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: 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.
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.
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FEBRUARY 10, 2025 / 1:00PM, ROIV.OQ - Q3 2024 Roivant Sciences Ltd Earnings Call
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.
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FEBRUARY 10, 2025 / 1:00PM, ROIV.OQ - Q3 2024 Roivant Sciences Ltd Earnings Call
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.
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.
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