Roivant Sciences Ltd Q1 2025 Earnings Call Summary

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

Question: Brian Cheng - JPMorgan Chase & Co - Analyst : Hey, guys. Thanks for taking our questions this morning. Matt, just on VM. Can you talk about just how much data we could get at the time of your top line, assuming the data is positive, how far are you from filing for approval? And what are some of the remaining gating factors from filings? I have a follow-up. Thank you.

Question: Brian Cheng - JPMorgan Chase & Co - Analyst : I got it. And then just on the Grave's trial, the second trial, can you talk about the trial design that we saw posted here in your latest deck. We noticed that there is 300 milligrams that you're testing. What's the rationale of testing a lower dose in that second Grave's trial? Thank you.

Question: Dennis Ding - Jefferies LLC - Analyst : Hi. Good morning. Thanks for taking our questions up. I have two on the -- the first question is just around how is a flare defined in the trial and how does the flare get treated on it? And can you give as much color as you can on how patients who require steroid rescue will be treated? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 11, 2025 / 12:00PM, ROIV.OQ - Q1 2025 Roivant Sciences Ltd Earnings Call And then my second question, you guys mentioned 40% of patients had eliminated steroids. That's a blinded or pool estimate correct? And can you hypothesize on what impact, if any, could an imbalance have on the primary endpoint of TIF between the 2 arms, meaning as more patients are able to eliminate steroids in the brepo arm versus the placebo arm. Could that mask the potential improvements on a placebo-adjusted basis? Thank you.

Question: Dennis Ding - Jefferies LLC - Analyst : Great. Thank you.

Question: Corinne Johnson - Goldman Sachs Group Inc - Analyst : Morning, guys. Thanks. Maybe could you provide some context around the upcoming grades remission data? What does clinically meaningful outcomes look like there? And how does that fit into the broader clinical strategy in Grave's? And then maybe one on just business development. You obviously have quite the balance sheet at your disposal. So how should we think about kind of the outlook for BD from here and the type size or structure of deals you're most interested in? Thanks.

Question: Prakhar Agrawal - Cantor Fitzgerald LP - Analyst : Hi. Congrats on the quarter and thank you so much for taking my questions. I had two, first a follow-up on the DM question on the flare up. So when the patient gets a flare up, what's typical steroid dose that these patients get? Is it close to their baseline or something even higher and is the steroid dose on a disease flare of defined in the protocol or is it up to investigator discretion? And secondly, a follow-up on BD. We've seen so many assets in autoimmune as well coming out of China, whether it's in licensing by pharma or formation of NewCo. Is the market an interest for your BD strategy? And what's your latest take on the China market as it relates to competition, the quality of assets and the valuation these assets are commanding now? Thank you.

Question: Sam Slutsky - LifeSci Capital LLC - Analyst : Hey. Good morning, everyone. Thanks for the questions. Just two for me. I guess on Brepo and DM, since physicians you're overall comfortable with the efficacy of JAK inhibitors and the disease, do you get the sense from doctors that the borrowers just hit that year so that they have it at their disposal to use on label or is there a specific bar on what they would consider when on the primary end point? And then second question is for batoclimab in TED. How might you leverage that data is positive, whether it's to help the positioning of FcRns in Graves disease or would you even consider a future program in TED with1402? Thanks.

Question: David Risinger - Leerink Partners LLC - Analyst : Yes. Thanks very much. Sorry about the background noise. Congrats on all the progress. My questions have been asked. So I'm curious just about Brepo and IU. If you could give us a road map for the pivotal development and the potential filing year. Thanks very much.

Question: David Risinger - Leerink Partners LLC - Analyst : Thank you.

Question: Emma Gutstein - Wolfe Research - Analyst : Hi, this is Emma for Andy. Thanks for taking our question. Two questions from us. Just looking at slide 16 and numerous companies are targeting DM. Can you elaborate on your approach for navigating this highly competitive market? And also in the press release, you mentioned preparations for potential launch in DM. Are there specific preparations or key milestones you're planning for in the next 6 to 12 months? Thank you.