Acadia Pharmaceuticals Enters Into an Agreement to Sell its Rare Pediatric Disease Priority Review Voucher for $150 Million

Rhea-AI Summary

Acadia Pharmaceuticals (Nasdaq: ACAD) has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million. The PRV was granted in March 2023 following FDA approval of DAYBUE™ for Rett syndrome treatment. Under a previous license agreement with Neuren Pharmaceuticals, Acadia must pay one-third of the net proceeds to Neuren. The company plans to use the proceeds to support commercial operations, R&D programs in central nervous system and rare disease, and future business development. The transaction is subject to customary closing conditions, including HSR Antitrust Act requirements.

Positive

• Sale of Priority Review Voucher for $150 million strengthens cash position
• Proceeds will fund commercial operations and R&D programs
• Strategic monetization of non-core asset

Negative

• One-third of proceeds must be paid to Neuren Pharmaceuticals, reducing net benefit to $100 million

Insights

Financial Analyst

The $150 million PRV sale represents a significant cash injection for ACAD, strengthening their balance sheet and providing strategic flexibility. After paying $50 million to Neuren per the license agreement, ACAD will retain $100 million for key business initiatives. This transaction is particularly valuable given ACAD's focus on expensive CNS drug development and commercialization efforts.

The PRV market has remained robust, with vouchers typically selling between $100-200 million. This price point aligns with recent market trends and represents fair value. The additional capital will help fund DAYBUE's commercial rollout and advance their pipeline, including promising programs in Prader-Willi syndrome and Alzheimer's disease psychosis, potentially reducing the need for dilutive financing in the near term.

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction.

Acadia was granted the PRV in March 2023 following approval by the U.S. Food and Drug Administration (FDA) of DAYBUE™ (trofinetide) for the treatment of Rett syndrome. DAYBUE was initially licensed by Acadia from Neuren Pharmaceuticals Limited in August 2018. Pursuant to the license agreement, Acadia is required to pay Neuren one-third of the net proceeds.

Acadia plans to invest proceeds from the sale of the PRV to support its commercial operations, R&D programs in central nervous system and rare disease, and future business development.

The transaction is subject to customary closing conditions, including expiration of applicable waiting period under the Hart-Scott Rodino (HSR) Antitrust Improvements Act. Jefferies LLC acted as financial advisor to Acadia on this transaction.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple 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 can be identified by terms such as “intends,” “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) the closing of the transaction and any expectations with respect to the timing for such closing, (ii) HSR clearance of the transaction and the timing of any such clearance, and (iii) the use of the proceeds from the transaction. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may 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, assumptions and other factors include, but are not limited to: our ability to satisfy or waive all required closing conditions for the transaction and ultimately close the transaction, our ability to obtain HSR clearance in a timely manner or at all, our ability to successfully deploy the proceeds of the transaction as anticipated, our ability to continue to successfully commercialize DAYBUE, the timing, enrollment and results of ongoing and future clinical trials and our ability to continue to stay in compliance with applicable laws and regulations. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission on August 7, 2024, as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241105089742/en/

Investor Contact:

Acadia Pharmaceuticals Inc.

Al Kildani

(858) 261-2872

ir@acadia-pharm.com

Media Contact:

Acadia Pharmaceuticals Inc.

Deb Kazenelson

(818) 395-3043

media@acadia-pharm.com

Source: Acadia Pharmaceuticals Inc.

FAQ

How much is Acadia Pharmaceuticals (ACAD) selling its Priority Review Voucher for?

Acadia Pharmaceuticals is selling its Rare Pediatric Disease Priority Review Voucher for $150 million.

When did ACAD receive the Priority Review Voucher being sold?

Acadia received the Priority Review Voucher in March 2023 following FDA approval of DAYBUE for Rett syndrome treatment.

How will Acadia (ACAD) use the proceeds from the PRV sale?

Acadia plans to use the proceeds to support commercial operations, R&D programs in central nervous system and rare disease, and future business development.

What portion of the PRV sale proceeds must ACAD share with Neuren Pharmaceuticals?

According to the license agreement, Acadia must pay one-third of the net proceeds to Neuren Pharmaceuticals.