Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 07, 2019 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | Intra-Cellular Therapies, Inc. | |
Trading Symbol | ITCI | |
Entity Central Index Key | 0001567514 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Common Stock, Shares Outstanding | 55,134,625 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 64,091,080 | $ 54,947,502 |
Investment securities, available-for-sale | 248,731,291 | 292,583,046 |
Prepaid expenses and other current assets | 8,305,259 | 7,908,133 |
Total current assets | 321,127,630 | 355,438,681 |
Property and equipment, net | 1,125,606 | 1,159,766 |
Right of use assets, net | 20,104,280 | |
Long term deferred tax asset, net | 529,218 | 529,218 |
Other assets | 86,083 | 78,833 |
Total assets | 342,972,817 | 357,206,498 |
Current liabilities: | ||
Accounts payable | 8,574,433 | 13,961,060 |
Accrued and other current liabilities | 18,700,638 | 20,044,866 |
Lease liabilities, short-term | 2,873,022 | |
Accrued employee benefits | 3,351,208 | 2,293,259 |
Total current liabilities | 33,499,301 | 36,299,185 |
Long-term deferred rent | 3,192,432 | |
Long-term lease liabilities | 20,859,089 | |
Total liabilities | 54,358,390 | 39,491,617 |
Stockholders' equity: | ||
Common stock, $.0001 par value: 100,000,000 shares authorized; 55,131,125 and 54,895,295 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 5,513 | 5,490 |
Additional paid-in capital | 885,888,318 | 880,753,339 |
Accumulated deficit | (597,211,954) | (562,376,191) |
Accumulated comprehensive loss | (67,450) | (667,757) |
Total stockholders' equity | 288,614,427 | 317,714,881 |
Total liabilities and stockholders' equity | $ 342,972,817 | $ 357,206,498 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 55,131,125 | 54,895,295 |
Common stock, shares outstanding | 55,131,125 | 54,895,295 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Revenues | ||
Costs and expenses: | ||
Research and development | 24,990,856 | $ 30,702,998 |
General and administrative | 11,704,984 | 6,381,228 |
Total costs and expenses | 36,695,840 | 37,084,226 |
Loss from operations | (36,695,840) | (37,084,226) |
Interest income | 1,860,077 | 1,604,148 |
Loss before provision for income taxes | (34,835,763) | (35,480,078) |
Net loss | $ (34,835,763) | $ (35,480,078) |
Net loss per common share: | ||
Basic & Diluted | $ (0.63) | $ (0.65) |
Weighted average number of common shares: | ||
Basic & Diluted | 55,113,226 | 54,676,175 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (34,835,763) | $ (35,480,078) |
Other comprehensive gain (loss): | ||
Unrealized gain (loss) on investment securities | 600,307 | (440,526) |
Comprehensive loss | $ (34,235,456) | $ (35,920,604) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Comprehensive Loss [Member] |
Balance at Dec. 31, 2017 | $ 454,436,961 | $ 5,460 | $ 862,479,505 | $ (407,248,780) | $ (799,224) |
Balance, shares at Dec. 31, 2017 | 54,597,679 | ||||
Exercise of stock options and issuances of restricted stock | 337,796 | $ 9 | 337,787 | ||
Exercise of stock options and issuances of restricted stock, shares | 94,773 | ||||
Stock issued for services | 47,669 | 47,669 | |||
Stock issued for services, shares | 2,266 | ||||
Share-based compensation | 4,287,103 | 4,287,103 | |||
Net loss | (35,480,078) | (35,480,078) | |||
Other comprehensive gain (loss) | (440,526) | (440,526) | |||
Balance at Mar. 31, 2018 | 423,188,925 | $ 5,469 | 867,152,064 | (442,728,858) | (1,239,750) |
Balance, shares at Mar. 31, 2018 | 54,694,718 | ||||
Balance at Dec. 31, 2018 | 317,714,881 | $ 5,490 | 880,753,339 | (562,376,191) | (667,757) |
Balance, shares at Dec. 31, 2018 | 54,895,295 | ||||
Exercise of stock options and issuances of restricted stock | 31,236 | $ 23 | 31,213 | ||
Exercise of stock options and issuances of restricted stock, shares | 231,844 | ||||
Stock issued for services | 48,549 | 48,549 | |||
Stock issued for services, shares | 3,986 | ||||
Share-based compensation | 5,055,217 | 5,055,217 | |||
Net loss | (34,835,763) | (34,835,763) | |||
Other comprehensive gain (loss) | 600,307 | 600,307 | |||
Balance at Mar. 31, 2019 | $ 288,614,427 | $ 5,513 | $ 885,888,318 | $ (597,211,954) | $ (67,450) |
Balance, shares at Mar. 31, 2019 | 55,131,125 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows used in operating activities | ||
Net loss | $ (34,835,763) | $ (35,480,078) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 101,353 | 82,498 |
Share-based compensation | 5,055,217 | 4,287,103 |
Stock issued for services | 48,549 | 47,699 |
Amortization of premiums and discounts on investment securities, net | (356,798) | (56,298) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (526,089) | (1,265,302) |
Accounts payable | (5,386,627) | 3,865,311 |
Accrued liabilities and other | 270,833 | 1,519,726 |
Deferred rent | 15,342 | |
Net cash used in operating activities | (35,629,325) | (26,983,999) |
Cash flows provided by investing activities | ||
Purchases of investments | (14,327,684) | (91,870,300) |
Maturities of investments | 59,136,544 | 155,442,867 |
Purchases of property and equipment | (67,193) | (295,092) |
Net cash provided by investing activities | 44,741,667 | 63,277,475 |
Cash flows provided by financing activities | ||
Proceeds from exercise of stock options | 31,236 | 337,796 |
Net cash provided by financing activities | 31,236 | 337,796 |
Net increase in cash and cash equivalents | 9,143,578 | 36,631,272 |
Cash and cash equivalents at beginning of period | 54,947,502 | 37,790,114 |
Cash and cash equivalents at end of period | 64,091,080 | $ 74,421,386 |
Non-cash investing and financing activities | ||
Right of use assets under operating leases | $ 219,703 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Intra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiaries, ITI, Inc. (“ITI”) and ITI Limited, is a biopharmaceutical company focused on the discovery 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 and bipolar depression. 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 In October 2017, the Company completed a public offering of common stock in which the Company sold 11,129,032 shares of common stock, which included the exercise of the underwriters’ option to purchase an additional 1,451,613 shares, at an offering price of $15.50 per share for aggregate gross proceeds of approximately $172 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $162 million. In order to further its research projects and support its collaborations, the Company will require additional financing until such time, if ever, that revenue streams are sufficient to generate consistent positive cash flow from operations. The Company currently projects that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital expenditures into the second half of 2020, at which time the Company will require additional financing. Possible sources of funds include public or private sales of the Company’s equity securities, sales of debt securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s product candidates and technology and, to a lesser extent, grant funding. On September 2, 2016, the Company filed a universal shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission (the “SEC”) on September 14, 2016, on which the Company registered for sale up to $350 million of any combination of its common stock, preferred stock, debt securities, warrants, rights, purchase contracts and/or units from time to time and at prices and on terms that the Company may determine. After the public offering in October 2017, approximately $178 In the third quarter of 2018, the Company completed the rolling submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for lumateperone, a once-daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia and in the fourth quarter of 2018 the FDA accepted the NDA for review. The NDA submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own subsidiaries have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States 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 consisted of the following (in thousands): March 31, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (unaudited) U.S. Government Agency Securities $ 109,649 $ 42 $ (110 ) $ 109,581 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 26,624 3 (8 ) 26,619 Corporate Notes/Bonds 111,281 86 (81 ) 111,286 $ 248,799 $ 131 $ (199 ) $ 248,731 December 31, 2018 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. The Company has classified all of its investment securities available-for-sale, including those with maturities beyond one year, as current assets on the consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of March 31, 2019 and December 31, 2018, the Company held $33.0 million and $64.6 million, respectively, of available-for-sale investment securities with contractual maturity dates more than one year and less than two years. 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 March 31, 2019, the aggregate related fair value of investments with unrealized losses was $170.5 $80.1 136,000 $180.4 million of investments with a continuous unrealized loss for 12 months or longer of approximately $345,000. The Company attributes the unrealized losses on the available-for-sale securities as of March 31, 2019 and December 31, 2018 to the rise in related market interest rates. The Company does not intend to sell these securities, nor is it more likely than not that the Company will be required to sell them prior to the end of their contractual terms. Furthermore, the Company does not believe that these securities expose the Company to undue market risk or counterparty credit risk. As such, the Company does not consider these securities to be other-than-temporarily impaired. Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures . ASC Topic 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value and requires expanded disclosures about fair value measurements. The ASC Topic 820 hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following categories based on the lowest level input used that is significant to a particular fair value measurement: • 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 March 31, 2019 and December 31, 2018. The carrying value of cash held in money market funds of approximately $39.3 million as of March 31, 2019 and $39.6 million as of December 31, 2018 is included in cash and cash equivalents and approximates market value based on quoted market price or The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at Reporting Date Using March 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,312 $ 39,312 $ — $ — U.S. Government Agency Securities 109,581 — 109,581 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 25,000 — 25,000 — Commercial Paper 26,619 — 26,619 — Corporate Notes/Bonds 111,286 — 111,286 — $ 312,043 $ 39,312 $ 272,731 $ — Fair Value Measurements at Reporting Date Using December 31, 2018 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,591 $ 39,591 $ — $ — U.S. Government Agency Securities 124,426 — 124,426 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 8,500 — 8,500 — Commercial Paper 41,272 — 41,272 — Corporate Notes/Bonds 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, prepaid expenses, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at March 31, 2019 and December 31, 2018. At March 31, 2019, the Company had approximately $2.4 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 March 31, 2019 and December 31, 2018, as the Company has a history of collecting on all its accounts including from government agencies and collaborations funding its research. As of March 31, 2019 and December 31, 2018, the Company did not have accounts receivable. Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment . The Company considers historical performance and anticipated future results in its evaluation of potential impairment. The Company evaluates the carrying value of those assets in relation to the operating performance of the business and undiscounted cash flows expected to result from the use of those assets. Impairment losses are recognized when carrying value exceeds the undiscounted cash flows, in which case management must determine the fair value of the underlying asset. No such impairment losses have been recognized to date. 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 service 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 various clinical information provided by vendors and discussion with applicable personnel and external service providers as to the progress toward or state of completion 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 three months ended March 31, 2019 and 2018, 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. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act” (“TCJA”) that significantly reforms the Internal Revenue Code of 1986, as amended (the “Code”). The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and net operating loss carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. In addition, the TCJA repealed the alternative minimum tax (“AMT”) and provides for a refund of taxes paid between 2018 and 2021. With the passing of the TCJA, the Company will receive a refund in future periods for AMT paid in prior years. The Company therefore recognized a benefit of approximately $1.1 million for these taxes for the year ended December 31, 2017. The Company’s effective tax rate for the three months ended March 31, 2019 and 2018 was approximately 0% for both periods, respectively. The Company’s annual effective tax rate of approximately 0% is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not at more-likely than not to recognize a future tax benefit. Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. In accordance with accounting guidance, the Company presents the impact of any unrealized gains or (losses) on its investment securities in a separate statement of comprehensive income (loss) for each period. Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation . The fair value of share-based payments is estimated, on the date of grant, using the Black-Scholes-Merton option-pricing model (the “Black-Scholes model”). The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. 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 three months ended March 31, 2019 and 2018 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 historical information about the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. The Company recognizes forfeitures when they are incurred. A restricted stock unit (“RSU”) is a stock-based 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 on the applicable vesting date. In the first quarter of each fiscal year beginning in 2016, the Company granted time based RSUs that vest in three equal annual installments. In the first quarter of 2017, the Company granted performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”), (ii) the approval of the NDA by the FDA (together, the “Milestone RSUs”) and (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSUs”). The Milestone RSUs were valued at the closing price on March 8, 2017. The Milestone RSUs related to the NDA submission have been fully amortized through December 31, 2018. The NDA submission milestone was achieved in the third quarter of 2018, so the Milestone RSUs related to the NDA submission vested on December 31, 2018. The amortization of the expenses for RSUs related to the approval of the NDA will commence if and when the NDA submission has been approved through the last day of the calendar year in which the milestone is achieved. The TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSU agreements which ends December 31, 2019. The Milestone RSUs and TSR RSUs are target based and the ultimate awards, if attained, could be the target amount or higher or lower than the target amount, depending on the timing or achievement of the goal. 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 . The deductible temporary difference is based on the compensation cost recognized for financial reporting purposes; however, these provisions currently do not impact the Company, as all the deferred tax assets have a full valuation allowance. Since the Company had net operating loss carryforwards as of March 31, 2019 and 2018, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. In June 2018, the Company’s stockholders approved the Company’s 2018 Equity Incentive Plan pursuant to which 4,750,000 additional shares of common stock were reserved for future equity grants. Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs. The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Stock Options 359,053 724,978 RSUs 455,265 314,302 TSR RSUs 79,002 59,344 Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, Revenue from Contracts with Customers (Topic 606), which has been subsequently updated (as updated, “ASC Topic 606”). The purpose of ASC Topic 606 is to provide enhancements to the quality and consistency of how revenue is reported while also improving comparability in the financial statements of companies using U.S. GAAP and International Financial Reporting Standards. The core principle requires entities to recognize revenue in a manner that depicts the transfer of goods or services to customers in amounts that reflect the consideration to which an entity expects to be entitled in exchange for those goods or services. ASC Topic 606 became effective for annual periods beginning after December 15, 2017. The Company adopted this standard using the “modified retrospective method” which did not result in an impact to its financial statements as the Company has not had product sales to date. Upon commercializing a product or executing any revenue generating contracts, the Company will provide additional disclosures in the notes to the consolidated financial statements related to the relevant aspects of any revenue generating contracts that the Company has or into which the Company expects to enter. In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. The classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the previous leases guidance. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and early adoption is permitted. The Company adopted the standard on January 1, 2019 using the simplified transition method, allowing us to not restate comparative periods and apply ASC 842 on a prospective basis, resulting in a balance sheet presentation that is not comparable to the prior period in the first year of adoption. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carry forward the historical lease classification. The Company has not elected the hindsight practical expedient. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off the balance sheet. The Company recognizes those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. The adoption of the standard resulted in recognition of additional net lease assets and lease liabilities of approximately $20.2 million and $23.4 million, In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” (ASU 2016-13) This guidance applies to all entities and impacts how entities account for credit losses for most financial assets and other instruments. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction to the carrying value of the asset. For trade receivables, loans and held-to-maturity debt securities, entities will be required to estimate lifetime expected credit losses. This guidance is effective for fiscal years beginning after December 15, 2019 and interim periods therein. Early adoption is permitted for annual periods beginning after December 15, 2018 and interim periods therein. We are currently analyzing the impact of ASU 2016-13 on the condensed consolidated financial statements. In February 2018, the FASB issued ASU 2018-02, Income Statement-Reporting Comprehensive Income (Topic 220)—Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, to address a specific consequence of the TCJA by allowing a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the TCJA’s reduction of the U.S. federal corporate income tax rate. ASU 2018-02 is effective for all entities for fiscal years beginning after December 15, 2018, with early adoption permitted, and is to be applied either in the period of adoption or retrospectively to each period in which the effect of the change in the U.S. federal corporate income tax rate in the TCJA is recognized. The Company does not have any stranded tax effects to which this ASU would apply. Therefore, there is no impact to the Company’s consolidated financial statements. In August 2018, the SEC issued a final rule Release No. 33-10532, “Disclosure Update and Simplification,” to amend certain disclosure requirements now seen as redundant, duplicative, overlapping, outdated or superseded in wake of recent accounting pronouncements. The amended rules became effective November 5, 2018. We analyzed the release in preparation of this Form 10-Q, which resulted in the additional disclosure of changes to stockholders’ equity during interim periods, as presented within this Form 10-Q within the condensed consolidated statements of stockholders’ equity. We note that many of the amended requirements under this Release are not applicable to the Company, as we do not make dividend payments to stockholders, currently report our activities under a single business segment, and already provided all other significant disclosure requirements. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following: March 31, 2019 December 31, 2018 Computer equipment $ 60,377 $ 44,427 Furniture and fixtures 366,808 341,582 Scientific equipment 3,681,613 3,658,209 Leasehold improvements 149,470 149,470 4,258,268 4,193,688 Less accumulated depreciation (3,132,662 ) (3,033,922 ) $ 1,125,606 $ 1,159,766 Depreciation expense for the three months ended March 31, 2019 and 2018 was $101,353 and $82,498, respectively. |
Right Of Use Assets and Lease L
Right Of Use Assets and Lease Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Right Of Use Assets and Lease Liabilities | 4 . Right Of Use Assets and Lease Liabilities In 2014, the Company entered into a long-term lease with a related party which, as amended, provided for a lease of 16,753 15,534 14.3 3,164 In adopting ASU 2016-02 as of January 1, 2019, the Company elected the package of practical expedients, which permit us not to reassess under the new standard the historical lease classification. The Company has not elected the hindsight practical expedient. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. We also elected the lessee component election, allowing us to account for the lease and non-lease components as a single lease component. In determining whether a contract contains a lease, asset and service agreements are assessed at onset and upon modification for criteria of specifically identified assets, control and economic benefit. The Company recognized those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. The Company uses the rate implicit in the contract whenever possible when determining the applicable discount rate. As the majority of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. On the lease commencement dates, the Company estimated the lease liabilities and the right of use assets at present value using its applicable incremental borrowing rates of its two long term leases of 7.21% Right of use assets and lease liabilities for operating leases were $20,104,280 and $23,732,111 as of March 31, 2019, respectively. Maturity analysis under the lease agreements are as follows: Nine months December 31 , 2019 $ 2,195,207 Year ended December 31 , 2020 3,346,376 Year ended December 31 , 2021 3,448,323 Year ended December 31 , 2022 3,491,166 Year ended December 31 , 2023 3,566,466 Thereafter 21,302,235 Total 37,349,773 Less: Present value discount (13,617,662 ) Total Lease liability $ 23,732,111 Less: current portion (2,873,022 Long-term lease liabilities $ 20,859,089 Lease expense for the three months ended March 31 , 2019 was approximately $830,000 . |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 5. Share-Based Compensation On June 18, 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan provides for the granting of stock-based awards, such as stock options, restricted common stock, RSUs and stock appreciation rights to employees, directors and consultants as determined by the Board of Directors. The 2018 Plan replaced the Company’s Amended and Restated 2013 Equity Incentive Plan (the “2013 Plan”). The Company will grant no further stock options or other awards under the 2013 Plan. Any options or other awards outstanding under the 2013 Plan remain outstanding in accordance with their terms and the terms of the 2013 Plan. As of December 31, 2018, the total number of shares reserved under all equity plans is 10,287,390 and the Company had 4,807,323 shares available for future issuance under the 2018 Plan. Stock options granted under the 2018 Plan may be either incentive stock options (“ISOs”) as defined by the Code, or non-qualified stock options. The Board of Directors determines who will receive options, the vesting periods (which are generally one to three years) and the exercise prices of such options. Options have a maximum term of 10 years. The exercise price of ISOs granted under the 2018 Plan must be at least equal to the fair market value of the common stock on the date of grant. Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs to employees, directors and consultants, recognized during the three months ended March 31, 2019 and 2018, was comprised of the following: Three Months Ended March 31, 2019 2018 Research and development $ 2,407,644 $ 1,917,730 General and administrative 2,647,573 2,369,373 Total share-based compensation expense $ 5,055,217 $ 4,287,103 The following table describes the weighted-average assumptions used for calculating the value of options granted during the three months ended March 31, 2019 and 2018: 2019 2018 Dividend yield 0 % 0 % Expected volatility 85.7 % 85.8 % Weighted-average risk-free interest rate 2.52 % 2.3 % Expected term (in years) 6.0 6.0 Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of March 31, 2019, and changes during the three-month period then ended, are summarized as follows: Number of Shares Weighted-Average Exercise Price Weighted-Average Contractual Life Outstanding at December 31, 2018 (audited) 4,748,391 $ 18.75 7.0 years Options granted (unaudited) 1,304,295 $ 12.74 9.8 years Options exercised (unaudited) (11,400 ) $ 2.74 1.7 years Options canceled or expired (unaudited) (29,217 ) $ 19.20 8.4 years Outstanding at March 31, 2019 (unaudited) 6,012,069 $ 17.09 7.4 years Vested or expected to vest at March 31, 2019 (unaudited) 6,012,069 $ 17.09 Exercisable at March 31, 2019 (unaudited) 3,425,158 $ 19.43 6.0 years The fair value of the time based RSUs and the Milestone RSUs is based on the closing price of the Company’s common stock on the date of grant. The fair value of the TSR RSUs was determined using the Monte Carlo simulation method. Information regarding the time based RSU activity and changes during the three-month period ended March 31, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 (audited) 647,411 $ 18.16 RSU’s granted in 2019 (unaudited) 886,802 $ 12.73 RSU’s vested in 2019 (unaudited) (223,577 ) $ 19.44 RSU’s cancelled in 2019 (unaudited) (14,002 ) $ 14.97 Outstanding at March 31, 2019 (unaudited) 1,296,634 $ 14.26 Information related to the Company’s Milestone RSUs and the TSR RSUs during the three-month period ended March 31, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 278,592 $ 15.64 RSU’s granted in 2019 — $ — RSU’s cancelled in 2019 (9,463 ) $ 15.64 Outstanding at March 31, 2019 269,129 $ 15.64 The weighted average estimated fair value per share of the TSR RSUs granted in 2017 was $17.08, which was derived from a Monte Carlo simulation. Significant assumptions utilized in estimating the value of the awards granted include an expected dividend yield of 0%, a risk free rate of 1.6%, and expected volatility of 95.4%. The TSR RSUs granted in 2017 will entitle the grantee to receive a number of shares of the Company’s common stock determined over a three-year performance period ending and vesting on December 31, 2019, provided the grantee remains in the service of the Company on the settlement date. The Company expenses the cost of these awards ratably over the requisite service period. The number of shares for which the TSR RSUs will be settled will be a percentage of shares for which the award is targeted and will depend on the Company’s total shareholder return (as defined below), expressed as a percentile ranking of the Company’s total shareholder return as compared to the Company’s peer group (as defined below). The number of shares for which the TSR RSUs will be settled vary depending on the level of achievement of the goal. Total shareholder return is determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2020 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2017, with a deemed reinvestment of any dividends declared during the performance period. The Company’s peer group includes 223 companies at December 31, 2018 which comprise the Nasdaq Biotechnology Index, which was selected by the Compensation Committee of the Company’s Board of Directors and includes a range of biotechnology companies operating in several business segments. The Company recognized non-cash stock-based compensation expense related to time based RSU’s for the three months ended March 31, 2019 and 2018 of approximately $1.9 million and $1.1 million, respectively. Total expense for all RSUs, including the time based and performance based RSUs, is $2.1 million and $1.5 million for the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, there was $ 15.7 2.5 |
Collaborations and License Agre
Collaborations and License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations and License Agreements | 6. 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 of BMS relating to lumateperone and other specified compounds. The agreement was amended on November 3, 2010. The licensed rights are exclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome and cardiovascular disease. However, BMS has no right to use, develop or commercialize lumateperone and other specified compounds in any field of use. The Company has the right to grant sublicenses of the rights conveyed by BMS. The Company is obliged under the agreement to use commercially reasonable efforts to develop and commercialize the licensed technology. The Company is also prohibited from engaging in the clinical development or commercialization of specified competitive compounds. Under the agreement, the Company made an upfront payment of $1.0 million to BMS, a milestone payment of $1.25 million in December 2013, and a milestone payment of $1.5 million in December 2014 following the initiation of the Company’s first Phase 3 clinical trial for lumateperone for patients with exacerbated schizophrenia. Upon FDA acceptance The agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of 10 years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product, its method of manufacture or use, or the expiration of other government grants providing market exclusivity, subject to certain rights of the parties to terminate the agreement on the occurrence of certain events. On termination of the agreement, the Company may be obliged to convey to BMS rights in developments relating to a licensed compound or licensed product, including regulatory filings, research results and other intellectual property rights. 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own subsidiaries have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States 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 consisted of the following (in thousands): March 31, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (unaudited) U.S. Government Agency Securities $ 109,649 $ 42 $ (110 ) $ 109,581 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 26,624 3 (8 ) 26,619 Corporate Notes/Bonds 111,281 86 (81 ) 111,286 $ 248,799 $ 131 $ (199 ) $ 248,731 December 31, 2018 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. The Company has classified all of its investment securities available-for-sale, including those with maturities beyond one year, as current assets on the consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of March 31, 2019 and December 31, 2018, the Company held $33.0 million and $64.6 million, respectively, of available-for-sale investment securities with contractual maturity dates more than one year and less than two years. 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 March 31, 2019, the aggregate related fair value of investments with unrealized losses was $170.5 $80.1 136,000 $180.4 million of investments with a continuous unrealized loss for 12 months or longer of approximately $345,000. The Company attributes the unrealized losses on the available-for-sale securities as of March 31, 2019 and December 31, 2018 to the rise in related market interest rates. The Company does not intend to sell these securities, nor is it more likely than not that the Company will be required to sell them prior to the end of their contractual terms. Furthermore, the Company does not believe that these securities expose the Company to undue market risk or counterparty credit risk. As such, the Company does not consider these securities to be other-than-temporarily impaired. |
Fair Value Measurements | Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures . ASC Topic 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value and requires expanded disclosures about fair value measurements. The ASC Topic 820 hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following categories based on the lowest level input used that is significant to a particular fair value measurement: • 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 March 31, 2019 and December 31, 2018. The carrying value of cash held in money market funds of approximately $39.3 million as of March 31, 2019 and $39.6 million as of December 31, 2018 is included in cash and cash equivalents and approximates market value based on quoted market price or The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at Reporting Date Using March 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,312 $ 39,312 $ — $ — U.S. Government Agency Securities 109,581 — 109,581 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 25,000 — 25,000 — Commercial Paper 26,619 — 26,619 — Corporate Notes/Bonds 111,286 — 111,286 — $ 312,043 $ 39,312 $ 272,731 $ — Fair Value Measurements at Reporting Date Using December 31, 2018 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,591 $ 39,591 $ — $ — U.S. Government Agency Securities 124,426 — 124,426 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 8,500 — 8,500 — Commercial Paper 41,272 — 41,272 — Corporate Notes/Bonds 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — |
Financial Instruments | Financial Instruments The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, prepaid expenses, accounts payable and accrued liabilities, to approximate their fair value because of their relatively short maturities at March 31, 2019 and December 31, 2018. At March 31, 2019, the Company had approximately $2.4 |
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 March 31, 2019 and December 31, 2018, as the Company has a history of collecting on all its accounts including from government agencies and collaborations funding its research. As of March 31, 2019 and December 31, 2018, the Company did not have accounts receivable. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred. When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic 360, Property, Plant and Equipment . The Company considers historical performance and anticipated future results in its evaluation of potential impairment. The Company evaluates the carrying value of those assets in relation to the operating performance of the business and undiscounted cash flows expected to result from the use of those assets. Impairment losses are recognized when carrying value exceeds the undiscounted cash flows, in which case management must determine the fair value of the underlying asset. No such impairment losses have been recognized to date. |
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 service 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 various clinical information provided by vendors and discussion with applicable personnel and external service providers as to the progress toward or state of completion 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 three months ended March 31, 2019 and 2018, 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. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a more-likely-than-not threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. On December 22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act” (“TCJA”) that significantly reforms the Internal Revenue Code of 1986, as amended (the “Code”). The TCJA, among other things, includes changes to U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest and net operating loss carryforwards, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system. In addition, the TCJA repealed the alternative minimum tax (“AMT”) and provides for a refund of taxes paid between 2018 and 2021. With the passing of the TCJA, the Company will receive a refund in future periods for AMT paid in prior years. The Company therefore recognized a benefit of approximately $1.1 million for these taxes for the year ended December 31, 2017. The Company’s effective tax rate for the three months ended March 31, 2019 and 2018 was approximately 0% for both periods, respectively. The Company’s annual effective tax rate of approximately 0% is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not at more-likely than not to recognize a future tax benefit. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. In accordance with accounting guidance, the Company presents the impact of any unrealized gains or (losses) on its investment securities in a separate statement of comprehensive income (loss) for each period. |
Share-Based Compensation | Share-Based Compensation Share-based payments are accounted for in accordance with the provisions of ASC Topic 718, Compensation—Stock Compensation . The fair value of share-based payments is estimated, on the date of grant, using the Black-Scholes-Merton option-pricing model (the “Black-Scholes model”). The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. 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 three months ended March 31, 2019 and 2018 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 historical information about the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant. The Company recognizes forfeitures when they are incurred. A restricted stock unit (“RSU”) is a stock-based 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 on the applicable vesting date. In the first quarter of each fiscal year beginning in 2016, the Company granted time based RSUs that vest in three equal annual installments. In the first quarter of 2017, the Company granted performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a new drug application (“NDA”) with the U.S. Food and Drug Administration (the “FDA”), (ii) the approval of the NDA by the FDA (together, the “Milestone RSUs”) and (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSUs”). The Milestone RSUs were valued at the closing price on March 8, 2017. The Milestone RSUs related to the NDA submission have been fully amortized through December 31, 2018. The NDA submission milestone was achieved in the third quarter of 2018, so the Milestone RSUs related to the NDA submission vested on December 31, 2018. The amortization of the expenses for RSUs related to the approval of the NDA will commence if and when the NDA submission has been approved through the last day of the calendar year in which the milestone is achieved. The TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSU agreements which ends December 31, 2019. The Milestone RSUs and TSR RSUs are target based and the ultimate awards, if attained, could be the target amount or higher or lower than the target amount, depending on the timing or achievement of the goal. 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 . The deductible temporary difference is based on the compensation cost recognized for financial reporting purposes; however, these provisions currently do not impact the Company, as all the deferred tax assets have a full valuation allowance. Since the Company had net operating loss carryforwards as of March 31, 2019 and 2018, no excess tax benefits for the tax deductions related to share-based awards were recognized in the statements of operations. In June 2018, the Company’s stockholders approved the Company’s 2018 Equity Incentive Plan pursuant to which 4,750,000 additional shares of common stock were reserved for future equity grants. |
Loss Per Share | Loss Per Share Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs. The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Stock Options 359,053 724,978 RSUs 455,265 314,302 TSR RSUs 79,002 59,344 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In May 2014, the FASB issued ASC Update No. 2014-09, Revenue from Contracts with Customers (Topic 606), which has been subsequently updated (as updated, “ASC Topic 606”). The purpose of ASC Topic 606 is to provide enhancements to the quality and consistency of how revenue is reported while also improving comparability in the financial statements of companies using U.S. GAAP and International Financial Reporting Standards. The core principle requires entities to recognize revenue in a manner that depicts the transfer of goods or services to customers in amounts that reflect the consideration to which an entity expects to be entitled in exchange for those goods or services. ASC Topic 606 became effective for annual periods beginning after December 15, 2017. The Company adopted this standard using the “modified retrospective method” which did not result in an impact to its financial statements as the Company has not had product sales to date. Upon commercializing a product or executing any revenue generating contracts, the Company will provide additional disclosures in the notes to the consolidated financial statements related to the relevant aspects of any revenue generating contracts that the Company has or into which the Company expects to enter. In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. The classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the previous leases guidance. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and early adoption is permitted. The Company adopted the standard on January 1, 2019 using the simplified transition method, allowing us to not restate comparative periods and apply ASC 842 on a prospective basis, resulting in a balance sheet presentation that is not comparable to the prior period in the first year of adoption. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed the Company to carry forward the historical lease classification. The Company has not elected the hindsight practical expedient. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off the balance sheet. The Company recognizes those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. The adoption of the standard resulted in recognition of additional net lease assets and lease liabilities of approximately $20.2 million and $23.4 million, In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” (ASU 2016-13) This guidance applies to all entities and impacts how entities account for credit losses for most financial assets and other instruments. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction to the carrying value of the asset. For trade receivables, loans and held-to-maturity debt securities, entities will be required to estimate lifetime expected credit losses. This guidance is effective for fiscal years beginning after December 15, 2019 and interim periods therein. Early adoption is permitted for annual periods beginning after December 15, 2018 and interim periods therein. We are currently analyzing the impact of ASU 2016-13 on the condensed consolidated financial statements. In February 2018, the FASB issued ASU 2018-02, Income Statement-Reporting Comprehensive Income (Topic 220)—Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, to address a specific consequence of the TCJA by allowing a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the TCJA’s reduction of the U.S. federal corporate income tax rate. ASU 2018-02 is effective for all entities for fiscal years beginning after December 15, 2018, with early adoption permitted, and is to be applied either in the period of adoption or retrospectively to each period in which the effect of the change in the U.S. federal corporate income tax rate in the TCJA is recognized. The Company does not have any stranded tax effects to which this ASU would apply. Therefore, there is no impact to the Company’s consolidated financial statements. In August 2018, the SEC issued a final rule Release No. 33-10532, “Disclosure Update and Simplification,” to amend certain disclosure requirements now seen as redundant, duplicative, overlapping, outdated or superseded in wake of recent accounting pronouncements. The amended rules became effective November 5, 2018. We analyzed the release in preparation of this Form 10-Q, which resulted in the additional disclosure of changes to stockholders’ equity during interim periods, as presented within this Form 10-Q within the condensed consolidated statements of stockholders’ equity. We note that many of the amended requirements under this Release are not applicable to the Company, as we do not make dividend payments to stockholders, currently report our activities under a single business segment, and already provided all other significant disclosure requirements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): March 31, 2019 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value (unaudited) U.S. Government Agency Securities $ 109,649 $ 42 $ (110 ) $ 109,581 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 26,624 3 (8 ) 26,619 Corporate Notes/Bonds 111,281 86 (81 ) 111,286 $ 248,799 $ 131 $ (199 ) $ 248,731 December 31, 2018 Amortized Cost Unrealized Gains Unrealized (Losses) Estimated Fair Value U.S. Government Agency Securities $ 124,691 $ 24 $ (289 ) $ 124,426 FDIC Certificates of Deposit (1) 245 — — 245 Certificates of Deposit 1,000 — — 1,000 Commercial Paper 41,317 — (45 ) 41,272 Corporate Notes/Bonds 125,998 7 (365 ) 125,640 $ 293,251 $ 31 $ (699 ) $ 292,583 (1) “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. |
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 investment securities are identified in the following tables (in thousands): Fair Value Measurements at Reporting Date Using March 31, 2019 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,312 $ 39,312 $ — $ — U.S. Government Agency Securities 109,581 — 109,581 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 25,000 — 25,000 — Commercial Paper 26,619 — 26,619 — Corporate Notes/Bonds 111,286 — 111,286 — $ 312,043 $ 39,312 $ 272,731 $ — Fair Value Measurements at Reporting Date Using December 31, 2018 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Money Market Funds $ 39,591 $ 39,591 $ — $ — U.S. Government Agency Securities 124,426 — 124,426 — FDIC Certificates of Deposit 245 — 245 — Certificates of Deposit 8,500 — 8,500 — Commercial Paper 41,272 — 41,272 — Corporate Notes/Bonds 125,640 — 125,640 — $ 339,674 $ 39,591 $ 300,083 $ — |
Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share | The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect would be anti-dilutive as applied to the loss from operations for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Stock Options 359,053 724,978 RSUs 455,265 314,302 TSR RSUs 79,002 59,344 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment consist of the following: March 31, 2019 December 31, 2018 Computer equipment $ 60,377 $ 44,427 Furniture and fixtures 366,808 341,582 Scientific equipment 3,681,613 3,658,209 Leasehold improvements 149,470 149,470 4,258,268 4,193,688 Less accumulated depreciation (3,132,662 ) (3,033,922 ) $ 1,125,606 $ 1,159,766 |
Right Of Use Assets and Lease_2
Right Of Use Assets and Lease Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule Of Maturity Analysis Under Lease Agreements | Maturity analysis under the lease agreements are as follows: Nine months December 31 , 2019 $ 2,195,207 Year ended December 31 , 2020 3,346,376 Year ended December 31 , 2021 3,448,323 Year ended December 31 , 2022 3,491,166 Year ended December 31 , 2023 3,566,466 Thereafter 21,302,235 Total 37,349,773 Less: Present value discount (13,617,662 ) Total Lease liability $ 23,732,111 Less: current portion (2,873,022 Long-term lease liabilities $ 20,859,089 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Total Stock-Based Compensation Expense | Total stock-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs to employees, directors and consultants, recognized during the three months ended March 31, 2019 and 2018, was comprised of the following: Three Months Ended March 31, 2019 2018 Research and development $ 2,407,644 $ 1,917,730 General and administrative 2,647,573 2,369,373 Total share-based compensation expense $ 5,055,217 $ 4,287,103 |
Assumptions Used for Calculating Value of Options Granted | The following table describes the weighted-average assumptions used for calculating the value of options granted during the three months ended March 31, 2019 and 2018: 2019 2018 Dividend yield 0 % 0 % Expected volatility 85.7 % 85.8 % Weighted-average risk-free interest rate 2.52 % 2.3 % Expected term (in years) 6.0 6.0 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of March 31, 2019, and changes during the three-month period then ended, are summarized as follows: Number of Shares Weighted-Average Exercise Price Weighted-Average Contractual Life Outstanding at December 31, 2018 (audited) 4,748,391 $ 18.75 7.0 years Options granted (unaudited) 1,304,295 $ 12.74 9.8 years Options exercised (unaudited) (11,400 ) $ 2.74 1.7 years Options canceled or expired (unaudited) (29,217 ) $ 19.20 8.4 years Outstanding at March 31, 2019 (unaudited) 6,012,069 $ 17.09 7.4 years Vested or expected to vest at March 31, 2019 (unaudited) 6,012,069 $ 17.09 Exercisable at March 31, 2019 (unaudited) 3,425,158 $ 19.43 6.0 years |
Time Based Restricted Stock Units [Member] | |
Summary of Information Regarding RSU Activity | Information regarding the time based RSU activity and changes during the three-month period ended March 31, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 (audited) 647,411 $ 18.16 RSU’s granted in 2019 (unaudited) 886,802 $ 12.73 RSU’s vested in 2019 (unaudited) (223,577 ) $ 19.44 RSU’s cancelled in 2019 (unaudited) (14,002 ) $ 14.97 Outstanding at March 31, 2019 (unaudited) 1,296,634 $ 14.26 |
Milestone and Total Shareholder Return Restricted Stock Units [Member] | |
Summary of Information Regarding RSU Activity | Information related to the Company’s Milestone RSUs and the TSR RSUs during the three-month period ended March 31, 2019 are summarized as follows: Number of Shares Weighted-Average Grant Date Fair Value Per Share Outstanding at December 31, 2018 278,592 $ 15.64 RSU’s granted in 2019 — $ — RSU’s cancelled in 2019 (9,463 ) $ 15.64 Outstanding at March 31, 2019 269,129 $ 15.64 |
Organization - Additional Infor
Organization - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | |
Oct. 31, 2017USD ($)$ / sharesshares | Mar. 31, 2019USD ($) | Sep. 14, 2016USD ($) | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Securities remained available for issuance under the Company's shelf registration | $ 178,000,000 | ||
IPO [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Initial public offering, Number of shares | shares | 11,129,032 | ||
Initial public offering, Price per share | $ / shares | $ 15.50 | ||
Initial public offering, Gross proceeds | $ 172,000,000 | ||
Initial public offering, Net proceeds | $ 162,000,000 | ||
Over-Allotment Option [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Initial public offering, Number of shares | shares | 1,451,613 | ||
Lumateperone [member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Number of clinical trials | 20 | ||
ITI Limited [Member] | Intellectual Property [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Finite lived intangible assets transactional gain | $ 125,000,000 | ||
Maximum [Member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Universal shelf registration statement, effective date value | $ 350,000,000 | ||
Minimum [Member] | Lumateperone [member] | |||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||
Number of subjects exposed medicine | 1,900 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | |||||
Mar. 31, 2019USD ($)Segment | Mar. 31, 2018USD ($) | Mar. 31, 2016 | Dec. 31, 2017USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | Jun. 30, 2018shares | |
Significant Accounting Policies [Line Items] | |||||||
Number of operating segments | Segment | 1 | ||||||
Maturity of highly liquid investments | 3 months | ||||||
Maturity of certificates of deposit, commercial paper, corporate notes and corporate bonds | more than three months | ||||||
Investment securities, available-for-sale | $ 248,731,291 | $ 292,583,046 | |||||
Aggregate related fair value of investments with unrealized losses | 170,500,000 | ||||||
Investment securities aggregate amount of unrealized loss | 200,000 | ||||||
Investment securities, held in continuous unrealized loss position for less than 12 months | 90,400,000 | 180,400,000 | |||||
Investment securities, held in continuous unrealized loss position for 12 months or longer | 80,100,000 | 345,000 | |||||
Total continuous unrealized loss for investments held for 12 months or longer | 136,000 | ||||||
Carrying value of cash held in money market funds | 39,300,000 | ||||||
Prepaid expense related to regulatory filing | 2,400,000 | ||||||
Impairment losses recognized | $ 0 | ||||||
Recognized tax benefit | $ 1,100,000 | ||||||
Effective tax rate | 0.00% | 0.00% | |||||
Annual effective tax rate | 0.00% | ||||||
US statutory rate | 21.00% | ||||||
Assumed expected dividend rate | 0.00% | 0.00% | |||||
Excess tax benefits for tax deductions | $ 0 | $ 0 | |||||
Net lease assets | 20,104,280 | ||||||
Net lease liabilities | 23,732,111 | ||||||
Cash and Cash Equivalents [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Carrying value of cash held in money market funds | 39,600,000 | ||||||
Carrying value of cash held in certificates of deposit | 24,000,000 | 7,500,000 | |||||
Significant Unobservable Inputs (Level 3) [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Assets measured using quoted prices | 0 | 0 | |||||
Liabilities measured using quoted prices | 0 | 0 | |||||
Accounting Standards Update 2016-02 [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Net lease assets | $ 20,200,000 | ||||||
Net lease liabilities | $ 23,400,000 | ||||||
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Investment securities, available-for-sale | $ 33,000,000 | $ 64,600,000 | |||||
2018 Equity Incentive Plan [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Additional shares of common stock reserved for future equity grants | shares | 4,750,000 | ||||||
RSUs [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Service period for granted RSUs, vest in annual installment | 3 years | ||||||
Minimum [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Property and equipment, estimated useful life | 3 years | ||||||
Maximum [Member] | |||||||
Significant Accounting Policies [Line Items] | |||||||
Property and equipment, estimated useful life | 5 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 | |
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 248,799,000 | $ 293,251,000 | |
Unrealized Gains | 131,000 | 31,000 | |
Unrealized (Losses) | (199,000) | (699,000) | |
Estimated Fair Value | 248,731,291 | 292,583,046 | |
U.S. Government Agency Securities [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 109,649,000 | 124,691,000 | |
Unrealized Gains | 42,000 | 24,000 | |
Unrealized (Losses) | (110,000) | (289,000) | |
Estimated Fair Value | 109,581,000 | 124,426,000 | |
FDIC Certificates of Deposit [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | [1] | 245,000 | 245,000 |
Estimated Fair Value | [1] | 245,000 | 245,000 |
Certificates of Deposit [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 1,000,000 | 1,000,000 | |
Estimated Fair Value | 1,000,000 | 1,000,000 | |
Commercial Paper [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 26,624,000 | 41,317,000 | |
Unrealized Gains | 3,000 | ||
Unrealized (Losses) | (8,000) | (45,000) | |
Estimated Fair Value | 26,619,000 | 41,272,000 | |
Corporate Notes/Bonds [Member] | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 111,281,000 | 125,998,000 | |
Unrealized Gains | 86,000 | 7,000 | |
Unrealized (Losses) | (81,000) | (365,000) | |
Estimated Fair Value | $ 111,286,000 | $ 125,640,000 | |
[1] | “FDIC Certificates of Deposit” consist of deposits that are less than $250,000. |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Investment Securities (Parenthetical) (Detail) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
FDIC Certificates of Deposit [Member] | Maximum [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Deposits under FDIC Certificates of Deposit | $ 250,000 | $ 250,000 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 312,043 | $ 339,674 |
Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 39,312 | 39,591 |
U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 109,581 | 124,426 |
FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 245 | 245 |
Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 25,000 | 8,500 |
Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 26,619 | 41,272 |
Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 111,286 | 125,640 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 39,312 | 39,591 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 39,312 | 39,591 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 272,731 | 300,083 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 109,581 | 124,426 |
Significant Other Observable Inputs (Level 2) [Member] | FDIC Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 245 | 245 |
Significant Other Observable Inputs (Level 2) [Member] | Certificates of Deposit [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 25,000 | 8,500 |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | 26,619 | 41,272 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes/Bonds [Member] | ||
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 111,286 | $ 125,640 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Number of anti-dilutive securities excluded from computation of earnings per share | 359,053 | 724,978 |
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 | 455,265 | 314,302 |
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 | 79,002 | 59,344 |
Property and Equipment - Proper
Property and Equipment - Property and Equipment (Detail) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 4,258,268 | $ 4,193,688 |
Less accumulated depreciation | (3,132,662) | (3,033,922) |
Property Plant and Equipment Net | 1,125,606 | 1,159,766 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 60,377 | 44,427 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 366,808 | 341,582 |
Scientific Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | 3,681,613 | 3,658,209 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment, gross | $ 149,470 | $ 149,470 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 101,353 | $ 82,498 |
Right Of Use Assets and Lease_3
Right Of Use Assets and Lease Liabilities - Additional Information (Detail) | 3 Months Ended | ||||
Mar. 31, 2019USD ($) | Feb. 28, 2019ft² | Jan. 01, 2019USD ($) | Sep. 30, 2018ft² | Jan. 01, 2014ft² | |
Right of use assets, net | $ 20,104,280 | ||||
Net lease liabilities | 23,732,111 | ||||
Operating lease expense | $ 830,000 | ||||
Accounting Standards Update 2016-02 [Member] | |||||
Right of use assets, net | $ 20,200,000 | ||||
Net lease liabilities | 23,400,000 | ||||
Eliminated deferred rent | $ 3,200,000 | ||||
NEW YORK | |||||
Area of usable laboratory and office space | ft² | 15,534 | 16,753 | |||
Term of long term lease | 14 years 3 months 18 days | ||||
NEW YORK | Accounting Standards Update 2016-02 [Member] | |||||
Operating lease discount rate | 7.21% | ||||
Operating Lease, Weighted Average Remaining Lease Term | 3 years 2 months 12 days | ||||
MARYLAND | |||||
Area of usable laboratory and office space | ft² | 3,164 | ||||
Term of long term lease | 3 years 2 months 12 days | ||||
MARYLAND | Accounting Standards Update 2016-02 [Member] | |||||
Operating lease discount rate | 9.10% | ||||
Operating Lease, Weighted Average Remaining Lease Term | 14 years 3 months 18 days |
Right Of Use Assets and Lease_4
Right Of Use Assets and Lease Liabilities - Maturity analysis under the lease agreements (Detail) | Mar. 31, 2019USD ($) |
Operating Lease Liabilities, Payments Due [Abstract] | |
Nine months December 31, 2019 | $ 2,195,207 |
Year ended December 31, 2020 | 3,346,376 |
Year ended December 31, 2021 | 3,448,323 |
Year ended December 31, 2022 | 3,491,166 |
Year ended December 31, 2023 | 3,566,466 |
Thereafter | 21,302,235 |
Total | 37,349,773 |
Less: Present value discount | (13,617,662) |
Total Lease liability | 23,732,111 |
Less: current portion | (2,873,022) |
Long-term lease liabilities | $ 20,859,089 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 10,287,390 | |||
Expected dividend yield | 0.00% | 0.00% | ||
Risk free interest rate | 2.52% | 2.30% | ||
Expected volatility | 85.70% | 85.80% | ||
2018 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock reserved for issuance | 4,807,323 | |||
Total Shareholder Return Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 3 years | |||
Weighted average grant date fair value of stock options granted | $ 17.08 | |||
Unrecognized compensation costs related to unvested RSUs | $ 2.5 | |||
Expected dividend yield | 0.00% | |||
Risk free interest rate | 1.60% | |||
Expected volatility | 95.40% | |||
Vesting date | Dec. 31, 2019 | |||
Terms of award | Total shareholder return is determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2020 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2017, with a deemed reinvestment of any dividends declared during the performance period. | |||
Time Based Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested RSUs | $ 15.7 | |||
Non-cash stock-based compensation expense recognized | 1.9 | $ 1.1 | ||
RSUs [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Non-cash stock-based compensation expense recognized | $ 2.1 | $ 1.5 | ||
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, maximum term | 10 years | |||
Stock Options [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 1 year | |||
Stock Options [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options, vesting term | 3 years |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total share-based compensation expense | $ 5,055,217 | $ 4,287,103 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total share-based compensation expense | 2,407,644 | 1,917,730 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Total share-based compensation expense | $ 2,647,573 | $ 2,369,373 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility | 85.70% | 85.80% |
Weighted-average risk-free interest rate | 2.52% | 2.30% |
Expected term (in years) | 6 years | 6 years |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding at beginning of period, Number of Shares | 4,748,391 | |
Options granted, Number of Shares | 1,304,295 | |
Options exercised, Number of Shares | (11,400) | |
Options canceled or expired, Number of Shares | (29,217) | |
Outstanding at end of period, Number of Shares | 6,012,069 | 4,748,391 |
Vested or expected to vest at end of period, Number of Shares | 6,012,069 | |
Exercisable at end of period, Number of Shares | 3,425,158 | |
Outstanding at beginning of period, Weighted-Average Exercise Price | $ 18.75 | |
Options granted, Weighted-Average Exercise Price | 12.74 | |
Options exercised, Weighted-Average Exercise Price | 2.74 | |
Options canceled or expired, Weighted-Average Exercise Price | 19.20 | |
Outstanding at end of period, Weighted-Average Exercise Price | 17.09 | $ 18.75 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price | 17.09 | |
Exercisable at end of period, Weighted-Average Exercise Price | $ 19.43 | |
Options granted, Weighted-Average Contractual Life | 9 years 9 months 18 days | |
Options exercised, Weighted-Average Contractual Life | 1 year 8 months 12 days | |
Options canceled or expired, Weighted-Average Contractual Life | 8 years 4 months 24 days | |
Outstanding at end of period, Weighted-Average Contractual Life | 7 years 4 months 24 days | 7 years |
Exercisable at end of period, Weighted-Average Contractual Life | 6 years |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 647,411 |
RSU's granted, Number of Shares | shares | 886,802 |
RSU's vested, Number of Shares | shares | (223,577) |
RSU's cancelled, Number of Shares | shares | (14,002) |
Outstanding at end of period, Number of Shares | shares | 1,296,634 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 18.16 |
RSU's granted, Weighted-Average Grant Date Fair Value | $ / shares | 12.73 |
RSU's vested, Weighted-Average Grant Date Fair Value | $ / shares | 19.44 |
RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 14.97 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 14.26 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Information Regarding Milestone RSU grants and TSR RSU grants (Detail) - Milestone and Total Shareholder Return Restricted Stock Units [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period, Number of Shares | shares | 278,592 |
RSU's granted, Number of Shares | shares | |
RSU's cancelled, Number of Shares | shares | (9,463) |
Outstanding at end of period, Number of Shares | shares | 269,129 |
Outstanding at beginning of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 15.64 |
RSU's granted, Weighted-Average Grant Date Fair Value Per Share | $ / shares | |
RSU's cancelled, Weighted-Average Grant Date Fair Value | $ / shares | 15.64 |
Outstanding at end of period, Weighted-Average Grant Date Fair Value | $ / shares | $ 15.64 |
Collaborations and License Ag_2
Collaborations and License Agreements - Additional Information (Detail) - Collaborative Arrangement, Product [Member] - Bristol-Myers Squibb Company [Member] - USD ($) | May 31, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2019 |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Company made an upfront payment | $ 1,000,000 | |||
Company made milestone payment | $ 1,500,000 | $ 1,250,000 | ||
Obliged to make milestone payments | $ 14,750,000 | |||
Company remaining milestone payment | $ 10,000,000 | |||
License expiration period | through the later of 10 years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product | |||
Minimum [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Royalty payment, percentage | 5.00% | |||
Maximum [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Royalty payment, percentage | 9.00% | |||
Food and Drug Administration [Member] | ||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ||||
Obliged to make milestone payments | $ 2,000,000 |