Document and Entity Information
Document and Entity Information - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 21, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ACAD | ||
Entity Registrant Name | ACADIA PHARMACEUTICALS INC | ||
Entity Central Index Key | 0001070494 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 164,771,521 | ||
Entity Public Float | $ 2.9 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Entity File Number | 000-50768 | ||
Security Exchange Name | NASDAQ | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 06-1376651 | ||
Entity Address, Address Line One | 12830 El Camino Real | ||
Entity Address, Address Line Two | Suite 400 | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92130 | ||
City Area Code | 858 | ||
Local Phone Number | 558-2871 | ||
Document Transition Report | false | ||
Document Annual Report | true | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement to be filed with the Securities and Exchange Commission by April 29, 2024 are incorporated by reference into Part III of this report. | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | California | ||
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Cash and cash equivalents | $ 188,657 | $ 114,846 |
Investment securities, available-for-sale | 250,208 | 301,977 |
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 | 0 |
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 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized at December 31, 2023 and 2022; no shares issued and outstanding at December 31, 2023 and 2022 | 0 | 0 |
Common stock, $0.0001 par value; 225,000,000 shares authorized at December 31, 2023 and 2022; 164,650,219 shares and 162,064,872 shares issued and outstanding at December 31, 2023 and 2022, respectively | 16 | 16 |
Additional paid-in capital | 2,862,552 | 2,770,923 |
Accumulated deficit | (2,430,837) | (2,369,551) |
Accumulated other comprehensive income (loss) | 24 | (975) |
Total stockholders’ equity | 431,755 | 400,413 |
Total liabilities and stockholders’ equity | $ 748,956 | $ 587,812 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 164,650,219 | 162,064,872 |
Common stock, shares outstanding | 164,650,219 | 162,064,872 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |||
Revenues | |||||
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | ||
Total revenues | $ 726,437 | $ 517,235 | $ 484,145 | ||
Operating expenses | |||||
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | ||
Cost of product sales | $ 41,638 | $ 10,166 | $ 19,141 | ||
Research and development | 351,619 | 361,575 | 239,415 | ||
Selling, general and administrative | 406,559 | 369,090 | 396,028 | ||
Total operating expenses | 799,816 | 740,831 | 654,584 | ||
Loss from operations | (73,379) | (223,596) | (170,439) | ||
Interest income, net | 17,234 | 6,610 | 591 | ||
Other income | 5,109 | 3,542 | 2,329 | ||
Loss before income taxes | (51,036) | (213,444) | (167,519) | ||
Income tax expense | 10,250 | 2,531 | 351 | ||
Net loss | $ (61,286) | $ (215,975) | $ (167,870) | ||
Net loss per common share, basic | $ (0.37) | [1] | $ (1.34) | [1] | $ (1.05) |
Net loss per common share, diluted | $ (0.37) | [1] | $ (1.34) | [1] | $ (1.05) |
Weighted average common shares outstanding, basic | 163,819 | 161,683 | 160,493 | ||
Weighted average common shares outstanding, diluted | 163,819 | 161,683 | 160,493 | ||
[1] Basic and diluted net income ( loss) per common share are computed independently for each quarter and the full year based upon respective average shares outstanding. Therefore, the sum of the quarterly net income (loss) per common share amounts may not equal the annual amounts reported. |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net Income (Loss) | $ (61,286) | $ (215,975) | $ (167,870) |
Other comprehensive income (loss): | |||
Unrealized income (loss) on investment securities | 1,017 | (789) | (235) |
Foreign currency translation adjustments | (18) | 6 | 7 |
Comprehensive loss | $ (60,287) | $ (216,758) | $ (168,098) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | |||
Net loss | $ (61,286) | $ (215,975) | $ (167,870) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 66,421 | 68,201 | 63,615 |
Amortization of premiums and accretion of discounts on investment securities | (7,533) | (2,736) | 2,404 |
Amortization of intangible assets | 4,093 | 0 | 1,108 |
Gain on strategic investment | (5,109) | (3,542) | (2,329) |
Depreciation | 1,459 | 2,026 | 2,236 |
Loss on sale of investment securities | 524 | 0 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (36,072) | 2,171 | (16,119) |
Interest and other receivables | (3,198) | 93 | 1,057 |
Inventory | (28,808) | 2,415 | (4,210) |
Prepaid expenses and other current assets | (17,693) | 2,494 | 1,802 |
Operating lease right-of-use assets | 5,769 | 6,566 | 6,287 |
Other assets | (33) | (48) | 10 |
Accounts payable | 4,797 | 5,870 | (1,617) |
Accrued liabilities | 93,170 | 24,306 | (8,455) |
Operating lease liabilities | (5,872) | (7,916) | (5,433) |
Long-term liabilities | 6,073 | 2,040 | 1,854 |
Net cash provided by (used in) operating activities | 16,702 | (114,035) | (125,660) |
Cash flows from investing activities | |||
Purchases of investment securities | (369,985) | (363,174) | (492,797) |
Sale and maturity of investment securities | 429,780 | 436,415 | 422,817 |
Proceeds from sales of strategic investment | 12,253 | 0 | 0 |
Net purchases of property and equipment | (50) | 0 | (1,122) |
Intangible assets | (40,000) | 0 | 0 |
Net cash provided by (used in) investing activities | 31,998 | 73,241 | (71,102) |
Cash flows from financing activities | |||
Proceeds from issuance of common stock, net of issuance costs | 25,129 | 8,199 | 18,162 |
Net cash provided by financing activities | 25,129 | 8,199 | 18,162 |
Effect of exchange rate changes on cash | (18) | 6 | 7 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 73,811 | (32,589) | (178,593) |
Cash, cash equivalents and restricted cash | |||
Beginning of period | 120,616 | 153,205 | 331,798 |
End of period | 194,427 | 120,616 | 153,205 |
Supplemental disclosure of cash flow information: | |||
Cash paid for income taxes | 5,850 | 2,190 | 1,038 |
Supplemental disclosure of noncash information: | |||
Accrued milestone and contingent payments in connection with asset acquisition | $ 29,583 | $ 0 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) |
Beginning balance at Dec. 31, 2020 | $ 627,009 | $ 16 | $ 2,612,663 | $ (1,985,706) | $ 36 |
Beginning balance (in shares) at Dec. 31, 2020 | 159,637,771 | ||||
Issuance of common stock from exercise of stock options and units | 12,850 | 12,850 | |||
Issuance of common stock from exercise of stock options and units (in shares) | 1,078,074 | ||||
Issuance of common stock pursuant to employee stock purchase plan | 5,312 | 5,312 | |||
Issuance of common stock pursuant to employee stock purchase plan (in shares) | 296,850 | ||||
Net Income (Loss) | (167,870) | (167,870) | |||
Stock-based compensation | 63,821 | 63,821 | |||
Other comprehensive income (loss) | (228) | (228) | |||
Ending balance at Dec. 31, 2021 | 540,894 | $ 16 | 2,694,646 | (2,153,576) | (192) |
Ending balance (in shares) at Dec. 31, 2021 | 161,012,695 | ||||
Issuance of common stock from exercise of stock options and units | 3,705 | 3,705 | |||
Issuance of common stock from exercise of stock options and units (in shares) | 721,652 | ||||
Issuance of common stock pursuant to employee stock purchase plan | 4,494 | 4,494 | |||
Issuance of common stock pursuant to employee stock purchase plan (in shares) | 330,525 | ||||
Net Income (Loss) | (215,975) | (215,975) | |||
Stock-based compensation | 68,078 | 68,078 | |||
Other comprehensive income (loss) | (783) | (783) | |||
Ending balance at Dec. 31, 2022 | $ 400,413 | $ 16 | 2,770,923 | (2,369,551) | (975) |
Ending balance (in shares) at Dec. 31, 2022 | 162,064,872 | ||||
Issuance of common stock from exercise of stock options and units (in shares) | 1,046,035 | ||||
Issuance of common stock from exercise of stock options and units | $ 20,309 | 20,309 | |||
Issuance of common stock from exercise of stock options and units (in shares) | 2,236,849 | ||||
Issuance of common stock pursuant to employee stock purchase plan | 4,820 | 4,820 | |||
Issuance of common stock pursuant to employee stock purchase plan (in shares) | 348,498 | ||||
Net Income (Loss) | (61,286) | (61,286) | |||
Stock-based compensation | 66,500 | 66,500 | |||
Other comprehensive income (loss) | 999 | 999 | |||
Ending balance at Dec. 31, 2023 | $ 431,755 | $ 16 | $ 2,862,552 | $ (2,430,837) | $ 24 |
Ending balance (in shares) at Dec. 31, 2023 | 164,650,219 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||||||||||
Net Income (Loss) | $ 45,797 | $ (65,176) | $ 1,114 | $ (43,021) | $ (41,725) | $ (27,183) | $ (34,011) | $ (113,056) | $ (61,286) | $ (215,975) | $ (167,870) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 shares | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | During the Company’s last fiscal quarter, the following officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) adopted or terminated a “Rule 10b5-1 trading arrangement” as defined in Item 408 of Regulation S-K, as follows: • On December 15, 2023 , Stephen R. Davis , President and Chief Executive Officer , adopted a Rule 10b5-1 trading arrangement providing for the sale of up to 370,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is from March 14, 2024 until July 15, 2024, or earlier if and when all transactions under the trading arrangement are completed. • On December 15, 2023 , Austin D. Kim , our former Executive Vice President, General Counsel and Secretary , adopted a Rule 10b5-1 trading arrangement providing for the sale of up to 10,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is from March 14, 2024 until June 14, 2024, or earlier if and when all transactions under the trading arrangement are completed. |
Stephen R. Davis [Member] | |
Trading Arrangements, by Individual | |
Name | Stephen R. Davis |
Title | President and Chief Executive Officer |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | December 15, 2023 |
Arrangement Duration | 123 days |
Aggregate Available | 370,000 |
Austin D. Kim [Member] | |
Trading Arrangements, by Individual | |
Name | Austin D. Kim |
Title | former Executive Vice President, General Counsel and Secretary |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | December 15, 2023 |
Arrangement Duration | 92 days |
Aggregate Available | 10,000 |
Organization and Business
Organization and Business | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Organization and Business | 1. Organization and Business Acadia Pharmaceuticals Inc. (the Company), based in San Diego, California, is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders and rare diseases. In April 2016, the U.S. Food and Drug Administration (FDA) approved the Company’s first drug, NUPLAZID ® (pimavanserin), for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). NUPLAZID became available for prescription in the United States in May 2016. In March 2023, the FDA approved the Company’s second drug, DAYBUE (trofinetide), for the treatment of Rett syndrome. DAYBUE became available for prescription in the United States in April 2023. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Significant accounting policies followed in the preparation of these financial statements are as follows: Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity date at the date of purchase of three months or less to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows (in thousands). Twelve Months Ended Twelve Months Ended Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 114,846 $ 188,657 $ 147,435 $ 114,846 Restricted cash 5,770 5,770 5,770 5,770 Total cash, cash equivalents and restricted $ 120,616 $ 194,427 $ 153,205 $ 120,616 Investment Securities Currently, all of the Company’s investment securities are debt securities. The Company has classified all of its investment securities as available-for-sale as the sale of such securities may be required prior to maturity to implement management strategies, and accordingly, carries these investments at fair value. Unrealized gains and losses, if any, are reported as a separate component of stockholders’ equity. The cost of investment securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses, if any, are also included in interest income. The cost of securities sold is based on the specific identification method. Fair Value of Financial Instruments The carrying values of the Company’s financial instruments, consisting of cash and cash equivalents, trade receivables, interest and other receivables, restricted cash, and accounts payable and accrued liabilities, approximate fair value due to the relative short-term nature of these instruments. As disclosed in Note 4, the Company classifies its cash equivalents and available-for-sale investment securities within the fair value hierarchy as defined by authoritative guidance: Level 1 Inputs — Quoted prices for identical instruments in active markets. Level 2 Inputs — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable. Level 3 Inputs — Valuation derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. Accounts Receivable Accounts receivable are recorded net of customer allowances for distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company adopted FASB Accounting Standards Codification 326-20, Financial Instruments – Credit Losses (ASC 326-20) as of January 1, 2020. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about the collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. Based on its assessment, as of December 31, 2023 , the Company determined that an allowance for credit loss was not required. Inventory Inventory is stated at the lower of cost or net realizable value under the first-in, first-out method (FIFO). The Company uses a combination of standard and actual costing methodologies to determine the cost basis for its inventories which approximates actual costs. Inventory consists of raw material, work in process, and finished goods, including third-party manufacturing costs, freight, and indirect overhead costs. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Prior to FDA approval of NUPLAZID in April 2016 and DAYBUE and March 2023, all costs related to the manufacturing of NUPLAZID and DAYBUE were charged to research and development expense in the period incurred. The Company periodically reviews inventory and reduces the carrying value of items to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life. During the years ended December 31, 2023, 2022 and 2021, the Company recorded charges of $ 0.9 million, $ 0.6 million and $ 1.3 million, respectively, to reduce certain finished goods and work in process inventory to its net realizable value. Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Leasehold improvements are amortized over the shorter of their estimated useful lives or the term of the lease by use of the straight-line method. Construction-in-process reflects amounts incurred for property, equipment or improvements that have not been placed in service. Maintenance and repair costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are removed from the respective accounts and any gain or loss is recognized. Estimated useful lives by major asset category are as follows: Useful Lives Machinery and equipment 5 to 7 years Computers and software 3 years Furniture and fixtures 10 years Impairment of Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Through December 31, 2023 , no such impairment losses have been recorded by the Company. License Fees and Royalties The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. In connection with the FDA approval of NUPLAZID in April 2016, the Company made a one-time milestone payment of $ 8.0 million pursuant to its 2006 license agreement with the Ipsen Group in which the Company licensed certain intellectual property rights that complement its patent portfolio for its serotonin platform, including NUPLAZID. The Company capitalized the $ 8.0 million payment as an intangible asset and is amortizing the asset on a straight-line basis over the estimated useful life which ended during the year ended December 31, 2021. The Company recorded no amortization expense related to its intangible asset for the years ended December 31, 2023 and 2022 and recorded amortization expense of $ 1.1 million for the year ended December 31, 2021. As of December 31, 2021, the intangible asset was fully amortized. In connection with the first commercial sale of DAYBUE in April 2023, the Company made a milestone payment of $ 40.0 million pursuant to its 2018 license agreement with Neuren, as disclosed in Note 9. The Company capitalized the $ 40.0 million payment as an intangible asset and began amortizing the asset in April 2023 on a straight-line basis over the estimated useful life of the licensed patents through early 2036. The Company recorded amortization expense related to this inta ngible asset of $ 2.4 million f or the year ended December 31, 2023. As of December 31, 2023 , estimated future amortization expense related to the Company’s intangible asset was $ 3.1 million for each subsequent year. Following the FDA approval of DAYBUE, the Company was granted a Rare Pediatric Disease Priority Review Voucher (PRV). Pursuant to the license agreement, the Company is required to pay Neuren one third of the value of the PRV at the time of sale or use of the PRV. If the PRV is sold, the amount to be paid will be the sale value net of applicable fees. If the PRV is not sold but used by the Company, the amount to be paid will be the average price of the three most recent publicly announced sales of Rare Pediatric Disease PRVs immediately preceding the issuance of the PRV to the Company. The Company capitalized the $ 29.6 million for the estimated PRV value owed to Neuren as an intangible asset and began amortizing it in April 2023 on a straight-line basis over the estimated useful life of the licensed patents through early 2036. The Company recorded amortization expense related to this intangible asset of $ 1.7 million for the year ended December 31, 2023. As of December 31, 2023 , estimated future amortization expense related to the Company’s intangible asset was $ 2.3 million for each subsequent year. Royalties incurred in connection with the Company’s license agreement with Neuren, as disclosed in Note 9, are expensed to cost of product sales as revenue from product sales is recognized . Intangible Assets Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. A mortization of finite-lived intangible assets is recorded over the assets’ estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. We review our finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such intangible assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of intangible the assets exceeds the estimated fair value of the intangible assets. No impairment loss was recorded on intangible assets during the years ended December 31, 2023 or 2022 . Acquisitions The Company accounts for acquisitions of an asset or group of similar identifiable assets that do not meet the definition of a business as asset acquisition using the cost accumulation method, whereby the cost of the acquisition, including certain transaction costs, is allocated to the assets acquired on the basis of their relative fair values. No goodwill is recognized in an asset acquisition. Intangible assets acquired in an asset acquisition for use in research and development activities which have no alternative future use are expensed as in-process research and development on the acquisition date. Intangible assets acquired for use in research and development activities which have an alternative future use are capitalized as in-process research and development. Future costs to develop these assets are recorded to research and development expense as they are incurred. Contingent milestone payments associated with asset acquisitions are recognized when probable and estimable. These amounts are expensed to research and development if there is no alternative future use associated with the asset, or capitalized as an intangible asset if alternative future use of the asset exists. Advertising Expense Advertising costs are expensed when services are performed or goods are delivered. The Company incurred $ 9.4 million, $ 5.5 mil lion and $ 41.8 million in advertising costs during the years ended December 31, 2023, 2022 and 2021 , respectively. No advertising costs were capitalized as prepaid expenses at December 31, 2023 or 2022 . Revenue Recognition The Company operates in one business segment. Results of its operations are reported on a consolidated basis for purposes of s egment reporting, consistent with internal management reporting. Revenues consist of net product sales to customers, all of which are sales in the U.S. Revenues by product are as follows (in thousands): Years Ended December 31, 2023 2022 2021 NUPLAZID $ 549,248 $ 517,235 $ 484,145 DAYBUE 177,189 — — Product sales, net $ 726,437 $ 517,235 $ 484,145 Product Sales, Net The Company accounts for contracts with its customers in accordance with Revenue from Contracts with Customers (Topic 606) . The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Payment terms differ by customer, but typically range from 31 to 35 days from the date of shipment. Revenue for the Company’s product sales has not been adjusted for the effects of a financing component as the Company expects, at contract inception, that the period between when the Company transfers control of the product and when the Company receives payment will be one year or less. The Company’s product sales, net consist of U.S. sales of NUPLAZID and DAYBUE. NUPLAZID was approved by the FDA in April 2016 and the Company commenced shipments of NUPLAZID to SPs and SDs in late May 2016. SPs dispense product to a patient based on the fulfillment of a prescription and SDs sell product to government facilities, long-term care pharmacies, or in-patient hospital pharmacies. DAYBUE was approved by the FDA in March 2023 and the Company commenced shipments of DAYBUE to a single wholesale distributor in April 2023. Product shipping and handling costs are included in cost of product sales. The Company recognizes revenue from product sales at the net sales price (the “transaction price”) which includes estimates of variable consideration for which reserves for sales discounts and allowance are established and reflects each of these as either a reduction to the related account receivable or as an accrued liability, depending on how the amount payable is settled. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which the Company is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from estimates, the Company may need to adjust its estimates, which would affect net revenue in the period of adjustment. The following are the Company’s significant categories of sales discounts and allowances: Distribution Fees : Distribution fees include distribution service fees paid to the SPs, SDs and wholesale distributor based on a contractually fixed percentage of the wholesale acquisition cost (WAC), fees for data, and prompt payment discounts. Distribution fees are recorded as an offset to revenue based on contractual terms at the time revenue from the sale is recognized. Rebates : Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare Part D prescription drug benefit. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements with, or statutory requirements pertaining to, Medicaid and Medicare benefit providers. The allowance for rebates is based on statutory discount rates, estimated payor mix, and expected utilization. The Company’s estimates for expected utilization of rebates are based on historical data received from the SPs, SDs and single wholesale distributor since product launch. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for prior quarters’ unpaid rebates still estimated to be incurred. Allowances for rebates also include amounts due under the Inflation Reduction act of 2022 for Medicare Part D unit sales with applicable period AMP increases that outpace inflation over the benchmark period. The applicable period will be twelve months on October 1 of each year, with the initial applicable period beginning on October 1, 2022. The benchmark period AMP price is January 1, 2021 through September 30, 2021. The Company’s estimates are based Medicare Part D sales as a percentage of gross sales and the rate AMP for the current period will be in excess the benchmark period. Chargebacks : Chargebacks are discounts and fees that relate to contracts with government and other entities purchasing from the SDs at a discounted price. The SDs charge back to the Company the difference between the price initially paid by the SDs and the discounted price paid to the SDs by these entities. The Company also incurs group purchasing organization fees for transactions through certain purchasing organizations. The Company estimates sales with these entities and accrues for anticipated chargebacks and organization fees, based on the applicable contractual terms. Co-Payment Assistance : The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. Co-payment assistance is accrued for based on actual program participation and estimates of program redemption using data provided by third-party administrators. Product Returns : Consistent with industry practice, the Company offers the SPs and SDs limited product return rights for damages, shipment errors, and expiring product; provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SPs and SDs and has the ability to control the amount of product that is sold to the SPs and SDs, it is able to make a reasonable estimate of future potential product returns based on this on-hand channel inventory data and sell-through data obtained from the SPs and SDs. In arriving at its estimate for product returns, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry. Research and Development Expenses Research and development expenses are charged to operations as incurred. Research and development expenses include costs associated with services provided by contract organizations for preclinical development, pre-commercialization manufacturing expenses, and clinical trials, salaries and related personnel expenses including stock-based compensation expense, and facilities and equipment expenses. The upfront consideration and transaction costs associated with acquired in-process research and development are also included in the research and development expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices received from its external service providers. When the Company makes payments in advance of services being provided, it records those amounts as prepaid expenses on its consolidated balance sheets and expense them as the services are rendered. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. Other indirect costs are generally recognized on a straight-line basis over the estimated period of the study. As actual costs become known, the Company adjusts its accruals accordingly. Concentration Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash, cash equivalents, investment securities, accounts receivable, and restricted cash. The Company invests its excess cash primarily in money market funds, U.S. treasury notes, and high quality, marketable debt instruments of corporations and government sponsored enterprises in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least Aa3/AA- or better, or P-1/A-1 or better, as determined by Moody’s Investors Service or Standard & Poor’s. Further, the Company specifies credit quality standards for its customers that are designed to limit the Company’s credit exposure to any single party. The Company does not currently have any of its own manufacturing facilities, and therefore it depends on an outsourced manufacturing strategy for the production of NUPLAZID and DAYBUE for commercial use and for the production of its product candidates for clinical trials. For the production of NUPLAZID, the Company has contracts in place with two third-party manufacturers of commercial drug product and one third-party manufacturer of drug substance that is approved for the production of NUPLAZID API. For the production of DAYBUE, the Company has contracts in place with two third-party manufacturers of commercial drug product and two third-party manufacturers of drug substance that is approved for the production of DAYBUE API. Although there are potential sources of supply other than the Company’s existing suppliers, any new supplier would be required to qualify under applicable regulatory requirements. The Company has entered into agreements for the distribution of NUPLAZID with a limited number of SPs and SDs, and all of the Company’s product sales of NUPLAZID are to these customers. The Company has also entered into agreements for the distribution of DAYBUE with a single wholesale distributor, and all of the Company’s product sales of DAYBUE and accounts receivable balance at December 31, 2023 are related to this customer. For the year ended December 31, 2023 , the Company’s four largest customers, including the single wholesale distributor, represented approximately 69 % of the Company’s product revenue and 73 % of the Company’s accounts receivable balance at December 31, 2023. For the year ended December 31, 2022 , the Company’s four largest customers represented approximately 73 % of the Company’s product revenue and 74 % of the Company’s accounts receivable balance at December 31, 2022 . Stock-Based Compensation The fair value of each employee stock option and each employee stock purchase right granted is estimated on the grant date under the fair value method using the Black-Scholes valuation model. The estimated fair value of each stock option and purchase right is then expensed on a straight-line basis over the requisite service period, which is generally the vesting period. The following weighted-average assumptions were used during these periods: Years Ended December 31, 2023 2022 2021 Stock Options: Expected volatility 66 % 68 % 64 % Risk-free interest rate 3.9 % 2.9 % 0.9 % Expected dividend yield 0 % 0 % 0 % Expected life of options in years 5.4 5.4 5.4 Years Ended December 31, 2023 2022 2021 Employee Stock Purchase Plan: Expected volatility 40 %- 67 % 62 %- 82 % 49 %- 100 % Risk-free interest rate 4.0 %- 5.3 % 1.5 %- 4.6 % 0.0 %- 0.5 % Expected dividend yield 0 % 0 % 0 % Expected life in years 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected Volatility. The Company considers its historical volatility and implied volatility when determining the expected volatility. Risk-Free Interest Rate. The Company determines its risk-free interest rate assumption based on the U.S. Treasury yield for obligations with contractual terms similar to the expected term of the stock option or purchase right being valued. Expected Dividend Yield. The Company has never paid any dividends and currently has no plans to do so. Expected Life. In determining the expected life for stock options, the Company considers, among other factors, its historical exercise experience to date as well as the mean time remaining to full vesting of all outstanding options and the mean time remaining to the end of the contractual term of all outstanding options. The estimated life for the Company’s employee stock purchase rights is based upon the terms of each offering period. Forfeitures. The Company recognizes forfeitures as they occur. The fair value of restricted stock units (RSUs) is estimated based on the closing market price of the Company’s common stock on the date of grant. RSUs generally vest over a four-year period. Certain RSUs also have an accelerated vesting clause based on specified market condition target and continued employment through a minimum vesting period. The fair value of RSUs expected to vest are recognized and amortized on a straight-line basis over the requisite service period, which is generally the vesting period. For those RSUs requiring satisfaction of both market and service conditions, the requisite service period is the longest of the explicit, implicit and derived service periods. The fair value of performance-based stock units (PSUs) is estimated based on the closing market price of the Company’s common stock on the date of grant. PSUs vest upon the achievement of certain pre-defined company-specific performance-based criteria. Expense related to these PSUs is recognized ratably over the expected performance period once the pre-defined performance-based criteria for vesting becomes probable. During the year ended December 31, 2021, the Company had a change in estimate related to the achievement of certain performance-based criteria for performance-based stock awards which resulted in a reduction in stock-based compensation expenses by approximatel y $ 6.8 m illion. The table below summarizes the total stock-based compensation expense included in the Company’s consolidated statements of operations for the periods presented (in thousands): Years Ended December 31, 2023 2022 2021 Cost of product sales $ 1,007 $ 1,106 $ 1,286 Research and development 17,408 22,580 21,969 Sales, general and administrative 48,006 44,515 40,360 $ 66,421 $ 68,201 $ 63,615 Income Taxes Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and income tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits and loss carryforwards. Deferred income tax expense or benefit represents the net change during the year in the deferred income tax asset or liability. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company recognizes the impact of a tax position in the financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected in income tax expense. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, employee stock purchase rights, RSUs, and PSUs are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be antidilutive. The Company incurred net losses for all periods presented and there were no reconciling items for potentially dilutive securities. More specifically, at December 31, 2023, 2022 and 2021 , stock options, employee stock purchase plan rights, RSUs and PSUs covering a total of approximately 21,264,000 shares, 21,185,000 shares and 17,535,000 shares, respectively, were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive. Segment Reporting The Company uses “the management approach” in determining reportable operating segments. The management approach considers the internal organization and reporting used by the Company’s chief operating decision maker for making operating decisions and assessing performance as the source for determining the Company’s reportable segments. The Company’s chief operating decision maker is the chief executive officer who reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. Management has determined that the Company operates in one business segment which is the development and commercialization of innovative medicines. All revenues for the years ended December 31, 2023, 2022 and 2021 were generated from customers in the United States. Recently Issued Accounting Standards In November 2023, the FASB issued Accounting Standards Update No. 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures . The amendments require disclosure of incremental segment information on an annual and interim basis. The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification 280, Segment Reporting . The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company does not expect the ad |
Investments
Investments | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 3. Investments The carrying value and amortized cost of the Company’s investments, summarized by major security type, consisted of the following (in thousands): December 31, 2023 Amortized Unrealized Unrealized Estimated U.S. Treasury notes $ 75,315 $ 47 $ ( 28 ) $ 75,334 Government sponsored enterprise securities 174,867 119 ( 112 ) 174,874 $ 250,182 $ 166 $ ( 140 ) $ 250,208 December 31, 2022 Amortized Unrealized Unrealized Estimated U.S. Treasury notes $ 15,956 $ — $ ( 11 ) $ 15,945 Government sponsored enterprise securities 81,216 16 ( 291 ) 80,941 Municipal bonds 20,873 — ( 98 ) 20,775 Commercial paper 184,923 30 ( 637 ) 184,316 $ 302,968 $ 46 $ ( 1,037 ) $ 301,977 The Company has classified all of its available-for-sale investment securities, including those with maturities beyond one year, as current assets on its consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of December 31, 2023 and 2022, all of the Company’s available-for-sale investment securities have contractual maturity dates of less than one year . The Company has classified all equity securities as other assets on its consolidated balance sheets. At December 31, 2023 and 2022 , the Company had 21 and 43 securities, respectively, in an unrealized loss position. The following table presents gross unrealized losses and fair value for those available-for-sale investments that were in an unrealized loss position as of December 31, 2023 and December 31, 2022, aggregated by investment category and length of time that individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Unrealized Estimated Unrealized Estimated Unrealized December 31, 2023 U.S. Treasury notes $ 41,366 $ ( 28 ) $ — $ — $ 41,366 $ ( 28 ) Government sponsored enterprise securities 108,587 ( 112 ) — — 108,587 ( 112 ) Total $ 149,953 $ ( 140 ) $ — $ — $ 149,953 $ ( 140 ) December 31, 2022 U.S. Treasury notes $ 15,945 $ ( 11 ) $ — $ — $ 15,945 $ ( 11 ) Government sponsored enterprise securities 58,254 ( 291 ) — — 58,254 ( 291 ) Municipal bonds 20,775 ( 98 ) — — 20,775 ( 98 ) Commercial paper 135,200 ( 637 ) — — 135,200 ( 637 ) Total $ 230,174 $ ( 1,037 ) $ — $ — $ 230,174 $ ( 1,037 ) During the first quarter of 2023, the Company made a sale of all of its investments in commercial paper. The proceeds from sales of these securities were $ 183.0 million and net realized losses from the related sales were $ 0.5 million. There were no other sales of available-for-sale investment securities in prior periods. At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are the result of credit losses. Impairment is assessed at the individual security level. Factors considered in determining whether a loss resulted from a credit loss or other factors include the Company’s intent and ability to hold the investment until the recovery of its amortized cost basis, the extent to which the fair value is less than the amortized cost basis, the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, any historical failure of the issuer to make scheduled interest or principal payments, any changes to the rating of the security by a rating agency, any adverse legal or regulatory events affecting the issuer or issuer’s industry, any significant deterioration in economic conditions. The Company does not intend to sell the investment in unrealized loss position and it is unlikely that the Company will be required to sell the investment before the recovery of its amortized cost basis. Based on its evaluation, the Company determined its year-to-date credit losses related to its available-for-sale securities were immaterial at December 31, 2023 . |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The Company’s investments include cash equivalents, available-for-sale investment securities consisting of money market funds, U.S. treasury notes, and marketable debt instruments of corporations and government sponsored enterprises in accordance with the Company’s investment policy, and equity investments. The Company’s investment policy defines allowable investment securities and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least Aa3/AA- or better, or P-1/A-1 or better, as determined by Moody’s Investors Service or Standard & Poor’s. The Company’s cash equivalents, available-for-sale investment securities, and equity securities are classified within the fair value hierarchy as defined by authoritative guidance. The Company’s investment securities and equity securities classified as Level 1 are valued using quoted market prices. The Company obtains the fair value of its Level 2 financial instruments from third-party pricing services. The pricing services utilize industry standard valuation models whereby all significant inputs, including benchmark yields, reported trades, broker/dealer quotes, issuer spreads, bids, offers, or other market-related data, are observable. The Company validates the prices provided by the third-party pricing services by reviewing their pricing methods and matrices and obtaining market values from other pricing sources. After completing the validation procedures, the Company did not adjust or override any fair value measurements provided by these pricing services as of December 31, 2023 and 2022, respectively. In November 2021, the Company established a plan whereby substantially all full-time employees excluding executive management are eligible to receive a series of cash bonuses based on achievement of certain conditions as described in more detail in Note 6 to the consolidated financial statements. The Company estimated the fair value of the cash awards using a Monte Carlo simulation, which utilizes level 3 inputs such as volatility, probabilities of success, and other inputs that are not observable in active markets. The cash awards are required to be measured at fair value on a recurring basis each reporting period, with changes in the fair value recognized as compensation cost over the derived service period of the awards. The Company has not transferred any investment securities between the classification levels. The recurring fair value measurements of the Company’s cash equivalents, available-for-sale investment securities, and equity securities at December 31, 2023 and 2022 consisted of the following (in thousands): Fair Value Measurements at December 31, 2023 Quoted Prices Significant Significant Assets Money market fund $ 64,586 $ 64,586 $ — $ — U.S. Treasury notes 75,334 75,334 — — Government sponsored enterprise securities 174,874 — 174,874 — Total $ 314,794 $ 139,920 $ 174,874 $ — Liabilities Cash awards $ 4,506 $ — $ — $ 4,506 Total $ 4,506 $ — $ — $ 4,506 Fair Value Measurements at December 31, 2022 Quoted Prices Significant Significant Assets Money market fund $ 72,578 $ 72,578 $ — $ — U.S. Treasury notes 15,945 15,945 — — Equity securities 7,180 7,180 — — Government sponsored enterprise securities 94,803 — 94,803 — Municipal bonds 20,775 — 20,775 — Commercial paper 184,316 — 184,316 — Total $ 395,597 $ 95,703 $ 299,894 $ — Liabilities Cash awards $ 898 $ — $ — $ 898 Total $ 898 $ — $ — $ 898 Changes in estimated fair value of contingent cash awards during the twelve months ended December 31, 2023 are as follows (in thousands): Balance as of December 31, 2022 $ 898 Vesting of awards 772 Expense forfeited ( 128 ) Change in fair value 2,964 Balance as of December 31, 2023 $ 4,506 |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | 5. Balance Sheet Details Inventory consisted of the following (in thousands): December 31, 2023 2022 Finished goods $ 5,001 $ 1,926 Work in process 4,134 4,427 Raw material 31,312 5,207 $ 40,447 $ 11,560 Reported as: Inventory $ 35,819 $ 6,636 Long-term inventory 4,628 4,924 Total $ 40,447 $ 11,560 Amount reported as long-term inventory consisted of raw materials as of December 31, 2023 and 2022. The Company has raw materials beyond its one-year production plan that prevent the Company from potential supply interruption. Those raw materials maintained beyond the one-year production plan are classified as long-term inventory. Property and equipment, net, consisted of the following (in thousands): December 31, 2023 2022 Computers and software $ 5,873 $ 5,873 Leasehold improvements 3,746 3,696 Furniture and fixtures 4,549 4,549 14,168 14,118 Accumulated depreciation ( 9,556 ) ( 8,097 ) $ 4,612 $ 6,021 Depreciation of property and equipment was $ 1.5 million, $ 2.0 million, and $ 2.2 million for the years ended December 31, 2023, 2022, and 2021, respectively. For the year ended December 31, 2023, the Compan y did no t retire any fully depreciated property and equipment. For the year ended December 31, 2022 , the Company retired $ 0.1 million of fully depreciated property and equipment. During 2021, the Company did not retire any fully depreciated property and equipment. Accrued liabilities consisted of the following (in thousands): December 31, 2023 2022 Accrued sales allowances $ 90,718 $ 26,046 Accrued compensation and benefits 42,718 28,023 Accrued research and development services 32,883 35,048 Accrued contingent payments 29,583 — Accrued consulting and professional fees 18,804 11,377 Current portion of lease liabilities 9,405 9,305 Accrued taxes 1,564 377 Other 11,036 2,708 $ 236,711 $ 112,884 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 6. Stockholders’ Equity Equity Awards The Company’s 2010 Equity Incentive Plan, as amended to date (the 2010 Plan), permits the grant of options to employees, directors and consultants. In addition, the 2010 Plan permits the grant of stock bonuses, rights to purchase restricted stock, and other stock awards. The exercise price of options granted under the 2010 Plan cannot be less than 100 percent of the fair market value of the common stock on the date of grant and the maximum term of any option is 10 years. Options granted under the 2010 Plan generally vest over a four-year period. All shares that remained eligible for grant under the Company’s 2004 Equity Incentive Plan (the 2004 Plan) at the time of approval of the 2010 Plan were transferred to the 2010 Plan. The 2010 Plan share reserve also has been, and may be, increased by the number of shares that otherwise would have reverted to the 2004 Plan reserve after June 2010. In June 2015, June 2016, June 2017, June 2018, June 2019 and June 2022, the Company’s stockholders approved amendments to its 2010 Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 5,000,000 shares, 3,000,000 shares, 5,500,000 shares, 6,700,000 shares, 8,300,000 shares and 6,000,000 shares, respectively. At December 31, 2023, there wer e 30,490,486 shar es of common stock authorized for issuance, of wh ich 7,731,848 share s were available for new grants under the 2010 Plan. Stock Options The 2010 Plan provided for the grant of options to employees, directors and consultants. The exercise price of options granted under the 2010 Plan was at 100 percent of the fair market value of the common stock on the date of grant and the maximum term of any option was 10 years. Options granted under the 2010 Plan generally vested over a four-year period. The following table summarizes the Company’s stock option activity during the year ended December 31, 2023: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2022 16,339,465 $ 29.83 Granted 3,157,634 $ 21.99 Exercised ( 1,046,035 ) $ 19.42 Cancelled/forfeited ( 1,825,035 ) $ 32.07 Outstanding at December 31, 2023 16,626,029 $ 28.75 5.6 $ 90,962 Vested and exercisable at December 31, 2023 11,152,607 $ 31.12 4.2 $ 44,951 Unvested at December 31, 2023 5,473,422 $ 23.92 8.4 $ 46,012 The aggregate intrinsic value of options exercisable as of December 31, 2023 is calculated as the difference between the exercise price of the underlying options and the closing market price of the Company’s common stock on that date, which was $ 31.31 per share. The aggregate intrinsic value of options exercised during the years ended December 31, 2023, 2022, and 2021 was approximately $ 7.9 million, $ 1.7 million, and $ 8.0 million, respectively, determined as of the date of exercise. The Company receive d approximately $ 20.3 million, $ 3.7 millio n and $ 12.9 million in cash from options exercised during the years ended December 31, 2023, 2022 and 2021, respectively. The weighted average per share fair value of options granted during the years ended December 31, 2023, 2022, and 2021 was approximately $ 13.25 , $ 13.66 , and $ 24.07 , respectively. As of December 31, 2023, 2022 and 2021 , total unrecognized compensation cost related to stock options was approximately $ 62.1 million, $ 63.9 million and $ 66.0 million , and the weighted averag e period over which this cost is expected to be recognized is approximately 2.6 years, 2.7 years and 2.3 years, respectively. Restricted Stock The Company grants RSUs and PSUs, both of which are considered restricted stock, pursuant to the 2010 Plan and satisfies such grants through the issuance of new shares. RSUs are share awards that, upon vesting, will deliver to the holder shares of the Company’s common stock. RSUs generally vest over a four-year period. Certain RSUs also have an accelerated vesting clause based on a specified market condition target and continued employment through the vesting period. PSUs for which the number of shares issuable at the end of performance period can reach up to 200% of the shares approved in the award based on the achievement of certain pre-defined Acadia-specific performance criteria and continued employment through the vesting period . The following table summarizes the Company’s restricted stock activity during the year ended December 31, 2023: Number of Weighted Aggregate Outstanding at December 31, 2022 4,187,107 $ 29.49 Granted 1,960,482 $ 21.97 Vested ( 1,190,814 ) $ 28.09 Cancelled/forfeited ( 571,030 ) $ 28.23 Outstanding at December 31, 2023 4,385,745 $ 26.67 $ 134,440 There were 1,734,828 , 2,055,574 and 1,276,936 PSUs outstanding at December 31, 2023, 2022 and 2021, respectivel y, of which 484,757 , 1,057,741 and 639,700 were related to the RSUs with an accelerated vesting clause based on a specified market condition target and continued employment through the vesting period. During the years ended 2023, 2022 and 2021, 517,290 , 986,739 , and 918,434 PSUs were granted, respectively, of which 459,420 were vested during the year ended December 31, 2023. There was no vesting during the years ended December 31, 2022 and 2021. D uring the years ended December 31, 2023, 2022 and 2021, total intrinsic value of PSUs outstanding was $ 50.0 million, $ 32.7 million and $ 29.8 million, respectively. Total unrecognized compensation cost related to RSUs was approximately $ 46.7 million, $ 44.6 million and $ 39.8 million for the years ended December 31, 2023, 2022 and 2021 , respectively, and the weighted average period over which the cost is expected to be recognized is approximately 2.9 years, 2.7 years and 2.3 years, respectively. Total unrecognized compensation cost related to PSUs was approximately $ 5.7 million, $ 12.7 million and $ 11.5 million for the years ended December 31, 2023, 2022 and 2021, respectively, and the weighted average remaining contractual term related to outstanding PSUs was 3.2 years, 3.0 years and 3.3 years, respectively. Employee Stock Purchase Plan The Company’s 2004 Employee Stock Purchase Plan (the Purchase Plan) became effective upon the closing of the Company’s initial public offering in June 2004. In June 2016, June 2019 and June 2020, the Company’s stockholders approved an amendment to the Purchase Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the Purchase Plan by 400,000 shares, 600,000 shares and 3,000,000 shares, respectively. At December 31, 2023, a total o f 5,525,000 sha res of common stock had been reserved for issuance under the Purchase Plan. At December 31, 2023 , 2,131,122 shares of common stock remained available for issuance pursuant to the Purchase Plan. Eligible employees who elect to participate in an offering under the Purchase Plan may have up to 15 percent of their earnings withheld, subject to certain limitations, to purchase shares of common stock pursuant to the Purchase Plan. The price of common stock purchased under the Purchase Plan is equal to 85 percent of the lower of the fair market value of the common stock at the commencement date of each offering period or the relevant purchase date. During the years ended December 31, 2023, 2022, and 2021, a total of 348,498 , 330,525 and 296,850 shares of common stock were issued under the Purchase Plan at average per share prices of $ 13.83 , $ 13.60 , and $ 17.89 , respectively. The weighted ave rage per share fair value of purchase rights granted during the years ended December 31, 2023, 2022, and 2021 was $ 22.25 , $ 13.91 , and $ 23.97 , respectively. During the years ended December 31, 2023, 2022, and 2021, the Company recorded cash received from the exercise of purchase rights of $ 4.8 million, $ 4.5 million, and $ 5.3 million, respectively. Contingent Cash Awards In November 2021, the Company established a plan whereby substantially all full-time employees excluding executive management are eligible to receive a series of cash bonuses over certain periods based on continued employment and the Company’s stock price reaching a pre-specified target. The maximum potential payout of the cash awards at the grant date was $ 15.1 million. The Company has determined that the cash awards were classified as liabilities pursuant to ASC Topic 718, Compensation – Stock Compensation . The Company estimates the fair value of the awards at each reporting period using the Monte Carlo simulation, which is recognized as compensation cost over the derived service period . Total fair value of the awards at the grant date was $ 4.4 million. The maximum potential payout at December 31, 2023 after adjusting for forfeitures was $ 10.1 million. The total fair value of the awards at December 31, 2023 was approximately $ 5.2 million, compared to $ 1.8 million at December 31, 2022. The estimated liability included on the December 31, 2023 and 2022 consolidated balance sheets was $ 4.5 mill ion and $ 0.9 million. During years ended December 31, 2023 and 2022 , the Company recorded a total of $ 3.6 million and $ 0.3 million compensation cost related to the awards. 2023 Inducement Plan The Board adopted the Company’s 2023 Inducement Plan (the Inducement Plan) on February 1, 2023. The Inducement Plan p ermits the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards and other stock-related awards. Stock awards granted under the Inducement Plan may only be made to individuals who did not previously serve as employees or non-employee directors of the Company or an affiliate of the Company. In addition, stock awards must be approved by either a majority of the Company’s independent directors or the Compensation Committee. The terms of the Inducement Plan are otherwise substantially similar to the Company’s 2010 Equity Incentive Plan. The maximum number of shares of Company common stock that may be issued under the Inducement Plan is 1,750,000 shares. At December 31, 2023 , there were 599,864 shares available for new grants. |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
401(k) Plan | 7. 401(k) Plan Effective January 1997, the Company established a deferred compensation plan (the 401(k) Plan) pursuant to Section 401(k) of the Internal Revenue Code of 1986, as amended (the Code), whereby substantially all employees are eligible to contribute up to 60 percent of their pretax earnings, not to exceed amounts allowed under the Code. The Company makes discretionary contributions to the 401(k) Plan equal to 100 percent of each employee’s pretax contributions up to 5 percent of his or her eligible compensation, subject to limitations under the Code. The Company’s total contributions to the 401(k) Plan were $ 6.1 mil lion, $ 5.1 million, and $ 5.8 million for the years ended December 31, 2023, 2022, and 2021 , respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes Domestic and foreign pre-tax income (loss) is as follows (in thousands): Years Ended December 31, 2023 2022 2021 Domestic $ ( 100,215 ) $ ( 233,216 ) $ ( 138,913 ) Foreign 49,179 19,772 ( 28,606 ) $ ( 51,036 ) $ ( 213,444 ) $ ( 167,519 ) The income tax provision consists of the following (in thousands): Years Ended December 31, 2023 2022 2021 Current provision: Federal $ 5,440 $ — $ — State 4,805 2,531 351 Foreign 5 — — Total deferred tax assets 10,250 2,531 351 Total income tax provision $ 10,250 $ 2,531 $ 351 At December 31, 2023, the Company had federal, state, and foreign net operating loss (NOL) carryforwards of approximately $ 196.8 million, $ 456.3 million, and $ 845.1 million, respectively. Utilization of the domestic NOL and research and development (R&D) credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred or that could occur in the future, as required by Section 382 of the Code, as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders or public groups. The Company previously completed a study to assess whether an ownership change, as defined by Section 382 of the Code, had occurred from the Company’s formation through December 31, 2013. Based upon this study, the Company determined that several ownership changes had occurred. Accordingly, the Company reduced its deferred tax assets related to the federal NOL carryforwards and the federal R&D credit carryforwards that are anticipated to expire unused as a result of these ownership changes. These tax attributes were excluded from deferred tax assets with a corresponding reduction of the valuation allowance with no net effect on income tax expense or the effective tax rate. The Company completed a study through December 31, 2022 and concluded no additional ownership changes occurred. Future ownership changes may further limit the Company’s ability to utilize its remaining tax attributes. The Company had federal and state carryforwards of $ 29.4 million and $ 454.4 million that will begin to expire in 2031 and 2024 respectively unless utilized. The remaining federal and state NOL carryforwards of $ 167.4 million and $ 1.9 million will carry forward indefinitely. At December 31, 2023, the Company had federal and state charitable contribution carryforwards of $ 174.8 million which will begin to expire in 2024. At December 31, 2023, the Company had $ 75.6 million of federal R&D credit carryforwards, of which $ 0.5 million will expire in 2024 unless utilized, and the remaining federal R&D credit carryforwards will begin to expire beginning in 2025. At December 31, 2023 , the Company had state R&D credit carryforwards of approximately $ 2.3 million that will begin to expire in 2025 and $ 20.3 million that have no expiration date. At December 31, 2023, the Company had foreign NOL carryforwards of $ 231.6 million that will expire in 2024 unless utilized and $ 6.5 million that have no expiration date. The Company continues to record the deferred tax assets related to these attributes, subject to valuation allowance, until expiration occurs. The components of the deferred tax assets are as follows (in thousands): December 31, 2023 2022 Deferred tax assets NOL carryforwards $ 149,049 $ 225,993 R&D credit carryforwards 70,906 83,074 Capitalized R&D 90,164 38,507 Stock-based compensation 51,028 51,661 Charitable contributions 40,956 42,677 Lease liabilities 13,671 14,730 Intangibles 43,220 24,030 Property and equipment 51 — Accrued rebates 19,401 5,748 Other 16,036 8,022 Total deferred tax assets 494,482 494,442 Valuation allowance ( 482,089 ) ( 481,210 ) Deferred tax liabilities Property and equipment — ( 29 ) Right-of-use assets ( 12,393 ) ( 13,203 ) Total deferred tax liabilities ( 12,393 ) ( 13,232 ) Total net deferred tax assets $ — $ — Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by approximately $ 0.9 million in 2023 primarily due to an increase in deferred tax assets generated by capitalization of research and development expenses, acquired intangibles and accrued rebates, offset in part by the utilization of US and state net operating losses and research credits, the expiration of Switzerland NOLs, and the remeasurement of the Company’s deferred tax balance for future state tax rates. An accounting policy may be selected to either (i) treat taxes due on future U.S. inclusions in taxable income related to global intangible low-taxed income (GILTI) as a current-period expense when incurred or (ii) factor such amounts into a company’s measurement of its deferred taxes. The Company has elected to account for GILTI as a period cost. A reconciliation of income taxes to the amount computed by applying the statutory federal income tax rate to the pretax loss is summarized as follows (in thousands): Years Ended December 31, 2023 2022 2021 Amounts computed at statutory federal rate $ ( 10,718 ) $ ( 44,823 ) $ ( 35,179 ) Stock-based compensation and other permanent differences 8,458 7,596 6,083 Branded pharmaceutical drug fee 1,848 1,454 613 Write-off of IP R&D — 2,449 1,277 R&D credits ( 5,827 ) ( 9,974 ) ( 11,727 ) Change in valuation allowance 1,100 11,227 36,099 State taxes ( 977 ) ( 2,232 ) ( 2,617 ) Contingencies ( 2,071 ) 6,993 3,879 Foreign rate differential ( 5,076 ) ( 1,971 ) 2,857 Deferred adjustments for limits on executive compensation 2,112 3,918 1,808 Deferred rate adjustment ( 192 ) 922 ( 2,424 ) Switzerland tax reform ( 246 ) — ( 923 ) Expiration of attributes 17,225 16,142 726 GILTI 7,665 10,804 — Other ( 3,051 ) 26 ( 121 ) Income tax expense $ 10,250 $ 2,531 $ 351 The tax years 2003-2022 remain open to examination by the major taxing jurisdictions to which the Company is subject. The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination. The Company recorded an uncertain tax position reserve of $ 18.0 million, $ 5.1 million and $ 4.1 million for the years ended December 31, 2023, 2022 and 2021 , respectively. Due to the valuation allowance recorded against the Company’s deferred tax assets, approximately $ 6.8 million and $ 1.2 million of the total unrecognized tax benefits as of December 31, 2023 and December 31, 2022, respectively, would reduce the annual effective tax rate if recognized. The Company does not anticipate that the amount of unrecognized tax benefits as of December 31, 2023 will significantly change within the next twelve months. The Company’s practice is to recognize interest and/or penalties related to uncertain income tax positions in income tax expense. The Company had immaterial interest and/or penalties accrued on the Company’s consolidated balance sheets at December 31, 2023 or 2022, respectively. Further, the Company recognized an insignificant amount of interest and/or penalties in the statement of operations for the years ended December 31, 2023, 2022 and 2021, respectively, related to uncertain tax positions. The following table provides a reconciliation of changes in unrecognized tax benefits (in thousands): Years Ended December 31, 2023 2022 2021 Balance at beginning of period $ 19,064 $ 13,923 $ 9,843 Additions related to current period tax positions 5,304 5,140 3,973 Additions related to prior period tax positions 12,956 38 140 Reductions related to prior period tax positions ( 212 ) ( 37 ) ( 33 ) Balance at end of period $ 37,112 $ 19,064 $ 13,923 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies License and Merger Agreements The Company has entered into various collaboration, licensing and merger agreements which provide the Company with rights to certain know-how, technology and patent rights. The agreements generally include upfront license fees, development and commercial milestone payments upon achievement of certain clinical and commercial development and annual net sales milestones, as well as royalties calculated as a percentage of product revenues, with rates that vary by agreement. The Company incurred $ 102.5 million, $ 88.7 million and $ 11.0 million in upfront and license payments in the years ended December 31, 2023, 2022 and 2021, respectively. These upfront and license payments were included in the research and development expenses in the consolidated statements of operations as there was no alternative future use associated with the payments. As of December 31, 2023, the Company may be required to make milestone payments up to $ 3.4 billion in the aggregate for candidates in its pipeline. In May 2018, the Company signed an Exclusivity Deed (the Deed) with Neuren that provided for exclusive negotiations for a period of three months from the date of the Deed. Under the terms of the Deed, the Company invested $ 3.1 million to subscribe for 1,330,000 shares of Neuren and paid $ 0.9 million for the exclusive right to negotiate a deal with Neuren, which was recorded in selling, general and administrative expenses in the consolidated statements of operations in the second quarter of 2018. In 2023 , the Company sold the 1,330,000 shares of Neuren for total proceeds of $ 12.3 million. Net gain on the strategic investments recognized in other income in the consolidated statements of operations for the year ended December 31, 2023, 2022 and 2021 was $ 5.1 million, $ 3.5 million and $ 2.3 million, respectively . In August 2018, the Company entered into a license agreement with Neuren and obtained exclusive North American rights to develop and commercialize trofinetide for Rett syndrome and other indications. Under the terms of the agreement, the Company paid Neuren an upfront license fee of $ 10.0 million and it may be required to pay up to an additional $ 455.0 million in milestone payments based on the achievement of certain development and annual net sales milestones. In addition, the Company will be required to pay Neuren tiered, escalating, double-digit percentage royalties based on net sales. The license agreement was accounted for as an asset acquisition and the upfront cash payment of $ 10.0 million was expensed to research and development in the third quarter of 2018 as there is no alternative use for the asset. In connection with the FDA approval of DAYBUE, the Company paid a milestone payment of $ 40.0 million to Neuren following the first commercial sale of DAYBUE pursuant to the license agreement. The Company capitalized the $ 40.0 million milestone payment as an intangible asset as it was deemed probable of occurring as of March 31, 2023. In addition, the Company was granted a Rare Pediatric Disease PRV following the FDA approval of DAYBUE. Pursuant to the license agreement, the Company is required to pay Neuren one third of the value of the PRV at the time of sale or use of the PRV. The Company capitalized the $ 29.6 million for the estimated PRV value owed to Neuren as an intangible asset. In July 2023, the Company expanded its licensing agreement for trofinetide with Neuren to acquire rights to the drug outside of North America as well as global rights in Rett syndrome and Fragile X syndrome to Neuren’s development candidate NNZ-2591. Under the terms of the expanded agreement, Neuren received an upfront payment of $ 100.0 million and is eligible to receive up to an additional $ 426.3 million in milestone payments based on the achievement of certain commercial and sales milestones for trofinetide outside of North America and up to $ 831.3 million in milestone payments based on the achievement of certain development and sales milestones for NNZ-2591. In addition, the Company will be required to pay Neuren tiered royalties from the mid-teens to low-twenties percent of trofinetide net sales outside of North America. Percentage royalties related to NNZ-2591 net sales are identical to the trofinetide in each of North America and outside North America. The expanded license agreement was accounted for as an asset acquisition and the upfront cash payment of $ 100.0 million was expensed to research and development in the third quarter of 2023 as there is no alternative use for the asset. In January 2022, the Company entered into a license and collaboration agreement with Stoke to discover, develop and commercialize novel RNA-based medicines for the potential treatment of severe and rare genetic neurodevelopmental diseases of the CNS. The collaboration includes SYNGAP1 syndrome, Rett syndrome (MECP2), and an undisclosed neurodevelopmental target. For the SYNGAP1 program, the two companies will jointly share global research, development and commercialization responsibilities and share 50/50 in all worldwide costs and future profits. In addition, Stoke is eligible to receive potential development, regulatory, first commercial sales and sales milestones. For the MECP2 program and the undisclosed neurodevelopmental program, the Company acquired an exclusive worldwide license to develop and commercialize MECP2 program and the undisclosed neurodevelopmental program. Stoke will lead research and pre-clinical development activities, while the Company will lead clinical development and commercialization activities. The Company will fund research and pre-clinical development activities related to these two targets and Stoke is eligible to receive potential development, regulatory, first commercial sales and sales milestones as well as tiered royalty payments on worldwide sales starting in the mid-single digit range and escalating to the mid-teens based on revenue levels. Under the terms of the agreement, the Company paid Stoke a $ 60.0 million upfront payment which was accounted for as an asset acquisition and was expensed to research and development in the first quarter of 2022 as there is no alternative use for the asset. The Company may be required to pay up to an additional $ 907.5 million in milestones as well as royalties on future sales. Corporate Credit Card Program In connection with the Company’s credit card program, the Company established a letter of credit in 2016 for $ 2.0 million, which has automatic annual extensions and is fully secured by restricted cash. Fleet Program In connection with the Company’s fleet program, the Company established a letter of credit for $ 0.4 million, which has automatic annual extensions and is fully secured by restricted cash. Legal Proceedings Patent Infringement On July 24, 2020, the Company filed complaints against (i) Aurobindo Pharma Limited and its affiliate Aurobindo Pharma USA, Inc. and (ii) Teva Pharmaceuticals USA, Inc. and its affiliate Teva Pharmaceutical Industries Ltd., and on July 30, 2020, the Company filed complaints against (i) Hetero Labs Limited and its affiliates Hetero Labs Limited Unit-V and Hetero USA Inc., (ii) MSN Laboratories Private Ltd. and its affiliate MSN Pharmaceuticals, Inc., and (iii) Zydus Pharmaceuticals (USA) Inc. and its affiliate Cadila Healthcare Limited. These complaints, which were filed in the United States District Court for the District of Delaware, allege infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID (Pimavanserin I Cases). The cases have been assigned to the Honorable Richard G. Andrews. On September 1, 2020, Aurobindo filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On September 22, 2020, the Company filed its answer to Aurobindo’s counterclaims. On August 31, 2020, Teva filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On September 21, 2020, the Company filed its answer to Teva’s counterclaims. On October 5, 2020, Hetero filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On October 26, 2020, the Company filed its answer to Hetero’s counterclaims. On September 30, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On November 5, 2020, the Company filed its first amended complaint against MSN in the United States District Court for the District of Delaware, alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On November 19, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On December 10, 2020, the Company filed its answer to MSN’s counterclaims. On November 2, 2020, Zydus filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On November 23, 2020, the Company filed its answer to Zydus’s counterclaims. On December 8, 2020, the parties’ joint proposed scheduling order was entered by Judge Andrews. On April 7, 2021, the Company filed its first amended complaints against Hetero and Teva and its second amended complaint against MSN, to include an additional Orange Book-listed patent covering NUPLAZID. On April 8, 2021, the Company filed its first amended complaint against Zydus and on April 9, 2021, the Company filed its first amended complaint against Aurobindo. On April 20, 2021, MSN filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On April 21, 2021, Teva filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On April 22, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On April 22, 2021, Aurobindo filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On May 11, 2021, the Company filed its answer to MSN’s counterclaims. On May 12, the Company filed its answer to Teva’s counterclaims. On May 13, the Company filed its answer to Zydus’s counterclaims and its answer to Aurobindo’s counterclaims. The Company entered into an agreement effective April 22, 2021 with Hetero settling all claims and counterclaims in the litigation. The agreement allows Hetero to launch its generic pimavanserin product on February 27, 2038, subject to certain triggers for earlier launch. The Hetero case was dismissed by joint agreement on May 3, 2021. On August 27, 2021, the Company filed its second amended complaint against Zydus to include an additional Orange Book-listed patent covering NUPLAZID. On September 10, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity. Also on September 10, 2021, the parties filed their Joint Claim Construction Chart. On October 1, 2021, the Company filed its answer to Zydus’s counterclaims. On November 30, 2021, the Company filed a stipulation and proposed order to dismiss two of its Orange Book-listed patents covering NUPLAZID against Teva, which was ordered by the Court on December 1, 2021. On January 28, 2022, the parties filed their Joint Claim Construction Brief and Appendix. On February 23, 2022, the Court heard oral argument on claim construction. On April 6, 2022, the Court issued a Memorandum Opinion construing several terms at issue, adopting the Company’s construction on two terms, Defendants’ construction on two terms, and one agreed-upon construction. On February 28, 2022, the Company filed a stipulation and proposed order to dismiss one patent against MSN, which was ordered by the Court on March 1, 2022. On March 10, 2022, the Company filed a stipulation and proposed order to dismiss one patent against Teva, which was ordered by the Court on March 10, 2022. On March 22, 2022, the Company filed a stipulation and proposed order to dismiss seven patents against Aurobindo, which was ordered by the Court on March 22, 2022. On March 30, 2022, the Company filed a stipulation and proposed order to dismiss two patents against Zydus, which was ordered by the Court on March 31, 2022. On April 22, 2022, the Company filed a stipulation and proposed order of non-infringement against Aurobindo regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 22, 2022. On April 26, 2022, the Company filed a stipulation and proposed order of non-infringement against MSN regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 26, 2022. On April 26, 2022, the Company filed a stipulation and proposed order of non-infringement against Teva regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 27, 2022. On May 10, 2022, the Company filed its second amended complaint against Teva to include an additional Orange Book-listed patent covering NUPLAZID. On May 18, 2022, the Company filed a stipulation and proposed order of non-infringement against Zydus regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on May 19, 2022. On May 24, 2022, Teva filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 1, 2022, the Company filed its second amended complaint against Aurobindo alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 2, 2022, the Company filed its third amended complaint against Zydus alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 14, 2022, the Company filed its answer to Teva’s counterclaims. June 15, 2022, Aurobindo filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 16, 2022, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s third amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On July 6, 2022, the Company filed its answer to Aurobindo’s counterclaims. On September 7, 2022, the consolidated cases were reassigned to the Honorable Judge Gregory B. Williams. On September 30, 2022, the Company filed a stipulation and proposed order to stay the claims currently asserted against Teva and for Teva to be bound by the result of the litigation rendered against the remaining Defendants, which was ordered by the Court on October 4, 2022. On October 21, 2022, the Company filed complaints against Aurobindo, MSN and Zydus in the United States District Court for the District of Delaware alleging infringement of an additional Orange Book-listed patent covering NUPLAZID (Pimavanserin II Cases). On March 29, 2023, following Aurobindo’s conversion of various patent certifications from Paragraph IV certifications to Paragraph III certifications in connection with the Pimavanserin I Case, the Company filed a stipulation and proposed order in the Pimavanserin I Case to dismiss the remaining asserted patents against Aurobindo. This stipulation was ordered by the Court on March 30, 2023. The Company entered into an agreement, effective March 31, 2023, with Zydus settling all claims and counterclaims in the Pimavanserin I Cases and Pimavanserin II Cases. The agreement allows Zydus to launch its generic pimavanserin 10 mg products on September 23, 2036 and 34 mg products on February 27, 2038, subject to certain triggers for earlier launch. On April 4, 2023, the Company filed a stipulation and proposed order to dismiss all claims and counterclaims between the Company and Zydus in the Pimavanserin I Cases and Pimavanserin II Cases, which was ordered by the Court on April 5, 2023. As a result of the above, only MSN remained as an active defendant in the Pimavanserin I Cases. On April 6, 2023, the Company and MSN filed a stipulation and proposed order requesting adjournment of the final pre-trial conference and trial, and requesting resolution of the remaining issue – MSN’s validity challenge of the sole patent in suit – through summary judgment briefing by the parties, which was ordered by the Court on April 10, 2023. Briefing was completed on June 28, 2023 and oral argument took place on September 27, 2023. On December 13, 2023, the Court ruled in the Company’s favor on the summary judgment motions – denying MSN’s motion for summary judgment of invalidity and granting the Company’s cross-motion for no invalidity. MSN had previously stipulated to infringement of the patent-in-suit. On January 11, 2024, the District Court entered final judgment in the Company’s favor that MSN’s submission of ANDA No. 214925 was an act of infringement in the Pimavanserin I Case. On January 18, 2024, MSN filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit from the December 13, 2023 Memorandum Order of the United States District Court for the District of Delaware, and final judgment entered on January 11, 2024. On February 12, 2024, the Company filed an Entry of Appearance for the appeal to the United States Court of Appeals for the Federal Circuit. MSN’s Opening Appeal Brief is due on March 29, 2024. In connection with the Pimavanserin II cases, MSN and Aurobindo are the remaining defendants. On December 13, 2023, the Court issued a claim construction order finding in favor of the Company on all disputed terms of the patent-in-suit. Fact discovery closes on March 21, 2024. Trial is scheduled in the matter for December 3, 2024 to December 5, 2024. Securities Class Action On April 19, 2021, a purported stockholder of the Company filed a putative securities class action complaint (captioned Marechal v. Acadia Pharmaceuticals, Inc., Case No. 21-cv-0762) in the U.S. District Court for the Southern District of California against the Company and certain of the Company’s current executive officers. On September 29, 2021, the Court issued an order designating lead plaintiff and lead counsel. On December 10, 2021, lead plaintiff filed an amended complaint. The amended complaint generally alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, by failing to disclose that the materials submitted in support of its sNDA seeking approval of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis contained statistical and design deficiencies and that the FDA was unlikely to approve the sNDA in its current form. The amended complaint seeks unspecified monetary damages and other relief. Defendants filed a motion to dismiss the amended complaint on February 15, 2022. On September 27, 2022, the Court issued an order denying Defendants’ motion to dismiss. Defendants filed their answer to the amended complaint on October 19, 2022, and filed a motion for reconsideration on October 25, 2022. On February 2, 2023, the Court issued an order denying the motion for reconsideration. On August 21, 2023, plaintiffs filed a motion for class certification. Briefing on that motion concluded on January 12, 2024, and the Court will hear oral argument on the motion on February 28, 2024. The parties are currently engaged in discovery. The cutoff for fact discovery is June 13, 2024. Derivative Suit On December 15, 2023, a purported stockholder of the Company filed a derivative action (captioned Kanner et al v. Biggar et al. , Case No. 23-cv-2293) in the U.S. District Court for the Southern District of California against certain of the Company’s current directors. The Company is named as a nominal defendant. The complaint is based on the same alleged misconduct as the Securities Class Action, and asserts state law claims, on behalf of the Company, against the individual defendants for breach of fiduciary duty, unjust enrichment, abuse of control, waste of corporate assets, and insider trading. The complaint also asserts federal claims under sections 10(b), 21D, and 14(a) of the Securities Exchange Act of 1934, as amended. On December 27, 2023, the action was reassigned to District Judge William Q. Hayes and Magistrate Judge Michael S. Berg due to its relation to the Securities Class Action. On January 30, 2024, the parties jointly requested a stay of the action. The Court granted that request and the action was stayed on February 20, 2024, pending the outcome of our Demand Review Committee’s investigation into the underlying claims. Given the unpredictability inherent in litigation, the Company cannot predict the outcome of these matters. The Company is unable to estimate possible losses or ranges of losses that may result from these matters, and therefore it has not accrued any amounts in connection with these matters other than attorneys’ fees incurred to date . |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | 10. Leases The Company leases facilities and certain equipment under noncancelable operating leases that expire at various dates through February 2031 . Under the terms of the facilities leases, the Company is required to pay its proportionate share of property taxes, insurance and normal maintenance costs. In 2015, the Company entered into a master lease agreement giving the Company the ability to lease vehicles under operating leases with initial terms of 36 months from the date of delivery. In 2018, the lease agreement was terminated and a new master lease agreement was entered into with a new vendor giving the Company the ability to lease vehicles under operating leases with initial terms ranging from 12 to 50 months from the date of delivery . In 2021, the Company entered into a new master lease agreement giving the Company the ability to lease vehicles under operating leases with initial terms of 60 months from the date of delivery. The Company leases facilities and certain equipment under noncancelable operating leases with remaining lease terms of 0.9 year to 7.4 years, some of which include options to extend the lease for up to two five-year terms. These optional periods were not considered in the determination of the right-of-use asset or the lease liability as the Company did not consider it reasonably certain that it would exercise such options. The operating lease costs were as follows (in thousands): Years Ended December 31, 2023 2022 2021 Operating lease cost $ 10,343 $ 8,095 $ 8,874 Operating sublease income ( 93 ) — — Net operating lease costs $ 10,250 $ 8,095 $ 8,874 Supplemental cash flow information related to the Company’s leases were as follows (in thousands): Years Ended December 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 9,456 $ 9,083 Right-of-use assets obtained in exchange for operating lease obligations: 2,051 3,871 The balance sheet classification of the Company’s lease liabilities was as follows (in thousands): December 31, 2023 December 31, 2022 Operating lease liabilities Current portion included in accrued liabilities $ 9,405 $ 9,305 Operating lease liabilities 47,800 52,695 Total operating lease liabilities $ 57,205 $ 62,000 Maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2024 $ 9,662 2025 9,744 2026 9,127 2027 8,831 2028 8,521 Thereafter 20,586 Total lease payments 66,471 Less: Imputed interest ( 9,266 ) Total operating lease liabilities $ 57,205 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. As of December 31, 2023 and 2022, the weighted average remaining lease term was 7.0 years and 7.9 years, respectively, and the weighted average discount rate used to determine the operating lease liability was 4.5 % and 4.4 %, respectively. In the fourth quarter of 2018, the Company entered into an agreement to lease the 4 th and 5 th floors of corporate office space in San Diego, California with total minimum lease payments of $ 50.4 million over an initial term of 10 years and 9 months . In February 2020, the Company entered into the first amendment to the lease agreement to lease the 2 nd floor of corporate office space in San Diego, California with total minimum lease payments of $ 25.3 million over an initial term of approximately 10 years and 7 months . In March 2020, the Company entered into the second amendment to the lease agreement which increased the total minimum lease payments of the original corporate office space to $ 51.4 million. In the third quarter of 2020, the lease for the 4 th and 5 th floors of corporate office space commenced and the Company capitalized a right of use asset and related lease liability of $ 40.3 million. In the first quarter of 2021 , the lease for the 2 nd floor of corporate office space commenced and the Company capitalized a right of use asset and related lease liability of $ 19.2 million. In connection with this lease and the amendment, the Company established a letter of credit for $ 3.1 million, which has automatic annual extensions and is fully secured by restricted cash. In May 2023, the Company entered into an agreement to sublease its 2 nd floor of corporate office space in San Diego to a s ublessee with a total minimum sublease income of $ 18.4 million over a term of approximately 7 years and 6 months . The Company delivered the full possession of its 2 nd floor of corporate office space to the sublessee in August 2023. Pursuant to the sublease agreement, the Company received the first sublease payment in December 2023. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2023 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | 11. Selected Quarterly Financial Data (Unaudited) The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for the years ended December 31, 2023 and 2022 are as follows (in thousands, except per share data): Fiscal Year 2023 Quarters 1st 2nd 3rd 4th Total Revenues $ 118,462 $ 165,235 $ 211,699 $ 231,041 $ 726,437 Gross profit (1) $ 116,795 $ 157,776 $ 197,077 $ 213,151 $ 684,799 Net income (loss) $ ( 43,021 ) $ 1,114 $ ( 65,176 ) $ 45,797 $ ( 61,286 ) Basic net income (loss) per share (2) $ ( 0.27 ) $ 0.01 $ ( 0.40 ) $ 0.28 $ ( 0.37 ) Diluted net income (loss) per share (2) $ ( 0.27 ) $ 0.01 $ ( 0.40 ) $ 0.28 $ ( 0.37 ) Fiscal Year 2022 Quarters 1st 2nd 3rd 4th Total Revenues $ 115,468 $ 134,563 $ 130,714 $ 136,490 $ 517,235 Gross profit (1) $ 112,518 $ 131,896 $ 128,578 $ 134,076 $ 507,068 Net loss $ ( 113,056 ) $ ( 34,011 ) $ ( 27,183 ) $ ( 41,725 ) $ ( 215,975 ) Basic and diluted net loss per share (2) $ ( 0.70 ) $ ( 0.21 ) $ ( 0.17 ) $ ( 0.26 ) $ ( 1.34 ) (1) Determined by subtracting cost of product sales from product sales, net. (2) Basic and diluted net income ( loss) per common share are computed independently for each quarter and the full year based upon respective average shares outstanding. Therefore, the sum of the quarterly net income (loss) per common share amounts may not equal the annual amounts reported. |
SCHEDULE II - Valuation and Qua
SCHEDULE II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2023 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
SCHEDULE II - Valuation and Qualifying Accounts | SCHEDULE II – Valuation and Qualifying Accounts (in thousands) Additions Deductions Balance at Provision Actual Actual Balance at Allowance for distribution fees, discounts and chargebacks: For the year ended December 31, 2021 $ 4,221 $ 72,011 $ ( 63,544 ) $ ( 4,221 ) $ 8,467 For the year ended December 31, 2022 $ 8,467 $ 80,836 $ ( 69,913 ) $ ( 8,467 ) $ 10,923 For the year ended December 31, 2023 $ 10,923 $ 97,797 $ ( 85,641 ) $ ( 10,923 ) $ 12,156 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity date at the date of purchase of three months or less to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows (in thousands). Twelve Months Ended Twelve Months Ended Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 114,846 $ 188,657 $ 147,435 $ 114,846 Restricted cash 5,770 5,770 5,770 5,770 Total cash, cash equivalents and restricted $ 120,616 $ 194,427 $ 153,205 $ 120,616 |
Investment Securities | Investment Securities Currently, all of the Company’s investment securities are debt securities. The Company has classified all of its investment securities as available-for-sale as the sale of such securities may be required prior to maturity to implement management strategies, and accordingly, carries these investments at fair value. Unrealized gains and losses, if any, are reported as a separate component of stockholders’ equity. The cost of investment securities classified as available-for-sale is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion are included in interest income. Realized gains and losses, if any, are also included in interest income. The cost of securities sold is based on the specific identification method. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying values of the Company’s financial instruments, consisting of cash and cash equivalents, trade receivables, interest and other receivables, restricted cash, and accounts payable and accrued liabilities, approximate fair value due to the relative short-term nature of these instruments. As disclosed in Note 4, the Company classifies its cash equivalents and available-for-sale investment securities within the fair value hierarchy as defined by authoritative guidance: Level 1 Inputs — Quoted prices for identical instruments in active markets. Level 2 Inputs — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable. Level 3 Inputs — Valuation derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. |
Accounts Receivable | Accounts Receivable Accounts receivable are recorded net of customer allowances for distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company adopted FASB Accounting Standards Codification 326-20, Financial Instruments – Credit Losses (ASC 326-20) as of January 1, 2020. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about the collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. Based on its assessment, as of December 31, 2023 , the Company determined that an allowance for credit loss was not required. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value under the first-in, first-out method (FIFO). The Company uses a combination of standard and actual costing methodologies to determine the cost basis for its inventories which approximates actual costs. Inventory consists of raw material, work in process, and finished goods, including third-party manufacturing costs, freight, and indirect overhead costs. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Prior to FDA approval of NUPLAZID in April 2016 and DAYBUE and March 2023, all costs related to the manufacturing of NUPLAZID and DAYBUE were charged to research and development expense in the period incurred. The Company periodically reviews inventory and reduces the carrying value of items to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life. During the years ended December 31, 2023, 2022 and 2021, the Company recorded charges of $ 0.9 million, $ 0.6 million and $ 1.3 million, respectively, to reduce certain finished goods and work in process inventory to its net realizable value. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Leasehold improvements are amortized over the shorter of their estimated useful lives or the term of the lease by use of the straight-line method. Construction-in-process reflects amounts incurred for property, equipment or improvements that have not been placed in service. Maintenance and repair costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are removed from the respective accounts and any gain or loss is recognized. Estimated useful lives by major asset category are as follows: Useful Lives Machinery and equipment 5 to 7 years Computers and software 3 years Furniture and fixtures 10 years |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Through December 31, 2023 , no such impairment losses have been recorded by the Company. |
License Fees and Royalties | License Fees and Royalties The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. In connection with the FDA approval of NUPLAZID in April 2016, the Company made a one-time milestone payment of $ 8.0 million pursuant to its 2006 license agreement with the Ipsen Group in which the Company licensed certain intellectual property rights that complement its patent portfolio for its serotonin platform, including NUPLAZID. The Company capitalized the $ 8.0 million payment as an intangible asset and is amortizing the asset on a straight-line basis over the estimated useful life which ended during the year ended December 31, 2021. The Company recorded no amortization expense related to its intangible asset for the years ended December 31, 2023 and 2022 and recorded amortization expense of $ 1.1 million for the year ended December 31, 2021. As of December 31, 2021, the intangible asset was fully amortized. In connection with the first commercial sale of DAYBUE in April 2023, the Company made a milestone payment of $ 40.0 million pursuant to its 2018 license agreement with Neuren, as disclosed in Note 9. The Company capitalized the $ 40.0 million payment as an intangible asset and began amortizing the asset in April 2023 on a straight-line basis over the estimated useful life of the licensed patents through early 2036. The Company recorded amortization expense related to this inta ngible asset of $ 2.4 million f or the year ended December 31, 2023. As of December 31, 2023 , estimated future amortization expense related to the Company’s intangible asset was $ 3.1 million for each subsequent year. Following the FDA approval of DAYBUE, the Company was granted a Rare Pediatric Disease Priority Review Voucher (PRV). Pursuant to the license agreement, the Company is required to pay Neuren one third of the value of the PRV at the time of sale or use of the PRV. If the PRV is sold, the amount to be paid will be the sale value net of applicable fees. If the PRV is not sold but used by the Company, the amount to be paid will be the average price of the three most recent publicly announced sales of Rare Pediatric Disease PRVs immediately preceding the issuance of the PRV to the Company. The Company capitalized the $ 29.6 million for the estimated PRV value owed to Neuren as an intangible asset and began amortizing it in April 2023 on a straight-line basis over the estimated useful life of the licensed patents through early 2036. The Company recorded amortization expense related to this intangible asset of $ 1.7 million for the year ended December 31, 2023. As of December 31, 2023 , estimated future amortization expense related to the Company’s intangible asset was $ 2.3 million for each subsequent year. Royalties incurred in connection with the Company’s license agreement with Neuren, as disclosed in Note 9, are expensed to cost of product sales as revenue from product sales is recognized |
Intangible Assets | Intangible Assets Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. A mortization of finite-lived intangible assets is recorded over the assets’ estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. We review our finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such intangible assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of intangible the assets exceeds the estimated fair value of the intangible assets. No impairment loss was recorded on intangible assets during the years ended December 31, 2023 or 2022 . |
Acquisitions | Acquisitions The Company accounts for acquisitions of an asset or group of similar identifiable assets that do not meet the definition of a business as asset acquisition using the cost accumulation method, whereby the cost of the acquisition, including certain transaction costs, is allocated to the assets acquired on the basis of their relative fair values. No goodwill is recognized in an asset acquisition. Intangible assets acquired in an asset acquisition for use in research and development activities which have no alternative future use are expensed as in-process research and development on the acquisition date. Intangible assets acquired for use in research and development activities which have an alternative future use are capitalized as in-process research and development. Future costs to develop these assets are recorded to research and development expense as they are incurred. Contingent milestone payments associated with asset acquisitions are recognized when probable and estimable. These amounts are expensed to research and development if there is no alternative future use associated with the asset, or capitalized as an intangible asset if alternative future use of the asset exists. |
Advertising Expense | Advertising Expense Advertising costs are expensed when services are performed or goods are delivered. The Company incurred $ 9.4 million, $ 5.5 mil lion and $ 41.8 million in advertising costs during the years ended December 31, 2023, 2022 and 2021 , respectively. No advertising costs were capitalized as prepaid expenses at December 31, 2023 or 2022 . |
Revenue Recognition | Revenue Recognition The Company operates in one business segment. Results of its operations are reported on a consolidated basis for purposes of s egment reporting, consistent with internal management reporting. Revenues consist of net product sales to customers, all of which are sales in the U.S. Revenues by product are as follows (in thousands): Years Ended December 31, 2023 2022 2021 NUPLAZID $ 549,248 $ 517,235 $ 484,145 DAYBUE 177,189 — — Product sales, net $ 726,437 $ 517,235 $ 484,145 Product Sales, Net The Company accounts for contracts with its customers in accordance with Revenue from Contracts with Customers (Topic 606) . The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Payment terms differ by customer, but typically range from 31 to 35 days from the date of shipment. Revenue for the Company’s product sales has not been adjusted for the effects of a financing component as the Company expects, at contract inception, that the period between when the Company transfers control of the product and when the Company receives payment will be one year or less. The Company’s product sales, net consist of U.S. sales of NUPLAZID and DAYBUE. NUPLAZID was approved by the FDA in April 2016 and the Company commenced shipments of NUPLAZID to SPs and SDs in late May 2016. SPs dispense product to a patient based on the fulfillment of a prescription and SDs sell product to government facilities, long-term care pharmacies, or in-patient hospital pharmacies. DAYBUE was approved by the FDA in March 2023 and the Company commenced shipments of DAYBUE to a single wholesale distributor in April 2023. Product shipping and handling costs are included in cost of product sales. The Company recognizes revenue from product sales at the net sales price (the “transaction price”) which includes estimates of variable consideration for which reserves for sales discounts and allowance are established and reflects each of these as either a reduction to the related account receivable or as an accrued liability, depending on how the amount payable is settled. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which the Company is entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from estimates, the Company may need to adjust its estimates, which would affect net revenue in the period of adjustment. The following are the Company’s significant categories of sales discounts and allowances: Distribution Fees : Distribution fees include distribution service fees paid to the SPs, SDs and wholesale distributor based on a contractually fixed percentage of the wholesale acquisition cost (WAC), fees for data, and prompt payment discounts. Distribution fees are recorded as an offset to revenue based on contractual terms at the time revenue from the sale is recognized. Rebates : Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare Part D prescription drug benefit. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements with, or statutory requirements pertaining to, Medicaid and Medicare benefit providers. The allowance for rebates is based on statutory discount rates, estimated payor mix, and expected utilization. The Company’s estimates for expected utilization of rebates are based on historical data received from the SPs, SDs and single wholesale distributor since product launch. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for prior quarters’ unpaid rebates still estimated to be incurred. Allowances for rebates also include amounts due under the Inflation Reduction act of 2022 for Medicare Part D unit sales with applicable period AMP increases that outpace inflation over the benchmark period. The applicable period will be twelve months on October 1 of each year, with the initial applicable period beginning on October 1, 2022. The benchmark period AMP price is January 1, 2021 through September 30, 2021. The Company’s estimates are based Medicare Part D sales as a percentage of gross sales and the rate AMP for the current period will be in excess the benchmark period. Chargebacks : Chargebacks are discounts and fees that relate to contracts with government and other entities purchasing from the SDs at a discounted price. The SDs charge back to the Company the difference between the price initially paid by the SDs and the discounted price paid to the SDs by these entities. The Company also incurs group purchasing organization fees for transactions through certain purchasing organizations. The Company estimates sales with these entities and accrues for anticipated chargebacks and organization fees, based on the applicable contractual terms. Co-Payment Assistance : The Company offers co-payment assistance to commercially insured patients meeting certain eligibility requirements. Co-payment assistance is accrued for based on actual program participation and estimates of program redemption using data provided by third-party administrators. Product Returns : Consistent with industry practice, the Company offers the SPs and SDs limited product return rights for damages, shipment errors, and expiring product; provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company does not allow product returns for product that has been dispensed to a patient. As the Company receives inventory reports from the SPs and SDs and has the ability to control the amount of product that is sold to the SPs and SDs, it is able to make a reasonable estimate of future potential product returns based on this on-hand channel inventory data and sell-through data obtained from the SPs and SDs. In arriving at its estimate for product returns, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry. |
Research and Development Expenses | Research and Development Expenses Research and development expenses are charged to operations as incurred. Research and development expenses include costs associated with services provided by contract organizations for preclinical development, pre-commercialization manufacturing expenses, and clinical trials, salaries and related personnel expenses including stock-based compensation expense, and facilities and equipment expenses. The upfront consideration and transaction costs associated with acquired in-process research and development are also included in the research and development expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial or services provided and the invoices received from its external service providers. When the Company makes payments in advance of services being provided, it records those amounts as prepaid expenses on its consolidated balance sheets and expense them as the services are rendered. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. Other indirect costs are generally recognized on a straight-line basis over the estimated period of the study. As actual costs become known, the Company adjusts its accruals accordingly. |
Concentration Risk | Concentration Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash, cash equivalents, investment securities, accounts receivable, and restricted cash. The Company invests its excess cash primarily in money market funds, U.S. treasury notes, and high quality, marketable debt instruments of corporations and government sponsored enterprises in accordance with the Company’s investment policy. The Company’s investment policy defines allowable investments and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least Aa3/AA- or better, or P-1/A-1 or better, as determined by Moody’s Investors Service or Standard & Poor’s. Further, the Company specifies credit quality standards for its customers that are designed to limit the Company’s credit exposure to any single party. The Company does not currently have any of its own manufacturing facilities, and therefore it depends on an outsourced manufacturing strategy for the production of NUPLAZID and DAYBUE for commercial use and for the production of its product candidates for clinical trials. For the production of NUPLAZID, the Company has contracts in place with two third-party manufacturers of commercial drug product and one third-party manufacturer of drug substance that is approved for the production of NUPLAZID API. For the production of DAYBUE, the Company has contracts in place with two third-party manufacturers of commercial drug product and two third-party manufacturers of drug substance that is approved for the production of DAYBUE API. Although there are potential sources of supply other than the Company’s existing suppliers, any new supplier would be required to qualify under applicable regulatory requirements. The Company has entered into agreements for the distribution of NUPLAZID with a limited number of SPs and SDs, and all of the Company’s product sales of NUPLAZID are to these customers. The Company has also entered into agreements for the distribution of DAYBUE with a single wholesale distributor, and all of the Company’s product sales of DAYBUE and accounts receivable balance at December 31, 2023 are related to this customer. For the year ended December 31, 2023 , the Company’s four largest customers, including the single wholesale distributor, represented approximately 69 % of the Company’s product revenue and 73 % of the Company’s accounts receivable balance at December 31, 2023. For the year ended December 31, 2022 , the Company’s four largest customers represented approximately 73 % of the Company’s product revenue and 74 % of the Company’s accounts receivable balance at December 31, 2022 . |
Stock-Based Compensation | Stock-Based Compensation The fair value of each employee stock option and each employee stock purchase right granted is estimated on the grant date under the fair value method using the Black-Scholes valuation model. The estimated fair value of each stock option and purchase right is then expensed on a straight-line basis over the requisite service period, which is generally the vesting period. The following weighted-average assumptions were used during these periods: Years Ended December 31, 2023 2022 2021 Stock Options: Expected volatility 66 % 68 % 64 % Risk-free interest rate 3.9 % 2.9 % 0.9 % Expected dividend yield 0 % 0 % 0 % Expected life of options in years 5.4 5.4 5.4 Years Ended December 31, 2023 2022 2021 Employee Stock Purchase Plan: Expected volatility 40 %- 67 % 62 %- 82 % 49 %- 100 % Risk-free interest rate 4.0 %- 5.3 % 1.5 %- 4.6 % 0.0 %- 0.5 % Expected dividend yield 0 % 0 % 0 % Expected life in years 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 Expected Volatility. The Company considers its historical volatility and implied volatility when determining the expected volatility. Risk-Free Interest Rate. The Company determines its risk-free interest rate assumption based on the U.S. Treasury yield for obligations with contractual terms similar to the expected term of the stock option or purchase right being valued. Expected Dividend Yield. The Company has never paid any dividends and currently has no plans to do so. Expected Life. In determining the expected life for stock options, the Company considers, among other factors, its historical exercise experience to date as well as the mean time remaining to full vesting of all outstanding options and the mean time remaining to the end of the contractual term of all outstanding options. The estimated life for the Company’s employee stock purchase rights is based upon the terms of each offering period. Forfeitures. The Company recognizes forfeitures as they occur. The fair value of restricted stock units (RSUs) is estimated based on the closing market price of the Company’s common stock on the date of grant. RSUs generally vest over a four-year period. Certain RSUs also have an accelerated vesting clause based on specified market condition target and continued employment through a minimum vesting period. The fair value of RSUs expected to vest are recognized and amortized on a straight-line basis over the requisite service period, which is generally the vesting period. For those RSUs requiring satisfaction of both market and service conditions, the requisite service period is the longest of the explicit, implicit and derived service periods. The fair value of performance-based stock units (PSUs) is estimated based on the closing market price of the Company’s common stock on the date of grant. PSUs vest upon the achievement of certain pre-defined company-specific performance-based criteria. Expense related to these PSUs is recognized ratably over the expected performance period once the pre-defined performance-based criteria for vesting becomes probable. During the year ended December 31, 2021, the Company had a change in estimate related to the achievement of certain performance-based criteria for performance-based stock awards which resulted in a reduction in stock-based compensation expenses by approximatel y $ 6.8 m illion. The table below summarizes the total stock-based compensation expense included in the Company’s consolidated statements of operations for the periods presented (in thousands): Years Ended December 31, 2023 2022 2021 Cost of product sales $ 1,007 $ 1,106 $ 1,286 Research and development 17,408 22,580 21,969 Sales, general and administrative 48,006 44,515 40,360 $ 66,421 $ 68,201 $ 63,615 |
Income Taxes | Income Taxes Current income tax expense or benefit represents the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is computed for the expected future impact of differences between the financial reporting and income tax bases of assets and liabilities and for the expected future tax benefit to be derived from tax credits and loss carryforwards. Deferred income tax expense or benefit represents the net change during the year in the deferred income tax asset or liability. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company recognizes the impact of a tax position in the financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected in income tax expense. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, employee stock purchase rights, RSUs, and PSUs are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be antidilutive. The Company incurred net losses for all periods presented and there were no reconciling items for potentially dilutive securities. More specifically, at December 31, 2023, 2022 and 2021 , stock options, employee stock purchase plan rights, RSUs and PSUs covering a total of approximately 21,264,000 shares, 21,185,000 shares and 17,535,000 shares, respectively, were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive. |
Segment Reporting | Segment Reporting The Company uses “the management approach” in determining reportable operating segments. The management approach considers the internal organization and reporting used by the Company’s chief operating decision maker for making operating decisions and assessing performance as the source for determining the Company’s reportable segments. The Company’s chief operating decision maker is the chief executive officer who reviews operating results to make decisions about allocating resources and assessing performance for the entire Company. Management has determined that the Company operates in one business segment which is the development and commercialization of innovative medicines. All revenues for the years ended December 31, 2023, 2022 and 2021 were generated from customers in the United States. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In November 2023, the FASB issued Accounting Standards Update No. 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures . The amendments require disclosure of incremental segment information on an annual and interim basis. The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification 280, Segment Reporting . The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its financial statements. In December 2023, the FASB issued Accounting Standards Update No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures . The amendments require (i) enhanced disclosures in connection with an entity’s effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows (in thousands). Twelve Months Ended Twelve Months Ended Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 114,846 $ 188,657 $ 147,435 $ 114,846 Restricted cash 5,770 5,770 5,770 5,770 Total cash, cash equivalents and restricted $ 120,616 $ 194,427 $ 153,205 $ 120,616 |
Schedule of Estimated Useful Lives by Major Asset Category | Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Leasehold improvements are amortized over the shorter of their estimated useful lives or the term of the lease by use of the straight-line method. Construction-in-process reflects amounts incurred for property, equipment or improvements that have not been placed in service. Maintenance and repair costs are expensed as incurred. When assets are retired or sold, the assets and accumulated depreciation are removed from the respective accounts and any gain or loss is recognized. Estimated useful lives by major asset category are as follows: Useful Lives Machinery and equipment 5 to 7 years Computers and software 3 years Furniture and fixtures 10 years |
Schedule of revenue consist of product sales to customers | The Company operates in one business segment. Results of its operations are reported on a consolidated basis for purposes of s egment reporting, consistent with internal management reporting. Revenues consist of net product sales to customers, all of which are sales in the U.S. Revenues by product are as follows (in thousands): Years Ended December 31, 2023 2022 2021 NUPLAZID $ 549,248 $ 517,235 $ 484,145 DAYBUE 177,189 — — Product sales, net $ 726,437 $ 517,235 $ 484,145 |
Weighted-Average Assumptions Used to Estimate Fair Value of Employee Stock Options | The estimated fair value of each stock option and purchase right is then expensed on a straight-line basis over the requisite service period, which is generally the vesting period. The following weighted-average assumptions were used during these periods: Years Ended December 31, 2023 2022 2021 Stock Options: Expected volatility 66 % 68 % 64 % Risk-free interest rate 3.9 % 2.9 % 0.9 % Expected dividend yield 0 % 0 % 0 % Expected life of options in years 5.4 5.4 5.4 |
Weighted-Average Assumptions Used to Estimate Fair Value of Employee Stock Purchase Plan Rights | Years Ended December 31, 2023 2022 2021 Employee Stock Purchase Plan: Expected volatility 40 %- 67 % 62 %- 82 % 49 %- 100 % Risk-free interest rate 4.0 %- 5.3 % 1.5 %- 4.6 % 0.0 %- 0.5 % Expected dividend yield 0 % 0 % 0 % Expected life in years 0.5 - 2.0 0.5 - 2.0 0.5 - 2.0 |
Summary of Stock-based Compensation Expense Included in Statements of Operations | The table below summarizes the total stock-based compensation expense included in the Company’s consolidated statements of operations for the periods presented (in thousands): Years Ended December 31, 2023 2022 2021 Cost of product sales $ 1,007 $ 1,106 $ 1,286 Research and development 17,408 22,580 21,969 Sales, general and administrative 48,006 44,515 40,360 $ 66,421 $ 68,201 $ 63,615 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Carrying Value and Amortized Cost of Company Investments Summarized by Major Security Type | The carrying value and amortized cost of the Company’s investments, summarized by major security type, consisted of the following (in thousands): December 31, 2023 Amortized Unrealized Unrealized Estimated U.S. Treasury notes $ 75,315 $ 47 $ ( 28 ) $ 75,334 Government sponsored enterprise securities 174,867 119 ( 112 ) 174,874 $ 250,182 $ 166 $ ( 140 ) $ 250,208 December 31, 2022 Amortized Unrealized Unrealized Estimated U.S. Treasury notes $ 15,956 $ — $ ( 11 ) $ 15,945 Government sponsored enterprise securities 81,216 16 ( 291 ) 80,941 Municipal bonds 20,873 — ( 98 ) 20,775 Commercial paper 184,923 30 ( 637 ) 184,316 $ 302,968 $ 46 $ ( 1,037 ) $ 301,977 |
Summary of Gross Unrealized Losses and Fair Value of Available-For-Sale Investment Securities in Unrealized Loss Position | The following table presents gross unrealized losses and fair value for those available-for-sale investments that were in an unrealized loss position as of December 31, 2023 and December 31, 2022, aggregated by investment category and length of time that individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Unrealized Estimated Unrealized Estimated Unrealized December 31, 2023 U.S. Treasury notes $ 41,366 $ ( 28 ) $ — $ — $ 41,366 $ ( 28 ) Government sponsored enterprise securities 108,587 ( 112 ) — — 108,587 ( 112 ) Total $ 149,953 $ ( 140 ) $ — $ — $ 149,953 $ ( 140 ) December 31, 2022 U.S. Treasury notes $ 15,945 $ ( 11 ) $ — $ — $ 15,945 $ ( 11 ) Government sponsored enterprise securities 58,254 ( 291 ) — — 58,254 ( 291 ) Municipal bonds 20,775 ( 98 ) — — 20,775 ( 98 ) Commercial paper 135,200 ( 637 ) — — 135,200 ( 637 ) Total $ 230,174 $ ( 1,037 ) $ — $ — $ 230,174 $ ( 1,037 ) During the first quarter of 2023, the Company made a sale of all of its investments in commercial paper. The proceeds from sales of these securities were $ 183.0 million and net realized losses from the related sales were $ 0.5 million. There were no other sales of available-for-sale investment securities in prior periods. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Cash Equivalents, Available-For-Sale Investment Securities and Equity Securities | The recurring fair value measurements of the Company’s cash equivalents, available-for-sale investment securities, and equity securities at December 31, 2023 and 2022 consisted of the following (in thousands): Fair Value Measurements at December 31, 2023 Quoted Prices Significant Significant Assets Money market fund $ 64,586 $ 64,586 $ — $ — U.S. Treasury notes 75,334 75,334 — — Government sponsored enterprise securities 174,874 — 174,874 — Total $ 314,794 $ 139,920 $ 174,874 $ — Liabilities Cash awards $ 4,506 $ — $ — $ 4,506 Total $ 4,506 $ — $ — $ 4,506 Fair Value Measurements at December 31, 2022 Quoted Prices Significant Significant Assets Money market fund $ 72,578 $ 72,578 $ — $ — U.S. Treasury notes 15,945 15,945 — — Equity securities 7,180 7,180 — — Government sponsored enterprise securities 94,803 — 94,803 — Municipal bonds 20,775 — 20,775 — Commercial paper 184,316 — 184,316 — Total $ 395,597 $ 95,703 $ 299,894 $ — Liabilities Cash awards $ 898 $ — $ — $ 898 Total $ 898 $ — $ — $ 898 |
Schedule of Changes in Estimated Fair Value of Contingent Cash Awards | Changes in estimated fair value of contingent cash awards during the twelve months ended December 31, 2023 are as follows (in thousands): Balance as of December 31, 2022 $ 898 Vesting of awards 772 Expense forfeited ( 128 ) Change in fair value 2,964 Balance as of December 31, 2023 $ 4,506 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): December 31, 2023 2022 Finished goods $ 5,001 $ 1,926 Work in process 4,134 4,427 Raw material 31,312 5,207 $ 40,447 $ 11,560 Reported as: Inventory $ 35,819 $ 6,636 Long-term inventory 4,628 4,924 Total $ 40,447 $ 11,560 |
Property and Equipment, Net | Property and equipment, net, consisted of the following (in thousands): December 31, 2023 2022 Computers and software $ 5,873 $ 5,873 Leasehold improvements 3,746 3,696 Furniture and fixtures 4,549 4,549 14,168 14,118 Accumulated depreciation ( 9,556 ) ( 8,097 ) $ 4,612 $ 6,021 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2023 2022 Accrued sales allowances $ 90,718 $ 26,046 Accrued compensation and benefits 42,718 28,023 Accrued research and development services 32,883 35,048 Accrued contingent payments 29,583 — Accrued consulting and professional fees 18,804 11,377 Current portion of lease liabilities 9,405 9,305 Accrued taxes 1,564 377 Other 11,036 2,708 $ 236,711 $ 112,884 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Summary of Company's Stock Option Activity | The following table summarizes the Company’s stock option activity during the year ended December 31, 2023: Number of Weighted- Weighted- Aggregate Outstanding at December 31, 2022 16,339,465 $ 29.83 Granted 3,157,634 $ 21.99 Exercised ( 1,046,035 ) $ 19.42 Cancelled/forfeited ( 1,825,035 ) $ 32.07 Outstanding at December 31, 2023 16,626,029 $ 28.75 5.6 $ 90,962 Vested and exercisable at December 31, 2023 11,152,607 $ 31.12 4.2 $ 44,951 Unvested at December 31, 2023 5,473,422 $ 23.92 8.4 $ 46,012 |
Summary of Company's RSU Activity | The following table summarizes the Company’s restricted stock activity during the year ended December 31, 2023: Number of Weighted Aggregate Outstanding at December 31, 2022 4,187,107 $ 29.49 Granted 1,960,482 $ 21.97 Vested ( 1,190,814 ) $ 28.09 Cancelled/forfeited ( 571,030 ) $ 28.23 Outstanding at December 31, 2023 4,385,745 $ 26.67 $ 134,440 There were 1,734,828 , |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Summary of Domestic and Foreign Pre-tax Loss | Domestic and foreign pre-tax income (loss) is as follows (in thousands): Years Ended December 31, 2023 2022 2021 Domestic $ ( 100,215 ) $ ( 233,216 ) $ ( 138,913 ) Foreign 49,179 19,772 ( 28,606 ) $ ( 51,036 ) $ ( 213,444 ) $ ( 167,519 ) |
Schedule of income tax provision consists | The income tax provision consists of the following (in thousands): Years Ended December 31, 2023 2022 2021 Current provision: Federal $ 5,440 $ — $ — State 4,805 2,531 351 Foreign 5 — — Total deferred tax assets 10,250 2,531 351 Total income tax provision $ 10,250 $ 2,531 $ 351 |
Components of Deferred Tax Assets | The components of the deferred tax assets are as follows (in thousands): December 31, 2023 2022 Deferred tax assets NOL carryforwards $ 149,049 $ 225,993 R&D credit carryforwards 70,906 83,074 Capitalized R&D 90,164 38,507 Stock-based compensation 51,028 51,661 Charitable contributions 40,956 42,677 Lease liabilities 13,671 14,730 Intangibles 43,220 24,030 Property and equipment 51 — Accrued rebates 19,401 5,748 Other 16,036 8,022 Total deferred tax assets 494,482 494,442 Valuation allowance ( 482,089 ) ( 481,210 ) Deferred tax liabilities Property and equipment — ( 29 ) Right-of-use assets ( 12,393 ) ( 13,203 ) Total deferred tax liabilities ( 12,393 ) ( 13,232 ) Total net deferred tax assets $ — $ — |
Reconciliation of Income Taxes to Amount Computed by Applying Statutory Federal Income Tax Rate to Pretax Loss | A reconciliation of income taxes to the amount computed by applying the statutory federal income tax rate to the pretax loss is summarized as follows (in thousands): Years Ended December 31, 2023 2022 2021 Amounts computed at statutory federal rate $ ( 10,718 ) $ ( 44,823 ) $ ( 35,179 ) Stock-based compensation and other permanent differences 8,458 7,596 6,083 Branded pharmaceutical drug fee 1,848 1,454 613 Write-off of IP R&D — 2,449 1,277 R&D credits ( 5,827 ) ( 9,974 ) ( 11,727 ) Change in valuation allowance 1,100 11,227 36,099 State taxes ( 977 ) ( 2,232 ) ( 2,617 ) Contingencies ( 2,071 ) 6,993 3,879 Foreign rate differential ( 5,076 ) ( 1,971 ) 2,857 Deferred adjustments for limits on executive compensation 2,112 3,918 1,808 Deferred rate adjustment ( 192 ) 922 ( 2,424 ) Switzerland tax reform ( 246 ) — ( 923 ) Expiration of attributes 17,225 16,142 726 GILTI 7,665 10,804 — Other ( 3,051 ) 26 ( 121 ) Income tax expense $ 10,250 $ 2,531 $ 351 |
Unrecognized Tax Benefits | The following table provides a reconciliation of changes in unrecognized tax benefits (in thousands): Years Ended December 31, 2023 2022 2021 Balance at beginning of period $ 19,064 $ 13,923 $ 9,843 Additions related to current period tax positions 5,304 5,140 3,973 Additions related to prior period tax positions 12,956 38 140 Reductions related to prior period tax positions ( 212 ) ( 37 ) ( 33 ) Balance at end of period $ 37,112 $ 19,064 $ 13,923 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Summary of Operating Lease Costs | The operating lease costs were as follows (in thousands): Years Ended December 31, 2023 2022 2021 Operating lease cost $ 10,343 $ 8,095 $ 8,874 Operating sublease income ( 93 ) — — Net operating lease costs $ 10,250 $ 8,095 $ 8,874 |
Supplemental Cash Flow Information Related to the Company's Leases | Supplemental cash flow information related to the Company’s leases were as follows (in thousands): Years Ended December 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 9,456 $ 9,083 Right-of-use assets obtained in exchange for operating lease obligations: 2,051 3,871 |
Summary of Balance Sheet Classification of Lease Liabilities | The balance sheet classification of the Company’s lease liabilities was as follows (in thousands): December 31, 2023 December 31, 2022 Operating lease liabilities Current portion included in accrued liabilities $ 9,405 $ 9,305 Operating lease liabilities 47,800 52,695 Total operating lease liabilities $ 57,205 $ 62,000 |
Summary of Maturities of Lease Liabilities | Maturities of lease liabilities were as follows (in thousands): Operating Leases Years ending December 31, 2024 $ 9,662 2025 9,744 2026 9,127 2027 8,831 2028 8,521 Thereafter 20,586 Total lease payments 66,471 Less: Imputed interest ( 9,266 ) Total operating lease liabilities $ 57,205 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data | Fiscal Year 2023 Quarters 1st 2nd 3rd 4th Total Revenues $ 118,462 $ 165,235 $ 211,699 $ 231,041 $ 726,437 Gross profit (1) $ 116,795 $ 157,776 $ 197,077 $ 213,151 $ 684,799 Net income (loss) $ ( 43,021 ) $ 1,114 $ ( 65,176 ) $ 45,797 $ ( 61,286 ) Basic net income (loss) per share (2) $ ( 0.27 ) $ 0.01 $ ( 0.40 ) $ 0.28 $ ( 0.37 ) Diluted net income (loss) per share (2) $ ( 0.27 ) $ 0.01 $ ( 0.40 ) $ 0.28 $ ( 0.37 ) Fiscal Year 2022 Quarters 1st 2nd 3rd 4th Total Revenues $ 115,468 $ 134,563 $ 130,714 $ 136,490 $ 517,235 Gross profit (1) $ 112,518 $ 131,896 $ 128,578 $ 134,076 $ 507,068 Net loss $ ( 113,056 ) $ ( 34,011 ) $ ( 27,183 ) $ ( 41,725 ) $ ( 215,975 ) Basic and diluted net loss per share (2) $ ( 0.70 ) $ ( 0.21 ) $ ( 0.17 ) $ ( 0.26 ) $ ( 1.34 ) (1) Determined by subtracting cost of product sales from product sales, net. (2) Basic and diluted net income ( loss) per common share are computed independently for each quarter and the full year based upon respective average shares outstanding. Therefore, the sum of the quarterly net income (loss) per common share amounts may not equal the annual amounts reported. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents, Including Disposal Group and Discontinued Operations [Abstract] | ||||
Cash and cash equivalents | $ 188,657 | $ 114,846 | $ 147,435 | |
Restricted cash | 5,770 | 5,770 | 5,770 | |
Total cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 194,427 | $ 120,616 | $ 153,205 | $ 331,798 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Apr. 30, 2023 USD ($) | Apr. 30, 2016 USD ($) | Dec. 31, 2023 USD ($) Customer Segment shares | Dec. 31, 2022 USD ($) Customer shares | Dec. 31, 2021 USD ($) shares | |
Summary Of Significant Accounting Policy [Line Items] | |||||
Charge on finished goods inventory | $ 900 | $ 600 | $ 1,300 | ||
Impairment losses | 0 | ||||
Finite-lived intangible assets, net | 65,490 | 0 | |||
Amortization of intangible assets | 4,093 | 0 | 1,108 | ||
Impairment Of Intangible Assets Finite lived | 0 | 0 | |||
Advertising costs | 9,400 | 5,500 | 41,800 | ||
Advertising costs capitalized as prepaid expenses | $ 0 | $ 0 | |||
Number of large customers | Customer | 4 | 4 | |||
Stock-based compensation expenses | $ 6,800 | ||||
Antidilutive securities to purchase common stock | shares | 21,264,000 | 21,185,000 | 17,535,000 | ||
Number of business segments | Segment | 1 | ||||
License Agreements | |||||
Summary Of Significant Accounting Policy [Line Items] | |||||
Finite-lived intangible assets, net | $ 40,000 | ||||
Amortization of intangible assets | $ 2,400 | ||||
Estimated future amortization expense, 2021 | 3,100 | ||||
License Agreements | Neuren | |||||
Summary Of Significant Accounting Policy [Line Items] | |||||
One-time contingent regulatory milestone payment pursuant to agreement with Ipsen Group | 40,000 | ||||
Finite-lived intangible assets, net | $ 29,600 | ||||
Amortization of intangible assets | 1,700 | ||||
Estimated future amortization expense, 2021 | 2,300 | ||||
License Agreements | Ipsen | |||||
Summary Of Significant Accounting Policy [Line Items] | |||||
One-time contingent regulatory milestone payment pursuant to agreement with Ipsen Group | $ 8,000 | ||||
Finite-lived intangible assets, net | $ 8,000 | ||||
Amortization of intangible assets | $ 0 | $ 0 | $ 1,100 | ||
Customer Concentration Risk | Revenue, Product and Service Benchmark | Four Customers | |||||
Summary Of Significant Accounting Policy [Line Items] | |||||
Concentration risk, percentage | 69% | 73% | |||
Customer Concentration Risk | Accounts Receivable | Four Customers | |||||
Summary Of Significant Accounting Policy [Line Items] | |||||
Concentration risk, percentage | 73% | 74% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Estimated Useful Lives by Major Asset Category (Detail) | Dec. 31, 2023 |
Machinery and Equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives | 5 years |
Machinery and Equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives | 7 years |
Computers and Software | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives | 3 years |
Furniture and Fixtures | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives | 10 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Revenues consist of product sales to customers (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | |||
Product sales, net | $ 726,437 | $ 517,235 | $ 484,145 |
NUPLAZID | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | 549,248 | 517,235 | 484,145 |
DAYBUE | |||
Disaggregation of Revenue [Line Items] | |||
Product sales, net | $ 177,189 | $ 0 | $ 0 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Weighted-Average Assumptions Used to Estimate Fair Value of Employee Stock Options (Detail) - Employee Stock Option | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Assumptions Used To Determine Fair Value Options [Line Items] | |||
Expected volatility | 66% | 68% | 64% |
Risk-free interest rate | 3.90% | 2.90% | 0.90% |
Expected dividend yield | 0% | 0% | 0% |
Expected life of options in years | 5 years 4 months 24 days | 5 years 4 months 24 days | 5 years 4 months 24 days |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Weighted-Average Assumptions Used to Estimate Fair Value of Employee Stock Purchase Plan Rights (Detail) - Employee Stock Purchase Plan | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Stock Purchase Plan [Line Items] | |||
Expected volatility, minimum | 40% | 62% | 49% |
Expected volatility, maximum | 67% | 82% | 100% |
Risk-free interest rate, minimum | 4% | 1.50% | 0% |
Risk-free interest rate, maximum | 5.30% | 4.60% | 0.50% |
Expected dividend yield | 0% | 0% | 0% |
Minimum | |||
Employee Stock Purchase Plan [Line Items] | |||
Expected life in years | 6 months | 6 months | 6 months |
Maximum | |||
Employee Stock Purchase Plan [Line Items] | |||
Expected life in years | 2 years | 2 years | 2 years |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Summary of Stock-based Compensation Expense Included in Statements of Operations (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 66,421 | $ 68,201 | $ 63,615 |
Cost of product sales | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 1,007 | 1,106 | 1,286 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 17,408 | 22,580 | 21,969 |
Sales, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 48,006 | $ 44,515 | $ 40,360 |
Investments - Carrying Value an
Investments - Carrying Value and Amortized Cost of Company's Investments Summarized by Major Security Type (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Estimated Fair Value | $ 250,208 | $ 301,977 |
Debt and equity securities, Amortized Cost | 250,182 | 302,968 |
Debt and equity securities, Unrealized Gains | 166 | 46 |
Debt and equity securities, Unrealized Losses | (140) | (1,037) |
Debt and equity securities, Estimated Fair Value | 250,208 | 301,977 |
US Treasury Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 75,315 | 15,956 |
Debt securities, Unrealized Gains | 47 | 0 |
Debt securities, Unrealized Losses | (28) | (11) |
Debt securities, Estimated Fair Value | 75,334 | 15,945 |
US Government Sponsored Enterprises Debt Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 174,867 | 81,216 |
Debt securities, Unrealized Gains | 119 | 16 |
Debt securities, Unrealized Losses | (112) | (291) |
Debt securities, Estimated Fair Value | $ 174,874 | 80,941 |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 20,873 | |
Debt securities, Unrealized Gains | 0 | |
Debt securities, Unrealized Losses | (98) | |
Debt securities, Estimated Fair Value | 20,775 | |
Commercial paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 184,923 | |
Debt securities, Unrealized Gains | 30 | |
Debt securities, Unrealized Losses | (637) | |
Debt securities, Estimated Fair Value | $ 184,316 |
Investments - Additional Inform
Investments - Additional Information (Detail) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 USD ($) | Dec. 31, 2023 Security | Dec. 31, 2022 Security | |
Investments, Debt and Equity Securities [Abstract] | |||
Available-for-sale investment securities contractual maturity dates | less than one year | less than one year | |
Number of available-for-sale investment securities in unrealized loss position | Security | 21 | 43 | |
Proceeds from sales of securities | $ 183 | ||
Net realized losses | $ 0.5 |
Investments - Summary of Gross
Investments - Summary of Gross Unrealized Losses and Fair Value of Available-For-Sale Investment Securities in Unrealized Loss Position (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | $ 149,953 | $ 230,174 |
Less Than 12 Months, Unrealized Losses | (140) | (1,037) |
Total, Estimated Fair Value | 149,953 | 230,174 |
Total, Unrealized Losses | (140) | (1,037) |
US Treasury Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 41,366 | 15,945 |
Less Than 12 Months, Unrealized Losses | (28) | (11) |
Total, Estimated Fair Value | 41,366 | 15,945 |
Total, Unrealized Losses | (28) | (11) |
US Government Sponsored Enterprises Debt Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 108,587 | 58,254 |
Less Than 12 Months, Unrealized Losses | (112) | (291) |
Total, Estimated Fair Value | 108,587 | 58,254 |
Total, Unrealized Losses | $ (112) | (291) |
Municipal Bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 20,775 | |
Less Than 12 Months, Unrealized Losses | (98) | |
Total, Estimated Fair Value | 20,775 | |
Total, Unrealized Losses | (98) | |
Commercial paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 135,200 | |
Less Than 12 Months, Unrealized Losses | (637) | |
Total, Estimated Fair Value | 135,200 | |
Total, Unrealized Losses | $ (637) |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurements of Cash Equivalents, Available-For-Sale Investment Securities and Equity Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | $ 314,794 | $ 395,597 |
Financial Liabilities Fair Value Disclosure | 4,506 | 898 |
Money market fund | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 64,586 | 72,578 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 139,920 | 95,703 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market fund | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 64,586 | 72,578 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 174,874 | 299,894 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial Liabilities Fair Value Disclosure | 4,506 | 898 |
Cash Awards [Member] | Cash [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial Liabilities Fair Value Disclosure | 4,506 | 898 |
Cash Awards [Member] | Significant Unobservable Inputs (Level 3) | Cash [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial Liabilities Fair Value Disclosure | 4,506 | 898 |
U.S. Treasury notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 75,334 | 15,945 |
U.S. Treasury notes | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 75,334 | 15,945 |
Equity securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 7,180 | |
Equity securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 7,180 | |
US Government Sponsored Enterprises Debt Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 174,874 | 94,803 |
US Government Sponsored Enterprises Debt Securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | $ 174,874 | 94,803 |
Municipal Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 20,775 | |
Municipal Bonds | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 20,775 | |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | 184,316 | |
Commercial paper | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments, fair value disclosure | $ 184,316 |
Fair value measurement - Change
Fair value measurement - Changes in estimated fair value of contingent cash award (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Fair Value Disclosures [Abstract] | |
Balance as of December 31, 2022 | $ 898 |
Vesting of awards | 772 |
Expense forfeited | (128) |
Change in fair value | 2,964 |
Balance as of December 31, 2023 | $ 4,506 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 5,001 | $ 1,926 |
Work in process | 4,134 | 4,427 |
Raw material | 31,312 | 5,207 |
Inventory | 40,447 | 11,560 |
Short term inventory | 35,819 | 6,636 |
Long-term inventory | $ 4,628 | $ 4,924 |
Balance Sheet Details - Propert
Balance Sheet Details - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 14,168 | $ 14,118 |
Accumulated depreciation | (9,556) | (8,097) |
Property and equipment, net | 4,612 | 6,021 |
Computers and Software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 5,873 | 5,873 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,746 | 3,696 |
Furniture and Fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,549 | $ 4,549 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Depreciation of property and equipment | $ 1,459 | $ 2,026 | $ 2,236 |
Removal of fully depreciated property, machinery and equipment | $ 0 | $ 100 |
Balance Sheet Details - Sched_2
Balance Sheet Details - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued Sales Allowances Current | $ 90,718 | $ 26,046 |
Accrued compensation and benefits | 42,718 | 28,023 |
Accrued research and development services | 32,883 | 35,048 |
Accrued contingent Payments | 29,583 | 0 |
Accrued consulting and professional fees | 18,804 | 11,377 |
Current portion included in accrued liabilities | 9,405 | 9,305 |
Accrued Taxes | 1,564 | 377 |
Other | 11,036 | 2,708 |
Accrued liabilities | $ 236,711 | $ 112,884 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||||
Nov. 02, 2021 | Jun. 30, 2022 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2010 | |
Class of Stock [Line Items] | ||||||||||||
Net proceeds from sale of common stock | $ 25,129 | $ 8,199 | $ 18,162 | |||||||||
Options vesting period | 4 years | |||||||||||
Aggregate intrinsic value of stock options exercised | $ 7,900 | 1,700 | 8,000 | |||||||||
Cash received from options exercised | $ 20,300 | $ 3,700 | $ 12,900 | |||||||||
Weighted average per share fair value of options granted | $ 13.25 | $ 13.66 | $ 24.07 | |||||||||
Unrecognized compensation costs | $ 62,100 | $ 63,900 | $ 66,000 | |||||||||
Weighted average period cost expected to be recognized | 2 years 7 months 6 days | 2 years 8 months 12 days | 2 years 3 months 18 days | |||||||||
Weighted average remaining contractual term, Outstanding | 5 years 7 months 6 days | |||||||||||
Terms of award | PSUs for which the number of shares issuable at the end of performance period can reach up to 200% of the shares approved in the award based on the achievement of certain pre-defined Acadia-specific performance criteria and continued employment through the vesting period | |||||||||||
Share price of common stock | $ 31.31 | |||||||||||
Issuance of common stock pursuant to employee stock purchase plan | $ 4,820 | $ 4,494 | $ 5,312 | |||||||||
Maximum amount paid as cash awards to employees | $ 15,100 | 10,100 | ||||||||||
Estimated Liability | 4,500 | 900 | ||||||||||
Fair value of awards | $ 4,400 | 5,200 | 1,800 | |||||||||
Compensation cost related to the awards | $ 3,600 | 300 | ||||||||||
Inducement Plan 2023 | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Common stock available for grants | 599,864 | |||||||||||
Employee Stock Option | Equity Incentive Plan 2010 | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Exercise price of Options as percentage of fair market value | 100% | |||||||||||
Options maximum expiration term | 10 years | |||||||||||
Options vesting period | 4 years | |||||||||||
Number of common stock authorized for issuance | 30,490,486 | |||||||||||
Common stock available for grants | 7,731,848 | |||||||||||
Common stock reserved for issuance under stock purchase plan | 6,000,000 | 8,300,000 | 6,700,000 | 5,500,000 | 3,000,000 | 5,000,000 | ||||||
Employee Stock Option | Equity Incentive Plan 2004 | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Exercise price of Options as percentage of fair market value | 100% | |||||||||||
Options vesting period | 4 years | |||||||||||
Number of periods additional number of shares could be added to shares authorized for issuance | 10 years | |||||||||||
PSU | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Unrecognized compensation costs | $ 5,700 | $ 12,700 | $ 11,500 | |||||||||
Weighted average period cost expected to be recognized | 2 years 10 months 24 days | 2 years 3 months 18 days | ||||||||||
Weighted average remaining contractual term, Outstanding | 3 years 2 months 12 days | 3 years | 3 years 3 months 18 days | |||||||||
Granted | 517,290 | 986,739 | 918,434 | |||||||||
Vested | 459,420 | 0 | 0 | |||||||||
Aggregate Intrinsic Value, Outstanding | $ 50,000 | $ 32,700 | $ 29,800 | |||||||||
Outstanding shares | 1,734,828 | 2,055,574 | 1,276,936 | |||||||||
Restricted Stock Units | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Unrecognized compensation costs | $ 46,700 | $ 44,600 | $ 39,800 | |||||||||
Weighted average period cost expected to be recognized | 2 years 8 months 12 days | |||||||||||
Outstanding shares | 484,757 | 1,057,741 | 639,700 | |||||||||
Employee Stock Purchase Plan | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of common stock authorized for issuance | 5,525,000 | |||||||||||
Common stock reserved for issuance under stock purchase plan | 3,000,000 | 600,000 | 400,000 | |||||||||
Common stock remained available for issuance pursuant to the Purchase Plan | 2,131,122 | |||||||||||
Eligible employees percentage of earnings withheld to purchase shares under purchase plan | 15% | |||||||||||
Purchase price of common stock as percentage of market value | 85% | |||||||||||
Issuance of common stock pursuant to employee stock purchase plan | 348,498 | 330,525 | 296,850 | |||||||||
Average per share price of stock issued under purchase plan | $ 13.83 | $ 13.6 | $ 17.89 | |||||||||
Weighted average per share fair value of purchase rights granted | $ 22.25 | $ 13.91 | $ 23.97 | |||||||||
Issuance of common stock pursuant to employee stock purchase plan | $ 4,800 | $ 4,500 | $ 5,300 | |||||||||
Maximum [Member] | Inducement Plan 2023 | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Number of common stock authorized for issuance | 1,750,000 |
Summary of Company's Stock Opti
Summary of Company's Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Number of Shares | |
Options Outstanding, Beginning Balance | shares | 16,339,465 |
Granted | shares | 3,157,634 |
Exercised | shares | (1,046,035) |
Cancelled/forfeited | shares | (1,825,035) |
Options Outstanding, Ending Balance | shares | 16,626,029 |
Vested at December 31, 2022 | shares | 11,152,607 |
Unvested at December 31, 2022 | shares | 5,473,422 |
Weighted Average Exercise Prices | |
Weighted Average Exercise Prices, Beginning Balance | $ / shares | $ 29.83 |
Weighted Average Exercise Prices, granted | $ / shares | 21.99 |
Weighted Average Exercise Prices, exercised | $ / shares | 19.42 |
Weighted Average Exercise Prices, Cancelled/forfeited | $ / shares | 32.07 |
Weighted Average Exercise Prices, Ending Balance | $ / shares | 28.75 |
Weighted Average Exercise Prices, Vested | $ / shares | 31.12 |
Weighted Average Exercise Prices, Unvested | $ / shares | $ 23.92 |
Weighted average remaining contractual term, Outstanding | 5 years 7 months 6 days |
Weighted average remaining contractual term, Vested | 4 years 2 months 12 days |
Weighted average remaining contractual term, Unvested | 8 years 4 months 24 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 90,962 |
Aggregate Intrinsic Value, Vested | $ | 44,951 |
Aggregate Intrinsic Value, Unvested | $ | $ 46,012 |
Summary of Company's RSU Activi
Summary of Company's RSU Activity (Detail) - Restricted Stock Units and Performance Stock Units $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Number of Shares | |
Outstanding, Begining Balance | shares | 4,187,107 |
Granted | shares | 1,960,482 |
Vested | shares | (1,190,814) |
Cancelled/forfeited | shares | (571,030) |
Outstanding, Ending Balance | shares | 4,385,745 |
Weighted Average Grant Date Fair Value | |
Weighted Average Grant Date Fair Value , Begining Balance | $ / shares | $ 29.49 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 21.97 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 28.09 |
Weighted Average Grant Date Fair Value, Cancelled/forfeited | $ / shares | 28.23 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 26.67 |
Aggregate Intrinsic Value | |
Aggregate Intrinsic Value, Outstanding | $ | $ 134,440 |
401 (k) Plan - Additional Infor
401 (k) Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |||
Maximum contribution by employee, percentage of pretax earnings | 60% | ||
Percentage of company's matching contribution with respect to each participant's contribution | 100% | ||
Company matching contributions to maximum employees eligible compensation | 5% | ||
Company contributions to 401 (k) plan | $ 6.1 | $ 5.1 | $ 5.8 |
Income Taxes - Summary of Domes
Income Taxes - Summary of Domestic and Foreign Pre-tax Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income (Loss) from Continuing Operations before Equity Method Investments, Income Taxes, Extraordinary Items, Noncontrolling Interest [Abstract] | |||
Domestic pre-tax income (loss) | $ (100,215) | $ (233,216) | $ (138,913) |
Foreign pre-tax income (loss) | 49,179 | 19,772 | (28,606) |
Income (Loss) from Equity Method Investments, Total | $ (51,036) | $ (213,444) | $ (167,519) |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Provision (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current provision: | |||
Federal | $ 5,440 | $ 0 | $ 0 |
State | 4,805 | 2,531 | 351 |
Foreign | 5 | 0 | 0 |
Total deferred tax assets | 10,250 | 2,531 | 351 |
Total income tax provision | $ 10,250 | $ 2,531 | $ 351 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax [Line Items] | |||
Charitable contribution carryforwards | $ 40,956 | $ 42,677 | |
Federal R&D credit carryforwards | 75,600 | ||
State Research and Development Credit Carryforwards | 2,300 | ||
Increase in valuation allowance of deferred tax assets | 900 | ||
Unrecognized tax reserves recorded during period | 18,000 | 5,100 | $ 4,100 |
Deferred tax assets | 6,800 | 1,200 | |
Operating Loss Carryforwards Expiring 2024 | |||
Income Tax [Line Items] | |||
Federal R&D credit carryforwards | 500 | ||
Federal | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 196,800 | ||
Remaining net operating loss carryforward, expiration year | 2031 | ||
Federal | Operating Loss Carryforwards Expiring 2031 | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 29,400 | 167,400 | |
State | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 456,300 | ||
Remaining net operating loss carryforward, expiration year | 2024 | ||
Charitable contribution carryforwards | $ 174,800 | ||
Research and development credit carryforwards with no expiration date | 20,300 | ||
State | Operating Loss Carryforwards Expiring 2024 | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | 454,400 | ||
State | Operating Loss Carryforwards Expiring 2031 | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 1,900 | ||
Foreign | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | 845,100 | ||
Net operating loss carryforwards with no expiration date | 6,500 | ||
Foreign | Operating Loss Carryforwards Expiring 2024 | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 231,600 |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets | ||
NOL carryforwards | $ 149,049 | $ 225,993 |
R&D credit carryforwards | 70,906 | 83,074 |
Capitalized R&D | 90,164 | 38,507 |
Stock-based compensation | 51,028 | 51,661 |
Charitable contributions | 40,956 | 42,677 |
Lease liabilities | 13,671 | 14,730 |
Intangibles | 43,220 | 24,030 |
Property and equipment | 51 | 0 |
Accrued rebates | 19,401 | 5,748 |
Other | 16,036 | 8,022 |
Total deferred tax assets | 494,482 | 494,442 |
Valuation allowance | (482,089) | (481,210) |
Deferred tax liabilities | ||
Propery and equipment | 0 | (29) |
Right-of-use assets | (12,393) | (13,203) |
Total deferred tax liabilities | (12,393) | (13,232) |
Total net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Taxes to Amount Computed by Applying Statutory Federal Income Tax Rate to Pretax Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Amounts computed at statutory federal rate | $ (10,718) | $ (44,823) | $ (35,179) |
Stock-based compensation and other permanent differences | 8,458 | 7,596 | 6,083 |
Branded pharmaceutical drug fee | 1,848 | 1,454 | 613 |
Write-off of IP R&D | 0 | 2,449 | 1,277 |
R&D credits | (5,827) | (9,974) | (11,727) |
Change in valuation allowance | 1,100 | 11,227 | 36,099 |
State taxes | (977) | (2,232) | (2,617) |
Contingencies | (2,071) | 6,993 | 3,879 |
Foreign rate differential | (5,076) | (1,971) | 2,857 |
Deferred adjustments for limits on executive compensation | 2,112 | 3,918 | 1,808 |
Deferred rate adjustment | (192) | 922 | (2,424) |
Switzerland tax reform | (246) | 0 | (923) |
Epiration of attributes | 17,225 | 16,142 | 726 |
GILTI | 7,665 | 10,804 | 0 |
Other | (3,051) | 26 | (121) |
Total income tax provision | $ 10,250 | $ 2,531 | $ 351 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Balance at beginning of period | $ 19,064 | $ 13,923 | $ 9,843 |
Additions related to current period tax positions | 5,304 | 5,140 | 3,973 |
Additions related to prior period tax positions | 12,956 | 38 | 140 |
Reductions related to prior period tax positions | (212) | (37) | (33) |
Balance at end of period | $ 37,112 | $ 19,064 | $ 13,923 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Jul. 31, 2023 | Jan. 31, 2022 | Aug. 31, 2018 | May 31, 2018 | Sep. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Other Commitments [Line Items] | ||||||||||
Gain (loss) on strategic investment | $ 5,109 | $ 3,542 | $ 2,329 | |||||||
Restricted cash | 5,770 | 5,770 | 5,770 | |||||||
Corporate Credit Card Program | Letter of Credit | ||||||||||
Other Commitments [Line Items] | ||||||||||
Restricted cash | 2,000 | |||||||||
Fleet Program | Letter of Credit | ||||||||||
Other Commitments [Line Items] | ||||||||||
Restricted cash | 400 | |||||||||
Other expense | ||||||||||
Other Commitments [Line Items] | ||||||||||
Gain (loss) on strategic investment | 5,100 | 3,500 | 2,300 | |||||||
Stoke Therapeutics, Inc. | Research and development | ||||||||||
Other Commitments [Line Items] | ||||||||||
Mile stone payments payable | $ 907,500 | |||||||||
Upfront consideration and transaction costs | $ 60,000 | |||||||||
Cost splits description | For the SYNGAP1 program, the two companies will jointly share global research, development and commercialization responsibilities and share 50/50 in all worldwide costs and future profits. | |||||||||
License Agreements | ||||||||||
Other Commitments [Line Items] | ||||||||||
Upfront payment | 102,500 | $ 88,700 | $ 11,000 | |||||||
License Agreements | North America | ||||||||||
Other Commitments [Line Items] | ||||||||||
Mile stone payments payable | $ 40,000 | |||||||||
License Agreements | Neuren | North America | ||||||||||
Other Commitments [Line Items] | ||||||||||
Upfront payment | $ 100,000 | |||||||||
Goodwill and Intangible Asset Impairment, Total | 40,000 | |||||||||
PRV liability | $ 29,600 | |||||||||
Upfront license fee | $ 10,000 | |||||||||
License Agreements | Neuren | Research and development | North America | ||||||||||
Other Commitments [Line Items] | ||||||||||
Upfront payment | $ 100,000 | $ 10,000 | ||||||||
License Agreements | Neuren | Development Commercialization and Sales Milestones | ||||||||||
Other Commitments [Line Items] | ||||||||||
Upfront payment | 831,300 | |||||||||
Exclusivity Deed | Neuren | ||||||||||
Other Commitments [Line Items] | ||||||||||
Aggregate carrying amount of strategic equity investment | $ 3,100 | |||||||||
Proceeds from sale of shares | $ 12,300 | |||||||||
Shares subscribed | 1,330,000 | |||||||||
Shares sold of Neuren | 1,330,000 | |||||||||
Exclusivity Deed | Neuren | Sales, general and administrative | ||||||||||
Other Commitments [Line Items] | ||||||||||
Payments for exclusive right | $ 900 | |||||||||
Maximum | ||||||||||
Other Commitments [Line Items] | ||||||||||
Mile stone payments payable | $ 3,400,000 | |||||||||
Maximum | License Agreements | Neuren | North America | ||||||||||
Other Commitments [Line Items] | ||||||||||
Mile stone payments payable | $ 426,300 | $ 455,000 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Mar. 31, 2021 USD ($) | Dec. 31, 2023 USD ($) Term | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 | Sep. 30, 2020 USD ($) | Mar. 31, 2020 USD ($) | Feb. 29, 2020 USD ($) | Dec. 31, 2018 | Dec. 31, 2015 | |
Lessee Lease Description [Line Items] | ||||||||||
Operating lease, expiration year | 2031-02 | |||||||||
Operating lease, description | The Company leases facilities and certain equipment under noncancelable operating leases with remaining lease terms of 0.9 year to 7.4 years, some of which include options to extend the lease for up to two five-year terms. | |||||||||
Operating lease, option to extend | true | |||||||||
Operating lease, options to extend | some of which include options to extend the lease for up to two five-year terms. | |||||||||
Weighted average remaining lease term | 7 years | 7 years 10 months 24 days | ||||||||
Weighted average discount rate | 4.50% | 4.40% | ||||||||
Capitalization of lease liability | $ 19,200 | $ 40,300 | ||||||||
Restricted cash | $ 5,770 | $ 5,770 | $ 5,770 | |||||||
Sublease Income | $ 93 | $ 0 | $ 0 | |||||||
Corporate Office Space Lease Agreement | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating leases arrangement term | 10 years 9 months | |||||||||
Corporate Office Space Lease Agreement | Letter of Credit | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Restricted cash | $ 3,100 | |||||||||
California | Corporate Office Space Lease Agreement | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating leases arrangement term | 10 years 7 months | |||||||||
Minimum lease payment amount | $ 50,400 | $ 51,400 | $ 25,300 | |||||||
Lease commencement period | first quarter of 2021 | |||||||||
San Diego [Member] | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Sublease Agreement Term | 7 years 6 months | |||||||||
Minimum | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating lease remaining lease term | 10 months 24 days | |||||||||
Minimum | San Diego [Member] | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Sublease Income | $ 18,400 | |||||||||
Maximum | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating lease remaining lease term | 7 years 4 months 24 days | |||||||||
Operating lease, renewal term | 5 years | |||||||||
Number of renewal option terms | Term | 2 | |||||||||
Vehicles | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating leases arrangement term | 60 months | 36 months | ||||||||
Vehicles | Minimum | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating leases arrangement term | 12 months | |||||||||
Vehicles | Maximum | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating leases arrangement term | 50 months |
Leases - Summary of Operating L
Leases - Summary of Operating Lease Costs (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Lease, Cost [Abstract] | |||
Operating lease cost | $ 10,343 | $ 8,095 | $ 8,874 |
Operating sublease income | (93) | 0 | 0 |
Net operating lease costs | $ 10,250 | $ 8,095 | $ 8,874 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to the Company's Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Lease, Cost [Abstract] | ||
Operating cash flows from operating leases | $ 9,456 | $ 9,083 |
Right-of-use assets obtained in exchange for operating lease obligations: | $ 2,051 | $ 3,871 |
Leases - Summary of Balance She
Leases - Summary of Balance Sheet Classification of Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Current portion included in accrued liabilities | $ 9,405 | $ 9,305 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued liabilities | Accrued liabilities |
Operating lease liabilities | $ 47,800 | $ 52,695 |
Total operating lease liabilities | $ 57,205 | $ 62,000 |
Leases - Summary of Maturities
Leases - Summary of Maturities of Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Operating Lease Liabilities [Abstract] | ||
2024 | $ 9,662 | |
2025 | 9,744 | |
2026 | 9,127 | |
2027 | 8,831 | |
2028 | 8,521 | |
Thereafter | 20,586 | |
Total lease payments | 66,471 | |
Less: | ||
Imputed interest | (9,266) | |
Total operating lease liabilities | $ 57,205 | $ 62,000 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) - Selected Quarterly Financial Data (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||||||||||||
Dec. 31, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | ||||||||||||
Quarterly Financial Information Disclosure [Abstract] | ||||||||||||||||||||||
Revenues | $ 231,041 | $ 211,699 | $ 165,235 | $ 118,462 | $ 136,490 | $ 130,714 | $ 134,563 | $ 115,468 | $ 726,437 | $ 517,235 | ||||||||||||
Gross profit | [1] | 213,151 | 197,077 | 157,776 | 116,795 | 134,076 | 128,578 | 131,896 | 112,518 | 684,799 | 507,068 | |||||||||||
Net income (loss) | $ 45,797 | $ (65,176) | $ 1,114 | $ (43,021) | $ (41,725) | $ (27,183) | $ (34,011) | $ (113,056) | $ (61,286) | $ (215,975) | $ (167,870) | |||||||||||
Basic net income (loss) per share | $ 0.28 | [2] | $ (0.4) | [2] | $ 0.01 | [2] | $ (0.27) | [2] | $ (0.26) | [2] | $ (0.17) | [2] | $ (0.21) | [2] | $ (0.7) | [2] | $ (0.37) | [2] | $ (1.34) | [2] | $ (1.05) | |
Diluted net income (loss) per share | $ 0.28 | [2] | $ (0.4) | [2] | $ 0.01 | [2] | $ (0.27) | [2] | $ (0.26) | [2] | $ (0.17) | [2] | $ (0.21) | [2] | $ (0.7) | [2] | $ (0.37) | [2] | $ (1.34) | [2] | $ (1.05) | |
[1] Determined by subtracting cost of product sales from product sales, net. Basic and diluted net income ( loss) per common share are computed independently for each quarter and the full year based upon respective average shares outstanding. Therefore, the sum of the quarterly net income (loss) per common share amounts may not equal the annual amounts reported. |
SCHEDULE II - Valuation and Q_2
SCHEDULE II - Valuation and Qualifying Accounts (Detail) - Allowance for Distribution Fees, Discounts and Chargebacks - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at Beginning of Period | $ 10,923 | $ 8,467 | $ 4,221 |
Additions, Provision Related to Current Period Sales | 97,797 | 80,836 | 72,011 |
Deductions, Actual Distribution Fees, Discounts and Chargebacks Related to Current Period Sales | (85,641) | (69,913) | (63,544) |
Deductions, Actual Distribution Fees, Discounts and Chargebacks Related to Prior Period Sales | (10,923) | (8,467) | (4,221) |
Balance at End of Period | $ 12,156 | $ 10,923 | $ 8,467 |