acad-ex991

- Completed Enrollment in Two Late-Stage Adjunctive Schizophrenia Studies with Pimavanserin

SAN DIEGO, CA, May 1, 2019 – ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced its financial results for the first quarter ended March 31, 2019.

“We’ve commenced 2019 with significant momentum. The commercial initiatives implemented by our team have driven continued sales growth of NUPLAZID,” said Steve Davis, ACADIA’s Chief Executive Officer. “This past month, we initiated our Phase 3 CLARITY program evaluating pimavanserin as an adjunctive treatment for patients with major depressive disorder. We also completed enrollment in our two schizophrenia studies and are on track to announce top-line data from our ENHANCE schizophrenia inadequate response study mid-year and top-line data from our ADVANCE schizophrenia negative symptoms study around year-end 2019.”

Net sales of NUPLAZID^® (pimavanserin) were $63.0 million for the first quarter of 2019, an

increase of 29% as compared to $48.9 million reported for the first quarter of 2018.

Research and development expenses for the first quarter of 2019 were $52.9 million, compared to $39.3 million for the same period of 2018. The increase was primarily due to additional clinical study costs for pimavanserin as well as development costs for trofinetide.

Selling, general and administrative expenses for the first quarter of 2019 were $93.1 million, compared to $60.9 million for the same period of 2018. The increase was primarily due to an increase in marketing expenses related to our direct-to-consumer advertising campaign as well as increased charitable contributions.

For the first quarter of 2019, ACADIA reported a net loss of $85.3 million, or $0.59 per common share, compared to a net loss of $54.3 million, or $0.44 per common share, for the same period in 2018. The net losses in the first quarter of 2019 and 2018 included $19.9 million and $20.4 million, respectively, of non-cash stock-based compensation expense.

At March 31, 2019, ACADIA’s cash, cash equivalents, and investment securities totaled $414.3 million, compared to $473.5 million at December 31, 2018.

ACADIA management will review its first quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the U.S. or Canada and 443-877-4067 for international callers (reference passcode 6759227). A telephone replay of the conference call may be accessed through May 8, 2019 by dialing 855-859-2056 for callers in the U.S. or Canada and 404-537-3406 for international callers (reference passcode 6759227). The conference call also will be webcast live on ACADIA’s website, www.acadia-pharm.com, under the investors section and will be archived there through June 1, 2019.

NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. NUPLAZID is a non-dopaminergic, selective

serotonin inverse agonist (SSIA) preferentially targeting 5-HT_2A receptors that are thought to play an important role in Parkinson’s disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. ACADIA discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.

ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, schizophrenia inadequate response, schizophrenia-negative symptoms, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

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 related to: the potential opportunity for future growth in sales of NUPLAZID, including through sales of new dosages and forms; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2019 NUPLAZID net sales and certain expense line items. 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 uncertainty of future commercial sales and related items that would impact net sales during 2019, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. 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, 2018 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.

	Three Months Ended March 31,
	2019			2018
Revenues
Product sales, net	$	62,959		$	48,868
Total revenues		62,959			48,868
Operating expenses
Cost of product sales, license fees and royalties ⁽¹⁾		4,580			3,485
Research and development ⁽¹⁾		52,923			39,276
Selling, general and administrative ⁽¹⁾		93,090			60,926
Total operating expenses		150,593			103,687
Loss from operations		(87,634	)		(54,819	)
Interest income, net		2,934			1,170
Other expense		(229	)		—
Loss before income taxes		(84,929	)		(53,649	)
Income tax expense		375			647
Net loss	$	(85,304	)	$	(54,296	)
Net loss per common share, basic and diluted	$	(0.59	)	$	(0.44	)
Weighted average common shares outstanding, basic and diluted		143,981			124,727


⁽¹⁾ Includes the following stock-based compensation expense

Cost of product sales, license fees and royalties	$	995		$	1,050
Research and development	$	7,880		$	7,657
Selling, general and administrative	$	11,008		$	11,735

	March 31, 2019		December 31, 2018
	(unaudited)
Assets
Cash, cash equivalents and investment securities	$	414,324	$	473,520
Accounts receivable, net		29,958		26,090
Interest and other receivables		3,812		1,699
Inventory		4,570		4,070
Prepaid expenses		23,742		20,727
Total current assets		476,406		526,106
Property and equipment, net		3,737		3,309
Operating lease right-of-use assets		10,918		—
Intangible assets, net		3,692		4,062
Restricted cash		4,787		4,826
Other assets		1,565		1,899
Total assets	$	501,105	$	540,202
Liabilities and stockholders’ equity
Accounts payable	$	3,275	$	3,167
Accrued liabilities		71,708		56,398
Total current liabilities		74,983		59,565
Operating lease liabilities		6,754		—
Other long-term liabilities		1,012		1,558
Total liabilities		82,749		61,123
Total stockholders’ equity		418,356		479,079
Total liabilities and stockholders’ equity	$	501,105	$	540,202