Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 28, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Amendment Flag | false | ||
Document Type | 10-K | ||
Document Fiscal Year Focus | 2019 | ||
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, 2019 | ||
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 | 66,133,183 | ||
Entity Public Float | $ 613.7 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 107,636,849 | $ 54,947,502 |
Investment securities, available-for-sale | 116,373,335 | 292,583,046 |
Prepaid expenses and other current assets | 6,313,785 | 7,908,133 |
Total current assets | 230,323,969 | 355,438,681 |
Property and equipment, net | 2,259,740 | 1,159,766 |
Right of use assets, net | 18,252,074 | |
Deferred tax asset, net | 264,609 | 529,218 |
Other assets | 86,084 | 78,833 |
Total assets | 251,186,476 | 357,206,498 |
Current liabilities: | ||
Accounts payable | 7,425,024 | 13,961,060 |
Accrued and other current liabilities | 16,138,909 | 20,044,866 |
Lease liabilities, short-term | 3,187,435 | |
Accrued employee benefits | 9,472,651 | 2,293,259 |
Total current liabilities | 36,224,019 | 36,299,185 |
Deferred rent | 3,192,432 | |
Lease liabilities | 19,955,186 | |
Total liabilities | 56,179,205 | 39,491,617 |
Stockholders' equity: | ||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 55,507,497 and 54,895,295 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 5,551 | 5,490 |
Additional paid-in capital | 904,971,772 | 880,753,339 |
Accumulated deficit | (710,098,369) | (562,376,191) |
Accumulated comprehensive gain/(loss) | 128,317 | (667,757) |
Total stockholders' equity | 195,007,271 | 317,714,881 |
Total liabilities and stockholders' equity | $ 251,186,476 | $ 357,206,498 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 55,507,497 | 54,895,295 |
Common stock, shares outstanding | 55,507,497 | 54,895,295 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Statement [Abstract] | |||
Grant revenue | $ 60,613 | $ 245,837 | |
Costs and expenses: | |||
Research and development | 89,124,838 | $ 132,166,913 | 79,419,009 |
General and administrative | 64,947,625 | 30,099,855 | 23,666,957 |
Total costs and expenses | 154,072,463 | 162,266,768 | 103,085,966 |
Loss from operations | (154,011,850) | (162,266,768) | (102,840,129) |
Interest income | (6,291,272) | (7,140,957) | (4,005,864) |
Loss before provision (benefit) for income taxes | (147,720,578) | (155,125,811) | (98,834,265) |
Income tax expense (benefit) | 1,600 | 1,600 | (1,060,851) |
Net loss | $ (147,722,178) | $ (155,127,411) | $ (97,773,414) |
Net loss per common share: | |||
Basic & Diluted | $ (2.68) | $ (2.84) | $ (2.12) |
Weighted average number of common shares: | |||
Basic & Diluted | 55,186,206 | 54,707,865 | 46,181,926 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (147,722,178) | $ (155,127,411) | $ (97,773,414) |
Other comprehensive income (loss): | |||
Unrealized gain (loss) on investment securities | 796,074 | 131,467 | (481,985) |
Comprehensive loss | $ (146,926,104) | $ (154,995,944) | $ (98,255,399) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Total | October 2017 [Member] | Common Stock [Member] | Common Stock [Member]October 2017 [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]October 2017 [Member] | Accumulated Deficit [Member] | Accumulated Comprehensive Gain (Loss) [Member] |
Balance at Dec. 31, 2016 | $ 375,502,539 | $ 4,329 | $ 685,290,815 | $ (309,475,366) | $ (317,239) | |||
Balance, shares at Dec. 31, 2016 | 43,292,906 | |||||||
Common shares issued | $ 162,072,256 | $ 1,113 | $ 162,071,143 | |||||
Common shares issued, shares | 11,129,032 | |||||||
Exercise of stock options and vesting of restricted stock (Value) | 285,160 | $ 17 | 285,143 | |||||
Exercise of stock options and vesting of restricted stock (Shares) | 162,642 | |||||||
Stock issued for services | 190,885 | $ 1 | 190,884 | |||||
Stock issued for services, shares | 13,099 | |||||||
Share-based compensation | 14,641,520 | 14,641,520 | ||||||
Net loss | (97,773,414) | (97,773,414) | ||||||
Other comprehensive income (loss) | (481,985) | (481,985) | ||||||
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 vesting of restricted stock (Value) | 674,206 | $ 29 | 674,177 | |||||
Exercise of stock options and vesting 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 vesting of restricted stock (Value) | 3,235,601 | $ 59 | 3,235,542 | |||||
Exercise of stock options and vesting 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 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities | |||
Net loss | $ (147,722,178) | $ (155,127,411) | $ (97,773,414) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 477,121 | 368,673 | 213,872 |
Share-based compensation | 20,788,688 | 17,396,146 | 14,641,520 |
Stock issued for services | 194,205 | 192,530 | 190,885 |
Amortization of premiums and discounts on investment activities | (1,131,597) | (943,239) | 429,839 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 94,339 | ||
Prepaid expenses and other assets | 1,465,384 | (3,026,908) | (879,200) |
Long term deferred tax asset, net | 264,609 | 529,217 | (1,058,435) |
Accounts payable | (6,536,036) | 7,787,521 | 2,418,892 |
Accrued liabilities and employee benefits | 3,327,095 | 14,386,774 | 1,211,103 |
Lease liabilities, net | 889,468 | ||
Deferred rent | 267,584 | 18,787 | |
Net cash used in operating activities | (127,983,241) | (118,169,113) | (80,491,812) |
Investing activities | |||
Purchases of investments | (80,720,301) | (271,156,707) | (520,926,824) |
Maturities of investments | 258,857,683 | 406,189,288 | 428,932,538 |
Purchases of property and equipment | (700,395) | (391,268) | (723,429) |
Net cash provided by (used in) investing activities | 177,436,987 | 134,641,313 | (92,717,715) |
Financing activities | |||
Exercise of stock options | 3,235,601 | 674,206 | 285,160 |
Proceeds of public offerings, net | 162,072,256 | ||
Proceeds from stock warrant | 10,982 | ||
Net cash provided by financing activities | 3,235,601 | 685,188 | 162,357,416 |
Net increase (decrease) in cash and cash equivalents | 52,689,347 | 17,157,388 | (10,852,111) |
Cash and cash equivalents at beginning of period | 54,947,502 | 37,790,114 | 48,642,225 |
Cash and cash equivalents at end of period | 107,636,849 | 54,947,502 | 37,790,114 |
Cash paid for taxes | $ 1,600 | $ 1,600 | $ 1,600 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2019 | |
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 (lumateperone) has been approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of schizophrenia in adults (42mg/day). As used in these Notes to Consolidated Financial Statements, “CAPLYTA” refers to lumateperone approved by the FDA for the treatment of schizophrenia in adults, and “lumateperone” refers to, where applicable, CAPLYTA as well as lumateperone for the treatment of indications beyond schizophrenia. Lumateperone is in Phase 3 clinical development as a novel treatment for bipolar depression and agitation associated with dementia, including Alzheimer’s disease. The Company was originally incorporated in the State of Delaware in August 2012 under the name “Oneida Resources Corp.” Prior to a reverse merger that occurred on August 29, 2013 (the “Merger”), Oneida Resources Corp. was a “shell” company registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with no specific business plan or purpose until it began operating the business of ITI, through the Merger transaction on August 29, 2013. ITI was incorporated in Delaware in May 2001 to focus primarily on the development of novel drugs for the treatment of neuropsychiatric and neurologic diseases and other disorders of the CNS. Effective upon the Merger, a wholly-owned subsidiary of the Company merged with and into ITI, and ITI continues as the operating subsidiary of the Company. 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 million. After deducting underwriting discounts, commissions and estimated offering expenses, the net proceeds to the Company were approximately $276.9 million. On October 2, 2017 and October 5, 2017, the Company completed a public offering of common stock in which the Company sold 11,129,032 shares of common stock, which included the exercise of the underwriters’ option to purchase an additional 1,451,613 shares, at an offering price of $15.50 per share for aggregate gross proceeds of approximately $172 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $162 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, |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
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 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. On December 31, 2019, the Company accrued approximately $5.8 million of expense for 2019 employee bonuses that were paid in the first quarter of 2020. In previous years, employee bonuses were paid in the year they were earned. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of checking accounts, money market accounts, money market mutual funds, and certificates of deposit with a maturity date of three months or less. The carrying values of cash and cash equivalents approximate the fair market value. Certificates of deposit, commercial paper, corporate notes and corporate bonds with a maturity date of more than three months are classified separately on the balance sheet. 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 period, and a new cost basis for the security is established. Dividend and interest income are recognized as interest income on the consolidated statements of operations when earned. The cost of securities sold is calculated using the specific identification method. Investment securities consisted of the following (in thousands): December 31, 2019 Amortized Unrealized Unrealized Estimated 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 December 31, 2018 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are $250,000 or less. The Company has classified all of its investment securities available-for-sale, available-for-sale The Company monitors its investment portfolio for impairment quarterly or more frequently if circumstances warrant. In the event that the carrying value of an investment exceeds its fair value and the decline in value is determined to be other-than-temporary, the Company records an impairment charge within earnings attributable to the estimated credit loss. In determining whether a decline in the value of an investment is other-than-temporary, the Company evaluates currently available factors that may include, among others: (1) general market conditions; (2) the duration and extent to which fair value has been less than the carrying value; (3) the investment issuer’s financial condition and business outlook; and (4) the Company’s assessment as to whether it is more likely than not that the Company will be required to sell a security prior to recovery of its amortized cost basis. As of December 31, 2019, the aggregate related fair value of investments with unrealized losses was $ million and the aggregate amount of unrealized losses was approximately $ thousand . Of the $ million, $ million have been held in a continuous unrealized loss position for less than months and $ million have been held in a continuous loss position for months or longer. The total continuous unrealized loss for investments held for months or longer is approximately $ thousand as of December , . As of December , , the aggregate related fair value of investments with unrealized losses was $ million and the aggregate amount of unrealized losses was $ million. Of the $ million, $ million have been held in a continuous unrealized loss position for less than months and $ million have been held in a continuous loss position for 12 months or longer. The total continuous unrealized loss for investments held for 12 months or longer is approximately $345 thousand The Company attributes the unrealized gains on the available-for-sale 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, 2019 and December 31, 2018. The carrying value of cash held in money market funds of approximately $49.9 million as of December 31, 2019 and $39.6 million as of December 31, 2018 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 approximately $47.6 million and $7.5 million as of December 31, 2019 and 2018, 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 $ 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 December 31, Quoted Prices Significant Significant 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 bonds/notes 38,861 — 38,861 — $ 216,874 $ 49,882 $ 166,992 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 39,591 $ 39,591 $ — $ — U.S. government agency securities 124,426 — 124,426 — FDIC certificates of deposit 245 — 245 — Certificates of deposit 8,500 — 8,500 — Commercial paper 41,272 — 41,272 — Corporate bonds/notes 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, prepaid expenses, right of use asset, net, other assets, accounts payable, accrued liabilities, accrued employee benefits, and, lease liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2019 and December 31, 2018. 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. Concentration of Credit Risk 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. Accounts Receivable Accounts receivable that management has the intent and ability to collect are reported in the balance sheets at outstanding amounts, less an allowance for doubtful accounts. The Company writes off uncollectible receivables when the likelihood of collection is not probable. The Company evaluates the collectability of accounts receivable on a regular basis. The allowance, if any, is based upon various factors including the financial condition and payment history of customers, an overall review of collections experience on other accounts and economic factors or events expected to affect future collections experience. No allowance was recorded as of December 31, 2019 and 2018, as the Company has a history of collecting on all its accounts including government agencies and collaborations funding its research and there were no balances in accounts receivable as of these dates. 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 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, 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, 2019, the Company recorded a change in estimate of approximately $ 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 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 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 are 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. 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. Beginning in the first quarter of 2016, 2017, 2018 and 2019, the Company granted time-based RSUs that vest in three (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSUs”). The Milestone RSUs were valued at the closing price on March 8, 2017. The Milestone RSUs related to the NDA submission has been fully amortized through December 31, 2018. The NDA submission milestone was achieved in the third quarter of 2018, so the Milestone RSUs related to the NDA submission vested on December 31, 2018. The Milestone RSU’s related to the NDA approval was achieved in the fourth quarter of 2019, so the RSU’s vested on December 31, 2019. The amortization of the expenses for Milestone RSUs related to the approval of the NDA was fully amortized on December 31, 2019. The TSR RSUs were valued using the Monte Carlo Simulation method and were amortized over the life of the RSUs based on the agreements which vested on January 24, 2020. The expense recognition related to these equity grants was based on the Company’s best estimate. 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 shall be considered to be a deductible difference in applying ASC Topic 740, Income Taxes In March 2016, the FASB issued ASU No. 2016-09, 2016-09”). ASU 2016-09 including simplification of the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. As of January 1, 2017, the Company adopted ASU 2016-09 for the quarter ended March 31, 2017. Accordingly, the Company recognized previously unrecognized excess tax benefits of $ million recorded as deferred tax assets with a corresponding offsetting full valuation allowance at the beginning of 2017, which yielded no tax impact. 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 pursuant to which 4,750,000 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, restricted stock units, stock awards and other stock-based awards for up to a total of 1,000,000 shares of common stock to new employees of the Company. No shares were granted under the 2019 Inducement Plan as of December 31, 2019 . 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, 2019, 2018 and 2017: Year Ended December 31, 2019 2018 2017 Common Stock Equivalents 6,039,945 4,748,391 3,755,739 RSUs 1,268,679 647,411 190,933 TSR RSUs 67,080 206,484 347,199 Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company adopted this standard on January 1, 2018 using the “modified retrospective method” which did not result in an impact to its financial statements as the Company has not had product sales to date. Upon commercializing a product or executing any revenue generating contracts, the Company will provide additional disclosures in the notes to the consolidated financial statements related to the relevant aspects of any revenue generating contracts that the Company has or into which the Company expects to enter. 2016-01, 2016-01”). 2016-01 measured at amortized cost on the balance sheet. The standard also clarifies the need to evaluate a valuation allowance on a deferred tax asset related to available-for-sale 2016-01 In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 2016-02 The adoption of the standard resulted in recognition of additional right of use assets and lease liabilities of approximately $20.2 million and $23.4 million, respectively, as of January 1, 2019. The difference between these amounts represents the net deferred rent as of January 1, 2019 with no impact on the accumulated deficit. The adoption of the new lease standard was a non-cash In June 2016, the FASB issued ASU No. 2016-13, 2016-13) available-for-sale held-to-maturity In February 2018, the FASB issued ASU No. 2018-02, In June 2018, the FASB issued ASU No. 2018-07, 2018-07”). 2018-07 In December 2019, the FASB issued ASU 2019-12, 2019-12) 2019-12 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following: December 31, 201 9 2018 Computer equipment $ 243,532 $ 44,427 Furniture and fixtures 423,097 341,582 Scientific equipment 3,861,227 3,658,209 Leasehold improvements 1,240,315 149,470 5,768,171 4,193,688 Less accumulated depreciation (3,508,431 ) (3,033,922 ) $ 2,259,740 $ 1,159,766 Depreciation expense for the years ended December 31, 2019, 2018 and 2017 was $477,121, $368,673 and $213,872, respectively. |
Right Of Use Assets and Lease L
Right Of Use Assets and Lease Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Right Of Use Assets and Lease Liabilities | 4. Right Of Use Assets and Lease Liabilities In 2014, the Company entered into a long-term lease with a related party which, as amended, provided for a lease of useable laboratory and office space located in New York, New York. A member of the Company’s board of directors is the Executive Chairman of the parent company to the landlord under this lease. Concurrent with this lease, the Company entered into a license agreement to occupy certain vivarium related space in the same facility for the same term and rent escalation provisions as the lease. This license has the primary characteristics of a lease and is characterized as a lease in accordance with ASU 2016-02 ending in May 2029. In February 2019, the Company entered into a long-term lease for office space in Towson, Maryland beginning March 1, 2019. The lease has a term of 3.2 years ending in April 2022 and includes limited rent abatement and escalation provisions. The Company has no other significant leases. In addition, no identified leases require allocations between lease and non-lease In adopting ASU 2016-02 non-lease 2016-02, At the execution of the Maryland lease in 2019, the Company recorded a right of use asset and a lease liability of $0.2 million which represented a non-cash Right of use assets and lease liabilities for operating leases were approximately respectively. The operating cash outflows related to operating lease obligations for the year ended December 31, 2019 were $2,521,576. Maturity analysis under the lease agreements are as follows: Year ending December 31, 2020 3,346,375 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 Thereafter 17,627,040 Total 35,154,566 Less: Present value discount (12,011,945 ) Total Lease liability $ 23,142,621 Less: current portion (3,187,435 ) Long-term lease liabilities $ 19,955,186 Lease expense for the year ended December 31, 2019, 2018 and 2017 million $1.8 million and $1.4 million, respectively. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 5. Share-Based Compensation On June 18, 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan provides for the granting of stock-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. The 2018 Plan replaced the Company’s Amended and Restated 2013 Equity Incentive Plan (the “2013 Plan”). The Company will grant no further stock options or other awards under the 2013 Plan. Any options or other awards outstanding under the 2013 Plan remain outstanding in accordance with their terms and the terms of the 2013 Plan. As of December 31, 2019, the total number of shares reserved under all equity plans is 11,287,390 and the Company had 2,208,317 shares available for future issuance under the 2018 Plan. Stock options granted under the 2018 Plan may be either incentive stock options (“ISOs”) as defined by the Internal Revenue Code of 1986, or non-qualified one In December 2019, the Company adopted the 2019 Inducement Plan for the grant of equity awards of up to 1,000,000 shares of common stock primarily to attract new employees to the Company’s commercial organization. No awards were granted as of December 31, 2019. Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs granted to employees, directors and consultants recognized during the years ended December 31, 2019, 2018 and 2017, was comprised of the following: Years Ended December 31, 2019 2018 2017 Research and development $ 9,411,056 $ 7,380,814 $ 5,082,823 General and administrative 11,377,632 10,015,332 9,558,697 Total share-based compensation expense $ 20,788,688 $ 17,396,146 $ 14,641,520 The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2019, 2018 and 2017: 2019 2018 2017 Dividend yield 0 % 0 % 0 % Expected volatility 85.7-96.5 % 85.2%-85.8 % 87.4%-90.4 % Weighted-average risk-free interest rate 2.32 % 2.48 % 2.1 % Expected term (in years) 6.0 6.0 6.0 Number of Weighted- Weighted- Outstanding at December 31, 2018 4,748,391 $ 18.26 7.0 years Options granted 1,833,102 $ 12.98 9.2 years Options exercised (264,663 ) $ 12.22 4.1 years Options canceled or expired (276,885 ) $ 20.82 6.8 years Outstanding at December 31, 2019 6,039,945 $ 16.81 7.0 years Vested or expected to vest at December 31, 2019 6,039,945 $ 16.81 Exercisable at December 31, 2019 3,313,108 $ 19.38 5.6 years The weighted-average grant date fair value for awards granted during the years ended December 31, 2019, 2018 and 2017 was $9.17, $15.22 and $15.08 per share, respectively. The total intrinsic value of the options exercised during the years ended December 31, 2019, 2018 and 2017 was $3,127,412, $1,683,679 and $1,609,268, respectively. The total intrinsic value of the options outstanding as o The total intrinsic value of the options exercisable as of The total fair value of shares vested during During 2018, the Company granted options to certain scientific advisory board members of the Company to purchase 12,000 shares of common stock, at an average exercise price per share of $15.47. The options vest ratably over a period of 2 years. Stock compensation related to these grants will fluctuate with any changes in the underlying value of the Company’s common stock. As of December 31, 2019, there w as of was , The total intrinsic value of the time based RSUs vested during the years ended December 31, 2019, 2018 and 2017 was $3,109,328, $1,165,323 and $471,779, respectively. The total intrinsic value of the time based RSU’s outstanding as of December 31, 2019 was $43,528,382. The total fair value of time based RSUs vested during the years ended December 31, 2019, 2018 and 2017 was $4,623,030, $2,109,705 and $1,508,083, 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. Information regarding time based RSU activity, including with respect to grants to employees as of December 31, 2019, and changes during the year then ended, is summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2018 647,411 $ 18.16 1.8 years Time based RSUs granted in 2019 950,449 $ 12.79 2.0 years Time based RSUs vested in 2019 (267,143 ) $ 21.64 0.7 years Time based RSUs cancelled in 2019 (62,038 ) $ 14.14 1.4 years Outstanding at December 31, 2019 1,268,679 $ 13.60 1.7 years The Company recognized non-cash Milestone Information related to the Company’s Milestone RSUs and the TSR RSUs during the year ended December 31, 2019 are summarized as follows: Number of Weighted- Average Per Share Weighted- Outstanding at December 31, 2018 278,592 $ 15.35 1.8 years Milestone RSUs and TSR RSUs vested (65,111 ) $ 14.16 0.2 years Milestone RSUs and TSR RSUs cancelled in 2019 (146,401 ) $ 15.64 0.2 years Outstanding at December 31, 2019 67,080 $ 17.08 0.2 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 ending 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 were settled as a percentage of shares for which the award was targeted 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 Nasdaq. The number of shares for which the TSR RSUs were settled depended 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 TSR RSUs valuation was complete and 67,080 As of December 31, 2019, there were no unrecognized compensation costs related to unvested Milestone RSU grants and TSR RSU grants. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes On December 22, 2017, President 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, 2019, the Company’s foreign operations do not generate 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 2019. Therefore, the Company has not included any tax impacts of BEAT in its consolidated financial statements for the year ended December 31, 2019. 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. Income (loss) before income taxes is as follows: 2019 2018 2017 U.S. (56,121,258 ) $ (30,299,751 ) $ (20,486,935 ) Non-U.S. (91,599,320 ) (124,826,060 ) (78,347,330 ) Total loss before taxes (147,720,578 ) $ (155,125,811 ) $ (98,834,265 ) Total income tax (benefit) expense for the years ended December 31, 2019, 2018 and 2017 is allocated as follows: 2019 2018 2017 Current $ 1,600 $ 1,600 $ (2,416 ) Deferred (8,484,822 ) (5,054,468 ) 13,713,987 Valuation allowance 8,484,822 5,054,468 (14,772,422 ) Provision (benefit) for income taxes $ 1,600 $ 1,600 $ (1,060,851 ) December 31, 2019 2018 2017 Income tax benefit at statutory federal rate 21.00 % 21.00 % 35.00 % Other Permanent differences (0.67 ) (0.58 ) (0.43 ) Foreign rate differential (13.02 ) (16.90 ) (27.75 ) 2017 US Tax Reform impact 0.00 0.00 (21.89 ) R&D Credit 0.00 0.00 (0.05 ) Change in effective state tax rates (0.16 ) (0.38 ) 0.84 State income tax expense (1.40 ) 0.12 0.40 Change in valuation allowance (5.75 ) (3.26 ) 14.95 Benefit for income taxes 0.0 % 0.00 % 1.07 % 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, 2019, the Company had $183.1 million of federal net operating loss carryforwards, of $131.2 million , 2016 The Company has not performed a complete Section 382 analysis to determine the effect on ownership related to the January 2020 public offering. If the Company experiences an ownership change from the January 2020 public offering or 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, 2019 and 2018, respectively: December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 49,668,232 $ 43,872,566 Accrued employee benefits 589,667 441,780 Research and development credit 9,321,214 9,321,214 Stock compensation 12,965,250 10,530,859 Federal AMT credit 264,609 529,218 Deferred rent — 712,314 Capital lease 4,973,618 — Unrealized comprehensive loss — 146,531 Depreciation — 1,082 Deferred tax liabilities: Right of use asset—capital lease (3,922,583 ) — Unrealized gains on investment (27,577 ) — Depreciation (230,760 ) — Net deferred tax asset before valuation allowance 73,601,670 65,555,564 Valuation allowance (73,337,061 ) (65,026,346 ) Net deferred tax asset $ 264,609 $ 529,218 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 2019 and 2018, 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. In 2018, the Company reclassified $529,218 Federal AMT to Other Current Assets. In 2019, the Company collected the $529,218 AMT credit reclassified to Other Current Assets in the prior year and reclassified $264,609 of AMT credit to Other Current Assets. The total amount of unrecognized tax benefits was $1.7 million as of December 31, 2019 and December 31, 2018. If recognized , The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2019 and 2018, respectively: December 31, 2019 2018 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 |
Collaborations and License Agre
Collaborations and License Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations and License Agreements | 7. Collaborations and License Agreements The Bristol-Myers Squibb License Agreement In know-how i Under the agreement, the Company made an upfront payment of $1.0 million to BMS, 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. The Company achieved the acceptance in the third quarter of 2018 and has therefore accrued the $2.0 million which was paid in January 2019. The FDA approved the the Company an additional milestone liability 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. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies From time to time, the Company may be subject to various litigation and related matters arising in the ordinary course of business. The Company does not believe it is currently subject to any material matters where there is at least a reasonable possibility that a material loss may be incurred. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | 9. Employee Benefit Plan The Company sponsors a defined contribution 401(k) plan covering all full-time employees. Participants may elect to contribute their annual pre-tax |
Related Parties
Related Parties | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Parties | 10. 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 . |
Unaudited Quarterly Financial I
Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | 1 1 The tables herein set forth the Company’s unaudited condensed consolidated 2019 and 2018 quarterly statements of operations. 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, Net loss (40,582,851 ) (34,862,399 ) (37,441,164 ) (34,835,764 ) Basic and diluted net loss per share $ (0.74 ) $ (0.63 ) $ (0.68 ) $ (0.63 ) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2018 quarters ended: 2018 Quarter Ended December 31, September 30, June 30, March 31, Net loss (40,748,036 ) (41,522,914 ) (37,376,383 ) (35,480,078 ) Basic and diluted net loss per share $ (0.75 ) $ (0.76 ) $ (0.68 ) $ (0.65 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
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 |
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. On December 31, 2019, the Company accrued approximately $5.8 million of expense for 2019 employee bonuses that were paid in the first quarter of 2020. In previous years, employee bonuses were paid in the year they were earned. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of checking accounts, money market accounts, money market mutual funds, and certificates of deposit with a maturity date of three months or less. The carrying values of cash and cash equivalents approximate the fair market value. Certificates of deposit, commercial paper, corporate notes and corporate bonds with a maturity date of more than three months are classified separately on the balance sheet. |
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 period, and a new cost basis for the security is established. Dividend and interest income are recognized as interest income on the consolidated statements of operations when earned. The cost of securities sold is calculated using the specific identification method. Investment securities consisted of the following (in thousands): December 31, 2019 Amortized Unrealized Unrealized Estimated 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 December 31, 2018 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are $250,000 or less. The Company has classified all of its investment securities available-for-sale, available-for-sale The Company monitors its investment portfolio for impairment quarterly or more frequently if circumstances warrant. In the event that the carrying value of an investment exceeds its fair value and the decline in value is determined to be other-than-temporary, the Company records an impairment charge within earnings attributable to the estimated credit loss. In determining whether a decline in the value of an investment is other-than-temporary, the Company evaluates currently available factors that may include, among others: (1) general market conditions; (2) the duration and extent to which fair value has been less than the carrying value; (3) the investment issuer’s financial condition and business outlook; and (4) the Company’s assessment as to whether it is more likely than not that the Company will be required to sell a security prior to recovery of its amortized cost basis. As of December 31, 2019, the aggregate related fair value of investments with unrealized losses was $ million and the aggregate amount of unrealized losses was approximately $ thousand . Of the $ million, $ million have been held in a continuous unrealized loss position for less than months and $ million have been held in a continuous loss position for months or longer. The total continuous unrealized loss for investments held for months or longer is approximately $ thousand as of December , . As of December , , the aggregate related fair value of investments with unrealized losses was $ million and the aggregate amount of unrealized losses was $ million. Of the $ million, $ million have been held in a continuous unrealized loss position for less than months and $ million have been held in a continuous loss position for 12 months or longer. The total continuous unrealized loss for investments held for 12 months or longer is approximately $345 thousand The Company attributes the unrealized gains on the available-for-sale |
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, 2019 and December 31, 2018. The carrying value of cash held in money market funds of approximately $49.9 million as of December 31, 2019 and $39.6 million as of December 31, 2018 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 approximately $47.6 million and $7.5 million as of December 31, 2019 and 2018, 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 $ 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 December 31, Quoted Prices Significant Significant 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 bonds/notes 38,861 — 38,861 — $ 216,874 $ 49,882 $ 166,992 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 39,591 $ 39,591 $ — $ — U.S. government agency securities 124,426 — 124,426 — FDIC certificates of deposit 245 — 245 — Certificates of deposit 8,500 — 8,500 — Commercial paper 41,272 — 41,272 — Corporate bonds/notes 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — |
Financial Instruments | Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, prepaid expenses, right of use asset, net, other assets, accounts payable, accrued liabilities, accrued employee benefits, and, lease liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2019 and December 31, 2018. 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. |
Concentration of Credit Risk | Concentration of Credit Risk 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. |
Accounts Receivable | Accounts Receivable Accounts receivable that management has the intent and ability to collect are reported in the balance sheets at outstanding amounts, less an allowance for doubtful accounts. The Company writes off uncollectible receivables when the likelihood of collection is not probable. |
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 |
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, 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, 2019, the Company recorded a change in estimate of approximately $ |
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 |
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 In June 2018, the Company’s stockholders approved the Company’s 2018 Equity Incentive Plan pursuant to which 4,750,000 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, restricted stock units, stock awards and other stock-based awards for up to a total of 1,000,000 shares of common stock to new employees of the Company. No shares were granted under the 2019 Inducement Plan as of December 31, 2019 . 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 are 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. 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. Beginning in the first quarter of 2016, 2017, 2018 and 2019, the Company granted time-based RSUs that vest in three (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSUs”). The Milestone RSUs were valued at the closing price on March 8, 2017. The Milestone RSUs related to the NDA submission has been fully amortized through December 31, 2018. The NDA submission milestone was achieved in the third quarter of 2018, so the Milestone RSUs related to the NDA submission vested on December 31, 2018. The Milestone RSU’s related to the NDA approval was achieved in the fourth quarter of 2019, so the RSU’s vested on December 31, 2019. The amortization of the expenses for Milestone RSUs related to the approval of the NDA was fully amortized on December 31, 2019. The TSR RSUs were valued using the Monte Carlo Simulation method and were amortized over the life of the RSUs based on the agreements which vested on January 24, 2020. The expense recognition related to these equity grants was based on the Company’s best estimate. 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 shall be considered to be a deductible difference in applying ASC Topic 740, Income Taxes In March 2016, the FASB issued ASU No. 2016-09, 2016-09”). ASU 2016-09 including simplification of the accounting for income taxes, classification of excess tax benefits on the Statement of Cash Flows and forfeitures. As of January 1, 2017, the Company adopted ASU 2016-09 for the quarter ended March 31, 2017. Accordingly, the Company recognized previously unrecognized excess tax benefits of $ million recorded as deferred tax assets with a corresponding offsetting full valuation allowance at the beginning of 2017, which yielded no tax impact. |
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, 2019, 2018 and 2017: Year Ended December 31, 2019 2018 2017 Common Stock Equivalents 6,039,945 4,748,391 3,755,739 RSUs 1,268,679 647,411 190,933 TSR RSUs 67,080 206,484 347,199 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company adopted this standard on January 1, 2018 using the “modified retrospective method” which did not result in an impact to its financial statements as the Company has not had product sales to date. Upon commercializing a product or executing any revenue generating contracts, the Company will provide additional disclosures in the notes to the consolidated financial statements related to the relevant aspects of any revenue generating contracts that the Company has or into which the Company expects to enter. 2016-01, 2016-01”). 2016-01 measured at amortized cost on the balance sheet. The standard also clarifies the need to evaluate a valuation allowance on a deferred tax asset related to available-for-sale 2016-01 In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 2016-02 The adoption of the standard resulted in recognition of additional right of use assets and lease liabilities of approximately $20.2 million and $23.4 million, respectively, as of January 1, 2019. The difference between these amounts represents the net deferred rent as of January 1, 2019 with no impact on the accumulated deficit. The adoption of the new lease standard was a non-cash In June 2016, the FASB issued ASU No. 2016-13, 2016-13) available-for-sale held-to-maturity In February 2018, the FASB issued ASU No. 2018-02, In June 2018, the FASB issued ASU No. 2018-07, 2018-07”). 2018-07 In December 2019, the FASB issued ASU 2019-12, 2019-12) 2019-12 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): December 31, 2019 Amortized Unrealized Unrealized Estimated 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 December 31, 2018 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are $250,000 or less. |
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 December 31, Quoted Prices Significant Significant 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 bonds/notes 38,861 — 38,861 — $ 216,874 $ 49,882 $ 166,992 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money market funds $ 39,591 $ 39,591 $ — $ — U.S. government agency securities 124,426 — 124,426 — FDIC certificates of deposit 245 — 245 — Certificates of deposit 8,500 — 8,500 — Commercial paper 41,272 — 41,272 — Corporate bonds/notes 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — |
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, 2019, 2018 and 2017: Year Ended December 31, 2019 2018 2017 Common Stock Equivalents 6,039,945 4,748,391 3,755,739 RSUs 1,268,679 647,411 190,933 TSR RSUs 67,080 206,484 347,199 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: December 31, 201 9 2018 Computer equipment $ 243,532 $ 44,427 Furniture and fixtures 423,097 341,582 Scientific equipment 3,861,227 3,658,209 Leasehold improvements 1,240,315 149,470 5,768,171 4,193,688 Less accumulated depreciation (3,508,431 ) (3,033,922 ) $ 2,259,740 $ 1,159,766 |
Right Of Use Assets and Lease_2
Right Of Use Assets and Lease Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule Of Maturity Analysis Under Lease Agreements | Maturity analysis under the lease agreements are as follows: Year ending December 31, 2020 3,346,375 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 Thereafter 17,627,040 Total 35,154,566 Less: Present value discount (12,011,945 ) Total Lease liability $ 23,142,621 Less: current portion (3,187,435 ) Long-term lease liabilities $ 19,955,186 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Total Stock-Based Compensation Expense | Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs granted to employees, directors and consultants recognized during the years ended December 31, 2019, 2018 and 2017, was comprised of the following: Years Ended December 31, 2019 2018 2017 Research and development $ 9,411,056 $ 7,380,814 $ 5,082,823 General and administrative 11,377,632 10,015,332 9,558,697 Total share-based compensation expense $ 20,788,688 $ 17,396,146 $ 14,641,520 |
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, 2019, 2018 and 2017: 2019 2018 2017 Dividend yield 0 % 0 % 0 % Expected volatility 85.7-96.5 % 85.2%-85.8 % 87.4%-90.4 % Weighted-average risk-free interest rate 2.32 % 2.48 % 2.1 % 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, 2019, and changes during the period then ended, are summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2018 4,748,391 $ 18.26 7.0 years Options granted 1,833,102 $ 12.98 9.2 years Options exercised (264,663 ) $ 12.22 4.1 years Options canceled or expired (276,885 ) $ 20.82 6.8 years Outstanding at December 31, 2019 6,039,945 $ 16.81 7.0 years Vested or expected to vest at December 31, 2019 6,039,945 $ 16.81 Exercisable at December 31, 2019 3,313,108 $ 19.38 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, 2019, and changes during the year then ended, is summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2018 647,411 $ 18.16 1.8 years Time based RSUs granted in 2019 950,449 $ 12.79 2.0 years Time based RSUs vested in 2019 (267,143 ) $ 21.64 0.7 years Time based RSUs cancelled in 2019 (62,038 ) $ 14.14 1.4 years Outstanding at December 31, 2019 1,268,679 $ 13.60 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, 2019 are summarized as follows: Number of Weighted- Average Per Share Weighted- Outstanding at December 31, 2018 278,592 $ 15.35 1.8 years Milestone RSUs and TSR RSUs vested (65,111 ) $ 14.16 0.2 years Milestone RSUs and TSR RSUs cancelled in 2019 (146,401 ) $ 15.64 0.2 years Outstanding at December 31, 2019 67,080 $ 17.08 0.2 years |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Summary of Income (loss) before Income Taxes | Income (loss) before income taxes is as follows: 2019 2018 2017 U.S. (56,121,258 ) $ (30,299,751 ) $ (20,486,935 ) Non-U.S. (91,599,320 ) (124,826,060 ) (78,347,330 ) Total loss before taxes (147,720,578 ) $ (155,125,811 ) $ (98,834,265 ) |
Total Income Tax (Benefit) Expense | Total income tax (benefit) expense for the years ended December 31, 2019, 2018 and 2017 is allocated as follows: 2019 2018 2017 Current $ 1,600 $ 1,600 $ (2,416 ) Deferred (8,484,822 ) (5,054,468 ) 13,713,987 Valuation allowance 8,484,822 5,054,468 (14,772,422 ) Provision (benefit) for income taxes $ 1,600 $ 1,600 $ (1,060,851 ) |
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, 2019, 2018 and 2017 is as follows: December 31, 2019 2018 2017 Income tax benefit at statutory federal rate 21.00 % 21.00 % 35.00 % Other Permanent differences (0.67 ) (0.58 ) (0.43 ) Foreign rate differential (13.02 ) (16.90 ) (27.75 ) 2017 US Tax Reform impact 0.00 0.00 (21.89 ) R&D Credit 0.00 0.00 (0.05 ) Change in effective state tax rates (0.16 ) (0.38 ) 0.84 State income tax expense (1.40 ) 0.12 0.40 Change in valuation allowance (5.75 ) (3.26 ) 14.95 Benefit for income taxes 0.0 % 0.00 % 1.07 % |
Deferred Tax Assets and Liabilities | The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2019 and 2018, respectively: December 31, 2019 2018 Deferred tax assets: Net operating loss carryforwards $ 49,668,232 $ 43,872,566 Accrued employee benefits 589,667 441,780 Research and development credit 9,321,214 9,321,214 Stock compensation 12,965,250 10,530,859 Federal AMT credit 264,609 529,218 Deferred rent — 712,314 Capital lease 4,973,618 — Unrealized comprehensive loss — 146,531 Depreciation — 1,082 Deferred tax liabilities: Right of use asset—capital lease (3,922,583 ) — Unrealized gains on investment (27,577 ) — Depreciation (230,760 ) — Net deferred tax asset before valuation allowance 73,601,670 65,555,564 Valuation allowance (73,337,061 ) (65,026,346 ) Net deferred tax asset $ 264,609 $ 529,218 |
Summary of Gross Unrecognized Tax Benefits | The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2019 and 2018, respectively: December 31, 2019 2018 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, 2019 | |
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 2019 quarters ended: 2019 Quarter Ended December 31, September 30, June 30, March 31, Net loss (40,582,851 ) (34,862,399 ) (37,441,164 ) (34,835,764 ) Basic and diluted net loss per share $ (0.74 ) $ (0.63 ) $ (0.68 ) $ (0.63 ) The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2018 quarters ended: 2018 Quarter Ended December 31, September 30, June 30, March 31, Net loss (40,748,036 ) (41,522,914 ) (37,376,383 ) (35,480,078 ) Basic and diluted net loss per share $ (0.75 ) $ (0.76 ) $ (0.68 ) $ (0.65 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) | Jan. 10, 2020 | Oct. 05, 2017 | Sep. 12, 2019 |
Subsequent Event [Member] | |||
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 | $ 276,900,000 | ||
IPO [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Initial public offering, Number of shares | 11,129,032 | ||
Initial public offering, Price per share | $ 15.50 | ||
Initial public offering, Gross proceeds | $ 172,000,000 | ||
Initial public offering, Net proceeds | $ 162,000,000 | ||
Over-Allotment Option [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Initial public offering, Number of shares | 1,451,613 | ||
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) | 3 Months Ended | 12 Months Ended | |||||||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2019USD ($)Segmentshares | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($) | Jan. 01, 2019USD ($) | 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 | $ 116,373,335 | $ 292,583,046 | |||||||
Aggregate related fair value of investments with unrealized losses | 29,600,000 | 272,500,000 | |||||||
Investment securities aggregate amount of unrealized loss | 8,000 | 700,000 | |||||||
Investment securities, held in continuous unrealized loss position for less than 12 months | 17,100,000 | 180,400,000 | |||||||
Investment securities, held in continuous unrealized loss position for 12 months or longer | 12,500,000 | 92,100,000 | |||||||
Total continuous unrealized loss for investments held for 12 months or longer | 3,000 | 345,000 | |||||||
Carrying value of cash held in money market funds | 49,900,000 | 39,600,000 | |||||||
Impairment losses recognized | 0 | ||||||||
Income tax expense (benefit) | $ 1,600 | $ 1,600 | $ (1,060,851) | ||||||
Effective tax rate | 0.00% | 0.00% | 1.07% | ||||||
US statutory rate | 21.00% | 21.00% | 35.00% | ||||||
Assumed expected dividend rate | 0.00% | 0.00% | 0.00% | ||||||
Net lease assets | $ 18,252,074 | ||||||||
Net lease liabilities | 23,142,621 | ||||||||
Bonus to employees accrued | $ 5,800,000 | ||||||||
Number of options granted during the period | shares | 1,833,102 | ||||||||
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 | 47,600,000 | $ 7,500,000 | |||||||
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 | |||||||
Adjustments for New Accounting Pronouncement [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Deferred tax assets | 9,700,000 | ||||||||
Accounting Standards Update 2016-02 [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Net lease assets | $ 20,200,000 | ||||||||
Net lease liabilities | $ 23,400,000 | ||||||||
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Investment securities, available-for-sale | $ 3,000,000 | $ 64,600,000 | |||||||
2018 Equity Incentive Plan [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Additional shares of common stock reserved for future equity grants | shares | 4,750,000 | ||||||||
Number of options granted during the period | shares | 12,000 | ||||||||
RSUs [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Service period for granted RSUs, vest in annual installment | 3 years | 3 years | 3 years | 3 years | |||||
Inducement Award Plan [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Issuance of shares, Inducement Award Plan | shares | 1,000,000 | ||||||||
2019 Inducement Plan [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Number of options granted during the period | shares | 0 | ||||||||
Minimum [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Property and equipment, estimated useful life | 3 years | ||||||||
Maximum [Member] | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Property and equipment, estimated useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 116,245,000 | $ 293,251,000 | |
Unrealized Gains | 136,000 | 31,000 | |
Unrealized (Losses) | (8,000) | (699,000) | |
Estimated Fair Value | 116,373,335 | 292,583,046 | |
U.S. Government Agency Securities [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 35,462,000 | 124,691,000 | |
Unrealized Gains | 35,000 | 24,000 | |
Unrealized (Losses) | (3,000) | (289,000) | |
Estimated Fair Value | 35,494,000 | 124,426,000 | |
FDIC Certificates of Deposit [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | [1] | 245,000 | |
Estimated Fair Value | [1] | 245,000 | |
Certificates of Deposit [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 3,000,000 | 1,000,000 | |
Estimated Fair Value | 3,000,000 | 1,000,000 | |
Commercial Paper [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 39,013,000 | 41,317,000 | |
Unrealized Gains | 10,000 | ||
Unrealized (Losses) | (5,000) | (45,000) | |
Estimated Fair Value | 39,018,000 | 41,272,000 | |
Corporate Notes/Bonds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 38,770,000 | 125,998,000 | |
Unrealized Gains | 91,000 | 7,000 | |
Unrealized (Losses) | (365,000) | ||
Estimated Fair Value | $ 38,861,000 | $ 125,640,000 | |
[1] | “FDIC Certificates of Deposit” consist of deposits that are $250,000 or less. |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Investment Securities (Parenthetical) (Detail) | Dec. 31, 2019USD ($) |
FDIC Certificates of Deposit [Member] | Maximum [Member] | |
Schedule of Available-for-sale Securities [Line Items] | |
Deposits under FDIC Certificates of Deposit | $ 250,000 |
Summary of Significant Accoun_7
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, 2019 | Dec. 31, 2018 |
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 216,874 | $ 339,674 |
Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 49,882 | 39,591 |
U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 35,494 | 124,426 |
FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 245 | |
Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 50,622 | 8,500 |
Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 42,015 | 41,272 |
Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 38,861 | 125,640 |
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 | 49,882 | 39,591 |
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 | 49,882 | 39,591 |
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 | 166,992 | 300,083 |
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 | 35,494 | 124,426 |
Significant Other Observable Inputs (Level 2) [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 245 | |
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 | 50,622 | 8,500 |
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 | 42,015 | 41,272 |
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 | $ 38,861 | $ 125,640 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
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 | 6,039,945 | 4,748,391 | 3,755,739 |
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 | 1,268,679 | 647,411 | 190,933 |
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 | 67,080 | 206,484 | 347,199 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 5,768,171 | $ 4,193,688 |
Less accumulated depreciation | (3,508,431) | (3,033,922) |
Property Plant and Equipment Net | 2,259,740 | 1,159,766 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 243,532 | 44,427 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 423,097 | 341,582 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 3,861,227 | 3,658,209 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 1,240,315 | $ 149,470 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 477,121 | $ 368,673 | $ 213,872 |
Right Of Use Assets and Lease_3
Right Of Use Assets and Lease Liabilities - Additional Information (Detail) - USD ($) | 12 Months Ended | |||||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Feb. 28, 2019 | Jan. 01, 2019 | Sep. 30, 2018 | |
Right of use assets, net | $ 18,252,074 | |||||
Net lease liabilities | 23,142,621 | |||||
Operating lease expense | 3,300,000 | $ 1,800,000 | $ 1,400,000 | |||
Right of use assets obtained in exchange for operating lease liability | 200,000 | |||||
Operating lease cash outflows | $ 2,521,576 | |||||
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% | |||||
Operating Lease, 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% | |||||
Operating Lease, 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) | Dec. 31, 2019USD ($) |
Operating Lease Liabilities, Payments Due [Abstract] | |
Year ending December 31, 2020 | $ 3,346,375 |
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 |
Thereafter | 17,627,040 |
Total | 35,154,566 |
Less: Present value discount | (12,011,945) |
Total Lease liability | 23,142,621 |
Less: current portion | (3,187,435) |
Long-term lease liabilities | $ 19,955,186 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 11,287,390 | |||
Weighted average grant date fair value of stock options granted | $ 9.17 | $ 15.22 | $ 15.08 | |
Total intrinsic value of the options exercised | $ 3,127,412 | $ 1,683,679 | $ 1,609,268 | |
Total fair value of shares vested | $ 11,983,108 | $ 11,348,595 | $ 7,212,195 | |
Options granted, Number of Shares | 1,833,102 | |||
Options granted, exercise price | $ 12.98 | |||
Unrecognized share-based compensation expense related to employee stock option awards | $ 17,892,399 | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% | |
Risk free interest rate | 2.32% | 2.48% | 2.10% | |
Total instrinsic value of stock units outstanding options | $ 113,241,283 | |||
Total instrinsic value of stock units exercisable | $ 57,173,972 | |||
2018 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 2,208,317 | |||
Options, vesting term | 2 years | |||
Options granted, Number of Shares | 12,000 | |||
Options granted, exercise price | $ 15.47 | |||
Time Based Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested RSUs | $ 10,522,078 | |||
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 | $ 3,109,328 | $ 1,165,323 | $ 471,779 | |
Total instrinsic value of stock units outstanding other than options | 43,528,382 | |||
Total fair value of time based vested | 4,623,030 | 2,109,705 | 1,508,083 | |
Milestone Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested RSUs | 0 | |||
Non-cash stock-based compensation expense recognized | 900,000 | 500,000 | 400,000 | |
Total fair value of time based vested | $ 921,972 | $ 1,062,212 | $ 0 | |
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 10 months 24 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 | 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 | |||
Unrecognized compensation costs related to unvested RSUs | $ 0 | |||
Expected dividend yield | 0.00% | |||
Risk free interest rate | 1.60% | |||
Expected volatility | 95.40% | |||
Terms of award | 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. | |||
Total instrinsic value of stock units vested,other than options | $ 2,301,515 |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 20,788,688 | $ 17,396,146 | $ 14,641,520 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 9,411,056 | 7,380,814 | 5,082,823 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 11,377,632 | $ 10,015,332 | $ 9,558,697 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 85.70% | 85.20% | 87.40% |
Expected volatility, maximum | 96.50% | 85.80% | 90.40% |
Weighted-average risk-free interest rate | 2.32% | 2.48% | 2.10% |
Expected term (in years) | 6 years | 6 years | 6 years |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 4,748,391 | |
Options granted, Number of Shares | 1,833,102 | |
Options exercised, Number of Shares | (264,663) | |
Options canceled or expired, Number of Shares | (276,885) | |
Outstanding at end of period, Number of Shares | 6,039,945 | 4,748,391 |
Vested or expected to vest at end of period, Number of Shares | 6,039,945 | |
Exercisable at end of period, Number of Shares | 3,313,108 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 18.26 | |
Options granted, Weighted-Average Exercise Price | 12.98 | |
Options exercised, Weighted-Average Exercise Price | 12.22 | |
Options canceled or expired, Weighted-Average Exercise Price | 20.82 | |
Outstanding at end of period, Weighted-Average Exercise Price | 16.81 | $ 18.26 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 16.81 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 19.38 | |
Options granted, Weighted-Average Contractual Life | 9 years 2 months 12 days | |
Options exercised, Weighted-Average Contractual Life | 4 years 1 month 6 days | |
Options canceled or expired, Weighted-Average Contractual Life | 6 years 9 months 18 days | |
Outstanding at end of period, Weighted-Average Contractual Life | 7 years | 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, 2019 | Dec. 31, 2018 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding at beginning of year, Number of Shares | 647,411 | ||
Time based RSU's granted, Number of Shares | 950,449 | ||
Time based RSU's vested, Number of Shares | (267,143) | ||
Time based RSU's cancelled, Number of Shares | (62,038) | ||
Outstanding at end of year, Number of Shares | 1,268,679 | 647,411 | 1,268,679 |
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value | $ 18.16 | ||
Time based RSU's granted, Weighted-Average Grant Date Fair Value | 12.79 | ||
Time based RSU's vested, Weighted-Average Grant Date Fair Value | 21.64 | ||
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value | 14.14 | ||
Outstanding at end of year, Weighted-Average Grant Date Fair Value | $ 13.60 | $ 18.16 | $ 13.60 |
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 9 months 18 days | |
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Average Remaining Contractual Terms | 2 years | ||
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 4 months 24 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, 2019 | Dec. 31, 2018 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding at beginning of year, Number of Shares | 278,592 | ||
Time based RSU's vested, Number of Shares | (65,111) | ||
Milestone RSUs and TSR RSU's cancelled, Number of Shares | (146,401) | ||
Outstanding at end of year, Number of Shares | 67,080 | 278,592 | 67,080 |
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value | $ 15.35 | ||
Milestone RSUs and TSR RSUs granted, Weighted- Average Grant Date Fair Value | 14.16 | ||
Milestone RSUs and TSR RSU's cancelled, Weighted-Average Grant Date Fair Value | 15.64 | ||
Outstanding at end of year, Weighted-Average Grant Date Fair Value | $ 17.08 | $ 15.35 | $ 17.08 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms | 2 months 12 days | 1 year 9 months 18 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 months 12 days |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2018 | |
Recognized tax benefit | $ 1,100,000 | ||
Federal net operating loss carryforwards | $ 183,100,000 | ||
Federal net operating loss carryforwards expiration year | 2037 | ||
Federal AMT credit | $ 264,609 | $ 529,218 | |
Unrecognized tax benefits | 1,738,815 | $ 1,738,815 | $ 1,738,815 |
Indefinite Period Carry Forward [Member] | |||
Federal net operating loss carryforwards | 51,900,000 | ||
Expire In 2037 [Member] | |||
Federal net operating loss carryforwards | $ 131,200,000 |
Income Taxes - Income (Loss) be
Income Taxes - Income (Loss) before Income Taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (56,121,258) | $ (30,299,751) | $ (20,486,935) |
Non-U.S. | (91,599,320) | (124,826,060) | (78,347,330) |
Loss before provision (benefit) for income taxes | $ (147,720,578) | $ (155,125,811) | $ (98,834,265) |
Income Taxes - Total Income Tax
Income Taxes - Total Income Tax (Benefit) Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Current | $ 1,600 | $ 1,600 | $ (2,416) |
Deferred | (8,484,822) | (5,054,468) | 13,713,987 |
Valuation allowance | 8,484,822 | 5,054,468 | (14,772,422) |
Provision (benefit) for income taxes | $ 1,600 | $ 1,600 | $ (1,060,851) |
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, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at statutory federal rate | 21.00% | 21.00% | 35.00% |
Other Permanent differences | (0.67%) | (0.58%) | (0.43%) |
Foreign rate differential | (13.02%) | (16.90%) | (27.75%) |
2017 US Tax Reform impact | 0.00% | 0.00% | (21.89%) |
R&D Credit | 0.00% | 0.00% | (0.05%) |
Change in effective state tax rates | (0.16%) | (0.38%) | 0.84% |
State income tax expense | (1.40%) | 0.12% | 0.40% |
Change in valuation allowance | (5.75%) | (3.26%) | 14.95% |
Benefit for income taxes | 0.00% | 0.00% | 1.07% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 49,668,232 | $ 43,872,566 |
Accrued employee benefits | 589,667 | 441,780 |
Research and development credit | 9,321,214 | 9,321,214 |
Stock compensation | 12,965,250 | 10,530,859 |
Federal AMT credit | 264,609 | 529,218 |
Deferred rent | 712,314 | |
Capital lease | 4,973,618 | |
Unrealized comprehensive loss | 146,531 | |
Depreciation | 1,082 | |
Deferred tax liabilities: | ||
Depreciation | (230,760) | |
Right of use asset—capital lease | (3,922,583) | |
Unrealized gains on investment | (27,577) | |
Net deferred tax asset | 73,601,670 | 65,555,564 |
Valuation allowance | (73,337,061) | (65,026,346) |
Net deferred tax asset | $ 264,609 | $ 529,218 |
Income Taxes - Summary of Gross
Income Taxes - Summary of Gross Unrecognized Tax Benefits (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
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 |
Collaborations and License Ag_2
Collaborations and License Agreements - Additional Information (Detail) - Product [Member] - Bristol-Myers Squibb Company [Member] - USD ($) | Dec. 23, 2019 | May 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2019 |
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 | ||||
License expiration period | through the later of ten years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product | ||||
Minimum [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Royalty payment, percentage | 5.00% | ||||
Maximum [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Royalty payment, percentage | 9.00% | ||||
Food and Drug Administration [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Obliged to make milestone payments | $ 2,000,000 | ||||
National Democratic Alliance [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Obliged to make milestone payments | 2,000,000 | ||||
Company remaining milestone payment | $ 5,000,000 | ||||
ITCI National Democratic Alliance Member [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Payment of milestone amount | $ 5,000,000 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Retirement Benefits [Abstract] | |||
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 | $ 658,179 | $ 429,318 | $ 378,233 |
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, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Net loss | $ (40,582,851) | $ (34,862,399) | $ (37,441,164) | $ (34,835,764) | $ (40,748,036) | $ (41,522,914) | $ (37,376,383) | $ (35,480,078) | $ (147,722,178) | $ (155,127,411) | $ (97,773,414) |
Basic and diluted net loss per share | $ (0.74) | $ (0.63) | $ (0.68) | $ (0.63) | $ (0.75) | $ (0.76) | $ (0.68) | $ (0.65) | $ (2.68) | $ (2.84) | $ (2.12) |