Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 28, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
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 | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 54,680,452 | ||
Entity Public Float | $ 443 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 37,790,114 | $ 48,642,225 |
Investment securities, available-for-sale | 426,540,921 | 335,458,459 |
Accounts receivable | 94,339 | |
Prepaid expenses and other current assets | 4,884,293 | 4,005,093 |
Total current assets | 469,215,328 | 388,200,116 |
Property and equipment, net | 1,137,171 | 627,614 |
Long term deferred tax asset, net | 1,058,435 | |
Other assets | 75,765 | 75,765 |
Total assets | 471,486,699 | 388,903,495 |
Current liabilities: | ||
Accounts payable | 6,173,539 | 3,754,647 |
Accrued and other current liabilities | 6,424,221 | 5,329,293 |
Accrued employee benefits | 1,611,846 | 1,448,394 |
Total current liabilities | 14,209,606 | 10,532,334 |
Long-term deferred rent | 2,840,132 | 2,868,622 |
Total liabilities | 17,049,738 | 13,400,956 |
Stockholders' equity: | ||
Common stock, $.0001 par value: 100,000,000 shares authorized; 54,597,679 and 43,292,906 shares issued and outstanding at December 31, 2017 and 2016, respectively | 5,460 | 4,329 |
Additional paid-in capital | 862,479,505 | 685,290,815 |
Accumulated deficit | (407,248,780) | (309,475,366) |
Accumulated comprehensive loss | (799,224) | (317,239) |
Total stockholders' equity | 454,436,961 | 375,502,539 |
Total liabilities and stockholders' equity | $ 471,486,699 | $ 388,903,495 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
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 | 54,597,679 | 43,292,906 |
Common stock, shares outstanding | 54,597,679 | 43,292,906 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenues: | |||
License and collaboration revenue | $ 30,659 | ||
Grant revenue | $ 245,837 | $ 330,702 | 60,705 |
Total revenues | 245,837 | 330,702 | 91,364 |
Costs and expenses: | |||
Research and development | 79,419,009 | 93,831,530 | 87,718,074 |
General and administrative | 23,666,957 | 24,758,063 | 18,187,286 |
Total costs and expenses | 103,085,966 | 118,589,593 | 105,905,360 |
Loss from operations | (102,840,129) | (118,258,891) | (105,813,996) |
Interest income | (4,005,864) | (2,935,077) | (1,022,455) |
Interest expense | 36,781 | ||
Loss before (benefit) provision for income taxes | (98,834,265) | (115,360,595) | (104,791,541) |
Income tax (benefit) expense | (1,060,851) | 1,065,673 | 1,600 |
Net loss | $ (97,773,414) | $ (116,426,268) | $ (104,793,141) |
Net loss per common share: | |||
Basic & Diluted | $ (2.12) | $ (2.69) | $ (2.91) |
Weighted average number of common shares: | |||
Basic & Diluted | 46,181,926 | 43,240,188 | 36,069,237 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (97,773,414) | $ (116,426,268) | $ (104,793,141) |
Other comprehensive loss: | |||
Unrealized (loss) gain on investment securities | (481,985) | 273,171 | (485,777) |
Comprehensive loss | $ (98,255,399) | $ (116,153,097) | $ (105,278,918) |
Consolidated Statement of Share
Consolidated Statement of Shareholders' Equity - USD ($) | Total | March 11, 2015 [Member] | September 28, 2015 [Member] | October 2017 [Member] | Common Stock [Member] | Common Stock [Member]March 11, 2015 [Member] | Common Stock [Member]September 28, 2015 [Member] | Common Stock [Member]October 2017 [Member] | Additional Paid-in Capital [Member] | Additional Paid-in Capital [Member]March 11, 2015 [Member] | Additional Paid-in Capital [Member]September 28, 2015 [Member] | Additional Paid-in Capital [Member]October 2017 [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] |
Balance at Dec. 31, 2014 | $ 120,554,705 | $ 2,950 | $ 208,912,345 | $ (88,255,957) | $ (104,633) | |||||||||
Common shares issued | $ 121,804,369 | $ 327,436,205 | $ 541 | $ 793 | $ 121,803,828 | $ 327,435,412 | ||||||||
Balance, shares at Dec. 31, 2014 | 29,499,059 | |||||||||||||
Common shares issued, shares | 5,411,481 | 7,935,000 | ||||||||||||
Exercise of stock options | 653,046 | $ 31 | 653,015 | |||||||||||
Exercise of stock options, shares | 305,005 | |||||||||||||
Stock issued for services | 182,599 | $ 1 | 182,598 | |||||||||||
Stock issued for services, shares | 5,330 | |||||||||||||
Share-based compensation | 10,890,905 | 10,890,905 | ||||||||||||
Net loss | (104,793,141) | (104,793,141) | ||||||||||||
Other comprehensive gain (loss) | (485,777) | (485,777) | ||||||||||||
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, shares | 135,999 | |||||||||||||
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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating activities | |||
Net loss | $ (97,773,414) | $ (116,426,268) | $ (104,793,141) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 213,872 | 196,872 | 139,626 |
Share-based compensation expense | 14,641,520 | 14,701,219 | 10,890,905 |
Issuance of stock for services | 190,885 | 233,772 | 182,599 |
Amortization of premiums on investment activities | 429,839 | 544,354 | 712,675 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 94,339 | (63,679) | 20,943 |
Prepaid expenses and other assets | (879,200) | 4,016,164 | (6,737,125) |
Long term deferred tax asset, net | (1,058,435) | ||
Accounts payable | 2,418,892 | 2,121,742 | (419,860) |
Accrued liabilities and employee benefits | 1,211,103 | 2,147,080 | (3,873,692) |
Deferred rent | 18,787 | 1,271,517 | 1,597,105 |
Net cash used in operating activities | (80,491,812) | (91,257,227) | (102,279,965) |
Investing activities | |||
Purchases of investments | (520,926,824) | (395,757,168) | (514,308,249) |
Maturities of investments | 428,932,538 | 488,068,547 | 153,389,448 |
Purchases of property and equipment | (723,429) | (48,964) | (860,595) |
Net cash (used in) provided by investing activities | (92,717,715) | 92,262,415 | (361,779,396) |
Financing activities | |||
Proceeds from line of credit | 125,000,000 | ||
Repayment of line of credit | (125,000,000) | ||
Proceeds from stock option exercises | 285,160 | 477,734 | 653,046 |
Proceeds of public offerings | 162,149,996 | 449,996,887 | |
Payment of costs of public offerings | (77,740) | (756,313) | |
Net cash provided by financing activities | 162,357,416 | 477,734 | 449,893,620 |
Net (decrease) increase in cash and cash equivalents | (10,852,111) | 1,482,922 | (14,165,741) |
Cash and cash equivalents at beginning of period | 48,642,225 | 47,159,303 | 61,325,044 |
Cash and cash equivalents at end of period | $ 37,790,114 | 48,642,225 | $ 47,159,303 |
Cash paid for interest | 36,781 | ||
Cash paid for taxes | $ 1,000,000 |
Organization
Organization | 12 Months Ended |
Dec. 31, 2017 | |
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. 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, |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value 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 bonds/notes 137,790 — (390 ) 137,400 $ 427,340 $ — $ (799 ) $ 426,541 December 31, 2016 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. government agency securities $ 67,199 $ 1 $ (74 ) $ 67,126 FDIC certificates of deposit (1) 20,740 1 — 20,741 Certificates of deposit 64,500 — — 64,500 Commercial paper 67,352 11 (52 ) 67,311 Corporate bonds/notes 115,985 — (205 ) 115,780 $ 335,776 $ 13 $ (331 ) $ 335,458 (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, 2017, the Company had $37.3 million of investments that had been held for greater than one year that have a temporary impairment of approximately $42,000. As of December 31, 2016, the Company had approximately $25.5 million of investments that have been held for greater than one year which had a temporary impairment of approximately $25,000. 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, 2017 and December 31, 2016. The carrying value of cash held in money market funds of approximately $26.2 million as of December 31, 2017 and $10.7 million as of December 31, 2016 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 Reporting Date Using December 31, 2017 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) 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 $ — Fair Value Measurements at December 31, 2016 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money market funds $ 10,724 $ 10,724 $ — $ — U.S. government agency securities 67,126 — 67,126 — FDIC certificates of deposit 20,741 — 20,741 — Certificates of deposit 64,500 — 64,500 — Commercial paper 67,311 — 67,311 — Corporate bonds/notes 115,780 — 115,780 — $ 346,182 $ 10,724 $ 335,458 $ — Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2017 and December 31, 2016. 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, 2017 and 2016, as the Company has a history of collecting on all its accounts including government agencies and collaborations funding its research. 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 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 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 discussion with applicable personnel and outside 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, 2017 and 2016, 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,” or TCJA, that significantly reforms the Internal Revenue Code of 1986, as amended. 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. See the tax footnote below for further discussion related to the tax impact to the Company. 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, 2017, 2016 and 2015 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. Prior to January 1, 2014, at which time there was no active market for the Company’s common stock, the exercise price of the stock options on the date of grant was determined and approved by the board of directors using several factors, including progress and milestones achieved in the Company’s business development and performance, the price per share of its convertible preferred stock offerings, and general industry and economic trends. In establishing the estimated fair value of the common stock, the Company considered the guidance set forth in American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation 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, the Company granted time based RSUs that vest in three equal annual installments. In the first quarter of 2017, the Company granted additional time-based RSUs as well as performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”), (ii) the approval of the NDA by the FDA (the “Milestone RSU grants”) and (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSU grants”). The Milestone RSU grants were valued at the closing price on March 8, 2017. The RSUs that vest upon the NDA submission will be amortized through December 31, 2018 based on the probable vesting date. The amortization of the expenses for RSUs related to the approval of the NDA will commence if and when the NDA filing has been approved through the last day of the calendar year in which the milestone is achieved. The TSR RSU grants 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 RSU grants and TSR RSU grants 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, 2017, 2016 and 2015, 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 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, 2017, 2016 and 2015: Year Ended December 31, 2017 2016 2015 Common Stock Equivalents 476,252 1,225,614 1,322,311 RSUs 87,988 32,781 — TSR RSUs 65,852 — — Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company does not expect the adoption of this standard to result in a material impact to its financial statements. Upon adopting FASB ASC Topic 606, 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 2018, the Company is implementing new internal controls as part of its efforts to adopt the new revenue recognition standard. These internal controls include providing training to the Company’s finance team and holding regular meetings with the Company’s management and the Audit Committee of the Company’s Board of Directors to review and approve key decisions. Upon adoption, the Company expects to implement new internal controls related to its accounting policies and procedures. The Company will require new internal controls to address risks associated with applying the five-step model. Additionally, the Company will establish monitoring controls to identify sales arrangements and changes in the Company’s business environment that could impact its current accounting assessment. The Company expects to finalize its impact assessment and redesign impacted processes, policies and controls prior to commercializing its products. 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 2016-02 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following: December 31, 2017 2016 Computer equipment $ 33,584 $ 39,095 Furniture and fixtures 301,509 292,423 Scientific equipment 3,494,866 2,844,865 3,829,959 3,176,383 Less accumulated depreciation (2,692,788 ) (2,548,769 ) $ 1,137,171 $ 627,614 Depreciation expense for the years ended December 31, 2017, 2016 and 2015 was $213,872, $196,872 and $139,626, respectively. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 4. Share-Based Compensation The Company’s Amended and Restated 2013 Equity Incentive Plan (the “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. As of December 31, 2017, there were options to purchase 3,755,736 shares of common stock outstanding under the Plan. On June 16, 2015, the stockholders of the Company approved, at the Company’s 2015 Annual Meeting of Stockholders, an amendment to the Plan to increase the number of shares of common stock available for issuance under the Plan by 3,100,000 shares, to increase by 100,000 shares the maximum number of shares available for the issuance of options, stock appreciation rights and other similar awards to any one participant in any calendar year for purposes of meeting the requirements for qualified performance-based compensation under Section 162(m) of the Internal Revenue Code of 1986, as amended in 2017 (the “Code”), and to eliminate the evergreen provisions of the Plan under which 800,000 shares were automatically added to the plan on each of January 1, 2014 and 2015. 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, 2017, 2016 and 2015, was comprised of the following: Years Ended December 31, 2017 2016 2015 Research and development $ 5,082,823 $ 4,472,658 $ 4,768,131 General and administrative 9,558,697 10,228,561 6,122,774 Total share-based compensation expense $ 14,641,520 $ 14,701,219 $ 10,890,905 The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2017, 2016 and 2015: 2017 2016 2015 Dividend yield 0 % 0 % 0 % Expected volatility 87.4%-90.4 % 80.0%-90.0 % 80.0 % Weighted-average risk-free interest rate 2.1 % 1.7 % 1.8 % Expected term (in years) 6.0 5.9 5.9 Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2017, and changes during the period then ended, are summarized as follows: Number of Shares Weighted- Average Exercise Price Aggregate Intrinsic Value Weighted- Average Contractual Life Outstanding at December 31, 2016 3,101,032 $ 19.63 $ 9,351,908 7.18 years Options granted 982,993 $ 15.08 9.29 years Options exercised (135,999 ) $ 2.27 2.28 years Options canceled or expired (192,290 ) $ 25.79 7.91 years Outstanding at December 31, 2017 3,755,736 $ 18.75 $ 7,450,293 7.04 years Vested or expected to vest at December 31, 2017 3,755,736 $ 18.75 Exercisable at December 31, 2017 2,362,595 $ 16.86 $ 7,212,195 6.19 years The weighted-average grant date fair value for awards granted during the years ended December 31, 2017, 2016 and 2015 was $15.08, $48.85 and $21.00 per share, respectively. Total intrinsic value of the options exercised during the years ended December 31, 2017, 2016 and 2015 was approximately $1,609,268, $2,984,283 and $10,951,057, respectively. The total fair value of shares vested in the years ended December 31, 2017, 2016 and 2015 was approximately $7,212,195, $9,310,898 and $5,207,073, respectively. During 2017, 2016 and 2015, the Company granted options to certain scientific advisory board members of the Company to purchase 0, 5,000 and 45,571 shares of common stock, respectively, at an average exercise price per share of $0, $53.63 and $17.57, respectively. The options vest ratably over a period of 1 to 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, 2017 and 2016, there were $2,866,164 and $3,022,843, respectively, of unrecognized compensation costs related to unvested time based RSUs which will be recognized over a weighted-average period 1.5 years. The unrecognized share-based compensation expense related to stock option awards at December 31, 2017 is $12,322,422 and will be recognized over a weighted-average period of 1.8 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, 2017, and changes during the year then ended, is summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Outstanding at December 31, 2016 82,321 $ 53.77 RSU’s granted in 2017 154,922 $ 15.73 RSU’s vested in 2017 (28,013 ) $ 53.84 RSU’s cancelled in 2017 (18,297 ) $ 26.80 Outstanding at December 31, 2017 190,933 $ 25.48 The Company recognized non-cash Information related to the Company’s Milestone RSU grants and the TSR RSU grants during the year ended December 31, 2017 are summarized as follows: Number of Shares Weighted- Grant Date Fair Value Outstanding at December 31, 2016 — $ — RSU’s granted in 2017 379,629 $ 15.35 RSU’s cancelled in 2017 (32,430 ) $ 15.35 Outstanding at December 31, 2017 347,199 $ 15.35 The weighted average estimated fair value per share of the TSR RSUs granted in the year ended December 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 the year ended December 31, 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 price of the Company’s common stock over the 30 calendar days preceding January 1, 2020 by the average share price of the Company’s common stock on March 8, 2017, with a deemed reinvestment of any dividends declared during the performance period. The Company’s peer group includes the companies 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, 2017 and 2016 there were $4,177,362 and $0 respectively of unrecognized compensation costs related to unvested Milestone RSU grants and TSR RSU grants which will be recognized over a weighted average period of 1.9 years. |
Line of Credit
Line of Credit | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 6. Income Taxes On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act,” or TCJA, that significantly reforms the Internal Revenue Code of 1986, as amended. 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. As a result of the reduction in the U.S. corporate income tax rate from 35% to 21% under TCJA the Company revalued its ending net deferred tax assets at December 31, 2017 and given we are still subject to a valuation allowance did not recognize any tax expense (related to such reduced tax rate) in the Company’s consolidated statement of income for the year ended December 31, 2017. However, the Company did provisionally recognize a $1.1 million tax benefit due to the release of the valuation allowance on its alternative minimum tax credit deferred tax asset as part of the TCJA. The TCJA repealed the corporate alternative minimum tax (AMT). Companies with AMT credit carryovers can generally use the credits to offset regular tax liability for any taxable year beginning in 2018. In addition, the AMT credit is refundable, subject to certain limitations, in any taxable year beginning after 2017. Lastly, any remaining AMT credit carryforward is fully refundable by 2022. 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. The Company may be subject to incremental U.S. tax on GILTI income in the future. The Company has elected to account for any GILTI tax in the period in which it is incurred, and therefore has not provided any deferred tax impacts of GILTI in its consolidated financial statements for the year ended December 31, 2017. 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 does not expect it will be subject to this tax in 2018, but will continue to monitor. Therefore, the Company has not included any tax impacts of BEAT in its consolidated financial statements for the year ended December 31, 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. We continue to evaluate the effects of the TCJA and consider the amounts recorded to be provisional. Additional time is needed to ensure that we have fully analyzed and computed the tax effects of the 2017 Tax Act on our tax accounts. We will complete our accounting during the measurement period provided under SAB 118 as we obtain further clarity on the application of the TCJA to our particular facts and report appropriately in 2018. Income (loss) before income taxes is as follows: 2017 2016 2015 U.S. $ (20,486,935 ) $ (86,965,860 ) $ (104,791,541 ) Non-U.S. (78,347,330 ) (28,394,735 ) — Total loss before taxes (98,834,265 ) (115,360,595 ) $ (104,791,541 ) Total income tax (benefit) expense for the years ended December 31, 2017, 2016 and 2015 is allocated as follows: 2017 2016 2015 Current $ (2,416 ) $ 1,065,673 $ 1,600 Deferred 13,713,987 19,605,520 51,165,859 Valuation allowance (14,772,422 ) (19,605,520 ) (51,165,859 ) (Benefit) provision for income taxes $ (1,060,851 ) $ 1,065,673 $ 1,600 A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2017, 2016 and 2015 is as follows: December 31, 2017 2016 2015 Income tax benefit at statutory federal rate 35.00 % 35.00 % 35.00 % Royalty Income 0.00 (37.93 ) 0.00 Other Permanent differences (0.43 ) (0.78 ) (0.56 ) Foreign rate differential (27.75 ) (8.61 ) 0.00 2017 US Tax Reform impact (21.89 ) (0.03 ) 0.00 R&D Credit (0.05 ) 2.11 4.19 Change in effective state tax rates 0.84 (6.98 ) (0.05 ) State income tax expense 0.40 (0.70 ) 10.24 Change in valuation allowance 14.95 16.99 (48.82 ) Benefit (provision) for income taxes 1.07 % (0.93 )% (0.00 )% Deferred income taxes reflect the net tax effect of temporary differences that exist between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, using enacted tax rates in effect for the year in which the differences are expected to reverse. As of December 31, 2017, the Company had $131.1 million of federal net operating loss carryforwards, which expire at various dates through 2035. 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 year ended December 31, 2017, 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, 2017 2016 Deferred tax assets: Net operating loss carryforwards $ 40,746,589 $ 49,627,652 Accrued employee benefits 378,058 535,158 Research and development credit 9,321,214 9,367,227 Stock compensation 8,711,721 9,360,025 Federal AMT credit 1,058,435 1,062,451 Deferred rent 699,560 1,095,220 Unrealized comprehensive loss 187,714 — Deferred tax liabilities: Depreciation (31,796 ) (44,732 ) Net deferred tax asset 61,071,495 71,003,001 Valuation allowance (60,013,060 ) (71,003,001 ) Net deferred tax asset $ 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, for financial reporting purposes because it is not more likely than not that these deferred tax assets will be realized. The total amount of unrecognized tax benefits as of December 31, 2017 and December 31, 2016 were $1.7 million and $1.7 million, respectively. 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, 2017 and 2016, respectively: December 31, 2017 2016 Balance at January 1, $ 1,738,815 $ 1,720,912 Current Year Uncertain Tax Positions: Gross Increases — 17,903 Balance at December 31, $ 1,738,815 $ 1,738,815 |
Collaborations and License Agre
Collaborations and License Agreements | 12 Months Ended |
Dec. 31, 2017 | |
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. Possible milestone payments remaining total $12.0 million. Under the agreement, the Company may be obliged to make other milestone payments to BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentage royalty payments 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, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies The Company currently has an operating lease agreement with a commitment for $14,956,082 for laboratory and office facilities through 2027. At December 31, 2017, future minimum lease payments under leases having an initial or remaining non-cancellable Year 2018 1,457,008 2019 1,500,718 2020 1,545,740 2021 1,592,112 2022 1,639,876 Thereafter 7,220,628 $ 14,956,082 Rent expense for the years ended December 31, 2017, 2016 and 2015 was $1,427,716, $1,419,940 and $1,385,207, respectively. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017 | |
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 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, 2017 | |
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 2017 and 2016 quarterly statements of operations. 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 ) The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2016 quarters ended: 2016 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 97,895 $ 4,362 $ 228,445 $ — Net loss (27,485,039 ) (30,265,327 ) (30,834,454 ) (27,841,449 ) Basic and diluted net loss per share $ (0.64 ) $ (0.70 ) $ (0.71 ) $ (0.64 ) |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value 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 bonds/notes 137,790 — (390 ) 137,400 $ 427,340 $ — $ (799 ) $ 426,541 December 31, 2016 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. government agency securities $ 67,199 $ 1 $ (74 ) $ 67,126 FDIC certificates of deposit (1) 20,740 1 — 20,741 Certificates of deposit 64,500 — — 64,500 Commercial paper 67,352 11 (52 ) 67,311 Corporate bonds/notes 115,985 — (205 ) 115,780 $ 335,776 $ 13 $ (331 ) $ 335,458 (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, 2017, the Company had $37.3 million of investments that had been held for greater than one year that have a temporary impairment of approximately $42,000. As of December 31, 2016, the Company had approximately $25.5 million of investments that have been held for greater than one year which had a temporary impairment of approximately $25,000. 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, 2017 and December 31, 2016. The carrying value of cash held in money market funds of approximately $26.2 million as of December 31, 2017 and $10.7 million as of December 31, 2016 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 Reporting Date Using December 31, 2017 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) 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 $ — Fair Value Measurements at December 31, 2016 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money market funds $ 10,724 $ 10,724 $ — $ — U.S. government agency securities 67,126 — 67,126 — FDIC certificates of deposit 20,741 — 20,741 — Certificates of deposit 64,500 — 64,500 — Commercial paper 67,311 — 67,311 — Corporate bonds/notes 115,780 — 115,780 — $ 346,182 $ 10,724 $ 335,458 $ — |
Financial Instruments | Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at December 31, 2017 and December 31, 2016. 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, 2017 and 2016, as the Company has a history of collecting on all its accounts including government agencies and collaborations funding its research. |
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 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 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 discussion with applicable personnel and outside 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, 2017 and 2016, 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,” or TCJA, that significantly reforms the Internal Revenue Code of 1986, as amended. 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. See the tax footnote below for further discussion related to the tax impact to the Company. |
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, 2017, 2016 and 2015 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. Prior to January 1, 2014, at which time there was no active market for the Company’s common stock, the exercise price of the stock options on the date of grant was determined and approved by the board of directors using several factors, including progress and milestones achieved in the Company’s business development and performance, the price per share of its convertible preferred stock offerings, and general industry and economic trends. In establishing the estimated fair value of the common stock, the Company considered the guidance set forth in American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation 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, the Company granted time based RSUs that vest in three equal annual installments. In the first quarter of 2017, the Company granted additional time-based RSUs as well as performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”), (ii) the approval of the NDA by the FDA (the “Milestone RSU grants”) and (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSU grants”). The Milestone RSU grants were valued at the closing price on March 8, 2017. The RSUs that vest upon the NDA submission will be amortized through December 31, 2018 based on the probable vesting date. The amortization of the expenses for RSUs related to the approval of the NDA will commence if and when the NDA filing has been approved through the last day of the calendar year in which the milestone is achieved. The TSR RSU grants 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 RSU grants and TSR RSU grants 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, 2017, 2016 and 2015, 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 |
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, 2017, 2016 and 2015: Year Ended December 31, 2017 2016 2015 Common Stock Equivalents 476,252 1,225,614 1,322,311 RSUs 87,988 32,781 — TSR RSUs 65,852 — — |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, The Company does not expect the adoption of this standard to result in a material impact to its financial statements. Upon adopting FASB ASC Topic 606, 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 2018, the Company is implementing new internal controls as part of its efforts to adopt the new revenue recognition standard. These internal controls include providing training to the Company’s finance team and holding regular meetings with the Company’s management and the Audit Committee of the Company’s Board of Directors to review and approve key decisions. Upon adoption, the Company expects to implement new internal controls related to its accounting policies and procedures. The Company will require new internal controls to address risks associated with applying the five-step model. Additionally, the Company will establish monitoring controls to identify sales arrangements and changes in the Company’s business environment that could impact its current accounting assessment. The Company expects to finalize its impact assessment and redesign impacted processes, policies and controls prior to commercializing its products. 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 2016-02 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): December 31, 2017 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value 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 bonds/notes 137,790 — (390 ) 137,400 $ 427,340 $ — $ (799 ) $ 426,541 December 31, 2016 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. government agency securities $ 67,199 $ 1 $ (74 ) $ 67,126 FDIC certificates of deposit (1) 20,740 1 — 20,741 Certificates of deposit 64,500 — — 64,500 Commercial paper 67,352 11 (52 ) 67,311 Corporate bonds/notes 115,985 — (205 ) 115,780 $ 335,776 $ 13 $ (331 ) $ 335,458 (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 Reporting Date Using December 31, 2017 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) 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 $ — Fair Value Measurements at December 31, 2016 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money market funds $ 10,724 $ 10,724 $ — $ — U.S. government agency securities 67,126 — 67,126 — FDIC certificates of deposit 20,741 — 20,741 — Certificates of deposit 64,500 — 64,500 — Commercial paper 67,311 — 67,311 — Corporate bonds/notes 115,780 — 115,780 — $ 346,182 $ 10,724 $ 335,458 $ — |
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, 2017, 2016 and 2015: Year Ended December 31, 2017 2016 2015 Common Stock Equivalents 476,252 1,225,614 1,322,311 RSUs 87,988 32,781 — TSR RSUs 65,852 — — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: December 31, 2017 2016 Computer equipment $ 33,584 $ 39,095 Furniture and fixtures 301,509 292,423 Scientific equipment 3,494,866 2,844,865 3,829,959 3,176,383 Less accumulated depreciation (2,692,788 ) (2,548,769 ) $ 1,137,171 $ 627,614 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017, 2016 and 2015, was comprised of the following: Years Ended December 31, 2017 2016 2015 Research and development $ 5,082,823 $ 4,472,658 $ 4,768,131 General and administrative 9,558,697 10,228,561 6,122,774 Total share-based compensation expense $ 14,641,520 $ 14,701,219 $ 10,890,905 |
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, 2017, 2016 and 2015: 2017 2016 2015 Dividend yield 0 % 0 % 0 % Expected volatility 87.4%-90.4 % 80.0%-90.0 % 80.0 % Weighted-average risk-free interest rate 2.1 % 1.7 % 1.8 % Expected term (in years) 6.0 5.9 5.9 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of December 31, 2017, and changes during the period then ended, are summarized as follows: Number of Shares Weighted- Average Exercise Price Aggregate Intrinsic Value Weighted- Average Contractual Life Outstanding at December 31, 2016 3,101,032 $ 19.63 $ 9,351,908 7.18 years Options granted 982,993 $ 15.08 9.29 years Options exercised (135,999 ) $ 2.27 2.28 years Options canceled or expired (192,290 ) $ 25.79 7.91 years Outstanding at December 31, 2017 3,755,736 $ 18.75 $ 7,450,293 7.04 years Vested or expected to vest at December 31, 2017 3,755,736 $ 18.75 Exercisable at December 31, 2017 2,362,595 $ 16.86 $ 7,212,195 6.19 years |
RSUs [Member] | |
Summary of Information Regarding RSU Activity | 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, 2017, and changes during the year then ended, is summarized as follows: Number of Shares Weighted- Average Grant Date Fair Value Outstanding at December 31, 2016 82,321 $ 53.77 RSU’s granted in 2017 154,922 $ 15.73 RSU’s vested in 2017 (28,013 ) $ 53.84 RSU’s cancelled in 2017 (18,297 ) $ 26.80 Outstanding at December 31, 2017 190,933 $ 25.48 |
Milestone and Total Shareholder Return Restricted Stock Units [Member] | |
Summary of Information Regarding RSU Activity | Information related to the Company’s Milestone RSU grants and the TSR RSU grants during the year ended December 31, 2017 are summarized as follows: Number of Shares Weighted- Grant Date Fair Value Outstanding at December 31, 2016 — $ — RSU’s granted in 2017 379,629 $ 15.35 RSU’s cancelled in 2017 (32,430 ) $ 15.35 Outstanding at December 31, 2017 347,199 $ 15.35 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Summary of Income (loss) before Income Taxes | Income (loss) before income taxes is as follows: 2017 2016 2015 U.S. $ (20,486,935 ) $ (86,965,860 ) $ (104,791,541 ) Non-U.S. (78,347,330 ) (28,394,735 ) — Total loss before taxes (98,834,265 ) (115,360,595 ) $ (104,791,541 ) |
Total Income Tax (Benefit) Expense | Total income tax (benefit) expense for the years ended December 31, 2017, 2016 and 2015 is allocated as follows: 2017 2016 2015 Current $ (2,416 ) $ 1,065,673 $ 1,600 Deferred 13,713,987 19,605,520 51,165,859 Valuation allowance (14,772,422 ) (19,605,520 ) (51,165,859 ) (Benefit) provision for income taxes $ (1,060,851 ) $ 1,065,673 $ 1,600 |
Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate | A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2017, 2016 and 2015 is as follows: December 31, 2017 2016 2015 Income tax benefit at statutory federal rate 35.00 % 35.00 % 35.00 % Royalty Income 0.00 (37.93 ) 0.00 Other Permanent differences (0.43 ) (0.78 ) (0.56 ) Foreign rate differential (27.75 ) (8.61 ) 0.00 2017 US Tax Reform impact (21.89 ) (0.03 ) 0.00 R&D Credit (0.05 ) 2.11 4.19 Change in effective state tax rates 0.84 (6.98 ) (0.05 ) State income tax expense 0.40 (0.70 ) 10.24 Change in valuation allowance 14.95 16.99 (48.82 ) Benefit (provision) for income taxes 1.07 % (0.93 )% (0.00 )% |
Deferred Tax Assets and Liabilities | The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2017 and 2016, respectively: December 31, 2017 2016 Deferred tax assets: Net operating loss carryforwards $ 40,746,589 $ 49,627,652 Accrued employee benefits 378,058 535,158 Research and development credit 9,321,214 9,367,227 Stock compensation 8,711,721 9,360,025 Federal AMT credit 1,058,435 1,062,451 Deferred rent 699,560 1,095,220 Unrealized comprehensive loss 187,714 — Deferred tax liabilities: Depreciation (31,796 ) (44,732 ) Net deferred tax asset 61,071,495 71,003,001 Valuation allowance (60,013,060 ) (71,003,001 ) Net deferred tax asset $ 1,058,435 $ — |
Summary of Gross Unrecognized Tax Benefits | The following summarizes the significant components of gross unrecognized tax benefits as of December 31, 2017 and 2016, respectively: December 31, 2017 2016 Balance at January 1, $ 1,738,815 $ 1,720,912 Current Year Uncertain Tax Positions: Gross Increases — 17,903 Balance at December 31, $ 1,738,815 $ 1,738,815 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments having Initial or Remaining Non Cancellable Lease Term | At December 31, 2017, future minimum lease payments under leases having an initial or remaining non-cancellable Year 2018 1,457,008 2019 1,500,718 2020 1,545,740 2021 1,592,112 2022 1,639,876 Thereafter 7,220,628 $ 14,956,082 |
Unaudited Quarterly Financial25
Unaudited Quarterly Financial Information (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
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 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 ) The following table sets for the Company’s unaudited condensed consolidated statements of operations for the 2016 quarters ended: 2016 Quarter Ended December 31, September 30, June 30, March 31, Revenue $ 97,895 $ 4,362 $ 228,445 $ — Net loss (27,485,039 ) (30,265,327 ) (30,834,454 ) (27,841,449 ) Basic and diluted net loss per share $ (0.64 ) $ (0.70 ) $ (0.71 ) $ (0.64 ) |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) | Oct. 05, 2017 | Dec. 31, 2017 | Oct. 30, 2017 | Sep. 14, 2016 |
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 | 11,129,032 | |||
Initial public offering, Price per share | $ 15.50 | |||
Initial public offering, Gross proceeds | $ 172,000,000 | |||
Initial public offering, Net proceeds | $ 162,000,000 | |||
Over-Allotment Option [Member] | ||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||
Initial public offering, Number of shares | 1,451,613 | |||
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 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2016 | Dec. 31, 2017USD ($)Segment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
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 | $ 426,540,921 | $ 335,458,459 | ||
Investment securities, available for sale noncurrent | 37,300,000 | 25,500,000 | ||
Investment securities, unrealized loss | 42,000 | 25,000 | ||
Carrying value of cash held in money market funds | 26,200,000 | $ 10,700,000 | ||
Impairment losses recognized | $ 0 | |||
Assumed expected dividend rate | 0.00% | 0.00% | 0.00% | |
Excess tax benefits for tax deductions | $ 0 | $ 0 | $ 0 | |
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 | |||
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Investment securities, available-for-sale | $ 93,300,000 | $ 47,900,000 | ||
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 Accoun28
Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 427,340,000 | $ 335,776,000 |
Unrealized Gains | 13,000 | |
Unrealized (Losses) | (799,000) | (331,000) |
Estimated Fair Value | 426,540,921 | 335,458,459 |
FDIC Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 8,306,000 | 20,740,000 |
Unrealized Gains | 1,000 | |
Estimated Fair Value | 8,306,000 | 20,741,000 |
U.S. Government Agency Securities [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 126,330,000 | 67,199,000 |
Unrealized Gains | 1,000 | |
Unrealized (Losses) | (348,000) | (74,000) |
Estimated Fair Value | 125,982,000 | 67,126,000 |
Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 103,500,000 | 64,500,000 |
Estimated Fair Value | 103,500,000 | 64,500,000 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 51,414,000 | 67,352,000 |
Unrealized Gains | 11,000 | |
Unrealized (Losses) | (61,000) | (52,000) |
Estimated Fair Value | 51,353,000 | 67,311,000 |
Corporate Notes/Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 137,790,000 | 115,985,000 |
Unrealized (Losses) | (390,000) | (205,000) |
Estimated Fair Value | $ 137,400,000 | $ 115,780,000 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Schedule of Investment Securities (Parenthetical) (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
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 Accoun30
Summary of Significant Accounting Policies - Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 452,722 | $ 346,182 |
Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 26,181 | 10,724 |
U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 125,982 | 67,126 |
FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 8,306 | 20,741 |
Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 103,500 | 64,500 |
Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 51,353 | 67,311 |
Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 137,400 | 115,780 |
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 | 26,181 | 10,724 |
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 | 26,181 | 10,724 |
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 | 426,541 | 335,458 |
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 | 125,982 | 67,126 |
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 | 8,306 | 20,741 |
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 | 103,500 | 64,500 |
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 | 51,353 | 67,311 |
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 | $ 137,400 | $ 115,780 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
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 | 476,252 | 1,225,614 | 1,322,311 |
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 | 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 | 65,852 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 3,829,959 | $ 3,176,383 |
Less accumulated depreciation | (2,692,788) | (2,548,769) |
Property Plant and Equipment Net | 1,137,171 | 627,614 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 33,584 | 39,095 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 301,509 | 292,423 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 3,494,866 | $ 2,844,865 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 213,872 | $ 196,872 | $ 139,626 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock options outstanding | 3,755,736 | 3,101,032 | |
Weighted average grant date fair value of stock options granted | $ 15.08 | $ 48.85 | $ 21 |
Total intrinsic value of the options exercised | $ 1,609,268 | $ 2,984,283 | $ 10,951,057 |
Total fair value of shares vested | $ 7,212,195 | 9,310,898 | $ 5,207,073 |
Options granted, Number of Shares | 982,993 | ||
Options granted, exercise price | $ 15.08 | ||
Unrecognized compensation costs related to unvested RSUs | $ 2,866,164 | $ 3,022,843 | |
Unrecognized share-based compensation expense related to employee stock option awards | $ 12,322,422 | ||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Risk free interest rate | 2.10% | 1.70% | 1.80% |
Expected volatility | 80.00% | ||
Scientific Advisory Board Members [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted, Number of Shares | 0 | 5,000 | 45,571 |
Options granted, exercise price | $ 0 | $ 53.63 | $ 17.57 |
Minimum [Member] | Scientific Advisory Board Members [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Incentive stock options (ISOs), vesting period | 1 year | ||
Maximum [Member] | Scientific Advisory Board Members [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Incentive stock options (ISOs), vesting period | 2 years | ||
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options, maximum term | 10 years | ||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 9 months 18 days | ||
Stock Options [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Incentive stock options (ISOs), vesting period | 2 years | ||
Stock Options [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Incentive stock options (ISOs), vesting period | 3 years | ||
Total Shareholder Return Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Incentive stock options (ISOs), vesting period | 3 years | ||
Weighted average grant date fair value of stock options granted | $ 17.08 | ||
Unrecognized compensation costs related to unvested RSUs | $ 0 | ||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 10 months 25 days | ||
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 price of the Company’s common stock over the 30 calendar days preceding January 1, 2020 by the average share price of the Company’s common stock on March 8, 2017, with a deemed reinvestment of any dividends declared during the performance period. | ||
RSUs [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense recognized | $ 2,100,000 | $ 1,500,000 | |
Time Based Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 6 months | 1 year 6 months | |
Milestone Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation costs related to unvested RSUs | $ 4,177,362 | $ 0 | |
Unrecognized share-based compensation expense, weighted-average recognition period | 1 year 10 months 25 days | ||
2013 Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock options outstanding | 3,755,736 | ||
Number of shares of common stock available for issuance under the plan | 3,100,000 | ||
Increase in maximum number of shares available for issuance of options, stock appreciation rights and other similar awards | 100,000 |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 14,641,520 | $ 14,701,219 | $ 10,890,905 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | 5,082,823 | 4,472,658 | 4,768,131 |
General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total share-based compensation expense | $ 9,558,697 | $ 10,228,561 | $ 6,122,774 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 80.00% | ||
Expected volatility, minimum | 87.40% | 80.00% | |
Expected volatility, maximum | 90.40% | 90.00% | |
Weighted-average risk-free interest rate | 2.10% | 1.70% | 1.80% |
Expected term | 6 years | 5 years 10 months 25 days | 5 years 10 months 25 days |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 3,101,032 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 19.63 | |
Options granted, Number of Shares | 982,993 | |
Outstanding at end of period, Aggregate Intrinsic Value | $ 7,450,293 | $ 9,351,908 |
Options exercised, Number of Shares | (135,999) | |
Exercisable at end of period, Aggregate Intrinsic Value | $ 7,212,195 | |
Options canceled or expired, Number of Shares | (192,290) | |
Options granted, Weighted-Average Contractual Life | 9 years 3 months 15 days | |
Outstanding at end of period, Number of Shares | 3,755,736 | 3,101,032 |
Options exercised, Weighted-Average Contractual Life | 2 years 3 months 11 days | |
Vested or expected to vest at end of period, Number of Shares | 3,755,736 | |
Options canceled or expired, Weighted-Average Contractual Life | 7 years 10 months 28 days | |
Exercisable at end of period, Number of Shares | 2,362,595 | |
Outstanding at end of period, Weighted-Average Contractual Life | 7 years 15 days | 7 years 2 months 5 days |
Options granted, Weighted-Average Exercise Price | $ 15.08 | |
Exercisable at end of period, Weighted-Average Contractual Life | 6 years 2 months 8 days | |
Options exercised, Weighted-Average Exercise Price | $ 2.27 | |
Options canceled or expired, Weighted-Average Exercise Price | 25.79 | |
Outstanding at end of period, Weighted-Average Exercise Price | 18.75 | $ 19.63 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 18.75 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 16.86 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding RSU Activity (Detail) - RSUs [Member] | 12 Months Ended |
Dec. 31, 2017$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 82,321 |
RSU's granted, Number of Shares | shares | 154,922 |
RSU's vested, Number of Shares | shares | (28,013) |
RSU's cancelled, Number of Shares | shares | (18,297) |
Outstanding at end of period, Number of Shares | shares | 190,933 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 53.77 |
RSU's granted, Weighted-Average Grant Date Fair Value | $ / shares | 15.73 |
RSU's vested, Weighted-Average Grant Date Fair Value | $ / shares | 53.84 |
RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 26.80 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 25.48 |
Share-Based Compensation - Su39
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, 2017$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSU's granted, Number of Shares | shares | 379,629 |
RSU's cancelled, Number of Shares | shares | (32,430) |
Outstanding at end of period, Number of Shares | shares | 347,199 |
RSU's granted, Weighted-Average Grant Date Fair Value | $ / shares | $ 15.35 |
RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 15.35 |
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 ($) | Oct. 03, 2016 | Sep. 30, 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, 2018 | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Income Tax [Line Items] | ||||
U.S. corporate income tax rate | 35.00% | 35.00% | 35.00% | |
Tax benefit due to release of valuation allowance on alternative minimum tax credit deferred tax asset | $ 1,058,435 | $ 1,062,451 | ||
AMT credit carryovers offset regular tax liability start year | 2,018 | |||
AMT credit carryovers offset regular tax liability closing year | 2,022 | |||
Number of new U.S. tax base erosion provisions | 2 | |||
Federal net operating loss carryforwards | $ 131,100,000 | |||
Federal net operating loss carryforwards expiration year | 2,035 | |||
Unrecognized tax benefits | $ 1,738,815 | $ 1,738,815 | $ 1,720,912 | |
Scenario, Forecast [Member] | ||||
Income Tax [Line Items] | ||||
U.S. corporate income tax rate | 21.00% |
Income Taxes - Income (Loss) be
Income Taxes - Income (Loss) before Income Taxes (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (20,486,935) | $ (86,965,860) | $ (104,791,541) |
Non-U.S. | (78,347,330) | (28,394,735) | |
Loss before (benefit) provision for income taxes | $ (98,834,265) | $ (115,360,595) | $ (104,791,541) |
Income Taxes - Total Income Tax
Income Taxes - Total Income Tax (Benefit) Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Current | $ (2,416) | $ 1,065,673 | $ 1,600 |
Deferred | 13,713,987 | 19,605,520 | 51,165,859 |
Valuation allowance | (14,772,422) | (19,605,520) | (51,165,859) |
(Benefit) provision for income taxes | $ (1,060,851) | $ 1,065,673 | $ 1,600 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Income tax benefit at statutory federal rate | 35.00% | 35.00% | 35.00% |
Royalty Income | 0.00% | (37.93%) | 0.00% |
Other Permanent differences | (0.43%) | (0.78%) | (0.56%) |
Foreign rate differential | (27.75%) | (8.61%) | 0.00% |
2017 US Tax Reform impact | (21.89%) | (0.03%) | 0.00% |
R&D Credit | (0.05%) | 2.11% | 4.19% |
Change in effective state tax rates | 0.84% | (6.98%) | (0.05%) |
State income tax expense | 0.40% | (0.70%) | 10.24% |
Change in valuation allowance | 14.95% | 16.99% | (48.82%) |
Benefit (provision) for income taxes | 1.07% | (0.93%) | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 40,746,589 | $ 49,627,652 |
Accrued employee benefits | 378,058 | 535,158 |
Research and development credit | 9,321,214 | 9,367,227 |
Stock compensation | 8,711,721 | 9,360,025 |
Federal AMT credit | 1,058,435 | 1,062,451 |
Deferred rent | 699,560 | 1,095,220 |
Unrealized comprehensive loss | 187,714 | |
Deferred tax liabilities: | ||
Depreciation | (31,796) | (44,732) |
Net deferred tax asset | 61,071,495 | 71,003,001 |
Valuation allowance | (60,013,060) | $ (71,003,001) |
Net deferred tax asset | $ 1,058,435 |
Income Taxes - Summary of Gross
Income Taxes - Summary of Gross Unrecognized Tax Benefits (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns [Abstract] | ||
Balance at January 1, | $ 1,738,815 | $ 1,720,912 |
Current Year Uncertain Tax Positions: | ||
Gross Increases | 0 | 17,903 |
Balance at December 31, | $ 1,738,815 | $ 1,738,815 |
Collaborations and License Ag47
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, 2017 |
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 | ||
Company remaining milestone payment | $ 12,000,000 | |||
Obliged to make milestone payments | $ 14,750,000 | |||
License expiration period | Through the later of ten years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Other Commitments [Line Items] | |||
Operating lease agreements with commitment through 2027 | $ 14,956,082 | ||
Rent expense | 1,427,716 | $ 1,419,940 | $ 1,385,207 |
Laboratory and Office Facilities [Member] | |||
Other Commitments [Line Items] | |||
Operating lease agreements with commitment through 2027 | $ 14,956,082 |
Commitments and Contingencies49
Commitments and Contingencies - Schedule of Future Minimum Lease Payments having Initial or Remaining Non Cancellable Lease Term (Detail) | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,018 | $ 1,457,008 |
2,019 | 1,500,718 |
2,020 | 1,545,740 |
2,021 | 1,592,112 |
2,022 | 1,639,876 |
Thereafter | 7,220,628 |
Total | $ 14,956,082 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Retirement Benefits [Abstract] | |||
Employer matching contribution | 100.00% | ||
Contributions made by participants for which the company makes matching contribution | 6.00% | ||
Contribution expense | $ 378,233 | $ 157,244 | $ 109,963 |
Related Party - Additional Info
Related Party - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2015ft² | |
Related Party Transactions [Abstract] | |
Area of useable laboratory and office space | 16,753 |
Term of long term lease | 12 years |
Unaudited Quarterly Financial52
Unaudited Quarterly Financial Information - Schedule of Quarterly Financial Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue | $ 5,055 | $ 30,754 | $ 114,741 | $ 95,287 | $ 97,895 | $ 4,362 | $ 228,445 | $ 245,837 | $ 330,702 | $ 91,364 | |
Net loss | $ (30,208,712) | $ (22,870,416) | $ (17,760,704) | $ (26,933,582) | $ (27,485,039) | $ (30,265,327) | $ (30,834,454) | $ (27,841,449) | $ (97,773,414) | $ (116,426,268) | $ (104,793,141) |
Basic and diluted net loss per share | $ (0.56) | $ (0.53) | $ (0.41) | $ (0.62) | $ (0.64) | $ (0.70) | $ (0.71) | $ (0.64) | $ (2.12) | $ (2.69) | $ (2.91) |