Acadia Pharmaceuticals Provides Business and Planning Updates at the 43rd Annual JP Morgan Healthcare By Investing.com Conference

SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced multiple business news and advances related to CNS and rare disease drug candidates, which will be discussed today during a presentation by Catherine Owen Adams, Chief Executive Officer, at the 43rd Annual JP Morgan Healthcare Conference in San Francisco, CA.

2025 is expected to be an exciting year as we build on the success of our two growth brands, NUPLAZID and DAYBUE, which are projected to collectively generate more than $1 billion in net sales this year, said Catherine Owen Adams, Chief Executive Officer. In addition to growing our strong commercial franchises, we are laying the foundations for future growth through global expansion and ongoing progress. Today, we announced the submission of a marketing application for DAYBUE to the European Medicines Agency, and we anticipate the start of sales related to the Managed Access Program in Europe as early as the second quarter. We are also pleased to share updates on our R&D, both today and at our first R&D Day in mid-2025, as our flagship programs are close to reading data. By expanding our reach outside the US and continuing to advance our product pipeline, we believe Acadia is poised for sustained top-line growth and positive cash flow accretion.

Key milestones in 2025-2026:

• It was announced today that the marketing application for DAYBUE™ has been submitted to the European Medicines Agency (EMA) with an expected approval in the first quarter of 2026.
• Launching a managed access program in Europe in the second quarter of 2025, potentially resulting in the company’s first revenues outside the US
• Enrollment of the final patient in the Phase 3 COMPASS PWS study of ACP-101 in Prader-Willi syndrome is expected in the fourth quarter of 2025, followed by the announcement of top-line results in the first half of 2026.
• Enrollment of the final patient in the RADIANT Phase 2 study of ACP-204 in Alzheimer’s disease psychosis is expected in the first quarter of 2026, followed by the release of top-line results in mid-2026.
• Initiation of phase 2 study of ACP-204 for the second indication in Lewy body dementia in the third quarter of 2025.
• The company will host its first R&D day in mid-2025.
• Annual net sales for the entire year 2025 are expected to exceed $1 billion for the first time in the company’s history.

Today’s presentation will take place at 9:00 AM Pacific Time / 12:00 PM Eastern Time. A live webcast of the presentation will be available on the Company’s website, Acadia.com, in the investor section, and an archived recording will be available on the website approximately one month after the presentation.

About Acadia Pharmaceuticals

Acadia advances discoveries in neuroscience to elevate life. Since our inception, we have worked at the forefront of healthcare to bring vital solutions to the people who need them most. We developed and commercialized the first and only FDA-approved drug for the treatment of hallucinations and delusions associated with the psychosis of Parkinson’s disease and the first and only drug approved in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, psychosis caused by Alzheimer’s disease, and numerous other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information visit us at Acadia.com and follow us LinkedIn and X.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and may be identified by expressions such as may, will , should, could, would, expects, plans, anticipates, believes, estimates, projects, predicts, potentially, continues and similar expressions (including the negative) intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about: (i) our business strategy, objectives and capabilities, including support and innovation in our assets and business development capabilities and the potential for enhanced shareholder value; (ii) plans for, including the timing, development and progress of commercialization, and expected regulatory deadlines for trofinetide in the EU; (iii) plans for our series, including the schedule and conduct of our clinical trials, expected enrollment milestones and the schedule and results of data from our clinical trials; and (iv) our estimates regarding our future financial performance, profitability and capital requirements, including our financial guidance for the full year 2024 and the potential achievement of our annual net sales milestone in 2025. Forward-looking statements are subject to known and unknown risks , uncertainties , assumptions and other factors that could cause our actual results, performance or achievements to differ materially and unfavorably from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependence on the continued successful commercialization of NUPLAZID ® and DAYBUE and our ability to maintain or increase sales of NUPLAZID or DAYBUE; our plans to commercialize DAYBUE outside the US, including Canada; the costs of our commercialization plans and development programs and the financial performance or revenues of the commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competing products and therapies; our ability to generate or obtain the necessary capital to finance our operations; our ability to grow, equip and train our specialized sales force; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and improve our intellectual property; and our ability to continue to comply with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please see our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC in November 7, 2024, available at www.sec.gov. The forward-looking statements contained herein are made as of the date hereof and we undertake no obligation to update them after such date, except as required by law.

See the original version on businesswire.com: https://www.businesswire.com/news/home/20250114304564/en/

Contact for investors:
Acadia Pharmaceuticals Inc.
Al Kildani
(858) 261-2872
ir@acadia-pharm.com

Media contact:
Acadia Pharmaceuticals Inc.
Deb Cazenelson
(818) 395-3043
media@acadia-pharm.com

Source: Acadia Pharmaceuticals Inc.