Roivant Sciences Bank of America Global Healthcare Conference
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Good afternoon. Welcome back from lunch. To introduce myself, my name is Richard Wagner. I work with Jason Gerberry on the U.S. large cap pharma names. I am based in London. On behalf of my colleagues, Chi Fong and Dina Ramadane, covering analysts for Roivant and Immunovant respectively, I am pleased to welcome Matt Gline, CEO of Roivant, for a 40-minute fireside chat.
Thank you. Thanks for having me.
It is a pleasure. Thank you for coming.
Roivant has achieved several key milestones this year, including positive phase II readout of your once daily inhaled sGC, mosliciguat in PH-ILD, and approval of your TYK2 JAK inhibitor, brepocitinib in dermatomyositis. We still have multiple readouts coming up before year end. To help level set the discussions, what would be the company's top priorities in the next 12 months?
Yeah, perfect. Look, it has been a period of a lot of progress for us. It has been a great 12 months behind. We just, as you mentioned, got brepocitinib, now LISRAYA, approved, and we are making some real progress on the sGC on the pulmonary hypertension franchise. Look, coming up the next 12 months, very busy 12 months ahead. Obviously, one of the most important things for us is, with brepocitinib now on the market, we are in the early innings of that launch, but we want it to go as well as we possibly can have it, and so there is a lot of work going into making that successful. We have some major clinical data coming in brepocitinib, including between now and the end of the year in non-infectious uveitis, where we have not given specific guidance on when, but relatively soon, we will have data from that phase III program.
If that's successful, we then file for registration there, that would be a second potential registered indication for LISRAYA, for brepocitinib. After that or in addition to that, we have a bunch of data and sort of goings on, as it were, for our FcRn programs at Immunovant, including later this year, updates on both the CLE program as well as probably more importantly, the D2T RA, the late line rheumatoid arthritis program, where we will talk about our development plan there and our path forward after putting out some good early data earlier this year. Next year for Immunovant is a huge year, with registration data, less importantly in myasthenia gravis and much more importantly in Graves' disease, which are major indications for us. Those are sort of upcoming data.
Other than that, I'd say major priorities here are getting everything else up and running, continuing to start new studies with pulmonary hypertension program and to initiate new indications for all the other drugs as well.
Thank you. That's a great introduction. I'd like to start with brepocitinib, or brepo. You mentioned one month into the launch in dermatomyositis. What can you say about the launch experience? How is it tracking with your internal expectations so far?
Well, our both internal and externally disclosed path there is slow and steady. That's what we said over and over and over again. The truth is, we are 3 weeks in, so there's really very little to say that's productive. I will say what I think most investors know, which is if you talk to treating physicians, at least the KOL community, there's a ton of enthusiasm, that has certainly translated into our early experience. What that means in terms of scripts and coverage and everything else, it's just too early to know. We feel great about what we are doing and optimistic that we are going to have a good outcome there. Slow and steady remains the guidance. Look, first time there has been a novel therapy launched in dermatomyositis in a very long time or ever, so it's just hard to know the unknown unknowns.
You mentioned scripts. What type of launch metrics can investors expect on the earnings call? Will you present patient numbers, enrollment forms?
Yeah. What we've mostly said about this is that we're focused on the launch itself, and focused on net sales as the ultimate judgment. We have not given specific guidance on what metrics we're going to provide. I'm sure we won't be able to help ourselves from providing some subset of that stuff. But the honest answer is it feels like companies have mostly not been rewarded for providing a lot of detail and guidance on this. I think mostly we're focused on having the launch itself go well, having the patient experience be positive, having the reimbursements be positive, and letting the sales speak for itself over the medium term.
Good. Thank you. Do you see any read-through from the evolving competitive landscape for the commercial opportunity for brepo and DM?
Mostly, no. I guess the most obvious version of that question is, argenx put out their myositis data, whenever it was, late in the summer. I think prior to their receiving that data set, my sense is that their expectations for DM were relatively muted, and they had had more hope in IMNM. Indeed, they hit a P value in the IMNM subset of patients as well as for the study overall and did not get a P value in the dermatomyositis subset. That said, I think their data in DM probably exceeded their own internal expectations. It's clear from their body language and their voice that they would like to see the product approved in DM ultimately. I think they've been a little bit equivocal on what that's going to take from a clinical development perspective.
I think a reasonable expectation is they will have to run a study in dermatomyositis, potentially some sort of small bridging study similar to what they did seronegative MG. We will have to see. Our view commercially all along has been, look, this is an orphan indication with very high morbidity, with reasonable mortality, a lot of unmet need. I think a rising tide is going to lift all boats here in the sense of my hope is that they get approved. I think their approval will be good for us. I think brepo remains in DM specifically, excuse me, the drug in pole position. I think it would be good if they got approved as well over time. I think their data was reasonably impressive for what they clearly view as a secondary indication of myositis.
Okay, good. So turning to non-infectious uveitis, what outcome would you define as a good outcome for brepocitinib?
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