phone 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.rovant.com. We'll also be providing the current slide numbers as we present to help you follow along.

Speaker 1

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

Speaker 2

Great. Thanks, Jeff, and thanks everybody for joining. It's always a pleasure to get on these calls. We in truth, we saved all of our fun updates for this fall. So today is a relatively straightforward set of updates, but a couple of really meaningful clinical execution points and a couple of other things that I'm happy to be talking about.

Speaker 2

So thank you again. I'll start just quickly on Slide 5 in the deck with a reminder, just kind of where we are this year, which is that this is a year of growth and expansion for us. So we're focused very much on delivering clinical data across multiple of our franchise, the anti FCRM franchise, where we have some meaningful data sets coming as soon as the near, near future as well as over the next call it 6 months. We have continued clinical development beyond that in our pipeline including in brepcitinib where we'll be beginning our Phase 3 program in NIU shortly where we have data coming in dumilumab late with your sarcoidosis and so on. We're very much looking forward to it.

Speaker 2

We'll talk a little bit about BECAMMA today, but the story for BEKAMMA for this year is really the expansion of the label into AD and some acceleration of psoriasis certainly volumes and revenues over time. And then we continue to be hard at work expanding our pipeline, looking at mid to late stage programs. I know there's a lot of focus on that activity. We will be unveiling our much discussed sort of so far unsupposed program just next month, so we'll hold on for a few more weeks there. And then continuing to work on prioritizing capital allocation, including thinking aggressively around the use of capital to continue to buy back shares and so on.

Speaker 2

We are super proud on Slide 6 of the pipeline as it currently stands. And one of the things that I struggle with sometimes I get all these questions about BD, but every time I look at our pipeline, I'm like, but we still have one of the best I and I pipelines even without any BD. So excited about the breadth of opportunities there, In particular, excited about the next, call it 18 months, both in the FDFRM, we'll talk a lot more about today and to brepcitinib where we have pivotal data coming shortly. So the main updates for the quarter, starting on Slide 8, One is on repsitinib, which is that we've now completed enrollment in our Phase 3 study in dermatomyositis, it's 241 subjects across 90 sites. It is the largest interventional DM study ever conducted and we can now say with confidence we expect top line data in the second half of next year that study completed enrollment a few weeks back.

Speaker 2

And we've completed our end of Phase 2 meeting with FDA on the NIU opportunity and are planning to begin a 52 week Phase 3 study in the near future in NIU or Phase 3 program. In Immutivant, Immutovant, we had announced that as you may recall a slight delay last quarter for the MG study. We can now say that that study has completed enrollment only a little bit behind the original schedule and so we'll get data in the Q1 of next year as we previously discussed. And we remain on track for the initiation of registrational program in MG for next year as well as multiple other programs. We'll talk more about that in a minute.

Speaker 2

We will unveil our upcoming Phase 2 program, as I said, in September next month, excited to do that. It will be a combination of the presentation of some data. We will likely do a phone call like this one. So looking forward to getting together at that time. And then a couple of other updates on Slide 9.

Speaker 2

One is just to say, we continue to be pleased with the progress we're making at Genovant in our IP litigation around the COVID-nineteen vaccines. Discovery continues and you may have seen, we requested a slightly amended case schedule so that we could get some more information from Moderna which if approved, we mean that the trial will be just about a year from now, so in September of 2025. And then we achieved some important clinical regulatory milestones that resulted in cash coming in the door. We're going to get a $28,000,000 milestone related to the Japanese approval of the Camelbreath that we got that in July and we have received our portion of $110,000,000 of the remaining Roche proceeds for Kilovant now that they've begun. They've hit the definition for that milestone.

Speaker 2

So that has been received this month. So pleased with that and obviously even $110,000,000 still on multiples even in this milestone of the capital that we originally invested in the program. So those are the main updates for the quarter. I want to spend a couple of minutes on some things in particular. One of them just to review where we are and our level of enthusiasm around Immunovant, around the NTF CRM opportunity.

Speaker 2

We've been having some conversations over the last few months and it occurs to me that I have a little bit of regret, only that we've been drawn into as a field I'd say a conversation about apportionment of a small pie. When in fact I think our view is that the biology for FcRn, the biology for B cell immunology and beyond is very broad. And so I just wanted to highlight again where we think we are, the amount of data that's been generated here that supports the breadth of the opportunity and a little bit of reminder of just why we are so excited about the program. So as a reminder on Slide 11, look, we've said this in multiple places. We really do believe that IMBD-four thousand and two has a potentially best in class profile here.

Speaker 2

That comes obviously 1st and foremost from our ability to suppress IgG as deeply or deeper than any of the other anti FcR antibodies in our view without any impacts on things like albumin and LDL, which obviously was something that affected our 1st generation program. And then I think it's worth remembering, we are also going to be able to launch in all likelihood IMG1402 in an auto injector. It will be a simple subcutaneous injection that should enable self administration at home subject to FDA being okay with that. And we think that will be a really compelling format for patients and a differentiated option versus where certainly where the field is right now and our sense is potentially differentiated relative to even where the field will be in a couple of years. There has been on Slide 12 just absolutely explosive growth over the past couple of years in the breadth of what FcRn has demonstrated.

Speaker 2

We're going back to 2020, there were 8 total FcRn indications in development with about 700,000 addressable patients. There are now 23 indications in development for anti FcRn antibodies with a current total addressable population of 4,000,000 and that number is growing often and we expect to add some to it in the relatively near future as well. So just a huge area of biology and a patient population that prior to this moment had a ton of unmet need. On Slide 13, you can see there have now been across 22 positive late stage studies in 9 indications, 4 different anti antibodies have been studied in about 2,000 patients. There's a tremendous amount of data about this mechanism, some of which generated by us, such etoclimab in Graves and etoclimab in TED, some of which generated by others such as in Sjogren's recently.

Speaker 2

But overall, just a really compelling picture of a well tolerated class that shows meaningful efficacy and clinical benefit in a pretty wide range at this point of diseases. So we are really excited about that. The other piece, I don't want to spend too much time dwelling on this, on Slide 14, is there's been a lot of interest, let's say, in competitive mechanisms, IG degradation or some of the CAR T or B cell biology, T cell engagers for autoimmune disease. I want to say nothing on this slide is meant to suggest that we are not enthusiastic about much of that biology. We think it's really great biology.

Speaker 2

But I think it's been interesting to us only in the sense that it's so much earlier than FcRn and FcRn is sort of elegantly cleared this bar that there's still a lot of work to do in some of these other mechanisms. You can see here again multiple approvals for our class in immunology, multiple positive Phase 3 studies, multiple positive Phase 2 studies and thousands of patients. It just sets up a different picture in terms of the level of validation and the proximity of the opportunity. And so look, we're excited about that vis a vis our place in the competitive field. Again, we think many of these other classes are interesting.

Speaker 2

We're watching them closely. We make investments in other areas. And so you can imagine we're watching these areas We like the biology, but we feel really good about where FcRn is positioned competitively and just how different it looks in terms of stage of opportunity. On Slide 15, everyone wants to compare themselves to the biggest drugs and so the HUMIRA comparison is maybe overdone, but I liked a couple of things about it here. But one of the things I liked about it is if you try and stack up where FcRn is versus where the TNF class was at various points in history, it just feels exciting to be at this stage in the biology, right?

Speaker 2

We are in a much larger set of indications than TNFs were being studied in at the time and growing. FcRn have sold extremely well on a time adjusted basis. The first FGRN approved reported about $1,200,000,000 in net sales in its 1st year post launch. And if you look at our forecast, you look at street forecasts, I think there's a chance this class will build, especially given the breadth of early development, meaningfully quicker over time than the TNF class was able. And I think it's notable apropos the competitive point, the TNF class didn't achieve these obviously phenomenal results just on their own.

Speaker 2

There were by 20 years after launch, there were 9 other approved MOAs sort of directly competing with TNFs in many of their indications. And yet TNFs being a foundational class, being novel biology, being well tolerated, we're able to carve out a really meaningful portion of that. So I think as we look at and there's many other examples we could have picked, but as we look at these other spaces, I think our view is the opportunity here is big, it's broad. Notably, these are not just many indications. Many of these indications are very large indications.

Speaker 2

And so we've got even success in a handful of them for any given program can make a big impact. And indications that are big enough as with many of the TNF indications to accommodate multiple programs, multiple mechanisms. This is a big tent. ImmuneVant on Slide 16 has an aggressive plan. We are excited about that plan.

Speaker 2

1402 will be in 4 to 5 potential registrational programs this fiscal year, moving up to 10 indications by next fiscal year. So 3 IND is expected to be active by the end of this calendar year, really excited about what we're doing with 1402, what we're going to generate for data in the coming months to validate that approach. So enough said on Immunavant, but wanted to revisit that topic. And a couple of other smaller things, one on Slide 18, just a quick update on the Vekama, dollars 18,400,000 in product revenue for the quarter relatively flat on GTN yield. Notably, script volumes are doing actually relatively well for we get frequently the question, it looks flat, it looks flattish.

Speaker 2

Script volumes are up 20% year over year relative to the same quarter last year. They're growing single digit percent quarter on quarter, every quarter and we continue to see that. So that suggests we are continuing to slowly build into this psoriasis market and we're happy with that and it suggests a willingness over time for this doc behavior to change. We remain the best selling from the volume perspective novel topical. I think psoriasis and all that sets us up really well for as we said before the main event, which is the launch in AD that will come after approval at the end of this year.

Speaker 2

I think on GTN quickly because the GTN yield fluctuations have sort of obscured the overall positive trend in volume here. I'll just say, we had one payer contract that had a reset effectively earlier this year that we were not getting a rebate on last year that we are rebating now. So that resulted in bolt on some one time and also just like an overall reset of GTN. I expect to accrete from here. It will continue to be sort of slow accretion from here.

Speaker 2

Long term, I don't have a huge difference in my expectations, but I think this year it will build sort of build from here instead of going what we hoped might have been higher level. Notably, net price continues to increase over time outside of that one contract. Continue to see everything trending in the direction that we want it. Key upcoming catalysts on Slide 20. First of all, not on this slide, but we'll be presenting this undisclosed program including some clinical data in September.

Speaker 2

Also upcoming here, we've got 1402 putting out detailed development plan information as well as data from the vedoclimab study in Graves. Coming this fall. We're pretty excited to put that data out there. We think Graves is a really exciting opportunity. Namilumab, we're going to get top line data from that Phase II trial.

Speaker 2

So arthidosis, again, not an area of great sort of external focus right now. But if that data are positive, those data are positive, we're excited about what that will mean. VUKAMA, again, the big event, the atopic dermatitis label expansion hopefully coming at the end of this year. And then by the end of the fiscal year data from betoklamab in mycenugravis as we talked about as well as data from the period 1 of the Phase 2b study in CIDP. And then by the end of this fiscal year initiating 4 or 5 cancer retrofit programs in 1402, all of which we together with Immunomedra will report to speaking more about that in the near future.

Speaker 2

So finally, before I wrap up this relatively quick update on Slide 22, just a financial update. I think overall a pretty normal quarter for us from a finance perspective. We actually had net income this year this quarter of $57,000,000 net revenues of $55,000,000 including product revenues as I said about 18, expenses sort of within our historical balance. We ended the quarter with $5,700,000,000 in cash and cash equivalents that sort of reflects the Sumitomo repurchase that we had made in April, I want to say of last quarter. And then the carrying value of our debt has come down a bit, thanks to the renegotiation that we have done at Dermovant.

Speaker 2

And you can see shares outstanding on the slide as well about $7,900,000 So with that, I will I'll wrap up the presentation portion of this on Slide 24. You can see that we have a pretty exciting catalyst calendar coming up with frankly a pretty rich couple of months ahead between the unveil of the new program, continue to work on the BD side and data coming from toplumab and exclimutimab generally in the coming months. So really looking forward to getting together what I'm sure will be multiple times in the next few months talking about those updates and to continue to see this all develop. And with that, I will wrap up the presentation for the morning. Thank you again for listening and I'll hand it back to the operator for Q and A.

Operator

Thank And our first question comes from Alison Ratzl of Piper Sandler. Your line is open.

Speaker 3

Hey, good morning. Thanks for the update, Matt, and thanks for taking the question. Just one for me on Priovant. Now that you've met with FDA on BREPO and NIU,

Speaker 1

just I guess what

Speaker 3

is left to be worked out or decided on the Phase III design? I think you'd given some high level guidance looking for 300 to 350 ish patients and a protocol basically as close to Neptune as possible. I guess just high level, is that still the case? And is any of this protocol design dependent on the 52 week readout later this year? And then just I guess on that longer term follow-up, what would you view as an outcome that reinforces view on the opportunity in uveitis?

Speaker 3

Thanks.

Speaker 2

Yes, sure. Thanks. So look, first of all, extremely constructive interaction with FDA. I think they are really excited to see a new opportunity in NIU, which is a disease that really needs to be studied. I think we feel good about where that's headed.

Speaker 2

I'd say the previous guidance we gave was largely in line with what we expect to see. And I think we got just about everything we really feel like we needed to make that program a success. So really at this point small fleets, but just getting the study up and running and we'll be able to provide a full description of it pretty soon here honestly. And then I'd say basically none of the study design hinges on the 52 week data, although obviously we saw something surprising, we look closely at it. And I think I don't think there's anything in particular we're looking for in 52 weeks to reinforce the program other than continued strong benefit to patients, which given the quality of the clinical data, we certainly expect.

Speaker 2

Thanks, Alex. Thanks for the great question.

Operator

Thank you. Our next question comes from Corren Johnson of Goldman Sachs. Your line is open.

Speaker 4

Hey, good morning team. This is Craig on for Corrine. So following the completion of enrollment of the VALOR study, can you kind of outline how the final enrollment compares to your original expectations and maybe walk us through some powering assumptions there?

Speaker 2

Yes, sure. A couple of things. One is the actual number base to be enrolled at two forty 41 was a little bit higher than our original plan for the study. Originally it had been 225. So we feel extremely well powered.

Speaker 2

I don't have a lot to say on like baseline characteristics or demographics right now. I think we're perfectly happy with the patients that we've enrolled and we think it sets us up well. I guess the other comment I'll make with a shout out to the Priovant team is DM is an incredibly difficult indication in which to develop drugs. These patients are hard to find and frankly our experience is that the key is a lot of leg work with the sites. So we spend a lot of time out and about talking to investigators trying to get out there in the field to make sure that we had what we needed.

Speaker 2

And so yes, I'm very proud of the effort there. I'm proud of how quickly that study was able to get to fully enrolled and looking forward to sharing that data once available. So larger side as I said earlier, so I think UGM today. Thanks for the question on Jan Diem.

Speaker 4

Of course. Just one more if I may. Could you just remind us of what you're looking for in terms of a go, no go decision for the Phase 2 nimidumab data coming relatively soon?

Speaker 2

We haven't so thanks. Yes, look, I think we haven't articulated like a simple straightforward bar and I think the truth is that sarcoidosis is one of these diseases where there's not a lot of other approved mechanisms, there's not a lot of options for patients who are sick with the disease. So I don't think the I think the bar is meaningful. I think the bar is if the study works, certainly worth progressing. As with all Phase 2 trials, we're going to evaluate the totality of the data and we'll think about what else is on our plate.

Speaker 2

We're also looking for consistency across not just the primary, but across a few secondaries. There's a bunch of different ways that people look at the treatment of sarcoid patients.

Operator

Our next question comes from Brian Chan of JPMorgan. Your line is open.

Speaker 5

Hey, guys. Good morning. Thanks for taking our questions. Maybe sources, with the recent sell off in the market just, does it make it easier or harder for you to find a new asset? Does it change the way how you negotiate?

Speaker 2

Thanks, Brian, for the great question. I will hand over to Mayuk, But the short thing I'll say is we look, we work with a wide range of different prospective partners. They are affected by varying degrees to the financial markets, but mostly we're focused on getting great opportunities at prices that we're excited about. But maybe what would you say to the question about the sell offs? Yes.

Speaker 2

Look I think the short answer

Speaker 6

is it depends. But I think I don't have too much more to add to what Matt said.

Speaker 2

Thanks, Fajid. So look, Brian, I think the short answer the other piece of this that sort of the question behind the question is we remain really excited with what we see in the world and we're looking forward to doing the right deal at the right time.

Speaker 5

Okay. Maybe just one question on 1402. I guess just overall I just want to get a better sense of how you're thinking around this asset. As we think through the 10 indications that you're lining up for through the next fiscal year, And you talk about a lot about the range of themes of opportunities that you have laid out in your slide deck today. So how do you pick and choose the different areas?

Speaker 5

And I think most importantly is how you get credit for it in front of investors? Because it seems that investors today are very fixated on MG and CIDP. So in other words, how do you intend to get credit for to push 1402 into uncharted indications? And then maybe just one last one, more like a housekeeping one. What is the data what is the cadence of CALA's flow in the fall?

Speaker 5

Because we're going to get Phase 2 asset unveiling in September, Graves' plan also unveiling for immuno van and cycloidosis data coming out. So what's the cadence of data flow? Thanks.

Speaker 2

Thanks, Brian. All great questions. Look, on 14:02, I think the Anadine answer that's also true is obviously the biggest factor of the gonorbi contributing indications are the quality of the biology, the size of the unmet need, where we can be competitively positioned, cost and risk kind of trade offs. Like those are obviously like the main factors that go in. I'd say a couple of things about a 14 or 2 that I find exciting or about the S and R landscape and this is like maybe you may want to jump in also.

Speaker 2

On one of the things that we've said over and over again about FcRn is that anyone's Phase II studies, everyone's Phase II study that goes both ways. It means that we need to be careful about when we put our data out, but it means that once you know what the depth of IgG suppression does in a patient population, you really would be front of the pack. And so I think we're looking at indications where we can be in the front of the pack, where we can get out there commercially and sort of be neck and neck with our feathers hopefully with deeper IgG suppression. So I think that's obviously a factor. For what it's worth, we also think MG is a really big opportunity.

Speaker 2

We often think CIDP is a big opportunity. And as a reminder, we're generating a meaningful data set in MG with documab that will underscore and get to the more is better question just in the coming months. So I think there's a lot to sort of focus on there even through the more myopically focused on the existing commercial indications.

Speaker 6

Yes, I think you hit most of the point Matt. I just like the way Brian that you frame the question which is, all right, people are focused on MG and CDP and everything else basically is upside.

Speaker 2

That's right. Yes, I think that's a great way to put it. And in terms of cadence of catalyst flow, look, we have a busy, call it, 6 to 7 months ahead here. I'd say September will be a busy month and then the mill map data comes later, later this fall. And then I think we've said MG will come kind of early next year and CIDP intend kind of probably a little bit thereafter.

Speaker 2

So I think that's what the sort of immediate flow looks like. And obviously, shortly on the heels of that, we'll be looking at VM and beyond. Thanks, guys. Great. Thanks, Brian.

Operator

Thank you. Our next question comes from Dave Risinger of Leerink Partners. Your line is open.

Speaker 2

Thanks very much and thanks for all the updates. So I have two questions, please. First, could you provide more color on the LNP litigation, including the event path ahead? And then second, could you discuss external transaction prospects, including the size potential of deals that you're looking at? Thanks very much.

Speaker 2

Yes, sure. Thanks, Dave. Both great questions. So on the L and P litigation, again, there's not that much that we're generally able to say about an ongoing litigation, but in terms of what's coming. So we're in discovery now.

Speaker 2

And as I mentioned on the call, that process is going to continue, we hope for a few more months. We together with Moderna and Arvudis and Genovant have asked for a moderate extension of that process to get answers to a few of the outstanding questions. So I think that's the sort of next thing here. And then that calendar there's a call to judge in the next few weeks to get that approved. But if that calendar is approved, it would have summary judgment happening kind of in the beginning portion of next year followed by a trial a year from now.

Speaker 2

So a little bit later than the most recent version of the calendar, but for good reason instigated by our side. On external transaction price prospects, I guess I'll hand over to Mike to answer that question straight from the source.

Speaker 6

Sure. Hi, Dave. Thanks for the question. So I think we have carefully avoided I think getting bucketed whenever sort of asked. And I think that that continues.

Speaker 6

I think so I would think about size of opportunity and things that we're looking at. We really think about this, I think as you know Dave as a portfolio and so there's going to be heterogeneity in any one deal. But I think overall, I think obviously our arc so we think about things kind of on a deal by deal basis really through that investment lens is a good investment. But then over sort of the surface area of all those deals, we're looking to move the needle on our enterprise overall.

Speaker 2

The only thing I'd add is because we get the question sometimes and I'm always surprised when I get it. I think we are a very unlikely buyer of multibillion dollar public companies. I think we are stingy by nature and are looking for places where we can spend more of the dollars on clinical development. So we are never say never company, but I think that's just true about who we are. Thanks, Dave.

Speaker 7

Thank you.

Operator

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

Speaker 8

Hi, good morning. Thanks for taking our questions. 2 from me. So maybe if you can revisit sarcoidosis briefly. Correct me if I'm wrong, but previously you may have characterized the Phase 2 as potentially registrational.

Speaker 8

Can you reiterate that and see if and confirm if that's true? And maybe talk a little bit about the path forward if that data is positive? And then number 2, around OpEx. I mean, given ImmunoVant will start a bunch of new trials over the next few years, how do you think your OpEx will evolve during that time? Thank you.

Speaker 2

Yes. Thank you. That's a great set of questions. Look, we are on sarcoidosis, the truth is it's a Phase 2 study. It's 100 patients.

Speaker 2

It's certainly large enough to serve as at least a pivotal study if successful and obviously communication with high unmet needs. So depending on the quality of the data, there's always a conversation to have with the regulators. But then I think our expectation is that it's a Phase 2 study and that we would have a program behind it in basically all scenarios. And we're just excited to be developing the disease. There are no approved agents outside of steroids, so the unmet need is really significant.

Speaker 2

On the Nunavut question, look, I think the short answer to the question on its face is given that UNIDENTIFIED is starting a number of pivotal studies, I would expect their OpEx to increase. I don't have super specific financial guidance right now to offer. The cost of a Phase 3 program for an FcRn in general has ranged from call it $80,000,000 to $120,000,000 And so over the life of those programs, I think those are like reasonable estimates plus overhead and personnel and stuff like that. So I'd expect burn to go up there over time. Obviously, if you look at some of our competitors, I'd say like their R and D expenses may be useful, but a big piece of the cost here ultimately winds up coming as you get closer to G and A perspective as well.

Speaker 2

And notably, ImmunoVent is well capitalized right now for this program and we are obviously excited to be a good partner for that.

Speaker 8

Great. Thank you.

Speaker 2

Thanks, Ram. Thank you.

Operator

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

Speaker 7

Great. Thanks for taking my question. I have a couple. Maybe just the first one, we started getting questions and I think you highlighted now that you're planning on unveiling your recently in licensed Phase 2 program in September. Is there anything you can unveil a little bit today, just indication or how big is the study?

Speaker 7

Is it a randomized study? Is it just an open label study? Has there been other studies with this mechanism in whatever indication you're examining? And then maybe just secondly, so it sounds like, gMG and CIDP will start Phase 3, let's say Q1 potentially with 1402. For the other 3, is it sort of Graves, Sjogren's and maybe Ted?

Speaker 7

Is that sort of the order? Thank you.

Speaker 2

Thanks, Yaron. On the Minnesota asset, we're weeks away. So I think I'm going to mostly reserve comment other than to reiterate some things we've already said. Mainly, first of all, obviously we're excited about the program. There is clinical data to share when we release the program.

Speaker 2

That clinical data I think is useful and people will find it informative. And there is a competitor program. There's another program of the same mechanism being studied by big pharma company to different indication. We've said that publicly before. And other than that, we'll reserve comment until we unveil the rest in September, but looking forward to it.

Speaker 2

Of the programs that we've sort of described, obviously the Graves data is coming shortly and we expect both to communicate the motoqimab data as well as the development plan for that program. And then the Batto MG data and CIDP data are coming at the beginning of next year. And we've said clearly and affirmatively that we plan to study in MG. We haven't said exactly what the other indications are yet. I think ImmunoVet will paint a fulsome picture of that relatively soon.

Speaker 2

But my expectation to be clear is the Phase 3 studies for some of those programs, again, we expect that 3 INDs by the end of this year, All of those INDs will be for registrational sort of Phase IIIII kind of programs. And so I would expect at least 3 of these studies to in essence have begun by the end of this year and the other 2 in the Q1. Thanks, Jerome.

Operator

Thank you. Our next question comes from Louise Chen of Cantor. Your line is open.

Speaker 9

Hi, thank you for taking my questions here. I just had 2 for you. The first one I wanted to ask you is, if the launch of FcRn is a possibility just for Rivian to do on its own, is that on the table? And then secondly, just curious on the market opportunity for VITAMA and AD and how you're preparing for the launch of this product coming at the end of this year? Thank you.

Speaker 2

On the first question, I'll say, we are certainly aware of a once upon a time small biotech company that launched an anti FSR antibody on its own and that's some success doing so. And so it certainly seems possible to do that ourselves. And look, I think that has been an exciting outcome. I think as the class presents itself, the breadth of the opportunity is large. So I think we're going to do what maximizes the value of that opportunity for us.

Speaker 2

And beyond that, while things are on the table. On the camera and AD, look, I think there's a couple of things. One is and probably most importantly, looking for the prescribers who were not currently in front of, allergist pediatric allergist, pediatric dermatologists really hitting hard in peds where we'll be alone at launch among novel topicals. So I think that's sure that that prep is important. And then looking taking a hard look at our existing sales force targeting and making sure that we're covering all the right docs for the opportunity and getting our messaging exactly right to those docs, especially frankly because I think the story in AD is a little bit different than the story they're used to seeing in psoriasis, right.

Speaker 2

I think like the pediatric population is different, The safety the tolerability profile, I should say, of the drug is even better in the AD data set. I think the quality of our data in AD is differentiated to an even greater degree relative to some of the other novel topicals than it is in psoriasis. And so I think we need to we need to get that across. Itch for example is a major symptom in AD, it's acute. Our itch data is very, very good.

Speaker 2

And I think we'll be making sure to highlight that. So I think we're really trying to get the messaging with all docs right, make sure we're talking to the right docs and make sure we're especially covering the docs who are not kind of overlapping with the psoriasis docs that we're so ready to get out in front of those as soon as we get the IP and out from FDA. Thank you. Those are both great questions. Appreciate it.

Operator

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

Speaker 10

Yes, thank you for taking my question.

Speaker 2

Maybe just one more on

Speaker 10

Vitama, specifically on the psoriasis side. I mean, if you look at the past, I would say, 4, 5 quarters, you are in that $18,000,000 to $20,000,000 range on a quarterly basis. I mean, what does that imply about the

Speaker 2

overall market opportunity? What can you

Speaker 10

do to sort of reinflex sales in psoriasis? I understand atopic dermatitis could give a lift, but just in psoriasis, just curious how you view the market? What's your peak sales you are assuming? Thanks.

Speaker 2

Yes. So thanks. It's a good question. First of all, I'll say, I continue to be pleased with how we're set up on the camo, which is to say, I think it gives us no credit for it. So I think it's all upside from here, which is always a nice place to be.

Speaker 2

Look, I think on the sort of tracking the progress as it were, as I said in my prepared remarks, I think the sort of mechanical sales number probably understates the progression in the sense that we've had a little bit of like like noise around gross to net that we expect to climb out of from here and volumes are actually building. People have been asking us about supposed flattening of this curve for a while, we're up 20% from a volumes perspective versus the same quarter last year and continuing to grow every quarter. I think as GTN climbs, as GTN normalizes that sort of base that we've been building month in, month out, quarter in and quarter out from a volume perspective will continue to work for us. And I still have hope that over time there will be some real compounding effects there, the docs that like the product, the docs that write the product will continue to write it more and more. So I do think psoriasis has the potential to be very meaningful over time.

Speaker 2

It's been a little bit of a slower burn. And I think the thing about AD is it's got the potential to be a like inflection of a different sort, which is a much larger patient population with a set of data that we can use through easier facial to see the differences versus our peers and so excited for that launch as well. Thank you very much.

Operator

Thank you. Our next question comes from Douglas Tsao of H. C. Wainwright. Your line is open.

Operator

Douglas, your line is open.

Speaker 11

Hi, good morning. Thanks for taking my questions. Matt, I think from a business development standpoint, you have largely focused on pulling individual assets out. Just given the sort of ongoing status in biotech, does it ever change that you become more focused on looking at potentially acquiring

Speaker 2

companies? We are generally just agnostic to the form in which great programs come our way. And so I think whether it's a company, whether it's an asset, I don't know that that's like the dividing line for us versus what are we getting and is the value there and what do we think we can do something that matters with it. But Meyer, you got anything you could add to that? No, I think you got it.

Speaker 2

Yes. So I think the answer to that question is, we've always sort of been indifferent to that. I think there's I guess the only thing I'll say is like, I think a lot of what we are focused on right now, I'd say the vast majority of what we're focused on right now is stuff that's in clinical development. And so when we talk about companies versus assets, I don't think it matters so much whether it's company or asset, but we're mostly going to be looking at companies that clinical stage or sort of development stage programs. Thank you, Doug.

Speaker 11

Great. Thank you.

Operator

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

Speaker 12

Good morning. Thank you for taking the question. One more question about VITAMA. Can you talk about specifically how you view competitive dynamics between you and your competition such as ArQulez and Incyte, which patients do you think is going to prefer which product? And then on a related note, and your pre approval engagement work with PBMs, do you foresee getting hit on gross to net if they prefer your competition?

Speaker 12

Thank you.

Speaker 2

Thanks, Andy. Those are good questions and I want to give you a special thanks because I think the analysts who come late in the rotation on these calls have a lot of work to do. So appreciate the thoughtful question late in the morning. Look, on the first question, the key thing about these markets, which we've said from the beginning is the competition is not other novel agents. The competition is steroids.

Speaker 2

There are many, many, many steroid scripts written. And the challenge is in changing well ingrained doc behavior. I don't think in general it's like for the median psoriasis or the median AD patients, it's like, oh, some doc is sitting there and carefully thinking about the attributes of Zorin versus Absoluro versus vutama and deciding on a patient by patient basis to give 1 or the other. I think the key point is getting docs comfortable that they have things to reach for. There are differences.

Speaker 2

In AD, for example, we would hope for a label all the way down to A2. I think our competitors don't have labels that cover anything like quite that young. So I think there are opportunities to address patient populations that are different there. I think the once a day application in AD is probably helpful, the consistency of formulation, the fact that it's a single concentration, whereas at least one of our competitors has a couple of different concentrations going to be on the market. I think those things are all helpful, but it's not about like segmenting versus the other novel topicals per se.

Speaker 2

That's not sort of a major challenge mostly. And on the sort of PBM side, I think the short answer is commercially insured patients should have coverage for Vekama under our current managed care agreements. So I don't expect any super significant changes in the GTN or commercial dynamics on AD approval, which is a great question. Thank you. Thank you.

Operator

Thank you. This concludes the question and answer session. I would like to turn it back to Matt Gline for closing remarks.

Speaker 2

Look, yes, thank you everybody. Thank you to all of our analysts for the great questions. Thank you everyone for dialing in for a relatively quiet quarterly update. I'm looking forward to getting back on the phone in the coming weeks with some other things to share. And thanks to the revenue team, thanks to those folks actually in this call, thanks to all of the patients and investigators who trust us and work with us and we will talk to you very soon.

Speaker 2

Have a great day.

Operator

This concludes today's conference call. Thank you for

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Earnings Conference Call
Roivant Sciences Q1 2025
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