“2025 is shaping up to be an exciting year as we build on the success of our two growth brands, NUPLAZID and DAYBUE, which together are projected to generate more than $1 billion in net sales this year,” said Catherine Owen Adams, Chief Executive Officer . The officer. “In addition to growing our strong commercial franchises, we are laying the foundation for future growth through global expansion and pipeline advancement. Today, we announced our submission of a marketing authorization application for DAYBUE with the European Medicines Agency and anticipate the initiation of the Program of Managed Access – related sales in Europe as early as Q2 We are also pleased to share updates on our pipeline of R&D – both today and on our first day of R&D. mid-2025 – as our key programs close to reading data expanding our reach beyond the US and continuing to advance our pipeline, we believe that Acadia is poised for steady top line growth and positive cash flow growth.
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 accessible on the Company’s website, Acadia.com, under the investor section, and an archived recording will be available on the website for approximately one month following the presentation.
About Acadia Pharmaceuticals
Acadia is advancing advances in neuroscience to elevate life. Since our founding, 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 to treat hallucinations and delusions associated with the psychosis of Parkinson’s disease and the first and only drug approved in the United States and Canada to treat Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and many other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on 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 terms such as “may,” “will”, “should”, “may”, “will”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “projects”, “anticipates,” “potential,” “continuing” and similar expressions (including their negatives) intended to identify forward-looking statements. The forward-looking statements contained in this press release include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities, including support and innovations in our pipeline assets and business development opportunities, and the potential to improve 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 pipeline, including the timing and conduct of our clinical trials, anticipated timing of enrollment and the timing 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 2024 and the potential achievement of our annual net sales milestones 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 adversely 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 impact or revenue from any 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 results, 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 capital necessary 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 rely on these forward-looking statements. For a discussion of these and other risks, uncertainties and factors that could cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q for the quarter ended September 30, 2024, filed to the SEC on November 7, 2024, available at www.sec.gov. The forward-looking statements contained herein were made as of the date hereof, and we undertake no obligation to update them after such date, except as required by law.
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contacts
Investor contact:
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
