Roivant Sciences Ltd. (NASDAQ:ROIV) Q2 2023 Earnings Call Transcript

Mayukh Sukhatme: Yes, sure. I mean, I think you hit most of it, Matt. I think what Brian said was well appreciated, it is a — it’s a heterogeneous disease and there’s a lot of different several different subtleties and nuances to really, every trial and, you know, you asked about the steroid taper, I think a couple of other factors might be for example, just to give you a sense of things that are different or slightly different in any trial and each of these contribute in their own different ways. But severity of disease at baseline, so baseline CDAI or things like baseline steroids all sort of contribute to the max.

Brian Cheng: And also just on Graves readout later this quarter. Can you help us set the expectations there? How does success look like to you? And you know, given it’s a single-arm trial and the first FcRn program in Graves, how do you think of the success rate? You know, how do you think of the read-through coming from efficacy of FcRn showing in other indications?

Matt Gline: Yes, thanks. It’s a great question. We are tremendously excited about what Graves could be. I’ll take it and then frank or 100 of what you’ve gotten any there. The Immunovant team has spoken about this. You know, Graves is pretty straightforward biologically here, and that it’s relatively well understood to be auto antibody-mediated and there’s a clear biomarker, entire hormone levels that you’re looking to normalize. So, I think the data will tell us what we’ve got. I think we’ll have a clear sense of what we’ve got. I think what we are looking for is relatively high rates of normalization of thyroid hormone levels, and we are also tracking people’s ability to get off oral anti-thyroid drugs, and I think we will have a pretty clear answer to that question from this data. Frank, anything you’d add to that?

Frank Torti: I would say as a bar as we talked to KOLs, they’ve said, look, if you can get patients you know, about 50% of the patients to normalize thyroid levels that would be very clinically meaningful to them. And so, that’s the bar we look to as, you know, a level of importance.

Brian Cheng: Great. Thank you so much. Thanks.

Matt Gline: Thanks, Brian.

Operator: Thank you. And one moment for our next question. Our next question will come from Yaron Werber of TD Cowen. Your line is open.

Yaron Werber: Great. Thanks for taking my question. So, I also have a couple, one on brepo and then another on just on immunovant. So, for brepocitinib, maybe just to follow up for lupus and SLEs for non-infectious uveitis, definitely more, little bit less competitive. Where is the bar for you in lupus? Is it — we sort of have a good sense already what the safety profile of brepo is? So, is it mostly on the efficacy side as you are looking to differentiate and for non-infectious uveitis what do you want to see to continue forward? And then I have a quick follow-up.

Matt Gline: Yes, I’ll take the SLE question. Mayuk, maybe I’ll hand it over to you for the NIU question. Maybe on SLE, I think we’ve said this before, we think the safety profile of brepo is as you said well-understood. We’ve been in well over a 1,000 patients. We have a lot of data. It is, you know, effectively JAK-like from a safety profile perspective and we expect the FDA to treat it like a JAK inhibitor, so we will have the appropriate labels and so on. So, you know, I think that’s pretty well-characterized. I think for us it’s about efficacy. I think we feel the bar has been set by the Deucra studies, which are the current sort of best oral data in a large late-stage program that we’ve seen. Our view of the bar that Deucra adjusting for some pretty significant imbalances in their dosing arms.

It’s like a mid-teens SRI 4 placebo-adjusted delta and so we’d like to do kind of better than that in order to feel confident about progressing the program, but it will be a balance of the factors we’ll look at multiple endpoints and so on. You know on NIU, I hand it for Mayukh, I think we should lay this out on the last call, but Mayukh. Please go ahead.

Mayukh Sukhatme: Sure. So, I think we’ll make an overall assessment. This is you know kind of signal finding study here really. We are looking for treatment failure rate of no greater than 70%, the treatment failure rate is quite high in not on treatment. And so that’s a good bar. And overall. I think really the bet here across these indications, fundamentally is on efficacy. And so, that’s the thing that we are really looking to hit robustly.

Yaron Werber: And that’s just to clarify the NIU study you running or it’s not Pfizer?

Matt Gline: That’s right. That’s right. That’s our study.

Yaron Werber: Okay. And we’ve got a lot of questions and then you as well when you guys announced the TL1A deal with Roche, the words you use was ruthlessly monetized the immunovant stake. Can you just help us understand kind of philosophically or conceptually how you’re thinking about that? Thank you.

Matt Gline: Sorry, I apologize you cut out, literally, as you said, what word we used, something monetize?

Yaron Werber: I think it was ruthlessly monetized immunovant stake.

Matt Gline: I think we said we’d be ruthlessly economic about immunovant stake. I think I said, although we can go back and look at the transcript, but I think that’s true. The way that we’ve always thought about this is, we are going to do what maximizes value. We think the FcRn program is as good a program as biotech has to offer at this point. It has true best-in-class potential. Numerically has an investment class potential in an area where IgG has been a phenomenal biomarker for clinical efficacy and where we have really exciting IgG suppression. We have been safety picture as what we can tell so far. So I think that program, our hands without monetizing it. Could be the basis for? Yes, one of the great I&I biotech companies of the next generation and we are excited and fully resourced to progress that program that way.