- First quarter total revenues of
- First quarter NUPLAZID® (pimavanserin) net product sales of
- First quarter DAYBUE® (trofinetide) net product sales of
- Reiterates full year 2025 revenue guidance including DAYBUE net sales of
- Accelerated timing for COMPASS PWS Phase 3 study of ACP-101 in Prader Willi Syndrome, topline results now expected in early Q4 2025
“2025 is off to a strong start for Acadia, achieving total revenue of
Company Updates
- During the first quarter, the Company reached a record high with 954 unique patients receiving a DAYBUE shipment.
- In May, the Company completed its planned 30% expansion of the DAYBUE field force to support broader engagement with healthcare professionals that treat Rett syndrome patients.
- In April, the first shipment of DAYBUE was made to a Rett syndrome patient in the
European Union under Acadia’s managed access program. - As a result of favorable enrollment trends in the COMPASS PWS Phase 3 study of ACP-101 (intranasal carbetocin) in Prader Willi Syndrome, the Company now expects topline results from the study early in the fourth quarter of 2025. If results are positive, the Company anticipates submitting a New Drug Application to the
U.S. Food and Drug Administration in the first quarter of 2026.
Financial Results
Revenues
Total revenues comprising of net product sales from NUPLAZID and DAYBUE were
Net product sales of NUPLAZID were
Net product sales of DAYBUE were
Research and Development
Research and development expenses were
Selling, General and Administrative
Selling, general and administrative expenses were
Net Income
For the three months ended
Cash and Investments
At
Full Year 2025 Financial Guidance
Acadia is reiterating its 2025 guidance that was provided on
- Total Revenues (
U.S. only) of$1.03 to$1.095 billion . - NUPLAZID net product sales in the range of
$650 to$690 million . - DAYBUE net product sales (
U.S. only) in the range of$380 to$405 million . - R&D expense in the range of
$330 to$350 million , up from prior guidance range of$310 to$330 million primarily due to the acceleration of the ACP-101 Phase 3 study timeline. - SG&A expense in the range of
$535 to$565 million .
Conference Call and Webcast Information
Acadia will host a conference call to discuss the first quarter 2025 results today,
About NUPLAZID® (pimavanserin)
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the
About DAYBUE® (trofinetide)
Trofinetide is a synthetic version of a naturally occurring molecule known as the tripeptide glycine-proline-glutamate (GPE). The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. Trofinetide was approved for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older by the
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
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 “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” “continue” 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) our business strategy, objectives and opportunities, including support for and innovations in our pipeline assets and business development opportunities, investments in consumer activation, expansion of our DAYBUE sales force in the US, and building of our EU commercial team, and potential for enhanced shareholder value; (ii) plans for, including timing, development and progress of commercialization or regulatory timelines for our products, including NUPLAZID and DAYBUE, and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of our products; (iv) the timing and conduct of and topline results for our clinical trials, including the timing of topline results from our clinical trial in Prader-Willi syndrome, the continuing enrollment in our clinical trials in Alzheimer’s disease psychosis, the initiation of our clinical trial in Lewy Body Dementia Psychosis, and the timing and content of our presentations or announcements regarding our clinical trials; (v) our estimates regarding our future financial performance, profitability, capital requirements or expenses, including our full year 2025 financial guidance, and (vi) our ability to successfully complete additional business development transactions. 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 and other factors include, but are not limited to: our dependency on the continued successful commercialization of our products and our ability to maintain or increase sales of our products; our plans to commercialize DAYBUE globally and trofinetide in the EU; the costs of our commercialization plans and development programs, and the financial impact or revenues 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; the 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 competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance 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 refer to our annual report on Form 10-K for the year ended
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(in thousands, except per share amounts) | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
2025 | 2024 | |||||||
Revenues | ||||||||
Product sales, net | $ | 244,317 | $ | 205,831 | ||||
Total revenues | 244,317 | 205,831 | ||||||
Operating expenses | ||||||||
Cost of product sales (1)(2) | 20,392 | 22,951 | ||||||
Research and development (2) | 78,265 | 59,679 | ||||||
Selling, general and administrative (2) | 126,370 | 107,991 | ||||||
Total operating expenses | 225,027 | 190,621 | ||||||
Income from operations | 19,290 | 15,210 | ||||||
Interest income, net | 7,901 | 5,506 | ||||||
Other income | 588 | 286 | ||||||
Income before income taxes | 27,779 | 21,002 | ||||||
Income tax expense | 8,792 | 4,447 | ||||||
Net income | $ | 18,987 | $ | 16,555 | ||||
Earnings per share: | ||||||||
Basic | $ | 0.11 | $ | 0.10 | ||||
Diluted | $ | 0.11 | $ | 0.10 | ||||
Weighted average common shares outstanding: | ||||||||
Basic | 166,808 | 164,798 | ||||||
Diluted | 167,668 | 166,623 | ||||||
(1) Includes license fees and royalties | ||||||||
(2) Includes the following stock-based compensation expense | ||||||||
Cost of product sales, license fees and royalties | $ | 334 | $ | 153 | ||||
Research and development | $ | 3,433 | $ | 4,093 | ||||
Selling, general and administrative | $ | 7,613 | $ | 10,504 | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(in thousands) | ||||||||
|
| |||||||
(unaudited) | ||||||||
Assets | ||||||||
Cash, cash equivalents and investment securities | $ | 681,577 | $ | 755,993 | ||||
Accounts receivable, net | 105,743 | 98,739 | ||||||
Interest and other receivables | 7,971 | 5,956 | ||||||
Inventory | 22,948 | 21,949 | ||||||
Prepaid expenses | 52,703 | 55,681 | ||||||
Total current assets | 870,942 | 938,318 | ||||||
Property and equipment, net | 3,498 | 4,215 | ||||||
Operating lease right-of-use assets | 50,614 | 46,571 | ||||||
Intangible assets, net | 117,060 | 119,782 | ||||||
Restricted cash | 8,770 | 8,770 | ||||||
Long-term inventory | 80,025 | 69,741 | ||||||
Other assets | 1,455 | 359 | ||||||
Total assets | $ | 1,132,364 | $ | 1,187,756 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable | $ | 18,095 | $ | 16,192 | ||||
Accrued liabilities | 284,435 | 378,678 | ||||||
Total current liabilities | 302,530 | 394,870 | ||||||
Operating lease liabilities | 44,634 | 42,037 | ||||||
Other long-term liabilities | 19,963 | 18,056 | ||||||
Total liabilities | 367,127 | 454,963 | ||||||
Total stockholders’ equity | 765,237 | 732,793 | ||||||
Total liabilities and stockholders’ equity | $ | 1,132,364 | $ | 1,187,756 | ||||
Investor Contact:
(858) 261-2872
ir@acadia-pharm.com
(858) 261-2950
ir@acadia-pharm.com
Media Contact:
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com
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