Acadia Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operating Overview

02 Nov 2023
www.biospace.com
Executive ChangeFinancial StatementDrug ApprovalPhase 3Phase 2
- Company reports record revenues resulting from strong DAYBUE launch and growth in NUPLAZID franchise - 3Q23 DAYBUE™ (trofinetide) net product sales of $66.9 million - 3Q23 NUPLAZID® (pimavanserin) net product sales of $144.8 million SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the third quarter ended September 30, 2023. “In the third quarter, Acadia delivered record product revenue, underscoring the continued strong launch of DAYBUE for the treatment of Rett syndrome, and market share growth for the very successful NUPLAZID franchise,” said Steve Davis, President and Chief Executive Officer. “In addition to our strong commercial performance, we continue to add to our late stage pipeline with the planned initiations in the fourth quarter of a Phase 3 study of ACP-101 for Prader-Willi syndrome and a Phase 2 / Phase 3 program of ACP-204 for the treatment of Alzheimer’s disease psychosis.” Company Highlights Acquired global rights to trofinetide (DAYBUE) through an expanded agreement with Neuren Pharmaceuticals. The Company expects to report top-line results from ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia in the first quarter of 2024. The Company plans to initiate a Phase 3 placebo-controlled study of ACP-101 for the treatment of hyperphagia in Prader-Willi syndrome in the fourth quarter of 2023. The Company plans to initiate a Phase 2 study of ACP-204 as a potential treatment for Alzheimer’s disease psychosis in the fourth quarter of 2023. Appointed Albert Kildani as Senior Vice President, Investor Relations and Corporate Communications, and Stephanie Kim as Senior Vice President, Regulatory Affairs. Albert and Stephanie both join Acadia’s Executive Management Committee. Financial Results Revenues Total revenues, comprised of net product sales from NUPLAZID and DAYBUE were $211.7 million for the three months ended September 30, 2023, and were $495.4 million for the nine months ended September 30, 2023. Net product sales of NUPLAZID were $144.8 million and $130.7 million for the three months ended September 30, 2023 and 2022, respectively. The approximately $14 million dollar increase year over year is comprised of a $7 million in-channel inventory reduction in the prior year that did not recur this year, $4 million attributable to lower 340B volumes, and $3 million as a result of 2% demand bottle growth. Net product sales of NUPLAZID were $405.3 million and $380.7 million for the nine months ended September 30, 2023 and 2022, respectively. Net product sales of DAYBUE were $66.9 million for the quarter ended September 30, 2023, the first full quarter of commercialization of DAYBUE following the April 17, 2023 launch. Research and Development Research and development expenses for the three months ended September 30, 2023 were $157.0 million, compared to $81.3 million for the same period of 2022. The increase in research and development expenses was mainly due to the July 2023 agreement with Neuren to expand Acadia’s license to trofinetide (DAYBUE) from North American to worldwide rights, offset in part by other reductions in research and development. For the nine months ended September 30, 2023 and 2022, research and development expenses were $284.9 million and $285.8 million, respectively. Selling, General and Administrative Selling, general and administrative expenses for the three months ended September 30, 2023 were $97.9 million, compared to $78.1 million for the same period of 2022. For the nine months ended September 30, 2023 and 2022, selling, general and administrative expenses were $295.1 million and $264.7 million, respectively. The increase in selling, general and administrative expenses in both periods was primarily due to increased commercial costs associated with the DAYBUE launch, partially offset by reductions in expenses associated with NUPLAZID. Net Loss For the three months ended September 30, 2023, Acadia reported a net loss of $65.2 million, or $0.40 per common share, compared to a net loss of $27.2 million, or $0.17 per common share, for the same period in 2022. Net loss for the three months ended September 30, 2023 included the $100 million upfront payment to expand Acadia's license to trofinetide (DAYBUE) from North American to worldwide rights. Net loss for the three months ended September 30, 2023 and 2022 included $18.5 million and $18.3 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2023, Acadia reported a net loss of $107.1 million, or $0.65 per common share, compared to a net loss of $174.3 million, or $1.08 per common share, for the same period in 2022. The net losses for the nine months ended September 30, 2023 and 2022 included $48.4 million and $53.8 million, respectively, of non-cash stock-based compensation expense. Cash and Investments At September 30, 2023, Acadia’s cash, cash equivalents and investment securities totaled $345.9 million, compared to $416.8 million at December 31, 2022. The change in these balances is primarily due to the July 2023 $100 million upfront payment for worldwide rights to trofinetide (DAYBUE) referenced above. Financial Guidance Fourth Quarter 2023 DAYBUE net sales in the range of $80 to $87.5 million. Full Year 2023 NUPLAZID net sales in the range of $537.5 to $545 million. R&D expense in the range of $340 to $350 million. SG&A expense in the range of $390 to $400 million. Conference Call and Webcast Information The conference call will be available on Acadia’s website, under the investors section and will be archived there until December 4, 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 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 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, Prader-Willi syndrome, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at and follow us on LinkedIn and 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 1Tropea 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. 2Acadia 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 September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Revenues Product sales, net $ 211,699 $ 130,714 $ 495,396 $ 380,745 Total revenues 211,699 130,714 495,396 380,745 Operating expenses Cost of product sales (1)(2) 14,622 2,136 23,747 7,753 Research and development (2) 156,963 81,336 284,878 285,837 Selling, general and administrative (2) 97,890 78,108 295,094 264,688 Total operating expenses 269,475 161,580 603,719 558,278 Loss from operations (57,776 ) (30,866 ) (108,323 ) (177,533 ) Interest income, net 4,125 2,295 12,475 2,980 Other income 1,508 2,156 5,109 1,999 Loss before income taxes (52,143 ) (26,415 ) (90,739 ) (172,554 ) Income tax expense 13,033 768 16,344 1,696 Net loss $ (65,176 ) $ (27,183 ) $ (107,083 ) $ (174,250 ) Net loss per common share, basic and diluted $ (0.40 ) $ (0.17 ) $ (0.65 ) $ (1.08 ) Weighted average common shares outstanding, basic and diluted 164,234 161,852 163,488 161,580 (1) Includes license fees and royalties (2) Includes the following stock-based compensation expense Cost of product sales, license fees and royalties $ 276 $ 344 $ 644 $ 1,013 Research and development $ 5,063 $ 6,452 $ 12,701 $ 19,148 Selling, general and administrative $ 13,200 $ 11,516 $ 35,053 $ 33,626 ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30, 2023 December 31, 2022 (unaudited) Assets Cash, cash equivalents and investment securities $ 345,920 $ 416,823 Accounts receivable, net 92,802 62,195 Interest and other receivables 1,730 885 Inventory 20,768 6,636 Prepaid expenses 37,950 21,398 Total current assets 499,170 507,937 Property and equipment, net 4,884 6,021 Operating lease right-of-use assets 50,758 55,573 Intangible assets, net 66,855 — Restricted cash 5,770 5,770 Long-term inventory 4,628 4,924 Other assets 475 7,587 Total assets $ 632,540 $ 587,812 Liabilities and stockholders’ equity Accounts payable $ 12,310 $ 12,746 Accrued liabilities 197,293 112,884 Total current liabilities 209,603 125,630 Operating lease liabilities 48,103 52,695 Other long-term liabilities 12,660 9,074 Total liabilities 270,366 187,399 Total stockholders’ equity 362,174 400,413 Total liabilities and stockholders’ equity $ 632,540 $ 587,812
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