8-K
ACADIA PHARMACEUTICALS INC (ACAD)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
| Date of Report (Date of earliest event reported): August 06, 2025 |
|---|
Acadia Pharmaceuticals Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 000-50768 | 06-1376651 |
|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| 12830 El Camino Real, Suite 400 | ||
| San Diego, California | 92130 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
| Registrant’s Telephone Number, Including Area Code: (858) 558-2871 | ||
| --- | ||
| N/A | ||
| --- |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | ACAD | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 6, 2025, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the three and six months ended June 30, 2025. A copy of this press release is furnished herewith as Exhibit 99.1. Pursuant to the rules and regulations of the Securities and Exchange Commission, such exhibit and the information set forth therein and in this Item 2.02 have been furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing regardless of any general incorporation language.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit<br>Number | Description |
|---|---|
| 99.1 | Press Release dated August 6, 2025. |
| 104 | Cover page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Acadia Pharmaceuticals Inc. | |||
|---|---|---|---|
| Date: | August 6, 2025 | By: | /s/ Jennifer J. Rhodes |
| Jennifer J. Rhodes<br>Executive Vice President, Chief Legal Officer & Secretary |
EX-99.1
Exhibit 99.1
Acadia Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operating Overview
Second quarter total revenues of $264.6 million, up 9% year-over-year
Second quarter NUPLAZID® (pimavanserin) net product sales of $168.5 million, up 7% year-over-year
Second quarter DAYBUE® (trofinetide) net product sales of $96.1 million, up 14% year-over-year
Raising low end of NUPLAZID net product sales guidance range to $665 to $690 million; reiterating all other prior 2025 guidance
Top-line results expected for COMPASS PWS Phase 3 study of ACP-101 in Prader Willi Syndrome in early Q4 2025
SAN DIEGO, CA, August 6, 2025 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the second quarter ended June 30, 2025.
“Acadia continued to build momentum in the second quarter, resulting in total revenue of $264.6 million,” said Catherine Owen Adams, Chief Executive Officer. “NUPLAZID delivered a very strong quarter, particularly in terms of referrals and new patient starts, driven by strong commercial execution and increased engagement from our direct-to-consumer campaigns. DAYBUE grew 14% year-over-year and reached its highest paid patient count to date, reflecting disciplined execution of our plan to accelerate growth. In addition, we recently hosted our inaugural R&D Day showcasing the depth of our pipeline and its potential to drive our long-term value.”
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 of net product sales from NUPLAZID and DAYBUE were $264.6 million, up 9% from the second quarter of 2024.
Net product sales of NUPLAZID were $168.5 million in the second quarter of 2025, an increase of 7% as compared to $157.4 million for the second quarter of 2024. The 7% year-over-year increase in net product sales of NUPLAZID included 5% volume growth in 2025 compared to 2024.
Net product sales of DAYBUE were $96.1 million for the second quarter of 2025, an increase of 14% as compared to $84.6 million for the second quarter of 2024. The increase in net product sales of DAYBUE was primarily due to the growth in unit sales as the Company shipped to more unique patients.
Research and Development
Research and development expenses were $78.0 million, compared to $76.2 million for the three months ended June 30, 2025, and 2024, respectively.
Selling, General and Administrative
Selling, general and administrative expenses were $133.5 million and $117.1 million for the three months ended June 30, 2025, and 2024, respectively. The increase was primarily driven by increased expenditures for both DAYBUE and NUPLAZID in the U.S., including the planned expansion of the DAYBUE commercial team.
Net Income
For the three months ended June 30, 2025, Acadia reported net income of $26.7 million, or $0.16 per common share, compared to net income of $33.4 million, or $0.20 per common share, for the same period in 2024. The decline in net income primarily reflects an increase in pre-tax income, which was more than offset by a higher effective tax rate. This higher tax rate was largely driven by reduced utilization of tax credits and net operating loss carryforwards under U.S. GAAP.
Cash and Investments
At June 30, 2025, Acadia’s cash, cash equivalents and investment securities totaled $762.0 million, compared to $756.0 million at December 31, 2024.
Full Year 2025 Financial Guidance
Acadia is reiterating its 2025 guidance that was provided on May 7, 2025 with the exception of raising the low end of the guidance range for NUPLAZID net product sales and the related impact on guidance for total revenues:
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, Wednesday, August 6, 2025 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed by registering for the call here. Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call.
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 U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID.
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 U.S. Food and Drug Administration in March 2023 under the trade name DAYBUE.
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 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 neuroscience and neuro-rare diseases. 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 “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 December 31, 2024 as well as our subsequent filings with the Securities and Exchange Commission from time to time, including our quarterly report on Form 10-Q for the quarter ended June 30, 2025. 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.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 |
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| June 30,<br>2025 | December 31,<br>2024 | |||
|---|---|---|---|---|
| (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:
Acadia Pharmaceuticals Inc.
Al Kildani
(858) 261-2872
ir@acadia-pharm.com
Acadia Pharmaceuticals Inc.
Jessica Tieszen
(858) 261-2950
ir@acadia-pharm.com
Media Contact:
Acadia Pharmaceuticals Inc.
Deb Kazenelson (818) 395-3043
media@acadia-pharm.com