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: Brian Abrahams - RBC Capital Markets - Analyst
: Congrats on the recent LEQEMBI approval in Europe. Can you talk about what the rollout strategy could look like there and your sense of what the
reimbursement process and amenability could be?
Question: Evan Seigerman - BMO Capital Markets Equity Research - Analyst
: I wanted to touch again on LEQEMBI, but this time with the subcutaneous formulation. Maybe remind us how that potential for at-home administration
can help accelerate sales in the United States. We're seeing some good uptake, but I think that, that could really help get things going further. And
maybe some of the hurdles that you have to overcome to really get full penetration there.
Question: Salveen Richter - Goldman Sachs Group, Inc. - Analyst
: Just following up on Evan's question here. Could you just speak to your thoughts on LEQEMBI uptick in growth on the forward, not only with
subcutaneous maintenance dosing in the second half, but also with Fujirebio's in-vitro diagnostic, which should enter the market as well?
Question: Timothy Anderson - BofA Securities - Analyst
: On LEQEMBI, how are you seeing the market parse out between your product and Lilly's Kisunla? Because obviously, there's a very big difference
in terms of commercial positioning around finite dosing. And I'm wondering who's going to kind of win that battle.
And Chris, you answered an earlier question starting off talking about getting docs to keep patients on therapy. So the product -- your product is
on the market now for coming up on 2.5 years. Are you actually seeing some prescribers take patients off therapy after a period under the idea
that once plaque is gone, you no longer need to give drug?
Question: Christopher Schott - JPMorgan Chase & Co - Analyst
: I just would love a bit more elaboration on latest thoughts on business development in terms of the size and scopes of deals you're considering.
It's obviously been a pretty volatile market out there. And I'm just wondering if that's changing your views at all or the range of opportunities that
might be available to Biogen.
Question: Michael Yee - Jefferies - Analyst
: I wanted to ask Priya, about the early AHEAD 3-45 study. I know that you've guided to a 2028 readout. Your competitor is also guiding to a readout,
although I think there's an assumption that, that may come earlier. Can you just talk about maybe one or two points about your positioning versus
that study and particularly what would get you extremely confident that, that's going to work and/or readout? Because I know that you have an
interim, but I'm just going to assume you're not going to take that interim.
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MAY 01, 2025 / 12:30PM, BIIB.OQ - Q1 2025 Biogen Inc Earnings Call
Question: Michael DiFiore - Evercore ISI Institutional Equities - Analyst
: This is Mike DiFiore on for Umer. Again, one on LEQEMBI. Lilly's drug did about $20 million -- $21 million of sales in Q1, which is its second full
quarter of launch. And this tracks slightly ahead of LEQEMBI sales at the same time point.
So my question is, has Biogen and Eisai perhaps paved the way for Lilly in terms of opening up health care infrastructure? And maybe perhaps
could you speak to any competitive dynamics at play now that you're roughly 18 months into launch.
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MAY 01, 2025 / 12:30PM, BIIB.OQ - Q1 2025 Biogen Inc Earnings Call
Question: Terence Flynn - Morgan Stanley - Analyst
: Obviously, there's been a lot of focus on the FDA under the new administration. And I know you made some comments about your Dravet program
moving into a Phase III. So just wondering if you could comment high level, number one, on your interactions with FDA and if there have been any
changes to the review teams, things like that. But then also in some of these rare diseases, do you think this FDA is going to be advancing very
rapidly and be more favorable to the industry in terms of thinking about maybe surrogate endpoints?
Question: Geoffrey Meacham - Citigroup Inc. Exchange Research - Analyst
: For Chris or Robin, on manufacturing, Biogen has historically had a lot of capacity in the US going back to the original expectations in Alzheimer's.
I guess the question is, as we see more companies in biopharma announce plans to onshore capacity, do you guys view your own capacity or
resources differently? I wonder if there's a short-term opportunity to partner that's not in the model. Obviously, all, of course, depends on what
you have in excess.
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