8-K

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): May 08, 2023

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 May 8, 2023, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the three months ended March 31, 2023. 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 May 8, 2023.
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:	May 8, 2023	By:	/s/ Austin D. Kim
			Austin D. Kim Executive Vice President, General Counsel & Secretary

EX-99

Exhibit 99.1

Acadia Pharmaceuticals Reports

First Quarter 2023 Financial Results and Operating Overview

- 1Q23 NUPLAZID® net sales of $118.5 million

- Announced the U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adult and Pediatric Patients Two Years of Age and Older on March 10, 2023

- Announced DAYBUE Availability on April 17, 2023

SAN DIEGO, CA, May 8, 2023 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the first quarter ended March 31, 2023.

“We are excited with the recent approval and subsequent launch of DAYBUE, the first and only FDA-approved medicine for the treatment of Rett syndrome. We are executing on our launch strategy to bring this important new treatment to the Rett patient community, while remaining focused on delivering increasing profitability from our NUPLAZID franchise for Parkinson’s disease psychosis,” said Steve Davis, Chief Executive Officer. “In addition to our commercial business, we’ve made important strides in our pipeline including completion of the Phase 1 development program for ACP-204. And finally, we are nearing enrollment completion of the Phase 3 program for pimavanserin as a potential treatment for the negative symptoms of schizophrenia with top-line results expected in early 2024.”

Company Operational, Scientific, and Regulatory Updates

•On March 10, 2023, DAYBUE™ (trofinetide) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.

•In connection with the FDA approval of DAYBUE, Acadia received a Rare Pediatric Disease Priority Review Voucher.

•Announced DAYBUE availability on April 17, 2023.

•The Company expects to complete enrollment in ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia, around mid-year with top-line results expected in early 2024.

•ACP-204 has completed Phase 1 development. ACP-204 demonstrated a favorable safety and tolerability profile and we identified the doses we plan to evaluate in Phase 2. The Phase 1 data supports ACP-204’s target product profile as a potential treatment for Alzheimer’s disease psychosis. Acadia plans to meet with the FDA to discuss the clinical development plan.

Financial Results

Revenue

Net sales of NUPLAZID® were $118.5 million for the three months ended March 31, 2023, an increase of 3% as compared to $115.5 million reported for the three months ended March 31, 2022. Year over year demand growth was up approximately 2% in the quarter, driven by an increase in new patient starts across both specialty pharmacy and specialty distribution channels. Overall sell-in volume declined approximately 2% year over year as in-channel inventory declined in the first quarter of 2023 compared to an increase in in-channel inventory in the first quarter of 2022.

Research and Development

Research and development expenses for the three months ended March 31, 2023 were $69.1 million, compared to $128.9 million for the same period of 2022. The decrease was primarily due to a $60 million upfront payment made to Stoke Therapeutics for a license and collaboration agreement in the first quarter of 2022.

Selling, General and Administrative

Selling, general and administrative expenses for the three months ended March 31, 2023 were $101.2 million, compared to $96.7 million for the same period of 2022. Selling, general and administrative expense remained relatively steady year over year as a result of a reduction in spend in the PDP commercial franchise which was offset by investments in the DAYBUE launch.

Net Loss

For the three months ended March 31, 2023, Acadia reported a net loss of $43.0 million, or $0.27 per common share, compared to a net loss of $113.1 million, or $0.70 per common share, for the same period in 2022. The difference was primarily due to the $60 million upfront payment made to Stoke Therapeutics for a license and collaboration agreement. The net losses for the three months ended March 31, 2023 and 2022 included $14.7 million and $15.0 million, respectively, of non-cash stock-based compensation expense.

Cash and Investments

At March 31, 2023, Acadia’s cash, cash equivalents, and investment securities totaled $402.9 million, compared to $416.8 million at December 31, 2022.

2023 Financial Guidance

Acadia is reiterating all of its 2023 guidance provided on February 27, 2023.

•NUPLAZID net sales in the range of $520 to $550 million.

•R&D expense in the range of $235 to $255 million, which includes approximately $20 million of stock-based compensation expense.

•SG&A expense in the range of $360 to $380 million, which includes approximately $45 million of stock-based compensation expense.

Conference Call and Webcast Information

The conference call will be available on Acadia’s website, www.acadia.comunder the investors section and will be archived there until June 7, 2023. The conference call may also 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. In addition, Acadia is developing pimavanserin as a potential treatment for the negative symptoms of schizophrenia.

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. In animal studies, trofinetide has been shown to increase branching of dendrites and synaptic plasticity signals.1,2 More information can be found at DAYBUE.com.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. For almost 30 years 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 approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia.com and follow us on LinkedInand Twitter.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia’s annual report on Form 10-K for the year ended December 31, 2022 as well as Acadia’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

References

1 Tropea D, Giacometti E, Wilson NR, et al. Partial reversal of Rett Syndrome-like symptoms in MeCP2 mutant mice. Proc Natl Acad Sci USA. 2009;106(6):2029-2034.
2 Acadia Pharmaceuticals Inc., Data on file. Study Report 2566-026. 2010.

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(Unaudited)

	Three Months Ended March 31,
	2023			2022
Revenues
Product sales, net	$	118,462		$	115,468
Total revenues		118,462			115,468
Operating expenses
Cost of product sales, license fees and royalties (1)		1,667			2,950
Research and development (1)		69,144			128,855
Selling, general and administrative (1)		101,235			96,679
Total operating expenses		172,046			228,484
Loss from operations		(53,584	)		(113,016	)
Interest income, net		3,800			105
Other income		4,845			340
Loss before income taxes		(44,939	)		(112,571	)
Income tax (benefit) expense		(1,918	)		485
Net loss	$	(43,021	)	$	(113,056	)
Net loss per common share, basic and diluted	$	(0.27	)	$	(0.70	)
Weighted average common shares outstanding, basic and diluted		162,263			161,231
(1) Includes the following stock-based compensation expense
Cost of product sales, license fees and royalties	$	168		$	323
Research and development	$	3,972		$	5,464
Selling, general and administrative	$	10,565		$	9,176

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

	March 31, 2023		December 31, 2022
	(unaudited)
Assets
Cash, cash equivalents and investment securities	$	402,873	$	416,823
Accounts receivable, net		65,915		62,195
Interest and other receivables		4,335		885
Inventory		6,095		6,636
Prepaid expenses		23,632		21,398
Total current assets		502,850		507,937
Property and equipment, net		5,595		6,021
Operating lease right-of-use assets		54,151		55,573
Intangible assets, net		69,583		—
Restricted cash		5,770		5,770
Long-term inventory		4,924		4,924
Other assets		12,432		7,587
Total assets	$	655,305	$	587,812
Liabilities and stockholders’ equity
Accounts payable	$	17,422	$	12,746
Accrued liabilities		206,879		112,884
Total current liabilities		224,301		125,630
Operating lease liabilities		51,441		52,695
Other long-term liabilities		5,305		9,074
Total liabilities		281,047		187,399
Total stockholders’ equity		374,258		400,413
Total liabilities and stockholders’ equity	$	655,305	$	587,812

Media Contact:

Acadia Pharmaceuticals Inc.

Deb Kazenelson
(818) 395-3043

media@acadia-pharm.com

Investor Contact:

Acadia Pharmaceuticals Inc.

Mark Johnson, CFA

(858) 261-2771

ir@acadia-pharm.com

XML

Document And Entity Information	May 08, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 08, 2023
Entity Registrant Name	Acadia Pharmaceuticals Inc.
Entity Central Index Key	0001070494
Entity Emerging Growth Company	false
Securities Act 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
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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