The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Yeah. I know I feel like we waited for a long time. And now we're talking about Phase III data in the third quarter for Brepocitinib.
So maybe just talk about the VALOR study in dermatomyositis. Remind us the rationale for brepo in this patient population? And can you talk to
some of the clinical evidence that exists for the mechanism?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. Perfect. I want to talk about TIS in a second, but let's start with dosing. You mentioned there's two doses. How did you determine the doses
that were appropriate to take for this patient population?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. So talk to me about TIS. How does it work? How is it measured? How do you think about kind of controlling that outcome?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. So a couple of follow-up questions on that. Maybe one, how do you think about baseline patient characteristics then given TIS is not going
to be something that can establish your baseline?
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JUNE 10, 2025 / 11:00PM, ROIV.OQ - Roivant Sciences Ltd at Goldman Sachs Global Healthcare Conference
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Next Tuesday, 1:00 PM, right?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. So then given this is an improvement score. And there's a bunch of different things that are improvements. Are there things that are like
easier to get improvement in than others? And how do you think about like the impact of the different components of the TIS score on trial
execution?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. In terms of powering assumptions, what's embedded in those higher yield?
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JUNE 10, 2025 / 11:00PM, ROIV.OQ - Roivant Sciences Ltd at Goldman Sachs Global Healthcare Conference
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. There is a force taper in the steroid taper study. How do you anticipate that affects outcomes?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: You maybe just answered this, but what is the thing that you worry about as you think about execution?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. What should we think about as the next steps pending success on the VALOR trial?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. Great. So maybe talk a little bit more about the market opportunity. How many patients? And how should we think about which are like
appropriate candidates for new therapies?
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JUNE 10, 2025 / 11:00PM, ROIV.OQ - Roivant Sciences Ltd at Goldman Sachs Global Healthcare Conference
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. How should we think about pricing?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. You're also evaluating this in NIU, noninfectious uveitis. Remind us the Phase II data you reported last year.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: I think the dosing is higher in this patient population than DM. So talk about that.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. Can you talk to us about the Phase III trial design?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. You talked about the steroid burst and taper. I guess, like what is the role of that in this patient population?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Yeah. Okay. What do you think the market is missing with respect to the NIU opportunity?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: No, that's why I'm asking. I don't know, I'm on maternity leaves.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: I see. Okay. You've also disclosed Phase II study in cutaneous sarcoidosis. Maybe you can share the mechanistic clinical data like rationale for this
program.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. So what does that look like in terms of a nice clinical profile to set us up for registration?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. What are the most relevant endpoints in this?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. How do you think about further indication expansion? We just talked about three. There's JAKs could work.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. I guess where does like brepo indication expansion sit on your priority list, and this will hopefully be a good segue to the rest of our conversation.
But like how do you think about allocating resources behind this program versus some of the other things you could be doing?
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JUNE 10, 2025 / 11:00PM, ROIV.OQ - Roivant Sciences Ltd at Goldman Sachs Global Healthcare Conference
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Is any of this contingent on whether it works in DM?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. Maybe we can spend a little time on Immunovant. You obviously took a greater role in the strategic direction and execution there. I guess
what compelled you to take that step on Immunovant?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. One of the changes was just kind of like streamlining the strategic -- the clinical programs you're executing. Talk to us about why that was
the right decision.
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JUNE 10, 2025 / 11:00PM, ROIV.OQ - Roivant Sciences Ltd at Goldman Sachs Global Healthcare Conference
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. You did obviously make some personnel changes with the positioning of Eric there. Any other personnel changes that need to happen for
Immunovant from here? Any new roles?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. You had MG data, CIDP data earlier this year. Just like what are the key take-homes you want people to take from this?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. Myasthenia gravis is relatively crowded. But as you think about where the puck is moving for this indication, you talked a little bit about this,
but maybe you could help us understand how you think this market is going to break down in the next 5 to 10 years.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: There's tons of other things to talk about, but I'd love to let you on Graves' disease. A lot of people are following you now into this market. So maybe
you could talk about why you're so excited about that one.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Yes. I mean speaking of things that we've been waiting for a long time kind of going back to the beginning, Moderna litigation is coming. Can you
just give us a time line and the key decisions we're waiting for?
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. Capital allocation from here, remind us kind of like the pillars that you guys are looking at?
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JUNE 10, 2025 / 11:00PM, ROIV.OQ - Roivant Sciences Ltd at Goldman Sachs Global Healthcare Conference
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Okay. We have about a minute left. I've asked you about a number of things, but there's so much going on. I haven't gotten everything. Anything
you want to make sure is highlighted or that you don't think people quite understand.
Question: Corinne Jenkins - Goldman Sachs - Analyst
: Beautiful. Great having you. Thanks, everyone, for joining us here and online. Thank you so much, Matt.
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