ACADIA Pharmaceuticals Inc Q1 2025 Earnings Call Transcript

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

Question: Ritu Baral - TD Securities (USA) LLC - Analyst : Good afternoon, guys. Thanks for taking the question. I wanted to ask about, I guess, one question on 101, and then one question about DAYBUE for Europe. One, what does good 101 data look like? And can you discuss how that may relate to your last discussions with FDA on the filing strategy? And then as far as Europe, how should we be thinking about modeling a European price for DAYBUE, and then just balancing the pricing risk from a potential most favored nation drug pricing development that I think we're all sort of watching? Thanks for taking the questions.

Question: Ritu Baral - TD Securities (USA) LLC - Analyst : Thank you.

Question: Tess Romero - JPMorgan Securities LLC - Analyst : Good afternoon, Catherine and team. Thanks so much for taking our question. So for each of your brands, NUPLAZID and DAYBUE, what is the right way for us to be thinking about what we are likely to see sequentially from 1Q to 2Q from a growth perspective? What are the key factors and

Question: Tess Romero - JPMorgan Securities LLC - Analyst : Great. Thank you.

Question: Ash Verma - UBS Securities LLC - Analyst : Okay, so congrats on the progress. I wanted to ask about the pipeline. So maybe just on carbetocin, so the prior attempt by Levo Therapeutics had failed on the high dose but successful on the low dose. And typically, you generally don't see inverse dose relationship. What makes you confident that the low dose can generate positive data and be accepted by the FDA. And then just secondly, any thoughts on GLP-1 using Prader-Willi? Thanks.

Question: Ash Verma - UBS Securities LLC - Analyst : Thank you.

Question: Elaine Kim - Cantor Fitzgerald & Co. - Analyst : Hi, this is Elaine Kim for Charles. Thank you for taking our questions. I just wanted to ask for the Phase 3 COMPASS trial, are there any phenotypic behaviors or patient subsets like genetic subtypes or age groups that are more likely to respond to treatment?

Question: Elaine Kim - Cantor Fitzgerald & Co. - Analyst : That makes sense, and congrats on the accelerated enrollment. I just wanted to ask a quick follow-up regarding the R&D Day next month. I understand that you're giving additional details and data across the pipeline programs, but will you be going through each clinical programs individually? I understand that essential tremors joined recently, so what are your -- could you provide additional color in your plans?

Question: Elaine Kim - Cantor Fitzgerald & Co. - Analyst : Fantastic. Thank you for taking our questions.

Question: Basma Radwan - Leerink Partners LLC - Analyst : Hi, good afternoon. This is Basma on for Mark. Thank you for taking our question. We have a question on DAYBUE. Can you provide some color on the utilization rate or the compliance in the quarter? And also, if you can provide some color on the average age and weight of the patient on therapy to date, and whether you see correlation between the age and the discontinuation rate. That's it for us. Thank you.

Question: Basma Radwan - Leerink Partners LLC - Analyst : Yes. Thank you very much.

Question: Julian Pino - Stifel, Nicolaus & Co., Inc. - Analyst : Hey there, this is Julian on for Paul. Thanks so much for taking our question. I guess another one on trofinetide for ex-US approvals, I guess, what do you guys see as maybe the biggest risk to the approval process? I guess, could you just speak to your confidence in getting EMA approval and eventual reimbursement there? And then I guess a second quick one is just where does BD fit on your list of priorities this year? Is this mainly about execution under new management, or are you interested in transacting as other executives have mentioned that valuations have come down and biotechs have been reaching out to pharmas for partnership? Thank you.

Question: Julian Pino - Stifel, Nicolaus & Co., Inc. - Analyst : Absolutely.

Question: David Huang - Deutsche Bank Securities, Inc. - Analyst : Hi there. Thanks so much for taking my questions. So first on DAYBUE, I just wanted to ask about the persistency you're seeing here long-term at 12 months. I think you mentioned it was a little bit north of 50%. Is there more work to do there? Do you think that can materially improve, or are we kind of more at steady state and it would be more beneficial to focus on net patient ads? And then just with Prader-Willi, your asset versus commercial positioning of Soleno's product, which is now on the market, how do you kind of think about that? Thanks a lot.

Question: David Huang - Deutsche Bank Securities, Inc. - Analyst : Yes, 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. MAY 07, 2025 / 8:30PM, ACAD.OQ - Q1 2025 ACADIA Pharmaceuticals Inc Earnings Call

Question: Tazeen Ahmad - BofA Securities, Inc. - Analyst : Hi, good afternoon. Thanks for taking my question. For trofinetide in EU, can you maybe, Catherine, give us a sense on in what ways the launch could be different from the trajectory that DAYBUE has seen in the US? I know you bring a lot of experience from launching products outside of the US. What kind of attention to specifics should we be paying as we think about how to model out European launches for your drugs and how we think about DAYBUE in general.

Question: Anish Nikhanj - RBC Capital Markets LLC - Analyst : Hi, Catherine and team. It's Anish on for Greg. Congrats on the progress this quarter, and thanks for taking our questions. Firstly, as a follow on to David's previous question, what unique aspects of your commercial engine or priorities within the target market do you believe you'll be able to leverage to rise above competitors in the PWS market with respect to Soleno and other therapies in development? And secondly, obviously, there's a lot of concern across the sector on macro and policy exposure for companies. I know you commented on inventory already, but maybe if you could just share some thoughts around where DAYBUE and NUPLAZID might be impacted along their respective supply chains and how you're navigating that. Thanks so much.

Question: Yatin Suneja - Guggenheim Securities LLC - Analyst : Hey, guys. Thank you for taking my question. A question on the Prader-Willi study. Are you able to talk about the powering of the study and the size of the study to be robust? What effect size are you powered for? What is the minimum you are able to achieve? Thank you.

Question: Joel Beatty - Robert W. Baird & Co., Inc. - Analyst : Hi, thanks for taking the question. It's a little bit of a math question on DAYBUE and the ability to find new patients starts faster than patients discontinue. And I guess it's in the context of you're getting close to a thousand patients on therapy in a quarter now. And then a discontinuation or a persistency rate at 12 months of about 50%. So putting those numbers together, I guess the question is, would that mean to expect about 500 patients dropping off over the course of a year? And then if so, how realistic is it to be able to find 500-plus patients of new starts to be able to replace that?

Question: Sumant Kulkarni - Canaccord Genuity LLC - Analyst : Good afternoon. Thanks for taking our questions. I have two quick ones. Given post-trial briefing is done on the pimavanserin-2 case, could you remind us of your latest assumptions on when you might expect generic competition on NUPLAZID? And second, on trofinetide, do you expect to start recognizing European revenue from France via the paid early access program that country allows? And how important might that type of initiative be to give you a good sense of how the product might launch in the rest of Europe.

Question: Malcolm Hoffman - BMO Capital Markets Corp. - Analyst : Hi, Malcolm on for Evan from BMO. I wanted to touch on NUPLAZID gross net. I believe you said gross net for the quarter was roughly 24% and the guide suggests a range for the year of 22.5% to 25.5%. Can you just talk through what pushes and pulls you expect can move this gross net one side or another of the guide? Thank you.