Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 25, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ITCI | ||
Entity Registrant Name | Intra-Cellular Therapies, Inc. | ||
Entity Central Index Key | 1,567,514 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Shell company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 55,116,739 | ||
Entity Public Float | $ 793 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 54,947,502 | $ 37,790,114 |
Investment securities, available-for-sale | 292,583,046 | 426,540,921 |
Prepaid expenses and other current assets | 7,908,133 | 4,884,293 |
Total current assets | 355,438,681 | 469,215,328 |
Property and equipment, net | 1,159,766 | 1,137,171 |
Long term deferred tax asset, net | 529,218 | 1,058,435 |
Other assets | 78,833 | 75,765 |
Total assets | 357,206,498 | 471,486,699 |
Current liabilities: | ||
Accounts payable | 13,961,060 | 6,173,539 |
Accrued and other current liabilities | 20,044,866 | 6,424,221 |
Accrued employee benefits | 2,293,259 | 1,611,846 |
Total current liabilities | 36,299,185 | 14,209,606 |
Long-term deferred rent | 3,192,432 | 2,840,132 |
Total liabilities | 39,491,617 | 17,049,738 |
Stockholders' equity: | ||
Common stock, $.0001 par value: 100,000,000 shares authorized; 54,895,295 and 54,597,679 shares issued and outstanding at December 31, 2018 and 2017, respectively | 5,490 | 5,460 |
Additional paid-in capital | 880,753,339 | 862,479,505 |
Accumulated deficit | (562,376,191) | (407,248,780) |
Accumulated comprehensive loss | (667,757) | (799,224) |
Total stockholders' equity | 317,714,881 | 454,436,961 |
Total liabilities and stockholders' equity | $ 357,206,498 | $ 471,486,699 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
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 | 54,895,295 | 54,597,679 |
Common stock, shares outstanding | 54,895,295 | 54,597,679 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Statement [Abstract] | |||
Grant revenue | $ 245,837 | $ 330,702 | |
Costs and expenses: | |||
Research and development | $ 132,166,913 | 79,419,009 | 93,831,530 |
General and administrative | 30,099,855 | 23,666,957 | 24,758,063 |
Total costs and expenses | 162,266,768 | 103,085,966 | 118,589,593 |
Loss from operations | (162,266,768) | (102,840,129) | (118,258,891) |
Interest income | (7,140,957) | (4,005,864) | (2,935,077) |
Interest expense | 36,781 | ||
Loss before provision (benefit) for income taxes | (155,125,811) | (98,834,265) | (115,360,595) |
Income tax expense (benefit) | 1,600 | (1,060,851) | 1,065,673 |
Net loss | $ (155,127,411) | $ (97,773,414) | $ (116,426,268) |
Net loss per common share: | |||
Basic & Diluted | $ (2.84) | $ (2.12) | $ (2.69) |
Weighted average number of common shares: | |||
Basic & Diluted | 54,707,865 | 46,181,926 | 43,240,188 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (155,127,411) | $ (97,773,414) | $ (116,426,268) |
Other comprehensive loss: | |||
Unrealized gain (loss) on investment securities | 131,467 | (481,985) | 273,171 |
Comprehensive loss | $ (154,995,944) | $ (98,255,399) | $ (116,153,097) |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' 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 Loss [Member] |
Balance at Dec. 31, 2015 | $ 476,242,911 | $ 4,316 | $ 669,878,103 | $ (193,049,098) | $ (590,410) | |||
Balance, shares at Dec. 31, 2015 | 43,155,875 | |||||||
Exercise of stock options | 477,734 | $ 12 | 477,722 | |||||
Exercise of stock options, shares | 123,745 | |||||||
Restricted Stock issued to employee | 0 | $ 0 | 0 | 0 | 0 | |||
Restricted Stock issued to employee, shares | 1,757 | |||||||
Stock issued for services | 233,772 | $ 1 | 233,771 | |||||
Stock issued for services, shares | 11,529 | |||||||
Share-based compensation | 14,701,219 | 14,701,219 | ||||||
Net loss | (116,426,268) | (116,426,268) | ||||||
Other comprehensive gain (loss) | 273,171 | 273,171 | ||||||
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 issuances of restricted stock | 285,160 | $ 17 | 285,143 | |||||
Exercise of stock options and issuances 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 gain (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 issuances of restricted stock | $ 674,206 | $ 29 | 674,177 | |||||
Exercise of stock options, shares | 143,056 | |||||||
Exercise of stock options and issuances of restricted stock, shares | 284,326 | |||||||
Stock issued for services | $ 192,530 | $ 1 | 192,529 | |||||
Stock issued for services, shares | 11,468 | |||||||
Share-based compensation | 17,396,146 | 17,396,146 | ||||||
Stock warrant | 10,982 | 10,982 | ||||||
Stock warrant, shares | 1,822 | |||||||
Net loss | (155,127,411) | (155,127,411) | ||||||
Other comprehensive gain (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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (155,127,411) | $ (97,773,414) | $ (116,426,268) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 368,673 | 213,872 | 196,872 |
Share-based compensation | 17,396,146 | 14,641,520 | 14,701,219 |
Stock issued for services | 192,530 | 190,885 | 233,772 |
Amortization of premiums and discounts on investment activities | (943,239) | 429,839 | 544,354 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 94,339 | (63,679) | |
Prepaid expenses and other assets | (3,026,908) | (879,200) | 4,016,164 |
Long term deferred tax asset, net | 529,217 | (1,058,435) | |
Accounts payable | 7,787,521 | 2,418,892 | 2,121,742 |
Accrued liabilities and employee benefits | 14,386,774 | 1,211,103 | 2,147,080 |
Deferred rent | 267,584 | 18,787 | 1,271,517 |
Net cash used in operating activities | (118,169,113) | (80,491,812) | (91,257,227) |
Investing activities | |||
Purchases of investments | (271,156,707) | (520,926,824) | (395,757,168) |
Maturities of investments | 406,189,288 | 428,932,538 | 488,068,547 |
Purchases of property and equipment | (391,268) | (723,429) | (48,964) |
Net cash provided by (used in) investing activities | 134,641,313 | (92,717,715) | 92,262,415 |
Financing activities | |||
Proceeds from line of credit | 125,000,000 | ||
Repayment of line of credit | (125,000,000) | ||
Proceeds from stock option exercises | 674,206 | 285,160 | 477,734 |
Proceeds of public offerings, net | 162,072,256 | ||
Proceeds from stock warrant | 10,982 | ||
Net cash provided by financing activities | 685,188 | 162,357,416 | 477,734 |
Net increase (decrease) in cash and cash equivalents | 17,157,388 | (10,852,111) | 1,482,922 |
Cash and cash equivalents at beginning of period | 37,790,114 | 48,642,225 | 47,159,303 |
Cash and cash equivalents at end of period | 54,947,502 | 37,790,114 | 48,642,225 |
Cash paid for interest | 36,781 | ||
Cash paid for taxes | $ 1,600 | $ 1,600 | $ 1,001,600 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2018 | |
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 and clinical development of innovative, small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system (“CNS”). The Company’s lead product candidate, lumateperone, is in Phase 3 clinical development as a novel treatment for schizophrenia, 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. In September 2016, the Company licensed certain intellectual property rights to its wholly-owned subsidiary, ITI Limited, which was formed in the third quarter of 2016. Although the license of intellectual property rights did not result in any gain or loss in the consolidated statements of operations, the $125 million of gain related to the transaction helped generate net taxable income for tax purposes in the U.S. and the Company utilized a portion of its available federal and state net operating loss carryforwards to offset the majority of this gain. Any taxes incurred related to intercompany transactions were treated as tax expense in the Company’s consolidated statement of operations. In addition to the license, the Company also entered into a research and development agreement with ITI Limited pursuant to which the Company will conduct research and development services related to the license agreement and charge ITI Limited for these services. 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 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 into the second half of 2020, at which time the Company will require additional financing. 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 September 2, 2016, the Company filed a universal shelf registration statement on Form S-3, In the third quarter of 2018, the Company completed the rolling submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia and in the fourth quarter of 2018 the FDA accepted the NDA for review. The NDA submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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 generally accepted accounting principles set forth in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is discovering and developing drugs for the treatment of neurological and psychiatric disorders. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of checking accounts, money market accounts, money market 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 Investment securities consisted of the following (in thousands): 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 December 31, 2017 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 126,330 $ — $ (348 ) $ 125,982 FDIC certificates of deposit (1) 8,306 — — 8,306 Certificates of deposit 103,500 — — 103,500 Commercial paper 51,414 — (61 ) 51,353 Corporate notes/bonds 137,790 — (390 ) 137,400 $ 427,340 $ — $ (799 ) $ 426,541 (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, 2018, the aggregate related fair value of investments with unrealized losses was $272.5 million and the aggregate amount of unrealized losses was $0.7 million. Of the $272.5 million, $180.4 million have been held in a continuous unrealized loss position for less than 12 months and $92.1 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 $345,000 as of December 31, 2018. As of December 31, 2017, the Company had approximately $37.3 million of investments with a continuous unrealized loss for 12 months or longer of approximately $42,000. The Company attributes the unrealized losses 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, 2018 and December 31, 2017. The carrying value of cash held in money market funds of approximately $39.6 million as of December 31, 2018 and $26.2 million as of December 31, 2017 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 $7.5 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 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 $ 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 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money market funds $ 26,181 $ 26,181 $ — $ — U.S. government agency securities 125,982 — 125,982 — FDIC certificates of deposit 8,306 — 8,306 — Certificates of deposit 103,500 — 103,500 — Commercial paper 51,353 — 51,353 — Corporate bonds/notes 137,400 — 137,400 — $ 452,722 $ 26,181 $ 426,541 $ — Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, prepaid expenses, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2018 and December 31, 2017. At December 31, 2018, the Company has approximately $2.4 million as a prepaid expense related to a regulatory filing fee that is expected to be refunded within the next year. Management believes that the risks associated with its 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, 2018 and 2017, 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 to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. 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 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 years ended December 31, 2018 and 2017, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. 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 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 taxes paid between 2018 and 2021. With the passing of the TCJA, the Company will receive a refund in future periods for AMT paid in prior years. The Company therefore has recognized a benefit of approximately $1.1 million for these taxes for the year ended December 31, 2017. 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 4th quarter 2018 and the provisional amounts the Company accounted for in its December 31, 2017 provision were finalized in 2018 with no adjustments. The Company recorded income tax expense of $1,600, a benefit of $1.1 million, and a tax expense of $1,065,673 for the years ended December 31, 2018, 2017, and 2016, respectively. The Company’s effective tax rate for the years ended December 31, 2018 and 2017 was approximately 0% and 1.1% respectively. The Company’s annual effective tax rate of approximately 0% is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not more likely than not to recognize a future tax benefit. Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized in the statements of operations for the years ended December 31, 2018, 2017 and 2016 is based on share-based awards ultimately expected to vest. 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 and in 2017 and 2018, the Company granted time-based RSUs that vest in three equal annual installments. In the first quarter of 2017, the Company granted performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a NDA with the FDA, (ii) the approval of the NDA by the FDA (collectively, the “Milestone RSUs”) and (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 amortization of the expenses for Milestone RSUs related to the approval of the NDA will commence if and when the NDA submission has been approved through the last day of the calendar year in which the milestone is achieved. The TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSU agreements which ends December 31, 2019. The Milestone RSUs and TSR RSUs are target based and the ultimate awards, if attained, could be the target amount or higher or lower than the target amount, depending on the timing or achievement of the goal. The expense recognition related to these equity grants is 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 Since the Company had net operating loss carryforwards as of December 31, 2018, 2017 and 2016, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. In March 2016, the FASB issued ASU No. 2016-09, 2016-09”). 2016-09 2016-09 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. 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 would be anti-dilutive as applied to the net loss for the years ended December 31, 2018, 2017 and 2016: Year Ended December 31, 2018 2017 2016 Common Stock Equivalents 610,429 476,252 1,225,614 RSUs 386,678 87,988 32,781 TSR RSUs 48,500 65,852 — Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company adopted this standard 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. In January 2016, the FASB issued ASU No. 2016-01, 2016-01”). 2016-01 available-for-sale 2016-01 In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 2016-02 We estimate adoption of the standard will result in recognition of additional net lease assets and lease liabilities of approximately $18 million and $21 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. We do not believe the new standard will have a notable impact on our liquidity. In February 2018, the FASB issued ASU No. 2018-02, In June 2018, the FASB issued ASU No. 2018-07, 2018-07”). 2018-07. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following: December 31, 2018 2017 Computer equipment $ 44,427 $ 33,584 Furniture and fixtures 341,582 301,509 Scientific equipment 3,658,209 3,494,866 Leasehold improvements 149,470 — 4,193,688 3,829,959 Less accumulated depreciation (3,033,922 ) (2,692,788 ) $ 1,159,766 $ 1,137,171 Depreciation expense for the years ended December 31, 2018, 2017 and 2016 was $368,673, $213,872 and $196,872, respectively. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 4. 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, 2018, the total number of shares reserved under all equity plans is 10,287,390 and the Company had 4,807,323 shares available for future issuance under the 2018 Plan. Stock options granted under the Plan may be either incentive stock options (“ISOs”) as defined by the Code, or non-qualified 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, 2018, 2017 and 2016, was comprised of the following: Years Ended December 31, 2018 2017 2016 Research and development $ 7,380,814 $ 5,082,823 $ 4,472,658 General and administrative 10,015,332 9,558,697 10,228,561 Total share-based compensation expense $ 17,396,146 $ 14,641,520 $ 14,701,219 The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2018, 2017 and 2016: 2018 2017 2016 Dividend yield 0 % 0 % 0 % Expected volatility 85.2%-85.8 % 87.4%-90.4 % 80.0%-90.0 % Weighted-average risk-free interest rate 2.48 % 2.1 % 1.7 % Expected term (in years) 6.0 6.0 5.9 Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2018, and changes during the period then ended, are summarized as follows: Number of Weighted- Aggregate Weighted- Outstanding at December 31, 2017 3,755,736 $ 18.75 $ 7,450,293 7.04 years Options granted 1,175,187 $ 15.22 9.37 years Options exercised (143,056 ) $ 4.71 1.55 years Options canceled or expired (39,476 ) $ 23.25 8.33 years Outstanding at December 31, 2018 4,748,391 $ 18.26 $ 4,074,116 6.98 years Vested or expected to vest at December 31, 2018 4,748,391 $ 18.26 Exercisable at December 31, 2018 2,936,552 $ 18.70 $ 4,074,116 5.89 years The weighted-average grant date fair value for awards granted during the years ended December 31, 2018, 2017 and 2016 was $15.22, $15.08 and $48.85 per share, respectively. Total intrinsic value of the options exercised during the years ended December 31, 2018, 2017 and 2016 was approximately $1,683,679, $1,609,268 and $2,984,283, respectively. The total fair value of shares vested in the years ended December 31, 2018, 2017 and 2016 was approximately $11,348,595, $7,212,195 and $9,310,898, respectively. During 2018, 2017 and 2016, the Company granted options to certain scientific advisory board members of the Company to purchase 12,000, 0 and 5,000 shares of common stock, respectively, at an average exercise price per share of $15.47, $0 and $53.63, respectively. 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, 2018 and 2017, there were $6,493,399 and $2,866,164, respectively, of unrecognized compensation costs related to unvested time based RSUs which will be recognized over a weighted-average period 1.9 years. The unrecognized share-based compensation expense related to stock option awards at December 31, 2018 is $13,669,451 and will be recognized over a weighted-average period of 2.0 years. The fair value of an RSU is based on the closing price of the Company’s common stock on the date of grant. Information regarding RSU activity, including with respect to grants to employees as of December 31, 2018, and changes during the year then ended, is summarized as follows: Number of Weighted- Outstanding at December 31, 2017 190,933 $ 25.48 RSU’s granted 544,542 $ 17.02 RSU’s vested (72,663 ) $ 29.03 RSU’s cancelled (15,401 ) $ 17.13 Outstanding at December 31, 2018 647,411 $ 18.16 The Company recognized non-cash Information related to the Company’s Milestone RSUs and the TSR RSUs during the year ended December 31, 2018 are summarized as follows: Number of Weighted- Outstanding at December 31, 2017 347,199 $ 15.35 RSU’s granted — $ — RSU’s vested (68,607 ) $ 15.35 RSU’s cancelled — $ — Outstanding at December 31, 2018 278,592 $ 15.35 The weighted average estimated fair value per share of the TSR RSUs granted in March 31, 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 will entitle the grantee to receive a number of shares of the Company’s common stock determined over a three-year performance period ending and vesting on December 31, 2019, provided the grantee remains in the service of the Company on the settlement date. The Company expenses the cost of these awards ratably over the requisite service period. The number of shares for which the TSR RSUs will be settled will be a percentage of shares for which the award is targeted and will depend on the Company’s total shareholder return (as defined below), expressed as a percentile ranking of the Company’s total shareholder return as compared to the Company’s peer group (as defined below). The number of shares for which the TSR RSUs will be settled vary depending on the level of achievement of the goal. Total shareholder return is determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2020 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2017, with a deemed reinvestment of any dividends declared during the performance period. The Company’s peer group includes 223 companies at December 31, 2018 which comprise the Nasdaq Biotechnology Index, which was selected by the Compensation Committee of the Company’s Board of Directors and includes a range of biotechnology companies operating in several business segments. As of December 31, 2018 and 2017 there were $2,795,202 and $4,177,362 respectively of unrecognized compensation costs related to unvested Milestone RSU grants and TSR RSU grants which will be recognized over a weighted average period of 1.0 years. |
Line of Credit
Line of Credit | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Line of Credit | 5. Line of Credit On September 30, 2016, the Company entered into a secured line of credit with a lender for an amount not to exceed $150.8 million. This line of credit was secured by approximately $150.8 million of collateral held by the lender. The interest on advances under this line of credit was fixed at LIBOR plus 2.991% on the date of advance. The Company borrowed $125.0 million on September 30, 2016 and repaid the entire amount on October 3, 2016. Interest expense under this secured line of credit was $36,781 for the year ended December 31, 2016. On October 6, 2016, the line of credit was terminated by the Company. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
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 taxes paid between 2018 and 2021. With the passing of the TCJA, the Company will receive a refund in future periods for AMT paid in prior years. The Company therefore has recognized a benefit of approximately $1.1 million for these taxes 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 year ended December 31, 2018, 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 eliminates 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 2018. Therefore, the Company has not included any tax impacts of BEAT in its consolidated financial statements for the year ended December 31, 2018. 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 4th quarter 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: 2018 2017 2016 U.S. $ (30,299,751 ) $ (20,486,935 ) $ (86,965,860 ) Non-U.S. (124,826,060 ) (78,347,330 ) (28,394,735 ) Total loss before taxes $ (155,125,811 ) $ (98,834,265 ) $ (115,360,595 ) Total income tax (benefit) expense for the years ended December 31, 2018, 2017 and 2016 is allocated as follows: 2018 2017 2016 Current $ 1,600 $ (2,416 ) $ 1,065,673 Deferred (5,054,468 ) 13,713,987 19,605,520 Valuation allowance 5,054,468 (14,772,422 ) (19,605,520 ) Provision (benefit) for income taxes $ 1,600 $ (1,060,851 ) $ 1,065,673 A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2018, 2017 and 2016 is as follows: December 31, 2018 2017 2016 Income tax benefit at statutory federal rate 21.00 % 35.00 % 35.00 % Royalty Income 0.00 0.00 (37.93 ) Other Permanent differences (0.58 ) (0.43 ) (0.78 ) Foreign rate differential (16.90 ) (27.75 ) (8.61 ) 2017 US Tax Reform impact 0.00 (21.89 ) 0.00 R&D Credit 0.00 (0.05 ) 2.08 Change in effective state tax rates (0.38 ) 0.84 (6.98 ) State income tax expense 0.12 0.40 (0.70 ) Change in valuation allowance (3.26 ) 14.95 16.99 Benefit (provision) for income taxes 0.00 % 1.07 % (0.93 )% 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, 2018, the Company had $145.3 million of federal net operating loss carryforwards, which expire at various dates through 2037. The gross amount of the state net operating loss carryforwards is equal to or less than the federal net operating loss carryforwards and expires over various periods based on individual state tax law. In general, businesses with U.S. net operating losses (“NOLs”) are considered loss corporations for U.S. federal income tax purposes. Pursuant to Section 382 of the Code, loss corporations that undergo an ownership change, as defined under the Code, may be subject to an annual limitation on the amount of NOLs (and certain other tax attributes) available to offset taxable income earned after such ownership change. For the years ended December 31, 2018, 2017 and 2015, the Company performed a Section 382 ownership analysis and determined that an ownership change occurred (within the meaning of Section 382 of the Code) in 2015 but not in subsequent periods. Based on the analysis performed, however, the Company does not believe that the Section 382 annual limitation will impact the Company’s ability to utilize the tax attributes that existed as of the date of the ownership change in a material manner. If the Company experiences an ownership change in the future, the tax benefits related to the NOLs and tax credit carryforwards may be further limited or lost. In September 2016, the Company licensed certain intellectual property rights to its wholly-owned subsidiary, ITI Limited, which was formed in the third quarter of 2016. The costs to develop, test, manufacture and perform other activities related to the lumateperone (also known as ITI-007) December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 43,872,566 $ 40,746,589 Accrued employee benefits 441,780 378,058 Research and development credit 9,321,214 9,321,214 Stock compensation 10,530,859 8,711,721 Federal AMT credit 529,218 1,058,435 Deferred rent 712,314 699,560 Unrealized comprehensive loss 146,531 187,714 Depreciation 1,082 — Deferred tax liabilities: Depreciation — (31,796 ) Net deferred tax asset 65,555,564 61,071,495 Valuation allowance (65,026,346 ) (60,013,060 ) Net deferred tax asset $ 529,218 $ 1,058,435 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, excluding the refundable alternative minimum tax credit in 2017 and 2018, 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 (50%) Federal AMT to Other Current Assets. The total amount of unrecognized tax benefits was $1.7 million as of December 31, 2018 and December 31, 2017. If recognized none of these tax benefits would affect the effective tax rate due to valuation allowances. The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2018 and 2017, respectively: December 31, 2018 2017 Balance at January 1, $ 1,738,815 $ 1,738,815 Current Year Uncertain Tax Positions: Gross Increases — — Balance at December 31, $ 1,738,815 $ 1,738,815 |
Collaborations and License Agre
Collaborations and License Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations and License Agreements | 7. Collaborations and License Agreements The Bristol-Myers Squibb License Agreement On May 31, 2005, the Company entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), pursuant to which the Company holds a license to certain patents and know-how Under the agreement, the Company made an upfront payment of $1.0 million to BMS, 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. Possible milestone payments remaining total $10.0 million, including a $5.0 million milestone payable upon an NDA approval. Under the agreement, the Company may be obliged to make other milestone payments to BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentage royalty payments ranging between 5 – 9% on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty The agreement extends, and royalties are payable, on a country-by-country product-by-product In September 2016, the Company transferred certain of its rights under the BMS Agreement to its wholly owned subsidiary, ITI Limited. In connection with the transfer, the Company guaranteed ITI Limited’s performance of its obligations under the BMS Agreement. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies The Company currently has an operating lease agreement with a commitment for $33,406,432 for laboratory and office facilities through 2029. At December 31, 2018, future minimum lease payments under leases having an initial or remaining non-cancellable Year 2019 $ 2,522,918 2020 2,946,086 2021 3,034,469 2022 3,125,503 2023 3,219,268 Thereafter 18,558,188 $ 33,406,432 Rent expense for the years ended December 31, 2018, 2017 and 2016 was $1,847,392, $1,427,716 and $1,419,940, respectively. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 | |
Related Party Transactions [Abstract] | |
Related Parties | 10. Related Parties In the first quarter of 2015, the Company moved its headquarters to 430 East 29th Street, New York, New York 10016. The Company has entered into a long-term lease with a related party for approximately 16,753 square feet of useable laboratory and office space . |
Unaudited Quarterly Financial I
Unaudited Quarterly Financial Information | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Financial Information | 11. Unaudited Quarterly Financial Information The tables herein set forth the Company’s unaudited condensed consolidated 2018 and 2017 quarterly statements of operations. The following table sets for 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 ) The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2017 quarters ended: 2017 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 5,055 $ 30,754 $ 114,741 $ 95,287 Net loss (30,208,712 ) (22,870,416 ) (17,760,704 ) (26,933,582 ) Basic and diluted net loss per share $ (0.56 ) $ (0.53 ) $ (0.41 ) $ (0.62 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
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 generally accepted accounting principles set forth in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is discovering and developing drugs for the treatment of neurological and psychiatric disorders. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of three months 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 Investment securities consisted of the following (in thousands): 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 December 31, 2017 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 126,330 $ — $ (348 ) $ 125,982 FDIC certificates of deposit (1) 8,306 — — 8,306 Certificates of deposit 103,500 — — 103,500 Commercial paper 51,414 — (61 ) 51,353 Corporate notes/bonds 137,790 — (390 ) 137,400 $ 427,340 $ — $ (799 ) $ 426,541 (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, 2018, the aggregate related fair value of investments with unrealized losses was $272.5 million and the aggregate amount of unrealized losses was $0.7 million. Of the $272.5 million, $180.4 million have been held in a continuous unrealized loss position for less than 12 months and $92.1 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 $345,000 as of December 31, 2018. As of December 31, 2017, the Company had approximately $37.3 million of investments with a continuous unrealized loss for 12 months or longer of approximately $42,000. The Company attributes the unrealized losses 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, 2018 and December 31, 2017. The carrying value of cash held in money market funds of approximately $39.6 million as of December 31, 2018 and $26.2 million as of December 31, 2017 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 $7.5 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 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 $ 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 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money market funds $ 26,181 $ 26,181 $ — $ — U.S. government agency securities 125,982 — 125,982 — FDIC certificates of deposit 8,306 — 8,306 — Certificates of deposit 103,500 — 103,500 — Commercial paper 51,353 — 51,353 — Corporate bonds/notes 137,400 — 137,400 — $ 452,722 $ 26,181 $ 426,541 $ — |
Financial Instruments | Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, prepaid expenses, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2018 and December 31, 2017. At December 31, 2018, the Company has approximately $2.4 million as a prepaid expense related to a regulatory filing fee that is expected to be refunded within the next year. Management believes that the risks associated with its 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. 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, 2018 and 2017, 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 Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. 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 | Research and Development 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 years ended December 31, 2018 and 2017, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
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 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 taxes paid between 2018 and 2021. With the passing of the TCJA, the Company will receive a refund in future periods for AMT paid in prior years. The Company therefore has recognized a benefit of approximately $1.1 million for these taxes for the year ended December 31, 2017. 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 4th quarter 2018 and the provisional amounts the Company accounted for in its December 31, 2017 provision were finalized in 2018 with no adjustments. The Company recorded income tax expense of $1,600, a benefit of $1.1 million, and a tax expense of $1,065,673 for the years ended December 31, 2018, 2017, and 2016, respectively. The Company’s effective tax rate for the years ended December 31, 2018 and 2017 was approximately 0% and 1.1% respectively. The Company’s annual effective tax rate of approximately 0% is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not more likely than not to recognize a future tax benefit. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner |
Share-Based Compensation | Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized in the statements of operations for the years ended December 31, 2018, 2017 and 2016 is based on share-based awards ultimately expected to vest. 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 and in 2017 and 2018, the Company granted time-based RSUs that vest in three equal annual installments. In the first quarter of 2017, the Company granted performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a NDA with the FDA, (ii) the approval of the NDA by the FDA (collectively, the “Milestone RSUs”) and (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 amortization of the expenses for Milestone RSUs related to the approval of the NDA will commence if and when the NDA submission has been approved through the last day of the calendar year in which the milestone is achieved. The TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSU agreements which ends December 31, 2019. The Milestone RSUs and TSR RSUs are target based and the ultimate awards, if attained, could be the target amount or higher or lower than the target amount, depending on the timing or achievement of the goal. The expense recognition related to these equity grants is 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 Since the Company had net operating loss carryforwards as of December 31, 2018, 2017 and 2016, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. In March 2016, the FASB issued ASU No. 2016-09, 2016-09”). 2016-09 2016-09 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. |
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 would be anti-dilutive as applied to the net loss for the years ended December 31, 2018, 2017 and 2016: Year Ended December 31, 2018 2017 2016 Common Stock Equivalents 610,429 476,252 1,225,614 RSUs 386,678 87,988 32,781 TSR RSUs 48,500 65,852 — |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company adopted this standard 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. In January 2016, the FASB issued ASU No. 2016-01, 2016-01”). 2016-01 available-for-sale 2016-01 In February 2016, the FASB issued ASU No. 2016-02, 2016-02”). 2016-02 2016-02 We estimate adoption of the standard will result in recognition of additional net lease assets and lease liabilities of approximately $18 million and $21 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. We do not believe the new standard will have a notable impact on our liquidity. In February 2018, the FASB issued ASU No. 2018-02, In June 2018, the FASB issued ASU No. 2018-07, 2018-07”). 2018-07. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): 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 December 31, 2017 Amortized Unrealized Unrealized Estimated U.S. government agency securities $ 126,330 $ — $ (348 ) $ 125,982 FDIC certificates of deposit (1) 8,306 — — 8,306 Certificates of deposit 103,500 — — 103,500 Commercial paper 51,414 — (61 ) 51,353 Corporate notes/bonds 137,790 — (390 ) 137,400 $ 427,340 $ — $ (799 ) $ 426,541 (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 $ 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 $ — Fair Value Measurements at Reporting Date Using December 31, Quoted Prices Significant Significant Money market funds $ 26,181 $ 26,181 $ — $ — U.S. government agency securities 125,982 — 125,982 — FDIC certificates of deposit 8,306 — 8,306 — Certificates of deposit 103,500 — 103,500 — Commercial paper 51,353 — 51,353 — Corporate bonds/notes 137,400 — 137,400 — $ 452,722 $ 26,181 $ 426,541 $ — |
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 would be anti-dilutive as applied to the net loss for the years ended December 31, 2018, 2017 and 2016: Year Ended December 31, 2018 2017 2016 Common Stock Equivalents 610,429 476,252 1,225,614 RSUs 386,678 87,988 32,781 TSR RSUs 48,500 65,852 — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: December 31, 2018 2017 Computer equipment $ 44,427 $ 33,584 Furniture and fixtures 341,582 301,509 Scientific equipment 3,658,209 3,494,866 Leasehold improvements 149,470 — 4,193,688 3,829,959 Less accumulated depreciation (3,033,922 ) (2,692,788 ) $ 1,159,766 $ 1,137,171 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, 2017 and 2016, was comprised of the following: Years Ended December 31, 2018 2017 2016 Research and development $ 7,380,814 $ 5,082,823 $ 4,472,658 General and administrative 10,015,332 9,558,697 10,228,561 Total share-based compensation expense $ 17,396,146 $ 14,641,520 $ 14,701,219 |
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, 2018, 2017 and 2016: 2018 2017 2016 Dividend yield 0 % 0 % 0 % Expected volatility 85.2%-85.8 % 87.4%-90.4 % 80.0%-90.0 % Weighted-average risk-free interest rate 2.48 % 2.1 % 1.7 % Expected term (in years) 6.0 6.0 5.9 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2018, and changes during the period then ended, are summarized as follows: Number of Weighted- Aggregate Weighted- Outstanding at December 31, 2017 3,755,736 $ 18.75 $ 7,450,293 7.04 years Options granted 1,175,187 $ 15.22 9.37 years Options exercised (143,056 ) $ 4.71 1.55 years Options canceled or expired (39,476 ) $ 23.25 8.33 years Outstanding at December 31, 2018 4,748,391 $ 18.26 $ 4,074,116 6.98 years Vested or expected to vest at December 31, 2018 4,748,391 $ 18.26 Exercisable at December 31, 2018 2,936,552 $ 18.70 $ 4,074,116 5.89 years |
Time Based Restricted Stock Units [Member] | |
Summary of Information Regarding RSU Activity | Information regarding RSU activity, including with respect to grants to employees as of December 31, 2018, and changes during the year then ended, is summarized as follows: Number of Weighted- Outstanding at December 31, 2017 190,933 $ 25.48 RSU’s granted 544,542 $ 17.02 RSU’s vested (72,663 ) $ 29.03 RSU’s cancelled (15,401 ) $ 17.13 Outstanding at December 31, 2018 647,411 $ 18.16 |
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, 2018 are summarized as follows: Number of Weighted- Outstanding at December 31, 2017 347,199 $ 15.35 RSU’s granted — $ — RSU’s vested (68,607 ) $ 15.35 RSU’s cancelled — $ — Outstanding at December 31, 2018 278,592 $ 15.35 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Summary of Income (loss) before Income Taxes | Income (loss) before income taxes is as follows: 2018 2017 2016 U.S. $ (30,299,751 ) $ (20,486,935 ) $ (86,965,860 ) Non-U.S. (124,826,060 ) (78,347,330 ) (28,394,735 ) Total loss before taxes $ (155,125,811 ) $ (98,834,265 ) $ (115,360,595 ) |
Total Income Tax (Benefit) Expense | Total income tax (benefit) expense for the years ended December 31, 2018, 2017 and 2016 is allocated as follows: 2018 2017 2016 Current $ 1,600 $ (2,416 ) $ 1,065,673 Deferred (5,054,468 ) 13,713,987 19,605,520 Valuation allowance 5,054,468 (14,772,422 ) (19,605,520 ) Provision (benefit) for income taxes $ 1,600 $ (1,060,851 ) $ 1,065,673 |
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, 2018, 2017 and 2016 is as follows: December 31, 2018 2017 2016 Income tax benefit at statutory federal rate 21.00 % 35.00 % 35.00 % Royalty Income 0.00 0.00 (37.93 ) Other Permanent differences (0.58 ) (0.43 ) (0.78 ) Foreign rate differential (16.90 ) (27.75 ) (8.61 ) 2017 US Tax Reform impact 0.00 (21.89 ) 0.00 R&D Credit 0.00 (0.05 ) 2.08 Change in effective state tax rates (0.38 ) 0.84 (6.98 ) State income tax expense 0.12 0.40 (0.70 ) Change in valuation allowance (3.26 ) 14.95 16.99 Benefit (provision) for income taxes 0.00 % 1.07 % (0.93 )% |
Deferred Tax Assets and Liabilities | The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017, respectively: December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 43,872,566 $ 40,746,589 Accrued employee benefits 441,780 378,058 Research and development credit 9,321,214 9,321,214 Stock compensation 10,530,859 8,711,721 Federal AMT credit 529,218 1,058,435 Deferred rent 712,314 699,560 Unrealized comprehensive loss 146,531 187,714 Depreciation 1,082 — Deferred tax liabilities: Depreciation — (31,796 ) Net deferred tax asset 65,555,564 61,071,495 Valuation allowance (65,026,346 ) (60,013,060 ) Net deferred tax asset $ 529,218 $ 1,058,435 |
Summary of Gross Unrecognized Tax Benefits | The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2018 and 2017, respectively: December 31, 2018 2017 Balance at January 1, $ 1,738,815 $ 1,738,815 Current Year Uncertain Tax Positions: Gross Increases — — Balance at December 31, $ 1,738,815 $ 1,738,815 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments having Initial or Remaining Non Cancellable Lease Term | At December 31, 2018, future minimum lease payments under leases having an initial or remaining non-cancellable Year 2019 $ 2,522,918 2020 2,946,086 2021 3,034,469 2022 3,125,503 2023 3,219,268 Thereafter 18,558,188 $ 33,406,432 |
Unaudited Quarterly Financial_2
Unaudited Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The following table sets for 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 ) The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2017 quarters ended: 2017 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 5,055 $ 30,754 $ 114,741 $ 95,287 Net loss (30,208,712 ) (22,870,416 ) (17,760,704 ) (26,933,582 ) Basic and diluted net loss per share $ (0.56 ) $ (0.53 ) $ (0.41 ) $ (0.62 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) | Oct. 05, 2017USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | Oct. 30, 2017USD ($) | Sep. 14, 2016USD ($) |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Securities remained available for issuance under the Company's shelf registration | $ 178,000,000 | |||
IPO [Member] | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Initial public offering, Number of shares | shares | 11,129,032 | |||
Initial public offering, Price per share | $ / shares | $ 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 | shares | 1,451,613 | |||
Lumateperone [member] | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Number of clinical trials | 20 | |||
ITI Limited [Member] | Intellectual Property [Member] | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Finite lived intangible assets transactional gain | $ 125,000,000 | |||
Maximum [Member] | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Universal shelf registration statement, effective date value | $ 350,000,000 | |||
Minimum [Member] | Lumateperone [member] | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Number of subjects exposed medicine | 1,900 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2016 | Dec. 31, 2018USD ($)Segment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 01, 2019USD ($) | 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 | $ 292,583,046 | $ 426,540,921 | ||||
Aggregate related fair value of investments with unrealized losses | 272,500,000 | |||||
Investment securities aggregate amount of unrealized loss | 700,000 | |||||
Investment securities, held in continuous unrealized loss position for less than 12 months | 180,400,000 | 37,300,000 | ||||
Investment securities, held in continuous unrealized loss position for 12 months or longer | 92,100,000 | 42,000 | ||||
Total continuous unrealized loss for investments held for 12 months or longer | 345,000 | |||||
Carrying value of cash held in money market funds | 39,600,000 | 26,200,000 | ||||
Prepaid expense related to regulatory filing | 2,400,000 | |||||
Impairment losses recognized | 0 | |||||
Recognized tax benefit | (1,100,000) | |||||
Income tax expense (benefit) | $ 1,600 | $ (1,060,851) | $ 1,065,673 | |||
Effective tax rate | 0.00% | 1.07% | (0.93%) | |||
Annual effective tax rate | 0.00% | |||||
US statutory rate | 21.00% | 35.00% | 35.00% | |||
Assumed expected dividend rate | 0.00% | 0.00% | 0.00% | |||
Excess tax benefits for tax deductions | $ 0 | $ 0 | $ 0 | |||
Cash and Cash Equivalents [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Carrying value of cash held in certificates of deposit | 7,500,000 | |||||
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] | Subsequent Event [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Net lease assets | $ 18,000,000 | |||||
Net lease liabilities | $ 21,000,000 | |||||
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Investment securities, available-for-sale | $ 64,600,000 | $ 93,300,000 | ||||
2018 Equity Incentive Plan [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Additional shares of common stock reserved for future equity grants | shares | 4,750,000 | |||||
RSUs [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Service period for granted RSUs, vest in annual installment | 3 years | 3 years | ||||
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, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 293,251,000 | $ 427,340,000 |
Unrealized Gains | 31,000 | |
Unrealized (Losses) | (699,000) | (799,000) |
Estimated Fair Value | 292,583,046 | 426,540,921 |
FDIC Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 245,000 | 8,306,000 |
Estimated Fair Value | 245,000 | 8,306,000 |
U.S. Government Agency Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 124,691,000 | 126,330,000 |
Unrealized Gains | 24,000 | |
Unrealized (Losses) | (289,000) | (348,000) |
Estimated Fair Value | 124,426,000 | 125,982,000 |
Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,000,000 | 103,500,000 |
Estimated Fair Value | 1,000,000 | 103,500,000 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 41,317,000 | 51,414,000 |
Unrealized (Losses) | (45,000) | (61,000) |
Estimated Fair Value | 41,272,000 | 51,353,000 |
Corporate Notes/Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 125,998,000 | 137,790,000 |
Unrealized Gains | 7,000 | |
Unrealized (Losses) | (365,000) | (390,000) |
Estimated Fair Value | $ 125,640,000 | $ 137,400,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Investment Securities (Parenthetical) (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
FDIC Certificates of Deposit [Member] | Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Deposits under FDIC Certificates of Deposit | $ 250,000 | $ 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, 2018 | Dec. 31, 2017 |
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 339,674 | $ 452,722 |
Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 39,591 | 26,181 |
U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 124,426 | 125,982 |
FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 245 | 8,306 |
Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 8,500 | 103,500 |
Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 41,272 | 51,353 |
Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 125,640 | 137,400 |
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 | 39,591 | 26,181 |
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 | 39,591 | 26,181 |
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 | 300,083 | 426,541 |
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 | 124,426 | 125,982 |
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 | 8,306 |
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 | 8,500 | 103,500 |
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 | 41,272 | 51,353 |
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 | $ 125,640 | $ 137,400 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
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 | 610,429 | 476,252 | 1,225,614 |
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 | 386,678 | 87,988 | 32,781 |
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 | 48,500 | 65,852 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 4,193,688 | $ 3,829,959 |
Less accumulated depreciation | (3,033,922) | (2,692,788) |
Property Plant and Equipment Net | 1,159,766 | 1,137,171 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 44,427 | 33,584 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 341,582 | 301,509 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 3,658,209 | $ 3,494,866 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 149,470 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 368,673 | $ 213,872 | $ 196,872 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 10,287,390 | |||
Weighted average grant date fair value of stock options granted | $ 15.22 | $ 15.08 | $ 48.85 | |
Total intrinsic value of the options exercised | $ 1,683,679 | $ 1,609,268 | $ 2,984,283 | |
Total fair value of shares vested | $ 11,348,595 | $ 7,212,195 | $ 9,310,898 | |
Options granted, Number of Shares | 1,175,187 | |||
Options granted, exercise price | $ 15.22 | |||
Unrecognized share-based compensation expense related to employee stock option awards | $ 13,669,451 | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% | |
Risk free interest rate | 2.48% | 2.10% | 1.70% | |
Scientific Advisory Board Members [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 2 years | |||
Options granted, Number of Shares | 12,000 | 0 | 5,000 | |
Options granted, exercise price | $ 15.47 | $ 0 | $ 53.63 | |
2018 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 4,807,323 | |||
Total Shareholder Return Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 3 years | |||
Weighted average grant date fair value of stock options granted | $ 17.08 | |||
Unrecognized compensation costs related to unvested RSUs | $ 4,177,362 | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year | |||
Expected dividend yield | 0.00% | |||
Risk free interest rate | 1.60% | |||
Expected volatility | 95.40% | |||
Vesting date | Dec. 31, 2019 | |||
Terms of award | Total shareholder return is 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. | |||
Time Based Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested RSUs | $ 6,493,399 | $ 2,866,164 | ||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 10 months 24 days | |||
RSUs [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Non-cash stock-based compensation expense recognized | $ 4,800,000 | $ 2,100,000 | $ 1,500,000 | |
Milestone Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested RSUs | $ 2,795,202 | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year | |||
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 | 2 years | |||
Stock Options [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 1 year | |||
Stock Options [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 3 years |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 17,396,146 | $ 14,641,520 | $ 14,701,219 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 7,380,814 | 5,082,823 | 4,472,658 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 10,015,332 | $ 9,558,697 | $ 10,228,561 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility, minimum | 85.20% | 87.40% | 80.00% |
Expected volatility, maximum | 85.80% | 90.40% | 90.00% |
Weighted-average risk-free interest rate | 2.48% | 2.10% | 1.70% |
Expected term (in years) | 6 years | 6 years | 5 years 10 months 24 days |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 3,755,736 | |
Options granted, Number of Shares | 1,175,187 | |
Options exercised, Number of Shares | (143,056) | |
Options canceled or expired, Number of Shares | (39,476) | |
Outstanding at end of period, Number of Shares | 4,748,391 | 3,755,736 |
Vested or expected to vest at end of period, Number of Shares | 4,748,391 | |
Exercisable at end of period, Number of Shares | 2,936,552 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 18.75 | |
Options granted, Weighted-Average Exercise Price | 15.22 | |
Options exercised, Weighted-Average Exercise Price | 4.71 | |
Options canceled or expired, Weighted-Average Exercise Price | 23.25 | |
Outstanding at end of period, Weighted-Average Exercise Price | 18.26 | $ 18.75 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 18.26 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 18.70 | |
Outstanding at end of period, Aggregate Intrinsic Value | $ 4,074,116 | $ 7,450,293 |
Exercisable at end of period, Aggregate Intrinsic Value | $ 4,074,116 | |
Options granted, Weighted-Average Contractual Life | 9 years 4 months 13 days | |
Options exercised, Weighted-Average Contractual Life | 1 year 6 months 18 days | |
Options canceled or expired, Weighted-Average Contractual Life | 8 years 3 months 29 days | |
Outstanding at end of period, Weighted-Average Contractual Life | 6 years 11 months 23 days | 7 years 14 days |
Exercisable at end of period, Weighted-Average Contractual Life | 5 years 10 months 20 days |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs [Member] | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 190,933 |
RSU's granted, Number of Shares | shares | 544,542 |
RSU's vested, Number of Shares | shares | (72,663) |
RSU's cancelled, Number of Shares | shares | (15,401) |
Outstanding at end of period, Number of Shares | shares | 647,411 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 25.48 |
RSU's granted, Weighted-Average Grant Date Fair Value | $ / shares | 17.02 |
RSU's vested, Weighted-Average Grant Date Fair Value | $ / shares | 29.03 |
RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 17.13 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 18.16 |
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] | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 347,199 |
RSU's granted, Number of Shares | shares | 0 |
RSU's vested, Number of Shares | shares | (68,607) |
RSU's cancelled, Number of Shares | shares | 0 |
Outstanding at end of period, Number of Shares | shares | 278,592 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 15.35 |
RSU's granted, Weighted-Average Grant Date Fair Value Per Share | $ / shares | 0 |
RSU's vested, Weighted-Average Grant Date Fair Value | $ / shares | 15.35 |
RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 0 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 15.35 |
Line of Credit - Additional Inf
Line of Credit - Additional Information (Detail) - USD ($) | Sep. 30, 2018 | Oct. 03, 2016 | Dec. 31, 2016 |
Line of Credit Facility [Line Items] | |||
Repayment of line of credit | $ 125,000,000 | ||
Interest expense | 36,781 | ||
Secured Line of Credit [Member] | |||
Line of Credit Facility [Line Items] | |||
Line of credit maximum amount | $ 150,800,000 | ||
Line of credit, collateral amount held by the lender | 150,800,000 | ||
Line of credit borrowed amount | $ 125,000,000 | ||
Repayment of line of credit | $ 125,000,000 | ||
Description of variable rate basis | LIBOR plus 2.991% | ||
Interest expense | $ 36,781 | ||
Secured Line of Credit [Member] | London Interbank Offered Rate (LIBOR) [Member] | |||
Line of Credit Facility [Line Items] | |||
Variable interest rate | 2.991% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Income Tax Disclosure [Abstract] | |||
Recognized tax benefit | $ (1,100,000) | ||
Number of new U.S. tax base erosion provisions | 2 | ||
Federal net operating loss carryforwards | $ 145,300,000 | ||
Federal net operating loss carryforwards expiration year | 2,037 | ||
Federal AMT credit | $ 529,218 | 1,058,435 | |
Percentage of alternative minimum tax | 50.00% | ||
Unrecognized tax benefits | $ 1,738,815 | $ 1,738,815 | $ 1,738,815 |
Income Taxes - Income (Loss) be
Income Taxes - Income (Loss) before Income Taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (30,299,751) | $ (20,486,935) | $ (86,965,860) |
Non-U.S. | (124,826,060) | (78,347,330) | (28,394,735) |
Loss before provision (benefit) for income taxes | $ (155,125,811) | $ (98,834,265) | $ (115,360,595) |
Income Taxes - Total Income Tax
Income Taxes - Total Income Tax (Benefit) Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Current | $ 1,600 | $ (2,416) | $ 1,065,673 |
Deferred | (5,054,468) | 13,713,987 | 19,605,520 |
Valuation allowance | 5,054,468 | (14,772,422) | (19,605,520) |
Provision (benefit) for income taxes | $ 1,600 | $ (1,060,851) | $ 1,065,673 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at statutory federal rate | 21.00% | 35.00% | 35.00% |
Royalty Income | 0.00% | 0.00% | (37.93%) |
Other Permanent differences | (0.58%) | (0.43%) | (0.78%) |
Foreign rate differential | (16.90%) | (27.75%) | (8.61%) |
2017 US Tax Reform impact | 0.00% | (21.89%) | 0.00% |
R&D Credit | 0.00% | (0.05%) | 2.08% |
Change in effective state tax rates | (0.38%) | 0.84% | (6.98%) |
State income tax expense | 0.12% | 0.40% | (0.70%) |
Change in valuation allowance | (3.26%) | 14.95% | 16.99% |
Benefit (provision) for income taxes | 0.00% | 1.07% | (0.93%) |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 43,872,566 | $ 40,746,589 |
Accrued employee benefits | 441,780 | 378,058 |
Research and development credit | 9,321,214 | 9,321,214 |
Stock compensation | 10,530,859 | 8,711,721 |
Federal AMT credit | 529,218 | 1,058,435 |
Deferred rent | 712,314 | 699,560 |
Unrealized comprehensive loss | 146,531 | 187,714 |
Depreciation | 1,082 | |
Deferred tax liabilities: | ||
Depreciation | (31,796) | |
Net deferred tax asset | 65,555,564 | 61,071,495 |
Valuation allowance | (65,026,346) | (60,013,060) |
Net deferred tax asset | $ 529,218 | $ 1,058,435 |
Income Taxes - Summary of Gross
Income Taxes - Summary of Gross Unrecognized Tax Benefits (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
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 Increases | 0 | 0 |
Balance at December 31, | $ 1,738,815 | $ 1,738,815 |
Collaborations and License Ag_2
Collaborations and License Agreements - Additional Information (Detail) - Collaborative Arrangement, Product [Member] - Bristol-Myers Squibb Company [Member] - USD ($) | May 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2018 |
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 | |||
Company remaining milestone payment | $ 10,000,000 | |||
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 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Other Commitments [Line Items] | |||
Operating lease agreements with commitment through 2027 | $ 33,406,432 | ||
Rent expense | 1,847,392 | $ 1,427,716 | $ 1,419,940 |
Laboratory and Office Facilities [Member] | |||
Other Commitments [Line Items] | |||
Operating lease agreements with commitment through 2027 | $ 33,406,432 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Minimum Lease Payments having Initial or Remaining Non Cancellable Lease Term (Detail) | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,019 | $ 2,522,918 |
2,020 | 2,946,086 |
2,021 | 3,034,469 |
2,022 | 3,125,503 |
2,023 | 3,219,268 |
Thereafter | 18,558,188 |
Total | $ 33,406,432 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Retirement Benefits [Abstract] | |||
Employer matching contribution | 100.00% | 100.00% | 50.00% |
Contributions made by participants for which the company makes matching contribution | 6.00% | 6.00% | 6.00% |
Contribution expense | $ 429,318 | $ 378,233 | $ 157,244 |
Related Party - Additional Info
Related Party - Additional Information (Detail) - ft² | Sep. 28, 2018 | Mar. 31, 2015 |
Related Party Transactions [Abstract] | ||
Area of usable laboratory and office space | 15,534 | 16,753 |
Term of long term lease | 14 years 2 months 12 days |
Unaudited Quarterly Financial_3
Unaudited Quarterly Financial Information - Schedule of Quarterly Financial Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 5,055 | $ 30,754 | $ 114,741 | $ 95,287 | |||||||
Net loss | $ (40,748,036) | $ (41,522,914) | $ (37,376,383) | $ (35,480,078) | $ (30,208,712) | $ (22,870,416) | $ (17,760,704) | $ (26,933,582) | $ (155,127,411) | $ (97,773,414) | $ (116,426,268) |
Basic and diluted net loss per share | $ (0.75) | $ (0.76) | $ (0.68) | $ (0.65) | $ (0.56) | $ (0.53) | $ (0.41) | $ (0.62) | $ (2.84) | $ (2.12) | $ (2.69) |