Form 8-K

8-K — ACADIA PHARMACEUTICALS INC

Accession: 0001193125-26-332858

Filed: 2026-08-04

Period: 2026-08-04

CIK: 0001070494

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — acad-20260804.htm (Primary)

EX-99.1 (acad-ex99_1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: acad-20260804.htm · Sequence: 1

8-K

0001070494false00010704942026-08-042026-08-04

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, 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 04, 2026

Acadia Pharmaceuticals Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

000-50768

06-1376651

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

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

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 4, 2026, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the six months ended June 30, 2026. 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

Number

Description

99.1

Press Release dated August 4, 2026.

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 4, 2026

By:

/s/ Jennifer J. Rhodes

Jennifer J. Rhodes

Executive Vice President, Chief Legal Officer

EX-99.1

Filename: acad-ex99_1.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Acadia Pharmaceuticals Reports Second Quarter 2026 Financial Results

- Second quarter DAYBUE® GAAP net sales of $125 million, up 30% year-over-year driven by strong uptake of DAYBUE STIX

- Second quarter NUPLAZID® GAAP net sales of $183 million, up 10% year-over-year on a non-GAAP adjusted basis

- Increased full year 2026 total revenue guidance to $1.24 to $1.30 billion, reflecting higher DAYBUE guidance of $480 to $510 million and reaffirmed NUPLAZID guidance of $760 to $790 million

- Topline results from the Phase 2 remlifanserin study in Alzheimer’s disease psychosis anticipated September to October 2026

SAN DIEGO, CA, August 4, 2026 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the second quarter ended June 30, 2026.

“Acadia delivered an outstanding second quarter, highlighted by strong commercial execution across both DAYBUE and NUPLAZID, resulting in total revenue growth of 17% year-over-year on an adjusted basis,” said Catherine Owen Adams, Chief Executive Officer of Acadia. “For DAYBUE, continued patient demand and robust uptake of STIX drove another quarter of strong performance. For NUPLAZID, we continued to see strong momentum, especially in new-to-brand prescriptions as our recently expanded sales force gained traction in the field. We remain confident that both franchises are on track to achieve our long-term ambition of approximately $1.7 billion in annual net sales in 2028. Looking ahead, we are excited about the anticipated topline results from our Phase 2 program evaluating remlifanserin in Alzheimer's disease psychosis in the September to October timeframe, which we believe represents a potentially transformational opportunity for Acadia.”

Company Updates

•

Completed enrollment in the Phase 2 portion of the RADIANT program evaluating remlifanserin in Alzheimer's disease psychosis and initiated Phase 3 screening and enrollment; topline Phase 2 results are expected in September to October 2026.

•

Received FDA Fast Track designation for remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis, recognizing its potential to address a significant unmet medical need.

•

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If approved by the European Commission, DAYBU would become the first authorized treatment for Rett syndrome in the European Union.

Financial Results

Revenues

GAAP total revenues, comprised of net product sales from NUPLAZID and DAYBUE, were $308 million for the second quarter of 2026, up 16% as compared to GAAP total revenues of $265 million in

the second quarter of 2025, and up 17% as compared to non-GAAP adjusted total revenues of $262 million in the second quarter of 2025.

GAAP net product sales of NUPLAZID were $183 million for the second quarter of 2026, up 9% compared to GAAP net product sales of $168 million for the second quarter of 2025, and up 10% as compared to non-GAAP adjusted net product sales of $166 million for the second quarter of 2025.

Net product sales of DAYBUE were $125 million for the second quarter of 2026, an increase of 30% as compared to $96 million for the second quarter of 2025.

A reconciliation of NUPLAZID non-GAAP adjusted net product sales and non-GAAP adjusted total revenues is provided in Table 1. A description of these adjustments is included under ‘Non-GAAP Financial Measures.’

Research and Development

Research and development expenses for the second quarter of 2026 were $82 million, compared to $78 million for the same period of 2025.

Selling, General and Administrative

Selling, general and administrative expenses for the second quarter of 2026 were $160 million, compared to $134 million for the same period of 2025.

Net Income

For the second quarter of 2026, Acadia reported net income of $32 million, or $0.18 per diluted share, compared to a net income of $27 million, or $0.16 per diluted share, for the same period in 2025.

Cash and Investments

At June 30, 2026, Acadia’s cash, cash equivalents, and investment securities totaled $956 million, compared to $820 million at December 31, 2025.

Full Year 2026 Financial Guidance (GAAP):

Acadia is updating its 2026 guidance:

•

Total revenues revised to a range of $1.24 to $1.30 billion, up from the previous range of $1.22 to $1.28 billion.

•

NUPLAZID net product sales in the range of $760 to $790 million.

•

DAYBUE (including all forms of trofinetide) global net product sales in the range of $480 to $510 million, up from the previous range of $460 to $490 million.

•

R&D expense in the range of $355 to $380 million, down from the previous range of $385 to $410 million.

•

SG&A expense in the range of $660 to $700 million.

Conference Call and Webcast Information

Acadia will host a conference call to discuss the second quarter 2026 results today, Tuesday, August 4, 2026 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 or DAYBUE STIX.

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X.

Non-GAAP Financial Measures

This press release contains the following financial measures that do not comply with U.S. generally accepted accounting principles (GAAP): non-GAAP adjusted net product sales for NUPLAZID for the second quarter of 2025 and non-GAAP adjusted total revenues for the second quarter of 2025. In preparing these non-GAAP financial results, the Company includes adjustments made to reflect the impact of a change in estimate related to NUPLAZID IRA rebate accruals. Please refer to our press release dated February 25, 2026, for additional details. These non-GAAP financial measures complement GAAP results and are used by management to analyze financial performance and evaluate period-to-period changes. Management believes these non-GAAP financial measures are useful to investors and other users of the Company’s financial statements to facilitate period-to-period comparability. These non-GAAP financial measures are not meant to be considered as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are unlikely to be comparable with non-GAAP disclosures released by other companies.

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, sales growth for DAYBUE and uptake in DAYBUE STIX, and potential for enhanced shareholder value; (ii) the momentum and expectations for NUPLAZID with the expanded sales force, (iii) the FDA’s potential review of a new drug application for remlifanserin as a treatment for Alzheimer’s disease psychosis, (iv) the receipt and timing of the topline results of the RADIANT Phase 2 study, the transformational opportunity of those

results, and the enrollment of the Phase 3 portion of the RADIANT development program, (v) potential approval of DAYBU (trofinetide) in the European Union, (vi) plans for, including timing, development and progress of commercialization or regulatory timelines for our products and our product candidates; (vii) benefits to be derived from and efficacy of our products, including the potential advantages of our products; and (viii) our estimates regarding our future financial performance, profitability, capital requirements or expenses, including our full year 2026 financial guidance and anticipated net product sales by the end of 2028. 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; the success of our plans to continue commercial growth; 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, 2025 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.

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,

2026

2025

2026

2025

Revenues

Product sales, net

307,959

264,566

576,021

508,882

Total revenues

307,959

264,566

576,021

508,882

Operating expenses

Cost of product sales (1)(2)

28,316

20,734

53,107

41,126

Research and development (2)

81,555

77,951

158,423

156,216

Selling, general and administrative (2)

160,252

133,507

331,271

259,877

Total operating expenses

270,123

232,192

542,801

457,219

(Loss) income from operations

37,836

32,374

33,220

51,663

Interest income, net

7,990

7,243

16,045

15,144

Other income

647

594

1,189

1,183

Income before income taxes

46,473

40,211

50,454

67,990

Income tax expense

14,973

13,545

15,317

22,337

Net income

31,500

26,666

35,137

45,653

Earnings per share:

Basic

0.18

0.16

0.21

0.27

Diluted

0.18

0.16

0.20

0.27

Weighted average common shares outstanding:

Basic

171,603

167,827

171,063

167,321

Diluted

172,851

168,681

172,890

168,219

(1) Includes license fees and royalties

(2) Includes the following stock-based compensation expense

Cost of product sales

510

838

352

Research and development

4,746

4,477

8,888

7,910

Selling, general and administrative

11,684

9,845

21,912

17,458

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

June 30,

2026

December 31,

2025

(unaudited)

Assets

Cash, cash equivalents and investment securities

956,474

819,686

Accounts receivable, net

150,642

121,457

Interest and other receivables

15,688

26,774

Inventory

32,372

34,670

Prepaid expenses and other current assets

69,369

59,526

Total current assets

1,224,545

1,062,113

Property and equipment, net

17,107

7,511

Operating lease right-of-use assets

69,424

47,354

Intangible assets, net

103,448

108,893

Restricted cash

7,846

7,845

Long-term inventory

76,301

76,704

Deferred tax assets

240,679

249,879

Other assets

3,550

3,896

Total assets

1,742,900

1,564,195

Liabilities and stockholders’ equity

Accounts payable

44,566

10,903

Accrued liabilities

316,870

266,211

Total current liabilities

361,436

277,114

Operating lease liabilities

59,547

40,554

Other long-term liabilities

15,308

19,137

Total liabilities

436,291

336,805

Total stockholders’ equity

1,306,609

1,227,390

Total liabilities and stockholders’ equity

1,742,900

1,564,195

Table 1. ACADIA PHARMACEUTICALS INC.

NON-GAAP RECONCILIATION

(in millions)

(Unaudited)

2Q25

2Q26

GAAP NUPLAZID Net Sales

168.5

183.2

Allocation of 2025 Amount

(2.4

)

—

Non-GAAP Adjusted NUPLAZID Net Sales

166.1

183.2

DAYBUE products Net Sales

96.1

124.8

Non-GAAP Adjusted Total Revenues

262.2

308.0

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

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dei_TradingSymbol

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

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dei_WrittenCommunications

Namespace Prefix:

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Data Type:

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Period Type:

duration