Roivant Sciences Ltd Q3 2024 Earnings Call Transcript

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

Question: Dave Risinger - Leerink Partners LLC - Analyst : Great. Thanks very much. So congrats on all the progress, Matt. I have two questions, please. First, could you review the batoclimab efficacy bars for success ahead of the release of results in coming weeks? And then second, could you also discuss the additional batoclimab-GD data, the six month treatment-free remission results that are coming this summer, including what you're hoping to see? Thanks so much.

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

Question: Dennis Ding - Jefferies LLC - Analyst : Hi, good morning. Thanks for taking the question. We had a question around the LNP litigation and the upcoming summary judgment. Can you help us understand the range of outcomes as it relates to 1498, meaning will the judge rule that either Moderna or the US government will be liable for all the patent infringement liabilities or could there be a middle scenario based on terms within the contract where Moderna would only be liable for damages for, I don't know, like 25%, 50%, 75% of the doses? Thank you.

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

Question: Yaron Werber - TD Cowen (Research) - Analyst : Great. Good morning. Thanks for taking. Matt, I got a couple of questions. Maybe just the first one on cutaneous sarcoidosis statistic, a really interesting opportunity. So as your -- thanks for that slide showing us the BEACON trial design. So this is a study that got 3 to -- 3 to 2 randomization. Can you give us a little bit of a sense sort of how do you power it? What do you want to see in terms of delta over placebo? And then secondly, just for the Graves' disease in terms of remitted ability, what would be good data from your KOL checks in terms of remission at six months? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 10, 2025 / 1:00PM, ROIV.OQ - Q3 2024 Roivant Sciences Ltd Earnings Call

Question: Brian Cheng - J.P. Morgan Securities LLC - Analyst : Hi, guys. Thanks for taking our questions this morning. We have two. First on Immunovant. There's certainly a lot of investor questions on how the high dose batoclimab is going to look compared to the low dose. But just curious if you can tell us the level of your commitment you have today to advance 1402 specifically into MG and CIDP, regardless of what the data show? Will you still proceed in both indications or pivotal studies?

Question: Brian Cheng - J.P. Morgan Securities LLC - Analyst : Okay. And then on the neuocyclodoses indication for brepo, the Phase II BEACON seem to be a relatively small study. So can you give us a sense of the trials powering on the CSAMI score? How do you assume the placebo will perform in a target indication -- in the target population? And just wondering if the tours of psychodosis here for brepo here today, has anything to do with the infrastructure that you already built with Kinevant? Thanks.

Question: Brian Cheng - J.P. Morgan Securities LLC - Analyst : Thank you

Question: Yatin Suneja - Guggenheim Securities, LLC - Analyst : Hey guys, thank you for taking my question. The question is on the recent investment you made in Immunovant. Could you just talk about why that investment was made or what was your thought process to make it before the data versus after the data? And then if part of the question is that devaluation is attractive, you made the investment now, why not bring the whole asset in-house and sort of take advantage of the dislocation in pricing?

Question: Yatin Suneja - Guggenheim Securities, LLC - Analyst : Got it. One more question, if I may. And this is regarding the data, the Immunovant data that's coming up. I think there is increasing focus in terms of the relative better efficacy or a little bit more efficacy that you have to show versus other FcRn. And it is our understanding that in many different classes a drug with similar efficacy and maybe some differentiation can still get significant share. So do you really need to produce more efficacy than other FcRn play? I'm just curious like how you are benchmarking the data to the others.

Question: Yatin Suneja - Guggenheim Securities, LLC - Analyst : Thank you.

Question: Emma Gutstein - Wolfe Research - Analyst : This is Emma on for Andy. Thank you for taking our question. Just one question from us. With the top line DM readout expected in the second half of 2025, with potential registration on the table and with also argenx's recent success in DM, I guess what are your expectations for the brepo Phase III readout and the future just competitive landscape if argenx successfully completes its Phase III? Thank you.

Question: Emma Gutstein - Wolfe Research - Analyst : Great. I appreciate the results.

Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst : Hi, good morning. Thanks for taking the question. And Matt, I guess just maybe starting with brepocitinib, and obviously, we now have another indication. I'm just curious if you have thoughts on sort of the pace that you would potentially roll out additional indications with brepocitinib, just given the fact that it seems to be an asset that could have fairly broad applicability across a range of orphan indications, which I know sort of has been your initial focus? Thank you. And I have a follow-up. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 10, 2025 / 1:00PM, ROIV.OQ - Q3 2024 Roivant Sciences Ltd Earnings Call

Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst : I mean, I guess, Matt, as a follow-up, I mean, it's like Immunovant has talked about sort of 10 studies over a certain amount of period. And I get you don't want to necessarily commit to that similar timing, but do you think that -- that's a fair number of opportunities that brepo can ultimately be relevant in?

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