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: Ami Fadia - Needham & Company Inc. - Analyst
: Hi, good afternoon. Thanks for taking my question. Just with regards to DAYBUE, how should we think about sort of the evolution of gross-to-net
over sort of the foreseeable future over the next one or two years? And where do you see this drug peaking as you continue to invest more behind
growing the product?
And just with regards to NUPLAZID, there seems to be obviously an improvement in gross-to-net this year. How do we think about that over the
next couple of years? Thank you.
Question: Ami Fadia - Needham & Company Inc. - Analyst
: Thanks, Mark.
Question: Tessa Romero - J.P. Morgan Securities LLC - Analyst
: Good afternoon, Catherine and team. Thanks so much for taking our question. So for DAYBUE, is the correct way to think about 1Q that you expect
to have a decline in active patients on therapy from where you ended 4Q?
And as a follow-up, is there a target number of patients that you think could be on or have been treated by the drug by the year-end here? And
what is the long-term target you think you can get to in terms of penetration? Thanks so much.
Question: Tessa Romero - J.P. Morgan Securities LLC - Analyst
: Thanks, Tom.
Question: Joel Beatty - Robert W. Baird & Co., Inc. - Analyst
: Hi, thanks for taking the questions. The first one is on -- I noticed since the last earnings call, there's been an increased estimate of diagnosed US
patients from about 5,000 before to between 5,500 to 5,800 now. Could you kind of discuss how you arrived at that number and your confidence
in that?
And then as a second question is on ACP-711. Can you discuss how that compares with SAGE-324, which I think has a somewhat similar but different
mechanism? And we saw that fail in Phase 2 in essential tremor last year. Thanks.
Question: Basma Radwan - Leerink Partners - Analyst
: Hi, good afternoon. Thank you for taking our questions. This is Basma, on for Marc. Our first question is related to 204 and its life cycle management
strategy.
Given that you recently initiated a new trial in dementia with Lewy bodies, if the drug proved to be efficacious in both Alzheimer's disease psychosis
and Lewy bodies, would you expect going back to the FDA and maybe revive the whole basket trial opportunity in other dementia-related psychosis?
And we have another question on NUPLAZID regarding the product awareness. You mentioned before that it's gone down from 30% in 2020 to
8% currently. What is your goal with the current unbranded campaign in terms of the -- what level of awareness you need to achieve? And what
is the timeline for that? Thank you.
Question: Basma Radwan - Leerink Partners - Analyst
: Thank you.
Question: Tazeen Ahmad - BofA Global Research - Analyst
: Hi, guys. Can you hear me?
Question: Tazeen Ahmad - BofA Global Research - Analyst
: Okay. Great. Thank you. I had a question on Prader-Willi. As you think about the secondary endpoints that are going to be important to look at,
can you talk to us about some of those and what we should be looking for with those secondaries?
And maybe an overall question about the competitive landscape in Prader-Willi. It does seem like a few companies are pursuing approaches with
different twists to treat the same disease. And I was curious about what you think if there is just one right approach, and if not, what the advantage
of your approach could be? Thanks.
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FEBRUARY 26, 2025 / 9:30PM, ACAD.OQ - Q4 2024 ACADIA Pharmaceuticals Inc Earnings Call
Question: Gregory Renza - RBC Capital Markets - Analyst
: Great. Thank you. Catherine and team, congrats on the progress, and thanks for taking my question. Catherine, you've aptly noted that ACADIA's
pipeline looks vastly different than even a quarter ago. And as you build that out, I'm just curious with respect to exploring those additional external
investments that you speak of, where are the current gaps in ACADIA's portfolio right now?
Perhaps a little color on where you see dimensions of rightsizing and getting to the optimal pipeline state, whether it's across the stage, the technical
success, or even the area of therapeutic interest. Thank you very much.
Question: Charles Duncan - Cantor Fitzgerald & Co. - Analyst
: Yeah, thank you for taking the question. Congrats, Catherine and team, on the commercial execution '24 and refreshed communication. I appreciate
all the guidance. But I had a pipeline question, and specifically around ACP-101, I noted that you are enrolling a big range in terms of age 5 to 30,
and that's not new.
But I'm wondering if Liz has a thought on the dynamic range of HQ-CT and whether or not she expects there to be an age-related, call it, impact
on being able to see a signal. And if there is an open-label extension study going, has there been rollover, and is there persistence in that? Thanks.
Question: Sumant Kulkarni - Canaccord Genuity - Analyst
: Good afternoon. Thanks for taking my question. It's a bit of a bigger picture question, but has a specific ACADIA-related angle.
Given you're well into your Phase 3 program in Prader-Willi, do you foresee any changes at the FDA that might make things different versus what
you might currently expect in terms of a potential back and forth with the agency on the data that you generate in what is a high unmet need
indication?
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