ACAD Acadia Pharmaceuticals Inc

 

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): February 26, 2025

 

 

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:

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On February 26, 2025, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2024. 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 February 26, 2025.
104		Cover page Interactive Data File (embedded within the Inline XBRL document).

 

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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:	February 26, 2025	By:	/s/ Jennifer J. Rhodes
			Jennifer J. Rhodes Executive Vice President, Chief Legal Officer

 

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Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operating Overview

 

- 2024 total net product sales of $957.8 million, reflecting 32% revenue growth

 

- Fourth quarter DAYBUE™ (trofinetide) net product sales of $96.7 million and full year 2024 net product sales of $348.4 million

 

- Fourth quarter NUPLAZID® (pimavanserin) net product sales of $162.9 million and full year 2024 net product sales of $609.4 million

 

- Full year 2025 total revenue guidance of $1.03 to $1.095 billion including DAYBUE net sales guidance of $380 to $405 million and NUPLAZID net sales guidance of $650 to $690 million

 

 

SAN DIEGO, CA, February 26, 2025 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the fourth quarter and full year ended December 31, 2024.

 

“We closed 2024 on a strong note with each of our brands achieving record revenues in the fourth quarter and well-positioned for continued growth in 2025,” said Catherine Owen Adams, Chief Executive Officer. “To support this growth in 2025 we will continue investing in consumer activation to drive market share expansion for NUPLAZID in the US. We plan to expand our DAYBUE field force in the US and build our EU commercial team in anticipation of potentially launching trofinetide there next year. Beyond the growth of our commercial brands, our later-stage pipeline programs are advancing toward key milestones, including topline readouts starting in the first half of 2026, and our ongoing business development efforts continue to produce compelling opportunities like ACP-711 and other programs that we are excited to share more about at our inaugural R&D Day in June.”

 

 

Company Updates

 

 

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Financial Results

 

Revenues

Total revenues, comprised of net product sales from NUPLAZID and DAYBUE, were $259.6 million for the fourth quarter of 2024 and $957.8 million for the full year 2024.

 

Net product sales of NUPLAZID were $162.9 million for the fourth quarter of 2024, an increase of 13% as compared to $143.9 million for the fourth quarter of 2023. Net product sales of NUPLAZID were $609.4 million for the full year 2024, an increase of 11% as compared to $549.2 million for the full year 2023. The increase in net product sales of NUPLAZID was due to growth in unit sales and a higher average net selling price in 2024 compared to 2023.

 

Net product sales of DAYBUE were $96.7 million for the fourth quarter of 2024, an increase of 11% as compared to $87.1 million for the fourth quarter of 2023. Net product sales of DAYBUE were $348.4 million for the full year 2024, an increase of 97% as compared to $177.2 million for the full year 2023. The increase in net product sales of DAYBUE was mainly due to the growth in unit sales in 2024 compared to 2023.

Research and Development

Research and development expenses for the fourth quarter of 2024 were $100.7 million, compared to $66.7 million for the same period of 2023. For the full years of 2024 and 2023, research and development expenses were $303.2 million and $351.6 million, respectively. The decrease in research and development expenses during 2024 was due to decreased business development payments, which in the period ending December 31, 2023 included the $100.0 million payment to Neuren Pharmaceutical Limited under the expanded license agreement for trofinetide, partially offset by increased costs from clinical stage programs.

 

Selling, General and Administrative

Selling, general and administrative expenses for the fourth quarter of 2024 were $130.1 million, compared to $111.5 million for the same period of 2023. For the full years of 2024 and 2023, selling, general and administrative expenses were $488.4 million and $406.6 million, respectively. The increase in selling, general and administrative expenses was primarily driven by increased marketing costs to support the NUPLAZID and DAYBUE franchises in the U.S. and investments to support commercialization of trofinetide outside the U.S.

 

Net Income (Loss)

For the fourth quarter of 2024, Acadia reported net income of $143.7 million, or $0.86 per common share, compared to a net income of $45.8 million, or $0.28 per common share, for the same period in 2023. Net income for the fourth quarters of 2024 and 2023 included $10.5 million and $18.0 million, respectively, of non-cash stock-based compensation expense. For the full year 2024, Acadia reported a net income of $226.5 million, or $1.37 per common share, compared to a net loss of $61.3 million, or $0.37 per common share, for the same period in 2023. Net income in the fourth quarter and for the full year of 2024 included a one-time gain on sale of a non-financial asset as we sold the PRV to a third party for the

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aggregate net proceeds of $146.5 million. The net income and loss for the full years of 2024 and 2023 included $67.0 million and $66.4 million, respectively, of non-cash stock-based compensation expense.

 

Cash and Investments

At December 31, 2024, Acadia’s cash, cash equivalents, and investment securities totaled $756.0 million, compared to $438.9 million at December 31, 2023.

 

Full Year 2025 Financial Guidance

 

 

Conference Call and Webcast Information

Acadia will host a conference call to discuss the fourth quarter and full year December 31, 2024 results today, Wednesday, February 26, 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 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 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

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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 our clinical trials, including continued enrollment of our clinical trials in Prader-Willi syndrome and 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 or capital requirements, 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 in Canada 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 quarterly report on Form 10-Q for the quarter ended September 30, 2024, filed 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.

 

 

 

 

 

 

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ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(Unaudited)

 

		Three Months Ended December 31,								Years Ended December 31,
		2024				2023				2024				2023
Revenues
Product sales, net		$	259,602			$	231,041			$	957,797			$	726,437
Total revenues			259,602				231,041				957,797				726,437
Operating expenses
Cost of product sales (1)(2)			21,803				17,891				81,841				41,638
Research and development (2)			100,731				66,741				303,249				351,619
Selling, general and administrative (2)			130,080				111,465				488,428				406,559
Gain on sale of non-financial asset			(146,515	)			—				(146,515	)			—
Total operating expenses			106,099				196,097				727,003				799,816
Income (loss) from operations			153,503				34,944				230,794				(73,379	)
Interest income, net			7,007				4,759				25,458				17,234
Other income			575				—				1,823				5,109
Income (loss) before income taxes			161,085				39,703				258,075				(51,036	)
Income tax expense (benefit)			17,343				(6,094	)			31,624				10,250
Net income (loss)		$	143,742			$	45,797			$	226,451			$	(61,286	)
Earnings (net loss) per share:
Basic		$	0.86			$	0.28			$	1.37			$	(0.37	)
Diluted		$	0.86			$	0.28			$	1.36			$	(0.37	)
Weighted average common shares outstanding:
Basic			166,535				164,812				165,717				163,819
Diluted			166,696				166,510				166,362				163,819
(1) Includes license fees and royalties
(2) Includes the following share-based compensation expenses
Cost of product sales, license fees and royalties		$	421			$	363			$	1,319			$	1,007
Research and development		$	2,395			$	4,707			$	14,100			$	17,408
Selling, general and administrative		$	7,634			$	12,953			$	51,630			$	48,006

 

 

 

 

 

 

 

 

 

 

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ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

 

		December 31, 2024				December 31, 2023
Assets
Cash, cash equivalents and investment securities		$	755,993			$	438,865
Accounts receivable, net			98,739				98,267
Interest and other receivables			5,956				4,083
Inventory			21,949				35,819
Prepaid expenses			55,681				39,091
Total current assets			938,318				616,125
Property and equipment, net			4,215				4,612
Operating lease right-of-use assets			46,571				51,855
Intangible assets, net			119,782				65,490
Restricted cash			8,770				5,770
Long-term inventory			69,741				4,628
Other assets			359				476
Total assets		$	1,187,756			$	748,956
Liabilities and stockholders’ equity
Accounts payable		$	16,192			$	17,543
Accrued liabilities			378,678				236,711
Total current liabilities			394,870				254,254
Operating lease liabilities			42,037				47,800
Other long-term liabilities			18,056				15,147
Total liabilities			454,963				317,201
Total stockholders’ equity			732,793				431,755
Total liabilities and stockholders’ equity		$	1,187,756			$	748,956

 

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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

 

 

 

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v3.25.0.1

Document And Entity Information	Feb. 26, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 26, 2025
Entity Registrant Name	Acadia Pharmaceuticals Inc.
Entity Central Index Key	0001070494
Entity Emerging Growth Company	false
Entity File Number	000-50768
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	06-1376651
Entity Address, Address Line One	12830 El Camino Real, Suite 400
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92130
City Area Code	(858)
Local Phone Number	558-2871
Entity Information, Former Legal or Registered Name	N/A
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	ACAD
Security Exchange Name	NASDAQ

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