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SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2020. Acadia delivered strong financial results in the fourth quarter and full year 2020, driven by robust sales of NUPLAZID in Parkinsons disease psychosis. Additionally, we made significant advancements in two Phase 3 programs and further expanded our pipeline in pain and neuropsychiatry through strategic business development, said Steve Davis, Chief Executive Officer. In 2021, we are focused on delivering continued growth of NUPLAZID, the upcoming potential approval and launch of pimavanserin for dementia-related psychosis and advancing our business development strategy. Company Highlights Financial Results Revenue Net sales of NUPLAZID (pimavanserin) were $121.0 million for the fourth quarter of 2020, an increase of 23% as compared to $98.3 million reported for the fourth quarter of 2019. For the years ended December 31, 2020 and 2019, Acadia reported net product sales of $441.8 million and $339.1 million, respectively, an increase of 30% year-over-year. Research and Development Research and development expenses for the fourth quarter of 2020 were $62.1 million, compared to $57.5 million for the same period of 2019. For the years ended December 31, 2020 and 2019, research and development expenses were $319.1 million and $240.4 million, respectively. The increase in full year 2020 was primarily due to the upfront expenses of $52.8 million related to the acquisition of CerSci Therapeutics and a $10.0 million upfront payment to Vanderbilt University related to the license agreement and collaboration for novel therapeutic programs targeting muscarinic M1 receptors. Selling, General and Administrative Selling, general and administrative expenses for the fourth quarter of 2020 were $120.8 million, compared to $91.9 million for the same period of 2019. For the years ended December 31, 2020 and 2019, selling, general and administrative expenses were $388.7 million and $325.6 million, respectively. This increase during the 2020 period as compared to 2019 was primarily due to increased advertising and promotional costs, dementia-related psychosis launch preparation expenses, as well as an increase in personnel and related costs. Net Loss For the fourth quarter of 2020, Acadia reported a net loss of $66.8 million, or $0.42 per common share, compared to a net loss of $53.0 million, or $0.34 per common share, for the same period in 2019. The net losses for the fourth quarters of 2020 and 2019 included $21.2 million and $19.8 million, respectively, of non-cash stock-based compensation expense. For the year ended December 31, 2020, Acadia reported a net loss of $281.6 million, or $1.79 per common share, compared to a net loss of $235.3 million, or $1.60 per common share, for the same period in 2019. The net losses for the years ended December 31, 2020 and 2019 included $84.4 million and $82.3 million, respectively, of non-cash stock-based compensation expense. Cash and Investments At December 31, 2020, Acadias cash, cash equivalents, and investment securities totaled $632.0 million, compared to $697.4 million at December 31, 2019. 2021 Financial Guidance Conference Call and Webcast Information Acadia management will review its fourth quarter and full year 2020 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 United States or Canada and 443-877-4067 for international callers (reference passcode 9576845). A telephone replay of the conference call may be accessed through March 10, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9576845). The conference call also will be webcast live on Acadias website, www.acadia-pharm.com under the investors section and will be archived there through March 24, 2021. About NUPLAZID (pimavanserin) NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinsons disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinsons disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for dementia-related psychosis, schizophrenia, major depressive disorder, or depressive symptoms in patients with Parkinsons disease. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID. About Trofinetide Trofinetide is an investigational drug. It is a novel synthetic analog of the amino-terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome. About Acadia Pharmaceuticals Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 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 therapy for hallucinations and delusions associated with Parkinsons disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn. 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 related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinsons disease psychosis only 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 2021, 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 Acadias annual report on Form 10-K for the year ended December 31, 2019 as well as Acadias 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. ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended December 31, Years Ended December 31, 2020 2019 2020 2019 Revenues Product sales, net $ 121,007 $ 98,326 $ 441,755 $ 339,076 Total revenues 121,007 98,326 441,755 339,076 Operating expenses Cost of product sales, license fees and royalties (1) 5,301 5,334 20,550 19,598 Research and development (1) 62,116 57,520 319,130 240,385 Selling, general and administrative (1) 120,752 91,871 388,661 325,638 Total operating expenses 188,169 154,725 728,341 585,621 Loss from operations (67,162 ) (56,399 ) (286,586 ) (246,545 ) Interest income, net 554 3,272 6,610 11,165 Other income (expense) 265 491 (997 ) 997 Loss before income taxes (66,343 ) (52,636 ) (280,973 ) (234,383 ) Income tax (benefit) expense 417 400 611 876 Net loss $ (66,760 ) $ (53,036 ) $ (281,584 ) $ (235,259 ) Net loss per common share, basic and diluted $ (0.42 ) $ (0.34 ) $ (1.79 ) $ (1.60 ) Weighted average common shares outstanding, basic and diluted 159,263 154,492 157,331 147,199 (1) Includes the following share-based compensation expenses Cost of product sales, license fees and royalties $ 545 $ 592 $ 2,632 $ 2,936 Research and development $ 7,669 $ 8,072 $ 31,314 $ 32,533 Selling, general and administrative $ 12,981 $ 11,099 $ 50,476 $ 46,796 ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) December 31, 2020 December 31, 2019 (unaudited) Assets Cash, cash equivalents and investment securities $ 631,958 $ 697,429 Accounts receivable, net 48,247 35,781 Interest and other receivables 2,035 2,093 Inventory 9,682 6,341 Prepaid expenses 25,694 18,606 Total current assets 717,616 760,250 Property and equipment, net 9,161 3,180 Operating lease right-of-use assets 47,283 9,524 Intangible assets, net 1,108 2,585 Restricted cash 5,770 4,787 Other assets 1,678 2,857 Total assets $ 782,616 $ 783,183 Liabilities and stockholders equity Accounts payable $ 8,493 $ 7,222 Accrued liabilities 97,474 67,604 Total current liabilities 105,967 74,826 Operating lease liabilities 44,460 6,361 Long-term liabilities 5,180 2,861 Total liabilities 155,607 84,048 Total stockholders equity 627,009 699,135 Total liabilities and stockholders equity $ 782,616 $ 783,183

Answer: Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results - Full year 2020 net sales grew to $441.8 million, a 30% increase over 2019 - Upcoming PDUFA action date of April 3, 2021 for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis