Cover Page
Cover Page - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 20, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36274 | ||
Entity Registrant Name | Intra-Cellular Therapies, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 36-4742850 | ||
Entity Address, Address Line One | 430 East 29th Street | ||
Entity Address, City or Town | New York | ||
Entity Address, State or Province | NY | ||
Entity Address, Postal Zip Code | 10016 | ||
City Area Code | 646 | ||
Local Phone Number | 440-9333 | ||
Title of 12(b) Security | Common Stock | ||
Trading Symbol | ITCI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 6 | ||
Entity Common Stock, Shares Outstanding | 96,807,191 | ||
Entity Central Index Key | 0001567514 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Documents Incorporated by Reference | The following documents (or parts thereof) are incorporated by reference into the following parts of this Form 10-K: Certain information required in Part III of this Annual Report on Form 10-K is incorporated by reference from the Registrant’s Proxy Statement for the 2024 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission. |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Firm ID | 42 |
Auditor Location | Baltimore, Maryland |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 147,767 | $ 148,615 |
Investment securities, available-for-sale | 350,174 | 443,290 |
Restricted cash | 1,750 | 1,750 |
Accounts receivable, net | 114,018 | 75,189 |
Inventory | 11,647 | 23,920 |
Prepaid expenses and other current assets | 42,443 | 45,193 |
Total current assets | 667,799 | 737,957 |
Property and equipment, net | 1,654 | 1,913 |
Right of use assets, net | 12,928 | 14,824 |
Inventory, non-current | 38,621 | 0 |
Other assets | 7,293 | 86 |
Total assets | 728,295 | 754,780 |
Current liabilities: | ||
Accounts payable | 11,452 | 10,395 |
Accrued and other current liabilities | 27,944 | 19,657 |
Accrued customer programs | 53,173 | 25,621 |
Accrued employee benefits | 27,364 | 22,996 |
Operating lease liabilities | 3,612 | 4,567 |
Total current liabilities | 123,545 | 83,236 |
Operating lease liabilities, non-current | 13,326 | 15,474 |
Total liabilities | 136,871 | 98,710 |
Stockholders’ equity: | ||
Common stock, $0.0001 par value: 175,000,000 shares authorized at December 31, 2023 and December 31, 2022, respectively; 96,379,811 and 94,829,794 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 10 | 9 |
Additional paid-in capital | 2,208,470 | 2,137,737 |
Accumulated deficit | (1,617,160) | (1,477,486) |
Accumulated comprehensive income (loss) | 104 | (4,190) |
Total stockholders’ equity | 591,424 | 656,070 |
Total liabilities and stockholders’ equity | $ 728,295 | $ 754,780 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 175,000,000 | 175,000,000 |
Common stock, shares issued (in shares) | 96,379,811 | 94,829,794 |
Common stock, shares outstanding (in shares) | 96,379,811 | 94,829,794 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Total revenues, net | $ 464,370 | $ 250,314 | $ 83,803 |
Operating expenses: | |||
Cost of product sales | 33,745 | 20,443 | 8,035 |
Selling, general and administrative | 409,864 | 358,782 | 272,611 |
Research and development | 180,142 | 134,715 | 88,845 |
Total operating expenses | 623,751 | 513,940 | 369,491 |
Loss from operations | (159,381) | (263,626) | (285,688) |
Interest income | 20,343 | 7,376 | 1,568 |
Loss before provision for income taxes | (139,038) | (256,250) | (284,120) |
Income tax expense | (636) | (6) | (6) |
Net loss | $ (139,674) | $ (256,256) | $ (284,126) |
Net loss per common share: | |||
Basic (in dollars per share) | $ (1.46) | $ (2.72) | $ (3.50) |
Diluted (in dollars per share) | $ (1.46) | $ (2.72) | $ (3.50) |
Weighted average number of common shares: | |||
Basic (in shares) | 95,881,729 | 94,046,670 | 81,253,394 |
Diluted (in shares) | 95,881,729 | 94,046,670 | 81,253,394 |
Product sales, net | |||
Total revenues, net | $ 462,175 | $ 249,132 | $ 81,708 |
Grant revenue | |||
Total revenues, net | $ 2,195 | $ 1,182 | $ 2,095 |
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 loss | $ (139,674) | $ (256,256) | $ (284,126) |
Other comprehensive income (loss): | |||
Unrealized gain (loss) on investment securities | 4,294 | (3,826) | (845) |
Comprehensive loss | $ (135,380) | $ (260,082) | $ (284,971) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive Income (Loss) |
Balance, shares (in shares) at Dec. 31, 2020 | 80,463,089 | ||||
Balance at Dec. 31, 2020 | $ 656,860 | $ 8 | $ 1,593,475 | $ (937,104) | $ 481 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options and issuances of restricted stock (in shares) | 1,419,331 | ||||
Exercise of stock options and issuances of restricted stock | 11,519 | 11,519 | |||
Stock issued for services (in shares) | 4,545 | ||||
Stock issued for services | 179 | $ 0 | 179 | ||
Share-based compensation | 34,303 | 34,303 | |||
Net loss | (284,126) | (284,126) | |||
Other comprehensive income (loss) | (845) | (845) | |||
Balance at Dec. 31, 2021 | 417,890 | $ 8 | 1,639,476 | (1,221,230) | (364) |
Balance, shares (in shares) at Dec. 31, 2021 | 81,886,965 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Common shares issued (in shares) | 10,952,381 | ||||
Common shares issued January 7, 2022 | 433,718 | $ 1 | 433,717 | ||
Exercise of stock options and issuances of restricted stock (in shares) | 1,988,775 | ||||
Exercise of stock options and issuances of restricted stock | 21,441 | 21,441 | |||
Stock issued for services (in shares) | 1,673 | ||||
Stock issued for services | 90 | 90 | |||
Share-based compensation | 43,013 | 43,013 | |||
Net loss | (256,256) | (256,256) | |||
Other comprehensive income (loss) | (3,826) | (3,826) | |||
Balance at Dec. 31, 2022 | 656,070 | $ 9 | 2,137,737 | (1,477,486) | (4,190) |
Balance, shares (in shares) at Dec. 31, 2022 | 94,829,794 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options and issuances of restricted stock (in shares) | 1,548,468 | ||||
Exercise of stock options and issuances of restricted stock | 17,810 | $ 1 | 17,809 | ||
Stock issued for services (in shares) | 1,549 | ||||
Stock issued for services | 92 | 92 | |||
Share-based compensation | 52,832 | 52,832 | |||
Net loss | (139,674) | (139,674) | |||
Other comprehensive income (loss) | 4,294 | 4,294 | |||
Balance at Dec. 31, 2023 | $ 591,424 | $ 10 | $ 2,208,470 | $ (1,617,160) | $ 104 |
Balance, shares (in shares) at Dec. 31, 2023 | 96,379,811 |
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 used in operating activities | |||
Net loss | $ (139,674) | $ (256,256) | $ (284,126) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 528 | 656 | 533 |
Share-based compensation | 52,832 | 43,013 | 34,303 |
Stock issued for services | 92 | 90 | 179 |
Amortization of premiums and accretion of discounts on investment securities, net | (8,400) | 447 | (4,080) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (38,829) | (55,033) | (9,391) |
Inventory | (26,348) | (15,972) | (892) |
Prepaid expenses and other assets | (4,457) | (19,749) | (11,208) |
Accounts payable | 1,057 | 1,704 | 3,189 |
Accrued and other current liabilities | 8,287 | 8,584 | 3,177 |
Accrued customer programs | 27,552 | 19,657 | 2,958 |
Accrued employee benefits | 4,368 | 2,099 | 5,989 |
Lease liabilities, net | (1,207) | 574 | (175) |
Net cash used in operating activities | (124,199) | (270,186) | (259,544) |
Cash flows provided by (used in) investing activities | |||
Purchases of investments | (415,269) | (759,209) | (224,575) |
Maturities of investments | 521,079 | 631,614 | 505,244 |
Purchases of property and equipment | (269) | (778) | (325) |
Net cash provided by (used in) investing activities | 105,541 | (128,373) | 280,344 |
Cash flows provided by financing activities | |||
Proceeds of public offerings, net | 0 | 433,718 | 0 |
Proceeds from exercise of stock options | 17,810 | 21,441 | 11,519 |
Net cash provided by financing activities | 17,810 | 455,159 | 11,519 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (848) | 56,600 | 32,319 |
Cash, cash equivalents, and restricted cash at beginning of period | 150,365 | 93,765 | 61,446 |
Cash, cash equivalents, and restricted cash at end of period | 149,517 | 150,365 | 93,765 |
Cash paid for taxes | 162 | 6 | 6 |
Non-cash investing and financing activities | |||
Right of use assets under operating leases | $ 0 | $ 419 | $ 108 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Cash Flows [Abstract] | ||||
Cash and cash equivalents | $ 147,767 | $ 148,615 | $ 92,365 | |
Restricted cash | 1,750 | 1,750 | 1,400 | |
Total cash, cash equivalents and restricted cash | $ 149,517 | $ 150,365 | $ 93,765 | $ 61,446 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Intra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiary, ITI, Inc. (“ITI”), is a biopharmaceutical company focused on the discovery, clinical development and commercialization of innovative, small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system (“CNS”). In December 2019, CAPLYTA® (lumateperone) was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of schizophrenia in adults (42 mg/day) and the Company initiated the commercial launch of CAPLYTA in March 2020. In December 2021, CAPLYTA was approved by the FDA for the treatment of bipolar depression in adults (42 mg/day) and the Company initiated the commercial launch of CAPLYTA for the treatment of bipolar depression. Additionally, in April 2022, the FDA approved two additional dosage strengths of CAPLYTA, 10.5 mg and 21 mg capsules, to provide dosage recommendations for patients concomitantly taking strong or moderate CYP3A4 inhibitors, and 21 mg for patients with moderate or severe hepatic impairment (Child-Pugh class B or C). The commercial launch of these special population doses occurred in August 2022. As used in these Notes to Consolidated Financial Statements, “CAPLYTA” refers to lumateperone approved by the FDA for the treatment of schizophrenia in adults and for the treatment of bipolar depression in adults, and “lumateperone” refers to, where applicable, CAPLYTA as well as lumateperone for the treatment of indications beyond schizophrenia and bipolar depression. Lumateperone is in Phase 3 clinical development as a novel treatment for major depressive disorder. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly-owned subsidiary have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP set forth in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is discovering, developing, and commercializing drugs primarily for the treatment of neurological and psychiatric disorders. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of checking accounts, money market accounts, money market funds, and certificates of deposit with a maturity date of three months or less. The carrying values of cash and cash equivalents approximate the fair market value. Certificates of deposit, commercial paper, corporate notes and corporate bonds with an original maturity date of more than three months are classified separately on the consolidated balance sheets. Investment Securities Investment securities may consist of investments in U.S. Treasuries, various U.S. governmental agency debt securities, corporate bonds, certificates of deposit, and other fixed income securities with an average maturity of approximately twelve months or less. Management classifies the Company’s investments as available-for-sale. Such securities are carried at estimated fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity. Realized gains and losses and declines in value judged to be other-than-temporary, if any, are included in the consolidated statement of operations. A decline in the market value of any available-for-sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income are recognized as interest income on the consolidated statements of operations when earned. The cost of securities sold is calculated using the specific identification method. The Company monitors its investment portfolio for overall risk, specifically credit loss, quarterly or more frequently if circumstances warrant. The Company has estimated the expected credit loss over the lifetime of the asset and has determined an allowance for credit losses is not material with respect to the investment portfolio. Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurement . ASC Topic 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value and requires expanded disclosures about fair value measurements. The ASC Topic 820 hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following categories based on the lowest level input used that is significant to a particular fair value measurement: • Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC Topic 820 hierarchy. Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, restricted cash, accounts receivable, prepaid expenses, right of use asset, net, other assets, accounts payable, accrued liabilities, accrued customer programs, accrued employee benefits, and operating lease liabilities to approximate their fair value because of their relatively short maturities at December 31, 2023 and 2022. Management believes that the risks associated with the Company’s financial instruments are minimal as the counterparties are various corporations, financial institutions and government agencies of high credit standing. Restricted Cash Restricted cash is collateral used under the letter of credit arrangement for the Company’s vehicle lease agreement (see Note 7). The Company adopted ASU No. 2016-18, Restricted Cash (“ASU 2016-18”) and includes restricted cash balances within the cash, cash equivalents and restricted cash balance on the statement of cash flows. Accounts Receivable, net The Company’s accounts receivable arise from product sales and are recorded net of allowances for returns, distribution fees, chargebacks, and prompt pay discounts. The Company monitors the financial performance and creditworthiness of its customers so that it can respond to changes in the customers’ credit profiles. The Company reserves against accounts receivable for estimated losses that may arise from a customer’s inability to pay and any amounts determined to be uncollectible are written off against the reserve when it is probable that the receivable will not be collected. The reserve amount for estimated collectability losses was not significant as of December 31, 2023 and 2022. The Company estimates expected credit losses of its accounts receivable by assessing the risk of loss based on available relevant information. Historically, we have not experienced credit losses on our accounts receivable. As of December 31, 2023 and 2022, our credit loss reserve on receivables was not significant. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist of accounts receivable, net from customers and cash, cash equivalents and investments held at financial institutions. For the years ended December 31, 2023 and 2022, 97% of product sales were generated from three major industry wholesalers. Three individual customers accounted for approximately 36%, 32%, and 29% and 39%, 30%, and 28% of product sales for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company believes that these customers are of high credit quality. Cash equivalents are held with major financial institutions in the United States. Certificates of deposit, cash and cash equivalents held with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. Inventory The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to direct materials, production costs, and manufacturing overhead, on a first-in,first-out (“FIFO”) basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within cost of product sales. The Company capitalizes inventory costs associated with the Company’s products when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized typically after regulatory approval. Inventory acquired and manufactured prior to regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign. Inventory that is used in the production of sample product is reclassified to prepaid and other current assets and is then expensed to selling, general and administrative expenses when the sample product is distributed. The Company analyzes its inventory based on the stage of production and classifies work in process and finished goods as current assets. Raw materials includes the active pharmaceutical ingredients ("API") and any related intermediate compounds. The raw material supply exceeds 12 months of current operating requirements and is recorded as inventory, non-current on the consolidated balance sheet. Shipping and handling costs for product shipments to customers are recorded as part of cost of product sales along with costs associated with manufacturing the product, and any inventory write-downs. Based on contractual terms, the Company has made advances on API production campaigns. Deposits related to production campaigns when delivery is expected within the next 12-month period from the balance sheet date are included in prepaid and other current assets on the consolidated balance sheets and if delivery is expected beyond the next 12-month period from the balance sheet date are included in other assets on the consolidated balance sheets. Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment . The Company considers historical performance and anticipated future results in its evaluation of potential impairment. The Company evaluates the carrying value of those assets in relation to the operating performance of the business and undiscounted cash flows expected to result from the use of those assets. Impairment losses are recognized when carrying value exceeds the undiscounted cash flows, in the amount by which the carrying value exceeds the fair value of the underlying asset. No such impairment losses have been recognized to date. Leases In accordance with ASC Topic 842, Leases , the Company made an accounting policy election to keep leases with an initial term of 12 months or less off of the consolidated balance sheets. The Company also elected the lessee component election, allowing the Company to account for the lease and non-lease components as a single lease component. To determine whether a contract contains a lease, asset and service agreements are assessed at onset and upon modification for criteria of specifically identified assets, control and economic benefit. Payments for identified leases are recognized in the consolidated statements of operations on a straight-line basis over the lease term. The Company uses the rate implicit in the contract whenever possible when determining the applicable discount rate. As the majority of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Revenue Recognition In accordance with ASC Topic 606, Revenue from contracts with customers , the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration that the Company expects to receive in exchange for the good or service. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 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 entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC Topic 606, including 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. Product Sales, net To date, the Company’s only source of product sales has been from sales of CAPLYTA in the United States, which the Company began shipping to customers in March 2020. The Company sells CAPLYTA to a limited number of customers which include national and regional distributors. These customers subsequently resell the Company’s products to retail pharmacies, specialty pharmacy providers, and certain medical centers or hospitals. In addition to distribution agreements with customers, the Company enters into arrangements with health care providers and payers that obligate the Company to have government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company also voluntarily offers patient assistance programs which are intended to provide financial assistance to qualified commercially-insured patients. The Company recognizes revenue on product sales when the customer obtains control of the Company’s product, which occurs upon delivery. Product revenues are recorded net of applicable reserves for the sales obligations that are considered variable consideration, including rebates, discounts and allowances, among others. Reserves for Variable Consideration The Company recognizes revenue from product sales at the net sales price (the "transaction price") which includes the wholesale acquisition cost that the Company charges to its customers less variable consideration for which reserves are established. Components of variable consideration may include trade discounts and allowances, product returns, chargebacks, government and payer rebates, and patient assistance. The amount of variable consideration 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 under the contract 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 the Company’s estimates, the Company will adjust these estimates, which would affect net product sales and earnings in the period of the adjustment. The provision for rebates, discounts, and other incentives is based on expected patient usage, as well as inventory levels in the distribution channel to determine the contractual obligations to the benefit providers. Additionally, sales are generally made with a limited right of return under certain conditions. Revenue is recorded net of provisions for rebates, discounts, and other incentives and returns, which are established at the time of sale. The Company uses payer mix utilization data, changes to product price, government pricing calculations and prior payment history in order to estimate the variable consideration. Trade Discounts and Allowances — The Company generally provides customers with discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its customers for sales order management, data, and distribution services. The Company has determined such services received to date are not distinct from the Company’s sale of products to the customer and, therefore, these payments have been recorded as a reduction to revenue and accounts receivable, net on the consolidated balance sheets. Product Returns — The Company offers customers a limited right of return for product that has been purchased based on the product’s expiration date, such right lapses upon patient's receipt of product. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as accounts receivable, net on the consolidated balance sheets. The Company currently estimates product return liabilities primarily using its own sales returns experience and, when appropriate, benchmarking data for similar products and industry experience. Chargebacks — Chargebacks represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who purchase the product directly from the Company. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net. Chargeback amounts are determined at the time of resale to the qualified healthcare provider by customers. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at the end of each reporting period, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit. Government and Payer Rebates — The Company is liable for rebates that apply to Medicaid, managed care and private payer organizations, primarily insurance companies and pharmacy benefit managers. 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 or contractual percentages, estimated payer mix, and expected utilization. The Company's estimates for expected utilization of rebates are based on historical data since product launch. The Company's liability for these rebates consists of invoices received for claims from prior periods that have not been paid or for which an invoice has not yet been received, estimates of claims for the current period, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized and, records a reserve in accrued customer programs on the consolidated balance sheets. Patient Assistance — The Company offers programs such as the co-pay assistance and voucher programs, which are intended to provide financial assistance to eligible patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance and voucher programs is based on monthly claims activity as well as estimated claims related to product in the distribution channel and the estimated cost per claim based on historical activity. The Company records a reserve in accrued customer programs on the consolidated balance sheets. Cost of Product Sales Our cost of product sales relates to sales of CAPLYTA. Cost of product sales primarily includes product royalty fees, and direct costs (inclusive of material and manufacturing costs), and overhead. For the product royalty fees, the Company entered into an exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), for which the Company is obliged to make tiered single digit percentage royalty payments ranging between 5-9% on sales of licensed products. The related royalties are recorded within cost of product sales on the consolidated statements of operations. Prior to the FDA approval of CAPLYTA, the Company expensed all costs associated with the manufacturing of lumateperone as part of research and development expenses. The cost of product sales in the years ended December 31, 2023, 2022 and 2021 are lower than incurred because of previously expensed inventory. Research and Development Expenses Research and development costs primarily consist of external costs for contract services, such as pre-clinical testing, manufacturing and related testing, clinical trial activities; and internal recurring costs for labor and benefits, facilities and other. The Company recognizes research and development expenses as the services are incurred. The Company has entered into various research and development contracts with clinical research organizations and other companies both inside and outside of the U.S. These agreements are generally cancellable. At the end of each financial reporting period, the Company records expenses incurred to date related to these agreements and recognizes accruals or prepaid expenses, as appropriate. These accruals or prepaid expenses occur when billing terms under these contracts do not coincide with the timing of when the work is performed. Estimates are based on a number of factors, including the Company’s knowledge of the progress towards completion of the research and development activities, communication from the clinical research organizations or other companies of any actual costs incurred during the period that have not yet been invoiced, the costs included in the contracts, and invoicing to date under the contracts. Significant judgments and estimates are made in determining the accrued or prepaid balances at the end of any reporting period. Actual results could differ from the estimates made by the Company. The historical estimates made by the Company have not been materially different from the actual costs. Advertising Expense Advertising costs are expensed when services are rendered. The Company incurred $92.2 million, $85.8 million and $82.5 million in advertising expenses during the years ended December 31, 2023, 2022, and 2021, respectively, related to its marketed product, CAPLYTA. Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and the change during the period in deferred tax assets and liabilities. The Company accounts for uncertain tax positions pursuant to ASC Topic 740, Income Taxes . Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. The Company’s effective tax rate for the years ended December 31, 2023, 2022 and 2021 was approximately (0.5)%, 0% and 0%, respectively. This effective tax rate is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not more likely than not to recognize a future tax benefit. On August 9, 2022, the United States enacted the CHIPS and Science Act which provides an investment tax credit for 25% of qualified investments primarily used for manufacturing of semiconductors and related equipment in the U.S. On August 16, 2022, the United States enacted the Inflation Reduction Act (“IRA”) which includes a provision for a 15% corporate alternative minimum tax on companies with average annual adjusted financial statement income over $1 billion effective for tax years ending after December 31, 2022. The Company reviewed the provisions and there was not a material tax impact on its financial statements for the years ended December 31, 2023 and 2022. On December 31, 2022, ITI Limited, our wholly-owned Bermuda subsidiary, was merged into Intra-Cellular Therapies, Inc., a Delaware corporation. The intellectual property rights associated with lumateperone were transferred to the Delaware corporation as a result of this merger. This merger and the subsequent liquidation of ITI Limited does not have any material impact from a U.S. or Bermuda income tax perspective. Comprehensive Loss All components of comprehensive loss, including net loss, are reported in the financial statements in the period in which they are incurred. Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. In accordance with accounting guidance, the Company presents the impact of any unrealized gains or losses on its investment securities in a separate statement of comprehensive loss for each period. Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation . The fair value of share-based payments related to stock options is estimated, on the date of grant, using the Black-Scholes-Merton option-pricing model (the “Black-Scholes Model”). The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized in the statements of operations for the years ended December 31, 2023, 2022 and 2021 accounts for forfeitures as they occur. The Company utilizes the Black-Scholes Model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes Model, require the input of subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. The expected volatility rates are based entirely on the historical volatility of the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. A restricted stock unit (“RSU”) is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the fair market value of the Company’s common stock on the date of grant. In each fiscal year beginning in 2016, the Company has granted RSUs that vest in three equal annual installments provided that the employee remains employed with the Company. The Company grants select employees performance based RSUs which vest upon the Compensation Committee’s approval at the end of the three year service period based on the achievement of select performance milestones and comparative shareholder returns against the Company’s peers. The cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future tax deduction under existing tax law is considered to be a deductible difference in applying ASC Topic 740, Income Taxes . The deductible temporary difference is based on the compensation cost recognized for financial reporting purposes; however, these provisions currently do not impact the Company, as all the deferred tax assets have a full valuation allowance. Equity instruments issued to non-employees for services are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-Based Payments to Non-Employees . Accordingly, the estimated fair value of the equity instrument is recorded on the earlier of the performance commitment date or the date the required services are completed and are marked to market during the service period. In 2020, the Company’s stockholders approved the Company’s 2018 Amended and Restated Equity Incentive Plan (the “Amended 2018 Plan”) pursuant to which 6,500,000 additional shares of common stock were reserved for future equity grants. In December 2019, the Company adopted the 2019 Inducement Award Plan (the “2019 Inducement Plan”) for the grant of equity awards of up to 1,000,000 shares of common stock to newly hired employees. Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs. Foreign Currency Translation Expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date the expense is incurred. Assets and liabilities of foreign operations are translated at period-end exchange rates. The effect of exchange rate fluctuations on translating foreign currency into U.S. dollars is included in the statements of operations and is not material to the Company’s financial statements. Recently Issued Accounting Standards |
Investment Securities
Investment Securities | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investment Securities | Investment Securities Investment securities consisted of the following (in thousands): December 31, 2023 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 150,651 $ 148 $ (204) $ 150,595 FDIC Certificates of Deposit 4,410 2 (12) 4,400 Certificates of Deposit 60,000 — — 60,000 Commercial Paper 78,610 59 (27) 78,642 Corporate Notes/Bonds 118,899 281 (143) 119,037 $ 412,570 $ 490 $ (386) $ 412,674 December 31, 2022 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 188,465 $ 14 $ (1,729) $ 186,750 FDIC Certificates of Deposit 4,155 3 (72) 4,086 Certificates of Deposit 7,500 — — 7,500 Commercial Paper 100,711 3 (269) 100,445 Corporate Notes/Bonds 189,588 1 (2,141) 187,448 $ 490,419 $ 21 $ (4,211) $ 486,229 The Company has classified all of its investment securities as available-for-sale, including those with maturities beyond one year, as current assets on the 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, the Company held $77.8 million and $71.5 million, respectively, of available-for-sale investment securities with contractual maturity dates more than one year and less than two years, with the remainder of the available-for-sale investment securities having contractual maturity dates less than one year. The aggregate related fair value of investments with unrealized losses as of December 31, 2023 was $165.2 million, which consisted of $78.0 million from U.S. government agency securities, $3.7 million of certificates of deposit, $32.1 million of commercial paper, and $51.4 million of corporate notes/bonds. $70.1 million of the aggregate fair value of investments with unrealized losses as of December 31, 2023 has been held in a continuous unrealized loss position for over 12 months, with the remaining $95.1 million held in a continuous unrealized loss position for less than 12 months. As of December 31, 2023, $60.0 million of the certificates of deposit and $2.5 million of the U.S. Government Agency Securities balance are listed as cash equivalents. As of December 31, 2022, the aggregate related fair value of investments with unrealized losses was $438.3 million. $49.1 million of the aggregate fair value of investments with unrealized losses as of December 31, 2022 has been held in a continuous unrealized loss position for over than 12 months, with the remaining $389.2 million held in a continuous unrealized loss position for less than 12 months. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company has no assets or liabilities that were measured for significant unobservable inputs (Level 3 assets and liabilities) as of December 31, 2023 and 2022. The carrying value of cash held in money market funds of approximately $10.7 million as of December 31, 2023 and $12.2 million as of December 31, 2022 is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. The carrying value of U.S. Government Agency Securities of $2.5 million and certificates of deposit of $60.0 million as of December 31, 2023 are included in cash and cash equivalents. The carrying value of cash held in commercial paper of approximately $14.9 million, U.S. Government Agency Securities of $20.5 million, and certificates of deposit of $7.5 million as of December 31, 2022 are included in cash and cash equivalents. The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at December 31, Quoted Prices Significant Significant Money Market Funds $ 10,698 $ 10,698 $ — $ — U.S. Government Agency Securities 150,595 — 150,595 — FDIC Certificates of Deposit 4,400 — 4,400 — Certificates of Deposit 60,000 — 60,000 — Commercial Paper 78,642 — 78,642 — Corporate Notes/Bonds 119,037 — 119,037 — $ 423,372 $ 10,698 $ 412,674 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money Market Funds $ 12,203 $ 12,203 $ — $ — U.S. Government Agency Securities 186,750 — 186,750 — FDIC Certificates of Deposit 4,086 — 4,086 — Certificates of Deposit 7,500 — 7,500 — Commercial Paper 100,445 — 100,445 — Corporate Notes/Bonds 187,448 — 187,448 — $ 498,432 $ 12,203 $ 486,229 $ — |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consists of the following (in thousands): December 31, 2023 December 31, 2022 Raw materials $ 38,621 $ 17,227 Work in process 4,277 2,594 Finished goods 7,370 4,099 Total 50,268 23,920 Less: Current portion (11,647) (23,920) Total inventory, non-current $ 38,621 $ — As of December 31, 2023 and 2022, the Company has recorded $7.7 million and $0, respectively, in inventory on the consolidated balance sheets which is subject to supplemental regulatory procedures but believes it is probable that it has future economic benefit. |
Prepaid and Other Assets
Prepaid and Other Assets | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid and Other Assets | Prepaid and Other Assets Prepaid expenses and other assets consists of the following (in thousands): December 31, 2023 December 31, 2022 Prepaid operating expenses, non-clinical $ 19,465 $ 11,335 Production campaign deposits 15,127 21,575 Clinical trial advances 11,630 11,808 Prefunded customer programs 3,514 561 Total 49,736 45,279 Less: Current portion (42,443) (45,193) Total other assets $ 7,293 $ 86 |
Right of Use Assets and Lease L
Right of Use Assets and Lease Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Right of Use Assets and Lease Liabilities | Right of Use Assets and Lease Liabilities In 2014, the Company entered into a long-term lease with a related party which, as amended, provided for a lease of useable laboratory and office space located in New York, New York. A member of the Company’s board of directors is the Executive Chairman of the parent company to the landlord under this lease. Concurrent with this lease, the Company entered into a license agreement to occupy certain vivarium-related space in the same facility for the same term and rent escalation provisions as the lease. This license has the primary characteristics of a lease and is characterized as a lease in accordance with ASU No. 2016-02, Leases , for accounting purposes. In September 2018, the Company further amended the lease to obtain an additional office space beginning October 1, 2018 and to extend the term of the lease for previously acquired space. The lease, as amended, has a term of 14.3 years ending in May 2029. The Company has also entered into an agreement (the “Vehicle Lease”) with a company (the “Lessor”) to acquire motor vehicles for certain employees. The Vehicle Lease provides for individual leases for the vehicles, which at each lease commencement was determined to qualify for operating lease treatment. The contractual period of each lease is 12 months, followed by month-to-month renewal periods. The Company estimates the lease term for each vehicle to be 12 months. Leases which the Company determined to have a lease term of 12 months or less will be treated as short-term in accordance with the accounting policy election and are not recognized on the balance sheet. Each lease permits either party to terminate the lease at any time via written notice to the other party. The Company neither acquires ownership of, nor has the option to purchase the vehicles at any time. The Company is required to maintain an irrevocable $1.75 million letter of credit that the Lessor may draw upon in the event the Company defaults on the Vehicle Lease, which has been recorded as restricted cash on the consolidated balance sheets. The following table presents the lease cost for the years ended December 31, 2023, 2022, and 2021 (in thousands): Years Ended December 31, 2023 2022 2021 Lease cost Operating lease cost $ 3,851 $ 4,719 $ 5,774 Variable lease cost 1,536 1,612 2,676 Short-term lease cost 2,298 873 — $ 7,685 $ 7,204 $ 8,450 The following table presents the weighted average remaining lease term, and the weighted average discount rates related to leases as of December 31, 2023 and 2022: December 31, 2023 December 31, 2022 Other information Weighted average remaining lease term 5.3 years 5.9 years Weighted average discount rate 9.07 % 8.76 % Maturity analysis under the lease agreements are as follows: Year ending December 31, 2024 $ 3,792 Year ending December 31, 2025 3,907 Year ending December 31, 2026 3,974 Year ending December 31, 2027 4,022 Year ending December 31, 2028 4,144 Thereafter 1,771 Total 21,610 Less: Present value discount (4,672) Total Lease liability 16,938 Less: Current portion (3,612) Long-term lease liabilities $ 13,326 |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation The Board of Directors determines who receives options, the vesting periods (which are generally one Total share-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs granted to employees and directors recognized during the years ended December 31, 2023, 2022, and 2021, was comprised of the following (in thousands): Years Ended December 31, 2023 2022 2021 Inventoriable costs $ 1,610 $ 1,791 $ 1,624 Research and development 15,781 15,387 9,832 Selling, general and administrative 35,441 25,835 22,847 Total share-based compensation expense $ 52,832 $ 43,013 $ 34,303 The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2023, 2022 and 2021: Years Ended December 31, 2023 2022 2021 Dividend yield 0 % 0 % 0 % Expected volatility 74.8%-78.0% 78.7-88.7% 89.4-94.9% Weighted-average risk-free interest rate 3.92 % 2.22 % 0.87 % Expected term (in years) 6.0 5.9 5.9 The weighted-average grant date fair value for awards granted during the years ended December 31, 2023, 2022 and 2021 was $33.49, $41.71 and $29.01 per share, respectively. Information regarding the stock options activity, including with respect to grants to employees, directors and consultants under the Amended 2018 Plan and 2019 Inducement Plan as of December 31, 2023, and changes during the year then ended, are summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2022 4,785,972 $ 26.27 5.8 years Options granted 2023 289,084 48.13 Options exercised 2023 (791,795) 22.49 Options canceled 2023 (39,854) 51.05 Options expired 2023 (3,425) 40.94 Outstanding at December 31, 2023 4,239,982 $ 28.22 5.2 years Vested and expected to vest at December 31, 2023 4,239,982 $ 28.22 Exercisable at December 31, 2023 3,470,018 $ 23.55 4.5 years The unrecognized share-based compensation expense related to stock option awards at December 31, 2023 was $15.8 million, and will be recognized over a weighted-average period of 1.2 years. The following table details the value of options during the years ended December 31, 2023, 2022 and 2021 (in thousands): Years Ended December 31, 2023 2022 2021 Intrinsic value of options exercised $ 27,187 $ 48,267 $ 19,688 Intrinsic value of options outstanding 184,027 130,078 172,964 Intrinsic value of options exercisable 166,820 118,340 131,235 Fair value of shares vested 19,120 17,145 10,583 Information regarding time based RSU activity, including with respect to grants to employees under the Amended 2018 Plan and 2019 Inducement Plan as of December 31, 2023, and changes during the year then ended, is summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2022 1,274,664 $ 42.76 0.8 years Time based RSUs granted in 2023 1,109,622 48.58 Time based RSUs vested in 2023 (665,824) 36.65 Time based RSUs cancelled in 2023 (73,332) 48.29 Outstanding at December 31, 2023 1,645,130 $ 48.92 1.0 years The following table details the value of time based RSUs during the years ended December 31, 2023, 2022 and 2021 (in thousands): Years Ended December 31, 2023 2022 2021 Intrinsic value of time based RSUs outstanding 117,824 67,455 80,062 Fair value of RSUs vested 24,400 17,873 12,411 The fair value of time based RSUs is based on the closing price of the Company’s common stock on the date of grant. As of December 31, 2023, there was $52.8 million of unrecognized compensation costs related to unvested time based RSUs which will be recognized over a weighted-average period of 1.4 years. |
Loss per Share
Loss per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Loss per Share | Loss per Share The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect could be anti-dilutive as applied to the net loss for the years ended December 31, 2023, 2022 and 2021: Years Ended December 31, 2023 2022 2021 Stock options 4,239,982 4,785,972 5,451,398 RSUs 1,860,714 1,469,678 1,666,848 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Loss before income taxes is as follows (in thousands): Years Ended December 31, 2023 2022 2021 U.S. $ (139,038) $ (223,465) $ (221,216) Non-U.S. — (32,785) (62,904) Total loss before taxes $ (139,038) $ (256,250) $ (284,120) Total income tax expense for the years ended December 31, 2023, 2022 and 2021 is allocated as follows: Years Ended December 31, 2023 2022 2021 Current $ 636 $ 6 $ 6 Deferred (51,341) (52,789) (53,070) Valuation allowance 51,341 52,789 53,070 Provision for income taxes $ 636 $ 6 $ 6 A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2023, 2022 and 2021 is as follows: Years Ended December 31, 2023 2022 2021 Income tax at statutory federal rate 21.0 % 21.0 % 21.0 % Executive and share-based compensation (0.4) 1.9 0.6 Subpart F Inclusion — (3.4) — Foreign rate differential — (2.7) (4.6) Change in effective state tax rates (1.6) 0.2 (0.3) State income tax expense 4.8 3.6 2.0 Research and development credits 14.1 — — Other permanent items (1.5) — — Change in valuation allowance (36.9) (20.6) (18.7) Provision for income taxes (0.5) % — % — % Deferred income taxes reflect the net tax effect of temporary differences that exist between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, using enacted tax rates in effect for the year in which the differences are expected to reverse. As of December 31, 2023, the Company had $528.4 million of federal net operating loss carryforwards, of which $73.6 million expire at various dates through 2037 and $454.8 million do not expire. The gross amount of the state net operating loss carryforwards is equal to or less than the federal net operating loss carryforwards and expires over various periods based on individual state tax law. In general, businesses with U.S. net operating losses (“NOLs”) are considered loss corporations for U.S. federal income tax purposes. Pursuant to Section 382 of the Internal Revenue Code of 1986, as amended (the "Code"), loss corporations that undergo an ownership change, as defined under the Code, may be subject to an annual limitation on the amount of NOLs (and certain other tax attributes) available to offset taxable income earned after such ownership change. For the years ended December 31, 2015 through 2022, the Company performed a Section 382 ownership analysis and determined that an ownership change occurred (within the meaning of Section 382 of the Code) in 2015 but not in subsequent periods. Based on the analysis performed through December 31, 2023, the Company does not believe that the Section 382 annual limitation will impact the Company’s ability to utilize the tax attributes that existed as of the date of the ownership change in a material manner. If the Company experiences an ownership change in the future, the tax benefits related to the NOLs and tax credit carryforwards may be further limited or lost. The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2023 and 2022, respectively (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 138,685 $ 168,606 Accrued expenditures 17,842 9,169 Research and development credit, net 31,109 9,321 Research and development expenditures 62,432 13,525 Share-based compensation 19,753 17,085 Other — 1,466 Capital lease 4,198 4,980 Deferred tax liabilities: Right of use asset—capital lease (3,204) (3,684) Depreciation (140) (154) Other (86) — Net deferred tax asset before valuation allowance 270,589 220,314 Valuation allowance (270,589) (220,314) Net deferred tax asset $ — $ — Based upon the Company’s historical operating performance and the reported cumulative net losses to date, the Company presently does not have sufficient objective evidence to support the recovery of its net deferred tax assets. Accordingly, the Company has established a full valuation allowance against its net deferred tax assets in 2023 and 2022, for financial reporting purposes because it is not more likely than not that these deferred tax assets will be realized. The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The open years subject to tax audits vary depending on the tax jurisdictions. In the U.S. federal jurisdiction, we are no longer subject to income tax audits by taxing authorities for years before 2020. In addition, for federal tax purposes and certain state taxing jurisdictions, in the case of carryover tax attributes to years open for assessment, such attributes may be subject to reduction by taxing authorities. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies License and Royalty Commitments On May 31, 2005, the Company entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company, pursuant to which the Company holds a license to certain patents and know-how of BMS relating to lumateperone and other specified compounds. The agreement was amended on November 3, 2010. The licensed rights are exclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome and cardiovascular disease. However, BMS has no right to use, develop, or commercialize lumateperone and other specified compounds in any field of use. The Company has the right to grant sublicenses of the rights conveyed by BMS. The Company is obliged under the agreement to use commercially reasonable efforts to develop and commercialize the licensed technology. The Company is also prohibited from engaging in the clinical development or commercialization of specified competitive compounds. Under the agreement, the Company has made payments of $10.8 million to BMS related to milestones achieved to date for lumateperone. Possible milestone payments remaining total $5.0 million. Under the agreement, the Company may be obliged to make other milestone payments to BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentage royalty payments ranging between 5 – 9% on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty payments made in consideration of any sublicense. The agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of 10 years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product, its method of manufacture or use, or the expiration of other government grants providing market exclusivity, subject to certain rights of the parties to terminate the agreement on the occurrence of certain events. On termination of the agreement, the Company may be obliged to convey to BMS rights in developments relating to a licensed compound or licensed product, including regulatory filings, research results and other intellectual property rights. In September 2016, the Company transferred certain of its rights under the BMS agreement to its wholly owned subsidiary, ITI Limited. However, in December 2022, ITI Limited merged into Intra-Cellular Therapies, Inc. The Company expensed approximately $26.4 million, $12.5 million, and $4.1 million in cost of product sales to satisfy its obligation under the BMS agreement for the years ended December 31, 2023, 2022 and 2021, respectively. Purchase Commitments The Company enters into certain other long-term commitments for goods and services that are outstanding for periods greater than one year. The Company has manufacturing service agreements committing the Company to certain minimum annual purchase commitments which the Company anticipates making payments for within the years 2025 through 2029. As of December 31, 2023, the Company has committed to purchasing production campaigns for various raw materials including API and its intermediates from each of its supply vendors. The current campaigns are expected to be received into inventory during 2024 and 2025. The Company has paid deposits of $15.1 million and $21.6 million as of December 31, 2023 and 2022, respectively, for these campaigns. Of the $15.1 million as of December 31, 2023, $7.9 million is recorded within prepaid expenses and other current assets as the campaigns are expected to be received within one year of the balance sheet date and $7.2 million is recorded within other assets on the consolidated balance sheet as the campaigns are expected to be received after December 31, 2024. The $21.6 million balance as of December 31, 2022 is recorded within prepaid expenses and other current assets on the consolidated balance sheet. Over the course of the vendors’ manufacturing period, the Company will remit payments to each vendor based on the payment plan within the executed agreements. Retirement savings plan 401(k) contributions The Company sponsors a defined contribution 401(k) plan covering all full-time employees. Participants may elect to contribute their annual pre-tax earnings up to the federally allowed maximum limits. The Company made a matching contribution of 100% on the first 6% of contributions made by participants in the years ended December 31, 2023, 2022 and 2021. Participant and company contributions vest immediately. During the years ended December 31, 2023, 2022 and 2021, the Company recorded matching contribution expense of $4.3 million, $3.9 million and $3.0 million, respectively. Contingencies |
Unaudited Quarterly Financial I
Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2023 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | Unaudited Quarterly Financial Information The tables herein set forth the Company’s unaudited condensed consolidated 2023 and 2022 quarterly statements of operations. The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2023 quarters ended (in thousands): 2023 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 132,099 $ 126,173 $ 110,792 $ 95,306 Operating expenses (166,196) (155,886) (157,971) (143,698) Interest income 5,966 5,498 4,530 4,349 Income tax expense (448) (43) (135) (10) Net loss $ (28,579) $ (24,258) $ (42,784) $ (44,053) Basic and diluted net loss per share $ (0.30) $ (0.25) $ (0.45) $ (0.46) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2022 quarters ended (in thousands): 2022 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 87,869 $ 71,870 $ 55,579 $ 34,996 Operating expenses (135,281) (127,499) (143,502) (107,658) Interest income 3,386 2,122 1,320 548 Income tax expense — (1) — (5) Net loss $ (44,026) $ (53,508) $ (86,603) $ (72,119) Basic and diluted net loss per share $ (0.45) $ (0.57) $ (0.92) $ (0.78) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
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 amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
Investment Securities | Investment Securities Investment securities may consist of investments in U.S. Treasuries, various U.S. governmental agency debt securities, corporate bonds, certificates of deposit, and other fixed income securities with an average maturity of approximately twelve months or less. Management classifies the Company’s investments as available-for-sale. Such securities are carried at estimated fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity. Realized gains and losses and declines in value judged to be other-than-temporary, if any, are included in the consolidated statement of operations. A decline in the market value of any available-for-sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income are recognized as interest income on the consolidated statements of operations when earned. The cost of securities sold is calculated using the specific identification method. |
Fair Value Measurements | Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurement . ASC Topic 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value and requires expanded disclosures about fair value measurements. The ASC Topic 820 hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following categories based on the lowest level input used that is significant to a particular fair value measurement: • Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. |
Financial Instruments | Financial Instruments |
Restricted Cash | Restricted Cash Restricted cash is collateral used under the letter of credit arrangement for the Company’s vehicle lease agreement (see Note 7). The Company adopted ASU No. 2016-18, Restricted Cash |
Accounts Receivable, net | Accounts Receivable, net The Company’s accounts receivable arise from product sales and are recorded net of allowances for returns, distribution fees, chargebacks, and prompt pay discounts. The Company monitors the financial performance and creditworthiness of its customers so that it can respond to changes in the customers’ credit profiles. The Company reserves against accounts receivable for estimated losses that may arise from a customer’s inability to pay and any amounts determined to be uncollectible are written off against the reserve when it is probable that the receivable will not be collected. The reserve amount for estimated collectability losses was not significant as of December 31, 2023 and 2022. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist of accounts receivable, net from customers and cash, cash equivalents and investments held at financial institutions. For the years ended December 31, 2023 and 2022, 97% of product sales were generated from three major industry wholesalers. Three individual customers accounted for approximately 36%, 32%, and 29% and 39%, 30%, and 28% of product sales for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company believes that these customers are of high credit quality. |
Inventory | Inventory The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to direct materials, production costs, and manufacturing overhead, on a first-in,first-out (“FIFO”) basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within cost of product sales. The Company capitalizes inventory costs associated with the Company’s products when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized typically after regulatory approval. Inventory acquired and manufactured prior to regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign. Inventory that is used in the production of sample product is reclassified to prepaid and other current assets and is then expensed to selling, general and administrative expenses when the sample product is distributed. The Company analyzes its inventory based on the stage of production and classifies work in process and finished goods as current assets. Raw materials includes the active pharmaceutical ingredients ("API") and any related intermediate compounds. The raw material supply exceeds 12 months of current operating requirements and is recorded as inventory, non-current on the consolidated balance sheet. Shipping and handling costs for product shipments to customers are recorded as part of cost of product sales along with costs associated with manufacturing the product, and any inventory write-downs. Based on contractual terms, the Company has made advances on API production campaigns. Deposits related to production campaigns when delivery is expected within the next 12-month period from the balance sheet date are included in prepaid and other current assets on the consolidated balance sheets and if delivery is expected beyond the next 12-month period from the balance sheet date are included in other assets on the consolidated balance sheets. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment |
Leases | Leases In accordance with ASC Topic 842, Leases , the Company made an accounting policy election to keep leases with an initial term of 12 months or less off of the consolidated balance sheets. The Company also elected the lessee component election, allowing the Company to account for the lease and non-lease components as a single lease component. |
Revenue Recognition | Revenue Recognition In accordance with ASC Topic 606, Revenue from contracts with customers , the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration that the Company expects to receive in exchange for the good or service. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 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 entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC Topic 606, including 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. Product Sales, net To date, the Company’s only source of product sales has been from sales of CAPLYTA in the United States, which the Company began shipping to customers in March 2020. The Company sells CAPLYTA to a limited number of customers which include national and regional distributors. These customers subsequently resell the Company’s products to retail pharmacies, specialty pharmacy providers, and certain medical centers or hospitals. In addition to distribution agreements with customers, the Company enters into arrangements with health care providers and payers that obligate the Company to have government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company also voluntarily offers patient assistance programs which are intended to provide financial assistance to qualified commercially-insured patients. The Company recognizes revenue on product sales when the customer obtains control of the Company’s product, which occurs upon delivery. Product revenues are recorded net of applicable reserves for the sales obligations that are considered variable consideration, including rebates, discounts and allowances, among others. Reserves for Variable Consideration The Company recognizes revenue from product sales at the net sales price (the "transaction price") which includes the wholesale acquisition cost that the Company charges to its customers less variable consideration for which reserves are established. Components of variable consideration may include trade discounts and allowances, product returns, chargebacks, government and payer rebates, and patient assistance. The amount of variable consideration 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 under the contract 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 the Company’s estimates, the Company will adjust these estimates, which would affect net product sales and earnings in the period of the adjustment. The provision for rebates, discounts, and other incentives is based on expected patient usage, as well as inventory levels in the distribution channel to determine the contractual obligations to the benefit providers. Additionally, sales are generally made with a limited right of return under certain conditions. Revenue is recorded net of provisions for rebates, discounts, and other incentives and returns, which are established at the time of sale. The Company uses payer mix utilization data, changes to product price, government pricing calculations and prior payment history in order to estimate the variable consideration. Trade Discounts and Allowances — The Company generally provides customers with discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its customers for sales order management, data, and distribution services. The Company has determined such services received to date are not distinct from the Company’s sale of products to the customer and, therefore, these payments have been recorded as a reduction to revenue and accounts receivable, net on the consolidated balance sheets. Product Returns — The Company offers customers a limited right of return for product that has been purchased based on the product’s expiration date, such right lapses upon patient's receipt of product. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as accounts receivable, net on the consolidated balance sheets. The Company currently estimates product return liabilities primarily using its own sales returns experience and, when appropriate, benchmarking data for similar products and industry experience. Chargebacks — Chargebacks represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who purchase the product directly from the Company. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net. Chargeback amounts are determined at the time of resale to the qualified healthcare provider by customers. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at the end of each reporting period, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit. Government and Payer Rebates — The Company is liable for rebates that apply to Medicaid, managed care and private payer organizations, primarily insurance companies and pharmacy benefit managers. 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 or contractual percentages, estimated payer mix, and expected utilization. The Company's estimates for expected utilization of rebates are based on historical data since product launch. The Company's liability for these rebates consists of invoices received for claims from prior periods that have not been paid or for which an invoice has not yet been received, estimates of claims for the current period, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized and, records a reserve in accrued customer programs on the consolidated balance sheets. Patient Assistance — The Company offers programs such as the co-pay assistance and voucher programs, which are intended to provide financial assistance to eligible patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance and voucher programs is based on monthly claims activity as well as estimated claims related to product in the distribution channel and the estimated cost per claim based on historical activity. The Company records a reserve in accrued customer programs on the consolidated balance sheets. |
Cost of Product Sales | Cost of Product Sales Our cost of product sales relates to sales of CAPLYTA. Cost of product sales primarily includes product royalty fees, and direct costs (inclusive of material and manufacturing costs), and overhead. For the product royalty fees, the Company entered into an exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), for which the Company is obliged to make tiered single digit percentage royalty payments ranging between 5-9% on sales of licensed products. The related royalties are recorded within cost of product sales on the consolidated statements of operations. Prior to the FDA approval of CAPLYTA, the Company expensed all costs associated with the manufacturing of lumateperone as part of research and development expenses. The cost of product sales in the years ended December 31, 2023, 2022 and 2021 are lower than incurred because of previously expensed inventory. |
Research and Development Expenses | Research and Development Expenses Research and development costs primarily consist of external costs for contract services, such as pre-clinical testing, manufacturing and related testing, clinical trial activities; and internal recurring costs for labor and benefits, facilities and other. The Company recognizes research and development expenses as the services are incurred. The Company has entered into various research and development contracts with clinical research organizations and other companies both inside and outside of the U.S. These agreements are generally cancellable. At the end of each financial reporting period, the Company records expenses incurred to date related to these agreements and recognizes accruals or prepaid expenses, as appropriate. These accruals or prepaid expenses occur when billing terms under these contracts do not coincide with the timing of when the work is performed. Estimates are based on a number of factors, including the Company’s knowledge of the progress towards completion of the research and development activities, communication from the clinical research organizations or other companies of any actual costs incurred during the period that have not yet been invoiced, the costs included in the contracts, and invoicing to date under the contracts. Significant judgments and estimates are made in determining the accrued or prepaid balances at the end of any reporting period. Actual results could differ from the estimates made by the Company. The historical estimates made by the Company have not been materially different from the actual costs. |
Advertising Expense | Advertising Expense |
Income Taxes | Income Taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and the change during the period in deferred tax assets and liabilities. The Company accounts for uncertain tax positions pursuant to ASC Topic 740, Income Taxes . Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. The Company’s effective tax rate for the years ended December 31, 2023, 2022 and 2021 was approximately (0.5)%, 0% and 0%, respectively. This effective tax rate is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not more likely than not to recognize a future tax benefit. On August 9, 2022, the United States enacted the CHIPS and Science Act which provides an investment tax credit for 25% of qualified investments primarily used for manufacturing of semiconductors and related equipment in the U.S. On August 16, 2022, the United States enacted the Inflation Reduction Act (“IRA”) which includes a provision for a 15% corporate alternative minimum tax on companies with average annual adjusted financial statement income over $1 billion effective for tax years ending after December 31, 2022. The Company reviewed the provisions and there was not a material tax impact on its financial statements for the years ended December 31, 2023 and 2022. |
Comprehensive Loss | Comprehensive Loss |
Share-Based Compensation | Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation . The fair value of share-based payments related to stock options is estimated, on the date of grant, using the Black-Scholes-Merton option-pricing model (the “Black-Scholes Model”). The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized in the statements of operations for the years ended December 31, 2023, 2022 and 2021 accounts for forfeitures as they occur. The Company utilizes the Black-Scholes Model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes Model, require the input of subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award. The expected volatility rates are based entirely on the historical volatility of the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. A restricted stock unit (“RSU”) is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the fair market value of the Company’s common stock on the date of grant. In each fiscal year beginning in 2016, the Company has granted RSUs that vest in three equal annual installments provided that the employee remains employed with the Company. The Company grants select employees performance based RSUs which vest upon the Compensation Committee’s approval at the end of the three year service period based on the achievement of select performance milestones and comparative shareholder returns against the Company’s peers. The cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future tax deduction under existing tax law is considered to be a deductible difference in applying ASC Topic 740, Income Taxes . The deductible temporary difference is based on the compensation cost recognized for financial reporting purposes; however, these provisions currently do not impact the Company, as all the deferred tax assets have a full valuation allowance. Equity instruments issued to non-employees for services are accounted for under the provisions of ASC Topic 718 and ASC Topic 505-50, Equity/Equity-Based Payments to Non-Employees . Accordingly, the estimated fair value of the equity instrument is recorded on the earlier of the performance commitment date or the date the required services are completed and are marked to market during the service period. In 2020, the Company’s stockholders approved the Company’s 2018 Amended and Restated Equity Incentive Plan (the “Amended 2018 Plan”) pursuant to which 6,500,000 additional shares of common stock were reserved for future equity grants. In December 2019, the Company adopted the 2019 Inducement Award Plan (the “2019 Inducement Plan”) for the grant of equity awards of up to 1,000,000 shares of common stock to newly hired employees. |
Loss Per Share | Loss Per Share |
Foreign Currency Translation | Foreign Currency Translation Expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date the expense is incurred. Assets and liabilities of foreign operations are translated at period-end exchange rates. The effect of exchange rate fluctuations on translating foreign currency into U.S. dollars is included in the statements of operations and is not material to the Company’s financial statements. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards |
Investment Securities (Tables)
Investment Securities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): December 31, 2023 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 150,651 $ 148 $ (204) $ 150,595 FDIC Certificates of Deposit 4,410 2 (12) 4,400 Certificates of Deposit 60,000 — — 60,000 Commercial Paper 78,610 59 (27) 78,642 Corporate Notes/Bonds 118,899 281 (143) 119,037 $ 412,570 $ 490 $ (386) $ 412,674 December 31, 2022 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 188,465 $ 14 $ (1,729) $ 186,750 FDIC Certificates of Deposit 4,155 3 (72) 4,086 Certificates of Deposit 7,500 — — 7,500 Commercial Paper 100,711 3 (269) 100,445 Corporate Notes/Bonds 189,588 1 (2,141) 187,448 $ 490,419 $ 21 $ (4,211) $ 486,229 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities | The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at December 31, Quoted Prices Significant Significant Money Market Funds $ 10,698 $ 10,698 $ — $ — U.S. Government Agency Securities 150,595 — 150,595 — FDIC Certificates of Deposit 4,400 — 4,400 — Certificates of Deposit 60,000 — 60,000 — Commercial Paper 78,642 — 78,642 — Corporate Notes/Bonds 119,037 — 119,037 — $ 423,372 $ 10,698 $ 412,674 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money Market Funds $ 12,203 $ 12,203 $ — $ — U.S. Government Agency Securities 186,750 — 186,750 — FDIC Certificates of Deposit 4,086 — 4,086 — Certificates of Deposit 7,500 — 7,500 — Commercial Paper 100,445 — 100,445 — Corporate Notes/Bonds 187,448 — 187,448 — $ 498,432 $ 12,203 $ 486,229 $ — |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consists of the following (in thousands): December 31, 2023 December 31, 2022 Raw materials $ 38,621 $ 17,227 Work in process 4,277 2,594 Finished goods 7,370 4,099 Total 50,268 23,920 Less: Current portion (11,647) (23,920) Total inventory, non-current $ 38,621 $ — |
Prepaid and Other Assets (Table
Prepaid and Other Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Assets | Prepaid expenses and other assets consists of the following (in thousands): December 31, 2023 December 31, 2022 Prepaid operating expenses, non-clinical $ 19,465 $ 11,335 Production campaign deposits 15,127 21,575 Clinical trial advances 11,630 11,808 Prefunded customer programs 3,514 561 Total 49,736 45,279 Less: Current portion (42,443) (45,193) Total other assets $ 7,293 $ 86 |
Right of Use Assets and Lease_2
Right of Use Assets and Lease Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Schedule Of Quantitative Information About Operating Leases | The following table presents the lease cost for the years ended December 31, 2023, 2022, and 2021 (in thousands): Years Ended December 31, 2023 2022 2021 Lease cost Operating lease cost $ 3,851 $ 4,719 $ 5,774 Variable lease cost 1,536 1,612 2,676 Short-term lease cost 2,298 873 — $ 7,685 $ 7,204 $ 8,450 The following table presents the weighted average remaining lease term, and the weighted average discount rates related to leases as of December 31, 2023 and 2022: December 31, 2023 December 31, 2022 Other information Weighted average remaining lease term 5.3 years 5.9 years Weighted average discount rate 9.07 % 8.76 % |
Schedule Of Maturity Analysis Under Lease Agreements | Maturity analysis under the lease agreements are as follows: Year ending December 31, 2024 $ 3,792 Year ending December 31, 2025 3,907 Year ending December 31, 2026 3,974 Year ending December 31, 2027 4,022 Year ending December 31, 2028 4,144 Thereafter 1,771 Total 21,610 Less: Present value discount (4,672) Total Lease liability 16,938 Less: Current portion (3,612) Long-term lease liabilities $ 13,326 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Total Stock-Based Compensation Expense | Total share-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs granted to employees and directors recognized during the years ended December 31, 2023, 2022, and 2021, was comprised of the following (in thousands): Years Ended December 31, 2023 2022 2021 Inventoriable costs $ 1,610 $ 1,791 $ 1,624 Research and development 15,781 15,387 9,832 Selling, general and administrative 35,441 25,835 22,847 Total share-based compensation expense $ 52,832 $ 43,013 $ 34,303 |
Assumptions Used for Calculating Value of Options Granted | The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2023, 2022 and 2021: Years Ended December 31, 2023 2022 2021 Dividend yield 0 % 0 % 0 % Expected volatility 74.8%-78.0% 78.7-88.7% 89.4-94.9% Weighted-average risk-free interest rate 3.92 % 2.22 % 0.87 % Expected term (in years) 6.0 5.9 5.9 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants under the Amended 2018 Plan and 2019 Inducement Plan as of December 31, 2023, and changes during the year then ended, are summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2022 4,785,972 $ 26.27 5.8 years Options granted 2023 289,084 48.13 Options exercised 2023 (791,795) 22.49 Options canceled 2023 (39,854) 51.05 Options expired 2023 (3,425) 40.94 Outstanding at December 31, 2023 4,239,982 $ 28.22 5.2 years Vested and expected to vest at December 31, 2023 4,239,982 $ 28.22 Exercisable at December 31, 2023 3,470,018 $ 23.55 4.5 years The following table details the value of options during the years ended December 31, 2023, 2022 and 2021 (in thousands): Years Ended December 31, 2023 2022 2021 Intrinsic value of options exercised $ 27,187 $ 48,267 $ 19,688 Intrinsic value of options outstanding 184,027 130,078 172,964 Intrinsic value of options exercisable 166,820 118,340 131,235 Fair value of shares vested 19,120 17,145 10,583 |
Summary of Information Regarding RSU Activity | Information regarding time based RSU activity, including with respect to grants to employees under the Amended 2018 Plan and 2019 Inducement Plan as of December 31, 2023, and changes during the year then ended, is summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2022 1,274,664 $ 42.76 0.8 years Time based RSUs granted in 2023 1,109,622 48.58 Time based RSUs vested in 2023 (665,824) 36.65 Time based RSUs cancelled in 2023 (73,332) 48.29 Outstanding at December 31, 2023 1,645,130 $ 48.92 1.0 years The following table details the value of time based RSUs during the years ended December 31, 2023, 2022 and 2021 (in thousands): Years Ended December 31, 2023 2022 2021 Intrinsic value of time based RSUs outstanding 117,824 67,455 80,062 Fair value of RSUs vested 24,400 17,873 12,411 |
Loss per Share (Tables)
Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share | The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect could be anti-dilutive as applied to the net loss for the years ended December 31, 2023, 2022 and 2021: Years Ended December 31, 2023 2022 2021 Stock options 4,239,982 4,785,972 5,451,398 RSUs 1,860,714 1,469,678 1,666,848 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Summary of Loss Before Income Taxes | Loss before income taxes is as follows (in thousands): Years Ended December 31, 2023 2022 2021 U.S. $ (139,038) $ (223,465) $ (221,216) Non-U.S. — (32,785) (62,904) Total loss before taxes $ (139,038) $ (256,250) $ (284,120) |
Total Income Tax Expense | Total income tax expense for the years ended December 31, 2023, 2022 and 2021 is allocated as follows: Years Ended December 31, 2023 2022 2021 Current $ 636 $ 6 $ 6 Deferred (51,341) (52,789) (53,070) Valuation allowance 51,341 52,789 53,070 Provision for income taxes $ 636 $ 6 $ 6 |
Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate | A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2023, 2022 and 2021 is as follows: Years Ended December 31, 2023 2022 2021 Income tax at statutory federal rate 21.0 % 21.0 % 21.0 % Executive and share-based compensation (0.4) 1.9 0.6 Subpart F Inclusion — (3.4) — Foreign rate differential — (2.7) (4.6) Change in effective state tax rates (1.6) 0.2 (0.3) State income tax expense 4.8 3.6 2.0 Research and development credits 14.1 — — Other permanent items (1.5) — — Change in valuation allowance (36.9) (20.6) (18.7) Provision for income taxes (0.5) % — % — % |
Deferred Tax Assets and Liabilities | The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2023 and 2022, respectively (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 138,685 $ 168,606 Accrued expenditures 17,842 9,169 Research and development credit, net 31,109 9,321 Research and development expenditures 62,432 13,525 Share-based compensation 19,753 17,085 Other — 1,466 Capital lease 4,198 4,980 Deferred tax liabilities: Right of use asset—capital lease (3,204) (3,684) Depreciation (140) (154) Other (86) — Net deferred tax asset before valuation allowance 270,589 220,314 Valuation allowance (270,589) (220,314) Net deferred tax asset $ — $ — |
Unaudited Quarterly Financial_2
Unaudited Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2023 quarters ended (in thousands): 2023 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 132,099 $ 126,173 $ 110,792 $ 95,306 Operating expenses (166,196) (155,886) (157,971) (143,698) Interest income 5,966 5,498 4,530 4,349 Income tax expense (448) (43) (135) (10) Net loss $ (28,579) $ (24,258) $ (42,784) $ (44,053) Basic and diluted net loss per share $ (0.30) $ (0.25) $ (0.45) $ (0.46) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2022 quarters ended (in thousands): 2022 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 87,869 $ 71,870 $ 55,579 $ 34,996 Operating expenses (135,281) (127,499) (143,502) (107,658) Interest income 3,386 2,122 1,320 548 Income tax expense — (1) — (5) Net loss $ (44,026) $ (53,508) $ (86,603) $ (72,119) Basic and diluted net loss per share $ (0.45) $ (0.57) $ (0.92) $ (0.78) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | 223 Months Ended | ||||||
Aug. 16, 2022 | Aug. 09, 2022 | Dec. 31, 2023 USD ($) segment installment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2023 | Dec. 31, 2020 shares | Dec. 31, 2019 shares | |
Significant Accounting Policies [Line Items] | ||||||||
Number of operating segments | segment | 1 | |||||||
Impairment losses recognized | $ 0 | |||||||
Effective tax rate | (0.50%) | 0% | 0% | |||||
Percentage of investment qualified for investment tax credit (as a percent) | 15% | 25% | ||||||
Average annual adjusted income | $ 1,000,000,000 | |||||||
Assumed expected dividend rate | 0% | 0% | 0% | |||||
RSUs | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Service period (in years) | 3 years | |||||||
Number of equal installments | installment | 3 | |||||||
2018 Equity Incentive Plan | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Additional shares of common stock reserved for future equity grants (in shares) | shares | 6,500,000 | |||||||
CAPLYTA | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Advertising costs | $ 92,200,000 | $ 85,800,000 | $ 82,500,000 | |||||
Three Major Industry Wholesalers | Accounts Receivable | Customer Concentration Risk | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration risk (as a percent) | 97% | 97% | ||||||
Customer One | Accounts Receivable | Customer Concentration Risk | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration risk (as a percent) | 36% | 39% | ||||||
Customer Two | Accounts Receivable | Customer Concentration Risk | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration risk (as a percent) | 32% | 30% | ||||||
Customer Three | Accounts Receivable | Customer Concentration Risk | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration risk (as a percent) | 29% | 28% | ||||||
Minimum | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Property and equipment, estimated useful life (in years) | 3 years | 3 years | ||||||
Minimum | Product | Bristol-Myers Squibb Company | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Royalty payment (as a percent) | 5% | 5% | ||||||
Maximum | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Property and equipment, estimated useful life (in years) | 5 years | 5 years | ||||||
Maximum | Inducement Award Plan | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Issuance of shares, inducement award plan (in shares) | shares | 1,000,000 | |||||||
Maximum | Product | Bristol-Myers Squibb Company | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Royalty payment (as a percent) | 9% | 9% |
Investment Securities - Summary
Investment Securities - Summary of Investment Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | $ 412,570 | $ 490,419 |
Unrealized Gains | 490 | 21 |
Unrealized (Losses) | (386) | (4,211) |
Estimated Fair Value | 412,674 | 486,229 |
U.S. Government Agency Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 150,651 | 188,465 |
Unrealized Gains | 148 | 14 |
Unrealized (Losses) | (204) | (1,729) |
Estimated Fair Value | 150,595 | 186,750 |
FDIC Certificates of Deposit | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 4,410 | 4,155 |
Unrealized Gains | 2 | 3 |
Unrealized (Losses) | (12) | (72) |
Estimated Fair Value | 4,400 | 4,086 |
Certificates of Deposit | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 60,000 | 7,500 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | 0 | 0 |
Estimated Fair Value | 60,000 | 7,500 |
Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 78,610 | 100,711 |
Unrealized Gains | 59 | 3 |
Unrealized (Losses) | (27) | (269) |
Estimated Fair Value | 78,642 | 100,445 |
Corporate Notes/Bonds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 118,899 | 189,588 |
Unrealized Gains | 281 | 1 |
Unrealized (Losses) | (143) | (2,141) |
Estimated Fair Value | $ 119,037 | $ 187,448 |
Investment Securities - Additio
Investment Securities - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-Sale [Line Items] | ||
Investment securities, available-for-sale | $ 77.8 | $ 71.5 |
Aggregate related fair value of investments with unrealized losses | 165.2 | 438.3 |
Continuous unrealized loss position, less than 12 months | 95.1 | 389.2 |
Continuous unrealized loss position, 12 months or longer | 70.1 | 49.1 |
Cash and Cash Equivalents | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Certificates of deposit, at carrying value | 60 | 7.5 |
US government agencies securities, at carrying value | 2.5 | $ 20.5 |
U.S. Government Agency Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 78 | |
Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 32.1 | |
Corporate Notes/Bonds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 51.4 | |
Certificates of Deposit | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | $ 3.7 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying value of cash held in money market funds | $ 10.7 | $ 12.2 |
Cash and Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
US government agencies securities, at carrying value | 2.5 | 20.5 |
Certificates of deposit, at carrying value | 60 | 7.5 |
Commercial paper, at carrying value | 14.9 | |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities measured using quoted prices | 0 | 0 |
Assets measured using quoted prices | $ 0 | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value Measurements of Cash Equivalents (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 423,372 | $ 498,432 |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 10,698 | 12,203 |
Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 150,595 | 186,750 |
Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 4,400 | 4,086 |
Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 60,000 | 7,500 |
Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 78,642 | 100,445 |
Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 119,037 | 187,448 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 10,698 | 12,203 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 10,698 | 12,203 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 412,674 | 486,229 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 150,595 | 186,750 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 4,400 | 4,086 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 60,000 | 7,500 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 78,642 | 100,445 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 119,037 | 187,448 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 0 | $ 0 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 38,621 | $ 17,227 |
Work in process | 4,277 | 2,594 |
Finished goods | 7,370 | 4,099 |
Total | 50,268 | 23,920 |
Less: Current portion | (11,647) | (23,920) |
Total inventory, non-current | 38,621 | 0 |
Inventory subject to supplemental regulatory procedures | $ 7,700 | $ 0 |
Prepaid and Other Assets (Detai
Prepaid and Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid operating expenses, non-clinical | $ 19,465 | $ 11,335 |
Production campaign deposits | 15,127 | 21,575 |
Clinical trial advances | 11,630 | 11,808 |
Prefunded customer programs | 3,514 | 561 |
Total | 49,736 | 45,279 |
Prepaid expenses and other current assets | (42,443) | (45,193) |
Other assets | $ 7,293 | $ 86 |
Right of Use Assets and Lease_3
Right of Use Assets and Lease Liabilities - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Sep. 30, 2018 |
Term of long term lease | 12 months | |
Vehicles | ||
Guarantee obligations | $ 1,750 | |
NEW YORK | ||
Term of long term lease | 14 years 3 months 18 days |
Right of Use Assets and Lease_4
Right of Use Assets and Lease Liabilities - Schedule of Quantitative Information About Operating Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Lease cost | |||
Operating lease cost | $ 3,851 | $ 4,719 | $ 5,774 |
Variable lease cost | 1,536 | 1,612 | 2,676 |
Short-term lease cost | 2,298 | 873 | 0 |
Total lease cost | $ 7,685 | $ 7,204 | $ 8,450 |
Other information | |||
Weighted average remaining lease term (in years) | 5 years 3 months 18 days | 5 years 10 months 24 days | |
Weighted average discount rate (as a percent) | 9.07% | 8.76% |
Right of Use Assets and Lease_5
Right of Use Assets and Lease Liabilities - Maturity Analysis of the Company's fleet lease liability (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Year ending December 31, 2024 | $ 3,792 | |
Year ending December 31, 2025 | 3,907 | |
Year ending December 31, 2026 | 3,974 | |
Year ending December 31, 2027 | 4,022 | |
Year ending December 31, 2028 | 4,144 | |
Thereafter | 1,771 | |
Total | 21,610 | |
Less: Present value discount | (4,672) | |
Total Lease liability | 16,938 | |
Less: Current portion | (3,612) | $ (4,567) |
Operating lease liabilities, non-current | $ 13,326 | $ 15,474 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | 36 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant date fair value of stock options granted (in shares) | $ 33.49 | $ 41.71 | $ 29.01 | |
Unrecognized share-based compensation expense related to employee stock option awards | $ 15.8 | $ 15.8 | ||
Options granted, Number of Shares (in shares) | 289,084 | |||
Inducement Award Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Nonvested award, cost not yet recognized, amount | $ 0 | $ 0 | ||
Time based RSU's granted, Number of Shares (in shares) | 0 | |||
Options granted, Number of Shares (in shares) | 0 | |||
Share-based compensation expense | $ 0.2 | |||
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, maximum term (in years) | 10 years | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 2 months 12 days | |||
RSUs | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 4 months 24 days | |||
Unrecognized compensation costs related to unvested RSUs | $ 52.8 | $ 52.8 | ||
Time based RSU's granted, Number of Shares (in shares) | 1,109,622 | |||
Minimum | Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term (in years) | 1 year | |||
Maximum | Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term (in years) | 3 years |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (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] | |||
Total share-based compensation expense | $ 52,832 | $ 43,013 | $ 34,303 |
Inventoriable costs | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 1,610 | 1,791 | 1,624 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 15,781 | 15,387 | 9,832 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 35,441 | $ 25,835 | $ 22,847 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | |||
Dividend yield (as a percent) | 0% | 0% | 0% |
Expected volatility, minimum (as a percent) | 74.80% | 78.70% | 89.40% |
Expected volatility, maximum (as a percent) | 78% | 88.70% | 94.90% |
Weighted-average risk-free interest rate (as a percent) | 3.92% | 2.22% | 0.87% |
Expected term (in years) | 6 years | 5 years 10 months 24 days | 5 years 10 months 24 days |
Share-Based Compensation - Valu
Share-Based Compensation - Value of Options and Time Based RSUs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total intrinsic value of the options exercised | $ 27,187 | $ 48,267 | $ 19,688 |
Total intrinsic value of stock units outstanding options | 184,027 | 130,078 | 172,964 |
Total intrinsic value of stock units exercisable | 166,820 | 118,340 | 131,235 |
Total fair value of shares vested | 19,120 | 17,145 | 10,583 |
RSUs | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total intrinsic value of stock units outstanding other than options | 117,824 | 67,455 | 80,062 |
Total fair value of time based vested | $ 24,400 | $ 17,873 | $ 12,411 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - $ / shares | 12 Months Ended |
Dec. 31, 2023 | |
Number of Shares | |
Outstanding at beginning of period, Number of Shares (in shares) | 4,785,972 |
Options granted, Number of Shares (in shares) | 289,084 |
Options exercised, Number of Shares (in shares) | (791,795) |
Options canceled, Number of Shares (in shares) | (39,854) |
Options expired, Number of Shares (in shares) | (3,425) |
Outstanding at end of period, Number of Shares (in shares) | 4,239,982 |
Vested or expected to vest at end of period, Number of Shares (in shares) | 4,239,982 |
Exercisable at end of period, Number of Shares (in shares) | 3,470,018 |
Weighted- Average Exercise Price | |
Outstanding at beginning of period, Weighted-Average Exercise Price (in dollars per share) | $ 26.27 |
Options granted, exercise price (in dollars per share) | 48.13 |
Options exercised, Weighted-Average Exercise Price (in dollars per share) | 22.49 |
Options canceled Weighted-Average Exercise Price (in dollars per share) | 51.05 |
Options expired, Weighted-Average Exercise Price (in dollars per share) | 40.94 |
Outstanding at end of period, Weighted-Average Exercise Price (in dollars per share) | 28.22 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price (in dollars per share) | 28.22 |
Exercisable at end of period, Weighted-Average Exercise Price (in dollars per share) | $ 23.55 |
Options granted, Weighted-Average Contractual Life (in years) | 5 years 9 months 18 days |
Options exercised, Weighted-Average Contractual Life (in years) | 5 years 2 months 12 days |
Exercisable at end of period, Weighted-Average Contractual Life (in years) | 4 years 6 months |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Outstanding at beginning of year, Number of Shares (in shares) | 1,274,664 | |
Time based RSU's granted, Number of Shares (in shares) | 1,109,622 | |
Time based RSU's vested, Number of Shares (in shares) | (665,824) | |
Time based RSU's cancelled, Number of Shares (in shares) | (73,332) | |
Outstanding at end of year, Number of Shares (in shares) | 1,645,130 | 1,274,664 |
Weighted-Average Grant Date Fair Value Per Share | ||
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value (in dollars per share) | $ 42.76 | |
Time based RSU's granted, Weighted-Average Grant Date Fair Value (in dollars per share) | 48.58 | |
Time based RSU's vested, Weighted-Average Grant Date Fair Value (in dollars per share) | 36.65 | |
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value (in dollars per share) | 48.29 | |
Outstanding at end of year, Weighted-Average Grant Date Fair Value (in dollars per share) | $ 48.92 | $ 42.76 |
Weighted-Average Contractual Life (in years) | 1 year | 9 months 18 days |
Loss Per Share - Common Stock E
Loss Per Share - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities excluded from computation of earnings per share (in shares) | 4,239,982 | 4,785,972 | 5,451,398 |
RSUs | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities excluded from computation of earnings per share (in shares) | 1,860,714 | 1,469,678 | 1,666,848 |
Income Taxes - Loss before Inco
Income Taxes - Loss before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (139,038) | $ (223,465) | $ (221,216) |
Non-U.S. | 0 | (32,785) | (62,904) |
Loss before provision for income taxes | $ (139,038) | $ (256,250) | $ (284,120) |
Income Taxes - Total Income Tax
Income Taxes - Total Income Tax Expense (Detail) - 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 | |
Income Tax Disclosure [Abstract] | |||||||||||
Current | $ 636 | $ 6 | $ 6 | ||||||||
Deferred | (51,341) | (52,789) | (53,070) | ||||||||
Valuation allowance | 51,341 | 52,789 | 53,070 | ||||||||
Provision for income taxes | $ 448 | $ 43 | $ 135 | $ 10 | $ 0 | $ 1 | $ 0 | $ 5 | $ 636 | $ 6 | $ 6 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Income tax at statutory federal rate | 21% | 21% | 21% |
Executive and share-based compensation | (0.40%) | 1.90% | 0.60% |
Subpart F Inclusion | 0% | (3.40%) | 0% |
Foreign rate differential | 0% | (2.70%) | (4.60%) |
Change in effective state tax rates | (1.60%) | 0.20% | (0.30%) |
State income tax expense | 4.80% | 3.60% | 2% |
Research and development credits | 14.10% | 0% | |
Other permanent items | (1.50%) | 0% | 0% |
Change in valuation allowance | (36.90%) | (20.60%) | (18.70%) |
Provision for income taxes | (0.50%) | 0% | 0% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Contingency [Line Items] | ||
Federal net operating loss carryforwards | $ 528.4 | |
Unrecognized tax benefits | 2.5 | $ 1.7 |
Expire In 2037 | ||
Income Tax Contingency [Line Items] | ||
Federal net operating loss carryforwards | 73.6 | |
Indefinite Period Carry Forward | ||
Income Tax Contingency [Line Items] | ||
Federal net operating loss carryforwards | $ 454.8 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 138,685 | $ 168,606 |
Accrued expenditures | 17,842 | 9,169 |
Research and development credit, net | 31,109 | 9,321 |
Research and development expenditures | 62,432 | 13,525 |
Share-based compensation | 19,753 | 17,085 |
Other | 0 | 1,466 |
Capital lease | 4,198 | 4,980 |
Deferred tax liabilities: | ||
Right of use asset—capital lease | (3,204) | (3,684) |
Depreciation | (140) | (154) |
Other | (86) | 0 |
Net deferred tax asset before valuation allowance | 270,589 | 220,314 |
Valuation allowance | (270,589) | (220,314) |
Net deferred tax asset | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | 223 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2023 | May 31, 2005 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Employer matching contribution | 100% | 100% | 100% | ||
Contributions made by participants for which the company makes matching contribution | 6% | 6% | 6% | ||
Contribution expense | $ 4,300 | $ 3,900 | $ 3,000 | ||
Purchase Commitment | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Deposits assets | 15,100 | 21,600 | $ 15,100 | ||
Deposits assets, current | 7,900 | 7,900 | |||
Deposits assets, noncurrent | 7,200 | 7,200 | |||
Product | Bristol-Myers Squibb Company | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Company made an upfront payment | 10,800 | ||||
Possible milestone payments remaining | $ 5,000 | $ 5,000 | |||
Obliged to make milestone payments | $ 14,750 | ||||
Collaborative arrangement license expiration term (in years) | 10 years | ||||
Cost of product sales | $ 26,400 | $ 12,500 | $ 4,100 | ||
Product | Bristol-Myers Squibb Company | Minimum | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Royalty payment (as a percent) | 5% | 5% | |||
Product | Bristol-Myers Squibb Company | Maximum | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Royalty payment (as a percent) | 9% | 9% |
Unaudited Quarterly Financial_3
Unaudited Quarterly Financial Information - Schedule of Quarterly Financial Information (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] | |||||||||||
Revenue, net | $ 132,099 | $ 126,173 | $ 110,792 | $ 95,306 | $ 87,869 | $ 71,870 | $ 55,579 | $ 34,996 | $ 464,370 | $ 250,314 | $ 83,803 |
Operating expenses | (166,196) | (155,886) | (157,971) | (143,698) | (135,281) | (127,499) | (143,502) | (107,658) | (623,751) | (513,940) | (369,491) |
Interest income | 5,966 | 5,498 | 4,530 | 4,349 | 3,386 | 2,122 | 1,320 | 548 | 20,343 | 7,376 | 1,568 |
Income tax expense | (448) | (43) | (135) | (10) | 0 | (1) | 0 | (5) | (636) | (6) | (6) |
Net loss | $ (28,579) | $ (24,258) | $ (42,784) | $ (44,053) | $ (44,026) | $ (53,508) | $ (86,603) | $ (72,119) | $ (139,674) | $ (256,256) | $ (284,126) |
Basic (in dollars per share) | $ (0.30) | $ (0.25) | $ (0.45) | $ (0.46) | $ (0.45) | $ (0.57) | $ (0.92) | $ (0.78) | $ (1.46) | $ (2.72) | $ (3.50) |
Diluted (in dollars per share) | $ (0.30) | $ (0.25) | $ (0.45) | $ (0.46) | $ (0.45) | $ (0.57) | $ (0.92) | $ (0.78) | $ (1.46) | $ (2.72) | $ (3.50) |