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: Derek Archila - Wells Fargo Securities, LLC - Analyst
: So just two quick ones for us. I guess maybe to Matt and Eric, I just wanted to understand some of the changes that might be employed now with
more alignment with Roivant in terms of the execution? I know you hinted at some of that, but -- just trying to understand how that might impact
some of the time lines that you guys laid out here?
And then just on CRE, which again, I find very interesting, probably very hard to compare now, but just curious how you're thinking about 1402's
profile here relative to some of the other agents and development, particularly ones targeting PDCs and type 1 interferon and whether you're
seeing any correlation between the reduction in type 1 interferon and IgG reduction.
Question: Dave Risinger - Leerink Partners - Analyst
: Great. Thanks very much, operator. Thanks for hosting this event, Matt and team. So I have two questions. First, could you provide some more color
on the decision to develop six indications rather than maybe just comment on what you decided to subtract and why?
And then second, on slide 27, I see the design for the proof-of-concept study in CLE. But I guess -- could you just explain why you have an open-label
period at all? Why not just do period one and go into period three with the two different doses. Thanks very much.
Question: Sam Slutsky - LifeSci Capital - Analyst
: I guess two for me. One, can you discuss more broadly the open-label case study program where the TLA patients were evaluated how many TLE
patients do you plan general here? And then are there other indications where you also have data from this program? And then just second, just
a reminder on when the second Grave's disease study might be started? And is that also expected to read out in 2027?
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APRIL 21, 2025 / 12:00PM, ROIV.OQ - Roivant Sciences Ltd Investor Call
Question: Brian Cheng - JPMorgan - Analyst
: Maybe just on Sjogren's, compared to nipocalimab Phase 3, we know that there are some differences in terms of the Phase 3 design, like having
primary endpoint and defining the treatment period to two periods.
First, can you provide a bit more color on the differences and then second, Matt, you talk about how Sjogren's, you can potentially catch up to
Nipuk-Hallemapp's program. What are some of the potential levers that you're considering to close the gap?
Question: Yaron Werber - TD Cowen - Analyst
: Great. I appreciate it, and this is super useful. So I have a couple of questions. One is just maybe Gredy a little bit about Sjogren's, I noticed that
you're going to do your study in moderate to severe systemic disease, which is comparable to the other two companies. What about symptomatic
because one would think that this mechanism would lend itself to work in symptomatic patients as well?
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APRIL 21, 2025 / 12:00PM, ROIV.OQ - Roivant Sciences Ltd Investor Call
And then secondly, just a broader question. I mean, this is obviously a fairly big shift historically, I think we used to get a lot of questions whether
the goal is to sell Immunovant and then maybe even to sell brepocitinib, just like you did with Telvent.
But I think that the compensation of the management team has now changed to be very much aligned with the stock price, which I think would
potentially lead one to believe that you're thinking and you're planning on actually commercializing requacitinib and 1402. Can you comment on
that? And are we thinking about this correctly, maybe from a broader strategic viewpoint?
Question: Yaron Werber - TD Cowen - Analyst
: And just maybe if I could just follow up quickly. So on brepocitinib, is your goal as of now to commercialize brepocitinib, we're expecting positive
Phase 3 data in dermatomyositis in September or October, I think you said second half. But are you thinking about commercializing it yourself?
Question: Thomas Smith - Leerink Partners - Analyst
: Just coming back to Sjogren's. So on slide 25 that you're planning this is a 180-patient study which is smaller than the Argenx and the J&J Phase 3
programs. Now I think you mentioned you've engaged in a lot of regulatory dialogue here. You have nice alignment on this program. I was wondering
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APRIL 21, 2025 / 12:00PM, ROIV.OQ - Roivant Sciences Ltd Investor Call
if you could just elaborate on that and your expectations about whether you think this could be registrational with a single study or whether there
might be a need for a second study potentially down the line?
Question: Jason Gerberry - BofA Global Research - Analyst
: Just one question just in love of the changes today. I'm curious if there's any updated thoughts on monetizing this upcoming TED data for 1401.
It would seem like you could have a carve-out single indication for 1401 and perhaps take it to market data depending, whereas pursuing all other
opportunities with 1402. So just curious if that's a reasonable expectation or if you would, I don't know, guide us differently.
And then just from a capital financing perspective, just given how Immunovant stocks been trading of late. Just curious appetite to be an even
larger shareholder of Immunovant or maintaining current levels and just being -- revisiting during financing opportunities?
Question: Prakhar Agrawal - Cantor Fitzgerald - Analyst
: So Matthew has had a few times that you wanted to execute the high-value opportunities on an versus going broader. So I guess that is to my
question, what was the status of the Grave's and RA trials that are ongoing where they're running slow and what environment would have hoped
for?
And do you still have a high conviction of being first-in-class in these indications? And the second question is, given this more active operational
and strategic involvement in immune end, what's the latest on Roivant strategy certify 2 billion or so for beating. So any.
Question: Alex Thompson - Stifel Nicolaus and Company, Incorporated - Analyst
: Maybe a follow-up on commentary related to capital allocation, et cetera. Could you talk a little bit about what this new cash runway guidance for
Immunovant really encompasses in terms of ways in which with your balance sheet to help potentially accelerate development here, particularly
within this really competitive as you've menioned couple of times.
Question: Leland Gershell - Oppenheimer & Co., Inc. - Analyst
: I just want to ask a with all the indications for the two new ones you're announcing. I'm just thinking about time lines and sequencing. I think in
past conversations, even the grades that come to the fore, it looks like NG might be the first indication to launch for 142. Is that still the view or just
to see what your view is on first indication for 1402 launch.
Question: Derek Archila - Wells Fargo Securities, LLC - Analyst
: And then in terms of additional facilitations for Porto, are those announcements we may hear in the near future? Or may those be dependent on
data you may see from some of the trials you're doing now which could help to inform additional indications.
Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst
: Just in terms of the pursuit of CLE, I'm just curious because we've obviously seen an and pursue SLE. And I'm just curious, what led you to CLE versus
SME with 1402. What was it about the disease that made you think that this was a better indication for FcRn?
Question: Douglas Tsao - H.C. Wainwright & Co., LLC - Analyst
: At is pursuing has that SLA.
Question: Dennis Ding - Jefferies - Analyst
: I have one maybe for Eric. Just here's what new perspective you bring to Immunovant SEO? And is there any differences in how you approach
capital allocation and the return on investments are maybe stir up to you at all at a map. But like, I guess, for men volume, are you guys 100%
committed today to finishing out the MG and CIDP studies? And then as a follow-up, I'm just curious for Sjogren's and CLE. What implementations
will you make to minimize placebo?
Question: Ash Verma - UBS Equities - Analyst
: Just on taking the instantiate for company is have the second half of the effect that went be?
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