Acadia Pharmaceuticals Announces Closing of Sale of Rare Pediatric Disease Priority Review Voucher for $150 Million

Rhea-AI Summary

Acadia Pharmaceuticals (ACAD) has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million before fees and expenses. Per a previous agreement announced on November 5, 2024, Neuren Pharmaceuticals will receive one-third of the net proceeds. The company plans to utilize the funds to support its commercial operations, R&D programs in central nervous system and rare disease, and future business development.

Acadia specializes in neuroscience breakthroughs and has developed FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. Their clinical-stage pipeline includes programs for Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.

Positive

• Secured $150 million from PRV sale, strengthening cash position
• Funds available for commercial operations and R&D program advancement
• Established commercial products for Parkinson's disease psychosis and Rett syndrome
• Diverse clinical pipeline targeting multiple CNS disorders

Negative

• One-third of net proceeds must be paid to Neuren Pharmaceuticals, reducing actual cash benefit

Insights

Financial Analyst

The $150 million PRV sale represents a significant cash injection for ACAD, strengthening their balance sheet and providing strategic flexibility. After sharing one-third with Neuren, ACAD will retain approximately $100 million for key growth initiatives. This non-dilutive funding will support their commercial operations, particularly the rollout of trofinetide for Rett syndrome and advance their CNS pipeline development. The transaction is particularly well-timed given current market conditions where capital raising can be challenging. This additional liquidity extends their operational runway and reduces near-term financing needs, allowing them to focus on execution rather than fundraising.

Market Research Analyst

The successful sale of the Priority Review Voucher demonstrates strong market demand for these regulatory assets, which can accelerate FDA review timelines. The $150 million price point aligns with recent PRV transactions, suggesting ACAD extracted fair market value. The company's strategic decision to monetize this asset rather than retain it indicates a focus on near-term operational needs and pipeline advancement. The proceeds will help fund their commercial infrastructure and R&D programs in CNS disorders and rare diseases, potentially accelerating their path to additional revenue streams beyond their current approved products.

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million before fees and expenses. As described at the time the agreement to sell was announced on November 5, 2024, Acadia is required to pay Neuren Pharmaceuticals Limited one-third of the net proceeds, pursuant to a license agreement between the companies.

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.

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: 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 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 September 30, 2024 filed with the Securities and Exchange Commission on November 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/20241211326451/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 did ACAD sell its Priority Review Voucher for?

Acadia Pharmaceuticals sold its Rare Pediatric Disease Priority Review Voucher for $150 million before fees and expenses.

What will ACAD do with the proceeds from the PRV sale?

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

How much of the PRV sale proceeds will Neuren Pharmaceuticals receive?

Neuren Pharmaceuticals will receive one-third of the net proceeds from the PRV sale, as per their license agreement with Acadia.

What are ACAD's main FDA-approved products?

Acadia has FDA-approved drugs for treating hallucinations and delusions associated with Parkinson's disease psychosis and for the treatment of Rett syndrome.

What conditions are in ACAD's clinical development pipeline?

Acadia's clinical-stage development pipeline includes programs for Prader-Willi syndrome, Alzheimer's disease psychosis, and other neuropsychiatric symptoms in CNS disorders.