- Second quarter total revenues of
- Second quarter NUPLAZID® (pimavanserin) net product sales of
- Second quarter DAYBUE® (trofinetide) net product sales of
- Raising low end of NUPLAZID net product sales guidance range to
- Top-line results expected for COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi Syndrome in early Q4 2025
“Acadia continued to build momentum in the second quarter, resulting in total revenue of
Company Updates
- Hosted inaugural R&D Day in June, highlighting nine disclosed programs, with seven Phase 2 or Phase 3 studies expected to initiate during 2025-2026 and five readouts anticipated through 2027, reinforcing momentum behind Acadia’s R&D strategy and pipeline depth.
- Completed enrollment in the COMPASS PWS Phase 3 study of ACP-101 in the second quarter with top-line results expected early in the fourth quarter of 2025.
- Achieved two significant patent litigation wins securing market exclusivity for NUPLAZID; affirming the validity of the composition-of-matter patent for pimavanserin, with an expiry date in 2030, and upholding the formulation patent covering the marketed 34 mg capsule, with an expiry date in 2038.
- Reached new DAYBUE record high with 987 unique patients in the
U.S. receiving a shipment in the second quarter and completed implementation of its planned field force expansion. - Appointed
Allyson McMillan-Youngblood as Senior Vice President, Rare Disease Franchise, bringing extensive commercial and launch experience to lead DAYBUE and Rare franchise expansion. - Appointed
Scott Cenci as Senior Vice President, Chief Information and Data Officer, leading enterprise-wide data, IT, cybersecurity, and analytics to drive innovation and decision-making across the organization. - Commenced named patient supply of trofinetide for eligible patients based upon healthcare professional requests in
Europe ,Israel , and select rest of the world countries.
Financial Results
Revenues
Total revenues comprising 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$1.045 to$1.095 billion , compared with the prior guidance range of$1.030 to$1.095 billion . - NUPLAZID net product sales in the range of
$665 to$690 million , compared with the prior guidance 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 . - 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 second 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 neurological and rare diseases 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,” “guidance,” “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 top-line results for our clinical trials, including the timing of top-line results from our clinical trial in Prader-Willi syndrome, 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 | Six Months Ended | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Revenues | ||||||||||||||||
Product sales, net | $ | 264,566 | $ | 241,963 | $ | 508,882 | $ | 447,794 | ||||||||
Total revenues | 264,566 | 241,963 | 508,882 | 447,794 | ||||||||||||
Operating expenses | ||||||||||||||||
Cost of product sales (1)(2) | 20,734 | 18,230 | 41,126 | 41,181 | ||||||||||||
Research and development (2) | 77,951 | 76,233 | 156,216 | 135,912 | ||||||||||||
Selling, general and administrative (2) | 133,507 | 117,063 | 259,877 | 225,054 | ||||||||||||
Total operating expenses | 232,192 | 211,526 | 457,219 | 402,147 | ||||||||||||
Income from operations | 32,374 | 30,437 | 51,663 | 45,647 | ||||||||||||
Interest income, net | 7,243 | 6,359 | 15,144 | 11,865 | ||||||||||||
Other income | 594 | 386 | 1,183 | 672 | ||||||||||||
Income before income taxes | 40,211 | 37,182 | 67,990 | 58,184 | ||||||||||||
Income tax expense | 13,545 | 3,793 | 22,337 | 8,240 | ||||||||||||
Net income | $ | 26,666 | $ | 33,389 | $ | 45,653 | $ | 49,944 | ||||||||
Earnings per share: | ||||||||||||||||
Basic | $ | 0.16 | $ | 0.20 | $ | 0.27 | $ | 0.30 | ||||||||
Diluted | $ | 0.16 | $ | 0.20 | $ | 0.27 | $ | 0.30 | ||||||||
Weighted average common shares outstanding: | ||||||||||||||||
Basic | 167,827 | 165,551 | 167,321 | 165,174 | ||||||||||||
Diluted | 168,681 | 166,174 | 168,219 | 166,391 | ||||||||||||
(1) Includes license fees and royalties | ||||||||||||||||
(2) Includes the following stock-based compensation expense | ||||||||||||||||
Cost of product sales | $ | 18 | $ | 362 | $ | 352 | $ | 515 | ||||||||
Research and development | $ | 4,477 | $ | 3,749 | $ | 7,910 | $ | 7,842 | ||||||||
Selling, general and administrative | $ | 9,845 | $ | 11,574 | $ | 17,458 | $ | 22,078 | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(in thousands) | ||||||||
|
| |||||||
(unaudited) | ||||||||
Assets | ||||||||
Cash, cash equivalents and investment securities | $ | 761,996 | $ | 755,993 | ||||
Accounts receivable, net | 107,505 | 98,739 | ||||||
Interest and other receivables | 12,181 | 5,956 | ||||||
Inventory | 26,124 | 21,949 | ||||||
Prepaid expenses | 52,747 | 55,681 | ||||||
Total current assets | 960,553 | 938,318 | ||||||
Property and equipment, net | 3,547 | 4,215 | ||||||
Operating lease right-of-use assets | 50,991 | 46,571 | ||||||
Intangible assets, net | 114,338 | 119,782 | ||||||
Restricted cash | 9,471 | 8,770 | ||||||
Long-term inventory | 84,402 | 69,741 | ||||||
Other assets | 2,253 | 359 | ||||||
Total assets | $ | 1,225,555 | $ | 1,187,756 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable | $ | 20,097 | $ | 16,192 | ||||
Accrued liabilities | 309,927 | 378,678 | ||||||
Total current liabilities | 330,024 | 394,870 | ||||||
Operating lease liabilities | 44,601 | 42,037 | ||||||
Other long-term liabilities | 28,548 | 18,056 | ||||||
Total liabilities | 403,173 | 454,963 | ||||||
Total stockholders’ equity | 822,382 | 732,793 | ||||||
Total liabilities and stockholders’ equity | $ | 1,225,555 | $ | 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
Source: