Cover Page
Cover Page - USD ($) $ in Billions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 22, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Amendment Flag | false | ||
Document Type | 10-K | ||
Document Fiscal Year Focus | 2020 | ||
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, 2020 | ||
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 | 80,917,013 | ||
Entity Public Float | $ 1.5 | ||
ICFR Auditor Attestation Flag | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 60,045,933 | $ 107,636,849 |
Investment securities, available-for-sale | 597,402,126 | 116,373,335 |
Restricted cash | 1,400,000 | |
Accounts receivable, less allowance of $120,000 and $0 at December 31, 2020 and 2019, respectively | 10,764,583 | |
Inventory | 7,056,385 | |
Prepaid expenses and other current assets | 14,235,455 | 6,313,785 |
Total current assets | 690,904,482 | 230,323,969 |
Property and equipment, net | 1,998,346 | 2,259,740 |
Right of use assets, net | 24,324,762 | 18,252,074 |
Deferred tax asset, net | 264,609 | |
Other assets | 86,084 | 86,084 |
Total assets | 717,313,674 | 251,186,476 |
Current liabilities: | ||
Accounts payable | 5,501,825 | 7,425,024 |
Accrued and other current liabilities | 10,902,117 | 16,138,909 |
Lease liabilities, short-term | 5,541,802 | 3,187,435 |
Accrued employee benefits | 14,907,479 | 9,472,651 |
Total current liabilities | 36,853,223 | 36,224,019 |
Lease liabilities | 23,600,347 | 19,955,186 |
Total liabilities | 60,453,570 | 56,179,205 |
Stockholders' equity: | ||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 80,463,089 and 55,507,497 shares issued and outstanding at December 31, 2020 and 2019, respectively | 8,046 | 5,551 |
Additional paid-in capital | 1,593,475,506 | 904,971,772 |
Accumulated deficit | (937,104,032) | (710,098,369) |
Accumulated comprehensive income | 480,584 | 128,317 |
Total stockholders' equity | 656,860,104 | 195,007,271 |
Total liabilities and stockholders' equity | $ 717,313,674 | $ 251,186,476 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Accounts receivable | $ 120,000 | $ 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 80,463,089 | 55,507,497 |
Common stock, shares outstanding | 80,463,089 | 55,507,497 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue | $ 22,812,979 | $ 60,613 | |
Operating expenses: | |||
Cost of product sales | 1,895,029 | ||
Research and development | 65,782,137 | 89,124,838 | $ 132,166,913 |
Selling, general and administrative | 186,363,444 | 64,947,625 | 30,099,855 |
Total operating expenses | 254,040,610 | 154,072,463 | 162,266,768 |
Loss from operations | (231,227,631) | (154,011,850) | (162,266,768) |
Interest income | (4,235,481) | (6,291,272) | (7,140,957) |
Loss before provision for income taxes | (226,992,150) | (147,720,578) | (155,125,811) |
Income tax expense | 13,513 | 1,600 | 1,600 |
Net loss | $ (227,005,663) | $ (147,722,178) | $ (155,127,411) |
Net loss per common share: | |||
Basic & Diluted | $ (3.23) | $ (2.68) | $ (2.84) |
Weighted average number of common shares: | |||
Basic & Diluted | 70,364,800 | 55,186,206 | 54,707,865 |
Product sales, net [Member] | |||
Revenue | $ 22,530,753 | ||
Grant revenue [Member] | |||
Revenue | $ 282,226 | $ 60,613 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (227,005,663) | $ (147,722,178) | $ (155,127,411) |
Other comprehensive income: | |||
Unrealized gain on investment securities | 352,267 | 796,074 | 131,467 |
Comprehensive loss | $ (226,653,396) | $ (146,926,104) | $ (154,995,944) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Comprehensive Gain (Loss) [Member] |
Balance at Dec. 31, 2017 | $ 454,436,961 | $ 5,460 | $ 862,479,505 | $ (407,248,780) | $ (799,224) |
Balance, shares at Dec. 31, 2017 | 54,597,679 | ||||
Exercise of stock options and issuances of restricted stock (Value) | $ 674,206 | $ 29 | 674,177 | ||
Exercise of stock options and issuances of restricted stock (Shares) | 284,326 | ||||
Stock issued for services | $ 192,530 | $ 1 | 192,529 | ||
Stock issued for services, shares | 11,468 | ||||
Share-based compensation | 17,396,146 | 17,396,146 | |||
Stock warrant | 10,982 | 10,982 | |||
Stock warrant, shares | 1,822 | ||||
Net loss | (155,127,411) | (155,127,411) | |||
Other comprehensive income (loss) | 131,467 | 131,467 | |||
Balance at Dec. 31, 2018 | 317,714,881 | $ 5,490 | 880,753,339 | (562,376,191) | (667,757) |
Balance, shares at Dec. 31, 2018 | 54,895,295 | ||||
Exercise of stock options and issuances of restricted stock (Value) | $ 3,235,601 | $ 59 | 3,235,542 | ||
Exercise of stock options and issuances of restricted stock (Shares) | 596,558 | ||||
Stock issued for services | $ 194,205 | $ 2 | 194,203 | ||
Stock issued for services, shares | 15,644 | ||||
Share-based compensation | 20,788,688 | 20,788,688 | |||
Net loss | (147,722,178) | (147,722,178) | |||
Other comprehensive income (loss) | 796,074 | 796,074 | |||
Balance at Dec. 31, 2019 | 195,007,271 | $ 5,551 | 904,971,772 | (710,098,369) | 128,317 |
Balance, shares at Dec. 31, 2019 | 55,507,497 | ||||
Common shares issued | 652,712,011 | $ 2,341 | 652,709,670 | ||
Common shares issued, shares | 23,409,458 | ||||
Exercise of stock options and issuances of restricted stock (Value) | 11,464,918 | $ 153 | 11,464,765 | ||
Exercise of stock options and issuances of restricted stock (Shares) | 1,536,797 | ||||
Stock issued for services | 214,103 | $ 1 | 214,102 | ||
Stock issued for services, shares | 9,337 | ||||
Share-based compensation | 24,115,197 | 24,115,197 | |||
Net loss | (227,005,663) | (227,005,663) | |||
Other comprehensive income (loss) | 352,267 | 352,267 | |||
Balance at Dec. 31, 2020 | $ 656,860,104 | $ 8,046 | $ 1,593,475,506 | $ (937,104,032) | $ 480,584 |
Balance, shares at Dec. 31, 2020 | 80,463,089 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows used in operating activities | |||
Net loss | $ (227,005,663) | $ (147,722,178) | $ (155,127,411) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 528,118 | 477,121 | 368,673 |
Share-based compensation | 24,115,197 | 20,788,688 | 17,396,146 |
Stock issued for services | 214,103 | 194,205 | 192,530 |
Amortization of premiums and discounts on investment securities, net | (648,248) | (1,131,597) | (943,239) |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (10,764,583) | ||
Inventory | (7,056,385) | ||
Prepaid expenses and other assets | (7,921,670) | 1,465,384 | (3,026,908) |
Long term deferred tax asset, net | 264,609 | 264,609 | 529,217 |
Accounts payable | (1,923,199) | (6,536,036) | 7,787,521 |
Accrued liabilities and other | 198,036 | 3,327,095 | 14,386,774 |
Lease liabilities, net | (73,160) | 889,468 | |
Deferred rent | 267,584 | ||
Net cash used in operating activities | (230,072,845) | (127,983,241) | (118,169,113) |
Cash flows (used in) provided by investing activities | |||
Purchases of investments | (755,629,547) | (80,720,301) | (271,156,707) |
Maturities of investments | 275,601,271 | 258,857,683 | 406,189,288 |
Purchases of property and equipment | (266,724) | (700,395) | (391,268) |
Net cash (used in) provided by investing activities | (480,295,000) | 177,436,987 | 134,641,313 |
Cash flows provided by financing activities | |||
Proceeds from exercise of stock options | 11,464,918 | 3,235,601 | 674,206 |
Proceeds of public offerings, net | 652,712,011 | ||
Proceeds from stock warrant | 10,982 | ||
Net cash provided by financing activities | 664,176,929 | 3,235,601 | 685,188 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (46,190,916) | 52,689,347 | 17,157,388 |
Cash, cash equivalents, and restricted cash at beginning of period | 107,636,849 | 54,947,502 | 37,790,114 |
Cash, cash equivalents, and restricted cash at end of period | 61,445,933 | 107,636,849 | 54,947,502 |
Cash paid for taxes | 1,600 | 1,600 | $ 1,600 |
Non-cash investing and financing activities | |||
Right of use assets under operating leases | 200,000 | ||
Vehicle Fleet Lease [Member] | |||
Non-cash investing and financing activities | |||
Right of use assets under operating leases | $ 8,917,935 | ||
Real Estate Lease [Member] | |||
Non-cash investing and financing activities | |||
Right of use assets under operating leases | $ 219,703 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Cash Flows [Abstract] | ||||
Cash and cash equivalents | $ 60,045,933 | $ 107,636,849 | $ 54,947,502 | |
Restricted cash | 1,400,000 | |||
Total cash, cash equivalents and restricted cash | $ 61,445,933 | $ 107,636,849 | $ 54,947,502 | $ 37,790,114 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Intra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiaries, ITI, Inc. (“ITI”) and ITI Limited, is a biopharmaceutical company focused on the discovery, clinical development and commercialization of innovative, small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system (“CNS”). In December 2019, the Company announced that CAPLYTA TM On January 10, 2020, the Company completed a public offering of common stock in which the Company sold 10,000,000 shares of common stock at an offering price of $29.50 per share for aggregate gross proceeds of $295.0 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $277.0 million. On September 15, 2020, the Company completed a public offering of common stock in which the Company sold 12,666,667 shares of common stock at an offering price of $30.00 per share for aggregate gross proceeds of $380.0 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $357.8 million. In order to further its commercial activities and research projects and support its collaborations, the Company will 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 securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s product candidates and technology and, to a lesser extent, grant funding. On August 30, 2019, the Company filed a universal shelf registration statement on Form S-3, “at-the-market” “at-the-market” During the year ended December 31, 2020, the Company issued an aggregate “at-the-market” In addition, on January 6, 2020, the Company filed an automatic shelf registration statement on Form S-3 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
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 subsidiaries 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 and developing drugs primarily for the treatment of neurological and psychiatric disorders . Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months 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 twelve months or less. Management classifies the Company’s investments as available-for-sale. available-for-sale Investment securities consisted of the following (in thousands): December 31, 2020 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 259,304 $ 3 $ (31 ) $ 259,276 Certificates of Deposit 10,500 — — 10,500 Commercial Paper 124,368 23 (21 ) 124,370 Corporate Notes/Bonds 202,749 624 (117 ) 203,256 $ 596,921 $ 650 $ (169 ) $ 597,402 December 31, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 35,462 $ 35 $ (3 ) $ 35,494 Certificates of Deposit 3,000 — — 3,000 Commercial Paper 39,013 10 (5 ) 39,018 Corporate Notes/Bonds 38,770 91 — 38,861 $ 116,245 $ 136 $ (8 ) $ 116,373 The Company has classified all of its investment securities 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 would estimate the expected credit loss over the lifetime of the asset and record an allowance for the portion of the amortized cost basis of the financial asset that the company does not expect to collect. The aggregate related fair value of investments with unrealized losses as of December 31, 2020 was $372.3 million, which consisted of $180.0 million from U.S. government agency securities, $84.4 million of commercial paper, and $107.8 million of corporate notes/bonds. The aggregate amount of unrealized losses as of December 31, 2020 was approximately $169,000, which consisted of $31,000 from U.S. government agency securities, $21,000 from commercial paper, and $117,000 from corporate notes/bonds. The $372.3 million aggregate fair value of investments with unrealized losses as of December 31, 2020 has been held in a continuous unrealized loss position for less than 12 months. As of December 31, 2019, the aggregate related fair value of investments with unrealized losses was $29.6 million and the aggregate amount of unrealized losses was approximately $8 thousand. Of the $29.6 million, $17.1 million ha d 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 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. The Company has no assets or liabilities that were measured using quoted prices for significant unobservable inputs (Level 3 assets and liabilities) as of December 31, 2020 and December 31, 2019. The carrying value of cash held in money market funds of approximately $27.9 million as of December 31, 2020 and $49.9 million as of December 31, 2019 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 certificates of deposit of $0 and approximately $47.6 million as of December 31, 2020 and 2019, respectively, is included in cash and cash equivalents and approximates market value based on quoted market price or Level 2 inputs. The carrying value of cash held in commercial paper of approximately $3.0 million as of December 31, 2019 is included in cash and cash equivalents and approximates market value based on quoted market price or Level 2 inputs. The fair value measurements of the Company’s cash equivalents and available-for-sale Fair Value Measurements at Reporting Date Using December 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 27,917 $ 27,917 $ — $ — U.S. Government Agency Securities 259,276 — 259,276 — Certificates of Deposit 10,500 — 10,500 — Commercial Paper 124,370 — 124,370 — Corporate Notes/Bonds 203,256 — 203,256 — $ 625,319 $ 27,917 $ 597,402 $ — Fair Value Measurements at Reporting Date Using December 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 49,882 $ 49,882 $ — $ — U.S. Government Agency Securities 35,494 — 35,494 — Certificates of Deposit 50,622 — 50,622 — Commercial Paper 42,015 — 42,015 — Corporate Notes/Bonds 38,861 — 38,861 — $ 216,874 $ 49,882 $ 166,992 $ — 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, lease liabilities, short term, to approximate their fair value because of their relatively short maturities at December 31, 2020 and December 31, 2019. 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 5). 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 from chargebacks, prompt pay discounts, and distribution fees. 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, 2020. 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 and as of December 31, 2020, our credit loss reserve on receivables was not material. 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 year ended December 31, 2020, all of the Company’s accounts receivable, net arose from product sales in the U.S. and all customers have standard payment terms which generally require payment within 60 days. For the year ended December 31, 2020, 96% of sales were generated from three major industry wholesalers, respectively. Three individual customers accounted for approximately 39%, 29%, and 28% of product sales for the year ended December 31, 2020. As of December 31, 2020, the Company believes that such 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 incurred in 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 Revenue Recognition Effective January 1, 2018, the Company adopted FASB ASC Topic 606, Revenue from Contracts with Customers 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 U.S., 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 estimates that take into consideration a range of possible outcomes which are either considered more likely or probability-weighted 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, forecasted customer buying and payment patterns. The Company’s estimates regarding the payer mix for CAPLYTA and historical industry information regarding the payer mix for comparable pharmaceutical products and product portfolios, in particular, historical information related to similar products in their initial launch stages. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts after considering whether revenue should be constrained under ASC 606. 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 a material reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2020 and, therefore, the transaction price was not reduced further during the year ended December 31, 2020. 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 number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability 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% on sales of licensed products. The related royalties are recorded within cost of product sales on the statement of operations. Prior to the Research and Development, Including Clinical Trial Expenses Except for payments made in advance of services, the Company expenses its research and development costs as incurred. For payments made in advance, the Company recognizes research and development expense as the services are rendered. 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 preclinical 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. For the year ended December 31, 2020, the company $5.3 million related to the prior year estimates of accrued expenses for clinical trials that resulted in a reduction of research and development expenses. Advertising Expense In connection with the FDA approval of CAPLYTA in 2019, the Company began to incur advertising costs in connection with the subsequent commercial launch of CAPLYTA in 2020. Advertising costs are expensed when services are rendered. The Company incurred $36.3 million in advertising costs during the year ended December 31, 2020, and $0 in advertising costs during the years ended December 31, 2019, and 2018, 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 (previously included in FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109 more-likely-than-not The Company’s effective tax rate for the years ended December 31, 2020 and 2019 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. The Company reviewed the provisions and there was not a material tax impact on its financial statements for the year ended December 31, 2020. The Company did reclassify its deferred tax asset related to the AMT tax credit carryforward of $265,000 to a current tax receivable in the first quarter of 2020 upon the filing of its tax return for year ended December 31, 2019 and received the refund in July 2020. Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (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, 2020, 2019 and 2018 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. Expected volatility rates for quarterly periods prior to December 31, 2019 were based on a combination of the historical volatility of the common stock of comparable publicly traded entities and the limited historical information about the Company’s common stock. In the fourth quarter of 2019 and for all periods thereafter, expected volatility rates are based entirely on the historical volatility of the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. A restricted stock unit (“RSU”) is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the fair market value of the Company’s common stock on the date of grant. The Company has granted RSUs that vest in three equal annual installments provided that the employee remains employed with the Company. In the first quarter of each fiscal year beginning in 2016, the Company granted time based RSUs that vest in three In the first quarter of 2020, the Company granted performance-based RSUs for approximately 86,000 shares of common stock, which vest based on the achievement of certain milestones that include (i) the approval of a planned NDA by the FDA and (ii) the achievement of certain comparative shareholder returns against the Company’s peers (the “2020 TSR RSUs”). The 2020 TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSUs based on the agreements. 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 June 2018, the Company’s stockholders approved the Company’s 2018 Equity Incentive Plan (the “2018 Plan”) pursuant to which 4,750,000 additional shares of common stock were reserved for future equity grants. In May 2020, the Company’s stockholders approved the Company’s 2018 Amended and Restated Equity Incentive Plan (the “Amended 2018 Plan”) pursuant to which additional shares of common stock were reserved for future equity grants. In December 2019, the Company adopted the Intra-Cellular Therapies, Inc. 2019 Inducement Award Plan (the “2019 Inducement Plan”) without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Pursuant to the 2019 Inducement Plan, the Company may grant stock options, RSUs, stock awards and other share-based awards for up to a total of 1,000,000 shares of common stock to new employees of the Company. As of December 31, 2020, stock options and RSUs for 314,138 shares have been granted under the 2019 Inducement Plan. The Company does not intend to make additional grants under the 2019 Inducement Plan. 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. 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, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Stock options 5,517,622 6,039,945 4,748,391 RSUs 1,600,083 1,268,679 647,411 TSR RSUs 36,339 67,080 206,484 Recently Issued Accounting S |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | 3. Inventory Inventory consists of the following: December 31, 2020 Raw materials $ 2,483,801 Work in process 1,781,101 Finished goods 2,791,483 $ 7,056,385 Inventory acquired prior to receipt of the FDA approval on December 20, 2019 for CAPLYTA was expensed as research and development expense as incurred. No inventory was produced from the FDA approval date through the end of 2019; therefore, no inventory was capitalized on the consolidated balance sheet as of December 31, 2019. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment Property and equipment consist of the following: December 31, 2020 December 31, 2019 Computer equipment $ 243,532 $ 243,532 Furniture and fixtures 423,097 423,097 Scientific equipment 4,127,951 3,861,227 Leasehold improvements 1,240,315 1,240,315 6,034,895 5,768,171 Less accumulated depreciation (4,036,549 ) (3,508,431 ) $ 1,998,346 $ 2,259,740 Depreciation expense for the years ended December 31, 2020, 2019 and 2018 was $528,118, $477,121 and $368,673, respectively. |
Right Of Use Assets and Lease L
Right Of Use Assets and Lease Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Right Of Use Assets and Lease Liabilities | 5. Right Of Use Assets and Lease Liabilities Real Estate Leases 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 non-lease In adopting ASU 2016-02 non-lease the lease commencement dates, the Company estimated the lease liabilities and the right of use assets at present value using its applicable incremental borrowing rates of its two long-term leases of 7.2% for the Company’s Maryland lease of 3.2 years and 9.1% for the Company’s New York leases of 14.3 years. On January 1, 2019, upon adoption of ASU 2016-02, non-cash Right of use assets and lease liabilities for operating leases were approximately $17.0 million and $21.8 million as of December 31, 2020, respectively. The operating cash outflows related to operating lease obligations for the year ended December 31, 2020 were approximately $3.3 million. Maturity analysis under the lease agreements are as follows: Year ending December 31, 2021 $ 3,448,323 Year ending December 31, 2022 3,491,166 Year ending December 31, 2023 3,566,466 Year ending December 31, 2024 3,675,196 Year ending December 31, 2025 3,787,248 Thereafter 13,839,791 Total 31,808,190 Less: Present value discount (9,961,556 ) Total Lease liability 21,846,634 Less: Current portion (3,284,540 ) Long-term lease liabilities $ 18,562,094 Lease expense for the year ended December 31, 2020, 2019 and 2018 was approximately $3.3 million $3.3 million and $1.8 million, respectively. Vehicle Fleet Lease 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 The nature of the lease is one commonly referred to as “TRAC” lease, as it contains a terminal rental adjustment clause, or “TRAC” clause.” The TRAC clause limits lessee 12-month Right of use asset and lease liability for the vehicle fleet lease were approximately $7.3 million and $0, respectively, as of December 31, 2020 and December 31, 2019. The vehicle leases entered into since March 2020 represent non-cash The following table presents the Vehicle Lease balances within the consolidated balance sheet, weighted average remaining fleet lease term, and the weighted average discount rates related to the Vehicle Lease as of December 31, 2020: Lease Assets and Liabilities – Fleet Classification December 31, 2020 Assets Right of use assets, net Operating lease right of use assets $ 7,295,515 $ 7,295,515 Liabilities Current Lease liabilities, short-term Operating lease liabilities $ 2,257,262 Non-Current Lease liabilities Non-current operating lease liabilities 5,038,253 Total lease liabilities $ 7,295,515 Weighted average remaining lease term 2.0 years Weighted average discount rate 1.74 % The following table presents the maturity of the Company’s fleet lease liability as of December 31, 2020: Year ending December 31, 2021 $ 2,363,058 Year ending December 31, 2022 3,458,449 Year ending December 31, 2023 1,640,337 Year ending December 31, 2024 — Thereafter — Total 7,461,844 Less: Present value discount (166,329 ) Total operating lease liabilities 7,295,515 Less: Current portion (2,257,262 ) Long-term lease liabilities $ 5,038,253 Right of use assets and lease liabilities for all operating leases were approximately $24.3 million and $29.1 million, respectively, as of December 31, 2020. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 6. Share On June 18, 2018, the Company’s stockholders approved the 2018 Plan which provided for the granting of share-based awards, such as stock options, restricted common stock, RSUs and stock appreciation rights to employees, directors and consultants as determined by the Board of Directors. On May 27, 2020, the Company’s stockholders approved the Amended 2018 Plan, which provides for the granting of up to 6,500,000 additional share-based awards, such as stock options, restricted common stock, RSUs and stock appreciation rights to employees, directors and consultants as determined by the Board of Directors. In December 2019, the Company adopted the 2019 Inducement Plan for the grant of equity awards of up to shares of common stock to newly hired employees. As of December 31, 2020, the total number of shares reserved under all equity plans was 17,787,390 and the Company had 7,459,117 shares available for future issuance under the Amended 2018 Plan and the 2019 Inducement Plan. Stock options granted under the Amended 2018 Plan and the 2019 Inducement Plan may be either incentive stock options (“ISOs”) as defined by the Internal Revenue Code of 1986, as amended, or non-qualified one Total share Years Ended December 31, 2020 2019 2018 Inventoriable costs $ 1,342,262 — — Research and development 7,072,545 $ 9,411,056 $ 7,380,814 Selling, general and administrative 15,700,390 11,377,632 10,015,332 Total share-based compensation expense $ 24,115,197 $ 20,788,688 $ 17,396,146 The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2020, 2019 and 2018: 2020 2019 2018 Dividend yield 0 % 0 % 0 % Expected volatility 91.6%-95.5 % 85.7-96.5 % 85.2%-85.8 % Weighted-average risk-free interest rate 1.29 % 2.32 % 2.48 % Expected term (in years) 6.0 6.0 6.0 Information regarding stock option awards under the 2019 Inducement Plan, including with respect to grants to employees as of December 31, 2020, and changes during the period then ended, are summarized as follows: Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Life Outstanding at December 31, 2019 — $ — Options granted in 2020 39,728 $ 17.18 9.2 years Outstanding at December 31, 2020 39,728 $ 17.18 9.2 years Vested or expected to vest at December 31, 2020 39,728 $ 17.18 Exercisable at December 31, 2020 — $ — The weighted-average grant date fair value for awards granted during the years ended December 31, 2020, 2019 and 2018 was $12.84, $0 and $0 per share, respectively. The total intrinsic value of the options exercised during the years ended December 31, 2020, 2019 and 2018 was $0, respectively. The total intrinsic value of the options outstanding as of December 31, 2020 was $ . The total intrinsic value of the options exercisable as of December 31, 2020 was $ . The total fair value of shares vested during the years ended December 31, 2020, 2019 and 2018 was $ , respectively. The unrecognized share-based compensation expense related to stock option awards at December 31, 2020 was $377,146 and will be recognized over a weighted-average period of 2.2 years. Information regarding RSU awards under the 2019 Inducement Plan during the period then ended are summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Per Share Weighted- Average Contractual Life Outstanding at December 31, 2019 — $ — Time based RSUs granted in 2020 274,410 $ 16.01 2.2 years Time based RSUs cancelled in 2020 (22,543 ) $ 15.81 2.2 years Outstanding at December 31, 2020 251,867 $ 16.03 2.2 years Vested or expected to vest at December 31, 2020 251,867 $ 16.03 The total intrinsic value of the time based RSUs vested during the years ended December 31, 2020, 2019 and 2018 was $0, respectively. The total intrinsic value of the time based RSU’s outstanding as of December 31, 2020 was $8,009,370. The total fair value of time based RSUs vested during the years ended December 31, 2020, 2019 and 2018 was $0, 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. As of December 31, 2020, there was $2,859,070 of unrecognized compensation costs related to unvested time based RSUs which will be recognized over a weighted-average period of 2.2 years. During the year ended December 31, 2020, the Company issued options and time based RSUs totaling 314,138 shares in the 2019 Inducement Plan. The Company does not intend to issue any additional equity awards under the 2019 Inducement Plan. Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2020, and changes during the year then ended, are summarized as follows: Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Life Outstanding at December 31, 2019 6,039,945 $ 16.81 7.0 years Options granted in 2020 760,472 $ 24.03 9.2 years Options exercised in 2020 (999,479 ) $ 12.58 4.8 years Options canceled or expired in 2020 (323,044 ) $ 19.42 7.6 years Outstanding at December 31, 2020 5,477,894 $ 18.43 6.6 years Vested or expected to vest at December 31, 2020 5,477,894 $ 18.43 Exercisable at December 31, 2020 3,441,115 $ 19.19 5.6 years The weighted-average grant date fair value for awards granted during the years ended December 31, 2020, 2019 and 2018 was $17.98, $9.17 and $15.22 per share, respectively. The total intrinsic value of the options exercised during the years ended December 31, 2020, 2019 and 2018 was $11,099,951, $3,127,412 and $1,683,679, respectively. The total intrinsic value of the options outstanding as of December 31, 2020 was $81,234,131. The total intrinsic value of the options exercisable as of December 31, 2020 was $51,341,624. The total fair value of shares vested during the years ended December 31, 2020, 2019 and 2018 was $13,366,276, $11,983,108 and $11,348,595, respectively. The unrecognized share-based compensation expense related to stock option awards at December 31, 2020 was $16,083,760, and will be recognized over a weighted-average period of 1.7 years. Information regarding time based RSU activity, including with respect to grants to employees as of December 31, 2020, and changes during the year then ended, is summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Per Share Weighted- Average Contractual Life Outstanding at December 31, 2019 1,268,679 $ 13.60 1.7 years Time based RSUs granted in 2020 732,992 $ 23.09 2.4 years Time based RSUs vested in 2020 (519,994 ) $ 13.90 0.7 years Time based RSUs cancelled in 2020 (169,800 ) $ 17.23 1.3 years Outstanding at December 31, 2020 1,311,877 $ 18.77 1.7 years The total intrinsic value of the time based RSUs vested during the years ended December 31, 2020, 2019 and 2018 was $14,553,421, $3,109,328 and $1,165,323, respectively. The total intrinsic value of the time based RSU’s outstanding as of December 31, 2020 was $40,816,730. The total fair value of time based RSUs vested during the years ended December 31, 2020, 2019 and 2018 was $7,230,027, $4,623,030 and $2,109,705, 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. As of December 31, 2020, there was $14,600,601 of unrecognized compensation costs related to unvested time based RSUs which will be recognized over a weighted-average period of 1.8 years. The Company recognized non-cash share Information related to the Company’s Milestone RSUs and the TSR RSUs during the year ended December 31, 2020 are summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Per Share Weighted- Average Contractual Life Outstanding at December 31, 2019 67,080 $ 17.08 0.2 years Milestone RSUs and TSR RSUs granted in 2020 86,044 $ 28.25 2.1 years Milestone RSUs and TSR RSUs vested in 2020 (67,080 ) $ 17.08 0.2 years Milestone RSUs and TSR RSUs cancelled in 2020 (13,366 ) $ 28.25 2.1 years Outstanding at December 31, 2020 72,678 $ 28.25 2.1 years The total intrinsic value of the Company’s Milestone RSUs and the TSR RSUs vested during the years ended December 31, 2020, 2019 and 2018 was $1,583,759, $2,233,958, and $781,434, respectively. The total intrinsic value of the Company’s Milestone RSU’s and the TSR RSUs outstanding as of December 31, 2020 was $2,311,160. The total fair value of the Company’s Milestone RSUs and the TSR RSUs vested during the years ended December 31, 2020, 2019 and 2018 was $1,145,732, $921,972, and $971,475, respectively. As of December 31, 2020 and 2019 there were $1,658,764 and $0 respectively of unrecognized compensation costs related to unvested Milestone RSU grants and TSR RSU grants which will be recognized over a weighted average period of 2.1 years. The weighted average estimated fair value per share of the TSR RSUs granted in 2017 was $17.08, which was derived from a Monte Carlo simulation. Significant assumptions utilized in estimating the value of the awards granted include an expected dividend yield of 0%, a risk free rate of 1.6%, and expected volatility of 95.4%. The TSR RSUs granted in 2017 entitled the grantee to receive a number of shares of the Company’s common stock determined over a three-year performance period ended and vested on December 31, 2019, provided the grantee remained in the service of the Company on the settlement date. The Company expensed the cost of these awards ratably over the requisite service period. The number of shares for which the TSR RSUs was settled was a percentage of shares for which the award was targeted and depended on the Company’s total shareholder return (as defined below), expressed as a percentile ranking of the Company’s total shareholder return as compared to the Company’s peer group (as defined below). The number of shares for which the TSR RSUs were settled varied depending on the level of achievement of the goal. Total shareholder return was determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2020 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2017, with a deemed reinvestment of any dividends declared during the performance period. The Company’s peer group originally included 223 companies that comprised the Nasdaq Biotechnology Index at December 31, 2018, which was selected by the Compensation Committee of the Company’s Board of Directors and included a range of biotechnology companies operating in several business segments. The TSR RSUs valuation was complete and 67,080 shares subject to the TSR RSU’s were issued in the first quarter of 2020. The weighted average estimated fair value per share of the TSR RSUs granted in 2020 was $32.56, which was derived from a Monte Carlo simulation. Significant assumptions utilized in estimating the value of the awards granted include an expected dividend yield of 0%, a risk free rate of 1.4%, and expected volatility of 91.3%. The TSR RSUs granted in 2020 will entitle the grantee to receive a number of shares of the Company’s common stock determined over a three-year performance period ending and vesting on December 31, 2022, provided the grantee remained in the service of the Company on the settlement date. The Company is expensing the cost of these awards ratably over the requisite service period. The number of shares for which the TSR RSUs will be settled is a percentage of shares for which the award is targeted and depends on the Company’s total shareholder return, expressed as a percentile ranking of the Company’s total shareholder return as compared to the Company’s peer group, which is consistent with the TSR RSUs granted in 2017. The number of shares for which the TSR RSUs will be settled will vary depending on the level of achievement of the goal. Total shareholder return will be determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2023 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2020, with a deemed reinvestment of any dividends declared during the performance period. The Company’s peer group included companies that compromised the Nasdaq Biotechnology Index at December 31, 2019. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes On December 22, 2017, former President Donald Trump signed into law the “Tax Cuts and Jobs Act” (“TCJA”) that significantly reforms the Internal Revenue Code of 1986, as amended (the “Code”). The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and net operating loss carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. In addition, the TCJA repealed the alternative minimum tax (“AMT”) and provides for a refund of AMT paid or a reduction of future taxes payable over a prescribed period of years between 2018 and 2021. With the passing of the TCJA, the Company recorded a receivable for prior period AMT, and therefore, the Company recognized an income tax benefit of approximately $1.1 million related to this prior period AMT in December 2017. While the TCJA provide for a territorial tax system, beginning in 2018, it includes two new U.S. tax base erosion provisions, the global intangible low-taxed The GILTI provisions require the Company to include in its U.S. income tax return foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s tangible assets. As of the year ended December 31, 2020, the Company’s foreign operations do not generate positive income and the Company is not currently subject to the GILTI provisions. The Company has not made an accounting policy election for GILTI and will analyze and formulate its GILTI accounting policy in the period which the Company becomes subject to the GILTI provisions. The BEAT provisions eliminate the deduction of certain base-erosion payments made to related foreign corporations, and impose a minimum tax if greater than regular tax. The Company has not made any qualifying payments and the BEAT tax is not applicable in 2020. Therefore, the Company has not included any tax impacts of BEAT in its consolidated financial statements for the year ended December 31, 2020. During December 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”) to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the TCJA. The Company has recognized the provisional tax impacts related to the release of the valuation allowance with respect to AMT credits and the revaluation of deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The Company completed its evaluation of the effects of the TCJA during the fourth quarter of 2018 and the provisional amounts the Company accounted for in its December 31, 2017 provision were finalized in 2018 with no adjustments. Loss before income taxes is as follows: 2020 2019 2018 U.S. (155,615,614 ) (56,121,258 ) $ (30,299,751 ) Non-U.S. (71,376,536 ) (91,599,320 ) (124,826,060 ) Total loss before taxes (226,992,150 ) (147,720,578 ) $ (155,125,811 ) Total income tax expense for the years ended December 31, 2020, 2019 and 2018 is allocated as follows: 2020 2019 2018 Current $ 13,513 $ 1,600 $ 1,600 Deferred (40,049,094 ) (8,484,822 ) (5,054,468 ) Valuation allowance 40,049,094 8,484,822 5,054,468 Provision for income taxes $ 13,513 $ 1,600 $ 1,600 A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2020, 2019 and 2018 is as follows: December 31, 2020 2019 2018 Income tax benefit at statutory federal rate 21.00 % 21.00 % 21.00 % Other permanent differences (1.01 ) (0.67 ) (0.58 ) Foreign rate differential (6.60 ) (13.02 ) (16.90 ) Change in effective state tax rates 1.12 (0.16 ) (0.38 ) State income tax expense 3.14 (1.40 ) 0.12 Change in valuation allowance (17.65 ) (5.75 ) (3.26 ) Provision for income taxes 0.0 % 0.0 % 0.00 % 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, 2020, the Company had $323.0 million of federal net operating loss carryforwards, of which $131.1 million expire at various dates through 2037 and $191.9 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, 2020, 2019, 2018, 2017, 2016 and 2015, 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, 2020, 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, 2020 and 2019, respectively: December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 85,751,154 $ 49,668,232 Accrued employee benefits 1,363,082 589,667 Research and development credit 9,321,214 9,321,214 Stock compensation 15,137,990 12,965,250 Other accruals 850,900 — Federal AMT credit — 264,609 Capital lease 7,461,587 4,973,618 Deferred tax liabilities: Right of use asset—capital lease (6,228,138 ) (3,922,583 ) Unrealized gains on investment (123,049 ) (27,577 ) Depreciation (244,058 ) (230,760 ) Net deferred tax asset before valuation allowance 113,290,682 73,601,670 Valuation allowance (113,290,682 ) (73,337,061 ) Net deferred tax asset $ — $ 264,609 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 2020 and 2019, excluding the AMT paid in prior years that is refundable or available as a reduction to future taxes payable, for financial reporting purposes because it is not more likely than not that these deferred tax assets will be realized. The Company did reclassify its deferred tax asset related to the AMT tax credit carryforward of $ to a current tax receivable in the first quarter of 2020 upon the filing of its tax return for year ended December 31, 2019 and received the refund in July 2020. As of December 31, 2020, the Company received all of these refunds. The total amount of unrecognized tax benefits was $1.7 million as of December 31, 2020 and December 31, 2019. If recognized, none of these tax benefits would affect the effective tax rate due to valuation allowances. The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2020 and 2019, respectively: December 31, 2020 2019 Balance at January 1, $ 1,738,815 $ 1,738,815 Current Year Uncertain Tax Positions: Gross Change — — Balance at December 31, $ 1,738,815 $ 1,738,815 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. 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 (“BMS”), 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 23, 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. In connection with the transfer, the Company guaranteed ITI Limited’s performance of its obligations under the BMS agreement. With the initial recognition of product sales revenue in the year ended December 31, 2020, the Company expensed approximately $1,126,538 in cost of product sales to satisfy its obligation under the BMS agreement. Research and Other Commitments As of December 31, 2020, the Company has committed to purchasing a production campaign for active pharmaceutical ingredients (API) from each of our supply vendors – Siegfried Evionnaz SA (Siegfried) and Lonza Ltd. (Lonza). Both campaigns are expected to be received into inventory during 2022. The Company has a total commitment of $16.4 million related to these two agreements. As of December 31, 2020, the Company had paid a deposit of $3.0 million for the Siegfried campaign which is recorded within prepaids and other current assets. Over the course of the vendors’ manufacturing period, the Company will remit payment to each vendor based on executed agreement. Each payment will subsequently be recorded into prepaid and other current assets. Upon title transfer of the product, the Company will recognize the material as inventory. 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, 2020 and 2019, 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. |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Parties | 9. Related Parties In the first quarter of 2015, the Company moved its headquarters to New York, New York. The Company has entered into a long-term lease with a related party for laboratory and office space . the Company’s board of directors is the Chairman of the board of directors, Chief Executive Officer and President of the parent company to the landlord under this lease. |
Unaudited Quarterly Financial I
Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | 10. Unaudited Quarterly Financial Information The tables herein set forth the Company’s unaudited condensed consolidated 2020 and 2019 quarterly statements of operations. The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2020 quarters ended: 2020 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 12,454,270 $ 7,368,594 $ 1,906,636 $ 1,083,479 Operating expenses (73,787,606 ) (63,305,048 ) (66,778,953 ) (50,169,003 ) Interest income 644,390 752,829 1,160,059 1,678,203 Income tax expense (13,513 ) — — (3,281 ) Net loss (60,699,178 ) (55,183,625 ) (63,712,258 ) (47,410,602 ) Basic and diluted net loss per share $ (0.76 ) $ (0.79 ) $ (0.96 ) $ (0.73 ) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2019 quarters ended: 2019 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net 60,613 — — — Operating expenses (41,829,272 ) (36,376,236 ) (39,171,114 ) (36,695,841 ) Interest income 1,185,808 1,513,837 1,731,550 1,860,077 Income tax expense — — (1,600 ) — Net loss (40,582,851 ) (34,862,399 ) (37,441,164 ) (34,835,764 ) Basic and diluted net loss per share $ (0.73 ) $ (0.63 ) $ (0.68 ) $ (0.63 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own subsidiaries 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 and developing 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. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months |
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 twelve months or less. Management classifies the Company’s investments as available-for-sale. available-for-sale Investment securities consisted of the following (in thousands): December 31, 2020 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 259,304 $ 3 $ (31 ) $ 259,276 Certificates of Deposit 10,500 — — 10,500 Commercial Paper 124,368 23 (21 ) 124,370 Corporate Notes/Bonds 202,749 624 (117 ) 203,256 $ 596,921 $ 650 $ (169 ) $ 597,402 December 31, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 35,462 $ 35 $ (3 ) $ 35,494 Certificates of Deposit 3,000 — — 3,000 Commercial Paper 39,013 10 (5 ) 39,018 Corporate Notes/Bonds 38,770 91 — 38,861 $ 116,245 $ 136 $ (8 ) $ 116,373 The Company has classified all of its investment securities 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 would estimate the expected credit loss over the lifetime of the asset and record an allowance for the portion of the amortized cost basis of the financial asset that the company does not expect to collect. The aggregate related fair value of investments with unrealized losses as of December 31, 2020 was $372.3 million, which consisted of $180.0 million from U.S. government agency securities, $84.4 million of commercial paper, and $107.8 million of corporate notes/bonds. The aggregate amount of unrealized losses as of December 31, 2020 was approximately $169,000, which consisted of $31,000 from U.S. government agency securities, $21,000 from commercial paper, and $117,000 from corporate notes/bonds. The $372.3 million aggregate fair value of investments with unrealized losses as of December 31, 2020 has been held in a continuous unrealized loss position for less than 12 months. As of December 31, 2019, the aggregate related fair value of investments with unrealized losses was $29.6 million and the aggregate amount of unrealized losses was approximately $8 thousand. Of the $29.6 million, $17.1 million ha d 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 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. The Company has no assets or liabilities that were measured using quoted prices for significant unobservable inputs (Level 3 assets and liabilities) as of December 31, 2020 and December 31, 2019. The carrying value of cash held in money market funds of approximately $27.9 million as of December 31, 2020 and $49.9 million as of December 31, 2019 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 certificates of deposit of $0 and approximately $47.6 million as of December 31, 2020 and 2019, respectively, is included in cash and cash equivalents and approximates market value based on quoted market price or Level 2 inputs. The carrying value of cash held in commercial paper of approximately $3.0 million as of December 31, 2019 is included in cash and cash equivalents and approximates market value based on quoted market price or Level 2 inputs. The fair value measurements of the Company’s cash equivalents and available-for-sale Fair Value Measurements at Reporting Date Using December 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 27,917 $ 27,917 $ — $ — U.S. Government Agency Securities 259,276 — 259,276 — Certificates of Deposit 10,500 — 10,500 — Commercial Paper 124,370 — 124,370 — Corporate Notes/Bonds 203,256 — 203,256 — $ 625,319 $ 27,917 $ 597,402 $ — Fair Value Measurements at Reporting Date Using December 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 49,882 $ 49,882 $ — $ — U.S. Government Agency Securities 35,494 — 35,494 — Certificates of Deposit 50,622 — 50,622 — Commercial Paper 42,015 — 42,015 — Corporate Notes/Bonds 38,861 — 38,861 — $ 216,874 $ 49,882 $ 166,992 $ — |
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, lease liabilities, short term, to approximate their fair value because of their relatively short maturities at December 31, 2020 and December 31, 2019. 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 5). 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 from chargebacks, prompt pay discounts, and distribution fees. 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, 2020. 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 and as of December 31, 2020, our credit loss reserve on receivables was not material. |
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 year ended December 31, 2020, all of the Company’s accounts receivable, net arose from product sales in the U.S. and all customers have standard payment terms which generally require payment within 60 days. For the year ended December 31, 2020, 96% of sales were generated from three major industry wholesalers, respectively. Three individual customers accounted for approximately 39%, 29%, and 28% of product sales for the year ended December 31, 2020. As of December 31, 2020, the Company believes that such 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 incurred in 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 |
Revenue Recognition | Revenue Recognition Effective January 1, 2018, the Company adopted FASB ASC Topic 606, Revenue from Contracts with Customers 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 U.S., 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 estimates that take into consideration a range of possible outcomes which are either considered more likely or probability-weighted 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, forecasted customer buying and payment patterns. The Company’s estimates regarding the payer mix for CAPLYTA and historical industry information regarding the payer mix for comparable pharmaceutical products and product portfolios, in particular, historical information related to similar products in their initial launch stages. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts after considering whether revenue should be constrained under ASC 606. 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 a material reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2020 and, therefore, the transaction price was not reduced further during the year ended December 31, 2020. 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 number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability 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. |
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% on sales of licensed products. The related royalties are recorded within cost of product sales on the statement of operations. Prior to the |
Research and Development, including Clinical trial expenses | Research and Development, Including Clinical Trial Expenses Except for payments made in advance of services, the Company expenses its research and development costs as incurred. For payments made in advance, the Company recognizes research and development expense as the services are rendered. 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 preclinical 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. For the year ended December 31, 2020, the company $5.3 million related to the prior year estimates of accrued expenses for clinical trials that resulted in a reduction of research and development expenses. |
Advertising Expense | Advertising Expense In connection with the FDA approval of CAPLYTA in 2019, the Company began to incur advertising costs in connection with the subsequent commercial launch of CAPLYTA in 2020. Advertising costs are expensed when services are rendered. The Company incurred $36.3 million in advertising costs during the year ended December 31, 2020, and $0 in advertising costs during the years ended December 31, 2019, and 2018, 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 (previously included in FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No. 109 more-likely-than-not The Company’s effective tax rate for the years ended December 31, 2020 and 2019 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. The Company reviewed the provisions and there was not a material tax impact on its financial statements for the year ended December 31, 2020. The Company did reclassify its deferred tax asset related to the AMT tax credit carryforward of $265,000 to a current tax receivable in the first quarter of 2020 upon the filing of its tax return for year ended December 31, 2019 and received the refund in July 2020. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (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, 2020, 2019 and 2018 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. Expected volatility rates for quarterly periods prior to December 31, 2019 were based on a combination of the historical volatility of the common stock of comparable publicly traded entities and the limited historical information about the Company’s common stock. In the fourth quarter of 2019 and for all periods thereafter, expected volatility rates are based entirely on the historical volatility of the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. A restricted stock unit (“RSU”) is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the fair market value of the Company’s common stock on the date of grant. The Company has granted RSUs that vest in three equal annual installments provided that the employee remains employed with the Company. In the first quarter of each fiscal year beginning in 2016, the Company granted time based RSUs that vest in three In the first quarter of 2020, the Company granted performance-based RSUs for approximately 86,000 shares of common stock, which vest based on the achievement of certain milestones that include (i) the approval of a planned NDA by the FDA and (ii) the achievement of certain comparative shareholder returns against the Company’s peers (the “2020 TSR RSUs”). The 2020 TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSUs based on the agreements. 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 June 2018, the Company’s stockholders approved the Company’s 2018 Equity Incentive Plan (the “2018 Plan”) pursuant to which 4,750,000 additional shares of common stock were reserved for future equity grants. In May 2020, the Company’s stockholders approved the Company’s 2018 Amended and Restated Equity Incentive Plan (the “Amended 2018 Plan”) pursuant to which additional shares of common stock were reserved for future equity grants. In December 2019, the Company adopted the Intra-Cellular Therapies, Inc. 2019 Inducement Award Plan (the “2019 Inducement Plan”) without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Pursuant to the 2019 Inducement Plan, the Company may grant stock options, RSUs, stock awards and other share-based awards for up to a total of 1,000,000 shares of common stock to new employees of the Company. As of December 31, 2020, stock options and RSUs for 314,138 shares have been granted under the 2019 Inducement Plan. The Company does not intend to make additional grants under the 2019 Inducement Plan. |
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. 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, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Stock options 5,517,622 6,039,945 4,748,391 RSUs 1,600,083 1,268,679 647,411 TSR RSUs 36,339 67,080 206,484 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In June 2016, the FASB issued ASU No. 2016-13, 2016-13”). available-for-sale held-to-maturity |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): December 31, 2020 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 259,304 $ 3 $ (31 ) $ 259,276 Certificates of Deposit 10,500 — — 10,500 Commercial Paper 124,368 23 (21 ) 124,370 Corporate Notes/Bonds 202,749 624 (117 ) 203,256 $ 596,921 $ 650 $ (169 ) $ 597,402 December 31, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 35,462 $ 35 $ (3 ) $ 35,494 Certificates of Deposit 3,000 — — 3,000 Commercial Paper 39,013 10 (5 ) 39,018 Corporate Notes/Bonds 38,770 91 — 38,861 $ 116,245 $ 136 $ (8 ) $ 116,373 |
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, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 27,917 $ 27,917 $ — $ — U.S. Government Agency Securities 259,276 — 259,276 — Certificates of Deposit 10,500 — 10,500 — Commercial Paper 124,370 — 124,370 — Corporate Notes/Bonds 203,256 — 203,256 — $ 625,319 $ 27,917 $ 597,402 $ — Fair Value Measurements at Reporting Date Using December 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 49,882 $ 49,882 $ — $ — U.S. Government Agency Securities 35,494 — 35,494 — Certificates of Deposit 50,622 — 50,622 — Commercial Paper 42,015 — 42,015 — Corporate Notes/Bonds 38,861 — 38,861 — $ 216,874 $ 49,882 $ 166,992 $ — |
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, 2020, 2019 and 2018: Year Ended December 31, 2020 2019 2018 Stock options 5,517,622 6,039,945 4,748,391 RSUs 1,600,083 1,268,679 647,411 TSR RSUs 36,339 67,080 206,484 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consists of the following: December 31, 2020 Raw materials $ 2,483,801 Work in process 1,781,101 Finished goods 2,791,483 $ 7,056,385 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: December 31, 2020 December 31, 2019 Computer equipment $ 243,532 $ 243,532 Furniture and fixtures 423,097 423,097 Scientific equipment 4,127,951 3,861,227 Leasehold improvements 1,240,315 1,240,315 6,034,895 5,768,171 Less accumulated depreciation (4,036,549 ) (3,508,431 ) $ 1,998,346 $ 2,259,740 |
Right Of Use Assets and Lease_2
Right Of Use Assets and Lease Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Schedule Of Maturity Analysis Under Lease Agreements | Maturity analysis under the lease agreements are as follows: Year ending December 31, 2021 $ 3,448,323 Year ending December 31, 2022 3,491,166 Year ending December 31, 2023 3,566,466 Year ending December 31, 2024 3,675,196 Year ending December 31, 2025 3,787,248 Thereafter 13,839,791 Total 31,808,190 Less: Present value discount (9,961,556 ) Total Lease liability 21,846,634 Less: Current portion (3,284,540 ) Long-term lease liabilities $ 18,562,094 |
Vehicle Fleet Lease [Member] | |
Schedule Of Maturity Analysis Under Lease Agreements | The following table presents the maturity of the Company’s fleet lease liability as of December 31, 2020: Year ending December 31, 2021 $ 2,363,058 Year ending December 31, 2022 3,458,449 Year ending December 31, 2023 1,640,337 Year ending December 31, 2024 — Thereafter — Total 7,461,844 Less: Present value discount (166,329 ) Total operating lease liabilities 7,295,515 Less: Current portion (2,257,262 ) Long-term lease liabilities $ 5,038,253 |
Schedule Of Quantitative Information About Operating Leases | The following table presents the Vehicle Lease balances within the consolidated balance sheet, weighted average remaining fleet lease term, and the weighted average discount rates related to the Vehicle Lease as of December 31, 2020: Lease Assets and Liabilities – Fleet Classification December 31, 2020 Assets Right of use assets, net Operating lease right of use assets $ 7,295,515 $ 7,295,515 Liabilities Current Lease liabilities, short-term Operating lease liabilities $ 2,257,262 Non-Current Lease liabilities Non-current operating lease liabilities 5,038,253 Total lease liabilities $ 7,295,515 Weighted average remaining lease term 2.0 years Weighted average discount rate 1.74 % |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Total Stock-Based Compensation Expense | Total share Years Ended December 31, 2020 2019 2018 Inventoriable costs $ 1,342,262 — — Research and development 7,072,545 $ 9,411,056 $ 7,380,814 Selling, general and administrative 15,700,390 11,377,632 10,015,332 Total share-based compensation expense $ 24,115,197 $ 20,788,688 $ 17,396,146 |
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, 2020, 2019 and 2018: 2020 2019 2018 Dividend yield 0 % 0 % 0 % Expected volatility 91.6%-95.5 % 85.7-96.5 % 85.2%-85.8 % Weighted-average risk-free interest rate 1.29 % 2.32 % 2.48 % Expected term (in years) 6.0 6.0 6.0 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2020, and changes during the year then ended, are summarized as follows: Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Life Outstanding at December 31, 2019 6,039,945 $ 16.81 7.0 years Options granted in 2020 760,472 $ 24.03 9.2 years Options exercised in 2020 (999,479 ) $ 12.58 4.8 years Options canceled or expired in 2020 (323,044 ) $ 19.42 7.6 years Outstanding at December 31, 2020 5,477,894 $ 18.43 6.6 years Vested or expected to vest at December 31, 2020 5,477,894 $ 18.43 Exercisable at December 31, 2020 3,441,115 $ 19.19 5.6 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 as of December 31, 2020, and changes during the year then ended, is summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Per Share Weighted- Average Contractual Life Outstanding at December 31, 2019 1,268,679 $ 13.60 1.7 years Time based RSUs granted in 2020 732,992 $ 23.09 2.4 years Time based RSUs vested in 2020 (519,994 ) $ 13.90 0.7 years Time based RSUs cancelled in 2020 (169,800 ) $ 17.23 1.3 years Outstanding at December 31, 2020 1,311,877 $ 18.77 1.7 years |
Milestone and Total Shareholder Return Restricted Stock Units [Member] | |
Summary of Information Regarding RSU Activity | Information related to the Company’s Milestone RSUs and the TSR RSUs during the year ended December 31, 2020 are summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Per Share Weighted- Average Contractual Life Outstanding at December 31, 2019 67,080 $ 17.08 0.2 years Milestone RSUs and TSR RSUs granted in 2020 86,044 $ 28.25 2.1 years Milestone RSUs and TSR RSUs vested in 2020 (67,080 ) $ 17.08 0.2 years Milestone RSUs and TSR RSUs cancelled in 2020 (13,366 ) $ 28.25 2.1 years Outstanding at December 31, 2020 72,678 $ 28.25 2.1 years |
Inducement Award Plan [Member] | |
Stock Option Activity | Information regarding stock option awards under the 2019 Inducement Plan, including with respect to grants to employees as of December 31, 2020, and changes during the period then ended, are summarized as follows: Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Life Outstanding at December 31, 2019 — $ — Options granted in 2020 39,728 $ 17.18 9.2 years Outstanding at December 31, 2020 39,728 $ 17.18 9.2 years Vested or expected to vest at December 31, 2020 39,728 $ 17.18 Exercisable at December 31, 2020 — $ — |
Summary of Information Regarding RSU Activity | Information regarding RSU awards under the 2019 Inducement Plan during the period then ended are summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Per Share Weighted- Average Contractual Life Outstanding at December 31, 2019 — $ — Time based RSUs granted in 2020 274,410 $ 16.01 2.2 years Time based RSUs cancelled in 2020 (22,543 ) $ 15.81 2.2 years Outstanding at December 31, 2020 251,867 $ 16.03 2.2 years Vested or expected to vest at December 31, 2020 251,867 $ 16.03 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Summary of Loss Before Income Taxes | Loss before income taxes is as follows: 2020 2019 2018 U.S. (155,615,614 ) (56,121,258 ) $ (30,299,751 ) Non-U.S. (71,376,536 ) (91,599,320 ) (124,826,060 ) Total loss before taxes (226,992,150 ) (147,720,578 ) $ (155,125,811 ) |
Total Income Tax Expense | Total income tax expense for the years ended December 31, 2020, 2019 and 2018 is allocated as follows: 2020 2019 2018 Current $ 13,513 $ 1,600 $ 1,600 Deferred (40,049,094 ) (8,484,822 ) (5,054,468 ) Valuation allowance 40,049,094 8,484,822 5,054,468 Provision for income taxes $ 13,513 $ 1,600 $ 1,600 |
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, 2020, 2019 and 2018 is as follows: December 31, 2020 2019 2018 Income tax benefit at statutory federal rate 21.00 % 21.00 % 21.00 % Other permanent differences (1.01 ) (0.67 ) (0.58 ) Foreign rate differential (6.60 ) (13.02 ) (16.90 ) Change in effective state tax rates 1.12 (0.16 ) (0.38 ) State income tax expense 3.14 (1.40 ) 0.12 Change in valuation allowance (17.65 ) (5.75 ) (3.26 ) Provision for income taxes 0.0 % 0.0 % 0.00 % |
Deferred Tax Assets and Liabilities | The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2020 and 2019, respectively: December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 85,751,154 $ 49,668,232 Accrued employee benefits 1,363,082 589,667 Research and development credit 9,321,214 9,321,214 Stock compensation 15,137,990 12,965,250 Other accruals 850,900 — Federal AMT credit — 264,609 Capital lease 7,461,587 4,973,618 Deferred tax liabilities: Right of use asset—capital lease (6,228,138 ) (3,922,583 ) Unrealized gains on investment (123,049 ) (27,577 ) Depreciation (244,058 ) (230,760 ) Net deferred tax asset before valuation allowance 113,290,682 73,601,670 Valuation allowance (113,290,682 ) (73,337,061 ) Net deferred tax asset $ — $ 264,609 |
Summary of Gross Unrecognized Tax Benefits | The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2020 and 2019, respectively: December 31, 2020 2019 Balance at January 1, $ 1,738,815 $ 1,738,815 Current Year Uncertain Tax Positions: Gross Change — — Balance at December 31, $ 1,738,815 $ 1,738,815 |
Unaudited Quarterly Financial_2
Unaudited Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 2020 quarters ended: 2020 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net $ 12,454,270 $ 7,368,594 $ 1,906,636 $ 1,083,479 Operating expenses (73,787,606 ) (63,305,048 ) (66,778,953 ) (50,169,003 ) Interest income 644,390 752,829 1,160,059 1,678,203 Income tax expense (13,513 ) — — (3,281 ) Net loss (60,699,178 ) (55,183,625 ) (63,712,258 ) (47,410,602 ) Basic and diluted net loss per share $ (0.76 ) $ (0.79 ) $ (0.96 ) $ (0.73 ) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2019 quarters ended: 2019 Quarter Ended December 31, September 30, June 30, March 31, Revenue, net 60,613 — — — Operating expenses (41,829,272 ) (36,376,236 ) (39,171,114 ) (36,695,841 ) Interest income 1,185,808 1,513,837 1,731,550 1,860,077 Income tax expense — — (1,600 ) — Net loss (40,582,851 ) (34,862,399 ) (37,441,164 ) (34,835,764 ) Basic and diluted net loss per share $ (0.73 ) $ (0.63 ) $ (0.68 ) $ (0.63 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) | Sep. 15, 2020 | Jan. 10, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Sep. 12, 2019 |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||
Initial public offering, Number of shares | 10,000,000 | ||||
Initial public offering, Price per share | $ 29.50 | ||||
Initial public offering, Gross proceeds | $ 295,000,000 | ||||
Initial public offering, Net proceeds | $ 277,000,000 | ||||
Proceeds from Issuance of Common Stock | $ 652,712,011 | ||||
Common stock, shares issued | 80,463,089 | 55,507,497 | |||
Common Stock [Member] | |||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||
Initial public offering, Number of shares | 23,409,458 | ||||
Proceeds from Issuance of Common Stock | $ 17,900,000 | ||||
Common stock, shares issued | 742,791 | ||||
IPO [Member] | |||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||
Initial public offering, Number of shares | 12,666,667 | ||||
Initial public offering, Price per share | $ 30 | ||||
Initial public offering, Gross proceeds | $ 380,000,000 | ||||
Initial public offering, Net proceeds | $ 357,800,000 | ||||
Maximum [Member] | |||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||
Universal shelf registration statement, effective date value | $ 350,000,000 | ||||
Maximum [Member] | Common Stock [Member] | |||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||
Universal shelf registration statement, effective date value | $ 75,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | Mar. 31, 2020shares | Mar. 31, 2017 | Dec. 31, 2020USD ($)CustomersSegmentshares | Dec. 31, 2019USD ($)shares | Dec. 31, 2018USD ($) | May 31, 2020shares | Mar. 27, 2020USD ($) | Jun. 30, 2018shares |
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 | |||||||
Investment securities, available-for-sale | $ 597,402,126 | $ 116,373,335 | ||||||
Aggregate related fair value of investments with unrealized losses | 372,300,000 | 29,600,000 | ||||||
Investment securities aggregate amount of unrealized loss | 169,000 | 8,000 | ||||||
Investment securities, held in continuous unrealized loss position for less than 12 months | 17,100,000 | |||||||
Investment securities, held in continuous unrealized loss position for 12 months or longer | 12,500,000 | |||||||
Carrying value of cash held in money market funds | 27,900,000 | $ 49,900,000 | ||||||
Impairment losses recognized | $ 0 | |||||||
Effective tax rate | 0.00% | 0.00% | 0.00% | |||||
Annual effective tax rate | 0.00% | |||||||
US statutory rate | 21.00% | 21.00% | 21.00% | |||||
Assumed expected dividend rate | 0.00% | 0.00% | 0.00% | |||||
Manufacturing Costs | $ 0 | |||||||
Inventory Costs | 0 | |||||||
Amt Tax Credit [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Deferred Tax Assets, Gross | $ 265,000 | |||||||
CAPLYTA [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Advertising costs | $ 36,300,000 | 0 | $ 0 | |||||
Accounts Receivable [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration Risk, Percentage | 96.00% | |||||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Number Of Customers | Customers | 3 | |||||||
Customer one [Member] | Accounts Receivable [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration Risk, Percentage | 39.00% | |||||||
Customer two [Member] | Accounts Receivable [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration Risk, Percentage | 29.00% | |||||||
Customer three [Member] | Accounts Receivable [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Concentration Risk, Percentage | 28.00% | |||||||
Clinical Tral [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Reveral of accrued expenses | 5,300,000 | |||||||
Cash and Cash Equivalents [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Carrying value of cash held in certificates of deposit | $ 0 | 47,600,000 | ||||||
Carrying value of cash held in commercial papers | 3,000,000 | |||||||
Significant Unobservable Inputs (Level 3) [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Assets measured using quoted prices | 0 | 0 | ||||||
Liabilities measured using quoted prices | 0 | 0 | ||||||
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Investment securities, available-for-sale | 188,500,000 | $ 3,000,000 | ||||||
U.S. Government Agency Securities [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Aggregate related fair value of investments with unrealized losses | 180,000,000 | |||||||
Investment securities aggregate amount of unrealized loss | 31,000 | |||||||
Commercial Paper [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Aggregate related fair value of investments with unrealized losses | 84,400,000 | |||||||
Investment securities aggregate amount of unrealized loss | 21,000 | |||||||
Corporate Notes/Bonds [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Aggregate related fair value of investments with unrealized losses | 107,800,000 | |||||||
Investment securities aggregate amount of unrealized loss | $ 117,000 | |||||||
2018 Equity Incentive Plan [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Additional shares of common stock reserved for future equity grants | shares | 6,500,000 | 4,750,000 | ||||||
RSUs [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Service period for granted RSUs, vest in annual installment | 3 years | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | shares | 732,992 | |||||||
Inducement Award Plan [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Issuance of shares, Inducement Award Plan | shares | 1,000,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | shares | 274,410 | |||||||
Performance Based Restricted Stock Units [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | shares | 86,000 | |||||||
ITCI Inducement Award Plan [Member] | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period | shares | 314,138 | |||||||
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 | 5.00% | |||||||
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 | 9.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 596,921,000 | $ 116,245,000 |
Unrealized Gains | 650,000 | 136,000 |
Unrealized (Losses) | (169,000) | (8,000) |
Estimated Fair Value | 597,402,126 | 116,373,335 |
U.S. Government Agency Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 259,304,000 | 35,462,000 |
Unrealized Gains | 3,000 | 35,000 |
Unrealized (Losses) | (31,000) | (3,000) |
Estimated Fair Value | 259,276,000 | 35,494,000 |
Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 10,500,000 | 3,000,000 |
Estimated Fair Value | 10,500,000 | 3,000,000 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 124,368,000 | 39,013,000 |
Unrealized Gains | 23,000 | 10,000 |
Unrealized (Losses) | (21,000) | (5,000) |
Estimated Fair Value | 124,370,000 | 39,018,000 |
Corporate Notes/Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 202,749,000 | 38,770,000 |
Unrealized Gains | 624,000 | 91,000 |
Unrealized (Losses) | (117,000) | |
Estimated Fair Value | $ 203,256,000 | $ 38,861,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 625,319 | $ 216,874 |
Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 27,917 | 49,882 |
U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 259,276 | 35,494 |
Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 10,500 | 50,622 |
Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 124,370 | 42,015 |
Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 203,256 | 38,861 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 27,917 | 49,882 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 27,917 | 49,882 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 597,402 | 166,992 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 259,276 | 35,494 |
Significant Other Observable Inputs (Level 2) [Member] | Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 10,500 | 50,622 |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 124,370 | 42,015 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 203,256 | $ 38,861 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
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 | 5,517,622 | 6,039,945 | 4,748,391 |
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 | 1,600,083 | 1,268,679 | 647,411 |
Total Shareholder Return Restricted Stock Units [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Number of anti-dilutive securities excluded from computation of earnings per share | 36,339 | 67,080 | 206,484 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Detail) | Dec. 31, 2020USD ($) |
Inventory Disclosure [Abstract] | |
Raw materials | $ 2,483,801 |
Work in process | 1,781,101 |
Finished goods | 2,791,483 |
Total inventories | $ 7,056,385 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 6,034,895 | $ 5,768,171 |
Less accumulated depreciation | (4,036,549) | (3,508,431) |
Property Plant and Equipment Net | 1,998,346 | 2,259,740 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 243,532 | 243,532 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 423,097 | 423,097 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 4,127,951 | 3,861,227 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 1,240,315 | $ 1,240,315 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation | $ 528,118 | $ 477,121 | $ 368,673 |
Right Of Use Assets and Lease_3
Right Of Use Assets and Lease Liabilities - Additional Information (Detail) - USD ($) | 12 Months Ended | |||||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Feb. 28, 2019 | Jan. 01, 2019 | Sep. 30, 2018 | |
Right of use assets, net | $ 24,324,762 | $ 18,252,074 | ||||
Net lease liabilities | 29,100,000 | |||||
Operating lease expense | 3,300,000 | 3,300,000 | $ 1,800,000 | |||
Right of use assets obtained in exchange for operating lease liability | 200,000 | |||||
Operating lease cash outflows | 3.3 | |||||
Operating Lease, Cost | $ 1,183,072,000,000 | |||||
Vehicle Fleet Lease [Member] | ||||||
Operating lease discount rate | 1.74% | |||||
Right of use assets, net | $ 7,295,515 | 0 | ||||
Net lease liabilities | $ 7,295,515 | $ 0 | ||||
Term of long term lease | 12 months | |||||
Weighted average remaining lease term | 2 years | |||||
Operating lease cash outflows | $ 1,183,072,000,000 | |||||
Restricted Cash | $ 1,400,000 | |||||
Percentage Of Minimum Net Proceeds Of Capitalized Costs In First Twelve Months | 20.00% | |||||
Percentage Of Minimum Net Proceeds Of Capitalized Costs Later Than Twelve Months | 30.00% | |||||
Vehicle Fleet Lease [Member] | Financial Standby Letter of Credit [Member] | ||||||
Guarantee Obligations | $ 1,400,000 | |||||
Real Estates Lease [Member] | ||||||
Right of use assets, net | 17,000,000 | |||||
Net lease liabilities | $ 21,846,634 | |||||
Accounting Standards Update 2016-02 [Member] | ||||||
Right of use assets, net | $ 20,200,000 | |||||
Net lease liabilities | 23,400,000 | |||||
Eliminated deferred rent | $ 3,200,000 | |||||
NEW YORK | ||||||
Term of long term lease | 14 years 3 months 18 days | |||||
NEW YORK | Accounting Standards Update 2016-02 [Member] | ||||||
Operating lease discount rate | 7.20% | |||||
Weighted average remaining lease term | 3 years 2 months 12 days | |||||
MARYLAND | ||||||
Term of long term lease | 3 years 2 months 12 days | |||||
MARYLAND | Accounting Standards Update 2016-02 [Member] | ||||||
Operating lease discount rate | 9.10% | |||||
Weighted average remaining lease term | 14 years 3 months 18 days |
Right Of Use Assets and Lease_4
Right Of Use Assets and Lease Liabilities - Maturity analysis under the lease agreements (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Total Lease liability | $ 29,100,000 | |
Less: Current portion | (5,541,802) | $ (3,187,435) |
Long-term lease liabilities | 23,600,347 | $ 19,955,186 |
Real Estates Lease [Member] | ||
Year ending December 31, 2021 | 3,448,323 | |
Year ending December 31, 2022 | 3,491,166 | |
Year ending December 31, 2023 | 3,566,466 | |
Year ending December 31, 2024 | 3,675,196 | |
Year ending December 31, 2025 | 3,787,248 | |
Thereafter | 13,839,791 | |
Total | 31,808,190 | |
Less: Present value discount | (9,961,556) | |
Total Lease liability | 21,846,634 | |
Less: Current portion | (3,284,540) | |
Long-term lease liabilities | $ 18,562,094 |
Right Of Use Assets and Lease_5
Right Of Use Assets and Lease Liabilities - Schedule Of Quantitative Information About Operating Leases (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Lessee, Lease, Description [Line Items] | ||
Right of use assets, net | $ 24,324,762 | $ 18,252,074 |
Lease liabilities, short-term | 5,541,802 | 3,187,435 |
Lease liabilities | 23,600,347 | 19,955,186 |
Total Lease liability | 29,100,000 | |
Vehicle Fleet Lease [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Right of use assets, net | 7,295,515 | 0 |
Lease liabilities, short-term | 2,257,262 | |
Lease liabilities | 5,038,253 | |
Total Lease liability | $ 7,295,515 | $ 0 |
Weighted average remaining lease term | 2 years | |
Weighted average discount rate | 1.74% |
Right Of Use Assets and Lease_6
Right Of Use Assets and Lease Liabilities - Maturity analysis of the Company's fleet lease liability (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Lessee, Lease, Description [Line Items] | ||
Total operating lease liabilities | $ 29,100,000 | |
Less: Current portion | (5,541,802) | $ (3,187,435) |
Long-term lease liabilities | 23,600,347 | 19,955,186 |
Vehicle Fleet Lease [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Year ending December 31, 2021 | 2,363,058 | |
Year ending December 31, 2022 | 3,458,449 | |
Year ending December 31, 2023 | 1,640,337 | |
Year ending December 31, 2024 | 0 | |
Thereafter | 0 | |
Total | 7,461,844 | |
Less: Present value discount | (166,329) | |
Total operating lease liabilities | 7,295,515 | $ 0 |
Less: Current portion | (2,257,262) | |
Long-term lease liabilities | $ 5,038,253 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2017 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 17,787,390 | |||
Weighted average grant date fair value of stock options granted | $ 17.98 | $ 9.17 | $ 15.22 | |
Total intrinsic value of the options exercised | $ 11,099,951 | $ 3,127,412 | $ 1,683,679 | |
Total fair value of shares vested | 13,366,276 | $ 11,983,108 | $ 11,348,595 | |
Unrecognized share-based compensation expense related to employee stock option awards | $ 16,083,760 | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% | |
Risk free interest rate | 1.29% | 2.32% | 2.48% | |
Total instrinsic value of stock units outstanding options | $ 81,234,131 | |||
Total instrinsic value of stock units exercisable | $ 51,341,624 | |||
2018 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 7,459,117 | |||
Additional Stock- based awards, grant | 6,500,000 | |||
Time Based Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested RSUs | $ 14,600,601 | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 9 months 18 days | |||
RSUs [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total instrinsic value of stock units vested,other than options | $ 14,553,421 | $ 3,109,328 | $ 1,165,323 | |
Total instrinsic value of stock units outstanding other than options | 40,816,730 | |||
Total fair value of time based vested | 7,230,027 | 4,623,030 | 2,109,705 | |
Milestone Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested RSUs | $ 1,658,764 | 0 | ||
Unrecognized share-based compensation expense, weighted-average recognition period | 2 years 1 month 6 days | |||
Non-cash stock-based compensation expense recognized | $ 0 | 900,000 | 500,000 | |
Total fair value of time based vested | $ 0 | $ 921,972 | $ 1,062,212 | |
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, maximum term | 10 years | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 8 months 12 days | |||
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] | ||||
Issuance of shares, Inducement Award Plan | 1,000,000 | |||
Awards granted | 314,138 | |||
Weighted average grant date fair value of stock options granted | $ 12.84 | $ 0 | $ 0 | |
Total intrinsic value of the options exercised | $ 0 | $ 0 | $ 0 | |
Total fair value of shares vested | 0 | 0 | 0 | |
Unrecognized compensation costs related to unvested RSUs | $ 2,859,070 | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 2 years 2 months 12 days | |||
Unrecognized share-based compensation expense related to employee stock option awards | $ 377,146 | |||
Total instrinsic value of stock units outstanding options | 580,877 | |||
Total instrinsic value of stock units exercisable | 0 | |||
Total instrinsic value of stock units vested,other than options | 0 | 0 | 0 | |
Total instrinsic value of stock units outstanding other than options | 8,009,370 | |||
Total fair value of time based vested | $ 0 | 0 | 0 | |
Total Shareholder Return Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 3 years | 3 years | ||
Weighted average grant date fair value of stock options granted | $ 17.08 | $ 32.56 | ||
Unrecognized compensation costs related to unvested RSUs | $ 1,658,764 | $ 0 | ||
Unrecognized share-based compensation expense, weighted-average recognition period | 2 years 1 month 6 days | |||
Expected dividend yield | 0.00% | 0.00% | ||
Risk free interest rate | 1.60% | 1.40% | ||
Expected volatility | 95.40% | 91.30% | ||
Terms of award | Total shareholder return will be determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2023 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2020, with a deemed reinvestment of any dividends declared during the performance period. | Total shareholder return was determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2020 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2017, with a deemed reinvestment of any dividends declared during the performance period. | ||
Milestone And Total Shareholder Return Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total instrinsic value of stock units vested,other than options | $ 1,583,759 | $ 2,233,958 | 781,434 | |
Total instrinsic value of stock units outstanding other than options | 2,311,160 | |||
Total fair value of time based vested | $ 1,145,732 | $ 921,972 | $ 971,475 |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 24,115,197 | $ 20,788,688 | $ 17,396,146 |
Inventoriable Costs [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 1,342,262 | ||
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 7,072,545 | 9,411,056 | 7,380,814 |
Selling, General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 15,700,390 | $ 11,377,632 | $ 10,015,332 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 91.60% | 85.70% | 85.20% |
Expected volatility, maximum | 95.50% | 96.50% | 85.80% |
Weighted-average risk-free interest rate | 1.29% | 2.32% | 2.48% |
Expected term (in years) | 6 years | 6 years | 6 years |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity of Inducement Plan (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding at beginning of period, Number of Shares | 6,039,945 | |
Options granted, Number of Shares | 760,472 | |
Outstanding at end of period, Number of Shares | 5,477,894 | 6,039,945 |
Vested or expected to vest at end of period, Number of Shares | 5,477,894 | |
Exercisable at end of period, Number of Shares | 3,441,115 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 16.81 | |
Options granted, exercise price | 24.03 | |
Outstanding at end of period, Weighted-Average Exercise Price | 18.43 | $ 16.81 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 18.43 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 19.19 | |
Options granted, Weighted-Average Contractual Life | 9 years 2 months 12 days | |
Outstanding at end of period, Weighted-Average Contractual Life | 6 years 7 months 6 days | 7 years |
Inducement Award Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding at beginning of period, Number of Shares | 0 | |
Options granted, Number of Shares | 39,728 | |
Outstanding at end of period, Number of Shares | 39,728 | 0 |
Vested or expected to vest at end of period, Number of Shares | 39,728 | |
Exercisable at end of period, Number of Shares | 0 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 0 | |
Options granted, exercise price | 17.18 | |
Outstanding at end of period, Weighted-Average Exercise Price | 17.18 | $ 0 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 17.18 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 0 | |
Options granted, Weighted-Average Contractual Life | 9 years 2 months 12 days | |
Outstanding at end of period, Weighted-Average Contractual Life | 9 years 2 months 12 days |
Share-Based Compensation- Summa
Share-Based Compensation- Summary of Information Regarding the Time Based RSU Activity and Changes Under the Inducement Plan (Detail) - Inducement Award Plan [Member] - $ / shares | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of year, Number of Shares | 0 |
Time based RSU's granted, Number of Shares | 274,410 |
Time based RSU's cancelled, Number of Shares | (22,543) |
Outstanding at end of year, Number of Shares | 251,867 |
Vested or expected to vest, Number of Shares | 251,867 |
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value | $ 0 |
Time based RSU's granted, Weighted-Average Grant Date Fair Value | 16.01 |
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value | 15.81 |
Outstanding at end of year, Weighted-Average Grant Date Fair Value | 16.03 |
Vested or expected to vest, Weighted- Average Exercise Price | $ 16.03 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms | 2 years 2 months 12 days |
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Average Remaining Contractual Terms | 2 years 2 months 12 days |
Share Based Compensation By Share Based Payment Arrangement Other Than Options Weighted Average Contractual Term Of Instruments Forefeited | 2 years 2 months 12 days |
Share-Based Compensation - St_2
Share-Based Compensation - Stock Options Activity (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 6,039,945 | |
Options granted, Number of Shares | 760,472 | |
Options exercised, Number of Shares | (999,479) | |
Options canceled or expired, Number of Shares | (323,044) | |
Outstanding at end of period, Number of Shares | 5,477,894 | 6,039,945 |
Vested or expected to vest at end of period, Number of Shares | 5,477,894 | |
Exercisable at end of period, Number of Shares | 3,441,115 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 16.81 | |
Options granted, Weighted-Average Exercise Price | 24.03 | |
Options exercised, Weighted-Average Exercise Price | 12.58 | |
Options canceled or expired, Weighted-Average Exercise Price | 19.42 | |
Outstanding at end of period, Weighted-Average Exercise Price | 18.43 | $ 16.81 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 18.43 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 19.19 | |
Options granted, Weighted-Average Contractual Life | 9 years 2 months 12 days | |
Options exercised, Weighted-Average Contractual Life | 4 years 9 months 18 days | |
Options canceled or expired, Weighted-Average Contractual Life | 7 years 7 months 6 days | |
Outstanding at end of period, Weighted-Average Contractual Life | 6 years 7 months 6 days | 7 years |
Exercisable at end of period, Weighted-Average Contractual Life | 5 years 7 months 6 days |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs [Member] - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding at beginning of year, Number of Shares | 1,268,679 | ||
Time based RSU's granted, Number of Shares | 732,992 | ||
Time based RSU's vested, Number of Shares | (519,994) | ||
Time based RSU's cancelled, Number of Shares | (169,800) | ||
Outstanding at end of year, Number of Shares | 1,311,877 | 1,268,679 | 1,311,877 |
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value | $ 13.60 | ||
Time based RSU's granted, Weighted-Average Grant Date Fair Value | 23.09 | ||
Time based RSU's vested, Weighted-Average Grant Date Fair Value | 13.90 | ||
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value | 17.23 | ||
Outstanding at end of year, Weighted-Average Grant Date Fair Value | $ 18.77 | $ 13.60 | $ 18.77 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms | 1 year 8 months 12 days | 1 year 8 months 12 days | |
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Average Remaining Contractual Terms | 2 years 4 months 24 days | ||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Vested Remaining Contractual Terms | 8 months 12 days | ||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Forfeited Average Remaining Contractual Terms | 1 year 3 months 18 days |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Information Regarding Milestone RSU grants and TSR RSU grants (Detail) - Milestone and Total Shareholder Return Restricted Stock Units [Member] - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding at beginning of year, Number of Shares | 67,080 | ||
Milestone RSUs and TSR RSUs granted, Number of Shares | 86,044 | ||
Time based RSU's vested, Number of Shares | (67,080) | ||
Milestone RSUs and TSR RSU's cancelled, Number of Shares | (13,366) | ||
Outstanding at end of year, Number of Shares | 72,678 | 67,080 | 72,678 |
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value | $ 17.08 | ||
Milestone RSUs and TSR RSUs granted, Weighted- Average Grant Date Fair Value | 28.25 | ||
Time based RSU's vested, Weighted-Average Grant Date Fair Value | 17.08 | ||
Milestone RSUs and TSR RSU's cancelled, Weighted-Average Grant Date Fair Value | 28.25 | ||
Outstanding at end of year, Weighted-Average Grant Date Fair Value | $ 28.25 | $ 17.08 | $ 28.25 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms | 2 years 1 month 6 days | 2 months 12 days | |
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Average Remaining Contractual Terms | 2 years 1 month 6 days | ||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Vested Remaining Contractual Terms | 2 months 12 days | ||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Forfeited Average Remaining Contractual Terms | 2 years 1 month 6 days |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2020 | Dec. 31, 2017 | Jul. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Recognized tax benefit | $ 1,100,000 | ||||
Federal net operating loss carryforwards | $ 323,000,000 | ||||
Federal net operating loss carryforwards expiration year | 2037 | ||||
Federal AMT credit | $ 265,000 | $ 264,609 | |||
Unrecognized tax benefits | $ 1,738,815 | $ 1,738,815 | $ 1,738,815 | ||
Indefinite Period Carry Forward [Member] | |||||
Federal net operating loss carryforwards | 191,900,000 | ||||
Expire In 2037 [Member] | |||||
Federal net operating loss carryforwards | $ 131,100,000 |
Income Taxes - Loss before Inco
Income Taxes - Loss before Income Taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (155,615,614) | $ (56,121,258) | $ (30,299,751) |
Non-U.S. | (71,376,536) | (91,599,320) | (124,826,060) |
Loss before provision for income taxes | $ (226,992,150) | $ (147,720,578) | $ (155,125,811) |
Income Taxes - Total Income Tax
Income Taxes - Total Income Tax Expense (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||
Dec. 31, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||||||
Current | $ 13,513 | $ 1,600 | $ 1,600 | |||
Deferred | (40,049,094) | (8,484,822) | (5,054,468) | |||
Valuation allowance | 40,049,094 | 8,484,822 | 5,054,468 | |||
Provision for income taxes | $ (13,513) | $ (3,281) | $ (1,600) | $ 13,513 | $ 1,600 | $ 1,600 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at statutory federal rate | 21.00% | 21.00% | 21.00% |
Other permanent differences | (1.01%) | (0.67%) | (0.58%) |
Foreign rate differential | (6.60%) | (13.02%) | (16.90%) |
Change in effective state tax rates | 1.12% | (0.16%) | (0.38%) |
State income tax expense | 3.14% | (1.40%) | 0.12% |
Change in valuation allowance | (17.65%) | (5.75%) | (3.26%) |
Provision for income taxes | 0.00% | 0.00% | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2020 | Jul. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 85,751,154 | $ 49,668,232 | |
Accrued employee benefits | 1,363,082 | 589,667 | |
Research and development credit | 9,321,214 | 9,321,214 | |
Stock compensation | 15,137,990 | 12,965,250 | |
Other accruals | 850,900 | ||
Federal AMT credit | $ 265,000 | 264,609 | |
Capital lease | 7,461,587 | 4,973,618 | |
Deferred tax liabilities: | |||
Right of use asset—capital lease | (6,228,138) | (3,922,583) | |
Unrealized gains on investment | (123,049) | (27,577) | |
Depreciation | (244,058) | (230,760) | |
Net deferred tax asset | 113,290,682 | 73,601,670 | |
Valuation allowance | (113,290,682) | (73,337,061) | |
Net deferred tax asset | $ 0 | $ 264,609 |
Income Taxes - Summary of Gross
Income Taxes - Summary of Gross Unrecognized Tax Benefits (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns [Abstract] | ||
Balance at January 1, | $ 1,738,815 | $ 1,738,815 |
Current Year Uncertain Tax Positions: | ||
Gross Change | 0 | 0 |
Balance at December 31, | $ 1,738,815 | $ 1,738,815 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | Dec. 23, 2019 | May 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 31, 2019 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Employer matching contribution | 100.00% | 100.00% | 100.00% | |||||
Contributions made by participants for which the company makes matching contribution | 6.00% | 6.00% | 6.00% | |||||
Contribution expense | $ 1,771,380 | $ 658,179 | $ 429,318 | |||||
Purchase Commitment [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Commitments | 16,400,000 | |||||||
Cash paid | 3,000,000 | |||||||
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 | $ 1,126,538 | |||||||
Product [Member] | Bristol-Myers Squibb Company [Member] | Minimum [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Royalty payment, percentage | 5.00% | |||||||
Product [Member] | Bristol-Myers Squibb Company [Member] | Maximum [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Royalty payment, percentage | 9.00% | |||||||
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 [Member] | ||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||||||
Payment of milestone amount | $ 5,000,000 |
Related Party - Additional Info
Related Party - Additional Information (Detail) | Sep. 28, 2018 |
Amendment [Member] | |
Related Party Transaction [Line Items] | |
Term of long term lease | 14 years 3 months 18 days |
Unaudited Quarterly Financial_3
Unaudited Quarterly Financial Information - Schedule of Quarterly Financial Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue, net | $ 12,454,270 | $ 7,368,594 | $ 1,906,636 | $ 1,083,479 | $ 60,613 | ||||||
Operating expenses | (73,787,606) | (63,305,048) | (66,778,953) | (50,169,003) | (41,829,272) | $ (36,376,236) | $ (39,171,114) | $ (36,695,841) | $ (254,040,610) | $ (154,072,463) | $ (162,266,768) |
Interest income | 644,390 | 752,829 | 1,160,059 | 1,678,203 | 1,185,808 | 1,513,837 | 1,731,550 | 1,860,077 | 4,235,481 | 6,291,272 | 7,140,957 |
Income tax expense | (13,513) | (3,281) | (1,600) | 13,513 | 1,600 | 1,600 | |||||
Net loss | $ (60,699,178) | $ (55,183,625) | $ (63,712,258) | $ (47,410,602) | $ (40,582,851) | $ (34,862,399) | $ (37,441,164) | $ (34,835,764) | $ (227,005,663) | $ (147,722,178) | $ (155,127,411) |
Basic and diluted net loss per share | $ (0.76) | $ (0.79) | $ (0.96) | $ (0.73) | $ (0.73) | $ (0.63) | $ (0.68) | $ (0.63) | $ (3.23) | $ (2.68) | $ (2.84) |