Acadia Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operating Overview

Rhea-AI Summary

Acadia Pharmaceuticals announced its third quarter 2024 financial results, reporting total revenues of $250.4 million, an 18% increase year-over-year. NUPLAZID net product sales were $159.2 million, up 10% year-over-year, while DAYBUE net product sales reached $91.2 million, a 36% increase. CEO Catherine Owen Adams highlighted the company's path to achieving over $1 billion in annualized sales by 2025. Research and development expenses decreased to $66.6 million, primarily due to reduced business development payments. Selling, general, and administrative expenses rose to $133.3 million, driven by marketing costs. The company reported a net income of $32.8 million, or $0.20 per share, compared to a net loss of $65.2 million in the same period last year. Acadia's cash and investments totaled $565.3 million. The company updated its 2024 guidance, expecting total revenues between $940 to $960 million, NUPLAZID sales of $600 to $610 million, and DAYBUE sales of $340 to $350 million.

Positive

• 18% increase in total revenues year-over-year.
• NUPLAZID net product sales up 10%.
• DAYBUE net product sales up 36%.
• Net income of $32.8 million, or $0.20 per share.
• Cash and investments increased to $565.3 million.
• Updated 2024 guidance with total revenues expected between $940 to $960 million.

Negative

• Increase in selling, general, and administrative expenses to $133.3 million.
• DAYBUE net product sales guidance narrowed to the low end of the prior range, now expected to be $340 to $350 million.

Insights

Financial Analyst

The Q3 results showcase impressive performance with $250.4M in total revenue, up 18% YoY. Key highlights include NUPLAZID sales reaching $159.2M (10% growth) and DAYBUE delivering $91.2M (36% growth). The company's transition to profitability is notable, with $32.8M net income versus a $65.2M loss in the previous year. Strong cash position of $565.3M provides solid operational runway.

The updated 2024 guidance reflects confidence in NUPLAZID's performance with narrowed range of $600-610M, while DAYBUE's guidance adjustment to $340-350M suggests some moderation in growth expectations. The $150M PRV sale will further strengthen the balance sheet. The company appears on track to reach $1B in annualized sales by 2025, marking a significant milestone in commercial execution.

- 3Q24 total revenues of $250.4 million, up 18% year-over-year

- 3Q24 NUPLAZID^® (pimavanserin) net product sales of $159.2 million, up 10% year-over-year

- 3Q24 DAYBUE^™ (trofinetide) net product sales of $91.2 million, up 36% year-over-year

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the third quarter ended September 30, 2024.

“The success of Acadia’s two growing commercial franchises is clearly reflected in our third quarter 2024 results, where we delivered $250.4 million in total revenues, putting us on track to reach an impressive milestone of more than $1 billion in annualized sales in 2025,” said Catherine Owen Adams, Chief Executive Officer. “In my new role as CEO, I’m inspired and excited by the possibilities that lie ahead for Acadia, both with our current portfolio and the exciting innovations in our pipeline. The opportunity to deliver additional groundbreaking therapies to patients who need them is truly compelling. Furthermore, I see significant potential to enhance shareholder value as we continue to execute our commercial priorities and advance our pipeline assets.”

Company Updates

• In August, world-renowned actor/entrepreneur and Parkinson’s disease advocate Ryan Reynolds announced with the Company the launch of a multi-faceted disease education campaign, More to Parkinson’s^®, to raise awareness among caregivers, patients and their care providers about a common, yet under-recognized aspect of Parkinson’s disease – Parkinson’s-related hallucinations and delusions.
• Advancing the science in Parkinson’s disease with data presentations at the International Congress of Parkinson’s Disease and Movement Disorders Society in October on the topics of sleep improvements and the value of early treatment of Parkinson’s disease psychosis with pimavanserin versus treating later in disease progression.
• In October, Health Canada granted marketing authorization of DAYBUE (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older under its Priority Review process. The Notice of Compliance authorization of DAYBUE makes it the first and only drug approved in Canada for the treatment of Rett syndrome.
• In November, the Company announced it entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million, following the closing of the sale. Pursuant to the license agreement, Acadia is required to pay Neuren Pharmaceuticals Limited one-third of the net proceeds received from the sale of the PRV.

Financial Results

Revenues

Net product sales of NUPLAZID were $159.2 million and $144.8 million for the three months ended September 30, 2024 and 2023, respectively. The 10% year-over-year increase in net product sales of NUPLAZID included 7% volume growth in 2024 compared to 2023. Net product sales of NUPLAZID were $446.5 million and $405.3 million for the nine months ended September 30, 2024 and 2023, respectively.

Net product sales of DAYBUE were $91.2 million and $66.9 million for the three months ended September 30, 2024 and 2023, respectively. Net product sales of DAYBUE were $251.7 million and $90.1 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in net product sales of DAYBUE for both periods was primarily due to the growth in unit sales.

Research and Development

Research and development expenses were $66.6 million, compared to $157.0 million for the three months ended September 30, 2024 and 2023, respectively. The decrease was mainly due to decreased business development payments, which in the period ending September 30, 2023 included the $100.0 million payment to Neuren under the license agreement for trofinetide. For the nine months ended September 30, 2024 and 2023, research and development expenses were $202.5 million and $284.9 million, respectively. The decrease was mainly due to the aforementioned payment, partially offset by increased costs from clinical stage programs.

Selling, General and Administrative

Selling, general and administrative expenses were $133.3 million and $97.9 million for the three months ended September 30, 2024 and 2023, respectively. For the nine months ended September 30, 2024 and 2023, selling, general and administrative expenses were $358.3 million and $295.1 million, respectively. The increase for this period was primarily driven by the costs related to the consumer activation program to support the NUPLAZID franchise, increased marketing costs in the U.S. to support DAYBUE and investments to support commercialization of DAYBUE outside the U.S.

Net Income (Loss)

For the three months ended September 30, 2024, Acadia reported net income of $32.8 million, or $0.20 per common share, compared to net loss of $65.2 million, or $0.40 per common share, for the same period in 2023. Net income for the three months ended September 30, 2024 included $26.2 million of non-cash stock-based compensation expense. Net loss for the three months ended September 30, 2023 included $18.5 million of non-cash stock-based compensation expense. For the nine months ended September 30, 2024, Acadia reported net income of $82.7 million, or $0.50 per common share, compared to a net loss of $107.1 million, or $0.65 per common share. Net income for the nine months ended September 30, 2024 included $56.6 million of non-cash stock-based compensation expense. Net loss for the nine months ended September 30, 2023 included $48.4 million of non-cash stock-based compensation expense.

Cash and Investments

At September 30, 2024, Acadia’s cash, cash equivalents and investment securities totaled $565.3 million, compared to $438.9 million at December 31, 2023.

Full Year 2024 Financial Guidance

Acadia is updating its 2024 guidance:

• NUPLAZID net product sales guidance is narrowed to the high end of the prior range and is now expected to be $600 to $610 million.
• DAYBUE net product sales guidance is narrowed to the low end of the prior range and is now expected to be $340 to $350 million.
• Total revenue guidance is revised to a range of $940 to $960 million.
• R&D expense guidance is lowered and is now expected to be between $280 to $290 million.
• SG&A expense guidance is increased and is now expected to be between $480 to $495 million.

Conference Call and Webcast Information

Acadia will host a conference call to discuss the third quarter 2024 results today, Wednesday, November 6, 2024 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 neuropsychiatric symptoms in central nervous system disorders. 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,” “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, and potential for enhanced shareholder value; (ii) plans for, including timing, development and progress of commercialization or regulatory timelines for, NUPLAZID, DAYBUE (both within and outside the U.S.) and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of NUPLAZID and DAYBUE; (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, and the timing and content of our presentations regarding our clinical trials; (v) our estimates regarding our future financial performance, profitability or capital requirements, including our full year 2024 financial guidance and potential achievement of our milestone of annualized sales in 2025; and (vi) the closing of the sale of the PRV, receipt of payment for the PRV in connection with the closing, HSR clearance of the sale and the anticipated use of proceeds from the sale of the PRV. 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 NUPLAZID and DAYBUE and our ability to maintain or increase sales of NUPLAZID or DAYBUE; our plans to commercialize DAYBUE outside the U.S., including in Canada; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to satisfy or waive all required closing conditions for the sale of the PRV and ultimately close the PRV sale; our ability to obtain HSR clearance in a timely manner or at all; our ability to successfully deploy the proceeds of the PRV sale as anticipated; 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 June 30, 2024 as well as our subsequent filings with the Securities and Exchange Commission (SEC) from time to time, including our quarterly report on Form 10-Q for the quarter ended September 30, 2024 being filed with the SEC today, which will be available at www.sec.gov. 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 September 30,								Nine Months Ended September 30,
			2024				2023				2024				2023
Revenues
Product sales, net		$	250,401			$	211,699			$	698,195			$	495,396
Total revenues			250,401				211,699				698,195				495,396
Operating expenses
Cost of product sales (1)(2)			18,857				14,622				60,038				23,747
Research and development (2)			66,606				156,963				202,518				284,878
Selling, general and administrative (2)			133,294				97,890				358,348				295,094
Total operating expenses			218,757				269,475				620,904				603,719
Income (loss) from operations			31,644				(57,776	)			77,291				(108,323	)
Interest income, net			6,586				4,125				18,451				12,475
Other income (loss)			576				1,508				1,248				5,109
Income (loss) before income taxes			38,806				(52,143	)			96,990				(90,739	)
Income tax expense			6,041				13,033				14,281				16,344
Net income (loss)		$	32,765			$	(65,176	)		$	82,709			$	(107,083	)
Earnings (net loss) per share:
Basic		$	0.20			$	(0.40	)		$	0.50			$	(0.65	)
Diluted		$	0.20			$	(0.40	)		$	0.50			$	(0.65	)
Weighted average common shares outstanding:
Basic			165,974				164,234				165,443				163,488
Diluted			166,178				164,234				166,136				163,488
(1) Includes license fees and royalties
(2) Includes the following stock-based compensation expense
Cost of product sales, license fees and royalties		$	383			$	276			$	898			$	644
Research and development		$	3,863			$	5,063			$	11,705			$	12,701
Selling, general and administrative		$	21,918			$	13,200			$	43,996			$	35,053

ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)
		September 30, 2024				December 31, 2023
		(unaudited)
Assets
Cash, cash equivalents and investment securities		$	565,330			$	438,865
Accounts receivable, net			98,209				98,267
Interest and other receivables			12,154				4,083
Inventory			61,041				35,819
Prepaid expenses			51,550				39,091
Total current assets			788,284				616,125
Property and equipment, net			3,988				4,612
Operating lease right-of-use assets			44,253				51,855
Intangible assets, net			105,515				65,490
Restricted cash			8,770				5,770
Long-term inventory			25,699				4,628
Other assets			359				476
Total assets		$	976,868			$	748,956
Liabilities and stockholders’ equity
Accounts payable		$	19,081			$	17,543
Accrued liabilities			324,864				236,711
Total current liabilities			343,945				254,254
Operating lease liabilities			40,421				47,800
Other long-term liabilities			15,322				15,147
Total liabilities			399,688				317,201
Total stockholders’ equity			577,180				431,755
Total liabilities and stockholders’ equity		$	976,868			$	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

Source: Acadia Pharmaceuticals Inc.

FAQ

What were Acadia Pharmaceuticals' total revenues for Q3 2024?

Acadia Pharmaceuticals reported total revenues of $250.4 million for Q3 2024, an 18% increase year-over-year.

How did NUPLAZID perform in Q3 2024?

NUPLAZID net product sales were $159.2 million in Q3 2024, up 10% year-over-year.

What was the net income for Acadia Pharmaceuticals in Q3 2024?

Acadia Pharmaceuticals reported a net income of $32.8 million, or $0.20 per share, in Q3 2024.

What is the updated 2024 revenue guidance for Acadia Pharmaceuticals?

Acadia Pharmaceuticals updated its 2024 revenue guidance to a range of $940 to $960 million.

How did DAYBUE perform in Q3 2024?

DAYBUE net product sales were $91.2 million in Q3 2024, up 36% year-over-year.