Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operating Overview

2024-02-27

上市批准财报临床3期高管变更临床2期

- 2023 total net product sales of $726.4 million, reflecting 40% revenue growth. - Fourth quarter DAYBUE™ (trofinetide) net product sales of $87.1 million and full year 2023 net product sales of $177.2 million. - Fourth quarter NUPLAZID® (pimavanserin) net product sales of $143.9 million and full year 2023 net product sales of $549.2 million. SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the fourth quarter and full year ended December 31, 2023. “2023 was a transformational year for Acadia that positioned us for continued success in 2024 and beyond. We achieved 40% revenue growth primarily driven by the launch of our second commercial product, DAYBUE for the treatment of Rett syndrome, in addition to 6% growth in our established NUPLAZID franchise,” said Steve Davis, Chief Executive Officer. “In the fourth quarter we significantly advanced our pipeline with the initiation of a Phase 3 trial of ACP-101 in Prader-Willi syndrome, as well as our seamless Phase 2 / Phase 3 program for ACP-204 in Alzheimer’s disease psychosis. We look forward to announcing top-line results from our ADVANCE-2 study of pimavanserin for the negative symptoms of schizophrenia by the end of the first quarter.” Company Updates Anticipated to report top-line results from ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia, by the end of the first quarter. Initiated a pivotal Phase 3 COMPASS PWS study of ACP-101 (intranasal carbetocin) for the treatment of hyperphagia in Prader-Willi syndrome in the fourth quarter of 2023. Initiated a Phase 2 clinical trial of ACP-204 for the treatment of Alzheimer’s disease psychosis in the fourth quarter of 2023. Appointed Jennifer J. Rhodes as Executive Vice President, Chief Legal Officer and Secretary and Kimberly J. Manhard as Senior Vice President, Global Strategic Planning and Execution. Jennifer and Kimberly both joined Acadia’s executive leadership team. Financial Results Revenues Total revenues, comprised of net product sales from NUPLAZID and DAYBUE, were $231.0 million for the fourth quarter of 2023 and $726.4 million for the full year 2023. Net product sales of NUPLAZID were $143.9 million for the fourth quarter of 2023, an increase of 5% as compared to $136.5 million for the fourth quarter of 2022. Net product sales of NUPLAZID were $549.2 million for the full year 2023, an increase of 6% as compared to $517.2 million for the full year 2022. The increase in net product sales of NUPLAZID was due to growth in unit sales and a higher average net selling price in 2023 compared to 2022. Net product sales of DAYBUE were $87.1 million for the fourth quarter of 2023 and $177.2 million for the full year 2023. During 2022, there were no net product sales of DAYBUE, which was launched in April 2023. Research and Development Research and development expenses for the fourth quarter of 2023 were $66.7 million, compared to $75.7 million for the same period of 2022. For the full years of 2023 and 2022, research and development expenses were $351.6 million and $361.6 million, respectively. The decrease in research and development expenses during 2023 was mainly due to trofinetide commercial supply build that was expensed prior to approval. There was a similar level of clinical spend and business development investment year over year. Selling, General and Administrative Selling, general and administrative expenses for the fourth quarter of 2023 were $111.5 million, compared to $104.4 million for the same period of 2022. For the full years of 2023 and 2022, selling, general and administrative expenses were $406.6 million and $369.1 million, respectively. The increase in selling, general and administrative expenses was primarily due to increased commercial costs associated with the DAYBUE launch, partially offset by reductions in expenses associated with NUPLAZID. Net Income (Loss) For the fourth quarter of 2023, Acadia reported net income of $45.8 million, or $0.28 per common share, compared to a net loss of $41.7 million, or $0.26 per common share, for the same period in 2022. The net income and loss for the fourth quarters of 2023 and 2022 included $18.0 million and $14.4 million, respectively, of non-cash stock-based compensation expense. For the full year 2023, Acadia reported a net loss of $61.3 million, or $0.37 per common share, compared to a net loss of $216.0 million, or $1.34 per common share, for the same period in 2022. The net losses for the full years of 2023 and 2022 included $66.4 million and $68.2 million, respectively, of non-cash stock-based compensation expense. Cash and Investments At December 31, 2023, Acadia’s cash, cash equivalents, and investment securities totaled $438.9 million, compared to $416.8 million at December 31, 2022. Full Year 2024 Financial Guidance DAYBUE net product sales in the range of $370 to $420 million. NUPLAZID net product sales in the range of $560 to $590 million. GAAP R&D expense in the range of $305 to $325 million. GAAP SG&A expense in the range of $455 to $480 million. Conference Call and Webcast Information Acadia will host a conference call to discuss the fourth quarter and full year December 31, 2023 results today, Tuesday, February 27, 2024 at 1:30 p.m. PT/4:30 p.m. ET. The conference call will be available on Acadia’s website, Acadia.com, under the investors section and will be archived there until March 26, 2024. 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. Trofinetide was approved for the treatment of Rett syndrome in adults and pediatric patients two 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. For 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 FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, 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 Twitter. 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” 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; (ii) plans for, including timing, development and progress of commercialization or regulatory timelines for, NUPLAZID, DAYBUE and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of NUPLAZID and DAYBUE; and (iv) our estimates regarding our future financial performance, profitability or capital requirements. 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; 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; 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, 2023 as well as our subsequent filings with the Securities and Exchange Commission from time to time, including our annual report on Form 10-K for the year ended December 31, 2023. 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 December 31, Years Ended December 31, 2023 2022 2023 2022 Revenues Product sales, net $ 231,041 $ 136,490 $ 726,437 $ 517,235 Total revenues 231,041 136,490 726,437 517,235 Operating expenses Cost of product sales (1)(2) 17,891 2,413 41,638 10,166 Research and development (2) 66,741 75,738 351,619 361,575 Selling, general and administrative (2) 111,465 104,402 406,559 369,090 Total operating expenses 196,097 182,553 799,816 740,831 Income (loss) from operations 34,944 (46,063 ) (73,379 ) (223,596 ) Interest income, net 4,759 3,630 17,234 6,610 Other income — 1,543 5,109 3,542 Income (loss) before income taxes 39,703 (40,890 ) (51,036 ) (213,444 ) Income tax expense (benefit) (6,094 ) 835 10,250 2,531 Net income (loss) $ 45,797 $ (41,725 ) $ (61,286 ) $ (215,975 ) Earnings (net loss) per share: Basic $ 0.28 $ (0.26 ) $ (0.37 ) $ (1.34 ) Diluted $ 0.28 $ (0.26 ) $ (0.37 ) $ (1.34 ) Weighted average common shares outstanding: Basic 164,812 161,988 163,819 161,683 Diluted 166,510 161,988 163,819 161,683 (1) Includes license fees and royalties (2) Includes the following share-based compensation expenses Cost of product sales, license fees and royalties $ 363 $ 93 $ 1,007 $ 1,106 Research and development $ 4,707 $ 3,432 $ 17,408 $ 22,580 Selling, general and administrative $ 12,953 $ 10,889 $ 48,006 $ 44,515 ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) December 31, 2023 December 31, 2022 Assets Cash, cash equivalents and investment securities $ 438,865 $ 416,823 Accounts receivable, net 98,267 62,195 Interest and other receivables 4,083 885 Inventory 35,819 6,636 Prepaid expenses 39,091 21,398 Total current assets 616,125 507,937 Property and equipment, net 4,612 6,021 Operating lease right-of-use assets 51,855 55,573 Intangible assets, net 65,490 — Restricted cash 5,770 5,770 Long-term inventory 4,628 4,924 Other assets 476 7,587 Total assets $ 748,956 $ 587,812 Liabilities and stockholders’ equity Accounts payable $ 17,543 $ 12,746 Accrued liabilities 236,711 112,884 Total current liabilities 254,254 125,630 Operating lease liabilities 47,800 52,695 Other long-term liabilities 15,147 9,074 Total liabilities 317,201 187,399 Total stockholders’ equity 431,755 400,413 Total liabilities and stockholders’ equity $ 748,956 $ 587,812