Roivant Sciences Ltd Q2 2024 Earnings Call Transcript

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

Question: Louise Chen - Cantor Fitzgerald - Analyst : Hi. Congratulations on all the progress and the data today. Thanks for taking my questions. So I had two on brepocitinib. I wanted to ask you what set of efficacy you'd like to see in your Phase 3 NIU trial? And then also for brepo and HS, where do you stand and what's the latest update there? Thank you.

Question: Brian Cheng - JPMorgan - Analyst : Hey, guys. Thanks for taking our questions this morning. Maybe just a question on CLARITY design. Are you requiring patients to have a certain steroid dose for entry? And are there any certification strategy that we should make note of? And also on the sub studies between CLARITY-1 and 2, what is the difference here? Is there a geographical location difference?

Question: Joyce Zhou - TD Cowen - Analyst : Hey. Good morning, guys. This is Joyce on for Yaron. Thank you for taking my quesition. Can you talk about your thoughts around pricing for brepocitinib, of course, orphan price point here, but how should we think about pricing by indication? Thank you.

Question: Andy Chen - Wolfe Research - Analyst : Hey, good morning. Thank you for taking the question. On uveitis Phase 3, can you talk about what placebo response you're assuming? So in the Humira trial, I think they saw 13 weeks or 3 months. But in your trial, you have a more stringent tapering. So your tapering is 8 weeks versus Humira trial, which was, I think, 15 weeks. So in other words, are you assuming 13 weeks, is that going to be the placebo response on the primary endpoint? Is it going to be less than 13 weeks? Or should we be assuming that it's going to be less than 13 weeks? Thank you.

Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst : Hi, good morning. Thank you for taking the questions. Matt, just on that last one, do patients automatically switch to brepo if they have treatment dose or do they have the option to switch? And is there a sort of alternative protocol that they can pursue? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 12, 2024 / 1:00PM, ROIV.OQ - Q2 2024 Roivant Sciences Ltd Earnings Call

Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst : Okay. Great. Thanks. And just as a follow-up for Matt. From a business development standpoint, obviously, with Mosli and the creation of namilumab we have sort of gone beyond what has been a short-term focus on I&I. I'm just curious how you're thinking about Roivant from a therapeutic category standpoint right now? And does this move respiratory like a big focus for adding additional assets? Or you're just going to continue to be as you put sort of rip off the economics and dig out the best opportunities as you identify them? Thank you.

Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst : Okay, great. Thank you.

Question: Craig McLean - Goldman Sachs - Analyst : Hey, good morning. This is Craig on for Corinne. So the first question here is given the emergence of Humira biosimilars, how do you expect brepo could be positioned if it potentially gains approval? And then from there, will you recruit or target patients that are refractory to anti-TNF-type medicines within CLARITY?

Question: Craig McLean - Goldman Sachs - Analyst : Yeah.

Question: Craig McLean - Goldman Sachs - Analyst : Yeah.

Question: Craig McLean - Goldman Sachs - Analyst : Great. Thank you very much.