Cover Page
Cover Page - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 27, 2023 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Amendment Flag | false | ||
Document Type | 10-K | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Annual Report | true | ||
Entity Central Index Key | 0001567514 | ||
Document Transition Report | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Document Period End Date | Dec. 31, 2022 | ||
Entity Registrant Name | Intra-Cellular Therapies, Inc. | ||
Trading Symbol | ITCI | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Interactive Data Current | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity File Number | 001-36274 | ||
Entity Tax Identification Number | 36-4742850 | ||
Entity Incorporation, State or Country Code | DE | ||
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 | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 95,280,003 | ||
Entity Public Float | $ 5.3 | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Baltimore, Maryland |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 148,615 | $ 92,365 |
Investment securities, available-for-sale | 443,290 | 319,968 |
Restricted cash | 1,750 | 1,400 |
Accounts receivable, net | 75,189 | 20,156 |
Inventory | 23,920 | 7,948 |
Prepaid expenses and other current assets | 45,193 | 25,444 |
Total current assets | 737,957 | 467,281 |
Property and equipment, net | 1,913 | 1,791 |
Right of use assets, net | 14,824 | 20,764 |
Other assets | 86 | 86 |
Total assets | 754,780 | 489,922 |
Current liabilities: | ||
Accounts payable | 10,395 | 8,691 |
Accrued and other current liabilities | 19,657 | 11,073 |
Accrued Customer Programs | 25,621 | 5,964 |
Accrued employee benefits | 22,996 | 20,897 |
Operating lease liabilities | 4,567 | 6,732 |
Total current liabilities | 83,236 | 53,357 |
Operating lease liabilities, non-current | 15,474 | 18,675 |
Total liabilities | 98,710 | 72,032 |
Stockholders' equity: | ||
Common stock, $0.0001 par value: 175,000,000 shares authorized at December 31, 2022 and December 31, 2021, respectively; 94,829,794 and 81,886,965 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 9 | 8 |
Additional paid-in capital | 2,137,737 | 1,639,476 |
Accumulated deficit | (1,477,486) | (1,221,230) |
Accumulated comprehensive loss | (4,190) | (364) |
Total stockholders' equity | 656,070 | 417,890 |
Total liabilities and stockholders' equity | $ 754,780 | $ 489,922 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 175,000,000 | 175,000,000 |
Common stock, shares issued | 94,829,794 | 81,886,965 |
Common stock, shares outstanding | 94,829,794 | 81,886,965 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue | $ 250,314 | $ 83,803 | $ 22,813 |
Operating expenses: | |||
Cost of product sales | 20,443 | 8,035 | 1,895 |
Selling, general and administrative | 358,782 | 272,611 | 186,364 |
Research and development | 134,715 | 88,845 | 65,782 |
Total operating expenses | 513,940 | 369,491 | 254,041 |
Loss from operations | (263,626) | (285,688) | (231,228) |
Interest income | 7,376 | 1,568 | 4,236 |
Loss before provision for income taxes | (256,250) | (284,120) | (226,992) |
Income tax expense | (6) | (6) | (14) |
Net loss | $ (256,256) | $ (284,126) | $ (227,006) |
Net loss per common share: | |||
Basic | $ (2.72) | $ (3.5) | $ (3.23) |
Diluted | $ (2.72) | $ (3.5) | $ (3.23) |
Weighted average number of common shares: | |||
Basic | 94,046,670 | 81,253,394 | 70,364,800 |
Diluted | 94,046,670 | 81,253,394 | 70,364,800 |
Product sales, net [Member] | |||
Revenue | $ 249,132 | $ 81,708 | $ 22,531 |
Grant revenue [Member] | |||
Revenue | $ 1,182 | $ 2,095 | $ 282 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (256,256) | $ (284,126) | $ (227,006) |
Other comprehensive loss: | |||
Unrealized (loss) gain on investment securities | (3,826) | (845) | 353 |
Comprehensive loss | $ (260,082) | $ (284,971) | $ (226,653) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Comprehensive Gain (Loss) [Member] |
Balance at Dec. 31, 2019 | $ 195,007 | $ 6 | $ 904,971 | $ (710,098) | $ 128 |
Balance, shares at Dec. 31, 2019 | 55,507,497 | ||||
Common shares issued | 652,712 | $ 2 | 652,710 | ||
Common shares issued, shares | 23,409,458 | ||||
Exercise of stock options and issuances of restricted stock (Value) | 11,465 | $ 0 | 11,465 | ||
Exercise of stock options and issuances of restricted stock (Shares) | 1,536,797 | ||||
Stock issued for services | 214 | $ 0 | 214 | ||
Stock issued for services, shares | 9,337 | ||||
Share-based compensation | 24,115 | 24,115 | |||
Net loss | (227,006) | (227,006) | |||
Other comprehensive income (loss) | 353 | 353 | |||
Balance at Dec. 31, 2020 | 656,860 | $ 8 | 1,593,475 | (937,104) | 481 |
Balance, shares at Dec. 31, 2020 | 80,463,089 | ||||
Exercise of stock options and issuances of restricted stock (Value) | 11,519 | $ 0 | 11,519 | ||
Exercise of stock options and issuances of restricted stock (Shares) | 1,419,331 | ||||
Stock issued for services | 179 | 179 | |||
Stock issued for services, shares | 4,545 | ||||
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 at Dec. 31, 2021 | 81,886,965 | ||||
Common shares issued | 433,718 | $ 1 | 433,717 | ||
Common shares issued, shares | 10,952,381 | ||||
Exercise of stock options and issuances of restricted stock (Value) | 21,441 | $ 0 | 21,441 | ||
Exercise of stock options and issuances of restricted stock (Shares) | 1,988,775 | ||||
Stock issued for services | 90 | 90 | |||
Stock issued for services, shares | 1,673 | ||||
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 at Dec. 31, 2022 | 94,829,794 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows used in operating activities | |||
Net loss | $ (256,256) | $ (284,126) | $ (227,006) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 656 | 533 | 528 |
Share-based compensation | 43,013 | 34,303 | 24,115 |
Stock issued for services | 90 | 179 | 214 |
Amortization of premiums and accretion of discounts on investment securities, net | 447 | (4,080) | (648) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (55,033) | (9,391) | (10,765) |
Inventory | (15,972) | (892) | (7,056) |
Prepaid expenses and other assets | (19,749) | (11,208) | (7,922) |
Long term deferred tax asset, net | 0 | 0 | 265 |
Accounts payable | 1,704 | 3,189 | (1,923) |
Accrued and other current liabilities | 8,584 | 3,177 | (8,242) |
Accrued customer programs | 19,657 | 2,958 | 5,435 |
Accrued employee benefits | 2,099 | 5,989 | 3,005 |
Lease liabilities, net | 574 | (175) | (73) |
Net cash used in operating activities | (270,186) | (259,544) | (230,073) |
Cash flows (used in) provided by investing activities | |||
Purchases of investments | (759,209) | (224,575) | (755,629) |
Maturities of investments | 631,614 | 505,244 | 275,601 |
Purchases of property and equipment | (778) | (325) | (267) |
Net cash (used in) provided by investing activities | (128,373) | 280,344 | (480,295) |
Cash flows provided by financing activities | |||
Proceeds of public offerings, net | 433,718 | 0 | 652,712 |
Proceeds from exercise of stock options | 21,441 | 11,519 | 11,465 |
Net cash provided by financing activities | 455,159 | 11,519 | 664,177 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 56,600 | 32,319 | (46,191) |
Cash, cash equivalents, and restricted cash at beginning of period | 93,765 | 61,446 | 107,637 |
Cash, cash equivalents, and restricted cash at end of period | 150,365 | 93,765 | 61,446 |
Cash paid for taxes | 6 | 6 | 2 |
Vehicle Fleet Lease [Member] | |||
Non-cash investing and financing activities | |||
Right of use assets under operating leases | $ 419 | $ 108 | $ 8,918 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Cash Flows [Abstract] | ||||
Cash and cash equivalents | $ 148,615 | $ 92,365 | $ 60,046 | |
Restricted cash | 1,750 | 1,400 | 1,400 | |
Total cash, cash equivalents and restricted cash | $ 150,365 | $ 93,765 | $ 61,446 | $ 107,637 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. 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. In December 2019, CAPLYTA ® On January 7, 2022, the Company completed a public offering of common stock in which the Company sold 10,952,381 shares of common stock at a public offering price of $42.00 per share for aggregate gross proceeds of $460.0 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $433.7 million. In order to further its commercial activities and research projects and support its collaborations, the Company may require additional financing until such time, if ever, that revenue streams are sufficient to generate consistent positive cash flow from operations. The Company currently projects that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital expenditures for at least one year from the date that these financial statements are filed with the Securities and Exchange Commission (the “SEC”). Possible sources of funds include public or private sales of the Company’s equity securities, sales of debt or convertible debt securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s products, product candidates and technology and, to a much lesser extent, grant funding. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own 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. Reclassifications Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation. These reclassifications have no material effect on previously reported financial position, cash flows, or results of operations. 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 mutual 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 a 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. available-for-sale 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 Measurements and Disclosures • 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 employee benefits, and operating lease liabilities, current, to approximate their fair value because of their relatively short maturities at December 31, 2022 and 2021. 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, 2016-18”) Accounts Receivable, net The Company’s accounts receivable, net, primarily arise from product sales. They are generally stated at the invoiced amount and do not bear interest. Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result primarily from chargebacks, prompt pay discounts, and distribution fees. All customers have standard payment terms which generally require payment within 60 days. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and 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, 2022 and 2021. We are also subject to credit risk from our accounts receivable related to our product sales. We monitor our exposure within accounts receivable and record a credit loss reserve against uncollectible accounts receivable as necessary. We extend credit primarily to pharmaceutical wholesale distributors. Customer creditworthiness is monitored and collateral is not required. Historically, we have not experienced credit losses on our accounts receivable. As of December 31, 2022 and 2021, 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 equivalent and investments held at financial institutions. For the years ended December 31, 2022 and 2021, 97% and 96% of product sales were generated from three major industry wholesalers, respectively. Three individual customers accounted for approximately 39%, 30%, and 28% and 40%, 28%, and 28% of product sales for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, 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 materials and manufacturing overhead, on a first-in, first-out The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired and manufactured prior to receipt of 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. 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. 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 No. 360, Property, Plant and Equipment Leases In accordance with ASC 842, the Company elected the package of practical expedients, which permit the Company not to reassess under the new standard the historical lease classification. 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 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, 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. The reported results for the years ended December 31, 2022 and 2021 reflect the application of ASC Topic 606. 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. At contract inception, once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For additional discussion of accounting for product sales, see 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. Product Sales, net The Company sells CAPLYTA to a limited number of customers which include a number of national and select regional distributors. These customers subsequently resell the Company’s products to specialty pharmacy providers, as well as other retail pharmacies 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 provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the customer obtains control of the Company’s product, which occurs at a point in time (upon delivery). Product revenues are recorded net of applicable reserves for variable consideration, including rebates, discounts and allowances, among others. If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. Reserves for Variable Consideration Revenues are calculated based on the wholesale acquisition cost that the Company charges to distributors for CAPLYTA less variable consideration for which reserves are established. Components of variable consideration may include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payers, and other indirect customers relating to the Company’s sales of its product. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, include the Company’s best estimates that take into consideration a range of possible outcomes which are considered more likely in accordance with the expected value method in ASC Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, and forecasted customer buying and payment patterns. The Company’s estimates utilizing payer mix are based on CAPLYTA’s actual channel mix in 2022. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined it was probable that a significant reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2022 and 2021, therefore, the transaction price was not reduced further during the years ended December 31, 2022 and 2021. 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 such variances become known. Trade Discounts and Allowances Product Returns Provider Chargebacks and Discounts period-end Government Rebates under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payer Rebates Other Incentives co-pay co-payments co-pay The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the consolidated balance sheets. Chargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the consolidated balance sheets. Government and other rebates are recorded as a component of accrued expenses and other current liabilities 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, overhead, and direct costs (inclusive of material, shipping, and manufacturing costs). 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% 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, 2022, 2021 and 2020 are lower than incurred because of previously expensed inventory. Research and Development, Including Clinical Trial Expenses The Company recognizes its research and development expenses as the services are incurred. Research and development costs primarily consist of salaries and related expenses for personnel and resources and the costs of clinical trials. Other research and development expenses include nonclinical analytical testing, manufacturing of drug product for use in clinical and nonclinical trials, outside services, providers, materials and consulting fees. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors, among other factors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account various clinical information provided by vendors and discussion with applicable personnel and external service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations, clinical sites and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. Advertising Expense Advertising costs are expensed when services are rendered. The Company incurred $85.8 million, $82.5 million and $36.3 million in advertising costs during the years ended December 31, 2022, 2021, and 2020, 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 more-likely-than-not The Company’s effective tax rate for the years ended December 31, 2022, 2021 and 2020 was approximately 0%. 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 March 27, 2020, the United States enacted The Coronavirus Aid, Relief and Economic Security (“CARES”) Act which includes several significant business tax provisions, of which the immediate relevance to the Company is the acceleration of refunds of previously generated corporate Alternative Minimum Tax (“AMT”) credits. The CARES Act also adds an employee retention credit to encourage employers to maintain headcounts even if employees cannot report to work because of issues related to the coronavirus, and a temporary provision allowing companies to defer remitting to the government the employee share of some payroll taxes, among other things. 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 year ended December 31, 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 Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation 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, 2022, 2021 and 2020 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. T he 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. In each fiscal year beginning in 2020, the Company has granted select employees performance based RSUs which vest upon the Board’s approval at the end of the three year service period based on the achievement of select clinical development performance milestones and comparative shareholder returns against the Company’s peers. Under ASC Topic 718, 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 Equity instruments issued to non-employees 505-50, Equity/Equity-Based Payments to Non-Employees 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. Recently Issued Accounting Standards The Company considers the applicability and impact of any recent ASU issued by the FASB. Based on our assessment, there are no recent accounting pronouncements that have or are expected to have a material impact on the Company’s consolidated financial statements or related disclosures. |
Investment Securities
Investment Securities | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investment Securities | 3. Investment Securities Investment securities consisted of the following (in thousands): 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 December 31, 2021 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 71,752 $ — $ (100 ) $ 71,652 Certificates of Deposit 26,232 1 — 26,233 Commercial Paper 55,955 — (36 ) 55,919 Corporate Notes/Bonds 166,394 19 (249 ) 166,164 $ 320,333 $ 20 $ (385 ) $ 319,968 The Company has classified all of its investment securities as available-for-sale, available-for-sale available-for-sale The aggregate related fair value of investments with unrealized losses as of December 31, 2022 was $438.3 million, which consisted of $153.1 million from U.S. government agency securities, $3.1 million of certificates of deposit, $96.6 million of commercial paper, and $185.5 million of corporate notes/bonds. $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. As of December 31, 2022, $14.9 million of the commercial paper balance , $20.5 million of the U.S. Government Agency Securities balance, and $7.5 million of the certificates of deposit balance are listed as cash equivalents. As of December 31, 2021, the aggregate related fair value of investments with unrealized losses was $263.5 million. $9.5 million of the aggregate fair value of investments with unrealized losses as of December 31, 2021 has been held in a continuous unrealized loss position for over than 12 months, with the remaining $254.1 million held in a continuous unrealized loss position for less than 12 months. The Company reviewed all of the investments which were in a loss position at the respective balance sheet dates, as well as the remainder of the portfolio. The Company has analyzed the unrealized losses and determined that market conditions were the primary factor driving these changes. After analyzing the securities in an unrealized loss position, the portion of these losses that relate to changes in credit quality is insignificant. The Company does not intend to sell these securities, nor is it more likely than not that the Company will be required to sell them prior to the end of their contractual terms. Furthermore, the Company does not believe that these securities expose the Company to undue market risk or counterparty credit risk. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. 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, 2022 and 2021. The carrying value of cash held in money market funds of approximately $12.2 million as of December 31, 2022 and $56.5 million as of December 31, 2021 is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. The carrying value of cash held in commercial paper of approximately $14.9 million , U and certificates of deposit of $7.5 million are included in cash and cash equivalents. The carrying value of cash held in investment securities of $0 as of December 31, 2021 is included in cash and cash equivalents. The fair value measurements of the Company’s cash equivalents and available-for-sale Fair Value Measurements at Reporting Date Using 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 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money Market Funds $ 56,539 $ 56,539 $ — $ — U.S. Government Agency Securities 71,652 — 71,652 — Certificates of Deposit 26,233 — 26,233 — Commercial Paper 55,919 — 55,919 — Corporate Notes/Bonds 166,164 — 166,164 — $ 376,507 $ 56,539 $ 319,968 $ — |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | 5. Inventory Inventory consists of the following (in thousands): December 31, December 31, Raw materials $ 17,227 $ 2,484 Work in process 2,594 2,407 Finished goods 4,099 3,057 $ 23,920 $ 7,948 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 6. Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2022 December 31, 2021 Computer equipment $ 409 $ 409 Furniture and fixtures 423 423 Scientific equipment 5,065 4,287 Leasehold improvements 1,240 1,240 7,137 6,359 Less accumulated depreciation (5,224 ) (4,568 ) $ 1,913 $ 1,791 Depreciation expense for the year ended December 31, 2022, 2021 and 2020 was $0.7 million, $0.5 and $0.5 million, respectively. |
Right of Use Assets and Lease L
Right of Use Assets and Lease Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Right of Use Assets and Lease Liabilities | 7. 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 2016-02 On May 17, 2019, the Company 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 Company began leasing vehicles under the Vehicle Lease in March 2020. The contractual period of each lease is 12 months, followed by month-to-month between 12 and 30 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. The following tables present the lease balances within the consolidated balance sheet, operating cash outflows, weighted average remaining lease term, and the weighted average discount rates related to leases as of December 31, 2022 and 2021 (in thousands, except years and percentages): December 31, December 31, Operating lease balance sheet classification Right of use assets, net $ 14,824 $ 20,764 Lease liabilities, short term 4,567 6,732 Lease liabilities, noncurrent 15,474 18,675 Total lease liabilities $ 20,041 $ 25,407 Lease cost Operating lease cost $ 4,719 $ 5,774 Variable lease cost 1,612 2,676 Short-term lease cost 873 — $ 7,204 $ 8,450 Other information Weighted average remaining lease term 5.9 years 6.1 years Weighted average discount rate 8.76 % 8.46 % Maturity analysis under the lease agreements are as follows: Year ending December 31, 2023 $ 4,741 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 Thereafter 5,915 Total 26,351 Less: Present value discount (6,310 ) Total Lease liability 20,041 Less: Current portion (4,567 ) Long-term lease liabilities $ 15,474 |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 8. Share-Based Compensation The Board of Directors determines who will receive 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, 2022, 2021, and 2020, was comprised of the following (in thousands): Years Ended December 31, 2022 2021 2020 Inventoriable costs $ 1,791 $ 1,624 $ 1,342 Research and development 15,387 9,832 7,073 Selling, general and administrative 25,835 22,847 15,700 Total share-based compensation expense $ 43,013 $ 34,303 $ 24,115 The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2022, 2021 and 2020: 2022 2021 2020 Dividend yield 0 % 0 % 0 % Expected volatility 78.7%-88.7 % 89.4-94.9 % 91.6-95.5 % Weighted-average risk-free interest rate 2.22 % 0.87 % 1.29 % Expected term (in years) 5.9 5.9 6.0 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, 2022, and changes during the year then ended, are summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2021 5,451,398 $ 21.09 6.1 years Options granted 2022 612,945 $ 56.65 Options exercised 2022 (1,219,421 ) $ 17.58 Options canceled 2022 (56,792 ) $ 41.01 Options expired 2022 (2,158 ) $ 12.73 Outstanding at December 31, 2022 4,785,972 $ 26.27 5.8 years Vested and expected to vest at December 31, 2022 4,785,972 $ 26.27 Exercisable at December 31, 2022 3,628,867 $ 20.38 5.0 years The weighted-average grant date fair value for awards granted during the years ended December 31, 2022, 2021 and 2020 was $41.71, $29.01 and $17.98 per share, respectively. The total intrinsic value of the options exercised during the years ended December 31, 2022, 2021 and 2020 was $48.3 million, $19.6 million and $11.1 million, respectively. The total intrinsic value of the options outstanding as of December 31, 2022 was $130.1 million. The total intrinsic value of the options exercisable as of December 31, 2022 was $118.3 million. The total fair value of shares vested during the years ended December 31, 2022, 2021 and 2020 was $17.1 million, $10.6 million and $13.4 million, respectively. The unrecognized share-based compensation expense related to stock option awards at December 31, 2022 was $23.6 million, and will be recognized over a weighted-average period of 1.3 years. 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, 2022, and changes during the year then ended, is summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2021 1,529,652 $ 26.95 1.5 years Time based RSUs granted in 2022 601,055 $ 57.53 Time based RSUs vested in 2022 (769,355 ) $ 23.23 Time based RSUs cancelled in 2022 (86,688 ) $ 39.73 Outstanding at December 31, 2022 1,274,664 $ 42.76 0.8 years The total intrinsic value of the time based RSUs vested during the years ended December 31, 2022, 2021 and 2020 was $40.7 million, $25.0 million and $14.6 million, respectively. The total intrinsic value of the time based RSU’s outstanding as of December 31, 2022 was $67.5 million. The total fair value of time based RSUs vested during the years ended December 31, 2022, 2021 and 2020 was $17.9 million, $12.4 million and $7.2 million, respectively. The fair value of time based RSUs is based on the closing price of the Company’s common stock on the date of grant. The Company did not issue any options or RSUs under the 2019 Inducement Plan in 2022 or 2021. As of December 31, 2022, there was approximately $0.3 million of unrecognized compensation costs related to unvested options and RSUs under the 2019 Inducement Plan, and $1.2 million was recognized during 2022 under this plan. As of December 31, 2022, 11,126 options and 64,302 RSUs are expected to vest in the future. As of D ecember 31, 2022, there was $34.7 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, 2022 | |
Earnings Per Share [Abstract] | |
Loss per Share | 9. 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, 2022, 2021 and 2020: Year Ended December 31, 2022 2021 2020 Stock options 4,785,972 5,451,398 5,517,622 RSUs 1,469,678 1,666,848 1,636,422 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes Loss before income taxes is as follows (in thousands): 2022 2021 2020 U.S. $ (223,465 ) $ (221,216 ) $ (155,616 ) Non-U.S. (32,785 ) (62,904 ) (71,376 ) Total loss before taxes $ (256,250 ) $ (284,120 ) $ (226,992 ) Total income tax expense for the years ended December 31, 2022, 2021 and 2020 is allocated as follows: 2022 2021 2020 Current $ 6 $ 6 $ 14 Deferred (52,789 ) (53,070 ) (40,049 ) Valuation allowance 52,789 53,070 40,049 Provision for income taxes $ 6 $ 6 $ 14 A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2022, 2021 and 2020 is as follows: December 31, 2022 2021 2020 Income tax at statutory federal rate 21.00 % 21.00 % 21.00 % Executive and share-based compensation 1.92 0.60 (1.01 ) Subpart F Inclusion (3.38 ) 0.0 0.0 Foreign rate differential (2.69 ) (4.63 ) (6.60 ) Change in effective state tax rates 0.17 (0.31 ) 1.12 State income tax expense 3.58 2.04 3.14 Change in valuation allowance (20.60 ) (18.70 ) (17.65 ) Provision for income taxes 0.0 % 0.0 % 0.0 % 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, 2022, the Company had $663.2 million of federal net operating loss carryforwards, of which $131.1 million expire at various dates through 2037 and $532.1 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 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, 2022, however, 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, 2022 and 2021, respectively (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 168,606 $ 137,561 Accrued expenditures 9,169 2,723 Research and development credit, net 9,321 9,321 Research and development expenditures 13,525 — Share-based compensation 17,085 15,947 Other 1,466 93 Capital lease 4,980 6,178 Deferred tax liabilities: Right of use asset—capital lease (3,684 ) (5,049 ) Depreciation (154 ) (201 ) Net deferred tax asset before valuation allowance 220,314 166,573 Valuation allowance (220,314 ) (166,573 ) 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 2022 and 2021, 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 201 4 The total amount of unrecognized tax benefits was $1.7 million as of December 31, 2022 and 2021. If recognized, none of these tax benefits would affect the effective tax rate due to valuation allowances. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. 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 Under the agreement, the Company made an upfront payment of $1.0 million to BMS in 2005, a milestone payment of $1.25 million in December 2013, and a milestone payment of $1.5 million in December 2014 following the initiation of the Company’s first Phase 3 clinical trial for lumateperone for patients with exacerbated schizophrenia. Upon FDA acceptance of an NDA filing for lumateperone, the Company was obligated to pay BMS a $ 2.0 million milestone payment, which was paid in January 2019. The FDA approved the NDA filing on December 20, 2019 and as a result the Company accrued an additional milestone liability of $5.0 million in the fourth quarter of 2019 which was paid in January 2020. 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 The agreement extends, and royalties are payable, on a country-by-country product-by-product 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 , $4.1 million, and $1.1 million in cost of product sales to satisfy its obligation under the BMS agreement for the years ended December 31, 2022 , 202 1 and 202 0 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 recently amended the significant manufacturing service agreements with Siegfried Evionnaz SA and Lonza Ltd, committing to certain minimum annual purchase commitments which the Company anticipates making payments for within the years 2025 $21.6 million and $9.5 million as of December 31, 2022 and 2021, respectively, for the various campaigns, which are recorded within prepaid expenses and other current assets. 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 Contingencies During the normal course of our business, we are occasionally involved with various claims and litigation. Reserves are established in connection with such matters when a loss is probable and the amount of such loss can be reasonably estimated. At December 31, 2022 and 2021, no material reserves were recorded. The determination of probability and the estimation of the actual amount of any such loss are inherently unpredictable, and it is therefore possible that the eventual outcome of such claims and litigation could exceed the estimated reserves, if any. However, we believe that the likelihood that any such excess might have a material adverse effect on our financial statements is remote. |
Unaudited Quarterly Financial I
Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2022 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | 12. Unaudited Quarterly Financial Information The tables herein set forth the Company’s unaudited condensed consolidated 2022 and 2021 quarterly statements of operations. 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 ) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2021 quarters ended (in thousands): 2021 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 25,671 $ 22,207 $ 20,047 $ 15,878 Operating expenses (111,675 ) (99,531 ) (89,188 ) (69,097 ) Interest income 270 393 421 484 Income tax benefit (expense) — 23 (24 ) (5 ) Net loss (85,734 ) (76,908 ) (68,744 ) (52,740 ) Basic and diluted net loss per share $ (1.05 ) $ (0.95 ) $ (0.85 ) $ (0.65 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own 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 | 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. |
Reclassifications | Reclassifications Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation. These reclassifications have no material effect on previously reported financial position, cash flows, or results of operations. |
Cash and Cash Equivalents | 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 mutual 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 a maturity date of more than three months are classified separately on the consolidated balance sheets. |
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. available-for-sale 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 | Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures • 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 | 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 employee benefits, and operating lease liabilities, current, to approximate their fair value because of their relatively short maturities at December 31, 2022 and 2021. 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 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, 2016-18”) |
Accounts Receivable, net | Accounts Receivable, net The Company’s accounts receivable, net, primarily arise from product sales. They are generally stated at the invoiced amount and do not bear interest. Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result primarily from chargebacks, prompt pay discounts, and distribution fees. All customers have standard payment terms which generally require payment within 60 days. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and 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, 2022 and 2021. We are also subject to credit risk from our accounts receivable related to our product sales. We monitor our exposure within accounts receivable and record a credit loss reserve against uncollectible accounts receivable as necessary. We extend credit primarily to pharmaceutical wholesale distributors. Customer creditworthiness is monitored and collateral is not required. Historically, we have not experienced credit losses on our accounts receivable. As of December 31, 2022 and 2021, our credit loss reserve on receivables was not significant. |
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 equivalent and investments held at financial institutions. For the years ended December 31, 2022 and 2021, 97% and 96% of product sales were generated from three major industry wholesalers, respectively. Three individual customers accounted for approximately 39%, 30%, and 28% and 40%, 28%, and 28% of product sales for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, 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 | 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 materials and manufacturing overhead, on a first-in, first-out The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired and manufactured prior to receipt of 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. 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. |
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 No. 360, Property, Plant and Equipment |
Leases | Leases In accordance with ASC 842, the Company elected the package of practical expedients, which permit the Company not to reassess under the new standard the historical lease classification. 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 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 | Revenue Recognition In accordance with ASC Topic 606, 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. The reported results for the years ended December 31, 2022 and 2021 reflect the application of ASC Topic 606. 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. At contract inception, once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For additional discussion of accounting for product sales, see 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. Product Sales, net The Company sells CAPLYTA to a limited number of customers which include a number of national and select regional distributors. These customers subsequently resell the Company’s products to specialty pharmacy providers, as well as other retail pharmacies 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 provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the customer obtains control of the Company’s product, which occurs at a point in time (upon delivery). Product revenues are recorded net of applicable reserves for variable consideration, including rebates, discounts and allowances, among others. If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue. Reserves for Variable Consideration Revenues are calculated based on the wholesale acquisition cost that the Company charges to distributors for CAPLYTA less variable consideration for which reserves are established. Components of variable consideration may include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payers, and other indirect customers relating to the Company’s sales of its product. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, include the Company’s best estimates that take into consideration a range of possible outcomes which are considered more likely in accordance with the expected value method in ASC Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, and forecasted customer buying and payment patterns. The Company’s estimates utilizing payer mix are based on CAPLYTA’s actual channel mix in 2022. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined it was probable that a significant reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2022 and 2021, therefore, the transaction price was not reduced further during the years ended December 31, 2022 and 2021. 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 such variances become known. Trade Discounts and Allowances Product Returns Provider Chargebacks and Discounts period-end Government Rebates under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payer Rebates Other Incentives co-pay co-payments co-pay The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the consolidated balance sheets. Chargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the consolidated balance sheets. Government and other rebates are recorded as a component of accrued expenses and other current liabilities 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, overhead, and direct costs (inclusive of material, shipping, and manufacturing costs). 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% 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, 2022, 2021 and 2020 are lower than incurred because of previously expensed inventory. |
Research and Development, including Clinical trial expenses | Research and Development, Including Clinical Trial Expenses The Company recognizes its research and development expenses as the services are incurred. Research and development costs primarily consist of salaries and related expenses for personnel and resources and the costs of clinical trials. Other research and development expenses include nonclinical analytical testing, manufacturing of drug product for use in clinical and nonclinical trials, outside services, providers, materials and consulting fees. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors, among other factors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account various clinical information provided by vendors and discussion with applicable personnel and external service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations, clinical sites and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. |
Advertising Expense | Advertising Expense Advertising costs are expensed when services are rendered. The Company incurred $85.8 million, $82.5 million and $36.3 million in advertising costs during the years ended December 31, 2022, 2021, and 2020, respectively, related to its marketed product, CAPLYTA. |
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 more-likely-than-not The Company’s effective tax rate for the years ended December 31, 2022, 2021 and 2020 was approximately 0%. 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 March 27, 2020, the United States enacted The Coronavirus Aid, Relief and Economic Security (“CARES”) Act which includes several significant business tax provisions, of which the immediate relevance to the Company is the acceleration of refunds of previously generated corporate Alternative Minimum Tax (“AMT”) credits. The CARES Act also adds an employee retention credit to encourage employers to maintain headcounts even if employees cannot report to work because of issues related to the coronavirus, and a temporary provision allowing companies to defer remitting to the government the employee share of some payroll taxes, among other things. 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 year ended December 31, 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 | 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 |
Share-Based Compensation | Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation 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, 2022, 2021 and 2020 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. T he 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. In each fiscal year beginning in 2020, the Company has granted select employees performance based RSUs which vest upon the Board’s approval at the end of the three year service period based on the achievement of select clinical development performance milestones and comparative shareholder returns against the Company’s peers. Under ASC Topic 718, 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 Equity instruments issued to non-employees 505-50, Equity/Equity-Based Payments to Non-Employees 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 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. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards The Company considers the applicability and impact of any recent ASU issued by the FASB. Based on our assessment, there are no recent accounting pronouncements that have or are expected to have a material impact on the Company’s consolidated financial statements or related disclosures. |
Investment Securities (Tables)
Investment Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): 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 December 31, 2021 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 71,752 $ — $ (100 ) $ 71,652 Certificates of Deposit 26,232 1 — 26,233 Commercial Paper 55,955 — (36 ) 55,919 Corporate Notes/Bonds 166,394 19 (249 ) 166,164 $ 320,333 $ 20 $ (385 ) $ 319,968 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 Fair Value Measurements at Reporting Date Using 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 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money Market Funds $ 56,539 $ 56,539 $ — $ — U.S. Government Agency Securities 71,652 — 71,652 — Certificates of Deposit 26,233 — 26,233 — Commercial Paper 55,919 — 55,919 — Corporate Notes/Bonds 166,164 — 166,164 — $ 376,507 $ 56,539 $ 319,968 $ — |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consists of the following (in thousands): December 31, December 31, Raw materials $ 17,227 $ 2,484 Work in process 2,594 2,407 Finished goods 4,099 3,057 $ 23,920 $ 7,948 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following (in thousands): December 31, 2022 December 31, 2021 Computer equipment $ 409 $ 409 Furniture and fixtures 423 423 Scientific equipment 5,065 4,287 Leasehold improvements 1,240 1,240 7,137 6,359 Less accumulated depreciation (5,224 ) (4,568 ) $ 1,913 $ 1,791 |
Right of Use Assets and Lease_2
Right of Use Assets and Lease Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Schedule Of Maturity Analysis Under Lease Agreements | Maturity analysis under the lease agreements are as follows: Year ending December 31, 2023 $ 4,741 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 Thereafter 5,915 Total 26,351 Less: Present value discount (6,310 ) Total Lease liability 20,041 Less: Current portion (4,567 ) Long-term lease liabilities $ 15,474 |
Schedule Of Quantitative Information About Operating Leases | The following tables present the lease balances within the consolidated balance sheet, operating cash outflows, weighted average remaining lease term, and the weighted average discount rates related to leases as of December 31, 2022 and 2021 (in thousands, except years and percentages): December 31, December 31, Operating lease balance sheet classification Right of use assets, net $ 14,824 $ 20,764 Lease liabilities, short term 4,567 6,732 Lease liabilities, noncurrent 15,474 18,675 Total lease liabilities $ 20,041 $ 25,407 Lease cost Operating lease cost $ 4,719 $ 5,774 Variable lease cost 1,612 2,676 Short-term lease cost 873 — $ 7,204 $ 8,450 Other information Weighted average remaining lease term 5.9 years 6.1 years Weighted average discount rate 8.76 % 8.46 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022, 2021, and 2020, was comprised of the following (in thousands): Years Ended December 31, 2022 2021 2020 Inventoriable costs $ 1,791 $ 1,624 $ 1,342 Research and development 15,387 9,832 7,073 Selling, general and administrative 25,835 22,847 15,700 Total share-based compensation expense $ 43,013 $ 34,303 $ 24,115 |
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, 2022, 2021 and 2020: 2022 2021 2020 Dividend yield 0 % 0 % 0 % Expected volatility 78.7%-88.7 % 89.4-94.9 % 91.6-95.5 % Weighted-average risk-free interest rate 2.22 % 0.87 % 1.29 % Expected term (in years) 5.9 5.9 6.0 |
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, 2022, and changes during the year then ended, are summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2021 5,451,398 $ 21.09 6.1 years Options granted 2022 612,945 $ 56.65 Options exercised 2022 (1,219,421 ) $ 17.58 Options canceled 2022 (56,792 ) $ 41.01 Options expired 2022 (2,158 ) $ 12.73 Outstanding at December 31, 2022 4,785,972 $ 26.27 5.8 years Vested and expected to vest at December 31, 2022 4,785,972 $ 26.27 Exercisable at December 31, 2022 3,628,867 $ 20.38 5.0 years |
Time Based Restricted Stock Units [Member] | |
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, 2022, and changes during the year then ended, is summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2021 1,529,652 $ 26.95 1.5 years Time based RSUs granted in 2022 601,055 $ 57.53 Time based RSUs vested in 2022 (769,355 ) $ 23.23 Time based RSUs cancelled in 2022 (86,688 ) $ 39.73 Outstanding at December 31, 2022 1,274,664 $ 42.76 0.8 years |
Loss per Share (Tables)
Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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, 2022, 2021 and 2020: Year Ended December 31, 2022 2021 2020 Stock options 4,785,972 5,451,398 5,517,622 RSUs 1,469,678 1,666,848 1,636,422 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Summary of Loss Before Income Taxes | Loss before income taxes is as follows (in thousands): 2022 2021 2020 U.S. $ (223,465 ) $ (221,216 ) $ (155,616 ) Non-U.S. (32,785 ) (62,904 ) (71,376 ) Total loss before taxes $ (256,250 ) $ (284,120 ) $ (226,992 ) |
Total Income Tax Expense | Total income tax expense for the years ended December 31, 2022, 2021 and 2020 is allocated as follows: 2022 2021 2020 Current $ 6 $ 6 $ 14 Deferred (52,789 ) (53,070 ) (40,049 ) Valuation allowance 52,789 53,070 40,049 Provision for income taxes $ 6 $ 6 $ 14 |
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, 2022, 2021 and 2020 is as follows: December 31, 2022 2021 2020 Income tax at statutory federal rate 21.00 % 21.00 % 21.00 % Executive and share-based compensation 1.92 0.60 (1.01 ) Subpart F Inclusion (3.38 ) 0.0 0.0 Foreign rate differential (2.69 ) (4.63 ) (6.60 ) Change in effective state tax rates 0.17 (0.31 ) 1.12 State income tax expense 3.58 2.04 3.14 Change in valuation allowance (20.60 ) (18.70 ) (17.65 ) Provision for income taxes 0.0 % 0.0 % 0.0 % |
Deferred Tax Assets and Liabilities | The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2022 and 2021, respectively (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 168,606 $ 137,561 Accrued expenditures 9,169 2,723 Research and development credit, net 9,321 9,321 Research and development expenditures 13,525 — Share-based compensation 17,085 15,947 Other 1,466 93 Capital lease 4,980 6,178 Deferred tax liabilities: Right of use asset—capital lease (3,684 ) (5,049 ) Depreciation (154 ) (201 ) Net deferred tax asset before valuation allowance 220,314 166,573 Valuation allowance (220,314 ) (166,573 ) Net deferred tax asset $ — $ — |
Unaudited Quarterly Financial_2
Unaudited Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 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 ) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2021 quarters ended (in thousands): 2021 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 25,671 $ 22,207 $ 20,047 $ 15,878 Operating expenses (111,675 ) (99,531 ) (89,188 ) (69,097 ) Interest income 270 393 421 484 Income tax benefit (expense) — 23 (24 ) (5 ) Net loss (85,734 ) (76,908 ) (68,744 ) (52,740 ) Basic and diluted net loss per share $ (1.05 ) $ (0.95 ) $ (0.85 ) $ (0.65 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) $ / shares in Units, $ in Millions | Jan. 07, 2022 USD ($) $ / shares shares |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Initial public offering, Number of shares | shares | 10,952,381 |
Initial public offering, Price per share | $ / shares | $ 42 |
IPO [Member] | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |
Initial public offering, Gross proceeds | $ 460 |
Initial public offering, Net proceeds | $ 433.7 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||||
Aug. 16, 2022 | Aug. 09, 2022 | Dec. 31, 2022 USD ($) Segment | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) shares | Dec. 31, 2019 shares | |
Significant Accounting Policies [Line Items] | ||||||
Number of operating segments | Segment | 1 | |||||
Maturity of highly liquid investments | 3 months | |||||
Maturity of certificates of deposit, commercial paper, corporate notes and corporate bonds | more than three months | |||||
Impairment losses recognized | $ 0 | |||||
Assumed expected dividend rate | 0% | 0% | 0% | |||
Average Annual Adjusted Income | $ 1,000,000,000 | |||||
Percentage Of Provision For Corporate Alternative Minimum Tax Rate | 15% | 25% | ||||
CAPLYTA [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Advertising costs | $ 85,800,000 | $ 82,500,000 | $ 36,300,000 | |||
Customer one [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration Risk, Percentage | 39% | 40% | ||||
Customer two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration Risk, Percentage | 30% | 28% | ||||
Customer three [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration Risk, Percentage | 28% | 28% | ||||
2018 Equity Incentive Plan [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Additional shares of common stock reserved for future equity grants | shares | 6,500,000 | |||||
Minimum [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Property and equipment, estimated useful life | 3 years | |||||
Minimum [Member] | Product [Member] | Bristol Myers Squibb Company [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Royalty Payment Percentage | 5% | |||||
Maximum [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Property and equipment, estimated useful life | 5 years | |||||
Maximum [Member] | Product [Member] | Bristol Myers Squibb Company [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Royalty Payment Percentage | 9% | |||||
Maximum [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Concentration Risk, Percentage | 97% | 96% | ||||
Maximum [Member] | Inducement Award Plan [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Issuance of shares, Inducement Award Plan | shares | 1,000,000 |
Investment Securities - Summary
Investment Securities - Summary of Investment Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 490,419 | $ 320,333 |
Unrealized Gains | 21 | 20 |
Unrealized (Losses) | (4,211) | (385) |
Estimated Fair Value | 486,229 | 319,968 |
U.S. Government Agency Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 188,465 | 71,752 |
Unrealized Gains | 14 | 0 |
Unrealized (Losses) | (1,729) | (100) |
Estimated Fair Value | 186,750 | 71,652 |
FDIC Certificates of Deposit [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 4,155 | |
Unrealized Gains | 3 | |
Unrealized (Losses) | (72) | |
Estimated Fair Value | 4,086 | |
Certificates of Deposit [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 7,500 | 26,232 |
Unrealized Gains | 0 | 1 |
Unrealized (Losses) | 0 | 0 |
Estimated Fair Value | 7,500 | 26,233 |
Commercial Paper [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 100,711 | 55,955 |
Unrealized Gains | 3 | 0 |
Unrealized (Losses) | (269) | (36) |
Estimated Fair Value | 100,445 | 55,919 |
Corporate Notes/Bonds [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 189,588 | 166,394 |
Unrealized Gains | 1 | 19 |
Unrealized (Losses) | (2,141) | (249) |
Estimated Fair Value | $ 187,448 | $ 166,164 |
Investment Securities - Additio
Investment Securities - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Investment securities, available-for-sale | $ 443,290 | $ 319,968 |
Aggregate related fair value of investments with unrealized losses | 438,300 | 263,500 |
Debt Securities, Available-for-sale, Continuous Unrealized Loss Position, Less than 12 Months | 389,200 | 254,100 |
Debt Securities, Available-for-sale, Continuous Unrealized Loss Position, 12 Months or Longer | 49,100 | 9,500 |
Cash and Cash Equivalents [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Certificates of Deposit, at Carrying Value | 7,500 | |
US Government Agencies Securities, at Carrying Value | 20,500 | |
Commercial Paper, at Carrying Value | 14,900 | |
Contractual Maturity More Than One Year And Less Than Two Years [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Investment securities, available-for-sale | 71,500 | $ 67,200 |
US Government Agencies Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 153,100 | |
Commercial Paper [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 96,600 | |
Corporate Debt Securities [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 185,500 | |
Certificates of Deposit [Member] | ||
Debt Securities, Available-for-sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | $ 3,100 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value Measurements of Cash Equivalents (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 498,432 | $ 376,507 |
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 12,203 | 56,539 |
Fair Value, Measurements, Recurring [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 186,750 | 71,652 |
Fair Value, Measurements, Recurring [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 4,086 | |
Fair Value, Measurements, Recurring [Member] | Certificates of Deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 7,500 | 26,233 |
Fair Value, Measurements, Recurring [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 100,445 | 55,919 |
Fair Value, Measurements, Recurring [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 187,448 | 166,164 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 12,203 | 56,539 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 12,203 | 56,539 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | U.S. Government Agency Securities [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | Certificates of Deposit [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | Commercial Paper [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | Corporate Notes/Bonds [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 486,229 | 319,968 |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 186,750 | 71,652 |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 4,086 | |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Certificates of Deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 7,500 | 26,233 |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 100,445 | 55,919 |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 187,448 | 166,164 |
Significant Unobservable Inputs (Level 3) [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | U.S. Government Agency Securities [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | |
Significant Unobservable Inputs (Level 3) [Member] | Fair Value, Measurements, Recurring [Member] | Certificates of Deposit [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | Commercial Paper [Member] | ||
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) [Member] | Fair Value, Measurements, Recurring [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying value of cash held in money market funds | $ 12.2 | $ 56.5 |
Cash and Cash Equivalents [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investment Securities At Carrying Value | 0 | |
Certificates of Deposit, at Carrying Value | 7.5 | |
US Government Agencies Securities, at Carrying Value | 20.5 | |
Commercial Paper, at Carrying Value | 14.9 | |
Significant Unobservable Inputs (Level 3) [Member] | ||
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 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 17,227 | $ 2,484 |
Work in process | 2,594 | 2,407 |
Finished goods | 4,099 | 3,057 |
Total inventories | $ 23,920 | $ 7,948 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 7,137 | $ 6,359 |
Less accumulated depreciation | (5,224) | (4,568) |
Property Plant and Equipment Net | 1,913 | 1,791 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 409 | 409 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 423 | 423 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 5,065 | 4,287 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 1,240 | $ 1,240 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation | $ 656 | $ 533 | $ 528 |
Right of Use Assets and Lease_3
Right of Use Assets and Lease Liabilities - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Sep. 30, 2018 |
Term of long term lease | 12 months | |
Minimum [Member] | ||
Term of long term lease | 12 months | |
Maximum [Member] | ||
Term of long term lease | 30 months | |
Vehicle Fleet Lease [Member] | ||
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, 2022 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | ||
Right of use assets, net | $ 14,824 | $ 20,764 |
Lease liabilities, short term | 4,567 | 6,732 |
Lease liabilities, noncurrent | 15,474 | 18,675 |
Total Lease liability | 20,041 | 25,407 |
Lease cost | ||
Operating lease cost | 4,719 | 5,774 |
Variable lease cost | 1,612 | 2,676 |
Short-term lease cost | 873 | 0 |
Lease, Cost | $ 7,204 | $ 8,450 |
Other information | ||
Weighted average remaining lease term | 5 years 10 months 24 days | 6 years 1 month 6 days |
Weighted average discount rate | 8.76% | 8.46% |
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, 2022 | Dec. 31, 2021 |
Lessee, Lease, Description [Line Items] | ||
Year ending December 31, 2023 | $ 4,741 | |
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 | |
Thereafter | 5,915 | |
Total | 26,351 | |
Less: Present value discount | (6,310) | |
Total Lease liability | 20,041 | $ 25,407 |
Less: Current portion | (4,567) | (6,732) |
Long-term lease liabilities | $ 15,474 | $ 18,675 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Inducement Award Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Awards granted | 0 | ||
Share-Based Payment Arrangement, Expense | $ 1.2 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 11,126 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 0.3 | ||
Time Based Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation costs related to unvested RSUs | $ 34.7 | ||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 4 months 24 days | ||
RSUs [Member] | Inducement Award Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based Compensation Arrangement by Share based Payment Award Equity Instruments Other than Options Vested and Expected to Vest Outstanding Number | 64,302 | ||
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options, maximum term | 10 years | ||
Stock Options [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options, vesting term | 1 year | ||
Stock Options [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options, vesting term | 3 years | ||
Inducement Award Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average grant date fair value of stock options granted | $ 41.71 | $ 29.01 | $ 17.98 |
Total intrinsic value of the options exercised | $ 48.3 | $ 19.6 | $ 11.1 |
Total fair value of shares vested | $ 17.1 | 10.6 | 13.4 |
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 3 months 18 days | ||
Unrecognized share-based compensation expense related to employee stock option awards | $ 23.6 | ||
Total instrinsic value of stock units outstanding options | 130.1 | ||
Total instrinsic value of stock units exercisable | 118.3 | ||
Total instrinsic value of stock units vested,other than options | 40.7 | 25 | 14.6 |
Total instrinsic value of stock units outstanding other than options | 67.5 | ||
Total fair value of time based vested | $ 17.9 | $ 12.4 | $ 7.2 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 4,785,972 |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 43,013 | $ 34,303 | $ 24,115 |
Inventoriable Costs [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 1,791 | 1,624 | 1,342 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 15,387 | 9,832 | 7,073 |
Selling, General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 25,835 | $ 22,847 | $ 15,700 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Dividend yield | 0% | 0% | 0% |
Expected volatility, minimum | 78.70% | 89.40% | 91.60% |
Expected volatility, maximum | 88.70% | 94.90% | 95.50% |
Weighted-average risk-free interest rate | 2.22% | 0.87% | 1.29% |
Expected term (in years) | 5 years 10 months 24 days | 5 years 10 months 24 days | 6 years |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity of Inducement Plan (Detail) - Inducement Award Plan [Member] | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 5,451,398 |
Options granted, Number of Shares | shares | 612,945 |
Options exercised, Number of Shares | shares | (1,219,421) |
Options canceled Number of Shares | shares | (56,792) |
Options expired Number of Shares | shares | (2,158) |
Outstanding at end of period, Number of Shares | shares | 4,785,972 |
Vested or expected to vest at end of period, Number of Shares | shares | 4,785,972 |
Exercisable at end of period, Number of Shares | shares | 3,628,867 |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ / shares | $ 21.09 |
Options granted, exercise price | $ / shares | 56.65 |
Options exercised, Weighted-Average Exercise Price | $ / shares | 17.58 |
Options canceled Weighted-Average Exercise Price | $ / shares | 41.01 |
Options expired, Weighted-Average Exercise Price | $ / shares | 12.73 |
Outstanding at end of period, Weighted-Average Exercise Price | $ / shares | 26.27 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | $ / shares | 26.27 |
Exercisable at end of period, Weighted-Average Exercise Price | $ / shares | $ 20.38 |
Options granted, Weighted-Average Contractual Life | 6 years 1 month 6 days |
Options exercised, Weighted-Average Contractual Life | 5 years 9 months 18 days |
Exercisable at end of period, Weighted-Average Contractual Life | 5 years |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding at beginning of year, Number of Shares | 1,529,652 | |
Time based RSU's granted, Number of Shares | 601,055 | |
Time based RSU's vested, Number of Shares | (769,355) | |
Time based RSU's cancelled, Number of Shares | (86,688) | |
Outstanding at end of year, Number of Shares | 1,274,664 | 1,529,652 |
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value | $ 26.95 | |
Time based RSU's granted, Weighted-Average Grant Date Fair Value | 57.53 | |
Time based RSU's vested, Weighted-Average Grant Date Fair Value | 23.23 | |
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value | 39.73 | |
Outstanding at end of year, Weighted-Average Grant Date Fair Value | $ 42.76 | $ 26.95 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms | 9 months 18 days | 1 year 6 months |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities excluded from computation of earnings per share | 4,785,972 | 5,451,398 | 5,517,622 |
RSUs [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities excluded from computation of earnings per share | 1,469,678 | 1,666,848 | 1,636,422 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Federal net operating loss carryforwards | $ 663.2 | |
Federal net operating loss carryforwards expiration year | 2037 | |
Unrecognized tax benefits | $ 1.7 | $ 1.7 |
Indefinite Period Carry Forward [Member] | ||
Federal net operating loss carryforwards | 532.1 | |
Expire In 2037 [Member] | ||
Federal net operating loss carryforwards | $ 131.1 |
Income Taxes - Loss before Inco
Income Taxes - Loss before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (223,465) | $ (221,216) | $ (155,616) |
Non-U.S. | (32,785) | (62,904) | (71,376) |
Loss before provision for income taxes | $ (256,250) | $ (284,120) | $ (226,992) |
Income Taxes - Total Income Tax
Income Taxes - Total Income Tax Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||||||||
Current | $ 6 | $ 6 | $ 14 | ||||||
Deferred | (52,789) | (53,070) | (40,049) | ||||||
Valuation allowance | 52,789 | 53,070 | 40,049 | ||||||
Provision for income taxes | $ (1) | $ 0 | $ (5) | $ 23 | $ (24) | $ (5) | $ 6 | $ 6 | $ 14 |
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, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Income tax at statutory federal rate | 21% | 21% | 21% |
Executive and share-based compensation | 1.92% | 0.60% | (1.01%) |
Subpart F Inclusion | (3.38%) | 0% | 0% |
Foreign rate differential | (2.69%) | (4.63%) | (6.60%) |
Change in effective state tax rates | 0.17% | (0.31%) | 1.12% |
State income tax expense | 3.58% | 2.04% | 3.14% |
Change in valuation allowance | (20.60%) | (18.70%) | (17.65%) |
Provision for income taxes | 0% | 0% | 0% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 168,606 | $ 137,561 |
Accrued expenditures | 9,169 | 2,723 |
Research and development credit, net | 9,321 | 9,321 |
Research and development expenditures | 13,525 | 0 |
Share-based compensation | 17,085 | 15,947 |
Other | 1,466 | 93 |
Capital lease | 4,980 | 6,178 |
Deferred tax liabilities: | ||
Right of use asset—capital lease | (3,684) | (5,049) |
Depreciation | (154) | (201) |
Net deferred tax asset before valuation allowance | 220,314 | 166,573 |
Valuation allowance | (220,314) | (166,573) |
Net deferred tax asset | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 23, 2019 | May 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 31, 2019 | |
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 | $ 3,900,000 | $ 3,000,000 | $ 1,800,000 | |||||
Purchase Commitment [Member] | Siegfried Campaign and Lonza Campaign [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Cash paid | $ 21,600,000 | 9,500,000 | ||||||
Minimum [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Purchase Obligation Year Of Payment | 2025 years | |||||||
Maximum [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Purchase Obligation Year Of Payment | 2029 years | |||||||
Product [Member] | Bristol-Myers Squibb Company [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Company made an upfront payment | $ 1,000,000 | |||||||
Company made milestone payment | $ 1,500,000 | $ 1,250,000 | ||||||
Obliged to make milestone payments | $ 14,750,000 | $ 2,000,000 | ||||||
License expiration period | 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 | |||||||
Cost of product sales | $ 12,500,000 | $ 4,100,000 | 1,100,000 | |||||
Product [Member] | Bristol-Myers Squibb Company [Member] | Minimum [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Royalty payment, percentage | 5% | |||||||
Product [Member] | Bristol-Myers Squibb Company [Member] | Maximum [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Royalty payment, percentage | 9% | |||||||
Product [Member] | Bristol-Myers Squibb Company [Member] | National Democratic Alliance [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Company remaining milestone payment | $ 5,000,000 | |||||||
Product [Member] | Bristol-Myers Squibb Company [Member] | ITCI National Democratic Alliance [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Payment of milestone amount | $ 5,000,000 |
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, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue, net | $ 87,869 | $ 71,870 | $ 55,579 | $ 34,996 | $ 25,671 | $ 22,207 | $ 20,047 | $ 15,878 | |||
Operating expenses | (135,281) | (127,499) | (143,502) | (107,658) | (111,675) | (99,531) | (89,188) | (69,097) | $ (513,940) | $ (369,491) | $ (254,041) |
Interest income | 3,386 | 2,122 | 1,320 | 548 | 270 | 393 | 421 | 484 | 7,376 | 1,568 | 4,236 |
Income tax benefit (expense) | (1) | 0 | (5) | 23 | (24) | (5) | 6 | 6 | 14 | ||
Net loss | $ (44,026) | $ (53,508) | $ (86,603) | $ (72,119) | $ (85,734) | $ (76,908) | $ (68,744) | $ (52,740) | $ (256,256) | $ (284,126) | $ (227,006) |
Earnings Per Share, Basic | $ (0.57) | $ (0.92) | $ (0.78) | $ (1.05) | $ (0.95) | $ (0.85) | $ (0.65) | $ (2.72) | $ (3.5) | $ (3.23) | |
Earnings Per Share, Diluted | $ (0.45) | $ (0.57) | $ (0.92) | $ (0.78) | $ (1.05) | $ (0.95) | $ (0.85) | $ (0.65) | $ (2.72) | $ (3.5) | $ (3.23) |