Roivant Sciences Ltd Brepocitinib in DM: VALOR Phase 3 Study Results Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Dennis Ding - Jefferies LLC - Analyst : Hi, good morning. Thanks for the question and congrats on the really strong data here. I had a question on just in terms of doctor feedback. Have you done market research or survey work with rheumatologists and where they see brepo fitting in? And I know you said TIS is an artificial clinical trial endpoint that's not really relevant in practice, but what endpoint really resonates with these DM doctors? And if there's any way to quantify what percentage of their DM patients would they prescribe brepo to given the data you have?

Question: Brian Cheng - JPMorgan Chase & Co - Analyst : Hey, guys. Thanks for taking our question and truly congrats on the data. Maybe just first on the trial data, can you comment on the treatment compliance in the high dose? And when it comes to the extent of the rescue medication, can you also kind of give us more color on what medications are being used and for how long? And then I have a quick follow-up.

Question: Brian Cheng - JPMorgan Chase & Co - Analyst : Right. And then based on the profile and receptivity of brepo among the physicians that we spoke to and also considering the existing off-label use of JAK in the space, how should we think about pricing at this point in the grand scheme of things? How much flexibility do you have? Will you be able to anchor this to a rare disease pricing?

Question: Corinne Jenkins - Goldman Sachs & Company, Inc. - Analyst : Thanks, then I'll add my congratulations to you all on this data. Maybe two quick questions for me, maybe first, can you just speak to how the kind of robust skin and muscle disease activity you saw might point to any additional indication expansion opportunities with the drug? I know, obviously, you saw robust activity across both of those. And then, can you also just talk to the sequencing you anticipate as we look forward to some of the clinical stage assets that are in development? How do these data kind of inform your expectations for brepo sequence in the treatment paradigm as you look forward on a three- to five-year view?

Question: Yaron Werber - Cowen and Company LLC - Analyst : Great, thanks so much and congrats, really, on the consistency of the data pretty much all across the board. Maybe just a couple of questions, number one, the safety profile looks really clean and safe, and there were actually more dropouts on placebo relating to AEs. Can you discuss that? It was 11% on placebo versus 6% on brepo. And then I think there's probably going to be a little confusion on the CDASI on the 12% versus 7%, which shows you a 5% delta. What's clinically meaningful? Where we believe from physicians, anything with a CDASI different of over 5% is clinically meaningful? So getting to 12% is pretty good, but I want to know your thoughts.

Question: Prakhar Agrawal - Cantor Fitzgerald LP - Analyst : Hi, thank you for taking my questions and congratulations on the really strong data. Maybe just following up on the CDASI and specifically on slide 19, the placebo response was also a little bit higher than what we typically expect on CDASI. So I was wondering if there was any explanation for the placebo as well, which saw 7 points decrease on CDASI. And then just a couple of follow-ups. Do you plan to file for just one dose, which is the 30 milligram? And if you can provide your perspective on what percentage of DM patients might be on off-label JAKs. I know it's a little bit of hard data point to get, but any benchmark would be super helpful.

Question: Sam Slutsky - LifeSci Capital LLC - Analyst : Hey, good morning. Thanks for taking the questions and great work on this update. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 17, 2025 / 12:00PM, ROIV.OQ - Roivant Sciences Ltd Brepocitinib in DM: VALOR Phase 3 Study Results Just two for me, just any details you're able to provide on commercialization plans as you think about the number of sales reps and then how quick you can ramp up the infrastructure for the launch? And then second question is, it looks like about 20% of patients in the study had a history of ILD. Just remind me, did you measure if there was any impact on ILD symptoms or progression? And then do any of the drugs used now for dermatomyositis have an impact here?

Question: Samantha Semenkow - Citi Infrastructure Investments LLC - Analyst : Hi, good morning. Thanks very much for taking the question, and I'll add my congratulations on on the data today as well. Just building on that prior question, I was wondering if you could speak a little bit to the DM landscape right now. I think, Matt, you mentioned there are only 13% of patients roughly on IVIG. I'm wondering if there are any dynamics outside of maybe IVIG just not being a suitable treatment for the majority of DM patients. I know the data today likely speaks for itself in terms of potentially driving adoption. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 17, 2025 / 12:00PM, ROIV.OQ - Roivant Sciences Ltd Brepocitinib in DM: VALOR Phase 3 Study Results But is there anything you can share about your expectations on what that could look like over time and how that compares to what we've seen for IVIG thus far?